Drug-coated balloons: The future of hemodialysis access?

The future of hemodialysis access?
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– Drug-coated balloons show promise of being a long-sought major advance in the endovascular treatment of stenotic arteriovenous fistulae and grafts for hemodialysis access, Syed M. Hussain, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Something significantly better than today’s standard treatment options is needed, according to Dr. Hussain. Medicare pays out more than $50 billion annually for the treatment of patients with end-stage renal disease, and a hefty chunk of that money goes for oft-repeated procedures aimed at preserving the patency of the access sites.

Dr. Syed M. Hussain

“Primary patency rates leave much room for improvement,” observed Dr. Hussain, a vascular surgeon at the Christie Clinic in Champaign, Ill.

Indeed, the 50% primary patency rate at 6 months that was optimistically declared a “reasonable goal” in the 2006 Kidney Disease Outcomes Quality Initiative is actually far-fetched using the conventional tools.

“That 50% patency at 6 months would be a tall order to try to meet. Anybody in this room that does fistulography and angioplasty knows the numbers are actually a lot lower than 50%,” said Dr. Hussain.

Plain old balloon angioplasty, the standard first-line intervention for stenotic hemodialysis access sites, has a 6-month patency rate of about 30%. Bare metal stents push the rate up to about 39%. Covered stent grafts are the most effective of the conventional treatment modalities, with a 6-month patency of 51%-53%; however, they are widely considered too expensive for routine use.

Drug-coated balloons (DCBs) have been available for close to 3 years for treatment of lower extremity peripheral artery disease, where they have achieved considerable success. The Food and Drug Administration has approved three commercially available DCBs for this purpose: Bard’s Lutonix 035 AV, Medtronic’s IN.PACT Admiral, and most recently the Stellarex DCB.

 

 


In addition, the Lutonix DCB is approved for treatment of dysfunctional or stenotic arteriovenous (AV) fistulae on the strength of the positive results of the first prospective randomized multicenter trial of a DCB versus balloon angioplasty for AV access stenosis as reported at a conference in Leipzig, Germany, in 2017 and summarized by Dr. Hussain.

The pathophysiology of arterial atherosclerotic stenosis is very different from the stenosis that plagues AV access for dialysis. Arterial atherosclerotic stenosis is due to neointimal hyperplasia caused by inflammation and barotrauma secondary to angioplasty. In contrast, the neointimal hyperplasia in AV access stenosis is due to smooth muscle cell proliferation in response to nonphysiologic blood flow dynamics and shear forces between a high-pressure arterial system and the low-pressure venous system to which it has been connected, with resultant stenosis at the venous outflow anastomosis and often at the cephalic arch, Dr. Hussain explained.

Other contributors to the high rate of early stenosis in AV fistulae and grafts include traumatic balloon dilation, uremia, and repetitive traumatic needle insertion.

The breakthrough for DCBs as a potential game changer in dialysis access stenosis came with the discovery that venous smooth muscle cells are much more sensitive to paclitaxel and other antiproliferative drugs than are arterial smooth muscle cells. All three commercially available DCBs utilize paclitaxel as their active agent.
 

 


Multiple small single-center studies involving off-label use of the DCBs for dialysis access stenosis strongly suggested 6-month patency rates were higher than with balloon angioplasty. Then came the core lab-adjudicated Lutonix multicenter trial, in which 285 hemodialysis patients at 23 sites were randomized to the DCB or balloon angioplasty. Participants had to have a target lesion less than 10 cm long and had to undergo successful predilatation with high-pressure balloon angioplasty.

“The key thing to remember when we talk about dialysis grafts or fistulae is that we have to look at patency in periods of months. We can’t look at years because it’s pretty unusual to see a fistula stay open that long. So most of the time we’re trying to achieve extra months on these types of circuits,” noted Dr. Hussain.

That being said, the 8-month target lesion primary patency rate was 61.6% in the Lutonix DCB group, compared with 49.4% for percutaneous angioplasty, a statistically significant and clinically meaningful difference. Moreover, 66 interventions were required to maintain target lesion patency during that time frame in the DCB group, versus 94 in the angioplasty group; that translated to a 30% reduction in repeat interventions.

“This clearly has the potential to save a lot of money for the health care system,” he said.
 

 


The two forms of treatment were equally safe.

The expanded indication for the Lutonix DCB that resulted from this large randomized trial has triggered considerable research interest in DCBs for AV access stenosis around the world. Major ongoing randomized trials include the PAVE trial in the United Kingdom, the Spanish FISBOL trial, the APERTO trial in the Netherlands, and an Israeli randomized trial restricted to patients with cephalic arch stenosis.

Dr. Hussain is particularly excited about the ongoing 330-patient, prospective, multicenter, single-blinded clinical trial of the IN.PACT Admiral DCB versus plain balloon angioplasty. The Medtronic DCB employs a higher dosage of paclitaxel: 3.5 mcg/mm2, compared with 2.0 mcg/mm2 for the Lutonix DCB. Also, due to differences in the excipients used in the two DCBs, the paclitaxel from the IN.PACT device stays in the media of blood vessels for up to 180 days, compared with 60 days following drug delivery with the Lutonix balloon. Whether this longer period of close range antiproliferative activity will translate into a higher patency rate remains to be seen.

Dr. Hussain reported having no financial conflicts of interest regarding his presentation.
Body

 

Costs associated with the management of patients with chronic kidney disease, particularly those with end-stage renal disease requiring hemodialysis, is a huge component of the Medicare budget. The maintenance of functional vascular access in these patients remains an ongoing challenge and reduction of costs related to access failure is critical to the continued funding of the program. Traditional methods of maintaining access patency such as balloon angioplasty and bare metal stents have poor long-term outcomes, and moderate improvement is seen with the use of covered stents.

Dr. Hussain reviews the current status of drug-coated balloons (DCB) in the endovascular treatment of dysfunctional hemodialysis fistulas and grafts. Safety and efficacy data from a prospective randomized multicenter trial comparing the Bard Lutonix DCB and plain old balloon angioplasty demonstrated a significant improvement in primary patency and a 30% reduction in repeat interventions with the DCB. This led to FDA approval for the Lutonix DCB in the treatment of dysfunctional or stenotic arteriovenous fistulas. Encouraged by these results, researchers conducting ongoing international randomized trials are attempting to clarify the potential expanded indications for DCB in access stenosis. Of particular interest is the ongoing 330-patient prospective, multicenter IN-PACT trial comparing Admiral DCB to balloon angioplasty in failing arteriovenous fistulas. Both the Admiral DCB and Lutonix DCB utilize paclitaxel as the antiproliferative agent. Dr. Hussain describes the increased sensitivity of venous smooth muscle cells to paclitaxel and other antiproliferative drugs when compared with arterial smooth muscle cells. This exciting finding may explain the improved outcomes in the treatment of dialysis access lesions where pathology frequently occurs at the venous anastomosis or in the venous conduit.

Although early results with the use of DCBs are promising, ongoing clinical trials and careful analysis of data and cost effectiveness are critical to optimize outcomes in treating dialysis access dysfunction. Dr. Hussain appropriately expresses cautious optimism regarding the future of hemodialysis access with this new tool available to interventionists treating these complex patients.

Larry A. Scher, MD, is a vascular surgeon at Montefiore Einstein Center for Heart and Vascular Care, New York, and an associate medical editor for Vascular Specialist.

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Costs associated with the management of patients with chronic kidney disease, particularly those with end-stage renal disease requiring hemodialysis, is a huge component of the Medicare budget. The maintenance of functional vascular access in these patients remains an ongoing challenge and reduction of costs related to access failure is critical to the continued funding of the program. Traditional methods of maintaining access patency such as balloon angioplasty and bare metal stents have poor long-term outcomes, and moderate improvement is seen with the use of covered stents.

Dr. Hussain reviews the current status of drug-coated balloons (DCB) in the endovascular treatment of dysfunctional hemodialysis fistulas and grafts. Safety and efficacy data from a prospective randomized multicenter trial comparing the Bard Lutonix DCB and plain old balloon angioplasty demonstrated a significant improvement in primary patency and a 30% reduction in repeat interventions with the DCB. This led to FDA approval for the Lutonix DCB in the treatment of dysfunctional or stenotic arteriovenous fistulas. Encouraged by these results, researchers conducting ongoing international randomized trials are attempting to clarify the potential expanded indications for DCB in access stenosis. Of particular interest is the ongoing 330-patient prospective, multicenter IN-PACT trial comparing Admiral DCB to balloon angioplasty in failing arteriovenous fistulas. Both the Admiral DCB and Lutonix DCB utilize paclitaxel as the antiproliferative agent. Dr. Hussain describes the increased sensitivity of venous smooth muscle cells to paclitaxel and other antiproliferative drugs when compared with arterial smooth muscle cells. This exciting finding may explain the improved outcomes in the treatment of dialysis access lesions where pathology frequently occurs at the venous anastomosis or in the venous conduit.

Although early results with the use of DCBs are promising, ongoing clinical trials and careful analysis of data and cost effectiveness are critical to optimize outcomes in treating dialysis access dysfunction. Dr. Hussain appropriately expresses cautious optimism regarding the future of hemodialysis access with this new tool available to interventionists treating these complex patients.

Larry A. Scher, MD, is a vascular surgeon at Montefiore Einstein Center for Heart and Vascular Care, New York, and an associate medical editor for Vascular Specialist.

Body

 

Costs associated with the management of patients with chronic kidney disease, particularly those with end-stage renal disease requiring hemodialysis, is a huge component of the Medicare budget. The maintenance of functional vascular access in these patients remains an ongoing challenge and reduction of costs related to access failure is critical to the continued funding of the program. Traditional methods of maintaining access patency such as balloon angioplasty and bare metal stents have poor long-term outcomes, and moderate improvement is seen with the use of covered stents.

Dr. Hussain reviews the current status of drug-coated balloons (DCB) in the endovascular treatment of dysfunctional hemodialysis fistulas and grafts. Safety and efficacy data from a prospective randomized multicenter trial comparing the Bard Lutonix DCB and plain old balloon angioplasty demonstrated a significant improvement in primary patency and a 30% reduction in repeat interventions with the DCB. This led to FDA approval for the Lutonix DCB in the treatment of dysfunctional or stenotic arteriovenous fistulas. Encouraged by these results, researchers conducting ongoing international randomized trials are attempting to clarify the potential expanded indications for DCB in access stenosis. Of particular interest is the ongoing 330-patient prospective, multicenter IN-PACT trial comparing Admiral DCB to balloon angioplasty in failing arteriovenous fistulas. Both the Admiral DCB and Lutonix DCB utilize paclitaxel as the antiproliferative agent. Dr. Hussain describes the increased sensitivity of venous smooth muscle cells to paclitaxel and other antiproliferative drugs when compared with arterial smooth muscle cells. This exciting finding may explain the improved outcomes in the treatment of dialysis access lesions where pathology frequently occurs at the venous anastomosis or in the venous conduit.

Although early results with the use of DCBs are promising, ongoing clinical trials and careful analysis of data and cost effectiveness are critical to optimize outcomes in treating dialysis access dysfunction. Dr. Hussain appropriately expresses cautious optimism regarding the future of hemodialysis access with this new tool available to interventionists treating these complex patients.

Larry A. Scher, MD, is a vascular surgeon at Montefiore Einstein Center for Heart and Vascular Care, New York, and an associate medical editor for Vascular Specialist.

Title
The future of hemodialysis access?
The future of hemodialysis access?

– Drug-coated balloons show promise of being a long-sought major advance in the endovascular treatment of stenotic arteriovenous fistulae and grafts for hemodialysis access, Syed M. Hussain, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Something significantly better than today’s standard treatment options is needed, according to Dr. Hussain. Medicare pays out more than $50 billion annually for the treatment of patients with end-stage renal disease, and a hefty chunk of that money goes for oft-repeated procedures aimed at preserving the patency of the access sites.

Dr. Syed M. Hussain

“Primary patency rates leave much room for improvement,” observed Dr. Hussain, a vascular surgeon at the Christie Clinic in Champaign, Ill.

Indeed, the 50% primary patency rate at 6 months that was optimistically declared a “reasonable goal” in the 2006 Kidney Disease Outcomes Quality Initiative is actually far-fetched using the conventional tools.

“That 50% patency at 6 months would be a tall order to try to meet. Anybody in this room that does fistulography and angioplasty knows the numbers are actually a lot lower than 50%,” said Dr. Hussain.

Plain old balloon angioplasty, the standard first-line intervention for stenotic hemodialysis access sites, has a 6-month patency rate of about 30%. Bare metal stents push the rate up to about 39%. Covered stent grafts are the most effective of the conventional treatment modalities, with a 6-month patency of 51%-53%; however, they are widely considered too expensive for routine use.

Drug-coated balloons (DCBs) have been available for close to 3 years for treatment of lower extremity peripheral artery disease, where they have achieved considerable success. The Food and Drug Administration has approved three commercially available DCBs for this purpose: Bard’s Lutonix 035 AV, Medtronic’s IN.PACT Admiral, and most recently the Stellarex DCB.

 

 


In addition, the Lutonix DCB is approved for treatment of dysfunctional or stenotic arteriovenous (AV) fistulae on the strength of the positive results of the first prospective randomized multicenter trial of a DCB versus balloon angioplasty for AV access stenosis as reported at a conference in Leipzig, Germany, in 2017 and summarized by Dr. Hussain.

The pathophysiology of arterial atherosclerotic stenosis is very different from the stenosis that plagues AV access for dialysis. Arterial atherosclerotic stenosis is due to neointimal hyperplasia caused by inflammation and barotrauma secondary to angioplasty. In contrast, the neointimal hyperplasia in AV access stenosis is due to smooth muscle cell proliferation in response to nonphysiologic blood flow dynamics and shear forces between a high-pressure arterial system and the low-pressure venous system to which it has been connected, with resultant stenosis at the venous outflow anastomosis and often at the cephalic arch, Dr. Hussain explained.

Other contributors to the high rate of early stenosis in AV fistulae and grafts include traumatic balloon dilation, uremia, and repetitive traumatic needle insertion.

The breakthrough for DCBs as a potential game changer in dialysis access stenosis came with the discovery that venous smooth muscle cells are much more sensitive to paclitaxel and other antiproliferative drugs than are arterial smooth muscle cells. All three commercially available DCBs utilize paclitaxel as their active agent.
 

 


Multiple small single-center studies involving off-label use of the DCBs for dialysis access stenosis strongly suggested 6-month patency rates were higher than with balloon angioplasty. Then came the core lab-adjudicated Lutonix multicenter trial, in which 285 hemodialysis patients at 23 sites were randomized to the DCB or balloon angioplasty. Participants had to have a target lesion less than 10 cm long and had to undergo successful predilatation with high-pressure balloon angioplasty.

“The key thing to remember when we talk about dialysis grafts or fistulae is that we have to look at patency in periods of months. We can’t look at years because it’s pretty unusual to see a fistula stay open that long. So most of the time we’re trying to achieve extra months on these types of circuits,” noted Dr. Hussain.

That being said, the 8-month target lesion primary patency rate was 61.6% in the Lutonix DCB group, compared with 49.4% for percutaneous angioplasty, a statistically significant and clinically meaningful difference. Moreover, 66 interventions were required to maintain target lesion patency during that time frame in the DCB group, versus 94 in the angioplasty group; that translated to a 30% reduction in repeat interventions.

“This clearly has the potential to save a lot of money for the health care system,” he said.
 

 


The two forms of treatment were equally safe.

The expanded indication for the Lutonix DCB that resulted from this large randomized trial has triggered considerable research interest in DCBs for AV access stenosis around the world. Major ongoing randomized trials include the PAVE trial in the United Kingdom, the Spanish FISBOL trial, the APERTO trial in the Netherlands, and an Israeli randomized trial restricted to patients with cephalic arch stenosis.

Dr. Hussain is particularly excited about the ongoing 330-patient, prospective, multicenter, single-blinded clinical trial of the IN.PACT Admiral DCB versus plain balloon angioplasty. The Medtronic DCB employs a higher dosage of paclitaxel: 3.5 mcg/mm2, compared with 2.0 mcg/mm2 for the Lutonix DCB. Also, due to differences in the excipients used in the two DCBs, the paclitaxel from the IN.PACT device stays in the media of blood vessels for up to 180 days, compared with 60 days following drug delivery with the Lutonix balloon. Whether this longer period of close range antiproliferative activity will translate into a higher patency rate remains to be seen.

Dr. Hussain reported having no financial conflicts of interest regarding his presentation.

– Drug-coated balloons show promise of being a long-sought major advance in the endovascular treatment of stenotic arteriovenous fistulae and grafts for hemodialysis access, Syed M. Hussain, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Something significantly better than today’s standard treatment options is needed, according to Dr. Hussain. Medicare pays out more than $50 billion annually for the treatment of patients with end-stage renal disease, and a hefty chunk of that money goes for oft-repeated procedures aimed at preserving the patency of the access sites.

Dr. Syed M. Hussain

“Primary patency rates leave much room for improvement,” observed Dr. Hussain, a vascular surgeon at the Christie Clinic in Champaign, Ill.

Indeed, the 50% primary patency rate at 6 months that was optimistically declared a “reasonable goal” in the 2006 Kidney Disease Outcomes Quality Initiative is actually far-fetched using the conventional tools.

“That 50% patency at 6 months would be a tall order to try to meet. Anybody in this room that does fistulography and angioplasty knows the numbers are actually a lot lower than 50%,” said Dr. Hussain.

Plain old balloon angioplasty, the standard first-line intervention for stenotic hemodialysis access sites, has a 6-month patency rate of about 30%. Bare metal stents push the rate up to about 39%. Covered stent grafts are the most effective of the conventional treatment modalities, with a 6-month patency of 51%-53%; however, they are widely considered too expensive for routine use.

Drug-coated balloons (DCBs) have been available for close to 3 years for treatment of lower extremity peripheral artery disease, where they have achieved considerable success. The Food and Drug Administration has approved three commercially available DCBs for this purpose: Bard’s Lutonix 035 AV, Medtronic’s IN.PACT Admiral, and most recently the Stellarex DCB.

 

 


In addition, the Lutonix DCB is approved for treatment of dysfunctional or stenotic arteriovenous (AV) fistulae on the strength of the positive results of the first prospective randomized multicenter trial of a DCB versus balloon angioplasty for AV access stenosis as reported at a conference in Leipzig, Germany, in 2017 and summarized by Dr. Hussain.

The pathophysiology of arterial atherosclerotic stenosis is very different from the stenosis that plagues AV access for dialysis. Arterial atherosclerotic stenosis is due to neointimal hyperplasia caused by inflammation and barotrauma secondary to angioplasty. In contrast, the neointimal hyperplasia in AV access stenosis is due to smooth muscle cell proliferation in response to nonphysiologic blood flow dynamics and shear forces between a high-pressure arterial system and the low-pressure venous system to which it has been connected, with resultant stenosis at the venous outflow anastomosis and often at the cephalic arch, Dr. Hussain explained.

Other contributors to the high rate of early stenosis in AV fistulae and grafts include traumatic balloon dilation, uremia, and repetitive traumatic needle insertion.

The breakthrough for DCBs as a potential game changer in dialysis access stenosis came with the discovery that venous smooth muscle cells are much more sensitive to paclitaxel and other antiproliferative drugs than are arterial smooth muscle cells. All three commercially available DCBs utilize paclitaxel as their active agent.
 

 


Multiple small single-center studies involving off-label use of the DCBs for dialysis access stenosis strongly suggested 6-month patency rates were higher than with balloon angioplasty. Then came the core lab-adjudicated Lutonix multicenter trial, in which 285 hemodialysis patients at 23 sites were randomized to the DCB or balloon angioplasty. Participants had to have a target lesion less than 10 cm long and had to undergo successful predilatation with high-pressure balloon angioplasty.

“The key thing to remember when we talk about dialysis grafts or fistulae is that we have to look at patency in periods of months. We can’t look at years because it’s pretty unusual to see a fistula stay open that long. So most of the time we’re trying to achieve extra months on these types of circuits,” noted Dr. Hussain.

That being said, the 8-month target lesion primary patency rate was 61.6% in the Lutonix DCB group, compared with 49.4% for percutaneous angioplasty, a statistically significant and clinically meaningful difference. Moreover, 66 interventions were required to maintain target lesion patency during that time frame in the DCB group, versus 94 in the angioplasty group; that translated to a 30% reduction in repeat interventions.

“This clearly has the potential to save a lot of money for the health care system,” he said.
 

 


The two forms of treatment were equally safe.

The expanded indication for the Lutonix DCB that resulted from this large randomized trial has triggered considerable research interest in DCBs for AV access stenosis around the world. Major ongoing randomized trials include the PAVE trial in the United Kingdom, the Spanish FISBOL trial, the APERTO trial in the Netherlands, and an Israeli randomized trial restricted to patients with cephalic arch stenosis.

Dr. Hussain is particularly excited about the ongoing 330-patient, prospective, multicenter, single-blinded clinical trial of the IN.PACT Admiral DCB versus plain balloon angioplasty. The Medtronic DCB employs a higher dosage of paclitaxel: 3.5 mcg/mm2, compared with 2.0 mcg/mm2 for the Lutonix DCB. Also, due to differences in the excipients used in the two DCBs, the paclitaxel from the IN.PACT device stays in the media of blood vessels for up to 180 days, compared with 60 days following drug delivery with the Lutonix balloon. Whether this longer period of close range antiproliferative activity will translate into a higher patency rate remains to be seen.

Dr. Hussain reported having no financial conflicts of interest regarding his presentation.
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Femoral artery endarterectomy still ‘gold standard’

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– Additional higher quality supporting evidence is needed before endovascular therapies can legitimately be placed on equal footing as an alternative to open surgery in patients with symptomatic common femoral artery stenosis, Jeffrey J. Siracuse, MD, FACS, asserted at a symposium on vascular surgery sponsored by Northwestern University.

“Open surgery in the CFA [common femoral artery] is probably still the gold standard in most cases,” said Dr. Siracuse, a vascular surgeon at Boston University.

Bruce Jancin/MDedge News
Dr. Jeffrey J. Siracuse

He was quick to note that others would disagree. Stenting and other endovascular interventions in the CFA are booming in popularity, particularly among cardiologists, interventional radiologists, and the patients to whom the clinicians present the option in a favorable light. But this enthusiasm is based almost entirely on small, single-center, retrospective studies conducted in patients with heterogeneous profiles. The one prospective randomized multicenter trial of stenting versus surgery for CFA stenosis published to date – the French TECCO study – has a number of key limitations, flaws, and unanswered questions, which endovascular proponents have overlooked in their enthusiasm to promote an “endo-first” approach in the CFA, according to Dr. Siracuse.

“Everyone’s pretty much jumping on the bandwagon now. I think endovascular therapy of the CFA is here to stay. You’re going to see more people doing it, and potentially doing it incorrectly,” he predicted.

“The biggest thing I worry about with stenting is covering or jailing out the deep femoral artery. On multiple occasions – including a case just 2 weeks ago – I’ve taken out stents placed in the CFA by others that developed in-stent hyperplasia to the extent that the entire stent goes down, the DFA is covered, and now all of a sudden you’ve lost all flow to the leg. That’s my biggest concern with stenting,” he said.

Dr. Siracuse has other reservations as well. The CFA has traditionally been considered a “no-stent zone” because of the unique biomechanical stresses the artery is subjected to as a result of torsion, flexion, and extension at the hip joint. These forces render the area particularly vulnerable to neointimal hyperplasia, acute thrombosis, and stent fracture.

 

 


In addition, he noted, CFA endarterectomy for atherosclerotic lesions is a mature, well-established operation with an excellent track record for safety and durability. Dr. Siracuse’s review of procedural safety in 1,513 patients in the American College of Surgeons National Surgical Quality Improvement Project database during 2007-2010 showed a 30-day mortality of 1.5% and a 7.9% rate of major or minor complications (Vasc Endovascular Surg. 2014 Jan;48[1]:27-33).

In contrast, his review of 1,014 patients who underwent nonemergent endovascular CFA interventions for CFA stenosis without acute limb ischemia in the Vascular Quality Initiative registry demonstrated a 1-year patency rate of 85.3%, significantly lower than historically observed patency rates for endarterectomy. The 30-day mortality rate of 1.6% associated with endovascular interventions was essentially the same as in his earlier analysis of endarterectomy in the ACS NSQIP database, and the average 1.5-day hospital length of stay was shorter than with open surgery. Of considerable concern, however, stent implantation, which was performed in 35% of the endovascular interventions, was an independent predictor of amputation or death, with an associated 195% increased risk (J Vasc Surg. 2017 Apr;[4]:1039-46).

The travails of TECCO

The 17-center French TECCO study randomized 117 patients with de novo CFA atherosclerotic lesions to treatment via self-expanding stents or open surgery. A total of 98 participants were Rutherford stage 3, making TECCO primarily a study of claudicants. The primary outcome – the 30-day combined rate of morbidity and mortality – occurred in 26% of the surgical patients, a significantly higher rate than the 12.5% in the stent population. After a median follow-up of 24 months, the rates of primary patency, target lesion and extremity revascularization, and sustained clinical improvement were similar in the two groups (JACC Cardiovasc Interv. 2017 Jul 10;10[13]:1344-54).

The TECCO findings were hailed by endovascular therapy partisans as a big win. However, closer examination tells a different story, according to Dr. Siracuse.

 

 

There was no 30-day mortality in this rather small study. All 16 morbidity events occurring in the open surgery group within 30 days were relatively minor: 10 cases of delayed wound healing, 4 cases of postoperative paresthesia requiring medication, and 2 cases of lymphorrhea lasting longer than 3 days. In contrast, the seven morbidity events in the stent group included a complication requiring urgent open surgical repair at the time of stenting, one stent fracture, and a major amputation.

“The investigators didn’t elaborate on that major amputation, but I thought it was a little alarming because you should not have a major amputation with CFA interventions for claudicants,” the vascular surgeon commented. “Really, do people care about a lymphatic leak or do they care about amputation? I think more needs to be fleshed out about what really happened in that case.”

He was also puzzled by the hospital lengths of stay: a mean of 3.2 days in the stent group and 6.3 days in the open surgery group. “I think those lengths of stay are astounding. Very high and unusual,” he observed.

Dr. Siracuse predicted that much-needed high-quality data comparing treatments of the CFA will be provided by the BEST-CLI trial (Best Endovascular versus Surgical Treatment for Critical Limb Ischemia), which has been updated to include both open and endovascular interventions.

He reported having no financial conflicts of interest regarding his presentation.

 

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– Additional higher quality supporting evidence is needed before endovascular therapies can legitimately be placed on equal footing as an alternative to open surgery in patients with symptomatic common femoral artery stenosis, Jeffrey J. Siracuse, MD, FACS, asserted at a symposium on vascular surgery sponsored by Northwestern University.

“Open surgery in the CFA [common femoral artery] is probably still the gold standard in most cases,” said Dr. Siracuse, a vascular surgeon at Boston University.

Bruce Jancin/MDedge News
Dr. Jeffrey J. Siracuse

He was quick to note that others would disagree. Stenting and other endovascular interventions in the CFA are booming in popularity, particularly among cardiologists, interventional radiologists, and the patients to whom the clinicians present the option in a favorable light. But this enthusiasm is based almost entirely on small, single-center, retrospective studies conducted in patients with heterogeneous profiles. The one prospective randomized multicenter trial of stenting versus surgery for CFA stenosis published to date – the French TECCO study – has a number of key limitations, flaws, and unanswered questions, which endovascular proponents have overlooked in their enthusiasm to promote an “endo-first” approach in the CFA, according to Dr. Siracuse.

“Everyone’s pretty much jumping on the bandwagon now. I think endovascular therapy of the CFA is here to stay. You’re going to see more people doing it, and potentially doing it incorrectly,” he predicted.

“The biggest thing I worry about with stenting is covering or jailing out the deep femoral artery. On multiple occasions – including a case just 2 weeks ago – I’ve taken out stents placed in the CFA by others that developed in-stent hyperplasia to the extent that the entire stent goes down, the DFA is covered, and now all of a sudden you’ve lost all flow to the leg. That’s my biggest concern with stenting,” he said.

Dr. Siracuse has other reservations as well. The CFA has traditionally been considered a “no-stent zone” because of the unique biomechanical stresses the artery is subjected to as a result of torsion, flexion, and extension at the hip joint. These forces render the area particularly vulnerable to neointimal hyperplasia, acute thrombosis, and stent fracture.

 

 


In addition, he noted, CFA endarterectomy for atherosclerotic lesions is a mature, well-established operation with an excellent track record for safety and durability. Dr. Siracuse’s review of procedural safety in 1,513 patients in the American College of Surgeons National Surgical Quality Improvement Project database during 2007-2010 showed a 30-day mortality of 1.5% and a 7.9% rate of major or minor complications (Vasc Endovascular Surg. 2014 Jan;48[1]:27-33).

In contrast, his review of 1,014 patients who underwent nonemergent endovascular CFA interventions for CFA stenosis without acute limb ischemia in the Vascular Quality Initiative registry demonstrated a 1-year patency rate of 85.3%, significantly lower than historically observed patency rates for endarterectomy. The 30-day mortality rate of 1.6% associated with endovascular interventions was essentially the same as in his earlier analysis of endarterectomy in the ACS NSQIP database, and the average 1.5-day hospital length of stay was shorter than with open surgery. Of considerable concern, however, stent implantation, which was performed in 35% of the endovascular interventions, was an independent predictor of amputation or death, with an associated 195% increased risk (J Vasc Surg. 2017 Apr;[4]:1039-46).

The travails of TECCO

The 17-center French TECCO study randomized 117 patients with de novo CFA atherosclerotic lesions to treatment via self-expanding stents or open surgery. A total of 98 participants were Rutherford stage 3, making TECCO primarily a study of claudicants. The primary outcome – the 30-day combined rate of morbidity and mortality – occurred in 26% of the surgical patients, a significantly higher rate than the 12.5% in the stent population. After a median follow-up of 24 months, the rates of primary patency, target lesion and extremity revascularization, and sustained clinical improvement were similar in the two groups (JACC Cardiovasc Interv. 2017 Jul 10;10[13]:1344-54).

The TECCO findings were hailed by endovascular therapy partisans as a big win. However, closer examination tells a different story, according to Dr. Siracuse.

 

 

There was no 30-day mortality in this rather small study. All 16 morbidity events occurring in the open surgery group within 30 days were relatively minor: 10 cases of delayed wound healing, 4 cases of postoperative paresthesia requiring medication, and 2 cases of lymphorrhea lasting longer than 3 days. In contrast, the seven morbidity events in the stent group included a complication requiring urgent open surgical repair at the time of stenting, one stent fracture, and a major amputation.

“The investigators didn’t elaborate on that major amputation, but I thought it was a little alarming because you should not have a major amputation with CFA interventions for claudicants,” the vascular surgeon commented. “Really, do people care about a lymphatic leak or do they care about amputation? I think more needs to be fleshed out about what really happened in that case.”

He was also puzzled by the hospital lengths of stay: a mean of 3.2 days in the stent group and 6.3 days in the open surgery group. “I think those lengths of stay are astounding. Very high and unusual,” he observed.

Dr. Siracuse predicted that much-needed high-quality data comparing treatments of the CFA will be provided by the BEST-CLI trial (Best Endovascular versus Surgical Treatment for Critical Limb Ischemia), which has been updated to include both open and endovascular interventions.

He reported having no financial conflicts of interest regarding his presentation.

 

– Additional higher quality supporting evidence is needed before endovascular therapies can legitimately be placed on equal footing as an alternative to open surgery in patients with symptomatic common femoral artery stenosis, Jeffrey J. Siracuse, MD, FACS, asserted at a symposium on vascular surgery sponsored by Northwestern University.

“Open surgery in the CFA [common femoral artery] is probably still the gold standard in most cases,” said Dr. Siracuse, a vascular surgeon at Boston University.

Bruce Jancin/MDedge News
Dr. Jeffrey J. Siracuse

He was quick to note that others would disagree. Stenting and other endovascular interventions in the CFA are booming in popularity, particularly among cardiologists, interventional radiologists, and the patients to whom the clinicians present the option in a favorable light. But this enthusiasm is based almost entirely on small, single-center, retrospective studies conducted in patients with heterogeneous profiles. The one prospective randomized multicenter trial of stenting versus surgery for CFA stenosis published to date – the French TECCO study – has a number of key limitations, flaws, and unanswered questions, which endovascular proponents have overlooked in their enthusiasm to promote an “endo-first” approach in the CFA, according to Dr. Siracuse.

“Everyone’s pretty much jumping on the bandwagon now. I think endovascular therapy of the CFA is here to stay. You’re going to see more people doing it, and potentially doing it incorrectly,” he predicted.

“The biggest thing I worry about with stenting is covering or jailing out the deep femoral artery. On multiple occasions – including a case just 2 weeks ago – I’ve taken out stents placed in the CFA by others that developed in-stent hyperplasia to the extent that the entire stent goes down, the DFA is covered, and now all of a sudden you’ve lost all flow to the leg. That’s my biggest concern with stenting,” he said.

Dr. Siracuse has other reservations as well. The CFA has traditionally been considered a “no-stent zone” because of the unique biomechanical stresses the artery is subjected to as a result of torsion, flexion, and extension at the hip joint. These forces render the area particularly vulnerable to neointimal hyperplasia, acute thrombosis, and stent fracture.

 

 


In addition, he noted, CFA endarterectomy for atherosclerotic lesions is a mature, well-established operation with an excellent track record for safety and durability. Dr. Siracuse’s review of procedural safety in 1,513 patients in the American College of Surgeons National Surgical Quality Improvement Project database during 2007-2010 showed a 30-day mortality of 1.5% and a 7.9% rate of major or minor complications (Vasc Endovascular Surg. 2014 Jan;48[1]:27-33).

In contrast, his review of 1,014 patients who underwent nonemergent endovascular CFA interventions for CFA stenosis without acute limb ischemia in the Vascular Quality Initiative registry demonstrated a 1-year patency rate of 85.3%, significantly lower than historically observed patency rates for endarterectomy. The 30-day mortality rate of 1.6% associated with endovascular interventions was essentially the same as in his earlier analysis of endarterectomy in the ACS NSQIP database, and the average 1.5-day hospital length of stay was shorter than with open surgery. Of considerable concern, however, stent implantation, which was performed in 35% of the endovascular interventions, was an independent predictor of amputation or death, with an associated 195% increased risk (J Vasc Surg. 2017 Apr;[4]:1039-46).

The travails of TECCO

The 17-center French TECCO study randomized 117 patients with de novo CFA atherosclerotic lesions to treatment via self-expanding stents or open surgery. A total of 98 participants were Rutherford stage 3, making TECCO primarily a study of claudicants. The primary outcome – the 30-day combined rate of morbidity and mortality – occurred in 26% of the surgical patients, a significantly higher rate than the 12.5% in the stent population. After a median follow-up of 24 months, the rates of primary patency, target lesion and extremity revascularization, and sustained clinical improvement were similar in the two groups (JACC Cardiovasc Interv. 2017 Jul 10;10[13]:1344-54).

The TECCO findings were hailed by endovascular therapy partisans as a big win. However, closer examination tells a different story, according to Dr. Siracuse.

 

 

There was no 30-day mortality in this rather small study. All 16 morbidity events occurring in the open surgery group within 30 days were relatively minor: 10 cases of delayed wound healing, 4 cases of postoperative paresthesia requiring medication, and 2 cases of lymphorrhea lasting longer than 3 days. In contrast, the seven morbidity events in the stent group included a complication requiring urgent open surgical repair at the time of stenting, one stent fracture, and a major amputation.

“The investigators didn’t elaborate on that major amputation, but I thought it was a little alarming because you should not have a major amputation with CFA interventions for claudicants,” the vascular surgeon commented. “Really, do people care about a lymphatic leak or do they care about amputation? I think more needs to be fleshed out about what really happened in that case.”

He was also puzzled by the hospital lengths of stay: a mean of 3.2 days in the stent group and 6.3 days in the open surgery group. “I think those lengths of stay are astounding. Very high and unusual,” he observed.

Dr. Siracuse predicted that much-needed high-quality data comparing treatments of the CFA will be provided by the BEST-CLI trial (Best Endovascular versus Surgical Treatment for Critical Limb Ischemia), which has been updated to include both open and endovascular interventions.

He reported having no financial conflicts of interest regarding his presentation.

 

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Promising outcomes of thrombolysis for caval extension of iliofemoral DVT

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– Caval extension of an acute iliofemoral deep vein thrombosis paradoxically portends better treatment outcomes than does thrombolysis of a DVT without involvement of the inferior vena cava, according to Rabih A. Chaer, MD, professor of surgery at the University of Pittsburgh.

This finding from a retrospective analysis of the University of Pittsburgh experience might seem counterintuitive. After all, caval extension clearly indicates a greater clot burden. One possible explanation: Clearing a thrombus from a large vessel, such as the inferior vena cava (IVC), provides an added protective effect. Also, since the caval segments don’t have valves – their flow is based upon negative pressure in the chest – they may not contribute as much to postthrombotic morbidity to the same extent as do thrombosed iliofemoral segments, Dr. Chaer speculated at a symposium on vascular surgery sponsored by Northwestern University.

Bruce Jancin/Frontline Medical News
Dr. Rabih A. Chaer
In addition, patients with caval extension were treated more aggressively: 98% of them underwent pharmacomechanical thrombolysis with the Angiojet or another device as an adjunct to catheter-directed thrombolysis, compared with 82% of noncaval patients.

The impetus for Dr. Chaer and coinvestigators to review the Pittsburgh experience was a lack of clarity in the literature as to the effect IVC thrombosis has on thrombolysis outcomes in patients with acute iliofemoral DVT. Even though caval thrombus extension is present in up to 22% of patients with iliofemoral DVT, current guidelines issued by the American College of Chest Physicians, the American Heart Association, and the Society for Vascular Surgery don’t address the distinction between iliofemoral DVT with and without IVC extension in regard to the occurrence of postthrombotic syndrome (PTS), the most common complication of DVT.

The incidence of PTS in patients whose iliofemoral DVT is treated by anticoagulation and compression alone is up to 50%. Mounting evidence indicates that catheter-directed thrombolysis and pharmacomechanical thrombolysis aimed at achieving early thrombus removal and symptom relief help maintain valvular competence and reduce the risk of PTS, the surgeon noted.

PTS is diagnosed using the validated Villalta scale, which incorporates clinical signs including pain on calf compression, skin edema and redness, and ulcers, as well as symptoms such as leg cramping, heaviness, itching, and paresthesia.



The Pittsburgh series included 102 consecutive patients treated with various combinations of catheter-directed or pharmacomechanical thrombolysis in 127 limbs with acute iliofemoral thrombosis. In 46 patients, the thrombus extended into the IVC, all the way up to the renal veins in most cases.

The groups with and without caval extension were similar in terms of age and prevalence of malignancy, hypercoagulable state, and clot age. However, a history of previous DVT was significantly more common in the group with IVC thrombus. Also, more than 60% of patients with caval extension got an IVC filter, a rate more than 10-fold greater than that in patients without caval extension.

In this series, caval thrombosis had no effect on the technical success of thrombolysis. The technical success rate –defined as at least 50% clot lysis – was 89% in both groups. Rates of recurrent DVT within 30 days were similar in the two groups as well: 11% in the caval thrombosis group and 14% in the noncaval group. At 2 years postintervention, 77%-78% of patients in both groups remained free of DVT recurrence. The rate of PTS – defined by a Villalta score of 5 or more – at 2 years was 34% in the noncaval group, which was significantly higher than the 11% rate in patients with IVC thrombus extension. Ultrasound-identified valve reflux was present in 51% of the noncaval group at 2 years, compared with 51% of the noncaval group.

On multivariate analysis, incomplete clot lysis was associated with nearly a 23-fold increased risk of recurrent DVT and a 5.6-fold increased risk of PTS. Caval involvement was independently associated with a 78% reduction in PTS risk.

The Society for Vascular Surgery’s guidelines recommend pharmacomechanical thrombolysis over catheter-directed thrombolysis if the expertise is available. The Pittsburgh experience speaks to the worth of that recommendation.

“Pharmacomechanical techniques can be advantageous. They can expedite the lysis process by clearing most of the clot. In our series, 20 patients were treated with pharmacomechanical techniques in a single session,” Dr. Chaer noted.

The use of IVC filters in the setting of caval extension of iliofemoral DVT is controversial, according to the surgeon: A thrombus that gets trapped in the filter is tough to remove, precluding successful recanalization.

“One-third of the patients in our series got a filter, but we’ve become more conservative nowadays. We don’t use filters anymore. But I think those patients who might benefit from an IVC filter are those who present with a PE [pulmonary embolism], because that’s telling you they might develop another PE, as well as those patients in whom pharmacomechanical thrombolysis is anticipated because we’ve seen that those patients are also more likely to develop a PE,” he said.

The University of Pittsburgh study on the effect of IVC thrombus extension has been published (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:385-91).

Dr. Chaer reported serving as a paid speaker for Boston Scientific.

SOURCE: Chaer RA. Northwestern Vascular Symposium 2017.

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– Caval extension of an acute iliofemoral deep vein thrombosis paradoxically portends better treatment outcomes than does thrombolysis of a DVT without involvement of the inferior vena cava, according to Rabih A. Chaer, MD, professor of surgery at the University of Pittsburgh.

This finding from a retrospective analysis of the University of Pittsburgh experience might seem counterintuitive. After all, caval extension clearly indicates a greater clot burden. One possible explanation: Clearing a thrombus from a large vessel, such as the inferior vena cava (IVC), provides an added protective effect. Also, since the caval segments don’t have valves – their flow is based upon negative pressure in the chest – they may not contribute as much to postthrombotic morbidity to the same extent as do thrombosed iliofemoral segments, Dr. Chaer speculated at a symposium on vascular surgery sponsored by Northwestern University.

Bruce Jancin/Frontline Medical News
Dr. Rabih A. Chaer
In addition, patients with caval extension were treated more aggressively: 98% of them underwent pharmacomechanical thrombolysis with the Angiojet or another device as an adjunct to catheter-directed thrombolysis, compared with 82% of noncaval patients.

The impetus for Dr. Chaer and coinvestigators to review the Pittsburgh experience was a lack of clarity in the literature as to the effect IVC thrombosis has on thrombolysis outcomes in patients with acute iliofemoral DVT. Even though caval thrombus extension is present in up to 22% of patients with iliofemoral DVT, current guidelines issued by the American College of Chest Physicians, the American Heart Association, and the Society for Vascular Surgery don’t address the distinction between iliofemoral DVT with and without IVC extension in regard to the occurrence of postthrombotic syndrome (PTS), the most common complication of DVT.

The incidence of PTS in patients whose iliofemoral DVT is treated by anticoagulation and compression alone is up to 50%. Mounting evidence indicates that catheter-directed thrombolysis and pharmacomechanical thrombolysis aimed at achieving early thrombus removal and symptom relief help maintain valvular competence and reduce the risk of PTS, the surgeon noted.

PTS is diagnosed using the validated Villalta scale, which incorporates clinical signs including pain on calf compression, skin edema and redness, and ulcers, as well as symptoms such as leg cramping, heaviness, itching, and paresthesia.



The Pittsburgh series included 102 consecutive patients treated with various combinations of catheter-directed or pharmacomechanical thrombolysis in 127 limbs with acute iliofemoral thrombosis. In 46 patients, the thrombus extended into the IVC, all the way up to the renal veins in most cases.

The groups with and without caval extension were similar in terms of age and prevalence of malignancy, hypercoagulable state, and clot age. However, a history of previous DVT was significantly more common in the group with IVC thrombus. Also, more than 60% of patients with caval extension got an IVC filter, a rate more than 10-fold greater than that in patients without caval extension.

In this series, caval thrombosis had no effect on the technical success of thrombolysis. The technical success rate –defined as at least 50% clot lysis – was 89% in both groups. Rates of recurrent DVT within 30 days were similar in the two groups as well: 11% in the caval thrombosis group and 14% in the noncaval group. At 2 years postintervention, 77%-78% of patients in both groups remained free of DVT recurrence. The rate of PTS – defined by a Villalta score of 5 or more – at 2 years was 34% in the noncaval group, which was significantly higher than the 11% rate in patients with IVC thrombus extension. Ultrasound-identified valve reflux was present in 51% of the noncaval group at 2 years, compared with 51% of the noncaval group.

On multivariate analysis, incomplete clot lysis was associated with nearly a 23-fold increased risk of recurrent DVT and a 5.6-fold increased risk of PTS. Caval involvement was independently associated with a 78% reduction in PTS risk.

The Society for Vascular Surgery’s guidelines recommend pharmacomechanical thrombolysis over catheter-directed thrombolysis if the expertise is available. The Pittsburgh experience speaks to the worth of that recommendation.

“Pharmacomechanical techniques can be advantageous. They can expedite the lysis process by clearing most of the clot. In our series, 20 patients were treated with pharmacomechanical techniques in a single session,” Dr. Chaer noted.

The use of IVC filters in the setting of caval extension of iliofemoral DVT is controversial, according to the surgeon: A thrombus that gets trapped in the filter is tough to remove, precluding successful recanalization.

“One-third of the patients in our series got a filter, but we’ve become more conservative nowadays. We don’t use filters anymore. But I think those patients who might benefit from an IVC filter are those who present with a PE [pulmonary embolism], because that’s telling you they might develop another PE, as well as those patients in whom pharmacomechanical thrombolysis is anticipated because we’ve seen that those patients are also more likely to develop a PE,” he said.

The University of Pittsburgh study on the effect of IVC thrombus extension has been published (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:385-91).

Dr. Chaer reported serving as a paid speaker for Boston Scientific.

SOURCE: Chaer RA. Northwestern Vascular Symposium 2017.

 

– Caval extension of an acute iliofemoral deep vein thrombosis paradoxically portends better treatment outcomes than does thrombolysis of a DVT without involvement of the inferior vena cava, according to Rabih A. Chaer, MD, professor of surgery at the University of Pittsburgh.

This finding from a retrospective analysis of the University of Pittsburgh experience might seem counterintuitive. After all, caval extension clearly indicates a greater clot burden. One possible explanation: Clearing a thrombus from a large vessel, such as the inferior vena cava (IVC), provides an added protective effect. Also, since the caval segments don’t have valves – their flow is based upon negative pressure in the chest – they may not contribute as much to postthrombotic morbidity to the same extent as do thrombosed iliofemoral segments, Dr. Chaer speculated at a symposium on vascular surgery sponsored by Northwestern University.

Bruce Jancin/Frontline Medical News
Dr. Rabih A. Chaer
In addition, patients with caval extension were treated more aggressively: 98% of them underwent pharmacomechanical thrombolysis with the Angiojet or another device as an adjunct to catheter-directed thrombolysis, compared with 82% of noncaval patients.

The impetus for Dr. Chaer and coinvestigators to review the Pittsburgh experience was a lack of clarity in the literature as to the effect IVC thrombosis has on thrombolysis outcomes in patients with acute iliofemoral DVT. Even though caval thrombus extension is present in up to 22% of patients with iliofemoral DVT, current guidelines issued by the American College of Chest Physicians, the American Heart Association, and the Society for Vascular Surgery don’t address the distinction between iliofemoral DVT with and without IVC extension in regard to the occurrence of postthrombotic syndrome (PTS), the most common complication of DVT.

The incidence of PTS in patients whose iliofemoral DVT is treated by anticoagulation and compression alone is up to 50%. Mounting evidence indicates that catheter-directed thrombolysis and pharmacomechanical thrombolysis aimed at achieving early thrombus removal and symptom relief help maintain valvular competence and reduce the risk of PTS, the surgeon noted.

PTS is diagnosed using the validated Villalta scale, which incorporates clinical signs including pain on calf compression, skin edema and redness, and ulcers, as well as symptoms such as leg cramping, heaviness, itching, and paresthesia.



The Pittsburgh series included 102 consecutive patients treated with various combinations of catheter-directed or pharmacomechanical thrombolysis in 127 limbs with acute iliofemoral thrombosis. In 46 patients, the thrombus extended into the IVC, all the way up to the renal veins in most cases.

The groups with and without caval extension were similar in terms of age and prevalence of malignancy, hypercoagulable state, and clot age. However, a history of previous DVT was significantly more common in the group with IVC thrombus. Also, more than 60% of patients with caval extension got an IVC filter, a rate more than 10-fold greater than that in patients without caval extension.

In this series, caval thrombosis had no effect on the technical success of thrombolysis. The technical success rate –defined as at least 50% clot lysis – was 89% in both groups. Rates of recurrent DVT within 30 days were similar in the two groups as well: 11% in the caval thrombosis group and 14% in the noncaval group. At 2 years postintervention, 77%-78% of patients in both groups remained free of DVT recurrence. The rate of PTS – defined by a Villalta score of 5 or more – at 2 years was 34% in the noncaval group, which was significantly higher than the 11% rate in patients with IVC thrombus extension. Ultrasound-identified valve reflux was present in 51% of the noncaval group at 2 years, compared with 51% of the noncaval group.

On multivariate analysis, incomplete clot lysis was associated with nearly a 23-fold increased risk of recurrent DVT and a 5.6-fold increased risk of PTS. Caval involvement was independently associated with a 78% reduction in PTS risk.

The Society for Vascular Surgery’s guidelines recommend pharmacomechanical thrombolysis over catheter-directed thrombolysis if the expertise is available. The Pittsburgh experience speaks to the worth of that recommendation.

“Pharmacomechanical techniques can be advantageous. They can expedite the lysis process by clearing most of the clot. In our series, 20 patients were treated with pharmacomechanical techniques in a single session,” Dr. Chaer noted.

The use of IVC filters in the setting of caval extension of iliofemoral DVT is controversial, according to the surgeon: A thrombus that gets trapped in the filter is tough to remove, precluding successful recanalization.

“One-third of the patients in our series got a filter, but we’ve become more conservative nowadays. We don’t use filters anymore. But I think those patients who might benefit from an IVC filter are those who present with a PE [pulmonary embolism], because that’s telling you they might develop another PE, as well as those patients in whom pharmacomechanical thrombolysis is anticipated because we’ve seen that those patients are also more likely to develop a PE,” he said.

The University of Pittsburgh study on the effect of IVC thrombus extension has been published (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:385-91).

Dr. Chaer reported serving as a paid speaker for Boston Scientific.

SOURCE: Chaer RA. Northwestern Vascular Symposium 2017.

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REPORTING FROM THE NORTHWESTERN VASCULAR SYMPOSIUM

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Know risk factors for ischemic colitis after AAA repair

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EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM

– Postoperative ischemic colitis after abdominal aortic aneurysm (AAA) repair is a feared, potentially devastating complication with a mortality approaching 50%, but early diagnosis can mitigate that risk, Roy M. Fujitani, MD, said at a symposium on vascular surgery sponsored by Northwestern University in Chicago.

Bruce Jancin/Frontline Medical News
Dr. Roy M. Fujitani
The key is to be familiar with the risk factors for this complication. Close surveillance of patients with multiple risk factors is particularly important for the first 4 days after AAA repair since more than three-quarters of cases are diagnosed in this time frame, according to Dr. Fujitani, professor and vice chair of surgery at University of California, Irvine.

The most common etiology of ischemic colitis following AAA repair is hypoperfusion of the mesenteric vasculature leading to nonocclusive ischemia. Caught early – in the initial hyperactive phase of colonic ischemia – the complication is typically transient and can be managed medically without further sequelae. Improvement is generally noted within a day or 2, with complete resolution within 1-2 weeks.

The earliest indicator that a patient is in the hyperactive phase of ischemic colitis following completion of an AAA repair can be defecation while still on the operating table.

“When you’ve just completed an operation and the patient has a bowel movement right on the operating table, that always makes me very, very concerned because of the likelihood of an associated ischemic colitis,” the surgeon noted.

A conscious patient in the first phase of ischemic colitis will describe an urgent desire to defecate, along with crampy pain and loose bowel movements with or without blood in the stool.

In the second, paralytic phase of ischemic colitis, the pain diminishes in intensity but becomes more continuous and diffuse, usually in the lateral borders of the abdomen. The abdomen becomes distended and much more tender, and there are no bowel sounds.

In patients whose ischemic colitis has been misdiagnosed or undiagnosed, the shock phase comes next. This is marked by massive fluid, protein, and electrolyte loss through the gangrenous mucosa. The result is severe dehydration, metabolic acidosis, and hypovolemic shock.

Nonocclusive colonic ischemia most often affects the watershed areas of the colon, such as the Sudeck point at the rectosigmoid junction.

The two other etiologies of ischemic colitis occurring as a complication of AAA repair are acute arterial occlusion, typically caused by iatrogenic embolization from a proximal source, often during endovascular aneurysm repair (EVAR), or rarely, venous thrombosis.
 

Making the diagnosis

When a patient is suspected of having ischemic colitis, one of the easiest ways of advancing toward a diagnosis is to obtain an abdominal plain x-ray, which classically shows thumb printing indicative of submucosal edema. CT with IV contrast typically shows bowel wall thickening, pericolonic fat stranding, and – most significantly – there may be free air within the colonic wall, an indicator of more advanced ischemia that occurs shortly before transmural gangrenous changes.

Colonoscopy is, however, the mainstay of diagnosis. It should be performed in any patient where postoperative ischemic colitis is suspected.
 

Ischemic colitis risk factors and outcomes

Dr. Fujitani was senior author of the largest ever study of risk factors for and outcomes of postoperative ischemic colitis in patients undergoing contemporary methods of open and endovascular AAA repair. This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database included 3,486 patients who underwent AAA repair in U.S. hospitals during 2011-2012. Twelve percent had an open repair, while the other 88% underwent EVAR.

The incidence of postoperative ischemic colitis was 2.2%. The median time of diagnosis was on postoperative day 2. The rate was nearly threefold higher in the open repair group: 5.2% versus 1.8%. However, the open-repair group had a higher rate of emergency admission, ruptured aneurysm before surgery, and other high-risk features. Upon multivariate analysis, the adjusted risk of postoperative ischemic colitis was no longer significantly different in the open-repair and EVAR groups.

The mean hospital length of stay in patients with postoperative ischemic colitis was 20 days, compared with 5 days in those without the complication. The unadjusted in-hospital mortality rate in patients with ischemic colitis was 39% versus 4% in those without ischemic colitis.

Of the 75 patients who developed postoperative ischemic colitis, 37 were managed medically, 38 surgically.

“What was quite surprising was that there was a 56.8% in-hospital mortality in the surgically treated patients. The point being that if you end up having ischemic colitis, there’s a 50% chance you’ll end up requiring an operation, and if you do undergo an operation you have more than a 50% chance of succumbing from the process,” Dr. Fujitani observed.

Dr. Fujitani and his coinvestigators scrutinized a plethora of potential risk factors for postoperative ischemic colitis. Six emerged as significant upon multivariate analysis: ruptured aneurysm before surgery, with an associated adjusted 4.1-fold increased risk; need for intra- or postoperative transfusion, with a 6-fold increased risk; renal failure requiring dialysis, with a 3.9-fold risk; proximal extension of the aneurysm, with a 2.2-fold elevation in risk; diabetes, with a 1.9-fold risk; and female sex, with an adjusted 1.75-fold increased risk (J Vasc Surg. 2016 Apr;63[4]:866-72).

Of note, these risk factors are largely unmodifiable, which underscores the importance of vigorous surveillance for possible signs of ischemic colitis during the first 4 days after AAA repair, especially in patients with multiple risk factors, Dr. Fujitani said.

Also, careful intraoperative assessment of the collateral mesenteric vascular anatomy is important in assessing a patient’s risk for postoperative ischemic colitis. This assessment should include the superior and inferior mesenteric arteries, as well as the celiac and internal iliac arteries. It’s worth bearing in mind that, even though collateral flow may appear adequate, it can be affected by hypovolemia, hypotension, or low cardiac output, the surgeon continued.

In the NSQIP data analysis, no patients who underwent reimplantation of the inferior mesenteric artery during open repair developed postoperative ischemic colitis. While this is an encouraging finding, the numbers were too small to draw definitive conclusions as to whether reimplantation of the artery is protective. It’s an important issue for further study, though, since so few of the recognized risk factors for the complication are modifiable, Dr. Fujitani noted.

He reported having no financial conflicts regarding his presentation.

 

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EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM

– Postoperative ischemic colitis after abdominal aortic aneurysm (AAA) repair is a feared, potentially devastating complication with a mortality approaching 50%, but early diagnosis can mitigate that risk, Roy M. Fujitani, MD, said at a symposium on vascular surgery sponsored by Northwestern University in Chicago.

Bruce Jancin/Frontline Medical News
Dr. Roy M. Fujitani
The key is to be familiar with the risk factors for this complication. Close surveillance of patients with multiple risk factors is particularly important for the first 4 days after AAA repair since more than three-quarters of cases are diagnosed in this time frame, according to Dr. Fujitani, professor and vice chair of surgery at University of California, Irvine.

The most common etiology of ischemic colitis following AAA repair is hypoperfusion of the mesenteric vasculature leading to nonocclusive ischemia. Caught early – in the initial hyperactive phase of colonic ischemia – the complication is typically transient and can be managed medically without further sequelae. Improvement is generally noted within a day or 2, with complete resolution within 1-2 weeks.

The earliest indicator that a patient is in the hyperactive phase of ischemic colitis following completion of an AAA repair can be defecation while still on the operating table.

“When you’ve just completed an operation and the patient has a bowel movement right on the operating table, that always makes me very, very concerned because of the likelihood of an associated ischemic colitis,” the surgeon noted.

A conscious patient in the first phase of ischemic colitis will describe an urgent desire to defecate, along with crampy pain and loose bowel movements with or without blood in the stool.

In the second, paralytic phase of ischemic colitis, the pain diminishes in intensity but becomes more continuous and diffuse, usually in the lateral borders of the abdomen. The abdomen becomes distended and much more tender, and there are no bowel sounds.

In patients whose ischemic colitis has been misdiagnosed or undiagnosed, the shock phase comes next. This is marked by massive fluid, protein, and electrolyte loss through the gangrenous mucosa. The result is severe dehydration, metabolic acidosis, and hypovolemic shock.

Nonocclusive colonic ischemia most often affects the watershed areas of the colon, such as the Sudeck point at the rectosigmoid junction.

The two other etiologies of ischemic colitis occurring as a complication of AAA repair are acute arterial occlusion, typically caused by iatrogenic embolization from a proximal source, often during endovascular aneurysm repair (EVAR), or rarely, venous thrombosis.
 

Making the diagnosis

When a patient is suspected of having ischemic colitis, one of the easiest ways of advancing toward a diagnosis is to obtain an abdominal plain x-ray, which classically shows thumb printing indicative of submucosal edema. CT with IV contrast typically shows bowel wall thickening, pericolonic fat stranding, and – most significantly – there may be free air within the colonic wall, an indicator of more advanced ischemia that occurs shortly before transmural gangrenous changes.

Colonoscopy is, however, the mainstay of diagnosis. It should be performed in any patient where postoperative ischemic colitis is suspected.
 

Ischemic colitis risk factors and outcomes

Dr. Fujitani was senior author of the largest ever study of risk factors for and outcomes of postoperative ischemic colitis in patients undergoing contemporary methods of open and endovascular AAA repair. This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database included 3,486 patients who underwent AAA repair in U.S. hospitals during 2011-2012. Twelve percent had an open repair, while the other 88% underwent EVAR.

The incidence of postoperative ischemic colitis was 2.2%. The median time of diagnosis was on postoperative day 2. The rate was nearly threefold higher in the open repair group: 5.2% versus 1.8%. However, the open-repair group had a higher rate of emergency admission, ruptured aneurysm before surgery, and other high-risk features. Upon multivariate analysis, the adjusted risk of postoperative ischemic colitis was no longer significantly different in the open-repair and EVAR groups.

The mean hospital length of stay in patients with postoperative ischemic colitis was 20 days, compared with 5 days in those without the complication. The unadjusted in-hospital mortality rate in patients with ischemic colitis was 39% versus 4% in those without ischemic colitis.

Of the 75 patients who developed postoperative ischemic colitis, 37 were managed medically, 38 surgically.

“What was quite surprising was that there was a 56.8% in-hospital mortality in the surgically treated patients. The point being that if you end up having ischemic colitis, there’s a 50% chance you’ll end up requiring an operation, and if you do undergo an operation you have more than a 50% chance of succumbing from the process,” Dr. Fujitani observed.

Dr. Fujitani and his coinvestigators scrutinized a plethora of potential risk factors for postoperative ischemic colitis. Six emerged as significant upon multivariate analysis: ruptured aneurysm before surgery, with an associated adjusted 4.1-fold increased risk; need for intra- or postoperative transfusion, with a 6-fold increased risk; renal failure requiring dialysis, with a 3.9-fold risk; proximal extension of the aneurysm, with a 2.2-fold elevation in risk; diabetes, with a 1.9-fold risk; and female sex, with an adjusted 1.75-fold increased risk (J Vasc Surg. 2016 Apr;63[4]:866-72).

Of note, these risk factors are largely unmodifiable, which underscores the importance of vigorous surveillance for possible signs of ischemic colitis during the first 4 days after AAA repair, especially in patients with multiple risk factors, Dr. Fujitani said.

Also, careful intraoperative assessment of the collateral mesenteric vascular anatomy is important in assessing a patient’s risk for postoperative ischemic colitis. This assessment should include the superior and inferior mesenteric arteries, as well as the celiac and internal iliac arteries. It’s worth bearing in mind that, even though collateral flow may appear adequate, it can be affected by hypovolemia, hypotension, or low cardiac output, the surgeon continued.

In the NSQIP data analysis, no patients who underwent reimplantation of the inferior mesenteric artery during open repair developed postoperative ischemic colitis. While this is an encouraging finding, the numbers were too small to draw definitive conclusions as to whether reimplantation of the artery is protective. It’s an important issue for further study, though, since so few of the recognized risk factors for the complication are modifiable, Dr. Fujitani noted.

He reported having no financial conflicts regarding his presentation.

 

 

EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM

– Postoperative ischemic colitis after abdominal aortic aneurysm (AAA) repair is a feared, potentially devastating complication with a mortality approaching 50%, but early diagnosis can mitigate that risk, Roy M. Fujitani, MD, said at a symposium on vascular surgery sponsored by Northwestern University in Chicago.

Bruce Jancin/Frontline Medical News
Dr. Roy M. Fujitani
The key is to be familiar with the risk factors for this complication. Close surveillance of patients with multiple risk factors is particularly important for the first 4 days after AAA repair since more than three-quarters of cases are diagnosed in this time frame, according to Dr. Fujitani, professor and vice chair of surgery at University of California, Irvine.

The most common etiology of ischemic colitis following AAA repair is hypoperfusion of the mesenteric vasculature leading to nonocclusive ischemia. Caught early – in the initial hyperactive phase of colonic ischemia – the complication is typically transient and can be managed medically without further sequelae. Improvement is generally noted within a day or 2, with complete resolution within 1-2 weeks.

The earliest indicator that a patient is in the hyperactive phase of ischemic colitis following completion of an AAA repair can be defecation while still on the operating table.

“When you’ve just completed an operation and the patient has a bowel movement right on the operating table, that always makes me very, very concerned because of the likelihood of an associated ischemic colitis,” the surgeon noted.

A conscious patient in the first phase of ischemic colitis will describe an urgent desire to defecate, along with crampy pain and loose bowel movements with or without blood in the stool.

In the second, paralytic phase of ischemic colitis, the pain diminishes in intensity but becomes more continuous and diffuse, usually in the lateral borders of the abdomen. The abdomen becomes distended and much more tender, and there are no bowel sounds.

In patients whose ischemic colitis has been misdiagnosed or undiagnosed, the shock phase comes next. This is marked by massive fluid, protein, and electrolyte loss through the gangrenous mucosa. The result is severe dehydration, metabolic acidosis, and hypovolemic shock.

Nonocclusive colonic ischemia most often affects the watershed areas of the colon, such as the Sudeck point at the rectosigmoid junction.

The two other etiologies of ischemic colitis occurring as a complication of AAA repair are acute arterial occlusion, typically caused by iatrogenic embolization from a proximal source, often during endovascular aneurysm repair (EVAR), or rarely, venous thrombosis.
 

Making the diagnosis

When a patient is suspected of having ischemic colitis, one of the easiest ways of advancing toward a diagnosis is to obtain an abdominal plain x-ray, which classically shows thumb printing indicative of submucosal edema. CT with IV contrast typically shows bowel wall thickening, pericolonic fat stranding, and – most significantly – there may be free air within the colonic wall, an indicator of more advanced ischemia that occurs shortly before transmural gangrenous changes.

Colonoscopy is, however, the mainstay of diagnosis. It should be performed in any patient where postoperative ischemic colitis is suspected.
 

Ischemic colitis risk factors and outcomes

Dr. Fujitani was senior author of the largest ever study of risk factors for and outcomes of postoperative ischemic colitis in patients undergoing contemporary methods of open and endovascular AAA repair. This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database included 3,486 patients who underwent AAA repair in U.S. hospitals during 2011-2012. Twelve percent had an open repair, while the other 88% underwent EVAR.

The incidence of postoperative ischemic colitis was 2.2%. The median time of diagnosis was on postoperative day 2. The rate was nearly threefold higher in the open repair group: 5.2% versus 1.8%. However, the open-repair group had a higher rate of emergency admission, ruptured aneurysm before surgery, and other high-risk features. Upon multivariate analysis, the adjusted risk of postoperative ischemic colitis was no longer significantly different in the open-repair and EVAR groups.

The mean hospital length of stay in patients with postoperative ischemic colitis was 20 days, compared with 5 days in those without the complication. The unadjusted in-hospital mortality rate in patients with ischemic colitis was 39% versus 4% in those without ischemic colitis.

Of the 75 patients who developed postoperative ischemic colitis, 37 were managed medically, 38 surgically.

“What was quite surprising was that there was a 56.8% in-hospital mortality in the surgically treated patients. The point being that if you end up having ischemic colitis, there’s a 50% chance you’ll end up requiring an operation, and if you do undergo an operation you have more than a 50% chance of succumbing from the process,” Dr. Fujitani observed.

Dr. Fujitani and his coinvestigators scrutinized a plethora of potential risk factors for postoperative ischemic colitis. Six emerged as significant upon multivariate analysis: ruptured aneurysm before surgery, with an associated adjusted 4.1-fold increased risk; need for intra- or postoperative transfusion, with a 6-fold increased risk; renal failure requiring dialysis, with a 3.9-fold risk; proximal extension of the aneurysm, with a 2.2-fold elevation in risk; diabetes, with a 1.9-fold risk; and female sex, with an adjusted 1.75-fold increased risk (J Vasc Surg. 2016 Apr;63[4]:866-72).

Of note, these risk factors are largely unmodifiable, which underscores the importance of vigorous surveillance for possible signs of ischemic colitis during the first 4 days after AAA repair, especially in patients with multiple risk factors, Dr. Fujitani said.

Also, careful intraoperative assessment of the collateral mesenteric vascular anatomy is important in assessing a patient’s risk for postoperative ischemic colitis. This assessment should include the superior and inferior mesenteric arteries, as well as the celiac and internal iliac arteries. It’s worth bearing in mind that, even though collateral flow may appear adequate, it can be affected by hypovolemia, hypotension, or low cardiac output, the surgeon continued.

In the NSQIP data analysis, no patients who underwent reimplantation of the inferior mesenteric artery during open repair developed postoperative ischemic colitis. While this is an encouraging finding, the numbers were too small to draw definitive conclusions as to whether reimplantation of the artery is protective. It’s an important issue for further study, though, since so few of the recognized risk factors for the complication are modifiable, Dr. Fujitani noted.

He reported having no financial conflicts regarding his presentation.

 

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Controversy surrounds calf vein thrombosis treatment

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– The use of therapeutic-dose anticoagulation in hospitalized patients with calf vein thrombosis significantly reduces the risk of venous thromboembolic complications, compared with lower-dose prophylactic anticoagulation or surveillance alone, Heron E. Rodriguez, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Moreover, placement of an inferior vena cava filter in patients with calf vein thrombosis when anticoagulation is contraindicated accomplishes nothing beneficial and had a 10% complication rate in a large retrospective single-center study, added Dr. Rodriguez of Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News
Dr. Heron E. Rodriguez
“In our population – patients that are in the hospital with risk factors for venous thromboembolic complications – we think that anticoagulation is a good idea. Low-risk patients or patients in whom anticoagulation is contraindicated should not be getting a filter. There’s really not any advantage in putting in a filter,” the vascular surgeon said.

Deep vein thrombosis (DVT) remains a significant source of morbidity and mortality despite worldwide awareness of the problem.

“Specifically, calf vein thrombosis [CVT] is very common, and we know that in some series up to 30% of patients end up propagating proximally if they’re not treated, and a good number of them develop chronic venous insufficiency, with long-term consequences,” he noted.

“Unfortunately there is no consensus regarding treatment. The guidelines are very vague. For example, there is no mention [in current American College of Chest Physicians guidelines] of how to manage muscular vein thrombosis and much ambiguity on how to treat calf vein thrombosis,” he continued.

Dr. Rodriguez cited as an indication of the lack of consensus on management of CVT a single-institution survey by other investigators of the practices of physicians in various specialties. Forty-nine percent of respondents indicated they anticoagulate patients with CVT; 51% don’t. Of those who did, 62% prescribed low-molecular-weight heparin and 11% intravenous heparin. Fifty-eight percent of physicians who anticoagulated did so for 3 months, 30% for 6. And 46% of physicians used an inferior vena cava (IVC) filter when anticoagulation was contraindicated (Vascular. 2014 Apr;22[2]:93-7).

That rate of IVC placement “seemed really high” given the paucity of supporting evidence for safety and efficacy of filter placement in the setting of CVT, so Dr. Rodriguez and coinvestigators decided to conduct a retrospective review of practices at Northwestern Memorial Hospital. He explained the study hypothesis: “Our thinking was that these kinds of thrombi are associated with low risk of propagation and pulmonary embolism, and they can and should be managed conservatively.”

Of 647 patients with isolated thrombosis of the anterior and posterior tibial, soleal, peroneal, or gastrocnemius veins, 44% received an IVC filter, and the rest got medical treatment alone. Of the 362 patients managed medically, 49% received therapeutic anticoagulation, 12% got low-dose prophylactic anticoagulation, and 39% underwent surveillance without anticoagulation.

The primary outcome was the incidence of venous thromboembolic complications – that is, propagation of DVT or pulmonary embolism. The incidence was 35% in the surveillance-only group, 30% with prophylactic anticoagulation, and 10% in patients who got therapeutic anticoagulation.

Of note, the rate of the most feared complication, pulmonary embolism, was low and similar in the filter recipients and medically managed group: 2.5% in the IVC group, 3.3% with medical management.

“Distal vein thromboses have low rates of pulmonary embolism, regardless of whether or not they are so-called protected with a filter. On the other hand, a filter was associated with a 10% rate of complications. I have to make clear that these were radiographic abnormalities – tilting, migration, caval perforation – that didn’t have clinical consequences, but we were very aggressive in removing the IVC filters, and I’m guessing if they’d been left inside they would create problems in the long term,” Dr. Rodriguez said.

An important point about this study is that these were all sick patients, and most were hospitalized. The filter recipients and medical groups differed in key ways. For example, 49% of the filter patients had a malignancy, and 56% had a baseline history of venous thromboembolic events, compared with 26% and 16%, respectively, of the medical group. For that reason, the investigators performed propensity score matching and came up with 157 closely matched patient pairs. The outcomes remained unchanged.

Of course, this was a retrospective study, with its inherent limitations, but Dr. Rodriguez characterized the published randomized trials on management of CVT as “small and limited.” The most frequently quoted study is the double-blind multicenter CACTUS trial, which randomized 252 outpatients with symptomatic CVT to 6 weeks of low-molecular-weight heparin or placebo and found no difference in the rates of proximal extension of venous thromboembolic events (Lancet Haematol. 2016 Dec;3[12]:e556-62). But these were all low-risk patients. Prior DVT or malignancy were exclusion criteria, so this was a very different population than treated at Northwestern.

Based upon the results of the retrospective study at Northwestern, which have been published (J Vasc Surg Venous Lymphat Disord. 2017 Jan;5[1]:25-32), the vascular surgery service has developed a management algorithm for DVT management based upon the lesion site. For acute isolated lower extremity DVT, the algorithm calls for 3 months of therapeutic anticoagulation. If a patient is unable to undergo anticoagulation, venous duplex ultrasound is repeated at 1 week. If the imaging shows propagation into the popliteal vein and anticoagulation remains contraindicated, only then is placement of an IVC filter warranted.

Dr. Rodriguez reported serving as a paid speaker for Abbott, Endologix, and W.L. Gore.

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– The use of therapeutic-dose anticoagulation in hospitalized patients with calf vein thrombosis significantly reduces the risk of venous thromboembolic complications, compared with lower-dose prophylactic anticoagulation or surveillance alone, Heron E. Rodriguez, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Moreover, placement of an inferior vena cava filter in patients with calf vein thrombosis when anticoagulation is contraindicated accomplishes nothing beneficial and had a 10% complication rate in a large retrospective single-center study, added Dr. Rodriguez of Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News
Dr. Heron E. Rodriguez
“In our population – patients that are in the hospital with risk factors for venous thromboembolic complications – we think that anticoagulation is a good idea. Low-risk patients or patients in whom anticoagulation is contraindicated should not be getting a filter. There’s really not any advantage in putting in a filter,” the vascular surgeon said.

Deep vein thrombosis (DVT) remains a significant source of morbidity and mortality despite worldwide awareness of the problem.

“Specifically, calf vein thrombosis [CVT] is very common, and we know that in some series up to 30% of patients end up propagating proximally if they’re not treated, and a good number of them develop chronic venous insufficiency, with long-term consequences,” he noted.

“Unfortunately there is no consensus regarding treatment. The guidelines are very vague. For example, there is no mention [in current American College of Chest Physicians guidelines] of how to manage muscular vein thrombosis and much ambiguity on how to treat calf vein thrombosis,” he continued.

Dr. Rodriguez cited as an indication of the lack of consensus on management of CVT a single-institution survey by other investigators of the practices of physicians in various specialties. Forty-nine percent of respondents indicated they anticoagulate patients with CVT; 51% don’t. Of those who did, 62% prescribed low-molecular-weight heparin and 11% intravenous heparin. Fifty-eight percent of physicians who anticoagulated did so for 3 months, 30% for 6. And 46% of physicians used an inferior vena cava (IVC) filter when anticoagulation was contraindicated (Vascular. 2014 Apr;22[2]:93-7).

That rate of IVC placement “seemed really high” given the paucity of supporting evidence for safety and efficacy of filter placement in the setting of CVT, so Dr. Rodriguez and coinvestigators decided to conduct a retrospective review of practices at Northwestern Memorial Hospital. He explained the study hypothesis: “Our thinking was that these kinds of thrombi are associated with low risk of propagation and pulmonary embolism, and they can and should be managed conservatively.”

Of 647 patients with isolated thrombosis of the anterior and posterior tibial, soleal, peroneal, or gastrocnemius veins, 44% received an IVC filter, and the rest got medical treatment alone. Of the 362 patients managed medically, 49% received therapeutic anticoagulation, 12% got low-dose prophylactic anticoagulation, and 39% underwent surveillance without anticoagulation.

The primary outcome was the incidence of venous thromboembolic complications – that is, propagation of DVT or pulmonary embolism. The incidence was 35% in the surveillance-only group, 30% with prophylactic anticoagulation, and 10% in patients who got therapeutic anticoagulation.

Of note, the rate of the most feared complication, pulmonary embolism, was low and similar in the filter recipients and medically managed group: 2.5% in the IVC group, 3.3% with medical management.

“Distal vein thromboses have low rates of pulmonary embolism, regardless of whether or not they are so-called protected with a filter. On the other hand, a filter was associated with a 10% rate of complications. I have to make clear that these were radiographic abnormalities – tilting, migration, caval perforation – that didn’t have clinical consequences, but we were very aggressive in removing the IVC filters, and I’m guessing if they’d been left inside they would create problems in the long term,” Dr. Rodriguez said.

An important point about this study is that these were all sick patients, and most were hospitalized. The filter recipients and medical groups differed in key ways. For example, 49% of the filter patients had a malignancy, and 56% had a baseline history of venous thromboembolic events, compared with 26% and 16%, respectively, of the medical group. For that reason, the investigators performed propensity score matching and came up with 157 closely matched patient pairs. The outcomes remained unchanged.

Of course, this was a retrospective study, with its inherent limitations, but Dr. Rodriguez characterized the published randomized trials on management of CVT as “small and limited.” The most frequently quoted study is the double-blind multicenter CACTUS trial, which randomized 252 outpatients with symptomatic CVT to 6 weeks of low-molecular-weight heparin or placebo and found no difference in the rates of proximal extension of venous thromboembolic events (Lancet Haematol. 2016 Dec;3[12]:e556-62). But these were all low-risk patients. Prior DVT or malignancy were exclusion criteria, so this was a very different population than treated at Northwestern.

Based upon the results of the retrospective study at Northwestern, which have been published (J Vasc Surg Venous Lymphat Disord. 2017 Jan;5[1]:25-32), the vascular surgery service has developed a management algorithm for DVT management based upon the lesion site. For acute isolated lower extremity DVT, the algorithm calls for 3 months of therapeutic anticoagulation. If a patient is unable to undergo anticoagulation, venous duplex ultrasound is repeated at 1 week. If the imaging shows propagation into the popliteal vein and anticoagulation remains contraindicated, only then is placement of an IVC filter warranted.

Dr. Rodriguez reported serving as a paid speaker for Abbott, Endologix, and W.L. Gore.

 

– The use of therapeutic-dose anticoagulation in hospitalized patients with calf vein thrombosis significantly reduces the risk of venous thromboembolic complications, compared with lower-dose prophylactic anticoagulation or surveillance alone, Heron E. Rodriguez, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Moreover, placement of an inferior vena cava filter in patients with calf vein thrombosis when anticoagulation is contraindicated accomplishes nothing beneficial and had a 10% complication rate in a large retrospective single-center study, added Dr. Rodriguez of Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News
Dr. Heron E. Rodriguez
“In our population – patients that are in the hospital with risk factors for venous thromboembolic complications – we think that anticoagulation is a good idea. Low-risk patients or patients in whom anticoagulation is contraindicated should not be getting a filter. There’s really not any advantage in putting in a filter,” the vascular surgeon said.

Deep vein thrombosis (DVT) remains a significant source of morbidity and mortality despite worldwide awareness of the problem.

“Specifically, calf vein thrombosis [CVT] is very common, and we know that in some series up to 30% of patients end up propagating proximally if they’re not treated, and a good number of them develop chronic venous insufficiency, with long-term consequences,” he noted.

“Unfortunately there is no consensus regarding treatment. The guidelines are very vague. For example, there is no mention [in current American College of Chest Physicians guidelines] of how to manage muscular vein thrombosis and much ambiguity on how to treat calf vein thrombosis,” he continued.

Dr. Rodriguez cited as an indication of the lack of consensus on management of CVT a single-institution survey by other investigators of the practices of physicians in various specialties. Forty-nine percent of respondents indicated they anticoagulate patients with CVT; 51% don’t. Of those who did, 62% prescribed low-molecular-weight heparin and 11% intravenous heparin. Fifty-eight percent of physicians who anticoagulated did so for 3 months, 30% for 6. And 46% of physicians used an inferior vena cava (IVC) filter when anticoagulation was contraindicated (Vascular. 2014 Apr;22[2]:93-7).

That rate of IVC placement “seemed really high” given the paucity of supporting evidence for safety and efficacy of filter placement in the setting of CVT, so Dr. Rodriguez and coinvestigators decided to conduct a retrospective review of practices at Northwestern Memorial Hospital. He explained the study hypothesis: “Our thinking was that these kinds of thrombi are associated with low risk of propagation and pulmonary embolism, and they can and should be managed conservatively.”

Of 647 patients with isolated thrombosis of the anterior and posterior tibial, soleal, peroneal, or gastrocnemius veins, 44% received an IVC filter, and the rest got medical treatment alone. Of the 362 patients managed medically, 49% received therapeutic anticoagulation, 12% got low-dose prophylactic anticoagulation, and 39% underwent surveillance without anticoagulation.

The primary outcome was the incidence of venous thromboembolic complications – that is, propagation of DVT or pulmonary embolism. The incidence was 35% in the surveillance-only group, 30% with prophylactic anticoagulation, and 10% in patients who got therapeutic anticoagulation.

Of note, the rate of the most feared complication, pulmonary embolism, was low and similar in the filter recipients and medically managed group: 2.5% in the IVC group, 3.3% with medical management.

“Distal vein thromboses have low rates of pulmonary embolism, regardless of whether or not they are so-called protected with a filter. On the other hand, a filter was associated with a 10% rate of complications. I have to make clear that these were radiographic abnormalities – tilting, migration, caval perforation – that didn’t have clinical consequences, but we were very aggressive in removing the IVC filters, and I’m guessing if they’d been left inside they would create problems in the long term,” Dr. Rodriguez said.

An important point about this study is that these were all sick patients, and most were hospitalized. The filter recipients and medical groups differed in key ways. For example, 49% of the filter patients had a malignancy, and 56% had a baseline history of venous thromboembolic events, compared with 26% and 16%, respectively, of the medical group. For that reason, the investigators performed propensity score matching and came up with 157 closely matched patient pairs. The outcomes remained unchanged.

Of course, this was a retrospective study, with its inherent limitations, but Dr. Rodriguez characterized the published randomized trials on management of CVT as “small and limited.” The most frequently quoted study is the double-blind multicenter CACTUS trial, which randomized 252 outpatients with symptomatic CVT to 6 weeks of low-molecular-weight heparin or placebo and found no difference in the rates of proximal extension of venous thromboembolic events (Lancet Haematol. 2016 Dec;3[12]:e556-62). But these were all low-risk patients. Prior DVT or malignancy were exclusion criteria, so this was a very different population than treated at Northwestern.

Based upon the results of the retrospective study at Northwestern, which have been published (J Vasc Surg Venous Lymphat Disord. 2017 Jan;5[1]:25-32), the vascular surgery service has developed a management algorithm for DVT management based upon the lesion site. For acute isolated lower extremity DVT, the algorithm calls for 3 months of therapeutic anticoagulation. If a patient is unable to undergo anticoagulation, venous duplex ultrasound is repeated at 1 week. If the imaging shows propagation into the popliteal vein and anticoagulation remains contraindicated, only then is placement of an IVC filter warranted.

Dr. Rodriguez reported serving as a paid speaker for Abbott, Endologix, and W.L. Gore.

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Asymptomatic carotid in-stent restenosis? Think medical management

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Modern medical management is as effective as carotid artery reintervention for stroke prevention in asymptomatic patients with a carotid in-stent restenosis in excess of 70%, Jayer Chung, MD, asserted at a symposium on vascular surgery sponsored by Northwestern University.

That, in his view, makes medical management the clear preferred strategy.

Bruce Jancin/Frontline Medical News
Dr. Jayer Chung
“A carotid intervention costs about $17,000. If we choose medical management, we can better allocate our resources. Furthermore, if it doesn’t really help, I don’t want to do one of these procedures to my patients. I want to avoid the periprocedural risks. Early on, the stroke and death rates are higher in the intervention arm,” explained Dr. Chung, a vascular surgeon at Baylor College of Medicine, Houston.

A growing body of evidence, mainly from nested cohorts within randomized controlled trials, indicates that the late ipsilateral stroke rate associated with post–carotid endarterectomy restenosis (CEA) is much higher than that for carotid in-stent restenosis (C-ISR). In a recent meta-analysis of nine randomized trials, the difference in risk was more than 10-fold, with a 9.2% stroke rate at a mean of 37 months of follow-up in patients with post-CEA restenosis, compared with a 0.8% rate with 50 months of follow-up in patients with C-ISR (Eur J Vasc Endovasc Surg. 2017 Jun;53[6]:766-75).

“These pathologies behave very, very differently,” Dr. Chung observed. “The C-ISR lesions tend to be less embologenic.”

C-ISR is an uncommon event. Extrapolating from the landmark CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) and other randomized trials, about 6% of patients who undergo percutaneous carotid stenting will be develop C-ISR within 2 years. But since the proportion of all carotid revascularizations that are done by carotid stent angioplasty has steadily increased over the past 15 years as the frequency of CEA has dropped, C-ISR is a problem that vascular specialists will continue to encounter on a regular basis.

Symptomatic C-ISR warrants reintervention; broad agreement exists on that. But there is a paucity of data to guide treatment decisions regarding asymptomatic yet angiographically severe C-ISR. Indeed, Dr. Chung was lead author of the only retrospective study of the natural history of untreated C-ISR, as opposed to carefully selected cohorts from randomized trials involving highly experienced operators. This study was a retrospective review of 59 patients with 75 C-ISRs of at least 50% seen at a single Veterans Affairs medical center over a 13-year period. Three-quarters of the ISRs were asymptomatic.

Forty of the 79 C-ISRs underwent percutaneous intervention at the physician’s discretion. Those patients did not differ from the observation-only group in age, comorbid conditions, type of original stent, or clopidogrel use. Reintervention was safe: There was one stent thrombosis resulting in stroke and death within 30 days in the reintervention group and no 30-day strokes in the observation-only group. During a mean 2.6 years of follow-up, the composite rate of death, stroke, or MI was low and not statistically significantly different between the two groups. Indeed, during up to 13 years of follow-up only one patient with untreated C-ISR experienced an ipsilateral stroke, as did two patients in the percutaneous intervention group (J Vasc Surg. 2016 Nov;64[5]:1286-94).
 

Dr. Chung does the math

According to data from the National Inpatient Sample, vascular surgeons do an average of 15 carotid angioplasty and stenting procedures per year. If 6% of those stents develop in-stent restenosis, and with a number needed to treat with revascularization of 25 to prevent 1 stroke, Dr. Chung estimated that hypothetically it would take the typical vascular surgeon 27 years to prevent one stroke due to C-ISR.

“That’s a very long time to prevent one stroke, in my opinion,” he said.
 

How his study has affected his own practice

Dr. Chung now intervenes only for symptomatic C-ISRs, and only after an affected patient is on optimal medical therapy, including a statin and dual-antiplatelet therapy.

“I try to do an open procedure if possible, especially if the restenosis is above C-2. The ones I tend to do percutaneously are the post-irradiation stenoses or those with excessive scarring, and I use a cerebral protection device,” the surgeon explained.

He emphasized, however, that the final word on the appropriate management of C-ISRs isn’t in yet. A standardized definition of C-ISR is needed, as are multicenter prospective registries of medically managed patients as well as those undergoing various forms of reintervention. And a pathologic study is warranted to confirm the hypothesis that the histopathology of post-CEA and post-stent restenosis – and hence the natural history – is markedly different.

Dr. Chung reported having no financial conflicts regarding his presentation.

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Modern medical management is as effective as carotid artery reintervention for stroke prevention in asymptomatic patients with a carotid in-stent restenosis in excess of 70%, Jayer Chung, MD, asserted at a symposium on vascular surgery sponsored by Northwestern University.

That, in his view, makes medical management the clear preferred strategy.

Bruce Jancin/Frontline Medical News
Dr. Jayer Chung
“A carotid intervention costs about $17,000. If we choose medical management, we can better allocate our resources. Furthermore, if it doesn’t really help, I don’t want to do one of these procedures to my patients. I want to avoid the periprocedural risks. Early on, the stroke and death rates are higher in the intervention arm,” explained Dr. Chung, a vascular surgeon at Baylor College of Medicine, Houston.

A growing body of evidence, mainly from nested cohorts within randomized controlled trials, indicates that the late ipsilateral stroke rate associated with post–carotid endarterectomy restenosis (CEA) is much higher than that for carotid in-stent restenosis (C-ISR). In a recent meta-analysis of nine randomized trials, the difference in risk was more than 10-fold, with a 9.2% stroke rate at a mean of 37 months of follow-up in patients with post-CEA restenosis, compared with a 0.8% rate with 50 months of follow-up in patients with C-ISR (Eur J Vasc Endovasc Surg. 2017 Jun;53[6]:766-75).

“These pathologies behave very, very differently,” Dr. Chung observed. “The C-ISR lesions tend to be less embologenic.”

C-ISR is an uncommon event. Extrapolating from the landmark CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) and other randomized trials, about 6% of patients who undergo percutaneous carotid stenting will be develop C-ISR within 2 years. But since the proportion of all carotid revascularizations that are done by carotid stent angioplasty has steadily increased over the past 15 years as the frequency of CEA has dropped, C-ISR is a problem that vascular specialists will continue to encounter on a regular basis.

Symptomatic C-ISR warrants reintervention; broad agreement exists on that. But there is a paucity of data to guide treatment decisions regarding asymptomatic yet angiographically severe C-ISR. Indeed, Dr. Chung was lead author of the only retrospective study of the natural history of untreated C-ISR, as opposed to carefully selected cohorts from randomized trials involving highly experienced operators. This study was a retrospective review of 59 patients with 75 C-ISRs of at least 50% seen at a single Veterans Affairs medical center over a 13-year period. Three-quarters of the ISRs were asymptomatic.

Forty of the 79 C-ISRs underwent percutaneous intervention at the physician’s discretion. Those patients did not differ from the observation-only group in age, comorbid conditions, type of original stent, or clopidogrel use. Reintervention was safe: There was one stent thrombosis resulting in stroke and death within 30 days in the reintervention group and no 30-day strokes in the observation-only group. During a mean 2.6 years of follow-up, the composite rate of death, stroke, or MI was low and not statistically significantly different between the two groups. Indeed, during up to 13 years of follow-up only one patient with untreated C-ISR experienced an ipsilateral stroke, as did two patients in the percutaneous intervention group (J Vasc Surg. 2016 Nov;64[5]:1286-94).
 

Dr. Chung does the math

According to data from the National Inpatient Sample, vascular surgeons do an average of 15 carotid angioplasty and stenting procedures per year. If 6% of those stents develop in-stent restenosis, and with a number needed to treat with revascularization of 25 to prevent 1 stroke, Dr. Chung estimated that hypothetically it would take the typical vascular surgeon 27 years to prevent one stroke due to C-ISR.

“That’s a very long time to prevent one stroke, in my opinion,” he said.
 

How his study has affected his own practice

Dr. Chung now intervenes only for symptomatic C-ISRs, and only after an affected patient is on optimal medical therapy, including a statin and dual-antiplatelet therapy.

“I try to do an open procedure if possible, especially if the restenosis is above C-2. The ones I tend to do percutaneously are the post-irradiation stenoses or those with excessive scarring, and I use a cerebral protection device,” the surgeon explained.

He emphasized, however, that the final word on the appropriate management of C-ISRs isn’t in yet. A standardized definition of C-ISR is needed, as are multicenter prospective registries of medically managed patients as well as those undergoing various forms of reintervention. And a pathologic study is warranted to confirm the hypothesis that the histopathology of post-CEA and post-stent restenosis – and hence the natural history – is markedly different.

Dr. Chung reported having no financial conflicts regarding his presentation.

 

Modern medical management is as effective as carotid artery reintervention for stroke prevention in asymptomatic patients with a carotid in-stent restenosis in excess of 70%, Jayer Chung, MD, asserted at a symposium on vascular surgery sponsored by Northwestern University.

That, in his view, makes medical management the clear preferred strategy.

Bruce Jancin/Frontline Medical News
Dr. Jayer Chung
“A carotid intervention costs about $17,000. If we choose medical management, we can better allocate our resources. Furthermore, if it doesn’t really help, I don’t want to do one of these procedures to my patients. I want to avoid the periprocedural risks. Early on, the stroke and death rates are higher in the intervention arm,” explained Dr. Chung, a vascular surgeon at Baylor College of Medicine, Houston.

A growing body of evidence, mainly from nested cohorts within randomized controlled trials, indicates that the late ipsilateral stroke rate associated with post–carotid endarterectomy restenosis (CEA) is much higher than that for carotid in-stent restenosis (C-ISR). In a recent meta-analysis of nine randomized trials, the difference in risk was more than 10-fold, with a 9.2% stroke rate at a mean of 37 months of follow-up in patients with post-CEA restenosis, compared with a 0.8% rate with 50 months of follow-up in patients with C-ISR (Eur J Vasc Endovasc Surg. 2017 Jun;53[6]:766-75).

“These pathologies behave very, very differently,” Dr. Chung observed. “The C-ISR lesions tend to be less embologenic.”

C-ISR is an uncommon event. Extrapolating from the landmark CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) and other randomized trials, about 6% of patients who undergo percutaneous carotid stenting will be develop C-ISR within 2 years. But since the proportion of all carotid revascularizations that are done by carotid stent angioplasty has steadily increased over the past 15 years as the frequency of CEA has dropped, C-ISR is a problem that vascular specialists will continue to encounter on a regular basis.

Symptomatic C-ISR warrants reintervention; broad agreement exists on that. But there is a paucity of data to guide treatment decisions regarding asymptomatic yet angiographically severe C-ISR. Indeed, Dr. Chung was lead author of the only retrospective study of the natural history of untreated C-ISR, as opposed to carefully selected cohorts from randomized trials involving highly experienced operators. This study was a retrospective review of 59 patients with 75 C-ISRs of at least 50% seen at a single Veterans Affairs medical center over a 13-year period. Three-quarters of the ISRs were asymptomatic.

Forty of the 79 C-ISRs underwent percutaneous intervention at the physician’s discretion. Those patients did not differ from the observation-only group in age, comorbid conditions, type of original stent, or clopidogrel use. Reintervention was safe: There was one stent thrombosis resulting in stroke and death within 30 days in the reintervention group and no 30-day strokes in the observation-only group. During a mean 2.6 years of follow-up, the composite rate of death, stroke, or MI was low and not statistically significantly different between the two groups. Indeed, during up to 13 years of follow-up only one patient with untreated C-ISR experienced an ipsilateral stroke, as did two patients in the percutaneous intervention group (J Vasc Surg. 2016 Nov;64[5]:1286-94).
 

Dr. Chung does the math

According to data from the National Inpatient Sample, vascular surgeons do an average of 15 carotid angioplasty and stenting procedures per year. If 6% of those stents develop in-stent restenosis, and with a number needed to treat with revascularization of 25 to prevent 1 stroke, Dr. Chung estimated that hypothetically it would take the typical vascular surgeon 27 years to prevent one stroke due to C-ISR.

“That’s a very long time to prevent one stroke, in my opinion,” he said.
 

How his study has affected his own practice

Dr. Chung now intervenes only for symptomatic C-ISRs, and only after an affected patient is on optimal medical therapy, including a statin and dual-antiplatelet therapy.

“I try to do an open procedure if possible, especially if the restenosis is above C-2. The ones I tend to do percutaneously are the post-irradiation stenoses or those with excessive scarring, and I use a cerebral protection device,” the surgeon explained.

He emphasized, however, that the final word on the appropriate management of C-ISRs isn’t in yet. A standardized definition of C-ISR is needed, as are multicenter prospective registries of medically managed patients as well as those undergoing various forms of reintervention. And a pathologic study is warranted to confirm the hypothesis that the histopathology of post-CEA and post-stent restenosis – and hence the natural history – is markedly different.

Dr. Chung reported having no financial conflicts regarding his presentation.

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Pendulum swings on mesenteric venous thrombosis treatment

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– Treatment of isolated acute mesenteric venous thrombosis remains a topic of controversy, with no established guidelines available, Thomas S. Maldonado, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.

“There has been a pendulum swing. Earlier on there was a lot of excitement about surgical thrombectomy, then we tended to become more nonoperative and conservative, using just anticoagulation. But in recent years endovascular therapy has been gaining some traction and shows good preliminary results,” according to Dr. Maldonado, professor of surgery at New York University.

Bruce Jancin/Frontline Medical News
Dr. Thomas S. Maldonado
In addition to describing contemporary treatment of mesenteric venous thrombosis (MVT), he also highlighted the challenges posed in achieving prompt diagnosis of this life-threatening disorder whose incidence has steadily increased during the last several decades.

Today MVT accounts for 1 in 1,000 emergency department visits and 6%-9% of cases of acute mesenteric ischemia. Dr. Maldonado cited two reasons for the increasing incidence. One is the widespread recognition that contrast-enhanced helical CT is the diagnostic imaging method of choice; it is being employed more liberally because of its ready availability and overall 95%-100% accuracy, which allows for rapid and reliable diagnosis with precise location of the thrombus.

The other factor is that bariatric surgery is booming. While the most common local etiologies of the hypercoagulable state predisposing to MVT remain cancer and intra-abdominal inflammatory diseases such as pancreatitis, there is no doubt that laparoscopic bariatric surgery is emerging as another contributing factor, according to the surgeon.
 

Diagnosis

MVT is an insidious and lethal disease. In most series, it has a mortality of at least 25%, and it doesn’t appear to be going down in recent years. This is probably because of difficulty in making a prompt diagnosis before bowel ischemia occurs. Multiple studies show that onset of symptoms typically occurs 6-14 days before patients present for care.

“I think this is really the Achilles heel of this diagnosis – that it can be delayed. The diagnosis can be elusive. There is no constellation of signs or symptoms that is pathognomonic for MVT. This is where prompt recognition and a CT scan can really play an important role,” Dr. Maldonado said.

He and a coworker conducted a review of 37 studies on MVT published in 1997-2016 which underscored the challenges in making a prompt diagnosis. The most common presenting symptom was nonspecific abdominal pain out of proportion to findings on physical exam. Other possible symptoms included anorexia, nausea, vomiting, constipation, and/or passage of blood through the anus. The disease occurred most often in men aged 40-60. A history of unprovoked venous thromboembolism was often present (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:501-7).

The three-phase CT scan – arterial, venous, and delayed venous – not only locates the thrombus with precision, it also shows whether the occlusion is partial or complete, which is important information prognostically (see below). The scan also provides information on bowel ischemia with at least 90% sensitivity and specificity. Bowel compromise shows up on CT as a thickened bowel wall with dilated lumen, mesenteric fat stranding, and ascites.

CT imaging has become so useful for rapid diagnosis of MVT that duplex ultrasound, although considerably less costly and radiation-free, has become relegated to a secondary role. At most centers its use is restricted to follow-up surveillance to assess for thrombus resolution and vascular recanalization after the acute episode has been treated. Duplex ultrasound simply can’t match CT in the crucial task of assessment for bowel ischemia.
 

Treatment

The mainstay of treatment in patients with MVT without bowel ischemia is medical management: immediate anticoagulation with unfractionated or low-molecular-weight heparin bridging to warfarin, bowel rest, aggressive fluid resuscitation, and correction of electrolyte imbalances. Most patients with nonocclusive MVT and no ischemic bowel can be managed in this way without surgical intervention. The newer oral anticoagulants haven’t yet been studied in patients with MVT.

How long to continue oral anticoagulation is an unresolved issue. In Dr. Maldonado’s literature review, the median duration was 90 days. In his own practice, anticoagulants aren’t stopped until duplex ultrasound demonstrates recanalization of the mesenteric venous system. If residual thrombus is present or a patient has an underlying hypercoagulable state, treatment continues indefinitely.

In a series of 50 noncirrhotic MVT patients treated at New York University using various strategies, 19, or 38%, were completely recanalized. Recurrence of MVT after successful treatment occurred in only 2 of these 19 patients, in both cases upon discontinuation of anticoagulation.

“It speaks to the issue of length of treatment – or should it be discontinued at all?” the surgeon said.

Open surgical thrombectomy has fallen into disfavor because the thrombus tends to recur within 7 days post surgery. It is now best reserved for patients with acute MVT with a contraindication to thrombolytic therapy, such as cirrhosis or recent major surgery, according to Dr. Maldonado.

Multiple patient series using endovascular catheter-directed thrombolytic therapy with a transhepatic, transvenous, transarterial, or combined approach have reported high rates of successful recanalization – even in the 90% range – with low recurrence rates and fewer bowel resections than with anticoagulation alone.

Indeed, Dr. Maldonado and his fellow vascular surgeons at New York University have recently developed a management algorithm whereby patients with occlusive MVT and no bowel ischemia undergo catheter-directed thrombolysis provided there are no contraindications, such as uncontrolled hypertension or a recent hemorrhagic stroke. The surgeons will also seriously consider catheter-directed lytic therapy in MVT patients with bowel ischemia who show no improvement after laparotomy, bowel resection, and open thrombectomy.
 

 

 

Prognosis

A retrospective review by Dr. Maldonado and coinvestigators of 80 noncirrhotic patients with MVT managed at New York University raised a red flag regarding the high risk of portal hypertension as a long-term sequela. At a median follow-up of 480 days, fully half of patients with imaging results available displayed radiographic features of portal hypertension, although as yet none had developed frank clinical manifestations of cirrhosis.

The investigators identified two predictors of portal hypertension. One was complete as opposed to partial thrombosis at the initial event. Complete thrombosis was present in 73% of patients who eventually developed portal hypertension, compared with 43% of those who didn’t. The other predictor was lack of successful recanalization: only 37% of patients who developed portal hypertension were successfully recanalized, compared with a 65% recanalization rate in those who remained free of this long-term complication (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:400-6).

These observations raise the possibility that initial complete thrombosis of the mesenteric vein and nonrecanalization with medical therapy might tip the balance in favor of endovascular lytic therapy as a potential means of preventing later portal hypertension.

“I don’t think we know the answer, but there’s certainly room for research,” Dr. Maldonado observed.

He reported having no financial conflicts regarding his presentation.

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– Treatment of isolated acute mesenteric venous thrombosis remains a topic of controversy, with no established guidelines available, Thomas S. Maldonado, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.

“There has been a pendulum swing. Earlier on there was a lot of excitement about surgical thrombectomy, then we tended to become more nonoperative and conservative, using just anticoagulation. But in recent years endovascular therapy has been gaining some traction and shows good preliminary results,” according to Dr. Maldonado, professor of surgery at New York University.

Bruce Jancin/Frontline Medical News
Dr. Thomas S. Maldonado
In addition to describing contemporary treatment of mesenteric venous thrombosis (MVT), he also highlighted the challenges posed in achieving prompt diagnosis of this life-threatening disorder whose incidence has steadily increased during the last several decades.

Today MVT accounts for 1 in 1,000 emergency department visits and 6%-9% of cases of acute mesenteric ischemia. Dr. Maldonado cited two reasons for the increasing incidence. One is the widespread recognition that contrast-enhanced helical CT is the diagnostic imaging method of choice; it is being employed more liberally because of its ready availability and overall 95%-100% accuracy, which allows for rapid and reliable diagnosis with precise location of the thrombus.

The other factor is that bariatric surgery is booming. While the most common local etiologies of the hypercoagulable state predisposing to MVT remain cancer and intra-abdominal inflammatory diseases such as pancreatitis, there is no doubt that laparoscopic bariatric surgery is emerging as another contributing factor, according to the surgeon.
 

Diagnosis

MVT is an insidious and lethal disease. In most series, it has a mortality of at least 25%, and it doesn’t appear to be going down in recent years. This is probably because of difficulty in making a prompt diagnosis before bowel ischemia occurs. Multiple studies show that onset of symptoms typically occurs 6-14 days before patients present for care.

“I think this is really the Achilles heel of this diagnosis – that it can be delayed. The diagnosis can be elusive. There is no constellation of signs or symptoms that is pathognomonic for MVT. This is where prompt recognition and a CT scan can really play an important role,” Dr. Maldonado said.

He and a coworker conducted a review of 37 studies on MVT published in 1997-2016 which underscored the challenges in making a prompt diagnosis. The most common presenting symptom was nonspecific abdominal pain out of proportion to findings on physical exam. Other possible symptoms included anorexia, nausea, vomiting, constipation, and/or passage of blood through the anus. The disease occurred most often in men aged 40-60. A history of unprovoked venous thromboembolism was often present (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:501-7).

The three-phase CT scan – arterial, venous, and delayed venous – not only locates the thrombus with precision, it also shows whether the occlusion is partial or complete, which is important information prognostically (see below). The scan also provides information on bowel ischemia with at least 90% sensitivity and specificity. Bowel compromise shows up on CT as a thickened bowel wall with dilated lumen, mesenteric fat stranding, and ascites.

CT imaging has become so useful for rapid diagnosis of MVT that duplex ultrasound, although considerably less costly and radiation-free, has become relegated to a secondary role. At most centers its use is restricted to follow-up surveillance to assess for thrombus resolution and vascular recanalization after the acute episode has been treated. Duplex ultrasound simply can’t match CT in the crucial task of assessment for bowel ischemia.
 

Treatment

The mainstay of treatment in patients with MVT without bowel ischemia is medical management: immediate anticoagulation with unfractionated or low-molecular-weight heparin bridging to warfarin, bowel rest, aggressive fluid resuscitation, and correction of electrolyte imbalances. Most patients with nonocclusive MVT and no ischemic bowel can be managed in this way without surgical intervention. The newer oral anticoagulants haven’t yet been studied in patients with MVT.

How long to continue oral anticoagulation is an unresolved issue. In Dr. Maldonado’s literature review, the median duration was 90 days. In his own practice, anticoagulants aren’t stopped until duplex ultrasound demonstrates recanalization of the mesenteric venous system. If residual thrombus is present or a patient has an underlying hypercoagulable state, treatment continues indefinitely.

In a series of 50 noncirrhotic MVT patients treated at New York University using various strategies, 19, or 38%, were completely recanalized. Recurrence of MVT after successful treatment occurred in only 2 of these 19 patients, in both cases upon discontinuation of anticoagulation.

“It speaks to the issue of length of treatment – or should it be discontinued at all?” the surgeon said.

Open surgical thrombectomy has fallen into disfavor because the thrombus tends to recur within 7 days post surgery. It is now best reserved for patients with acute MVT with a contraindication to thrombolytic therapy, such as cirrhosis or recent major surgery, according to Dr. Maldonado.

Multiple patient series using endovascular catheter-directed thrombolytic therapy with a transhepatic, transvenous, transarterial, or combined approach have reported high rates of successful recanalization – even in the 90% range – with low recurrence rates and fewer bowel resections than with anticoagulation alone.

Indeed, Dr. Maldonado and his fellow vascular surgeons at New York University have recently developed a management algorithm whereby patients with occlusive MVT and no bowel ischemia undergo catheter-directed thrombolysis provided there are no contraindications, such as uncontrolled hypertension or a recent hemorrhagic stroke. The surgeons will also seriously consider catheter-directed lytic therapy in MVT patients with bowel ischemia who show no improvement after laparotomy, bowel resection, and open thrombectomy.
 

 

 

Prognosis

A retrospective review by Dr. Maldonado and coinvestigators of 80 noncirrhotic patients with MVT managed at New York University raised a red flag regarding the high risk of portal hypertension as a long-term sequela. At a median follow-up of 480 days, fully half of patients with imaging results available displayed radiographic features of portal hypertension, although as yet none had developed frank clinical manifestations of cirrhosis.

The investigators identified two predictors of portal hypertension. One was complete as opposed to partial thrombosis at the initial event. Complete thrombosis was present in 73% of patients who eventually developed portal hypertension, compared with 43% of those who didn’t. The other predictor was lack of successful recanalization: only 37% of patients who developed portal hypertension were successfully recanalized, compared with a 65% recanalization rate in those who remained free of this long-term complication (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:400-6).

These observations raise the possibility that initial complete thrombosis of the mesenteric vein and nonrecanalization with medical therapy might tip the balance in favor of endovascular lytic therapy as a potential means of preventing later portal hypertension.

“I don’t think we know the answer, but there’s certainly room for research,” Dr. Maldonado observed.

He reported having no financial conflicts regarding his presentation.

 

– Treatment of isolated acute mesenteric venous thrombosis remains a topic of controversy, with no established guidelines available, Thomas S. Maldonado, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.

“There has been a pendulum swing. Earlier on there was a lot of excitement about surgical thrombectomy, then we tended to become more nonoperative and conservative, using just anticoagulation. But in recent years endovascular therapy has been gaining some traction and shows good preliminary results,” according to Dr. Maldonado, professor of surgery at New York University.

Bruce Jancin/Frontline Medical News
Dr. Thomas S. Maldonado
In addition to describing contemporary treatment of mesenteric venous thrombosis (MVT), he also highlighted the challenges posed in achieving prompt diagnosis of this life-threatening disorder whose incidence has steadily increased during the last several decades.

Today MVT accounts for 1 in 1,000 emergency department visits and 6%-9% of cases of acute mesenteric ischemia. Dr. Maldonado cited two reasons for the increasing incidence. One is the widespread recognition that contrast-enhanced helical CT is the diagnostic imaging method of choice; it is being employed more liberally because of its ready availability and overall 95%-100% accuracy, which allows for rapid and reliable diagnosis with precise location of the thrombus.

The other factor is that bariatric surgery is booming. While the most common local etiologies of the hypercoagulable state predisposing to MVT remain cancer and intra-abdominal inflammatory diseases such as pancreatitis, there is no doubt that laparoscopic bariatric surgery is emerging as another contributing factor, according to the surgeon.
 

Diagnosis

MVT is an insidious and lethal disease. In most series, it has a mortality of at least 25%, and it doesn’t appear to be going down in recent years. This is probably because of difficulty in making a prompt diagnosis before bowel ischemia occurs. Multiple studies show that onset of symptoms typically occurs 6-14 days before patients present for care.

“I think this is really the Achilles heel of this diagnosis – that it can be delayed. The diagnosis can be elusive. There is no constellation of signs or symptoms that is pathognomonic for MVT. This is where prompt recognition and a CT scan can really play an important role,” Dr. Maldonado said.

He and a coworker conducted a review of 37 studies on MVT published in 1997-2016 which underscored the challenges in making a prompt diagnosis. The most common presenting symptom was nonspecific abdominal pain out of proportion to findings on physical exam. Other possible symptoms included anorexia, nausea, vomiting, constipation, and/or passage of blood through the anus. The disease occurred most often in men aged 40-60. A history of unprovoked venous thromboembolism was often present (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:501-7).

The three-phase CT scan – arterial, venous, and delayed venous – not only locates the thrombus with precision, it also shows whether the occlusion is partial or complete, which is important information prognostically (see below). The scan also provides information on bowel ischemia with at least 90% sensitivity and specificity. Bowel compromise shows up on CT as a thickened bowel wall with dilated lumen, mesenteric fat stranding, and ascites.

CT imaging has become so useful for rapid diagnosis of MVT that duplex ultrasound, although considerably less costly and radiation-free, has become relegated to a secondary role. At most centers its use is restricted to follow-up surveillance to assess for thrombus resolution and vascular recanalization after the acute episode has been treated. Duplex ultrasound simply can’t match CT in the crucial task of assessment for bowel ischemia.
 

Treatment

The mainstay of treatment in patients with MVT without bowel ischemia is medical management: immediate anticoagulation with unfractionated or low-molecular-weight heparin bridging to warfarin, bowel rest, aggressive fluid resuscitation, and correction of electrolyte imbalances. Most patients with nonocclusive MVT and no ischemic bowel can be managed in this way without surgical intervention. The newer oral anticoagulants haven’t yet been studied in patients with MVT.

How long to continue oral anticoagulation is an unresolved issue. In Dr. Maldonado’s literature review, the median duration was 90 days. In his own practice, anticoagulants aren’t stopped until duplex ultrasound demonstrates recanalization of the mesenteric venous system. If residual thrombus is present or a patient has an underlying hypercoagulable state, treatment continues indefinitely.

In a series of 50 noncirrhotic MVT patients treated at New York University using various strategies, 19, or 38%, were completely recanalized. Recurrence of MVT after successful treatment occurred in only 2 of these 19 patients, in both cases upon discontinuation of anticoagulation.

“It speaks to the issue of length of treatment – or should it be discontinued at all?” the surgeon said.

Open surgical thrombectomy has fallen into disfavor because the thrombus tends to recur within 7 days post surgery. It is now best reserved for patients with acute MVT with a contraindication to thrombolytic therapy, such as cirrhosis or recent major surgery, according to Dr. Maldonado.

Multiple patient series using endovascular catheter-directed thrombolytic therapy with a transhepatic, transvenous, transarterial, or combined approach have reported high rates of successful recanalization – even in the 90% range – with low recurrence rates and fewer bowel resections than with anticoagulation alone.

Indeed, Dr. Maldonado and his fellow vascular surgeons at New York University have recently developed a management algorithm whereby patients with occlusive MVT and no bowel ischemia undergo catheter-directed thrombolysis provided there are no contraindications, such as uncontrolled hypertension or a recent hemorrhagic stroke. The surgeons will also seriously consider catheter-directed lytic therapy in MVT patients with bowel ischemia who show no improvement after laparotomy, bowel resection, and open thrombectomy.
 

 

 

Prognosis

A retrospective review by Dr. Maldonado and coinvestigators of 80 noncirrhotic patients with MVT managed at New York University raised a red flag regarding the high risk of portal hypertension as a long-term sequela. At a median follow-up of 480 days, fully half of patients with imaging results available displayed radiographic features of portal hypertension, although as yet none had developed frank clinical manifestations of cirrhosis.

The investigators identified two predictors of portal hypertension. One was complete as opposed to partial thrombosis at the initial event. Complete thrombosis was present in 73% of patients who eventually developed portal hypertension, compared with 43% of those who didn’t. The other predictor was lack of successful recanalization: only 37% of patients who developed portal hypertension were successfully recanalized, compared with a 65% recanalization rate in those who remained free of this long-term complication (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:400-6).

These observations raise the possibility that initial complete thrombosis of the mesenteric vein and nonrecanalization with medical therapy might tip the balance in favor of endovascular lytic therapy as a potential means of preventing later portal hypertension.

“I don’t think we know the answer, but there’s certainly room for research,” Dr. Maldonado observed.

He reported having no financial conflicts regarding his presentation.

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Carotid stenting isn’t safer than endarterectomy with contralateral carotid occlusion

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– Carotid angioplasty and stenting (CAS) isn’t associated with a lower 30-day stroke risk than carotid endarterectomy (CEA) for revascularization of the internal carotid artery in patients with contralateral carotid occlusion, Leila Mureebe, MD, said at a symposium on vascular surgery sponsored by Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News
Dr. Leila Mureebe
“Procedure type is not protective. So we urge ongoing restraint for the wider application of CAS at this time. We know that CEA is well tolerated, with outstanding real-world outcomes,” noted Dr. Mureebe, a vascular surgeon at Duke University in Durham, N.C.

The reported prevalence of contralateral carotid occlusion (CCO) in patients undergoing revascularization for carotid artery disease is 3%-15%. Of late Dr. Mureebe has been particularly interested in two questions regarding CCO in patients undergoing revascularization of their other carotid artery: Is CCO truly a risk factor for perioperative stroke? And if so, can this risk be mitigated by the choice of procedure?

To answer the first question, Dr. Mureebe and her coinvestigators performed a meta-analysis of eight representative studies published between 1994 and 2012; they determined that CCO in patients undergoing CEA was indeed associated with a near doubling of perioperative stroke risk, compared with that of patients without CCO.

In order to learn whether CAS mitigates this risk, she and her coworkers analyzed the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for the period between 2011 and 2015, in which they identified 15,619 fully documented CEA and 496 CAS.

“This NSQIP data is not just academic medical centers or big centers. I think it’s a pretty good look at what’s actually being done in the real world today,” according to Dr. Mureebe.

The analysis showed that CCO has already had an effect on practice. A higher proportion of patients with CCO now undergo stenting as opposed to endarterectomy. Only 4.6% of all CEAs were done in patients with CCO, compared with 11.5% of CAS procedures. Moreover, the majority of revascularizations in the setting of CCO were performed in patients with asymptomatic disease: 57% of all CEA and 53% of the CAS. The CAS finding was surprising given that reimbursement for CAS is at present limited to symptomatic patients at high surgical risk who have a significant internal carotid artery stenosis, Dr. Mureebe observed.

The 30-day stroke rate in patients with CCO was 3.22% after CEA and 1.75% after CAS, a difference that wasn’t statistically significant. In patients without CCO, the stroke rate was 2.03% after CEA and 2.96% after CAS.

Next, the investigators analyzed differences in stroke rates according to symptom status. Among patients with CCO and preprocedural transient ischemic attack, stroke, or transient monocular blindness who underwent CEA, the 30-day stroke risk associated with CEA was 5.2%, a significantly higher rate than the 2.1% rate seen in patients without symptoms. The number of patients with CCO undergoing CAS was too small to draw conclusions regarding possible differences in stroke risk based upon symptom status.

In the NSQIP database, patients with CCO had higher prevalences of heart failure, hypertension, and smoking. For this reason, Dr. Mureebe said she suspects CCO is a surrogate for greater atherosclerotic disease burden and not an independent risk factor for periprocedural stroke. If future studies of the minimally invasive transcarotid artery revascularization procedure also show a higher rate of bad outcomes in patients with CCO, that would further support the hypothesis that CCO is a marker of higher atherosclerotic disease burden, Dr. Mureebe said.

A limitation of the NSQIP database is that it captures only those CAS cases done in operating rooms. “Maybe patients undergoing CAS in the OR are different from those undergoing CAS in a radiologic suite or cath lab,” she noted.

Dr. Mureebe reported having no financial conflicts of interest regarding her presentation.


 

SOURCE: Mureebe L. 42nd Annual Northwestern Vascular Symposium.

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– Carotid angioplasty and stenting (CAS) isn’t associated with a lower 30-day stroke risk than carotid endarterectomy (CEA) for revascularization of the internal carotid artery in patients with contralateral carotid occlusion, Leila Mureebe, MD, said at a symposium on vascular surgery sponsored by Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News
Dr. Leila Mureebe
“Procedure type is not protective. So we urge ongoing restraint for the wider application of CAS at this time. We know that CEA is well tolerated, with outstanding real-world outcomes,” noted Dr. Mureebe, a vascular surgeon at Duke University in Durham, N.C.

The reported prevalence of contralateral carotid occlusion (CCO) in patients undergoing revascularization for carotid artery disease is 3%-15%. Of late Dr. Mureebe has been particularly interested in two questions regarding CCO in patients undergoing revascularization of their other carotid artery: Is CCO truly a risk factor for perioperative stroke? And if so, can this risk be mitigated by the choice of procedure?

To answer the first question, Dr. Mureebe and her coinvestigators performed a meta-analysis of eight representative studies published between 1994 and 2012; they determined that CCO in patients undergoing CEA was indeed associated with a near doubling of perioperative stroke risk, compared with that of patients without CCO.

In order to learn whether CAS mitigates this risk, she and her coworkers analyzed the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for the period between 2011 and 2015, in which they identified 15,619 fully documented CEA and 496 CAS.

“This NSQIP data is not just academic medical centers or big centers. I think it’s a pretty good look at what’s actually being done in the real world today,” according to Dr. Mureebe.

The analysis showed that CCO has already had an effect on practice. A higher proportion of patients with CCO now undergo stenting as opposed to endarterectomy. Only 4.6% of all CEAs were done in patients with CCO, compared with 11.5% of CAS procedures. Moreover, the majority of revascularizations in the setting of CCO were performed in patients with asymptomatic disease: 57% of all CEA and 53% of the CAS. The CAS finding was surprising given that reimbursement for CAS is at present limited to symptomatic patients at high surgical risk who have a significant internal carotid artery stenosis, Dr. Mureebe observed.

The 30-day stroke rate in patients with CCO was 3.22% after CEA and 1.75% after CAS, a difference that wasn’t statistically significant. In patients without CCO, the stroke rate was 2.03% after CEA and 2.96% after CAS.

Next, the investigators analyzed differences in stroke rates according to symptom status. Among patients with CCO and preprocedural transient ischemic attack, stroke, or transient monocular blindness who underwent CEA, the 30-day stroke risk associated with CEA was 5.2%, a significantly higher rate than the 2.1% rate seen in patients without symptoms. The number of patients with CCO undergoing CAS was too small to draw conclusions regarding possible differences in stroke risk based upon symptom status.

In the NSQIP database, patients with CCO had higher prevalences of heart failure, hypertension, and smoking. For this reason, Dr. Mureebe said she suspects CCO is a surrogate for greater atherosclerotic disease burden and not an independent risk factor for periprocedural stroke. If future studies of the minimally invasive transcarotid artery revascularization procedure also show a higher rate of bad outcomes in patients with CCO, that would further support the hypothesis that CCO is a marker of higher atherosclerotic disease burden, Dr. Mureebe said.

A limitation of the NSQIP database is that it captures only those CAS cases done in operating rooms. “Maybe patients undergoing CAS in the OR are different from those undergoing CAS in a radiologic suite or cath lab,” she noted.

Dr. Mureebe reported having no financial conflicts of interest regarding her presentation.


 

SOURCE: Mureebe L. 42nd Annual Northwestern Vascular Symposium.

 

– Carotid angioplasty and stenting (CAS) isn’t associated with a lower 30-day stroke risk than carotid endarterectomy (CEA) for revascularization of the internal carotid artery in patients with contralateral carotid occlusion, Leila Mureebe, MD, said at a symposium on vascular surgery sponsored by Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News
Dr. Leila Mureebe
“Procedure type is not protective. So we urge ongoing restraint for the wider application of CAS at this time. We know that CEA is well tolerated, with outstanding real-world outcomes,” noted Dr. Mureebe, a vascular surgeon at Duke University in Durham, N.C.

The reported prevalence of contralateral carotid occlusion (CCO) in patients undergoing revascularization for carotid artery disease is 3%-15%. Of late Dr. Mureebe has been particularly interested in two questions regarding CCO in patients undergoing revascularization of their other carotid artery: Is CCO truly a risk factor for perioperative stroke? And if so, can this risk be mitigated by the choice of procedure?

To answer the first question, Dr. Mureebe and her coinvestigators performed a meta-analysis of eight representative studies published between 1994 and 2012; they determined that CCO in patients undergoing CEA was indeed associated with a near doubling of perioperative stroke risk, compared with that of patients without CCO.

In order to learn whether CAS mitigates this risk, she and her coworkers analyzed the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for the period between 2011 and 2015, in which they identified 15,619 fully documented CEA and 496 CAS.

“This NSQIP data is not just academic medical centers or big centers. I think it’s a pretty good look at what’s actually being done in the real world today,” according to Dr. Mureebe.

The analysis showed that CCO has already had an effect on practice. A higher proportion of patients with CCO now undergo stenting as opposed to endarterectomy. Only 4.6% of all CEAs were done in patients with CCO, compared with 11.5% of CAS procedures. Moreover, the majority of revascularizations in the setting of CCO were performed in patients with asymptomatic disease: 57% of all CEA and 53% of the CAS. The CAS finding was surprising given that reimbursement for CAS is at present limited to symptomatic patients at high surgical risk who have a significant internal carotid artery stenosis, Dr. Mureebe observed.

The 30-day stroke rate in patients with CCO was 3.22% after CEA and 1.75% after CAS, a difference that wasn’t statistically significant. In patients without CCO, the stroke rate was 2.03% after CEA and 2.96% after CAS.

Next, the investigators analyzed differences in stroke rates according to symptom status. Among patients with CCO and preprocedural transient ischemic attack, stroke, or transient monocular blindness who underwent CEA, the 30-day stroke risk associated with CEA was 5.2%, a significantly higher rate than the 2.1% rate seen in patients without symptoms. The number of patients with CCO undergoing CAS was too small to draw conclusions regarding possible differences in stroke risk based upon symptom status.

In the NSQIP database, patients with CCO had higher prevalences of heart failure, hypertension, and smoking. For this reason, Dr. Mureebe said she suspects CCO is a surrogate for greater atherosclerotic disease burden and not an independent risk factor for periprocedural stroke. If future studies of the minimally invasive transcarotid artery revascularization procedure also show a higher rate of bad outcomes in patients with CCO, that would further support the hypothesis that CCO is a marker of higher atherosclerotic disease burden, Dr. Mureebe said.

A limitation of the NSQIP database is that it captures only those CAS cases done in operating rooms. “Maybe patients undergoing CAS in the OR are different from those undergoing CAS in a radiologic suite or cath lab,” she noted.

Dr. Mureebe reported having no financial conflicts of interest regarding her presentation.


 

SOURCE: Mureebe L. 42nd Annual Northwestern Vascular Symposium.

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Vascular surgeons are top tier for burnout risk

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– Vascular surgeons are solidly within the top tier of surgical subspecialists in terms of risk for burnout, Joan M. Anzia, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.

Joining them in this unwelcome company with an elevated rate of lower quality of life are trauma surgeons, urologists, and otolaryngologists, according to the results of a 9-year-old national study of burnout and career satisfaction among American surgeons that has served as a wakeup call for the profession (Ann Surg. 2009 Sep;250[3]:463-71).

Bruce Jancin/Frontline Medical News
Dr. Joan M. Anzia
The good news for physicians, regardless of specialty, is that the major institutional stakeholders in U.S. medicine, have in the past few years come to recognize that physician burnout is a systemwide problem. It’s associated with abundantly well-documented increases in medical errors and malpractice lawsuits, impaired professionalism, reduced patient satisfaction, staff turnover, depression and suicidal thoughts, and motor vehicle crashes. And these stakeholders are eager to do something about it.

“This is where the biggest impact on burnout is going to be: institutional interventions to target the known drivers of burnout. Looking at nights on call, work compression, looking at the amount of time you guys spend in front of a computer documenting your EHR and your billing. Do you really need to do those things? You need help from midlevel professionals and others who can free you to practice at the top of your life, doing the work you love, which for most surgeons is being in the OR,” said Dr. Anzia, professor of psychiatry and behavioral sciences and the departmental vice chair of education at Northwestern University in Chicago.

The Society for Vascular Surgery is one of many professional specialty organizations that are focusing on the burnout problem. They are joined by the Association of American Medical Colleges, the Accreditation Council for Graduate Medical Education, the National Academy of Medicine, the Liaison Committee on Medical Education, the American Medical Association, and other interested groups.

“Since 2008, burnout rates in every specialty have increased by an average of an absolute 10%. That’s just remarkable, and it’s why people are very, very concerned,” noted the psychiatrist, who serves as the physician health liaison at Northwestern Memorial Hospital. In that capacity, she is frequently called upon to help physicians with the classic manifestations of burnout, including substance use disorders that arose as the practitioners tried to self-treat their burnout rather than seeking help.

Courtesy Mayo Clinic
Dr. Tait Shanafelt
A strong signal that the times are changing and physician burnout has become a front burner issue is that, in September 2017, Tait Shanafelt, MD, a prominent researcher in the field while at the Mayo Clinic – assumed the post of chief wellness officer at Stanford (Calif.) Medical Center, the first U.S. academic medical center to create such a post. Dr. Shanafelt was first author of that landmark American College of Surgeons’ commissioned study on burnout among surgical subspecialists.

“He reports only to the dean,” according to Dr. Anzia.

Why are vascular surgeons at such high risk for burnout? According to the Maslach Burnout Inventory, the leading psychological assessment tool for burnout, the syndrome has three main components: emotional exhaustion, a sense of loss of meaning in work, and feeling ineffective in one’s work. Studies show vascular surgeons often score high in all three domains.

Vascular surgeons’ work is extremely stressful. They average 20 hours per week in the OR, and almost 3 nights on call per week. They care for acutely ill patients and perform high-intensity, high-risk procedures in which unpredictable events are common.

“Work compression – not just workload, but facing multiple demands at once that you’re trying to balance – that’s one of the key drivers of burnout, and work compression is really common in vascular surgery,” Dr. Anzia noted.

In the national surgeon burnout study, younger surgeons and those with children still living at home were at increased risk for burnout. So were surgeons whose compensation was entirely based upon the Relative Value Unit system. The number of nights on call per week was another independent risk factor.

Dr. Shanafelt and his coinvestigators found that roughly 30% of respondent surgeons screened positive for depression, and 6.4% of the study population reported having suicidal thoughts within the past 12 months.

“We lose the equivalent of two to three medical school classes worth of physicians every year to suicide. And let me tell you: 98% of those folks, at the time they suicided, had major depression, which is eminently treatable. And the reason they weren’t treated was they, like most physicians, avoided treatment. They had difficulty accessing care. They were worried about stigma, life insurance, things like that. This is a huge problem which is mostly preventable, but we are not addressing it effectively,” Dr. Anzia said.

While institutional interventions aimed at the prevention of physician burnout such as spending less time on the electronic health record will have a major impact on the problem, thought leaders in medical education have come to realize that it also will be necessary to address the broader culture of medicine.

“There are so many implicit beliefs that every one of us grew up with, like ‘I work when I’m sick,’ or ‘I can work without sleep.’ All those things that we believe make us good physicians actually may not be entirely true,” the psychiatrist said.

She reported having no financial conflicts of interest regarding her presentation.

 

 

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– Vascular surgeons are solidly within the top tier of surgical subspecialists in terms of risk for burnout, Joan M. Anzia, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.

Joining them in this unwelcome company with an elevated rate of lower quality of life are trauma surgeons, urologists, and otolaryngologists, according to the results of a 9-year-old national study of burnout and career satisfaction among American surgeons that has served as a wakeup call for the profession (Ann Surg. 2009 Sep;250[3]:463-71).

Bruce Jancin/Frontline Medical News
Dr. Joan M. Anzia
The good news for physicians, regardless of specialty, is that the major institutional stakeholders in U.S. medicine, have in the past few years come to recognize that physician burnout is a systemwide problem. It’s associated with abundantly well-documented increases in medical errors and malpractice lawsuits, impaired professionalism, reduced patient satisfaction, staff turnover, depression and suicidal thoughts, and motor vehicle crashes. And these stakeholders are eager to do something about it.

“This is where the biggest impact on burnout is going to be: institutional interventions to target the known drivers of burnout. Looking at nights on call, work compression, looking at the amount of time you guys spend in front of a computer documenting your EHR and your billing. Do you really need to do those things? You need help from midlevel professionals and others who can free you to practice at the top of your life, doing the work you love, which for most surgeons is being in the OR,” said Dr. Anzia, professor of psychiatry and behavioral sciences and the departmental vice chair of education at Northwestern University in Chicago.

The Society for Vascular Surgery is one of many professional specialty organizations that are focusing on the burnout problem. They are joined by the Association of American Medical Colleges, the Accreditation Council for Graduate Medical Education, the National Academy of Medicine, the Liaison Committee on Medical Education, the American Medical Association, and other interested groups.

“Since 2008, burnout rates in every specialty have increased by an average of an absolute 10%. That’s just remarkable, and it’s why people are very, very concerned,” noted the psychiatrist, who serves as the physician health liaison at Northwestern Memorial Hospital. In that capacity, she is frequently called upon to help physicians with the classic manifestations of burnout, including substance use disorders that arose as the practitioners tried to self-treat their burnout rather than seeking help.

Courtesy Mayo Clinic
Dr. Tait Shanafelt
A strong signal that the times are changing and physician burnout has become a front burner issue is that, in September 2017, Tait Shanafelt, MD, a prominent researcher in the field while at the Mayo Clinic – assumed the post of chief wellness officer at Stanford (Calif.) Medical Center, the first U.S. academic medical center to create such a post. Dr. Shanafelt was first author of that landmark American College of Surgeons’ commissioned study on burnout among surgical subspecialists.

“He reports only to the dean,” according to Dr. Anzia.

Why are vascular surgeons at such high risk for burnout? According to the Maslach Burnout Inventory, the leading psychological assessment tool for burnout, the syndrome has three main components: emotional exhaustion, a sense of loss of meaning in work, and feeling ineffective in one’s work. Studies show vascular surgeons often score high in all three domains.

Vascular surgeons’ work is extremely stressful. They average 20 hours per week in the OR, and almost 3 nights on call per week. They care for acutely ill patients and perform high-intensity, high-risk procedures in which unpredictable events are common.

“Work compression – not just workload, but facing multiple demands at once that you’re trying to balance – that’s one of the key drivers of burnout, and work compression is really common in vascular surgery,” Dr. Anzia noted.

In the national surgeon burnout study, younger surgeons and those with children still living at home were at increased risk for burnout. So were surgeons whose compensation was entirely based upon the Relative Value Unit system. The number of nights on call per week was another independent risk factor.

Dr. Shanafelt and his coinvestigators found that roughly 30% of respondent surgeons screened positive for depression, and 6.4% of the study population reported having suicidal thoughts within the past 12 months.

“We lose the equivalent of two to three medical school classes worth of physicians every year to suicide. And let me tell you: 98% of those folks, at the time they suicided, had major depression, which is eminently treatable. And the reason they weren’t treated was they, like most physicians, avoided treatment. They had difficulty accessing care. They were worried about stigma, life insurance, things like that. This is a huge problem which is mostly preventable, but we are not addressing it effectively,” Dr. Anzia said.

While institutional interventions aimed at the prevention of physician burnout such as spending less time on the electronic health record will have a major impact on the problem, thought leaders in medical education have come to realize that it also will be necessary to address the broader culture of medicine.

“There are so many implicit beliefs that every one of us grew up with, like ‘I work when I’m sick,’ or ‘I can work without sleep.’ All those things that we believe make us good physicians actually may not be entirely true,” the psychiatrist said.

She reported having no financial conflicts of interest regarding her presentation.

 

 

 

– Vascular surgeons are solidly within the top tier of surgical subspecialists in terms of risk for burnout, Joan M. Anzia, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.

Joining them in this unwelcome company with an elevated rate of lower quality of life are trauma surgeons, urologists, and otolaryngologists, according to the results of a 9-year-old national study of burnout and career satisfaction among American surgeons that has served as a wakeup call for the profession (Ann Surg. 2009 Sep;250[3]:463-71).

Bruce Jancin/Frontline Medical News
Dr. Joan M. Anzia
The good news for physicians, regardless of specialty, is that the major institutional stakeholders in U.S. medicine, have in the past few years come to recognize that physician burnout is a systemwide problem. It’s associated with abundantly well-documented increases in medical errors and malpractice lawsuits, impaired professionalism, reduced patient satisfaction, staff turnover, depression and suicidal thoughts, and motor vehicle crashes. And these stakeholders are eager to do something about it.

“This is where the biggest impact on burnout is going to be: institutional interventions to target the known drivers of burnout. Looking at nights on call, work compression, looking at the amount of time you guys spend in front of a computer documenting your EHR and your billing. Do you really need to do those things? You need help from midlevel professionals and others who can free you to practice at the top of your life, doing the work you love, which for most surgeons is being in the OR,” said Dr. Anzia, professor of psychiatry and behavioral sciences and the departmental vice chair of education at Northwestern University in Chicago.

The Society for Vascular Surgery is one of many professional specialty organizations that are focusing on the burnout problem. They are joined by the Association of American Medical Colleges, the Accreditation Council for Graduate Medical Education, the National Academy of Medicine, the Liaison Committee on Medical Education, the American Medical Association, and other interested groups.

“Since 2008, burnout rates in every specialty have increased by an average of an absolute 10%. That’s just remarkable, and it’s why people are very, very concerned,” noted the psychiatrist, who serves as the physician health liaison at Northwestern Memorial Hospital. In that capacity, she is frequently called upon to help physicians with the classic manifestations of burnout, including substance use disorders that arose as the practitioners tried to self-treat their burnout rather than seeking help.

Courtesy Mayo Clinic
Dr. Tait Shanafelt
A strong signal that the times are changing and physician burnout has become a front burner issue is that, in September 2017, Tait Shanafelt, MD, a prominent researcher in the field while at the Mayo Clinic – assumed the post of chief wellness officer at Stanford (Calif.) Medical Center, the first U.S. academic medical center to create such a post. Dr. Shanafelt was first author of that landmark American College of Surgeons’ commissioned study on burnout among surgical subspecialists.

“He reports only to the dean,” according to Dr. Anzia.

Why are vascular surgeons at such high risk for burnout? According to the Maslach Burnout Inventory, the leading psychological assessment tool for burnout, the syndrome has three main components: emotional exhaustion, a sense of loss of meaning in work, and feeling ineffective in one’s work. Studies show vascular surgeons often score high in all three domains.

Vascular surgeons’ work is extremely stressful. They average 20 hours per week in the OR, and almost 3 nights on call per week. They care for acutely ill patients and perform high-intensity, high-risk procedures in which unpredictable events are common.

“Work compression – not just workload, but facing multiple demands at once that you’re trying to balance – that’s one of the key drivers of burnout, and work compression is really common in vascular surgery,” Dr. Anzia noted.

In the national surgeon burnout study, younger surgeons and those with children still living at home were at increased risk for burnout. So were surgeons whose compensation was entirely based upon the Relative Value Unit system. The number of nights on call per week was another independent risk factor.

Dr. Shanafelt and his coinvestigators found that roughly 30% of respondent surgeons screened positive for depression, and 6.4% of the study population reported having suicidal thoughts within the past 12 months.

“We lose the equivalent of two to three medical school classes worth of physicians every year to suicide. And let me tell you: 98% of those folks, at the time they suicided, had major depression, which is eminently treatable. And the reason they weren’t treated was they, like most physicians, avoided treatment. They had difficulty accessing care. They were worried about stigma, life insurance, things like that. This is a huge problem which is mostly preventable, but we are not addressing it effectively,” Dr. Anzia said.

While institutional interventions aimed at the prevention of physician burnout such as spending less time on the electronic health record will have a major impact on the problem, thought leaders in medical education have come to realize that it also will be necessary to address the broader culture of medicine.

“There are so many implicit beliefs that every one of us grew up with, like ‘I work when I’m sick,’ or ‘I can work without sleep.’ All those things that we believe make us good physicians actually may not be entirely true,” the psychiatrist said.

She reported having no financial conflicts of interest regarding her presentation.

 

 

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EVAR, venous CPT coding revamped for 2018

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– Current Procedural Terminology coding for endovascular aneurysm repair has been totally overhauled for 2018 with the introduction of a family of 20 new codes and codes for other vascular procedures have also been updated.

The new EVAR CPT codes attempt to capture the work involved in performing the procedures based upon the anatomy of the aneurysm and the treated vessels rather than being device-based, as previously, Matthew J. Sideman, MD, explained in presenting the coding and reimbursement for 2018 at a symposium on vascular surgery sponsored by Northwestern University.

Bruce Jancin/Frontline Medical News
Dr. Matthew J. Sideman
Other CPT coding changes affecting vascular surgeons for 2018 include creation of four new codes for treatment of incompetent veins via transcatheter ablation using adhesive glue (CPT 36465 and 36466) and ultrasound-guided foam ablation (36482 and 36483). Also, several existing codes got more favorable valuations. But all these changes are dwarfed in impact by the restructuring of EVAR coding.

“The new EVAR codes for 2018 have got a lot of gains. There are some losses as well, but overall, I think it’s going to be very positive moving forward,” according to Dr. Sideman, a vascular surgeon at the University of Texas, San Antonio, who serves as chair of the Society for Vascular Surgery Coding and Reimbursement Committee and an adviser to the American Medical Association Relative Value Scale Update Committee (RUC).

“What we gained was a new code for ruptured aneurysm repair, a new code for enhanced fixation, a new code for percutaneous access, new codes for alternative access options, and now all the access codes are add-on codes. But what we traded off was loss due to bundling. So catheterization is now bundled into the main procedure, radiographic supervision and interpretation is now bundled. The big thing that really hurt was we lost all proximal extensions to the renal arteries and all distal extensions to the iliac bifurcations – they’re also bundled into the main procedure,” he said.

Restructuring the EVAR codes was a multiyear collaborative project of the SVS, the American College of Surgeons, the Society of Interventional Radiology, the Society of Thoracic Surgery, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions. The impetus was twofold: recognition that the existing codes seriously undervalued the work involved in EVAR because, for example, they didn’t distinguish between ruptured and elective aneurysm repair, nor did they recognize the unique challenges and advantages of percutaneous access.

Also, representatives of the professional societies involved with vascular medicine recognized that they had to develop a detailed proposal for coding restructuring or matters might be taken out of their hands. Bundling of codes has become the prevailing dogma at the RUC and the Centers for Medicare and Medicaid. Their current policy is that when analysis of coding patterns indicates two codes are billed together at least 51% of the time, that’s considered a ‘typical’ situation and a new code must be created combining them. The harsh reality for clinicians is that under what Dr. Sideman called “RUC math,” the new bundled codes invariably pay less than the two old ones.

“There was a little bit of smoke and mirrors – ‘Look at the pretty flashing lights and not what’s going on behind over here’ – as we tried to maintain value as we bundled these EVAR codes,” Dr. Sideman recalled. “I can stand here and tell you I did my very best to push for the best values possible. It can be a painful process, but I thought we came out ok.”
 

How the new EVAR codes work

Dr. Sideman explained that the impact of the new EVAR codes will depend upon a surgeon’s practice pattern.

He offered as a concrete example a patient undergoing elective EVAR of the aorta and both iliac arteries with percutaneous access and placement of a bifurcated device with one docking limb. In 2017, this might have been handled using CPT codes 34802, 36200-50, and 75952-26, for a total of 31.05 Relative Value Units (RVUs) of work.

In 2018, however, this same surgical strategy would be coded as 34705 (elective endovascular repair of infrarenal aorta and/or iliac artery or arteries) plus 34713 x 2 (percutaneous access and closure), for a total of 34.58 RVUs. Thus, the surgeon would come out 3.53 RVUs ahead in 2018, which at a conversion factor of $35.78/RVU translates to an extra $126.30.

On the other hand, if the surgeon chose to use a bifurcated device with one docking limb, a left iliac bell-bottom extension, a right iliac bell-bottom extension, and percutaneous access, in 2017, this would have been coded as 34802, 34825, 34826, 36200-50, 75952-26, and 75953-26 x 2, for a total of 44.29 RVUs of work. In 2018, this same treatment strategy would be coded as 34705 plus 34713 x 2, for a total of 34.58 RVUs, or a knockdown of 9.71 fewer RVUs compared with the year before, which translates to $347.42 less.

“The more extensions you use, the more you’re going to come out behind going forward,” according to Dr. Sideman.
 

Other coding changes in 2018

Sclerotherapy of single and multiple veins (codes 36470 and 36471) got down-valued from 1.10 and 2.49 to 0.75 and 1.5 RVUs, respectively.

Angiography of the extremities (75710 and 75716) will be better reimbursed in 2018. In what Dr. Sideman called “a good win,” unilateral angiography will be rated as 1.75 RVUs, up from 1.14 in 2017, while bilateral angiography increased from 1.31 to 1.97 RVUs.

“The other nice thing I can tell you is that through campaigning and lobbying and comments to CMS [Centers for Medicare & Medicaid Services], we got them to reverse their recommendations from 2017 to 2018 on the dialysis family of codes,” the surgeon continued.

Reimbursement for the dialysis codes took a big hit from 2016 to 2017, amounting to several hundred million dollars less in reimbursement, but CMS has reversed its policy on that score. The RVUs for the various dialysis codes have increased from 2017 to 2018 by 5%-21%, with central venous angioplasty (CPT 36907) garnering the biggest increase.

Existing RVUs were retained for 2018 in three of the four selective catheter placement codes. However, reimbursement for 36215 (first order catheterization of the thoracic or brachiocephalic branch) dropped from 4.67 to 4.17 RVUs because physician surveys showed the time involved was less than previously rated. Once the RUC and CMS saw that the time involved in a procedure has decreased, it became impossible to maintain the RVU, Dr. Sideman explained.

And speaking of time involved in procedures, Dr. Sideman offered a final plea to his vascular medicine colleagues:

“When you get surveys from the RUC asking for your input, please, please, please, fill them out because that’s how we get our direct physician input into the valuation of codes.”

He reported having no financial conflicts of interest regarding his presentation.

A detailed listing of many of the codes and changes can be found at the American College of Radiology website, and the Society for Vascular Surgery has coding resources available on their website, as well.

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– Current Procedural Terminology coding for endovascular aneurysm repair has been totally overhauled for 2018 with the introduction of a family of 20 new codes and codes for other vascular procedures have also been updated.

The new EVAR CPT codes attempt to capture the work involved in performing the procedures based upon the anatomy of the aneurysm and the treated vessels rather than being device-based, as previously, Matthew J. Sideman, MD, explained in presenting the coding and reimbursement for 2018 at a symposium on vascular surgery sponsored by Northwestern University.

Bruce Jancin/Frontline Medical News
Dr. Matthew J. Sideman
Other CPT coding changes affecting vascular surgeons for 2018 include creation of four new codes for treatment of incompetent veins via transcatheter ablation using adhesive glue (CPT 36465 and 36466) and ultrasound-guided foam ablation (36482 and 36483). Also, several existing codes got more favorable valuations. But all these changes are dwarfed in impact by the restructuring of EVAR coding.

“The new EVAR codes for 2018 have got a lot of gains. There are some losses as well, but overall, I think it’s going to be very positive moving forward,” according to Dr. Sideman, a vascular surgeon at the University of Texas, San Antonio, who serves as chair of the Society for Vascular Surgery Coding and Reimbursement Committee and an adviser to the American Medical Association Relative Value Scale Update Committee (RUC).

“What we gained was a new code for ruptured aneurysm repair, a new code for enhanced fixation, a new code for percutaneous access, new codes for alternative access options, and now all the access codes are add-on codes. But what we traded off was loss due to bundling. So catheterization is now bundled into the main procedure, radiographic supervision and interpretation is now bundled. The big thing that really hurt was we lost all proximal extensions to the renal arteries and all distal extensions to the iliac bifurcations – they’re also bundled into the main procedure,” he said.

Restructuring the EVAR codes was a multiyear collaborative project of the SVS, the American College of Surgeons, the Society of Interventional Radiology, the Society of Thoracic Surgery, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions. The impetus was twofold: recognition that the existing codes seriously undervalued the work involved in EVAR because, for example, they didn’t distinguish between ruptured and elective aneurysm repair, nor did they recognize the unique challenges and advantages of percutaneous access.

Also, representatives of the professional societies involved with vascular medicine recognized that they had to develop a detailed proposal for coding restructuring or matters might be taken out of their hands. Bundling of codes has become the prevailing dogma at the RUC and the Centers for Medicare and Medicaid. Their current policy is that when analysis of coding patterns indicates two codes are billed together at least 51% of the time, that’s considered a ‘typical’ situation and a new code must be created combining them. The harsh reality for clinicians is that under what Dr. Sideman called “RUC math,” the new bundled codes invariably pay less than the two old ones.

“There was a little bit of smoke and mirrors – ‘Look at the pretty flashing lights and not what’s going on behind over here’ – as we tried to maintain value as we bundled these EVAR codes,” Dr. Sideman recalled. “I can stand here and tell you I did my very best to push for the best values possible. It can be a painful process, but I thought we came out ok.”
 

How the new EVAR codes work

Dr. Sideman explained that the impact of the new EVAR codes will depend upon a surgeon’s practice pattern.

He offered as a concrete example a patient undergoing elective EVAR of the aorta and both iliac arteries with percutaneous access and placement of a bifurcated device with one docking limb. In 2017, this might have been handled using CPT codes 34802, 36200-50, and 75952-26, for a total of 31.05 Relative Value Units (RVUs) of work.

In 2018, however, this same surgical strategy would be coded as 34705 (elective endovascular repair of infrarenal aorta and/or iliac artery or arteries) plus 34713 x 2 (percutaneous access and closure), for a total of 34.58 RVUs. Thus, the surgeon would come out 3.53 RVUs ahead in 2018, which at a conversion factor of $35.78/RVU translates to an extra $126.30.

On the other hand, if the surgeon chose to use a bifurcated device with one docking limb, a left iliac bell-bottom extension, a right iliac bell-bottom extension, and percutaneous access, in 2017, this would have been coded as 34802, 34825, 34826, 36200-50, 75952-26, and 75953-26 x 2, for a total of 44.29 RVUs of work. In 2018, this same treatment strategy would be coded as 34705 plus 34713 x 2, for a total of 34.58 RVUs, or a knockdown of 9.71 fewer RVUs compared with the year before, which translates to $347.42 less.

“The more extensions you use, the more you’re going to come out behind going forward,” according to Dr. Sideman.
 

Other coding changes in 2018

Sclerotherapy of single and multiple veins (codes 36470 and 36471) got down-valued from 1.10 and 2.49 to 0.75 and 1.5 RVUs, respectively.

Angiography of the extremities (75710 and 75716) will be better reimbursed in 2018. In what Dr. Sideman called “a good win,” unilateral angiography will be rated as 1.75 RVUs, up from 1.14 in 2017, while bilateral angiography increased from 1.31 to 1.97 RVUs.

“The other nice thing I can tell you is that through campaigning and lobbying and comments to CMS [Centers for Medicare & Medicaid Services], we got them to reverse their recommendations from 2017 to 2018 on the dialysis family of codes,” the surgeon continued.

Reimbursement for the dialysis codes took a big hit from 2016 to 2017, amounting to several hundred million dollars less in reimbursement, but CMS has reversed its policy on that score. The RVUs for the various dialysis codes have increased from 2017 to 2018 by 5%-21%, with central venous angioplasty (CPT 36907) garnering the biggest increase.

Existing RVUs were retained for 2018 in three of the four selective catheter placement codes. However, reimbursement for 36215 (first order catheterization of the thoracic or brachiocephalic branch) dropped from 4.67 to 4.17 RVUs because physician surveys showed the time involved was less than previously rated. Once the RUC and CMS saw that the time involved in a procedure has decreased, it became impossible to maintain the RVU, Dr. Sideman explained.

And speaking of time involved in procedures, Dr. Sideman offered a final plea to his vascular medicine colleagues:

“When you get surveys from the RUC asking for your input, please, please, please, fill them out because that’s how we get our direct physician input into the valuation of codes.”

He reported having no financial conflicts of interest regarding his presentation.

A detailed listing of many of the codes and changes can be found at the American College of Radiology website, and the Society for Vascular Surgery has coding resources available on their website, as well.

 

– Current Procedural Terminology coding for endovascular aneurysm repair has been totally overhauled for 2018 with the introduction of a family of 20 new codes and codes for other vascular procedures have also been updated.

The new EVAR CPT codes attempt to capture the work involved in performing the procedures based upon the anatomy of the aneurysm and the treated vessels rather than being device-based, as previously, Matthew J. Sideman, MD, explained in presenting the coding and reimbursement for 2018 at a symposium on vascular surgery sponsored by Northwestern University.

Bruce Jancin/Frontline Medical News
Dr. Matthew J. Sideman
Other CPT coding changes affecting vascular surgeons for 2018 include creation of four new codes for treatment of incompetent veins via transcatheter ablation using adhesive glue (CPT 36465 and 36466) and ultrasound-guided foam ablation (36482 and 36483). Also, several existing codes got more favorable valuations. But all these changes are dwarfed in impact by the restructuring of EVAR coding.

“The new EVAR codes for 2018 have got a lot of gains. There are some losses as well, but overall, I think it’s going to be very positive moving forward,” according to Dr. Sideman, a vascular surgeon at the University of Texas, San Antonio, who serves as chair of the Society for Vascular Surgery Coding and Reimbursement Committee and an adviser to the American Medical Association Relative Value Scale Update Committee (RUC).

“What we gained was a new code for ruptured aneurysm repair, a new code for enhanced fixation, a new code for percutaneous access, new codes for alternative access options, and now all the access codes are add-on codes. But what we traded off was loss due to bundling. So catheterization is now bundled into the main procedure, radiographic supervision and interpretation is now bundled. The big thing that really hurt was we lost all proximal extensions to the renal arteries and all distal extensions to the iliac bifurcations – they’re also bundled into the main procedure,” he said.

Restructuring the EVAR codes was a multiyear collaborative project of the SVS, the American College of Surgeons, the Society of Interventional Radiology, the Society of Thoracic Surgery, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions. The impetus was twofold: recognition that the existing codes seriously undervalued the work involved in EVAR because, for example, they didn’t distinguish between ruptured and elective aneurysm repair, nor did they recognize the unique challenges and advantages of percutaneous access.

Also, representatives of the professional societies involved with vascular medicine recognized that they had to develop a detailed proposal for coding restructuring or matters might be taken out of their hands. Bundling of codes has become the prevailing dogma at the RUC and the Centers for Medicare and Medicaid. Their current policy is that when analysis of coding patterns indicates two codes are billed together at least 51% of the time, that’s considered a ‘typical’ situation and a new code must be created combining them. The harsh reality for clinicians is that under what Dr. Sideman called “RUC math,” the new bundled codes invariably pay less than the two old ones.

“There was a little bit of smoke and mirrors – ‘Look at the pretty flashing lights and not what’s going on behind over here’ – as we tried to maintain value as we bundled these EVAR codes,” Dr. Sideman recalled. “I can stand here and tell you I did my very best to push for the best values possible. It can be a painful process, but I thought we came out ok.”
 

How the new EVAR codes work

Dr. Sideman explained that the impact of the new EVAR codes will depend upon a surgeon’s practice pattern.

He offered as a concrete example a patient undergoing elective EVAR of the aorta and both iliac arteries with percutaneous access and placement of a bifurcated device with one docking limb. In 2017, this might have been handled using CPT codes 34802, 36200-50, and 75952-26, for a total of 31.05 Relative Value Units (RVUs) of work.

In 2018, however, this same surgical strategy would be coded as 34705 (elective endovascular repair of infrarenal aorta and/or iliac artery or arteries) plus 34713 x 2 (percutaneous access and closure), for a total of 34.58 RVUs. Thus, the surgeon would come out 3.53 RVUs ahead in 2018, which at a conversion factor of $35.78/RVU translates to an extra $126.30.

On the other hand, if the surgeon chose to use a bifurcated device with one docking limb, a left iliac bell-bottom extension, a right iliac bell-bottom extension, and percutaneous access, in 2017, this would have been coded as 34802, 34825, 34826, 36200-50, 75952-26, and 75953-26 x 2, for a total of 44.29 RVUs of work. In 2018, this same treatment strategy would be coded as 34705 plus 34713 x 2, for a total of 34.58 RVUs, or a knockdown of 9.71 fewer RVUs compared with the year before, which translates to $347.42 less.

“The more extensions you use, the more you’re going to come out behind going forward,” according to Dr. Sideman.
 

Other coding changes in 2018

Sclerotherapy of single and multiple veins (codes 36470 and 36471) got down-valued from 1.10 and 2.49 to 0.75 and 1.5 RVUs, respectively.

Angiography of the extremities (75710 and 75716) will be better reimbursed in 2018. In what Dr. Sideman called “a good win,” unilateral angiography will be rated as 1.75 RVUs, up from 1.14 in 2017, while bilateral angiography increased from 1.31 to 1.97 RVUs.

“The other nice thing I can tell you is that through campaigning and lobbying and comments to CMS [Centers for Medicare & Medicaid Services], we got them to reverse their recommendations from 2017 to 2018 on the dialysis family of codes,” the surgeon continued.

Reimbursement for the dialysis codes took a big hit from 2016 to 2017, amounting to several hundred million dollars less in reimbursement, but CMS has reversed its policy on that score. The RVUs for the various dialysis codes have increased from 2017 to 2018 by 5%-21%, with central venous angioplasty (CPT 36907) garnering the biggest increase.

Existing RVUs were retained for 2018 in three of the four selective catheter placement codes. However, reimbursement for 36215 (first order catheterization of the thoracic or brachiocephalic branch) dropped from 4.67 to 4.17 RVUs because physician surveys showed the time involved was less than previously rated. Once the RUC and CMS saw that the time involved in a procedure has decreased, it became impossible to maintain the RVU, Dr. Sideman explained.

And speaking of time involved in procedures, Dr. Sideman offered a final plea to his vascular medicine colleagues:

“When you get surveys from the RUC asking for your input, please, please, please, fill them out because that’s how we get our direct physician input into the valuation of codes.”

He reported having no financial conflicts of interest regarding his presentation.

A detailed listing of many of the codes and changes can be found at the American College of Radiology website, and the Society for Vascular Surgery has coding resources available on their website, as well.

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