Vascular

LAS VEGAS – Venous thromboembolism prophylaxis – a sine qua non of the Joint Commission and others – doesn’t seem to prevent deep vein thrombosis or pulmonary embolism in hospitalized medical patients, but it does make them more likely to bleed, according to investigators from the Michigan Hospital Medicine Safety Consortium.

The findings are prompting one of those investigators to reassess his own approach. In an interview at the Society of Hospital Medicine’s 2014 meeting, Dr. Scott Kaatz, chief quality officer at Hurley Medical Center in Flint, Mich., told us how he’s thinking a bit differently these days when it comes to VTE prophylaxis in medical inpatients.

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LAS VEGAS – Venous thromboembolism prophylaxis – a sine qua non of the Joint Commission and others – doesn’t seem to prevent deep vein thrombosis or pulmonary embolism in hospitalized medical patients, but it does make them more likely to bleed, according to investigators from the Michigan Hospital Medicine Safety Consortium.

The findings are prompting one of those investigators to reassess his own approach. In an interview at the Society of Hospital Medicine’s 2014 meeting, Dr. Scott Kaatz, chief quality officer at Hurley Medical Center in Flint, Mich., told us how he’s thinking a bit differently these days when it comes to VTE prophylaxis in medical inpatients.

[email protected]

LAS VEGAS – Venous thromboembolism prophylaxis – a sine qua non of the Joint Commission and others – doesn’t seem to prevent deep vein thrombosis or pulmonary embolism in hospitalized medical patients, but it does make them more likely to bleed, according to investigators from the Michigan Hospital Medicine Safety Consortium.

The findings are prompting one of those investigators to reassess his own approach. In an interview at the Society of Hospital Medicine’s 2014 meeting, Dr. Scott Kaatz, chief quality officer at Hurley Medical Center in Flint, Mich., told us how he’s thinking a bit differently these days when it comes to VTE prophylaxis in medical inpatients.

[email protected]

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

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.

[email protected]

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

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.

[email protected]

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

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.

[email protected]

SAN DIEGO - An intra-arterial infusion drug cocktail of nicardipine, verapamil, and nitroglycerin appears to work better than nicardipine or verapamil alone – the usual approach – to open up cerebral vasospasms after subarachnoid hemorrhage. The early results are so promising that lead investigator Dr. Peng Roc Chen, a cerebrovascular neurosurgeon at the University of Texas, Houston, and his colleagues are following up with a randomized controlled trial. Dr. Chen explained the project to us at this year’s International Stroke Conference.

SAN DIEGO - An intra-arterial infusion drug cocktail of nicardipine, verapamil, and nitroglycerin appears to work better than nicardipine or verapamil alone – the usual approach – to open up cerebral vasospasms after subarachnoid hemorrhage. The early results are so promising that lead investigator Dr. Peng Roc Chen, a cerebrovascular neurosurgeon at the University of Texas, Houston, and his colleagues are following up with a randomized controlled trial. Dr. Chen explained the project to us at this year’s International Stroke Conference.

SAN DIEGO - An intra-arterial infusion drug cocktail of nicardipine, verapamil, and nitroglycerin appears to work better than nicardipine or verapamil alone – the usual approach – to open up cerebral vasospasms after subarachnoid hemorrhage. The early results are so promising that lead investigator Dr. Peng Roc Chen, a cerebrovascular neurosurgeon at the University of Texas, Houston, and his colleagues are following up with a randomized controlled trial. Dr. Chen explained the project to us at this year’s International Stroke Conference.

SAN DIEGO – Cerebral vasospasms open up, on average, 34.9% more when patients are infused with an intra-arterial cocktail of nicardipine, verapamil, and nitroglycerin, instead of the usual approach of nicardipine or verapamil alone, according to a retrospective study from the University of Texas, Houston.

Investigators there compared the cocktail to single-agent infusions in patients with vasospasms due to aneurysmal subarachnoid hemorrhages, after the offending aneurysms had been clipped or coiled.

Fifty-four patients with 116 spasmed vessels were infused with verapamil 10 mg or nicardipine 5 mg per vascular territory. Another 50 patients with 106 spasmed vessels were infused with verapamil 10 mg, nicardipine 5 mg, and nitroglycerin 200 mcg per vascular territory. The patients underwent repeat cerebral angiography at least 15 minutes after treatment.

In addition to having greater average dilation, the cocktail group had significantly greater improvement in the ratio of arterial lumen diameter before and after treatment than did the single-agent group (45.8% vs. 10.9%, respectively). The effect was independent of age.

There was a trend toward more modified Rankin Scale (mRS) scores of 0-2 in the multiple-agent group, but it was not statistically significant. Lead investigator Dr. Peng Roc Chen, a cerebrovascular neurosurgeon at the University of Texas, Houston, has launched a prospective randomized trial with his colleagues to investigate the matter further. Nine medical centers have signed up so far, and they are looking for more.

Single-agent infusion is standard practice in the United States, usually with verapamil, but it doesn’t work well, "and there’s no conclusive literature suggesting the best intra-arterial infusion regimen for vasospasm, particularly when balloon angioplasty is not feasible," Dr. Chen said at the International Stroke Conference, sponsored by the American Heart Association.

The team hoped for synergistic effects by combining commonly used intra-arterial vasodilators with different mechanisms of action, while avoiding the cardiovascular instability that comes with high-dose infusion of single agents. Verapamil and nicardipine are both calcium-channel blockers, but they work on different receptors, he said.

At discharge, 24 (44.4%) patients in the single-agent group had an mRS score of 0-2, 28 (51.9%) had an mRS score of 3-5, and 2 (3.7%) had died. At 3 months, 25 of the 34 patients not lost to follow-up (73.5%) had an mRS score of 0-2, seven (20.6%) had an mRS score of 3-5, and 2 (5.9%) had died.

In the multiagent group, 31 (62%) had an mRS score of 0-2 at discharge, 16 (32%) had an mRS score of 3-5, and 3 patients (6%) had died. At 3 months, 29 of the 36 patients not lost to follow-up (80.6%) had an mRS score of 0-2, 4 (11.1%) had an mRS score of 3-5, and 3 (8.3%) had died.

Small numbers and follow-up loss may have contributed to the lack of outcome significance. It’s also possible that subarachnoid hemorrhage drove outcomes, regardless of vasospasm treatment. In any case, multiagent infusion is now the standard approach at Dr. Chen’s medical center; the single-agent patients were historical controls, he said.

Sixteen (29.6%) patients in the single-agent arm needed additional treatment, either repeat infusions or balloon angioplasties. Twenty-two (44%) needed additional treatment in the multiple-agent group (P = .128).

Dr. Chen did not report patient demographics, but said there were no differences in post-treatment blood pressures, heart rate changes, or intracranial pressures between the two treatment groups. Patients who had balloon angioplasties before vasodilation were excluded from the study.

Verapamil and nicardipine were infused at a rate of 1 mg/min and nitroglycerin, at a rate of 100 mcg/min. In the single-agent arm, the investigators found no differences in vessel diameter change between verapamil and nicardipine.

The investigators reported having no relevant financial disclosures.

SAN DIEGO – Cerebral vasospasms open up, on average, 34.9% more when patients are infused with an intra-arterial cocktail of nicardipine, verapamil, and nitroglycerin, instead of the usual approach of nicardipine or verapamil alone, according to a retrospective study from the University of Texas, Houston.

Investigators there compared the cocktail to single-agent infusions in patients with vasospasms due to aneurysmal subarachnoid hemorrhages, after the offending aneurysms had been clipped or coiled.

Fifty-four patients with 116 spasmed vessels were infused with verapamil 10 mg or nicardipine 5 mg per vascular territory. Another 50 patients with 106 spasmed vessels were infused with verapamil 10 mg, nicardipine 5 mg, and nitroglycerin 200 mcg per vascular territory. The patients underwent repeat cerebral angiography at least 15 minutes after treatment.

In addition to having greater average dilation, the cocktail group had significantly greater improvement in the ratio of arterial lumen diameter before and after treatment than did the single-agent group (45.8% vs. 10.9%, respectively). The effect was independent of age.

There was a trend toward more modified Rankin Scale (mRS) scores of 0-2 in the multiple-agent group, but it was not statistically significant. Lead investigator Dr. Peng Roc Chen, a cerebrovascular neurosurgeon at the University of Texas, Houston, has launched a prospective randomized trial with his colleagues to investigate the matter further. Nine medical centers have signed up so far, and they are looking for more.

Single-agent infusion is standard practice in the United States, usually with verapamil, but it doesn’t work well, "and there’s no conclusive literature suggesting the best intra-arterial infusion regimen for vasospasm, particularly when balloon angioplasty is not feasible," Dr. Chen said at the International Stroke Conference, sponsored by the American Heart Association.

The team hoped for synergistic effects by combining commonly used intra-arterial vasodilators with different mechanisms of action, while avoiding the cardiovascular instability that comes with high-dose infusion of single agents. Verapamil and nicardipine are both calcium-channel blockers, but they work on different receptors, he said.

At discharge, 24 (44.4%) patients in the single-agent group had an mRS score of 0-2, 28 (51.9%) had an mRS score of 3-5, and 2 (3.7%) had died. At 3 months, 25 of the 34 patients not lost to follow-up (73.5%) had an mRS score of 0-2, seven (20.6%) had an mRS score of 3-5, and 2 (5.9%) had died.

In the multiagent group, 31 (62%) had an mRS score of 0-2 at discharge, 16 (32%) had an mRS score of 3-5, and 3 patients (6%) had died. At 3 months, 29 of the 36 patients not lost to follow-up (80.6%) had an mRS score of 0-2, 4 (11.1%) had an mRS score of 3-5, and 3 (8.3%) had died.

Small numbers and follow-up loss may have contributed to the lack of outcome significance. It’s also possible that subarachnoid hemorrhage drove outcomes, regardless of vasospasm treatment. In any case, multiagent infusion is now the standard approach at Dr. Chen’s medical center; the single-agent patients were historical controls, he said.

Sixteen (29.6%) patients in the single-agent arm needed additional treatment, either repeat infusions or balloon angioplasties. Twenty-two (44%) needed additional treatment in the multiple-agent group (P = .128).

Dr. Chen did not report patient demographics, but said there were no differences in post-treatment blood pressures, heart rate changes, or intracranial pressures between the two treatment groups. Patients who had balloon angioplasties before vasodilation were excluded from the study.

Verapamil and nicardipine were infused at a rate of 1 mg/min and nitroglycerin, at a rate of 100 mcg/min. In the single-agent arm, the investigators found no differences in vessel diameter change between verapamil and nicardipine.

The investigators reported having no relevant financial disclosures.

SAN DIEGO – Cerebral vasospasms open up, on average, 34.9% more when patients are infused with an intra-arterial cocktail of nicardipine, verapamil, and nitroglycerin, instead of the usual approach of nicardipine or verapamil alone, according to a retrospective study from the University of Texas, Houston.

Investigators there compared the cocktail to single-agent infusions in patients with vasospasms due to aneurysmal subarachnoid hemorrhages, after the offending aneurysms had been clipped or coiled.

Fifty-four patients with 116 spasmed vessels were infused with verapamil 10 mg or nicardipine 5 mg per vascular territory. Another 50 patients with 106 spasmed vessels were infused with verapamil 10 mg, nicardipine 5 mg, and nitroglycerin 200 mcg per vascular territory. The patients underwent repeat cerebral angiography at least 15 minutes after treatment.

In addition to having greater average dilation, the cocktail group had significantly greater improvement in the ratio of arterial lumen diameter before and after treatment than did the single-agent group (45.8% vs. 10.9%, respectively). The effect was independent of age.

There was a trend toward more modified Rankin Scale (mRS) scores of 0-2 in the multiple-agent group, but it was not statistically significant. Lead investigator Dr. Peng Roc Chen, a cerebrovascular neurosurgeon at the University of Texas, Houston, has launched a prospective randomized trial with his colleagues to investigate the matter further. Nine medical centers have signed up so far, and they are looking for more.

Single-agent infusion is standard practice in the United States, usually with verapamil, but it doesn’t work well, "and there’s no conclusive literature suggesting the best intra-arterial infusion regimen for vasospasm, particularly when balloon angioplasty is not feasible," Dr. Chen said at the International Stroke Conference, sponsored by the American Heart Association.

The team hoped for synergistic effects by combining commonly used intra-arterial vasodilators with different mechanisms of action, while avoiding the cardiovascular instability that comes with high-dose infusion of single agents. Verapamil and nicardipine are both calcium-channel blockers, but they work on different receptors, he said.

At discharge, 24 (44.4%) patients in the single-agent group had an mRS score of 0-2, 28 (51.9%) had an mRS score of 3-5, and 2 (3.7%) had died. At 3 months, 25 of the 34 patients not lost to follow-up (73.5%) had an mRS score of 0-2, seven (20.6%) had an mRS score of 3-5, and 2 (5.9%) had died.

In the multiagent group, 31 (62%) had an mRS score of 0-2 at discharge, 16 (32%) had an mRS score of 3-5, and 3 patients (6%) had died. At 3 months, 29 of the 36 patients not lost to follow-up (80.6%) had an mRS score of 0-2, 4 (11.1%) had an mRS score of 3-5, and 3 (8.3%) had died.

Small numbers and follow-up loss may have contributed to the lack of outcome significance. It’s also possible that subarachnoid hemorrhage drove outcomes, regardless of vasospasm treatment. In any case, multiagent infusion is now the standard approach at Dr. Chen’s medical center; the single-agent patients were historical controls, he said.

Sixteen (29.6%) patients in the single-agent arm needed additional treatment, either repeat infusions or balloon angioplasties. Twenty-two (44%) needed additional treatment in the multiple-agent group (P = .128).

Dr. Chen did not report patient demographics, but said there were no differences in post-treatment blood pressures, heart rate changes, or intracranial pressures between the two treatment groups. Patients who had balloon angioplasties before vasodilation were excluded from the study.

Verapamil and nicardipine were infused at a rate of 1 mg/min and nitroglycerin, at a rate of 100 mcg/min. In the single-agent arm, the investigators found no differences in vessel diameter change between verapamil and nicardipine.

The investigators reported having no relevant financial disclosures.

The risk of amputation and death appears to increase as the number of revascularization procedures increases, according to findings from a retrospective analysis of data.

The amputation risk was present among patients who underwent percutaneous transluminal angioplasty (PTA) only, as well as among subsets of patients who underwent lower extremity bypass (LEB) only, reported Dr. Alexander T. Hawkins of the Center for Surgery and Public Health, Boston, and his colleagues.

Among 11,190 patients with critical limb ischemia who underwent one, two, three, four, or five or more revascularization procedures, the 1-year estimated amputation rates were 23.3%, 27.1%, 30.3%, 26.7%, and 28.6%, and the 1-year estimated mortality rates were 18.7%, 21.1%, 26.3%, 23.6%, and 32.1%, respectively, the investigators reported. The findings were published in the January issue of Annals of Vascular Surgery.

The risk of amputation increased significantly for those with two vs. one revascularization procedures (hazard ratio, 1.22) and for those with three vs. two procedures (HR, 1.33). The risk for death at 1 year also increased significantly among those with two vs. one procedure (HR, 1.18) (Ann. Vasc. Surg. 2014;28:35-47).

Similar trends for amputation were seen in the PTA-only (1: 24.5%; 2: 26.1%; 3: 27.9%; 4: 31.3%; 5+: 26.8%), and LEB-only (1: 26.0%; 2: 32.5%; 3+: 45.5%) groups. "The increases did not appear to be exponential," they noted.

No changes were seen in the PTA-only and LEB-only groups with respect to 1-year estimates of in-hospital death.

A subgroup analysis further showed that timing between procedures was significantly associated with 1-year amputation risk; the risk was 27.2% for a 1-7 day interval, 36.4% for 8 days to 1 month, 19.4% for 1-6 months; and 22.2% for 6 months or more.

"There was also a difference in 1-year amputation rates between bypass patients who underwent bypass first and who underwent PTA followed by bypass" (21.8% vs. 30.7%), the researchers wrote.

Study subjects were adult patients with a mean age of 71 years who underwent revascularization between July 2007 and December 2009. The patients, including 6,225 men (55.9%), were identified from the California State Inpatient Database and had a high burden of comorbidities; 55.2% abused tobacco, 64.9% had coronary artery disease, 51.3% had hypertension, and 68% had diabetes.

Though limited by factors inherent in the use of an administrative database (such as potential inconsistencies in coding accuracy) and in a nonrandomized study (subject to confounding), the findings nonetheless provide "novel and useful information on the increasing risk of amputation and death in patients undergoing multiple revascularization procedures," the investigators said.

They stressed that they are "by no means making the claim that secondary revascularization is inappropriate," but rather, that they are presenting the risks associated with further procedures in an effort to inform the decision-making process.

Critical limb ischemia confers a high risk of limb loss without treatment, they said, noting that 16%-50% of revascularized patients require secondary revascularization. A "major proportion" of these patients will require further procedures, they noted.

"We emphasize continued communication between clinicians and patients on the true risks and benefits of these procedures," they concluded.

Dr. Hawkins and his coauthor, Dr. Stuart Lipsitz, are supported by a grant from the Brigham and Women’s Center for Surgery and Public Health Arthur Tracy Cabot Fellowship. Dr. Hawkins is also supported by the NIH NHLBI T32 Harvard/Longwood Vascular Surgery Training Program. Another author, Dr. Maria J. Schaumeier, is supported by a grant from the Freiwillige Akademische Gesellschaft, Basel, Switzerland.

The risk of amputation and death appears to increase as the number of revascularization procedures increases, according to findings from a retrospective analysis of data.

The amputation risk was present among patients who underwent percutaneous transluminal angioplasty (PTA) only, as well as among subsets of patients who underwent lower extremity bypass (LEB) only, reported Dr. Alexander T. Hawkins of the Center for Surgery and Public Health, Boston, and his colleagues.

Among 11,190 patients with critical limb ischemia who underwent one, two, three, four, or five or more revascularization procedures, the 1-year estimated amputation rates were 23.3%, 27.1%, 30.3%, 26.7%, and 28.6%, and the 1-year estimated mortality rates were 18.7%, 21.1%, 26.3%, 23.6%, and 32.1%, respectively, the investigators reported. The findings were published in the January issue of Annals of Vascular Surgery.

The risk of amputation increased significantly for those with two vs. one revascularization procedures (hazard ratio, 1.22) and for those with three vs. two procedures (HR, 1.33). The risk for death at 1 year also increased significantly among those with two vs. one procedure (HR, 1.18) (Ann. Vasc. Surg. 2014;28:35-47).

Similar trends for amputation were seen in the PTA-only (1: 24.5%; 2: 26.1%; 3: 27.9%; 4: 31.3%; 5+: 26.8%), and LEB-only (1: 26.0%; 2: 32.5%; 3+: 45.5%) groups. "The increases did not appear to be exponential," they noted.

No changes were seen in the PTA-only and LEB-only groups with respect to 1-year estimates of in-hospital death.

A subgroup analysis further showed that timing between procedures was significantly associated with 1-year amputation risk; the risk was 27.2% for a 1-7 day interval, 36.4% for 8 days to 1 month, 19.4% for 1-6 months; and 22.2% for 6 months or more.

"There was also a difference in 1-year amputation rates between bypass patients who underwent bypass first and who underwent PTA followed by bypass" (21.8% vs. 30.7%), the researchers wrote.

Study subjects were adult patients with a mean age of 71 years who underwent revascularization between July 2007 and December 2009. The patients, including 6,225 men (55.9%), were identified from the California State Inpatient Database and had a high burden of comorbidities; 55.2% abused tobacco, 64.9% had coronary artery disease, 51.3% had hypertension, and 68% had diabetes.

Though limited by factors inherent in the use of an administrative database (such as potential inconsistencies in coding accuracy) and in a nonrandomized study (subject to confounding), the findings nonetheless provide "novel and useful information on the increasing risk of amputation and death in patients undergoing multiple revascularization procedures," the investigators said.

They stressed that they are "by no means making the claim that secondary revascularization is inappropriate," but rather, that they are presenting the risks associated with further procedures in an effort to inform the decision-making process.

Critical limb ischemia confers a high risk of limb loss without treatment, they said, noting that 16%-50% of revascularized patients require secondary revascularization. A "major proportion" of these patients will require further procedures, they noted.

"We emphasize continued communication between clinicians and patients on the true risks and benefits of these procedures," they concluded.

Dr. Hawkins and his coauthor, Dr. Stuart Lipsitz, are supported by a grant from the Brigham and Women’s Center for Surgery and Public Health Arthur Tracy Cabot Fellowship. Dr. Hawkins is also supported by the NIH NHLBI T32 Harvard/Longwood Vascular Surgery Training Program. Another author, Dr. Maria J. Schaumeier, is supported by a grant from the Freiwillige Akademische Gesellschaft, Basel, Switzerland.

The risk of amputation and death appears to increase as the number of revascularization procedures increases, according to findings from a retrospective analysis of data.

The amputation risk was present among patients who underwent percutaneous transluminal angioplasty (PTA) only, as well as among subsets of patients who underwent lower extremity bypass (LEB) only, reported Dr. Alexander T. Hawkins of the Center for Surgery and Public Health, Boston, and his colleagues.

Among 11,190 patients with critical limb ischemia who underwent one, two, three, four, or five or more revascularization procedures, the 1-year estimated amputation rates were 23.3%, 27.1%, 30.3%, 26.7%, and 28.6%, and the 1-year estimated mortality rates were 18.7%, 21.1%, 26.3%, 23.6%, and 32.1%, respectively, the investigators reported. The findings were published in the January issue of Annals of Vascular Surgery.

The risk of amputation increased significantly for those with two vs. one revascularization procedures (hazard ratio, 1.22) and for those with three vs. two procedures (HR, 1.33). The risk for death at 1 year also increased significantly among those with two vs. one procedure (HR, 1.18) (Ann. Vasc. Surg. 2014;28:35-47).

Similar trends for amputation were seen in the PTA-only (1: 24.5%; 2: 26.1%; 3: 27.9%; 4: 31.3%; 5+: 26.8%), and LEB-only (1: 26.0%; 2: 32.5%; 3+: 45.5%) groups. "The increases did not appear to be exponential," they noted.

No changes were seen in the PTA-only and LEB-only groups with respect to 1-year estimates of in-hospital death.

A subgroup analysis further showed that timing between procedures was significantly associated with 1-year amputation risk; the risk was 27.2% for a 1-7 day interval, 36.4% for 8 days to 1 month, 19.4% for 1-6 months; and 22.2% for 6 months or more.

"There was also a difference in 1-year amputation rates between bypass patients who underwent bypass first and who underwent PTA followed by bypass" (21.8% vs. 30.7%), the researchers wrote.

Study subjects were adult patients with a mean age of 71 years who underwent revascularization between July 2007 and December 2009. The patients, including 6,225 men (55.9%), were identified from the California State Inpatient Database and had a high burden of comorbidities; 55.2% abused tobacco, 64.9% had coronary artery disease, 51.3% had hypertension, and 68% had diabetes.

Though limited by factors inherent in the use of an administrative database (such as potential inconsistencies in coding accuracy) and in a nonrandomized study (subject to confounding), the findings nonetheless provide "novel and useful information on the increasing risk of amputation and death in patients undergoing multiple revascularization procedures," the investigators said.

They stressed that they are "by no means making the claim that secondary revascularization is inappropriate," but rather, that they are presenting the risks associated with further procedures in an effort to inform the decision-making process.

Critical limb ischemia confers a high risk of limb loss without treatment, they said, noting that 16%-50% of revascularized patients require secondary revascularization. A "major proportion" of these patients will require further procedures, they noted.

"We emphasize continued communication between clinicians and patients on the true risks and benefits of these procedures," they concluded.

Dr. Hawkins and his coauthor, Dr. Stuart Lipsitz, are supported by a grant from the Brigham and Women’s Center for Surgery and Public Health Arthur Tracy Cabot Fellowship. Dr. Hawkins is also supported by the NIH NHLBI T32 Harvard/Longwood Vascular Surgery Training Program. Another author, Dr. Maria J. Schaumeier, is supported by a grant from the Freiwillige Akademische Gesellschaft, Basel, Switzerland.

CHICAGO – Pinning down the anatomic characteristics that increase the risk of stroke with carotid artery stenting continues to be a challenge, as demonstrated by a database study and literature review presented at a symposium on vascular surgery sponsored by Northwestern University.

"I am absolutely convinced that certain anatomic and plaque characteristics increase the risk of a stroke for patients with carotid artery stenting," Dr. Melina R. Kibbe said in presenting her study. "The studies are not consistent in the literature, but there is a pattern."

She presented a prospective database review that evaluated no less than a dozen anatomic variables in 381 carotid arteries stented at the university from 2001 to 2010. The mostly male (75%), asymptomatic (70%), and moderate- to high-risk cohort had an average age of 70.5 years.

Within 30 days of carotid stenting, there were six strokes and eight transient ischemic attacks (TIAs), for an overall neurologic event rate of 3.7%, she said. Three patients had a heart attack, and two died.

The risk of perioperative stroke or TIA was significantly increased only in patients with a higher degree of internal carotid artery (ICA) stenosis (87% stenosis vs. 81% stenosis; P = .03).

It also trended higher, but fell short of significance, in those with greater arch calcification (P = .06).

Surprisingly, no statistical association was found between neurologic events and arch type (P = .16), despite the clinical belief that increasing arch type can be associated with more difficulty accessing the target lesion, said Dr. Kibbe, professor of vascular surgery and surgical research at Northwestern University, Chicago.

Other variables with trends that failed to reach statistical significance included internal to common carotid artery angulation, tortuous carotid artery, ipsilateral external carotid artery (ECA) stenosis, plaque calcification, and lesion length.

Turning to the literature for more answers, Dr. Kibbe and her colleagues performed a review of eight carotid stenting studies between 1993 and 2013. These studies included SAPPHIRE, which demonstrated an association between type II and III arches and increased stroke risk. Two other studies implicated type II, type III, and bovine arches, while three other studies, including a systematic review that incorporated the EVA-3S study (Stroke 2011;42:380-8), found no association between arch type and stroke.

Still, Dr. Kibbe said she’s convinced no two patients are alike when it comes to arterial anatomy and called for data from pivotal trials like CREST to be reanalyzed for stroke, based on arch type and plaque characteristics.

"Even better, I’d like to see a prospective, randomized study that excludes patients for carotid artery stenting based on their anatomy; for example, excluding all type III arches," she said. "My own personal bias is that patients with type III arches should not have carotid stenting. We don’t need to push the envelope."

Interestingly, no study in the review has shown ICA stenosis to be a risk factor for stroke or TIA, although lesions with a higher degree of stenosis would be expected to contribute to perioperative stroke risk.

Arch calcification, ECA stenosis, and plaque calcification also failed to register as risk factors, despite their potential to increase the risk of embolization with wire or catheter manipulation, Dr. Kibbe observed.

Two studies found that lesions longer than 1 cm or 1.5 cm were predictive of stroke, while one study (Catheter Cardiovasc. Interv. 2012;80:321-8) linked stroke with ICA tortuosity, defined as a distal ICA angle of more than 60 degrees.

Conventional thinking would suggest that right-sided carotid stenting would also confer a greater stroke risk because selecting the right ICA requires crossing the orifice of the left ICA, but only the SAPPHIRE trial reported more strokes with right-sided lesions, she said.

Finally, Dr. Kibbe highlighted an anatomic scoring system for carotid artery stenting developed by an international panel of seven vascular surgeons and five interventional radiologists (Stroke 2009;40:1698-703). Based on expert consensus, the greatest risk factor is type III arch, followed in descending order of risk by arch atheroma, diseased common carotid artery, ECA disease, angulated distal ICA, bovine arch, and pinhole stenosis. The resulting color-coded, traffic-light scoring system looks rather busy, but is relatively easy to use and provides guidance on carotid stenting suitability for the novice physician, she said.

Dr. Kibbe reported having no financial disclosures.

[email protected]

CHICAGO – Pinning down the anatomic characteristics that increase the risk of stroke with carotid artery stenting continues to be a challenge, as demonstrated by a database study and literature review presented at a symposium on vascular surgery sponsored by Northwestern University.

"I am absolutely convinced that certain anatomic and plaque characteristics increase the risk of a stroke for patients with carotid artery stenting," Dr. Melina R. Kibbe said in presenting her study. "The studies are not consistent in the literature, but there is a pattern."

She presented a prospective database review that evaluated no less than a dozen anatomic variables in 381 carotid arteries stented at the university from 2001 to 2010. The mostly male (75%), asymptomatic (70%), and moderate- to high-risk cohort had an average age of 70.5 years.

Within 30 days of carotid stenting, there were six strokes and eight transient ischemic attacks (TIAs), for an overall neurologic event rate of 3.7%, she said. Three patients had a heart attack, and two died.

The risk of perioperative stroke or TIA was significantly increased only in patients with a higher degree of internal carotid artery (ICA) stenosis (87% stenosis vs. 81% stenosis; P = .03).

It also trended higher, but fell short of significance, in those with greater arch calcification (P = .06).

Surprisingly, no statistical association was found between neurologic events and arch type (P = .16), despite the clinical belief that increasing arch type can be associated with more difficulty accessing the target lesion, said Dr. Kibbe, professor of vascular surgery and surgical research at Northwestern University, Chicago.

Other variables with trends that failed to reach statistical significance included internal to common carotid artery angulation, tortuous carotid artery, ipsilateral external carotid artery (ECA) stenosis, plaque calcification, and lesion length.

Turning to the literature for more answers, Dr. Kibbe and her colleagues performed a review of eight carotid stenting studies between 1993 and 2013. These studies included SAPPHIRE, which demonstrated an association between type II and III arches and increased stroke risk. Two other studies implicated type II, type III, and bovine arches, while three other studies, including a systematic review that incorporated the EVA-3S study (Stroke 2011;42:380-8), found no association between arch type and stroke.

Still, Dr. Kibbe said she’s convinced no two patients are alike when it comes to arterial anatomy and called for data from pivotal trials like CREST to be reanalyzed for stroke, based on arch type and plaque characteristics.

"Even better, I’d like to see a prospective, randomized study that excludes patients for carotid artery stenting based on their anatomy; for example, excluding all type III arches," she said. "My own personal bias is that patients with type III arches should not have carotid stenting. We don’t need to push the envelope."

Interestingly, no study in the review has shown ICA stenosis to be a risk factor for stroke or TIA, although lesions with a higher degree of stenosis would be expected to contribute to perioperative stroke risk.

Arch calcification, ECA stenosis, and plaque calcification also failed to register as risk factors, despite their potential to increase the risk of embolization with wire or catheter manipulation, Dr. Kibbe observed.

Two studies found that lesions longer than 1 cm or 1.5 cm were predictive of stroke, while one study (Catheter Cardiovasc. Interv. 2012;80:321-8) linked stroke with ICA tortuosity, defined as a distal ICA angle of more than 60 degrees.

Conventional thinking would suggest that right-sided carotid stenting would also confer a greater stroke risk because selecting the right ICA requires crossing the orifice of the left ICA, but only the SAPPHIRE trial reported more strokes with right-sided lesions, she said.

Finally, Dr. Kibbe highlighted an anatomic scoring system for carotid artery stenting developed by an international panel of seven vascular surgeons and five interventional radiologists (Stroke 2009;40:1698-703). Based on expert consensus, the greatest risk factor is type III arch, followed in descending order of risk by arch atheroma, diseased common carotid artery, ECA disease, angulated distal ICA, bovine arch, and pinhole stenosis. The resulting color-coded, traffic-light scoring system looks rather busy, but is relatively easy to use and provides guidance on carotid stenting suitability for the novice physician, she said.

Dr. Kibbe reported having no financial disclosures.

[email protected]

CHICAGO – Pinning down the anatomic characteristics that increase the risk of stroke with carotid artery stenting continues to be a challenge, as demonstrated by a database study and literature review presented at a symposium on vascular surgery sponsored by Northwestern University.

"I am absolutely convinced that certain anatomic and plaque characteristics increase the risk of a stroke for patients with carotid artery stenting," Dr. Melina R. Kibbe said in presenting her study. "The studies are not consistent in the literature, but there is a pattern."

She presented a prospective database review that evaluated no less than a dozen anatomic variables in 381 carotid arteries stented at the university from 2001 to 2010. The mostly male (75%), asymptomatic (70%), and moderate- to high-risk cohort had an average age of 70.5 years.

Within 30 days of carotid stenting, there were six strokes and eight transient ischemic attacks (TIAs), for an overall neurologic event rate of 3.7%, she said. Three patients had a heart attack, and two died.

The risk of perioperative stroke or TIA was significantly increased only in patients with a higher degree of internal carotid artery (ICA) stenosis (87% stenosis vs. 81% stenosis; P = .03).

It also trended higher, but fell short of significance, in those with greater arch calcification (P = .06).

Surprisingly, no statistical association was found between neurologic events and arch type (P = .16), despite the clinical belief that increasing arch type can be associated with more difficulty accessing the target lesion, said Dr. Kibbe, professor of vascular surgery and surgical research at Northwestern University, Chicago.

Other variables with trends that failed to reach statistical significance included internal to common carotid artery angulation, tortuous carotid artery, ipsilateral external carotid artery (ECA) stenosis, plaque calcification, and lesion length.

Turning to the literature for more answers, Dr. Kibbe and her colleagues performed a review of eight carotid stenting studies between 1993 and 2013. These studies included SAPPHIRE, which demonstrated an association between type II and III arches and increased stroke risk. Two other studies implicated type II, type III, and bovine arches, while three other studies, including a systematic review that incorporated the EVA-3S study (Stroke 2011;42:380-8), found no association between arch type and stroke.

Still, Dr. Kibbe said she’s convinced no two patients are alike when it comes to arterial anatomy and called for data from pivotal trials like CREST to be reanalyzed for stroke, based on arch type and plaque characteristics.

"Even better, I’d like to see a prospective, randomized study that excludes patients for carotid artery stenting based on their anatomy; for example, excluding all type III arches," she said. "My own personal bias is that patients with type III arches should not have carotid stenting. We don’t need to push the envelope."

Interestingly, no study in the review has shown ICA stenosis to be a risk factor for stroke or TIA, although lesions with a higher degree of stenosis would be expected to contribute to perioperative stroke risk.

Arch calcification, ECA stenosis, and plaque calcification also failed to register as risk factors, despite their potential to increase the risk of embolization with wire or catheter manipulation, Dr. Kibbe observed.

Two studies found that lesions longer than 1 cm or 1.5 cm were predictive of stroke, while one study (Catheter Cardiovasc. Interv. 2012;80:321-8) linked stroke with ICA tortuosity, defined as a distal ICA angle of more than 60 degrees.

Conventional thinking would suggest that right-sided carotid stenting would also confer a greater stroke risk because selecting the right ICA requires crossing the orifice of the left ICA, but only the SAPPHIRE trial reported more strokes with right-sided lesions, she said.

Finally, Dr. Kibbe highlighted an anatomic scoring system for carotid artery stenting developed by an international panel of seven vascular surgeons and five interventional radiologists (Stroke 2009;40:1698-703). Based on expert consensus, the greatest risk factor is type III arch, followed in descending order of risk by arch atheroma, diseased common carotid artery, ECA disease, angulated distal ICA, bovine arch, and pinhole stenosis. The resulting color-coded, traffic-light scoring system looks rather busy, but is relatively easy to use and provides guidance on carotid stenting suitability for the novice physician, she said.

Dr. Kibbe reported having no financial disclosures.

[email protected]

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

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.

[email protected]

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

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.

[email protected]

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

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.

[email protected]

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

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

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.

[email protected]

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

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

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.

[email protected]

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

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

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.

[email protected]

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

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.

[email protected]

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

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.

[email protected]

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

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.

[email protected]