Early Results of a Resheathable Transcatheter Aortic Valve System

Study Questions:

What are the immediate and 30-day results with the CoreValve Evolut R re-sheathable transcatheter aortic valve replacement (TAVR) system?

Methods:

In a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis, 60 patients underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per VARC-2 (Valve Academic Research Consortium-2) criteria, and the percentage of patients with greater than mild aortic regurgitation 24 hours to 7 days after the procedure.

Results:

Patients (66.7% women; mean age 83 ± 6 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29 mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation after TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients.

Conclusions:

The authors concluded that the repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic patients with aortic stenosis. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation, and low rates of permanent pacemaker implantation.

Perspective:

Vascular access, paraprosthetic aortic regurgitation, stroke, pacemaker requirement, and procedural complications are limits to the use of TAVR among symptomatic patients with severe aortic stenosis. With two TAVR devices currently approved by the Food and Drug Administration (FDA) for clinical use in the United States, a variety of devices are either approved in other countries or under active development or investigation. The CoreValve Evolut R system (Medtronic, Inc.) is deployed using a built-in sheath with an equivalent outer diameter of a 14-F sheath, and the device can be resheathed and repositioned during deployment. Along with other devices in use or under development, it helps address some of the limitations of earlier devices, and might help improve the feasibility and safety of TAVR.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and CHD & Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD & Pediatrics and Interventions, CHD & Pediatrics and Quality Improvement, Interventions and Structural Heart Disease

Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Defects, Congenital, Heart Valve Diseases, Pacemaker, Artificial, Risk, Stroke, Transcatheter Aortic Valve Replacement


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