Pacemaker Rates With Improved TAVR Devices

Mar 24, 2016
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Authors:
De Torres-Alba F, Kaleschke G, Diller GP, et al.
Citation:
Changes in the Pacemaker Rate After Transition From Edwards SAPIEN XT to SAPIEN 3 Transcatheter Aortic Valve Implantation: The Critical Role of Valve Implantation Height. JACC Cardiovasc Interv 2016;Mar 23:[Epub ahead of print].
Summary By:
Troy M LaBounty, MD, FACC

Study Questions:

Does a newer generation of transcatheter aortic valve replacement (TAVR) result in a change in the need for post-procedural pacemaker implantation?

Methods:

This study compared the rate of pacemaker implantation following TAVR in 162 patients treated with a newer generation Edwards Sapien-3 (S3) device compared to 287 individuals treated with the earlier Sapien XT device, after exclusion of those with prior pacemaker or defibrillator, or with transapical or valve-in-valve procedures. The rate of conduction abnormalities, need for permanent pacemaker, and prosthesis implantation height were evaluated at 7 days.

Results:

Cohorts had similar age, gender, and rates of baseline conduction abnormalities. Pacemaker implantation rate was higher in those treated with the S3 device (19.1% vs. 12.2%, p = 0.046). In those treated with the S3 prosthesis, there was a small difference in implant height between those with (n = 31) and without (n = 131) pacemaker implantation (66.5 ± 8.9% vs. 72.3 ± 14.0% aortic, p = 0.03). Valve size and the proportion of oversizing were not associated with a difference in pacemaker implantation. On multivariable analysis, the only predictor of pacemaker implantation was implant height (odds ratio, 0.94; 95% confidence interval, 0.90-0.99; p = 0.009). Between the first half and second half of S3 procedures, there was an increase in implant height (68% vs. 75% aortic, p < 0.001), and a decrease in pacemaker implantation rate (25.9% vs. 12.3%, p = 0.028).

Conclusions:

The S3 TAVR device is associated with an increased rate of pacemaker implantation, which appears related to implant height.

Perspective:

A newer generation balloon-expandable TAVR device, the Edwards Sapien-3, has been reported to reduce paravalvular regurgitation as compared to the prior Sapien XT device, but there have been concerns about the rate of pacemaker implantation. This study finds that the S3 devices are associated with a higher rate of pacemaker implantation than the earlier XT devices, and suggests that lower implant height may be associated with increased need for pacemaker implantation. These findings support the use of a higher implant height. However, the mean difference in implant height between groups was small, and TAVR devices can shift during deployment, which presents challenges. Further prospective study is needed to determine whether a higher target implant height is associated with a lower rate of pacemaker implantation.

Keywords: Aortic Valve Stenosis, Arrhythmias, Cardiac, Cardiac Surgical Procedures, Defibrillators, Heart Valve Diseases, Pacemaker, Artificial, Prostheses and Implants, Transcatheter Aortic Valve Replacement


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