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An analysis of patient outcomes for those undergoing transfemoral TAVR from 2008-2018 sugggests permanent pacemaker implantation was not associated with an increase in risk of cardiovascular mortality, heart failure, or endocarditis.
Data from an analysis of patients within the SWEDEHEART registry suggests there were no differences in long-term survival between patients who did and did not undergo permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR).
A look at data from patients who underwent transfemoral TAVR in Sweden from 2008-2018, results of the study provide insight into the effects of pacemaker implantation on survival over a period lasting up to 10 years, including a lack of significant difference observed in cardiovascular mortality, heart failure, and endocarditis between the groups.
“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,” says Natalie Glaser, MD, PhD, study investigator and researcher at the Department of Molecular Medicine and Surgery at Karolinska Institutet, in a statement.
With previous studies producing uncertainty related to differences in outcomes observed with patients who underwent permanent pacemaker implantation after TAVR compared to their counterparts who did not receive a pacemaker, the current study was designed by Glaser and colleagues to fill this apparent knowledge gap. To do so, the current study was designed as an observational, population-based cohort study using data from the SWEDEHEART registry.
Pooling data from 8 sites performing TAVR in Sweden, investigators sought to identify a cohort containing all patients who underwent TAVR from 2008-2018. Using this data, investigators hoped to evaluate the unadjusted and multivariable-adjusted risks of all-cause mortality, cardiovascular death, heart failure hospitalizations, and endocarditis using Cox proportional hazards regression. For the purpose of analysis, the exposure of interest was defined as implantation of a permanent pacemaker or implantable cardioverter-defibrillator within 30 days of undergoing TAVR.
Incidence of cardiovascular mortality was considered the primary outcome of interest while heart failure hospitalization and endocarditis were considered secondary outcomes. Of note, the index date for the study was defined as 30 days after TAVR. Additionally, investigators noted the end of follow-up for all-cause mortality was March 20, 2020, and the end of follow-up for cardiovascular mortality, heart failure, and endocarditis was December 31, 2018.
From SWEDEHEART, investigators identified 4750 patients who underwent TAVR from 2008-2018. Of these, 124 were excluded because they died within 30 days, 465 were excluded due to having had a CIED prior to undergoing TAVR, 581 were excluded for nontransfemoral access, and 160 were excluded for undergoing valve-in-valve procedures. Of the 3420 included in the study population, 481 (14%) received a pacemaker following TAVR.
At 1, 5, and 10 years, the survival rates were 90.0%, 52.7%, and 10.9% in the pacemaker group and 92.7%, 53.8%, and 15.3% in the nonpacemaker group, respectively (HR: 1.03; 95% CI: 0.88-1.22; P=.692). Further analysis indicated the cumulative incidence of heart failure at 1, 5, and 8 years was 6.6%, 21.1%, and 26.6% in the pacemaker group and 4.7%, 15.7%, and 20.5% in the nonpacemaker group, respectively. For endocarditis, the cumulative incidence rate at 1, 5, and 8 years was 1.8%, 3.8%, and 4.2% in the pacemaker group and 1.7%, 3.8%, and 4.2% in the nonpacemaker group, respectively.
In multivariable-adjusted analyses, investigators observed no significant difference in risk of cardiovascular mortality (HR, 0.91 [95% CI, 0.71-1.18]; P=.611), heart failure (HR, 1.23 [95% CI: 0.92-1.63]; P=.157), or endocarditis (HR, 0.90 [95% CI, 0.47-1.69]; P=.734) between the study groups.
“As the use of TAVR expands to younger and low-risk patients, studies including younger and low-risk patients with longer follow-up are needed to confirm the present findings in these patient populations,” wrote investigators.
This study, “Outcomes following permanent pacemaker implantation after transcatheter aortic valve replacement: SWEDEHEART observational study,” was published in JACC: Cardiovascular Interventions.