Abstract

Limited data are available about the impact of permanent pacemaker (PPM) implantation on long term survival in patients with bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with trans catheter aortic valve replacement (TAVR). We aimed to evaluate long-term clinical outcomes of BAV patients with AS who underwent peri-procedural PPM implantation after TAVR with self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService - CoreValve Project were collected. Patients were categorized in two groups according to PPM implantation after TAVR ("PPM" group") or not ("no PPM" group"). Co-primary endpoints were all-cause death and a composite of cardiac mortality, re-hospitalization due to cardiac causes, stroke and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between groups in terms of follow-up and baseline characteristics. Patients in the "PPM" group were more likely to show baseline conduction abnormalities (p=0.023). Patients in the "PPM" group were more often treated with older generation prosthesis as compared to those in the "no PPM" group (respectively 28.1% vs 5.4% p=0.013). At two-years follow-up, all-cause death in the "no PPM" and "PPM" groups occurred in 20.0 % and 10.0 % of patients, respectively [HR 0.37, 95% CI (0.08-1.67)]. Similarly, no difference was evident for the composite endpoint between the two groups ["no PPM" vs "PPM": 8 (14.6 %) vs 6 (19.3 %), HR 1.67, 95% CI (0.58-4.81)]. In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at two years of follow-up.

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