Future Therapy for Low-Risk Patients With Severe Aortic Stenosis—A Provider Survey

Article Citation:

Aisha Ahmed, Emmanouil S Brilakis, Karol Mudy, Benjamin Sun, Paul Sorajja, and Mario Gössl (2018) Future Therapy for Low-Risk Patients With Severe Aortic Stenosis—A Provider Survey. Journal of the Minneapolis Heart Institute Foundation: Fall/Winter 2018, Vol. 2, No. 2, pp. 1-3.

Editorial

Aisha Ahmed, BS

Emmanouil S Brilakis, MD, PhD, FACC

Karol Mudy, MD

Benjamin Sun, MD

Paul Sorajja, MD, FACC

Mario Gössl, MD, PhD, FACC

Valve Science Center, Minneapolis Heart Institute Foundation; Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN

Disclosures: The authors have no conflict of interest.

Address for correspondence: Mario Gössl, MD, PhD, Director, Transcatheter Research and Education, Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis Heart Institute at Abbott Northwestern Hospital, 920 East 28th Street, Suite 300, Minneapolis, MN 55407, Tel: 612-863-8097, E-mail: Mario.Goessl@Allina.com

ABSTRACT

With the expansion of transcatheter aortic valve replacement in low-risk patients, we sought to explore current implanters’ predictions on the future of this therapy by sending a survey to a sample of 8,261 healthcare professionals using Internet-based software. The survey contained six questions regarding physician specialty and experience, transcatheter aortic valve replacement age cutoff, optimal treatment for low-risk patients, transcatheter aortic valve replacement valve sequence, and transcatheter aortic valve replacement concerns. The majority, 29% percent, of all respondents felt that transcatheter aortic valve replacement will become the first-choice therapy for all patients, regardless of age and 70% felt that the optimal treatment would be transcatheter aortic valve replacement, with transcatheter aortic valve replacement valve-in-valve if the first valve degenerates. Regarding the sequence of transcatheter aortic valve replacement valves, 78% preferred the Edwards Sapien 3 valve (ES-3) as the first transcatheter aortic valve replacement valve followed by either a second ES-3 or Medtronic Evolut valve. Despite the high acceptance of transcatheter aortic valve replacement, many respondents (56%) felt that surgical aortic valve replacement might still remain the preferred treatment in low-risk patients due to an unknown durability of transcatheter aortic valve replacement valves. A majority of implanters see transcatheter aortic valve replacement followed by valve-in-valve transcatheter aortic valve replacement as the first-line therapy for low-risk patients with severe aortic stenosis, but long-term durability of transcatheter aortic valve replacement is an unanswered concern.

Keywords: TAVR, SAVR, severe aortic stenosis, low risk, survey

INTRODUCTION

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe symptomatic aortic stenosis. Indications for TAVR have continued to expand with the Placement of Aortic Transcatheter Valve (PARTNER II) and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trials demonstrating TAVR as a noninferior alternative to surgery, leading to U.S. approval in the intermediate-risk population.1,2 Given this data, along with continued safety and technological advancements of TAVR, two randomized controlled trials are now underway to determine the feasibility of TAVR in low-risk patients.

As we are exploring the expansion of TAVR technology in low-risk patients, there are still many unanswered questions regarding the use of TAVR valves in this patient population. We sought to explore some questions by sending a survey to a sample of 8,261 healthcare professionals using Internet-based software (SurveyMonkey, San Mateo, California).

In October 2017, an e-mail invitation and link to the electronic survey was sent explaining the purpose of the research and requesting a voluntary response. A follow-up e-mail reminder was sent 2 weeks later. We requested only implanting interventional cardiologists and surgeons complete the survey. The survey contained six questions regarding physician specialty, years of experience, TAVR age cutoff, optimal treatment for a low-risk-patient, TAVR valve sequence, and TAVR concerns.

The final completed response rate was 5.6% (463 of 8,261). Most (92%) of the respondents were interventional cardiologists and 56% of these interventional cardiologists had less than 5 years of experience (239). A total of 137 (30%) respondents had 5 to 10 years of experience; the remaining 14% had 10+ years of experience (mostly surgeons).

Of all the respondents, 29% felt that if TAVR is approved for low-risk patients, TAVR will be the first-choice therapy for all patients, regardless of age. The next prevalent opinion was that TAVR would be indicated for patients older than 70 and 75 years of age (26% and 22% of respondents, respectively). Interestingly, most surgeons felt that the age-cutoff for TAVR should be >80 years of age.

Of those that responded, 322 (70%) implanting interventional cardiologists and surgeons felt that the optimal treatment for low-risk patients, 65 to 75 years of age, with severe aortic stenosis would be TAVR, with a second TAVR valve (valve-in-valve) if the first valve degenerates. Of those surveyed, 110 physicians (24%) felt SAVR should be the first intervention followed by TAVR. The remaining 7% felt TAVR should be the first procedure, followed by SAVR and then TAVR again (Figure 1a). Amongst the surgeon-respondents alone the opinion was essentially split with a majority (53%) voting for TAVR followed by TAVR valve-in-valve and 45% voting for SAVR followed by TAVR valve-in-valve.

FIGURE 1a. Responders perspective on the optimal treatment for a low-risk patient with severe aortic stenosis in the current era.

b. Responders currently preferred transcatheter aortic valve replacement (TAVR) valve sequence in a low-risk patient with severe aortic stenosis.

Regarding the sequence of TAVR valves used in low-risk patients severe aortic stenosis, the vast majority of respondents (78%) felt that the Edwards Sapien 3 valve (ES-3; Edwards Lifesciences Ltd, Irvine, California) should be the first TAVR valve. Among the 78%, half felt that the ES-3 should also be the second TAVR valve if reintervention is indicated. The other half felt that the Medtronic Evolut valve (MEV; Medtronic Inc., Minneapolis, Minnesota) should be used as the second TAVR valve. It was a less common opinion that the MEV should be implanted first in this patient population (Figure 1b).

Lastly, we sought to determine the biggest, current caveats and concerns of TAVR once it is FDA approved in low-risk patients. Most respondents (56%) felt that SAVR might still be preferred in low-risk patients due to the questionable durability of TAVR valves. Others were concerned about the high incidence of paravalvular leak, cost inefficiency of the TAVR procedure, and the high rates of pacemaker implants post-TAVR (12%, 12%, and 9%, respectively). Some respondents reported that SAVR would be preferred due to vascular access issues, severe coronary artery disease, multiple valve disease, high-risk anatomical features (severe annular/annular calcification or low coronary ostia), bicuspid aortic valve, and to maintain a surgical skill set.

The top disagreement amongst implanters was the age-cutoff for TAVR. Age is an important risk factor, as even if patients meet criteria for low risk (usually defined STS < 3), but are older than 80 years in age, they may, in some institutions, be considered intermediate risk due to their age and subsequently offered TAVR. On the other hand, younger patients with a longer life expectancy are offered SAVR due to the unknown durability of TAVR valves. Providers must ask themselves if the benefit of TAVR over SAVR outweighs the unknowns of durability. The current randomized controlled trials will follow patients for 10 years, shedding light on whether TAVR is a feasible option for this patient population. However, there are likely to be newer technological advancements of TAVR therapies in this time frame, and the degree to which these new therapies are related to current research done on the MEV and ES-3 valves is unknown.

The top agreement among implanters was that the optimal treatment for a low-risk patient should be TAVR with an ES-3 valve, followed by TAVR valve-in-valve if needed. The ES-3 valve is preferred in our practice in patients with severe coronary artery disease, in which future coronary interventions are a possibility (access through the frame cells is easier). The MEV valve is preferred in patients with smaller, highly calcified annuli and moderate to severe peripheral artery disease to reduce the risk of annulus rupture and vascular complications. Along with patient-specific considerations, there are also center-specific considerations that dictate the valve given to a patient, including physician preference, training, and cost limitations.

The major limitation of this study is that a comprehensive list of implanting interventional cardiologists and surgeons email addresses was not available. Therefore, we emailed many healthcare professionals, and asked that only AVR experts reply.

In summary, there was a consensus among >400 responding structural heart disease experts that, in the future, the preferred first-line of therapy for low-risk patients with severe aortic stenosis will be TAVR with the ES-3 as the first TAVR implant, followed by a MEV valve-in-valve TAVR if necessary. There was agreement amongst the AVR specialists that the unknown long-term durability of TAVR valves is still a concern for low-risk patients.

References

1.Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609–1620. [Crossref] [Google Scholar]
2.Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 376; 14:1321–1331. [Google Scholar]
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