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Sapien 3 Evolves Into Novel Mitral Valve Device

Sapien 3 Evolves Into Novel Mitral Valve Device

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WASHINGTON — A slight tweak to the Sapien 3 turned it into a device usable for transcatheter mitral valve replacement (TMVR), a first-in-human experience showed.

By adding a new sealing skirt, Edwards Lifesciences turned the Sapien 3 into the Sapien M3, a novel transcatheter device that corrects severe mitral regurgitation.

The first ten cases were followed by one stroke but no deaths in 30 days. Eight out of the 10 patients were left with no or trace mitral regurgitation, while one had mild regurgitation and one was left with severe regurgitation, John Webb, MD, of St. Paul’s Hospital in Vancouver, told the audience here at the Cardiovascular Research Technologies meeting.

“This early experience is encouraging,” said Webb, noting that patients remained hemodynamically stable throughout the transeptal procedure and that no left ventricular outflow tract obstruction was observed.

“Early data suggests that use of the Sapien M3 system is feasible for treating patients with severe mitral regurgitation who are at high risk for mitral valve surgery and warrants further investigation,” he concluded.

Webb pointed out a modest learning curve associated with the Sapien M3, as the first two cases took 4 and 7.3 hours, respectively, while the tenth took just 1.3 hours.

Indeed, the methods of Sapien M3 use would already be familiar to many proceduralists, according to Paul Sorajja, MD, of Minneapolis Heart Institute and Abbott Northwestern Hospital. He called it “groundbreaking.”

“If effectiveness and safety are confirmed in larger studies, there is enormous potential for broad adoption,” suggested Sorajja, who was not involved with testing the device.

The first ten Sapien M3 cases involved patients averaging 74.1 years of age, among whom four were men. All had New York Heart Association class III or IV heart failure. Their mean Society of Thoracic Surgeons score for mitral valve replacement was 4.9%.

For the procedure, an anchoring dock corrals the native mitral leaflets to anchor and seal the Sapien M3 in place. So far there has been no conversion to surgery, device embolization, device migration, or implantation of more than one valve; all cases were marked by successful access, delivery, and deployment.

However, one patient did need reintervention due to chordal rupture during dock deployment resulting in severe paravalvular leak, which was closed with plugs during the procedure.

Paravalvular leak will remain a concern with this strategy, Scott Lim, MD, of University of Virginia Health System in Charlottesville, told MedPage Today.

Nonetheless, he said, “in a small number of patients, this study showed excellent safety results with the M3 TMVR device in a field in which higher complication rates have been seen with other devices.”

Webb reported relationships with Edwards Lifesciences, Abbott Vascular, and Essential Medical.

Lim disclosed researching for clinical trials on other TMVR devices, but having no direct financial conflict of interest.


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