Abstract

Abstract Aims The TAVI registry represents a single-centre observational retrospective study that consecutively collected symptomatic patients with severe aortic stenosis between September 2009 and February 2021 at the Magna Graecia University (Catanzaro, Italy). Our aim was to evaluate the rate of complications which can occur after Transcatheter aortic valve replacement (TAVR) and its possible predictors. Methods We included a total of 346 consecutive patients, admitted to our institution between September 2009 and February 2021. Inclusion criteria were: severe aortic stenosis in high-risk patients unsuitable for surgery after cardiac team consent, valve anatomy adjusted according to device instructions for use, life expectancy> 1 year. Clinical, echocardiographic and procedural data were collected and reported in an electronic database. Surgical risk was prospectively assessed using the European Cardiac Operational Risk Assessment System (EuroSCORE II, https://www.euros core.org/calc.html). The mean age of the population was 80.3 ± 5.4 years; 144 patients (41.6%) were male. The average EuroSCORE II was 6.3 ± 5.7. All reported P-values are two-sided and P-values <0.05 were considered significant. STATA (StataCorp, USA) was used for data analysis. Results Out of the total population analysed, the number of patients who underwent a vascular complication was 23 or 6.6%. Female sex was an independent predictor of vascular complication (P 0.015) regardless of the presence of peripheral vascular disease (OR 3.73; 95% CI 1.20–11.5), while no correlation was found with BSA. The number of patients experiencing severe bleeding and/or need for transfusion was 85 or 24.6% of the total. Mean baseline haemoglobin values were 12.1 g/dL ± 1.7 with lower mean values reported during hospitalization of 9.2 g/dL ± 1.4 (P <0.001), while predicted values at discharge were 9.8 g/dL ± 1.2. The pre and post procedural PR interval value was 171.1 ± 33.6 ms vs. 193.3 ± 35.7 ms (P <0.001) (Figure 2). The pre-procedural QRS interval value was 95.0 ± 21.7, the post-procedural mean value was 115.4 ± 26.5 (P <0.001). The number of patients with QRS> 120 ms after the procedure was 92 (26.5%). Out of the total number of patients analysed, the number of subjects who required PM implantation was 77 patients, i.e. 22.3% of the total. Of these, 25 patients (32.4%), Evolut R 45 patients (58.6%) and Sapien 7 patients (9.0%) had received implants. The need for pacemaker implantation did not affect the average length of stay (P 0.5). Conclusions Since its advent, the transfemoral aortic valve prosthesis implant has experienced impressive and continuous growth, radically revolutionizing the treatment of symptomatic severe aortic stenosis. Furthermore, the clear improvement of the procedural safety and efficacy profiles, due on the one hand to the technological evolution of the devices, of the introduction and release systems and of the experience of the operators, has reduced the number of complications related to the implant and improved the management of the same.

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