New Volume and Operator Standards for Mitral Valve Intervention

Debra L. Beck

December 24, 2019

As the use of edge-to-edge repair of mitral regurgitation (MR) ramps up, an expert consensus statement proposes volume standards, as well as operator and institutional requirements for all institutions providing treatment of mitral valve (MV) disease via transcatheter techniques.

"These recommendations attempt to balance the need to support optimal quality outcomes with the goal of facilitating access to such innovative therapies — an important paradigm for the development and implementation of future, less invasive approaches to structural heart disease," the writing committee states.

Adherence to these recommendations, they say, will "maximize the chances that these therapies will be successfully incorporated into management pathways for patients with MV disease in the United States."

The recommendations, published online December 16 in the Journal of the American College of Cardiology, are a joint effort of the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS).

These recommendations update a 2014 expert consensus document on transcatheter mitral valve intervention for mitral regurgitation (MR). This new consensus statement considers new clinical trial and registry data, including STS/ACC Transcatheter Valve Therapy (TVT) registry data on operator experience and procedural outcomes, and the findings of the MITRA-FR and COAPT trials.

COAPT demonstrated a marked clinical benefit from edge-to-edge clip repair plus medical therapy vs medical therapy alone in patients with heart failure and secondary MR. MITRA-FR, which also enrolled patients with HF and secondary MR, did not show benefit.

"This effort was driven by the results of recent clinical trials in secondary or functional MR which were ongoing when the 2014 recommendations were written. At that time, there was no FDA approval or CMS reimbursement for transcatheter mitral valve procedures, pending the results of these trials,” said writing committee chair Robert O. Bonow, MD, Northwestern University, Chicago, Illinois.

The MitraClip — first approved for use in patients with primary MR in 2013 — remains the only transcatheter MV repair device in the U.S. approved for clinical use.

In March, the Food and Drug Administration expanded MitraClip's indication to include selected patients with significant symptomatic functional or secondary MR, and in August the Centers for Medicare & Medicaid Services (CMS) opened a coverage review for transcatheter mitral valve repair (TMVR) to include these patients. Currently, reimbursement is only available when the device is used in patients with primary MR. A national coverage decision is expected by May.

The Right Team, the Right Outcomes

The statement writers focused on the overarching goal of ensuring optimal patient outcomes across all transcatheter MV sites, they note. To this end they emphasized the need for a multidisciplinary team (MDT) approach that includes individuals with expertise in valvular heart disease, heart failure, electrophysiology, cardiac imaging, interventional cardiology, cardiac valve surgery, and cardiac anesthesia.

"The heart team becomes especially important," said Bonow, "because, unlike with transcatheter aortic valve intervention or primary MR, where we're dealing with a valve problem, with secondary MR we are essentially dealing with a heart failure population.

"To even be a candidate for mitral valve repair, the patient should be on optimized medical therapy for starters, which is why we emphasize that a heart failure specialist is an important part of the interventional team, both to ensure this optimal therapy and to identify appropriate candidates for transcatheter repair."

The authors also recommended that new and established transcatheter MV sites ensure they have systems in place that promote patient- and family-centered care with informed decision-making. "This recommendation goes beyond patient education and traditional use of informed consent…[and] specifically includes an individualized approach utilizing patient-specific, data-driven risk assessment; clear explanation of treatment options; explanation of the rationale for MDT's recommendations; and the incorporation of patients goals, preferences, and values into treatment decisions," they write.

Site and Operator Volumes

The authors acknowledge that standards for MV surgical programs are intimately related to the outcomes achieved with transcatheter interventions, and hence "the infrastructure and case volumes required to support an active MV surgical program constitute reasonable metrics by which to assess a site's capability to provide the anticipated spectrum of transcatheter interventions."

To that end, they suggest the following volume minimums for transcatheter MV repair with MitraClip for primary or secondary MR for a new TMVR program:

  • The interventionalist (cardiologist or surgeon) should have board and device-specific certifications, and document 50 lifetime structural heart procedures, and prior transcatheter MV repair experience (including while proctored) with participation in 20 trans-septal interventions, including 10 as primary or coprimary operator.

  • The interventional echocardiographer should document participation in 10 trans-septal guidance procedures and 30 structural heart procedures (lifetime).

  • The site should have a minimum total MV surgical volume of at least 40 cases/year or 80 cases over 2 years (of which at least 50% are repairs) and have on staff a surgeon who has performed 20 MV surgeries in the previous year or 40 MV surgeries over the previous 2 years, of which at least 50% should be repairs.

The authors also provide minimum case volumes for established transcatheter MV programs, namely maintaining a 20-case per year volume or 40 cases over 2 years for both transcatheter and surgical interventions.

In an interview with theheart.org | Medscape Cardiology, Bonow discussed the challenge of setting volume requirements. "We're trying to balance the better outcomes associated with being a higher volume operator and center vs making sure this procedure is accessible to patients without making them travel long distances. We think we came up with the appropriate sweet spot to balance these competing forces."

Reflective of the multisociety effort, the statement was copublished in the Journal of Thoracic and Cardiovascular Surgery, the Annals of Thoracic Surgery, and Catheterization and Cardiovascular Interventions. It was reprinted in the Journal of Cardiac Failure and received an endorsement by the Heart Failure Society of America.

The partnering societies used the ACC's policy on relationships with industry as guidance, which included requirements that the writing chair and a majority of the writing committee have no relevant relationships with industry. Authors with industry relationships were required to disclose all current healthcare-related relationships, including those existing 12 months before initiation of the project.

The work of the writing committee was supported exclusively by the partnering societies without commercial support.

J Amer Coll Cardiol. Published online December 16, 2019. Consensus Systems of Care Document

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