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Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation: Impact on Late Clinical Outcomes and Left Ventricular Function
Study Questions:
What is the impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) on late outcomes (including mortality and rehospitalization for heart failure), left ventricular function, and functional status changes after the intervention?
Methods:
Consecutive patients who underwent TAVI with either a balloon-expendable valve (BEV) or a self-expandable valve (SEV) in eight centers, between January 2005 and February 2013, were screened. Of these, 233 patients were excluded because of pre-existing pacemaker implantation and 22 patients because of an unsuccessful procedure without valve implantation.
Results:
A total of 1,556 consecutive patients without prior PPI undergoing TAVI were included (BEV, 858 patients; SEV, 698 patients). Of them, 239 patients (15.4%) required a PPI within the first 30 days after TAVI. At a mean follow-up of 22 ± 17 months, no association was observed between the need for 30-day PPI and all-cause mortality (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.74-1.30; p = 0.871), cardiovascular mortality (HR, 0.81; 95% CI, 0.56-1.17; = 0.270), and all-cause mortality or rehospitalization for heart failure (HR, 1.00; 95% CI, 0.77-1.30; p = 0.980). A lower rate of unexpected (sudden or unknown) death was observed in patients with PPI (HR, 0.31; 95% CI, 0.11-0.85; p = 0.023). Patients with new PPI showed a poorer evolution of left ventricular ejection fraction over time (p = 0.017), and new PPI was an independent predictor of left ventricular ejection fraction decrease at the 6- to 12-month follow-up (estimated coefficient, −2.26; 95% CI, −4.07 to −0.44; p = 0.013; R2 = 0.121).
Conclusions:
The need for PPI was a frequent complication of TAVI, but it was not associated with increase in overall or cardiovascular death or rehospitalization for heart failure after a mean follow-up of approximately 2 years. Thirty-day PPI was a protective factor for the occurrence of unexpected (sudden or unknown) death. However, new PPI did have a negative effect on left ventricular function over time.
Perspective:
The study offers new insights into one of the most common complications of TAVI – the requirement for pacing. Similar to other patient populations needing right ventricular pacing, PPI after TAVI has a negative impact on left ventricular function, although no deleterious effects of PPI were observed on mortality and heart failure status in this study. The occurrence of new-onset persistent left bundle branch block was an independent predictor of sudden cardiac death. PPI was associated with a decrease in sudden (or unexplained) death. Interestingly, the protective effect of PPI persisted even after landmark analysis with a cut-off at 30 days, suggesting that progression to atrioventricular (AV) block may occur late. On the other hand, many patients with complete AV block post-TAVI subsequently recovered AV conduction, highlighting the need to optimize device programming to minimize RV pacing. Future studies should explore the most appropriate management of new conduction disturbances that do not meet criteria for PPI. Additionally, potential benefits of cardiac resynchronization therapy in the PPI post -AVI population should be explored.
Keywords: Atrioventricular Block, Follow-Up Studies, Ventricular Function, Left, Heart Failure, Bundle-Branch Block, Stroke Volume, Pacemaker, Artificial, Confidence Intervals, Death, Sudden, Cardiac, Cardiac Resynchronization Therapy
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