Marco Balducelli

In many countries, patients’ access to transcatheter aortic valve implantation (TAVI) is limited by reimbursement issues or delayed admission to heart valve centers, thus increasing the risk of adverse events in wait-listed patients. The TAVI AT HOME (TAH) is a single-arm, multicenter study aiming to evaluate the safety and efficacy of transfemoral TAVI performed at centers without on-site cardiac surgery by expert operators. The primary endpoint is 30-day all-cause mortality. This study focuses on the run-in phase of the registry, which was required by the ethics committee to perform an interim safety analysis. The outcome of 20 TAH patients enrolled at three Italian centers from May 2023 to May 2024 was compared to 41 TAVI cases included in the permanent local registry, matching the TAH inclusion/exclusion criteria. The two groups had similar baseline characteristics. Significantly more patients in the TAH group were deemed at prohibitive risk (85.0% vs. 56.1%; p = 0.026) but had similar surgical risk scores. A self-expanding device was used in most cases (60.7%). Technical success did not differ between groups (95.0% in the TAH vs. 85.4%, p = 0.409). No deaths at 30 days (primary endpoint) were observed. The 1-year survival rate did not differ between groups. After interim data analysis, the ethics committee authorized the completion of the TAH enrollment and extension to other centers. The TAH approach might represent an alternative model to allow timely access to TAVI without compromising safety and effectiveness.

Transcatheter aortic valve implantation (TAVI) has become the standard of care for elderly patients with aortic stenosis. International guidelines recommend that TAVI should be performed only in centers with on-site cardiac surgery (CS). However, rapidly evolving TAVI technology and increasing operator expertise have significantly reduced peri-procedural complications, including those requiring rescue surgery, which occur in less than 0.5% of cases. Furthermore, only a minority of major complications are treated with CS, and the outcomes remain unfavorable. TAVI in centers without CS could represent a solution to reduce waiting times and ensure continuity of care for fragile patients. “TAVI at Home” is a single-arm prospective interventional study. According to sample size calculations based on literature data, the study aims to enroll a total of 200 patients, beginning with a run-in phase of 20 patients to establish safety. The primary endpoint is 30-day all-cause mortality. Secondary endpoints include technical success and the evaluation of single complications 30 days after the procedure. Hospitals without CS that are eligible to perform TAVI must have a high volume of coronary percutaneous interventions, operators with established TAVI experience, collaboration with vascular surgeons, and regular Heart Team meetings to ensure rigorous patient selection.