Background: Transcatheter aortic valve imlantation (TAVI) has evolved as an important alternative to surgical AVR in high risk patients and is associated with a significant risk of injury to the native conduction system.
Objectives: To investigate the "real life" predictors of periprocedural pacemaker (PM) implantation in patients undergoing TAVI with an Edwards Sapien valve in the US using the National Inpatient Sample (NIS) dataset.
Methods: Using the NIS database for 2012-2013, we identified patients with no prior history of a permanent pacemaker who underwent TAVI with an Edwards Sapien valve. The study period was chosen for the reason that the Edwards Sapien Valve was the only one with FDA aproval during these years. Baseline demographics, clinical characteristics and Elixhauser Comorbidity Index (ECI), as well as outcomes including periprocedural pacemaker implantation, length of stay and in-hospital mortality were analyzed.
Results: An estimated total of 19,060 TAVIs were performed in US during the study period, with 9.9% of patients requiring subsequent PM implantation. The median patient age was 83 (IQR: 77-87) years, 49.5% were female. Although no significant difference was observed in baseline co-morbidities, patients who required PM included more octogenarians (p=0.012) with a higher ECI (p<0.001). Independent predictors of PM implantation in a multivariable analysis included age>80, preexisting right bundle branch block, higher Elixhauser Comorbidity Index. Interestingly, transfemoral approach for TAVI with Edwards Sapien valve was found to be another independent predictor, associated with a 51% higher risk for PM implantation compared to transapical approach (OR=1.51, 95%CI 1.13-2.01, p=0.005). Patient’s requiring PM implantation had a significantly prolonged hospitalization stay (10 vs. 8.6 days, p<0.001).
Conclusion: Independent predictors of PM implantation in patients undergoing TAVI include: age>80, preexisting conduction system disease, higher comorbidity index, and transfemoral approach, the latter of which has not been previously described.