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Endologix announces FDA approval of AFX2 Bifurcated Endograft

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Endologix announces FDA approval of AFX2 Bifurcated Endograft

The U.S. Food and Drug Administration has approved the AFX2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms (AAA), the device’s manufacturer, Endologix, announced in a statement.

Endologix also touts the AFX2 as a way to facilitate percutaneous endovascular aneurysm repair (EVAR) by providing low-profile contralateral access through a 7F introducer. The device incorporates Endologix’s ActiveSeal technology, DuraPly expanded polytetrafluoroethylene graft material, and the Vela proximal endograft.

The AFX2 is expected to hit the market in the United States in the first quarter of 2016.

mbock@frontlinemedcom.com

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The U.S. Food and Drug Administration has approved the AFX2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms (AAA), the device’s manufacturer, Endologix, announced in a statement.

Endologix also touts the AFX2 as a way to facilitate percutaneous endovascular aneurysm repair (EVAR) by providing low-profile contralateral access through a 7F introducer. The device incorporates Endologix’s ActiveSeal technology, DuraPly expanded polytetrafluoroethylene graft material, and the Vela proximal endograft.

The AFX2 is expected to hit the market in the United States in the first quarter of 2016.

mbock@frontlinemedcom.com

The U.S. Food and Drug Administration has approved the AFX2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms (AAA), the device’s manufacturer, Endologix, announced in a statement.

Endologix also touts the AFX2 as a way to facilitate percutaneous endovascular aneurysm repair (EVAR) by providing low-profile contralateral access through a 7F introducer. The device incorporates Endologix’s ActiveSeal technology, DuraPly expanded polytetrafluoroethylene graft material, and the Vela proximal endograft.

The AFX2 is expected to hit the market in the United States in the first quarter of 2016.

mbock@frontlinemedcom.com

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Reattaching intercostals fails to squelch spinal cord ischemia in TAAA repairs

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CHICAGO – Intercostal artery reimplantation fails to significantly reduce spinal cord injury following thoracoabdominal aortic aneurysm surgery, results of a large retrospective study show.

“Although there was a small decrease in spinal cord ischemia with ICAR, reattaching the intercostals did not produce a statistically significant reduction in spinal cord ischemia, even in the highest risk patients,” Dr. Charles W. Acher of the University of Wisconsin–Madison, said at the annual meeting of the Midwestern Vascular Surgical Society.

Intercostal artery reimplantation (ICAR) is one of several strategies that have been used to prevent spinal cord ischemia (SCI), paraplegia, and paraparesis that occurs from the interruption of the blood supply to intercostal arteries (ICAs) during thoracoabdominal aortic aneurysm (TAAA) repair.

Surgeons at UW–Madison adopted the ICAR strategy in 2005and now reimplant open ICAs located at T7-L2 in all Type I, II, and III TAAAs, using a previously published technique (J Surg Res. 2009;154:99-104).

Dr. Charles W. Acher
Dr. Charles W. Acher

Using a prospectively maintained database, the current analysis sought to compare outcomes between 540 patients who had TAAA surgery during 1989-2004 when open ICAs were ligated and 265 patients who had surgery during 2005-2013 with ICAR.The surgical technique for both groups was cross clamp without assisted circulation. The anesthetic technique was also uniform during the study period and included moderate systemic hypothermia (32° - 33° C); spinal fluid drainage (spinal fluid pressure less than 5 mm Hg); naloxone 1 mcg/kg per hour; use of mannitol, methylprednisolone, and barbiturate burst suppression; goal-directed therapy for a mean arterial pressure of 90-100 mm Hg and cardiac index of 2.5 L per minute/meter2; and proactive component blood therapy to avoid anemia, hypovolemia, and hypertension.

Aneurysm extent, acuity, mortality, renal failure, and pulmonary failure were the same in both groups.

The incidence of SCI was similar in all TAAAs at 5.25% without ICAR and 3.4% with ICAR (P = .23) and in the subset of patients with Type I, II, and III aneurysms (8.8% vs. 5.1%; P = .152), Dr. Acher reported on behalf of lead author and his colleague, Dr. Martha M. Wynn.

Interestingly, ICAR patients had more dissections than did the open ICA ligation patients (18% vs. 15%; P = .0016), more previous aortic surgery (47% vs. 31%; P = .0004), and longer renal ischemia time (61 minutes vs. 53 minutes; P = .0001), but had a shorter length of stay (14 days vs. 22 days; P = .0001) and were younger (mean age, 66 years vs. 70 years; P = .0001).

In a multivariate model of all TAAAs, significant predictors of spinal cord ischemia/injury were type II TAAA (odds ratio, 7.59; P = .0001), dissection (OR, 4.25; P = .0015), age as a continuous variable (P = .0085), and acute TAAA (OR, 2.1; P = .0525), Dr. Acher said. Time period of surgery, and therefore ICAR, was not significant (OR, 0.78; P = .55).

ICAR also failed to achieve significance as an SCI predictor in a subanalysis restricted to the highest-risk patients, defined as those having Type II TAAA, dissection, and acute surgery (OR, 0.67; P = .3387).

“Interrupting blood supply to the spinal cord causes spinal cord ischemia that can be mitigated almost entirely by physiologic interventions that increase spinal cord ischemic tolerance and collateral network perfusion during and after surgery,” Dr. Acher said. “Although the cause of SCI in TAAA surgery is anatomic, prevention of the injury is largely physiologic.”

During a discussion of the study, Dr. Acher surprised the audience by saying the findings have not changed current practice at the university. He cited several reasons, observing that there were more dissections in the ICAR group, and most of the ischemia in the ICAR group was delayed, suggesting that more patients could be rescued. In addition, there was a slight downward trend in spinal cord injury and immediate paraplegia with ICAR, however, these were not statistically significant.

“Because of those things, I still think it’s valuable, particularly in patients that are at highest risk, which are the dissections, with lots of open intercostals, but the emphasis should still be on physiologic parameters,” he said. “If you want to salvage patients, that’s the most important thing.

“Even if ICAR were ever shown to be statistically significant in a larger patient population, any role it has in reducing spinal cord injury would be extremely small,” he added in an interview.

The authors reported having no conflicts of interest.

pwendling@frontlinemedcom.com

References

Body

Spinal cord ischemia is a rare but devastating complication of thoracoabdominal aneurysm repair. Crawford and his colleagues documented in 1993 an incidence of spinal cord ischemia (SCI) as high as 30% for extensive thoracoabdominal repairs. Efforts to diminish the risk of SCI were concentrated in identifying and preserving the direct arterial perfusion to the spinal cord from segmental arteries but continued experimental and clinical experience have suggested that multiple factors contribute to SCI.

Dr. Luis A. Sanchez

Some generally accepted principles for minimizing SCI include hypothermia, distal aortic perfusion with atriofemoral bypass or partial cardiopulmonary bypass, cerebrospinal fluid drainage, and avoidance of hemodynamic instability. Reimplantation of intercostal branches has been suggested as an adjunct to these techniques by some investigators with limited data to support its generalized application. More recently, a growing body of evidence supports the concept of a collateral network that can support the perfusion to the spinal cord after interruption of multiple intercostal arteries and the importance of the hypogastric and subclavian arteries as critical branches that perfuse the spinal collateral network.

The retrospective review of the extensive experience at the University of Wisconsin in Madison supports the concept that “physiologic interventions that increase spinal cord tolerance and collateral network perfusion during and after surgery” are more important than the reimplantation of intercostal vessels during this complex procedure, even in patients considered at the highest risk for SCI. Intercostal artery reimplantation failed to achieve significance as an SCI predictor when comparing two large cohorts of patients (540 vs. 265) treated with intercostal ligation vs. reimplantation. Increasingly, available data support the concept of a collateral network that maintains perfusion to the spinal cord after intercostal artery occlusion.

Additional new concepts and techniques including a two-stage approach for extensive thoracoabdominal repair, preliminary occlusion of some segmental arteries, and the use of hybrid and endovascular techniques may further decrease the incidence of SCI by taking advantage of the collateral network and allow some preconditioning of the spinal cord. Fortunately for these challenging patients, significant advances continue to be made to better understand and prevent spinal cord ischemia.

Dr. Luis A. Sanchez is Chief, Section of Vascular Surgery and the Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Department of Surgery, Washington University in St. Louis.

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Spinal cord ischemia is a rare but devastating complication of thoracoabdominal aneurysm repair. Crawford and his colleagues documented in 1993 an incidence of spinal cord ischemia (SCI) as high as 30% for extensive thoracoabdominal repairs. Efforts to diminish the risk of SCI were concentrated in identifying and preserving the direct arterial perfusion to the spinal cord from segmental arteries but continued experimental and clinical experience have suggested that multiple factors contribute to SCI.

Dr. Luis A. Sanchez

Some generally accepted principles for minimizing SCI include hypothermia, distal aortic perfusion with atriofemoral bypass or partial cardiopulmonary bypass, cerebrospinal fluid drainage, and avoidance of hemodynamic instability. Reimplantation of intercostal branches has been suggested as an adjunct to these techniques by some investigators with limited data to support its generalized application. More recently, a growing body of evidence supports the concept of a collateral network that can support the perfusion to the spinal cord after interruption of multiple intercostal arteries and the importance of the hypogastric and subclavian arteries as critical branches that perfuse the spinal collateral network.

The retrospective review of the extensive experience at the University of Wisconsin in Madison supports the concept that “physiologic interventions that increase spinal cord tolerance and collateral network perfusion during and after surgery” are more important than the reimplantation of intercostal vessels during this complex procedure, even in patients considered at the highest risk for SCI. Intercostal artery reimplantation failed to achieve significance as an SCI predictor when comparing two large cohorts of patients (540 vs. 265) treated with intercostal ligation vs. reimplantation. Increasingly, available data support the concept of a collateral network that maintains perfusion to the spinal cord after intercostal artery occlusion.

Additional new concepts and techniques including a two-stage approach for extensive thoracoabdominal repair, preliminary occlusion of some segmental arteries, and the use of hybrid and endovascular techniques may further decrease the incidence of SCI by taking advantage of the collateral network and allow some preconditioning of the spinal cord. Fortunately for these challenging patients, significant advances continue to be made to better understand and prevent spinal cord ischemia.

Dr. Luis A. Sanchez is Chief, Section of Vascular Surgery and the Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Department of Surgery, Washington University in St. Louis.

Body

Spinal cord ischemia is a rare but devastating complication of thoracoabdominal aneurysm repair. Crawford and his colleagues documented in 1993 an incidence of spinal cord ischemia (SCI) as high as 30% for extensive thoracoabdominal repairs. Efforts to diminish the risk of SCI were concentrated in identifying and preserving the direct arterial perfusion to the spinal cord from segmental arteries but continued experimental and clinical experience have suggested that multiple factors contribute to SCI.

Dr. Luis A. Sanchez

Some generally accepted principles for minimizing SCI include hypothermia, distal aortic perfusion with atriofemoral bypass or partial cardiopulmonary bypass, cerebrospinal fluid drainage, and avoidance of hemodynamic instability. Reimplantation of intercostal branches has been suggested as an adjunct to these techniques by some investigators with limited data to support its generalized application. More recently, a growing body of evidence supports the concept of a collateral network that can support the perfusion to the spinal cord after interruption of multiple intercostal arteries and the importance of the hypogastric and subclavian arteries as critical branches that perfuse the spinal collateral network.

The retrospective review of the extensive experience at the University of Wisconsin in Madison supports the concept that “physiologic interventions that increase spinal cord tolerance and collateral network perfusion during and after surgery” are more important than the reimplantation of intercostal vessels during this complex procedure, even in patients considered at the highest risk for SCI. Intercostal artery reimplantation failed to achieve significance as an SCI predictor when comparing two large cohorts of patients (540 vs. 265) treated with intercostal ligation vs. reimplantation. Increasingly, available data support the concept of a collateral network that maintains perfusion to the spinal cord after intercostal artery occlusion.

Additional new concepts and techniques including a two-stage approach for extensive thoracoabdominal repair, preliminary occlusion of some segmental arteries, and the use of hybrid and endovascular techniques may further decrease the incidence of SCI by taking advantage of the collateral network and allow some preconditioning of the spinal cord. Fortunately for these challenging patients, significant advances continue to be made to better understand and prevent spinal cord ischemia.

Dr. Luis A. Sanchez is Chief, Section of Vascular Surgery and the Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Department of Surgery, Washington University in St. Louis.

Title
Counting on collaterals
Counting on collaterals

CHICAGO – Intercostal artery reimplantation fails to significantly reduce spinal cord injury following thoracoabdominal aortic aneurysm surgery, results of a large retrospective study show.

“Although there was a small decrease in spinal cord ischemia with ICAR, reattaching the intercostals did not produce a statistically significant reduction in spinal cord ischemia, even in the highest risk patients,” Dr. Charles W. Acher of the University of Wisconsin–Madison, said at the annual meeting of the Midwestern Vascular Surgical Society.

Intercostal artery reimplantation (ICAR) is one of several strategies that have been used to prevent spinal cord ischemia (SCI), paraplegia, and paraparesis that occurs from the interruption of the blood supply to intercostal arteries (ICAs) during thoracoabdominal aortic aneurysm (TAAA) repair.

Surgeons at UW–Madison adopted the ICAR strategy in 2005and now reimplant open ICAs located at T7-L2 in all Type I, II, and III TAAAs, using a previously published technique (J Surg Res. 2009;154:99-104).

Dr. Charles W. Acher
Dr. Charles W. Acher

Using a prospectively maintained database, the current analysis sought to compare outcomes between 540 patients who had TAAA surgery during 1989-2004 when open ICAs were ligated and 265 patients who had surgery during 2005-2013 with ICAR.The surgical technique for both groups was cross clamp without assisted circulation. The anesthetic technique was also uniform during the study period and included moderate systemic hypothermia (32° - 33° C); spinal fluid drainage (spinal fluid pressure less than 5 mm Hg); naloxone 1 mcg/kg per hour; use of mannitol, methylprednisolone, and barbiturate burst suppression; goal-directed therapy for a mean arterial pressure of 90-100 mm Hg and cardiac index of 2.5 L per minute/meter2; and proactive component blood therapy to avoid anemia, hypovolemia, and hypertension.

Aneurysm extent, acuity, mortality, renal failure, and pulmonary failure were the same in both groups.

The incidence of SCI was similar in all TAAAs at 5.25% without ICAR and 3.4% with ICAR (P = .23) and in the subset of patients with Type I, II, and III aneurysms (8.8% vs. 5.1%; P = .152), Dr. Acher reported on behalf of lead author and his colleague, Dr. Martha M. Wynn.

Interestingly, ICAR patients had more dissections than did the open ICA ligation patients (18% vs. 15%; P = .0016), more previous aortic surgery (47% vs. 31%; P = .0004), and longer renal ischemia time (61 minutes vs. 53 minutes; P = .0001), but had a shorter length of stay (14 days vs. 22 days; P = .0001) and were younger (mean age, 66 years vs. 70 years; P = .0001).

In a multivariate model of all TAAAs, significant predictors of spinal cord ischemia/injury were type II TAAA (odds ratio, 7.59; P = .0001), dissection (OR, 4.25; P = .0015), age as a continuous variable (P = .0085), and acute TAAA (OR, 2.1; P = .0525), Dr. Acher said. Time period of surgery, and therefore ICAR, was not significant (OR, 0.78; P = .55).

ICAR also failed to achieve significance as an SCI predictor in a subanalysis restricted to the highest-risk patients, defined as those having Type II TAAA, dissection, and acute surgery (OR, 0.67; P = .3387).

“Interrupting blood supply to the spinal cord causes spinal cord ischemia that can be mitigated almost entirely by physiologic interventions that increase spinal cord ischemic tolerance and collateral network perfusion during and after surgery,” Dr. Acher said. “Although the cause of SCI in TAAA surgery is anatomic, prevention of the injury is largely physiologic.”

During a discussion of the study, Dr. Acher surprised the audience by saying the findings have not changed current practice at the university. He cited several reasons, observing that there were more dissections in the ICAR group, and most of the ischemia in the ICAR group was delayed, suggesting that more patients could be rescued. In addition, there was a slight downward trend in spinal cord injury and immediate paraplegia with ICAR, however, these were not statistically significant.

“Because of those things, I still think it’s valuable, particularly in patients that are at highest risk, which are the dissections, with lots of open intercostals, but the emphasis should still be on physiologic parameters,” he said. “If you want to salvage patients, that’s the most important thing.

“Even if ICAR were ever shown to be statistically significant in a larger patient population, any role it has in reducing spinal cord injury would be extremely small,” he added in an interview.

The authors reported having no conflicts of interest.

pwendling@frontlinemedcom.com

CHICAGO – Intercostal artery reimplantation fails to significantly reduce spinal cord injury following thoracoabdominal aortic aneurysm surgery, results of a large retrospective study show.

“Although there was a small decrease in spinal cord ischemia with ICAR, reattaching the intercostals did not produce a statistically significant reduction in spinal cord ischemia, even in the highest risk patients,” Dr. Charles W. Acher of the University of Wisconsin–Madison, said at the annual meeting of the Midwestern Vascular Surgical Society.

Intercostal artery reimplantation (ICAR) is one of several strategies that have been used to prevent spinal cord ischemia (SCI), paraplegia, and paraparesis that occurs from the interruption of the blood supply to intercostal arteries (ICAs) during thoracoabdominal aortic aneurysm (TAAA) repair.

Surgeons at UW–Madison adopted the ICAR strategy in 2005and now reimplant open ICAs located at T7-L2 in all Type I, II, and III TAAAs, using a previously published technique (J Surg Res. 2009;154:99-104).

Dr. Charles W. Acher
Dr. Charles W. Acher

Using a prospectively maintained database, the current analysis sought to compare outcomes between 540 patients who had TAAA surgery during 1989-2004 when open ICAs were ligated and 265 patients who had surgery during 2005-2013 with ICAR.The surgical technique for both groups was cross clamp without assisted circulation. The anesthetic technique was also uniform during the study period and included moderate systemic hypothermia (32° - 33° C); spinal fluid drainage (spinal fluid pressure less than 5 mm Hg); naloxone 1 mcg/kg per hour; use of mannitol, methylprednisolone, and barbiturate burst suppression; goal-directed therapy for a mean arterial pressure of 90-100 mm Hg and cardiac index of 2.5 L per minute/meter2; and proactive component blood therapy to avoid anemia, hypovolemia, and hypertension.

Aneurysm extent, acuity, mortality, renal failure, and pulmonary failure were the same in both groups.

The incidence of SCI was similar in all TAAAs at 5.25% without ICAR and 3.4% with ICAR (P = .23) and in the subset of patients with Type I, II, and III aneurysms (8.8% vs. 5.1%; P = .152), Dr. Acher reported on behalf of lead author and his colleague, Dr. Martha M. Wynn.

Interestingly, ICAR patients had more dissections than did the open ICA ligation patients (18% vs. 15%; P = .0016), more previous aortic surgery (47% vs. 31%; P = .0004), and longer renal ischemia time (61 minutes vs. 53 minutes; P = .0001), but had a shorter length of stay (14 days vs. 22 days; P = .0001) and were younger (mean age, 66 years vs. 70 years; P = .0001).

In a multivariate model of all TAAAs, significant predictors of spinal cord ischemia/injury were type II TAAA (odds ratio, 7.59; P = .0001), dissection (OR, 4.25; P = .0015), age as a continuous variable (P = .0085), and acute TAAA (OR, 2.1; P = .0525), Dr. Acher said. Time period of surgery, and therefore ICAR, was not significant (OR, 0.78; P = .55).

ICAR also failed to achieve significance as an SCI predictor in a subanalysis restricted to the highest-risk patients, defined as those having Type II TAAA, dissection, and acute surgery (OR, 0.67; P = .3387).

“Interrupting blood supply to the spinal cord causes spinal cord ischemia that can be mitigated almost entirely by physiologic interventions that increase spinal cord ischemic tolerance and collateral network perfusion during and after surgery,” Dr. Acher said. “Although the cause of SCI in TAAA surgery is anatomic, prevention of the injury is largely physiologic.”

During a discussion of the study, Dr. Acher surprised the audience by saying the findings have not changed current practice at the university. He cited several reasons, observing that there were more dissections in the ICAR group, and most of the ischemia in the ICAR group was delayed, suggesting that more patients could be rescued. In addition, there was a slight downward trend in spinal cord injury and immediate paraplegia with ICAR, however, these were not statistically significant.

“Because of those things, I still think it’s valuable, particularly in patients that are at highest risk, which are the dissections, with lots of open intercostals, but the emphasis should still be on physiologic parameters,” he said. “If you want to salvage patients, that’s the most important thing.

“Even if ICAR were ever shown to be statistically significant in a larger patient population, any role it has in reducing spinal cord injury would be extremely small,” he added in an interview.

The authors reported having no conflicts of interest.

pwendling@frontlinemedcom.com

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Reattaching intercostals fails to squelch spinal cord ischemia in TAAA repairs
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Key clinical point: Intercostal artery reimplantation (ICAR) did not produce a significant reduction in spinal cord ischemia following thoracoabdominal aortic aneurysm repair, even in the highest risk patients.

Major finding: ICAR was not a significant predictor of spinal cord ischemia (OR, 0.78; P = .55).

Data source: Retrospective analysis of 805 patients undergoing TAAA with or without ICAR.

Disclosures: The authors reported having no conflicts of interest.

Women dogged by unplanned readmissions after aortic surgery

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CHICAGO – Women undergoing aortic surgery have a 30% higher chance of unplanned readmission within 30 days than men.

This occurs despite a significantly longer length of stay (6.4 vs. 4.8 days; P < .001), Dr. Benjamin Flink said at the annual meeting of the Midwestern Vascular Surgical Society.

Women undergoing aortic surgery are known to have higher morbidity and mortality with respect to cardiovascular events and infections, but no studies have specifically looked at sex disparities in readmission following aortic surgery, he said.

Dr. Benjamin Flink
Patrice Wendling/Frontline Medical News
Dr. Benjamin Flink

“We feel gender disparities are an understudied area of surgical care and there is a lot of work to be done in reducing these differences,” principal investigator Dr. Shipra Arya said in an interview.

To better examine this issue, Dr. Arya and Dr. Flink, both of Emory University in Atlanta, and investigators at the University of Michigan identified all patients undergoing open or endovascular abdominal aortic aneurysm (AAA), thoracic aortic aneurysm (TAA), and thoracoabdominal aortic aneurysm (TAAA) repair from 2011 to 2013 who were in the American College of Surgeons National Surgical Quality Improvement Program (ACS/NSQIP) database. Of the 18,977 patients, 23% were women.

Use of endovascular procedures varied significantly by sex, with women having significantly fewer endovascular AAA (68.8% vs. 77.1%; P less than .001) and TAAA (43.2% vs. 65.2%; P < .001) repairs than men. Endovascular TAA repairs were similar in women and men (96.1% vs. 95.6%; P = .8), Dr. Flink said.

Overall, 1,541 patients (8.1%) experienced the primary outcome of an unplanned readmission within 30 days, with a significantly higher risk observed in women than men (10.1% vs. 7.6%; P less than .001).

This risk persisted for most aneurysm types, with women having a higher risk of readmission for AAA (9.4% vs. 7.3%; P less than .001) and TAAA (13.7% vs. 8.3%; P = .03) aneurysms, but not TAAs (13% vs. 12.5%; P = .8), he said.

The overall length of stay was 5.2 days. Women stayed 1.6 days longer than men (data above), readmitted patients stayed 1 day longer during their index hospitalization than patients who avoided readmission (5.1 days vs. 4.1 days; P less than .001), and open-repair patients stayed more than twice as long as endovascular patients (10.3 days vs. 3.7 days; P less than .001).

Patients discharged to home, however, had less than one-third the length of stay as those discharged to a facility other than home (4 days vs. 12.8 days; P less than .001).

Notably, women were discharged to a facility other than home nearly twice as often as men (20.4% vs. 10.6%; P less than .001), Dr. Flink said.

In multivariate analysis, the odds of an unplanned readmission were 30% higher for women than men after controlling for 13 variables (odds ratio, 1.3; 95% confidence interval, 1.14-1.48).

When the analysis was stratified by discharge destination, the higher odds of readmission among women remained for those discharged home (OR, 1.3; 95% CI, 1.12-1.51), but not when discharged to a skilled or rehabilitation facility (OR, 1.1; 95% CI, 0.83-1.45).

“Further study into the discharge planning process, social factors, and the use of rehabilitation is needed,” Dr. Flink said. “For example, why are we keeping women longer? Are we missing opportunities to better utilize rehabilitation in hospital? And what gender-specific social factors might be influencing unplanned readmissions that we’re currently not measuring?”

Dr. John Blebea of the University of Oklahoma, Tulsa, asked whether marital status was examined as an independent variable, “because I would suspect that’s the answer to the question. More women are widowed than men and therefore are less likely to have a spouse at home to take care of them, which would also explain why they’d be in the hospital longer.”

Unfortunately, that information is not available in the ACS/NSQIP database, but “I do agree that home-social factors are likely playing a role,” Dr. Flink responded.

Along the same vein, another attendee questioned whether the study accounted for frailty index scores. They were not, but the analysis included patients’ functional status as well as comorbidities such as congestive heart failure, stroke, peripheral arterial disease, and dialysis dependence that would limit their physical independence, Dr. Flink said.

Dr. Flink reported having no financial disclosures. Principal investigator Dr. Shipra Arya is funded by a research grant from the American Heart Association.

pwendling@frontlinemedcom.com

On Twitter @pwendl

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CHICAGO – Women undergoing aortic surgery have a 30% higher chance of unplanned readmission within 30 days than men.

This occurs despite a significantly longer length of stay (6.4 vs. 4.8 days; P < .001), Dr. Benjamin Flink said at the annual meeting of the Midwestern Vascular Surgical Society.

Women undergoing aortic surgery are known to have higher morbidity and mortality with respect to cardiovascular events and infections, but no studies have specifically looked at sex disparities in readmission following aortic surgery, he said.

Dr. Benjamin Flink
Patrice Wendling/Frontline Medical News
Dr. Benjamin Flink

“We feel gender disparities are an understudied area of surgical care and there is a lot of work to be done in reducing these differences,” principal investigator Dr. Shipra Arya said in an interview.

To better examine this issue, Dr. Arya and Dr. Flink, both of Emory University in Atlanta, and investigators at the University of Michigan identified all patients undergoing open or endovascular abdominal aortic aneurysm (AAA), thoracic aortic aneurysm (TAA), and thoracoabdominal aortic aneurysm (TAAA) repair from 2011 to 2013 who were in the American College of Surgeons National Surgical Quality Improvement Program (ACS/NSQIP) database. Of the 18,977 patients, 23% were women.

Use of endovascular procedures varied significantly by sex, with women having significantly fewer endovascular AAA (68.8% vs. 77.1%; P less than .001) and TAAA (43.2% vs. 65.2%; P < .001) repairs than men. Endovascular TAA repairs were similar in women and men (96.1% vs. 95.6%; P = .8), Dr. Flink said.

Overall, 1,541 patients (8.1%) experienced the primary outcome of an unplanned readmission within 30 days, with a significantly higher risk observed in women than men (10.1% vs. 7.6%; P less than .001).

This risk persisted for most aneurysm types, with women having a higher risk of readmission for AAA (9.4% vs. 7.3%; P less than .001) and TAAA (13.7% vs. 8.3%; P = .03) aneurysms, but not TAAs (13% vs. 12.5%; P = .8), he said.

The overall length of stay was 5.2 days. Women stayed 1.6 days longer than men (data above), readmitted patients stayed 1 day longer during their index hospitalization than patients who avoided readmission (5.1 days vs. 4.1 days; P less than .001), and open-repair patients stayed more than twice as long as endovascular patients (10.3 days vs. 3.7 days; P less than .001).

Patients discharged to home, however, had less than one-third the length of stay as those discharged to a facility other than home (4 days vs. 12.8 days; P less than .001).

Notably, women were discharged to a facility other than home nearly twice as often as men (20.4% vs. 10.6%; P less than .001), Dr. Flink said.

In multivariate analysis, the odds of an unplanned readmission were 30% higher for women than men after controlling for 13 variables (odds ratio, 1.3; 95% confidence interval, 1.14-1.48).

When the analysis was stratified by discharge destination, the higher odds of readmission among women remained for those discharged home (OR, 1.3; 95% CI, 1.12-1.51), but not when discharged to a skilled or rehabilitation facility (OR, 1.1; 95% CI, 0.83-1.45).

“Further study into the discharge planning process, social factors, and the use of rehabilitation is needed,” Dr. Flink said. “For example, why are we keeping women longer? Are we missing opportunities to better utilize rehabilitation in hospital? And what gender-specific social factors might be influencing unplanned readmissions that we’re currently not measuring?”

Dr. John Blebea of the University of Oklahoma, Tulsa, asked whether marital status was examined as an independent variable, “because I would suspect that’s the answer to the question. More women are widowed than men and therefore are less likely to have a spouse at home to take care of them, which would also explain why they’d be in the hospital longer.”

Unfortunately, that information is not available in the ACS/NSQIP database, but “I do agree that home-social factors are likely playing a role,” Dr. Flink responded.

Along the same vein, another attendee questioned whether the study accounted for frailty index scores. They were not, but the analysis included patients’ functional status as well as comorbidities such as congestive heart failure, stroke, peripheral arterial disease, and dialysis dependence that would limit their physical independence, Dr. Flink said.

Dr. Flink reported having no financial disclosures. Principal investigator Dr. Shipra Arya is funded by a research grant from the American Heart Association.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Women undergoing aortic surgery have a 30% higher chance of unplanned readmission within 30 days than men.

This occurs despite a significantly longer length of stay (6.4 vs. 4.8 days; P < .001), Dr. Benjamin Flink said at the annual meeting of the Midwestern Vascular Surgical Society.

Women undergoing aortic surgery are known to have higher morbidity and mortality with respect to cardiovascular events and infections, but no studies have specifically looked at sex disparities in readmission following aortic surgery, he said.

Dr. Benjamin Flink
Patrice Wendling/Frontline Medical News
Dr. Benjamin Flink

“We feel gender disparities are an understudied area of surgical care and there is a lot of work to be done in reducing these differences,” principal investigator Dr. Shipra Arya said in an interview.

To better examine this issue, Dr. Arya and Dr. Flink, both of Emory University in Atlanta, and investigators at the University of Michigan identified all patients undergoing open or endovascular abdominal aortic aneurysm (AAA), thoracic aortic aneurysm (TAA), and thoracoabdominal aortic aneurysm (TAAA) repair from 2011 to 2013 who were in the American College of Surgeons National Surgical Quality Improvement Program (ACS/NSQIP) database. Of the 18,977 patients, 23% were women.

Use of endovascular procedures varied significantly by sex, with women having significantly fewer endovascular AAA (68.8% vs. 77.1%; P less than .001) and TAAA (43.2% vs. 65.2%; P < .001) repairs than men. Endovascular TAA repairs were similar in women and men (96.1% vs. 95.6%; P = .8), Dr. Flink said.

Overall, 1,541 patients (8.1%) experienced the primary outcome of an unplanned readmission within 30 days, with a significantly higher risk observed in women than men (10.1% vs. 7.6%; P less than .001).

This risk persisted for most aneurysm types, with women having a higher risk of readmission for AAA (9.4% vs. 7.3%; P less than .001) and TAAA (13.7% vs. 8.3%; P = .03) aneurysms, but not TAAs (13% vs. 12.5%; P = .8), he said.

The overall length of stay was 5.2 days. Women stayed 1.6 days longer than men (data above), readmitted patients stayed 1 day longer during their index hospitalization than patients who avoided readmission (5.1 days vs. 4.1 days; P less than .001), and open-repair patients stayed more than twice as long as endovascular patients (10.3 days vs. 3.7 days; P less than .001).

Patients discharged to home, however, had less than one-third the length of stay as those discharged to a facility other than home (4 days vs. 12.8 days; P less than .001).

Notably, women were discharged to a facility other than home nearly twice as often as men (20.4% vs. 10.6%; P less than .001), Dr. Flink said.

In multivariate analysis, the odds of an unplanned readmission were 30% higher for women than men after controlling for 13 variables (odds ratio, 1.3; 95% confidence interval, 1.14-1.48).

When the analysis was stratified by discharge destination, the higher odds of readmission among women remained for those discharged home (OR, 1.3; 95% CI, 1.12-1.51), but not when discharged to a skilled or rehabilitation facility (OR, 1.1; 95% CI, 0.83-1.45).

“Further study into the discharge planning process, social factors, and the use of rehabilitation is needed,” Dr. Flink said. “For example, why are we keeping women longer? Are we missing opportunities to better utilize rehabilitation in hospital? And what gender-specific social factors might be influencing unplanned readmissions that we’re currently not measuring?”

Dr. John Blebea of the University of Oklahoma, Tulsa, asked whether marital status was examined as an independent variable, “because I would suspect that’s the answer to the question. More women are widowed than men and therefore are less likely to have a spouse at home to take care of them, which would also explain why they’d be in the hospital longer.”

Unfortunately, that information is not available in the ACS/NSQIP database, but “I do agree that home-social factors are likely playing a role,” Dr. Flink responded.

Along the same vein, another attendee questioned whether the study accounted for frailty index scores. They were not, but the analysis included patients’ functional status as well as comorbidities such as congestive heart failure, stroke, peripheral arterial disease, and dialysis dependence that would limit their physical independence, Dr. Flink said.

Dr. Flink reported having no financial disclosures. Principal investigator Dr. Shipra Arya is funded by a research grant from the American Heart Association.

pwendling@frontlinemedcom.com

On Twitter @pwendl

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Key clinical point: Women undergoing aortic surgery are at higher risk for unplanned readmissions, compared with men, especially when discharged to home.

Major finding: The odds of an unplanned readmission at 30 days were 30% higher for women than men.

Data source: Retrospective study of 18,977 patients undergoing aortic aneurysm repair in the ACS/NSQIP database.

Disclosures: Dr. Flink reported having no financial disclosures. Principal investigator Dr. Shipra Arya is funded by a research grant from the American Heart Association.

Sept. JVS: Vascular surgeons do higher percentage of AAA repairs

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Sept. JVS: Vascular surgeons do higher percentage of AAA repairs

The impact of endovascular repair on specialties performing abdominal aortic aneurysm repair.

Klaas H. J. Ultee, BSc,Rob Hurks, MD, PhD, Dominique B. Buck, MD, George S. DaSilva, BS, Peter A. Soden, MD,Joost A. van Herwaarden, MD, PhD, Hence J. M. Verhagen, MD, PhD, and Marc L. Schermerhorn, MD

Due to the increased use of EVAR for both intact and ruptured AAA repair, vascular surgeons are performing an increasing majority of AAA repairs, according to a new study reported in the September edition of Journal of Vascular 
Surgery.

The study examined the years 2001 through 2009 using the Nationwide Inpatient Sample, the largest national administrative database, which is maintained by the Agency for Healthcare Research and Quality as part of the Healthcare Cost and Utilization Project.

After 2009 the surgeon identification variables in the database were discontinued so more recent data were unavailable for the study.

“We do plan to analyze (this same subject) using Medicare data,” according to Dr. Marc L. Schermerhorn, “but our access to it lags several years behind. It will allow better risk adjustment as well.”

The study was interested in AAA repairs by the following types of physicians: vascular surgeons, general surgeons, cardiac surgeons, as well as nonsurgical specialists such as interventional cardiologists and interventional radiologists.

Overall, 108,587 EVARS and 85,080 open AAA repairs were identified. Of all repairs, 61 percent were performed by vascular surgeons, 20 percent by general surgeons, and 16 percent by cardiac surgeons. ICs and IRs performed the remaining 3 percent.

Significantly, the absolute number of vascular surgeons performing AAA repair increased 30 percent during the study period, whereas the number of GS and CS repairs decreased 46 and 30 percent, respectively.

AAA repairs are still done by general surgeons and cardiovascular surgeons; however, in those cases, patients are less likely to receive EVAR.

Researchers also found that whether patients received open or endovascular repair varied with the type of surgeon, but also by the patient’s gender, emergent admission, and race.

Other influencing factors were age of patient, treatment in a teaching hospital, year, and whether or not the hospital was in an urban area.

“The big question,” Schermerhorn noted, “is whether specialty has an influence on outcomes. We chose not to try to analyze this using this database because we did not think we could adequately do risk adjustment. It is difficult to distinguish a pre-existing condition from a post-op complication, for example, renal failure.”

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The impact of endovascular repair on specialties performing abdominal aortic aneurysm repair.

Klaas H. J. Ultee, BSc,Rob Hurks, MD, PhD, Dominique B. Buck, MD, George S. DaSilva, BS, Peter A. Soden, MD,Joost A. van Herwaarden, MD, PhD, Hence J. M. Verhagen, MD, PhD, and Marc L. Schermerhorn, MD

Due to the increased use of EVAR for both intact and ruptured AAA repair, vascular surgeons are performing an increasing majority of AAA repairs, according to a new study reported in the September edition of Journal of Vascular 
Surgery.

The study examined the years 2001 through 2009 using the Nationwide Inpatient Sample, the largest national administrative database, which is maintained by the Agency for Healthcare Research and Quality as part of the Healthcare Cost and Utilization Project.

After 2009 the surgeon identification variables in the database were discontinued so more recent data were unavailable for the study.

“We do plan to analyze (this same subject) using Medicare data,” according to Dr. Marc L. Schermerhorn, “but our access to it lags several years behind. It will allow better risk adjustment as well.”

The study was interested in AAA repairs by the following types of physicians: vascular surgeons, general surgeons, cardiac surgeons, as well as nonsurgical specialists such as interventional cardiologists and interventional radiologists.

Overall, 108,587 EVARS and 85,080 open AAA repairs were identified. Of all repairs, 61 percent were performed by vascular surgeons, 20 percent by general surgeons, and 16 percent by cardiac surgeons. ICs and IRs performed the remaining 3 percent.

Significantly, the absolute number of vascular surgeons performing AAA repair increased 30 percent during the study period, whereas the number of GS and CS repairs decreased 46 and 30 percent, respectively.

AAA repairs are still done by general surgeons and cardiovascular surgeons; however, in those cases, patients are less likely to receive EVAR.

Researchers also found that whether patients received open or endovascular repair varied with the type of surgeon, but also by the patient’s gender, emergent admission, and race.

Other influencing factors were age of patient, treatment in a teaching hospital, year, and whether or not the hospital was in an urban area.

“The big question,” Schermerhorn noted, “is whether specialty has an influence on outcomes. We chose not to try to analyze this using this database because we did not think we could adequately do risk adjustment. It is difficult to distinguish a pre-existing condition from a post-op complication, for example, renal failure.”

The impact of endovascular repair on specialties performing abdominal aortic aneurysm repair.

Klaas H. J. Ultee, BSc,Rob Hurks, MD, PhD, Dominique B. Buck, MD, George S. DaSilva, BS, Peter A. Soden, MD,Joost A. van Herwaarden, MD, PhD, Hence J. M. Verhagen, MD, PhD, and Marc L. Schermerhorn, MD

Due to the increased use of EVAR for both intact and ruptured AAA repair, vascular surgeons are performing an increasing majority of AAA repairs, according to a new study reported in the September edition of Journal of Vascular 
Surgery.

The study examined the years 2001 through 2009 using the Nationwide Inpatient Sample, the largest national administrative database, which is maintained by the Agency for Healthcare Research and Quality as part of the Healthcare Cost and Utilization Project.

After 2009 the surgeon identification variables in the database were discontinued so more recent data were unavailable for the study.

“We do plan to analyze (this same subject) using Medicare data,” according to Dr. Marc L. Schermerhorn, “but our access to it lags several years behind. It will allow better risk adjustment as well.”

The study was interested in AAA repairs by the following types of physicians: vascular surgeons, general surgeons, cardiac surgeons, as well as nonsurgical specialists such as interventional cardiologists and interventional radiologists.

Overall, 108,587 EVARS and 85,080 open AAA repairs were identified. Of all repairs, 61 percent were performed by vascular surgeons, 20 percent by general surgeons, and 16 percent by cardiac surgeons. ICs and IRs performed the remaining 3 percent.

Significantly, the absolute number of vascular surgeons performing AAA repair increased 30 percent during the study period, whereas the number of GS and CS repairs decreased 46 and 30 percent, respectively.

AAA repairs are still done by general surgeons and cardiovascular surgeons; however, in those cases, patients are less likely to receive EVAR.

Researchers also found that whether patients received open or endovascular repair varied with the type of surgeon, but also by the patient’s gender, emergent admission, and race.

Other influencing factors were age of patient, treatment in a teaching hospital, year, and whether or not the hospital was in an urban area.

“The big question,” Schermerhorn noted, “is whether specialty has an influence on outcomes. We chose not to try to analyze this using this database because we did not think we could adequately do risk adjustment. It is difficult to distinguish a pre-existing condition from a post-op complication, for example, renal failure.”

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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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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.

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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: Opt for early repair of PDA/GDA splanchnic aneurysms

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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

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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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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.

VIDEO: Sometimes, comfort care is best for ruptured AAAs

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CHICAGO – Four preoperative variables predict whether or not patients will survive ruptured abdominal aortic aneurysm repairs, according to investigators from Harborview Medical Center in Seattle.

It’s an important finding because until now, it’s been hard to know how they’ll do. Previous risk scores also rely on intraoperative variables, or haven’t been validated for endovascular repair.

Investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, explained in a video interview what the four variables are at a meeting hosted by the Society for Vascular Surgery, and why it was so important for a level 1 trauma center like Harborview to identify them.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

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CHICAGO – Four preoperative variables predict whether or not patients will survive ruptured abdominal aortic aneurysm repairs, according to investigators from Harborview Medical Center in Seattle.

It’s an important finding because until now, it’s been hard to know how they’ll do. Previous risk scores also rely on intraoperative variables, or haven’t been validated for endovascular repair.

Investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, explained in a video interview what the four variables are at a meeting hosted by the Society for Vascular Surgery, and why it was so important for a level 1 trauma center like Harborview to identify them.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

CHICAGO – Four preoperative variables predict whether or not patients will survive ruptured abdominal aortic aneurysm repairs, according to investigators from Harborview Medical Center in Seattle.

It’s an important finding because until now, it’s been hard to know how they’ll do. Previous risk scores also rely on intraoperative variables, or haven’t been validated for endovascular repair.

Investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, explained in a video interview what the four variables are at a meeting hosted by the Society for Vascular Surgery, and why it was so important for a level 1 trauma center like Harborview to identify them.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

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Perioperative factors influenced open TAAA repair

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Open thoracoabdominal aortic aneurysm (TAAA) repair produced respectable early outcomes, although preoperative and intraoperative factors were found to influence risk, according to Dr. Joseph S. Coselli, who presented the results of the study he and his colleagues at the Baylor College of Medicine in Houston performed at the annual meeting of the American Association for Thoracic Surgery.

They analyzed data from 3,309 open TAAA repairs performed between October 1986 and December 2014.

“I have been very fortunate to have spent my entire career at Baylor College of Medicine, the epicenter of aortic surgery in the 1950s, ’60s, and ’70s, as well as to have been mentored by Dr. E. Stanley Crawford, who was arguably the finest aortic surgeon of his era. Since transitioning from Dr. Crawford’s surgical practice to my own surgical practice, we have kept his pioneering spirit alive by developing a multimodal strategy for thoracoabdominal aortic aneurysm repair that is based on the Crawford extent of repair and our evolving investigation. We sought to describe our series of over 3,000 TAAA repairs and to identify predictors of early death and other adverse postoperative outcomes,” said Dr. Coselli.

The median patient age was around 67 years, and the repairs involved acute or subacute aortic dissection in about 5% of the cases. Nearly 31% of the case involved chronic dissection, with nearly 22% emergent or urgent repairs and around 5% ruptured aneurysms. Connective tissue disorders were present in roughly 10% of patients. “Operatively, we tend to reserve surgical adjuncts for use in the most-extensive repairs, namely extents I and II TAAA repair; intercostal or lumbar artery reattachment was used in just over half of the repairs, left heart bypass (LHB) was used in around 45% of patients, cold renal perfusion was performed in 58%. and cerebrospinal fluid drainage (CSFD) was used in 45%,” said Dr. Coselli.

There was substantial atherosclerotic disease in older patients, and in nearly 41% of repairs, a visceral vessel procedure was performed.

Unlike many aortic centers that routinely use deep hypothermic circulatory arrest (HCA) for extensive TAAA repair, Dr. Coselli reserved this approach for a small number of highly complex repairs (1.4%) in which the aorta could not be safely clamped.

Of the more than a thousand most extensive (i.e., Crawford extent II) repairs, intercostal/lumbar artery reattachment was used in the vast majority (88%), LHB in 82%, and CSFD in 61%. They used multivariable analysis to identify predictors of operative (30-day or in-hospital) mortality and adverse event, a composite outcome comprising operative death and permanent (present at discharge) spinal cord deficit, renal failure, or stroke, according to Dr. Coselli.

Their results showed an operative mortality rate of 7.5%, a 30-day death rate of 4.8%, with the adverse event outcome occurring in about 14% of repairs. A video of his presentation is available at the AATS website.

The statistically significant predictors of operative death were rupture; renal insufficiency, symptoms, procedures targeting visceral vessels, increasing age, and increasing clamp time, while extent IV repair (the least extensive form of TAAA repair) was inversely associated with death. Their analysis showed that the significant predictors of adverse event were use of HCA, renal insufficiency, rupture, extent II repair, visceral vessel procedures, urgent or emergent repair, increasing age, and increasing clamp time. In addition, they used multivariable analysis to identify predictors of renal failure and paraplegia.

In the 3,060 early survivors, roughly 7% had a life-altering complication at discharge: Nearly 3% of patients had renal failure necessitating dialysis, slightly more than 1% had a unresolved stroke, and about 4% had unresolved paraplegia or paraparesis. Repair failure, primarily pseudoaneurysm, or patch aneurysm, occurred after nearly 3% of repairs, said Dr. Coselli.

Outcomes differed by extent of repair, with the risk being greatest in extent II repair. Actuarial survival was 63.6% at 5 years, 36.8% at 10 years, and 18.3% at 15 years. Freedom from repair failure was nearly 98% at 5 years, around 95% at 10 years, and 94% at 15 years.

“Along with respectable early outcomes, after repair, patients have acceptable long-term survival, and late repair failure was uncommon. Notably, there are several subgroups of patients that do exceedingly well. Paraplegia in young patients with connective tissue disorders, even in the most-extensive repair (extent II), is remarkably rare – these patients do extremely well across the board,” he concluded.

Dr. Cosselli reported that he is a principal investigator and consultant for Medtronic and W.L. Gore & Assoc., as well as being a principal investigator, consultant, and having various financial relationships with Vascutek.

 

 

mlesney@frontlinemedcom.com

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Open thoracoabdominal aortic aneurysm (TAAA) repair produced respectable early outcomes, although preoperative and intraoperative factors were found to influence risk, according to Dr. Joseph S. Coselli, who presented the results of the study he and his colleagues at the Baylor College of Medicine in Houston performed at the annual meeting of the American Association for Thoracic Surgery.

They analyzed data from 3,309 open TAAA repairs performed between October 1986 and December 2014.

“I have been very fortunate to have spent my entire career at Baylor College of Medicine, the epicenter of aortic surgery in the 1950s, ’60s, and ’70s, as well as to have been mentored by Dr. E. Stanley Crawford, who was arguably the finest aortic surgeon of his era. Since transitioning from Dr. Crawford’s surgical practice to my own surgical practice, we have kept his pioneering spirit alive by developing a multimodal strategy for thoracoabdominal aortic aneurysm repair that is based on the Crawford extent of repair and our evolving investigation. We sought to describe our series of over 3,000 TAAA repairs and to identify predictors of early death and other adverse postoperative outcomes,” said Dr. Coselli.

The median patient age was around 67 years, and the repairs involved acute or subacute aortic dissection in about 5% of the cases. Nearly 31% of the case involved chronic dissection, with nearly 22% emergent or urgent repairs and around 5% ruptured aneurysms. Connective tissue disorders were present in roughly 10% of patients. “Operatively, we tend to reserve surgical adjuncts for use in the most-extensive repairs, namely extents I and II TAAA repair; intercostal or lumbar artery reattachment was used in just over half of the repairs, left heart bypass (LHB) was used in around 45% of patients, cold renal perfusion was performed in 58%. and cerebrospinal fluid drainage (CSFD) was used in 45%,” said Dr. Coselli.

There was substantial atherosclerotic disease in older patients, and in nearly 41% of repairs, a visceral vessel procedure was performed.

Unlike many aortic centers that routinely use deep hypothermic circulatory arrest (HCA) for extensive TAAA repair, Dr. Coselli reserved this approach for a small number of highly complex repairs (1.4%) in which the aorta could not be safely clamped.

Of the more than a thousand most extensive (i.e., Crawford extent II) repairs, intercostal/lumbar artery reattachment was used in the vast majority (88%), LHB in 82%, and CSFD in 61%. They used multivariable analysis to identify predictors of operative (30-day or in-hospital) mortality and adverse event, a composite outcome comprising operative death and permanent (present at discharge) spinal cord deficit, renal failure, or stroke, according to Dr. Coselli.

Their results showed an operative mortality rate of 7.5%, a 30-day death rate of 4.8%, with the adverse event outcome occurring in about 14% of repairs. A video of his presentation is available at the AATS website.

The statistically significant predictors of operative death were rupture; renal insufficiency, symptoms, procedures targeting visceral vessels, increasing age, and increasing clamp time, while extent IV repair (the least extensive form of TAAA repair) was inversely associated with death. Their analysis showed that the significant predictors of adverse event were use of HCA, renal insufficiency, rupture, extent II repair, visceral vessel procedures, urgent or emergent repair, increasing age, and increasing clamp time. In addition, they used multivariable analysis to identify predictors of renal failure and paraplegia.

In the 3,060 early survivors, roughly 7% had a life-altering complication at discharge: Nearly 3% of patients had renal failure necessitating dialysis, slightly more than 1% had a unresolved stroke, and about 4% had unresolved paraplegia or paraparesis. Repair failure, primarily pseudoaneurysm, or patch aneurysm, occurred after nearly 3% of repairs, said Dr. Coselli.

Outcomes differed by extent of repair, with the risk being greatest in extent II repair. Actuarial survival was 63.6% at 5 years, 36.8% at 10 years, and 18.3% at 15 years. Freedom from repair failure was nearly 98% at 5 years, around 95% at 10 years, and 94% at 15 years.

“Along with respectable early outcomes, after repair, patients have acceptable long-term survival, and late repair failure was uncommon. Notably, there are several subgroups of patients that do exceedingly well. Paraplegia in young patients with connective tissue disorders, even in the most-extensive repair (extent II), is remarkably rare – these patients do extremely well across the board,” he concluded.

Dr. Cosselli reported that he is a principal investigator and consultant for Medtronic and W.L. Gore & Assoc., as well as being a principal investigator, consultant, and having various financial relationships with Vascutek.

 

 

mlesney@frontlinemedcom.com

Open thoracoabdominal aortic aneurysm (TAAA) repair produced respectable early outcomes, although preoperative and intraoperative factors were found to influence risk, according to Dr. Joseph S. Coselli, who presented the results of the study he and his colleagues at the Baylor College of Medicine in Houston performed at the annual meeting of the American Association for Thoracic Surgery.

They analyzed data from 3,309 open TAAA repairs performed between October 1986 and December 2014.

“I have been very fortunate to have spent my entire career at Baylor College of Medicine, the epicenter of aortic surgery in the 1950s, ’60s, and ’70s, as well as to have been mentored by Dr. E. Stanley Crawford, who was arguably the finest aortic surgeon of his era. Since transitioning from Dr. Crawford’s surgical practice to my own surgical practice, we have kept his pioneering spirit alive by developing a multimodal strategy for thoracoabdominal aortic aneurysm repair that is based on the Crawford extent of repair and our evolving investigation. We sought to describe our series of over 3,000 TAAA repairs and to identify predictors of early death and other adverse postoperative outcomes,” said Dr. Coselli.

The median patient age was around 67 years, and the repairs involved acute or subacute aortic dissection in about 5% of the cases. Nearly 31% of the case involved chronic dissection, with nearly 22% emergent or urgent repairs and around 5% ruptured aneurysms. Connective tissue disorders were present in roughly 10% of patients. “Operatively, we tend to reserve surgical adjuncts for use in the most-extensive repairs, namely extents I and II TAAA repair; intercostal or lumbar artery reattachment was used in just over half of the repairs, left heart bypass (LHB) was used in around 45% of patients, cold renal perfusion was performed in 58%. and cerebrospinal fluid drainage (CSFD) was used in 45%,” said Dr. Coselli.

There was substantial atherosclerotic disease in older patients, and in nearly 41% of repairs, a visceral vessel procedure was performed.

Unlike many aortic centers that routinely use deep hypothermic circulatory arrest (HCA) for extensive TAAA repair, Dr. Coselli reserved this approach for a small number of highly complex repairs (1.4%) in which the aorta could not be safely clamped.

Of the more than a thousand most extensive (i.e., Crawford extent II) repairs, intercostal/lumbar artery reattachment was used in the vast majority (88%), LHB in 82%, and CSFD in 61%. They used multivariable analysis to identify predictors of operative (30-day or in-hospital) mortality and adverse event, a composite outcome comprising operative death and permanent (present at discharge) spinal cord deficit, renal failure, or stroke, according to Dr. Coselli.

Their results showed an operative mortality rate of 7.5%, a 30-day death rate of 4.8%, with the adverse event outcome occurring in about 14% of repairs. A video of his presentation is available at the AATS website.

The statistically significant predictors of operative death were rupture; renal insufficiency, symptoms, procedures targeting visceral vessels, increasing age, and increasing clamp time, while extent IV repair (the least extensive form of TAAA repair) was inversely associated with death. Their analysis showed that the significant predictors of adverse event were use of HCA, renal insufficiency, rupture, extent II repair, visceral vessel procedures, urgent or emergent repair, increasing age, and increasing clamp time. In addition, they used multivariable analysis to identify predictors of renal failure and paraplegia.

In the 3,060 early survivors, roughly 7% had a life-altering complication at discharge: Nearly 3% of patients had renal failure necessitating dialysis, slightly more than 1% had a unresolved stroke, and about 4% had unresolved paraplegia or paraparesis. Repair failure, primarily pseudoaneurysm, or patch aneurysm, occurred after nearly 3% of repairs, said Dr. Coselli.

Outcomes differed by extent of repair, with the risk being greatest in extent II repair. Actuarial survival was 63.6% at 5 years, 36.8% at 10 years, and 18.3% at 15 years. Freedom from repair failure was nearly 98% at 5 years, around 95% at 10 years, and 94% at 15 years.

“Along with respectable early outcomes, after repair, patients have acceptable long-term survival, and late repair failure was uncommon. Notably, there are several subgroups of patients that do exceedingly well. Paraplegia in young patients with connective tissue disorders, even in the most-extensive repair (extent II), is remarkably rare – these patients do extremely well across the board,” he concluded.

Dr. Cosselli reported that he is a principal investigator and consultant for Medtronic and W.L. Gore & Assoc., as well as being a principal investigator, consultant, and having various financial relationships with Vascutek.

 

 

mlesney@frontlinemedcom.com

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Medicolegal issues: The consequences of AAA repair

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Dr. Risley together with associate editor Dr. O. William Brown describe a case involving failure to document, a common complaint in malpractice litigation.

A 63-year-old white male, actively working, presented with a 5.3-cm infra-renal abdominal aortic aneurysm (AAA). His anatomy was deemed appropriate for endovascular AAA repair and was cleared by his cardiologist for that procedure. The patient underwent a thorough informed consent regarding endovascular and open options as well as the option for continued AAA surveillance. Of note, the patient never had his family with him at any time during the decision-making process, nor with him in the preoperative holding area.

He underwent an aorto- bi- iliac unibody endovascular graft placement. During delivery of the main body, the right common iliac artery ruptured. Initial attempts at endovascular control and subsequent right retroperitoneal exposure and repair of the iliac rupture were unsuccessful, ultimately requiring laparotomy, explant of the device, and aorto- bi-femoral bypass graft. The first time the surgeon met the large family was at the completion of the procedure to explain the complications that were encountered. The patient had a very “rocky” ICU course with complications of ARDS (acute respiratory distress syndrome), acute renal insufficiency, anemia, encephalopathy, and thrombocytopenia. He was initially started on Lovenox on POD # 2 in addition to SCDs (sequential compression devices) for DVT prophylaxis.

Lovenox was stopped because of thrombocytopenia, and mechanical SCD prophylaxis was maintained. As his platelet count recovered and his HIT (heparin-induced thrombocytopenia) screen came back negative, discussion was undertaken to resume his chemical thromboprophylaxis.

It was elected to leave him on only the SCDs because of potential bleeding complications. He continued to improve, but developed a swollen left lower extremity as a result of a DVT. He was placed on heparin drip and converted to Coumadin. Despite an INR of 2.7 on the day he was to be discharged to the rehabilitation center, and shortly after a walk with the therapists and his family, he suffered a fatal pulmonary embolism.

Ultimately, the hospital, the intensivist and the surgeon were sued for failure to adequately provide prophylaxis and treat the DVT. The case was settled. The criticisms were that the physicians failed to provide both mechanical and chemical thromboprophylaxis, particularly after the HIT panel was negative. No criticisms of the intra-operative complications were levied.

The plaintiff’s expert in this case was a physician who was board certified in internal medicine, anesthesiology, and critical care. He had no training in general surgery or vascular surgery. Accordingly, although he may have made suggestions regarding post operative surgical care he had no experience in being the responsible physician for making a postoperative surgical decision. In addition, assertions regarding the incidence of DVT in specific patient populations were exaggerated. Yet the case still settled.

This case emphasizes several important issues. First, communication is paramount in potentially avoiding medical malpractice litigation. The surgeon never met anyone from the patient’s large and involved family until he had to explain the reason his 2-hour planned procedure took 8 hours. The patient had clearly minimized to his family any of the risks discussed with him preoperatively. Prior to proceeding with any surgical intervention it is important that, if possible, a family member be informed of the risks and benefits of the planned procedure and that this conversation be documented in the chart.

Documentation remains very important not only during the informed consent process prior to surgery, but also in decision making regarding postoperative care. Although the physicians discussed the options of resuming the patient’s chemothromboprophylaxis, nothing was documented in the chart. If the discussion was documented, they may have been able to refute the allegation of failure to prevent the DVT.

Finally, in certain instances even when the facts support the judgments that were made regarding the care given, it may be the best “business decision” to settle a case. This is perhaps the most difficult concept for practicing surgeons to grasp. Whether physicians like it or not, medicine is a business and decisions made regarding defending or settling a law suit should not be based on emotion. We don’t do that in the operating room, and we should not do it in the courtroom.

Dr. Risley is the medical director of the Jacksonville Vein Center, Fla.

The opinions expressed by the author neither imply nor establish a standard of care. Cases have been modified and may be fictional in order to maintain HIPPA and confidentiality regulations.

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Dr. Risley together with associate editor Dr. O. William Brown describe a case involving failure to document, a common complaint in malpractice litigation.

A 63-year-old white male, actively working, presented with a 5.3-cm infra-renal abdominal aortic aneurysm (AAA). His anatomy was deemed appropriate for endovascular AAA repair and was cleared by his cardiologist for that procedure. The patient underwent a thorough informed consent regarding endovascular and open options as well as the option for continued AAA surveillance. Of note, the patient never had his family with him at any time during the decision-making process, nor with him in the preoperative holding area.

He underwent an aorto- bi- iliac unibody endovascular graft placement. During delivery of the main body, the right common iliac artery ruptured. Initial attempts at endovascular control and subsequent right retroperitoneal exposure and repair of the iliac rupture were unsuccessful, ultimately requiring laparotomy, explant of the device, and aorto- bi-femoral bypass graft. The first time the surgeon met the large family was at the completion of the procedure to explain the complications that were encountered. The patient had a very “rocky” ICU course with complications of ARDS (acute respiratory distress syndrome), acute renal insufficiency, anemia, encephalopathy, and thrombocytopenia. He was initially started on Lovenox on POD # 2 in addition to SCDs (sequential compression devices) for DVT prophylaxis.

Lovenox was stopped because of thrombocytopenia, and mechanical SCD prophylaxis was maintained. As his platelet count recovered and his HIT (heparin-induced thrombocytopenia) screen came back negative, discussion was undertaken to resume his chemical thromboprophylaxis.

It was elected to leave him on only the SCDs because of potential bleeding complications. He continued to improve, but developed a swollen left lower extremity as a result of a DVT. He was placed on heparin drip and converted to Coumadin. Despite an INR of 2.7 on the day he was to be discharged to the rehabilitation center, and shortly after a walk with the therapists and his family, he suffered a fatal pulmonary embolism.

Ultimately, the hospital, the intensivist and the surgeon were sued for failure to adequately provide prophylaxis and treat the DVT. The case was settled. The criticisms were that the physicians failed to provide both mechanical and chemical thromboprophylaxis, particularly after the HIT panel was negative. No criticisms of the intra-operative complications were levied.

The plaintiff’s expert in this case was a physician who was board certified in internal medicine, anesthesiology, and critical care. He had no training in general surgery or vascular surgery. Accordingly, although he may have made suggestions regarding post operative surgical care he had no experience in being the responsible physician for making a postoperative surgical decision. In addition, assertions regarding the incidence of DVT in specific patient populations were exaggerated. Yet the case still settled.

This case emphasizes several important issues. First, communication is paramount in potentially avoiding medical malpractice litigation. The surgeon never met anyone from the patient’s large and involved family until he had to explain the reason his 2-hour planned procedure took 8 hours. The patient had clearly minimized to his family any of the risks discussed with him preoperatively. Prior to proceeding with any surgical intervention it is important that, if possible, a family member be informed of the risks and benefits of the planned procedure and that this conversation be documented in the chart.

Documentation remains very important not only during the informed consent process prior to surgery, but also in decision making regarding postoperative care. Although the physicians discussed the options of resuming the patient’s chemothromboprophylaxis, nothing was documented in the chart. If the discussion was documented, they may have been able to refute the allegation of failure to prevent the DVT.

Finally, in certain instances even when the facts support the judgments that were made regarding the care given, it may be the best “business decision” to settle a case. This is perhaps the most difficult concept for practicing surgeons to grasp. Whether physicians like it or not, medicine is a business and decisions made regarding defending or settling a law suit should not be based on emotion. We don’t do that in the operating room, and we should not do it in the courtroom.

Dr. Risley is the medical director of the Jacksonville Vein Center, Fla.

The opinions expressed by the author neither imply nor establish a standard of care. Cases have been modified and may be fictional in order to maintain HIPPA and confidentiality regulations.

Dr. Risley together with associate editor Dr. O. William Brown describe a case involving failure to document, a common complaint in malpractice litigation.

A 63-year-old white male, actively working, presented with a 5.3-cm infra-renal abdominal aortic aneurysm (AAA). His anatomy was deemed appropriate for endovascular AAA repair and was cleared by his cardiologist for that procedure. The patient underwent a thorough informed consent regarding endovascular and open options as well as the option for continued AAA surveillance. Of note, the patient never had his family with him at any time during the decision-making process, nor with him in the preoperative holding area.

He underwent an aorto- bi- iliac unibody endovascular graft placement. During delivery of the main body, the right common iliac artery ruptured. Initial attempts at endovascular control and subsequent right retroperitoneal exposure and repair of the iliac rupture were unsuccessful, ultimately requiring laparotomy, explant of the device, and aorto- bi-femoral bypass graft. The first time the surgeon met the large family was at the completion of the procedure to explain the complications that were encountered. The patient had a very “rocky” ICU course with complications of ARDS (acute respiratory distress syndrome), acute renal insufficiency, anemia, encephalopathy, and thrombocytopenia. He was initially started on Lovenox on POD # 2 in addition to SCDs (sequential compression devices) for DVT prophylaxis.

Lovenox was stopped because of thrombocytopenia, and mechanical SCD prophylaxis was maintained. As his platelet count recovered and his HIT (heparin-induced thrombocytopenia) screen came back negative, discussion was undertaken to resume his chemical thromboprophylaxis.

It was elected to leave him on only the SCDs because of potential bleeding complications. He continued to improve, but developed a swollen left lower extremity as a result of a DVT. He was placed on heparin drip and converted to Coumadin. Despite an INR of 2.7 on the day he was to be discharged to the rehabilitation center, and shortly after a walk with the therapists and his family, he suffered a fatal pulmonary embolism.

Ultimately, the hospital, the intensivist and the surgeon were sued for failure to adequately provide prophylaxis and treat the DVT. The case was settled. The criticisms were that the physicians failed to provide both mechanical and chemical thromboprophylaxis, particularly after the HIT panel was negative. No criticisms of the intra-operative complications were levied.

The plaintiff’s expert in this case was a physician who was board certified in internal medicine, anesthesiology, and critical care. He had no training in general surgery or vascular surgery. Accordingly, although he may have made suggestions regarding post operative surgical care he had no experience in being the responsible physician for making a postoperative surgical decision. In addition, assertions regarding the incidence of DVT in specific patient populations were exaggerated. Yet the case still settled.

This case emphasizes several important issues. First, communication is paramount in potentially avoiding medical malpractice litigation. The surgeon never met anyone from the patient’s large and involved family until he had to explain the reason his 2-hour planned procedure took 8 hours. The patient had clearly minimized to his family any of the risks discussed with him preoperatively. Prior to proceeding with any surgical intervention it is important that, if possible, a family member be informed of the risks and benefits of the planned procedure and that this conversation be documented in the chart.

Documentation remains very important not only during the informed consent process prior to surgery, but also in decision making regarding postoperative care. Although the physicians discussed the options of resuming the patient’s chemothromboprophylaxis, nothing was documented in the chart. If the discussion was documented, they may have been able to refute the allegation of failure to prevent the DVT.

Finally, in certain instances even when the facts support the judgments that were made regarding the care given, it may be the best “business decision” to settle a case. This is perhaps the most difficult concept for practicing surgeons to grasp. Whether physicians like it or not, medicine is a business and decisions made regarding defending or settling a law suit should not be based on emotion. We don’t do that in the operating room, and we should not do it in the courtroom.

Dr. Risley is the medical director of the Jacksonville Vein Center, Fla.

The opinions expressed by the author neither imply nor establish a standard of care. Cases have been modified and may be fictional in order to maintain HIPPA and confidentiality regulations.

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Mortality, outcomes good in AAA repair in octogenarians

Elective AAA repair worth the cost
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Mortality, outcomes good in AAA repair in octogenarians

SCOTTSDALE, ARIZ.– Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.

Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.

 

Courtesy Wikimedia Commons/Milorad Dimic, MD/Creative Commons License

According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting.

“However, whether we should be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria; there were nearly seven men for every woman, all with a median age of 83 years. Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).

Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation–related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.

A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).

Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data were warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”

The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.

 

Dr. Samuel R. Money
Dr. Samuel R. Money

“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.

 

 

As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost-effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”

“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within 6 months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

Body

This discussion is provocative and raises some interesting points. Obviously cost-effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.

This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.

 

Dr. Frank J. Veith

I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.

Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.

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Body

This discussion is provocative and raises some interesting points. Obviously cost-effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.

This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.

 

Dr. Frank J. Veith

I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.

Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.

Body

This discussion is provocative and raises some interesting points. Obviously cost-effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.

This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.

 

Dr. Frank J. Veith

I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.

Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.

Title
Elective AAA repair worth the cost
Elective AAA repair worth the cost

SCOTTSDALE, ARIZ.– Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.

Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.

 

Courtesy Wikimedia Commons/Milorad Dimic, MD/Creative Commons License

According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting.

“However, whether we should be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria; there were nearly seven men for every woman, all with a median age of 83 years. Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).

Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation–related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.

A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).

Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data were warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”

The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.

 

Dr. Samuel R. Money
Dr. Samuel R. Money

“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.

 

 

As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost-effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”

“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within 6 months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ.– Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.

Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.

 

Courtesy Wikimedia Commons/Milorad Dimic, MD/Creative Commons License

According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting.

“However, whether we should be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria; there were nearly seven men for every woman, all with a median age of 83 years. Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).

Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation–related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.

A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).

Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data were warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”

The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.

 

Dr. Samuel R. Money
Dr. Samuel R. Money

“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.

 

 

As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost-effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”

“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within 6 months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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