TAVR patients who received a pacemaker did not show a significantly higher risk of death, heart failure or endocarditis compared with peers who did not need a pacemaker, the study team reports in JACC: Cardiovascular Interventions.
"Our study contributes to understanding the impact of pacemaker implantation after transcatheter aortic valve replacement, which is becoming increasingly important as the use of this method expands to include younger and low-risk patients with a long life expectancy," Dr. Natalie Glaser, the study's corresponding author from Karolinska Institutet, said in a news release.
Permanent pacemaker implantation (PPI) is the most common complication of TAVR. Studies evaluating the effect of PPI after TAVR on clinical outcomes have produced mixed results.
Using the SWEDEHEART registry, Dr. Glaser and colleagues evaluated 3,420 patients (mean age, 81 years) who underwent transfemoral TAVR in Sweden from 2008 to 2018 and were followed for up to 11.8 years (mean follow-up, 2.7 years). A total of 481 (14%) required a permanent pacemaker within 30 days of TAVR.
There was no significant difference in long-term survival between patients who did and did not receive a pacemaker, the researchers report.
The survival rate at one, five and 10 years was 90%, 53%, and 11% in the pacemaker group and 93%, 54%, and 15% in the nonpacemaker group, respectively (hazard ratio, 1.03; P=0.692).
There was also no significant between-group difference in the risk of cardiovascular death (HR, 0.91; P=0.611), heart failure (HR, 1.23; P=0.157), or endocarditis (HR, 0.90; P=0.734).
The researchers say strengths of the study include the large cohort of patients, long follow-up period and accuracy of the Swedish health data registers. However, the observational design includes an inevitable risk of residual confounding. The team lacked information about preprocedural conduction disturbances or indications for PPI; pacing dependency and left ventricular function during follow-up was also unknown.
"Although we carefully analyzed clinically important outcomes, we acknowledge that we did not examine other important aspects of health, such as quality of life and functional capacity," the study team states.
The authors of an editorial say, "Overall, this study provides reassuring outcomes ('a light that does not overshadow the forecast'); however, we must be cautious when extrapolating these results to the rest of the TAVR population, as it is still poorly understood."
Dr. Antonio J. Munoz-Garcia and Dr. Erika Munoz-Garcia of University Hospital Virgen de la Victoria, in Malaga, Spain, note that inconsistency in published results may be explained by multiple confounding factors, including the heterogeneity of patients analyzed, indications for PPI (prophylactic or absolute), time of PPI, basal left ventricular ejection fraction and longer follow-up needed to detect a negative effect of PPI on clinical outcomes.
"To date, the impact of PPI on late clinical outcomes after TAVR remains controversial; however, this study to some extent helps clarify this controversy. But to solve this lack of consensus, it is necessary to reduce the rate of PPI, homogenize criteria and studies, and have long-term clinical follow-up," they write.
The study had no commercial funding and the authors have declared no relevant conflicts of interest.
SOURCE: https://bit.ly/3oy68CE and https://bit.ly/2YeEhMz JACC: Cardiovascular Interventions, online October 4, 2021.
By Reuters Staff
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