Post procedure clopidogrel cuts amputation rates

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Post procedure clopidogrel cuts amputation rates

CHICAGO – Clopidogrel use after endovascular lower-extremity revascularization was significantly associated with 1-year freedom from amputation and survival, but only 38% of the Medicare population was on the drug post intervention in a large retrospective analysis.

Patients with the most severe peripheral vascular disease, ulceration, or gangrene benefited the most from post revascularization clopidogrel (Plavix), but were the least likely to be using the drug, Dr. Mark L. Janzen said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/Frontline Medical News
Dr. Mark L. Janzen

The analysis involved 14,353 patients, 65 years and older, who underwent lower-extremity revascularization in 2007 and 2008 and were identified from the Medicare Provider Analysis and Review files using ICD-9 codes. Of these, 5,697 had claudication (50%), 1,467 rest pain (10%), and 7,189 ulceration or gangrene (50%).

Overall amputation rates for patients started on clopidogrel right after the procedure were significantly lower than for nonusers at 30 days (10.34% vs. 14.1%), 90 days (14.1% vs. 18.7%), and 1 year (19.7% vs. 24.1%; all P values less than .0001), said Dr. Janzen of the University of Missouri Hospitals and Clinics, Columbia.

Among patients with ulceration or gangrene, limb loss was 21.2% and 26.6% with and without clopidogrel at 30 days, 28.5% and 34.8% at 90 days (P less than .0001), and 38.2% and 43.5% at 1 year.

Only 35.7% of patients with ulceration or gangrene were on post-procedure clopidogrel, compared with 37.4% with rest pain and 40.4% with claudication, according to National Drug Code Directory and Medicare Part D files. Combination therapy with aspirin and clopidogrel or other antiplatelet therapies was not evaluated.

Interestingly, clopidogrel did not significantly affect amputation rates in patients with claudication or rest pain, Dr. Janzen said.

Multivariate logistic regression analyses adjusted for patient demographics, comorbidities, and disease severity, confirmed that clopidogrel nonusers were more likely than users to undergo amputation at 30 days (odds ratio, 1.28), 90 days (OR, 1.29), and 1 year (OR, 1.16).

In the ulceration/gangrene subgroup, failure to use clopidogrel increased the odds of amputation (OR, 1.2) "to levels approaching renal failure (OR, 1.24) and diabetes (OR, 1.6), two known risk factors for below-the-knee amputation," he observed.

Cox regression analyses revealed a 20% higher hazard of death at 1 year among all patients for nonusers than for clopidogrel users (hazard ratio 1.2; P less than .0001).

During a discussion of the study, Dr. Sean Patrick Lyden of the Cleveland Clinic, questioned the impact of end-stage renal disease (ESRD) on the results, remarking that ESRD is probably the strongest predictor of limb loss in patients with ulceration or gangrene and that clopidogrel is typically not given to ESRD patients because the pharmacodynamics are unknown.

Dr. Janzen said it was a valid point, but that the study did not look specifically at ESRD.

This line of questioning was picked up by another attendee, who asked whether amputation rates were calculated for patients with ESRD and diabetes. Although the analysis did not look at outcomes for this lethal combination of comorbidities, Dr. Janzen said a prior study reported a 5-year amputation rate of about 27% in patients with peripheral vascular disease and diabetes (Diabetes Care 2003;26:491-4).

Dr. Iraklis Pipinos, professor of surgery at the University of Nebraska Medical Center in Omaha, commented that "This is a fantastic study and a tremendously important question."

He went on to ask whether the patients with ulceration or gangrene underwent additional lower extremity revascularization procedures, observing that the 1-year amputation rates were quite high in this subgroup.

Dr. Janzen said the study was not designed to determine rates of procedure repetition, although it was noted that overall clopidogrel users were less likely to convert to open bypass early in their post-procedure course.

Finally, the audience asked about the optimal duration of post-procedure clopidogrel, with one attendee observing that it’s not unusual for patients to discontinue clopidogrel 6 weeks after an endovascular revascularization procedure. Dr. Janzen said new cardiology trends recommend that patients with both bare metal and drug-eluting stents remain on clopidogrel for a full year after stent placement and that the optimal duration for patients undergoing endovascular lower limb revascularization is unknown and hopefully will be answered in properly powered randomized trials.

Dr. Janzen and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

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CHICAGO – Clopidogrel use after endovascular lower-extremity revascularization was significantly associated with 1-year freedom from amputation and survival, but only 38% of the Medicare population was on the drug post intervention in a large retrospective analysis.

Patients with the most severe peripheral vascular disease, ulceration, or gangrene benefited the most from post revascularization clopidogrel (Plavix), but were the least likely to be using the drug, Dr. Mark L. Janzen said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/Frontline Medical News
Dr. Mark L. Janzen

The analysis involved 14,353 patients, 65 years and older, who underwent lower-extremity revascularization in 2007 and 2008 and were identified from the Medicare Provider Analysis and Review files using ICD-9 codes. Of these, 5,697 had claudication (50%), 1,467 rest pain (10%), and 7,189 ulceration or gangrene (50%).

Overall amputation rates for patients started on clopidogrel right after the procedure were significantly lower than for nonusers at 30 days (10.34% vs. 14.1%), 90 days (14.1% vs. 18.7%), and 1 year (19.7% vs. 24.1%; all P values less than .0001), said Dr. Janzen of the University of Missouri Hospitals and Clinics, Columbia.

Among patients with ulceration or gangrene, limb loss was 21.2% and 26.6% with and without clopidogrel at 30 days, 28.5% and 34.8% at 90 days (P less than .0001), and 38.2% and 43.5% at 1 year.

Only 35.7% of patients with ulceration or gangrene were on post-procedure clopidogrel, compared with 37.4% with rest pain and 40.4% with claudication, according to National Drug Code Directory and Medicare Part D files. Combination therapy with aspirin and clopidogrel or other antiplatelet therapies was not evaluated.

Interestingly, clopidogrel did not significantly affect amputation rates in patients with claudication or rest pain, Dr. Janzen said.

Multivariate logistic regression analyses adjusted for patient demographics, comorbidities, and disease severity, confirmed that clopidogrel nonusers were more likely than users to undergo amputation at 30 days (odds ratio, 1.28), 90 days (OR, 1.29), and 1 year (OR, 1.16).

In the ulceration/gangrene subgroup, failure to use clopidogrel increased the odds of amputation (OR, 1.2) "to levels approaching renal failure (OR, 1.24) and diabetes (OR, 1.6), two known risk factors for below-the-knee amputation," he observed.

Cox regression analyses revealed a 20% higher hazard of death at 1 year among all patients for nonusers than for clopidogrel users (hazard ratio 1.2; P less than .0001).

During a discussion of the study, Dr. Sean Patrick Lyden of the Cleveland Clinic, questioned the impact of end-stage renal disease (ESRD) on the results, remarking that ESRD is probably the strongest predictor of limb loss in patients with ulceration or gangrene and that clopidogrel is typically not given to ESRD patients because the pharmacodynamics are unknown.

Dr. Janzen said it was a valid point, but that the study did not look specifically at ESRD.

This line of questioning was picked up by another attendee, who asked whether amputation rates were calculated for patients with ESRD and diabetes. Although the analysis did not look at outcomes for this lethal combination of comorbidities, Dr. Janzen said a prior study reported a 5-year amputation rate of about 27% in patients with peripheral vascular disease and diabetes (Diabetes Care 2003;26:491-4).

Dr. Iraklis Pipinos, professor of surgery at the University of Nebraska Medical Center in Omaha, commented that "This is a fantastic study and a tremendously important question."

He went on to ask whether the patients with ulceration or gangrene underwent additional lower extremity revascularization procedures, observing that the 1-year amputation rates were quite high in this subgroup.

Dr. Janzen said the study was not designed to determine rates of procedure repetition, although it was noted that overall clopidogrel users were less likely to convert to open bypass early in their post-procedure course.

Finally, the audience asked about the optimal duration of post-procedure clopidogrel, with one attendee observing that it’s not unusual for patients to discontinue clopidogrel 6 weeks after an endovascular revascularization procedure. Dr. Janzen said new cardiology trends recommend that patients with both bare metal and drug-eluting stents remain on clopidogrel for a full year after stent placement and that the optimal duration for patients undergoing endovascular lower limb revascularization is unknown and hopefully will be answered in properly powered randomized trials.

Dr. Janzen and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Clopidogrel use after endovascular lower-extremity revascularization was significantly associated with 1-year freedom from amputation and survival, but only 38% of the Medicare population was on the drug post intervention in a large retrospective analysis.

Patients with the most severe peripheral vascular disease, ulceration, or gangrene benefited the most from post revascularization clopidogrel (Plavix), but were the least likely to be using the drug, Dr. Mark L. Janzen said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/Frontline Medical News
Dr. Mark L. Janzen

The analysis involved 14,353 patients, 65 years and older, who underwent lower-extremity revascularization in 2007 and 2008 and were identified from the Medicare Provider Analysis and Review files using ICD-9 codes. Of these, 5,697 had claudication (50%), 1,467 rest pain (10%), and 7,189 ulceration or gangrene (50%).

Overall amputation rates for patients started on clopidogrel right after the procedure were significantly lower than for nonusers at 30 days (10.34% vs. 14.1%), 90 days (14.1% vs. 18.7%), and 1 year (19.7% vs. 24.1%; all P values less than .0001), said Dr. Janzen of the University of Missouri Hospitals and Clinics, Columbia.

Among patients with ulceration or gangrene, limb loss was 21.2% and 26.6% with and without clopidogrel at 30 days, 28.5% and 34.8% at 90 days (P less than .0001), and 38.2% and 43.5% at 1 year.

Only 35.7% of patients with ulceration or gangrene were on post-procedure clopidogrel, compared with 37.4% with rest pain and 40.4% with claudication, according to National Drug Code Directory and Medicare Part D files. Combination therapy with aspirin and clopidogrel or other antiplatelet therapies was not evaluated.

Interestingly, clopidogrel did not significantly affect amputation rates in patients with claudication or rest pain, Dr. Janzen said.

Multivariate logistic regression analyses adjusted for patient demographics, comorbidities, and disease severity, confirmed that clopidogrel nonusers were more likely than users to undergo amputation at 30 days (odds ratio, 1.28), 90 days (OR, 1.29), and 1 year (OR, 1.16).

In the ulceration/gangrene subgroup, failure to use clopidogrel increased the odds of amputation (OR, 1.2) "to levels approaching renal failure (OR, 1.24) and diabetes (OR, 1.6), two known risk factors for below-the-knee amputation," he observed.

Cox regression analyses revealed a 20% higher hazard of death at 1 year among all patients for nonusers than for clopidogrel users (hazard ratio 1.2; P less than .0001).

During a discussion of the study, Dr. Sean Patrick Lyden of the Cleveland Clinic, questioned the impact of end-stage renal disease (ESRD) on the results, remarking that ESRD is probably the strongest predictor of limb loss in patients with ulceration or gangrene and that clopidogrel is typically not given to ESRD patients because the pharmacodynamics are unknown.

Dr. Janzen said it was a valid point, but that the study did not look specifically at ESRD.

This line of questioning was picked up by another attendee, who asked whether amputation rates were calculated for patients with ESRD and diabetes. Although the analysis did not look at outcomes for this lethal combination of comorbidities, Dr. Janzen said a prior study reported a 5-year amputation rate of about 27% in patients with peripheral vascular disease and diabetes (Diabetes Care 2003;26:491-4).

Dr. Iraklis Pipinos, professor of surgery at the University of Nebraska Medical Center in Omaha, commented that "This is a fantastic study and a tremendously important question."

He went on to ask whether the patients with ulceration or gangrene underwent additional lower extremity revascularization procedures, observing that the 1-year amputation rates were quite high in this subgroup.

Dr. Janzen said the study was not designed to determine rates of procedure repetition, although it was noted that overall clopidogrel users were less likely to convert to open bypass early in their post-procedure course.

Finally, the audience asked about the optimal duration of post-procedure clopidogrel, with one attendee observing that it’s not unusual for patients to discontinue clopidogrel 6 weeks after an endovascular revascularization procedure. Dr. Janzen said new cardiology trends recommend that patients with both bare metal and drug-eluting stents remain on clopidogrel for a full year after stent placement and that the optimal duration for patients undergoing endovascular lower limb revascularization is unknown and hopefully will be answered in properly powered randomized trials.

Dr. Janzen and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

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Key clinical point: Post procedure clopidogrel use was associated with a lower risk of amputation at 1 year for all patients and for patients with ulceration or gangrene.

Major finding: Cox regression analyses revealed a 20% higher hazard of death at 1 year among all patients for nonusers than for clopidogrel users (hazard ratio 1.2; P less than .0001).

Data source: Retrospective analysis of 14,353 patients undergoing endovascular lower-extremity revascularization.

Disclosures: Dr. Janzen and his coauthors reported having no financial disclosures.

Failure to rescue driving AAA repair mortality

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CHICAGO – Failure to rescue patients from major complications drives much of the variation in hospital mortality for abdominal aortic aneurysm repair, an award-winning study suggests.

"Careful attention to early recognition and management of postoperative complications could be the key to improving mortality," Dr. Seth Waits reported at the annual meeting of the Midwestern Vascular Surgical Society.

Failure to rescue (FTR), or death after a complication, is increasing being recognized as a source of differences in hospital mortality. A recent study reported that women who experienced a major complication after ovarian cancer treatment at a low-volume hospital were 48% more likely to die than were their counterparts at a high-volume hospital. Complication rates, long thought to be the culprit behind higher hospital mortality, were similar at the hospitals, while FTR rates were almost double at the low-volume hospitals (J. Clin. Oncol. 2012;30:3976-82).

For the current analysis, Dr. Waits and his colleagues at the University of Michigan Frankel Cardiovascular Center in Ann Arbor, calculated risk-adjusted mortality rates for 3,215 patients who underwent open or endovascular abdominal aortic aneurysm (AAA) repair at 40 hospitals participating in the Michigan Surgical Quality Collaborative between 2007 and 2012.

For 2,440 patients undergoing endovascular repair, hospital mortality ranged from a low of 0.07% to a high of 6.14%.

Though low- and high-mortality hospitals had similar major complication rates (11.6% vs. 10.6%), FTR rates were 45 times greater in high-mortality hospitals (0.83% vs. 37.5%), Dr. Waits reported.

For 775 patients who underwent open AAA repair, hospital mortality ranged from 4.5% to 16.4%.

Once again, despite low- and high-mortality hospitals having nearly identical complication rates (45.1% vs. 45.8%), but FTR rates were three times higher at the high-mortality hospitals (10.3% vs. 33%), he said.

An average of 2.85 and 2.66 severe complications occurred per FTR event for open and endovascular repair, respectively.

Transfusion was the most common postoperative complication leading to a FTR event for endovascular and open repair (5.8% and 29.8%, respectively), followed by prolonged intubation (2.4%; 18.2%) and reintubation (9.2%; 2%), according to the meeting’s best poster presentation.

No significant difference was seen in rupture/emergent repair between low- and high-mortality hospitals.

Dr. Waits called for preoperative identification of high-risk patients and use of FTR countermeasures, such as improved ICU admission, anesthesia alerts, and nurse/physician awareness to improve AAA mortality.

"Understanding the mechanisms that underlie failure to rescue offers the opportunity to move from a reactive to proactive approach in our management of complications following abdominal aortic aneurysm repair," he said in an interview.

Dr. Waits and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

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CHICAGO – Failure to rescue patients from major complications drives much of the variation in hospital mortality for abdominal aortic aneurysm repair, an award-winning study suggests.

"Careful attention to early recognition and management of postoperative complications could be the key to improving mortality," Dr. Seth Waits reported at the annual meeting of the Midwestern Vascular Surgical Society.

Failure to rescue (FTR), or death after a complication, is increasing being recognized as a source of differences in hospital mortality. A recent study reported that women who experienced a major complication after ovarian cancer treatment at a low-volume hospital were 48% more likely to die than were their counterparts at a high-volume hospital. Complication rates, long thought to be the culprit behind higher hospital mortality, were similar at the hospitals, while FTR rates were almost double at the low-volume hospitals (J. Clin. Oncol. 2012;30:3976-82).

For the current analysis, Dr. Waits and his colleagues at the University of Michigan Frankel Cardiovascular Center in Ann Arbor, calculated risk-adjusted mortality rates for 3,215 patients who underwent open or endovascular abdominal aortic aneurysm (AAA) repair at 40 hospitals participating in the Michigan Surgical Quality Collaborative between 2007 and 2012.

For 2,440 patients undergoing endovascular repair, hospital mortality ranged from a low of 0.07% to a high of 6.14%.

Though low- and high-mortality hospitals had similar major complication rates (11.6% vs. 10.6%), FTR rates were 45 times greater in high-mortality hospitals (0.83% vs. 37.5%), Dr. Waits reported.

For 775 patients who underwent open AAA repair, hospital mortality ranged from 4.5% to 16.4%.

Once again, despite low- and high-mortality hospitals having nearly identical complication rates (45.1% vs. 45.8%), but FTR rates were three times higher at the high-mortality hospitals (10.3% vs. 33%), he said.

An average of 2.85 and 2.66 severe complications occurred per FTR event for open and endovascular repair, respectively.

Transfusion was the most common postoperative complication leading to a FTR event for endovascular and open repair (5.8% and 29.8%, respectively), followed by prolonged intubation (2.4%; 18.2%) and reintubation (9.2%; 2%), according to the meeting’s best poster presentation.

No significant difference was seen in rupture/emergent repair between low- and high-mortality hospitals.

Dr. Waits called for preoperative identification of high-risk patients and use of FTR countermeasures, such as improved ICU admission, anesthesia alerts, and nurse/physician awareness to improve AAA mortality.

"Understanding the mechanisms that underlie failure to rescue offers the opportunity to move from a reactive to proactive approach in our management of complications following abdominal aortic aneurysm repair," he said in an interview.

Dr. Waits and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Failure to rescue patients from major complications drives much of the variation in hospital mortality for abdominal aortic aneurysm repair, an award-winning study suggests.

"Careful attention to early recognition and management of postoperative complications could be the key to improving mortality," Dr. Seth Waits reported at the annual meeting of the Midwestern Vascular Surgical Society.

Failure to rescue (FTR), or death after a complication, is increasing being recognized as a source of differences in hospital mortality. A recent study reported that women who experienced a major complication after ovarian cancer treatment at a low-volume hospital were 48% more likely to die than were their counterparts at a high-volume hospital. Complication rates, long thought to be the culprit behind higher hospital mortality, were similar at the hospitals, while FTR rates were almost double at the low-volume hospitals (J. Clin. Oncol. 2012;30:3976-82).

For the current analysis, Dr. Waits and his colleagues at the University of Michigan Frankel Cardiovascular Center in Ann Arbor, calculated risk-adjusted mortality rates for 3,215 patients who underwent open or endovascular abdominal aortic aneurysm (AAA) repair at 40 hospitals participating in the Michigan Surgical Quality Collaborative between 2007 and 2012.

For 2,440 patients undergoing endovascular repair, hospital mortality ranged from a low of 0.07% to a high of 6.14%.

Though low- and high-mortality hospitals had similar major complication rates (11.6% vs. 10.6%), FTR rates were 45 times greater in high-mortality hospitals (0.83% vs. 37.5%), Dr. Waits reported.

For 775 patients who underwent open AAA repair, hospital mortality ranged from 4.5% to 16.4%.

Once again, despite low- and high-mortality hospitals having nearly identical complication rates (45.1% vs. 45.8%), but FTR rates were three times higher at the high-mortality hospitals (10.3% vs. 33%), he said.

An average of 2.85 and 2.66 severe complications occurred per FTR event for open and endovascular repair, respectively.

Transfusion was the most common postoperative complication leading to a FTR event for endovascular and open repair (5.8% and 29.8%, respectively), followed by prolonged intubation (2.4%; 18.2%) and reintubation (9.2%; 2%), according to the meeting’s best poster presentation.

No significant difference was seen in rupture/emergent repair between low- and high-mortality hospitals.

Dr. Waits called for preoperative identification of high-risk patients and use of FTR countermeasures, such as improved ICU admission, anesthesia alerts, and nurse/physician awareness to improve AAA mortality.

"Understanding the mechanisms that underlie failure to rescue offers the opportunity to move from a reactive to proactive approach in our management of complications following abdominal aortic aneurysm repair," he said in an interview.

Dr. Waits and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

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Major finding: FTR rates were 45 times higher in high AAA-mortality hospitals vs. low AAA-mortality hospitals (0.83% vs. 37.5%).

Data source: Retrospective study of 3,215 patients with abdominal aortic aneurysm repair.

Disclosures: Dr. Waits and his coauthors reported having no financial disclosures.

Zenith AAA fenestrated graft: 30-day outcomes match those seen in trial

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CHICAGO – Real-world 30-day outcomes with the Zenith fenestrated endovascular graft compared well with those in the U.S. fenestrated trial for the treatment of juxtarenal aortic aneurysms, based on a multicenter, retrospective study of 57 patients.

The good results were seen despite higher rates of comorbidities and more challenging anatomy in the patients treated post approval. But "these are short-term outcomes and, ultimately, we’re going to need to know the long-term durability of this type of repair," Dr. Chandu Vemuri said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/IMNG Medical Media
Dr. Chandu Vemuri

The Zenith fenestrated AAA endovascular graft (zFEN) has been commercially available outside the United States since November 2002, and it gained federal approval in April 2012 based on the results of the pivotal U.S. fenestrated trial (USFT). The graft is indicated for the treatment of patients with abdominal aortic or aortoiliac aneurysms that have an infrarenal aortic neck at least 4 mm in length.

Notably, 47% of patients in the current analysis did not meet the USFT anatomic criteria of a 4- to 15-mm infrarenal neck. There were also significantly more mesenteric stents used in this group than in the USFT (13 vs. 0; P < .05), reflecting the higher anatomic complexity of these patients, said Dr. Vemuri, of Washington University, St. Louis.

Compared with the 42 USFT patients, study patients also had significantly higher rates of preoperative coronary artery disease (79% vs. 52%), myocardial infarction (60% vs. 24%), and renal insufficiency (26% vs. 9.5%); all P < .05).

Dr. Vemuri was quick to point out, however, that the results of the study may not broadly translate. The trial was conducted at institutions that had a high aortic volume, and involved highly experienced surgeons, many of whom took part in the USFT and were familiar with the zFEN device.

The technical success rate, with regard to aneurysm exclusion, was 100% in both the study and the USFT. In two study patients, the left renal artery (RA) fenestration was not able to be aligned. One patient had a kinked renal stent that was successfully restented, and one patient was converted to a unibody prosthesis with femoral-femoral bypass and an iliac plug, he said.

Other 30-day outcomes were similar between the study and USFT patients, including mortality (1 vs. 0), renal insufficiency (4 vs. 0), postoperative dialysis (1 vs. 0), and endoleak (10 vs. 9). Two of the 10 endoleaks were type III and 8 were type II.

The most common graft configuration was a scallop of the superior mesenteric artery (SMA) and bilateral RA fenestration in 40 patients, followed by bilateral RA fenestrations alone in 8, and a celiac scallop, SMA fenestration, and bilateral RA fenestration in 3, Dr. Vemuri observed.

One patient each had the following: right RA scallop plus left RA fenestration, right RA fenestration, right accessory RA fenestration, left RA fenestration, celiac scallop and SMA fenestration with a right RA fenestration, and an SMA scallop with left RA fenestration.

Total operative time averaged 250 minutes.

Audience members pressed Dr. Vemuri for details on the 47% of patients who did not meet the USFT anatomic criteria and whether the current cohort was really anatomically challenging or just consisted of on-label cases that were harder than usual.

Dr. Vemuri responded that the intervention was off-label in 27% of patients who did not have the minimum 4-mm infrarenal neck. One graft configuration was more complex than in the device’s instructions for use (IFU) document. All of the patients had a sufficient infrarenal neck for appropriate seal.

"I don’t think the purpose of this study is to endorse use outside the IFU of the device, but to report that when people do, this is what happens," he added.

Dr. Vemuri reported having no financial disclosures. His coauthors reported relationships including serving as consultants or researchers for Cook, which produces the Zenith graft.

pwendling@frontlinemedcom.com

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CHICAGO – Real-world 30-day outcomes with the Zenith fenestrated endovascular graft compared well with those in the U.S. fenestrated trial for the treatment of juxtarenal aortic aneurysms, based on a multicenter, retrospective study of 57 patients.

The good results were seen despite higher rates of comorbidities and more challenging anatomy in the patients treated post approval. But "these are short-term outcomes and, ultimately, we’re going to need to know the long-term durability of this type of repair," Dr. Chandu Vemuri said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/IMNG Medical Media
Dr. Chandu Vemuri

The Zenith fenestrated AAA endovascular graft (zFEN) has been commercially available outside the United States since November 2002, and it gained federal approval in April 2012 based on the results of the pivotal U.S. fenestrated trial (USFT). The graft is indicated for the treatment of patients with abdominal aortic or aortoiliac aneurysms that have an infrarenal aortic neck at least 4 mm in length.

Notably, 47% of patients in the current analysis did not meet the USFT anatomic criteria of a 4- to 15-mm infrarenal neck. There were also significantly more mesenteric stents used in this group than in the USFT (13 vs. 0; P < .05), reflecting the higher anatomic complexity of these patients, said Dr. Vemuri, of Washington University, St. Louis.

Compared with the 42 USFT patients, study patients also had significantly higher rates of preoperative coronary artery disease (79% vs. 52%), myocardial infarction (60% vs. 24%), and renal insufficiency (26% vs. 9.5%); all P < .05).

Dr. Vemuri was quick to point out, however, that the results of the study may not broadly translate. The trial was conducted at institutions that had a high aortic volume, and involved highly experienced surgeons, many of whom took part in the USFT and were familiar with the zFEN device.

The technical success rate, with regard to aneurysm exclusion, was 100% in both the study and the USFT. In two study patients, the left renal artery (RA) fenestration was not able to be aligned. One patient had a kinked renal stent that was successfully restented, and one patient was converted to a unibody prosthesis with femoral-femoral bypass and an iliac plug, he said.

Other 30-day outcomes were similar between the study and USFT patients, including mortality (1 vs. 0), renal insufficiency (4 vs. 0), postoperative dialysis (1 vs. 0), and endoleak (10 vs. 9). Two of the 10 endoleaks were type III and 8 were type II.

The most common graft configuration was a scallop of the superior mesenteric artery (SMA) and bilateral RA fenestration in 40 patients, followed by bilateral RA fenestrations alone in 8, and a celiac scallop, SMA fenestration, and bilateral RA fenestration in 3, Dr. Vemuri observed.

One patient each had the following: right RA scallop plus left RA fenestration, right RA fenestration, right accessory RA fenestration, left RA fenestration, celiac scallop and SMA fenestration with a right RA fenestration, and an SMA scallop with left RA fenestration.

Total operative time averaged 250 minutes.

Audience members pressed Dr. Vemuri for details on the 47% of patients who did not meet the USFT anatomic criteria and whether the current cohort was really anatomically challenging or just consisted of on-label cases that were harder than usual.

Dr. Vemuri responded that the intervention was off-label in 27% of patients who did not have the minimum 4-mm infrarenal neck. One graft configuration was more complex than in the device’s instructions for use (IFU) document. All of the patients had a sufficient infrarenal neck for appropriate seal.

"I don’t think the purpose of this study is to endorse use outside the IFU of the device, but to report that when people do, this is what happens," he added.

Dr. Vemuri reported having no financial disclosures. His coauthors reported relationships including serving as consultants or researchers for Cook, which produces the Zenith graft.

pwendling@frontlinemedcom.com

CHICAGO – Real-world 30-day outcomes with the Zenith fenestrated endovascular graft compared well with those in the U.S. fenestrated trial for the treatment of juxtarenal aortic aneurysms, based on a multicenter, retrospective study of 57 patients.

The good results were seen despite higher rates of comorbidities and more challenging anatomy in the patients treated post approval. But "these are short-term outcomes and, ultimately, we’re going to need to know the long-term durability of this type of repair," Dr. Chandu Vemuri said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/IMNG Medical Media
Dr. Chandu Vemuri

The Zenith fenestrated AAA endovascular graft (zFEN) has been commercially available outside the United States since November 2002, and it gained federal approval in April 2012 based on the results of the pivotal U.S. fenestrated trial (USFT). The graft is indicated for the treatment of patients with abdominal aortic or aortoiliac aneurysms that have an infrarenal aortic neck at least 4 mm in length.

Notably, 47% of patients in the current analysis did not meet the USFT anatomic criteria of a 4- to 15-mm infrarenal neck. There were also significantly more mesenteric stents used in this group than in the USFT (13 vs. 0; P < .05), reflecting the higher anatomic complexity of these patients, said Dr. Vemuri, of Washington University, St. Louis.

Compared with the 42 USFT patients, study patients also had significantly higher rates of preoperative coronary artery disease (79% vs. 52%), myocardial infarction (60% vs. 24%), and renal insufficiency (26% vs. 9.5%); all P < .05).

Dr. Vemuri was quick to point out, however, that the results of the study may not broadly translate. The trial was conducted at institutions that had a high aortic volume, and involved highly experienced surgeons, many of whom took part in the USFT and were familiar with the zFEN device.

The technical success rate, with regard to aneurysm exclusion, was 100% in both the study and the USFT. In two study patients, the left renal artery (RA) fenestration was not able to be aligned. One patient had a kinked renal stent that was successfully restented, and one patient was converted to a unibody prosthesis with femoral-femoral bypass and an iliac plug, he said.

Other 30-day outcomes were similar between the study and USFT patients, including mortality (1 vs. 0), renal insufficiency (4 vs. 0), postoperative dialysis (1 vs. 0), and endoleak (10 vs. 9). Two of the 10 endoleaks were type III and 8 were type II.

The most common graft configuration was a scallop of the superior mesenteric artery (SMA) and bilateral RA fenestration in 40 patients, followed by bilateral RA fenestrations alone in 8, and a celiac scallop, SMA fenestration, and bilateral RA fenestration in 3, Dr. Vemuri observed.

One patient each had the following: right RA scallop plus left RA fenestration, right RA fenestration, right accessory RA fenestration, left RA fenestration, celiac scallop and SMA fenestration with a right RA fenestration, and an SMA scallop with left RA fenestration.

Total operative time averaged 250 minutes.

Audience members pressed Dr. Vemuri for details on the 47% of patients who did not meet the USFT anatomic criteria and whether the current cohort was really anatomically challenging or just consisted of on-label cases that were harder than usual.

Dr. Vemuri responded that the intervention was off-label in 27% of patients who did not have the minimum 4-mm infrarenal neck. One graft configuration was more complex than in the device’s instructions for use (IFU) document. All of the patients had a sufficient infrarenal neck for appropriate seal.

"I don’t think the purpose of this study is to endorse use outside the IFU of the device, but to report that when people do, this is what happens," he added.

Dr. Vemuri reported having no financial disclosures. His coauthors reported relationships including serving as consultants or researchers for Cook, which produces the Zenith graft.

pwendling@frontlinemedcom.com

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Major finding: The technical success rate was 100%.

Data source: Retrospective study of 57 patients with juxtarenal aortic aneurysms treated post approval with the Zenith fenestrated endovascular graft.

Disclosures: Dr. Vemuri reported having no financial disclosures. His coauthors reported relationships including serving as consultants or researchers for Cook, which produces the Zenith graft.

Aortic arch repair outcomes held acceptable

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CHICAGO – Repair of the isolated nontraumatic aortic arch aneurysm can be performed with acceptable early and late results, based on a 20-year review of 137 patients.

Early mortality was seen in nine patients (6.6%), and was similarly split between endovascular and open repair (7.3% vs. 6.5%, respectively).

Patrice Wendling/IMNG Medical Media
Dr Himanshu J. Patel

Five-year survival did not differ between the endovascular- and open-repair groups (86% vs. 70%; P = .57), although the risk of reintervention was significantly higher with an endovascular strategy (94% vs. 77.5%; P = .02).

"These data support ongoing efforts to develop branched endografts specifically tailored for complex and difficult-to-treat pathology to potentially reduce the morbidity of therapy for this population," Dr. Himanshu J. Patel said at the annual meeting of the Midwestern Vascular Surgical Society.

Marginal landing zones and the need for complex arch debranching procedures to extend landing zones and facilitate repair can hinder endovascular repair, though open aortic repair is challenged by the frequent need for hypothermic circulatory arrest. Early and late results with either option are ill defined for this pathology, observed Dr. Patel, with the Cardiovascular Center, University of Michigan, Ann Arbor.

To investigate these outcomes, the authors evaluated data from 1993 to 2013 for 137 patients with nontraumatic aortic aneurysms located between the left and right pulmonary artery; 93 patients underwent open repair and 44 had an endovascular or hybrid repair.

The pathology was saccular in 39%, dissection in 11%, pseudoaneurysm in 18%, and anomalous arch in 11%. Rupture was identified in 14%. The average patient age was 59 years, and 46% were male.

Courtesy Dr. Himanshu Patel
75 year old male Coronary artery disease, contained rupture of saccular aneurysm arising from penetrating ulcer. Treated with total arch debranching, Coronary artery bypass grafting including LIMA-LAD (left internal mammary artery to left anterior descending artery) and Thoracic endovascular aortic repair (TEVAR).

In the open-repair group, 84 patients underwent a posterolateral thoracotomy and 9 had a median sternotomy. Extracorporeal perfusion was used in all, and 80 required deep hypothermic arrest.

In the endovascular group, the proximal extent of surgery was classified as Ishimaru zone 0 in 10 patients, zone 1 in 1, and zone 2 in 33. Treatment included full arch debranching and stent graft repair for zone 0 and zone 2 patients, respectively. A chimney stent of the carotid artery and left subclavian arterial bypass was used for the zone 1 patient.

Although the institutional preference is to utilize left subclavian artery (LSCA) revascularization for all, 76% of endovascular patients requiring LSCA coverage underwent preoperative bypass, Dr. Patel observed.

Significant differences existed at baseline between the two groups, with the endovascular group almost a full decade older than the open group (65 vs. 56 years). The endovascular group was also more likely to have saccular pathology (57% vs. 30%), and less likely to have a history of tobacco use (12% vs. 84%) or prior arch repair (16% vs. 36%).

Early morbidity included stroke in 6.6%, spinal cord ischemia in 0.7%, need for dialysis in 3.6%, and tracheostomy in 7.2%, Dr. Patel said.

The composite endpoint of stroke or early mortality was independently predicted by increasing age (odds ratio, 1.05; P = .055) and use of a hybrid procedure (OR, 6.4; P = .01).

Two-year freedom from aortic rupture or reintervention was 78% in the open group and 94% in the endovascular group (P = .02).

After a mean follow-up of 66 months, four patients had died of stroke, two from myocardial infarction, one from a proximal anastomosis disruption/rupture, and one from a type A dissection/rupture, Dr. Patel said.

The average survival was 145 months and 5-year survival rate was 59%.

Independent predictors of late mortality were increasing age (hazard ratio, 1.06; P = .001), peripheral vascular disease (HR, 2.4; P = .024), postoperative stroke (HR, 6.4; P less than .001), and postoperative dialysis (HR, 11.4; P less than .001). Notably, repair type was not predictive (P = .22), Dr. Patel said.

He cautioned the audience, however, that "cerebrovascular accidents remain an important cause of early and late mortality."

Dr. Patel reported consulting fees from W.L. Gore and Terumo.

pwendling@frontlinemedcom.com

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CHICAGO – Repair of the isolated nontraumatic aortic arch aneurysm can be performed with acceptable early and late results, based on a 20-year review of 137 patients.

Early mortality was seen in nine patients (6.6%), and was similarly split between endovascular and open repair (7.3% vs. 6.5%, respectively).

Patrice Wendling/IMNG Medical Media
Dr Himanshu J. Patel

Five-year survival did not differ between the endovascular- and open-repair groups (86% vs. 70%; P = .57), although the risk of reintervention was significantly higher with an endovascular strategy (94% vs. 77.5%; P = .02).

"These data support ongoing efforts to develop branched endografts specifically tailored for complex and difficult-to-treat pathology to potentially reduce the morbidity of therapy for this population," Dr. Himanshu J. Patel said at the annual meeting of the Midwestern Vascular Surgical Society.

Marginal landing zones and the need for complex arch debranching procedures to extend landing zones and facilitate repair can hinder endovascular repair, though open aortic repair is challenged by the frequent need for hypothermic circulatory arrest. Early and late results with either option are ill defined for this pathology, observed Dr. Patel, with the Cardiovascular Center, University of Michigan, Ann Arbor.

To investigate these outcomes, the authors evaluated data from 1993 to 2013 for 137 patients with nontraumatic aortic aneurysms located between the left and right pulmonary artery; 93 patients underwent open repair and 44 had an endovascular or hybrid repair.

The pathology was saccular in 39%, dissection in 11%, pseudoaneurysm in 18%, and anomalous arch in 11%. Rupture was identified in 14%. The average patient age was 59 years, and 46% were male.

Courtesy Dr. Himanshu Patel
75 year old male Coronary artery disease, contained rupture of saccular aneurysm arising from penetrating ulcer. Treated with total arch debranching, Coronary artery bypass grafting including LIMA-LAD (left internal mammary artery to left anterior descending artery) and Thoracic endovascular aortic repair (TEVAR).

In the open-repair group, 84 patients underwent a posterolateral thoracotomy and 9 had a median sternotomy. Extracorporeal perfusion was used in all, and 80 required deep hypothermic arrest.

In the endovascular group, the proximal extent of surgery was classified as Ishimaru zone 0 in 10 patients, zone 1 in 1, and zone 2 in 33. Treatment included full arch debranching and stent graft repair for zone 0 and zone 2 patients, respectively. A chimney stent of the carotid artery and left subclavian arterial bypass was used for the zone 1 patient.

Although the institutional preference is to utilize left subclavian artery (LSCA) revascularization for all, 76% of endovascular patients requiring LSCA coverage underwent preoperative bypass, Dr. Patel observed.

Significant differences existed at baseline between the two groups, with the endovascular group almost a full decade older than the open group (65 vs. 56 years). The endovascular group was also more likely to have saccular pathology (57% vs. 30%), and less likely to have a history of tobacco use (12% vs. 84%) or prior arch repair (16% vs. 36%).

Early morbidity included stroke in 6.6%, spinal cord ischemia in 0.7%, need for dialysis in 3.6%, and tracheostomy in 7.2%, Dr. Patel said.

The composite endpoint of stroke or early mortality was independently predicted by increasing age (odds ratio, 1.05; P = .055) and use of a hybrid procedure (OR, 6.4; P = .01).

Two-year freedom from aortic rupture or reintervention was 78% in the open group and 94% in the endovascular group (P = .02).

After a mean follow-up of 66 months, four patients had died of stroke, two from myocardial infarction, one from a proximal anastomosis disruption/rupture, and one from a type A dissection/rupture, Dr. Patel said.

The average survival was 145 months and 5-year survival rate was 59%.

Independent predictors of late mortality were increasing age (hazard ratio, 1.06; P = .001), peripheral vascular disease (HR, 2.4; P = .024), postoperative stroke (HR, 6.4; P less than .001), and postoperative dialysis (HR, 11.4; P less than .001). Notably, repair type was not predictive (P = .22), Dr. Patel said.

He cautioned the audience, however, that "cerebrovascular accidents remain an important cause of early and late mortality."

Dr. Patel reported consulting fees from W.L. Gore and Terumo.

pwendling@frontlinemedcom.com

CHICAGO – Repair of the isolated nontraumatic aortic arch aneurysm can be performed with acceptable early and late results, based on a 20-year review of 137 patients.

Early mortality was seen in nine patients (6.6%), and was similarly split between endovascular and open repair (7.3% vs. 6.5%, respectively).

Patrice Wendling/IMNG Medical Media
Dr Himanshu J. Patel

Five-year survival did not differ between the endovascular- and open-repair groups (86% vs. 70%; P = .57), although the risk of reintervention was significantly higher with an endovascular strategy (94% vs. 77.5%; P = .02).

"These data support ongoing efforts to develop branched endografts specifically tailored for complex and difficult-to-treat pathology to potentially reduce the morbidity of therapy for this population," Dr. Himanshu J. Patel said at the annual meeting of the Midwestern Vascular Surgical Society.

Marginal landing zones and the need for complex arch debranching procedures to extend landing zones and facilitate repair can hinder endovascular repair, though open aortic repair is challenged by the frequent need for hypothermic circulatory arrest. Early and late results with either option are ill defined for this pathology, observed Dr. Patel, with the Cardiovascular Center, University of Michigan, Ann Arbor.

To investigate these outcomes, the authors evaluated data from 1993 to 2013 for 137 patients with nontraumatic aortic aneurysms located between the left and right pulmonary artery; 93 patients underwent open repair and 44 had an endovascular or hybrid repair.

The pathology was saccular in 39%, dissection in 11%, pseudoaneurysm in 18%, and anomalous arch in 11%. Rupture was identified in 14%. The average patient age was 59 years, and 46% were male.

Courtesy Dr. Himanshu Patel
75 year old male Coronary artery disease, contained rupture of saccular aneurysm arising from penetrating ulcer. Treated with total arch debranching, Coronary artery bypass grafting including LIMA-LAD (left internal mammary artery to left anterior descending artery) and Thoracic endovascular aortic repair (TEVAR).

In the open-repair group, 84 patients underwent a posterolateral thoracotomy and 9 had a median sternotomy. Extracorporeal perfusion was used in all, and 80 required deep hypothermic arrest.

In the endovascular group, the proximal extent of surgery was classified as Ishimaru zone 0 in 10 patients, zone 1 in 1, and zone 2 in 33. Treatment included full arch debranching and stent graft repair for zone 0 and zone 2 patients, respectively. A chimney stent of the carotid artery and left subclavian arterial bypass was used for the zone 1 patient.

Although the institutional preference is to utilize left subclavian artery (LSCA) revascularization for all, 76% of endovascular patients requiring LSCA coverage underwent preoperative bypass, Dr. Patel observed.

Significant differences existed at baseline between the two groups, with the endovascular group almost a full decade older than the open group (65 vs. 56 years). The endovascular group was also more likely to have saccular pathology (57% vs. 30%), and less likely to have a history of tobacco use (12% vs. 84%) or prior arch repair (16% vs. 36%).

Early morbidity included stroke in 6.6%, spinal cord ischemia in 0.7%, need for dialysis in 3.6%, and tracheostomy in 7.2%, Dr. Patel said.

The composite endpoint of stroke or early mortality was independently predicted by increasing age (odds ratio, 1.05; P = .055) and use of a hybrid procedure (OR, 6.4; P = .01).

Two-year freedom from aortic rupture or reintervention was 78% in the open group and 94% in the endovascular group (P = .02).

After a mean follow-up of 66 months, four patients had died of stroke, two from myocardial infarction, one from a proximal anastomosis disruption/rupture, and one from a type A dissection/rupture, Dr. Patel said.

The average survival was 145 months and 5-year survival rate was 59%.

Independent predictors of late mortality were increasing age (hazard ratio, 1.06; P = .001), peripheral vascular disease (HR, 2.4; P = .024), postoperative stroke (HR, 6.4; P less than .001), and postoperative dialysis (HR, 11.4; P less than .001). Notably, repair type was not predictive (P = .22), Dr. Patel said.

He cautioned the audience, however, that "cerebrovascular accidents remain an important cause of early and late mortality."

Dr. Patel reported consulting fees from W.L. Gore and Terumo.

pwendling@frontlinemedcom.com

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Major finding: Five-year survival was 86% in the endovascular group and 70% in the open group (P = .57).

Data source: A retrospective study of 137 patients undergoing isolated aortic arch repair between 1993 and 2013.

Disclosures: Dr. Patel reported consulting fees from W.L. Gore and Terumo.

Renal injury taints proximal AAA repair

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CHICAGO – Proximal abdominal aortic aneurysm repair can be achieved with a low perioperative mortality of about 3%, although renal dysfunction remains an Achilles’ heel, according to a 27-year review involving 245 patients.

In all, 60% of patients had postoperative acute kidney injury (AKI), 28% had persistent AKI at discharge, and 1.6% were discharged on hemodialysis. Persistent AKI at discharge was also associated with reduced long-term survival, Dr. Loay Kabbani said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/IMNG Medical Media
Dr. Loay Kabbani

AKI stage was based on the Risk, Injury, Failure, Loss, and End-stage (RIFLE) kidney disease/Acute Kidney Injury Network (AKIN) classification system, with a change in serum creatinine of more than 0.3 mg/dL considered positive for injury. This is a much more sensitive criterion than what was used in previous studies, but is the new standard for reporting renal injury.

"This data should assist in establishing a benchmark for endovascular repair of these complex aneurysms," said Dr. Kabbani, a vascular surgeon at Henry Ford Hospital in Detroit.

The investigators identified 245 patients who underwent proximal AAA repair between 1986 and February 2013 at Henry Ford Hospital for juxtarenal (127), suprarenal (68), or type IV thoracoabdominal AAAs (50). The average aneurysm size was 6.4 cm (range, 3.1-14 cm), and mean preoperative estimated glomerular filtration rate was 62 mL/min per 1.73 m2 (range, 14-166 mL/min per 1.73 m2).

Most patients were male (69%), white (88.5%), and hypertensive (84%); 55% had chronic kidney disease based on a preoperative estimated glomerular filtration rate below 60 mL/min per 1.73 m2. Their average age was 71 years.

For most patients, the approach was retroperitoneal (48%) or thoracoabdominal (30%); the clamp was placed supraceliac (58%); and tube grafts were used (64%).

In-hospital mortality was 2.9% (7 patients) and 30-day mortality 3.3% (8 patients), Dr. Kabbani said.

Postoperative complications were AKI in 144 patients (60%), major pulmonary complications in 55 (22%), myocardial infarction in 9 (4%), return to the operating room for postoperative bleeding in 7 (3%), neurologic complications in 7 (3%), and bowel ischemia in 5 (2%).

Specifically, postoperative AKI was stage 1 (mild) in 35%, stage 2 (moderate) in 15%, and stage 3 (severe) in 10%, improving to 12%, 4%, and 3%, respectively, at discharge.

Though preoperative comorbidities were similar between patients with juxtarenal, suprarenal, and type IV aneurysms, postoperative complications increased significantly as the aneurysm extended more proximally (31% vs. 50% vs. 72%; P < .0001), Dr. Kabbani said.

Rates of AKI at discharge also followed the same pattern (18.2% vs. 35.4% vs. 43.8%; P less than .0012).

After a median follow-up of 54 months, the 5-year survival estimate was 70% and 10-year survival 43% based on a review of electronic medical records and the Social Security Death Index.

Cox regression analyses revealed no difference in long-term survival based on aneurysm type, but significantly worse survival based on increased aneurysm size (hazard ratio, 1.1; P = .01), preoperative chronic obstructive pulmonary disease (HR, 1.8; P = .002), congestive heart failure (HR, 3.5; P less than .001), history of stroke (HR, 1.9; P = .04), and persistent stage 2 (HR, 5.29; P = .001) and stage 3 AKI at discharge (HR, 2.71; P = .014), he said.

During a discussion of the results, Dr. Kabbani said the hospital usually uses mannitol (12.5-25 g) for renal protection and cold renal perfusion in select patients, although the latter did not jump out as a risk factor for CKI. The data were not broken down to see whether use of renal bypass during surgery affected outcomes for specific AAA types. Some attendees countered that renal protection should be used for all patients undergoing proximal AAA repair.

Dr. Kabbani reported having no financial disclosures.

pwendling@frontlinemedcom.com

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CHICAGO – Proximal abdominal aortic aneurysm repair can be achieved with a low perioperative mortality of about 3%, although renal dysfunction remains an Achilles’ heel, according to a 27-year review involving 245 patients.

In all, 60% of patients had postoperative acute kidney injury (AKI), 28% had persistent AKI at discharge, and 1.6% were discharged on hemodialysis. Persistent AKI at discharge was also associated with reduced long-term survival, Dr. Loay Kabbani said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/IMNG Medical Media
Dr. Loay Kabbani

AKI stage was based on the Risk, Injury, Failure, Loss, and End-stage (RIFLE) kidney disease/Acute Kidney Injury Network (AKIN) classification system, with a change in serum creatinine of more than 0.3 mg/dL considered positive for injury. This is a much more sensitive criterion than what was used in previous studies, but is the new standard for reporting renal injury.

"This data should assist in establishing a benchmark for endovascular repair of these complex aneurysms," said Dr. Kabbani, a vascular surgeon at Henry Ford Hospital in Detroit.

The investigators identified 245 patients who underwent proximal AAA repair between 1986 and February 2013 at Henry Ford Hospital for juxtarenal (127), suprarenal (68), or type IV thoracoabdominal AAAs (50). The average aneurysm size was 6.4 cm (range, 3.1-14 cm), and mean preoperative estimated glomerular filtration rate was 62 mL/min per 1.73 m2 (range, 14-166 mL/min per 1.73 m2).

Most patients were male (69%), white (88.5%), and hypertensive (84%); 55% had chronic kidney disease based on a preoperative estimated glomerular filtration rate below 60 mL/min per 1.73 m2. Their average age was 71 years.

For most patients, the approach was retroperitoneal (48%) or thoracoabdominal (30%); the clamp was placed supraceliac (58%); and tube grafts were used (64%).

In-hospital mortality was 2.9% (7 patients) and 30-day mortality 3.3% (8 patients), Dr. Kabbani said.

Postoperative complications were AKI in 144 patients (60%), major pulmonary complications in 55 (22%), myocardial infarction in 9 (4%), return to the operating room for postoperative bleeding in 7 (3%), neurologic complications in 7 (3%), and bowel ischemia in 5 (2%).

Specifically, postoperative AKI was stage 1 (mild) in 35%, stage 2 (moderate) in 15%, and stage 3 (severe) in 10%, improving to 12%, 4%, and 3%, respectively, at discharge.

Though preoperative comorbidities were similar between patients with juxtarenal, suprarenal, and type IV aneurysms, postoperative complications increased significantly as the aneurysm extended more proximally (31% vs. 50% vs. 72%; P < .0001), Dr. Kabbani said.

Rates of AKI at discharge also followed the same pattern (18.2% vs. 35.4% vs. 43.8%; P less than .0012).

After a median follow-up of 54 months, the 5-year survival estimate was 70% and 10-year survival 43% based on a review of electronic medical records and the Social Security Death Index.

Cox regression analyses revealed no difference in long-term survival based on aneurysm type, but significantly worse survival based on increased aneurysm size (hazard ratio, 1.1; P = .01), preoperative chronic obstructive pulmonary disease (HR, 1.8; P = .002), congestive heart failure (HR, 3.5; P less than .001), history of stroke (HR, 1.9; P = .04), and persistent stage 2 (HR, 5.29; P = .001) and stage 3 AKI at discharge (HR, 2.71; P = .014), he said.

During a discussion of the results, Dr. Kabbani said the hospital usually uses mannitol (12.5-25 g) for renal protection and cold renal perfusion in select patients, although the latter did not jump out as a risk factor for CKI. The data were not broken down to see whether use of renal bypass during surgery affected outcomes for specific AAA types. Some attendees countered that renal protection should be used for all patients undergoing proximal AAA repair.

Dr. Kabbani reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Proximal abdominal aortic aneurysm repair can be achieved with a low perioperative mortality of about 3%, although renal dysfunction remains an Achilles’ heel, according to a 27-year review involving 245 patients.

In all, 60% of patients had postoperative acute kidney injury (AKI), 28% had persistent AKI at discharge, and 1.6% were discharged on hemodialysis. Persistent AKI at discharge was also associated with reduced long-term survival, Dr. Loay Kabbani said at the annual meeting of the Midwestern Vascular Surgical Society.

Patrice Wendling/IMNG Medical Media
Dr. Loay Kabbani

AKI stage was based on the Risk, Injury, Failure, Loss, and End-stage (RIFLE) kidney disease/Acute Kidney Injury Network (AKIN) classification system, with a change in serum creatinine of more than 0.3 mg/dL considered positive for injury. This is a much more sensitive criterion than what was used in previous studies, but is the new standard for reporting renal injury.

"This data should assist in establishing a benchmark for endovascular repair of these complex aneurysms," said Dr. Kabbani, a vascular surgeon at Henry Ford Hospital in Detroit.

The investigators identified 245 patients who underwent proximal AAA repair between 1986 and February 2013 at Henry Ford Hospital for juxtarenal (127), suprarenal (68), or type IV thoracoabdominal AAAs (50). The average aneurysm size was 6.4 cm (range, 3.1-14 cm), and mean preoperative estimated glomerular filtration rate was 62 mL/min per 1.73 m2 (range, 14-166 mL/min per 1.73 m2).

Most patients were male (69%), white (88.5%), and hypertensive (84%); 55% had chronic kidney disease based on a preoperative estimated glomerular filtration rate below 60 mL/min per 1.73 m2. Their average age was 71 years.

For most patients, the approach was retroperitoneal (48%) or thoracoabdominal (30%); the clamp was placed supraceliac (58%); and tube grafts were used (64%).

In-hospital mortality was 2.9% (7 patients) and 30-day mortality 3.3% (8 patients), Dr. Kabbani said.

Postoperative complications were AKI in 144 patients (60%), major pulmonary complications in 55 (22%), myocardial infarction in 9 (4%), return to the operating room for postoperative bleeding in 7 (3%), neurologic complications in 7 (3%), and bowel ischemia in 5 (2%).

Specifically, postoperative AKI was stage 1 (mild) in 35%, stage 2 (moderate) in 15%, and stage 3 (severe) in 10%, improving to 12%, 4%, and 3%, respectively, at discharge.

Though preoperative comorbidities were similar between patients with juxtarenal, suprarenal, and type IV aneurysms, postoperative complications increased significantly as the aneurysm extended more proximally (31% vs. 50% vs. 72%; P < .0001), Dr. Kabbani said.

Rates of AKI at discharge also followed the same pattern (18.2% vs. 35.4% vs. 43.8%; P less than .0012).

After a median follow-up of 54 months, the 5-year survival estimate was 70% and 10-year survival 43% based on a review of electronic medical records and the Social Security Death Index.

Cox regression analyses revealed no difference in long-term survival based on aneurysm type, but significantly worse survival based on increased aneurysm size (hazard ratio, 1.1; P = .01), preoperative chronic obstructive pulmonary disease (HR, 1.8; P = .002), congestive heart failure (HR, 3.5; P less than .001), history of stroke (HR, 1.9; P = .04), and persistent stage 2 (HR, 5.29; P = .001) and stage 3 AKI at discharge (HR, 2.71; P = .014), he said.

During a discussion of the results, Dr. Kabbani said the hospital usually uses mannitol (12.5-25 g) for renal protection and cold renal perfusion in select patients, although the latter did not jump out as a risk factor for CKI. The data were not broken down to see whether use of renal bypass during surgery affected outcomes for specific AAA types. Some attendees countered that renal protection should be used for all patients undergoing proximal AAA repair.

Dr. Kabbani reported having no financial disclosures.

pwendling@frontlinemedcom.com

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Major finding: Perioperative mortality was 2.9%, but 60% of patients had postoperative acute kidney injury.

Data source: A retrospective analysis of 245 patients undergoing open proximal abdominal aortic aneurysm repair.

Disclosures: Dr. Kabbani reported having no financial disclosures.

Radiation exposure: Unwanted baggage in the endo suite

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CHICAGO – The growing number of endovascular interventions over the past 2 decades has changed the face of surgery, but also has brought with it increased radiation exposure for patients, surgeons, and medical personnel involved in patient care.

"It’s unwanted baggage. The downside of more endovascular procedures is more radiation exposure" said Dr. Raghu L. Motaganahalli, with Indiana University School of Medicine, in Indianapolis.

The most recent 2009 report from the National Council on Radiation Protection and Measurements says the average effective dose received by Americans from medical uses, excluding radiotherapy, is 3.0 millisieverts or essentially the same as that received from natural background radiation.

Patrice Wendling/IMNG Medical Media
Dr. Raghu Motaganahalli

Still, the use of computed tomography imaging has doubled every 2 years since the early 1980s to nearly 70 million scans in 2007 and at least 2% of all cancers are estimated to caused by CT radiation scan exposure, he said.

While patient exposure garners the lion’s share of attention, Dr. Motaganahalli urged surgeons at the annual meeting of the Midwestern Vascular Surgical Society to play a more active role in reducing radiation exposure. Personal monitoring is the first step, with the nonprofit International Commission on Radiological Protection recommending the use of two dosimeters – one at the neck and the second under the lead shielding at the waist – for the greatest measurement accuracy.

Lead aprons should be worn by all medical staff within about six feet of the patient, while thyroid collars and lead glasses also should be part of protective gear to reduce the risk of cancers or cataracts.

Distance from the radiation source in the interventional suite is also critical, he said. A recent study demonstrated that radiation doses vary widely around the perimeter of the angiography table and change according to the imaging angle (J. Vasc. Surg. 2013 [doi:10.1016/j.jvs.2013.01.025]).

The highest radiation doses were seen on the emitter side of the table, and thus, special emphasis should be paid to moving staff away from the scatter source, that is the patient, when standing on this side of the table, Dr. Motaganahalli said.

Other efforts to reduce radiation scatter to staff include minimizing the use of fluoroscopy and digital acquisition ("cine") times. The dose rate during a cine run is 10-20 times that during fluoroscopy. Using the "last image hold" capabilities may reduce the need for additional fluoroscopic time.

Pulsed fluoroscopy is also a better option than continuous fluoroscopy because the short bursts of x-ray decrease the exposure time and radiation exposure to the patient, he said. If the pulse rate is increased to approximately 30 pulses per second, however, the dose rate is virtually equivalent to that of continuous fluoroscopy.

High-dose fluoroscopy should be reserved for procedures requiring very high levels of detail because it allows exposure rates of up to 20 roentgens (R) per minute, whereas the normal operating mode is limited to 10 R/min., the Food and Drug Administration limit, Dr. Motaganahalli said.

Similarly, the use of magnification modes should be limited to the extent practicable because higher magnification modes result in higher radiation doses to smaller areas of the skin.

The "good news" is that vascular surgeons are exposed to about 70% of the ICRP occupational exposure limits over a 1-year-period (J. Vasc. Surg. 2000;32:704-10), he said. A more recent study reports even lower effective eye and hand doses, even after adjustments for longer fluoroscopy time, possibly because of extra protective devices such as a table-side lead shield and mobile lead shield reducing scatter radiation (J. Vasc. Surg. 2007;46:455-9).

A number of protection devices have been created including portable shields, under-table shields, lead caps, and zero gravity lead suits, although audience members commented that the suit has proven too unwieldy for practical use.

Dr. Motaganahalli reported having no conflicts of interest.

pwendling@frontlinemedcom.com

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CHICAGO – The growing number of endovascular interventions over the past 2 decades has changed the face of surgery, but also has brought with it increased radiation exposure for patients, surgeons, and medical personnel involved in patient care.

"It’s unwanted baggage. The downside of more endovascular procedures is more radiation exposure" said Dr. Raghu L. Motaganahalli, with Indiana University School of Medicine, in Indianapolis.

The most recent 2009 report from the National Council on Radiation Protection and Measurements says the average effective dose received by Americans from medical uses, excluding radiotherapy, is 3.0 millisieverts or essentially the same as that received from natural background radiation.

Patrice Wendling/IMNG Medical Media
Dr. Raghu Motaganahalli

Still, the use of computed tomography imaging has doubled every 2 years since the early 1980s to nearly 70 million scans in 2007 and at least 2% of all cancers are estimated to caused by CT radiation scan exposure, he said.

While patient exposure garners the lion’s share of attention, Dr. Motaganahalli urged surgeons at the annual meeting of the Midwestern Vascular Surgical Society to play a more active role in reducing radiation exposure. Personal monitoring is the first step, with the nonprofit International Commission on Radiological Protection recommending the use of two dosimeters – one at the neck and the second under the lead shielding at the waist – for the greatest measurement accuracy.

Lead aprons should be worn by all medical staff within about six feet of the patient, while thyroid collars and lead glasses also should be part of protective gear to reduce the risk of cancers or cataracts.

Distance from the radiation source in the interventional suite is also critical, he said. A recent study demonstrated that radiation doses vary widely around the perimeter of the angiography table and change according to the imaging angle (J. Vasc. Surg. 2013 [doi:10.1016/j.jvs.2013.01.025]).

The highest radiation doses were seen on the emitter side of the table, and thus, special emphasis should be paid to moving staff away from the scatter source, that is the patient, when standing on this side of the table, Dr. Motaganahalli said.

Other efforts to reduce radiation scatter to staff include minimizing the use of fluoroscopy and digital acquisition ("cine") times. The dose rate during a cine run is 10-20 times that during fluoroscopy. Using the "last image hold" capabilities may reduce the need for additional fluoroscopic time.

Pulsed fluoroscopy is also a better option than continuous fluoroscopy because the short bursts of x-ray decrease the exposure time and radiation exposure to the patient, he said. If the pulse rate is increased to approximately 30 pulses per second, however, the dose rate is virtually equivalent to that of continuous fluoroscopy.

High-dose fluoroscopy should be reserved for procedures requiring very high levels of detail because it allows exposure rates of up to 20 roentgens (R) per minute, whereas the normal operating mode is limited to 10 R/min., the Food and Drug Administration limit, Dr. Motaganahalli said.

Similarly, the use of magnification modes should be limited to the extent practicable because higher magnification modes result in higher radiation doses to smaller areas of the skin.

The "good news" is that vascular surgeons are exposed to about 70% of the ICRP occupational exposure limits over a 1-year-period (J. Vasc. Surg. 2000;32:704-10), he said. A more recent study reports even lower effective eye and hand doses, even after adjustments for longer fluoroscopy time, possibly because of extra protective devices such as a table-side lead shield and mobile lead shield reducing scatter radiation (J. Vasc. Surg. 2007;46:455-9).

A number of protection devices have been created including portable shields, under-table shields, lead caps, and zero gravity lead suits, although audience members commented that the suit has proven too unwieldy for practical use.

Dr. Motaganahalli reported having no conflicts of interest.

pwendling@frontlinemedcom.com

CHICAGO – The growing number of endovascular interventions over the past 2 decades has changed the face of surgery, but also has brought with it increased radiation exposure for patients, surgeons, and medical personnel involved in patient care.

"It’s unwanted baggage. The downside of more endovascular procedures is more radiation exposure" said Dr. Raghu L. Motaganahalli, with Indiana University School of Medicine, in Indianapolis.

The most recent 2009 report from the National Council on Radiation Protection and Measurements says the average effective dose received by Americans from medical uses, excluding radiotherapy, is 3.0 millisieverts or essentially the same as that received from natural background radiation.

Patrice Wendling/IMNG Medical Media
Dr. Raghu Motaganahalli

Still, the use of computed tomography imaging has doubled every 2 years since the early 1980s to nearly 70 million scans in 2007 and at least 2% of all cancers are estimated to caused by CT radiation scan exposure, he said.

While patient exposure garners the lion’s share of attention, Dr. Motaganahalli urged surgeons at the annual meeting of the Midwestern Vascular Surgical Society to play a more active role in reducing radiation exposure. Personal monitoring is the first step, with the nonprofit International Commission on Radiological Protection recommending the use of two dosimeters – one at the neck and the second under the lead shielding at the waist – for the greatest measurement accuracy.

Lead aprons should be worn by all medical staff within about six feet of the patient, while thyroid collars and lead glasses also should be part of protective gear to reduce the risk of cancers or cataracts.

Distance from the radiation source in the interventional suite is also critical, he said. A recent study demonstrated that radiation doses vary widely around the perimeter of the angiography table and change according to the imaging angle (J. Vasc. Surg. 2013 [doi:10.1016/j.jvs.2013.01.025]).

The highest radiation doses were seen on the emitter side of the table, and thus, special emphasis should be paid to moving staff away from the scatter source, that is the patient, when standing on this side of the table, Dr. Motaganahalli said.

Other efforts to reduce radiation scatter to staff include minimizing the use of fluoroscopy and digital acquisition ("cine") times. The dose rate during a cine run is 10-20 times that during fluoroscopy. Using the "last image hold" capabilities may reduce the need for additional fluoroscopic time.

Pulsed fluoroscopy is also a better option than continuous fluoroscopy because the short bursts of x-ray decrease the exposure time and radiation exposure to the patient, he said. If the pulse rate is increased to approximately 30 pulses per second, however, the dose rate is virtually equivalent to that of continuous fluoroscopy.

High-dose fluoroscopy should be reserved for procedures requiring very high levels of detail because it allows exposure rates of up to 20 roentgens (R) per minute, whereas the normal operating mode is limited to 10 R/min., the Food and Drug Administration limit, Dr. Motaganahalli said.

Similarly, the use of magnification modes should be limited to the extent practicable because higher magnification modes result in higher radiation doses to smaller areas of the skin.

The "good news" is that vascular surgeons are exposed to about 70% of the ICRP occupational exposure limits over a 1-year-period (J. Vasc. Surg. 2000;32:704-10), he said. A more recent study reports even lower effective eye and hand doses, even after adjustments for longer fluoroscopy time, possibly because of extra protective devices such as a table-side lead shield and mobile lead shield reducing scatter radiation (J. Vasc. Surg. 2007;46:455-9).

A number of protection devices have been created including portable shields, under-table shields, lead caps, and zero gravity lead suits, although audience members commented that the suit has proven too unwieldy for practical use.

Dr. Motaganahalli reported having no conflicts of interest.

pwendling@frontlinemedcom.com

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IVC filter complications common, retrieval rare

Reappraisal warranted
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IVC filter complications common, retrieval rare

CHICAGO – Penetration of the inferior vena cava and adjacent organs occurred with 46% of IVC filters placed among 262 patients, an award-winning analysis shows.

Grade 2 or 3 penetration was significantly associated with filter type (49% temporary vs. 5.3% permanent; P = .0001) and length of time in place (18.2% less than 30 days vs. 57.3% 30 days or more; P less than .0001).

"The majority of filters were placed for prophylaxis or relative indications and were temporary," Dr. Michael Go said at the annual meeting of the Midwestern Vascular Surgical Society.

The filter penetrated the aorta in 12 cases; duodenum in 26; and spine, colon, or kidney in 6; and simultaneously penetrated two organs in 7. Another 100 filters had struts immediately adjacent to the external aspect of the IVC, possibly indicating tenting of the cava.

Patrice Wendling/IMNG Medical Media
Dr. Michael Go

Only 1.6% of temporary filters, however, were retrieved during the 3-year study period, he said.

A filter retrieval rate between 1.2% and 5.1% was cited in a recent Medicare data analysis, which reported an alarming 111% increase in the rate of IVC filter placement from 1999 through 2008 (J. Am. Coll. Radio. 2011;8:483-9).

"IVC filter placement is an epidemic because of the ever-increasing number of risk factors being identified for VTE [venous thromboembolism]," said Dr. Go, with the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

Other culprits behind the explosive growth of IVC filters are that angiography suites and catheter labs are now commonplace, the skill needed to insert a filter is easily disseminated, and temporary filters have decreased the threshold for placement.

"Concern over filter complications is increasing, as are referrals for removal, but little long-term data exist," he remarked.

A total of 591 patients had an IVC filter placed at Ohio State University between January 2006 and December 2009, with an adequate postfilter computed tomography (CT) scan available in 262. CT findings were graded, based on a modified, previously published scale (J. Vasc. Interv. Radiol. 2011;22:70-4), ranging from 0 (struts confined entirely within the IVC) to 3 (strut interacts with aorta, duodenum, or other organs).

Indications for filter placement were prophylaxis in 16.4% and VTE in 83.6%. Among the filters placed for VTE, 44.7% were for absolute indications (inability/failure of anticoagulation) and 55.3% for relative indications.

Grade 0 penetration occurred in 42 filters, grade 1 in 100, grade 2 in 83, and grade 3 in 37, Dr. Go said.

Grade 2 or 3 penetration was present in 44.6% of Tulip filters, 74.4% of Celect, 5.3% of Greenfield, and 0% of Optease (P = .0000), according to the analysis, which won this year’s Pfeifer Venous Award from the society.

There was a trend toward increased grade 2 or 3 penetration with uniconical filters vs. biconical filters (46.7% vs. 0%; P = .0645).

In all, 32 patients sought clinical follow-up for abdominal or back pain, but none were conclusively tied to filter problems or penetration.

"It remains unclear if most penetrations caused clinically significant problems," he said. "Monitoring of penetrations with CT, or some other follow-up, may be important to understand the natural history of this condition."

Audience members remarked that the retrieval rate in the series was extremely low and asked whether efforts, such as percutaneous retrieval, were being undertaken.

"We have attempted to remove some of these filters, sometimes successfully, sometimes not," Dr. Go responded. "As far as our retrieval rate, I agree 1.6% is dismal. Vascular surgery put in 19% of the filters. We don’t have a specific protocol in place, other than hyperawareness amongst all of us partners about who has a filter in place and to bring them back when appropriate."

He also observed that even when retrieval is undertaken, technical failure rates are high at about 8.5% in the recent literature (Eur. J. Vasc. Endovasc. Surg. 2013;46:353-9).

Dr. Go and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com

Body

The results of this study speak for themselves – only a very small proportion of temporary filters are actually removed, and penetration of the inferior vena cava and adjacent structures by filter components is relatively common. It is particularly noteworthy that penetration was significantly more common with temporary filters vs. permanent filters, and the risk of penetration increased with time in place. These observations alone should inspire efforts to remove temporary filters as soon as clinically possible. The data presented also indicate that a large proportion of filters are being placed for prophylaxis or relative indications, suggesting that current evidence-based guidelines are not being followed.

However, in spite of the high observed penetration rate, this study does not provide much information on the clinical significance of this finding. In addition, this study represents a highly selected patient population, since a postfilter CT scan was available on less than half of all patients who received inferior vena cava filters during the study period. So while these results may not be completely generalizable, they certainly suggest that the majority of temporary filters become permanent filters, and a critical reappraisal of filter use is warranted.

Dr. R. Eugene Zierler is a professor of surgery at the University of Washington, Seattle, and an associate medical editor of Vascular Specialist.

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Body

The results of this study speak for themselves – only a very small proportion of temporary filters are actually removed, and penetration of the inferior vena cava and adjacent structures by filter components is relatively common. It is particularly noteworthy that penetration was significantly more common with temporary filters vs. permanent filters, and the risk of penetration increased with time in place. These observations alone should inspire efforts to remove temporary filters as soon as clinically possible. The data presented also indicate that a large proportion of filters are being placed for prophylaxis or relative indications, suggesting that current evidence-based guidelines are not being followed.

However, in spite of the high observed penetration rate, this study does not provide much information on the clinical significance of this finding. In addition, this study represents a highly selected patient population, since a postfilter CT scan was available on less than half of all patients who received inferior vena cava filters during the study period. So while these results may not be completely generalizable, they certainly suggest that the majority of temporary filters become permanent filters, and a critical reappraisal of filter use is warranted.

Dr. R. Eugene Zierler is a professor of surgery at the University of Washington, Seattle, and an associate medical editor of Vascular Specialist.

Body

The results of this study speak for themselves – only a very small proportion of temporary filters are actually removed, and penetration of the inferior vena cava and adjacent structures by filter components is relatively common. It is particularly noteworthy that penetration was significantly more common with temporary filters vs. permanent filters, and the risk of penetration increased with time in place. These observations alone should inspire efforts to remove temporary filters as soon as clinically possible. The data presented also indicate that a large proportion of filters are being placed for prophylaxis or relative indications, suggesting that current evidence-based guidelines are not being followed.

However, in spite of the high observed penetration rate, this study does not provide much information on the clinical significance of this finding. In addition, this study represents a highly selected patient population, since a postfilter CT scan was available on less than half of all patients who received inferior vena cava filters during the study period. So while these results may not be completely generalizable, they certainly suggest that the majority of temporary filters become permanent filters, and a critical reappraisal of filter use is warranted.

Dr. R. Eugene Zierler is a professor of surgery at the University of Washington, Seattle, and an associate medical editor of Vascular Specialist.

Title
Reappraisal warranted
Reappraisal warranted

CHICAGO – Penetration of the inferior vena cava and adjacent organs occurred with 46% of IVC filters placed among 262 patients, an award-winning analysis shows.

Grade 2 or 3 penetration was significantly associated with filter type (49% temporary vs. 5.3% permanent; P = .0001) and length of time in place (18.2% less than 30 days vs. 57.3% 30 days or more; P less than .0001).

"The majority of filters were placed for prophylaxis or relative indications and were temporary," Dr. Michael Go said at the annual meeting of the Midwestern Vascular Surgical Society.

The filter penetrated the aorta in 12 cases; duodenum in 26; and spine, colon, or kidney in 6; and simultaneously penetrated two organs in 7. Another 100 filters had struts immediately adjacent to the external aspect of the IVC, possibly indicating tenting of the cava.

Patrice Wendling/IMNG Medical Media
Dr. Michael Go

Only 1.6% of temporary filters, however, were retrieved during the 3-year study period, he said.

A filter retrieval rate between 1.2% and 5.1% was cited in a recent Medicare data analysis, which reported an alarming 111% increase in the rate of IVC filter placement from 1999 through 2008 (J. Am. Coll. Radio. 2011;8:483-9).

"IVC filter placement is an epidemic because of the ever-increasing number of risk factors being identified for VTE [venous thromboembolism]," said Dr. Go, with the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

Other culprits behind the explosive growth of IVC filters are that angiography suites and catheter labs are now commonplace, the skill needed to insert a filter is easily disseminated, and temporary filters have decreased the threshold for placement.

"Concern over filter complications is increasing, as are referrals for removal, but little long-term data exist," he remarked.

A total of 591 patients had an IVC filter placed at Ohio State University between January 2006 and December 2009, with an adequate postfilter computed tomography (CT) scan available in 262. CT findings were graded, based on a modified, previously published scale (J. Vasc. Interv. Radiol. 2011;22:70-4), ranging from 0 (struts confined entirely within the IVC) to 3 (strut interacts with aorta, duodenum, or other organs).

Indications for filter placement were prophylaxis in 16.4% and VTE in 83.6%. Among the filters placed for VTE, 44.7% were for absolute indications (inability/failure of anticoagulation) and 55.3% for relative indications.

Grade 0 penetration occurred in 42 filters, grade 1 in 100, grade 2 in 83, and grade 3 in 37, Dr. Go said.

Grade 2 or 3 penetration was present in 44.6% of Tulip filters, 74.4% of Celect, 5.3% of Greenfield, and 0% of Optease (P = .0000), according to the analysis, which won this year’s Pfeifer Venous Award from the society.

There was a trend toward increased grade 2 or 3 penetration with uniconical filters vs. biconical filters (46.7% vs. 0%; P = .0645).

In all, 32 patients sought clinical follow-up for abdominal or back pain, but none were conclusively tied to filter problems or penetration.

"It remains unclear if most penetrations caused clinically significant problems," he said. "Monitoring of penetrations with CT, or some other follow-up, may be important to understand the natural history of this condition."

Audience members remarked that the retrieval rate in the series was extremely low and asked whether efforts, such as percutaneous retrieval, were being undertaken.

"We have attempted to remove some of these filters, sometimes successfully, sometimes not," Dr. Go responded. "As far as our retrieval rate, I agree 1.6% is dismal. Vascular surgery put in 19% of the filters. We don’t have a specific protocol in place, other than hyperawareness amongst all of us partners about who has a filter in place and to bring them back when appropriate."

He also observed that even when retrieval is undertaken, technical failure rates are high at about 8.5% in the recent literature (Eur. J. Vasc. Endovasc. Surg. 2013;46:353-9).

Dr. Go and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Penetration of the inferior vena cava and adjacent organs occurred with 46% of IVC filters placed among 262 patients, an award-winning analysis shows.

Grade 2 or 3 penetration was significantly associated with filter type (49% temporary vs. 5.3% permanent; P = .0001) and length of time in place (18.2% less than 30 days vs. 57.3% 30 days or more; P less than .0001).

"The majority of filters were placed for prophylaxis or relative indications and were temporary," Dr. Michael Go said at the annual meeting of the Midwestern Vascular Surgical Society.

The filter penetrated the aorta in 12 cases; duodenum in 26; and spine, colon, or kidney in 6; and simultaneously penetrated two organs in 7. Another 100 filters had struts immediately adjacent to the external aspect of the IVC, possibly indicating tenting of the cava.

Patrice Wendling/IMNG Medical Media
Dr. Michael Go

Only 1.6% of temporary filters, however, were retrieved during the 3-year study period, he said.

A filter retrieval rate between 1.2% and 5.1% was cited in a recent Medicare data analysis, which reported an alarming 111% increase in the rate of IVC filter placement from 1999 through 2008 (J. Am. Coll. Radio. 2011;8:483-9).

"IVC filter placement is an epidemic because of the ever-increasing number of risk factors being identified for VTE [venous thromboembolism]," said Dr. Go, with the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

Other culprits behind the explosive growth of IVC filters are that angiography suites and catheter labs are now commonplace, the skill needed to insert a filter is easily disseminated, and temporary filters have decreased the threshold for placement.

"Concern over filter complications is increasing, as are referrals for removal, but little long-term data exist," he remarked.

A total of 591 patients had an IVC filter placed at Ohio State University between January 2006 and December 2009, with an adequate postfilter computed tomography (CT) scan available in 262. CT findings were graded, based on a modified, previously published scale (J. Vasc. Interv. Radiol. 2011;22:70-4), ranging from 0 (struts confined entirely within the IVC) to 3 (strut interacts with aorta, duodenum, or other organs).

Indications for filter placement were prophylaxis in 16.4% and VTE in 83.6%. Among the filters placed for VTE, 44.7% were for absolute indications (inability/failure of anticoagulation) and 55.3% for relative indications.

Grade 0 penetration occurred in 42 filters, grade 1 in 100, grade 2 in 83, and grade 3 in 37, Dr. Go said.

Grade 2 or 3 penetration was present in 44.6% of Tulip filters, 74.4% of Celect, 5.3% of Greenfield, and 0% of Optease (P = .0000), according to the analysis, which won this year’s Pfeifer Venous Award from the society.

There was a trend toward increased grade 2 or 3 penetration with uniconical filters vs. biconical filters (46.7% vs. 0%; P = .0645).

In all, 32 patients sought clinical follow-up for abdominal or back pain, but none were conclusively tied to filter problems or penetration.

"It remains unclear if most penetrations caused clinically significant problems," he said. "Monitoring of penetrations with CT, or some other follow-up, may be important to understand the natural history of this condition."

Audience members remarked that the retrieval rate in the series was extremely low and asked whether efforts, such as percutaneous retrieval, were being undertaken.

"We have attempted to remove some of these filters, sometimes successfully, sometimes not," Dr. Go responded. "As far as our retrieval rate, I agree 1.6% is dismal. Vascular surgery put in 19% of the filters. We don’t have a specific protocol in place, other than hyperawareness amongst all of us partners about who has a filter in place and to bring them back when appropriate."

He also observed that even when retrieval is undertaken, technical failure rates are high at about 8.5% in the recent literature (Eur. J. Vasc. Endovasc. Surg. 2013;46:353-9).

Dr. Go and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com

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Major finding: Penetration of the inferior vena cava and adjacent organs occurred with 46% of IVC filters placed.

Data source: Retrospective study of 262 patients receiving inferior vena cava filters between January 2006 and December 2009.

Disclosures: Dr. Go and his coauthors reported no financial disclosures.

Amputations/revascularization top vascular readmission list

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CHICAGO – Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date.

Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the annual meeting of the Midwestern Vascular Surgical Society.*

Patrice Wendling/IMNG Medical Media
Dr. Travis Engelbert

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244).

Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (LOS) (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service’s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... we need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they’re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

When asked by the audience what the university has done to reduce its vascular readmission rates, Dr. Engelbert said they have looked at using in-patient swabs to reduce infection and dedicated vascular nurse practitioners or case managers to ensure patients are being discharged to the appropriate level of care.

"I think further efforts need to focus on how we can reduce outpatient complications, through closer and quicker follow-up perhaps, as well as ways to use technology to monitor patients," he said.

One example of this is the use of outpatient remote wound analysis using smartphone photograph technology.

"Wound complications and subsequent readmissions are frequent, costly, and a significant burden to the patients," Dr. Engelbert said in an interview. "Hopefully, this method will reduce the severity of wound complications if they can be caught and treated at an earlier stage with digital photograph analysis."

One audience member argued that the vast majority of vascular problems could be cared for outpatient, but that vascular surgeons frequently aren’t told their patients have been readmitted until after they’ve been in the hospital for 2 or 3 days.

 

 

Dr. Engelbert reported having no financial disclosures. A coauthor reported grant funding from Abbott, Cook, Covidien, Endologix, Gore, and the National Institutes of Health.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

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CHICAGO – Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date.

Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the annual meeting of the Midwestern Vascular Surgical Society.*

Patrice Wendling/IMNG Medical Media
Dr. Travis Engelbert

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244).

Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (LOS) (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service’s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... we need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they’re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

When asked by the audience what the university has done to reduce its vascular readmission rates, Dr. Engelbert said they have looked at using in-patient swabs to reduce infection and dedicated vascular nurse practitioners or case managers to ensure patients are being discharged to the appropriate level of care.

"I think further efforts need to focus on how we can reduce outpatient complications, through closer and quicker follow-up perhaps, as well as ways to use technology to monitor patients," he said.

One example of this is the use of outpatient remote wound analysis using smartphone photograph technology.

"Wound complications and subsequent readmissions are frequent, costly, and a significant burden to the patients," Dr. Engelbert said in an interview. "Hopefully, this method will reduce the severity of wound complications if they can be caught and treated at an earlier stage with digital photograph analysis."

One audience member argued that the vast majority of vascular problems could be cared for outpatient, but that vascular surgeons frequently aren’t told their patients have been readmitted until after they’ve been in the hospital for 2 or 3 days.

 

 

Dr. Engelbert reported having no financial disclosures. A coauthor reported grant funding from Abbott, Cook, Covidien, Endologix, Gore, and the National Institutes of Health.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date.

Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the annual meeting of the Midwestern Vascular Surgical Society.*

Patrice Wendling/IMNG Medical Media
Dr. Travis Engelbert

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244).

Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (LOS) (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service’s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... we need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they’re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

When asked by the audience what the university has done to reduce its vascular readmission rates, Dr. Engelbert said they have looked at using in-patient swabs to reduce infection and dedicated vascular nurse practitioners or case managers to ensure patients are being discharged to the appropriate level of care.

"I think further efforts need to focus on how we can reduce outpatient complications, through closer and quicker follow-up perhaps, as well as ways to use technology to monitor patients," he said.

One example of this is the use of outpatient remote wound analysis using smartphone photograph technology.

"Wound complications and subsequent readmissions are frequent, costly, and a significant burden to the patients," Dr. Engelbert said in an interview. "Hopefully, this method will reduce the severity of wound complications if they can be caught and treated at an earlier stage with digital photograph analysis."

One audience member argued that the vast majority of vascular problems could be cared for outpatient, but that vascular surgeons frequently aren’t told their patients have been readmitted until after they’ve been in the hospital for 2 or 3 days.

 

 

Dr. Engelbert reported having no financial disclosures. A coauthor reported grant funding from Abbott, Cook, Covidien, Endologix, Gore, and the National Institutes of Health.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

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FROM THE ANNUAL MEETING OF THE MIDWESTERN VASCULAR SURGICAL SOCIETY

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Major finding: The 30-day vascular readmission rate was 9.7%, with amputation/lower-limb revascularization comprising 63% of readmissions.

Data source: A retrospective review of 2,505 patients undergoing vascular surgery at a single institution.

Disclosures: Dr. Engelbert reported having no financial disclosures. A coauthor reported grant funding from Abbott, Cook, Covidien, Endologix, Gore, and the National Institutes of Health.

Endovascular coiling aids pelvic congestion syndrome

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CHICAGO – Endovascular coiling should be offered to women with pelvic congestion syndrome as an effective treatment.

"The technical success rate is high, pain scores were significantly improved, and most importantly, the patient satisfaction with resolution of their symptoms is very high," Dr. Axel Thors said at the annual meeting of the Midwestern Vascular Surgical Society*.

He reported on a 4-year review involving 15 women with pelvic congestion syndrome (PCS) who underwent endovenous coil embolization (n = 14) or stenting of the iliac vein (n = 1).

The diagnosis of PCS was made clinically by the presence of chronic pelvic pain for 6 months or more, sensations of pelvic fullness, dyspareunia, or perineal varicosities. There was no evidence of nutcracker syndrome or perirenal varicosities. Other pathologies had been previously ruled out.

Patrice Wendling/IMNG Medical Media
Dr. Axel Thors

"By the time these women got to us, we were probably the last provider they had seen and they had all undergone extensive evaluation for their pelvic pain, all the way from their primary providers to the ob.gyns.," said Dr. Thors of Ohio State University, Columbus.

Their average age was 36 years. Fourteen patients had a previous pregnancy, with an average parity of two.

Twelve patients presented with symptomatic vulvar varices and three with imaging or laproscopic findings of tubo-ovarian varices. All had complaints of chronic pelvic pain.

"Lower extremity venous insufficiency was closely associated with the incidence [of PCS], as was chronic dyspareunia," Dr. Thors said.

Gonadal vein venograms were performed during normal breath and the Valsalva maneuver. Embolization was performed if there was gonadal vein incompetence, congestion of the ovarian venous plexus, uterine venous congestion, cross-pelvic congestion, or marked enlargement of gonadal veins (minimum 6 mm). The average venality size was 7.3 mm.

In all, 13 gonadal veins were embolized with an average of three coils, ranging in size from 6 mm to 12 mm, Dr. Thors said.

Four gonadal veins were occluded using an Amplatzer plug (range 12-18 mm). One iliac vein was stented with a 16 mm by 60 mm stent.

Lower-extremity venous insufficiency was treated with ablation and subsequently followed clinically, he said.

Pain scores on a 10-point visual analog scale declined significantly from baseline for eight evaluable patients for pelvic pain (9.3 vs. 1.8), dyspareunia (8.875 vs. 1.5), painful vulvar varices (9.2 vs. 1.2), and lower extremity venous insufficiency (7 vs. 1), he said.

Two patients had recurrence, and their baseline pain score of 1.2 increased to 4.0 after a mean of 21 months.

All eight patients reported that they were "satisfied" or "very satisfied" with their procedure.

"Patients with chronic pelvic pain, vulvar varices, multiparity, and lower extremity venous insufficiency should be offered endovascular evaluation and treatment," Dr. Thors concluded.

Audience members said that the study represents an important concept in the management of these patients. It is a validation of a very old treatment that sometimes is not offered because of a lack of knowledge or perceived lack of data. A 2012 Agency for Healthcare Research and Quality review estimated that outpatient management of chronic pelvic pain cost $1.2 billion annually. The AHRQ review of 36 studies concluded that there is insufficient evidence to demonstrate the effectiveness of surgical approaches for chronic pelvic pain.

Dr. Thors and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

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CHICAGO – Endovascular coiling should be offered to women with pelvic congestion syndrome as an effective treatment.

"The technical success rate is high, pain scores were significantly improved, and most importantly, the patient satisfaction with resolution of their symptoms is very high," Dr. Axel Thors said at the annual meeting of the Midwestern Vascular Surgical Society*.

He reported on a 4-year review involving 15 women with pelvic congestion syndrome (PCS) who underwent endovenous coil embolization (n = 14) or stenting of the iliac vein (n = 1).

The diagnosis of PCS was made clinically by the presence of chronic pelvic pain for 6 months or more, sensations of pelvic fullness, dyspareunia, or perineal varicosities. There was no evidence of nutcracker syndrome or perirenal varicosities. Other pathologies had been previously ruled out.

Patrice Wendling/IMNG Medical Media
Dr. Axel Thors

"By the time these women got to us, we were probably the last provider they had seen and they had all undergone extensive evaluation for their pelvic pain, all the way from their primary providers to the ob.gyns.," said Dr. Thors of Ohio State University, Columbus.

Their average age was 36 years. Fourteen patients had a previous pregnancy, with an average parity of two.

Twelve patients presented with symptomatic vulvar varices and three with imaging or laproscopic findings of tubo-ovarian varices. All had complaints of chronic pelvic pain.

"Lower extremity venous insufficiency was closely associated with the incidence [of PCS], as was chronic dyspareunia," Dr. Thors said.

Gonadal vein venograms were performed during normal breath and the Valsalva maneuver. Embolization was performed if there was gonadal vein incompetence, congestion of the ovarian venous plexus, uterine venous congestion, cross-pelvic congestion, or marked enlargement of gonadal veins (minimum 6 mm). The average venality size was 7.3 mm.

In all, 13 gonadal veins were embolized with an average of three coils, ranging in size from 6 mm to 12 mm, Dr. Thors said.

Four gonadal veins were occluded using an Amplatzer plug (range 12-18 mm). One iliac vein was stented with a 16 mm by 60 mm stent.

Lower-extremity venous insufficiency was treated with ablation and subsequently followed clinically, he said.

Pain scores on a 10-point visual analog scale declined significantly from baseline for eight evaluable patients for pelvic pain (9.3 vs. 1.8), dyspareunia (8.875 vs. 1.5), painful vulvar varices (9.2 vs. 1.2), and lower extremity venous insufficiency (7 vs. 1), he said.

Two patients had recurrence, and their baseline pain score of 1.2 increased to 4.0 after a mean of 21 months.

All eight patients reported that they were "satisfied" or "very satisfied" with their procedure.

"Patients with chronic pelvic pain, vulvar varices, multiparity, and lower extremity venous insufficiency should be offered endovascular evaluation and treatment," Dr. Thors concluded.

Audience members said that the study represents an important concept in the management of these patients. It is a validation of a very old treatment that sometimes is not offered because of a lack of knowledge or perceived lack of data. A 2012 Agency for Healthcare Research and Quality review estimated that outpatient management of chronic pelvic pain cost $1.2 billion annually. The AHRQ review of 36 studies concluded that there is insufficient evidence to demonstrate the effectiveness of surgical approaches for chronic pelvic pain.

Dr. Thors and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Endovascular coiling should be offered to women with pelvic congestion syndrome as an effective treatment.

"The technical success rate is high, pain scores were significantly improved, and most importantly, the patient satisfaction with resolution of their symptoms is very high," Dr. Axel Thors said at the annual meeting of the Midwestern Vascular Surgical Society*.

He reported on a 4-year review involving 15 women with pelvic congestion syndrome (PCS) who underwent endovenous coil embolization (n = 14) or stenting of the iliac vein (n = 1).

The diagnosis of PCS was made clinically by the presence of chronic pelvic pain for 6 months or more, sensations of pelvic fullness, dyspareunia, or perineal varicosities. There was no evidence of nutcracker syndrome or perirenal varicosities. Other pathologies had been previously ruled out.

Patrice Wendling/IMNG Medical Media
Dr. Axel Thors

"By the time these women got to us, we were probably the last provider they had seen and they had all undergone extensive evaluation for their pelvic pain, all the way from their primary providers to the ob.gyns.," said Dr. Thors of Ohio State University, Columbus.

Their average age was 36 years. Fourteen patients had a previous pregnancy, with an average parity of two.

Twelve patients presented with symptomatic vulvar varices and three with imaging or laproscopic findings of tubo-ovarian varices. All had complaints of chronic pelvic pain.

"Lower extremity venous insufficiency was closely associated with the incidence [of PCS], as was chronic dyspareunia," Dr. Thors said.

Gonadal vein venograms were performed during normal breath and the Valsalva maneuver. Embolization was performed if there was gonadal vein incompetence, congestion of the ovarian venous plexus, uterine venous congestion, cross-pelvic congestion, or marked enlargement of gonadal veins (minimum 6 mm). The average venality size was 7.3 mm.

In all, 13 gonadal veins were embolized with an average of three coils, ranging in size from 6 mm to 12 mm, Dr. Thors said.

Four gonadal veins were occluded using an Amplatzer plug (range 12-18 mm). One iliac vein was stented with a 16 mm by 60 mm stent.

Lower-extremity venous insufficiency was treated with ablation and subsequently followed clinically, he said.

Pain scores on a 10-point visual analog scale declined significantly from baseline for eight evaluable patients for pelvic pain (9.3 vs. 1.8), dyspareunia (8.875 vs. 1.5), painful vulvar varices (9.2 vs. 1.2), and lower extremity venous insufficiency (7 vs. 1), he said.

Two patients had recurrence, and their baseline pain score of 1.2 increased to 4.0 after a mean of 21 months.

All eight patients reported that they were "satisfied" or "very satisfied" with their procedure.

"Patients with chronic pelvic pain, vulvar varices, multiparity, and lower extremity venous insufficiency should be offered endovascular evaluation and treatment," Dr. Thors concluded.

Audience members said that the study represents an important concept in the management of these patients. It is a validation of a very old treatment that sometimes is not offered because of a lack of knowledge or perceived lack of data. A 2012 Agency for Healthcare Research and Quality review estimated that outpatient management of chronic pelvic pain cost $1.2 billion annually. The AHRQ review of 36 studies concluded that there is insufficient evidence to demonstrate the effectiveness of surgical approaches for chronic pelvic pain.

Dr. Thors and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

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Local anesthesia improves hemodynamic stability during carotid endarterectomy

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CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society*.

Patrice Wendling/IMNG Medical Media
Dr. Markia Gassner

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or perform a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

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CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society*.

Patrice Wendling/IMNG Medical Media
Dr. Markia Gassner

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or perform a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society*.

Patrice Wendling/IMNG Medical Media
Dr. Markia Gassner

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or perform a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

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Local anesthesia improves hemodynamic stability during carotid endarterectomy
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Local anesthesia improves hemodynamic stability during carotid endarterectomy
Legacy Keywords
carotid endarterectomy, cervical block anesthesia, hemodynamic fluctuations, vasoactive medications, general anesthesia, cervical block anesthesia, carotid endarterectomy, Dr. Marika Y. Gassner, Midwestern Vascular Surgical Society,

Legacy Keywords
carotid endarterectomy, cervical block anesthesia, hemodynamic fluctuations, vasoactive medications, general anesthesia, cervical block anesthesia, carotid endarterectomy, Dr. Marika Y. Gassner, Midwestern Vascular Surgical Society,

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FROM THE ANNUAL MEETING OF THE MIDWESTERN VASCULAR SURGICAL SOCIETY

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Major finding: The incidence of intraoperative hypotension was 0.52% with cervical block anesthesia and 17.84% with general anesthesia.

Data source: Retrospective review of 651 patients undergoing carotid endarterectomy.

Disclosures: Dr. Gassner and her coauthors reported having no financial disclosures.