Beta-blockers cut CAS stroke, deaths

Beta-blockade for all CAS patients?
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Beta-blockers cut CAS stroke, deaths

CHICAGO – Carotid artery stenting is safer if patients have been on beta-blockers for at least a month beforehand, according to a review of 5,248 stent cases during 2005-2014.

“Compared to nonusers, patients on long-term beta-blockers are at 34% less risk of stroke and death after carotid artery stenting [odds ratio, 0.66; 95% confidence interval, 0.46-0.95; P = .025], and this risk reduction is amplified to 65% in patients with postop hypertension [OR, 0.35; 95% CI, 0.17-0.73; P = .005].

“Beta-blockers significantly reduce the stroke and death risk ... and should be investigated prospectively for potential use during” carotid artery stenting (CAS), said senior investigator Dr. Mahmoud Malas, director of endovascular surgery and associate professor of surgery at Johns Hopkins Bayview Medical Center in Baltimore.

In the study, long-term beta-blocker use was not associated with postprocedure hypotension in the study. Among patients who developed it, however, beta-blockers were associated with a 48% reduction in the risk of stroke or death at 30 days (OR, 0.52; 95% CI, 0.28-0.98; P = .43).

Dr. Mahmoud B. Malas
Dr. Mahmoud B. Malas

“We think [the benefits are due to] up-regulation of adrenergic receptors. We think also there is better baroreceptor reflex sensitivity.” Long-term use of beta-blockers reduces heart rate variability, as well, and decreases the risk of hyperperfusion fourfold, Dr. Malas said at the meeting hosted by the Society for Vascular Surgery.

The researchers looked into the issue because they are trying to find a way to make CAS safer in the wake of the Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and others that have shown increased risk compared with carotid endarterectomy.

The subjects were all captured in SVS’s Vascular Quality Initiative database; 2,152 were not on beta-blockers before CAS, 259 were on them for less than 30 days, and 2,837 were on them for more than 30 days.

There were no statistical between-group differences in lesion sites, approach (femoral in almost all the cases), or contrast volume used in surgery, a marker of case complexity.

Long-term users had more diabetes, hypertension, coronary artery disease, and congestive heart failure, whereas short-term users were more symptomatic; those and other differences were controlled for on multivariate analysis.

Aspirin, clopidogrel, and statin use were similar between the groups. About two-thirds of the subjects were men, and the average patientage in the study was about 70 years old.

Overall, the 30-day stroke and death rate was 3.4% (minor stroke 1.5%, major 0.9%, and death 1.2%).

Predictors of postoperative stroke or death at 30 days included symptomatic status, age, diabetes, and perioperative hypotension and hypertension. Prior carotid endarterectomy and distal embolic protection were both protective.

The investigators reported that they had no disclosures.

aotto@frontlinemedcom.com

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This retrospective study by Malas et al. showed a 34% significant reduction of stroke and death in patients undergoing carotid artery stenting (CAS) who had been on beta-blockade (BB) for at least 1 month beforehand. Presumably, most of these patients were already on longstanding BB. Current cardiology guidelines recommend the continuation of established BB for surgical patients, and this may also mitigate the cardiac risk in CAS patients. The short-term use of BB has been shown to have risk during and after noncardiac surgery and, intuitively, could lead to severe hypotension during CAS. The reason for the stroke reduction seen with well-established BB is not clearly understood.

This study begs the question: Should every patient being considered for CAS be on BB at least 1 month before the intervention, even those with few or no cardiac risk factors? If so, then it would be difficult to advocate for CAS in acutely symptomatic patients not already on a BB, thus further limiting the usefulness of this procedure.

Dr. Mark L. Friedell is chairman of the department of Surgery, University of Missouri Kansas City School of Medicine.

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This retrospective study by Malas et al. showed a 34% significant reduction of stroke and death in patients undergoing carotid artery stenting (CAS) who had been on beta-blockade (BB) for at least 1 month beforehand. Presumably, most of these patients were already on longstanding BB. Current cardiology guidelines recommend the continuation of established BB for surgical patients, and this may also mitigate the cardiac risk in CAS patients. The short-term use of BB has been shown to have risk during and after noncardiac surgery and, intuitively, could lead to severe hypotension during CAS. The reason for the stroke reduction seen with well-established BB is not clearly understood.

This study begs the question: Should every patient being considered for CAS be on BB at least 1 month before the intervention, even those with few or no cardiac risk factors? If so, then it would be difficult to advocate for CAS in acutely symptomatic patients not already on a BB, thus further limiting the usefulness of this procedure.

Dr. Mark L. Friedell is chairman of the department of Surgery, University of Missouri Kansas City School of Medicine.

Body

This retrospective study by Malas et al. showed a 34% significant reduction of stroke and death in patients undergoing carotid artery stenting (CAS) who had been on beta-blockade (BB) for at least 1 month beforehand. Presumably, most of these patients were already on longstanding BB. Current cardiology guidelines recommend the continuation of established BB for surgical patients, and this may also mitigate the cardiac risk in CAS patients. The short-term use of BB has been shown to have risk during and after noncardiac surgery and, intuitively, could lead to severe hypotension during CAS. The reason for the stroke reduction seen with well-established BB is not clearly understood.

This study begs the question: Should every patient being considered for CAS be on BB at least 1 month before the intervention, even those with few or no cardiac risk factors? If so, then it would be difficult to advocate for CAS in acutely symptomatic patients not already on a BB, thus further limiting the usefulness of this procedure.

Dr. Mark L. Friedell is chairman of the department of Surgery, University of Missouri Kansas City School of Medicine.

Title
Beta-blockade for all CAS patients?
Beta-blockade for all CAS patients?

CHICAGO – Carotid artery stenting is safer if patients have been on beta-blockers for at least a month beforehand, according to a review of 5,248 stent cases during 2005-2014.

“Compared to nonusers, patients on long-term beta-blockers are at 34% less risk of stroke and death after carotid artery stenting [odds ratio, 0.66; 95% confidence interval, 0.46-0.95; P = .025], and this risk reduction is amplified to 65% in patients with postop hypertension [OR, 0.35; 95% CI, 0.17-0.73; P = .005].

“Beta-blockers significantly reduce the stroke and death risk ... and should be investigated prospectively for potential use during” carotid artery stenting (CAS), said senior investigator Dr. Mahmoud Malas, director of endovascular surgery and associate professor of surgery at Johns Hopkins Bayview Medical Center in Baltimore.

In the study, long-term beta-blocker use was not associated with postprocedure hypotension in the study. Among patients who developed it, however, beta-blockers were associated with a 48% reduction in the risk of stroke or death at 30 days (OR, 0.52; 95% CI, 0.28-0.98; P = .43).

Dr. Mahmoud B. Malas
Dr. Mahmoud B. Malas

“We think [the benefits are due to] up-regulation of adrenergic receptors. We think also there is better baroreceptor reflex sensitivity.” Long-term use of beta-blockers reduces heart rate variability, as well, and decreases the risk of hyperperfusion fourfold, Dr. Malas said at the meeting hosted by the Society for Vascular Surgery.

The researchers looked into the issue because they are trying to find a way to make CAS safer in the wake of the Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and others that have shown increased risk compared with carotid endarterectomy.

The subjects were all captured in SVS’s Vascular Quality Initiative database; 2,152 were not on beta-blockers before CAS, 259 were on them for less than 30 days, and 2,837 were on them for more than 30 days.

There were no statistical between-group differences in lesion sites, approach (femoral in almost all the cases), or contrast volume used in surgery, a marker of case complexity.

Long-term users had more diabetes, hypertension, coronary artery disease, and congestive heart failure, whereas short-term users were more symptomatic; those and other differences were controlled for on multivariate analysis.

Aspirin, clopidogrel, and statin use were similar between the groups. About two-thirds of the subjects were men, and the average patientage in the study was about 70 years old.

Overall, the 30-day stroke and death rate was 3.4% (minor stroke 1.5%, major 0.9%, and death 1.2%).

Predictors of postoperative stroke or death at 30 days included symptomatic status, age, diabetes, and perioperative hypotension and hypertension. Prior carotid endarterectomy and distal embolic protection were both protective.

The investigators reported that they had no disclosures.

aotto@frontlinemedcom.com

CHICAGO – Carotid artery stenting is safer if patients have been on beta-blockers for at least a month beforehand, according to a review of 5,248 stent cases during 2005-2014.

“Compared to nonusers, patients on long-term beta-blockers are at 34% less risk of stroke and death after carotid artery stenting [odds ratio, 0.66; 95% confidence interval, 0.46-0.95; P = .025], and this risk reduction is amplified to 65% in patients with postop hypertension [OR, 0.35; 95% CI, 0.17-0.73; P = .005].

“Beta-blockers significantly reduce the stroke and death risk ... and should be investigated prospectively for potential use during” carotid artery stenting (CAS), said senior investigator Dr. Mahmoud Malas, director of endovascular surgery and associate professor of surgery at Johns Hopkins Bayview Medical Center in Baltimore.

In the study, long-term beta-blocker use was not associated with postprocedure hypotension in the study. Among patients who developed it, however, beta-blockers were associated with a 48% reduction in the risk of stroke or death at 30 days (OR, 0.52; 95% CI, 0.28-0.98; P = .43).

Dr. Mahmoud B. Malas
Dr. Mahmoud B. Malas

“We think [the benefits are due to] up-regulation of adrenergic receptors. We think also there is better baroreceptor reflex sensitivity.” Long-term use of beta-blockers reduces heart rate variability, as well, and decreases the risk of hyperperfusion fourfold, Dr. Malas said at the meeting hosted by the Society for Vascular Surgery.

The researchers looked into the issue because they are trying to find a way to make CAS safer in the wake of the Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and others that have shown increased risk compared with carotid endarterectomy.

The subjects were all captured in SVS’s Vascular Quality Initiative database; 2,152 were not on beta-blockers before CAS, 259 were on them for less than 30 days, and 2,837 were on them for more than 30 days.

There were no statistical between-group differences in lesion sites, approach (femoral in almost all the cases), or contrast volume used in surgery, a marker of case complexity.

Long-term users had more diabetes, hypertension, coronary artery disease, and congestive heart failure, whereas short-term users were more symptomatic; those and other differences were controlled for on multivariate analysis.

Aspirin, clopidogrel, and statin use were similar between the groups. About two-thirds of the subjects were men, and the average patientage in the study was about 70 years old.

Overall, the 30-day stroke and death rate was 3.4% (minor stroke 1.5%, major 0.9%, and death 1.2%).

Predictors of postoperative stroke or death at 30 days included symptomatic status, age, diabetes, and perioperative hypotension and hypertension. Prior carotid endarterectomy and distal embolic protection were both protective.

The investigators reported that they had no disclosures.

aotto@frontlinemedcom.com

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SVS: AAA surveillance comes at an emotional cost

To survey and protect
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SVS: AAA surveillance comes at an emotional cost

CHICAGO – For some patients, surveillance of low-risk abdominal aortic aneurysms is so stressful that early repair might be a better option.

Until now, though, it’s been hard to know who those patients are. There hasn’t been a way to quantify the impact of abdominal aortic aneurysm (AAA) surveillance on quality of life.

Dr. Bjoern Suckow, a vascular surgeon at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his colleagues at the University of Massachusetts and elsewhere are working to fix that problem. “I do believe that there is a certain subset of patients who we know are” at low risk for rupture “who are so consumed by fear and anxiety during surveillance that the impact on quality of life might make us want to repair them slightly sooner. I hope this will help us weed out who that subgroup might be,” Dr. Suckow said at a meeting hosted by the Society for Vascular Surgery.

Dr. Bjoern Suckow
Alexander Otto/Frontline Medical News
Dr. Bjoern Suckow

With the help of patient and physician focus groups and interviews, the team developed AAA-specific quality of life (QOL) surveys and administered them to 351 patients under surveillance for aneurysms below about 5.5 cm, and 657 who had undergone mostly endovascular AAA repair at six United States institutions.

The surveys included nine questions to assess concerns about rupture, surgery, costs, and death. The responses were averaged to give an emotional impact score (EIS) ranging from 0 to 100, with higher scores indicating worse emotional QOL. The survey also included 10 questions to assess changes in heavy lifting, strenuous activity, travel habits, and other behaviors. Those results were averaged to give a behavioral change score (BCS) that also ranged from 0 to 100, with higher scores indicating greater negative impact.

A significant portion of the surveillance patients thought it was “very likely” their aneurysm would rupture within a year; their EIS was 45 and BCS 30; patients who thought rupture was unlikely had an EIS of 12 and BCS of 13 (P less than .001). Overall, patients under surveillance had worse emotional impact sores than did those who had undergone repair.

“We routinely counsel patients with small aneurysms that the rupture risk is low” – less than 5% – “and outweighed by the higher risk of repair. We were surprised that even though we feel we do a great job counseling and educating our patients, some of them do not understand or retain what we mean.” Eventually, surveys could be used in the clinic to identify patients with “less understanding, so [we can] spend more time with them,” Dr. Suckow said.

In general, “the range of impact on QOL by AAA surveillance is broad. For most patients, the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe. Overall, surveillance has a persistent negative impact on QOL, particularly emotional QOL. This impact appears to diminish following either open or endovascular repair,” he said.

The respondents were about 76 years old, on average. Most were white men, and about half were high school graduates.

Dr. Suckow has no relevant financial conflicts. The work was funded by the National Institutes of Health and career development awards from the Society for Vascular Surgery and the American College of Surgeons.

aotto@frontlinemedcom.com

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The diagnosis of a small aortic aneurysm, whether by screening or as an incidental finding, causes anxiety in our patients. The risk of rupture of small AAA has been demonstrated to be low – less than 1% per year below 5.0 cm in males (Health Technol. Assess. 2013;41:1-108) . Therefore, appropriate counseling and surveillance intervals should optimize the management of AAA patients. This study highlights the adverse effects of a diagnosis of small AAA on a proportion of our patients, despite appropriate explanation. Frequently patients know someone who died of AAA rupture and many do not understand the risk when it is explained in routine consultations. Perhaps we should all ensure that a member of our team contacts patients with small AAA post review and perform a short Quality of Life questionnaire by phone so that we can identify those who are suffering a negative impact on their QOL. We could then intensify our counseling and reassurance for this cohort of patients. This study should make us all reflect on whether our surveillance programs need to be modified, to ensure that our patients are not adversely affected by a diagnosis of small AAA.

Dr. Robert Fitridge is professor of vascular surgery, University of Adelaide, Australia, and associate medical editor of Vascular Specialist.

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The diagnosis of a small aortic aneurysm, whether by screening or as an incidental finding, causes anxiety in our patients. The risk of rupture of small AAA has been demonstrated to be low – less than 1% per year below 5.0 cm in males (Health Technol. Assess. 2013;41:1-108) . Therefore, appropriate counseling and surveillance intervals should optimize the management of AAA patients. This study highlights the adverse effects of a diagnosis of small AAA on a proportion of our patients, despite appropriate explanation. Frequently patients know someone who died of AAA rupture and many do not understand the risk when it is explained in routine consultations. Perhaps we should all ensure that a member of our team contacts patients with small AAA post review and perform a short Quality of Life questionnaire by phone so that we can identify those who are suffering a negative impact on their QOL. We could then intensify our counseling and reassurance for this cohort of patients. This study should make us all reflect on whether our surveillance programs need to be modified, to ensure that our patients are not adversely affected by a diagnosis of small AAA.

Dr. Robert Fitridge is professor of vascular surgery, University of Adelaide, Australia, and associate medical editor of Vascular Specialist.

Body

The diagnosis of a small aortic aneurysm, whether by screening or as an incidental finding, causes anxiety in our patients. The risk of rupture of small AAA has been demonstrated to be low – less than 1% per year below 5.0 cm in males (Health Technol. Assess. 2013;41:1-108) . Therefore, appropriate counseling and surveillance intervals should optimize the management of AAA patients. This study highlights the adverse effects of a diagnosis of small AAA on a proportion of our patients, despite appropriate explanation. Frequently patients know someone who died of AAA rupture and many do not understand the risk when it is explained in routine consultations. Perhaps we should all ensure that a member of our team contacts patients with small AAA post review and perform a short Quality of Life questionnaire by phone so that we can identify those who are suffering a negative impact on their QOL. We could then intensify our counseling and reassurance for this cohort of patients. This study should make us all reflect on whether our surveillance programs need to be modified, to ensure that our patients are not adversely affected by a diagnosis of small AAA.

Dr. Robert Fitridge is professor of vascular surgery, University of Adelaide, Australia, and associate medical editor of Vascular Specialist.

Title
To survey and protect
To survey and protect

CHICAGO – For some patients, surveillance of low-risk abdominal aortic aneurysms is so stressful that early repair might be a better option.

Until now, though, it’s been hard to know who those patients are. There hasn’t been a way to quantify the impact of abdominal aortic aneurysm (AAA) surveillance on quality of life.

Dr. Bjoern Suckow, a vascular surgeon at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his colleagues at the University of Massachusetts and elsewhere are working to fix that problem. “I do believe that there is a certain subset of patients who we know are” at low risk for rupture “who are so consumed by fear and anxiety during surveillance that the impact on quality of life might make us want to repair them slightly sooner. I hope this will help us weed out who that subgroup might be,” Dr. Suckow said at a meeting hosted by the Society for Vascular Surgery.

Dr. Bjoern Suckow
Alexander Otto/Frontline Medical News
Dr. Bjoern Suckow

With the help of patient and physician focus groups and interviews, the team developed AAA-specific quality of life (QOL) surveys and administered them to 351 patients under surveillance for aneurysms below about 5.5 cm, and 657 who had undergone mostly endovascular AAA repair at six United States institutions.

The surveys included nine questions to assess concerns about rupture, surgery, costs, and death. The responses were averaged to give an emotional impact score (EIS) ranging from 0 to 100, with higher scores indicating worse emotional QOL. The survey also included 10 questions to assess changes in heavy lifting, strenuous activity, travel habits, and other behaviors. Those results were averaged to give a behavioral change score (BCS) that also ranged from 0 to 100, with higher scores indicating greater negative impact.

A significant portion of the surveillance patients thought it was “very likely” their aneurysm would rupture within a year; their EIS was 45 and BCS 30; patients who thought rupture was unlikely had an EIS of 12 and BCS of 13 (P less than .001). Overall, patients under surveillance had worse emotional impact sores than did those who had undergone repair.

“We routinely counsel patients with small aneurysms that the rupture risk is low” – less than 5% – “and outweighed by the higher risk of repair. We were surprised that even though we feel we do a great job counseling and educating our patients, some of them do not understand or retain what we mean.” Eventually, surveys could be used in the clinic to identify patients with “less understanding, so [we can] spend more time with them,” Dr. Suckow said.

In general, “the range of impact on QOL by AAA surveillance is broad. For most patients, the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe. Overall, surveillance has a persistent negative impact on QOL, particularly emotional QOL. This impact appears to diminish following either open or endovascular repair,” he said.

The respondents were about 76 years old, on average. Most were white men, and about half were high school graduates.

Dr. Suckow has no relevant financial conflicts. The work was funded by the National Institutes of Health and career development awards from the Society for Vascular Surgery and the American College of Surgeons.

aotto@frontlinemedcom.com

CHICAGO – For some patients, surveillance of low-risk abdominal aortic aneurysms is so stressful that early repair might be a better option.

Until now, though, it’s been hard to know who those patients are. There hasn’t been a way to quantify the impact of abdominal aortic aneurysm (AAA) surveillance on quality of life.

Dr. Bjoern Suckow, a vascular surgeon at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his colleagues at the University of Massachusetts and elsewhere are working to fix that problem. “I do believe that there is a certain subset of patients who we know are” at low risk for rupture “who are so consumed by fear and anxiety during surveillance that the impact on quality of life might make us want to repair them slightly sooner. I hope this will help us weed out who that subgroup might be,” Dr. Suckow said at a meeting hosted by the Society for Vascular Surgery.

Dr. Bjoern Suckow
Alexander Otto/Frontline Medical News
Dr. Bjoern Suckow

With the help of patient and physician focus groups and interviews, the team developed AAA-specific quality of life (QOL) surveys and administered them to 351 patients under surveillance for aneurysms below about 5.5 cm, and 657 who had undergone mostly endovascular AAA repair at six United States institutions.

The surveys included nine questions to assess concerns about rupture, surgery, costs, and death. The responses were averaged to give an emotional impact score (EIS) ranging from 0 to 100, with higher scores indicating worse emotional QOL. The survey also included 10 questions to assess changes in heavy lifting, strenuous activity, travel habits, and other behaviors. Those results were averaged to give a behavioral change score (BCS) that also ranged from 0 to 100, with higher scores indicating greater negative impact.

A significant portion of the surveillance patients thought it was “very likely” their aneurysm would rupture within a year; their EIS was 45 and BCS 30; patients who thought rupture was unlikely had an EIS of 12 and BCS of 13 (P less than .001). Overall, patients under surveillance had worse emotional impact sores than did those who had undergone repair.

“We routinely counsel patients with small aneurysms that the rupture risk is low” – less than 5% – “and outweighed by the higher risk of repair. We were surprised that even though we feel we do a great job counseling and educating our patients, some of them do not understand or retain what we mean.” Eventually, surveys could be used in the clinic to identify patients with “less understanding, so [we can] spend more time with them,” Dr. Suckow said.

In general, “the range of impact on QOL by AAA surveillance is broad. For most patients, the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe. Overall, surveillance has a persistent negative impact on QOL, particularly emotional QOL. This impact appears to diminish following either open or endovascular repair,” he said.

The respondents were about 76 years old, on average. Most were white men, and about half were high school graduates.

Dr. Suckow has no relevant financial conflicts. The work was funded by the National Institutes of Health and career development awards from the Society for Vascular Surgery and the American College of Surgeons.

aotto@frontlinemedcom.com

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Key clinical point: Check with your AAA surveillance patients to make sure they know their rupture risk is low.

Major finding: Surveillance patients who thought it was “very likely” their aneurysm would rupture within a year had an emotional impact score of 45. Patients who thought rupture was unlikely had a sore of 12 (P less than .001).

Data source: Surveys of 1,008 AAA patients at six U.S. medical centers.

Disclosures: There was no outside funding for the work, and the lead investigator has no relevant disclosures.

SVS: AAA reimbursement needs to take anatomic complexity into account

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SVS: AAA reimbursement needs to take anatomic complexity into account

CHICAGO – Anatomic complexity should be factored into reimbursements for abdominal aortic aneurysm repairs, University of Rochester (N.Y.) investigators concluded after they compared costs to complexity in 33 open and 107 endovascular repairs during 2007-2010.

They found that complex aneurysms – especially ones with Anatomic Severity Grade (ASG) scores above 15 – need more adjunctive procedures and cost more to repair, although at the moment, payers don’t usually take complexity directly into account.

It’s the first study to show a direct relationship between anatomic complexity and hospital cost. “Preoperative assessment with ASG scores can delineate patients at greater risk for increased resource utilization. A critical examination of the relationship between anatomic complexity and finances is required within the context of aggressive endovascular treatment strategies and shifts towards value-based reimbursement. Anatomy is related to cost. [Complexity] should be considered as a factor when calculating limited bundle reimbursements,” said investigator Dr. Khurram Rasheed, a vascular surgery resident in Rochester.

Developed by the Society for Vascular Surgery, the ASG is an assessment of the aortic neck, aneurysm body, iliac arteries, and pelvic perfusion for 16 parameters, including angles, calcifications, and tortuosity. Each parameter is scored from 0-3. Higher scores mean greater complexity, with 48 being the highest possible score (J. Vasc. Surg. 2002;35:1061-6).

An ASG of 15 proved to be a handy marker for when complexity starts to affect the bottom line. A score of 15 or higher correlated with increased costs and increased propensity for requiring intraoperative adjuncts such as renal artery stenting (odds ratio, 5.75; 95% confidence interval, 1.82-18.19). It also correlated with chronic kidney disease and end-stage renal disease, meaning that sicker patients were likely to have worse anatomy and cost more to repair, Dr. Rasheed reported at the meeting hosted by the Society for Special Surgery.

All the cases in the study were elective, and the majority of the patients were elderly white men.

The mean total-cost of endovascular aortic repair (EVAR) was $24,701, mean length of stay (LOS) of 3.0 days, and mean ASG score of 15.9. Cases below an ASG score of 15 cost a mean of $22,020 and had a mean LOS of 2.93 days. Above 15, the mean cost was $26,574 and mean LOS was 3.07 days.

About a quarter of EVAR patients required intraoperative adjuncts, most above an ASG score of 15; their cases cost a mean of $31,509, with a mean ASG score of 18.48 and LOS of 3.85 days.

For open repair, the mean total cost was $38,310, LOS of 13.5 days, and ASG score of 18.1. When five patients with unusually long hospital stays were excluded, open repair cost less than EVAR, which is consistent with previous reports. Just two open-repair patients (6%) needed adjunct procedures.

Open-repair cases with an ASG score below 15 cost a mean of $24,508 and had a mean LOS of 10 days. Cases with a higher score cost a mean of $41,071 and stayed in the hospital an average of 14.2 days. Despite trends, the ASG score differences in cost and LOS for open-repair cases did not reach statistical significance; type II error was probably to blame, Dr. Rasheed said.

The investigators have no disclosures.

aotto@frontlinemedcom.com

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CHICAGO – Anatomic complexity should be factored into reimbursements for abdominal aortic aneurysm repairs, University of Rochester (N.Y.) investigators concluded after they compared costs to complexity in 33 open and 107 endovascular repairs during 2007-2010.

They found that complex aneurysms – especially ones with Anatomic Severity Grade (ASG) scores above 15 – need more adjunctive procedures and cost more to repair, although at the moment, payers don’t usually take complexity directly into account.

It’s the first study to show a direct relationship between anatomic complexity and hospital cost. “Preoperative assessment with ASG scores can delineate patients at greater risk for increased resource utilization. A critical examination of the relationship between anatomic complexity and finances is required within the context of aggressive endovascular treatment strategies and shifts towards value-based reimbursement. Anatomy is related to cost. [Complexity] should be considered as a factor when calculating limited bundle reimbursements,” said investigator Dr. Khurram Rasheed, a vascular surgery resident in Rochester.

Developed by the Society for Vascular Surgery, the ASG is an assessment of the aortic neck, aneurysm body, iliac arteries, and pelvic perfusion for 16 parameters, including angles, calcifications, and tortuosity. Each parameter is scored from 0-3. Higher scores mean greater complexity, with 48 being the highest possible score (J. Vasc. Surg. 2002;35:1061-6).

An ASG of 15 proved to be a handy marker for when complexity starts to affect the bottom line. A score of 15 or higher correlated with increased costs and increased propensity for requiring intraoperative adjuncts such as renal artery stenting (odds ratio, 5.75; 95% confidence interval, 1.82-18.19). It also correlated with chronic kidney disease and end-stage renal disease, meaning that sicker patients were likely to have worse anatomy and cost more to repair, Dr. Rasheed reported at the meeting hosted by the Society for Special Surgery.

All the cases in the study were elective, and the majority of the patients were elderly white men.

The mean total-cost of endovascular aortic repair (EVAR) was $24,701, mean length of stay (LOS) of 3.0 days, and mean ASG score of 15.9. Cases below an ASG score of 15 cost a mean of $22,020 and had a mean LOS of 2.93 days. Above 15, the mean cost was $26,574 and mean LOS was 3.07 days.

About a quarter of EVAR patients required intraoperative adjuncts, most above an ASG score of 15; their cases cost a mean of $31,509, with a mean ASG score of 18.48 and LOS of 3.85 days.

For open repair, the mean total cost was $38,310, LOS of 13.5 days, and ASG score of 18.1. When five patients with unusually long hospital stays were excluded, open repair cost less than EVAR, which is consistent with previous reports. Just two open-repair patients (6%) needed adjunct procedures.

Open-repair cases with an ASG score below 15 cost a mean of $24,508 and had a mean LOS of 10 days. Cases with a higher score cost a mean of $41,071 and stayed in the hospital an average of 14.2 days. Despite trends, the ASG score differences in cost and LOS for open-repair cases did not reach statistical significance; type II error was probably to blame, Dr. Rasheed said.

The investigators have no disclosures.

aotto@frontlinemedcom.com

CHICAGO – Anatomic complexity should be factored into reimbursements for abdominal aortic aneurysm repairs, University of Rochester (N.Y.) investigators concluded after they compared costs to complexity in 33 open and 107 endovascular repairs during 2007-2010.

They found that complex aneurysms – especially ones with Anatomic Severity Grade (ASG) scores above 15 – need more adjunctive procedures and cost more to repair, although at the moment, payers don’t usually take complexity directly into account.

It’s the first study to show a direct relationship between anatomic complexity and hospital cost. “Preoperative assessment with ASG scores can delineate patients at greater risk for increased resource utilization. A critical examination of the relationship between anatomic complexity and finances is required within the context of aggressive endovascular treatment strategies and shifts towards value-based reimbursement. Anatomy is related to cost. [Complexity] should be considered as a factor when calculating limited bundle reimbursements,” said investigator Dr. Khurram Rasheed, a vascular surgery resident in Rochester.

Developed by the Society for Vascular Surgery, the ASG is an assessment of the aortic neck, aneurysm body, iliac arteries, and pelvic perfusion for 16 parameters, including angles, calcifications, and tortuosity. Each parameter is scored from 0-3. Higher scores mean greater complexity, with 48 being the highest possible score (J. Vasc. Surg. 2002;35:1061-6).

An ASG of 15 proved to be a handy marker for when complexity starts to affect the bottom line. A score of 15 or higher correlated with increased costs and increased propensity for requiring intraoperative adjuncts such as renal artery stenting (odds ratio, 5.75; 95% confidence interval, 1.82-18.19). It also correlated with chronic kidney disease and end-stage renal disease, meaning that sicker patients were likely to have worse anatomy and cost more to repair, Dr. Rasheed reported at the meeting hosted by the Society for Special Surgery.

All the cases in the study were elective, and the majority of the patients were elderly white men.

The mean total-cost of endovascular aortic repair (EVAR) was $24,701, mean length of stay (LOS) of 3.0 days, and mean ASG score of 15.9. Cases below an ASG score of 15 cost a mean of $22,020 and had a mean LOS of 2.93 days. Above 15, the mean cost was $26,574 and mean LOS was 3.07 days.

About a quarter of EVAR patients required intraoperative adjuncts, most above an ASG score of 15; their cases cost a mean of $31,509, with a mean ASG score of 18.48 and LOS of 3.85 days.

For open repair, the mean total cost was $38,310, LOS of 13.5 days, and ASG score of 18.1. When five patients with unusually long hospital stays were excluded, open repair cost less than EVAR, which is consistent with previous reports. Just two open-repair patients (6%) needed adjunct procedures.

Open-repair cases with an ASG score below 15 cost a mean of $24,508 and had a mean LOS of 10 days. Cases with a higher score cost a mean of $41,071 and stayed in the hospital an average of 14.2 days. Despite trends, the ASG score differences in cost and LOS for open-repair cases did not reach statistical significance; type II error was probably to blame, Dr. Rasheed said.

The investigators have no disclosures.

aotto@frontlinemedcom.com

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AT THE 2015 VASCULAR ANNUAL MEETING

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Key clinical point: Get the hang of calculating Anatomic Severity Grade scores on your triple A cases; it might one day increase your reimbursements.

Major finding: EVAR cases below an ASG score of 15 cost a mean of $22,020 and had a length of stay of 2.93 days. Above 15, the cost was $26,574 and mean LOS was 3.07 days.

Data source: Review of 33 open and 107 endovascular repairs at the University of Rochester in New York.

Disclosures: The investigators have no disclosures.

SVS: Cryoallografts, NAIS best to reconstruct infected aortic grafts

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SVS: Cryoallografts, NAIS best to reconstruct infected aortic grafts

CHICAGO – Neoaortoiliac system reconstruction or cryopreserved allografts should be used first-line to replace infected aortic endografts, followed by antibiotic-soaked prosthetic grafts, according to a review of 206 cases from vascular surgery centers across the United States.

In the study, 75 patients had cryoallograft reconstruction, mostly cryoartery, or neoaortoiliac system (NAIS) reconstruction with femoral vein; 53 (71%) were alive at 5 years. Forty-nine of the 92 (53%) patients reconstructed with antibiotic-soaked prosthetic grafts also made it to 5 years, while two of 19 (11%) reconstructed with untreated prosthetic grafts survived that long.

The cases were reconstructed inline. The index procedure had been endovascular aortic repair (EVAR) in 165, and thoracic EVAR (TEVAR) in 21, with a better 5-year survival for the EVAR group. Another 11 patients had extra-anatomic reconstruction after initial EVAR, and their 5-year survival was comparable to inline reconstruction at about 50% overall. Nine other patients were managed medically; the majority died soon after being diagnosed with an infected graft.

Dr. Audra Duncan
Dr. Audra Duncan

“Clinicians should have a high index of suspicion to diagnose symptomatic postop EVAR and TEVAR patients with graft infection, especially in those patients with chronic infections or contaminated index procedures. NAIS and cryopreserved allografts require longer procedure times” – about 500 minutes versus about 350 minutes for prosthetic grafts – “but offer improved survival, while prosthetics soaked in antibiotic do better than prosthetic grafts alone,” said lead investigator Dr. Audra Duncan, professor of surgery at the Mayo Clinic in Rochester, Minn.

Patients were treated at the Mayo Clinic, the Cleveland Clinic in Ohio, Johns Hopkins University in Baltimore, the University of California, Los Angeles, and 15 other vascular centers around the country during 2004-2014. They were 68 years old on average, and 78% were men. Comorbidities included hypertension in 84%, smoking in 58%, and renal insufficiency in 30%.

On multivariate analysis, chronic infection, polymicrobial infection, and prosthetic reconstruction, among other things, predicted mortality after reconstruction.

Graft infections were primarily polymicrobial and fungal, and were diagnosed a mean of 716 days after the initial implant, generally by CT. Symptoms included pain in 66%, mostly in the back and abdomen, and fever and chills, also in 66%. Streptococcus, Escherichia coli, and both methicillin-sensitive and -resistant Staphylococcus aureus were among the most commonly isolated organisms. No particular type of graft seemed more likely to get infected.

The sources of infection are unknown, but index procedures were complicated by urinary tract, groin, and other infections in about one-third of patients. About one-third also had interval procedures, including endoleak intervention. About 14% of patients were thought to have had a contaminated index procedure.

Patients stayed in the hospital a mean of 24 days after reconstruction. Early complications included persistent sepsis in 27 patients, myocardial infarction in 9, recurrent infection in 9, and pneumonia in 8. Mortality at 30 days was 11%.

Nineteen replacement grafts – mostly unsoaked Dacron – were explanted after a mean of 540 days. Persistent sepsis after reconstruction was associated with unsoaked Dacron and polytetrafluoroethylene (PTFE) grafts.

To prevent graft infections, Mayo patients “take an antibiotic for any invasive procedure,” including dental work. “I am not sure we have data to support that, but it is something we do,” Dr. Duncan said.

Dr. Duncan has no relevant disclosures.

aotto@frontlinemedcom.com

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CHICAGO – Neoaortoiliac system reconstruction or cryopreserved allografts should be used first-line to replace infected aortic endografts, followed by antibiotic-soaked prosthetic grafts, according to a review of 206 cases from vascular surgery centers across the United States.

In the study, 75 patients had cryoallograft reconstruction, mostly cryoartery, or neoaortoiliac system (NAIS) reconstruction with femoral vein; 53 (71%) were alive at 5 years. Forty-nine of the 92 (53%) patients reconstructed with antibiotic-soaked prosthetic grafts also made it to 5 years, while two of 19 (11%) reconstructed with untreated prosthetic grafts survived that long.

The cases were reconstructed inline. The index procedure had been endovascular aortic repair (EVAR) in 165, and thoracic EVAR (TEVAR) in 21, with a better 5-year survival for the EVAR group. Another 11 patients had extra-anatomic reconstruction after initial EVAR, and their 5-year survival was comparable to inline reconstruction at about 50% overall. Nine other patients were managed medically; the majority died soon after being diagnosed with an infected graft.

Dr. Audra Duncan
Dr. Audra Duncan

“Clinicians should have a high index of suspicion to diagnose symptomatic postop EVAR and TEVAR patients with graft infection, especially in those patients with chronic infections or contaminated index procedures. NAIS and cryopreserved allografts require longer procedure times” – about 500 minutes versus about 350 minutes for prosthetic grafts – “but offer improved survival, while prosthetics soaked in antibiotic do better than prosthetic grafts alone,” said lead investigator Dr. Audra Duncan, professor of surgery at the Mayo Clinic in Rochester, Minn.

Patients were treated at the Mayo Clinic, the Cleveland Clinic in Ohio, Johns Hopkins University in Baltimore, the University of California, Los Angeles, and 15 other vascular centers around the country during 2004-2014. They were 68 years old on average, and 78% were men. Comorbidities included hypertension in 84%, smoking in 58%, and renal insufficiency in 30%.

On multivariate analysis, chronic infection, polymicrobial infection, and prosthetic reconstruction, among other things, predicted mortality after reconstruction.

Graft infections were primarily polymicrobial and fungal, and were diagnosed a mean of 716 days after the initial implant, generally by CT. Symptoms included pain in 66%, mostly in the back and abdomen, and fever and chills, also in 66%. Streptococcus, Escherichia coli, and both methicillin-sensitive and -resistant Staphylococcus aureus were among the most commonly isolated organisms. No particular type of graft seemed more likely to get infected.

The sources of infection are unknown, but index procedures were complicated by urinary tract, groin, and other infections in about one-third of patients. About one-third also had interval procedures, including endoleak intervention. About 14% of patients were thought to have had a contaminated index procedure.

Patients stayed in the hospital a mean of 24 days after reconstruction. Early complications included persistent sepsis in 27 patients, myocardial infarction in 9, recurrent infection in 9, and pneumonia in 8. Mortality at 30 days was 11%.

Nineteen replacement grafts – mostly unsoaked Dacron – were explanted after a mean of 540 days. Persistent sepsis after reconstruction was associated with unsoaked Dacron and polytetrafluoroethylene (PTFE) grafts.

To prevent graft infections, Mayo patients “take an antibiotic for any invasive procedure,” including dental work. “I am not sure we have data to support that, but it is something we do,” Dr. Duncan said.

Dr. Duncan has no relevant disclosures.

aotto@frontlinemedcom.com

CHICAGO – Neoaortoiliac system reconstruction or cryopreserved allografts should be used first-line to replace infected aortic endografts, followed by antibiotic-soaked prosthetic grafts, according to a review of 206 cases from vascular surgery centers across the United States.

In the study, 75 patients had cryoallograft reconstruction, mostly cryoartery, or neoaortoiliac system (NAIS) reconstruction with femoral vein; 53 (71%) were alive at 5 years. Forty-nine of the 92 (53%) patients reconstructed with antibiotic-soaked prosthetic grafts also made it to 5 years, while two of 19 (11%) reconstructed with untreated prosthetic grafts survived that long.

The cases were reconstructed inline. The index procedure had been endovascular aortic repair (EVAR) in 165, and thoracic EVAR (TEVAR) in 21, with a better 5-year survival for the EVAR group. Another 11 patients had extra-anatomic reconstruction after initial EVAR, and their 5-year survival was comparable to inline reconstruction at about 50% overall. Nine other patients were managed medically; the majority died soon after being diagnosed with an infected graft.

Dr. Audra Duncan
Dr. Audra Duncan

“Clinicians should have a high index of suspicion to diagnose symptomatic postop EVAR and TEVAR patients with graft infection, especially in those patients with chronic infections or contaminated index procedures. NAIS and cryopreserved allografts require longer procedure times” – about 500 minutes versus about 350 minutes for prosthetic grafts – “but offer improved survival, while prosthetics soaked in antibiotic do better than prosthetic grafts alone,” said lead investigator Dr. Audra Duncan, professor of surgery at the Mayo Clinic in Rochester, Minn.

Patients were treated at the Mayo Clinic, the Cleveland Clinic in Ohio, Johns Hopkins University in Baltimore, the University of California, Los Angeles, and 15 other vascular centers around the country during 2004-2014. They were 68 years old on average, and 78% were men. Comorbidities included hypertension in 84%, smoking in 58%, and renal insufficiency in 30%.

On multivariate analysis, chronic infection, polymicrobial infection, and prosthetic reconstruction, among other things, predicted mortality after reconstruction.

Graft infections were primarily polymicrobial and fungal, and were diagnosed a mean of 716 days after the initial implant, generally by CT. Symptoms included pain in 66%, mostly in the back and abdomen, and fever and chills, also in 66%. Streptococcus, Escherichia coli, and both methicillin-sensitive and -resistant Staphylococcus aureus were among the most commonly isolated organisms. No particular type of graft seemed more likely to get infected.

The sources of infection are unknown, but index procedures were complicated by urinary tract, groin, and other infections in about one-third of patients. About one-third also had interval procedures, including endoleak intervention. About 14% of patients were thought to have had a contaminated index procedure.

Patients stayed in the hospital a mean of 24 days after reconstruction. Early complications included persistent sepsis in 27 patients, myocardial infarction in 9, recurrent infection in 9, and pneumonia in 8. Mortality at 30 days was 11%.

Nineteen replacement grafts – mostly unsoaked Dacron – were explanted after a mean of 540 days. Persistent sepsis after reconstruction was associated with unsoaked Dacron and polytetrafluoroethylene (PTFE) grafts.

To prevent graft infections, Mayo patients “take an antibiotic for any invasive procedure,” including dental work. “I am not sure we have data to support that, but it is something we do,” Dr. Duncan said.

Dr. Duncan has no relevant disclosures.

aotto@frontlinemedcom.com

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Key clinical point: Neoaortoiliac system reconstruction or cryopreserved allografts perform best in replacing infected aortic endografts, but if you have to use prosthetics, use ones soaked in antibiotics.

Major finding: Seventy-five patients had cryoallograft reconstruction, mostly cryoartery, or neoaortoiliac system (NAIS) reconstruction with femoral vein; 53 (71%) were alive at 5 years. Two of 19 (11%) patients reconstructed with untreated prosthetic grafts survived that long.

Data source: Review of 206 patients at 19 vascular surgery centers in the United States.

Disclosures: The lead investigator has no relevant disclosures.

SVS: Beta-blockers cut stroke, death risk in carotid stenting

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SVS: Beta-blockers cut stroke, death risk in carotid stenting

CHICAGO – Carotid artery stenting is safer if patients have been on beta-blockers for at least a month beforehand, according to a review of 5,248 stent cases during 2005-2014.

“Compared to non-users, patients on long-term beta-blockers are at 34% less risk of stroke and death after carotid artery stenting [odds ratio, 0.66; 95% confidence interval, 0.46-0.95; P = .025], and this risk reduction is amplified to 65% in patients with postop hypertension [OR, 0.35; 95% CI, 0.17-0.73; P = .005]. Beta-blockers significantly reduce the stroke and death risk ... and should be investigated prospectively for potential use during” carotid artery stenting (CAS), said senior investigator Dr. Mahmoud Malas, director of endovascular surgery and associate professor of surgery at Johns Hopkins Bayview Medical Center in Baltimore.

In the study, long-term beta-blocker use was not associated with post-procedure hypotension in the study. Among patients who developed it, however, beta-blockers were associated with a 48% reduction in the risk of stroke or death at 30 days (OR, 0.52; 95% CI, 0.28-0.98; P = .43).

Dr. Mahmoud B. Malas
Dr. Mahmoud B. Malas

“We think” the benefits are due to “up-regulation of adrenergic receptors. We think also there is better baroreceptor reflex sensitivity.” Long-term use of beta-blockers reduces heart rate variability, as well, and decreases the risk of hyperperfusion fourfold, Dr. Malas said at the meeting hosted by the Society for Vascular Surgery.

The researchers looked into the issue because they are trying to find a way to make CAS safer in the wake of the Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and others that have shown increased risk compared with carotid endarterectomy.

The subjects were all captured in SVS’s Vascular Quality Initiative database; 2,152 were not on beta-blockers before CAS, 259 were on them for less than 30 days, and 2,837 were on them for more than 30 days. There were no statistical between-group differences in lesion sites, approach (femoral in almost all the cases), or contrast volume used in surgery, a marker of case complexity.

Long-term users had more diabetes, hypertension, coronary artery disease, and congestive heart failure, whereas short term users were more symptomatic; those and other differences were controlled for on multivariate analysis. Aspirin, clopidogrel, and statin use were similar between the groups. About two-thirds of the subjects were men, and the average age in the study was about 70 years old.

Overall, the 30-day stroke and death rate was 3.4% (minor stroke 1.5%, major 0.9%, and death 1.2%).

Predictors of postoperative stroke or death at 30 days included symptomatic status, age, diabetes, and perioperative hypotension and hypertension. Prior carotid endarterectomy and distal embolic protection were both protective.

The investigators have no disclosures.

aotto@frontlinemedcom.com

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CHICAGO – Carotid artery stenting is safer if patients have been on beta-blockers for at least a month beforehand, according to a review of 5,248 stent cases during 2005-2014.

“Compared to non-users, patients on long-term beta-blockers are at 34% less risk of stroke and death after carotid artery stenting [odds ratio, 0.66; 95% confidence interval, 0.46-0.95; P = .025], and this risk reduction is amplified to 65% in patients with postop hypertension [OR, 0.35; 95% CI, 0.17-0.73; P = .005]. Beta-blockers significantly reduce the stroke and death risk ... and should be investigated prospectively for potential use during” carotid artery stenting (CAS), said senior investigator Dr. Mahmoud Malas, director of endovascular surgery and associate professor of surgery at Johns Hopkins Bayview Medical Center in Baltimore.

In the study, long-term beta-blocker use was not associated with post-procedure hypotension in the study. Among patients who developed it, however, beta-blockers were associated with a 48% reduction in the risk of stroke or death at 30 days (OR, 0.52; 95% CI, 0.28-0.98; P = .43).

Dr. Mahmoud B. Malas
Dr. Mahmoud B. Malas

“We think” the benefits are due to “up-regulation of adrenergic receptors. We think also there is better baroreceptor reflex sensitivity.” Long-term use of beta-blockers reduces heart rate variability, as well, and decreases the risk of hyperperfusion fourfold, Dr. Malas said at the meeting hosted by the Society for Vascular Surgery.

The researchers looked into the issue because they are trying to find a way to make CAS safer in the wake of the Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and others that have shown increased risk compared with carotid endarterectomy.

The subjects were all captured in SVS’s Vascular Quality Initiative database; 2,152 were not on beta-blockers before CAS, 259 were on them for less than 30 days, and 2,837 were on them for more than 30 days. There were no statistical between-group differences in lesion sites, approach (femoral in almost all the cases), or contrast volume used in surgery, a marker of case complexity.

Long-term users had more diabetes, hypertension, coronary artery disease, and congestive heart failure, whereas short term users were more symptomatic; those and other differences were controlled for on multivariate analysis. Aspirin, clopidogrel, and statin use were similar between the groups. About two-thirds of the subjects were men, and the average age in the study was about 70 years old.

Overall, the 30-day stroke and death rate was 3.4% (minor stroke 1.5%, major 0.9%, and death 1.2%).

Predictors of postoperative stroke or death at 30 days included symptomatic status, age, diabetes, and perioperative hypotension and hypertension. Prior carotid endarterectomy and distal embolic protection were both protective.

The investigators have no disclosures.

aotto@frontlinemedcom.com

CHICAGO – Carotid artery stenting is safer if patients have been on beta-blockers for at least a month beforehand, according to a review of 5,248 stent cases during 2005-2014.

“Compared to non-users, patients on long-term beta-blockers are at 34% less risk of stroke and death after carotid artery stenting [odds ratio, 0.66; 95% confidence interval, 0.46-0.95; P = .025], and this risk reduction is amplified to 65% in patients with postop hypertension [OR, 0.35; 95% CI, 0.17-0.73; P = .005]. Beta-blockers significantly reduce the stroke and death risk ... and should be investigated prospectively for potential use during” carotid artery stenting (CAS), said senior investigator Dr. Mahmoud Malas, director of endovascular surgery and associate professor of surgery at Johns Hopkins Bayview Medical Center in Baltimore.

In the study, long-term beta-blocker use was not associated with post-procedure hypotension in the study. Among patients who developed it, however, beta-blockers were associated with a 48% reduction in the risk of stroke or death at 30 days (OR, 0.52; 95% CI, 0.28-0.98; P = .43).

Dr. Mahmoud B. Malas
Dr. Mahmoud B. Malas

“We think” the benefits are due to “up-regulation of adrenergic receptors. We think also there is better baroreceptor reflex sensitivity.” Long-term use of beta-blockers reduces heart rate variability, as well, and decreases the risk of hyperperfusion fourfold, Dr. Malas said at the meeting hosted by the Society for Vascular Surgery.

The researchers looked into the issue because they are trying to find a way to make CAS safer in the wake of the Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and others that have shown increased risk compared with carotid endarterectomy.

The subjects were all captured in SVS’s Vascular Quality Initiative database; 2,152 were not on beta-blockers before CAS, 259 were on them for less than 30 days, and 2,837 were on them for more than 30 days. There were no statistical between-group differences in lesion sites, approach (femoral in almost all the cases), or contrast volume used in surgery, a marker of case complexity.

Long-term users had more diabetes, hypertension, coronary artery disease, and congestive heart failure, whereas short term users were more symptomatic; those and other differences were controlled for on multivariate analysis. Aspirin, clopidogrel, and statin use were similar between the groups. About two-thirds of the subjects were men, and the average age in the study was about 70 years old.

Overall, the 30-day stroke and death rate was 3.4% (minor stroke 1.5%, major 0.9%, and death 1.2%).

Predictors of postoperative stroke or death at 30 days included symptomatic status, age, diabetes, and perioperative hypotension and hypertension. Prior carotid endarterectomy and distal embolic protection were both protective.

The investigators have no disclosures.

aotto@frontlinemedcom.com

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AT THE 2015 VASCULAR ANNUAL MEETING

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Key clinical point: Carotid artery stenting is safer if patients have been on beta-blockers for at least a month beforehand.

Major finding: The risk of stroke or death after carotid artery stenting is reduced by 34% when patients are on long-term beta-blockers preoperatively.

Data source: Review of 5,248 stent cases during 2005-2014

Disclosures: The investigators have no disclosures.

SVS: Stroke reduction outweighs bleeding risk of dual antiplatelet therapy in CEA

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SVS: Stroke reduction outweighs bleeding risk of dual antiplatelet therapy in CEA

CHICAGO – Don’t automatically discontinue dual antiplatelet therapy for carotid endarterectomy because the neuroprotective effects may outweigh the bleeding risks, researchers concluded after a review of more than 28,000 patients who underwent the procedure during 2003-2014.

They found in the study that the 7,059 patients on perioperative dual antiplatelet therapy with clopidogrel (Plavix) and aspirin had about a 40% reduction in transient ischemic attacks (TIAs), strokes, and stroke-related deaths when compared with the 21,624 patients on aspirin alone.

The investigators found on multivariate analysis that bleeding bad enough for a return trip to the operating room was more common in their dual antiplatelet group (odds ratio, 1.73; P < .01), but they felt the neuroprotective effect was probably worth the “slightly increased bleeding risk.” Earlier research suggests that about half of vascular surgeons will discontinue clopidogrel a week or so before carotid endarterectomy (CEA) because of bleeding risks (Eur. J. Vasc. Endovasc. Surg. 2009;38:402-7).

“Although dual therapy increases perioperative bleeding, it confers an overall benefit by reducing stroke and death. Patients taking dual therapy at the time of CEA should continue treatment preoperatively. This study also suggests that initiating dual therapy is beneficial for asymptomatic patients,” lead investigator Dr. Douglas Jones of the New York Presbyterian Hospital in New York said at the meeting hosted by the Society for Vascular Surgery.

The team used the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative database. Patients were about 70 years old on average and about 60% were men. Dual-therapy patients had more coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, and diabetes.

On multivariate analysis to control for those differences, dual therapy was protective against TIA or stroke (OR, 0.60; P < .01); ipsilateral TIA or stroke (OR, 0.68; P = .05); stroke (OR, 0.62; P = .04); and stroke death (OR, 0.65; P = .03). It did not protect against myocardial infarction.

“More than 95% of patients received heparin for these cases,” said Dr. Jones, noting that protamine-reversal after the case “had the greatest protective effect” against major bleeding, which is consistent with previous reports. Protamine reversal reduced it by more than 50% (OR, 0.44; P < .01).

The results, for the most part, were similar on propensity matching of 4,548 patients on dual therapy to 4,548 on aspirin alone, all of whom had CEA after 2010. Dual-therapy patients were about twice as likely to return to the operating room for bleeding (1.3% vs. 0.7%), but also had fewer thrombotic complications (for instance, stroke 0.6% vs. 1.0% in the aspirin cohort).

Asymptomatic patients on dual therapy were again about twice as likely to return to surgery for major bleeding, but half as likely to have a stroke. Bleeding was more common in symptomatic dual therapy patients, as well, but for reasons that aren’t clear, a trend toward fewer thrombotic events in symptomatic patients on propensity matching did not reach statistical significance. “The protective effect was greatest among asymptomatic patients,” Dr. Jones said.

Patients on dual therapy were also more likely to have a drain placed, but drain placement did not protect against reoperation for bleeding (OR, 1.06; P = .75).

Dr. Jones has no disclosures. Other investigators disclosed consulting fees from Medtronic, Volcano, Bard, and AnGes.

aotto@frontlinemedcom.com

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CHICAGO – Don’t automatically discontinue dual antiplatelet therapy for carotid endarterectomy because the neuroprotective effects may outweigh the bleeding risks, researchers concluded after a review of more than 28,000 patients who underwent the procedure during 2003-2014.

They found in the study that the 7,059 patients on perioperative dual antiplatelet therapy with clopidogrel (Plavix) and aspirin had about a 40% reduction in transient ischemic attacks (TIAs), strokes, and stroke-related deaths when compared with the 21,624 patients on aspirin alone.

The investigators found on multivariate analysis that bleeding bad enough for a return trip to the operating room was more common in their dual antiplatelet group (odds ratio, 1.73; P < .01), but they felt the neuroprotective effect was probably worth the “slightly increased bleeding risk.” Earlier research suggests that about half of vascular surgeons will discontinue clopidogrel a week or so before carotid endarterectomy (CEA) because of bleeding risks (Eur. J. Vasc. Endovasc. Surg. 2009;38:402-7).

“Although dual therapy increases perioperative bleeding, it confers an overall benefit by reducing stroke and death. Patients taking dual therapy at the time of CEA should continue treatment preoperatively. This study also suggests that initiating dual therapy is beneficial for asymptomatic patients,” lead investigator Dr. Douglas Jones of the New York Presbyterian Hospital in New York said at the meeting hosted by the Society for Vascular Surgery.

The team used the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative database. Patients were about 70 years old on average and about 60% were men. Dual-therapy patients had more coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, and diabetes.

On multivariate analysis to control for those differences, dual therapy was protective against TIA or stroke (OR, 0.60; P < .01); ipsilateral TIA or stroke (OR, 0.68; P = .05); stroke (OR, 0.62; P = .04); and stroke death (OR, 0.65; P = .03). It did not protect against myocardial infarction.

“More than 95% of patients received heparin for these cases,” said Dr. Jones, noting that protamine-reversal after the case “had the greatest protective effect” against major bleeding, which is consistent with previous reports. Protamine reversal reduced it by more than 50% (OR, 0.44; P < .01).

The results, for the most part, were similar on propensity matching of 4,548 patients on dual therapy to 4,548 on aspirin alone, all of whom had CEA after 2010. Dual-therapy patients were about twice as likely to return to the operating room for bleeding (1.3% vs. 0.7%), but also had fewer thrombotic complications (for instance, stroke 0.6% vs. 1.0% in the aspirin cohort).

Asymptomatic patients on dual therapy were again about twice as likely to return to surgery for major bleeding, but half as likely to have a stroke. Bleeding was more common in symptomatic dual therapy patients, as well, but for reasons that aren’t clear, a trend toward fewer thrombotic events in symptomatic patients on propensity matching did not reach statistical significance. “The protective effect was greatest among asymptomatic patients,” Dr. Jones said.

Patients on dual therapy were also more likely to have a drain placed, but drain placement did not protect against reoperation for bleeding (OR, 1.06; P = .75).

Dr. Jones has no disclosures. Other investigators disclosed consulting fees from Medtronic, Volcano, Bard, and AnGes.

aotto@frontlinemedcom.com

CHICAGO – Don’t automatically discontinue dual antiplatelet therapy for carotid endarterectomy because the neuroprotective effects may outweigh the bleeding risks, researchers concluded after a review of more than 28,000 patients who underwent the procedure during 2003-2014.

They found in the study that the 7,059 patients on perioperative dual antiplatelet therapy with clopidogrel (Plavix) and aspirin had about a 40% reduction in transient ischemic attacks (TIAs), strokes, and stroke-related deaths when compared with the 21,624 patients on aspirin alone.

The investigators found on multivariate analysis that bleeding bad enough for a return trip to the operating room was more common in their dual antiplatelet group (odds ratio, 1.73; P < .01), but they felt the neuroprotective effect was probably worth the “slightly increased bleeding risk.” Earlier research suggests that about half of vascular surgeons will discontinue clopidogrel a week or so before carotid endarterectomy (CEA) because of bleeding risks (Eur. J. Vasc. Endovasc. Surg. 2009;38:402-7).

“Although dual therapy increases perioperative bleeding, it confers an overall benefit by reducing stroke and death. Patients taking dual therapy at the time of CEA should continue treatment preoperatively. This study also suggests that initiating dual therapy is beneficial for asymptomatic patients,” lead investigator Dr. Douglas Jones of the New York Presbyterian Hospital in New York said at the meeting hosted by the Society for Vascular Surgery.

The team used the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative database. Patients were about 70 years old on average and about 60% were men. Dual-therapy patients had more coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, and diabetes.

On multivariate analysis to control for those differences, dual therapy was protective against TIA or stroke (OR, 0.60; P < .01); ipsilateral TIA or stroke (OR, 0.68; P = .05); stroke (OR, 0.62; P = .04); and stroke death (OR, 0.65; P = .03). It did not protect against myocardial infarction.

“More than 95% of patients received heparin for these cases,” said Dr. Jones, noting that protamine-reversal after the case “had the greatest protective effect” against major bleeding, which is consistent with previous reports. Protamine reversal reduced it by more than 50% (OR, 0.44; P < .01).

The results, for the most part, were similar on propensity matching of 4,548 patients on dual therapy to 4,548 on aspirin alone, all of whom had CEA after 2010. Dual-therapy patients were about twice as likely to return to the operating room for bleeding (1.3% vs. 0.7%), but also had fewer thrombotic complications (for instance, stroke 0.6% vs. 1.0% in the aspirin cohort).

Asymptomatic patients on dual therapy were again about twice as likely to return to surgery for major bleeding, but half as likely to have a stroke. Bleeding was more common in symptomatic dual therapy patients, as well, but for reasons that aren’t clear, a trend toward fewer thrombotic events in symptomatic patients on propensity matching did not reach statistical significance. “The protective effect was greatest among asymptomatic patients,” Dr. Jones said.

Patients on dual therapy were also more likely to have a drain placed, but drain placement did not protect against reoperation for bleeding (OR, 1.06; P = .75).

Dr. Jones has no disclosures. Other investigators disclosed consulting fees from Medtronic, Volcano, Bard, and AnGes.

aotto@frontlinemedcom.com

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Key clinical point: Strokes are less likely after CEA if patients are on perioperative clopidogrel and aspirin.

Major finding: On multivariate analysis, dual therapy was protective against TIA or stroke (OR, 0.60; P < .01); ipsilateral TIA or stroke (OR, 0.68; P = .05); stroke (OR, 0.62, P = .04); and stroke death (OR, 0.65; P = .03).

Data source: Review of more than 28,000 carotid endarterectomy patients

Disclosures: The presenter has no disclosures. Other investigators disclosed consulting fees from Medtronic, Volcano, Bard, and AnGes.

SVS: Choose endarterectomy over stenting for complex carotid lesions

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SVS: Choose endarterectomy over stenting for complex carotid lesions

CHICAGO – Carotid endarterectomy is safer than stenting when lesions have greater complexity based on length, location, and presence of sequential lesions, according to a subanalysis of the CREST study.

Previous studies have shown that carotid artery stenting (CAS) is also risky in patients with type 3 aortic arches; atherosclerotic aortic arches; internal carotid artery tortuosity; circumferential calcification; and ulcerated lesions.

Taken together, “we can now begin to populate a list of conditions that are high risk for carotid artery stenting. For patients with these factors, we would strongly recommend that carotid endarterectomy be employed rather than carotid artery stenting,” said CREST (Carotid Revascularization Endarterectomy versus Stent Trial) investigator Dr. Wesley Moore, professor and chief, emeritus, of the division of vascular surgery at the University of California, Los Angeles.

Dr. Wesley Moore
Dr. Wesley Moore

“However, in the absence of these higher risk characteristics, carotid artery stenting should yield results equivalent to carotid endarterectomy,” he said at a meeting hosted by the Society for Vascular Surgery.

CREST demonstrated that carotid artery stenting carries about twice the risk of stroke and death (4.4%) as carotid endarterectomy (2.3%); the investigators revisited their subjects’ preop angiograms to see if lesion characteristics were to blame in a subanalysis of the trial results.

In CREST, 438 patients had angiograms before carotid endarterectomies (CEA), about a third of the total number of CEA patients, while preop angiograms were done in all of the 1,262 CAS patients. There were no statistically significant differences in age, gender, stenosis symptoms, smoking history, arrhythmias, and left ventricular hypertrophy between CEA and CAS patients.

For lesions longer than 12.85 mm – the median length in CREST – the combined outcome of strokes and death occurred in 1.9% of CEA and 6.1% of CAS patients (CAS odds ratio, 3.45; 95% confidence interval, 1.21-9.83). For sequential lesions, strokes and death occurred in 0.7% of CEA and 5.8% of CAS patients (CAS OR, 9.21; 95% CI, 1.23-68.94).

With long, sequential lesions distal to the carotid bulb, stroke and death occurred in 6.3% of CAS patients but no CEA patients, giving an “infinite odds ratio in favor of CEA,” Dr. Moore said.

Two-thirds of all the patients in CREST had lesion risk factors for CAS, which might help explain the original findings.

CREST also found that stenting was riskier in older people and women, but it seems likely now that age and gender were surrogates for adverse lesion characteristics.

“The fact of the matter is that older patients have more complex lesions, so age tended to be a surrogate for lesion complexity. If I have an 80-year-old with a short, isolated lesion, I don’t think the fact that they are 80 represents higher risk. I think the lesion being short puts them in the same low risk [category] as other favorable CAS characteristics. I think that’s also true for gender,” Dr. Moore said.

Angiograms almost always underestimate the length of carotid lesions. CT and MRI do a better job, but “ultrasound may be even better than those two,” he noted.

CREST was funded by the National Institutes of Health and Abbott Vascular Solutions. Dr. Moore has no disclosures. Other authors reported relationships with Abbott, Medtronic, Boston Scientific, and other companies.

aotto@frontlinemedcom.com

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CHICAGO – Carotid endarterectomy is safer than stenting when lesions have greater complexity based on length, location, and presence of sequential lesions, according to a subanalysis of the CREST study.

Previous studies have shown that carotid artery stenting (CAS) is also risky in patients with type 3 aortic arches; atherosclerotic aortic arches; internal carotid artery tortuosity; circumferential calcification; and ulcerated lesions.

Taken together, “we can now begin to populate a list of conditions that are high risk for carotid artery stenting. For patients with these factors, we would strongly recommend that carotid endarterectomy be employed rather than carotid artery stenting,” said CREST (Carotid Revascularization Endarterectomy versus Stent Trial) investigator Dr. Wesley Moore, professor and chief, emeritus, of the division of vascular surgery at the University of California, Los Angeles.

Dr. Wesley Moore
Dr. Wesley Moore

“However, in the absence of these higher risk characteristics, carotid artery stenting should yield results equivalent to carotid endarterectomy,” he said at a meeting hosted by the Society for Vascular Surgery.

CREST demonstrated that carotid artery stenting carries about twice the risk of stroke and death (4.4%) as carotid endarterectomy (2.3%); the investigators revisited their subjects’ preop angiograms to see if lesion characteristics were to blame in a subanalysis of the trial results.

In CREST, 438 patients had angiograms before carotid endarterectomies (CEA), about a third of the total number of CEA patients, while preop angiograms were done in all of the 1,262 CAS patients. There were no statistically significant differences in age, gender, stenosis symptoms, smoking history, arrhythmias, and left ventricular hypertrophy between CEA and CAS patients.

For lesions longer than 12.85 mm – the median length in CREST – the combined outcome of strokes and death occurred in 1.9% of CEA and 6.1% of CAS patients (CAS odds ratio, 3.45; 95% confidence interval, 1.21-9.83). For sequential lesions, strokes and death occurred in 0.7% of CEA and 5.8% of CAS patients (CAS OR, 9.21; 95% CI, 1.23-68.94).

With long, sequential lesions distal to the carotid bulb, stroke and death occurred in 6.3% of CAS patients but no CEA patients, giving an “infinite odds ratio in favor of CEA,” Dr. Moore said.

Two-thirds of all the patients in CREST had lesion risk factors for CAS, which might help explain the original findings.

CREST also found that stenting was riskier in older people and women, but it seems likely now that age and gender were surrogates for adverse lesion characteristics.

“The fact of the matter is that older patients have more complex lesions, so age tended to be a surrogate for lesion complexity. If I have an 80-year-old with a short, isolated lesion, I don’t think the fact that they are 80 represents higher risk. I think the lesion being short puts them in the same low risk [category] as other favorable CAS characteristics. I think that’s also true for gender,” Dr. Moore said.

Angiograms almost always underestimate the length of carotid lesions. CT and MRI do a better job, but “ultrasound may be even better than those two,” he noted.

CREST was funded by the National Institutes of Health and Abbott Vascular Solutions. Dr. Moore has no disclosures. Other authors reported relationships with Abbott, Medtronic, Boston Scientific, and other companies.

aotto@frontlinemedcom.com

CHICAGO – Carotid endarterectomy is safer than stenting when lesions have greater complexity based on length, location, and presence of sequential lesions, according to a subanalysis of the CREST study.

Previous studies have shown that carotid artery stenting (CAS) is also risky in patients with type 3 aortic arches; atherosclerotic aortic arches; internal carotid artery tortuosity; circumferential calcification; and ulcerated lesions.

Taken together, “we can now begin to populate a list of conditions that are high risk for carotid artery stenting. For patients with these factors, we would strongly recommend that carotid endarterectomy be employed rather than carotid artery stenting,” said CREST (Carotid Revascularization Endarterectomy versus Stent Trial) investigator Dr. Wesley Moore, professor and chief, emeritus, of the division of vascular surgery at the University of California, Los Angeles.

Dr. Wesley Moore
Dr. Wesley Moore

“However, in the absence of these higher risk characteristics, carotid artery stenting should yield results equivalent to carotid endarterectomy,” he said at a meeting hosted by the Society for Vascular Surgery.

CREST demonstrated that carotid artery stenting carries about twice the risk of stroke and death (4.4%) as carotid endarterectomy (2.3%); the investigators revisited their subjects’ preop angiograms to see if lesion characteristics were to blame in a subanalysis of the trial results.

In CREST, 438 patients had angiograms before carotid endarterectomies (CEA), about a third of the total number of CEA patients, while preop angiograms were done in all of the 1,262 CAS patients. There were no statistically significant differences in age, gender, stenosis symptoms, smoking history, arrhythmias, and left ventricular hypertrophy between CEA and CAS patients.

For lesions longer than 12.85 mm – the median length in CREST – the combined outcome of strokes and death occurred in 1.9% of CEA and 6.1% of CAS patients (CAS odds ratio, 3.45; 95% confidence interval, 1.21-9.83). For sequential lesions, strokes and death occurred in 0.7% of CEA and 5.8% of CAS patients (CAS OR, 9.21; 95% CI, 1.23-68.94).

With long, sequential lesions distal to the carotid bulb, stroke and death occurred in 6.3% of CAS patients but no CEA patients, giving an “infinite odds ratio in favor of CEA,” Dr. Moore said.

Two-thirds of all the patients in CREST had lesion risk factors for CAS, which might help explain the original findings.

CREST also found that stenting was riskier in older people and women, but it seems likely now that age and gender were surrogates for adverse lesion characteristics.

“The fact of the matter is that older patients have more complex lesions, so age tended to be a surrogate for lesion complexity. If I have an 80-year-old with a short, isolated lesion, I don’t think the fact that they are 80 represents higher risk. I think the lesion being short puts them in the same low risk [category] as other favorable CAS characteristics. I think that’s also true for gender,” Dr. Moore said.

Angiograms almost always underestimate the length of carotid lesions. CT and MRI do a better job, but “ultrasound may be even better than those two,” he noted.

CREST was funded by the National Institutes of Health and Abbott Vascular Solutions. Dr. Moore has no disclosures. Other authors reported relationships with Abbott, Medtronic, Boston Scientific, and other companies.

aotto@frontlinemedcom.com

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Key clinical point: Carotid endarterectomy had a lower rate of the combined outcome of stroke or death in patients with greater lesion complexity, which may be a better marker than age or gender for determining the best treatment modality.

Major finding: For lesions longer than 12.85 mm, the combined outcome of strokes and death occurred in 1.9% of carotid endarterectomy patients and 6.1% of carotid stent patients (CAS OR, 3.45; 95% CI, 1.21-9.83). Subsanalysis of the CREST study

Data source: Subsanalysis of the CREST study

Disclosures: CREST was funded by the National Institutes of Health and Abbott Vascular Solutions. The presenter has no disclosures. Other authors reported relationships with Abbott, Medtronic, Boston Scientific, and other companies.

SVS: Opt for early repair of PDA/GDA splanchnic aneurysms

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SVS: Opt for early repair of PDA/GDA splanchnic aneurysms

CHICAGO – Pancreaticoduodenal and gastroduodenal artery aneurysms should be repaired at diagnosis, according to Dr. Michael Corey, a vascular surgeon at Massachusetts General Hospital in Boston.

The reason is “they rupture at small sizes. Most other small splanchnic artery aneurysms” – below 25 mm – “do not grow or rupture over time and can safely undergo surveillance imaging every 3 years,” he said at a meeting hosted by the Society for Vascular Surgery.

The insights come from Dr. Corey’s review of 264 splanchnic artery aneurysms (SAAs) treated at Massachusetts General Hospital from 1994 to 2014 .

Pancreaticoduodenal (PDA) and gastroduodenal (GDA) artery aneurysms were the most likely to cause trouble. Almost all of the 36 in the study were associated with high-grade celiac axis stenosis, and 12 (33%) were symptomatic at presentation, including 7 (19%) that had ruptured at a mean size of 27.4 mm, range 15-48 mm.

Those 7 accounted for more than half of the 13 ruptures in the study. There were also five ruptures among 95 splenic artery aneurysms – the most common aneurysm type in the study – at a mean of 42 mm, and one among 34 hepatic artery aneurysms at 40 mm. Thirty-day morbidity after rupture repair was 54% and mortality 8%.

Pancreaticoduodenal (odds ratio, 14.41; 95% confidence interval, 3.5-59.9; P = .0002) and gastroduodenal artery aneurysms (OR, 6.95; 95% CI, 1.1-45.1; P = .042) were far more predictive of rupture than aneurysm size (OR, 1.04; 95% CI, 1.01-1.08; P = .0042). The strongest predictor was type 4 Ehlers-Danlos syndrome (OR, 34.09; 95% CI, 2.4-479.8; P = .0089). Calcification, meanwhile, did not predict rupture, growth, or thrombus burden.

Dr. Corey and his colleagues reviewed Massachusetts General’s experience with SAAs because “no strong consensus exists in the literature concerning the indications for treatment; 2 cm is currently the indication for surgical treatment of asymptomatic lesions,” he said.

Two centimeters might be too aggressive in some cases. Among 176 aneurysms put under surveillance for a mean of 36.1 months, the mean aneurysm size was 16.3 mm but ranged up to 40 mm. Even so, none of them ruptured. Just 12 aneurysms grew during surveillance, and only 8 eventually needed intervention. Perhaps most “small asymptomatic lesions do not affect longevity,” Dr. Corey said. The mean aneurysm size was 31.1 mm in the 88 patients repaired within 6 months of diagnosis. Splenic, pancreaticoduodenal, gastroduodenal, and hepatic aneurysms were the most likely to be repaired early, the majority by coil embolization and other endovascular techniques. Thirty-day morbidity for intact repair was 13% and mortality 3%.

Most of the splenic artery aneurysms were asymptomatic at presentation. In the half that were watched, just six grew.

Similarly, 78 celiac artery aneurysms – the second most common in the study – all presented without symptoms. Just 3 of the 60 under surveillance grew over a mean of 43.6 months. “These aneurysms rarely change,” Dr. Corey said.

Most of the 34 hepatic artery aneurysms and 17 superior mesenteric artery (SMA) aneurysms were asymptomatic. Between both groups, 20 aneurysms were put under surveillance; growth was noted in 1, an SMA lesion.

Although there was a shift from open to endovascular repair during the study period, there were no statistically significant differences in morbidity or mortality between the two approaches.

Dr. Corey has no disclosures.

aotto@frontlinemedcom.com

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CHICAGO – Pancreaticoduodenal and gastroduodenal artery aneurysms should be repaired at diagnosis, according to Dr. Michael Corey, a vascular surgeon at Massachusetts General Hospital in Boston.

The reason is “they rupture at small sizes. Most other small splanchnic artery aneurysms” – below 25 mm – “do not grow or rupture over time and can safely undergo surveillance imaging every 3 years,” he said at a meeting hosted by the Society for Vascular Surgery.

The insights come from Dr. Corey’s review of 264 splanchnic artery aneurysms (SAAs) treated at Massachusetts General Hospital from 1994 to 2014 .

Pancreaticoduodenal (PDA) and gastroduodenal (GDA) artery aneurysms were the most likely to cause trouble. Almost all of the 36 in the study were associated with high-grade celiac axis stenosis, and 12 (33%) were symptomatic at presentation, including 7 (19%) that had ruptured at a mean size of 27.4 mm, range 15-48 mm.

Those 7 accounted for more than half of the 13 ruptures in the study. There were also five ruptures among 95 splenic artery aneurysms – the most common aneurysm type in the study – at a mean of 42 mm, and one among 34 hepatic artery aneurysms at 40 mm. Thirty-day morbidity after rupture repair was 54% and mortality 8%.

Pancreaticoduodenal (odds ratio, 14.41; 95% confidence interval, 3.5-59.9; P = .0002) and gastroduodenal artery aneurysms (OR, 6.95; 95% CI, 1.1-45.1; P = .042) were far more predictive of rupture than aneurysm size (OR, 1.04; 95% CI, 1.01-1.08; P = .0042). The strongest predictor was type 4 Ehlers-Danlos syndrome (OR, 34.09; 95% CI, 2.4-479.8; P = .0089). Calcification, meanwhile, did not predict rupture, growth, or thrombus burden.

Dr. Corey and his colleagues reviewed Massachusetts General’s experience with SAAs because “no strong consensus exists in the literature concerning the indications for treatment; 2 cm is currently the indication for surgical treatment of asymptomatic lesions,” he said.

Two centimeters might be too aggressive in some cases. Among 176 aneurysms put under surveillance for a mean of 36.1 months, the mean aneurysm size was 16.3 mm but ranged up to 40 mm. Even so, none of them ruptured. Just 12 aneurysms grew during surveillance, and only 8 eventually needed intervention. Perhaps most “small asymptomatic lesions do not affect longevity,” Dr. Corey said. The mean aneurysm size was 31.1 mm in the 88 patients repaired within 6 months of diagnosis. Splenic, pancreaticoduodenal, gastroduodenal, and hepatic aneurysms were the most likely to be repaired early, the majority by coil embolization and other endovascular techniques. Thirty-day morbidity for intact repair was 13% and mortality 3%.

Most of the splenic artery aneurysms were asymptomatic at presentation. In the half that were watched, just six grew.

Similarly, 78 celiac artery aneurysms – the second most common in the study – all presented without symptoms. Just 3 of the 60 under surveillance grew over a mean of 43.6 months. “These aneurysms rarely change,” Dr. Corey said.

Most of the 34 hepatic artery aneurysms and 17 superior mesenteric artery (SMA) aneurysms were asymptomatic. Between both groups, 20 aneurysms were put under surveillance; growth was noted in 1, an SMA lesion.

Although there was a shift from open to endovascular repair during the study period, there were no statistically significant differences in morbidity or mortality between the two approaches.

Dr. Corey has no disclosures.

aotto@frontlinemedcom.com

CHICAGO – Pancreaticoduodenal and gastroduodenal artery aneurysms should be repaired at diagnosis, according to Dr. Michael Corey, a vascular surgeon at Massachusetts General Hospital in Boston.

The reason is “they rupture at small sizes. Most other small splanchnic artery aneurysms” – below 25 mm – “do not grow or rupture over time and can safely undergo surveillance imaging every 3 years,” he said at a meeting hosted by the Society for Vascular Surgery.

The insights come from Dr. Corey’s review of 264 splanchnic artery aneurysms (SAAs) treated at Massachusetts General Hospital from 1994 to 2014 .

Pancreaticoduodenal (PDA) and gastroduodenal (GDA) artery aneurysms were the most likely to cause trouble. Almost all of the 36 in the study were associated with high-grade celiac axis stenosis, and 12 (33%) were symptomatic at presentation, including 7 (19%) that had ruptured at a mean size of 27.4 mm, range 15-48 mm.

Those 7 accounted for more than half of the 13 ruptures in the study. There were also five ruptures among 95 splenic artery aneurysms – the most common aneurysm type in the study – at a mean of 42 mm, and one among 34 hepatic artery aneurysms at 40 mm. Thirty-day morbidity after rupture repair was 54% and mortality 8%.

Pancreaticoduodenal (odds ratio, 14.41; 95% confidence interval, 3.5-59.9; P = .0002) and gastroduodenal artery aneurysms (OR, 6.95; 95% CI, 1.1-45.1; P = .042) were far more predictive of rupture than aneurysm size (OR, 1.04; 95% CI, 1.01-1.08; P = .0042). The strongest predictor was type 4 Ehlers-Danlos syndrome (OR, 34.09; 95% CI, 2.4-479.8; P = .0089). Calcification, meanwhile, did not predict rupture, growth, or thrombus burden.

Dr. Corey and his colleagues reviewed Massachusetts General’s experience with SAAs because “no strong consensus exists in the literature concerning the indications for treatment; 2 cm is currently the indication for surgical treatment of asymptomatic lesions,” he said.

Two centimeters might be too aggressive in some cases. Among 176 aneurysms put under surveillance for a mean of 36.1 months, the mean aneurysm size was 16.3 mm but ranged up to 40 mm. Even so, none of them ruptured. Just 12 aneurysms grew during surveillance, and only 8 eventually needed intervention. Perhaps most “small asymptomatic lesions do not affect longevity,” Dr. Corey said. The mean aneurysm size was 31.1 mm in the 88 patients repaired within 6 months of diagnosis. Splenic, pancreaticoduodenal, gastroduodenal, and hepatic aneurysms were the most likely to be repaired early, the majority by coil embolization and other endovascular techniques. Thirty-day morbidity for intact repair was 13% and mortality 3%.

Most of the splenic artery aneurysms were asymptomatic at presentation. In the half that were watched, just six grew.

Similarly, 78 celiac artery aneurysms – the second most common in the study – all presented without symptoms. Just 3 of the 60 under surveillance grew over a mean of 43.6 months. “These aneurysms rarely change,” Dr. Corey said.

Most of the 34 hepatic artery aneurysms and 17 superior mesenteric artery (SMA) aneurysms were asymptomatic. Between both groups, 20 aneurysms were put under surveillance; growth was noted in 1, an SMA lesion.

Although there was a shift from open to endovascular repair during the study period, there were no statistically significant differences in morbidity or mortality between the two approaches.

Dr. Corey has no disclosures.

aotto@frontlinemedcom.com

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SVS: Opt for early repair of PDA/GDA splanchnic aneurysms
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Key clinical point: Pancreaticoduodenal and gastroduodenal artery aneurysms rupture at smaller sizes than do other visceral aneurysms.

Major finding: Almost all of the 36 aneurysms in the study were associated with high-grade celiac axis stenosis, and 12 (33%) were symptomatic at presentation, including 7 (19%) that had ruptured at a mean size of 27.4 mm (range, 15-48 mm).

Data source: Review of 264 splanchnic artery aneurysms treated at Massachusetts General Hospital from 1994 to 2014.

Disclosures: The lead investigator has no relevant disclosures.

SVS: Don’t let TPA delay urgent carotid interventions for mild and moderate strokes

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SVS: Don’t let TPA delay urgent carotid interventions for mild and moderate strokes

CHICAGO – Urgent carotid interventions were safe after thrombolysis for acute mild to moderate strokes, according to a review of 165 patients at the Ochsner Clinic in New Orleans.

“Our data support the practice of not denying a patient an urgent carotid intervention simply because of TPA [tissue plasminogen activator] administration during the acute stroke period,” said lead investigator Dr. Nicolas Zea, an Ochsner vascular surgeon.

“Urgent carotid endarterectomy [CEA] or coronary artery stenting [CAS] can be safely undertaken in minor to moderate strokes with NIH stroke scale scores less than 10; TPA itself does not appear to be a contraindication, even within 72 hours,” he added.

Urgent carotid interventions are becoming more common after ischemic strokes to prevent recurrences. The approach is most effective within 2 weeks of the index event, but there have been concerns that intracranial hemorrhages (ICH) and other complications might be more likely if patients have had TPA.

Dr. Ochsner and his colleagues conducted their review because, “as vascular surgeons, we are going to encounter a lot more of these patients in the very near future,” Dr. Zea said a meeting hosted by the Society for Vascular Surgery.

From January 2009 to January 2015, 31 patients at Ochsner had carotid interventions – 25 CEA, 6 CAS – a mean of 2.1 days after receiving TPA for transient ischemic attacks (TIA) or ischemic strokes. The patients’ mean National Institutes of Health Stroke Scale (NIHSS) score was 6.6.

Over the same period, 134 patients who had not received TPA had urgent carotid interventions – 110 CEA, 24 CAS – a mean of 2.6 days after TIA or ischemic stroke presentation. Their mean NIHSS score was 6.1.

There were no statistically significant demographic or comorbidity differences between the TPA and no-TPA groups; patients were about 70 years old, on average, and the majority were men. Most had ipsilateral carotid stenosis greater than 70%, or acute occlusions.

The 30-day overall complication rate was 12.9% in the TPA group and 6.7% in the non-TPA group, a nonsignificant difference (P = 0.35).

In the TPA group, there was one (3.2%) ICH, one (3.2%) neck hematoma, and two (6.4%) deaths. In the no-TPA group, there were two (1.5%) ICHs, two (1.5%) neck hematomas, one (0.7%) ischemic stroke, two (1.5%) myocardial infarctions, and two (1.5%) deaths.

In both groups, ICH patients had stroke scores greater than 10. Also, although the rate of death was higher in the TPA group, the deaths “were not necessarily related to thrombolysis,” Dr. Zea noted. One death was from pulmonary embolism, the second from unknown causes. Deaths were due to acute mesenteric ischemia and ICH in the no-TPA group, Dr. Zea said.

There was one (3.2%) hemorrhagic conversion in the TPA group and two (1.5%) in the no-TPA group. Similarly, one (3.2%) TPA patient and two (1.5%) no-TPA patients had complications from access site bleeding. The differences were not statistically significant.

In the TPA group, it didn’t seem to matter if intervention came within 72 hours of administration – as in about half the cases – or afterward, when TPA risks have largely passed. There was one death and one ICH in patients in the earlier group, and one death in the later group, a nonsignificant difference.

There was no outside funding for the study. Dr. Zea had no disclosures. One of the coinvestigators is a consultant for Lutonix.

aotto@frontlinemedcom.com

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CHICAGO – Urgent carotid interventions were safe after thrombolysis for acute mild to moderate strokes, according to a review of 165 patients at the Ochsner Clinic in New Orleans.

“Our data support the practice of not denying a patient an urgent carotid intervention simply because of TPA [tissue plasminogen activator] administration during the acute stroke period,” said lead investigator Dr. Nicolas Zea, an Ochsner vascular surgeon.

“Urgent carotid endarterectomy [CEA] or coronary artery stenting [CAS] can be safely undertaken in minor to moderate strokes with NIH stroke scale scores less than 10; TPA itself does not appear to be a contraindication, even within 72 hours,” he added.

Urgent carotid interventions are becoming more common after ischemic strokes to prevent recurrences. The approach is most effective within 2 weeks of the index event, but there have been concerns that intracranial hemorrhages (ICH) and other complications might be more likely if patients have had TPA.

Dr. Ochsner and his colleagues conducted their review because, “as vascular surgeons, we are going to encounter a lot more of these patients in the very near future,” Dr. Zea said a meeting hosted by the Society for Vascular Surgery.

From January 2009 to January 2015, 31 patients at Ochsner had carotid interventions – 25 CEA, 6 CAS – a mean of 2.1 days after receiving TPA for transient ischemic attacks (TIA) or ischemic strokes. The patients’ mean National Institutes of Health Stroke Scale (NIHSS) score was 6.6.

Over the same period, 134 patients who had not received TPA had urgent carotid interventions – 110 CEA, 24 CAS – a mean of 2.6 days after TIA or ischemic stroke presentation. Their mean NIHSS score was 6.1.

There were no statistically significant demographic or comorbidity differences between the TPA and no-TPA groups; patients were about 70 years old, on average, and the majority were men. Most had ipsilateral carotid stenosis greater than 70%, or acute occlusions.

The 30-day overall complication rate was 12.9% in the TPA group and 6.7% in the non-TPA group, a nonsignificant difference (P = 0.35).

In the TPA group, there was one (3.2%) ICH, one (3.2%) neck hematoma, and two (6.4%) deaths. In the no-TPA group, there were two (1.5%) ICHs, two (1.5%) neck hematomas, one (0.7%) ischemic stroke, two (1.5%) myocardial infarctions, and two (1.5%) deaths.

In both groups, ICH patients had stroke scores greater than 10. Also, although the rate of death was higher in the TPA group, the deaths “were not necessarily related to thrombolysis,” Dr. Zea noted. One death was from pulmonary embolism, the second from unknown causes. Deaths were due to acute mesenteric ischemia and ICH in the no-TPA group, Dr. Zea said.

There was one (3.2%) hemorrhagic conversion in the TPA group and two (1.5%) in the no-TPA group. Similarly, one (3.2%) TPA patient and two (1.5%) no-TPA patients had complications from access site bleeding. The differences were not statistically significant.

In the TPA group, it didn’t seem to matter if intervention came within 72 hours of administration – as in about half the cases – or afterward, when TPA risks have largely passed. There was one death and one ICH in patients in the earlier group, and one death in the later group, a nonsignificant difference.

There was no outside funding for the study. Dr. Zea had no disclosures. One of the coinvestigators is a consultant for Lutonix.

aotto@frontlinemedcom.com

CHICAGO – Urgent carotid interventions were safe after thrombolysis for acute mild to moderate strokes, according to a review of 165 patients at the Ochsner Clinic in New Orleans.

“Our data support the practice of not denying a patient an urgent carotid intervention simply because of TPA [tissue plasminogen activator] administration during the acute stroke period,” said lead investigator Dr. Nicolas Zea, an Ochsner vascular surgeon.

“Urgent carotid endarterectomy [CEA] or coronary artery stenting [CAS] can be safely undertaken in minor to moderate strokes with NIH stroke scale scores less than 10; TPA itself does not appear to be a contraindication, even within 72 hours,” he added.

Urgent carotid interventions are becoming more common after ischemic strokes to prevent recurrences. The approach is most effective within 2 weeks of the index event, but there have been concerns that intracranial hemorrhages (ICH) and other complications might be more likely if patients have had TPA.

Dr. Ochsner and his colleagues conducted their review because, “as vascular surgeons, we are going to encounter a lot more of these patients in the very near future,” Dr. Zea said a meeting hosted by the Society for Vascular Surgery.

From January 2009 to January 2015, 31 patients at Ochsner had carotid interventions – 25 CEA, 6 CAS – a mean of 2.1 days after receiving TPA for transient ischemic attacks (TIA) or ischemic strokes. The patients’ mean National Institutes of Health Stroke Scale (NIHSS) score was 6.6.

Over the same period, 134 patients who had not received TPA had urgent carotid interventions – 110 CEA, 24 CAS – a mean of 2.6 days after TIA or ischemic stroke presentation. Their mean NIHSS score was 6.1.

There were no statistically significant demographic or comorbidity differences between the TPA and no-TPA groups; patients were about 70 years old, on average, and the majority were men. Most had ipsilateral carotid stenosis greater than 70%, or acute occlusions.

The 30-day overall complication rate was 12.9% in the TPA group and 6.7% in the non-TPA group, a nonsignificant difference (P = 0.35).

In the TPA group, there was one (3.2%) ICH, one (3.2%) neck hematoma, and two (6.4%) deaths. In the no-TPA group, there were two (1.5%) ICHs, two (1.5%) neck hematomas, one (0.7%) ischemic stroke, two (1.5%) myocardial infarctions, and two (1.5%) deaths.

In both groups, ICH patients had stroke scores greater than 10. Also, although the rate of death was higher in the TPA group, the deaths “were not necessarily related to thrombolysis,” Dr. Zea noted. One death was from pulmonary embolism, the second from unknown causes. Deaths were due to acute mesenteric ischemia and ICH in the no-TPA group, Dr. Zea said.

There was one (3.2%) hemorrhagic conversion in the TPA group and two (1.5%) in the no-TPA group. Similarly, one (3.2%) TPA patient and two (1.5%) no-TPA patients had complications from access site bleeding. The differences were not statistically significant.

In the TPA group, it didn’t seem to matter if intervention came within 72 hours of administration – as in about half the cases – or afterward, when TPA risks have largely passed. There was one death and one ICH in patients in the earlier group, and one death in the later group, a nonsignificant difference.

There was no outside funding for the study. Dr. Zea had no disclosures. One of the coinvestigators is a consultant for Lutonix.

aotto@frontlinemedcom.com

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SVS: Don’t let TPA delay urgent carotid interventions for mild and moderate strokes
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stroke, TPA, tissue plasminogen activator, TIA, transient ischemic attack, intracranial hemorrhage, ICH, ischemic stroke, endarterectomy
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AT THE 2015 VASCULAR ANNUAL MEETING

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Inside the Article

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Key clinical point: Tissue plasminogen activator does not contraindicate urgent carotid endarterectomies or stenting.

Major finding: The 30-day overall complication rate was 12.9% in the TPA group and 6.7% in the no-TPA group, a nonsignificant difference (P = 0.35).

Data source: A retrospective study of 165 patients.

Disclosures: There was no outside funding for the study. Dr. Zea had no disclosures. One of the coinvestigators is a consultant for Lutonix.

SVS: Five-year data support Endurant stent durability

Long-term EVAR outcomes as good as open repair
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SVS: Five-year data support Endurant stent durability

CHICAGO – During 5 years of follow-up, there was one aneurysm-related death among 150 patients who received Endurant stent grafts for abdominal aortic aneurysms, according to outcome data from Endurant’s manufacturer, Medtronic.

The single death was in a man who developed a type I endoleak 2 years after implant. He declined further intervention, presented at about 3 years with a ruptured aneurysm, and died shortly thereafter. If that patient had been treated, it’s possible that Endurant’s freedom from aneurysm-related death would have been 100% at 5 years, instead of 99%.

Dr. Michael Singh
Dr. Michael Singh

Endurant “has proven to be safe and effective through 5 years of follow-up. Long-term outcomes indicate that it’s a durable repair with very low aneurysm-related mortality and a limited need for secondary interventions,” said Dr. Michael Singh, associate professor of surgery at the University of Pittsburgh, who presented the findings at a meeting hosted by the Society for Vascular Surgery.

The presentation completed Medtronic’s U.S. regulatory trial. The Food and Drug Administration approved the device in 2010 based on 30-day safety and 12-month efficacy data. Endurant is currently used in about half of endovascular triple A repairs worldwide, Medtronic said in a press release announcing the 5 year results.

The 150 subjects in the trial had aneurysms of at least 50 mm, with neck lengths of at least 10 mm, neck angulations no more than 60 degrees, and iliac fixation lengths of at least 15 mm. They were 73 years old, on average, and most were men. Endurant deployment was successful in all but one.

Twenty-five patients (17.7%) died during follow-up, all but the type I endoleak patient from causes expected in a triple A cohort, including stroke and lung disease. Six additional patients were lost to follow-up, and 18 withdrew for a variety of reasons, including physician advice.

At 5 years, aneurysm sacks had shrunk in about two-thirds of patients, and remained stable in most of the rest. Endurant didn’t fracture, migrate, or disconnect during follow-up.

Fifteen patients required 18 secondary endovascular interventions, including two for type I endoleaks, 10 for type II endoleaks, three for limb occlusion before 2 months, one for limb occlusion after 2 months, one for limb stenosis, and one for thromboembolism.

When asked to explain the robust outcomes, Dr. Singh noted that “we are dealing with trial patients ... with very selective inclusion and exclusion criteria” and favorable anatomy, “so you expect optimal results. In real-world experience, we might see something slightly” less optimal.

The type I endoleak patient who declined treatment might have had “the device placed in a degenerated aorta. We have come across this in our own practice regardless of the device that is utilized. I think the foundation” of endograft placement “is making sure that you are deploying the device in normal aorta,” at least as much as possible, he said.

The trial was funded by Medtronic. Dr. Singh said he has no relevant disclosures. The principal investigator is a Medtronic consultant.

aotto@frontlinemedcom.com

References

Body

What’s refreshing with this particular trial is that they showed us what happens in 5 years. There’s no question that EVAR has lower mortality than open repair immediately postop, but there have been arguments whether long-term survival is as good. The answer is ‘yes.’ The thing that impressed me the most was the freedom from aneurysm-related mortality at 99%. That’s phenomenal. It means that this device is very solid and very durable. At 5 years, they had a few type II endoleaks. I don’t think that’s too high compared to other trials. We are getting into the era when [these grafts] are very comparable. Selection comes down to anatomy, what physicians are comfortable with, and, to be honest, representative availability.

Dr. Mahmoud Malas is chief of endovascular surgery at Johns Hopkins Bayview Medical Center in Baltimore. He said he has no financial or other relationships with Medtronic.

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What’s refreshing with this particular trial is that they showed us what happens in 5 years. There’s no question that EVAR has lower mortality than open repair immediately postop, but there have been arguments whether long-term survival is as good. The answer is ‘yes.’ The thing that impressed me the most was the freedom from aneurysm-related mortality at 99%. That’s phenomenal. It means that this device is very solid and very durable. At 5 years, they had a few type II endoleaks. I don’t think that’s too high compared to other trials. We are getting into the era when [these grafts] are very comparable. Selection comes down to anatomy, what physicians are comfortable with, and, to be honest, representative availability.

Dr. Mahmoud Malas is chief of endovascular surgery at Johns Hopkins Bayview Medical Center in Baltimore. He said he has no financial or other relationships with Medtronic.

Body

What’s refreshing with this particular trial is that they showed us what happens in 5 years. There’s no question that EVAR has lower mortality than open repair immediately postop, but there have been arguments whether long-term survival is as good. The answer is ‘yes.’ The thing that impressed me the most was the freedom from aneurysm-related mortality at 99%. That’s phenomenal. It means that this device is very solid and very durable. At 5 years, they had a few type II endoleaks. I don’t think that’s too high compared to other trials. We are getting into the era when [these grafts] are very comparable. Selection comes down to anatomy, what physicians are comfortable with, and, to be honest, representative availability.

Dr. Mahmoud Malas is chief of endovascular surgery at Johns Hopkins Bayview Medical Center in Baltimore. He said he has no financial or other relationships with Medtronic.

Title
Long-term EVAR outcomes as good as open repair
Long-term EVAR outcomes as good as open repair

CHICAGO – During 5 years of follow-up, there was one aneurysm-related death among 150 patients who received Endurant stent grafts for abdominal aortic aneurysms, according to outcome data from Endurant’s manufacturer, Medtronic.

The single death was in a man who developed a type I endoleak 2 years after implant. He declined further intervention, presented at about 3 years with a ruptured aneurysm, and died shortly thereafter. If that patient had been treated, it’s possible that Endurant’s freedom from aneurysm-related death would have been 100% at 5 years, instead of 99%.

Dr. Michael Singh
Dr. Michael Singh

Endurant “has proven to be safe and effective through 5 years of follow-up. Long-term outcomes indicate that it’s a durable repair with very low aneurysm-related mortality and a limited need for secondary interventions,” said Dr. Michael Singh, associate professor of surgery at the University of Pittsburgh, who presented the findings at a meeting hosted by the Society for Vascular Surgery.

The presentation completed Medtronic’s U.S. regulatory trial. The Food and Drug Administration approved the device in 2010 based on 30-day safety and 12-month efficacy data. Endurant is currently used in about half of endovascular triple A repairs worldwide, Medtronic said in a press release announcing the 5 year results.

The 150 subjects in the trial had aneurysms of at least 50 mm, with neck lengths of at least 10 mm, neck angulations no more than 60 degrees, and iliac fixation lengths of at least 15 mm. They were 73 years old, on average, and most were men. Endurant deployment was successful in all but one.

Twenty-five patients (17.7%) died during follow-up, all but the type I endoleak patient from causes expected in a triple A cohort, including stroke and lung disease. Six additional patients were lost to follow-up, and 18 withdrew for a variety of reasons, including physician advice.

At 5 years, aneurysm sacks had shrunk in about two-thirds of patients, and remained stable in most of the rest. Endurant didn’t fracture, migrate, or disconnect during follow-up.

Fifteen patients required 18 secondary endovascular interventions, including two for type I endoleaks, 10 for type II endoleaks, three for limb occlusion before 2 months, one for limb occlusion after 2 months, one for limb stenosis, and one for thromboembolism.

When asked to explain the robust outcomes, Dr. Singh noted that “we are dealing with trial patients ... with very selective inclusion and exclusion criteria” and favorable anatomy, “so you expect optimal results. In real-world experience, we might see something slightly” less optimal.

The type I endoleak patient who declined treatment might have had “the device placed in a degenerated aorta. We have come across this in our own practice regardless of the device that is utilized. I think the foundation” of endograft placement “is making sure that you are deploying the device in normal aorta,” at least as much as possible, he said.

The trial was funded by Medtronic. Dr. Singh said he has no relevant disclosures. The principal investigator is a Medtronic consultant.

aotto@frontlinemedcom.com

CHICAGO – During 5 years of follow-up, there was one aneurysm-related death among 150 patients who received Endurant stent grafts for abdominal aortic aneurysms, according to outcome data from Endurant’s manufacturer, Medtronic.

The single death was in a man who developed a type I endoleak 2 years after implant. He declined further intervention, presented at about 3 years with a ruptured aneurysm, and died shortly thereafter. If that patient had been treated, it’s possible that Endurant’s freedom from aneurysm-related death would have been 100% at 5 years, instead of 99%.

Dr. Michael Singh
Dr. Michael Singh

Endurant “has proven to be safe and effective through 5 years of follow-up. Long-term outcomes indicate that it’s a durable repair with very low aneurysm-related mortality and a limited need for secondary interventions,” said Dr. Michael Singh, associate professor of surgery at the University of Pittsburgh, who presented the findings at a meeting hosted by the Society for Vascular Surgery.

The presentation completed Medtronic’s U.S. regulatory trial. The Food and Drug Administration approved the device in 2010 based on 30-day safety and 12-month efficacy data. Endurant is currently used in about half of endovascular triple A repairs worldwide, Medtronic said in a press release announcing the 5 year results.

The 150 subjects in the trial had aneurysms of at least 50 mm, with neck lengths of at least 10 mm, neck angulations no more than 60 degrees, and iliac fixation lengths of at least 15 mm. They were 73 years old, on average, and most were men. Endurant deployment was successful in all but one.

Twenty-five patients (17.7%) died during follow-up, all but the type I endoleak patient from causes expected in a triple A cohort, including stroke and lung disease. Six additional patients were lost to follow-up, and 18 withdrew for a variety of reasons, including physician advice.

At 5 years, aneurysm sacks had shrunk in about two-thirds of patients, and remained stable in most of the rest. Endurant didn’t fracture, migrate, or disconnect during follow-up.

Fifteen patients required 18 secondary endovascular interventions, including two for type I endoleaks, 10 for type II endoleaks, three for limb occlusion before 2 months, one for limb occlusion after 2 months, one for limb stenosis, and one for thromboembolism.

When asked to explain the robust outcomes, Dr. Singh noted that “we are dealing with trial patients ... with very selective inclusion and exclusion criteria” and favorable anatomy, “so you expect optimal results. In real-world experience, we might see something slightly” less optimal.

The type I endoleak patient who declined treatment might have had “the device placed in a degenerated aorta. We have come across this in our own practice regardless of the device that is utilized. I think the foundation” of endograft placement “is making sure that you are deploying the device in normal aorta,” at least as much as possible, he said.

The trial was funded by Medtronic. Dr. Singh said he has no relevant disclosures. The principal investigator is a Medtronic consultant.

aotto@frontlinemedcom.com

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SVS: Five-year data support Endurant stent durability
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AT THE 2015 VASCULAR ANNUAL MEETING

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Inside the Article

Vitals

Key clinical point: With careful selection and good follow-up, your triple A patients will do well with an Endurant stent.

Major finding: During 5 years of follow-up, there was one aneurysm-related death among 150 patients who received Endurant stent grafts.

Data source: Prospective, nonrandomized trial of 150 triple A patients at 26 U.S. medical centers.

Disclosures: The trial was funded by Medtronic. The presenter said he has no relevant disclosures. The principal investigator is a Medtronic consultant.