Planned MitraClip Implantation Safe, Feasible After TAVR, Small Series Suggests

PARIS, France—Percutaneous treatment of severe aortic stenosis and mitral regurgitation is feasible and safe, with encouraging midterm results and improvement of functional class, according to new data.

While as many as two-thirds of patients with aortic stenosis report some form of mitral regurgitation, treating severe concomitant disease has been controversial. Studies have linked severe mitral regurgitation with a more than doubled mortality risk within 30 days and 1 year after TAVR. Also, reports of mitral regurgitation developing after TAVR have led to questions about the unwanted effects of treating the aortic stenosis in the first place.

To assess outcomes associated with both treatments in the same patient, Martina Patanè, MD (Ferrarotto Hospital, Catania, Italy), and colleagues looked at 11 patients who underwent both transfemoral TAVR and MitraClip (Abbott Vascular) implantation at their institution between June 2007 and April 2016. At baseline, nine presented with severe mitral regurgitation and all but two were in NYHA Class III or IV. The average STS score was 6.17% and the average age was 77 years.

In her presentation at EuroPCR 2016, Patanè emphasized that no patient received both devices within the same session (median 63-day interim period) and all procedures were staged, although two underwent bivalvular transcatheter therapy within the same hospitalization. Additionally, TAVR always preceded MitraClip implantation.

Post-TAVR, mitral regurgitation improved for four patients and worsened in two, although all were classified as massive or severe. Disease etiology was functional in seven, degenerative in three, and dynamic in one, but MitraClip was only indicated after a wait-and-see phase in five and as bailout in three. Ultimately, mitral regurgitation was reduced in all patients, with two patients left with moderate regurgitation.

One patient died of GI bleeding in the hospital after MitraClip implantation. Over a mean follow-up of 326 days, two patients died of noncardiovascular causes and one was hospitalized for stroke. However, all but one surviving patient were reclassified as NYHA Class II or lower.

The results prove that significant mitral regurgitation is frequent among TAVR patients, Patanè said, and “can be pre-existent before TAVI or can appear afterwards as a mechanical impairment of the [transcatheter heart valve] with the mitral valve apparatus or as an anomalous cardiac pathophysiological response.”

Always A Plan

In a discussion following the presentation, panel moderator Ganesh Manoharan, MBBCh, MD (Royal Victoria Hospital, Belfast, Northern Ireland), praised the researchers for conducting a study in a “very, very challenging area. Even with the data they presented, [it is hard] to really know what to do with these kinds of patients,” he said.  

Remarking on the fact that the delay from TAVR to MitraClip procedure ranged from 14 days through 3 years, panelist Mao-Shin Lin, MD (National Taiwan University Hospital, Taipei), asked how the heart team came to a consensus.

Patanè explained that there was always a plan for MitraClip before TAVR was even performed. For patients with degenerative mitral regurgitation, for whom the heart team expected no change after TAVR, MitraClip was scheduled for between 1 and 3 months later. “We waited longer in patients with functional mitral regurgitation either because we saw amelioration of mitral regurgitation or just on clinical appearance,” she said. 

An audience member asked for clarification as to why the team did not perform simultaneous TAVR and MitraClip implantation at least in patients with degenerative mitral regurgitation when it was clear the patient would not improve after TAVR.

It came down to organization mostly, Patanè answered. Also, because mitral regurgitation is a chronic disease, they want to wait to see if the patient truly needs the second device. “We really want to be sure that that procedure is helpful for the patient for clinical improvement,” she said.

Source:

•  Patanè M. Combined percutaneous treatment of aortic stenosis and mitral regurgitation. Presented at: EuroPCR 2016. May 18, 2016. Paris, France.

Disclosures:

•  Patanè reports no relevant conflicts of interest.

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