Key result
New-generation valves in ViV-TAVR are linked to ~36% lower pacemaker implantation rates vs early-generation devices.
Why the study?
Permanent pacemaker implantation remains a major drawback of TAVR, yet data on its incidence, associated factors, and clinical impact after valve-in-valve TAVR—particularly with newer-generation transcatheter heart valves—were scarce.
Does the use of new-generation transcatheter heart valves reduce the incidence of permanent pacemaker implantation and associated mortality in patients undergoing valve-in-valve transcatheter aortic valve replacement?
Cohort (n=1,987)
Yes
Does the use of new-generation transcatheter heart valves reduce the incidence of permanent pacemaker implantation and associated mortality in patients undergoing valve-in-valve transcatheter aortic valve replacement?
In patients undergoing ViV-TAVR, periprocedural permanent pacemaker implantation occurred in 6.4% of cases, decreased significantly with new-generation valves, and was associated with a trend toward higher late mortality.
BACKGROUND Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). OBJECTIVES The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. METHODS Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. RESULTS A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). CONCLUSIONS In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.
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Alperi et al. (2021) conducted a cohort in Patients undergoing valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) (n=1,987). New-generation transcatheter heart valves (THVs) in ViV-TAVR vs. Early-generation THVs (CoreValve, Cribier-Edwards, Sapien, and Sapien XT) was evaluated on Periprocedural permanent pacemaker implantation (PPI) (p=0.017). New-generation transcatheter heart valves in ViV-TAVR significantly lowered permanent pacemaker implantation rates vs early-generation valves (4.7% vs 7.4%; p=0.017), with an overall PPI rate of 6.4%.
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