First US Patient Implanted with Novel TAVR Valve

The first U.S. procedure was performed by a team led by Dean J. Kereiakes, MD, FACC, FSCAI, at The Christ Hospital in Cincinnati. Cardiology Today’s Intervention previously reported on the world’s first procedure with the device, performed in Canada.

JC Medical announced that the first U.S. patient was successfully treated with its novel transfemoral transcatheter aortic valve replacement system.

The device (J-Valve TF system) is designed for patients who require TAVR due to aortic regurgitation, according to a press release from the company.

The first U.S. procedure was performed by a team led by Dean J. Kereiakes, MD, FACC, FSCAI, at The Christ Hospital in Cincinnati. Cardiology Today’s Intervention previously reported on the world’s first procedure with the device, performed in Canada.

“The existing TAVR valves were designed specifically to address aortic stenosis,” Kereiakes said in an interview. “Aortic stenosis is directly related to the density of calcification. The ability of a replacement valve to lock into a heavily calcified annulus and leaflets is different than to lock into a native valve that has little or no calcification. It’s a different substrate. When you use the existing replacement valves for aortic insufficiency, the results appear to be suboptimal. This has been confirmed in the TVT and VIVID registries. There is a greater risk for device migration, device displacement, need to put in another device and residual paravalvular regurgitation. Part of this is because of insufficient anchoring and sealing.”

According to the release, approximately 20 percent of surgical AVRs are due to aortic regurgitation, but there are no TAVR systems approved for that indication in the U.S.

Unique properties The product features an anchor mechanism linked to a self-expanding stent frame to attach to the failing native valve, which does not need to be calcified for fixation to take place, the company stated in the release.

“This valve has unique properties, one of which is anchor rings which land in the coronary sinuses,” Kereiakes told Cardiology Today’s Intervention. “Even though the annulus is difficult to see because it is not heavily calcified, you can see the anchor rings touch it, and then the device aligns itself by having the anchor rings steer it into the coronary sinuses. This allows you to orient the valve better and lock it into the sinuses, even in a native valve that is not calcified. These self-aligning and localizing characteristics are truly remarkable.”

In addition, he said, the device is designed so that the sinuses are not closed off when it is implanted, “which allows better flow characteristics and a lower likelihood of thrombus formation. This is theoretical but attractive.”

He said the first patient treated with the valve “did great and went home the next day.” Because the patient had tortuous aortic anatomy, the procedure was formed via subclavian access, but most of the time, transfemoral access will be feasible, he noted. “We didn’t think that transfemoral access was going to give us the optimal angle on the aorta to find the aortic annulus,” he said, noting the device’s flexion capabilities were helpful in aligning the replacement valve with the annulus.

Future study A U.S. clinical trial of the device, which is not yet approved for use in the U.S., is scheduled to launch in 2019, according to the release.

“A promising application for the device may be valve-in-valve procedures,” Kereiakes said.

“Inadvertent coronary obstruction is a common problem with valve-in-valve cases, and people go to great lengths to avoid it,” he said. “The J-Valve’s anchor rings become claspers and grasp the unstented valve leaflet material and lock down the prior bioprosthetic valve leaflet.”

– by Erik Swain

For more information: Dean J. Kereiakes, MD, FACC, FSCAI, can be reached at Disclosure: Kereiakes reports he received personal fees for consulting from Abbott Vascular, Boston Scientific, Caliber Therapeutics/Orchestra BioMed, Micell Technologies, Sino Medical Sciences Technologies and Svelte Medical Systems, and he is a major stock shareholder of Ablative Solutions. He has no financial ties to JC Medical.

About The Christ Hospital Health Network The Christ Hospital Health Network is an acute care hospital located in Mt. Auburn with six ambulatory centers and dozens of offices conveniently located throughout the region. More than 1,200 talented physicians and 6,100 dedicated employees support the Network. Its mission is to improve the health of the community and to create patient value by providing exceptional outcomes, the finest experiences, all in an affordable way. The Network has been recognized by Forbes Magazine as the 24th best large employer in the nation in the magazine’s “America’s 500 Best Large Employers” listing and by National Consumer Research as the region’s “Most Preferred Hospital” for more than 22 consecutive years. The Network is dedicated to transforming care by delivering integrated, personalized healthcare through its comprehensive, multi-specialty physician network. The Christ Hospital is among only six percent of hospitals in the nation to be awarded “Magnet” recognition for nursing excellence and among the top five percent of hospitals in the country for patient satisfaction. For more than 125 years, The Christ Hospital has provided compassionate care to those it serves.