ACC Mitral Regurgitation Decision Pathway Updated to Reflect New Evidence

Debra L. Beck

February 20, 2020

A 2020 Focused Update of the 2017 Expert Consensus Decision Pathway on the Management of Mitral Regurgitation has been released to reflect new evidence in the field.

The update, which is more of a "decision tree" than a clinical guideline, according to writing committee chair Robert O. Bonow, MD, Northwestern University, Chicago, Illinois, guides clinicians through the process of considering transcatheter mitral valve repair (TMVR) in select patients with secondary mitral regurgitation (MR), among other things.

The document was published online February 14 in the Journal of the American College of Cardiology.

The American College of Cardiology (ACC)-led effort was not an attempt to rewrite or reinterpret the 2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease or its 2017 Focused Update, but rather is designed to update recommendations put forth in 2017 that have since been influenced by interim developments.

New guidance was needed that considers recent clinical trial data on secondary MR, primarily the findings of the MITRA-FR and COAPT trials.

COAPT, presented in September 2018, 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 was presented the month before COAPT and also enrolled patients with HF and secondary MR, but failed to show benefit from MitraClip.

"It's a game changer in that there's now a device approved by the [Food and Drug Administration (FDA)] for use in certain patients with secondary MR, but [we want to make clear] that TMVR is not for everybody with secondary MR and there are certain clinical characteristics that are very important to consider," Bonow said.

Most important, said Bonow, is that before TMVR be considered, patients should first be treated aggressively with guideline-directed medical therapies, supervised by a cardiologist with expertise in heart failure.

"Medical therapy for heart failure makes people feel better, it makes your ventricles better and it prolongs life. Along the way it might make your mitral presentation better too because you have reverse remodeled the ventricle, but the indication for the device is only in patients who have been optimally treated," said Bonow in an interview with theheart.org | Medscape Cardiology.

Most of the changes to the old guidance statement revolve around enhanced recommendations for treatment of secondary MR.

"In the previous document there was kind of a dead end when it came to secondary MR, there was no statement at all, and now that dead end has been filled in," said Bonow.

The document includes a clinical algorithm for the referral of patients with chronic MR based on transesophageal echocardiography findings and severity of MR.

"The audience for this document is wider than the operators and heart team and includes clinicians who might be referring patients for procedures, so general cardiologists, imaging cardiologists, and heart failure specialists, but also internists," added Bonow.

The ducks appear to be lining up in a row for Abbott, MitraClip's manufacturer, who announced in November 2019 that they are ramping up production of the MitraClip device.

Data presented at Transcatheter Cardiovascular Therapeutics (TCT) conference last fall suggest that TMVR with MitraClip in the COAPT trial was cost-effective, if not cost saving. Use of the device cost almost $50,000 up front but saves nearly $12,000 on the back end in terms of follow-up costs, compared with guideline-directed medical therapy alone.

The MitraClip — first approved for use in patients with primary MR in 2013 — remains the only TMVR device approved in the United States for clinical use.

In March 2019, the FDA expanded MitraClip's indication to include selected patients with significant symptomatic functional or secondary MR.

In response to this, the Centers for Medicare & Medicaid Services (CMS) opened a coverage review for TMVR in August 2019 to include these patients. Currently, reimbursement is only available when the device is used in patients with primary MR.

The original proposed decision memo due date was February 14, but on February 18 CMS issued a notice that they will not be issuing a proposed national coverage determination on TMVR immediately, but that a decision is forthcoming. A national coverage decision is expected by May.

This decision pathway follows close on an expert consensus statement published in December 2019 proposing volume standards, as well as operator and institutional requirements for all institutions providing treatment of mitral valve disease via transcatheter techniques.

In keeping with the ACC's policy on relationships with industry, the writing chair (Bonow) and a majority of the writing committee have no relevant relationships with industry.

J Am Coll Cardiol. Published online February 14, 2020. Abstract

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