Early and Newer-Generation TAVR Devices Compared in Patients With Native Aortic Valve Regurgitation

March 5, 2018—Danny Dvir, MD, presented the results of a trial investigating transcatheter aortic valve replacement (TAVR) for the treatment of pure native aortic valve regurgitation (NAVR) at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.

According to CRT, the investigators saw significantly higher procedural success with newer-generation transcatheter heart valves (THV) compared with early generation THVs in the retrospective, international registry's high-risk (average Society of Thoracic Surgeons [STS] score of 6.5) population of 254 patients.

In the trial, the common approach for the procedures was general anesthesia (60%) and transfemoral access (76%). The main THV devices used were CoreValve (Medtronic; 41%), Evolut R/Pro (Medtronic; 15%), and JenaValve (JenaValve Technology GmbH; 13%).

As summarized by CRT, the investigators found that for early generation THVs versus new-generation THVs at 30-day follow-up, device success was 47% versus 82%; the early safety (composite of death, stroke, VARC-2 major bleed, vascular complication, acute kidney injury [AKI], coronary obstruction, or need for the second valve) was 72% versus 74%; and safety plus the valve stenosis by echo, moderate or severe aortic regurgitation of heart failure (New York Heart Association III/IV) was 56% versus 72%. Mortality was approximately 22%. STS score > 8 and AKI grade > 2 emerged as predictors of 1-year mortality, reported the investigators.

Dr. Dvir concluded, "Although significant improvement is seen with newer-generation THV devices, TAVR for NAVR is a challenge with limited procedural efficacy." Dr. Dvir added that he believes that earlier patient referral and novel THV devices for the treatment of NAVR may lead to improved clinical outcomes.