Safety Outcomes in the PS population
Mortality at 30-days post-procedure was similar between NC-ABL and C-ABL (2 vs.1 for NC-ABL and C-ABL, respectively, P=0.501). The complication rate was not different between both groups (9.3% vs. 14.0% respectively, P=0.738) (table 4). There was 1 pericardial effusion in the NC-ABL group vs 4 in the C-ABL group (P=0.167) and in only the C-ABL group occurred right ventricle puncture (2 patients). Two patients in the NC-ABL group developed complete heart block vs. 1 in the C-ABL group (P=0.567) (Table 4).