Sharon Worcester

CHARLESTON, S.C. – Mechanical bowel preparation prior to vaginal pelvic organ prolapse surgery offers no advantage over lack of any bowel preparation, with respect to surgeons’ assessment of acceptability, according to findings from a single-blind randomized trial involving 150 women.

Furthermore, the use of mechanical bowel preparation prior to surgery was associated with decreased patient satisfaction, Dr. Alicia C. Ballard reported at the annual meeting of the Society of Gynecologic Surgeons.

Surgeons’ acceptability, based on a rating of excellent or good in terms of bowel cleansing, was similar at 81.3% and 88% for 75 patients who underwent mechanical bowel preparation and 75 control subjects who received no bowel preparation. There also were no significant differences between the groups in intraoperative visualization, stooling, or difficulty in bowel handling, said Dr. Ballard of the University of Alabama at Birmingham.

Patient satisfaction was 61.3% in the bowel preparation group, compared with 89.3% in the control group. Patients in the bowel preparation group also were more likely to be willing to try a different form of bowel preparation (84.3% vs. 64.4%), she noted.

Study subjects were adult women scheduled to undergo vaginal prolapse surgery – with a planned apical suspension and posterior colporrhaphy – at a single center between January 2011 and August 2012. Those randomized to the intervention group were placed on a clear-liquid diet and administered saline enemas at 4 p.m. and 6 p.m. on the day prior to surgery. Those assigned to the control group continued on their regular diet. Both groups were instructed to take nothing by mouth after 12 a.m. on the day of the surgery.

The four participating surgeons were blinded as to patient allocation, and rated their acceptability of the bowel preparation using a 4-point Likert scale.

"Overall, surgeons assessed the bowel to be acceptably cleansed [excellent or good rating], with no differences noted between the intervention and control groups," Dr. Ballard said at the meeting, which was jointly sponsored by the American College of Surgeons.

In fact, bowel cleansing was assessed as "fair" or "poor" in more patients in the intervention group than the control group (14.7% vs. 9.3%), although this difference was not statistically significant.

Also, intraoperative assessment of the rectal vault showed no differences between the groups in the presence of gas or stool.

The findings are important given that 5 million women underwent prolapse procedures in the United States between 1976 and 2006, and that mechanical bowel preparation is commonly applied preoperatively - despite a lack of clear evidence that it is necessary or beneficial, Dr. Ballard said.

Although limited by the single-site design, this study has several strengths, including a robust sample size, randomization, and a well-defined surgical cohort that included patients undergoing concomitant apical suspension and posterior repair. It is also strengthened by the inclusion of both surgeon and patient assessments.

Therefore, the findings challenge the role of mechanical bowel preparation for vaginal prolapse surgery.

"Routine use of mechanical bowel preparation should be reconsidered," Dr. Ballard concluded.

She reported having no relevant financial disclosures.

CHARLESTON, S.C. – Mechanical bowel preparation prior to vaginal pelvic organ prolapse surgery offers no advantage over lack of any bowel preparation, with respect to surgeons’ assessment of acceptability, according to findings from a single-blind randomized trial involving 150 women.

Furthermore, the use of mechanical bowel preparation prior to surgery was associated with decreased patient satisfaction, Dr. Alicia C. Ballard reported at the annual meeting of the Society of Gynecologic Surgeons.

Surgeons’ acceptability, based on a rating of excellent or good in terms of bowel cleansing, was similar at 81.3% and 88% for 75 patients who underwent mechanical bowel preparation and 75 control subjects who received no bowel preparation. There also were no significant differences between the groups in intraoperative visualization, stooling, or difficulty in bowel handling, said Dr. Ballard of the University of Alabama at Birmingham.

Patient satisfaction was 61.3% in the bowel preparation group, compared with 89.3% in the control group. Patients in the bowel preparation group also were more likely to be willing to try a different form of bowel preparation (84.3% vs. 64.4%), she noted.

Study subjects were adult women scheduled to undergo vaginal prolapse surgery – with a planned apical suspension and posterior colporrhaphy – at a single center between January 2011 and August 2012. Those randomized to the intervention group were placed on a clear-liquid diet and administered saline enemas at 4 p.m. and 6 p.m. on the day prior to surgery. Those assigned to the control group continued on their regular diet. Both groups were instructed to take nothing by mouth after 12 a.m. on the day of the surgery.

The four participating surgeons were blinded as to patient allocation, and rated their acceptability of the bowel preparation using a 4-point Likert scale.

"Overall, surgeons assessed the bowel to be acceptably cleansed [excellent or good rating], with no differences noted between the intervention and control groups," Dr. Ballard said at the meeting, which was jointly sponsored by the American College of Surgeons.

In fact, bowel cleansing was assessed as "fair" or "poor" in more patients in the intervention group than the control group (14.7% vs. 9.3%), although this difference was not statistically significant.

Also, intraoperative assessment of the rectal vault showed no differences between the groups in the presence of gas or stool.

The findings are important given that 5 million women underwent prolapse procedures in the United States between 1976 and 2006, and that mechanical bowel preparation is commonly applied preoperatively - despite a lack of clear evidence that it is necessary or beneficial, Dr. Ballard said.

Although limited by the single-site design, this study has several strengths, including a robust sample size, randomization, and a well-defined surgical cohort that included patients undergoing concomitant apical suspension and posterior repair. It is also strengthened by the inclusion of both surgeon and patient assessments.

Therefore, the findings challenge the role of mechanical bowel preparation for vaginal prolapse surgery.

"Routine use of mechanical bowel preparation should be reconsidered," Dr. Ballard concluded.

She reported having no relevant financial disclosures.

CHARLESTON, S.C. – Mechanical bowel preparation prior to vaginal pelvic organ prolapse surgery offers no advantage over lack of any bowel preparation, with respect to surgeons’ assessment of acceptability, according to findings from a single-blind randomized trial involving 150 women.

Furthermore, the use of mechanical bowel preparation prior to surgery was associated with decreased patient satisfaction, Dr. Alicia C. Ballard reported at the annual meeting of the Society of Gynecologic Surgeons.

Surgeons’ acceptability, based on a rating of excellent or good in terms of bowel cleansing, was similar at 81.3% and 88% for 75 patients who underwent mechanical bowel preparation and 75 control subjects who received no bowel preparation. There also were no significant differences between the groups in intraoperative visualization, stooling, or difficulty in bowel handling, said Dr. Ballard of the University of Alabama at Birmingham.

Patient satisfaction was 61.3% in the bowel preparation group, compared with 89.3% in the control group. Patients in the bowel preparation group also were more likely to be willing to try a different form of bowel preparation (84.3% vs. 64.4%), she noted.

Study subjects were adult women scheduled to undergo vaginal prolapse surgery – with a planned apical suspension and posterior colporrhaphy – at a single center between January 2011 and August 2012. Those randomized to the intervention group were placed on a clear-liquid diet and administered saline enemas at 4 p.m. and 6 p.m. on the day prior to surgery. Those assigned to the control group continued on their regular diet. Both groups were instructed to take nothing by mouth after 12 a.m. on the day of the surgery.

The four participating surgeons were blinded as to patient allocation, and rated their acceptability of the bowel preparation using a 4-point Likert scale.

"Overall, surgeons assessed the bowel to be acceptably cleansed [excellent or good rating], with no differences noted between the intervention and control groups," Dr. Ballard said at the meeting, which was jointly sponsored by the American College of Surgeons.

In fact, bowel cleansing was assessed as "fair" or "poor" in more patients in the intervention group than the control group (14.7% vs. 9.3%), although this difference was not statistically significant.

Also, intraoperative assessment of the rectal vault showed no differences between the groups in the presence of gas or stool.

The findings are important given that 5 million women underwent prolapse procedures in the United States between 1976 and 2006, and that mechanical bowel preparation is commonly applied preoperatively - despite a lack of clear evidence that it is necessary or beneficial, Dr. Ballard said.

Although limited by the single-site design, this study has several strengths, including a robust sample size, randomization, and a well-defined surgical cohort that included patients undergoing concomitant apical suspension and posterior repair. It is also strengthened by the inclusion of both surgeon and patient assessments.

Therefore, the findings challenge the role of mechanical bowel preparation for vaginal prolapse surgery.

"Routine use of mechanical bowel preparation should be reconsidered," Dr. Ballard concluded.

She reported having no relevant financial disclosures.

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

cardionews@frontlinemedcom.com

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

cardionews@frontlinemedcom.com

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

cardionews@frontlinemedcom.com

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.

LOS ANGELES – Most older adults have sleep-related complaints, and most use some form of sleep aid, according to findings from the Successful Aging Evaluation study.

A large number of subjects reported using sleep aids that could have deleterious effects, such as alcohol and over-the-counter remedies.

Of 1,300 subjects included in the Successful Aging Evaluation (SAGE) study, 92.4% had sleep complaints, including waking feeling unrefreshed, early awakening, difficulty falling asleep, and middle of the night awakening. Each of these complaints was reported by between 75% and 79% of subjects, Dr. Nicolas Badre reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

©Nastasic/iStockphoto.com

More than half (55.5%) of the subjects reported using one or more forms of treatment for sleep disturbance: 8.1% reported using complementary or alternative treatments, 10% reported using alcohol, 14.8% reported using prescription medications, 21.3% reported using over-the-counter remedies, and 39% reported using behavioral techniques, according to Dr. Badre of the University of California, San Diego.

The use of any treatment for sleep was significantly associated with a higher number of doctor visits in the past year, lower Satisfaction With Life Scale scores, a lower average number of hours of sleep per night, depression as measured by the nine-item Patient Health Questionnaire, and reduced physical functioning as measured using the 36-Item Short Form Health Survey.

Clinical depression was associated with a significantly increased odds of any use of treatment for sleep (odds ratio, 2.4), and use of prescription treatment for sleep (OR, 3.3), Dr. Badre noted.

No significant association was seen between the use of any treatment for sleep and cognitive impairment.

The SAGE study was a structured, multicohort population-based study designed to assess successful aging. The survey included a 25-minute phone interview followed by a self-report survey of various domains of functioning. Respondents had a mean age of 77.3 years.

"Results from the SAGE investigation confirm the high prevalence of insomnia and its treatment in older adults," Dr. Badre wrote, noting that decreased activity of the suprachiasmatic nucleus and prescriptions often given to older adults – including stimulants, antihypertensives, respiratory medications, chemotherapy, and decongestants – are among the causes of sleep disturbance in older adults.

The high correlation between the use of any treatment for sleep and depression appears to be a significant risk factor for patients being prescribed medication for sleep, and the high rates of alcohol use and over-the-counter remedies as sleep aids are of concern, he said.

Dr. Badre reported having no relevant financial disclosures.

LOS ANGELES – Most older adults have sleep-related complaints, and most use some form of sleep aid, according to findings from the Successful Aging Evaluation study.

A large number of subjects reported using sleep aids that could have deleterious effects, such as alcohol and over-the-counter remedies.

Of 1,300 subjects included in the Successful Aging Evaluation (SAGE) study, 92.4% had sleep complaints, including waking feeling unrefreshed, early awakening, difficulty falling asleep, and middle of the night awakening. Each of these complaints was reported by between 75% and 79% of subjects, Dr. Nicolas Badre reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

©Nastasic/iStockphoto.com

More than half (55.5%) of the subjects reported using one or more forms of treatment for sleep disturbance: 8.1% reported using complementary or alternative treatments, 10% reported using alcohol, 14.8% reported using prescription medications, 21.3% reported using over-the-counter remedies, and 39% reported using behavioral techniques, according to Dr. Badre of the University of California, San Diego.

The use of any treatment for sleep was significantly associated with a higher number of doctor visits in the past year, lower Satisfaction With Life Scale scores, a lower average number of hours of sleep per night, depression as measured by the nine-item Patient Health Questionnaire, and reduced physical functioning as measured using the 36-Item Short Form Health Survey.

Clinical depression was associated with a significantly increased odds of any use of treatment for sleep (odds ratio, 2.4), and use of prescription treatment for sleep (OR, 3.3), Dr. Badre noted.

No significant association was seen between the use of any treatment for sleep and cognitive impairment.

The SAGE study was a structured, multicohort population-based study designed to assess successful aging. The survey included a 25-minute phone interview followed by a self-report survey of various domains of functioning. Respondents had a mean age of 77.3 years.

"Results from the SAGE investigation confirm the high prevalence of insomnia and its treatment in older adults," Dr. Badre wrote, noting that decreased activity of the suprachiasmatic nucleus and prescriptions often given to older adults – including stimulants, antihypertensives, respiratory medications, chemotherapy, and decongestants – are among the causes of sleep disturbance in older adults.

The high correlation between the use of any treatment for sleep and depression appears to be a significant risk factor for patients being prescribed medication for sleep, and the high rates of alcohol use and over-the-counter remedies as sleep aids are of concern, he said.

Dr. Badre reported having no relevant financial disclosures.

LOS ANGELES – Most older adults have sleep-related complaints, and most use some form of sleep aid, according to findings from the Successful Aging Evaluation study.

A large number of subjects reported using sleep aids that could have deleterious effects, such as alcohol and over-the-counter remedies.

Of 1,300 subjects included in the Successful Aging Evaluation (SAGE) study, 92.4% had sleep complaints, including waking feeling unrefreshed, early awakening, difficulty falling asleep, and middle of the night awakening. Each of these complaints was reported by between 75% and 79% of subjects, Dr. Nicolas Badre reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

©Nastasic/iStockphoto.com

More than half (55.5%) of the subjects reported using one or more forms of treatment for sleep disturbance: 8.1% reported using complementary or alternative treatments, 10% reported using alcohol, 14.8% reported using prescription medications, 21.3% reported using over-the-counter remedies, and 39% reported using behavioral techniques, according to Dr. Badre of the University of California, San Diego.

The use of any treatment for sleep was significantly associated with a higher number of doctor visits in the past year, lower Satisfaction With Life Scale scores, a lower average number of hours of sleep per night, depression as measured by the nine-item Patient Health Questionnaire, and reduced physical functioning as measured using the 36-Item Short Form Health Survey.

Clinical depression was associated with a significantly increased odds of any use of treatment for sleep (odds ratio, 2.4), and use of prescription treatment for sleep (OR, 3.3), Dr. Badre noted.

No significant association was seen between the use of any treatment for sleep and cognitive impairment.

The SAGE study was a structured, multicohort population-based study designed to assess successful aging. The survey included a 25-minute phone interview followed by a self-report survey of various domains of functioning. Respondents had a mean age of 77.3 years.

"Results from the SAGE investigation confirm the high prevalence of insomnia and its treatment in older adults," Dr. Badre wrote, noting that decreased activity of the suprachiasmatic nucleus and prescriptions often given to older adults – including stimulants, antihypertensives, respiratory medications, chemotherapy, and decongestants – are among the causes of sleep disturbance in older adults.

The high correlation between the use of any treatment for sleep and depression appears to be a significant risk factor for patients being prescribed medication for sleep, and the high rates of alcohol use and over-the-counter remedies as sleep aids are of concern, he said.

Dr. Badre reported having no relevant financial disclosures.

A novel noninvasive microwave technology is proving safe and effective for the treatment of axillary hyperhidrosis.

The treatment, which involves the delivery of microwave energy to eliminate sweat glands, has been used in more than 6,000 patients and is a welcome addition to a limited range of treatments for hyperhidrosis, Dr. Carolyn Jacob reported in Seminars in Cutaneous Medicine and Surgery.

Topical treatments, oral anticholinergics, surgical procedures, laser treatment, and injections all provide some benefit but have fallen short of the safe, long-term results patients want, said Dr. Jacob of Northwestern University, Chicago.

Microwaves, first introduced for medical use in the 1970s in surgical coagulation devices, can penetrate to depths where eccrine sweat glands are found.

"This depth is achieved by the use of an antenna that preferentially targets the skin-adipose interface, where most eccrine glands reside. There is an extremely dense network of sweat glands in the axillae (greater than 50,000), and their depth can vary from 2 to 5 mm below the skin surface, depending on the patient’s skin thickness," Dr. Jacob explained, adding that the microwave energy is concentrated along the dermal-adipose to create a focal energy zone.

"At the same time, continuous hydroceramic cooling prevents thermal conduction of heat superficially. The heat at the dermal-adipose energy zone leads to thermolysis of the eccrine glands," she said in her review article (Semin. Cutan. Med. Surg. 2013;32:2-8).

The current protocol for microwave therapy is two microwave treatments with a 3-month interval. Most patients experience mild edema and discomfort for a few days, and in rare cases, edema will occur outside of the treatment area (often in the dependent portion of the underarm and upper chest), Dr. Jacob noted. These effects resolve with standard posttreatment care, including application of ice packs for 20 minutes every 3-5 hours as needed and use of ibuprofen every 4-6 hours for 3 days.

In a recent Canadian study of this technology for axillary hyperhidrosis, 90% of 31 patients reported efficacy that persisted after 12 months, and patient satisfaction was 90% at 12 months (Dermatol. Surg. 2012;38:728-35).

Further follow-up showed 100% efficacy and 100% patient satisfaction at 18 months, the investigators reported.

"Efficacy was defined as a drop [in the Hyperhidrosis Disease Severity Scale] from 3 or 4 to a 1 or 2," noted Dr. Jacob, who was not involved in the study.

The average patient’s sweat reduction was 82%. Histology showed sweat gland necrosis at 11 days and sweat gland reduction at 6 months.

"The treatment of primary axillary hyperhidrosis can be rewarding using noninvasive microwave technology. Because the microwaves preferentially target the region of skin where the sweat glands reside, leading to localized thermolysis of the sweat glands, patients can now benefit from permanent targeted sweat reduction," Dr. Jacob said. With more studies and experience using this technology, parameters will be tightened, side effects further decreased, and patient satisfaction increased, she added.

Dr. Jacob is a board member of Miramar, which funded the Canadian study and manufactures microwave devices used to treat axillary hyperhidrosis.

A novel noninvasive microwave technology is proving safe and effective for the treatment of axillary hyperhidrosis.

The treatment, which involves the delivery of microwave energy to eliminate sweat glands, has been used in more than 6,000 patients and is a welcome addition to a limited range of treatments for hyperhidrosis, Dr. Carolyn Jacob reported in Seminars in Cutaneous Medicine and Surgery.

Topical treatments, oral anticholinergics, surgical procedures, laser treatment, and injections all provide some benefit but have fallen short of the safe, long-term results patients want, said Dr. Jacob of Northwestern University, Chicago.

Microwaves, first introduced for medical use in the 1970s in surgical coagulation devices, can penetrate to depths where eccrine sweat glands are found.

"This depth is achieved by the use of an antenna that preferentially targets the skin-adipose interface, where most eccrine glands reside. There is an extremely dense network of sweat glands in the axillae (greater than 50,000), and their depth can vary from 2 to 5 mm below the skin surface, depending on the patient’s skin thickness," Dr. Jacob explained, adding that the microwave energy is concentrated along the dermal-adipose to create a focal energy zone.

"At the same time, continuous hydroceramic cooling prevents thermal conduction of heat superficially. The heat at the dermal-adipose energy zone leads to thermolysis of the eccrine glands," she said in her review article (Semin. Cutan. Med. Surg. 2013;32:2-8).

The current protocol for microwave therapy is two microwave treatments with a 3-month interval. Most patients experience mild edema and discomfort for a few days, and in rare cases, edema will occur outside of the treatment area (often in the dependent portion of the underarm and upper chest), Dr. Jacob noted. These effects resolve with standard posttreatment care, including application of ice packs for 20 minutes every 3-5 hours as needed and use of ibuprofen every 4-6 hours for 3 days.

In a recent Canadian study of this technology for axillary hyperhidrosis, 90% of 31 patients reported efficacy that persisted after 12 months, and patient satisfaction was 90% at 12 months (Dermatol. Surg. 2012;38:728-35).

Further follow-up showed 100% efficacy and 100% patient satisfaction at 18 months, the investigators reported.

"Efficacy was defined as a drop [in the Hyperhidrosis Disease Severity Scale] from 3 or 4 to a 1 or 2," noted Dr. Jacob, who was not involved in the study.

The average patient’s sweat reduction was 82%. Histology showed sweat gland necrosis at 11 days and sweat gland reduction at 6 months.

"The treatment of primary axillary hyperhidrosis can be rewarding using noninvasive microwave technology. Because the microwaves preferentially target the region of skin where the sweat glands reside, leading to localized thermolysis of the sweat glands, patients can now benefit from permanent targeted sweat reduction," Dr. Jacob said. With more studies and experience using this technology, parameters will be tightened, side effects further decreased, and patient satisfaction increased, she added.

Dr. Jacob is a board member of Miramar, which funded the Canadian study and manufactures microwave devices used to treat axillary hyperhidrosis.

A novel noninvasive microwave technology is proving safe and effective for the treatment of axillary hyperhidrosis.

The treatment, which involves the delivery of microwave energy to eliminate sweat glands, has been used in more than 6,000 patients and is a welcome addition to a limited range of treatments for hyperhidrosis, Dr. Carolyn Jacob reported in Seminars in Cutaneous Medicine and Surgery.

Topical treatments, oral anticholinergics, surgical procedures, laser treatment, and injections all provide some benefit but have fallen short of the safe, long-term results patients want, said Dr. Jacob of Northwestern University, Chicago.

Microwaves, first introduced for medical use in the 1970s in surgical coagulation devices, can penetrate to depths where eccrine sweat glands are found.

"This depth is achieved by the use of an antenna that preferentially targets the skin-adipose interface, where most eccrine glands reside. There is an extremely dense network of sweat glands in the axillae (greater than 50,000), and their depth can vary from 2 to 5 mm below the skin surface, depending on the patient’s skin thickness," Dr. Jacob explained, adding that the microwave energy is concentrated along the dermal-adipose to create a focal energy zone.

"At the same time, continuous hydroceramic cooling prevents thermal conduction of heat superficially. The heat at the dermal-adipose energy zone leads to thermolysis of the eccrine glands," she said in her review article (Semin. Cutan. Med. Surg. 2013;32:2-8).

The current protocol for microwave therapy is two microwave treatments with a 3-month interval. Most patients experience mild edema and discomfort for a few days, and in rare cases, edema will occur outside of the treatment area (often in the dependent portion of the underarm and upper chest), Dr. Jacob noted. These effects resolve with standard posttreatment care, including application of ice packs for 20 minutes every 3-5 hours as needed and use of ibuprofen every 4-6 hours for 3 days.

In a recent Canadian study of this technology for axillary hyperhidrosis, 90% of 31 patients reported efficacy that persisted after 12 months, and patient satisfaction was 90% at 12 months (Dermatol. Surg. 2012;38:728-35).

Further follow-up showed 100% efficacy and 100% patient satisfaction at 18 months, the investigators reported.

"Efficacy was defined as a drop [in the Hyperhidrosis Disease Severity Scale] from 3 or 4 to a 1 or 2," noted Dr. Jacob, who was not involved in the study.

The average patient’s sweat reduction was 82%. Histology showed sweat gland necrosis at 11 days and sweat gland reduction at 6 months.

"The treatment of primary axillary hyperhidrosis can be rewarding using noninvasive microwave technology. Because the microwaves preferentially target the region of skin where the sweat glands reside, leading to localized thermolysis of the sweat glands, patients can now benefit from permanent targeted sweat reduction," Dr. Jacob said. With more studies and experience using this technology, parameters will be tightened, side effects further decreased, and patient satisfaction increased, she added.

Dr. Jacob is a board member of Miramar, which funded the Canadian study and manufactures microwave devices used to treat axillary hyperhidrosis.

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

MIAMI BEACH – Rheolytic pharmacomechanical thrombectomy used in combination with adjunctive therapies is safe and effective for the endovascular treatment of upper- and lower-extremity deep vein thrombosis, according to interim findings from a prospective multicenter registry.

Treatment time was reduced from more than 2 days with other catheter-directed thrombolysis approaches to less than 24 hours with rheolytic pharmacomechanical thrombectomy, Dr. Robert Lookstein reported at the International Symposium on Endovascular Therapy 2013.

He based that conclusion on findings in 371 voluntary registry participants treated at 35 centers across the United States as part of the PEARL I and II registries of patients treated using Bayer HealthCare’s MEDRAD AngioJet catheter.

The thrombectomy procedure fragments the thrombus and aspirates it. The mean catheter-directed thrombolysis drip time was 17 hours, compared with 48 hours in the Venous Registry (Radiology 1999;211:39-49) and 58 hours in the CaVenT Registry (Lancet 2012;379:31-8), he said.

Substantial or complete lysis was achieved in more than 90% of 1,346 vessel segments treated. At 6 months’ follow-up, 86% of patients remained free of thrombosis, and at 12 months 81% remained free of thrombosis, reported Dr. Lookstein, chief of interventional radiology at Mount Sinai Medical Center, New York.

The PEARL I Registry included patients followed for 3 months to document symptomatic improvement; PEARL II is an ongoing phase II study that follows patients to 12-month outcomes. Patients included in the interim analysis of the phase II data were 214 men and 157 women with a mean age of 52 years. Most (322) had lower-extremity DVT, 256 reported symptoms of less than 14 days’ duration, and 130 had previous DVT, suggesting that "this is not as isolated an acute systematic event as once thought," Dr. Lookstein said.

Most patients (86%) received two or more therapies, including a stent in 116 cases, an inferior vena cava filter in 84 cases, catheter-directed thrombolytics in 216 cases, and other thrombectomy in 19 cases.

Bleeding requiring transfusion was the most frequent adverse event, occurring in 2.2% of patients, and hematoma was the second most frequent (1.3%).

These findings from a "real-world" registry suggest that rheolytic thrombectomy is a "transformative technology" that will enable fast, effective, minimally invasive therapy for more DVT patients, Dr. Lookstein said.

Dr. Lookstein disclosed that he is a consultant for Bayer HealthCare, which is the maker of the AngioJet system and the sponsor of the PEARL registries.

MIAMI BEACH – Rheolytic pharmacomechanical thrombectomy used in combination with adjunctive therapies is safe and effective for the endovascular treatment of upper- and lower-extremity deep vein thrombosis, according to interim findings from a prospective multicenter registry.

Treatment time was reduced from more than 2 days with other catheter-directed thrombolysis approaches to less than 24 hours with rheolytic pharmacomechanical thrombectomy, Dr. Robert Lookstein reported at the International Symposium on Endovascular Therapy 2013.

He based that conclusion on findings in 371 voluntary registry participants treated at 35 centers across the United States as part of the PEARL I and II registries of patients treated using Bayer HealthCare’s MEDRAD AngioJet catheter.

The thrombectomy procedure fragments the thrombus and aspirates it. The mean catheter-directed thrombolysis drip time was 17 hours, compared with 48 hours in the Venous Registry (Radiology 1999;211:39-49) and 58 hours in the CaVenT Registry (Lancet 2012;379:31-8), he said.

Substantial or complete lysis was achieved in more than 90% of 1,346 vessel segments treated. At 6 months’ follow-up, 86% of patients remained free of thrombosis, and at 12 months 81% remained free of thrombosis, reported Dr. Lookstein, chief of interventional radiology at Mount Sinai Medical Center, New York.

The PEARL I Registry included patients followed for 3 months to document symptomatic improvement; PEARL II is an ongoing phase II study that follows patients to 12-month outcomes. Patients included in the interim analysis of the phase II data were 214 men and 157 women with a mean age of 52 years. Most (322) had lower-extremity DVT, 256 reported symptoms of less than 14 days’ duration, and 130 had previous DVT, suggesting that "this is not as isolated an acute systematic event as once thought," Dr. Lookstein said.

Most patients (86%) received two or more therapies, including a stent in 116 cases, an inferior vena cava filter in 84 cases, catheter-directed thrombolytics in 216 cases, and other thrombectomy in 19 cases.

Bleeding requiring transfusion was the most frequent adverse event, occurring in 2.2% of patients, and hematoma was the second most frequent (1.3%).

These findings from a "real-world" registry suggest that rheolytic thrombectomy is a "transformative technology" that will enable fast, effective, minimally invasive therapy for more DVT patients, Dr. Lookstein said.

Dr. Lookstein disclosed that he is a consultant for Bayer HealthCare, which is the maker of the AngioJet system and the sponsor of the PEARL registries.

MIAMI BEACH – Rheolytic pharmacomechanical thrombectomy used in combination with adjunctive therapies is safe and effective for the endovascular treatment of upper- and lower-extremity deep vein thrombosis, according to interim findings from a prospective multicenter registry.

Treatment time was reduced from more than 2 days with other catheter-directed thrombolysis approaches to less than 24 hours with rheolytic pharmacomechanical thrombectomy, Dr. Robert Lookstein reported at the International Symposium on Endovascular Therapy 2013.

He based that conclusion on findings in 371 voluntary registry participants treated at 35 centers across the United States as part of the PEARL I and II registries of patients treated using Bayer HealthCare’s MEDRAD AngioJet catheter.

The thrombectomy procedure fragments the thrombus and aspirates it. The mean catheter-directed thrombolysis drip time was 17 hours, compared with 48 hours in the Venous Registry (Radiology 1999;211:39-49) and 58 hours in the CaVenT Registry (Lancet 2012;379:31-8), he said.

Substantial or complete lysis was achieved in more than 90% of 1,346 vessel segments treated. At 6 months’ follow-up, 86% of patients remained free of thrombosis, and at 12 months 81% remained free of thrombosis, reported Dr. Lookstein, chief of interventional radiology at Mount Sinai Medical Center, New York.

The PEARL I Registry included patients followed for 3 months to document symptomatic improvement; PEARL II is an ongoing phase II study that follows patients to 12-month outcomes. Patients included in the interim analysis of the phase II data were 214 men and 157 women with a mean age of 52 years. Most (322) had lower-extremity DVT, 256 reported symptoms of less than 14 days’ duration, and 130 had previous DVT, suggesting that "this is not as isolated an acute systematic event as once thought," Dr. Lookstein said.

Most patients (86%) received two or more therapies, including a stent in 116 cases, an inferior vena cava filter in 84 cases, catheter-directed thrombolytics in 216 cases, and other thrombectomy in 19 cases.

Bleeding requiring transfusion was the most frequent adverse event, occurring in 2.2% of patients, and hematoma was the second most frequent (1.3%).

These findings from a "real-world" registry suggest that rheolytic thrombectomy is a "transformative technology" that will enable fast, effective, minimally invasive therapy for more DVT patients, Dr. Lookstein said.

Dr. Lookstein disclosed that he is a consultant for Bayer HealthCare, which is the maker of the AngioJet system and the sponsor of the PEARL registries.

CHARLESTON, S.C. – Obese women are at greater risk of complications from hysterectomy than are nonobese women, but the difference is primarily related to minor complications, according to findings from a large retrospective cohort study.

Of 907 women who underwent hysterectomy at a single center between July 2006 and January 2009, 267 (29%) were obese. Overall, 154 of the patients had at least one complication. After the investigators adjusted for race, prior cesarean section, malignancy, concomitant procedures, and previous surgeries, the obese women were found to be significantly more likely than the nonobese women to experience any complication (adjusted odds ratio, 1.62), Dr. Kristen A. Matteson reported at the annual meeting of the Society of Gynecologic Surgeons.

However, this was secondary to an increased odds of minor complications (adjusted OR, 1.69), not major complications (adjusted OR, 1.06), according to Dr. Matteson of the Women and Infants Hospital of Rhode Island and Brown University, both in Providence, R.I.

In the 142 obese women in the study who underwent hysterectomy for benign indications, but had no concomitant procedures, the minor complication rate was greatest with abdominal hysterectomy (23.3%), followed by laparoscopic hysterectomy (12.6%). No complications occurred in those who underwent vaginal hysterectomy, but the differences between the groups with respect to minor complications were not statistically significant.

"No difference was seen in major complication rates in this subgroup," Dr. Matteson said at the meeting, which was jointly sponsored by the American College of Surgeons.

Patients included in the study were all those who underwent laparoscopic hysterectomy at the Women and Infants Hospital during the study period, as well as a random subset of women who underwent abdominal and vaginal hysterectomies, who were selected as comparators. Obesity was determined based on body mass index and according to World Health Organization guidelines.

Minor complications included conversion to laparotomy, wound cellulitis, need for transfusion, prolonged surgery, and length of hospitalization above the 90th percentile. Major complications included bowel injury, blood vessel injury, trocar site hernia, pelvic hematoma, vaginal nonhealing, need for reoperation, pelvic infection, urinary tract infection, sepsis, and thromboembolic event.

The findings are important given that approximately 600,000 hysterectomies are performed in the United States each year, according to the Centers for Disease Control and Prevention, and given that the prevalence of obesity is skyrocketing, Dr. Matteson said, explaining that a better understanding of the complications associated with hysterectomy in obese women could facilitate patient counseling about the risks.

Dr. Matteson reported having no relevant financial disclosures.

CHARLESTON, S.C. – Obese women are at greater risk of complications from hysterectomy than are nonobese women, but the difference is primarily related to minor complications, according to findings from a large retrospective cohort study.

Of 907 women who underwent hysterectomy at a single center between July 2006 and January 2009, 267 (29%) were obese. Overall, 154 of the patients had at least one complication. After the investigators adjusted for race, prior cesarean section, malignancy, concomitant procedures, and previous surgeries, the obese women were found to be significantly more likely than the nonobese women to experience any complication (adjusted odds ratio, 1.62), Dr. Kristen A. Matteson reported at the annual meeting of the Society of Gynecologic Surgeons.

However, this was secondary to an increased odds of minor complications (adjusted OR, 1.69), not major complications (adjusted OR, 1.06), according to Dr. Matteson of the Women and Infants Hospital of Rhode Island and Brown University, both in Providence, R.I.

In the 142 obese women in the study who underwent hysterectomy for benign indications, but had no concomitant procedures, the minor complication rate was greatest with abdominal hysterectomy (23.3%), followed by laparoscopic hysterectomy (12.6%). No complications occurred in those who underwent vaginal hysterectomy, but the differences between the groups with respect to minor complications were not statistically significant.

"No difference was seen in major complication rates in this subgroup," Dr. Matteson said at the meeting, which was jointly sponsored by the American College of Surgeons.

Patients included in the study were all those who underwent laparoscopic hysterectomy at the Women and Infants Hospital during the study period, as well as a random subset of women who underwent abdominal and vaginal hysterectomies, who were selected as comparators. Obesity was determined based on body mass index and according to World Health Organization guidelines.

Minor complications included conversion to laparotomy, wound cellulitis, need for transfusion, prolonged surgery, and length of hospitalization above the 90th percentile. Major complications included bowel injury, blood vessel injury, trocar site hernia, pelvic hematoma, vaginal nonhealing, need for reoperation, pelvic infection, urinary tract infection, sepsis, and thromboembolic event.

The findings are important given that approximately 600,000 hysterectomies are performed in the United States each year, according to the Centers for Disease Control and Prevention, and given that the prevalence of obesity is skyrocketing, Dr. Matteson said, explaining that a better understanding of the complications associated with hysterectomy in obese women could facilitate patient counseling about the risks.

Dr. Matteson reported having no relevant financial disclosures.

CHARLESTON, S.C. – Obese women are at greater risk of complications from hysterectomy than are nonobese women, but the difference is primarily related to minor complications, according to findings from a large retrospective cohort study.

Of 907 women who underwent hysterectomy at a single center between July 2006 and January 2009, 267 (29%) were obese. Overall, 154 of the patients had at least one complication. After the investigators adjusted for race, prior cesarean section, malignancy, concomitant procedures, and previous surgeries, the obese women were found to be significantly more likely than the nonobese women to experience any complication (adjusted odds ratio, 1.62), Dr. Kristen A. Matteson reported at the annual meeting of the Society of Gynecologic Surgeons.

However, this was secondary to an increased odds of minor complications (adjusted OR, 1.69), not major complications (adjusted OR, 1.06), according to Dr. Matteson of the Women and Infants Hospital of Rhode Island and Brown University, both in Providence, R.I.

In the 142 obese women in the study who underwent hysterectomy for benign indications, but had no concomitant procedures, the minor complication rate was greatest with abdominal hysterectomy (23.3%), followed by laparoscopic hysterectomy (12.6%). No complications occurred in those who underwent vaginal hysterectomy, but the differences between the groups with respect to minor complications were not statistically significant.

"No difference was seen in major complication rates in this subgroup," Dr. Matteson said at the meeting, which was jointly sponsored by the American College of Surgeons.

Patients included in the study were all those who underwent laparoscopic hysterectomy at the Women and Infants Hospital during the study period, as well as a random subset of women who underwent abdominal and vaginal hysterectomies, who were selected as comparators. Obesity was determined based on body mass index and according to World Health Organization guidelines.

Minor complications included conversion to laparotomy, wound cellulitis, need for transfusion, prolonged surgery, and length of hospitalization above the 90th percentile. Major complications included bowel injury, blood vessel injury, trocar site hernia, pelvic hematoma, vaginal nonhealing, need for reoperation, pelvic infection, urinary tract infection, sepsis, and thromboembolic event.

The findings are important given that approximately 600,000 hysterectomies are performed in the United States each year, according to the Centers for Disease Control and Prevention, and given that the prevalence of obesity is skyrocketing, Dr. Matteson said, explaining that a better understanding of the complications associated with hysterectomy in obese women could facilitate patient counseling about the risks.

Dr. Matteson reported having no relevant financial disclosures.

CHARLESTON, S.C. – Most women who undergo an isolated midurethral sling procedure pass active bladder testing on the first attempt, but the likelihood of being discharged with an indwelling catheter increases as bladder capacity increases, maximum flow rate decreases, or detrusor overactivity occurs, findings from a retrospective cross-sectional study have shown.

Of 112 patients who underwent an isolated midurethral sling procedure at a single site, 90 (80.4%) passed active bladder testing (ABT) on the first attempt prior to discharge home, and 22 (19.6%) failed, Dr. Meadow M. Good reported at the annual meeting of the Society of Gynecologic Surgeons.

Bladder testing involved filling the bladder with sterile fluid to 300 mL or to patient discomfort, whichever came first. Passing the test required that two-thirds of the instilled volume was voided.

Average bladder capacity among those who failed ABT was 415 cc, compared with 381 cc in those who passed; average maximum flow rate in those who failed ABT was 15.6 cc/second, compared with 21.6 cc/second in those who passed; and detrusor overactivity was observed in 41% of those who failed ABT, compared with 20% of those who passed, said Dr. Good of the University of Texas Southwestern Medical Center, Dallas.

Furthermore, the capacity-to-infused volume ratio was 1:5 for those who failed ABT and 1:3 for those who passed. Most (81.8%) of those who failed had bladder capacity greater than the infused amount, but no significant difference in the capacity-to-infused volume ratios was seen in the group who passed ABT.

On multivariate analysis, every 50-cc increase in bladder capacity significantly increased the odds of failing ABT (odds ratio, 1.25); every unit increase in the maximum flow rate significantly decreased the odds of ABT failure (OR, 0.91); and the presence of detrusor overactivity was associated with a fivefold increase in the odds of failure (OR, 5.0).

Age, race, body mass index, maximum urethral closure pressure, and maximum detrusor pressure during pressure-flow studies were not found to be associated with ABT outcomes.

Patients included in this study were all those who underwent an isolated midurethral sling procedure at the medical center between January 2011 and August 2012, excluding those who had intraoperative complications requiring discharge with a Foley catheter.

The findings are important because the rates of postoperative urinary retention following midurethral sling procedures are highly variable, and the identification of factors associated with ABT failure could help improve outcomes.

"Patients with postoperative retention are generally discharged home with an indwelling catheter or intermittent self-catheterization; catheter-associated bacteria lead to increased urinary tract infections and health care costs, and to decreased quality of life," Dr. Good said, adding that reducing the rates of postoperative catheter use should be a priority.

"While further research is needed, filling patients to cystometric capacity may improve the success of postoperative bladder testing," she said.

Dr. Good reported having no relevant financial disclosures.

CHARLESTON, S.C. – Most women who undergo an isolated midurethral sling procedure pass active bladder testing on the first attempt, but the likelihood of being discharged with an indwelling catheter increases as bladder capacity increases, maximum flow rate decreases, or detrusor overactivity occurs, findings from a retrospective cross-sectional study have shown.

Of 112 patients who underwent an isolated midurethral sling procedure at a single site, 90 (80.4%) passed active bladder testing (ABT) on the first attempt prior to discharge home, and 22 (19.6%) failed, Dr. Meadow M. Good reported at the annual meeting of the Society of Gynecologic Surgeons.

Bladder testing involved filling the bladder with sterile fluid to 300 mL or to patient discomfort, whichever came first. Passing the test required that two-thirds of the instilled volume was voided.

Average bladder capacity among those who failed ABT was 415 cc, compared with 381 cc in those who passed; average maximum flow rate in those who failed ABT was 15.6 cc/second, compared with 21.6 cc/second in those who passed; and detrusor overactivity was observed in 41% of those who failed ABT, compared with 20% of those who passed, said Dr. Good of the University of Texas Southwestern Medical Center, Dallas.

Furthermore, the capacity-to-infused volume ratio was 1:5 for those who failed ABT and 1:3 for those who passed. Most (81.8%) of those who failed had bladder capacity greater than the infused amount, but no significant difference in the capacity-to-infused volume ratios was seen in the group who passed ABT.

On multivariate analysis, every 50-cc increase in bladder capacity significantly increased the odds of failing ABT (odds ratio, 1.25); every unit increase in the maximum flow rate significantly decreased the odds of ABT failure (OR, 0.91); and the presence of detrusor overactivity was associated with a fivefold increase in the odds of failure (OR, 5.0).

Age, race, body mass index, maximum urethral closure pressure, and maximum detrusor pressure during pressure-flow studies were not found to be associated with ABT outcomes.

Patients included in this study were all those who underwent an isolated midurethral sling procedure at the medical center between January 2011 and August 2012, excluding those who had intraoperative complications requiring discharge with a Foley catheter.

The findings are important because the rates of postoperative urinary retention following midurethral sling procedures are highly variable, and the identification of factors associated with ABT failure could help improve outcomes.

"Patients with postoperative retention are generally discharged home with an indwelling catheter or intermittent self-catheterization; catheter-associated bacteria lead to increased urinary tract infections and health care costs, and to decreased quality of life," Dr. Good said, adding that reducing the rates of postoperative catheter use should be a priority.

"While further research is needed, filling patients to cystometric capacity may improve the success of postoperative bladder testing," she said.

Dr. Good reported having no relevant financial disclosures.

CHARLESTON, S.C. – Most women who undergo an isolated midurethral sling procedure pass active bladder testing on the first attempt, but the likelihood of being discharged with an indwelling catheter increases as bladder capacity increases, maximum flow rate decreases, or detrusor overactivity occurs, findings from a retrospective cross-sectional study have shown.

Of 112 patients who underwent an isolated midurethral sling procedure at a single site, 90 (80.4%) passed active bladder testing (ABT) on the first attempt prior to discharge home, and 22 (19.6%) failed, Dr. Meadow M. Good reported at the annual meeting of the Society of Gynecologic Surgeons.

Bladder testing involved filling the bladder with sterile fluid to 300 mL or to patient discomfort, whichever came first. Passing the test required that two-thirds of the instilled volume was voided.

Average bladder capacity among those who failed ABT was 415 cc, compared with 381 cc in those who passed; average maximum flow rate in those who failed ABT was 15.6 cc/second, compared with 21.6 cc/second in those who passed; and detrusor overactivity was observed in 41% of those who failed ABT, compared with 20% of those who passed, said Dr. Good of the University of Texas Southwestern Medical Center, Dallas.

Furthermore, the capacity-to-infused volume ratio was 1:5 for those who failed ABT and 1:3 for those who passed. Most (81.8%) of those who failed had bladder capacity greater than the infused amount, but no significant difference in the capacity-to-infused volume ratios was seen in the group who passed ABT.

On multivariate analysis, every 50-cc increase in bladder capacity significantly increased the odds of failing ABT (odds ratio, 1.25); every unit increase in the maximum flow rate significantly decreased the odds of ABT failure (OR, 0.91); and the presence of detrusor overactivity was associated with a fivefold increase in the odds of failure (OR, 5.0).

Age, race, body mass index, maximum urethral closure pressure, and maximum detrusor pressure during pressure-flow studies were not found to be associated with ABT outcomes.

Patients included in this study were all those who underwent an isolated midurethral sling procedure at the medical center between January 2011 and August 2012, excluding those who had intraoperative complications requiring discharge with a Foley catheter.

The findings are important because the rates of postoperative urinary retention following midurethral sling procedures are highly variable, and the identification of factors associated with ABT failure could help improve outcomes.

"Patients with postoperative retention are generally discharged home with an indwelling catheter or intermittent self-catheterization; catheter-associated bacteria lead to increased urinary tract infections and health care costs, and to decreased quality of life," Dr. Good said, adding that reducing the rates of postoperative catheter use should be a priority.

"While further research is needed, filling patients to cystometric capacity may improve the success of postoperative bladder testing," she said.

Dr. Good reported having no relevant financial disclosures.