Hybrid approach tackles critical limb ischemia

The value of the hybrid approach
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Hybrid approach tackles critical limb ischemia

CHICAGO – A hybrid approach combining external iliac endarterectomy with stenting may offer vascular surgeons a more robust option to stenting alone or aortofemoral bypass in patients with critical limb ischemia.

“Hybrid-based iliofemoral endarterectomy provides a minimally invasive option for revascularization, producing robust inflow restoration and low perioperative morbidity,” study author Dr. Crystal Kavanagh of St. Joseph Mercy Health Center in Ann Arbor, Mich., said.

Dr. Crystal Kavanagh
Patrice Wendling/Frontline Medical News
Dr. Crystal Kavanagh

The 5-year retrospective series, presented here at the annual meeting of the Midwestern Vascular Surgical Society, earned the prestigious Szilagyi Award for best clinical research.

Dr. Kavanagh and her colleagues crafted the hybrid technique because conventional open approaches in managing external iliac occlusive disease are associated with considerable morbidity. At the same time, long or multisegmental external iliac-to-femoral arterial lesions treated with stenting alone have produced poor patency and typically require additional outflow procedures, she explained.

The technique uses external iliac endarterectomy, aided with a traditional moll-ring stripper. A longitudinal, femoral cut-down is completed. A wire is advanced through the ipsilateral external iliac artery into the aorta after heparinization and obtaining access via an 18-gauge micropuncture in the common femoral artery. Intraluminal positioning is confirmed and a moll-ring endarterectomy is completed over the wire using a balloon to create the distal transection point, Dr. Kavanagh explained. The moll-ring is sized to the maximum diameter that will be accommodated by the ring.

After partially deflating the balloon, the plaque is extracted. A long-segment endarterectomy is typically completed, leaving a widely patent external iliac artery, she said.

In cases where adjunct iliac stenting is required, such as a proximal dissection flap, the stent size is larger than what is typically placed with stenting alone, Dr. Kavanagh observed.

The 2007 TASC (TransAtlantic InterSociety Consensus) recommendations suggest that TASC A lesions should undergo endovascular treatment as first-line therapy, while TASC D lesions should undergo traditional open surgical bypass.

Consensus has been slow to form for TASC B and C lesions, although most TASC B lesions undergo endovascular treatment and most TASC C lesions undergo open bypass.

Among the 40 limbs in the series, a common iliac (CI) artery stent (mean diameter, 8 mm: mean length, 59 mm) was placed in 19 limbs; a CI-to-external iliac (EI) stent (mean diameter, 10 mm; mean length, 100 mm) in 7 limbs; and an EI stent (mean diameter, 10 mm; mean length, 100 mm) in 21 limbs.

None of the iliac lesions were TASC category A or B, 17% were TASC C, and 83% TASC D. Concomitant infrainguinal disease of these patients had femoral/popliteal lesions, of which 16% were type A, 33% type B, 19% type C, and 32% type D.

Half of the 33 patients had three-vessel runoff, 33% two-vessel runoff, and 17% single-vessel runoff.

The hybrid procedure was completed as planned in all 40 limbs, Dr. Kavanagh said. There was no intraoperative or 90-day mortality.

Perioperative complications were minimal, with a 30-day readmission rate of only 12%, she said. This included one patient with one-vessel run-off who re-presented with ischemia requiring common femoral-to-below-the-knee popliteal bypass.

A second patient was admitted at postoperative day 47 with an infected pseudoaneurysm requiring patch angioplasty revision, for a 90-day readmission rate of 15%.

“Concerns about potential plaque rupture or hemorrhage can easily be dealt with via a covered stent graft, given intraluminal wire access throughout the procedure,” senior author Dr. Abdulhameed Aziz said in an interview.

Significant gains were made from baseline in postoperative ankle-brachial index (mean, 0.4 vs. 076; P less than .001), as well as in toe pressures (mean, 32 mm Hg vs. 60 mm Hg; P less than .001), Dr. Kavanagh said.

After a median follow-up of 13 months, primary patency was 100%.

“Combined common femoral endarterectomy with iliac stenting has demonstrated comparable patency to operative bypass in the short term,” she said.

“We theorize that the longer-segment endarterectomy, in our case essentially going from the iliac bifurcation to the common femoral, may produce a more durable result ... Stenting the proximal transection point may prevent restenosis.”

The authors reported no financial disclosures.

pwendling@frontlinemedcom.com

References

Body

The combination of open surgical procedures with endovascular interventions has enriched the spectrum of vascular reconstructions significantly. These so-called hybrid procedures are especially worthwhile if pros and cons of both approaches could be combined and the groin could be considered as the hub. Technically spoken, the groin is the ideal hub for these kind of procedures. Why is that the case? Usually the surgical access to the common femoral artery (CFA) is easy. Furthermore the long-term results of femoral/retrograde iliac endarterectomy (often in combination with profundoplasty) are undoubtedly excellent. For the endovascular world, the (almost) NO-GO for any metal in the groin is still valid, and balloon dilatation of the femoral arteries is hemodynamically insufficient in most cases. However, PTA [percutaneous transluminal angioplasty] and stenting of the iliac arteries comes with good long-term results and avoids the sometimes-extended surgical access via the abdomen or the retroperitoneum.

Technically, it is advisable to perform the procedure in the following way: exposure of the CFA up to the inguinal ligament and down to the proximal superficial and deep femoral artery; puncture of the CFA in a noncalcified area and retrograde guide-wire access to the distal aorta (confirmation by angiography); balloon blockage of the proximal iliac artery (if technically possible; open endarterectomy of the CFA (including the proximal superficial and deep femoral artery; and retrograde ring-stripper endarterectomy of the iliac arteries and reconstruction of the femoral arteries (patchplasty, femoral transposition, profundoplasty). Balloon dilatation and stenting will be performed at the end of the procedure via a 7F or 9F sheath. We prefer balloon-expandable stents for the common and self-expandable stents for the external iliac artery, respectively. The contralateral groin should also be prepared for kissing stenting of both iliac arteries. Very rarely, an antegrade iliac access (via contralateral or brachial) access) is necessary. Whether or not covered stents have better long-term results is an open issue, however, covered stents should always be available to treat rare complications like an iatrogenic iliac rupture.

Especially Rutherford stage 5 or 6 patients very often present with multisegment disease including the femoropopliteal and the crural arteries. Since an even perfect inguinal inflow might not be sufficient in CLI [critical limb ischemia], these patients often need additional open or endovascular procedures. Again, the latter can be performed simultaneously via the hub femoral artery.

Even though hybrid procedures have been an essential part of vascular surgical practice for some years now, the Midwestern Vascular Surgical Society and Dr. Kavanagh have to be congratulated for raising this clinically very important topic again.

Dr. Hans-Henning Eckstein is a Professor at the Department for Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University Munich, and is an associate medical editor for Vascular Specialist.

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The combination of open surgical procedures with endovascular interventions has enriched the spectrum of vascular reconstructions significantly. These so-called hybrid procedures are especially worthwhile if pros and cons of both approaches could be combined and the groin could be considered as the hub. Technically spoken, the groin is the ideal hub for these kind of procedures. Why is that the case? Usually the surgical access to the common femoral artery (CFA) is easy. Furthermore the long-term results of femoral/retrograde iliac endarterectomy (often in combination with profundoplasty) are undoubtedly excellent. For the endovascular world, the (almost) NO-GO for any metal in the groin is still valid, and balloon dilatation of the femoral arteries is hemodynamically insufficient in most cases. However, PTA [percutaneous transluminal angioplasty] and stenting of the iliac arteries comes with good long-term results and avoids the sometimes-extended surgical access via the abdomen or the retroperitoneum.

Technically, it is advisable to perform the procedure in the following way: exposure of the CFA up to the inguinal ligament and down to the proximal superficial and deep femoral artery; puncture of the CFA in a noncalcified area and retrograde guide-wire access to the distal aorta (confirmation by angiography); balloon blockage of the proximal iliac artery (if technically possible; open endarterectomy of the CFA (including the proximal superficial and deep femoral artery; and retrograde ring-stripper endarterectomy of the iliac arteries and reconstruction of the femoral arteries (patchplasty, femoral transposition, profundoplasty). Balloon dilatation and stenting will be performed at the end of the procedure via a 7F or 9F sheath. We prefer balloon-expandable stents for the common and self-expandable stents for the external iliac artery, respectively. The contralateral groin should also be prepared for kissing stenting of both iliac arteries. Very rarely, an antegrade iliac access (via contralateral or brachial) access) is necessary. Whether or not covered stents have better long-term results is an open issue, however, covered stents should always be available to treat rare complications like an iatrogenic iliac rupture.

Especially Rutherford stage 5 or 6 patients very often present with multisegment disease including the femoropopliteal and the crural arteries. Since an even perfect inguinal inflow might not be sufficient in CLI [critical limb ischemia], these patients often need additional open or endovascular procedures. Again, the latter can be performed simultaneously via the hub femoral artery.

Even though hybrid procedures have been an essential part of vascular surgical practice for some years now, the Midwestern Vascular Surgical Society and Dr. Kavanagh have to be congratulated for raising this clinically very important topic again.

Dr. Hans-Henning Eckstein is a Professor at the Department for Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University Munich, and is an associate medical editor for Vascular Specialist.

Body

The combination of open surgical procedures with endovascular interventions has enriched the spectrum of vascular reconstructions significantly. These so-called hybrid procedures are especially worthwhile if pros and cons of both approaches could be combined and the groin could be considered as the hub. Technically spoken, the groin is the ideal hub for these kind of procedures. Why is that the case? Usually the surgical access to the common femoral artery (CFA) is easy. Furthermore the long-term results of femoral/retrograde iliac endarterectomy (often in combination with profundoplasty) are undoubtedly excellent. For the endovascular world, the (almost) NO-GO for any metal in the groin is still valid, and balloon dilatation of the femoral arteries is hemodynamically insufficient in most cases. However, PTA [percutaneous transluminal angioplasty] and stenting of the iliac arteries comes with good long-term results and avoids the sometimes-extended surgical access via the abdomen or the retroperitoneum.

Technically, it is advisable to perform the procedure in the following way: exposure of the CFA up to the inguinal ligament and down to the proximal superficial and deep femoral artery; puncture of the CFA in a noncalcified area and retrograde guide-wire access to the distal aorta (confirmation by angiography); balloon blockage of the proximal iliac artery (if technically possible; open endarterectomy of the CFA (including the proximal superficial and deep femoral artery; and retrograde ring-stripper endarterectomy of the iliac arteries and reconstruction of the femoral arteries (patchplasty, femoral transposition, profundoplasty). Balloon dilatation and stenting will be performed at the end of the procedure via a 7F or 9F sheath. We prefer balloon-expandable stents for the common and self-expandable stents for the external iliac artery, respectively. The contralateral groin should also be prepared for kissing stenting of both iliac arteries. Very rarely, an antegrade iliac access (via contralateral or brachial) access) is necessary. Whether or not covered stents have better long-term results is an open issue, however, covered stents should always be available to treat rare complications like an iatrogenic iliac rupture.

Especially Rutherford stage 5 or 6 patients very often present with multisegment disease including the femoropopliteal and the crural arteries. Since an even perfect inguinal inflow might not be sufficient in CLI [critical limb ischemia], these patients often need additional open or endovascular procedures. Again, the latter can be performed simultaneously via the hub femoral artery.

Even though hybrid procedures have been an essential part of vascular surgical practice for some years now, the Midwestern Vascular Surgical Society and Dr. Kavanagh have to be congratulated for raising this clinically very important topic again.

Dr. Hans-Henning Eckstein is a Professor at the Department for Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University Munich, and is an associate medical editor for Vascular Specialist.

Title
The value of the hybrid approach
The value of the hybrid approach

CHICAGO – A hybrid approach combining external iliac endarterectomy with stenting may offer vascular surgeons a more robust option to stenting alone or aortofemoral bypass in patients with critical limb ischemia.

“Hybrid-based iliofemoral endarterectomy provides a minimally invasive option for revascularization, producing robust inflow restoration and low perioperative morbidity,” study author Dr. Crystal Kavanagh of St. Joseph Mercy Health Center in Ann Arbor, Mich., said.

Dr. Crystal Kavanagh
Patrice Wendling/Frontline Medical News
Dr. Crystal Kavanagh

The 5-year retrospective series, presented here at the annual meeting of the Midwestern Vascular Surgical Society, earned the prestigious Szilagyi Award for best clinical research.

Dr. Kavanagh and her colleagues crafted the hybrid technique because conventional open approaches in managing external iliac occlusive disease are associated with considerable morbidity. At the same time, long or multisegmental external iliac-to-femoral arterial lesions treated with stenting alone have produced poor patency and typically require additional outflow procedures, she explained.

The technique uses external iliac endarterectomy, aided with a traditional moll-ring stripper. A longitudinal, femoral cut-down is completed. A wire is advanced through the ipsilateral external iliac artery into the aorta after heparinization and obtaining access via an 18-gauge micropuncture in the common femoral artery. Intraluminal positioning is confirmed and a moll-ring endarterectomy is completed over the wire using a balloon to create the distal transection point, Dr. Kavanagh explained. The moll-ring is sized to the maximum diameter that will be accommodated by the ring.

After partially deflating the balloon, the plaque is extracted. A long-segment endarterectomy is typically completed, leaving a widely patent external iliac artery, she said.

In cases where adjunct iliac stenting is required, such as a proximal dissection flap, the stent size is larger than what is typically placed with stenting alone, Dr. Kavanagh observed.

The 2007 TASC (TransAtlantic InterSociety Consensus) recommendations suggest that TASC A lesions should undergo endovascular treatment as first-line therapy, while TASC D lesions should undergo traditional open surgical bypass.

Consensus has been slow to form for TASC B and C lesions, although most TASC B lesions undergo endovascular treatment and most TASC C lesions undergo open bypass.

Among the 40 limbs in the series, a common iliac (CI) artery stent (mean diameter, 8 mm: mean length, 59 mm) was placed in 19 limbs; a CI-to-external iliac (EI) stent (mean diameter, 10 mm; mean length, 100 mm) in 7 limbs; and an EI stent (mean diameter, 10 mm; mean length, 100 mm) in 21 limbs.

None of the iliac lesions were TASC category A or B, 17% were TASC C, and 83% TASC D. Concomitant infrainguinal disease of these patients had femoral/popliteal lesions, of which 16% were type A, 33% type B, 19% type C, and 32% type D.

Half of the 33 patients had three-vessel runoff, 33% two-vessel runoff, and 17% single-vessel runoff.

The hybrid procedure was completed as planned in all 40 limbs, Dr. Kavanagh said. There was no intraoperative or 90-day mortality.

Perioperative complications were minimal, with a 30-day readmission rate of only 12%, she said. This included one patient with one-vessel run-off who re-presented with ischemia requiring common femoral-to-below-the-knee popliteal bypass.

A second patient was admitted at postoperative day 47 with an infected pseudoaneurysm requiring patch angioplasty revision, for a 90-day readmission rate of 15%.

“Concerns about potential plaque rupture or hemorrhage can easily be dealt with via a covered stent graft, given intraluminal wire access throughout the procedure,” senior author Dr. Abdulhameed Aziz said in an interview.

Significant gains were made from baseline in postoperative ankle-brachial index (mean, 0.4 vs. 076; P less than .001), as well as in toe pressures (mean, 32 mm Hg vs. 60 mm Hg; P less than .001), Dr. Kavanagh said.

After a median follow-up of 13 months, primary patency was 100%.

“Combined common femoral endarterectomy with iliac stenting has demonstrated comparable patency to operative bypass in the short term,” she said.

“We theorize that the longer-segment endarterectomy, in our case essentially going from the iliac bifurcation to the common femoral, may produce a more durable result ... Stenting the proximal transection point may prevent restenosis.”

The authors reported no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – A hybrid approach combining external iliac endarterectomy with stenting may offer vascular surgeons a more robust option to stenting alone or aortofemoral bypass in patients with critical limb ischemia.

“Hybrid-based iliofemoral endarterectomy provides a minimally invasive option for revascularization, producing robust inflow restoration and low perioperative morbidity,” study author Dr. Crystal Kavanagh of St. Joseph Mercy Health Center in Ann Arbor, Mich., said.

Dr. Crystal Kavanagh
Patrice Wendling/Frontline Medical News
Dr. Crystal Kavanagh

The 5-year retrospective series, presented here at the annual meeting of the Midwestern Vascular Surgical Society, earned the prestigious Szilagyi Award for best clinical research.

Dr. Kavanagh and her colleagues crafted the hybrid technique because conventional open approaches in managing external iliac occlusive disease are associated with considerable morbidity. At the same time, long or multisegmental external iliac-to-femoral arterial lesions treated with stenting alone have produced poor patency and typically require additional outflow procedures, she explained.

The technique uses external iliac endarterectomy, aided with a traditional moll-ring stripper. A longitudinal, femoral cut-down is completed. A wire is advanced through the ipsilateral external iliac artery into the aorta after heparinization and obtaining access via an 18-gauge micropuncture in the common femoral artery. Intraluminal positioning is confirmed and a moll-ring endarterectomy is completed over the wire using a balloon to create the distal transection point, Dr. Kavanagh explained. The moll-ring is sized to the maximum diameter that will be accommodated by the ring.

After partially deflating the balloon, the plaque is extracted. A long-segment endarterectomy is typically completed, leaving a widely patent external iliac artery, she said.

In cases where adjunct iliac stenting is required, such as a proximal dissection flap, the stent size is larger than what is typically placed with stenting alone, Dr. Kavanagh observed.

The 2007 TASC (TransAtlantic InterSociety Consensus) recommendations suggest that TASC A lesions should undergo endovascular treatment as first-line therapy, while TASC D lesions should undergo traditional open surgical bypass.

Consensus has been slow to form for TASC B and C lesions, although most TASC B lesions undergo endovascular treatment and most TASC C lesions undergo open bypass.

Among the 40 limbs in the series, a common iliac (CI) artery stent (mean diameter, 8 mm: mean length, 59 mm) was placed in 19 limbs; a CI-to-external iliac (EI) stent (mean diameter, 10 mm; mean length, 100 mm) in 7 limbs; and an EI stent (mean diameter, 10 mm; mean length, 100 mm) in 21 limbs.

None of the iliac lesions were TASC category A or B, 17% were TASC C, and 83% TASC D. Concomitant infrainguinal disease of these patients had femoral/popliteal lesions, of which 16% were type A, 33% type B, 19% type C, and 32% type D.

Half of the 33 patients had three-vessel runoff, 33% two-vessel runoff, and 17% single-vessel runoff.

The hybrid procedure was completed as planned in all 40 limbs, Dr. Kavanagh said. There was no intraoperative or 90-day mortality.

Perioperative complications were minimal, with a 30-day readmission rate of only 12%, she said. This included one patient with one-vessel run-off who re-presented with ischemia requiring common femoral-to-below-the-knee popliteal bypass.

A second patient was admitted at postoperative day 47 with an infected pseudoaneurysm requiring patch angioplasty revision, for a 90-day readmission rate of 15%.

“Concerns about potential plaque rupture or hemorrhage can easily be dealt with via a covered stent graft, given intraluminal wire access throughout the procedure,” senior author Dr. Abdulhameed Aziz said in an interview.

Significant gains were made from baseline in postoperative ankle-brachial index (mean, 0.4 vs. 076; P less than .001), as well as in toe pressures (mean, 32 mm Hg vs. 60 mm Hg; P less than .001), Dr. Kavanagh said.

After a median follow-up of 13 months, primary patency was 100%.

“Combined common femoral endarterectomy with iliac stenting has demonstrated comparable patency to operative bypass in the short term,” she said.

“We theorize that the longer-segment endarterectomy, in our case essentially going from the iliac bifurcation to the common femoral, may produce a more durable result ... Stenting the proximal transection point may prevent restenosis.”

The authors reported no financial disclosures.

pwendling@frontlinemedcom.com

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Hybrid approach tackles critical limb ischemia
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Hybrid approach tackles critical limb ischemia
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Key clinical point: Hybrid-based iliofemoral endarterectomy provides robust inflow restoration comparable to aortofemoral bypass, with minimal perioperative morbidity.

Major finding: Primary patency was 100% with a mean follow-up of 13 months.

Data source: Five-year retrospective study in 40 limbs in 33 patients with critical limb ischemia.

Disclosures: The authors reported having no financial disclosures.

Reattaching intercostals fails to squelch spinal cord ischemia in TAAA repairs

Counting on collaterals
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Reattaching intercostals fails to squelch spinal cord ischemia in TAAA repairs

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

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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.

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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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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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Women dogged by unplanned readmissions after aortic surgery

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.

Readmissions rise with endovascular lower limb procedures

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CHICAGO – Endovascular lower-extremity procedures were not associated with lower 30-day readmission rates compared with open surgery in a retrospective review of 7,089 patients.

All-cause, 30-day readmissions were actually higher with an endovascular approach at 12.3% vs. 9.6% for open procedures (Relative risk, 1.28; P = .0003).

Among all patients, an index diagnosis of gangrene was most predictive of readmission (RR, 1.89; P less than .0001), Dr. Todd R. Vogel said at the annual meeting of the Midwestern Vascular Surgical Society.

The data were compiled from 7,089 patients in the Cerner Health Facts database who were admitted for peripheral artery disease and elective lower extremity procedures (3,615 open; 3,474 endo) between September 2008 and March 2014. Their average age was 67.7 years, 44.7% were aged 70 years or older, 60% were men, and 21% were African American.

Dr. Todd R. Vogel
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Dr. Todd R. Vogel

Older patients and men were significantly more likely to receive endovascular procedures (P less than .0001), said Dr. Vogel, chief of vascular surgery, University of Missouri Health System in Columbia.

Overall, 767 patients (11%) were readmitted (344 open; 423 endo), with gangrene accounting for 21.7% of readmissions.

Other index diagnoses associated with higher 30-day readmissions for all lower extremity procedures were fluid and electrolyte disorders, chronic anemia, lower extremity infection, heart failure, chronic kidney disease, and chronic pulmonary disease.

When stratified by procedure type, the reasons for readmission were very different within the same population of patients based on procedure type, Dr. Vogel said.

Patients who underwent an open procedure were more likely to be readmitted if they had heart failure (RR, 1.78; P less than .0001) or posthemorrhagic anemia (RR, 1.54: P = .006).

Infections – be they lower extremity infection, other infection, postoperative infection, or sepsis – were not predictive of readmission when documented at the index admission for the open cohort.

In contrast, chronic conditions were the major predictors of readmission for patients undergoing endovascular procedures, he said. They included chronic anemia (RR, 1.58; P less than .0001), chronic airway obstruction (RR, 1.36; P = .0095), chronic heart disease (RR, 1.33; P = .0019), chronic kidney disease (RR, 1.37; P = .0013), diabetes (RR, 1.34; P = .0012), and hypertension (RR, 1.27; P = .023).

Fluid and electrolyte disorders (RR, 1.65, P less than .0001) and lower extremity infections (RR, 1.57, P = .0016) were also significant predictors of readmission in the endovascular group.

To ensure there were no disparities between index and readmission diagnoses, a final analysis was performed by procedure type in the 767 readmissions. It confirmed that for the endovascular procedures, chronic problems are bringing patients back to the hospital and not necessarily complications from the procedure, whereas infections, device complications, and hemorrhage are the reasons open surgery patients return, Dr. Vogel said.

“The question is are chronic conditions associated with readmissions the fault of the intervention? As physicians can we hope to curb this in patients who have chronic problems and are then readmitted?” he said.

Some audience members argued that no matter if the patient had a chronic condition or not preoperatively, the responsibility rests with the surgeon because he or she opted to put the patient through an elective endovascular procedure and now they’re returning with chronic heart failure, for example.

Dr. Vogel said this was the first pass at the data and trying to understand what drives readmissions and that it’s possible an endovascular procedure could exacerbate a chronic condition, but that surgeons should take steps to mitigate readmission risk in those with known chronic conditions.

Other attendees questioned how many of the readmissions were planned, hinting that the readmissions may not be directly related to the endovascular technique.

Dr. Vogel said it was difficult using only the ICD-9 codes in the database to determine exactly how many readmissions were planned, but noted that further analyses are intended.

“Reasons for readmission can be exacerbation of chronic patient issues, as seen in the endovascular group, or may be secondary to later complications of the procedure such as wound infections and device complications, as seen after open bypass procedures,” he said in an interview. “Identifying patients with increased risk for readmission after vascular procedures may lead to more effective and higher quality care during the index hospitalization. Our future studies will focus on a more detailed, granular evaluation of these high-risk diagnoses groups through use of the electronic medical record.”

Dr. Vogel reported having no financial disclosures.

pwendling@frontlinemedcom.com

On Twitter @pwendl

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CHICAGO – Endovascular lower-extremity procedures were not associated with lower 30-day readmission rates compared with open surgery in a retrospective review of 7,089 patients.

All-cause, 30-day readmissions were actually higher with an endovascular approach at 12.3% vs. 9.6% for open procedures (Relative risk, 1.28; P = .0003).

Among all patients, an index diagnosis of gangrene was most predictive of readmission (RR, 1.89; P less than .0001), Dr. Todd R. Vogel said at the annual meeting of the Midwestern Vascular Surgical Society.

The data were compiled from 7,089 patients in the Cerner Health Facts database who were admitted for peripheral artery disease and elective lower extremity procedures (3,615 open; 3,474 endo) between September 2008 and March 2014. Their average age was 67.7 years, 44.7% were aged 70 years or older, 60% were men, and 21% were African American.

Dr. Todd R. Vogel
Frontline Medical News
Dr. Todd R. Vogel

Older patients and men were significantly more likely to receive endovascular procedures (P less than .0001), said Dr. Vogel, chief of vascular surgery, University of Missouri Health System in Columbia.

Overall, 767 patients (11%) were readmitted (344 open; 423 endo), with gangrene accounting for 21.7% of readmissions.

Other index diagnoses associated with higher 30-day readmissions for all lower extremity procedures were fluid and electrolyte disorders, chronic anemia, lower extremity infection, heart failure, chronic kidney disease, and chronic pulmonary disease.

When stratified by procedure type, the reasons for readmission were very different within the same population of patients based on procedure type, Dr. Vogel said.

Patients who underwent an open procedure were more likely to be readmitted if they had heart failure (RR, 1.78; P less than .0001) or posthemorrhagic anemia (RR, 1.54: P = .006).

Infections – be they lower extremity infection, other infection, postoperative infection, or sepsis – were not predictive of readmission when documented at the index admission for the open cohort.

In contrast, chronic conditions were the major predictors of readmission for patients undergoing endovascular procedures, he said. They included chronic anemia (RR, 1.58; P less than .0001), chronic airway obstruction (RR, 1.36; P = .0095), chronic heart disease (RR, 1.33; P = .0019), chronic kidney disease (RR, 1.37; P = .0013), diabetes (RR, 1.34; P = .0012), and hypertension (RR, 1.27; P = .023).

Fluid and electrolyte disorders (RR, 1.65, P less than .0001) and lower extremity infections (RR, 1.57, P = .0016) were also significant predictors of readmission in the endovascular group.

To ensure there were no disparities between index and readmission diagnoses, a final analysis was performed by procedure type in the 767 readmissions. It confirmed that for the endovascular procedures, chronic problems are bringing patients back to the hospital and not necessarily complications from the procedure, whereas infections, device complications, and hemorrhage are the reasons open surgery patients return, Dr. Vogel said.

“The question is are chronic conditions associated with readmissions the fault of the intervention? As physicians can we hope to curb this in patients who have chronic problems and are then readmitted?” he said.

Some audience members argued that no matter if the patient had a chronic condition or not preoperatively, the responsibility rests with the surgeon because he or she opted to put the patient through an elective endovascular procedure and now they’re returning with chronic heart failure, for example.

Dr. Vogel said this was the first pass at the data and trying to understand what drives readmissions and that it’s possible an endovascular procedure could exacerbate a chronic condition, but that surgeons should take steps to mitigate readmission risk in those with known chronic conditions.

Other attendees questioned how many of the readmissions were planned, hinting that the readmissions may not be directly related to the endovascular technique.

Dr. Vogel said it was difficult using only the ICD-9 codes in the database to determine exactly how many readmissions were planned, but noted that further analyses are intended.

“Reasons for readmission can be exacerbation of chronic patient issues, as seen in the endovascular group, or may be secondary to later complications of the procedure such as wound infections and device complications, as seen after open bypass procedures,” he said in an interview. “Identifying patients with increased risk for readmission after vascular procedures may lead to more effective and higher quality care during the index hospitalization. Our future studies will focus on a more detailed, granular evaluation of these high-risk diagnoses groups through use of the electronic medical record.”

Dr. Vogel reported having no financial disclosures.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Endovascular lower-extremity procedures were not associated with lower 30-day readmission rates compared with open surgery in a retrospective review of 7,089 patients.

All-cause, 30-day readmissions were actually higher with an endovascular approach at 12.3% vs. 9.6% for open procedures (Relative risk, 1.28; P = .0003).

Among all patients, an index diagnosis of gangrene was most predictive of readmission (RR, 1.89; P less than .0001), Dr. Todd R. Vogel said at the annual meeting of the Midwestern Vascular Surgical Society.

The data were compiled from 7,089 patients in the Cerner Health Facts database who were admitted for peripheral artery disease and elective lower extremity procedures (3,615 open; 3,474 endo) between September 2008 and March 2014. Their average age was 67.7 years, 44.7% were aged 70 years or older, 60% were men, and 21% were African American.

Dr. Todd R. Vogel
Frontline Medical News
Dr. Todd R. Vogel

Older patients and men were significantly more likely to receive endovascular procedures (P less than .0001), said Dr. Vogel, chief of vascular surgery, University of Missouri Health System in Columbia.

Overall, 767 patients (11%) were readmitted (344 open; 423 endo), with gangrene accounting for 21.7% of readmissions.

Other index diagnoses associated with higher 30-day readmissions for all lower extremity procedures were fluid and electrolyte disorders, chronic anemia, lower extremity infection, heart failure, chronic kidney disease, and chronic pulmonary disease.

When stratified by procedure type, the reasons for readmission were very different within the same population of patients based on procedure type, Dr. Vogel said.

Patients who underwent an open procedure were more likely to be readmitted if they had heart failure (RR, 1.78; P less than .0001) or posthemorrhagic anemia (RR, 1.54: P = .006).

Infections – be they lower extremity infection, other infection, postoperative infection, or sepsis – were not predictive of readmission when documented at the index admission for the open cohort.

In contrast, chronic conditions were the major predictors of readmission for patients undergoing endovascular procedures, he said. They included chronic anemia (RR, 1.58; P less than .0001), chronic airway obstruction (RR, 1.36; P = .0095), chronic heart disease (RR, 1.33; P = .0019), chronic kidney disease (RR, 1.37; P = .0013), diabetes (RR, 1.34; P = .0012), and hypertension (RR, 1.27; P = .023).

Fluid and electrolyte disorders (RR, 1.65, P less than .0001) and lower extremity infections (RR, 1.57, P = .0016) were also significant predictors of readmission in the endovascular group.

To ensure there were no disparities between index and readmission diagnoses, a final analysis was performed by procedure type in the 767 readmissions. It confirmed that for the endovascular procedures, chronic problems are bringing patients back to the hospital and not necessarily complications from the procedure, whereas infections, device complications, and hemorrhage are the reasons open surgery patients return, Dr. Vogel said.

“The question is are chronic conditions associated with readmissions the fault of the intervention? As physicians can we hope to curb this in patients who have chronic problems and are then readmitted?” he said.

Some audience members argued that no matter if the patient had a chronic condition or not preoperatively, the responsibility rests with the surgeon because he or she opted to put the patient through an elective endovascular procedure and now they’re returning with chronic heart failure, for example.

Dr. Vogel said this was the first pass at the data and trying to understand what drives readmissions and that it’s possible an endovascular procedure could exacerbate a chronic condition, but that surgeons should take steps to mitigate readmission risk in those with known chronic conditions.

Other attendees questioned how many of the readmissions were planned, hinting that the readmissions may not be directly related to the endovascular technique.

Dr. Vogel said it was difficult using only the ICD-9 codes in the database to determine exactly how many readmissions were planned, but noted that further analyses are intended.

“Reasons for readmission can be exacerbation of chronic patient issues, as seen in the endovascular group, or may be secondary to later complications of the procedure such as wound infections and device complications, as seen after open bypass procedures,” he said in an interview. “Identifying patients with increased risk for readmission after vascular procedures may lead to more effective and higher quality care during the index hospitalization. Our future studies will focus on a more detailed, granular evaluation of these high-risk diagnoses groups through use of the electronic medical record.”

Dr. Vogel reported having no financial disclosures.

pwendling@frontlinemedcom.com

On Twitter @pwendl

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Key clinical point: Endovascular procedures were not superior to open surgery in reducing 30-day readmissions in patients undergoing lower extremity procedures.

Major finding: All-cause 30-day readmissions were 12.3% for endovascular and 9.6% for open (P = .0003).

Data source: Retrospective study in 7,089 patients undergoing elective lower extremity procedures.

Disclosures: The research was supported by an award from the Agency for Healthcare Research and Quality. Dr. Vogel reported having no conflicts of interest.

Sunshine Act shows vascular surgeons reap more industry payments

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Sunshine Act shows vascular surgeons reap more industry payments

CHICAGO – Drug- and device makers paid $3.4 billion to U.S. physicians and hospitals in the last 5 months of 2013, according to first-year data from the Centers for Medicare & Medicaid Services (CMS) Open Payments program, Dr. John Blebea reported at the annual meeting of the Midwestern Vascular Surgical Society.

The Open Payments program is the first step by the federal government toward transparency on the financial relationships between physicians and drug- and device makers and is charged with providing data that is both understandable by the public and searchable for individual physicians.

Dr. John Blebea
Patrice Wendling/Frontline Medical News
Dr. John Blebea

Under the Physician Payments Sunshine Act, a provision of the Affordable Care Act, manufacturers of drugs, medical devices, and biologics that participate in Medicare and Medicaid are required to report any payments or transfers of items with a $10 onetime value or $100 cumulative annual value to nonresident physicians and teaching hospitals.

Dr. Blebea and his colleagues at the University of Oklahoma in Tulsa sought to examine payments made to vascular specialists during the first year of the Open Payments program using data available from August 2013 to December 2013.

Nationally, 1,347 companies paid $2.9 billion (85%) to 470,000 physicians and $599 million (15%) to 1,019 hospitals during that period. Almost half of payments to physicians ($1.19 billion) was for research; $735 million was for food, travel, honoraria, and consulting services, and about one-third ($908 million) was in stock ownership or investments, Dr. Blebea said.

The investigators also looked at data from New York alone, where payments varied widely among specialties. Four vascular surgeons and one cardiologist reported ownership or investment interests totaling $1,092,025 and $98,689, respectively, but the data were skewed because one vascular surgeon had investment stock valued at $1,033,728, Dr. Blebea said.

Research grants were uncommon among the 223 vascular surgeons, 229 interventional cardiologists, and 88 radiologists and valued at just $4,250, $5,372, and $8,532.

General payments were significantly different between the three groups ($1,808,890 vs. $534,688 vs. $73,492; P less than .0001), he said. This averaged $3,196 per vascular surgeon, $1,889 per cardiologist, and $738 per radiologist. But, again there were broad variations in the data, resulting in medians of $279, $99, and $116, respectively.

One could argue that $279 isn’t a lot in terms of payments for services made or received, but a small number of vascular surgeons did receive what one could argue is a significant amount of money, Dr. Blebea said. Specifically, 8% received more than $5,000 over the 5 months, and three received more than $100,000.

“So you could ask the question: ‘Could this induce bias in scientific presentations?’ and you could answer, ‘Maybe yes, maybe no,’ ” he said. “But what about the three individuals who received more than $100,000? The answer there is that they are probably more likely to be consciously or unconsciously biased in their presentations.”

Dr. Iraklis Pipinos of the University of Nebraska, Omaha, questioned the number of specialists in the New York analysis, noting that he would expect the number of cardiologists to be four to five times that of vascular specialists.

“It’s an important point and I share your concern,” Dr. Blebea responded. “In actual fact, how people are reported in terms of their specialties is how the companies categorize you, so the data may not be completely accurate. It’s one of the challenges.”

Industry groups and professional societies have raised concerns about the incompleteness of the Open Payments data and argued that inaccuracies could harm reputations and undermine trust between patients and their physicians.

Physicians have 45 days after the data submission period to review their Open Payments data and dispute errors before the information is released publicly. Errors can be contested after the deadline has passed, with corrections made in the next reporting cycle.

Still, of the 4.3 million payments made nationally in the last 5 months of 2013, only 1,145 payments (0.02%) worth just $6.25 million were contested, Dr. Blebea reported.

“So it’s either accurate or most physicians didn’t bother to contest inaccuracies,” he said, adding, “I certainly did [contest the data] because there was an inaccuracy in what was reported for me and that was corrected, but how many people will correct these in the future? I hope everybody does.”

Of the $6.49 billion paid to physicians and hospitals in 2014, physicians have disputed only $5.06 million in general payments and $13.16 million in research payments, according to 2014 data reported by the CMS .

Dr. Daniel G. Clair
Dr. Daniel G. Clair
 

 

Dr. Daniel G. Clair, chair of vascular surgery at the Cleveland Clinic, commented that contrary to what the analysis suggests, it isn’t easy to distinguish between research dollars and nonresearch dollars and between payments made to an institution versus those made to an individual.

“I work for a facility where I am a salaried professional and contracts for some of these things are negotiated between the institution and the company. I’m completely left out of it, but because I happen to be the individual who provides services, it looks like that money is coming to me,” he said.

To provide more transparency in payments, Dr. Blebea said he would recommend quantitative disclosure of industry payments at scientific meetings and in publications with reporting of a range of payments, such as less than $1,000, $1,000-$5,000, $5,001-$10,000, and more than $10,000, rather than specific amounts.

Dr. Blebea and Dr. Pipinos reported having no relevant financial disclosures. Dr. Clair reported serving on the data and safety monitoring board for Bard, as an advisory board member for Boston Scientific and Medtronic, and as a consultant for Endologix.

pwendling@frontlinemedcom.com

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CHICAGO – Drug- and device makers paid $3.4 billion to U.S. physicians and hospitals in the last 5 months of 2013, according to first-year data from the Centers for Medicare & Medicaid Services (CMS) Open Payments program, Dr. John Blebea reported at the annual meeting of the Midwestern Vascular Surgical Society.

The Open Payments program is the first step by the federal government toward transparency on the financial relationships between physicians and drug- and device makers and is charged with providing data that is both understandable by the public and searchable for individual physicians.

Dr. John Blebea
Patrice Wendling/Frontline Medical News
Dr. John Blebea

Under the Physician Payments Sunshine Act, a provision of the Affordable Care Act, manufacturers of drugs, medical devices, and biologics that participate in Medicare and Medicaid are required to report any payments or transfers of items with a $10 onetime value or $100 cumulative annual value to nonresident physicians and teaching hospitals.

Dr. Blebea and his colleagues at the University of Oklahoma in Tulsa sought to examine payments made to vascular specialists during the first year of the Open Payments program using data available from August 2013 to December 2013.

Nationally, 1,347 companies paid $2.9 billion (85%) to 470,000 physicians and $599 million (15%) to 1,019 hospitals during that period. Almost half of payments to physicians ($1.19 billion) was for research; $735 million was for food, travel, honoraria, and consulting services, and about one-third ($908 million) was in stock ownership or investments, Dr. Blebea said.

The investigators also looked at data from New York alone, where payments varied widely among specialties. Four vascular surgeons and one cardiologist reported ownership or investment interests totaling $1,092,025 and $98,689, respectively, but the data were skewed because one vascular surgeon had investment stock valued at $1,033,728, Dr. Blebea said.

Research grants were uncommon among the 223 vascular surgeons, 229 interventional cardiologists, and 88 radiologists and valued at just $4,250, $5,372, and $8,532.

General payments were significantly different between the three groups ($1,808,890 vs. $534,688 vs. $73,492; P less than .0001), he said. This averaged $3,196 per vascular surgeon, $1,889 per cardiologist, and $738 per radiologist. But, again there were broad variations in the data, resulting in medians of $279, $99, and $116, respectively.

One could argue that $279 isn’t a lot in terms of payments for services made or received, but a small number of vascular surgeons did receive what one could argue is a significant amount of money, Dr. Blebea said. Specifically, 8% received more than $5,000 over the 5 months, and three received more than $100,000.

“So you could ask the question: ‘Could this induce bias in scientific presentations?’ and you could answer, ‘Maybe yes, maybe no,’ ” he said. “But what about the three individuals who received more than $100,000? The answer there is that they are probably more likely to be consciously or unconsciously biased in their presentations.”

Dr. Iraklis Pipinos of the University of Nebraska, Omaha, questioned the number of specialists in the New York analysis, noting that he would expect the number of cardiologists to be four to five times that of vascular specialists.

“It’s an important point and I share your concern,” Dr. Blebea responded. “In actual fact, how people are reported in terms of their specialties is how the companies categorize you, so the data may not be completely accurate. It’s one of the challenges.”

Industry groups and professional societies have raised concerns about the incompleteness of the Open Payments data and argued that inaccuracies could harm reputations and undermine trust between patients and their physicians.

Physicians have 45 days after the data submission period to review their Open Payments data and dispute errors before the information is released publicly. Errors can be contested after the deadline has passed, with corrections made in the next reporting cycle.

Still, of the 4.3 million payments made nationally in the last 5 months of 2013, only 1,145 payments (0.02%) worth just $6.25 million were contested, Dr. Blebea reported.

“So it’s either accurate or most physicians didn’t bother to contest inaccuracies,” he said, adding, “I certainly did [contest the data] because there was an inaccuracy in what was reported for me and that was corrected, but how many people will correct these in the future? I hope everybody does.”

Of the $6.49 billion paid to physicians and hospitals in 2014, physicians have disputed only $5.06 million in general payments and $13.16 million in research payments, according to 2014 data reported by the CMS .

Dr. Daniel G. Clair
Dr. Daniel G. Clair
 

 

Dr. Daniel G. Clair, chair of vascular surgery at the Cleveland Clinic, commented that contrary to what the analysis suggests, it isn’t easy to distinguish between research dollars and nonresearch dollars and between payments made to an institution versus those made to an individual.

“I work for a facility where I am a salaried professional and contracts for some of these things are negotiated between the institution and the company. I’m completely left out of it, but because I happen to be the individual who provides services, it looks like that money is coming to me,” he said.

To provide more transparency in payments, Dr. Blebea said he would recommend quantitative disclosure of industry payments at scientific meetings and in publications with reporting of a range of payments, such as less than $1,000, $1,000-$5,000, $5,001-$10,000, and more than $10,000, rather than specific amounts.

Dr. Blebea and Dr. Pipinos reported having no relevant financial disclosures. Dr. Clair reported serving on the data and safety monitoring board for Bard, as an advisory board member for Boston Scientific and Medtronic, and as a consultant for Endologix.

pwendling@frontlinemedcom.com

CHICAGO – Drug- and device makers paid $3.4 billion to U.S. physicians and hospitals in the last 5 months of 2013, according to first-year data from the Centers for Medicare & Medicaid Services (CMS) Open Payments program, Dr. John Blebea reported at the annual meeting of the Midwestern Vascular Surgical Society.

The Open Payments program is the first step by the federal government toward transparency on the financial relationships between physicians and drug- and device makers and is charged with providing data that is both understandable by the public and searchable for individual physicians.

Dr. John Blebea
Patrice Wendling/Frontline Medical News
Dr. John Blebea

Under the Physician Payments Sunshine Act, a provision of the Affordable Care Act, manufacturers of drugs, medical devices, and biologics that participate in Medicare and Medicaid are required to report any payments or transfers of items with a $10 onetime value or $100 cumulative annual value to nonresident physicians and teaching hospitals.

Dr. Blebea and his colleagues at the University of Oklahoma in Tulsa sought to examine payments made to vascular specialists during the first year of the Open Payments program using data available from August 2013 to December 2013.

Nationally, 1,347 companies paid $2.9 billion (85%) to 470,000 physicians and $599 million (15%) to 1,019 hospitals during that period. Almost half of payments to physicians ($1.19 billion) was for research; $735 million was for food, travel, honoraria, and consulting services, and about one-third ($908 million) was in stock ownership or investments, Dr. Blebea said.

The investigators also looked at data from New York alone, where payments varied widely among specialties. Four vascular surgeons and one cardiologist reported ownership or investment interests totaling $1,092,025 and $98,689, respectively, but the data were skewed because one vascular surgeon had investment stock valued at $1,033,728, Dr. Blebea said.

Research grants were uncommon among the 223 vascular surgeons, 229 interventional cardiologists, and 88 radiologists and valued at just $4,250, $5,372, and $8,532.

General payments were significantly different between the three groups ($1,808,890 vs. $534,688 vs. $73,492; P less than .0001), he said. This averaged $3,196 per vascular surgeon, $1,889 per cardiologist, and $738 per radiologist. But, again there were broad variations in the data, resulting in medians of $279, $99, and $116, respectively.

One could argue that $279 isn’t a lot in terms of payments for services made or received, but a small number of vascular surgeons did receive what one could argue is a significant amount of money, Dr. Blebea said. Specifically, 8% received more than $5,000 over the 5 months, and three received more than $100,000.

“So you could ask the question: ‘Could this induce bias in scientific presentations?’ and you could answer, ‘Maybe yes, maybe no,’ ” he said. “But what about the three individuals who received more than $100,000? The answer there is that they are probably more likely to be consciously or unconsciously biased in their presentations.”

Dr. Iraklis Pipinos of the University of Nebraska, Omaha, questioned the number of specialists in the New York analysis, noting that he would expect the number of cardiologists to be four to five times that of vascular specialists.

“It’s an important point and I share your concern,” Dr. Blebea responded. “In actual fact, how people are reported in terms of their specialties is how the companies categorize you, so the data may not be completely accurate. It’s one of the challenges.”

Industry groups and professional societies have raised concerns about the incompleteness of the Open Payments data and argued that inaccuracies could harm reputations and undermine trust between patients and their physicians.

Physicians have 45 days after the data submission period to review their Open Payments data and dispute errors before the information is released publicly. Errors can be contested after the deadline has passed, with corrections made in the next reporting cycle.

Still, of the 4.3 million payments made nationally in the last 5 months of 2013, only 1,145 payments (0.02%) worth just $6.25 million were contested, Dr. Blebea reported.

“So it’s either accurate or most physicians didn’t bother to contest inaccuracies,” he said, adding, “I certainly did [contest the data] because there was an inaccuracy in what was reported for me and that was corrected, but how many people will correct these in the future? I hope everybody does.”

Of the $6.49 billion paid to physicians and hospitals in 2014, physicians have disputed only $5.06 million in general payments and $13.16 million in research payments, according to 2014 data reported by the CMS .

Dr. Daniel G. Clair
Dr. Daniel G. Clair
 

 

Dr. Daniel G. Clair, chair of vascular surgery at the Cleveland Clinic, commented that contrary to what the analysis suggests, it isn’t easy to distinguish between research dollars and nonresearch dollars and between payments made to an institution versus those made to an individual.

“I work for a facility where I am a salaried professional and contracts for some of these things are negotiated between the institution and the company. I’m completely left out of it, but because I happen to be the individual who provides services, it looks like that money is coming to me,” he said.

To provide more transparency in payments, Dr. Blebea said he would recommend quantitative disclosure of industry payments at scientific meetings and in publications with reporting of a range of payments, such as less than $1,000, $1,000-$5,000, $5,001-$10,000, and more than $10,000, rather than specific amounts.

Dr. Blebea and Dr. Pipinos reported having no relevant financial disclosures. Dr. Clair reported serving on the data and safety monitoring board for Bard, as an advisory board member for Boston Scientific and Medtronic, and as a consultant for Endologix.

pwendling@frontlinemedcom.com

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