Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves

Quick Takes

  • New permanent pacemaker implantation (PPI) at 30 days was frequently needed in patients who underwent TAVR with self-expanding valves.
  • Furthermore, baseline RBBB and lower depth of transcatheter heart valve (THV) implantation independently predicted the need of PPI after TAVR and new PPI was associated with higher 1-year mortality, especially among patients with LV dysfunction.
  • These data suggest the need for careful THV selection and implantation in patients at risk for new PPI.

Study Questions:

What is the incidence, and what are the predictors and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV)?

Methods:

The investigators included 3,211 patients enrolled in the multicenter NEOPRO and NEOPRO-2 registries (January 2012–December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. Clinical outcomes at 1-year follow-up were calculated and compared between groups using the Kaplan-Meier method (log-rank p-value). Cox proportional hazard regression analysis was also performed to assess the prognostic impact of PPI on 1-year clinical outcomes.

Results:

New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons score for mortality, baseline right bundle branch block (RBBB), and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Pre-discharge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (p = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs. 10.8%; adjusted hazard ratio, 1.66; 95% confidence interval, 1.13-2.43; p = 0.010), particularly in patients with baseline EF <40% (p-interaction = 0.049).

Conclusions:

The authors report that new PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%.

Perspective:

This multicenter, observational registry study reports that new PPI at 30 days was needed in 11.3% of patients who underwent TAVR with SEV (Acurate neo or neo2, Evolut PRO or PRO+). Furthermore, baseline RBBB and lower depth of THV implantation independently predicted the need of PPI after TAVR and new PPI was associated with higher 1-year mortality, especially among patients with left ventricular (LV) dysfunction (i.e., LVEF <40%). These data suggest need for careful THV selection and implantation in patients at risk for new PPI, and alternative therapeutic options such as cardiac resynchronization therapy may be needed in patients with LV dysfunction needing PPI after TAVR. Additional studies are needed to better define predictors of advanced conduction disturbances after TAVR with SEV and to explore strategies to minimize the need of PPI.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, Arrhythmias, Cardiac, Bundle-Branch Block, Cardiac Surgical Procedures, Cardiac Resynchronization Therapy, Heart Failure, Heart Valve Diseases, Pacemaker, Artificial, Patient Discharge, Risk, Secondary Prevention, Stroke Volume, Transcatheter Aortic Valve Replacement, Ventricular Dysfunction, Left


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