Paris (FRONTLINE MEDICAL NEWS) – Transcatheter aortic valve replacement using the self-expanding Evolut R device in high-surgical-risk patients with failing surgical aortic bioprostheses showed promising 30-day safety and effectiveness results in the ongoing VIVA study, Ran Kornowski, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“We had a lot of patients with small, failing valves in this study. Despite this, our valve gradients postprocedure were very, very low. This means to me that this platform is very well suited to deal with valve-in-valve procedures in general and with small bioprosthetic valves in particular,” observed Dr. Kornowski , chairman of the department of cardiology at Rabin Medical Center in Petah Tikva, Israel, and president of the Israel Heart Society.
The ongoing VIVA (Valve In Valve) study is a formal prospective observational study of the less invasive valve-in-valve transcatheter procedure as an emerging alternative in the growing number of patients whose surgical bioprosthetic aortic valves are degenerating over time but who are not reasonable candidates for redo open surgery. VIVA is a 23-site, four-nation study of 202 such patients at high surgical risk as evidenced by a Society of Thoracic Surgeons predicted risk of mortality score of at least 10% or a logistic EuroSCORE greater than 20%. Of them, 183 underwent transcatheter aortic valve replacement (TAVR) with the FDA-approved repositionable Evolut R valve and, early on, 19 others received the device’s predecessor, the CoreValve.
The participants’ last surgical aortic valve replacement had been a mean of 9.3 years earlier. Seventy-one percent of subjects were New York Heart Association class III or IV. The mode of bioprosthetic failure was stenosis in 56% of cases, regurgitation in 23%, and both in the remainder. Ninety-three percent of their failing biosprothetic valves were stented devices. Forty-one percent of the devices were up to 21 mm and another 33% were more than 21 but less than 25 mm.
TAVR procedural access was by the iliofemoral route in 97% of cases. Local anesthesia was used in 42% of cases and conscious sedation in 35%. Fourteen percent of patients underwent preimplantation valvuloplasty; 21% postimplantation valvuloplasty. The procedural success rate was 98.5%.
The primary safety endpoint was 30-day cardiovascular mortality. The 2.0% rate was far lower than the prespecified cutoff which defined a positive outcome as less than a 10% rate in this high-surgical-risk population.
Other key 30-day outcomes:
• All-cause mortality occurred in 2.5% of patients.
• The 30-day stroke rate was 3%, with no disabling strokes.
• Major vascular complications occurred in 6.5% of the VIVA patients.
• Major bleeding occurred in 7%, minor bleeding in 7.9%. There were no cases of life-threatening bleeding.
• The incidence of Stage I acute kidney injury was rare, at 0.5%.
• Seven percent of patients received a permanent pacemaker.
• Eighty-seven percent of patients had no postprocedure paravalvular regurgitation (PVR), 11.4 had mild PVR, and 1.5% had moderate PVR.
• NYHA classification improved from baseline to 30 days in 81% of patients. At 30 days, 93% of participants were NYHA class I or II.
Turning to echocardiographic findings, the mean gradient improved from a mean baseline of 31.8 mm Hg to 12.6 mm Hg, while the effective orifice area rose from 1.0 to 1.5 cm2. The magnitude of both improvements was greater for patients with stenosis as their mode of valve failure.
“With the Evolut R, we aim for higher implantations – not more than about 4 mm below the ring – because going deeper could bring about higher gradients and functional deterioration later on,” the cardiologist explained.
The 1-year primary efficacy endpoint – lack of significant aortic stenosis as defined by a mean gradient less than 40 mm Hg – will be reported soon. The VIVA study is sponsored by Medtronic. Dr. Kornowski reported serving as a consultant to the company.