Single-center prospective study of accurate neo 2 in valve-in-valve TAVI: procedural and mid-to-long term outcomes

Background Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a pivotal approach for treating degenerated surgical bioprosthetic valves, with ACCURATE NEO 2 valve and its advanced sealing technology and optimized coronary access, representing a highly promising solution for addressing the unique challenges of these complex interventions. Purpose This study aims to evaluate the procedural and mid-to-long term outcomes of the ACCURATE NEO 2 valve in ViV TAVI procedures conducted at our center. Methods This prospective, single-center study included patients diagnosed with degenerated surgical bioprostheses and symptomatic valve dysfunction, classified in NYHA class III or IV, who underwent ViV TAVI with the ACCURATE NEO 2 valve at our center between July 2022 and December 2024. Data encompassing demographic, clinical, laboratory, imaging, and hemodynamic parameters were collected. Outcomes were assessed based on Valve Academic Research Consortium-3 (VARC-3) consensus criteria. Results A total of 55 patients (50% females) underwent ViV TAVI with a median age of 76 years (IQR: 8), at baseline assessment. The technical success rate was 98.2%, with one patient requiring the implantation of a second transcatheter valve during the index procedure due to slight aortic valve migration following post dilatation. The SENTINEL cerebral protection system was used in all patients, resulting in zero stroke incidents. There were no occurrences of bleeding, vascular complications, renal failure, conversion to surgery, new pacemaker implantation, or in-hospital mortality. Additionally, none of the patients experienced myocardial infarction; however, 3 patients (5.5%) underwent elective percutaneous coronary intervention with chimney stenting—2 (3.6%) in the left main and 1 (1.8%) in both the left main and right coronary artery—due to low coronary takeoff and potential obstruction. The post-procedural mean aortic gradient was 6.7 ± 1 mmHg, with a mean aortic valve area (AVA) of 2 ± 0.1 cm². No cases of aortic regurgitation greater than trivial were observed. Over a median follow-up period of 1.2 years, no deaths (0%) were observed, and the rate of heart failure-related hospitalizations was 3.6%. At 30-day and 1-year follow-up periods, the mean aortic valve gradient was 8.1 ± 2 mmHg and 7.9 ± 1.5 mmHg, respectively, while the mean AVA was 1.9 ± 0.2 cm² and 1.9 ± 0.1 cm², respectively. Improvement in functional status was observed in the total cohort, achieving NYHA class ≤ II in 100% in 30-days and 1-year follow-up. Conclusions The ACCURATE NEO 2 valve demonstrated excellent technical success, sustained hemodynamic performance, and significant clinical improvement in ViV TAVI procedures, The absence of major adverse events or mortality within follow-up period further underscores its safety, efficacy, and durability as a treatment for degenerated surgical bioprostheses.