Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial

Christopher U Meduri, Dean J Kereiakes, Vivek Rajagopal, Raj R Makkar, Daniel O'Hair, Axel Linke, Ron Waksman, Vasilis Babliaros, Robert C Stoler, Gregory J Mishkel, David G Rizik, Vijay S Iyer, John Schindler, Dominic J Allocco, Ian T Meredith, Ted E Feldman, Michael J Reardon, Christopher U Meduri, Dean J Kereiakes, Vivek Rajagopal, Raj R Makkar, Daniel O'Hair, Axel Linke, Ron Waksman, Vasilis Babliaros, Robert C Stoler, Gregory J Mishkel, David G Rizik, Vijay S Iyer, John Schindler, Dominic J Allocco, Ian T Meredith, Ted E Feldman, Michael J Reardon

Abstract

Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long-term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre-specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier NCT02202434.

Keywords: aortic valve stenosis; pacemaker dependency; permanent pacemaker; transcatheter aortic valve replacement.

Figures

Figure 1
Figure 1
Patient flow and pacemaker indications. A, Patient flow. B, Other/unknown indications: 6 other, 5 left bundle branch block, 3 second degree atrioventricular block type 1 and 1 first degree atrioventricular block. AVB indicates atrioventricular block
Figure 2
Figure 2
Clinical impact of pacemaker implantation. A, all‐cause death, (B) cardiac death, (C) all stroke, and (D) hospitalization for valve‐related symptoms/worsening congestive heart failure (New York Heart Association class III/IV) in patients with a prior pacemaker at baseline (red), patients who did not receive a pacemaker (purple), and patients who received a pacemaker within 30 days of the index procedure (green). Event rates between 31 and 365 days were calculated with Kaplan–Meier methods. Error bars indicate standard error. AVB indicates atrioventricular block
Figure 3
Figure 3
Pacemaker dependency at 30 days and 1 year. A, Pacemaker status and dependency in patients who did not have a prior pacemaker at baseline. B, Change in pacemaker status and dependency between 30 days and 1 year.
Figure 4
Figure 4
Clinical impact of pacemaker dependency. A, All‐cause death, (B) cardiac death, (C) all stroke, and (D) hospitalization for valve‐related symptoms/worsening congestive heart failure (New York Heart Association class III/IV) in patients without a pacemaker at baseline (purple) and in patients who received a pacemaker within 30 days of the index procedure who were pacemaker dependent (orange) or not pacemaker dependent (blue) at 30 days. Event rates between 31 and 365 days were calculated with Kaplan–Meier methods. Error bars indicate standard error.

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