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ABSTRACT
Background: There is limited data about transcatheter aortic valve replacement (TAVR) from China, where there are significant differences in the patient population both clinically and anatomically. This study sought to assess the clinical profile and outcomes of TAVR using the Venus MedTech A-valve in China.
Methods: From 2012 to 2015, 101 patients with Society of Thoracic Surgeon (STS) scores ≥4% or at prohibitive surgical risk were enrolled from four academic cardiovascular centers in China. Among 97 patients with native aortic stenosis (AS), there were 44 (45.4%) bicuspid aortic valve (BAV) and 53 (54.6%) tricuspid aortic valve (TAV) replacements.
Results: Patients were 75.4 ± 6.4 years old, and the median STS score was 5.5% (inter-quartile range, IQR, 3.8%–9.2%). The device success rate was 84.2% (85/101) and the 2-year cumulative survival rates was 90.1% overall. There was no significant difference between the BAV and TAV arms for device success (79.5% vs. 86.8%; p = 0.06), annulus rupture (0%), and other procedural complications. Periprocedural paravalvular regurgitation ≥ moderate (11.4% in BAV vs. 6.0% in TAV, p = 0.56), 30-day mean gradients (10.0 [IQR, 7.0–13.0] mmHg in BAV vs. 10.0 [IQR, 6.0–14.0] mmHg in TAV; p = 0.85), and 30-day mortality (6.8% vs. 3.8%; p = 0.50) were also similar in both groups. Significant cardiac function improvements were observed in both groups at 30-day and 180-day follow-up. At 2 years, the cumulative survival rates (90.9% in BAV vs. 88.6% in TAV, p = 0.72) showed no significant differences between the two groups.
Conclusions: The AS population in China presenting for TAVR has a high prevalence of BAV. The treatments with a Chinese TAVR device are favorable and similar to those in TAV.
Disclosure statements
Dr. Sievert has received fees for consulting and travel and honoraria from Abbott, Access Closure, AGA, Angiomed, Aptus, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, Carag, Cardiac Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex, Contego, Covidien, CSI, CVRx, EndoCross, ev3, FlowCardia, Gardia, Gore, Guided Delivery Systems, Hemoteq, InSeal Medical, Lumen Biomedical, HLT, Lifetech, Lutonix, Maya Medical, Medtronic, NDC, Occlutech, Osprey, Ostial, PendraCare, pfm Medical, Recor, ResMed, RoxMedical, SentreHeart, Spectranetics, SquareOne, Svelte Medical Systems, Trireme, Trivascular, Vascular Dynamics, Venus Medical, Veryan, and Vessix; owns stock options in Cardiokinetix, Access Closure, Velocimed, Lumen Biomedical, Coherex, and SMT; and has received grants from Cook and St. Jude Medical.
Dr. Jilaihawi is a consultant to Edwards Lifesciences and Venus Medtech and receives an institutional research grant from Medtronic and Abbott Vascular. All other authors have nothing to declare.