Larger Valve Size is Associated with Permanent Pacemaker Implantation in Edwards SAPIEN 3™ Transcatheter Aortic Valves.

Background: Transcatheter aortic valve replacement (TAVR) can be complicated with a high-degree atrioventricular (AV) block requiring a permanent pacemaker (PPM) in 5% - 25% of patients. TAVR valve size is a modifiable risk factor for permanent pacemaker implantation (PPI) after TAVR. We studied the association of valve size in PPI with Edwards SAPIEN 3™ (ESV3) (Edwards Lifesciences LLC, Irvine, CA, USA) TAVR valves.

Method: This is a single-center retrospective cohort analysis of 449 patients undergoing TAVR from December 2012 to April 2018. We excluded patients with TAVR valve types other than the ESV3 (113 patients) and those with prior PPM or implantable cardioverter defibrillator (37 patients). Patients with an aborted procedure and surgical conversion were also excluded (16). Data of 14 patients with missing values for different clinical variables were excluded as well. The final sample size was 269. The primary outcome was PPI. Statistical analysis was done using Chi-square, T-test, and multivariate regression analysis. Multivariate analysis was done for comparison between different clinical variables.

Results: Of the 269 patients (50.6% males; mean age of 79.5 ± 8.7 years; mean Society of Thoracic Surgeons (STS) score: 6.2), PPI was seen in 17 patients (6.3%). Time to PPI was 1.3 days. PPI was significantly high in patients with prior conduction defects (p = 0.016). There was a positive relationship between PPI and valve size for ESV3. PPI was seen in eight patients (47%) with 29 mm valves, six patients (35%) with 26 mm valves, three patients (17%) with 23 mm valves, and none with 20 mm valves. When taken as a reference, 23 mm valves had a significantly lower PPI compared with 29 mm valves (eight versus three; p = 0.04).

Conclusion: Larger valve size is a possible risk factor for a high-degree AV in patients receiving ESV3.