CoreValve Evolut R Device Performance

Study Questions:

What are the clinical outcomes associated with the CoreValve Evolut device?

Methods:

The FORWARD (CoreValve Evolut R FORWARD) study investigators reported data from a single-arm, multinational, multicenter registry of the next-generation self-expanding CoreValve device. All clinical endpoints and echocardiograms were evaluated by a core laboratory. The registry reported on 1,038 patients in whom transcatheter aortic valve replacement (TAVR) with the CoreValve Evolut device was attempted, from January 2016 to December 2016, for symptomatic, severe aortic stenosis (AS) at 53 centers on four continents.

Results:

The average age of the cohort was 82 years and the majority (65%) were women. The predicted Society of Thoracic Surgeons (STS) mortality risk was 5.5%. Local anesthesia was used in 65% and the valve was implanted via the transfemoral route in 98%. A single valve was implanted in the proper anatomic location in 98.9% of patients. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The mean aortic valve gradient at discharge was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was noted in only 1.9% of the patients.

Conclusions:

TAVR using the next-generation transcatheter heart valve is clinically safe and effective for treating older patients with severe AS.

Perspective:

This study adds to the growing evidence supporting the safety and efficacy of TAVR in intermediate-risk patients. The exceptional clinical outcome observed in this study is a testament to the maturation of TAVR technology and supports the rapid increase in use of TAVR for patients at intermediate surgical risk.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: Aortic Valve, Aortic Valve Insufficiency, Cardiac Surgical Procedures, Echocardiography, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Outcome Assessment (Health Care), Stroke, Transcatheter Aortic Valve Replacement


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