Abstract 17501: Initial Experience With a Novel Transcatheter Aortic Valve With Open-Cell Design and Staged Delivery for Challenging Anatomies in a Developing Country

Abstract

Introduction: Overcoming challenges of transcatheter aortic valve (TAVI) implantation, as coronary access, conduction disturbances and paravalvular leak are goals of device development. We aimed to describe the initial experience with a recently-approved self-expandable bioprosthetic valve, with supravalvular leaflets, a novel open-cell design and 2-stage deployment, in terms of efficacy and safety. Methods: Consecutive patients with aortic valve (AV) stenosis and indication for TAVI with favorable anatomy for self-expandable prostheses were prospectively enrolled in a high-volume center in Belo Horizonte, Brazil. Demographic, clinical and procedural data were collected in an online dedicated database (Coreware, RIBAC). Echocardiographic and CT-angio measurements were performed by 2 experts with proprietary software (Phillips Heart Navigator). Outcomes were prospectively collected. Results: At total, 23 patients eligible for the Acurate Neo/Neo2 TAVI were enrolled, being 15 men, mean age of 82±6 years (69 - 93). Hypertension was present in 20, diabetes in 8 and dyslipidemia in 17, and all were severely symptomatic, being 20 in functional class 3. The STS-score (morbi-mortality) was high: 19±6%. The mean AV area on echo was 0.7±0.2 cm 2 , with mean gradient of 44±15 mmHg. In CT-angio, the median calcium score was 2284, mean annular perimeter was 72±5 mm, and the height of the right and left coronary ostia were 15.2±2.6 mm and 11.9±3.2 mm (<10 mm in 5 cases). All implants were transfemoral (14F) and with general anesthesia, given the high-risk profile. Pre-dilation was performed in 20 (91%) and the TAVI was deployed without repositioning in all cases, with no coronary compromise. Post-dilation was required in 13 cases, being 11 due to mild and 2 due to moderate paravalvular leak: all regressed to trivial. Vascular complications requiring surgery occurred in 1 case, and 1 (4%) patient underwent permanent pacing. All patients were discharged home, with a mean AV gradient of 9.7±3.7 mmHg. Conclusion: The initial experience in Brazil with the novel Acurate Neo/Neo2 prosthesis was promising, with high success rates in challenging anatomical scenarios, and low rates of pacemaker implantation and no occurrence of coronary obstruction or significant leak.