2017 Buyer’s Guide

This buyer’s guide offers a searchable, comprehensive listing of the FDA-approved interventional devices available in the United States.

Analysis of Swiss Registry Compares Medtronic's Evolut R With Earlier-Generation CoreValve TAVR Prosthesis

 

April 17, 2017—Findings from an analysis of the Swiss TAVI Registry were published by Stephane Noble, MD, et al in the online e-edition of EuroIntervention (2017;12:e2170–e2176). The registry is comparing procedural and clinical outcomes with the new-generation self-expanding Evolut R transcatheter aortic valve replacement (TAVR) prosthesis (Medtronic) versus its predecessor, the CoreValve TAVR system (Medtronic).

In this assessment of the safety and efficacy of the Evolut R device compared with the CoreValve device, the investigators concluded that the 30-day clinical outcomes were favorable and comparable between the Evolut R and the CoreValve bioprostheses.

As summarized in EuroIntervention, this nationwide, prospective, multicenter cohort study investigated outcomes of consecutive transfemoral TAVR patients treated with the Evolut R device from September 2014 to February 2016 and the CoreValve device from February 2011 to February 2016. Events were reported according to the Valve Academic Research Consortium's VARC-2 initiative and adjudicated by a clinical events committee.

During the study period, 317 and 678 consecutive patients underwent TAVR with the Evolut R and CoreValve bioprostheses, respectively. Baseline clinical characteristics between the groups were comparable, although Evolut R patients were lower risk according to the Society of Thoracic Surgeons score (4.8% ± 3.4% vs 6.9% ± 5.0%; P < .001) and logistic EuroSCORE (17.3% ± 13% vs 20.1% ± 13%; P = .009).

Implantation of the Evolut R device was associated with less frequent use of predilatation (48.1% vs 72.4%; P < .001), a shorter procedure time (67.9 ± 36 min vs 76.7 ± 42 min; P = .002), and less contrast dye use during the procedure (155.2 ± 98 mL vs 208 ± 117 mL; P < .001). The postprocedural mean gradient was comparable (7.4 ± 4.7 mm Hg vs 7.5 ± 5.0 mm Hg), as were the 30-day rates of moderate to severe aortic regurgitation (8.5% vs 10.5%), major vascular (9.8% vs 10.3%) and life-threatening bleeding complications (5.4% vs 5.3%), disabling stroke (1.9% vs 1.6%), all-cause mortality (3.2% vs 3.4%), as well as permanent pacemaker implantation (22.1% vs 23.4%), reported the investigators in EuroIntervention.

 

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About Cardiac Interventions Today

Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.