Patrice Wendling

NAPLES, FLA. – The Assessment of Blood Consumption score was predictive of the need for massive transfusion in 89% of major trauma patients in a comparative analysis of three popular predictive models.

Of the 373 patients admitted to a rural level I trauma center from January 2008 to December 2009, 38 (10%) received massive transfusion or at least 10 units of packed red blood cells (PRBC) within 24 hours of admission.

Of these 38 patients, 34 were predicted by the ABC score, 6 by the McLaughlin score, and only 1 by the TASH (Trauma-Associated Severe Hemorrhage) score, Dr. Nicole Krumrei said at the annual meeting of the Eastern Association for the Surgery of Trauma. This resulted in sensitivities of 89%, 15.8%, and 2.6%, respectively.

The C index was 0.86 for the ABC score, 0.56 for the McLaughlin score, and 0.51 for the TASH; specificity was 85%, 98%, and 99.7%, respectively.

Although the McLaughlin and TASH scores were highly specific, they were not predictive in the rural trauma population, and therefore they place patients at a high risk for undertriage, said Dr. Krumrei, a resident with the Mayo Clinic in Rochester, Minn. In addition, the TASH and McLaughlin scores require time-consuming blood tests and cumbersome equations.

The advantages of the ABC score are that "it uses four nonweighted parameters, it’s available within minutes of arrival to the trauma bay or possibly prearrival, [and] it’s straightforward to memorize and easy to calculate," she said.

The ABC model assigns 1 point for each "yes" to the following four elements: heart rate greater than 120 beats per minute (bpm), systolic blood pressure less than 90 mm Hg, positive results on focused assessment with sonography for trauma (FAST), and penetrating mechanism of injury. A score of 2 or more is predictive of the need for transfusion.

Dr. Krumrei pointed out that three of the four elements in the ABC score are available en route, which allows for the identification of patients requiring massive transfusion prior to arrival in the trauma bay. Of the 373 patients, 183 (49%) were interfacility transfers and 48 (13%) had penetrating injuries.

The undertriage rate with the ABC model was 11% and the overtriage rate 13% – both in the acceptable range, she said.

Mortality was significantly higher (18.4%) in patients requiring massive transfusion, compared with 5.4% in those who did not require transfusion. Massive transfusion patients were also significantly more likely to have a higher median Injury Severity Score (34 vs. 13), lower median systolic blood pressure (73.5 vs. 107 mm Hg), higher median heart rate (126 vs. 103 bpm), and lower median Glasgow Coma Scale score (5 vs. 15).

"The ABC model should be widely implemented into urban and rural trauma centers," Dr. Krumrei concluded.

All three predictive models were developed and validated in urban or military settings using studies that required only that patients receive at least one unit of PRBC during their hospital stay. The validation studies also excluded interfacility transfers, which make up a majority of trauma cases, she said. Hemorrhage is the leading cause of preventable death in trauma patients, with up to 15% of trauma patients requiring massive transfusion.

Dr. Krumrei said one of the strengths of the analysis was its diverse patient population, but acknowledged that it was limited by retrospective design, incomplete data points, and the fact that the TASH and ABC scores utilize the FAST exam, which is user dependent.

Invited discussant Dr. Jay S. Jenoff of Jefferson University Hospital in Philadelphia asked whether the results may have been affected by the use of beta-blockade and the lack of certain data necessary to calculate the TASH and McLaughlin scores.

Dr. Krumrei said that it’s unlikely the outcomes were greatly affected because beta-blockade was used in only four mass transfusion patients, and that although 46% of all patients were missing pH data, the information was available for 82% of mass transfusion patients.

When asked whether her institution uses the ABC model to counsel referring centers, Dr. Krumrei said that they do, and that they’re also working on implementing it not only within the institution, but also in its catchment area.

Dr. Krumrei, her coinvestigators, and Dr. Jenoff disclosed no conflicts of interest.

NAPLES, FLA. – The Assessment of Blood Consumption score was predictive of the need for massive transfusion in 89% of major trauma patients in a comparative analysis of three popular predictive models.

Of the 373 patients admitted to a rural level I trauma center from January 2008 to December 2009, 38 (10%) received massive transfusion or at least 10 units of packed red blood cells (PRBC) within 24 hours of admission.

Of these 38 patients, 34 were predicted by the ABC score, 6 by the McLaughlin score, and only 1 by the TASH (Trauma-Associated Severe Hemorrhage) score, Dr. Nicole Krumrei said at the annual meeting of the Eastern Association for the Surgery of Trauma. This resulted in sensitivities of 89%, 15.8%, and 2.6%, respectively.

The C index was 0.86 for the ABC score, 0.56 for the McLaughlin score, and 0.51 for the TASH; specificity was 85%, 98%, and 99.7%, respectively.

Although the McLaughlin and TASH scores were highly specific, they were not predictive in the rural trauma population, and therefore they place patients at a high risk for undertriage, said Dr. Krumrei, a resident with the Mayo Clinic in Rochester, Minn. In addition, the TASH and McLaughlin scores require time-consuming blood tests and cumbersome equations.

The advantages of the ABC score are that "it uses four nonweighted parameters, it’s available within minutes of arrival to the trauma bay or possibly prearrival, [and] it’s straightforward to memorize and easy to calculate," she said.

The ABC model assigns 1 point for each "yes" to the following four elements: heart rate greater than 120 beats per minute (bpm), systolic blood pressure less than 90 mm Hg, positive results on focused assessment with sonography for trauma (FAST), and penetrating mechanism of injury. A score of 2 or more is predictive of the need for transfusion.

Dr. Krumrei pointed out that three of the four elements in the ABC score are available en route, which allows for the identification of patients requiring massive transfusion prior to arrival in the trauma bay. Of the 373 patients, 183 (49%) were interfacility transfers and 48 (13%) had penetrating injuries.

The undertriage rate with the ABC model was 11% and the overtriage rate 13% – both in the acceptable range, she said.

Mortality was significantly higher (18.4%) in patients requiring massive transfusion, compared with 5.4% in those who did not require transfusion. Massive transfusion patients were also significantly more likely to have a higher median Injury Severity Score (34 vs. 13), lower median systolic blood pressure (73.5 vs. 107 mm Hg), higher median heart rate (126 vs. 103 bpm), and lower median Glasgow Coma Scale score (5 vs. 15).

"The ABC model should be widely implemented into urban and rural trauma centers," Dr. Krumrei concluded.

All three predictive models were developed and validated in urban or military settings using studies that required only that patients receive at least one unit of PRBC during their hospital stay. The validation studies also excluded interfacility transfers, which make up a majority of trauma cases, she said. Hemorrhage is the leading cause of preventable death in trauma patients, with up to 15% of trauma patients requiring massive transfusion.

Dr. Krumrei said one of the strengths of the analysis was its diverse patient population, but acknowledged that it was limited by retrospective design, incomplete data points, and the fact that the TASH and ABC scores utilize the FAST exam, which is user dependent.

Invited discussant Dr. Jay S. Jenoff of Jefferson University Hospital in Philadelphia asked whether the results may have been affected by the use of beta-blockade and the lack of certain data necessary to calculate the TASH and McLaughlin scores.

Dr. Krumrei said that it’s unlikely the outcomes were greatly affected because beta-blockade was used in only four mass transfusion patients, and that although 46% of all patients were missing pH data, the information was available for 82% of mass transfusion patients.

When asked whether her institution uses the ABC model to counsel referring centers, Dr. Krumrei said that they do, and that they’re also working on implementing it not only within the institution, but also in its catchment area.

Dr. Krumrei, her coinvestigators, and Dr. Jenoff disclosed no conflicts of interest.

NAPLES, FLA. – The Assessment of Blood Consumption score was predictive of the need for massive transfusion in 89% of major trauma patients in a comparative analysis of three popular predictive models.

Of the 373 patients admitted to a rural level I trauma center from January 2008 to December 2009, 38 (10%) received massive transfusion or at least 10 units of packed red blood cells (PRBC) within 24 hours of admission.

Of these 38 patients, 34 were predicted by the ABC score, 6 by the McLaughlin score, and only 1 by the TASH (Trauma-Associated Severe Hemorrhage) score, Dr. Nicole Krumrei said at the annual meeting of the Eastern Association for the Surgery of Trauma. This resulted in sensitivities of 89%, 15.8%, and 2.6%, respectively.

The C index was 0.86 for the ABC score, 0.56 for the McLaughlin score, and 0.51 for the TASH; specificity was 85%, 98%, and 99.7%, respectively.

Although the McLaughlin and TASH scores were highly specific, they were not predictive in the rural trauma population, and therefore they place patients at a high risk for undertriage, said Dr. Krumrei, a resident with the Mayo Clinic in Rochester, Minn. In addition, the TASH and McLaughlin scores require time-consuming blood tests and cumbersome equations.

The advantages of the ABC score are that "it uses four nonweighted parameters, it’s available within minutes of arrival to the trauma bay or possibly prearrival, [and] it’s straightforward to memorize and easy to calculate," she said.

The ABC model assigns 1 point for each "yes" to the following four elements: heart rate greater than 120 beats per minute (bpm), systolic blood pressure less than 90 mm Hg, positive results on focused assessment with sonography for trauma (FAST), and penetrating mechanism of injury. A score of 2 or more is predictive of the need for transfusion.

Dr. Krumrei pointed out that three of the four elements in the ABC score are available en route, which allows for the identification of patients requiring massive transfusion prior to arrival in the trauma bay. Of the 373 patients, 183 (49%) were interfacility transfers and 48 (13%) had penetrating injuries.

The undertriage rate with the ABC model was 11% and the overtriage rate 13% – both in the acceptable range, she said.

Mortality was significantly higher (18.4%) in patients requiring massive transfusion, compared with 5.4% in those who did not require transfusion. Massive transfusion patients were also significantly more likely to have a higher median Injury Severity Score (34 vs. 13), lower median systolic blood pressure (73.5 vs. 107 mm Hg), higher median heart rate (126 vs. 103 bpm), and lower median Glasgow Coma Scale score (5 vs. 15).

"The ABC model should be widely implemented into urban and rural trauma centers," Dr. Krumrei concluded.

All three predictive models were developed and validated in urban or military settings using studies that required only that patients receive at least one unit of PRBC during their hospital stay. The validation studies also excluded interfacility transfers, which make up a majority of trauma cases, she said. Hemorrhage is the leading cause of preventable death in trauma patients, with up to 15% of trauma patients requiring massive transfusion.

Dr. Krumrei said one of the strengths of the analysis was its diverse patient population, but acknowledged that it was limited by retrospective design, incomplete data points, and the fact that the TASH and ABC scores utilize the FAST exam, which is user dependent.

Invited discussant Dr. Jay S. Jenoff of Jefferson University Hospital in Philadelphia asked whether the results may have been affected by the use of beta-blockade and the lack of certain data necessary to calculate the TASH and McLaughlin scores.

Dr. Krumrei said that it’s unlikely the outcomes were greatly affected because beta-blockade was used in only four mass transfusion patients, and that although 46% of all patients were missing pH data, the information was available for 82% of mass transfusion patients.

When asked whether her institution uses the ABC model to counsel referring centers, Dr. Krumrei said that they do, and that they’re also working on implementing it not only within the institution, but also in its catchment area.

Dr. Krumrei, her coinvestigators, and Dr. Jenoff disclosed no conflicts of interest.

Use of robotic prostatectomy has mushroomed in the United States, but new data suggest it is best left in the hands of expert surgeons.

A multicenter analysis of 3,794 cases of robotic-assisted laparoscopic radical prostatectomy (RALP) performed by three experienced surgeons found that at least 1,500-1,600 cases were needed to achieve a positive surgical margin (PSM) rate of less than 10%, which is widely accepted in the surgical literature as a sign of excellence.

"We recommend that this operation should not be done by all urologists in small community hospitals, but should be focused and concentrated into those high-volume centers of excellence where the operation can be done by surgeons doing a large number of cases, very frequently, in order that they can achieve the best possible cancer-control results for their patients," lead author Dr. Prasanna Sooriakumaran said during a Feb. 15 press briefing for a symposium on genitourinary cancers.

Of the roughly 90,000 radical prostatectomies performed each year in the United States to treat prostate cancer, more than 70,000 are robot assisted and more than 70% of these are performed by surgeons who do fewer than 100 cases of RALP per year, he said.

The growing popularity of RALP was stoked by reports that the learning curve with regard to safety is around 25-40 cases. There is no good evidence in the literature, however, as to how long it takes to achieve expert level or optimal results for the patient, said Dr. Sooriakumaran, a visiting fellow in urology at the Weill Cornell Medical College in New York.

The researchers divided the cases based on surgeon experience, beginning at fewer than 50 cases and progressing to more than 1,000 cases performed. The median preoperative prostate-specific antigen level (range 4.7-5.4 ng/mL) and median age at surgery (range 60-61 years) remained relatively constant with increasing surgeon experience.

As surgeon experience increased, however, the number of patients with high-grade cancer, defined by a Gleason score of more than 7, decreased from 8.2% to 5.6%, and the number of patients with extracapsular invasion or pT3 disease decreased from 27% to 16%, suggesting that patients should have better results since the cases were getting more curable with time, Dr. Sooriakumaran said.

PSM rates for all patients start off at about 20% when surgeons begin learning the procedure, and it takes about 1,500-1,600 cases for margin rates to reach less than 10%. Notably, margin rates continue to fall beyond 1,600 cases, suggesting that the learning curve continues, even when PSM rates fall below 10%, he said.

When only patients with pT3 disease were evaluated, the learning curve starts to plateau after 1,000-1,500 cases, which is to be expected because these patients have prostate cancer outside the prostate, and therefore an operation to simply remove the prostate is more likely to leave cancer cells behind, Dr. Sooriakumaran said.

Operating times for the three surgeons started off at 3 hours and plateaued at around 2 hours after 750-1,000 cases, regardless of whether patients had extracapsular extension or not.

When asked how surgeons at community hospitals should gain experience if the procedure is limited to high-volume centers, Dr. Sooriakumaran said there has to be a balance and likened the situation to what is occurring with laparoscopic radical prostatectomy, which was popularized in the United States but was found to be a difficult operation to perform safely and is now done by only a few expert surgeons.

Press briefing moderator Dr. Nicholas Vogelzang, who is with US Oncology, said this scenario is already playing out in Las Vegas, where internal discussions among 40-45 urologists have delineated the use of RALP to 4 or 5 who will become experts in the procedure.

When asked if it was fair to extrapolate the experiences of three surgeons to all surgeons with regard to RALP proficiency, Dr. Sooriakumaran said the three physicians studied were all experienced, high-volume surgeons at centers in the United States and Europe.

The study will be formally presented at the symposium, which is sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Dr. Sooriakumaran disclosed no conflicts. Coauthor Dr. Ashutosh Tewari disclosed research funding from Intuitive Surgical Inc. Dr. Vogelzang disclosed financial relationships with multiple pharmaceutical companies.

Use of robotic prostatectomy has mushroomed in the United States, but new data suggest it is best left in the hands of expert surgeons.

A multicenter analysis of 3,794 cases of robotic-assisted laparoscopic radical prostatectomy (RALP) performed by three experienced surgeons found that at least 1,500-1,600 cases were needed to achieve a positive surgical margin (PSM) rate of less than 10%, which is widely accepted in the surgical literature as a sign of excellence.

"We recommend that this operation should not be done by all urologists in small community hospitals, but should be focused and concentrated into those high-volume centers of excellence where the operation can be done by surgeons doing a large number of cases, very frequently, in order that they can achieve the best possible cancer-control results for their patients," lead author Dr. Prasanna Sooriakumaran said during a Feb. 15 press briefing for a symposium on genitourinary cancers.

Of the roughly 90,000 radical prostatectomies performed each year in the United States to treat prostate cancer, more than 70,000 are robot assisted and more than 70% of these are performed by surgeons who do fewer than 100 cases of RALP per year, he said.

The growing popularity of RALP was stoked by reports that the learning curve with regard to safety is around 25-40 cases. There is no good evidence in the literature, however, as to how long it takes to achieve expert level or optimal results for the patient, said Dr. Sooriakumaran, a visiting fellow in urology at the Weill Cornell Medical College in New York.

The researchers divided the cases based on surgeon experience, beginning at fewer than 50 cases and progressing to more than 1,000 cases performed. The median preoperative prostate-specific antigen level (range 4.7-5.4 ng/mL) and median age at surgery (range 60-61 years) remained relatively constant with increasing surgeon experience.

As surgeon experience increased, however, the number of patients with high-grade cancer, defined by a Gleason score of more than 7, decreased from 8.2% to 5.6%, and the number of patients with extracapsular invasion or pT3 disease decreased from 27% to 16%, suggesting that patients should have better results since the cases were getting more curable with time, Dr. Sooriakumaran said.

PSM rates for all patients start off at about 20% when surgeons begin learning the procedure, and it takes about 1,500-1,600 cases for margin rates to reach less than 10%. Notably, margin rates continue to fall beyond 1,600 cases, suggesting that the learning curve continues, even when PSM rates fall below 10%, he said.

When only patients with pT3 disease were evaluated, the learning curve starts to plateau after 1,000-1,500 cases, which is to be expected because these patients have prostate cancer outside the prostate, and therefore an operation to simply remove the prostate is more likely to leave cancer cells behind, Dr. Sooriakumaran said.

Operating times for the three surgeons started off at 3 hours and plateaued at around 2 hours after 750-1,000 cases, regardless of whether patients had extracapsular extension or not.

When asked how surgeons at community hospitals should gain experience if the procedure is limited to high-volume centers, Dr. Sooriakumaran said there has to be a balance and likened the situation to what is occurring with laparoscopic radical prostatectomy, which was popularized in the United States but was found to be a difficult operation to perform safely and is now done by only a few expert surgeons.

Press briefing moderator Dr. Nicholas Vogelzang, who is with US Oncology, said this scenario is already playing out in Las Vegas, where internal discussions among 40-45 urologists have delineated the use of RALP to 4 or 5 who will become experts in the procedure.

When asked if it was fair to extrapolate the experiences of three surgeons to all surgeons with regard to RALP proficiency, Dr. Sooriakumaran said the three physicians studied were all experienced, high-volume surgeons at centers in the United States and Europe.

The study will be formally presented at the symposium, which is sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Dr. Sooriakumaran disclosed no conflicts. Coauthor Dr. Ashutosh Tewari disclosed research funding from Intuitive Surgical Inc. Dr. Vogelzang disclosed financial relationships with multiple pharmaceutical companies.

Use of robotic prostatectomy has mushroomed in the United States, but new data suggest it is best left in the hands of expert surgeons.

A multicenter analysis of 3,794 cases of robotic-assisted laparoscopic radical prostatectomy (RALP) performed by three experienced surgeons found that at least 1,500-1,600 cases were needed to achieve a positive surgical margin (PSM) rate of less than 10%, which is widely accepted in the surgical literature as a sign of excellence.

"We recommend that this operation should not be done by all urologists in small community hospitals, but should be focused and concentrated into those high-volume centers of excellence where the operation can be done by surgeons doing a large number of cases, very frequently, in order that they can achieve the best possible cancer-control results for their patients," lead author Dr. Prasanna Sooriakumaran said during a Feb. 15 press briefing for a symposium on genitourinary cancers.

Of the roughly 90,000 radical prostatectomies performed each year in the United States to treat prostate cancer, more than 70,000 are robot assisted and more than 70% of these are performed by surgeons who do fewer than 100 cases of RALP per year, he said.

The growing popularity of RALP was stoked by reports that the learning curve with regard to safety is around 25-40 cases. There is no good evidence in the literature, however, as to how long it takes to achieve expert level or optimal results for the patient, said Dr. Sooriakumaran, a visiting fellow in urology at the Weill Cornell Medical College in New York.

The researchers divided the cases based on surgeon experience, beginning at fewer than 50 cases and progressing to more than 1,000 cases performed. The median preoperative prostate-specific antigen level (range 4.7-5.4 ng/mL) and median age at surgery (range 60-61 years) remained relatively constant with increasing surgeon experience.

As surgeon experience increased, however, the number of patients with high-grade cancer, defined by a Gleason score of more than 7, decreased from 8.2% to 5.6%, and the number of patients with extracapsular invasion or pT3 disease decreased from 27% to 16%, suggesting that patients should have better results since the cases were getting more curable with time, Dr. Sooriakumaran said.

PSM rates for all patients start off at about 20% when surgeons begin learning the procedure, and it takes about 1,500-1,600 cases for margin rates to reach less than 10%. Notably, margin rates continue to fall beyond 1,600 cases, suggesting that the learning curve continues, even when PSM rates fall below 10%, he said.

When only patients with pT3 disease were evaluated, the learning curve starts to plateau after 1,000-1,500 cases, which is to be expected because these patients have prostate cancer outside the prostate, and therefore an operation to simply remove the prostate is more likely to leave cancer cells behind, Dr. Sooriakumaran said.

Operating times for the three surgeons started off at 3 hours and plateaued at around 2 hours after 750-1,000 cases, regardless of whether patients had extracapsular extension or not.

When asked how surgeons at community hospitals should gain experience if the procedure is limited to high-volume centers, Dr. Sooriakumaran said there has to be a balance and likened the situation to what is occurring with laparoscopic radical prostatectomy, which was popularized in the United States but was found to be a difficult operation to perform safely and is now done by only a few expert surgeons.

Press briefing moderator Dr. Nicholas Vogelzang, who is with US Oncology, said this scenario is already playing out in Las Vegas, where internal discussions among 40-45 urologists have delineated the use of RALP to 4 or 5 who will become experts in the procedure.

When asked if it was fair to extrapolate the experiences of three surgeons to all surgeons with regard to RALP proficiency, Dr. Sooriakumaran said the three physicians studied were all experienced, high-volume surgeons at centers in the United States and Europe.

The study will be formally presented at the symposium, which is sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Dr. Sooriakumaran disclosed no conflicts. Coauthor Dr. Ashutosh Tewari disclosed research funding from Intuitive Surgical Inc. Dr. Vogelzang disclosed financial relationships with multiple pharmaceutical companies.

Use of robotic prostatectomy has mushroomed in the United States, but new data suggest it is best left in the hands of expert surgeons.

A multicenter analysis of 3,794 cases of robotic-assisted laparoscopic radical prostatectomy (RALP) performed by three experienced surgeons found that at least 1,500-1,600 cases were needed to achieve a positive surgical margin (PSM) rate of less than 10%, which is widely accepted in the surgical literature as a sign of excellence.

"We recommend that this operation should not be done by all urologists in small community hospitals, but should be focused and concentrated into those high-volume centers of excellence where the operation can be done by surgeons doing a large number of cases, very frequently, in order that they can achieve the best possible cancer-control results for their patients," lead author Dr. Prasanna Sooriakumaran said during a Feb. 15 press briefing for a symposium on genitourinary cancers.

Of the roughly 90,000 radical prostatectomies performed each year in the United States to treat prostate cancer, more than 70,000 are robot assisted and more than 70% of these are performed by surgeons who do fewer than 100 cases of RALP per year, he said.

The growing popularity of RALP was stoked by reports that the learning curve with regard to safety is around 25-40 cases. There is no good evidence in the literature, however, as to how long it takes to achieve expert level or optimal results for the patient, said Dr. Sooriakumaran, a visiting fellow in urology at the Weill Cornell Medical College in New York.

The researchers divided the cases based on surgeon experience, beginning at fewer than 50 cases and progressing to more than 1,000 cases performed. The median preoperative prostate-specific antigen level (range 4.7-5.4 ng/mL) and median age at surgery (range 60-61 years) remained relatively constant with increasing surgeon experience.

As surgeon experience increased, however, the number of patients with high-grade cancer, defined by a Gleason score of more than 7, decreased from 8.2% to 5.6%, and the number of patients with extracapsular invasion or pT3 disease decreased from 27% to 16%, suggesting that patients should have better results since the cases were getting more curable with time, Dr. Sooriakumaran said.

PSM rates for all patients start off at about 20% when surgeons begin learning the procedure, and it takes about 1,500-1,600 cases for margin rates to reach less than 10%. Notably, margin rates continue to fall beyond 1,600 cases, suggesting that the learning curve continues, even when PSM rates fall below 10%, he said.

When only patients with pT3 disease were evaluated, the learning curve starts to plateau after 1,000-1,500 cases, which is to be expected because these patients have prostate cancer outside the prostate, and therefore an operation to simply remove the prostate is more likely to leave cancer cells behind, Dr. Sooriakumaran said.

Operating times for the three surgeons started off at 3 hours and plateaued at around 2 hours after 750-1,000 cases, regardless of whether patients had extracapsular extension or not.

When asked how surgeons at community hospitals should gain experience if the procedure is limited to high-volume centers, Dr. Sooriakumaran said there has to be a balance and likened the situation to what is occurring with laparoscopic radical prostatectomy, which was popularized in the United States but was found to be a difficult operation to perform safely and is now done by only a few expert surgeons.

Press briefing moderator Dr. Nicholas Vogelzang, who is with US Oncology, said this scenario is already playing out in Las Vegas, where internal discussions among 40-45 urologists have delineated the use of RALP to 4 or 5 who will become experts in the procedure.

When asked if it was fair to extrapolate the experiences of three surgeons to all surgeons with regard to RALP proficiency, Dr. Sooriakumaran said the three physicians studied were all experienced, high-volume surgeons at centers in the United States and Europe.

The study will be formally presented at the symposium, which is sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Dr. Sooriakumaran disclosed no conflicts. Coauthor Dr. Ashutosh Tewari disclosed research funding from Intuitive Surgical Inc. Dr. Vogelzang disclosed financial relationships with multiple pharmaceutical companies.

Use of robotic prostatectomy has mushroomed in the United States, but new data suggest it is best left in the hands of expert surgeons.

A multicenter analysis of 3,794 cases of robotic-assisted laparoscopic radical prostatectomy (RALP) performed by three experienced surgeons found that at least 1,500-1,600 cases were needed to achieve a positive surgical margin (PSM) rate of less than 10%, which is widely accepted in the surgical literature as a sign of excellence.

"We recommend that this operation should not be done by all urologists in small community hospitals, but should be focused and concentrated into those high-volume centers of excellence where the operation can be done by surgeons doing a large number of cases, very frequently, in order that they can achieve the best possible cancer-control results for their patients," lead author Dr. Prasanna Sooriakumaran said during a Feb. 15 press briefing for a symposium on genitourinary cancers.

Of the roughly 90,000 radical prostatectomies performed each year in the United States to treat prostate cancer, more than 70,000 are robot assisted and more than 70% of these are performed by surgeons who do fewer than 100 cases of RALP per year, he said.

The growing popularity of RALP was stoked by reports that the learning curve with regard to safety is around 25-40 cases. There is no good evidence in the literature, however, as to how long it takes to achieve expert level or optimal results for the patient, said Dr. Sooriakumaran, a visiting fellow in urology at the Weill Cornell Medical College in New York.

The researchers divided the cases based on surgeon experience, beginning at fewer than 50 cases and progressing to more than 1,000 cases performed. The median preoperative prostate-specific antigen level (range 4.7-5.4 ng/mL) and median age at surgery (range 60-61 years) remained relatively constant with increasing surgeon experience.

As surgeon experience increased, however, the number of patients with high-grade cancer, defined by a Gleason score of more than 7, decreased from 8.2% to 5.6%, and the number of patients with extracapsular invasion or pT3 disease decreased from 27% to 16%, suggesting that patients should have better results since the cases were getting more curable with time, Dr. Sooriakumaran said.

PSM rates for all patients start off at about 20% when surgeons begin learning the procedure, and it takes about 1,500-1,600 cases for margin rates to reach less than 10%. Notably, margin rates continue to fall beyond 1,600 cases, suggesting that the learning curve continues, even when PSM rates fall below 10%, he said.

When only patients with pT3 disease were evaluated, the learning curve starts to plateau after 1,000-1,500 cases, which is to be expected because these patients have prostate cancer outside the prostate, and therefore an operation to simply remove the prostate is more likely to leave cancer cells behind, Dr. Sooriakumaran said.

Operating times for the three surgeons started off at 3 hours and plateaued at around 2 hours after 750-1,000 cases, regardless of whether patients had extracapsular extension or not.

When asked how surgeons at community hospitals should gain experience if the procedure is limited to high-volume centers, Dr. Sooriakumaran said there has to be a balance and likened the situation to what is occurring with laparoscopic radical prostatectomy, which was popularized in the United States but was found to be a difficult operation to perform safely and is now done by only a few expert surgeons.

Press briefing moderator Dr. Nicholas Vogelzang, who is with US Oncology, said this scenario is already playing out in Las Vegas, where internal discussions among 40-45 urologists have delineated the use of RALP to 4 or 5 who will become experts in the procedure.

When asked if it was fair to extrapolate the experiences of three surgeons to all surgeons with regard to RALP proficiency, Dr. Sooriakumaran said the three physicians studied were all experienced, high-volume surgeons at centers in the United States and Europe.

The study will be formally presented at the symposium, which is sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Dr. Sooriakumaran disclosed no conflicts. Coauthor Dr. Ashutosh Tewari disclosed research funding from Intuitive Surgical Inc. Dr. Vogelzang disclosed financial relationships with multiple pharmaceutical companies.

Use of robotic prostatectomy has mushroomed in the United States, but new data suggest it is best left in the hands of expert surgeons.

A multicenter analysis of 3,794 cases of robotic-assisted laparoscopic radical prostatectomy (RALP) performed by three experienced surgeons found that at least 1,500-1,600 cases were needed to achieve a positive surgical margin (PSM) rate of less than 10%, which is widely accepted in the surgical literature as a sign of excellence.

"We recommend that this operation should not be done by all urologists in small community hospitals, but should be focused and concentrated into those high-volume centers of excellence where the operation can be done by surgeons doing a large number of cases, very frequently, in order that they can achieve the best possible cancer-control results for their patients," lead author Dr. Prasanna Sooriakumaran said during a Feb. 15 press briefing for a symposium on genitourinary cancers.

Of the roughly 90,000 radical prostatectomies performed each year in the United States to treat prostate cancer, more than 70,000 are robot assisted and more than 70% of these are performed by surgeons who do fewer than 100 cases of RALP per year, he said.

The growing popularity of RALP was stoked by reports that the learning curve with regard to safety is around 25-40 cases. There is no good evidence in the literature, however, as to how long it takes to achieve expert level or optimal results for the patient, said Dr. Sooriakumaran, a visiting fellow in urology at the Weill Cornell Medical College in New York.

The researchers divided the cases based on surgeon experience, beginning at fewer than 50 cases and progressing to more than 1,000 cases performed. The median preoperative prostate-specific antigen level (range 4.7-5.4 ng/mL) and median age at surgery (range 60-61 years) remained relatively constant with increasing surgeon experience.

As surgeon experience increased, however, the number of patients with high-grade cancer, defined by a Gleason score of more than 7, decreased from 8.2% to 5.6%, and the number of patients with extracapsular invasion or pT3 disease decreased from 27% to 16%, suggesting that patients should have better results since the cases were getting more curable with time, Dr. Sooriakumaran said.

PSM rates for all patients start off at about 20% when surgeons begin learning the procedure, and it takes about 1,500-1,600 cases for margin rates to reach less than 10%. Notably, margin rates continue to fall beyond 1,600 cases, suggesting that the learning curve continues, even when PSM rates fall below 10%, he said.

When only patients with pT3 disease were evaluated, the learning curve starts to plateau after 1,000-1,500 cases, which is to be expected because these patients have prostate cancer outside the prostate, and therefore an operation to simply remove the prostate is more likely to leave cancer cells behind, Dr. Sooriakumaran said.

Operating times for the three surgeons started off at 3 hours and plateaued at around 2 hours after 750-1,000 cases, regardless of whether patients had extracapsular extension or not.

When asked how surgeons at community hospitals should gain experience if the procedure is limited to high-volume centers, Dr. Sooriakumaran said there has to be a balance and likened the situation to what is occurring with laparoscopic radical prostatectomy, which was popularized in the United States but was found to be a difficult operation to perform safely and is now done by only a few expert surgeons.

Press briefing moderator Dr. Nicholas Vogelzang, who is with US Oncology, said this scenario is already playing out in Las Vegas, where internal discussions among 40-45 urologists have delineated the use of RALP to 4 or 5 who will become experts in the procedure.

When asked if it was fair to extrapolate the experiences of three surgeons to all surgeons with regard to RALP proficiency, Dr. Sooriakumaran said the three physicians studied were all experienced, high-volume surgeons at centers in the United States and Europe.

The study will be formally presented at the symposium, which is sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Dr. Sooriakumaran disclosed no conflicts. Coauthor Dr. Ashutosh Tewari disclosed research funding from Intuitive Surgical Inc. Dr. Vogelzang disclosed financial relationships with multiple pharmaceutical companies.

An initial prostate-specific antigen level of less than 3.0 ng/mL can be safely used to stratify men at low risk of developing prostate cancer, according to data from a large, European population-based study.

The overall risk of prostate cancer death in 15,758 middle-age and elderly men with a PSA level of less than 3.0 ng/mL was 0.14/1,000 life-years, which is 3.5-fold lower than the population-based risk of 0.49/1,000 life-years.

In addition, the risk of prostate cancer death within this low-risk group increased with higher baseline PSA values, senior investigator Monique J. Roobol, Ph.D., said during a Feb. 15 press briefing for the symposium on genitourinary cancers in Orlando, where the data will be formally presented.

Prostate-specific deaths increased fourfold among those with PSA levels between 1.0-1.9 ng/mL and 7.6-fold amongst those with PSAs between 2.0-2.9 ng/mL when they were compared with men who had an initial PSA below 1 ng/mL (0.17% vs. 0.35% vs. 04%, respectively). The median time from diagnosis to death was 8.3 years among men in the lowest PSA group.

The results justify using the PSA threshold of 3.0 ng/mL or more as an indication for biopsy and contribute to risk stratification and management of men in PSA-based screening programs, she said. For example, the favorable outcome in men with initial PSA values of less than 1.0 ng/mL supports prolonging the screening interval for up to 8 years.

Press briefing moderator Nicholas Vogelzang of US Oncology said men with a PSA value less than 1 ng/mL and probably those with a PSA less than 2 ng/mL could be considered for substantially longer intervals of PSA screening.

"I believe this study gives us some confidence that annual PSA screening is going to soon become a thing of the past," Dr. Vogelzang said.

The study, which is part of the larger European Randomized Study of Screening for Prostate Cancer, screened 19,950 men between ages 55 and 74 years and recommended biopsies only for those with PSA levels of 3.0 ng/mL or more. Cancers were identified at rescreens conducted every 4 years or clinically during screening intervals. The median follow-up was 11 years.

Of the 19,950 men screened, 15,758 (almost 80%) had a PSA level less than 3.0 ng/mL, observed Dr. Roobol, an epidemiologist in the department of urology at Erasmus University Medical Center in Rotterdam, the Netherlands. In all, 915 of the 15,758 men (5.5%) were diagnosed with prostate cancer, and 23 died (0.14%) from the disease.

Men with a PSA level of less than 1.0 ng/mL were 2.7-fold less likely than were those with a PSA of 1.0-1.9 ng/mL to develop aggressive prostate cancer, and 6.2-fold less likely to do so than were their counterparts with a PSA of 2.0-2.9 ng/mL.

When asked whether patient age at the time of the initial PSA affects the findings, Dr. Roobol acknowledged that the age range in the study was not very broad but said that the PSA range is much more predictive than age.

Fellow presenter Dr. Neil Fleshner, head of urology at the University Health Network in Toronto pointed out that growing evidence suggests that the PSA test is better in younger men than in older patients where there is confounding with benign prosthetic hyperplasia. He also noted that the entire screening process will be refined with the emergence of new biomarkers in the coming decade.

Dr. Roobol responded that the PSA is very valuable in identifying men at low risk of prostate cancer and can remove almost half of men aged 55 to 74 years from the need for continued testing. Once that’s done, clinicians can use better biomarkers to increase detection in the remaining half.

"I think PSA is a very good first step," she said.

Dr. Meelan Bul, lead author, who is also from Erasmus University Medical Center, will present the study at the symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology.

Dr. Roobol disclosed a consultant/advisory role with Bechman Coulter, GlaxoSmithKline and Gen-Probe. Coauthor Dr. Fritz H. Schroder also disclosed consulting/advising for GSK. Dr. Vogelzang disclosed relationships with multiple pharmaceutical companies.

An initial prostate-specific antigen level of less than 3.0 ng/mL can be safely used to stratify men at low risk of developing prostate cancer, according to data from a large, European population-based study.

The overall risk of prostate cancer death in 15,758 middle-age and elderly men with a PSA level of less than 3.0 ng/mL was 0.14/1,000 life-years, which is 3.5-fold lower than the population-based risk of 0.49/1,000 life-years.

In addition, the risk of prostate cancer death within this low-risk group increased with higher baseline PSA values, senior investigator Monique J. Roobol, Ph.D., said during a Feb. 15 press briefing for the symposium on genitourinary cancers in Orlando, where the data will be formally presented.

Prostate-specific deaths increased fourfold among those with PSA levels between 1.0-1.9 ng/mL and 7.6-fold amongst those with PSAs between 2.0-2.9 ng/mL when they were compared with men who had an initial PSA below 1 ng/mL (0.17% vs. 0.35% vs. 04%, respectively). The median time from diagnosis to death was 8.3 years among men in the lowest PSA group.

The results justify using the PSA threshold of 3.0 ng/mL or more as an indication for biopsy and contribute to risk stratification and management of men in PSA-based screening programs, she said. For example, the favorable outcome in men with initial PSA values of less than 1.0 ng/mL supports prolonging the screening interval for up to 8 years.

Press briefing moderator Nicholas Vogelzang of US Oncology said men with a PSA value less than 1 ng/mL and probably those with a PSA less than 2 ng/mL could be considered for substantially longer intervals of PSA screening.

"I believe this study gives us some confidence that annual PSA screening is going to soon become a thing of the past," Dr. Vogelzang said.

The study, which is part of the larger European Randomized Study of Screening for Prostate Cancer, screened 19,950 men between ages 55 and 74 years and recommended biopsies only for those with PSA levels of 3.0 ng/mL or more. Cancers were identified at rescreens conducted every 4 years or clinically during screening intervals. The median follow-up was 11 years.

Of the 19,950 men screened, 15,758 (almost 80%) had a PSA level less than 3.0 ng/mL, observed Dr. Roobol, an epidemiologist in the department of urology at Erasmus University Medical Center in Rotterdam, the Netherlands. In all, 915 of the 15,758 men (5.5%) were diagnosed with prostate cancer, and 23 died (0.14%) from the disease.

Men with a PSA level of less than 1.0 ng/mL were 2.7-fold less likely than were those with a PSA of 1.0-1.9 ng/mL to develop aggressive prostate cancer, and 6.2-fold less likely to do so than were their counterparts with a PSA of 2.0-2.9 ng/mL.

When asked whether patient age at the time of the initial PSA affects the findings, Dr. Roobol acknowledged that the age range in the study was not very broad but said that the PSA range is much more predictive than age.

Fellow presenter Dr. Neil Fleshner, head of urology at the University Health Network in Toronto pointed out that growing evidence suggests that the PSA test is better in younger men than in older patients where there is confounding with benign prosthetic hyperplasia. He also noted that the entire screening process will be refined with the emergence of new biomarkers in the coming decade.

Dr. Roobol responded that the PSA is very valuable in identifying men at low risk of prostate cancer and can remove almost half of men aged 55 to 74 years from the need for continued testing. Once that’s done, clinicians can use better biomarkers to increase detection in the remaining half.

"I think PSA is a very good first step," she said.

Dr. Meelan Bul, lead author, who is also from Erasmus University Medical Center, will present the study at the symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology.

Dr. Roobol disclosed a consultant/advisory role with Bechman Coulter, GlaxoSmithKline and Gen-Probe. Coauthor Dr. Fritz H. Schroder also disclosed consulting/advising for GSK. Dr. Vogelzang disclosed relationships with multiple pharmaceutical companies.

An initial prostate-specific antigen level of less than 3.0 ng/mL can be safely used to stratify men at low risk of developing prostate cancer, according to data from a large, European population-based study.

The overall risk of prostate cancer death in 15,758 middle-age and elderly men with a PSA level of less than 3.0 ng/mL was 0.14/1,000 life-years, which is 3.5-fold lower than the population-based risk of 0.49/1,000 life-years.

In addition, the risk of prostate cancer death within this low-risk group increased with higher baseline PSA values, senior investigator Monique J. Roobol, Ph.D., said during a Feb. 15 press briefing for the symposium on genitourinary cancers in Orlando, where the data will be formally presented.

Prostate-specific deaths increased fourfold among those with PSA levels between 1.0-1.9 ng/mL and 7.6-fold amongst those with PSAs between 2.0-2.9 ng/mL when they were compared with men who had an initial PSA below 1 ng/mL (0.17% vs. 0.35% vs. 04%, respectively). The median time from diagnosis to death was 8.3 years among men in the lowest PSA group.

The results justify using the PSA threshold of 3.0 ng/mL or more as an indication for biopsy and contribute to risk stratification and management of men in PSA-based screening programs, she said. For example, the favorable outcome in men with initial PSA values of less than 1.0 ng/mL supports prolonging the screening interval for up to 8 years.

Press briefing moderator Nicholas Vogelzang of US Oncology said men with a PSA value less than 1 ng/mL and probably those with a PSA less than 2 ng/mL could be considered for substantially longer intervals of PSA screening.

"I believe this study gives us some confidence that annual PSA screening is going to soon become a thing of the past," Dr. Vogelzang said.

The study, which is part of the larger European Randomized Study of Screening for Prostate Cancer, screened 19,950 men between ages 55 and 74 years and recommended biopsies only for those with PSA levels of 3.0 ng/mL or more. Cancers were identified at rescreens conducted every 4 years or clinically during screening intervals. The median follow-up was 11 years.

Of the 19,950 men screened, 15,758 (almost 80%) had a PSA level less than 3.0 ng/mL, observed Dr. Roobol, an epidemiologist in the department of urology at Erasmus University Medical Center in Rotterdam, the Netherlands. In all, 915 of the 15,758 men (5.5%) were diagnosed with prostate cancer, and 23 died (0.14%) from the disease.

Men with a PSA level of less than 1.0 ng/mL were 2.7-fold less likely than were those with a PSA of 1.0-1.9 ng/mL to develop aggressive prostate cancer, and 6.2-fold less likely to do so than were their counterparts with a PSA of 2.0-2.9 ng/mL.

When asked whether patient age at the time of the initial PSA affects the findings, Dr. Roobol acknowledged that the age range in the study was not very broad but said that the PSA range is much more predictive than age.

Fellow presenter Dr. Neil Fleshner, head of urology at the University Health Network in Toronto pointed out that growing evidence suggests that the PSA test is better in younger men than in older patients where there is confounding with benign prosthetic hyperplasia. He also noted that the entire screening process will be refined with the emergence of new biomarkers in the coming decade.

Dr. Roobol responded that the PSA is very valuable in identifying men at low risk of prostate cancer and can remove almost half of men aged 55 to 74 years from the need for continued testing. Once that’s done, clinicians can use better biomarkers to increase detection in the remaining half.

"I think PSA is a very good first step," she said.

Dr. Meelan Bul, lead author, who is also from Erasmus University Medical Center, will present the study at the symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology.

Dr. Roobol disclosed a consultant/advisory role with Bechman Coulter, GlaxoSmithKline and Gen-Probe. Coauthor Dr. Fritz H. Schroder also disclosed consulting/advising for GSK. Dr. Vogelzang disclosed relationships with multiple pharmaceutical companies.

An initial prostate-specific antigen level of less than 3.0 ng/mL can be safely used to stratify men at low risk of developing prostate cancer, according to data from a large, European population-based study.

The overall risk of prostate cancer death in 15,758 middle-age and elderly men with a PSA level of less than 3.0 ng/mL was 0.14/1,000 life-years, which is 3.5-fold lower than the population-based risk of 0.49/1,000 life-years.

In addition, the risk of prostate cancer death within this low-risk group increased with higher baseline PSA values, senior investigator Monique J. Roobol, Ph.D., said during a Feb. 15 press briefing for the symposium on genitourinary cancers in Orlando, where the data will be formally presented.

Prostate-specific deaths increased fourfold among those with PSA levels between 1.0-1.9 ng/mL and 7.6-fold amongst those with PSAs between 2.0-2.9 ng/mL when they were compared with men who had an initial PSA below 1 ng/mL (0.17% vs. 0.35% vs. 04%, respectively). The median time from diagnosis to death was 8.3 years among men in the lowest PSA group.

The results justify using the PSA threshold of 3.0 ng/mL or more as an indication for biopsy and contribute to risk stratification and management of men in PSA-based screening programs, she said. For example, the favorable outcome in men with initial PSA values of less than 1.0 ng/mL supports prolonging the screening interval for up to 8 years.

Press briefing moderator Nicholas Vogelzang of US Oncology said men with a PSA value less than 1 ng/mL and probably those with a PSA less than 2 ng/mL could be considered for substantially longer intervals of PSA screening.

"I believe this study gives us some confidence that annual PSA screening is going to soon become a thing of the past," Dr. Vogelzang said.

The study, which is part of the larger European Randomized Study of Screening for Prostate Cancer, screened 19,950 men between ages 55 and 74 years and recommended biopsies only for those with PSA levels of 3.0 ng/mL or more. Cancers were identified at rescreens conducted every 4 years or clinically during screening intervals. The median follow-up was 11 years.

Of the 19,950 men screened, 15,758 (almost 80%) had a PSA level less than 3.0 ng/mL, observed Dr. Roobol, an epidemiologist in the department of urology at Erasmus University Medical Center in Rotterdam, the Netherlands. In all, 915 of the 15,758 men (5.5%) were diagnosed with prostate cancer, and 23 died (0.14%) from the disease.

Men with a PSA level of less than 1.0 ng/mL were 2.7-fold less likely than were those with a PSA of 1.0-1.9 ng/mL to develop aggressive prostate cancer, and 6.2-fold less likely to do so than were their counterparts with a PSA of 2.0-2.9 ng/mL.

When asked whether patient age at the time of the initial PSA affects the findings, Dr. Roobol acknowledged that the age range in the study was not very broad but said that the PSA range is much more predictive than age.

Fellow presenter Dr. Neil Fleshner, head of urology at the University Health Network in Toronto pointed out that growing evidence suggests that the PSA test is better in younger men than in older patients where there is confounding with benign prosthetic hyperplasia. He also noted that the entire screening process will be refined with the emergence of new biomarkers in the coming decade.

Dr. Roobol responded that the PSA is very valuable in identifying men at low risk of prostate cancer and can remove almost half of men aged 55 to 74 years from the need for continued testing. Once that’s done, clinicians can use better biomarkers to increase detection in the remaining half.

"I think PSA is a very good first step," she said.

Dr. Meelan Bul, lead author, who is also from Erasmus University Medical Center, will present the study at the symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology.

Dr. Roobol disclosed a consultant/advisory role with Bechman Coulter, GlaxoSmithKline and Gen-Probe. Coauthor Dr. Fritz H. Schroder also disclosed consulting/advising for GSK. Dr. Vogelzang disclosed relationships with multiple pharmaceutical companies.

An initial prostate-specific antigen level of less than 3.0 ng/mL can be safely used to stratify men at low risk of developing prostate cancer, according to data from a large, European population-based study.

The overall risk of prostate cancer death in 15,758 middle-age and elderly men with a PSA level of less than 3.0 ng/mL was 0.14/1,000 life-years, which is 3.5-fold lower than the population-based risk of 0.49/1,000 life-years.

In addition, the risk of prostate cancer death within this low-risk group increased with higher baseline PSA values, senior investigator Monique J. Roobol, Ph.D., said during a Feb. 15 press briefing for the symposium on genitourinary cancers in Orlando, where the data will be formally presented.

Prostate-specific deaths increased fourfold among those with PSA levels between 1.0-1.9 ng/mL and 7.6-fold amongst those with PSAs between 2.0-2.9 ng/mL when they were compared with men who had an initial PSA below 1 ng/mL (0.17% vs. 0.35% vs. 04%, respectively). The median time from diagnosis to death was 8.3 years among men in the lowest PSA group.

The results justify using the PSA threshold of 3.0 ng/mL or more as an indication for biopsy and contribute to risk stratification and management of men in PSA-based screening programs, she said. For example, the favorable outcome in men with initial PSA values of less than 1.0 ng/mL supports prolonging the screening interval for up to 8 years.

Press briefing moderator Nicholas Vogelzang of US Oncology said men with a PSA value less than 1 ng/mL and probably those with a PSA less than 2 ng/mL could be considered for substantially longer intervals of PSA screening.

"I believe this study gives us some confidence that annual PSA screening is going to soon become a thing of the past," Dr. Vogelzang said.

The study, which is part of the larger European Randomized Study of Screening for Prostate Cancer, screened 19,950 men between ages 55 and 74 years and recommended biopsies only for those with PSA levels of 3.0 ng/mL or more. Cancers were identified at rescreens conducted every 4 years or clinically during screening intervals. The median follow-up was 11 years.

Of the 19,950 men screened, 15,758 (almost 80%) had a PSA level less than 3.0 ng/mL, observed Dr. Roobol, an epidemiologist in the department of urology at Erasmus University Medical Center in Rotterdam, the Netherlands. In all, 915 of the 15,758 men (5.5%) were diagnosed with prostate cancer, and 23 died (0.14%) from the disease.

Men with a PSA level of less than 1.0 ng/mL were 2.7-fold less likely than were those with a PSA of 1.0-1.9 ng/mL to develop aggressive prostate cancer, and 6.2-fold less likely to do so than were their counterparts with a PSA of 2.0-2.9 ng/mL.

When asked whether patient age at the time of the initial PSA affects the findings, Dr. Roobol acknowledged that the age range in the study was not very broad but said that the PSA range is much more predictive than age.

Fellow presenter Dr. Neil Fleshner, head of urology at the University Health Network in Toronto pointed out that growing evidence suggests that the PSA test is better in younger men than in older patients where there is confounding with benign prosthetic hyperplasia. He also noted that the entire screening process will be refined with the emergence of new biomarkers in the coming decade.

Dr. Roobol responded that the PSA is very valuable in identifying men at low risk of prostate cancer and can remove almost half of men aged 55 to 74 years from the need for continued testing. Once that’s done, clinicians can use better biomarkers to increase detection in the remaining half.

"I think PSA is a very good first step," she said.

Dr. Meelan Bul, lead author, who is also from Erasmus University Medical Center, will present the study at the symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology.

Dr. Roobol disclosed a consultant/advisory role with Bechman Coulter, GlaxoSmithKline and Gen-Probe. Coauthor Dr. Fritz H. Schroder also disclosed consulting/advising for GSK. Dr. Vogelzang disclosed relationships with multiple pharmaceutical companies.

An initial prostate-specific antigen level of less than 3.0 ng/mL can be safely used to stratify men at low risk of developing prostate cancer, according to data from a large, European population-based study.

The overall risk of prostate cancer death in 15,758 middle-age and elderly men with a PSA level of less than 3.0 ng/mL was 0.14/1,000 life-years, which is 3.5-fold lower than the population-based risk of 0.49/1,000 life-years.

In addition, the risk of prostate cancer death within this low-risk group increased with higher baseline PSA values, senior investigator Monique J. Roobol, Ph.D., said during a Feb. 15 press briefing for the symposium on genitourinary cancers in Orlando, where the data will be formally presented.

Prostate-specific deaths increased fourfold among those with PSA levels between 1.0-1.9 ng/mL and 7.6-fold amongst those with PSAs between 2.0-2.9 ng/mL when they were compared with men who had an initial PSA below 1 ng/mL (0.17% vs. 0.35% vs. 04%, respectively). The median time from diagnosis to death was 8.3 years among men in the lowest PSA group.

The results justify using the PSA threshold of 3.0 ng/mL or more as an indication for biopsy and contribute to risk stratification and management of men in PSA-based screening programs, she said. For example, the favorable outcome in men with initial PSA values of less than 1.0 ng/mL supports prolonging the screening interval for up to 8 years.

Press briefing moderator Nicholas Vogelzang of US Oncology said men with a PSA value less than 1 ng/mL and probably those with a PSA less than 2 ng/mL could be considered for substantially longer intervals of PSA screening.

"I believe this study gives us some confidence that annual PSA screening is going to soon become a thing of the past," Dr. Vogelzang said.

The study, which is part of the larger European Randomized Study of Screening for Prostate Cancer, screened 19,950 men between ages 55 and 74 years and recommended biopsies only for those with PSA levels of 3.0 ng/mL or more. Cancers were identified at rescreens conducted every 4 years or clinically during screening intervals. The median follow-up was 11 years.

Of the 19,950 men screened, 15,758 (almost 80%) had a PSA level less than 3.0 ng/mL, observed Dr. Roobol, an epidemiologist in the department of urology at Erasmus University Medical Center in Rotterdam, the Netherlands. In all, 915 of the 15,758 men (5.5%) were diagnosed with prostate cancer, and 23 died (0.14%) from the disease.

Men with a PSA level of less than 1.0 ng/mL were 2.7-fold less likely than were those with a PSA of 1.0-1.9 ng/mL to develop aggressive prostate cancer, and 6.2-fold less likely to do so than were their counterparts with a PSA of 2.0-2.9 ng/mL.

When asked whether patient age at the time of the initial PSA affects the findings, Dr. Roobol acknowledged that the age range in the study was not very broad but said that the PSA range is much more predictive than age.

Fellow presenter Dr. Neil Fleshner, head of urology at the University Health Network in Toronto pointed out that growing evidence suggests that the PSA test is better in younger men than in older patients where there is confounding with benign prosthetic hyperplasia. He also noted that the entire screening process will be refined with the emergence of new biomarkers in the coming decade.

Dr. Roobol responded that the PSA is very valuable in identifying men at low risk of prostate cancer and can remove almost half of men aged 55 to 74 years from the need for continued testing. Once that’s done, clinicians can use better biomarkers to increase detection in the remaining half.

"I think PSA is a very good first step," she said.

Dr. Meelan Bul, lead author, who is also from Erasmus University Medical Center, will present the study at the symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology.

Dr. Roobol disclosed a consultant/advisory role with Bechman Coulter, GlaxoSmithKline and Gen-Probe. Coauthor Dr. Fritz H. Schroder also disclosed consulting/advising for GSK. Dr. Vogelzang disclosed relationships with multiple pharmaceutical companies.

NAPLES, Fla. – Episodes as brief as 5 minutes of severe intracranial hypertension and moderate to severe cerebral hypoperfusion were associated with worse outcome in patients with severe traumatic brain injury in a single-center analysis of 60 patients.

"Perhaps aggressive efforts to prevent these episodes, rather than merely react to them, are warranted," lead author Dr. Deborah M. Stein said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Treatment of intracranial hypertension (ICH) and cerebral hypoperfusion (CH) is typically initiated only when certain thresholds are reached, and brief episodes are largely ignored. Even in the most efficient of ICUs, however, it takes more than 5 minutes to initiate and achieve successful therapy for these insults.

Manual end-hour recordings are traditionally used to document ICH and CH, but recent work has shown that continuous automated monitoring might detect more ICH and is more closely correlated with outcome than are manual end-hour recordings, said Dr. Stein, director of neurotrauma critical care and chief of trauma critical care at the University of Maryland Medical Center in Baltimore.

Using a continuous vital signs data recorder, the researchers captured vital sign waveforms every 6 seconds for 60 patients with a head Abbreviated Injury Scale score of 3 or greater (mean, 4.2) requiring intracranial pressure (ICP) monitoring at the shock trauma center. The 5-minute means were calculated for ICP, cerebral perfusion pressure (CPP), and episodes of combined insult, measured by the Brain Trauma Index (BTI). All traces were visually reviewed and confirmed by a physician.

At admission, the prospectively enrolled cohort had a mean Injury Severity Scale score of 28.5, a mean Marshall Scale score of 2.5, and a mean Glasgow Coma Scale score of 6.4. Their average age was 34 years (range, 16-83 years), 85% were male, and 97% had blunt trauma injuries.

Eight patients (13%) died within 30 days of hospitalization. In all, 37 patients had a favorable functional outcome (defined by a Glasgow Outcome Scale–Extended score of 5-8) at 6 months, and 23 patients, including the 8 who died, had a poor outcome (defined as a GOSE score of 1-4), Dr. Stein said.

Patients with poor functional outcome had a significantly greater number of brief, 5-minute episodes per day than did patients with a favorable outcome of intracranial pressure greater than 30 mm Hg (mean, 0.5 vs. 0.3), cerebral perfusion pressure less than 50 mm Hg (mean, 0.7 vs. 0.3), CPP less than 60 mm Hg (mean, 1.1 vs. 0.7), brain trauma index score of less than 2 (mean, 0.7 vs. 0.3), and BTI less than 3 (1.1 vs. 0.6).

"This study demonstrates that these brief episodes, previously thought to be relatively benign, may in fact play a significant role," Dr. Stein said.

Invited discussant Dr. Michael Ditillo, a surgeon from Yale University in New Haven, Conn., asked whether the brief episodes are a cause of or a marker for worse outcomes, and how the data have affected bedside management.

Dr. Stein said the retrospective nature of the analysis did not allow for demonstration of cause and effect, but she conjectured that the brief episodes of ICH and CH probably are markers of disease severity.

"The analogy that I make is that we don’t ignore episodes of hypoxia or hypotension in our patients, however brief," she said. "We don’t turn down the ventilator and check to see if the patient is hypoxic, but for some reason with brain injury, we do have that tendency."

As a result of the findings, Dr. Stein said she is more aggressive about trying to prevent these episodes, particularly in patients with poor intracranial compliance. Her strategy includes more aggressive management of sodium levels, continuous drainage of cerebrospinal fluid, and better sedation during bedside procedures.

In some situations, transient episodes of ICH and CH are almost a medical necessity, such as neurological "wake-up tests," sedation vacations, bedside or operative procedures, and extraventricular drain clamping. Yet to be determined is whether there is a subset of patients at higher risk of episodic insults for whom these procedures and examinations might be more detrimental than beneficial, Dr. Stein said.

Dr. Stein reported a U.S. Department of Defense grant. Dr. Ditillo reported no conflicts.

NAPLES, Fla. – Episodes as brief as 5 minutes of severe intracranial hypertension and moderate to severe cerebral hypoperfusion were associated with worse outcome in patients with severe traumatic brain injury in a single-center analysis of 60 patients.

"Perhaps aggressive efforts to prevent these episodes, rather than merely react to them, are warranted," lead author Dr. Deborah M. Stein said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Treatment of intracranial hypertension (ICH) and cerebral hypoperfusion (CH) is typically initiated only when certain thresholds are reached, and brief episodes are largely ignored. Even in the most efficient of ICUs, however, it takes more than 5 minutes to initiate and achieve successful therapy for these insults.

Manual end-hour recordings are traditionally used to document ICH and CH, but recent work has shown that continuous automated monitoring might detect more ICH and is more closely correlated with outcome than are manual end-hour recordings, said Dr. Stein, director of neurotrauma critical care and chief of trauma critical care at the University of Maryland Medical Center in Baltimore.

Using a continuous vital signs data recorder, the researchers captured vital sign waveforms every 6 seconds for 60 patients with a head Abbreviated Injury Scale score of 3 or greater (mean, 4.2) requiring intracranial pressure (ICP) monitoring at the shock trauma center. The 5-minute means were calculated for ICP, cerebral perfusion pressure (CPP), and episodes of combined insult, measured by the Brain Trauma Index (BTI). All traces were visually reviewed and confirmed by a physician.

At admission, the prospectively enrolled cohort had a mean Injury Severity Scale score of 28.5, a mean Marshall Scale score of 2.5, and a mean Glasgow Coma Scale score of 6.4. Their average age was 34 years (range, 16-83 years), 85% were male, and 97% had blunt trauma injuries.

Eight patients (13%) died within 30 days of hospitalization. In all, 37 patients had a favorable functional outcome (defined by a Glasgow Outcome Scale–Extended score of 5-8) at 6 months, and 23 patients, including the 8 who died, had a poor outcome (defined as a GOSE score of 1-4), Dr. Stein said.

Patients with poor functional outcome had a significantly greater number of brief, 5-minute episodes per day than did patients with a favorable outcome of intracranial pressure greater than 30 mm Hg (mean, 0.5 vs. 0.3), cerebral perfusion pressure less than 50 mm Hg (mean, 0.7 vs. 0.3), CPP less than 60 mm Hg (mean, 1.1 vs. 0.7), brain trauma index score of less than 2 (mean, 0.7 vs. 0.3), and BTI less than 3 (1.1 vs. 0.6).

"This study demonstrates that these brief episodes, previously thought to be relatively benign, may in fact play a significant role," Dr. Stein said.

Invited discussant Dr. Michael Ditillo, a surgeon from Yale University in New Haven, Conn., asked whether the brief episodes are a cause of or a marker for worse outcomes, and how the data have affected bedside management.

Dr. Stein said the retrospective nature of the analysis did not allow for demonstration of cause and effect, but she conjectured that the brief episodes of ICH and CH probably are markers of disease severity.

"The analogy that I make is that we don’t ignore episodes of hypoxia or hypotension in our patients, however brief," she said. "We don’t turn down the ventilator and check to see if the patient is hypoxic, but for some reason with brain injury, we do have that tendency."

As a result of the findings, Dr. Stein said she is more aggressive about trying to prevent these episodes, particularly in patients with poor intracranial compliance. Her strategy includes more aggressive management of sodium levels, continuous drainage of cerebrospinal fluid, and better sedation during bedside procedures.

In some situations, transient episodes of ICH and CH are almost a medical necessity, such as neurological "wake-up tests," sedation vacations, bedside or operative procedures, and extraventricular drain clamping. Yet to be determined is whether there is a subset of patients at higher risk of episodic insults for whom these procedures and examinations might be more detrimental than beneficial, Dr. Stein said.

Dr. Stein reported a U.S. Department of Defense grant. Dr. Ditillo reported no conflicts.

NAPLES, Fla. – Episodes as brief as 5 minutes of severe intracranial hypertension and moderate to severe cerebral hypoperfusion were associated with worse outcome in patients with severe traumatic brain injury in a single-center analysis of 60 patients.

"Perhaps aggressive efforts to prevent these episodes, rather than merely react to them, are warranted," lead author Dr. Deborah M. Stein said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Treatment of intracranial hypertension (ICH) and cerebral hypoperfusion (CH) is typically initiated only when certain thresholds are reached, and brief episodes are largely ignored. Even in the most efficient of ICUs, however, it takes more than 5 minutes to initiate and achieve successful therapy for these insults.

Manual end-hour recordings are traditionally used to document ICH and CH, but recent work has shown that continuous automated monitoring might detect more ICH and is more closely correlated with outcome than are manual end-hour recordings, said Dr. Stein, director of neurotrauma critical care and chief of trauma critical care at the University of Maryland Medical Center in Baltimore.

Using a continuous vital signs data recorder, the researchers captured vital sign waveforms every 6 seconds for 60 patients with a head Abbreviated Injury Scale score of 3 or greater (mean, 4.2) requiring intracranial pressure (ICP) monitoring at the shock trauma center. The 5-minute means were calculated for ICP, cerebral perfusion pressure (CPP), and episodes of combined insult, measured by the Brain Trauma Index (BTI). All traces were visually reviewed and confirmed by a physician.

At admission, the prospectively enrolled cohort had a mean Injury Severity Scale score of 28.5, a mean Marshall Scale score of 2.5, and a mean Glasgow Coma Scale score of 6.4. Their average age was 34 years (range, 16-83 years), 85% were male, and 97% had blunt trauma injuries.

Eight patients (13%) died within 30 days of hospitalization. In all, 37 patients had a favorable functional outcome (defined by a Glasgow Outcome Scale–Extended score of 5-8) at 6 months, and 23 patients, including the 8 who died, had a poor outcome (defined as a GOSE score of 1-4), Dr. Stein said.

Patients with poor functional outcome had a significantly greater number of brief, 5-minute episodes per day than did patients with a favorable outcome of intracranial pressure greater than 30 mm Hg (mean, 0.5 vs. 0.3), cerebral perfusion pressure less than 50 mm Hg (mean, 0.7 vs. 0.3), CPP less than 60 mm Hg (mean, 1.1 vs. 0.7), brain trauma index score of less than 2 (mean, 0.7 vs. 0.3), and BTI less than 3 (1.1 vs. 0.6).

"This study demonstrates that these brief episodes, previously thought to be relatively benign, may in fact play a significant role," Dr. Stein said.

Invited discussant Dr. Michael Ditillo, a surgeon from Yale University in New Haven, Conn., asked whether the brief episodes are a cause of or a marker for worse outcomes, and how the data have affected bedside management.

Dr. Stein said the retrospective nature of the analysis did not allow for demonstration of cause and effect, but she conjectured that the brief episodes of ICH and CH probably are markers of disease severity.

"The analogy that I make is that we don’t ignore episodes of hypoxia or hypotension in our patients, however brief," she said. "We don’t turn down the ventilator and check to see if the patient is hypoxic, but for some reason with brain injury, we do have that tendency."

As a result of the findings, Dr. Stein said she is more aggressive about trying to prevent these episodes, particularly in patients with poor intracranial compliance. Her strategy includes more aggressive management of sodium levels, continuous drainage of cerebrospinal fluid, and better sedation during bedside procedures.

In some situations, transient episodes of ICH and CH are almost a medical necessity, such as neurological "wake-up tests," sedation vacations, bedside or operative procedures, and extraventricular drain clamping. Yet to be determined is whether there is a subset of patients at higher risk of episodic insults for whom these procedures and examinations might be more detrimental than beneficial, Dr. Stein said.

Dr. Stein reported a U.S. Department of Defense grant. Dr. Ditillo reported no conflicts.

NAPLES, Fla. – Episodes as brief as 5 minutes of severe intracranial hypertension and moderate to severe cerebral hypoperfusion were associated with worse outcome in patients with severe traumatic brain injury in a single-center analysis of 60 patients.

"Perhaps aggressive efforts to prevent these episodes, rather than merely react to them, are warranted," lead author Dr. Deborah M. Stein said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Treatment of intracranial hypertension (ICH) and cerebral hypoperfusion (CH) is typically initiated only when certain thresholds are reached, and brief episodes are largely ignored. Even in the most efficient of ICUs, however, it takes more than 5 minutes to initiate and achieve successful therapy for these insults.

Manual end-hour recordings are traditionally used to document ICH and CH, but recent work has shown that continuous automated monitoring might detect more ICH and is more closely correlated with outcome than are manual end-hour recordings, said Dr. Stein, director of neurotrauma critical care and chief of trauma critical care at the University of Maryland Medical Center in Baltimore.

Using a continuous vital signs data recorder, the researchers captured vital sign waveforms every 6 seconds for 60 patients with a head Abbreviated Injury Scale score of 3 or greater (mean, 4.2) requiring intracranial pressure (ICP) monitoring at the shock trauma center. The 5-minute means were calculated for ICP, cerebral perfusion pressure (CPP), and episodes of combined insult, measured by the Brain Trauma Index (BTI). All traces were visually reviewed and confirmed by a physician.

At admission, the prospectively enrolled cohort had a mean Injury Severity Scale score of 28.5, a mean Marshall Scale score of 2.5, and a mean Glasgow Coma Scale score of 6.4. Their average age was 34 years (range, 16-83 years), 85% were male, and 97% had blunt trauma injuries.

Eight patients (13%) died within 30 days of hospitalization. In all, 37 patients had a favorable functional outcome (defined by a Glasgow Outcome Scale–Extended score of 5-8) at 6 months, and 23 patients, including the 8 who died, had a poor outcome (defined as a GOSE score of 1-4), Dr. Stein said.

Patients with poor functional outcome had a significantly greater number of brief, 5-minute episodes per day than did patients with a favorable outcome of intracranial pressure greater than 30 mm Hg (mean, 0.5 vs. 0.3), cerebral perfusion pressure less than 50 mm Hg (mean, 0.7 vs. 0.3), CPP less than 60 mm Hg (mean, 1.1 vs. 0.7), brain trauma index score of less than 2 (mean, 0.7 vs. 0.3), and BTI less than 3 (1.1 vs. 0.6).

"This study demonstrates that these brief episodes, previously thought to be relatively benign, may in fact play a significant role," Dr. Stein said.

Invited discussant Dr. Michael Ditillo, a surgeon from Yale University in New Haven, Conn., asked whether the brief episodes are a cause of or a marker for worse outcomes, and how the data have affected bedside management.

Dr. Stein said the retrospective nature of the analysis did not allow for demonstration of cause and effect, but she conjectured that the brief episodes of ICH and CH probably are markers of disease severity.

"The analogy that I make is that we don’t ignore episodes of hypoxia or hypotension in our patients, however brief," she said. "We don’t turn down the ventilator and check to see if the patient is hypoxic, but for some reason with brain injury, we do have that tendency."

As a result of the findings, Dr. Stein said she is more aggressive about trying to prevent these episodes, particularly in patients with poor intracranial compliance. Her strategy includes more aggressive management of sodium levels, continuous drainage of cerebrospinal fluid, and better sedation during bedside procedures.

In some situations, transient episodes of ICH and CH are almost a medical necessity, such as neurological "wake-up tests," sedation vacations, bedside or operative procedures, and extraventricular drain clamping. Yet to be determined is whether there is a subset of patients at higher risk of episodic insults for whom these procedures and examinations might be more detrimental than beneficial, Dr. Stein said.

Dr. Stein reported a U.S. Department of Defense grant. Dr. Ditillo reported no conflicts.

NAPLES, Fla. – Episodes as brief as 5 minutes of severe intracranial hypertension and moderate to severe cerebral hypoperfusion were associated with worse outcome in patients with severe traumatic brain injury in a single-center analysis of 60 patients.

"Perhaps aggressive efforts to prevent these episodes, rather than merely react to them, are warranted," lead author Dr. Deborah M. Stein said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Treatment of intracranial hypertension (ICH) and cerebral hypoperfusion (CH) is typically initiated only when certain thresholds are reached, and brief episodes are largely ignored. Even in the most efficient of ICUs, however, it takes more than 5 minutes to initiate and achieve successful therapy for these insults.

Manual end-hour recordings are traditionally used to document ICH and CH, but recent work has shown that continuous automated monitoring might detect more ICH and is more closely correlated with outcome than are manual end-hour recordings, said Dr. Stein, director of neurotrauma critical care and chief of trauma critical care at the University of Maryland Medical Center in Baltimore.

Using a continuous vital signs data recorder, the researchers captured vital sign waveforms every 6 seconds for 60 patients with a head Abbreviated Injury Scale score of 3 or greater (mean, 4.2) requiring intracranial pressure (ICP) monitoring at the shock trauma center. The 5-minute means were calculated for ICP, cerebral perfusion pressure (CPP), and episodes of combined insult, measured by the Brain Trauma Index (BTI). All traces were visually reviewed and confirmed by a physician.

At admission, the prospectively enrolled cohort had a mean Injury Severity Scale score of 28.5, a mean Marshall Scale score of 2.5, and a mean Glasgow Coma Scale score of 6.4. Their average age was 34 years (range, 16-83 years), 85% were male, and 97% had blunt trauma injuries.

Eight patients (13%) died within 30 days of hospitalization. In all, 37 patients had a favorable functional outcome (defined by a Glasgow Outcome Scale–Extended score of 5-8) at 6 months, and 23 patients, including the 8 who died, had a poor outcome (defined as a GOSE score of 1-4), Dr. Stein said.

Patients with poor functional outcome had a significantly greater number of brief, 5-minute episodes per day than did patients with a favorable outcome of intracranial pressure greater than 30 mm Hg (mean, 0.5 vs. 0.3), cerebral perfusion pressure less than 50 mm Hg (mean, 0.7 vs. 0.3), CPP less than 60 mm Hg (mean, 1.1 vs. 0.7), brain trauma index score of less than 2 (mean, 0.7 vs. 0.3), and BTI less than 3 (1.1 vs. 0.6).

"This study demonstrates that these brief episodes, previously thought to be relatively benign, may in fact play a significant role," Dr. Stein said.

Invited discussant Dr. Michael Ditillo, a surgeon from Yale University in New Haven, Conn., asked whether the brief episodes are a cause of or a marker for worse outcomes, and how the data have affected bedside management.

Dr. Stein said the retrospective nature of the analysis did not allow for demonstration of cause and effect, but she conjectured that the brief episodes of ICH and CH probably are markers of disease severity.

"The analogy that I make is that we don’t ignore episodes of hypoxia or hypotension in our patients, however brief," she said. "We don’t turn down the ventilator and check to see if the patient is hypoxic, but for some reason with brain injury, we do have that tendency."

As a result of the findings, Dr. Stein said she is more aggressive about trying to prevent these episodes, particularly in patients with poor intracranial compliance. Her strategy includes more aggressive management of sodium levels, continuous drainage of cerebrospinal fluid, and better sedation during bedside procedures.

In some situations, transient episodes of ICH and CH are almost a medical necessity, such as neurological "wake-up tests," sedation vacations, bedside or operative procedures, and extraventricular drain clamping. Yet to be determined is whether there is a subset of patients at higher risk of episodic insults for whom these procedures and examinations might be more detrimental than beneficial, Dr. Stein said.

Dr. Stein reported a U.S. Department of Defense grant. Dr. Ditillo reported no conflicts.

NAPLES, Fla. – Episodes as brief as 5 minutes of severe intracranial hypertension and moderate to severe cerebral hypoperfusion were associated with worse outcome in patients with severe traumatic brain injury in a single-center analysis of 60 patients.

"Perhaps aggressive efforts to prevent these episodes, rather than merely react to them, are warranted," lead author Dr. Deborah M. Stein said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Treatment of intracranial hypertension (ICH) and cerebral hypoperfusion (CH) is typically initiated only when certain thresholds are reached, and brief episodes are largely ignored. Even in the most efficient of ICUs, however, it takes more than 5 minutes to initiate and achieve successful therapy for these insults.

Manual end-hour recordings are traditionally used to document ICH and CH, but recent work has shown that continuous automated monitoring might detect more ICH and is more closely correlated with outcome than are manual end-hour recordings, said Dr. Stein, director of neurotrauma critical care and chief of trauma critical care at the University of Maryland Medical Center in Baltimore.

Using a continuous vital signs data recorder, the researchers captured vital sign waveforms every 6 seconds for 60 patients with a head Abbreviated Injury Scale score of 3 or greater (mean, 4.2) requiring intracranial pressure (ICP) monitoring at the shock trauma center. The 5-minute means were calculated for ICP, cerebral perfusion pressure (CPP), and episodes of combined insult, measured by the Brain Trauma Index (BTI). All traces were visually reviewed and confirmed by a physician.

At admission, the prospectively enrolled cohort had a mean Injury Severity Scale score of 28.5, a mean Marshall Scale score of 2.5, and a mean Glasgow Coma Scale score of 6.4. Their average age was 34 years (range, 16-83 years), 85% were male, and 97% had blunt trauma injuries.

Eight patients (13%) died within 30 days of hospitalization. In all, 37 patients had a favorable functional outcome (defined by a Glasgow Outcome Scale–Extended score of 5-8) at 6 months, and 23 patients, including the 8 who died, had a poor outcome (defined as a GOSE score of 1-4), Dr. Stein said.

Patients with poor functional outcome had a significantly greater number of brief, 5-minute episodes per day than did patients with a favorable outcome of intracranial pressure greater than 30 mm Hg (mean, 0.5 vs. 0.3), cerebral perfusion pressure less than 50 mm Hg (mean, 0.7 vs. 0.3), CPP less than 60 mm Hg (mean, 1.1 vs. 0.7), brain trauma index score of less than 2 (mean, 0.7 vs. 0.3), and BTI less than 3 (1.1 vs. 0.6).

"This study demonstrates that these brief episodes, previously thought to be relatively benign, may in fact play a significant role," Dr. Stein said.

Invited discussant Dr. Michael Ditillo, a surgeon from Yale University in New Haven, Conn., asked whether the brief episodes are a cause of or a marker for worse outcomes, and how the data have affected bedside management.

Dr. Stein said the retrospective nature of the analysis did not allow for demonstration of cause and effect, but she conjectured that the brief episodes of ICH and CH probably are markers of disease severity.

"The analogy that I make is that we don’t ignore episodes of hypoxia or hypotension in our patients, however brief," she said. "We don’t turn down the ventilator and check to see if the patient is hypoxic, but for some reason with brain injury, we do have that tendency."

As a result of the findings, Dr. Stein said she is more aggressive about trying to prevent these episodes, particularly in patients with poor intracranial compliance. Her strategy includes more aggressive management of sodium levels, continuous drainage of cerebrospinal fluid, and better sedation during bedside procedures.

In some situations, transient episodes of ICH and CH are almost a medical necessity, such as neurological "wake-up tests," sedation vacations, bedside or operative procedures, and extraventricular drain clamping. Yet to be determined is whether there is a subset of patients at higher risk of episodic insults for whom these procedures and examinations might be more detrimental than beneficial, Dr. Stein said.

Dr. Stein reported a U.S. Department of Defense grant. Dr. Ditillo reported no conflicts.

NAPLES, Fla. – Patients who underwent surgical rib fixation for flail chest spent on average 10 fewer days on mechanical ventilation than did those managed traditionally in a single-center analysis of 21 patients with severe blunt chest trauma.

The total number of ventilator days was significantly lower in patients who underwent rib fixation, at a median of 4.5 days (range 0-30 days), compared with a median of 16 days (range 4-40 days) in those managed with pain control and respiratory therapy (P = .04).

Hospital length of stay was a median of 22 days in the nonsurgical group vs. 13 days in the surgical group, and ICU length of stay was a median of 18 days vs. 9 days, but those differences were not statistically significant. There was one postoperative seroma and no deaths in the surgical group.

Surgical rib fixation can be used as a rescue technique when the last resort is prolonged mechanical ventilation, but a large multicenter trial is needed to determine the best approach, Dr. Andrew R. Doben said at the annual meeting of the Eastern Association for the Surgery of Trauma.

"This study provides some of the first data suggesting that surgical fixation may prevent prolonged ventilation in flail chest patients who initially do not require invasive mechanical ventilation," he said in an interview.

Dr. Doben pointed out that major trauma centers see roughly two flail chest injuries per month and that up to 60% of patients do not return to full-time employment. A prospective randomized trial showed benefits with surgical stabilization with Judet struts, compared with internal pneumatic stabilization (J. Trauma 2002;52:727-32), but that trial included only 18 fixation patients and all required invasive mechanical ventilation, he said.

Dr. Doben and his colleagues at the Medical University of South Carolina, Charleston, defined flail chest deformity as three consecutive ribs broken in two or more locations, and they initially focused on patients who failed to wean from the ventilator 5 days post injury, had isolated chest wall trauma, and had good neurologic status. Surgical fixation using a combination of plates and intramedullary nails in three such patients produced positive results similar to those in the literature, but raised the question of whether mechanical ventilation could be avoided in patients who are failing, Dr. Doben said.

"Everybody’s seen these patients – the ‘in-betweeners’ – they’re not really failing, they’re not yet vented, but they’re heading that way," he said.

Dr. Doben highlighted the case of a 60-year-old man with seven total rib fractures including five segmental fractures and paradoxical chest wall motion, who had an epidural in place, was on oxycodone, NSAIDs, acetaminophen, and gabapentin, and was experiencing progressive pulmonary decline on bilevel positive airway pressure therapy for 3 days in the ICU. The patient underwent surgical rib fixation on hospital day 6, was mechanically ventilated overnight, and was extubated the following morning. He was discharged to home on hospital day 11, with no long-acting narcotics needed for pain, he said.

The retrospective chart review included the first 10 patients treated with surgical fixation from September 2008 to May 2010, matched with a previous group of 11 patients managed with standard therapy. Patients were required to have a Chest Abbreviated Injury Scale score of more than 3, a diagnosis of flail chest, and an ICU length of stay greater than 5 days. There were no surgical complications, and the average time on a ventilator after surgery was 1.5 days, said Dr. Doben, now with Baystate Medical Center in Springfield, Mass.

Invited discussant Dr. John C. Mayberry said no strong conclusions supporting flail chest repair can be drawn because of the small study size, but commended the authors for providing new data on its use in patients who do not require ventilation, but clinically worsen.

Dr. Mayberry, with Oregon Health and Science University in Portland, asked whether the study protocol evolved over time, and whether the 10 fixation patients represent the authors’ first experience with the technique. This line of questioning was continued by an audience member who asked what kind of course work prepared the authors to perform rib fixation.

Dr. Doben responded that he had limited experience with chest repairs as a general surgery resident in Maine, but that these were indeed the first 10 rib fixation patients in Charleston. The surgeries in both Maine and Charleston were performed in conjunction with cardiothoracic and orthopedic surgeons who had expertise in hardware insertion, he noted.

With respect to the study protocol, Dr. Doben said initially the authors were very strict and only treated patients on mechanical ventilation, as suggested in the literature, but expanded the scope to include those on nonmechanical ventilation. The analysis excluded patients with a Glasgow Coma Scale score of 8 or less for 5 days, all in-hospital deaths in the control group, and two 80-year-olds with "do not intubate" orders who declined surgery.

Finally, audience members asked why ICU times were not lower in the surgical group and how the authors addressed pulmonary contusions, since previous reports suggest either no benefit or worsened morbidity in patients with a significant underlying pulmonary contusion who undergo fixation for flail chest.

Dr. Doben said length of stay was likely not lower because they delayed surgery in a number of patients until their chest became their primary medical issue. He called for studies to address the issue of flail chest and contusions, but said that he and his colleagues have performed fixation in these patients reasonably early on, at 2 or 3 days into the course of their contusion, when their PaO2/FiO2 (P/F) ratio was markedly improved.

"Really, what kept them on the vent was more their mechanics and not their P/F ratios, and I think that’s a pretty definable time period," he said.

Dr. Doben and his coauthors reported having no conflicts of interest. Dr. Mayberry has grant/research support from, serves as a consultant to, and is on the speakers bureau for, Acute Innovations, a maker of thoracic surgery devices.

NAPLES, Fla. – Patients who underwent surgical rib fixation for flail chest spent on average 10 fewer days on mechanical ventilation than did those managed traditionally in a single-center analysis of 21 patients with severe blunt chest trauma.

The total number of ventilator days was significantly lower in patients who underwent rib fixation, at a median of 4.5 days (range 0-30 days), compared with a median of 16 days (range 4-40 days) in those managed with pain control and respiratory therapy (P = .04).

Hospital length of stay was a median of 22 days in the nonsurgical group vs. 13 days in the surgical group, and ICU length of stay was a median of 18 days vs. 9 days, but those differences were not statistically significant. There was one postoperative seroma and no deaths in the surgical group.

Surgical rib fixation can be used as a rescue technique when the last resort is prolonged mechanical ventilation, but a large multicenter trial is needed to determine the best approach, Dr. Andrew R. Doben said at the annual meeting of the Eastern Association for the Surgery of Trauma.

"This study provides some of the first data suggesting that surgical fixation may prevent prolonged ventilation in flail chest patients who initially do not require invasive mechanical ventilation," he said in an interview.

Dr. Doben pointed out that major trauma centers see roughly two flail chest injuries per month and that up to 60% of patients do not return to full-time employment. A prospective randomized trial showed benefits with surgical stabilization with Judet struts, compared with internal pneumatic stabilization (J. Trauma 2002;52:727-32), but that trial included only 18 fixation patients and all required invasive mechanical ventilation, he said.

Dr. Doben and his colleagues at the Medical University of South Carolina, Charleston, defined flail chest deformity as three consecutive ribs broken in two or more locations, and they initially focused on patients who failed to wean from the ventilator 5 days post injury, had isolated chest wall trauma, and had good neurologic status. Surgical fixation using a combination of plates and intramedullary nails in three such patients produced positive results similar to those in the literature, but raised the question of whether mechanical ventilation could be avoided in patients who are failing, Dr. Doben said.

"Everybody’s seen these patients – the ‘in-betweeners’ – they’re not really failing, they’re not yet vented, but they’re heading that way," he said.

Dr. Doben highlighted the case of a 60-year-old man with seven total rib fractures including five segmental fractures and paradoxical chest wall motion, who had an epidural in place, was on oxycodone, NSAIDs, acetaminophen, and gabapentin, and was experiencing progressive pulmonary decline on bilevel positive airway pressure therapy for 3 days in the ICU. The patient underwent surgical rib fixation on hospital day 6, was mechanically ventilated overnight, and was extubated the following morning. He was discharged to home on hospital day 11, with no long-acting narcotics needed for pain, he said.

The retrospective chart review included the first 10 patients treated with surgical fixation from September 2008 to May 2010, matched with a previous group of 11 patients managed with standard therapy. Patients were required to have a Chest Abbreviated Injury Scale score of more than 3, a diagnosis of flail chest, and an ICU length of stay greater than 5 days. There were no surgical complications, and the average time on a ventilator after surgery was 1.5 days, said Dr. Doben, now with Baystate Medical Center in Springfield, Mass.

Invited discussant Dr. John C. Mayberry said no strong conclusions supporting flail chest repair can be drawn because of the small study size, but commended the authors for providing new data on its use in patients who do not require ventilation, but clinically worsen.

Dr. Mayberry, with Oregon Health and Science University in Portland, asked whether the study protocol evolved over time, and whether the 10 fixation patients represent the authors’ first experience with the technique. This line of questioning was continued by an audience member who asked what kind of course work prepared the authors to perform rib fixation.

Dr. Doben responded that he had limited experience with chest repairs as a general surgery resident in Maine, but that these were indeed the first 10 rib fixation patients in Charleston. The surgeries in both Maine and Charleston were performed in conjunction with cardiothoracic and orthopedic surgeons who had expertise in hardware insertion, he noted.

With respect to the study protocol, Dr. Doben said initially the authors were very strict and only treated patients on mechanical ventilation, as suggested in the literature, but expanded the scope to include those on nonmechanical ventilation. The analysis excluded patients with a Glasgow Coma Scale score of 8 or less for 5 days, all in-hospital deaths in the control group, and two 80-year-olds with "do not intubate" orders who declined surgery.

Finally, audience members asked why ICU times were not lower in the surgical group and how the authors addressed pulmonary contusions, since previous reports suggest either no benefit or worsened morbidity in patients with a significant underlying pulmonary contusion who undergo fixation for flail chest.

Dr. Doben said length of stay was likely not lower because they delayed surgery in a number of patients until their chest became their primary medical issue. He called for studies to address the issue of flail chest and contusions, but said that he and his colleagues have performed fixation in these patients reasonably early on, at 2 or 3 days into the course of their contusion, when their PaO2/FiO2 (P/F) ratio was markedly improved.

"Really, what kept them on the vent was more their mechanics and not their P/F ratios, and I think that’s a pretty definable time period," he said.

Dr. Doben and his coauthors reported having no conflicts of interest. Dr. Mayberry has grant/research support from, serves as a consultant to, and is on the speakers bureau for, Acute Innovations, a maker of thoracic surgery devices.

NAPLES, Fla. – Patients who underwent surgical rib fixation for flail chest spent on average 10 fewer days on mechanical ventilation than did those managed traditionally in a single-center analysis of 21 patients with severe blunt chest trauma.

The total number of ventilator days was significantly lower in patients who underwent rib fixation, at a median of 4.5 days (range 0-30 days), compared with a median of 16 days (range 4-40 days) in those managed with pain control and respiratory therapy (P = .04).

Hospital length of stay was a median of 22 days in the nonsurgical group vs. 13 days in the surgical group, and ICU length of stay was a median of 18 days vs. 9 days, but those differences were not statistically significant. There was one postoperative seroma and no deaths in the surgical group.

Surgical rib fixation can be used as a rescue technique when the last resort is prolonged mechanical ventilation, but a large multicenter trial is needed to determine the best approach, Dr. Andrew R. Doben said at the annual meeting of the Eastern Association for the Surgery of Trauma.

"This study provides some of the first data suggesting that surgical fixation may prevent prolonged ventilation in flail chest patients who initially do not require invasive mechanical ventilation," he said in an interview.

Dr. Doben pointed out that major trauma centers see roughly two flail chest injuries per month and that up to 60% of patients do not return to full-time employment. A prospective randomized trial showed benefits with surgical stabilization with Judet struts, compared with internal pneumatic stabilization (J. Trauma 2002;52:727-32), but that trial included only 18 fixation patients and all required invasive mechanical ventilation, he said.

Dr. Doben and his colleagues at the Medical University of South Carolina, Charleston, defined flail chest deformity as three consecutive ribs broken in two or more locations, and they initially focused on patients who failed to wean from the ventilator 5 days post injury, had isolated chest wall trauma, and had good neurologic status. Surgical fixation using a combination of plates and intramedullary nails in three such patients produced positive results similar to those in the literature, but raised the question of whether mechanical ventilation could be avoided in patients who are failing, Dr. Doben said.

"Everybody’s seen these patients – the ‘in-betweeners’ – they’re not really failing, they’re not yet vented, but they’re heading that way," he said.

Dr. Doben highlighted the case of a 60-year-old man with seven total rib fractures including five segmental fractures and paradoxical chest wall motion, who had an epidural in place, was on oxycodone, NSAIDs, acetaminophen, and gabapentin, and was experiencing progressive pulmonary decline on bilevel positive airway pressure therapy for 3 days in the ICU. The patient underwent surgical rib fixation on hospital day 6, was mechanically ventilated overnight, and was extubated the following morning. He was discharged to home on hospital day 11, with no long-acting narcotics needed for pain, he said.

The retrospective chart review included the first 10 patients treated with surgical fixation from September 2008 to May 2010, matched with a previous group of 11 patients managed with standard therapy. Patients were required to have a Chest Abbreviated Injury Scale score of more than 3, a diagnosis of flail chest, and an ICU length of stay greater than 5 days. There were no surgical complications, and the average time on a ventilator after surgery was 1.5 days, said Dr. Doben, now with Baystate Medical Center in Springfield, Mass.

Invited discussant Dr. John C. Mayberry said no strong conclusions supporting flail chest repair can be drawn because of the small study size, but commended the authors for providing new data on its use in patients who do not require ventilation, but clinically worsen.

Dr. Mayberry, with Oregon Health and Science University in Portland, asked whether the study protocol evolved over time, and whether the 10 fixation patients represent the authors’ first experience with the technique. This line of questioning was continued by an audience member who asked what kind of course work prepared the authors to perform rib fixation.

Dr. Doben responded that he had limited experience with chest repairs as a general surgery resident in Maine, but that these were indeed the first 10 rib fixation patients in Charleston. The surgeries in both Maine and Charleston were performed in conjunction with cardiothoracic and orthopedic surgeons who had expertise in hardware insertion, he noted.

With respect to the study protocol, Dr. Doben said initially the authors were very strict and only treated patients on mechanical ventilation, as suggested in the literature, but expanded the scope to include those on nonmechanical ventilation. The analysis excluded patients with a Glasgow Coma Scale score of 8 or less for 5 days, all in-hospital deaths in the control group, and two 80-year-olds with "do not intubate" orders who declined surgery.

Finally, audience members asked why ICU times were not lower in the surgical group and how the authors addressed pulmonary contusions, since previous reports suggest either no benefit or worsened morbidity in patients with a significant underlying pulmonary contusion who undergo fixation for flail chest.

Dr. Doben said length of stay was likely not lower because they delayed surgery in a number of patients until their chest became their primary medical issue. He called for studies to address the issue of flail chest and contusions, but said that he and his colleagues have performed fixation in these patients reasonably early on, at 2 or 3 days into the course of their contusion, when their PaO2/FiO2 (P/F) ratio was markedly improved.

"Really, what kept them on the vent was more their mechanics and not their P/F ratios, and I think that’s a pretty definable time period," he said.

Dr. Doben and his coauthors reported having no conflicts of interest. Dr. Mayberry has grant/research support from, serves as a consultant to, and is on the speakers bureau for, Acute Innovations, a maker of thoracic surgery devices.

NAPLES, Fla. – Patients who underwent surgical rib fixation for flail chest spent on average 10 fewer days on mechanical ventilation than did those managed traditionally in a single-center analysis of 21 patients with severe blunt chest trauma.

The total number of ventilator days was significantly lower in patients who underwent rib fixation, at a median of 4.5 days (range 0-30 days), compared with a median of 16 days (range 4-40 days) in those managed with pain control and respiratory therapy (P = .04).

Hospital length of stay was a median of 22 days in the nonsurgical group vs. 13 days in the surgical group, and ICU length of stay was a median of 18 days vs. 9 days, but those differences were not statistically significant. There was one postoperative seroma and no deaths in the surgical group.

Surgical rib fixation can be used as a rescue technique when the last resort is prolonged mechanical ventilation, but a large multicenter trial is needed to determine the best approach, Dr. Andrew R. Doben said at the annual meeting of the Eastern Association for the Surgery of Trauma.

"This study provides some of the first data suggesting that surgical fixation may prevent prolonged ventilation in flail chest patients who initially do not require invasive mechanical ventilation," he said in an interview.

Dr. Doben pointed out that major trauma centers see roughly two flail chest injuries per month and that up to 60% of patients do not return to full-time employment. A prospective randomized trial showed benefits with surgical stabilization with Judet struts, compared with internal pneumatic stabilization (J. Trauma 2002;52:727-32), but that trial included only 18 fixation patients and all required invasive mechanical ventilation, he said.

Dr. Doben and his colleagues at the Medical University of South Carolina, Charleston, defined flail chest deformity as three consecutive ribs broken in two or more locations, and they initially focused on patients who failed to wean from the ventilator 5 days post injury, had isolated chest wall trauma, and had good neurologic status. Surgical fixation using a combination of plates and intramedullary nails in three such patients produced positive results similar to those in the literature, but raised the question of whether mechanical ventilation could be avoided in patients who are failing, Dr. Doben said.

"Everybody’s seen these patients – the ‘in-betweeners’ – they’re not really failing, they’re not yet vented, but they’re heading that way," he said.

Dr. Doben highlighted the case of a 60-year-old man with seven total rib fractures including five segmental fractures and paradoxical chest wall motion, who had an epidural in place, was on oxycodone, NSAIDs, acetaminophen, and gabapentin, and was experiencing progressive pulmonary decline on bilevel positive airway pressure therapy for 3 days in the ICU. The patient underwent surgical rib fixation on hospital day 6, was mechanically ventilated overnight, and was extubated the following morning. He was discharged to home on hospital day 11, with no long-acting narcotics needed for pain, he said.

The retrospective chart review included the first 10 patients treated with surgical fixation from September 2008 to May 2010, matched with a previous group of 11 patients managed with standard therapy. Patients were required to have a Chest Abbreviated Injury Scale score of more than 3, a diagnosis of flail chest, and an ICU length of stay greater than 5 days. There were no surgical complications, and the average time on a ventilator after surgery was 1.5 days, said Dr. Doben, now with Baystate Medical Center in Springfield, Mass.

Invited discussant Dr. John C. Mayberry said no strong conclusions supporting flail chest repair can be drawn because of the small study size, but commended the authors for providing new data on its use in patients who do not require ventilation, but clinically worsen.

Dr. Mayberry, with Oregon Health and Science University in Portland, asked whether the study protocol evolved over time, and whether the 10 fixation patients represent the authors’ first experience with the technique. This line of questioning was continued by an audience member who asked what kind of course work prepared the authors to perform rib fixation.

Dr. Doben responded that he had limited experience with chest repairs as a general surgery resident in Maine, but that these were indeed the first 10 rib fixation patients in Charleston. The surgeries in both Maine and Charleston were performed in conjunction with cardiothoracic and orthopedic surgeons who had expertise in hardware insertion, he noted.

With respect to the study protocol, Dr. Doben said initially the authors were very strict and only treated patients on mechanical ventilation, as suggested in the literature, but expanded the scope to include those on nonmechanical ventilation. The analysis excluded patients with a Glasgow Coma Scale score of 8 or less for 5 days, all in-hospital deaths in the control group, and two 80-year-olds with "do not intubate" orders who declined surgery.

Finally, audience members asked why ICU times were not lower in the surgical group and how the authors addressed pulmonary contusions, since previous reports suggest either no benefit or worsened morbidity in patients with a significant underlying pulmonary contusion who undergo fixation for flail chest.

Dr. Doben said length of stay was likely not lower because they delayed surgery in a number of patients until their chest became their primary medical issue. He called for studies to address the issue of flail chest and contusions, but said that he and his colleagues have performed fixation in these patients reasonably early on, at 2 or 3 days into the course of their contusion, when their PaO2/FiO2 (P/F) ratio was markedly improved.

"Really, what kept them on the vent was more their mechanics and not their P/F ratios, and I think that’s a pretty definable time period," he said.

Dr. Doben and his coauthors reported having no conflicts of interest. Dr. Mayberry has grant/research support from, serves as a consultant to, and is on the speakers bureau for, Acute Innovations, a maker of thoracic surgery devices.

NAPLES, Fla. – Patients who underwent surgical rib fixation for flail chest spent on average 10 fewer days on mechanical ventilation than did those managed traditionally in a single-center analysis of 21 patients with severe blunt chest trauma.

The total number of ventilator days was significantly lower in patients who underwent rib fixation, at a median of 4.5 days (range 0-30 days), compared with a median of 16 days (range 4-40 days) in those managed with pain control and respiratory therapy (P = .04).

Hospital length of stay was a median of 22 days in the nonsurgical group vs. 13 days in the surgical group, and ICU length of stay was a median of 18 days vs. 9 days, but those differences were not statistically significant. There was one postoperative seroma and no deaths in the surgical group.

Surgical rib fixation can be used as a rescue technique when the last resort is prolonged mechanical ventilation, but a large multicenter trial is needed to determine the best approach, Dr. Andrew R. Doben said at the annual meeting of the Eastern Association for the Surgery of Trauma.

"This study provides some of the first data suggesting that surgical fixation may prevent prolonged ventilation in flail chest patients who initially do not require invasive mechanical ventilation," he said in an interview.

Dr. Doben pointed out that major trauma centers see roughly two flail chest injuries per month and that up to 60% of patients do not return to full-time employment. A prospective randomized trial showed benefits with surgical stabilization with Judet struts, compared with internal pneumatic stabilization (J. Trauma 2002;52:727-32), but that trial included only 18 fixation patients and all required invasive mechanical ventilation, he said.

Dr. Doben and his colleagues at the Medical University of South Carolina, Charleston, defined flail chest deformity as three consecutive ribs broken in two or more locations, and they initially focused on patients who failed to wean from the ventilator 5 days post injury, had isolated chest wall trauma, and had good neurologic status. Surgical fixation using a combination of plates and intramedullary nails in three such patients produced positive results similar to those in the literature, but raised the question of whether mechanical ventilation could be avoided in patients who are failing, Dr. Doben said.

"Everybody’s seen these patients – the ‘in-betweeners’ – they’re not really failing, they’re not yet vented, but they’re heading that way," he said.

Dr. Doben highlighted the case of a 60-year-old man with seven total rib fractures including five segmental fractures and paradoxical chest wall motion, who had an epidural in place, was on oxycodone, NSAIDs, acetaminophen, and gabapentin, and was experiencing progressive pulmonary decline on bilevel positive airway pressure therapy for 3 days in the ICU. The patient underwent surgical rib fixation on hospital day 6, was mechanically ventilated overnight, and was extubated the following morning. He was discharged to home on hospital day 11, with no long-acting narcotics needed for pain, he said.

The retrospective chart review included the first 10 patients treated with surgical fixation from September 2008 to May 2010, matched with a previous group of 11 patients managed with standard therapy. Patients were required to have a Chest Abbreviated Injury Scale score of more than 3, a diagnosis of flail chest, and an ICU length of stay greater than 5 days. There were no surgical complications, and the average time on a ventilator after surgery was 1.5 days, said Dr. Doben, now with Baystate Medical Center in Springfield, Mass.

Invited discussant Dr. John C. Mayberry said no strong conclusions supporting flail chest repair can be drawn because of the small study size, but commended the authors for providing new data on its use in patients who do not require ventilation, but clinically worsen.

Dr. Mayberry, with Oregon Health and Science University in Portland, asked whether the study protocol evolved over time, and whether the 10 fixation patients represent the authors’ first experience with the technique. This line of questioning was continued by an audience member who asked what kind of course work prepared the authors to perform rib fixation.

Dr. Doben responded that he had limited experience with chest repairs as a general surgery resident in Maine, but that these were indeed the first 10 rib fixation patients in Charleston. The surgeries in both Maine and Charleston were performed in conjunction with cardiothoracic and orthopedic surgeons who had expertise in hardware insertion, he noted.

With respect to the study protocol, Dr. Doben said initially the authors were very strict and only treated patients on mechanical ventilation, as suggested in the literature, but expanded the scope to include those on nonmechanical ventilation. The analysis excluded patients with a Glasgow Coma Scale score of 8 or less for 5 days, all in-hospital deaths in the control group, and two 80-year-olds with "do not intubate" orders who declined surgery.

Finally, audience members asked why ICU times were not lower in the surgical group and how the authors addressed pulmonary contusions, since previous reports suggest either no benefit or worsened morbidity in patients with a significant underlying pulmonary contusion who undergo fixation for flail chest.

Dr. Doben said length of stay was likely not lower because they delayed surgery in a number of patients until their chest became their primary medical issue. He called for studies to address the issue of flail chest and contusions, but said that he and his colleagues have performed fixation in these patients reasonably early on, at 2 or 3 days into the course of their contusion, when their PaO2/FiO2 (P/F) ratio was markedly improved.

"Really, what kept them on the vent was more their mechanics and not their P/F ratios, and I think that’s a pretty definable time period," he said.

Dr. Doben and his coauthors reported having no conflicts of interest. Dr. Mayberry has grant/research support from, serves as a consultant to, and is on the speakers bureau for, Acute Innovations, a maker of thoracic surgery devices.

NAPLES, Fla. – Patients who underwent surgical rib fixation for flail chest spent on average 10 fewer days on mechanical ventilation than did those managed traditionally in a single-center analysis of 21 patients with severe blunt chest trauma.

The total number of ventilator days was significantly lower in patients who underwent rib fixation, at a median of 4.5 days (range 0-30 days), compared with a median of 16 days (range 4-40 days) in those managed with pain control and respiratory therapy (P = .04).

Hospital length of stay was a median of 22 days in the nonsurgical group vs. 13 days in the surgical group, and ICU length of stay was a median of 18 days vs. 9 days, but those differences were not statistically significant. There was one postoperative seroma and no deaths in the surgical group.

Surgical rib fixation can be used as a rescue technique when the last resort is prolonged mechanical ventilation, but a large multicenter trial is needed to determine the best approach, Dr. Andrew R. Doben said at the annual meeting of the Eastern Association for the Surgery of Trauma.

"This study provides some of the first data suggesting that surgical fixation may prevent prolonged ventilation in flail chest patients who initially do not require invasive mechanical ventilation," he said in an interview.

Dr. Doben pointed out that major trauma centers see roughly two flail chest injuries per month and that up to 60% of patients do not return to full-time employment. A prospective randomized trial showed benefits with surgical stabilization with Judet struts, compared with internal pneumatic stabilization (J. Trauma 2002;52:727-32), but that trial included only 18 fixation patients and all required invasive mechanical ventilation, he said.

Dr. Doben and his colleagues at the Medical University of South Carolina, Charleston, defined flail chest deformity as three consecutive ribs broken in two or more locations, and they initially focused on patients who failed to wean from the ventilator 5 days post injury, had isolated chest wall trauma, and had good neurologic status. Surgical fixation using a combination of plates and intramedullary nails in three such patients produced positive results similar to those in the literature, but raised the question of whether mechanical ventilation could be avoided in patients who are failing, Dr. Doben said.

"Everybody’s seen these patients – the ‘in-betweeners’ – they’re not really failing, they’re not yet vented, but they’re heading that way," he said.

Dr. Doben highlighted the case of a 60-year-old man with seven total rib fractures including five segmental fractures and paradoxical chest wall motion, who had an epidural in place, was on oxycodone, NSAIDs, acetaminophen, and gabapentin, and was experiencing progressive pulmonary decline on bilevel positive airway pressure therapy for 3 days in the ICU. The patient underwent surgical rib fixation on hospital day 6, was mechanically ventilated overnight, and was extubated the following morning. He was discharged to home on hospital day 11, with no long-acting narcotics needed for pain, he said.

The retrospective chart review included the first 10 patients treated with surgical fixation from September 2008 to May 2010, matched with a previous group of 11 patients managed with standard therapy. Patients were required to have a Chest Abbreviated Injury Scale score of more than 3, a diagnosis of flail chest, and an ICU length of stay greater than 5 days. There were no surgical complications, and the average time on a ventilator after surgery was 1.5 days, said Dr. Doben, now with Baystate Medical Center in Springfield, Mass.

Invited discussant Dr. John C. Mayberry said no strong conclusions supporting flail chest repair can be drawn because of the small study size, but commended the authors for providing new data on its use in patients who do not require ventilation, but clinically worsen.

Dr. Mayberry, with Oregon Health and Science University in Portland, asked whether the study protocol evolved over time, and whether the 10 fixation patients represent the authors’ first experience with the technique. This line of questioning was continued by an audience member who asked what kind of course work prepared the authors to perform rib fixation.

Dr. Doben responded that he had limited experience with chest repairs as a general surgery resident in Maine, but that these were indeed the first 10 rib fixation patients in Charleston. The surgeries in both Maine and Charleston were performed in conjunction with cardiothoracic and orthopedic surgeons who had expertise in hardware insertion, he noted.

With respect to the study protocol, Dr. Doben said initially the authors were very strict and only treated patients on mechanical ventilation, as suggested in the literature, but expanded the scope to include those on nonmechanical ventilation. The analysis excluded patients with a Glasgow Coma Scale score of 8 or less for 5 days, all in-hospital deaths in the control group, and two 80-year-olds with "do not intubate" orders who declined surgery.

Finally, audience members asked why ICU times were not lower in the surgical group and how the authors addressed pulmonary contusions, since previous reports suggest either no benefit or worsened morbidity in patients with a significant underlying pulmonary contusion who undergo fixation for flail chest.

Dr. Doben said length of stay was likely not lower because they delayed surgery in a number of patients until their chest became their primary medical issue. He called for studies to address the issue of flail chest and contusions, but said that he and his colleagues have performed fixation in these patients reasonably early on, at 2 or 3 days into the course of their contusion, when their PaO2/FiO2 (P/F) ratio was markedly improved.

"Really, what kept them on the vent was more their mechanics and not their P/F ratios, and I think that’s a pretty definable time period," he said.

Dr. Doben and his coauthors reported having no conflicts of interest. Dr. Mayberry has grant/research support from, serves as a consultant to, and is on the speakers bureau for, Acute Innovations, a maker of thoracic surgery devices.

NAPLES, Fla. – New data support the use of time to hemostasis as a surrogate primary end point in traumatic bleeding.

An analysis of 40 consecutive trauma patients admitted from the trauma bay to the operating room with moderate to severe bleeding from at least one primary site found that those who died had a greater than threefold longer time to hemostasis (TTH) than did survivors (P value = .016).

TTH was defined as the time frame between when the attending identified the active primary bleeding site and when hemostasis was achieved.

"To our knowledge, this is the first study to demonstrate that time to hemostasis is highly predictive of blood loss, transfusion requirement, and mortality in trauma patients with active hemorrhage," according to Dr. Grant Bochicchio and his colleagues, who presented their results in a poster at the annual meeting of the Eastern Association for the Surgery of Trauma.

The 40 prospectively followed patients had an average TTH of 12.7 minutes and average estimated blood loss of 1,300 cc (300 cc-5,000 cc). An average of 11 units of packed red blood cells and 10 units of fresh frozen plasma were transfused in the first 24 hours.

Overall mortality was 15%. When evaluated by multiple regression analysis, increasing TTH was associated with a significant increase in the transfusion of packed red blood cells (odds ratio 1.1, P = .02), of fresh frozen plasma (OR 0.5, P = .001), and of platelets (OR .05, P = .006).

In addition, increasing TTH was a significant predictor of greater blood loss (OR 24.7, P = .02).

Most important, for every minute of increase in TTH, mortality increased by 10% (OR 1.1, P = .0001), said Dr. Bochicchio, professor of surgery and director of clinical and outcomes research at the shock trauma center of the University of Maryland, Baltimore.

The Food and Drug Administration, in conjunction with the National Institutes of Health, recently asked the trauma community for surrogate outcome measures to accurately evaluate a growing number of hemostatic products in the pipeline indicated for severe bleeding.

A December 2010 workshop sponsored by the FDA’s Center for Biologics Evaluation and Research on product development for patients with severe bleeding from shock or other causes acknowledged that evaluation of new treatments has been hampered in part by a lack of consistent definitions for trauma-associated pathologic states such as moderate versus severe bleeding. The panel agreed that time to 100% hemostasis was an appropriate clinical end point among trauma patients for trials of local agents, while early mortality and hemostasis were appropriate end points for trials of systemic agents.

The trauma patients in the current trial had a mean age of 32 years. A total of 85% were male, 63% were black, and 63% sustained a penetrating trauma. The most common primary bleeding sites identified were liver, spleen, vascular, heart, and lung. Their mean Injury Severity Score was 22.

Dr. Bochicchio and his coauthors reported no conflicts of interest.

NAPLES, Fla. – New data support the use of time to hemostasis as a surrogate primary end point in traumatic bleeding.

An analysis of 40 consecutive trauma patients admitted from the trauma bay to the operating room with moderate to severe bleeding from at least one primary site found that those who died had a greater than threefold longer time to hemostasis (TTH) than did survivors (P value = .016).

TTH was defined as the time frame between when the attending identified the active primary bleeding site and when hemostasis was achieved.

"To our knowledge, this is the first study to demonstrate that time to hemostasis is highly predictive of blood loss, transfusion requirement, and mortality in trauma patients with active hemorrhage," according to Dr. Grant Bochicchio and his colleagues, who presented their results in a poster at the annual meeting of the Eastern Association for the Surgery of Trauma.

The 40 prospectively followed patients had an average TTH of 12.7 minutes and average estimated blood loss of 1,300 cc (300 cc-5,000 cc). An average of 11 units of packed red blood cells and 10 units of fresh frozen plasma were transfused in the first 24 hours.

Overall mortality was 15%. When evaluated by multiple regression analysis, increasing TTH was associated with a significant increase in the transfusion of packed red blood cells (odds ratio 1.1, P = .02), of fresh frozen plasma (OR 0.5, P = .001), and of platelets (OR .05, P = .006).

In addition, increasing TTH was a significant predictor of greater blood loss (OR 24.7, P = .02).

Most important, for every minute of increase in TTH, mortality increased by 10% (OR 1.1, P = .0001), said Dr. Bochicchio, professor of surgery and director of clinical and outcomes research at the shock trauma center of the University of Maryland, Baltimore.

The Food and Drug Administration, in conjunction with the National Institutes of Health, recently asked the trauma community for surrogate outcome measures to accurately evaluate a growing number of hemostatic products in the pipeline indicated for severe bleeding.

A December 2010 workshop sponsored by the FDA’s Center for Biologics Evaluation and Research on product development for patients with severe bleeding from shock or other causes acknowledged that evaluation of new treatments has been hampered in part by a lack of consistent definitions for trauma-associated pathologic states such as moderate versus severe bleeding. The panel agreed that time to 100% hemostasis was an appropriate clinical end point among trauma patients for trials of local agents, while early mortality and hemostasis were appropriate end points for trials of systemic agents.

The trauma patients in the current trial had a mean age of 32 years. A total of 85% were male, 63% were black, and 63% sustained a penetrating trauma. The most common primary bleeding sites identified were liver, spleen, vascular, heart, and lung. Their mean Injury Severity Score was 22.

Dr. Bochicchio and his coauthors reported no conflicts of interest.

NAPLES, Fla. – New data support the use of time to hemostasis as a surrogate primary end point in traumatic bleeding.

An analysis of 40 consecutive trauma patients admitted from the trauma bay to the operating room with moderate to severe bleeding from at least one primary site found that those who died had a greater than threefold longer time to hemostasis (TTH) than did survivors (P value = .016).

TTH was defined as the time frame between when the attending identified the active primary bleeding site and when hemostasis was achieved.

"To our knowledge, this is the first study to demonstrate that time to hemostasis is highly predictive of blood loss, transfusion requirement, and mortality in trauma patients with active hemorrhage," according to Dr. Grant Bochicchio and his colleagues, who presented their results in a poster at the annual meeting of the Eastern Association for the Surgery of Trauma.

The 40 prospectively followed patients had an average TTH of 12.7 minutes and average estimated blood loss of 1,300 cc (300 cc-5,000 cc). An average of 11 units of packed red blood cells and 10 units of fresh frozen plasma were transfused in the first 24 hours.

Overall mortality was 15%. When evaluated by multiple regression analysis, increasing TTH was associated with a significant increase in the transfusion of packed red blood cells (odds ratio 1.1, P = .02), of fresh frozen plasma (OR 0.5, P = .001), and of platelets (OR .05, P = .006).

In addition, increasing TTH was a significant predictor of greater blood loss (OR 24.7, P = .02).

Most important, for every minute of increase in TTH, mortality increased by 10% (OR 1.1, P = .0001), said Dr. Bochicchio, professor of surgery and director of clinical and outcomes research at the shock trauma center of the University of Maryland, Baltimore.

The Food and Drug Administration, in conjunction with the National Institutes of Health, recently asked the trauma community for surrogate outcome measures to accurately evaluate a growing number of hemostatic products in the pipeline indicated for severe bleeding.

A December 2010 workshop sponsored by the FDA’s Center for Biologics Evaluation and Research on product development for patients with severe bleeding from shock or other causes acknowledged that evaluation of new treatments has been hampered in part by a lack of consistent definitions for trauma-associated pathologic states such as moderate versus severe bleeding. The panel agreed that time to 100% hemostasis was an appropriate clinical end point among trauma patients for trials of local agents, while early mortality and hemostasis were appropriate end points for trials of systemic agents.

The trauma patients in the current trial had a mean age of 32 years. A total of 85% were male, 63% were black, and 63% sustained a penetrating trauma. The most common primary bleeding sites identified were liver, spleen, vascular, heart, and lung. Their mean Injury Severity Score was 22.

Dr. Bochicchio and his coauthors reported no conflicts of interest.