Abstract
ObjectivePermanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) is the most common complication after the procedure. PPMI rates remain high with the new-generation TAVI devices despite improved outcomes concerning paravalvular aortic regurgitation and vascular access complications. However, the impact of PPMI on mortality and clinical outcome is still a matter of debate, and data with new-generation devices on this matter are scarce. Therefore, we sought to analyse the influence of PPMI in patients treated with the new-generation devices on one-year outcome.MethodsWe enrolled 612 consecutive patients without prior pacemaker undergoing transfemoral TAVI with the new-generation devices. Patients with or without PPMI were compared with respect to clinical outcome within one year.ResultsPPMI was performed in 168 patients (24.4% of the overall study population). There was no significant difference in one-year outcome concerning all-cause mortality (PPMI vs. no-PPMI: 12.2% vs. 12.5%, p = 0.94), rate of major adverse events including cardiac, cerebral or valve-related events and bleeding complications (22.1% vs. 24.5%, p = 0.55) or need for rehospitalisation due to cardiac symptoms (16.1% vs. 18.1%, p = 0.63). In patients with reduced ejection fraction (<45%) there was also no impact of PPMI on one-year mortality (14.3% vs. 15.7%, p = 0.86). Furthermore, multivariate analysis did not reveal PPMI to be independently associated with one-year mortality (odds ratio 0.94, 95% confidence interval 0.50–1.74, p = 0.83).ConclusionsIn this large all-comers TAVI population with new-generation devices the need for postprocedural PPMI did not show a statistical significant impact on survival or combined endpoint of major adverse events within one year.
Highlights
Within the last decade, transcatheter aortic valve implantation (TAVI) has emerged as the standard care for severe aortic stenosis in inoperable patients or in patients at high risk for surgical valve replacement (SAVR) [1, 2]
In patients at intermediate risk for SAVR, noninferiority of TAVI in comparison with SAVR was shown for the balloon-expandable Edwards Sapien valves (Edwards Lifesciences, Irvine, CA, USA) in the PARTNER 2A randomised trial [3] as well as for the self-expandable Medtronic CoreValve (Medtronic, Minneapolis, MN, USA) in the SURTAVI trial [4]
Patients were at high or intermediate risk for SAVR indicated by the Society of Thoracic Surgeons (STS) score for mortality, were at high risk according to the risk assessment combining STS score for mortality, frailty or major organ system dysfunction according to the 2014 American College of Cardiology/American Heart Association Guidelines for Valvular Heart Disease [15] or had relevant further comorbidities favouring a transcatheter approach
Summary
Transcatheter aortic valve implantation (TAVI) has emerged as the standard care for severe aortic stenosis in inoperable patients or in patients at high risk for surgical valve replacement (SAVR) [1, 2]. Data from the FRANCE-2 registry evaluating TAVI revealed PPMI after TAVI as an independent predictor for 3-year mortality (p = 0.02) [13] , whereas a recently published meta-analysis of 23 studies including 20,287 patients undergoing TAVI did not observe an increased mortality during follow-up [14]. All of these data were generated from studies with the early-generation TAVI devices. There are no data on the impact of PPMI after TAVI with the new-generation devices
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