TAVI without onsite cardiac surgery backup achieved 99% procedural success, 2% 30-day mortality, and a 2.7% stroke rate, with outcomes comparable to national registry data.
Cohort (n=300)
No
Does transcatheter aortic valve implantation without onsite cardiac surgery backup provide safe and effective outcomes in patients requiring aortic valve replacement?
TAVI can be safely performed in appropriately equipped centers without immediate access to cardiac surgery, demonstrating excellent safety and efficacy outcomes comparable to national registries.
Abstract Introduction Transcatheter aortic valve implantation (TAVI) was traditionally performed with onsite surgical backup. Yet, advancements in technique, experience, and device technology have enhanced safety and predictability, reducing the need for surgical support. This study aims to describe our experience and the outcomes of TAVI in this paradigm shift to a center without a cardiac surgery backup onsite. Methods Retrospective cohort of 300 TAVI patients at a center without immediate cardiac surgery backup onsite between 2020 and 2024 was analyzed. The primary endpoints were procedural death, 30-day mortality, and stroke. Secondary outcomes included in-hospital mortality, length of hospital stay, surgical required complications, and permanent pacemaker implantation. Results 300 patients underwent TAVI, with a mean age of 82±5 years, and 54% female. The median STS risk score was 3,8 2.3–6.6, with 20% classified as high-risk patients (STS 8). Baseline echocardiographic characteristics were a mean aortic gradient of 48±14mmHg, left ventricular ejection fraction of 57±12%, and systolic pulmonary artery pressure of 38±14mmHg. The mean aortic valve calcium score was 2912±1572 UA. Bicuspid aortic valve was present in 6% of patients (n=18), and valve-in-valve procedures were performed in 7 cases (2.3%). Most procedures were elective (83%, n=249). Femoral access was preferred in 99% of cases, with the contralateral femoral artery as secondary access in 90%. Self-expandable Evolut CoreValve was used in 96% of procedures. Procedural success rate was 99% (n=298). In hospital and 30-day mortality was 2%, stroke occurred in 2.7%, and pacemaker was required in 20%. Tamponade occurred in 0.6% of cases (n=2), and surgical intervention in 0,3% (n=1). There was 8% of major bleeding and vascular complication rates. There were no cases of coronary obstruction, extra circulatory support, or bailout TAVI in TAVI deployment. The median hospital stay was 3 days, 2 at the ICU level. Significant symptomatic improvement was verified in 91% of the cases. After 1 year, the mortality rate was 12%. There were no significant differences in outcomes compared to the TAVI national registry results (Table 1). This first national single-center experience of TAVI performed without cardiac surgery backup demonstrates excellent safety and efficacy outcomes. Procedural success was achieved in 99% of cases, with low in-hospital and 30-day mortality rates, stroke, and major complications. One-year survival was comparable to outcomes from centers with onsite surgical backup. These findings suggest that TAVI can be safely performed in appropriately equipped centers without immediate access to cardiac surgery, potentially broadening the accessibility of this procedure.
Almeida et al. (Sat,) conducted a cohort in Patients undergoing Transcatheter Aortic Valve Implantation (TAVI) (n=300). Transcatheter aortic valve implantation (TAVI) without onsite cardiac surgery backup vs. TAVI national registry results (centers with onsite surgical backup) was evaluated on Procedural death, 30-day mortality, and stroke. TAVI without onsite cardiac surgery backup achieved 99% procedural success, 2% 30-day mortality, and a 2.7% stroke rate, with outcomes comparable to national registry data.