https://doi.org/10.1007/s00392-025-02625-4
1Universitätsklinikum Tübingen Innere Medizin III, Kardiologie und Angiologie Tübingen, Deutschland; 2Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; 3Academic Medical Center University of Amsterdam Department of Cardiology Amsterdam, Niederlande; 4Linköping University Hospital Department of Cardiology Linköping, Schweden; 5Edwards Lifesciences Prag, Tschechische Republik; 6IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH Cloppenburg, Deutschland; 7Universitätsklinikum Tübingen Innere Medizin III, Kardiologie und Kreislauferkrankungen Tübingen, Deutschland
The occurrence of new conduction abnormalities requiring permanent pacemaker implantation (PPI) is a common complication following transcatheter aortic valve replacement (TAVR). Previous studies have shown inconsistent findings on the clinical impact of new PPI after TAVR. This international registry aimed to compare one-year clinical outcomes in TAVR patients with and without PPI.
Methods:
The prospective CONDUCT registry enrolled patients at high risk for PPI after TAVR from four high-volume European centers. Patients were prospectively included in the registry if they underwent a successful transfemoral TAVR with a balloon-expandable aortic valve prosthesis and had at least one pre-identified risk factor for PPI, such as pre-existing conduction disturbances or a heavily calcified left ventricular outflow tract. One-year follow-up data were collected for patients with and without PPI after TAVR, assessing clinical outcomes including all-cause and cardiovascular mortality, hospitalization for congestive heart failure (CHF), stroke or TIA, and endocarditis. The composite endpoint of major adverse cardiac events (MACE) was defined as a combination of all-cause mortality, CHF rehospitalization, and stroke/TIA. Routine pacemaker check-ups recorded right ventricular (RV) stimulation in patients with PPI. Propensity score matching (PSM) was used to compare outcomes between patients with and without PPI.
Results:
A total of 295 patients undergoing TAVR were recruited. Of these, 39 received PPI, and 256 did not, within 30 days post-TAVR. The median patient age was 80 years, with a higher proportion of males, and a median BMI of 26 kg/m². EuroSCORE II and STS scores were similar across groups. Patients with PPI had a higher prevalence of diabetes (p=0.055), lower left ventricular ejection fraction (LVEF%) (p=0.034), and lower systolic pulmonary artery pressure (PAP) (p=0.013) compared to those without PPI, though these differences were not significant after propensity score matching.
At one year, PPI patients had a higher incidence of MACE (23.1% vs. 11.3%; p=0.041) with a hazard ratio (HR) of 2.08 (95% CI [1.01, 4.30]), driven by an increased rate of CHF (12.8% vs. 2.3%; p=0.008) with an HR of 5.85 (95% CI [1.77, 19.4]). One-year freedom from all-cause mortality, cardiovascular death, hospitalization due to CHF, stroke, and endocarditis was similar between groups. After PSM, rehospitalization for CHF remained significantly higher in patients receiving PPI (p=0.046), though the difference in the composite MACE endpoint was no longer significant (p=0.216).
High RV stimulation (>40%) was observed in 23 patients (82%), while five patients (18%) had low RV stimulation. One patient recovered from AV block and no longer required RV pacing.
Conclusions:
Patients with PPI after TAVR had a higher incidence of CHF rehospitalization. There was no difference in one-year mortality or the combined clinical endpoint for patients receiving PPI. Notably, 82% of PPI patients required high RV stimulation during follow-up.