TCT-103 The Transaortic Approach for Transcatheter Aortic Valve Replacement: Initial Clinical Experience in the United States

Abstract

CE Mark approval in September 2011 and to date over 100 commercial implants have been performed. The device is composed of a porcine biologic valve attached to a self-expanding nitinol stent designed for simple 2-step implantation and characterized by controlled positioning, self-seating in the native annulus resulting in a negligible paravalvular leak rate. The device was tested in patients at high-risk for mortality with open surgical repair. Methods: Ninety (90) patients (femaleϭ69%) with severe aortic stenosis, a mean age of 83.4 Ϯ 4.1 years, all presenting with NYHA Functional Class III or IV and a mean STS Score of 7.9 Ϯ 4.6 were enrolled in two studies in Germany at 6 centers. Patients are clinically followed at 7 and 30 days, at 6 and 12 months, and annually thereafter out to 5 years post-implant. The device was successfully implanted in 94.4% of patients (nϭ85) with a pacemaker implantation rate of 11.1% (nϭ10). Results: At 12 months the survival rate is 81.1% (nϭ73), the stroke rate is 4.4% (nϭ4), with no further re-intervention required on the implanted device since procedure. Of the returning patients, 87% presented with NYHA Functional Class I/II. The mean gradient at 6 months is 10.3 Ϯ 5.2 mmHg, the mean EOA is 1.5 Ϯ 0.4 cm2 and 77.3% of returning patients suffered no paravalvular leak, 21.2% exhibit mild paravalvular leak (ϩ1) and only 1 patient possesses a moderate paravalvular leak (ϩ2). Conclusions: These data confirm the safety profile at one year of this 2nd Generation TAVI system. We will report the full 12 months results of this multi-center, nonrandomized study of this transapically-placed transcatheter aortic valve at TCT 2012.

Transapical Versus Transaortic Transcatheter Aortic Valve Implantation: A Systematic Review

“…Finally, there appears to be a shorter learning curve with the transaortic approach than the transapical approach, thus exposing fewer patients to excess risk during the introduction of the technique [21]. Despite these potential advantages, our review failed to show that the transaortic approach is superior to the transapical approach in most outcomes and this requires further discussion.…”

High-Risk Patients With Inoperative Aortic Stenosis: Use of Transapical, Transaortic, and Transcarotid Techniques

“…Bapat and colleagues [15] examined TAVR by TA and TAo approaches and reported no significant difference in 30-day mortality (7.7% for 91 patients undergoing TA TAVR and 11.8% for 17 patients undergoing TAo TAVR; p ¼ 0.577). In their comparison of 44 patients undergoing TAVR through TAo access against 76 patients undergoing TAVR through a TA route, Lardizabal and colleagues [16] reported a 30-day all-cause death rate of 14% and 14% for TAo and TA, respectively. Other studies have reported 30-day mortality for TA TAVR ranging from 5.7% to 17.5% [17][18][19][20].…”

Transaortic Transcatheter Aortic Valve Replacement

“…Nonetheless, for transaxillary TAVR, the 30-day all-cause mortality rates were 8.6 % and 4.2 % ( p = 0.25), the 30-day major stroke rates were 8.6 % and 3.9 %, and the MACCE rates at 30 days were 14.3 % and 12.1 % ( p = 0.67) for the Pivotal study and continued access patients, respectively. Lardizabal et al [ 8 ] reported on 44 consecutive patients undergoing TAo-TAVR with the Edwards SAPIEN valve and compared them to 76 consecutive patients undergoing TA-TAVR. They found that the rate of device success was similar at 89 % for the TAo-TAVR group and 84 % for the TA-TAVR group ( p = 0.59) with no difference in signifi cant paravalvular regurgitation .…”