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Revisiting the Two-Surgeon Rule for TAVR
Mandatory visits to two surgeons can be a barrier to care for patients.
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More than 15 years after the first transcatheter aortic valve replacement, the need to have two cardiac surgeons sign off on every procedure may now be more of a hindrance to effective and expedient patient care than a safeguard against inappropriate treatment, some experts said.
“When we talk to patients on a day-to-day basis and describe to the patient what a workup for TAVR entails, a very common first question from patients is ‘Why am I seeing two surgeons?’ And it’s hard for me to come up with an answer that is supported by any evidence other than to say that as a group, our societies have decided this is how it’s going to be,” Satya Shreenivas, MD, from The Christ Hospital Heart and Vascular Center/The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, told Cardiology Today’s Intervention.
“Patients receive more complicated and protracted therapies — heart transplants, chemotherapy — and there’s not another instance in which two physicians from the same specialty have to document its necessity and appropriateness,” Scott Lilly, MD, PhD, from the division of cardiology at Ohio State University Wexner Medical Center, who co-wrote a recent editorial published in Catheterization and Cardiovascular Interventions on the topic with Shreenivas, said in an interview.
Changes Over Time
In 2012, the CMS adopted the two-surgeon rule as a major requirement of the National Coverage Decision (NCD) for TAVR programs.
One of the initial reasons for the two-surgeon rule was to prevent “risk-creep” and the use of TAVR in inappropriate populations, as TAVR was initially approved for only high-risk patients (Graphic), Shreenivas and Lilly wrote in their editorial. Now, though, TAVR is FDA-approved for prohibitive-risk, high-risk and intermediate-risk patients and the use of risk scores, such as the Society of Thoracic Surgeons Predicted Risk of Mortality, that objectively establish a patient’s surgical risk is more widespread.
“One or two surgeons may agree that an STS score of 3%, 4% or 5% underestimates a patient’s risk because there are things, such as frailty, that aren’t included in the STS score. In contrast, it’s incredibly uncommon to revise the calculated risk score and make the case that it overestimates the risk,” Lilly told Cardiology Today’s Intervention. “So, while the two-surgeon rule may have been useful at the inception of TAVR, with the responsible dispersion of this technology, the rule is inadvertently delaying care.”
Furthermore, disagreement between two colleagues of the same specialty is rare, Shreenivas added.
“When we look at our own data and see how frequently surgeons disagree, we found two cases out of 500 in the last 5 years in which evaluation by two surgeons actually affected management. In one case, the surgeon preferred surgical AVR and in the other, the initial surgeon recommended surgery and the second recommended TAVR, and we ended up performing TAVR,” he said.
Some have also pointed to the novelty of the procedure back in 2012 as the reason for the institution of the two-surgeon rule, but Shreenivas noted that there is no precedent for any other treatment requiring sign-off from two physicians in the same specialty.
“I would argue that the reason may have been a little bit different,” he said. “Aortic stenosis was always in the realm of surgery, and I think adding an extra layer of oversight was done to protect surgical volumes under the belief that surgeons would always prefer surgery. But now, many of our surgery colleagues can perform TAVR without requiring an interventional cardiologist, so I don’t think surgeons see TAVR vs. surgical AVR as a dichotomy. They see them both as treatments for the same disease process that can be done with either surgeons or interventionalists.”
An Undue Burden
Currently, not only is the two-surgeon rule perhaps obsolete in the changing landscape of TAVR, but it is also a significant barrier to care, Shreenivas and Lilly told Cardiology Today’s Intervention.
Unfortunately, cardiac surgeons are often in the OR and it is rare that more than one is available to see a patient at a given time, meaning that the patient waiting to undergo TAVR is usually required to come back for an additional visit before they can proceed. Because patients with severe symptomatic aortic stenosis are often elderly with multiple comorbidities, a second visit may be difficult and could place an undue burden on friends or family members who must accompany them, Shreenivas and Lilly noted.
More importantly, though, the lengthy process can put these patients at unnecessary risk, Lilly said. According to data presented by Shreenivas and colleagues at the recent ACC Legislative Conference, at two major medical centers — one academic and one private — the average length of time from the initial referral to TAVR is roughly 60 days, with about 2.5 weeks spent on the second surgery visit.
“Once patients are diagnosed with severe symptomatic aortic stenosis, about half of them are alive at 2 years if nothing is done, so in the course of prolonged evaluation, patients can die while waiting for the procedure,” Lilly said.
Benefits, Drawbacks to Elimination
In addition to relieving the burden on patients and saving lives, there may be other advantages to eliminating the two-surgeon rule.
From a surgeon’s perspective, Gilbert Tang, MD, MSc, MBA, FRCSC, FACC, surgical director of the structural heart program at Mount Sinai Health System and associate professor of cardiovascular surgery at Icahn School of Medicine at Mount Sinai, said that dropping the two-surgeon rule would mitigate a few challenges.
“Surgeons are busy, so not requiring the second face-to-face evaluation would free up the second surgeon to be in the OR or taking care of other patients rather than trying to logistically make the process work,” he told Cardiology Today’s Intervention. “Also, a second surgeon may not be incentivized or be part of the heart team, so they might not seem as relevant to the overall heart team discussion.”
Moreover, if the trials of TAVR in low-risk patients prove positive and the indication for the procedure is expanded, then the procedure could be considered for nearly every patient. In those circumstances, the heart team concept, which takes patient preference into account, would lose significance and the patient-physician relationship could be damaged, according to Shreenivas.
“When we let the bureaucracy of medicine dictate how we interact with our patients, that’s a slippery slope, especially in this setting in which we have no data to show that the second visit to a surgeon is actually beneficial,” he said.
The approval of TAVR for low-risk patients, though, could change the situation in some ways, according to Tang.
“I think it’s reasonable to proceed with TAVR if it can be done in a low-risk fashion, yet TAVR can potentially have a higher risk for complications, such as coronary obstruction, aortic root injury or high risk of pacemaker,” he said. “There’s been some provocative discussion about whether two cardiologists should discuss the option of TAVR vs. one surgeon if the surgeon operates on the patient, so I think it will be somewhere in between.”
Moving Forward
In the recently updated consensus document on systems of care for TAVR, endorsed by the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions and the STS, the writing committee states that only one cardiac surgeon’s independent face-to-face evaluation is necessary.
Also, in July, the Medicare Evidence Development and Coverage Advisory Committee of the CMS convened to reconsider the NCD, focusing on procedural volume thresholds and related issues. The agency will come to a decision sometime next year.
Shreenivas said he would like CMS to wait until after the release of the low-risk TAVR trials before making grand-scale changes.
“If the results of those trials are positive, then even small changes we might make today — getting rid of the two-surgeon rule — would still leave us with a little more bureaucratic oversight that might not be necessary after the spring of next year. That would be the real game-changer on how we treat these patients,” he said.
None of these arguments, however, diminish the importance of discussing a case in the multidisciplinary context of the heart team, Shreenivas, Lilly and Tang told Cardiology Today’s Intervention. The question is more about streamlining the process.
“We as physicians should always ask if the things we’re doing are in the best interest of the patients and not just following a rule, and if there’s anything we find ourselves asking patients to do that is just to simplify an insurance or bureaucratic requirement, then as physicians, it’s our duty to say, ‘Why are we doing this?’” Shreenivas said. “Our job should be to simplify the pre-procedure workup, just as we’ve simplified the procedure and post-procedure, to the point that hopefully, getting a valve replaced is similar to getting your coronaries fixed or a pacemaker put in.”
Tang agreed, noting that it will be interesting to see how the story unfolds.
“We need to evolve and having one surgeon and one cardiologist review the case as part of a heart team should be sufficient to discuss whether the patient would be a suitable TAVR candidate,” he said. “The crux of the discussion going forward, though, especially if TAVR gets approved for the low-risk patient, is how would that one surgeon be unbiased in his or her recommendation because some of these patients could be young and be very good surgical candidates?” – by Melissa Foster
- References:
- Bavaria JE, et al. J Am Coll Cardiol. 2018;doi: 10.1016/j.jacc.2018.07.002.
- Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N). Available at: www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=257&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR). Published May 1, 2012. Accessed Oct. 28, 2018.
- Shreenivas S, et al. Catheter Cardiovasc Interv. 2018;doi:10.1002/ccd.27666.
- For more information:
- Scott Lilly, MD, PhD, can be reached at scott.lilly@osumc.edu.
- Satya Shreenivas, MD, can be reached at satya.shreenivas@thechristhospital.com.
- Gilbert Tang, MD, MSc, MBA, FRCSC, FACC, can be reached at gilbert.tang@mountsinai.org.
Disclosures: Lilly and Shreenivas report no relevant financial disclosures. Tang reports he is a physician proctor for Edwards Lifesciences and Medtronic.