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Pacemaker implantation after TAVR failed to increase risk for death, HF
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Permanent pacemaker implantation after transcatheter aortic valve replacement was not associated with increases in overall death, CV death or rehospitalization due to HF at 22 months, according to new study findings.
Researchers found that permanent pacemaker implantation within 30 days was a frequent complication of TAVR and had a negative effect on left ventricular function over time, but implantation was a protective factor for the occurrence of sudden or unknown death.
Marina Urena, MD, of Laval University, Quebec City, Canada, and colleagues studied 1,556 patients with no prior permanent pacemaker implantation who were undergoing TAVR. Within 30 days after TAVR, 15.4% required permanent pacemaker implantation. Those who underwent TAVR with a self-expanding valve were more likely to require permanent pacemaker implantation than those undergoing TAVR with a balloon-expandable valve (25.5% vs. 7.1%; P<.001).
The primary outcome was a composite of all-cause mortality and hospitalization due to HF. Secondary endpoints were all-cause mortality, CV mortality, sudden cardiac death and death of unknown cause, rehospitalization due to HF, functional class changes and LV ejection fraction changes. Mean follow-up was 22 months.
The researchers observed no association between the need for permanent pacemaker implantation within 30 days and the primary outcome (HR=1; 95% CI, 0.77-1.3), all-cause mortality (HR=0.98; 95% CI, 0.74-1.3) or CV mortality (HR=0.81; 95% CI, 0.56-1.17).
However, patients who required permanent pacemaker implantation within 30 days had a lower rate of sudden or unknown death compared with those who did not require implantation (HR=0.31; 95% CI, 0.11-0.85).
Patients with permanent pacemaker implantation within 30 days after TAVR showed poorer evolution of LVEF over time compared with those without implantation (P=.017). Also, new permanent pacemaker implantation was an independent predictor of decline in LVEF from 6-month follow-up to 12-month follow-up (estimated coefficient: –2.26; 95% CI, –4.07 to –0.44), the researchers found.
There was no difference in NYHA functional class change between patients who had a permanent pacemaker implanted and those who did not (P=.672). Both groups experienced improvements in functional class after TAVR (P<.001 for both).
Disclosure: Several researchers report financial ties with Abbott, CeloNova, Edwards Lifesciences, Medtronic and St. Jude Medical.
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