ACS Surgery News

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

[email protected]

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

[email protected]

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

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 – Patients with resected advanced ovarian cancer and low-volume residual disease fare better in the long term with intraperitoneal chemotherapy instead of intravenous chemotherapy.

A team led by Dr. Devansu Tewari assessed outcomes in 876 women from two key Gynecologic Oncology Group trials: GOG 114 and GOG 172. Combined median follow-up in those trials approached 11 years.

Compared with their peers given intravenous chemotherapy, women given intraperitoneal (IP) chemotherapy had a 16% lower risk of progression or death and a 17% lower risk of death, according to results reported at the annual meeting of the Society of Gynecologic Oncology.

Benefit was evident regardless of the extent of residual disease. Also, each additional cycle of IP chemotherapy reduced the risk of death by 12%.

"A strength of this study is that it is a combined analysis of these two major IP trials that looked at long-term follow-up and showed survival outcomes that are quite significant. The defining difference between the two groups is that one received IP therapy and one did not, as it is very unlikely that IP therapy would have been administered in the recurrent setting," Dr. Tewari commented.

Although more than 7 years have elapsed since the National Cancer Institute recommended consideration of IP chemotherapy for advanced-stage low-volume ovarian cancer, uptake of this therapy has been limited given lingering questions about efficacy, safety, and issues such as the ideal regimen, noted Dr. Tewari, who is director of gynecologic oncology for the Southern California Permanente Medical Group in Orange County, California, and assistant professor of ob.gyn. at the University of California, Irvine.

"We have now updated the results of GOG 172 and GOG 114. But we also acknowledge that in the last 7 years, a lot has changed in the treatment of ovarian cancer in which these advantages may be further enhanced," he noted, for example, through use of bevacizumab (Avastin) and dose-dense therapy.

In particular, oncologists are awaiting results of the recently completed GOG 262 trial (assessing the role of bevacizumab and dose-dense paclitaxel) and the GOG 252 trial (assessing the role of IP carboplatin, bevacizumab, and dose-dense paclitaxel).

"We hope that the results of these studies, combined with the findings before, will bring in the foundation that we need to move forward in terms of laying the groundwork for treating women individually and tailoring their treatment for this cancer specifically for them," Dr. Tewari said.

One session attendee, noting the IP regimens used in the trials studied, asked, "Is it the dose-dense treatment or the IP that actually matters?"

"That’s a very good question. The whole issue with GOG 172 was essentially partial deployment of dose dense because patients [in the IP arm] received [an additional] day 8 treatment, so it has to be acknowledged," Dr. Tewari replied. "I think the answer is going to really come about when we see the findings of GOG 252."

Attendee Dr. Joan Walker of the University of Oklahoma, Oklahoma City, said, "I want to thank the presenters for emphasizing IP chemotherapy with cisplatin, and I think that it still needs to be emphasized."

She noted that the long-term survival gains being seen with IP chemotherapy are "just amazing. And we don’t know why that is, but obviously if GOG 104, 114, and 172 all show the same thing, it can’t necessarily be that the Taxol [paclitaxel] IP is the only contributing factor," she said.

"I think the future is bright for women and their survival, and it may be the bone marrow preservation of cisplatin that’s really causing the long-term effect because we know that patients get treated with multiple agents over and over again," Dr. Walker speculated.

The two trials that Dr. Tewari’s group studied – GOG 114 and GOG 172 – enrolled patients with resected stage III epithelial ovarian or peritoneal carcinoma who had residual disease measuring 1.0 cm or less.

The former trial compared IV carboplatin and paclitaxel with IP cisplatin; the latter trial compared IV paclitaxel with IP cisplatin and paclitaxel. About two-thirds of the women had macroscopic residual disease.

With a median follow-up of 10.7 years, relative to their counterparts given IV chemotherapy, women given IP chemotherapy had better progression-free survival (25 vs. 20 months; hazard ratio, 0.84; P = .03) and overall survival (62 vs. 51 months; hazard ratio, 0.83; P = .048).

The survival benefit of IP over IV chemotherapy was evident among both women with microscopic residual disease (5-year survival, 65% vs. 58%) and women with macroscopic residual disease (44% vs. 35%).

"There has been a lot of debate regarding the role of IP therapy in microscopic and macroscopic residual disease, and we saw an advantage in this cohort in both specific groups," commented Dr. Tewari.

Overall, half of patients given IP chemotherapy completed all six cycles of that chemotherapy. The risk of death fell with each additional cycle of IP chemotherapy (hazard ratio, 0.88, P less than .001).

Dr. Tewari disclosed no conflicts of interest related to the research.

LOS ANGELES – Patients with resected advanced ovarian cancer and low-volume residual disease fare better in the long term with intraperitoneal chemotherapy instead of intravenous chemotherapy.

A team led by Dr. Devansu Tewari assessed outcomes in 876 women from two key Gynecologic Oncology Group trials: GOG 114 and GOG 172. Combined median follow-up in those trials approached 11 years.

Compared with their peers given intravenous chemotherapy, women given intraperitoneal (IP) chemotherapy had a 16% lower risk of progression or death and a 17% lower risk of death, according to results reported at the annual meeting of the Society of Gynecologic Oncology.

Benefit was evident regardless of the extent of residual disease. Also, each additional cycle of IP chemotherapy reduced the risk of death by 12%.

"A strength of this study is that it is a combined analysis of these two major IP trials that looked at long-term follow-up and showed survival outcomes that are quite significant. The defining difference between the two groups is that one received IP therapy and one did not, as it is very unlikely that IP therapy would have been administered in the recurrent setting," Dr. Tewari commented.

Although more than 7 years have elapsed since the National Cancer Institute recommended consideration of IP chemotherapy for advanced-stage low-volume ovarian cancer, uptake of this therapy has been limited given lingering questions about efficacy, safety, and issues such as the ideal regimen, noted Dr. Tewari, who is director of gynecologic oncology for the Southern California Permanente Medical Group in Orange County, California, and assistant professor of ob.gyn. at the University of California, Irvine.

"We have now updated the results of GOG 172 and GOG 114. But we also acknowledge that in the last 7 years, a lot has changed in the treatment of ovarian cancer in which these advantages may be further enhanced," he noted, for example, through use of bevacizumab (Avastin) and dose-dense therapy.

In particular, oncologists are awaiting results of the recently completed GOG 262 trial (assessing the role of bevacizumab and dose-dense paclitaxel) and the GOG 252 trial (assessing the role of IP carboplatin, bevacizumab, and dose-dense paclitaxel).

"We hope that the results of these studies, combined with the findings before, will bring in the foundation that we need to move forward in terms of laying the groundwork for treating women individually and tailoring their treatment for this cancer specifically for them," Dr. Tewari said.

One session attendee, noting the IP regimens used in the trials studied, asked, "Is it the dose-dense treatment or the IP that actually matters?"

"That’s a very good question. The whole issue with GOG 172 was essentially partial deployment of dose dense because patients [in the IP arm] received [an additional] day 8 treatment, so it has to be acknowledged," Dr. Tewari replied. "I think the answer is going to really come about when we see the findings of GOG 252."

Attendee Dr. Joan Walker of the University of Oklahoma, Oklahoma City, said, "I want to thank the presenters for emphasizing IP chemotherapy with cisplatin, and I think that it still needs to be emphasized."

She noted that the long-term survival gains being seen with IP chemotherapy are "just amazing. And we don’t know why that is, but obviously if GOG 104, 114, and 172 all show the same thing, it can’t necessarily be that the Taxol [paclitaxel] IP is the only contributing factor," she said.

"I think the future is bright for women and their survival, and it may be the bone marrow preservation of cisplatin that’s really causing the long-term effect because we know that patients get treated with multiple agents over and over again," Dr. Walker speculated.

The two trials that Dr. Tewari’s group studied – GOG 114 and GOG 172 – enrolled patients with resected stage III epithelial ovarian or peritoneal carcinoma who had residual disease measuring 1.0 cm or less.

The former trial compared IV carboplatin and paclitaxel with IP cisplatin; the latter trial compared IV paclitaxel with IP cisplatin and paclitaxel. About two-thirds of the women had macroscopic residual disease.

With a median follow-up of 10.7 years, relative to their counterparts given IV chemotherapy, women given IP chemotherapy had better progression-free survival (25 vs. 20 months; hazard ratio, 0.84; P = .03) and overall survival (62 vs. 51 months; hazard ratio, 0.83; P = .048).

The survival benefit of IP over IV chemotherapy was evident among both women with microscopic residual disease (5-year survival, 65% vs. 58%) and women with macroscopic residual disease (44% vs. 35%).

"There has been a lot of debate regarding the role of IP therapy in microscopic and macroscopic residual disease, and we saw an advantage in this cohort in both specific groups," commented Dr. Tewari.

Overall, half of patients given IP chemotherapy completed all six cycles of that chemotherapy. The risk of death fell with each additional cycle of IP chemotherapy (hazard ratio, 0.88, P less than .001).

Dr. Tewari disclosed no conflicts of interest related to the research.

LOS ANGELES – Patients with resected advanced ovarian cancer and low-volume residual disease fare better in the long term with intraperitoneal chemotherapy instead of intravenous chemotherapy.

A team led by Dr. Devansu Tewari assessed outcomes in 876 women from two key Gynecologic Oncology Group trials: GOG 114 and GOG 172. Combined median follow-up in those trials approached 11 years.

Compared with their peers given intravenous chemotherapy, women given intraperitoneal (IP) chemotherapy had a 16% lower risk of progression or death and a 17% lower risk of death, according to results reported at the annual meeting of the Society of Gynecologic Oncology.

Benefit was evident regardless of the extent of residual disease. Also, each additional cycle of IP chemotherapy reduced the risk of death by 12%.

"A strength of this study is that it is a combined analysis of these two major IP trials that looked at long-term follow-up and showed survival outcomes that are quite significant. The defining difference between the two groups is that one received IP therapy and one did not, as it is very unlikely that IP therapy would have been administered in the recurrent setting," Dr. Tewari commented.

Although more than 7 years have elapsed since the National Cancer Institute recommended consideration of IP chemotherapy for advanced-stage low-volume ovarian cancer, uptake of this therapy has been limited given lingering questions about efficacy, safety, and issues such as the ideal regimen, noted Dr. Tewari, who is director of gynecologic oncology for the Southern California Permanente Medical Group in Orange County, California, and assistant professor of ob.gyn. at the University of California, Irvine.

"We have now updated the results of GOG 172 and GOG 114. But we also acknowledge that in the last 7 years, a lot has changed in the treatment of ovarian cancer in which these advantages may be further enhanced," he noted, for example, through use of bevacizumab (Avastin) and dose-dense therapy.

In particular, oncologists are awaiting results of the recently completed GOG 262 trial (assessing the role of bevacizumab and dose-dense paclitaxel) and the GOG 252 trial (assessing the role of IP carboplatin, bevacizumab, and dose-dense paclitaxel).

"We hope that the results of these studies, combined with the findings before, will bring in the foundation that we need to move forward in terms of laying the groundwork for treating women individually and tailoring their treatment for this cancer specifically for them," Dr. Tewari said.

One session attendee, noting the IP regimens used in the trials studied, asked, "Is it the dose-dense treatment or the IP that actually matters?"

"That’s a very good question. The whole issue with GOG 172 was essentially partial deployment of dose dense because patients [in the IP arm] received [an additional] day 8 treatment, so it has to be acknowledged," Dr. Tewari replied. "I think the answer is going to really come about when we see the findings of GOG 252."

Attendee Dr. Joan Walker of the University of Oklahoma, Oklahoma City, said, "I want to thank the presenters for emphasizing IP chemotherapy with cisplatin, and I think that it still needs to be emphasized."

She noted that the long-term survival gains being seen with IP chemotherapy are "just amazing. And we don’t know why that is, but obviously if GOG 104, 114, and 172 all show the same thing, it can’t necessarily be that the Taxol [paclitaxel] IP is the only contributing factor," she said.

"I think the future is bright for women and their survival, and it may be the bone marrow preservation of cisplatin that’s really causing the long-term effect because we know that patients get treated with multiple agents over and over again," Dr. Walker speculated.

The two trials that Dr. Tewari’s group studied – GOG 114 and GOG 172 – enrolled patients with resected stage III epithelial ovarian or peritoneal carcinoma who had residual disease measuring 1.0 cm or less.

The former trial compared IV carboplatin and paclitaxel with IP cisplatin; the latter trial compared IV paclitaxel with IP cisplatin and paclitaxel. About two-thirds of the women had macroscopic residual disease.

With a median follow-up of 10.7 years, relative to their counterparts given IV chemotherapy, women given IP chemotherapy had better progression-free survival (25 vs. 20 months; hazard ratio, 0.84; P = .03) and overall survival (62 vs. 51 months; hazard ratio, 0.83; P = .048).

The survival benefit of IP over IV chemotherapy was evident among both women with microscopic residual disease (5-year survival, 65% vs. 58%) and women with macroscopic residual disease (44% vs. 35%).

"There has been a lot of debate regarding the role of IP therapy in microscopic and macroscopic residual disease, and we saw an advantage in this cohort in both specific groups," commented Dr. Tewari.

Overall, half of patients given IP chemotherapy completed all six cycles of that chemotherapy. The risk of death fell with each additional cycle of IP chemotherapy (hazard ratio, 0.88, P less than .001).

Dr. Tewari disclosed no conflicts of interest related to the research.

NEW ORLEANS – Hospitals with palliative care programs had lower treatment intensity on average at the end of life than did those without palliative care, in a national sample of 3,593 hospitals.

ICU length of stay in the last 6 months of life was 0.4 days shorter (P less than .001) and hospice length of stay 1.6 days longer (P = .013) at hospitals with palliative care versus those without.

The study strengthens claims that palliative care cuts costs, and is the first to examine the impact of palliative care in such a large national sample of hospitals, Jay R. Horton said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Prior studies focused on the effects of palliative care. Mr. Horton’s study considers outcomes for the entire older adult population in the hospital.

Patrice Wendling/IMNG Medical Media

The researchers considered data from 3,593 hospitals with a palliative care status noted on the 2008 American Hospital Association survey. In all, 1,657 hospitals had palliative care programs and 1,936 hospitals did not. The researchers then linked the hospital data with the data from the Dartmouth Atlas on 896,097 fee-for-service Medicare patients, aged 67-99 years, with one or more chronic illnesses, who died in 2007. Patients were assigned to a hospital where they received the majority of their care in the last 2 years of life.

Covariates predictive of outcomes such as age, sex, race and comorbidities were already corrected for in the Dartmouth Atlas. Propensity scoring was used for variables predictive of outcomes or the presence of palliative care in the AHA survey such as Joint Commission Accreditation and total bed count. Finally, propensity scores were used to reweight the sample to reduce selection bias.

The effect of palliative care would very likely be stronger if the data had identified those patients who actually received palliative care, said Mr. Horton , director of the palliative care consult service at The Lilian and Benjamin Hertzberg Palliative Care Institute, Icahn School of Medicine at Mount Sinai Hospital, New York. Ongoing research uses data from the National Palliative Care Registry to better identify palliative care programs and socioeconomic factors to further reduce potential selection bias.

Treatment intensity for patients with serious illness varies widely across the country. One study showed that more than 40% of the variation is due to the supply of specialists and hospital capacity (BMJ 2002;325:961-4). Put another way, the greater the supply of physicians, the greater the utilization, even after adjustment for factors that should drive utilization, such as patient preference and disease severity.

"This supply-sensitive care, as it is sometimes called, is at the discretion of clinicians and to a certain extent at the discretion of patients, but more troubling is that much of this care may be unnecessary," said Mr. Horton.

Mr. Horton reported having no financial disclosures.

[email protected]

NEW ORLEANS – Hospitals with palliative care programs had lower treatment intensity on average at the end of life than did those without palliative care, in a national sample of 3,593 hospitals.

ICU length of stay in the last 6 months of life was 0.4 days shorter (P less than .001) and hospice length of stay 1.6 days longer (P = .013) at hospitals with palliative care versus those without.

The study strengthens claims that palliative care cuts costs, and is the first to examine the impact of palliative care in such a large national sample of hospitals, Jay R. Horton said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Prior studies focused on the effects of palliative care. Mr. Horton’s study considers outcomes for the entire older adult population in the hospital.

Patrice Wendling/IMNG Medical Media

The researchers considered data from 3,593 hospitals with a palliative care status noted on the 2008 American Hospital Association survey. In all, 1,657 hospitals had palliative care programs and 1,936 hospitals did not. The researchers then linked the hospital data with the data from the Dartmouth Atlas on 896,097 fee-for-service Medicare patients, aged 67-99 years, with one or more chronic illnesses, who died in 2007. Patients were assigned to a hospital where they received the majority of their care in the last 2 years of life.

Covariates predictive of outcomes such as age, sex, race and comorbidities were already corrected for in the Dartmouth Atlas. Propensity scoring was used for variables predictive of outcomes or the presence of palliative care in the AHA survey such as Joint Commission Accreditation and total bed count. Finally, propensity scores were used to reweight the sample to reduce selection bias.

The effect of palliative care would very likely be stronger if the data had identified those patients who actually received palliative care, said Mr. Horton , director of the palliative care consult service at The Lilian and Benjamin Hertzberg Palliative Care Institute, Icahn School of Medicine at Mount Sinai Hospital, New York. Ongoing research uses data from the National Palliative Care Registry to better identify palliative care programs and socioeconomic factors to further reduce potential selection bias.

Treatment intensity for patients with serious illness varies widely across the country. One study showed that more than 40% of the variation is due to the supply of specialists and hospital capacity (BMJ 2002;325:961-4). Put another way, the greater the supply of physicians, the greater the utilization, even after adjustment for factors that should drive utilization, such as patient preference and disease severity.

"This supply-sensitive care, as it is sometimes called, is at the discretion of clinicians and to a certain extent at the discretion of patients, but more troubling is that much of this care may be unnecessary," said Mr. Horton.

Mr. Horton reported having no financial disclosures.

[email protected]

NEW ORLEANS – Hospitals with palliative care programs had lower treatment intensity on average at the end of life than did those without palliative care, in a national sample of 3,593 hospitals.

ICU length of stay in the last 6 months of life was 0.4 days shorter (P less than .001) and hospice length of stay 1.6 days longer (P = .013) at hospitals with palliative care versus those without.

The study strengthens claims that palliative care cuts costs, and is the first to examine the impact of palliative care in such a large national sample of hospitals, Jay R. Horton said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Prior studies focused on the effects of palliative care. Mr. Horton’s study considers outcomes for the entire older adult population in the hospital.

Patrice Wendling/IMNG Medical Media

The researchers considered data from 3,593 hospitals with a palliative care status noted on the 2008 American Hospital Association survey. In all, 1,657 hospitals had palliative care programs and 1,936 hospitals did not. The researchers then linked the hospital data with the data from the Dartmouth Atlas on 896,097 fee-for-service Medicare patients, aged 67-99 years, with one or more chronic illnesses, who died in 2007. Patients were assigned to a hospital where they received the majority of their care in the last 2 years of life.

Covariates predictive of outcomes such as age, sex, race and comorbidities were already corrected for in the Dartmouth Atlas. Propensity scoring was used for variables predictive of outcomes or the presence of palliative care in the AHA survey such as Joint Commission Accreditation and total bed count. Finally, propensity scores were used to reweight the sample to reduce selection bias.

The effect of palliative care would very likely be stronger if the data had identified those patients who actually received palliative care, said Mr. Horton , director of the palliative care consult service at The Lilian and Benjamin Hertzberg Palliative Care Institute, Icahn School of Medicine at Mount Sinai Hospital, New York. Ongoing research uses data from the National Palliative Care Registry to better identify palliative care programs and socioeconomic factors to further reduce potential selection bias.

Treatment intensity for patients with serious illness varies widely across the country. One study showed that more than 40% of the variation is due to the supply of specialists and hospital capacity (BMJ 2002;325:961-4). Put another way, the greater the supply of physicians, the greater the utilization, even after adjustment for factors that should drive utilization, such as patient preference and disease severity.

"This supply-sensitive care, as it is sometimes called, is at the discretion of clinicians and to a certain extent at the discretion of patients, but more troubling is that much of this care may be unnecessary," said Mr. Horton.

Mr. Horton reported having no financial disclosures.

[email protected]

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.

The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

[email protected]

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.

The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

[email protected]

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.

The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

[email protected]

LOS ANGELES – Surgically exploring the retroperitoneum for disease may benefit some patients undergoing primary debulking of advanced ovarian cancer, a study reported at the annual meeting of the Society of Gynecologic Oncology has shown.

Investigators analyzed data from Gynecologic Oncology Group (GOG) trial 182, focusing on the 1,876 women who had stage IIIc epithelial ovarian cancer on the basis of intraperitoneal tumor size and who underwent optimal debulking.

Overall, one-third had a retroperitoneal exploration, defined in the study as removal of at least one pelvic or para-aortic lymph node.

Patients who had this procedure were 15% less likely to experience progression or death and 15% less likely to die after other factors were considered, reported lead investigator Dr. Bunja Rungruang, a gynecologic oncologist with Georgia Regents University in Augusta.

In stratified analyses, benefit was seen in the subgroup with minimal gross residual disease but not in the subgroup with microscopic residual disease.

"In this large multi-institutional trial, there is evidence that retroperitoneal exploration at the time of primary debulking surgery of patients with intraperitoneal stage IIIc epithelial ovarian cancer may provide survival benefit," she commented.

"Surgical effort and tumor biology interact to affect patient outcomes," Dr. Rungruang noted. "Retroperitoneal exploration may be a proxy for more thorough surgical effort in these patients, rather than tumor biology alone driving outcomes. Surgeon discretion is a potential factor here as well; it is conceivable that the surgeon’s impression or information about prognosis influences the retroperitoneal exploration decision, based on unmeasured indicators of patient disease burden or vitality.

"Given the small but significant survival differences and the large sample size of this study, it is possible that these survival advantages are to some degree indicative of unmeasured factors or the accuracy of the surgeon’s impression, and not completely about the act of pathologic exploration," she said.

One attendee noted that analyses have suggested that patients who do not have a retroperitoneal exploration fare even more poorly than those who have the procedure and are found to have positive lymph nodes.

"I am concerned that that is because the surgeon thought the prognosis was so bad that they didn’t bother. I don’t know whether you have a sense of whether that conclusion looked appropriate for your analysis of all the tumor burden in that patient," Dr. Rungruang said.

"For some of the patients, it seemed to be a surgeon preference that they didn’t sample the nodes because they felt that the patient was already stage IIIc and called them microscopic optimally debulked, or microscopic optimally debulked without assessing the lymph nodes. Other patients had a much larger surgery, a higher complexity of procedures, and still had a lymph node assessment on top of it. What I can tell from reading the actual operative notes is a lot of [the approach] is based on surgeon preference."

In discussing the lack of additional benefit for exploration in women with microscopic residual disease, Dr. Rungruang explained that "if you have microscopic residual disease, that seems like the best you can do for those patients. I think in the macroscopic residual patients, you see the difference because it is perhaps a proxy for just a more thorough surgical assessment in these patients. Plus, macroscopic residual disease is such a wide spectrum, you can be anywhere from one site of residual disease to miliary disease spread throughout, and that heterogeneity within that residual disease group also accounts for that difference."

Patients enrolled in GOG 182 had advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, and underwent primary debulking to optimal residual disease (less than 1 cm), followed by randomization to a variety of platinum- and paclitaxel-based adjuvant chemotherapy regimens.

The investigators restricted analyses to the subset whose disease was stage IIIc on the basis of an intraperitoneal tumor measuring at least 2 cm. Overall, 37% of this subset had a retroperitoneal exploration.

The patients undergoing this additional procedure had better median progression-free survival (18.5 vs. 16.0 months, P less than .0001) and overall survival (53.3 vs. 42.8 months, P less than .0001), reported Dr. Rungruang.

When patients were stratified, retroperitoneal exploration was beneficial in those with minimal gross residual disease in terms of both progression-free survival (16.8 vs. 15.1 months, P = .01) and overall survival (44.9 vs. 40.5 months, P = .008). But there was no such benefit in patients who had microscopic residual disease.

In a multivariate analysis, retroperitoneal exploration independently predicted better progression-free survival (hazard ratio, 0.85; P = .004) and overall survival (HR, 0.85; P = .009).

Dr. Rungruang disclosed no relevant financial conflicts.

LOS ANGELES – Surgically exploring the retroperitoneum for disease may benefit some patients undergoing primary debulking of advanced ovarian cancer, a study reported at the annual meeting of the Society of Gynecologic Oncology has shown.

Investigators analyzed data from Gynecologic Oncology Group (GOG) trial 182, focusing on the 1,876 women who had stage IIIc epithelial ovarian cancer on the basis of intraperitoneal tumor size and who underwent optimal debulking.

Overall, one-third had a retroperitoneal exploration, defined in the study as removal of at least one pelvic or para-aortic lymph node.

Patients who had this procedure were 15% less likely to experience progression or death and 15% less likely to die after other factors were considered, reported lead investigator Dr. Bunja Rungruang, a gynecologic oncologist with Georgia Regents University in Augusta.

In stratified analyses, benefit was seen in the subgroup with minimal gross residual disease but not in the subgroup with microscopic residual disease.

"In this large multi-institutional trial, there is evidence that retroperitoneal exploration at the time of primary debulking surgery of patients with intraperitoneal stage IIIc epithelial ovarian cancer may provide survival benefit," she commented.

"Surgical effort and tumor biology interact to affect patient outcomes," Dr. Rungruang noted. "Retroperitoneal exploration may be a proxy for more thorough surgical effort in these patients, rather than tumor biology alone driving outcomes. Surgeon discretion is a potential factor here as well; it is conceivable that the surgeon’s impression or information about prognosis influences the retroperitoneal exploration decision, based on unmeasured indicators of patient disease burden or vitality.

"Given the small but significant survival differences and the large sample size of this study, it is possible that these survival advantages are to some degree indicative of unmeasured factors or the accuracy of the surgeon’s impression, and not completely about the act of pathologic exploration," she said.

One attendee noted that analyses have suggested that patients who do not have a retroperitoneal exploration fare even more poorly than those who have the procedure and are found to have positive lymph nodes.

"I am concerned that that is because the surgeon thought the prognosis was so bad that they didn’t bother. I don’t know whether you have a sense of whether that conclusion looked appropriate for your analysis of all the tumor burden in that patient," Dr. Rungruang said.

"For some of the patients, it seemed to be a surgeon preference that they didn’t sample the nodes because they felt that the patient was already stage IIIc and called them microscopic optimally debulked, or microscopic optimally debulked without assessing the lymph nodes. Other patients had a much larger surgery, a higher complexity of procedures, and still had a lymph node assessment on top of it. What I can tell from reading the actual operative notes is a lot of [the approach] is based on surgeon preference."

In discussing the lack of additional benefit for exploration in women with microscopic residual disease, Dr. Rungruang explained that "if you have microscopic residual disease, that seems like the best you can do for those patients. I think in the macroscopic residual patients, you see the difference because it is perhaps a proxy for just a more thorough surgical assessment in these patients. Plus, macroscopic residual disease is such a wide spectrum, you can be anywhere from one site of residual disease to miliary disease spread throughout, and that heterogeneity within that residual disease group also accounts for that difference."

Patients enrolled in GOG 182 had advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, and underwent primary debulking to optimal residual disease (less than 1 cm), followed by randomization to a variety of platinum- and paclitaxel-based adjuvant chemotherapy regimens.

The investigators restricted analyses to the subset whose disease was stage IIIc on the basis of an intraperitoneal tumor measuring at least 2 cm. Overall, 37% of this subset had a retroperitoneal exploration.

The patients undergoing this additional procedure had better median progression-free survival (18.5 vs. 16.0 months, P less than .0001) and overall survival (53.3 vs. 42.8 months, P less than .0001), reported Dr. Rungruang.

When patients were stratified, retroperitoneal exploration was beneficial in those with minimal gross residual disease in terms of both progression-free survival (16.8 vs. 15.1 months, P = .01) and overall survival (44.9 vs. 40.5 months, P = .008). But there was no such benefit in patients who had microscopic residual disease.

In a multivariate analysis, retroperitoneal exploration independently predicted better progression-free survival (hazard ratio, 0.85; P = .004) and overall survival (HR, 0.85; P = .009).

Dr. Rungruang disclosed no relevant financial conflicts.

LOS ANGELES – Surgically exploring the retroperitoneum for disease may benefit some patients undergoing primary debulking of advanced ovarian cancer, a study reported at the annual meeting of the Society of Gynecologic Oncology has shown.

Investigators analyzed data from Gynecologic Oncology Group (GOG) trial 182, focusing on the 1,876 women who had stage IIIc epithelial ovarian cancer on the basis of intraperitoneal tumor size and who underwent optimal debulking.

Overall, one-third had a retroperitoneal exploration, defined in the study as removal of at least one pelvic or para-aortic lymph node.

Patients who had this procedure were 15% less likely to experience progression or death and 15% less likely to die after other factors were considered, reported lead investigator Dr. Bunja Rungruang, a gynecologic oncologist with Georgia Regents University in Augusta.

In stratified analyses, benefit was seen in the subgroup with minimal gross residual disease but not in the subgroup with microscopic residual disease.

"In this large multi-institutional trial, there is evidence that retroperitoneal exploration at the time of primary debulking surgery of patients with intraperitoneal stage IIIc epithelial ovarian cancer may provide survival benefit," she commented.

"Surgical effort and tumor biology interact to affect patient outcomes," Dr. Rungruang noted. "Retroperitoneal exploration may be a proxy for more thorough surgical effort in these patients, rather than tumor biology alone driving outcomes. Surgeon discretion is a potential factor here as well; it is conceivable that the surgeon’s impression or information about prognosis influences the retroperitoneal exploration decision, based on unmeasured indicators of patient disease burden or vitality.

"Given the small but significant survival differences and the large sample size of this study, it is possible that these survival advantages are to some degree indicative of unmeasured factors or the accuracy of the surgeon’s impression, and not completely about the act of pathologic exploration," she said.

One attendee noted that analyses have suggested that patients who do not have a retroperitoneal exploration fare even more poorly than those who have the procedure and are found to have positive lymph nodes.

"I am concerned that that is because the surgeon thought the prognosis was so bad that they didn’t bother. I don’t know whether you have a sense of whether that conclusion looked appropriate for your analysis of all the tumor burden in that patient," Dr. Rungruang said.

"For some of the patients, it seemed to be a surgeon preference that they didn’t sample the nodes because they felt that the patient was already stage IIIc and called them microscopic optimally debulked, or microscopic optimally debulked without assessing the lymph nodes. Other patients had a much larger surgery, a higher complexity of procedures, and still had a lymph node assessment on top of it. What I can tell from reading the actual operative notes is a lot of [the approach] is based on surgeon preference."

In discussing the lack of additional benefit for exploration in women with microscopic residual disease, Dr. Rungruang explained that "if you have microscopic residual disease, that seems like the best you can do for those patients. I think in the macroscopic residual patients, you see the difference because it is perhaps a proxy for just a more thorough surgical assessment in these patients. Plus, macroscopic residual disease is such a wide spectrum, you can be anywhere from one site of residual disease to miliary disease spread throughout, and that heterogeneity within that residual disease group also accounts for that difference."

Patients enrolled in GOG 182 had advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, and underwent primary debulking to optimal residual disease (less than 1 cm), followed by randomization to a variety of platinum- and paclitaxel-based adjuvant chemotherapy regimens.

The investigators restricted analyses to the subset whose disease was stage IIIc on the basis of an intraperitoneal tumor measuring at least 2 cm. Overall, 37% of this subset had a retroperitoneal exploration.

The patients undergoing this additional procedure had better median progression-free survival (18.5 vs. 16.0 months, P less than .0001) and overall survival (53.3 vs. 42.8 months, P less than .0001), reported Dr. Rungruang.

When patients were stratified, retroperitoneal exploration was beneficial in those with minimal gross residual disease in terms of both progression-free survival (16.8 vs. 15.1 months, P = .01) and overall survival (44.9 vs. 40.5 months, P = .008). But there was no such benefit in patients who had microscopic residual disease.

In a multivariate analysis, retroperitoneal exploration independently predicted better progression-free survival (hazard ratio, 0.85; P = .004) and overall survival (HR, 0.85; P = .009).

Dr. Rungruang disclosed no relevant financial conflicts.