Statistical analysis
Continuous variables were checked for normality using the Shapiro-Wilk test, and are reported as mean and standard deviation if normally distributed, or as median and interquartile range (IQR) if non-normally distributed. Categorical variables are presented as counts and percentages, and differences between groups were calculated with the 2-tailed Fisher exact test. The primary outcome was assessed in a time-to-event analysis, according to the Kaplan-Meier method. The EHRA scores at baseline and at 9-month follow-up were compared with the Wilcoxon rank-sum test for repeated measures. A 2-sided p<0 .05 defined statistical significance. All statistical analyses were performed with the software RStudio (RStudio Inc., Boston, MA).