August 24, 2017
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Transcatheter mitral valve repair system feasible in severe mitral regurgitation

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A novel transcatheter mitral valve repair system was found to reduce mitral regurgitation severity, according to results published in The Lancet.

A first-in-man compassionate use study of the transcatheter mitral valve repair system (Pascal, Edwards Lifesciences) established feasibility of the system with a high rate of technical success at end of procedure and at 30 days, researchers reported.

“Because of the increased risk of surgery ... about 50% of patients who present with severe symptomatic mitral regurgitation are unsuitable for open-heart surgery. Moreover, in-hospital mortality after mitral valve surgery in octogenarians has been reported to be as high as 6% after mitral valve repair and 13% after mitral valve replacement,” Fabien Praz, MD, from the department of cardiology at University Hospital Bern in Switzerland, and colleagues wrote. “Accordingly, less invasive procedures that are more suitable for elderly patients with associated comorbidities address an unmet clinical need.”

Praz and colleagues conducted a multicenter, prospective, observational, first-in-man study, between September 2016 and March 2017, in which they collected data on 23 patients presenting with symptomatic, severe functional, degenerative or mixed mitral regurgitation deemed at high risk or inoperable, who underwent transcatheter mitral valve repair.

The primary endpoints were technical success assessed after the procedure and device success at 30 days. The researchers assessed these endpoints using the Mitral Valve Academic Research Consortium definitions.

At baseline, the researchers found that the median EuroScore II was 7.1% (interquartile range [IQR], 3.6-12.8) and median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair and mitral valve replacement were 4.8% (IQR, 2.1-9) and 6.8% (IQR, 2.9-10.1), respectively.

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At baseline, 22 of the 23 patients were defined as NYHA class III or IV, according to the study.

All patients had a successful implantation of at least one device and 26% had two implants.

In 9% of patients, researchers observed periprocedural complications, including one minor bleeding event and one transient ischemic attack.

Technical success was achieved in 96% of patients and device success was achieved in 78% of patients at 30 days.

Thirteen percent of patients died of CV causes within 30-day follow-up, and of the 20 patients alive at the follow-up, 95% were classified as NYHA class I or II, according to the researchers.

“The [transcatheter mitral valve repair] system might increase the number of candidates eligible for minimally invasive mitral valve repair,” they wrote. “Assessment of long-term durability, particularly in the context of secondary mitral regurgitation with progressive annular dilation, will require careful investigation.”

The system is not yet approved by the FDA for use in the United States.

Disclosures: Praz reports receiving personal fees from Edwards Lifesciences. Please see the study for all other authors’ relevant financial disclosures.