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Etiologic Dx of Disorders of Sexual Development Elusive
CHICAGO – Etiology remains elusive in many patients with disorders of sexual development, according to data from one of the largest cohorts reported to date.
The analysis found that most patients with an XX disorder of sexual development (DSD) have an etiologic diagnosis, but that more than two-thirds of those with an XY disorder have only an anatomical diagnosis.
"We as clinicians should be aiming for an etiological diagnosis rather than an anatomical diagnosis in such patients to provide better care," Dr. Karamdeep Bhullar said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Recent consensus guidelines stress the importance of early diagnosis and coined the term DSD to describe any congenital condition in which the development of chromosomal, gonadal, or anatomical sex is atypical (Arch. Dis. Child. 2006;91:554-63). Although most cases of DSD are identified in infancy, individuals with normal male or female genitalia and discordant internal anatomy are often not identified until adulthood. A girl might present with primary amenorrhea in the case of vaginal agenesis or present with inguinal hernia that is actually testes in cases of complete androgen insensitivity syndrome, said Dr. Bhullar of the department of pediatrics at the University of Melbourne.
She presented an analysis of 199 patients, born between 1999 and 2008 and managed at the Royal Children’s Hospital in Melbourne, one of the world leaders in DSD research. In all, 107 (54%) presented with XY DSD, 64 (32%) with XX DSD, and 28 (14%) as sex chromosome aneuploidy DSD. A definitive diagnosis was made in only 57% of the cohort, Dr. Bhullar said.
An etiologic diagnosis was made in 87.5% of patients with XX DSD, but only 29% of those with XY DSD.
Of the XY children, 92% were raised as males and 8% as females, while only one (2%) XX DSD child was raised as a male. Of the chromosome aneuploidy DSD children, 68%were assigned female sex and 32%, male sex.
The consensus guidelines stress that all children with DSD should receive a sex assignment, and that evaluation and long-term management should be carried out at a center with an experienced multidisciplinary team. Senior author Dr. Garry Warne, director of Royal Children’s Hospital International, Melbourne, said that early assignment of sex is thought to be the best way to prevent psychosocial harm to the child. In addition, there is a significant risk of gonadal malignancy in 46, XY DSD and sex chromosome aneuploidy DSD when there is a Y chromosome. In two conditions – partial androgen insensitivity syndrome and Y chromosome–positive gonadal dysgenesis – the risk of cancer is around 50% if the gonad is intraabdominal.
"If the decision is made to retain a gonad in such circumstances, it is essential that a risk-management strategy be prepared and clearly communicated to the patient," Dr. Warne said in an interview. "This is done to prevent physical harm to the patient."
In the current analysis, the spectrum of diagnoses among children raised as males included cloacal and bladder exstrophy (17%), partial/mixed gonadal dysgenesis (6%), Klinefelter syndrome and its variants (4%), ovotesticular DSD (2%), testicular regression syndrome (2%), and partial androgen insensitivity syndrome (1%). An anatomical diagnosis without a definitive etiology was made in 68% of these patients, Dr. Bhullar said.
The most common diagnosis among children raised as females was congenital adrenal hyperplasia (CAH) (47%), followed by Turner syndrome and its variants (18%), cloacal and bladder exstrophy (12%), and ovotesticular DSD (6%). Other less common diagnoses included complete androgen insensitivity (CAIS) (4%), complete gonadal dysgenesis (1%), and partial/mixed gonadal dysgenesis (1%). About 11% of those raised as females had an anatomical diagnosis without any etiology established, she said.
Except for certain conditions such as CAH and CAIS, a female sex rearing is strongly preferred based on long-term outcomes, Dr. Warne said. For most other conditions, there are either insufficient long-term outcomes data or the diagnosis is so uncertain that it is impossible to be sure how things will turn out.
During a discussion of the analysis, an audience member said the data provide a good starting point for research aimed at better classifying these disorders, but pointed out that contention still exists regarding the consensus guidelines and the inclusion of isolated hypospadias with palpable gonads and the placement of coital entropies in the labial adhesion category.
Dr. Warne said it is important for guidelines to be evidence based as far as possible, and acknowledged that mistakes have been made in the past, resulting in postoperative gender dysphoria that is extremely difficult to treat and leaves many patients, understandably, feeling deeply aggrieved.
"There are movements dedicated to opposing what is perceived to be current medical practice," he said. "Having said that, the medical profession accepts that practices need to change, and is trying very hard to develop protocols that better protect the best interests of patients."
The researchers published a set of ethical principles for the management of infants with DSD (Horm. Res. Paediatr. 2010;74:412-8) that were endorsed by the Fifth World Congress on Family Law and Children’s Rights, and are looking to test the principles in Australia and other cultural settings. They also are studying new methods of molecular diagnosis using next-generation DNA sequencing and gene chip technology that may provide swift and accurate diagnoses, he said.
The authors said they had no relevant financial disclosures.
CHICAGO – Etiology remains elusive in many patients with disorders of sexual development, according to data from one of the largest cohorts reported to date.
The analysis found that most patients with an XX disorder of sexual development (DSD) have an etiologic diagnosis, but that more than two-thirds of those with an XY disorder have only an anatomical diagnosis.
"We as clinicians should be aiming for an etiological diagnosis rather than an anatomical diagnosis in such patients to provide better care," Dr. Karamdeep Bhullar said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Recent consensus guidelines stress the importance of early diagnosis and coined the term DSD to describe any congenital condition in which the development of chromosomal, gonadal, or anatomical sex is atypical (Arch. Dis. Child. 2006;91:554-63). Although most cases of DSD are identified in infancy, individuals with normal male or female genitalia and discordant internal anatomy are often not identified until adulthood. A girl might present with primary amenorrhea in the case of vaginal agenesis or present with inguinal hernia that is actually testes in cases of complete androgen insensitivity syndrome, said Dr. Bhullar of the department of pediatrics at the University of Melbourne.
She presented an analysis of 199 patients, born between 1999 and 2008 and managed at the Royal Children’s Hospital in Melbourne, one of the world leaders in DSD research. In all, 107 (54%) presented with XY DSD, 64 (32%) with XX DSD, and 28 (14%) as sex chromosome aneuploidy DSD. A definitive diagnosis was made in only 57% of the cohort, Dr. Bhullar said.
An etiologic diagnosis was made in 87.5% of patients with XX DSD, but only 29% of those with XY DSD.
Of the XY children, 92% were raised as males and 8% as females, while only one (2%) XX DSD child was raised as a male. Of the chromosome aneuploidy DSD children, 68%were assigned female sex and 32%, male sex.
The consensus guidelines stress that all children with DSD should receive a sex assignment, and that evaluation and long-term management should be carried out at a center with an experienced multidisciplinary team. Senior author Dr. Garry Warne, director of Royal Children’s Hospital International, Melbourne, said that early assignment of sex is thought to be the best way to prevent psychosocial harm to the child. In addition, there is a significant risk of gonadal malignancy in 46, XY DSD and sex chromosome aneuploidy DSD when there is a Y chromosome. In two conditions – partial androgen insensitivity syndrome and Y chromosome–positive gonadal dysgenesis – the risk of cancer is around 50% if the gonad is intraabdominal.
"If the decision is made to retain a gonad in such circumstances, it is essential that a risk-management strategy be prepared and clearly communicated to the patient," Dr. Warne said in an interview. "This is done to prevent physical harm to the patient."
In the current analysis, the spectrum of diagnoses among children raised as males included cloacal and bladder exstrophy (17%), partial/mixed gonadal dysgenesis (6%), Klinefelter syndrome and its variants (4%), ovotesticular DSD (2%), testicular regression syndrome (2%), and partial androgen insensitivity syndrome (1%). An anatomical diagnosis without a definitive etiology was made in 68% of these patients, Dr. Bhullar said.
The most common diagnosis among children raised as females was congenital adrenal hyperplasia (CAH) (47%), followed by Turner syndrome and its variants (18%), cloacal and bladder exstrophy (12%), and ovotesticular DSD (6%). Other less common diagnoses included complete androgen insensitivity (CAIS) (4%), complete gonadal dysgenesis (1%), and partial/mixed gonadal dysgenesis (1%). About 11% of those raised as females had an anatomical diagnosis without any etiology established, she said.
Except for certain conditions such as CAH and CAIS, a female sex rearing is strongly preferred based on long-term outcomes, Dr. Warne said. For most other conditions, there are either insufficient long-term outcomes data or the diagnosis is so uncertain that it is impossible to be sure how things will turn out.
During a discussion of the analysis, an audience member said the data provide a good starting point for research aimed at better classifying these disorders, but pointed out that contention still exists regarding the consensus guidelines and the inclusion of isolated hypospadias with palpable gonads and the placement of coital entropies in the labial adhesion category.
Dr. Warne said it is important for guidelines to be evidence based as far as possible, and acknowledged that mistakes have been made in the past, resulting in postoperative gender dysphoria that is extremely difficult to treat and leaves many patients, understandably, feeling deeply aggrieved.
"There are movements dedicated to opposing what is perceived to be current medical practice," he said. "Having said that, the medical profession accepts that practices need to change, and is trying very hard to develop protocols that better protect the best interests of patients."
The researchers published a set of ethical principles for the management of infants with DSD (Horm. Res. Paediatr. 2010;74:412-8) that were endorsed by the Fifth World Congress on Family Law and Children’s Rights, and are looking to test the principles in Australia and other cultural settings. They also are studying new methods of molecular diagnosis using next-generation DNA sequencing and gene chip technology that may provide swift and accurate diagnoses, he said.
The authors said they had no relevant financial disclosures.
CHICAGO – Etiology remains elusive in many patients with disorders of sexual development, according to data from one of the largest cohorts reported to date.
The analysis found that most patients with an XX disorder of sexual development (DSD) have an etiologic diagnosis, but that more than two-thirds of those with an XY disorder have only an anatomical diagnosis.
"We as clinicians should be aiming for an etiological diagnosis rather than an anatomical diagnosis in such patients to provide better care," Dr. Karamdeep Bhullar said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Recent consensus guidelines stress the importance of early diagnosis and coined the term DSD to describe any congenital condition in which the development of chromosomal, gonadal, or anatomical sex is atypical (Arch. Dis. Child. 2006;91:554-63). Although most cases of DSD are identified in infancy, individuals with normal male or female genitalia and discordant internal anatomy are often not identified until adulthood. A girl might present with primary amenorrhea in the case of vaginal agenesis or present with inguinal hernia that is actually testes in cases of complete androgen insensitivity syndrome, said Dr. Bhullar of the department of pediatrics at the University of Melbourne.
She presented an analysis of 199 patients, born between 1999 and 2008 and managed at the Royal Children’s Hospital in Melbourne, one of the world leaders in DSD research. In all, 107 (54%) presented with XY DSD, 64 (32%) with XX DSD, and 28 (14%) as sex chromosome aneuploidy DSD. A definitive diagnosis was made in only 57% of the cohort, Dr. Bhullar said.
An etiologic diagnosis was made in 87.5% of patients with XX DSD, but only 29% of those with XY DSD.
Of the XY children, 92% were raised as males and 8% as females, while only one (2%) XX DSD child was raised as a male. Of the chromosome aneuploidy DSD children, 68%were assigned female sex and 32%, male sex.
The consensus guidelines stress that all children with DSD should receive a sex assignment, and that evaluation and long-term management should be carried out at a center with an experienced multidisciplinary team. Senior author Dr. Garry Warne, director of Royal Children’s Hospital International, Melbourne, said that early assignment of sex is thought to be the best way to prevent psychosocial harm to the child. In addition, there is a significant risk of gonadal malignancy in 46, XY DSD and sex chromosome aneuploidy DSD when there is a Y chromosome. In two conditions – partial androgen insensitivity syndrome and Y chromosome–positive gonadal dysgenesis – the risk of cancer is around 50% if the gonad is intraabdominal.
"If the decision is made to retain a gonad in such circumstances, it is essential that a risk-management strategy be prepared and clearly communicated to the patient," Dr. Warne said in an interview. "This is done to prevent physical harm to the patient."
In the current analysis, the spectrum of diagnoses among children raised as males included cloacal and bladder exstrophy (17%), partial/mixed gonadal dysgenesis (6%), Klinefelter syndrome and its variants (4%), ovotesticular DSD (2%), testicular regression syndrome (2%), and partial androgen insensitivity syndrome (1%). An anatomical diagnosis without a definitive etiology was made in 68% of these patients, Dr. Bhullar said.
The most common diagnosis among children raised as females was congenital adrenal hyperplasia (CAH) (47%), followed by Turner syndrome and its variants (18%), cloacal and bladder exstrophy (12%), and ovotesticular DSD (6%). Other less common diagnoses included complete androgen insensitivity (CAIS) (4%), complete gonadal dysgenesis (1%), and partial/mixed gonadal dysgenesis (1%). About 11% of those raised as females had an anatomical diagnosis without any etiology established, she said.
Except for certain conditions such as CAH and CAIS, a female sex rearing is strongly preferred based on long-term outcomes, Dr. Warne said. For most other conditions, there are either insufficient long-term outcomes data or the diagnosis is so uncertain that it is impossible to be sure how things will turn out.
During a discussion of the analysis, an audience member said the data provide a good starting point for research aimed at better classifying these disorders, but pointed out that contention still exists regarding the consensus guidelines and the inclusion of isolated hypospadias with palpable gonads and the placement of coital entropies in the labial adhesion category.
Dr. Warne said it is important for guidelines to be evidence based as far as possible, and acknowledged that mistakes have been made in the past, resulting in postoperative gender dysphoria that is extremely difficult to treat and leaves many patients, understandably, feeling deeply aggrieved.
"There are movements dedicated to opposing what is perceived to be current medical practice," he said. "Having said that, the medical profession accepts that practices need to change, and is trying very hard to develop protocols that better protect the best interests of patients."
The researchers published a set of ethical principles for the management of infants with DSD (Horm. Res. Paediatr. 2010;74:412-8) that were endorsed by the Fifth World Congress on Family Law and Children’s Rights, and are looking to test the principles in Australia and other cultural settings. They also are studying new methods of molecular diagnosis using next-generation DNA sequencing and gene chip technology that may provide swift and accurate diagnoses, he said.
The authors said they had no relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE NORTH AMERICAN SOCIETY FOR PEDIATRIC AND ADOLESCENT GYNECOLOGY
Major Finding: An etiologic diagnosis was made in 87.5% of patients with an XX disorder, but only 29% of those with an XY disorder.
Data Source: Ten-year retrospective analysis of 199 patients with disorders of sexual development.
Disclosures: The authors said they had no relevant financial disclosures.
Water Colonoscopies Find More Adenomas
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Water Colonoscopies Find More Adenomas
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Major Finding: The overall adenoma detection rate increased from 46% with air insufflation to 57% with the water method (P = .04).
Data Source: Prospective randomized study in 368 patients.
Disclosures: Dr. Felix Leung, Dr. Francisco C. Ramirez, and Dr. Arnoldo Amato reported no conflict of interest. Dr. Walter Coyle reported a financial relationship with Takeda Pharmaceutical.
Water Colonoscopies Find More Adenomas
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.
After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.
A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).
The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.
Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.
In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).
The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.
Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).
The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.
Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).
The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).
Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.
Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.
Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.
"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.
Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.
The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).
Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).
Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.
Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.
As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.
Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.
Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.
Dr. Coyle said this has not been a problem, citing a detection rate of 60%.
Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Major Finding: The overall adenoma detection rate increased from 46% with air insufflation to 57% with the water method (P = .04).
Data Source: Prospective randomized study in 368 patients.
Disclosures: Dr. Felix Leung, Dr. Francisco C. Ramirez, and Dr. Arnoldo Amato reported no conflict of interest. Dr. Walter Coyle reported a financial relationship with Takeda Pharmaceutical.
Radial Artery Tops Saphenous Vein Graft in CABG
NEW ORLEANS – Long-term data from the Radial Artery Patency Study show that radial arteries, compared with saphenous veins, are associated with reduced rates of functional and complete graft occlusion in patients undergoing coronary artery bypass surgery.
In addition, radial arteries are associated with lower rates of graft disease, lead author Dr. Stephen E. Fremes said during a late-breaking trial session at the annual meeting of the American College of Cardiology.
The issue of which conduit provides the best long-term graft outcomes has been a subject of lengthy debate. Several trials have indicated that radial-artery grafts are no better than saphenous-vein grafts, including a recently published Veterans Affairs (VA) study showing similar 1-year graft patency among 757 patients undergoing first-time, elective coronary artery bypass grafting (JAMA 2011;305:167-74).
One-year data previously published from the Radial Artery Patency Study (RAPS) showed that complete graft occlusion was significantly reduced in radial-artery grafts compared with saphenous-vein grafts (8.2% vs. 13.6%), but that partial graft occlusion was similar (12.3% vs. 14.3%) between the two conduits (N. Engl. J. Med. 2004;351:2302-09).
When Dr. Fremes was asked how to reconcile the results of RAPS with those from the recent VA study, he replied that the VA study was conducted almost exclusively in men (99%), vein grafts performed better than predicted, and there were very high rates of evidence-based medicine. Adherence to evidence-based medicine was good in RAPS, but the trial accrued much earlier, from November 1996 to January 2001. The mean age of the 269 patients in the current analysis was 60 years, and 15% were women.
RAPS enrolled 561 patients with isolated triple-vessel disease and a left ventricular fraction of more than 35% from 12 Canadian centers and one in New Zealand. Randomization was unique in that it was performed within patients and not between patients, explained Dr. Fremes, head of the cardiovascular surgery division at Sunnybrook Health Sciences Centre and research director at the Schulich Heart Centre at Sunnybrook, Toronto. Patients were randomized to receive either a radial artery to the right coronary territory and a saphenous vein to the circumflex territory or a saphenous vein to the right coronary territory and a radial artery to the circumflex territory.
Late angiography was performed on 440 patients at 1 year and on 269 patients at a mean of 7.6 years after surgery. Grafts were considered occluded if they had a TIMI (Thrombolysis in Myocardial Infarction) score of 0-2, and were considered patent with a TIMI score of 3.
At 5 years, the primary end point of functional graft occlusion was significantly decreased in radial-artery grafts at 12%, compared with saphenous-vein grafts at 18.8% (odds ratio, 0.64), Dr. Fremes said. Significantly fewer radial-artery grafts also became completely occluded at 9%, compared with saphenous-vein grafts at 18% (OR 0.50).
Among 164 patients who had completely patent grafts at follow-up, graft stenosis was similar for both conduits for proximal and distal anastomotic lesions. There were fewer graft-body lesions at 6.7% in radial arteries, vs. saphenous veins at 15.2% (OR 0.42). Consequently, radial-artery grafts were significantly less likely to be either stenotic or completely occluded at 22%, compared with saphenous-vein grafts at 34% (OR 0.58), he said.
Target vessel stenosis, an important risk factor for graft occlusion at 1 year, was evaluated in a subgroup analysis. Target vessels with stenosis were classified a priori as those with 70%-89% narrowing and those with at least 90% narrowing. Although graft occlusion was reduced almost 50% for either graft in target vessels with at least 90% narrowing, radial-artery grafts had much lower functional (8.8%) and complete (6.3%) occlusion rates, as did saphenous-vein grafts (14.6% and 14.5%, respectively), in the more severely narrowed vessels.
The incidence of cardiac death beyond 1 year was 5%, of nonfatal myocardial infarction was 1.5%, and of major adverse cardiac events was 15%. Dr. Fremes pointed out that the clinical event findings were descriptive rather than explanatory since each patient received both graft types.
Overall survival in the entire cohort was 96% at 5 years, 91% at 7.5 years, and 78% at 10 years. Event-free survival was 95%, 90%, and 78%, respectively.
During the panel discussion of the study, Dr. James McClurken, professor and vice-chair of surgery at Temple University in Philadelphia, said, "This [study] lends credence to utilizing the radial artery, with obvious caveats that it is important to place it in highly obstructed vessels so there is not competitive flow and to maintain patency for the longest period of time.
"This is not quite as good as internal-mammary artery patency data, but certainly better than vein-graft data."
Fellow discussant Dr. Steven Bolling, a thoracic surgeon at the University of Michigan Medical Center in Ann Arbor, said he expects the data will shift practice and increase utilization of the radial-artery graft.
When asked about this point during a press conference at the meeting, Dr. Fremes said that radial-artery utilization varies by jurisdiction at about 20%, compared with more than 95% for the internal-mammary artery. He noted that the evidence to date on radial-artery grafts has been mixed and comes mainly from observational studies.
"The study we presented is the first multi-institutional, longitudinal, randomized comparison, so this is fairly unique data," he said. "Hopefully, it will be persuasive."
Press briefing moderator Dr. Spencer King III, with St. Joseph’s Heart and Vascular Institute in Atlanta, said RAPS challenges the prevailing attitude that the radial artery is not that much better than vein grafts. RAPS "says maybe it is going to last longer. So I think this is an interesting thing for surgeons to chew on," he noted.
The Canadian Institutes of Health Research funded the study. Dr. Fremes reported no conflicts.
NEW ORLEANS – Long-term data from the Radial Artery Patency Study show that radial arteries, compared with saphenous veins, are associated with reduced rates of functional and complete graft occlusion in patients undergoing coronary artery bypass surgery.
In addition, radial arteries are associated with lower rates of graft disease, lead author Dr. Stephen E. Fremes said during a late-breaking trial session at the annual meeting of the American College of Cardiology.
The issue of which conduit provides the best long-term graft outcomes has been a subject of lengthy debate. Several trials have indicated that radial-artery grafts are no better than saphenous-vein grafts, including a recently published Veterans Affairs (VA) study showing similar 1-year graft patency among 757 patients undergoing first-time, elective coronary artery bypass grafting (JAMA 2011;305:167-74).
One-year data previously published from the Radial Artery Patency Study (RAPS) showed that complete graft occlusion was significantly reduced in radial-artery grafts compared with saphenous-vein grafts (8.2% vs. 13.6%), but that partial graft occlusion was similar (12.3% vs. 14.3%) between the two conduits (N. Engl. J. Med. 2004;351:2302-09).
When Dr. Fremes was asked how to reconcile the results of RAPS with those from the recent VA study, he replied that the VA study was conducted almost exclusively in men (99%), vein grafts performed better than predicted, and there were very high rates of evidence-based medicine. Adherence to evidence-based medicine was good in RAPS, but the trial accrued much earlier, from November 1996 to January 2001. The mean age of the 269 patients in the current analysis was 60 years, and 15% were women.
RAPS enrolled 561 patients with isolated triple-vessel disease and a left ventricular fraction of more than 35% from 12 Canadian centers and one in New Zealand. Randomization was unique in that it was performed within patients and not between patients, explained Dr. Fremes, head of the cardiovascular surgery division at Sunnybrook Health Sciences Centre and research director at the Schulich Heart Centre at Sunnybrook, Toronto. Patients were randomized to receive either a radial artery to the right coronary territory and a saphenous vein to the circumflex territory or a saphenous vein to the right coronary territory and a radial artery to the circumflex territory.
Late angiography was performed on 440 patients at 1 year and on 269 patients at a mean of 7.6 years after surgery. Grafts were considered occluded if they had a TIMI (Thrombolysis in Myocardial Infarction) score of 0-2, and were considered patent with a TIMI score of 3.
At 5 years, the primary end point of functional graft occlusion was significantly decreased in radial-artery grafts at 12%, compared with saphenous-vein grafts at 18.8% (odds ratio, 0.64), Dr. Fremes said. Significantly fewer radial-artery grafts also became completely occluded at 9%, compared with saphenous-vein grafts at 18% (OR 0.50).
Among 164 patients who had completely patent grafts at follow-up, graft stenosis was similar for both conduits for proximal and distal anastomotic lesions. There were fewer graft-body lesions at 6.7% in radial arteries, vs. saphenous veins at 15.2% (OR 0.42). Consequently, radial-artery grafts were significantly less likely to be either stenotic or completely occluded at 22%, compared with saphenous-vein grafts at 34% (OR 0.58), he said.
Target vessel stenosis, an important risk factor for graft occlusion at 1 year, was evaluated in a subgroup analysis. Target vessels with stenosis were classified a priori as those with 70%-89% narrowing and those with at least 90% narrowing. Although graft occlusion was reduced almost 50% for either graft in target vessels with at least 90% narrowing, radial-artery grafts had much lower functional (8.8%) and complete (6.3%) occlusion rates, as did saphenous-vein grafts (14.6% and 14.5%, respectively), in the more severely narrowed vessels.
The incidence of cardiac death beyond 1 year was 5%, of nonfatal myocardial infarction was 1.5%, and of major adverse cardiac events was 15%. Dr. Fremes pointed out that the clinical event findings were descriptive rather than explanatory since each patient received both graft types.
Overall survival in the entire cohort was 96% at 5 years, 91% at 7.5 years, and 78% at 10 years. Event-free survival was 95%, 90%, and 78%, respectively.
During the panel discussion of the study, Dr. James McClurken, professor and vice-chair of surgery at Temple University in Philadelphia, said, "This [study] lends credence to utilizing the radial artery, with obvious caveats that it is important to place it in highly obstructed vessels so there is not competitive flow and to maintain patency for the longest period of time.
"This is not quite as good as internal-mammary artery patency data, but certainly better than vein-graft data."
Fellow discussant Dr. Steven Bolling, a thoracic surgeon at the University of Michigan Medical Center in Ann Arbor, said he expects the data will shift practice and increase utilization of the radial-artery graft.
When asked about this point during a press conference at the meeting, Dr. Fremes said that radial-artery utilization varies by jurisdiction at about 20%, compared with more than 95% for the internal-mammary artery. He noted that the evidence to date on radial-artery grafts has been mixed and comes mainly from observational studies.
"The study we presented is the first multi-institutional, longitudinal, randomized comparison, so this is fairly unique data," he said. "Hopefully, it will be persuasive."
Press briefing moderator Dr. Spencer King III, with St. Joseph’s Heart and Vascular Institute in Atlanta, said RAPS challenges the prevailing attitude that the radial artery is not that much better than vein grafts. RAPS "says maybe it is going to last longer. So I think this is an interesting thing for surgeons to chew on," he noted.
The Canadian Institutes of Health Research funded the study. Dr. Fremes reported no conflicts.
NEW ORLEANS – Long-term data from the Radial Artery Patency Study show that radial arteries, compared with saphenous veins, are associated with reduced rates of functional and complete graft occlusion in patients undergoing coronary artery bypass surgery.
In addition, radial arteries are associated with lower rates of graft disease, lead author Dr. Stephen E. Fremes said during a late-breaking trial session at the annual meeting of the American College of Cardiology.
The issue of which conduit provides the best long-term graft outcomes has been a subject of lengthy debate. Several trials have indicated that radial-artery grafts are no better than saphenous-vein grafts, including a recently published Veterans Affairs (VA) study showing similar 1-year graft patency among 757 patients undergoing first-time, elective coronary artery bypass grafting (JAMA 2011;305:167-74).
One-year data previously published from the Radial Artery Patency Study (RAPS) showed that complete graft occlusion was significantly reduced in radial-artery grafts compared with saphenous-vein grafts (8.2% vs. 13.6%), but that partial graft occlusion was similar (12.3% vs. 14.3%) between the two conduits (N. Engl. J. Med. 2004;351:2302-09).
When Dr. Fremes was asked how to reconcile the results of RAPS with those from the recent VA study, he replied that the VA study was conducted almost exclusively in men (99%), vein grafts performed better than predicted, and there were very high rates of evidence-based medicine. Adherence to evidence-based medicine was good in RAPS, but the trial accrued much earlier, from November 1996 to January 2001. The mean age of the 269 patients in the current analysis was 60 years, and 15% were women.
RAPS enrolled 561 patients with isolated triple-vessel disease and a left ventricular fraction of more than 35% from 12 Canadian centers and one in New Zealand. Randomization was unique in that it was performed within patients and not between patients, explained Dr. Fremes, head of the cardiovascular surgery division at Sunnybrook Health Sciences Centre and research director at the Schulich Heart Centre at Sunnybrook, Toronto. Patients were randomized to receive either a radial artery to the right coronary territory and a saphenous vein to the circumflex territory or a saphenous vein to the right coronary territory and a radial artery to the circumflex territory.
Late angiography was performed on 440 patients at 1 year and on 269 patients at a mean of 7.6 years after surgery. Grafts were considered occluded if they had a TIMI (Thrombolysis in Myocardial Infarction) score of 0-2, and were considered patent with a TIMI score of 3.
At 5 years, the primary end point of functional graft occlusion was significantly decreased in radial-artery grafts at 12%, compared with saphenous-vein grafts at 18.8% (odds ratio, 0.64), Dr. Fremes said. Significantly fewer radial-artery grafts also became completely occluded at 9%, compared with saphenous-vein grafts at 18% (OR 0.50).
Among 164 patients who had completely patent grafts at follow-up, graft stenosis was similar for both conduits for proximal and distal anastomotic lesions. There were fewer graft-body lesions at 6.7% in radial arteries, vs. saphenous veins at 15.2% (OR 0.42). Consequently, radial-artery grafts were significantly less likely to be either stenotic or completely occluded at 22%, compared with saphenous-vein grafts at 34% (OR 0.58), he said.
Target vessel stenosis, an important risk factor for graft occlusion at 1 year, was evaluated in a subgroup analysis. Target vessels with stenosis were classified a priori as those with 70%-89% narrowing and those with at least 90% narrowing. Although graft occlusion was reduced almost 50% for either graft in target vessels with at least 90% narrowing, radial-artery grafts had much lower functional (8.8%) and complete (6.3%) occlusion rates, as did saphenous-vein grafts (14.6% and 14.5%, respectively), in the more severely narrowed vessels.
The incidence of cardiac death beyond 1 year was 5%, of nonfatal myocardial infarction was 1.5%, and of major adverse cardiac events was 15%. Dr. Fremes pointed out that the clinical event findings were descriptive rather than explanatory since each patient received both graft types.
Overall survival in the entire cohort was 96% at 5 years, 91% at 7.5 years, and 78% at 10 years. Event-free survival was 95%, 90%, and 78%, respectively.
During the panel discussion of the study, Dr. James McClurken, professor and vice-chair of surgery at Temple University in Philadelphia, said, "This [study] lends credence to utilizing the radial artery, with obvious caveats that it is important to place it in highly obstructed vessels so there is not competitive flow and to maintain patency for the longest period of time.
"This is not quite as good as internal-mammary artery patency data, but certainly better than vein-graft data."
Fellow discussant Dr. Steven Bolling, a thoracic surgeon at the University of Michigan Medical Center in Ann Arbor, said he expects the data will shift practice and increase utilization of the radial-artery graft.
When asked about this point during a press conference at the meeting, Dr. Fremes said that radial-artery utilization varies by jurisdiction at about 20%, compared with more than 95% for the internal-mammary artery. He noted that the evidence to date on radial-artery grafts has been mixed and comes mainly from observational studies.
"The study we presented is the first multi-institutional, longitudinal, randomized comparison, so this is fairly unique data," he said. "Hopefully, it will be persuasive."
Press briefing moderator Dr. Spencer King III, with St. Joseph’s Heart and Vascular Institute in Atlanta, said RAPS challenges the prevailing attitude that the radial artery is not that much better than vein grafts. RAPS "says maybe it is going to last longer. So I think this is an interesting thing for surgeons to chew on," he noted.
The Canadian Institutes of Health Research funded the study. Dr. Fremes reported no conflicts.
FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF CARDIOLOGY
Major Finding: Functional graft occlusion at 5 years was 12% in radial-artery grafts and nearly 19% in saphenous-vein grafts.
Data Source: Multicenter, randomized Radial Artery Patency Study in 269 patients.
Disclosures: The Canadian Institutes of Health Research funded the study. Dr. Fremes reported no conflicts.
Recurrent PID Ups Risk of Adverse Long-Term Outcomes
CHICAGO – Women with recurrent pelvic inflammatory disease are significantly more likely to report infertility and chronic pelvic pain long-term than are those without recurrent PID, according to a secondary analysis of the PEACH study.
Rates of pregnancy (odds ratio, 1.0) and live births (OR, 0.7) were similar at 84 months after adjustment for age, race, parity, prior history of PID, and gonorrhea and chlamydia infection among 831 women with mild to moderate PID enrolled in the PID Evaluation and Clinical Health (PEACH) study.
Women with recurrent PID, however, were 1.8 times more likely to report infertility and 4.2 times more likely to report chronic pelvic pain than were those without recurrent episodes of PID, lead author Dr. Maria Trent said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Women with a subsequent sexually transmitted infection (STI) of the lower genital tract were 2.3 times more likely to have chronic pelvic pain than were those without an STI, but not more likely to have infertility.
"Our data and analysis substantiate the relationship between recurrent PID and adverse outcomes in the context of modern microbiology and outpatient and inpatient care approaches," said Dr. Trent, director of interdisciplinary education at the Johns Hopkins Children’s Center in Baltimore.
She explained that much of the current knowledge of the longitudinal outcomes of women with PID has been driven by research on a Scandinavian cohort of PID inpatients enrolled between 1960 and 1984. Since that time, however, there has been a shift in biological organisms causing PID and in clinical management to the outpatient setting. Previously, 60% of patients with PID had noncoccal or chlamydial disease, whereas newer data demonstrate that as few as 30% of PID patients have noncoccal or chlamydial disease and that newer organisms such as Mycoplasma genitalium are emerging, Dr. Trent said.
In the main PEACH study analysis, there was no difference in outcomes among the 831 women, aged 14-38 years, randomized to inpatient treatment initially using intravenous cefoxitin and doxycycline, or outpatient treatment with a single intramuscular injection of cefoxitin and oral doxycycline (Obstet. Gynecol. 2005;106:573-80). Participants were primarily African American (74.5%) and low income, and had regular access to care (65%).
When the women were interviewed at 84 months, 61% of them reported they were using some form of contraception. A prior history of PID was present in only 37% of women and 25% of adolescents (19 years or younger). Nine percent of all women and 12% of adolescents reported a new sexual partner.
At 84 months, 21% of women reported recurrent PID, 19% were categorized as infertile, 43% reported chronic pelvic pain, 57% became pregnant, and 42% had a live birth, Dr. Trent said.
Among the 209 adolescents, 71% had a pregnancy, 51% had a live birth, 18% were characterized as infertile, and 39% had chronic pelvic pain.
In an adjusted subanalysis of the adolescents, there were no significant differences in rates of pregnancy, live birth, and infertility based on PID status, but those with recurrent episodes of PID were five times more likely to report chronic pelvic pain than were adolescents without recurrent PID (OR, 5.0), Dr. Trent said.
"For PID, we often talk to adolescent girls about the difficulty of getting pregnant in the future, but we don’t necessarily talk to them about the possibility of chronic pelvic pain, which this study highlights is a significant issue," she said.
Based on the findings, the authors also advocate targeting public health interventions to young women and adolescents with PID.
"Acute PID should prompt linkage of affected patients to tailored STI risk-reduction services to prevent the adverse outcomes associated with PID," Dr. Trent said.
Dr. Maria Trent and her associates said they had no relevant financial disclosures.
CHICAGO – Women with recurrent pelvic inflammatory disease are significantly more likely to report infertility and chronic pelvic pain long-term than are those without recurrent PID, according to a secondary analysis of the PEACH study.
Rates of pregnancy (odds ratio, 1.0) and live births (OR, 0.7) were similar at 84 months after adjustment for age, race, parity, prior history of PID, and gonorrhea and chlamydia infection among 831 women with mild to moderate PID enrolled in the PID Evaluation and Clinical Health (PEACH) study.
Women with recurrent PID, however, were 1.8 times more likely to report infertility and 4.2 times more likely to report chronic pelvic pain than were those without recurrent episodes of PID, lead author Dr. Maria Trent said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Women with a subsequent sexually transmitted infection (STI) of the lower genital tract were 2.3 times more likely to have chronic pelvic pain than were those without an STI, but not more likely to have infertility.
"Our data and analysis substantiate the relationship between recurrent PID and adverse outcomes in the context of modern microbiology and outpatient and inpatient care approaches," said Dr. Trent, director of interdisciplinary education at the Johns Hopkins Children’s Center in Baltimore.
She explained that much of the current knowledge of the longitudinal outcomes of women with PID has been driven by research on a Scandinavian cohort of PID inpatients enrolled between 1960 and 1984. Since that time, however, there has been a shift in biological organisms causing PID and in clinical management to the outpatient setting. Previously, 60% of patients with PID had noncoccal or chlamydial disease, whereas newer data demonstrate that as few as 30% of PID patients have noncoccal or chlamydial disease and that newer organisms such as Mycoplasma genitalium are emerging, Dr. Trent said.
In the main PEACH study analysis, there was no difference in outcomes among the 831 women, aged 14-38 years, randomized to inpatient treatment initially using intravenous cefoxitin and doxycycline, or outpatient treatment with a single intramuscular injection of cefoxitin and oral doxycycline (Obstet. Gynecol. 2005;106:573-80). Participants were primarily African American (74.5%) and low income, and had regular access to care (65%).
When the women were interviewed at 84 months, 61% of them reported they were using some form of contraception. A prior history of PID was present in only 37% of women and 25% of adolescents (19 years or younger). Nine percent of all women and 12% of adolescents reported a new sexual partner.
At 84 months, 21% of women reported recurrent PID, 19% were categorized as infertile, 43% reported chronic pelvic pain, 57% became pregnant, and 42% had a live birth, Dr. Trent said.
Among the 209 adolescents, 71% had a pregnancy, 51% had a live birth, 18% were characterized as infertile, and 39% had chronic pelvic pain.
In an adjusted subanalysis of the adolescents, there were no significant differences in rates of pregnancy, live birth, and infertility based on PID status, but those with recurrent episodes of PID were five times more likely to report chronic pelvic pain than were adolescents without recurrent PID (OR, 5.0), Dr. Trent said.
"For PID, we often talk to adolescent girls about the difficulty of getting pregnant in the future, but we don’t necessarily talk to them about the possibility of chronic pelvic pain, which this study highlights is a significant issue," she said.
Based on the findings, the authors also advocate targeting public health interventions to young women and adolescents with PID.
"Acute PID should prompt linkage of affected patients to tailored STI risk-reduction services to prevent the adverse outcomes associated with PID," Dr. Trent said.
Dr. Maria Trent and her associates said they had no relevant financial disclosures.
CHICAGO – Women with recurrent pelvic inflammatory disease are significantly more likely to report infertility and chronic pelvic pain long-term than are those without recurrent PID, according to a secondary analysis of the PEACH study.
Rates of pregnancy (odds ratio, 1.0) and live births (OR, 0.7) were similar at 84 months after adjustment for age, race, parity, prior history of PID, and gonorrhea and chlamydia infection among 831 women with mild to moderate PID enrolled in the PID Evaluation and Clinical Health (PEACH) study.
Women with recurrent PID, however, were 1.8 times more likely to report infertility and 4.2 times more likely to report chronic pelvic pain than were those without recurrent episodes of PID, lead author Dr. Maria Trent said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Women with a subsequent sexually transmitted infection (STI) of the lower genital tract were 2.3 times more likely to have chronic pelvic pain than were those without an STI, but not more likely to have infertility.
"Our data and analysis substantiate the relationship between recurrent PID and adverse outcomes in the context of modern microbiology and outpatient and inpatient care approaches," said Dr. Trent, director of interdisciplinary education at the Johns Hopkins Children’s Center in Baltimore.
She explained that much of the current knowledge of the longitudinal outcomes of women with PID has been driven by research on a Scandinavian cohort of PID inpatients enrolled between 1960 and 1984. Since that time, however, there has been a shift in biological organisms causing PID and in clinical management to the outpatient setting. Previously, 60% of patients with PID had noncoccal or chlamydial disease, whereas newer data demonstrate that as few as 30% of PID patients have noncoccal or chlamydial disease and that newer organisms such as Mycoplasma genitalium are emerging, Dr. Trent said.
In the main PEACH study analysis, there was no difference in outcomes among the 831 women, aged 14-38 years, randomized to inpatient treatment initially using intravenous cefoxitin and doxycycline, or outpatient treatment with a single intramuscular injection of cefoxitin and oral doxycycline (Obstet. Gynecol. 2005;106:573-80). Participants were primarily African American (74.5%) and low income, and had regular access to care (65%).
When the women were interviewed at 84 months, 61% of them reported they were using some form of contraception. A prior history of PID was present in only 37% of women and 25% of adolescents (19 years or younger). Nine percent of all women and 12% of adolescents reported a new sexual partner.
At 84 months, 21% of women reported recurrent PID, 19% were categorized as infertile, 43% reported chronic pelvic pain, 57% became pregnant, and 42% had a live birth, Dr. Trent said.
Among the 209 adolescents, 71% had a pregnancy, 51% had a live birth, 18% were characterized as infertile, and 39% had chronic pelvic pain.
In an adjusted subanalysis of the adolescents, there were no significant differences in rates of pregnancy, live birth, and infertility based on PID status, but those with recurrent episodes of PID were five times more likely to report chronic pelvic pain than were adolescents without recurrent PID (OR, 5.0), Dr. Trent said.
"For PID, we often talk to adolescent girls about the difficulty of getting pregnant in the future, but we don’t necessarily talk to them about the possibility of chronic pelvic pain, which this study highlights is a significant issue," she said.
Based on the findings, the authors also advocate targeting public health interventions to young women and adolescents with PID.
"Acute PID should prompt linkage of affected patients to tailored STI risk-reduction services to prevent the adverse outcomes associated with PID," Dr. Trent said.
Dr. Maria Trent and her associates said they had no relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE NORTH AMERICAN SOCIETY FOR PEDIATRIC AND ADOLESCENT GYNECOLOGY
Major Finding: Women with recurrent PID were 1.8 times more likely to report infertility and 4.2 times more likely to report chronic pelvic pain than were those without recurrent PID. In an adjusted adolescent subanalysis, there were no significant differences in rates of pregnancy, live birth, and infertility based on PID status, but adolescents with recurrent episodes of PID were five times more likely to report chronic pelvic pain than were adolescents without recurrent PID (OR, 5.0).
Data Source: Secondary analysis of 831 women in the PEACH study, including 209 adolescents.
Disclosures: Dr. Maria Trent and her associates said they had no relevant financial disclosures.
Recurrent PID Ups Risk of Adverse Long-Term Outcomes
CHICAGO – Women with recurrent pelvic inflammatory disease are significantly more likely to report infertility and chronic pelvic pain long-term than are those without recurrent PID, according to a secondary analysis of the PEACH study.
Rates of pregnancy (odds ratio, 1.0) and live births (OR, 0.7) were similar at 84 months after adjustment for age, race, parity, prior history of PID, and gonorrhea and chlamydia infection among 831 women with mild to moderate PID enrolled in the PID Evaluation and Clinical Health (PEACH) study.
Women with recurrent PID, however, were 1.8 times more likely to report infertility and 4.2 times more likely to report chronic pelvic pain than were those without recurrent episodes of PID, lead author Dr. Maria Trent said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Women with a subsequent sexually transmitted infection (STI) of the lower genital tract were 2.3 times more likely to have chronic pelvic pain than were those without an STI, but not more likely to have infertility.
"Our data and analysis substantiate the relationship between recurrent PID and adverse outcomes in the context of modern microbiology and outpatient and inpatient care approaches," said Dr. Trent, director of interdisciplinary education at the Johns Hopkins Children’s Center in Baltimore.
She explained that much of the current knowledge of the longitudinal outcomes of women with PID has been driven by research on a Scandinavian cohort of PID inpatients enrolled between 1960 and 1984. Since that time, however, there has been a shift in biological organisms causing PID and in clinical management to the outpatient setting. Previously, 60% of patients with PID had noncoccal or chlamydial disease, whereas newer data demonstrate that as few as 30% of PID patients have noncoccal or chlamydial disease and that newer organisms such as Mycoplasma genitalium are emerging, Dr. Trent said.
In the main PEACH study analysis, there was no difference in outcomes among the 831 women, aged 14-38 years, randomized to inpatient treatment initially using intravenous cefoxitin and doxycycline, or outpatient treatment with a single intramuscular injection of cefoxitin and oral doxycycline (Obstet. Gynecol. 2005;106:573-80). Participants were primarily African American (74.5%) and low income, and had regular access to care (65%).
When the women were interviewed at 84 months, 61% of them reported they were using some form of contraception. A prior history of PID was present in only 37% of women and 25% of adolescents (19 years or younger). Nine percent of all women and 12% of adolescents reported a new sexual partner.
At 84 months, 21% of women reported recurrent PID, 19% were categorized as infertile, 43% reported chronic pelvic pain, 57% became pregnant, and 42% had a live birth, Dr. Trent said.
Among the 209 adolescents, 71% had a pregnancy, 51% had a live birth, 18% were characterized as infertile, and 39% had chronic pelvic pain.
In an adjusted subanalysis of the adolescents, there were no significant differences in rates of pregnancy, live birth, and infertility based on PID status, but those with recurrent episodes of PID were five times more likely to report chronic pelvic pain than were adolescents without recurrent PID (OR, 5.0), Dr. Trent said.
"For PID, we often talk to adolescent girls about the difficulty of getting pregnant in the future, but we don’t necessarily talk to them about the possibility of chronic pelvic pain, which this study highlights is a significant issue," she said.
Based on the findings, the authors also advocate targeting public health interventions to young women and adolescents with PID.
"Acute PID should prompt linkage of affected patients to tailored STI risk-reduction services to prevent the adverse outcomes associated with PID," Dr. Trent said.
Dr. Maria Trent and her associates said they had no relevant financial disclosures.
CHICAGO – Women with recurrent pelvic inflammatory disease are significantly more likely to report infertility and chronic pelvic pain long-term than are those without recurrent PID, according to a secondary analysis of the PEACH study.
Rates of pregnancy (odds ratio, 1.0) and live births (OR, 0.7) were similar at 84 months after adjustment for age, race, parity, prior history of PID, and gonorrhea and chlamydia infection among 831 women with mild to moderate PID enrolled in the PID Evaluation and Clinical Health (PEACH) study.
Women with recurrent PID, however, were 1.8 times more likely to report infertility and 4.2 times more likely to report chronic pelvic pain than were those without recurrent episodes of PID, lead author Dr. Maria Trent said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Women with a subsequent sexually transmitted infection (STI) of the lower genital tract were 2.3 times more likely to have chronic pelvic pain than were those without an STI, but not more likely to have infertility.
"Our data and analysis substantiate the relationship between recurrent PID and adverse outcomes in the context of modern microbiology and outpatient and inpatient care approaches," said Dr. Trent, director of interdisciplinary education at the Johns Hopkins Children’s Center in Baltimore.
She explained that much of the current knowledge of the longitudinal outcomes of women with PID has been driven by research on a Scandinavian cohort of PID inpatients enrolled between 1960 and 1984. Since that time, however, there has been a shift in biological organisms causing PID and in clinical management to the outpatient setting. Previously, 60% of patients with PID had noncoccal or chlamydial disease, whereas newer data demonstrate that as few as 30% of PID patients have noncoccal or chlamydial disease and that newer organisms such as Mycoplasma genitalium are emerging, Dr. Trent said.
In the main PEACH study analysis, there was no difference in outcomes among the 831 women, aged 14-38 years, randomized to inpatient treatment initially using intravenous cefoxitin and doxycycline, or outpatient treatment with a single intramuscular injection of cefoxitin and oral doxycycline (Obstet. Gynecol. 2005;106:573-80). Participants were primarily African American (74.5%) and low income, and had regular access to care (65%).
When the women were interviewed at 84 months, 61% of them reported they were using some form of contraception. A prior history of PID was present in only 37% of women and 25% of adolescents (19 years or younger). Nine percent of all women and 12% of adolescents reported a new sexual partner.
At 84 months, 21% of women reported recurrent PID, 19% were categorized as infertile, 43% reported chronic pelvic pain, 57% became pregnant, and 42% had a live birth, Dr. Trent said.
Among the 209 adolescents, 71% had a pregnancy, 51% had a live birth, 18% were characterized as infertile, and 39% had chronic pelvic pain.
In an adjusted subanalysis of the adolescents, there were no significant differences in rates of pregnancy, live birth, and infertility based on PID status, but those with recurrent episodes of PID were five times more likely to report chronic pelvic pain than were adolescents without recurrent PID (OR, 5.0), Dr. Trent said.
"For PID, we often talk to adolescent girls about the difficulty of getting pregnant in the future, but we don’t necessarily talk to them about the possibility of chronic pelvic pain, which this study highlights is a significant issue," she said.
Based on the findings, the authors also advocate targeting public health interventions to young women and adolescents with PID.
"Acute PID should prompt linkage of affected patients to tailored STI risk-reduction services to prevent the adverse outcomes associated with PID," Dr. Trent said.
Dr. Maria Trent and her associates said they had no relevant financial disclosures.
CHICAGO – Women with recurrent pelvic inflammatory disease are significantly more likely to report infertility and chronic pelvic pain long-term than are those without recurrent PID, according to a secondary analysis of the PEACH study.
Rates of pregnancy (odds ratio, 1.0) and live births (OR, 0.7) were similar at 84 months after adjustment for age, race, parity, prior history of PID, and gonorrhea and chlamydia infection among 831 women with mild to moderate PID enrolled in the PID Evaluation and Clinical Health (PEACH) study.
Women with recurrent PID, however, were 1.8 times more likely to report infertility and 4.2 times more likely to report chronic pelvic pain than were those without recurrent episodes of PID, lead author Dr. Maria Trent said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.
Women with a subsequent sexually transmitted infection (STI) of the lower genital tract were 2.3 times more likely to have chronic pelvic pain than were those without an STI, but not more likely to have infertility.
"Our data and analysis substantiate the relationship between recurrent PID and adverse outcomes in the context of modern microbiology and outpatient and inpatient care approaches," said Dr. Trent, director of interdisciplinary education at the Johns Hopkins Children’s Center in Baltimore.
She explained that much of the current knowledge of the longitudinal outcomes of women with PID has been driven by research on a Scandinavian cohort of PID inpatients enrolled between 1960 and 1984. Since that time, however, there has been a shift in biological organisms causing PID and in clinical management to the outpatient setting. Previously, 60% of patients with PID had noncoccal or chlamydial disease, whereas newer data demonstrate that as few as 30% of PID patients have noncoccal or chlamydial disease and that newer organisms such as Mycoplasma genitalium are emerging, Dr. Trent said.
In the main PEACH study analysis, there was no difference in outcomes among the 831 women, aged 14-38 years, randomized to inpatient treatment initially using intravenous cefoxitin and doxycycline, or outpatient treatment with a single intramuscular injection of cefoxitin and oral doxycycline (Obstet. Gynecol. 2005;106:573-80). Participants were primarily African American (74.5%) and low income, and had regular access to care (65%).
When the women were interviewed at 84 months, 61% of them reported they were using some form of contraception. A prior history of PID was present in only 37% of women and 25% of adolescents (19 years or younger). Nine percent of all women and 12% of adolescents reported a new sexual partner.
At 84 months, 21% of women reported recurrent PID, 19% were categorized as infertile, 43% reported chronic pelvic pain, 57% became pregnant, and 42% had a live birth, Dr. Trent said.
Among the 209 adolescents, 71% had a pregnancy, 51% had a live birth, 18% were characterized as infertile, and 39% had chronic pelvic pain.
In an adjusted subanalysis of the adolescents, there were no significant differences in rates of pregnancy, live birth, and infertility based on PID status, but those with recurrent episodes of PID were five times more likely to report chronic pelvic pain than were adolescents without recurrent PID (OR, 5.0), Dr. Trent said.
"For PID, we often talk to adolescent girls about the difficulty of getting pregnant in the future, but we don’t necessarily talk to them about the possibility of chronic pelvic pain, which this study highlights is a significant issue," she said.
Based on the findings, the authors also advocate targeting public health interventions to young women and adolescents with PID.
"Acute PID should prompt linkage of affected patients to tailored STI risk-reduction services to prevent the adverse outcomes associated with PID," Dr. Trent said.
Dr. Maria Trent and her associates said they had no relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE NORTH AMERICAN SOCIETY FOR PEDIATRIC AND ADOLESCENT GYNECOLOGY
Major Finding: Women with recurrent PID were 1.8 times more likely to report infertility and 4.2 times more likely to report chronic pelvic pain than were those without recurrent PID. In an adjusted adolescent subanalysis, there were no significant differences in rates of pregnancy, live birth, and infertility based on PID status, but adolescents with recurrent episodes of PID were five times more likely to report chronic pelvic pain than were adolescents without recurrent PID (OR, 5.0).
Data Source: Secondary analysis of 831 women in the PEACH study, including 209 adolescents.
Disclosures: Dr. Maria Trent and her associates said they had no relevant financial disclosures.
Intranasal Postop Steroids Same as Saline in Select Patients
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
rhinosinusitis and polyposis, dexamethasone eye drops,
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
rhinosinusitis and polyposis, dexamethasone eye drops,
rhinosinusitis and polyposis, dexamethasone eye drops,
FROM THE COMBINED OTOLARYNGOLOGY SPRING MEETINGS
Major Finding: At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively).
Data Source: Prospective, double-blind study in 60 patients with chronic rhinosinusitis and Samter’s triad who underwent functional endoscopic sinus surgery.
Disclosures: Dr. Rotenberg reported no relevant financial disclosures. Dr. Senior reported receiving honorarium from and serving as a consultant for BrainLAB, ENTrigue, and Gyrus ACMI, a subsidiary of Olympus.
Intranasal Postop Steroids Same as Saline in Select Patients
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
rhinosinusitis and polyposis, dexamethasone eye drops,
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
rhinosinusitis and polyposis, dexamethasone eye drops,
rhinosinusitis and polyposis, dexamethasone eye drops,
FROM THE COMBINED OTOLARYNGOLOGY SPRING MEETINGS
Intranasal Postop Steroids Same as Saline in Select Patients
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
rhinosinusitis and polyposis, dexamethasone eye drops,
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
rhinosinusitis and polyposis, dexamethasone eye drops,
rhinosinusitis and polyposis, dexamethasone eye drops,
FROM THE COMBINED OTOLARYNGOLOGY SPRING MEETINGS
Major Finding: At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively).
Data Source: Prospective, double-blind study in 60 patients with chronic rhinosinusitis and Samter’s triad who underwent functional endoscopic sinus surgery.
Disclosures: Dr. Rotenberg reported no relevant financial disclosures. Dr. Senior reported receiving honorarium from and serving as a consultant for BrainLAB, ENTrigue, and Gyrus ACMI, a subsidiary of Olympus.