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Since the Medtronic CoreValve’ (Medtronic Inc., Minneapolis, MN) gained commercial approval, there has been increased usage of the system for transcatheter aortic valve replacement (TAVR). Prior studies report the incidence of post-CoreValve’ permanent pacemaker implantation (PPI) rates between 18% and 34%. However, populations implanted post-market approval (PMA) may have different risks from that in the United States Pivotal Trial, and the next generation Evolut’ valve (Medtronic Inc., Minneapolis, MN) may have lower risks of PPI post TAVR. A single-center retrospective chart review of patients implanted with the CoreValve’ PMA was compared with our single-center experience in United States Pivotal Trial from July 2011 to May 2016. The original CoreValve’ population was also compared with patients receiving the newer Evolut’ valve. Univariate and multivariate analysis was performed to identify predictors of PPI. A total of 140 patients were included in this analysis, 113 with the CoreValve’ and 27 with Evolut’ valve. Patients undergoing PPI after CoreValve’ were 81.2±8.9 years old and 51.4% male. Patients in the PMA and Evolut’ groups were younger compared with the Pivotal Trial, and patients receiving the Evolut’ valve were more likely female. The PPI rate in the total population was 39.3% (N1⁄4 140). The PPI rate in the PMA group was 44.9% versus 40.0% in the Pivotal Trial group (p1⁄4 0.63). In the Evolut’ population, the PPI rate was 22.2% compared with 41.2% for the total CoreValve’ population (p1⁄4 0.04). Prior conduction disease and atrial fibrillation were found to be significant risk factors for pacemaker implantation (OR 2.62, p1⁄4 0.04 and OR 2.29, p1⁄4 0.05). There were no factors identified that were predictive of PPI within the comparison groups. Despite a more favorable risk profile in the PMA group, PPI remained comparable in the two groups implanted with the CoreValve’ system. The Evolut’ valve is associated with a lower rate of PPI. These findings suggest a more dominant impact of the TAVR procedure itself than patient risk factors when considering risk of conduction system injury. Patients eligible for surgical or percutaneous replacement should be counseled regarding risk regardless of age or other perceived favorable risk profiles.

Incidence and Predictors of Pacemaker Implant Post Commercial Approval of the CoreValve System for TAVR