Vascular Surgeons, Interventionalists Clash Over Guidelines

Reed Miller

March 05, 2012

March 5, 2012 (Washington, DC) — The long-running battle among different specialties over management of carotid disease is heating up again, with the society representing interventionalists charging that the group representing vascular surgeons is reneging on a hard-won compromise agreement.

At the start of 2011, the American College of Cardiology (ACC), American Heart Association (AHA), Society for Cardiovascular Angiography and Interventions (SCAI), American Academy of Neurology, and 10 other professional societies, including the Society for Vascular Surgery (SVS), released new guidelines on stenting and surgery in the management of patients with extracranial carotid and vertebral artery disease [1]. The guidelines, released soon after the publication of the seminal Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), stated that carotid stenting is an acceptable alternative to carotid endarterectomy for symptomatic patients at average or low risk of complications, with stenosis greater than 70% on duplex ultrasonography.

But while the SVS signed off on that multispecialty guidance, in September 2011 the group released its own carotid disease management guidelines [2]. The SVS document states that stenting should be reserved for symptomatic patients with stenosis of 50% to 99% at high risk for surgery and that endarterectomy surgery should be the first-line therapy for most symptomatic patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 60% to 99%.

Concordance (plus a little more data)?

Dr. John Ricotta

The lead author of the SVS guidance, Dr John Ricotta (Georgetown University, Washington, DC), told heartwire , "On the whole, the two sets of recommendations are largely concordant." Ricotta explained that the multispecialty guidelines recommend stenting as an "alternative" to endarterectomy in symptomatic patients where the periprocedural risk of stroke with stenting is low, while the SVS guidelines recommend stenting symptomatic lesions only when risk with surgery is thought to be high. The multispecialty guidelines recommend stenting as an alternative in asymptomatic patients in some selected circumstances, but the SVS guidelines state stenting of asymptomatic patients should be confined to clinical trials, he explained.

Ricotta says important new data were published after the release of the multispecialty guidelines, including a meta-analysis of 13 trials and nearly 7500 patients, showing that, compared with endarterectomy surgery, carotid artery stenting significantly increases the risk of any stroke and decreases the risk of MI [3].

"While the SVS endorsed the multispecialty document as a whole, it felt that these nuances were of sufficient importance, particularly in light of new data and an emphasis on stroke and death prevention, that a clarification of the SVS position was in order," Ricotta said.

Dr. Richard Cambria

In a conversation with heartwire , current SVS president Dr Richard Cambria (Massachusetts General Hospital, Boston) called the two documents "98% to 99% concordant, and the only disagreement is how you choose to interpret certain verbiage," he said. "A multisociety guideline [always] tends to be a compromise position that tries to achieve a consensus of different professional societies. . . . A single-specialty guideline tends to be much more declarative and much more [oriented to] 'what do we do in this particular patient subset?' "

There's a lot of 'eye of the beholder' in what those guidelines say.

Cambria maintains that physicians needed this more "declarative" guideline because the multisociety guideline is open to interpretation. For example, the multispecialty guidelines accepts stenting in "highly selected patients" with asymptomatic carotid stenosis with at least 60% stenosis by angiography but also states that stenting's effectiveness in these patients, compared with medical therapy alone, "is not well established." Cambria said.

"If you're a doctor trying to look up the role of stenting in asymptomatic patients because you want to practice consistent with the guidelines, how would you interpret that? I believe that you could interpret that any way you wanted to. You could just say that your patient is a 'highly selected' patient," he explained.

"If you're a studious academic, you might triage your guidelines on what you take from it according to the level of evidence, but if you're the active doc on the street, you can interpret them anyway you want," he continued. "What does 'alternative' mean? Does it mean in patients who can't be treated with carotid endarterectomy? Does it mean equivalent? So there's a lot of 'eye of the beholder' in what those guidelines say."

SCAI prepares "scathing" rebuke

Dr. Christopher White

Other signatories to the multispecialty guidelines, however, are not amused. SCAI president Dr Christopher White (Ochsner Medical Center, New Orleans, LA) told heartwire that he will soon be publishing a rebuke in Catheterization and Cardiovascular Interventions denouncing the SVS's decision to publish its own "discordant" guidelines that contradict the multisociety guidelines it signed off on.

"This is a classic example of the kinds of problems you run into with societal cooperation," White told heartwire . "If you want to be polite, you call it an end around; if you don't want to be polite, you call it a double cross.

If you want to be polite, you call it an end around; if you don't want to be polite you call it a double cross.

"The other professional societies are now laughing at them. This is such bad behavior, such bad manners; it's like farting in public. This is not done in polite company."

He points out that the multisociety guidelines support carotid stenting as an alternative to surgery only for some indications--"nowhere in the guideline does it say that it is preferred"--and to get to that relatively modest recommendation required "a lot of haggling and horse-trading that went on behind closed doors between the surgeons and the nurses and the vascular radiologists, all of the constituencies. [But] we came out with a consensus. All of the groups signed up and we published it."

"To get 14 societies together was a huge victory," White said. "I'm not 100% happy with the guideline, either. I think that carotid stenting is much more favorable in some populations than that guideline says, but we had to negotiate to keep those SVS guys at the table. They weren't going to sign off on what I like. . . . So they negotiated me away from what I like, and then six months later publish their own guideline anyway. Now why do I take them seriously at the negotiating table?"

White rejects SVS's contention that its new guidelines were warranted because important new data on carotid stenting came to light after the publication of the multisociety guidelines. "That's not true. There was no significant information that would trump a randomized controlled trial like CREST."

He added, "Anyone who has ever written a guideline knows it doesn't just take a few months. For SVS to have this guideline ready to publish in September, they'd have to have been writing this guideline and gathering this information while the other guideline was being prepared, which is really dirty pool and bad manners."

ACC/AHA content with its guidance

The cochair of the committee that wrote the multisociety guidelines, Dr Jonathan Halperin (Mount Sinai Hospital, New York, NY), told heartwire that the ACC and AHA are confident the multisociety guidelines represent the best available clinical data. Representatives of all of the societies that signed the multisociety guidelines have reviewed the additional data cited in the SVS guidance. "There's no new major primary randomized trial data, and our feeling is that these do not currently call for a change in the recommendations that were made in the multisociety guidelines, so we continue to stand behind those."

Dr. Jonathan Halperin

As for the SVS's decision to write its own guidelines, Halperin said, "It's a free country, and we don't want to control what anybody says, [but] there was a signed partnering agreement that led to the development of this document, and every single participating society acknowledged its approval of the recommendations that were published and the guideline overall that was published. To my knowledge, no one has rescinded that approval, so I still think the partnership is in place and I hope it will remain in place."

Fair or foul?

White maintains that the SVS breached the agreement it signed with the other societies when it participated in the development of the multisociety guidelines. "When you agree to be part of the guidelines, you agree not to do this. So now the problem is what is to be done to address this behavior. I can tell you that ACC and AHA are wrestling with how to address this behavior," he said. "It doesn't do much good to throw them out, because you want to have an inclusive guideline process, but then by the same token, it doesn't do any good to have them in the process and then sort of renege."

The SVS denies that it has violated an agreement because it maintains that its document is concordant with the multisociety guidelines. "All participants in multispecialty [group] sign an agreement letter that has a 'concordance' provision, [but] there is no prohibition about societies publishing their own guidelines, although they are asked to be concordant," Cambria told heartwire in an email.

Cambria also said, "We've had communication with the ACC/AHA guideline group to reconcile any difficulties in agreement, and the ACC/AHA guideline group has agreed that our document stands on its own because of new information available since the publication in Circulation."

Who will the CMS listen to?

These battles over the proper role of carotid stenting are not just an academic disagreement. In the past, the Centers for Medicare and Medicaid Services (CMS) has used the specialty societies' inability to present a united front on this issue as a reason to not expand coverage of carotid stenting. Medicare currently covers carotid stenting with embolic protection only in patients with carotid stenosis > 70% who would be at high risk for complications during carotid endarterectomy surgery.

The CMS is expected to formally reopen its Medicare coverage policy on carotid disease management later this year. At a recent meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), interventionalists argued that the CREST results justify presenting both stenting and surgery as options for their patients, but SVS representatives testified that surgery is still the best option in these patients, because the 30-day stroke rate was significantly higher with stenting than surgery in CREST.

Halperin said that although the MEDCAC expressed a diversity of opinions, "overall, they seemed more aligned with the multisociety recommendations than the SVS guidelines . . . and aligned with best available evidence."

White agrees with Halperin and says that, based on conversations he's had with CMS officials, he is confident the agency will take the multisociety guidelines as the consensus opinion of the physician community, expand coverage of carotid stenting, and largely ignore the SVS guidelines.

"We're getting to the end of the line where if the CMS doesn't do something about carotid stenting, the [carotid stent manufacturers] are going to start backing away and taking things off the shelf. The CMS knows there are patients who need carotid stenting and they don't want to take this away from patients," he said. "The CMS is looking for a way around this political consensus and . . . they are going to accept the vascular surgeons' signature on [the multisociety guidelines] as reasonable consensus."

Halperin has consulted for Astellas Pharma, Bayer HealthCare, Biotronik, Boehringer Ingelheim, Daiichi Sankyo, the Food and Drug Administration, GlaxoSmithKline, Johnson & Johnson, Portala, and Sanofi-Aventis. White is on the advisory boards of Neovasc and Baxter Cellular Therapy. Cambria and Ricotta declare they have no financial relationships relevant to the SVS guidelines.

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