Author + information
- S1936879815022372-1e0d37916cae4910c603d7a943cae610Jochen Wöhrle,
- S1936879815022372-3402c29673f7dbbd7cef5356396f84c2Birgid Gonska,
- S1936879815022372-c2ca4968c8501d71dc286e3667718ea4Christoph Rodewald,
- S1936879815022372-bedbc414fc7c89c70851b7ef3b65e878Julia Seeger,
- S1936879815022372-73153586b8169ed1c650d3c2af71c55bDominik Scharnbeck and
- S1936879815022372-35be92307b2a7aed4dd342668fc432caWolfgang Rottbauer
The Lotus valve (Boston Scientific Corporation) is designed to reduce the risk for residual paravalvular aortic regurgitation and can be easily repositioned. The study evaluates the procedural and 30-day results for the 23, 25 and 27mm Lotus valve in patients undergoing transfemoral aortic valve implantation (TAVI).
Methods and Results
We prospectively enrolled 110 patients with severe symptomatic aortic stenosis in a high-volume center. Procedures were performed without general anesthesia by transfemoral approach. Patients presented with diabetes in 23%, atrial fibrillation 38%, a mean STS score of 7 logistic EuroScore of 16. Patients were followed for 30 days. Events were adjudicated according to the VARC-2 criteria. Patients received the 23 mm (N=20), 25 mm (N=43) or 27 mm (N=47) Lotus device based on pre-procedural 256 multislice computed tomography. Mean oversizing in relation to annulus (8.7%) or left ventricular outflow tract (LVOT; 10.1%) did not differ between the three valve sizes. After valve release (including re-positioning) there was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation (9.1%; N=10/110) did not differ between groups. There was no valve embolization or need for a second valve. Rate of major vascular complication was 4.5% with no difference between valve and delivery sheath sizes. Device success according to VARC-2 was high with 96%. Patients without device success had a mean aortic gradient of more than 20mmHg assessed by echocardiography one day after valve implantation. There was no need for post-dilation, no annular rupture and no conversion to surgery. Contrast amount was mean 99mL. Need for pacemaker implantation due to grade II (type II)/III atrioventricular block was 18%. There was a significant higher need for pacemaker implantation in patients with LVOT calcification compared to patients without LVOT calcification (34.5% versus 14.1%, p<0.01). Within 30 days all cause mortality (0.9%) and stroke (disabling 2.7%, non-disabling 0.9%) were low with no difference between groups. NCT02162069
In patients with severe symptomatic aortic stenosis transfemoral TAVI with the repositionable Lotus valve was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, and low rates of major vascular complication, mortality and stroke within 30 days.