PARIS — The early commercial experience with transcatheter aortic valve replacement (TAVR or TAVI) for severe aortic regurgitation appeared promising, though device size issues and conduction disturbance risk leave room for improvement.
Performing TAVR with the Jenavalve Trilogy on 45 consecutive patients with severe aortic regurgitation, operators at German six centers achieved 100% technical success, defined as mean gradients <20 mmHg and reduction of regurgitation grade by at least 1 category. Patients were left with none or trace paravalvular regurgitation at discharge in 91% of cases, reported Alexander Tamm, MD, of Johannes Gutenberg-Universität in Mainz, Germany.
None converted to open surgery during the procedure, nor did any experience death, myocardial infarction, cardiothoracic surgery, and stroke by discharge, he said in a presentation at the EuroPCR meeting.
“This first, real-world data confirm that transfemoral TAVI treatment of aortic regurgitation using the Jenavalve Trilogy System is safe and effective,” he concluded.
The downside was the 23% rate of new pacemakers after TAVR.
This may be attributed to aortic regurgitation patients being more susceptible to conduction disturbances than the aortic stenosis cohort. With the lack of calcification in pure aortic regurgitation, the patient’s very soft tissue can result in the bioprosthesis traveling deeper into the annulus, Tamm explained.
In a separate aortic stenosis cohort, the Jenavalve is currently associated with a zero pacemaker rate that will likely stay in the single digits, he said.
The Jenvalve received Europe’s CE mark last year for treatment of both aortic regurgitation and aortic stenosis. “AR [aortic regurgitation] patients ineligible or at high risk for SAVR [surgical aortic valve replacement] were previously without treatment options. These results give confidence to TAVI as a life-saving procedure for AR patients,” Tamm concluded.
Stateside, Jenavalve Trilogy is not yet on the market. It has received FDA breakthrough therapy status and the agency’s blessing for a premarket approval trial (ALIGN-AR).
Implanted via a transfemoral access, the Jenavalve features locators that align the device with the patient’s cusps for proper alignment. These locators clip onto native leaflets of people with pure aortic regurgitation and non-calcified valves that preclude the use of other established TAVR devices.
“Thanks for keeping this technology alive…It’s got some cool features to it,” commented EuroPCR session panelist Ganesh Manoharan, MD, of Royal Victoria Hospital in Belfast, Northern Ireland.
The patients in the report averaged age 77, and 40% were women. Mean EuroSCORE II was 7.1%, and 71% of people were had New York Heart Association class III-IV symptoms.
Operators favored conscious sedation in most cases and used postdilatation in 4.4%. The average procedure lasted 77 minutes.
Tamm reported that patients left TAVR with a mean aortic valve gradient of 4.04 mmHg and aortic valve area of 2.62 cm2 at discharge.
There were no major bleeds associated with TAVR, though there was a 2.2% incidence of major vascular complications.
Jenavalve comes at a maximum size of 27 mm. One EuroPCR attendee said this may not be big enough for aortic regurgitation and suggested going two to three sizes larger.
Tamm said that the 27 mm prosthesis can treat an annulus of up to 29 mm, but acknowledged that even that may be insufficient for some patients.
“Future studies are needed to further prove safety and efficacy in larger cohorts and expanded patient populations,” he noted, and acknowledged that the Jenavalve has not been studied in people with bicuspid anatomy and aortopathy, for instance.
The study was supported by JenaValve Technology.
Tamm disclosed receiving personal fees from Edwards Lifesciences, JenaValve, and Medtronic.