ACS Clinical Congress

CHICAGO – Two commonly used dyes produced mixed results in sentinel lymph node mapping of early stage breast cancer in what was described as the highest-powered study to date.

The average number of sentinel lymph nodes identified per person was significantly higher with 1% methylene blue dye than with 1% lymphazurin (2.89 vs. 2.22; P less than .001).

Although there is extensive support for methylene blue as a safe and efficacious alternative to lymphazurin, this finding on the number of sentinel nodes identified is not replicated in any other study, Dr. Vaishali Patel said at the annual clinical congress of the American College of Surgeons. The study was conducted at the McLaren Flint (Mich.) Medical Center. Dr. Sukamal Saha was principal investigator.

On the other hand, lymphazurin identified significantly more additional lymph nodes than methylene blue (mean 4.48 vs. 2.84; P less than .001).

Nodal positivity was also significantly higher with lymphazurin than methylene blue (14.93% vs. 8.85%; P less than .001), which also has not been reported in other trials.

“We think this does offer a true comparison between the two dyes,” Dr. Patel of Detroit Medical Center Sinai-Grace Hospital said. “The volume of dye and technique were consistent for all 651 patients. … with one surgeon performing the injections and one surgeon performing the procedures.” The 651 consecutive patients were randomly assigned based on agent availability to a preoperative injection of lymphazurin (half intraparenchymal and half subareolar in the upper outer quadrant) or an intraoperative injection of methylene blue over 5 minutes (3 ccs intraparenchymal, 1 cc subareolar, and 1 cc intradermal).

The lymphazurin and methylene blue groups were also similar in number (298 patients vs. 353 patients), age (mean 61.6 years vs. 63.5 years), and T stage (in situ 12% vs. 17.8%; T1 64% vs. 65%; T2 23% vs. 17.5%).

In contrast, three smaller, well-established studies that came to different conclusions used four different surgeons and novel techniques to inject their radiocolloid and supervised residents for lymphatic mapping, she noted.

The radiocolloid lymphazurin first demonstrated superiority over methylene blue in 1990, but alternatives continue to be investigated due to frequent nonavailability and a host of adverse events including blue hives, blue discoloration or tattooing, and anaphylaxis.

Lymphazurin also costs 10-12 times more than methylene blue, which was reflected in the study in an average per patient cost of $815 vs. $75 for methylene blue, Dr. Patel said.

The American Society of Breast Surgeons, however, recommends dual-agent mapping using blue dye and a radioisotope in breast cancer to further improve the success in identifying the sentinel lymph nodes. The improvement is likely because of the dual mechanism at play: radiocolloids become entrapped within the lymph node, whereas certain blue dyes bind to interstitial albumin and are taken up by lymphatics, she explained.

The higher number of sentinel lymph nodes in the methylene blue group may be due to its particle size, which is smaller, weighs less, and diffused faster, Dr. Patel suggested.

The higher number of additional lymph nodes captured with lymphazurin may be because of the higher frequency of nodal dissection in this group than in the methylene blue group (25% vs. 16%).

The finding of greater nodal positivity in the lymphazurin group may be related to mechanism of action or the high percentage of patients with T1 disease enrolled in the study. Still, nodal positivity was higher with lymphazurin than methylene blue regardless of T stage, she said.

The lymphazurin group had higher rates than the methylene blue group of pseudohypoxemia (10% vs. 0%; P less than .0001), but blue hives (1.34% vs. 0%; P = .043) and anaphylaxis (.67% vs. 0%; P = .20) were kept in check. Patients were premedicated and early in the series, the surgeon began excising the area of injected blue skin during the primary surgery, Dr. Patel observed.

Despite being diluted, methylene blue was associated with higher rates of seroma (3.4% vs. 1.7%; P = .005) and skin necrosis (2.55% vs. 9%; P = .005).

Discussant Dr. Alyssa Throckmorton of Baptist Memorial Health Care in Memphis pointed out that more recent data show radiocolloid mapping alone is comparable to dual-agent mapping, suggesting that blue dye may not be needed. That said, there have been national shortages of methylene blue as well as lymphazurin.

“I think in surgeons who are going to use blue dye, with the way drug shortages have become in the last few years, you are going to have to be facile and familiar with both types of dye if you are going to use that as part of your clinical practice,” she said.

pwendling@frontlinemedcom.com

CHICAGO – Two commonly used dyes produced mixed results in sentinel lymph node mapping of early stage breast cancer in what was described as the highest-powered study to date.

The average number of sentinel lymph nodes identified per person was significantly higher with 1% methylene blue dye than with 1% lymphazurin (2.89 vs. 2.22; P less than .001).

Although there is extensive support for methylene blue as a safe and efficacious alternative to lymphazurin, this finding on the number of sentinel nodes identified is not replicated in any other study, Dr. Vaishali Patel said at the annual clinical congress of the American College of Surgeons. The study was conducted at the McLaren Flint (Mich.) Medical Center. Dr. Sukamal Saha was principal investigator.

On the other hand, lymphazurin identified significantly more additional lymph nodes than methylene blue (mean 4.48 vs. 2.84; P less than .001).

Nodal positivity was also significantly higher with lymphazurin than methylene blue (14.93% vs. 8.85%; P less than .001), which also has not been reported in other trials.

“We think this does offer a true comparison between the two dyes,” Dr. Patel of Detroit Medical Center Sinai-Grace Hospital said. “The volume of dye and technique were consistent for all 651 patients. … with one surgeon performing the injections and one surgeon performing the procedures.” The 651 consecutive patients were randomly assigned based on agent availability to a preoperative injection of lymphazurin (half intraparenchymal and half subareolar in the upper outer quadrant) or an intraoperative injection of methylene blue over 5 minutes (3 ccs intraparenchymal, 1 cc subareolar, and 1 cc intradermal).

The lymphazurin and methylene blue groups were also similar in number (298 patients vs. 353 patients), age (mean 61.6 years vs. 63.5 years), and T stage (in situ 12% vs. 17.8%; T1 64% vs. 65%; T2 23% vs. 17.5%).

In contrast, three smaller, well-established studies that came to different conclusions used four different surgeons and novel techniques to inject their radiocolloid and supervised residents for lymphatic mapping, she noted.

The radiocolloid lymphazurin first demonstrated superiority over methylene blue in 1990, but alternatives continue to be investigated due to frequent nonavailability and a host of adverse events including blue hives, blue discoloration or tattooing, and anaphylaxis.

Lymphazurin also costs 10-12 times more than methylene blue, which was reflected in the study in an average per patient cost of $815 vs. $75 for methylene blue, Dr. Patel said.

The American Society of Breast Surgeons, however, recommends dual-agent mapping using blue dye and a radioisotope in breast cancer to further improve the success in identifying the sentinel lymph nodes. The improvement is likely because of the dual mechanism at play: radiocolloids become entrapped within the lymph node, whereas certain blue dyes bind to interstitial albumin and are taken up by lymphatics, she explained.

The higher number of sentinel lymph nodes in the methylene blue group may be due to its particle size, which is smaller, weighs less, and diffused faster, Dr. Patel suggested.

The higher number of additional lymph nodes captured with lymphazurin may be because of the higher frequency of nodal dissection in this group than in the methylene blue group (25% vs. 16%).

The finding of greater nodal positivity in the lymphazurin group may be related to mechanism of action or the high percentage of patients with T1 disease enrolled in the study. Still, nodal positivity was higher with lymphazurin than methylene blue regardless of T stage, she said.

The lymphazurin group had higher rates than the methylene blue group of pseudohypoxemia (10% vs. 0%; P less than .0001), but blue hives (1.34% vs. 0%; P = .043) and anaphylaxis (.67% vs. 0%; P = .20) were kept in check. Patients were premedicated and early in the series, the surgeon began excising the area of injected blue skin during the primary surgery, Dr. Patel observed.

Despite being diluted, methylene blue was associated with higher rates of seroma (3.4% vs. 1.7%; P = .005) and skin necrosis (2.55% vs. 9%; P = .005).

Discussant Dr. Alyssa Throckmorton of Baptist Memorial Health Care in Memphis pointed out that more recent data show radiocolloid mapping alone is comparable to dual-agent mapping, suggesting that blue dye may not be needed. That said, there have been national shortages of methylene blue as well as lymphazurin.

“I think in surgeons who are going to use blue dye, with the way drug shortages have become in the last few years, you are going to have to be facile and familiar with both types of dye if you are going to use that as part of your clinical practice,” she said.

pwendling@frontlinemedcom.com

CHICAGO – Two commonly used dyes produced mixed results in sentinel lymph node mapping of early stage breast cancer in what was described as the highest-powered study to date.

The average number of sentinel lymph nodes identified per person was significantly higher with 1% methylene blue dye than with 1% lymphazurin (2.89 vs. 2.22; P less than .001).

Although there is extensive support for methylene blue as a safe and efficacious alternative to lymphazurin, this finding on the number of sentinel nodes identified is not replicated in any other study, Dr. Vaishali Patel said at the annual clinical congress of the American College of Surgeons. The study was conducted at the McLaren Flint (Mich.) Medical Center. Dr. Sukamal Saha was principal investigator.

On the other hand, lymphazurin identified significantly more additional lymph nodes than methylene blue (mean 4.48 vs. 2.84; P less than .001).

Nodal positivity was also significantly higher with lymphazurin than methylene blue (14.93% vs. 8.85%; P less than .001), which also has not been reported in other trials.

“We think this does offer a true comparison between the two dyes,” Dr. Patel of Detroit Medical Center Sinai-Grace Hospital said. “The volume of dye and technique were consistent for all 651 patients. … with one surgeon performing the injections and one surgeon performing the procedures.” The 651 consecutive patients were randomly assigned based on agent availability to a preoperative injection of lymphazurin (half intraparenchymal and half subareolar in the upper outer quadrant) or an intraoperative injection of methylene blue over 5 minutes (3 ccs intraparenchymal, 1 cc subareolar, and 1 cc intradermal).

The lymphazurin and methylene blue groups were also similar in number (298 patients vs. 353 patients), age (mean 61.6 years vs. 63.5 years), and T stage (in situ 12% vs. 17.8%; T1 64% vs. 65%; T2 23% vs. 17.5%).

In contrast, three smaller, well-established studies that came to different conclusions used four different surgeons and novel techniques to inject their radiocolloid and supervised residents for lymphatic mapping, she noted.

The radiocolloid lymphazurin first demonstrated superiority over methylene blue in 1990, but alternatives continue to be investigated due to frequent nonavailability and a host of adverse events including blue hives, blue discoloration or tattooing, and anaphylaxis.

Lymphazurin also costs 10-12 times more than methylene blue, which was reflected in the study in an average per patient cost of $815 vs. $75 for methylene blue, Dr. Patel said.

The American Society of Breast Surgeons, however, recommends dual-agent mapping using blue dye and a radioisotope in breast cancer to further improve the success in identifying the sentinel lymph nodes. The improvement is likely because of the dual mechanism at play: radiocolloids become entrapped within the lymph node, whereas certain blue dyes bind to interstitial albumin and are taken up by lymphatics, she explained.

The higher number of sentinel lymph nodes in the methylene blue group may be due to its particle size, which is smaller, weighs less, and diffused faster, Dr. Patel suggested.

The higher number of additional lymph nodes captured with lymphazurin may be because of the higher frequency of nodal dissection in this group than in the methylene blue group (25% vs. 16%).

The finding of greater nodal positivity in the lymphazurin group may be related to mechanism of action or the high percentage of patients with T1 disease enrolled in the study. Still, nodal positivity was higher with lymphazurin than methylene blue regardless of T stage, she said.

The lymphazurin group had higher rates than the methylene blue group of pseudohypoxemia (10% vs. 0%; P less than .0001), but blue hives (1.34% vs. 0%; P = .043) and anaphylaxis (.67% vs. 0%; P = .20) were kept in check. Patients were premedicated and early in the series, the surgeon began excising the area of injected blue skin during the primary surgery, Dr. Patel observed.

Despite being diluted, methylene blue was associated with higher rates of seroma (3.4% vs. 1.7%; P = .005) and skin necrosis (2.55% vs. 9%; P = .005).

Discussant Dr. Alyssa Throckmorton of Baptist Memorial Health Care in Memphis pointed out that more recent data show radiocolloid mapping alone is comparable to dual-agent mapping, suggesting that blue dye may not be needed. That said, there have been national shortages of methylene blue as well as lymphazurin.

“I think in surgeons who are going to use blue dye, with the way drug shortages have become in the last few years, you are going to have to be facile and familiar with both types of dye if you are going to use that as part of your clinical practice,” she said.

pwendling@frontlinemedcom.com

CHICAGO – Patients undergoing Roux-en-Y gastric bypass are twice as likely to need a reoperation as those having sleeve gastrectomy, according to ACS NSQIP data.

Reoperation among Roux-en-Y patients was associated with a 10-fold increase in mortality over sleeve gastrectomy (1.2% vs. 0.1%; P less than .01) and a 3-fold increase in length of stay (6 days vs. 2 days; P less than .01), Dr. Matthew Whealon reported at the American College of Surgeons Clinical Congress

The results are consistent with prior contemporary analyses using ACS National Surgical Quality Improvement Program (NSQIP) data reporting reoperation rates of 2.5%-5.1% for Roux-en-Y gastric bypass (RYGB) and 1.6%-3% for sleeve gastrectomy. Those analyses, however, did not include the reasons for reoperation, as these data were not available until the 2012 database release, he said.

Patrice Wendling/Frontline Medical News

With these data now in hand, lead author Dr. Mark Hanna and his fellow investigators at the University of California, Irvine, identified 36,757 adults in the 2012-2013 database who underwent RYGB (n = 19,597) or sleeve gastrectomy (n = 17,160) for morbid obesity and performed multivariate regression analyses to identify risk factors associated with reoperation.

In all, 518 RYGB patients and 231 sleeve gastrectomy patients required an unplanned return to the operating room (2.6% vs. 1.3%), Dr. Whealon said. The mean time from the index procedure to reoperation was 7.6 days and 7.1 days, respectively.

Obstruction was the biggest driver of reoperation following RYGB, accounting for 28% of reoperations. Other causes were bleeding (14.5%), leak (13%), and other unspecified reasons (18.5%), with data missing in 12%.

Bleeding was the most common indication for reoperation after sleeve gastrectomy (25.5%), followed by other unspecified reasons(24.6%), missing data (13%), leak (12.55%), and obstruction (11.2%), he said.

In adjusted multivariate analyses, factors that significantly increased the risk for reoperation were heart failure (adjusted odds ratio, 2.3), dependent functional status (aOR, 2.1), RYGB (aOR, 1.94), chronic obstructive pulmonary disease (aOR, 1.7), open operation (aOR, 1.6), and male sex (aOR, 1.1). The P values were less than .05 for all comparisons.

Factors not significant for reoperation included body mass index, age, smoking status, bleeding disorder, steroid use, dialysis, hypertension, diabetes, preoperative sepsis, emergent admission, elective operation, and preoperative weight loss.

While bariatric surgery remains a safe operation with low mortality and reoperation rates, additional studies are needed, because of the increased mortality associated with reoperation, to identify ways to mitigate these complications, Dr. Whealon said.

Limitations of the study were that ICD-9 codes for postoperative hemorrhage could not differentiate between intra-abdominal and gastrointestinal bleeding, the database is subject to coding errors, and missing data may have introduced bias into the study, he noted.

Discussant Dr. Matthew Goldblatt of the Medical College of Wisconsin in Milwaukee commented that use of the ACS MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) database would have avoided some of the coding errors for reoperation.

He also questioned whether the average 7-day return to surgery interval reflects the use of endoscopy, as few surgeons would wait that long if, as the analysis suggests, a primary reason for reoperation was postoperative bleeding.

Endoscopy was included in the reoperations, Dr. Whealon said, but he could not speak to the exact percentage it comprised.

Finally, Dr. Goldblatt said, “the patients that you identified as being the highest risk for complication, as is often the case in these reviews, are really the ones most likely to gain the most from the procedure. … So how can people avoid operating on these patients when they are the ones that can get the most out of it?”

Dr. Whealon agreed that high-risk patients have the most to gain and suggested that “optimizing their comorbid conditions before operation will help reduce their risk.”

The authors reported having no conflicts of interest.

pwendling@frontlinemedcom.com

CHICAGO – Patients undergoing Roux-en-Y gastric bypass are twice as likely to need a reoperation as those having sleeve gastrectomy, according to ACS NSQIP data.

Reoperation among Roux-en-Y patients was associated with a 10-fold increase in mortality over sleeve gastrectomy (1.2% vs. 0.1%; P less than .01) and a 3-fold increase in length of stay (6 days vs. 2 days; P less than .01), Dr. Matthew Whealon reported at the American College of Surgeons Clinical Congress

The results are consistent with prior contemporary analyses using ACS National Surgical Quality Improvement Program (NSQIP) data reporting reoperation rates of 2.5%-5.1% for Roux-en-Y gastric bypass (RYGB) and 1.6%-3% for sleeve gastrectomy. Those analyses, however, did not include the reasons for reoperation, as these data were not available until the 2012 database release, he said.

Patrice Wendling/Frontline Medical News

With these data now in hand, lead author Dr. Mark Hanna and his fellow investigators at the University of California, Irvine, identified 36,757 adults in the 2012-2013 database who underwent RYGB (n = 19,597) or sleeve gastrectomy (n = 17,160) for morbid obesity and performed multivariate regression analyses to identify risk factors associated with reoperation.

In all, 518 RYGB patients and 231 sleeve gastrectomy patients required an unplanned return to the operating room (2.6% vs. 1.3%), Dr. Whealon said. The mean time from the index procedure to reoperation was 7.6 days and 7.1 days, respectively.

Obstruction was the biggest driver of reoperation following RYGB, accounting for 28% of reoperations. Other causes were bleeding (14.5%), leak (13%), and other unspecified reasons (18.5%), with data missing in 12%.

Bleeding was the most common indication for reoperation after sleeve gastrectomy (25.5%), followed by other unspecified reasons(24.6%), missing data (13%), leak (12.55%), and obstruction (11.2%), he said.

In adjusted multivariate analyses, factors that significantly increased the risk for reoperation were heart failure (adjusted odds ratio, 2.3), dependent functional status (aOR, 2.1), RYGB (aOR, 1.94), chronic obstructive pulmonary disease (aOR, 1.7), open operation (aOR, 1.6), and male sex (aOR, 1.1). The P values were less than .05 for all comparisons.

Factors not significant for reoperation included body mass index, age, smoking status, bleeding disorder, steroid use, dialysis, hypertension, diabetes, preoperative sepsis, emergent admission, elective operation, and preoperative weight loss.

While bariatric surgery remains a safe operation with low mortality and reoperation rates, additional studies are needed, because of the increased mortality associated with reoperation, to identify ways to mitigate these complications, Dr. Whealon said.

Limitations of the study were that ICD-9 codes for postoperative hemorrhage could not differentiate between intra-abdominal and gastrointestinal bleeding, the database is subject to coding errors, and missing data may have introduced bias into the study, he noted.

Discussant Dr. Matthew Goldblatt of the Medical College of Wisconsin in Milwaukee commented that use of the ACS MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) database would have avoided some of the coding errors for reoperation.

He also questioned whether the average 7-day return to surgery interval reflects the use of endoscopy, as few surgeons would wait that long if, as the analysis suggests, a primary reason for reoperation was postoperative bleeding.

Endoscopy was included in the reoperations, Dr. Whealon said, but he could not speak to the exact percentage it comprised.

Finally, Dr. Goldblatt said, “the patients that you identified as being the highest risk for complication, as is often the case in these reviews, are really the ones most likely to gain the most from the procedure. … So how can people avoid operating on these patients when they are the ones that can get the most out of it?”

Dr. Whealon agreed that high-risk patients have the most to gain and suggested that “optimizing their comorbid conditions before operation will help reduce their risk.”

The authors reported having no conflicts of interest.

pwendling@frontlinemedcom.com

CHICAGO – Patients undergoing Roux-en-Y gastric bypass are twice as likely to need a reoperation as those having sleeve gastrectomy, according to ACS NSQIP data.

Reoperation among Roux-en-Y patients was associated with a 10-fold increase in mortality over sleeve gastrectomy (1.2% vs. 0.1%; P less than .01) and a 3-fold increase in length of stay (6 days vs. 2 days; P less than .01), Dr. Matthew Whealon reported at the American College of Surgeons Clinical Congress

The results are consistent with prior contemporary analyses using ACS National Surgical Quality Improvement Program (NSQIP) data reporting reoperation rates of 2.5%-5.1% for Roux-en-Y gastric bypass (RYGB) and 1.6%-3% for sleeve gastrectomy. Those analyses, however, did not include the reasons for reoperation, as these data were not available until the 2012 database release, he said.

Patrice Wendling/Frontline Medical News

With these data now in hand, lead author Dr. Mark Hanna and his fellow investigators at the University of California, Irvine, identified 36,757 adults in the 2012-2013 database who underwent RYGB (n = 19,597) or sleeve gastrectomy (n = 17,160) for morbid obesity and performed multivariate regression analyses to identify risk factors associated with reoperation.

In all, 518 RYGB patients and 231 sleeve gastrectomy patients required an unplanned return to the operating room (2.6% vs. 1.3%), Dr. Whealon said. The mean time from the index procedure to reoperation was 7.6 days and 7.1 days, respectively.

Obstruction was the biggest driver of reoperation following RYGB, accounting for 28% of reoperations. Other causes were bleeding (14.5%), leak (13%), and other unspecified reasons (18.5%), with data missing in 12%.

Bleeding was the most common indication for reoperation after sleeve gastrectomy (25.5%), followed by other unspecified reasons(24.6%), missing data (13%), leak (12.55%), and obstruction (11.2%), he said.

In adjusted multivariate analyses, factors that significantly increased the risk for reoperation were heart failure (adjusted odds ratio, 2.3), dependent functional status (aOR, 2.1), RYGB (aOR, 1.94), chronic obstructive pulmonary disease (aOR, 1.7), open operation (aOR, 1.6), and male sex (aOR, 1.1). The P values were less than .05 for all comparisons.

Factors not significant for reoperation included body mass index, age, smoking status, bleeding disorder, steroid use, dialysis, hypertension, diabetes, preoperative sepsis, emergent admission, elective operation, and preoperative weight loss.

While bariatric surgery remains a safe operation with low mortality and reoperation rates, additional studies are needed, because of the increased mortality associated with reoperation, to identify ways to mitigate these complications, Dr. Whealon said.

Limitations of the study were that ICD-9 codes for postoperative hemorrhage could not differentiate between intra-abdominal and gastrointestinal bleeding, the database is subject to coding errors, and missing data may have introduced bias into the study, he noted.

Discussant Dr. Matthew Goldblatt of the Medical College of Wisconsin in Milwaukee commented that use of the ACS MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) database would have avoided some of the coding errors for reoperation.

He also questioned whether the average 7-day return to surgery interval reflects the use of endoscopy, as few surgeons would wait that long if, as the analysis suggests, a primary reason for reoperation was postoperative bleeding.

Endoscopy was included in the reoperations, Dr. Whealon said, but he could not speak to the exact percentage it comprised.

Finally, Dr. Goldblatt said, “the patients that you identified as being the highest risk for complication, as is often the case in these reviews, are really the ones most likely to gain the most from the procedure. … So how can people avoid operating on these patients when they are the ones that can get the most out of it?”

Dr. Whealon agreed that high-risk patients have the most to gain and suggested that “optimizing their comorbid conditions before operation will help reduce their risk.”

The authors reported having no conflicts of interest.

pwendling@frontlinemedcom.com

CHICAGO – Infected ventral hernia mesh is most likely to be salvaged if it’s made from lightweight polypropylene, according to data from a series of 161 mesh infection cases at Carolinas Medical Center in Charlotte, N.C.

Investigators there were able to salvage 33% of lightweight polypropylene and 8% of polytetrafluoroethylene mesh patients, but salvage failed in patients with composite, polyester, or heavyweight polypropylene meshes. The overall salvage rate was less than 10%.

WikiMedia Commons/Zhangzhugang/Creative Commons

“We sometimes think that we’ve salvaged the mesh, but if we follow these patients long enough” – follow-up was an average of 37 months in the series – “the majority of them will need to be excised,” said investigator Dr. Vedra Augenstein of the department of surgery at the medical center.

Wound complications are common in ventral hernia repairs, and mesh infections, said Dr. Augenstein, are among “the most dreaded.” The North Carolina findings help define the small pool of patients in whom salvage might work.

The average body mass index in the series was 36 kg/m², and patients had an average of 2.6 previous ventral hernia repairs. The majority had a polypropylene mesh. Most of the cases were referred to the medical center from elsewhere, so mesh excision came an average of 10 months after the diagnosis of infection.

Almost a third of patients had their infections diagnosed a year or more after mesh implant, which goes against the common notion that mesh patients are out of the woods after a year. “It took a very long time for some of these infections to present. This was a big surprise for us,” Dr. Augenstein said.

The team tried to salvage all of their patients, using antibiotics in 90%, vacuum-assisted closure and/or debridement in 57%, and percutaneous drainage in 17%.

No patient presented with an obvious fistula, but the investigators found fistulas during surgery in about 16% of patients. Meanwhile, salvage failed in every patient who continued to smoke despite being diagnosed with a mesh infection.

The team assembled their findings into an informal algorithm for considering mesh salvage.

“Think about what you need to ask yourself. First, does the patient have a fistula or do you suspect one” from, for instance, gut bacteria in the wound or oral contrast above the mesh on CT? If so, “they are going to need an operation,” Dr. Augenstein said.

Smoking is the next stop point; salvage is likely to fail in smokers.

Mesh type is the third consideration; lightweight polypropylene is a good sign. “If they have heavyweight polypropylene, composite, or polyester mesh, they were not salvageable in our series,” she said.

For patients still in the running, Methicillin-resistant Staphylococcus aureus (MRSA) is the next concern. If it’s in the wound, mesh is going to be harder to salvage, said Dr. Augenstein. Most of the infections in the series were caused by Staphylococcus, with MRSA present in 45% of patients.

Infection recurrence is common even when salvage seems to work, so “we need to follow these patients for a very, very long time,” Dr. Augenstein said.

Along with clinical exams, the North Carolina team follows C-reactive protein and erythrocyte sedimentation rate. “If the abdomen gets red or if, for example, the C-reactive protein goes up, we’ll do a CT scan or ultrasound to make sure they are not brewing an infection,” she said.

Dr. Augenstein has received research and educational grants from Gore, Ethicon, Novadaq, Bard, and LifeCell.

aotto@frontlinemedcom.com

CHICAGO – Infected ventral hernia mesh is most likely to be salvaged if it’s made from lightweight polypropylene, according to data from a series of 161 mesh infection cases at Carolinas Medical Center in Charlotte, N.C.

Investigators there were able to salvage 33% of lightweight polypropylene and 8% of polytetrafluoroethylene mesh patients, but salvage failed in patients with composite, polyester, or heavyweight polypropylene meshes. The overall salvage rate was less than 10%.

WikiMedia Commons/Zhangzhugang/Creative Commons

“We sometimes think that we’ve salvaged the mesh, but if we follow these patients long enough” – follow-up was an average of 37 months in the series – “the majority of them will need to be excised,” said investigator Dr. Vedra Augenstein of the department of surgery at the medical center.

Wound complications are common in ventral hernia repairs, and mesh infections, said Dr. Augenstein, are among “the most dreaded.” The North Carolina findings help define the small pool of patients in whom salvage might work.

The average body mass index in the series was 36 kg/m², and patients had an average of 2.6 previous ventral hernia repairs. The majority had a polypropylene mesh. Most of the cases were referred to the medical center from elsewhere, so mesh excision came an average of 10 months after the diagnosis of infection.

Almost a third of patients had their infections diagnosed a year or more after mesh implant, which goes against the common notion that mesh patients are out of the woods after a year. “It took a very long time for some of these infections to present. This was a big surprise for us,” Dr. Augenstein said.

The team tried to salvage all of their patients, using antibiotics in 90%, vacuum-assisted closure and/or debridement in 57%, and percutaneous drainage in 17%.

No patient presented with an obvious fistula, but the investigators found fistulas during surgery in about 16% of patients. Meanwhile, salvage failed in every patient who continued to smoke despite being diagnosed with a mesh infection.

The team assembled their findings into an informal algorithm for considering mesh salvage.

“Think about what you need to ask yourself. First, does the patient have a fistula or do you suspect one” from, for instance, gut bacteria in the wound or oral contrast above the mesh on CT? If so, “they are going to need an operation,” Dr. Augenstein said.

Smoking is the next stop point; salvage is likely to fail in smokers.

Mesh type is the third consideration; lightweight polypropylene is a good sign. “If they have heavyweight polypropylene, composite, or polyester mesh, they were not salvageable in our series,” she said.

For patients still in the running, Methicillin-resistant Staphylococcus aureus (MRSA) is the next concern. If it’s in the wound, mesh is going to be harder to salvage, said Dr. Augenstein. Most of the infections in the series were caused by Staphylococcus, with MRSA present in 45% of patients.

Infection recurrence is common even when salvage seems to work, so “we need to follow these patients for a very, very long time,” Dr. Augenstein said.

Along with clinical exams, the North Carolina team follows C-reactive protein and erythrocyte sedimentation rate. “If the abdomen gets red or if, for example, the C-reactive protein goes up, we’ll do a CT scan or ultrasound to make sure they are not brewing an infection,” she said.

Dr. Augenstein has received research and educational grants from Gore, Ethicon, Novadaq, Bard, and LifeCell.

aotto@frontlinemedcom.com

CHICAGO – Infected ventral hernia mesh is most likely to be salvaged if it’s made from lightweight polypropylene, according to data from a series of 161 mesh infection cases at Carolinas Medical Center in Charlotte, N.C.

Investigators there were able to salvage 33% of lightweight polypropylene and 8% of polytetrafluoroethylene mesh patients, but salvage failed in patients with composite, polyester, or heavyweight polypropylene meshes. The overall salvage rate was less than 10%.

WikiMedia Commons/Zhangzhugang/Creative Commons

“We sometimes think that we’ve salvaged the mesh, but if we follow these patients long enough” – follow-up was an average of 37 months in the series – “the majority of them will need to be excised,” said investigator Dr. Vedra Augenstein of the department of surgery at the medical center.

Wound complications are common in ventral hernia repairs, and mesh infections, said Dr. Augenstein, are among “the most dreaded.” The North Carolina findings help define the small pool of patients in whom salvage might work.

The average body mass index in the series was 36 kg/m², and patients had an average of 2.6 previous ventral hernia repairs. The majority had a polypropylene mesh. Most of the cases were referred to the medical center from elsewhere, so mesh excision came an average of 10 months after the diagnosis of infection.

Almost a third of patients had their infections diagnosed a year or more after mesh implant, which goes against the common notion that mesh patients are out of the woods after a year. “It took a very long time for some of these infections to present. This was a big surprise for us,” Dr. Augenstein said.

The team tried to salvage all of their patients, using antibiotics in 90%, vacuum-assisted closure and/or debridement in 57%, and percutaneous drainage in 17%.

No patient presented with an obvious fistula, but the investigators found fistulas during surgery in about 16% of patients. Meanwhile, salvage failed in every patient who continued to smoke despite being diagnosed with a mesh infection.

The team assembled their findings into an informal algorithm for considering mesh salvage.

“Think about what you need to ask yourself. First, does the patient have a fistula or do you suspect one” from, for instance, gut bacteria in the wound or oral contrast above the mesh on CT? If so, “they are going to need an operation,” Dr. Augenstein said.

Smoking is the next stop point; salvage is likely to fail in smokers.

Mesh type is the third consideration; lightweight polypropylene is a good sign. “If they have heavyweight polypropylene, composite, or polyester mesh, they were not salvageable in our series,” she said.

For patients still in the running, Methicillin-resistant Staphylococcus aureus (MRSA) is the next concern. If it’s in the wound, mesh is going to be harder to salvage, said Dr. Augenstein. Most of the infections in the series were caused by Staphylococcus, with MRSA present in 45% of patients.

Infection recurrence is common even when salvage seems to work, so “we need to follow these patients for a very, very long time,” Dr. Augenstein said.

Along with clinical exams, the North Carolina team follows C-reactive protein and erythrocyte sedimentation rate. “If the abdomen gets red or if, for example, the C-reactive protein goes up, we’ll do a CT scan or ultrasound to make sure they are not brewing an infection,” she said.

Dr. Augenstein has received research and educational grants from Gore, Ethicon, Novadaq, Bard, and LifeCell.

aotto@frontlinemedcom.com

CHICAGO – Weight loss and comorbidity reduction from Roux-en-Y gastric bypass remain durable at 10 years, according to a reviewof 651 patients at the University of Virginia in Charlottesville.

Investigators checked up on their patients after a decade because “the long-term durability of this operation remains ill-defined in the American population.” Their study, likely the largest American series with 10-year follow-up, helps “to more clearly define long-term outcomes that may be achieved following performance of Roux-en-Y gastric bypass and establish a benchmark for future clinical investigation,” they said.

M. Alex Otto/Frontline Medical News

The study included 335 open and 316 laparoscopic Roux-en-Y gastric bypass (RYGB) patients. Although gastric bypass is preformed laparoscopically at the university now, the team felt comfortable including open cases in the analysis because patients and outcomes were similar in both groups. The mean preoperative body mass index, for instance, was about 53 kg/m² and the mean operative time about 230 minutes. Postoperative incisional hernia and anastomotic stenosis were more likely with open surgery.

As in other studies, weight loss peaked at 24 months, with patients shedding a mean of 74% of their excess weight. Although that had fallen to a mean of 52% at 10 years, “they still kept off half of their excess weight, which is outstanding,” investigator and general surgery resident Dr. Hunter Mehaffey said at the annual clinical congress of the American College of Surgeons.

Surgery also led to persistent reductions in obesity-related comorbidities. Before RYGB, for instance, 38% of patients had gastroesophageal reflux disease, versus 29% after 10 years. Similarly, the prevalence of degenerative joint disease fell from 61% to 32%, diabetes from 41% to 18%, obstructive sleep apnea from 36% to 16%, hypertension from 59% to 47%, pulmonary problems from 28% to 13%, and psychiatric issues from 39% to 29%. About a quarter of patients had cardiac comorbidities before RYGB, versus 16% at 10 years after surgery. The data came from chart reviews and patient interviews, and the findings were statistically significant.

Overall, patients seemed glad to have had the operation, reporting an average satisfaction score of 8.7 out of 10 points, he said, adding, “I would expect these findings to be generalizable to other institutions. This is a good, durable operation.”

Given the scope of the comorbidity reductions, “the savings in health care costs” from RYGB “are likely underestimated,” Dr. Mehaffey said.

There was another lesson from the study, as well. It took a while to track down patients for 10-year follow-up because they were no longer seeing their surgeons. “If we are not going to see these patients much after 2 years, we really have to make sure that their primary care physician knows” how to recognize and manage possible complications, such as nutritional deficiency or hypoglycemia, he said.

Dr. Mehaffey had no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

CHICAGO – Weight loss and comorbidity reduction from Roux-en-Y gastric bypass remain durable at 10 years, according to a reviewof 651 patients at the University of Virginia in Charlottesville.

Investigators checked up on their patients after a decade because “the long-term durability of this operation remains ill-defined in the American population.” Their study, likely the largest American series with 10-year follow-up, helps “to more clearly define long-term outcomes that may be achieved following performance of Roux-en-Y gastric bypass and establish a benchmark for future clinical investigation,” they said.

M. Alex Otto/Frontline Medical News

The study included 335 open and 316 laparoscopic Roux-en-Y gastric bypass (RYGB) patients. Although gastric bypass is preformed laparoscopically at the university now, the team felt comfortable including open cases in the analysis because patients and outcomes were similar in both groups. The mean preoperative body mass index, for instance, was about 53 kg/m² and the mean operative time about 230 minutes. Postoperative incisional hernia and anastomotic stenosis were more likely with open surgery.

As in other studies, weight loss peaked at 24 months, with patients shedding a mean of 74% of their excess weight. Although that had fallen to a mean of 52% at 10 years, “they still kept off half of their excess weight, which is outstanding,” investigator and general surgery resident Dr. Hunter Mehaffey said at the annual clinical congress of the American College of Surgeons.

Surgery also led to persistent reductions in obesity-related comorbidities. Before RYGB, for instance, 38% of patients had gastroesophageal reflux disease, versus 29% after 10 years. Similarly, the prevalence of degenerative joint disease fell from 61% to 32%, diabetes from 41% to 18%, obstructive sleep apnea from 36% to 16%, hypertension from 59% to 47%, pulmonary problems from 28% to 13%, and psychiatric issues from 39% to 29%. About a quarter of patients had cardiac comorbidities before RYGB, versus 16% at 10 years after surgery. The data came from chart reviews and patient interviews, and the findings were statistically significant.

Overall, patients seemed glad to have had the operation, reporting an average satisfaction score of 8.7 out of 10 points, he said, adding, “I would expect these findings to be generalizable to other institutions. This is a good, durable operation.”

Given the scope of the comorbidity reductions, “the savings in health care costs” from RYGB “are likely underestimated,” Dr. Mehaffey said.

There was another lesson from the study, as well. It took a while to track down patients for 10-year follow-up because they were no longer seeing their surgeons. “If we are not going to see these patients much after 2 years, we really have to make sure that their primary care physician knows” how to recognize and manage possible complications, such as nutritional deficiency or hypoglycemia, he said.

Dr. Mehaffey had no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

CHICAGO – Weight loss and comorbidity reduction from Roux-en-Y gastric bypass remain durable at 10 years, according to a reviewof 651 patients at the University of Virginia in Charlottesville.

Investigators checked up on their patients after a decade because “the long-term durability of this operation remains ill-defined in the American population.” Their study, likely the largest American series with 10-year follow-up, helps “to more clearly define long-term outcomes that may be achieved following performance of Roux-en-Y gastric bypass and establish a benchmark for future clinical investigation,” they said.

M. Alex Otto/Frontline Medical News

The study included 335 open and 316 laparoscopic Roux-en-Y gastric bypass (RYGB) patients. Although gastric bypass is preformed laparoscopically at the university now, the team felt comfortable including open cases in the analysis because patients and outcomes were similar in both groups. The mean preoperative body mass index, for instance, was about 53 kg/m² and the mean operative time about 230 minutes. Postoperative incisional hernia and anastomotic stenosis were more likely with open surgery.

As in other studies, weight loss peaked at 24 months, with patients shedding a mean of 74% of their excess weight. Although that had fallen to a mean of 52% at 10 years, “they still kept off half of their excess weight, which is outstanding,” investigator and general surgery resident Dr. Hunter Mehaffey said at the annual clinical congress of the American College of Surgeons.

Surgery also led to persistent reductions in obesity-related comorbidities. Before RYGB, for instance, 38% of patients had gastroesophageal reflux disease, versus 29% after 10 years. Similarly, the prevalence of degenerative joint disease fell from 61% to 32%, diabetes from 41% to 18%, obstructive sleep apnea from 36% to 16%, hypertension from 59% to 47%, pulmonary problems from 28% to 13%, and psychiatric issues from 39% to 29%. About a quarter of patients had cardiac comorbidities before RYGB, versus 16% at 10 years after surgery. The data came from chart reviews and patient interviews, and the findings were statistically significant.

Overall, patients seemed glad to have had the operation, reporting an average satisfaction score of 8.7 out of 10 points, he said, adding, “I would expect these findings to be generalizable to other institutions. This is a good, durable operation.”

Given the scope of the comorbidity reductions, “the savings in health care costs” from RYGB “are likely underestimated,” Dr. Mehaffey said.

There was another lesson from the study, as well. It took a while to track down patients for 10-year follow-up because they were no longer seeing their surgeons. “If we are not going to see these patients much after 2 years, we really have to make sure that their primary care physician knows” how to recognize and manage possible complications, such as nutritional deficiency or hypoglycemia, he said.

Dr. Mehaffey had no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

CHICAGO – Contralateral prophylactic mastectomy is more expensive and provides a lower quality of life than unilateral mastectomy in younger women with sporadic breast cancer, a cost-effectiveness analysis shows.

“Unilateral mastectomy dominated contralateral prophylactic mastectomy in the treatment of unilateral, sporadic breast cancer,” Robert C. Keskey said at the annual clinical congress of the American College of Surgeons.

Patrice Wendling/Frontline Medical News

Among these women without a family history of breast cancer, unilateral mastectomy (UM) with 20 years of routine surveillance cost an average of $5,583 less than contralateral prophylactic mastectomy (CPM) ($13,703 vs. $19,286).

Women who chose UM also gained 0.21 quality adjusted life-years (QALYs), or about 2-3 months in perfect health (21.75 vs. 21.54).

Despite a decline in contralateral breast cancers, the national rate of CPM has risen from 9.7% to 24% in women 45 years of age or younger, due in part to the Angelina Jolie effect.

CPM reduces the risk of contralateral breast cancer by up to 95%, but has not been proven to provide a survival advantage and increases complications, Mr. Keskey of the University of Louisville (Ky.) said.

Discussant Dr. Judy Boughey of the Mayo Clinic in Rochester, Minn., observed that this is the third model to tackle this important issue and that all three came up with different results and conclusions.

“This probably highlights that our models are highly dependent on the assumptions made and the costs that are involved in building the model,” she said.

The first model developed at the Mayo Clinic by Dr. Boughey and others, reported that CPM is cost effective for women younger than 70 years. However, it did not take into account reconstruction and complications (J Clin Oncol. 2011;29:2993-3000), Mr. Keskey said during his talk.

The second model showed that CPM is cost saving, but provides a lower quality of life than UM in women younger than 50 years (Ann Surg Oncol. 2014 Jul;21:2209-17). This study only provided 10-year follow-up and overestimated reconstruction and complication rates, he said.

Dr. Boughey observed that the new model did not include symmetry, which was shown to be a big driver of CPM in a separate University of Michigan survey presented during the same session.

In addition, the quality-of-life assumptions used are the same as those in the second model, but significantly different from those in the Mayo model. In that analysis, if a patient felt that their quality of life was improved by a CPM, then the CPM was clearly cost effective, Dr. Boughey noted.

“So for a patient you see in the clinic who feels their quality of life is better with a CPM than without a CPM, does this model really apply?” she asked.

Mr. Keskey replied, “I think it still does in terms of the patient understanding what they’re going to face financially. It’s an important component of the puzzle. If they’re okay spending that money because they feel that either psychologically they are going to have a better quality of life or they feel their outcomes will be positive no matter what, then I think it’s important to understand this difference in cost and use that to make their decision.”

Study details

The investigators, led by Dr. Nicolas Ajkay, also of Louisville, created a decision tree using TreeAge Pro 2015 software to analyze the long-term costs of CPM vs. UM with routine surveillance in women aged 45 years and younger with sporadic breast cancer. The model included 16 event probabilities taken from the recent literature including complications with and without reconstruction, 5- and 10-year contralateral breast cancer risk, cancer stage, and hormone-receptor status.

Effectiveness was measured by QALYs taken from surveyed breast cancer patients. Medical costs were obtained from the 2014 Medicare physician fee schedule.

Because the physician fee schedule is not all inclusive, the investigators compared CPM and UM using costs from the Healthcare Cost and Utilization Project (HCUP), which contain total costs on hospital discharge after a procedure. When this was done, CPM cost an average of $15,425 more than UM and provided a lower quality of life, Mr. Keskey said.

The investigators also replaced yearly mammography in the unilateral mastectomy group with more expensive surveillance using breast magnetic resonance imaging. In this model, CPM actually saved about $300 ($19,286 vs. $19,560), but again provided a lower quality of life (21.54 vs. 21.75), he said. It resulted in a savings of $1,300 per QALY lost, which is not enough to be deemed cost effective.

“So even using a more expensive surveillance method, contralateral prophylactic mastectomy was still not cost effective,” Mr. Keskey said.

Finally, reconstruction rates were varied to see whether this would impact outcomes. The national reconstruction rate following unilateral mastectomy is about 28%, which resulted in a lifetime cost in the initial analysis model of about $13,703.

In order to make CPM less expensive than UM, the reconstruction rate following CPM would have to be dropped to 0% ($12,580) from the national rate of 75% ($19,286), he said. Further, even if the UM reconstruction rate was hiked to 100%, the lifetime costs associated with a unilateral mastectomy were cheaper at $19,275.

Limitations of the model include the subjective nature of QALYs, the cost-effectiveness analysis is a theoretical model, and its costs need to be validated against real-world numbers, Mr. Keskey said.

During a discussion of the study, however, an attendee expressed concern that the data will be used to deny insurance coverage for women seeking a prophylactic contralateral mastectomy.

The decision to undergo prophylactic mastectomy is very personal and needs to be individualized, despite the suggestion of increased cost and less quality of life in the study, according to senior author and colleague Dr. Nicolas Ajkay.

“For some patients, the thought of repeating breast cancer treatment, though a low probability, may be unacceptable; for others, imaging surveillance may not be a reasonable option; and a patient with preexisting breast asymmetry may consider bilateral mastectomy as a way to achieve symmetry and better cosmesis,” he said in an interview. “Our objective from the inception of the study, even before analyzing the results, was that this information could be part of a patient-physician discussion, never the main factor in the decision-making process.”

The authors and Dr. Boughey reported no conflicts of interest.

pwendling@frontlinemedcom.com

CHICAGO – Contralateral prophylactic mastectomy is more expensive and provides a lower quality of life than unilateral mastectomy in younger women with sporadic breast cancer, a cost-effectiveness analysis shows.

“Unilateral mastectomy dominated contralateral prophylactic mastectomy in the treatment of unilateral, sporadic breast cancer,” Robert C. Keskey said at the annual clinical congress of the American College of Surgeons.

Patrice Wendling/Frontline Medical News

Among these women without a family history of breast cancer, unilateral mastectomy (UM) with 20 years of routine surveillance cost an average of $5,583 less than contralateral prophylactic mastectomy (CPM) ($13,703 vs. $19,286).

Women who chose UM also gained 0.21 quality adjusted life-years (QALYs), or about 2-3 months in perfect health (21.75 vs. 21.54).

Despite a decline in contralateral breast cancers, the national rate of CPM has risen from 9.7% to 24% in women 45 years of age or younger, due in part to the Angelina Jolie effect.

CPM reduces the risk of contralateral breast cancer by up to 95%, but has not been proven to provide a survival advantage and increases complications, Mr. Keskey of the University of Louisville (Ky.) said.

Discussant Dr. Judy Boughey of the Mayo Clinic in Rochester, Minn., observed that this is the third model to tackle this important issue and that all three came up with different results and conclusions.

“This probably highlights that our models are highly dependent on the assumptions made and the costs that are involved in building the model,” she said.

The first model developed at the Mayo Clinic by Dr. Boughey and others, reported that CPM is cost effective for women younger than 70 years. However, it did not take into account reconstruction and complications (J Clin Oncol. 2011;29:2993-3000), Mr. Keskey said during his talk.

The second model showed that CPM is cost saving, but provides a lower quality of life than UM in women younger than 50 years (Ann Surg Oncol. 2014 Jul;21:2209-17). This study only provided 10-year follow-up and overestimated reconstruction and complication rates, he said.

Dr. Boughey observed that the new model did not include symmetry, which was shown to be a big driver of CPM in a separate University of Michigan survey presented during the same session.

In addition, the quality-of-life assumptions used are the same as those in the second model, but significantly different from those in the Mayo model. In that analysis, if a patient felt that their quality of life was improved by a CPM, then the CPM was clearly cost effective, Dr. Boughey noted.

“So for a patient you see in the clinic who feels their quality of life is better with a CPM than without a CPM, does this model really apply?” she asked.

Mr. Keskey replied, “I think it still does in terms of the patient understanding what they’re going to face financially. It’s an important component of the puzzle. If they’re okay spending that money because they feel that either psychologically they are going to have a better quality of life or they feel their outcomes will be positive no matter what, then I think it’s important to understand this difference in cost and use that to make their decision.”

Study details

The investigators, led by Dr. Nicolas Ajkay, also of Louisville, created a decision tree using TreeAge Pro 2015 software to analyze the long-term costs of CPM vs. UM with routine surveillance in women aged 45 years and younger with sporadic breast cancer. The model included 16 event probabilities taken from the recent literature including complications with and without reconstruction, 5- and 10-year contralateral breast cancer risk, cancer stage, and hormone-receptor status.

Effectiveness was measured by QALYs taken from surveyed breast cancer patients. Medical costs were obtained from the 2014 Medicare physician fee schedule.

Because the physician fee schedule is not all inclusive, the investigators compared CPM and UM using costs from the Healthcare Cost and Utilization Project (HCUP), which contain total costs on hospital discharge after a procedure. When this was done, CPM cost an average of $15,425 more than UM and provided a lower quality of life, Mr. Keskey said.

The investigators also replaced yearly mammography in the unilateral mastectomy group with more expensive surveillance using breast magnetic resonance imaging. In this model, CPM actually saved about $300 ($19,286 vs. $19,560), but again provided a lower quality of life (21.54 vs. 21.75), he said. It resulted in a savings of $1,300 per QALY lost, which is not enough to be deemed cost effective.

“So even using a more expensive surveillance method, contralateral prophylactic mastectomy was still not cost effective,” Mr. Keskey said.

Finally, reconstruction rates were varied to see whether this would impact outcomes. The national reconstruction rate following unilateral mastectomy is about 28%, which resulted in a lifetime cost in the initial analysis model of about $13,703.

In order to make CPM less expensive than UM, the reconstruction rate following CPM would have to be dropped to 0% ($12,580) from the national rate of 75% ($19,286), he said. Further, even if the UM reconstruction rate was hiked to 100%, the lifetime costs associated with a unilateral mastectomy were cheaper at $19,275.

Limitations of the model include the subjective nature of QALYs, the cost-effectiveness analysis is a theoretical model, and its costs need to be validated against real-world numbers, Mr. Keskey said.

During a discussion of the study, however, an attendee expressed concern that the data will be used to deny insurance coverage for women seeking a prophylactic contralateral mastectomy.

The decision to undergo prophylactic mastectomy is very personal and needs to be individualized, despite the suggestion of increased cost and less quality of life in the study, according to senior author and colleague Dr. Nicolas Ajkay.

“For some patients, the thought of repeating breast cancer treatment, though a low probability, may be unacceptable; for others, imaging surveillance may not be a reasonable option; and a patient with preexisting breast asymmetry may consider bilateral mastectomy as a way to achieve symmetry and better cosmesis,” he said in an interview. “Our objective from the inception of the study, even before analyzing the results, was that this information could be part of a patient-physician discussion, never the main factor in the decision-making process.”

The authors and Dr. Boughey reported no conflicts of interest.

pwendling@frontlinemedcom.com

CHICAGO – Contralateral prophylactic mastectomy is more expensive and provides a lower quality of life than unilateral mastectomy in younger women with sporadic breast cancer, a cost-effectiveness analysis shows.

“Unilateral mastectomy dominated contralateral prophylactic mastectomy in the treatment of unilateral, sporadic breast cancer,” Robert C. Keskey said at the annual clinical congress of the American College of Surgeons.

Patrice Wendling/Frontline Medical News

Among these women without a family history of breast cancer, unilateral mastectomy (UM) with 20 years of routine surveillance cost an average of $5,583 less than contralateral prophylactic mastectomy (CPM) ($13,703 vs. $19,286).

Women who chose UM also gained 0.21 quality adjusted life-years (QALYs), or about 2-3 months in perfect health (21.75 vs. 21.54).

Despite a decline in contralateral breast cancers, the national rate of CPM has risen from 9.7% to 24% in women 45 years of age or younger, due in part to the Angelina Jolie effect.

CPM reduces the risk of contralateral breast cancer by up to 95%, but has not been proven to provide a survival advantage and increases complications, Mr. Keskey of the University of Louisville (Ky.) said.

Discussant Dr. Judy Boughey of the Mayo Clinic in Rochester, Minn., observed that this is the third model to tackle this important issue and that all three came up with different results and conclusions.

“This probably highlights that our models are highly dependent on the assumptions made and the costs that are involved in building the model,” she said.

The first model developed at the Mayo Clinic by Dr. Boughey and others, reported that CPM is cost effective for women younger than 70 years. However, it did not take into account reconstruction and complications (J Clin Oncol. 2011;29:2993-3000), Mr. Keskey said during his talk.

The second model showed that CPM is cost saving, but provides a lower quality of life than UM in women younger than 50 years (Ann Surg Oncol. 2014 Jul;21:2209-17). This study only provided 10-year follow-up and overestimated reconstruction and complication rates, he said.

Dr. Boughey observed that the new model did not include symmetry, which was shown to be a big driver of CPM in a separate University of Michigan survey presented during the same session.

In addition, the quality-of-life assumptions used are the same as those in the second model, but significantly different from those in the Mayo model. In that analysis, if a patient felt that their quality of life was improved by a CPM, then the CPM was clearly cost effective, Dr. Boughey noted.

“So for a patient you see in the clinic who feels their quality of life is better with a CPM than without a CPM, does this model really apply?” she asked.

Mr. Keskey replied, “I think it still does in terms of the patient understanding what they’re going to face financially. It’s an important component of the puzzle. If they’re okay spending that money because they feel that either psychologically they are going to have a better quality of life or they feel their outcomes will be positive no matter what, then I think it’s important to understand this difference in cost and use that to make their decision.”

Study details

The investigators, led by Dr. Nicolas Ajkay, also of Louisville, created a decision tree using TreeAge Pro 2015 software to analyze the long-term costs of CPM vs. UM with routine surveillance in women aged 45 years and younger with sporadic breast cancer. The model included 16 event probabilities taken from the recent literature including complications with and without reconstruction, 5- and 10-year contralateral breast cancer risk, cancer stage, and hormone-receptor status.

Effectiveness was measured by QALYs taken from surveyed breast cancer patients. Medical costs were obtained from the 2014 Medicare physician fee schedule.

Because the physician fee schedule is not all inclusive, the investigators compared CPM and UM using costs from the Healthcare Cost and Utilization Project (HCUP), which contain total costs on hospital discharge after a procedure. When this was done, CPM cost an average of $15,425 more than UM and provided a lower quality of life, Mr. Keskey said.

The investigators also replaced yearly mammography in the unilateral mastectomy group with more expensive surveillance using breast magnetic resonance imaging. In this model, CPM actually saved about $300 ($19,286 vs. $19,560), but again provided a lower quality of life (21.54 vs. 21.75), he said. It resulted in a savings of $1,300 per QALY lost, which is not enough to be deemed cost effective.

“So even using a more expensive surveillance method, contralateral prophylactic mastectomy was still not cost effective,” Mr. Keskey said.

Finally, reconstruction rates were varied to see whether this would impact outcomes. The national reconstruction rate following unilateral mastectomy is about 28%, which resulted in a lifetime cost in the initial analysis model of about $13,703.

In order to make CPM less expensive than UM, the reconstruction rate following CPM would have to be dropped to 0% ($12,580) from the national rate of 75% ($19,286), he said. Further, even if the UM reconstruction rate was hiked to 100%, the lifetime costs associated with a unilateral mastectomy were cheaper at $19,275.

Limitations of the model include the subjective nature of QALYs, the cost-effectiveness analysis is a theoretical model, and its costs need to be validated against real-world numbers, Mr. Keskey said.

During a discussion of the study, however, an attendee expressed concern that the data will be used to deny insurance coverage for women seeking a prophylactic contralateral mastectomy.

The decision to undergo prophylactic mastectomy is very personal and needs to be individualized, despite the suggestion of increased cost and less quality of life in the study, according to senior author and colleague Dr. Nicolas Ajkay.

“For some patients, the thought of repeating breast cancer treatment, though a low probability, may be unacceptable; for others, imaging surveillance may not be a reasonable option; and a patient with preexisting breast asymmetry may consider bilateral mastectomy as a way to achieve symmetry and better cosmesis,” he said in an interview. “Our objective from the inception of the study, even before analyzing the results, was that this information could be part of a patient-physician discussion, never the main factor in the decision-making process.”

The authors and Dr. Boughey reported no conflicts of interest.

pwendling@frontlinemedcom.com

CHICAGO – Patients receiving the LINX magnetic sphincter device for gastroesophageal reflux disease (GERD) at a community hospital have outcomes comparable with those achieved at the best academic centers, a study suggests.

“This is a safe and effective operation that, importantly, is very reproducible in the community setting,” Dr. F. Paul “Tripp” Buckley III said at the annual clinical congress of the American College of Surgeons. “Unlike a Nissen [fundoplication] where you have to have 50 [surgeries completed] to be considered an expert and then do over 35 a year to continue to have great outcomes, this is a highly teachable event and can be employed out in the community with little hesitation.”

Courtesy of Torax Medical Inc.

The magnetic sphincter augmentation device (LINX, Torax Medical) was approved in the United States in 2012 for the treatment of GERD and consists of a series of interlinked titanium-encased magnets implanted laparoscopically around the esophagus. The magnets augment a weak lower esophageal sphincter and avoid some of the complications of fundoplication, said Dr. Buckley, who disclosed serving as a proctor and speaker for Torax.

In the 5-year study leading to its approval, 64% of patients achieved the primary outcome of normalization of esophageal acid exposure or at least a 50% reduction in exposure at 1 year after sphincter augmentation and 93% of patients cut their use of proton-pump inhibitors (PPIs) by at least 50%. Six serious adverse events occurred (N Engl J Med. 2013;368:719-27).

Dr. Buckley, of Scott & White Health in Round Rock, Tex., and his associates evaluated their first 102 patients undergoing magnetic sphincter augmentation under general anesthesia at two community hospitals. GERD health-related quality of life (GERD-HRQL) scores were compared before and after surgery and overall results were compared with the clinical trial data. The highest possible total GERD-HRQL score is 75 (worst symptoms) and lowest score 0 (no symptoms).

The community and clinical trial cohorts were similar in age (median, 54 vs. 53 years), sex (both 52% male), median body mass index (both 28 kg/m²), and PPI use (98% vs. 100%), which was a requirement for trial entry.

After patients in the community underwent magnetic sphincter augmentation, PPI use decreased from 98% to 8%, median GERD-HRQL scores declined from 27 to 5, and patient satisfaction with GERD rose from 8% to 84%, which fell short of the satisfaction rate in the clinical trial (84% vs. 94%; P = .05), Dr. Buckley said.

Patrice Wendling/Frontline Medical News

The reduction in PPI use, however, was similar with that reported in the clinical trial, as was the percentage achieving at least 50% improvement in GERD-HRQL scores (86% vs. 92%), and operative times (median 49 vs. 36 minutes), he noted.

Device removal was rare at 1% in the community vs. 6% in the trial (P = .06).

Lower rates of dilation were noted in the community (9% vs. 19%; P = .04), perhaps because of refinements in technique and postoperative management, Dr. Buckley said.

“We know with this device you have to eat normally after implantation so that it will open and close within the scar capsule that’s naturally going to form,” he noted. “You have some patients that scar very tightly and you’ve got other patients that have a little bit of pain with eating and then suddenly they’re back on a liquid diet, which is a death knell for the success of this operation. So you really have to talk with these patients. I tell folks, ‘This is not a fix-it-and-forget-it type of operation.’ You’re going to get to know these patients pretty well, particularly in the early postoperative period.”

Final results recently reported with 5 years of follow-up in the clinical trial showed that 85% of patients were free from daily dependence on PPIs, heartburn was reduced from 89% to 12%, and moderate or severe regurgitation declined from 57% to 1.2%. No migrations or malfunctions occurred (J Laparoendosc Adv Surg Tech A. 2015 Oct;25[10]:787-92).

“One key aspect of this operation, and we think one of the reasons for its success and lack of migrations of the device, is that we keep the phrenoesophogeal ligament intact, so you are never in the mediastinum,” Dr. Buckley said. “For those of us who do a lot of Nissens, you end up blowing through it every time. But here when you keep it intact, you can roll it up on the distal esophagus and you can really reduce the hiatal hernia pretty significantly, even pretty large ones.”

A 3-cm cutoff was used for hiatal hernias in the trial and is recommended for early adoption in the community. A study is planned looking at hernias greater than 3 cm with no upper limit, where the minimal dissection method cannot reduce the hernia and full dissection is required, and the only requirement is that the patient have normal esophageal motility, he said.

Discussant Dr. Douglas Smink from Brigham and Women’s Hospital in Boston, said, “[There is a] lot of interest in this procedure obviously and it’s really nice to see what it’s like outside of the trials and to see your data is very similar.”

He went on to ask whether Dr. Buckley is still recommending fundoplication and, if so, in whom.

The LINX device has supplanted a classic Nissen fundoplication as the first-line operation in patients with good esophageal motility, although the device is not entirely covered by insurance, Dr. Buckley said.

“Basically, I tell patients I think it’s a marginally better operation. It’s not leaps and bounds, but it’s a marginally better operation,” he said, adding that though there has been concern about erosions, their erosion rate is zero and thus far, only seven erosions out of nearly 4,000 devices placed.

pwendling@frontlinemedcom.com

CHICAGO – Patients receiving the LINX magnetic sphincter device for gastroesophageal reflux disease (GERD) at a community hospital have outcomes comparable with those achieved at the best academic centers, a study suggests.

“This is a safe and effective operation that, importantly, is very reproducible in the community setting,” Dr. F. Paul “Tripp” Buckley III said at the annual clinical congress of the American College of Surgeons. “Unlike a Nissen [fundoplication] where you have to have 50 [surgeries completed] to be considered an expert and then do over 35 a year to continue to have great outcomes, this is a highly teachable event and can be employed out in the community with little hesitation.”

Courtesy of Torax Medical Inc.

The magnetic sphincter augmentation device (LINX, Torax Medical) was approved in the United States in 2012 for the treatment of GERD and consists of a series of interlinked titanium-encased magnets implanted laparoscopically around the esophagus. The magnets augment a weak lower esophageal sphincter and avoid some of the complications of fundoplication, said Dr. Buckley, who disclosed serving as a proctor and speaker for Torax.

In the 5-year study leading to its approval, 64% of patients achieved the primary outcome of normalization of esophageal acid exposure or at least a 50% reduction in exposure at 1 year after sphincter augmentation and 93% of patients cut their use of proton-pump inhibitors (PPIs) by at least 50%. Six serious adverse events occurred (N Engl J Med. 2013;368:719-27).

Dr. Buckley, of Scott & White Health in Round Rock, Tex., and his associates evaluated their first 102 patients undergoing magnetic sphincter augmentation under general anesthesia at two community hospitals. GERD health-related quality of life (GERD-HRQL) scores were compared before and after surgery and overall results were compared with the clinical trial data. The highest possible total GERD-HRQL score is 75 (worst symptoms) and lowest score 0 (no symptoms).

The community and clinical trial cohorts were similar in age (median, 54 vs. 53 years), sex (both 52% male), median body mass index (both 28 kg/m²), and PPI use (98% vs. 100%), which was a requirement for trial entry.

After patients in the community underwent magnetic sphincter augmentation, PPI use decreased from 98% to 8%, median GERD-HRQL scores declined from 27 to 5, and patient satisfaction with GERD rose from 8% to 84%, which fell short of the satisfaction rate in the clinical trial (84% vs. 94%; P = .05), Dr. Buckley said.

Patrice Wendling/Frontline Medical News

The reduction in PPI use, however, was similar with that reported in the clinical trial, as was the percentage achieving at least 50% improvement in GERD-HRQL scores (86% vs. 92%), and operative times (median 49 vs. 36 minutes), he noted.

Device removal was rare at 1% in the community vs. 6% in the trial (P = .06).

Lower rates of dilation were noted in the community (9% vs. 19%; P = .04), perhaps because of refinements in technique and postoperative management, Dr. Buckley said.

“We know with this device you have to eat normally after implantation so that it will open and close within the scar capsule that’s naturally going to form,” he noted. “You have some patients that scar very tightly and you’ve got other patients that have a little bit of pain with eating and then suddenly they’re back on a liquid diet, which is a death knell for the success of this operation. So you really have to talk with these patients. I tell folks, ‘This is not a fix-it-and-forget-it type of operation.’ You’re going to get to know these patients pretty well, particularly in the early postoperative period.”

Final results recently reported with 5 years of follow-up in the clinical trial showed that 85% of patients were free from daily dependence on PPIs, heartburn was reduced from 89% to 12%, and moderate or severe regurgitation declined from 57% to 1.2%. No migrations or malfunctions occurred (J Laparoendosc Adv Surg Tech A. 2015 Oct;25[10]:787-92).

“One key aspect of this operation, and we think one of the reasons for its success and lack of migrations of the device, is that we keep the phrenoesophogeal ligament intact, so you are never in the mediastinum,” Dr. Buckley said. “For those of us who do a lot of Nissens, you end up blowing through it every time. But here when you keep it intact, you can roll it up on the distal esophagus and you can really reduce the hiatal hernia pretty significantly, even pretty large ones.”

A 3-cm cutoff was used for hiatal hernias in the trial and is recommended for early adoption in the community. A study is planned looking at hernias greater than 3 cm with no upper limit, where the minimal dissection method cannot reduce the hernia and full dissection is required, and the only requirement is that the patient have normal esophageal motility, he said.

Discussant Dr. Douglas Smink from Brigham and Women’s Hospital in Boston, said, “[There is a] lot of interest in this procedure obviously and it’s really nice to see what it’s like outside of the trials and to see your data is very similar.”

He went on to ask whether Dr. Buckley is still recommending fundoplication and, if so, in whom.

The LINX device has supplanted a classic Nissen fundoplication as the first-line operation in patients with good esophageal motility, although the device is not entirely covered by insurance, Dr. Buckley said.

“Basically, I tell patients I think it’s a marginally better operation. It’s not leaps and bounds, but it’s a marginally better operation,” he said, adding that though there has been concern about erosions, their erosion rate is zero and thus far, only seven erosions out of nearly 4,000 devices placed.

pwendling@frontlinemedcom.com

CHICAGO – Patients receiving the LINX magnetic sphincter device for gastroesophageal reflux disease (GERD) at a community hospital have outcomes comparable with those achieved at the best academic centers, a study suggests.

“This is a safe and effective operation that, importantly, is very reproducible in the community setting,” Dr. F. Paul “Tripp” Buckley III said at the annual clinical congress of the American College of Surgeons. “Unlike a Nissen [fundoplication] where you have to have 50 [surgeries completed] to be considered an expert and then do over 35 a year to continue to have great outcomes, this is a highly teachable event and can be employed out in the community with little hesitation.”

Courtesy of Torax Medical Inc.

The magnetic sphincter augmentation device (LINX, Torax Medical) was approved in the United States in 2012 for the treatment of GERD and consists of a series of interlinked titanium-encased magnets implanted laparoscopically around the esophagus. The magnets augment a weak lower esophageal sphincter and avoid some of the complications of fundoplication, said Dr. Buckley, who disclosed serving as a proctor and speaker for Torax.

In the 5-year study leading to its approval, 64% of patients achieved the primary outcome of normalization of esophageal acid exposure or at least a 50% reduction in exposure at 1 year after sphincter augmentation and 93% of patients cut their use of proton-pump inhibitors (PPIs) by at least 50%. Six serious adverse events occurred (N Engl J Med. 2013;368:719-27).

Dr. Buckley, of Scott & White Health in Round Rock, Tex., and his associates evaluated their first 102 patients undergoing magnetic sphincter augmentation under general anesthesia at two community hospitals. GERD health-related quality of life (GERD-HRQL) scores were compared before and after surgery and overall results were compared with the clinical trial data. The highest possible total GERD-HRQL score is 75 (worst symptoms) and lowest score 0 (no symptoms).

The community and clinical trial cohorts were similar in age (median, 54 vs. 53 years), sex (both 52% male), median body mass index (both 28 kg/m²), and PPI use (98% vs. 100%), which was a requirement for trial entry.

After patients in the community underwent magnetic sphincter augmentation, PPI use decreased from 98% to 8%, median GERD-HRQL scores declined from 27 to 5, and patient satisfaction with GERD rose from 8% to 84%, which fell short of the satisfaction rate in the clinical trial (84% vs. 94%; P = .05), Dr. Buckley said.

Patrice Wendling/Frontline Medical News

The reduction in PPI use, however, was similar with that reported in the clinical trial, as was the percentage achieving at least 50% improvement in GERD-HRQL scores (86% vs. 92%), and operative times (median 49 vs. 36 minutes), he noted.

Device removal was rare at 1% in the community vs. 6% in the trial (P = .06).

Lower rates of dilation were noted in the community (9% vs. 19%; P = .04), perhaps because of refinements in technique and postoperative management, Dr. Buckley said.

“We know with this device you have to eat normally after implantation so that it will open and close within the scar capsule that’s naturally going to form,” he noted. “You have some patients that scar very tightly and you’ve got other patients that have a little bit of pain with eating and then suddenly they’re back on a liquid diet, which is a death knell for the success of this operation. So you really have to talk with these patients. I tell folks, ‘This is not a fix-it-and-forget-it type of operation.’ You’re going to get to know these patients pretty well, particularly in the early postoperative period.”

Final results recently reported with 5 years of follow-up in the clinical trial showed that 85% of patients were free from daily dependence on PPIs, heartburn was reduced from 89% to 12%, and moderate or severe regurgitation declined from 57% to 1.2%. No migrations or malfunctions occurred (J Laparoendosc Adv Surg Tech A. 2015 Oct;25[10]:787-92).

“One key aspect of this operation, and we think one of the reasons for its success and lack of migrations of the device, is that we keep the phrenoesophogeal ligament intact, so you are never in the mediastinum,” Dr. Buckley said. “For those of us who do a lot of Nissens, you end up blowing through it every time. But here when you keep it intact, you can roll it up on the distal esophagus and you can really reduce the hiatal hernia pretty significantly, even pretty large ones.”

A 3-cm cutoff was used for hiatal hernias in the trial and is recommended for early adoption in the community. A study is planned looking at hernias greater than 3 cm with no upper limit, where the minimal dissection method cannot reduce the hernia and full dissection is required, and the only requirement is that the patient have normal esophageal motility, he said.

Discussant Dr. Douglas Smink from Brigham and Women’s Hospital in Boston, said, “[There is a] lot of interest in this procedure obviously and it’s really nice to see what it’s like outside of the trials and to see your data is very similar.”

He went on to ask whether Dr. Buckley is still recommending fundoplication and, if so, in whom.

The LINX device has supplanted a classic Nissen fundoplication as the first-line operation in patients with good esophageal motility, although the device is not entirely covered by insurance, Dr. Buckley said.

“Basically, I tell patients I think it’s a marginally better operation. It’s not leaps and bounds, but it’s a marginally better operation,” he said, adding that though there has been concern about erosions, their erosion rate is zero and thus far, only seven erosions out of nearly 4,000 devices placed.

pwendling@frontlinemedcom.com