Aims:The aims of this study were to determine the appropriateness of permanent pacemaker implantation (PPI) after TAVI through an analysis of PM dependency at follow-up, and to assess long-term outcomes of patients undergoing PPI after TAVI.Methods and results: From June 2007 to February 2018, 1,116 consecutive patients without prior PM underwent TAVI in our institution. We assessed the incidence and predictors of PM dependency of patients who underwent PPI within 30 days, and also the six-year outcomes among patients who did not undergo PPI at 30 days. At 30 days, PPI was reported in 145 patients (13.0%). Rates of PM dependency were 35.7%, 35.8% and 33.3% at 1, 6 and 12 months, respectively. Analysing PPI timing, implantation on day 1 was found to be a predictor of PM dependency at six months (OR 20.7 [95% CI: 3.4-126.7]; p=0.001) and 12 months (OR 7.5 [95% CI: 1.4-40.2]; p=0.019). An interaction between PM dependency and the presence of baseline right bundle branch block (RBBB) at six months (p interaction =0.024) and 12 months (p interaction =0.028) was reported when PPI was performed on the same day as TAVI. At six years, patients who received a PM at 30 days showed a higher all-cause death rate (KM estimate 41.7% vs 57%; p log-rank =0.034).Conclusions: Among patients receiving PPI after TAVI, PM dependency rates were about 33-36% at one year. Patients with a baseline RBBB undergoing PPI at day 0 or at day 1 when severe CDs persisted for 24 hours after TAVI, irrespective of baseline CDs, had a higher chance of being PM-dependent at followups. Finally, PPI after TAVI was associated with increased six-year mortality.
BackgroundLong‐term data on durability of currently available transcatheter heart valves are sparse. We sought to assess the incidence of long‐term (8‐year) structural valve dysfunction and bioprosthetic valve failure in a cohort of patients with transcatheter aortic valve replacement (TAVR) who reached at least 5‐year follow‐up.Methods and ResultsConsecutive patients with at least 5‐year follow‐up available undergoing TAVR from June 4, 2007 to March 30, 2012 were included. Structural valve dysfunction and bioprosthetic valve failure were defined according to newly standardized European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio‐Thoracic Surgery criteria and reported as cumulative incidence function to account for the competing risk of death. A total of 288 consecutive patients with a mean age of 80.7±5.3 years and with a mean Society of Thoracic Surgery mortality score of 8.1±5.1% were analyzed. Survival rate at 8 years was 29.8%. Mean pressure gradients decreased from 53.3±15.9 mm Hg (pre‐TAVR) to 10.5±4.5 mm Hg (in‐hospital post‐TAVR) (P<0.001). There was a small, not significant, increase in the transaortic gradient throughout follow‐up. Bioprosthetic valve failure was observed in a total of 11 patients (8‐year cumulative incidence function: 4.51%; 95% confidence interval, 1.95%–8.76%). Severe and moderate structural valve dysfunctions were reported in 7 patients (8‐year cumulative incidence function: 2.39%; 95% confidence interval, 0.77%–5.71%) and 13 patients (8‐year cumulative incidence function: 5.87%; 95% confidence interval, 3.06%–9.96%), respectively. Aortic valve reintervention (redo TAVR) was successfully performed in 2 patients (0.7%) presenting with symptomatic severe restenosis and intraprosthetic regurgitation subsequent to endocarditis.ConclusionsIn an aged population of patients with symptomatic severe aortic stenosis treated with first‐generation bioprostheses, TAVR was associated with a survival rate of 30% but low rates of bioprosthetic valve failure and structural valve dysfunction at 8 years.
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