Pacemaker Implantation After Valve-in-Valve TAVR
- In a large valve-in-valve (ViV) TAVR registry, incidence of permanent pacemaker implantation (PPI) after ViV TAVR was low at 6.4%, and even lower (4.7%) with newer-generation TAVR valves.
- Older age, larger size of implanted TAVR valve, and baseline right bundle branch block were risk factors for PPI.
- Need for PPI after ViV TAVR was associated with worse survival in mid-term follow-up.
What are the incidences, associated factors, and clinical impact of permanent pacemaker implantation (PPI) after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR)?
This is a retrospective review of the VIVID (Valve-in-Valve International Database) Registry, a collaboration of 180 centers from the Americas, Europe, Middle East, Asia, Africa, and Oceania. Many different types of balloon-expandable valves (BEVs) (Cribier-Edwards, Sapien, Sapien XT, Sapien 3, Myval) and self-expanding valves (SEVs) (CoreValve, Evolut R/Pro, Portico, Engager, Symetis Acurate, Acurate Neo, JenaValve, Lotus, Allegra, Direct Flow) were implanted in prior surgical valves. Baseline patient and procedural characteristics were collected. In-hospital PPI and other major periprocedural complications were assessed using the Valve Academic Research Consortium (VARC)-2 criteria. Binary logistic regression was used to determine correlates for PPI after ViV TAVR. Proportional hazards modeling (univariable and adjusted) was used to compare mortality between PPI and no PPI groups. Kaplan-Meier time-to-event analysis was performed.
A total of 1,987 patients without prior PPI who underwent ViV TAVR from April 2007–April 2020 were included. Mean age was 77.6 ± 9.4 years and median Society of Thoracic Surgeons score for mortality was 6.1% (interquartile [IQR] range, 3.9-10.3%). 83.8% had a previous stented (as opposed to stentless) surgical valve, and mode of surgical valve failure was mixed in 49.5%. Access was transfemoral in 78.3%, and general anesthesia was used in 61.7% of cases. Median follow-up was 12.9 months (IQR, 2.9-41 months).
Incidence of in-hospital PPI was 6.4% (n = 128). Patients who underwent PPI were older (p < 0.001), had more peripheral vascular disease (p = 0.017), and had more frequently received an early-generation (p = 0.017) and larger (p = 0.03) TAVR valve. Type of previous surgical bioprosthesis, mechanism of valve dysfunction, and type of TAVR valve (BEV vs. SEV) were not significantly associated with PPI. Higher incidence of PPI was seen in early-generation self-expanding versus balloon-expandable valves (9.0% vs. 5.2%, p = 0.01). There was a significantly decreased incidence of PPI with newer-generation compared to early-generation valves (4.7% vs. 7.4%, p = 0.017), mostly related to lower incidence after newer- vs. early-generation SEV. In multivariable logistic regression analysis, older age (odds ratio [OR], 1.05; 95% confidence interval [CI], 1.02-1.07; p = 0.001), larger TAVR valve size (OR, 1.10; 95% CI, 1.01-1.20; p = 0.02), and baseline right bundle branch block (RBBB) (OR, 2.04; 95% CI, 1.00-4.17; p = 0.05) were independently associated with increased risk of PPI after ViV TAVR.
Incidence of stroke, major bleeding, major vascular complication, and coronary obstruction was not significantly different between the PPI and no PPI groups, but there was higher incidence of acute kidney injury in the former (11.5% vs. 4.8%, p = 0.001). Thirty-day mortality was not significantly different (PPI 4.7% vs. no PPI 2.7%, p = 0.19). Need for new PPI after ViV TAVR conferred higher risk of any-cause mortality at mid-term follow-up (hazard ratio, 1.39; 95% CI, 1.02-1.91; p = 0.04).
ViV TAVR is associated with relatively low incidence of PPI, with significant risk factors being older age, larger size of implanted TAVR valve, and baseline RBBB. Those who need PPI after ViV TAVR have worse mortality in mid-term follow-up.
This study shows much lower incidence of PPI after ViV TAVR compared to that after TAVR in native valve, as published in trials and other registries. This may be due to the TAVR being seated within a surgical frame with less direct contact with the conduction system, as well as more favorable positioning that is facilitated by the visualized stented frame of a surgical valve under fluoroscopy. The lower incidence of PPI can inform “fast-track”-type procedural protocols for management of the temporary transvenous pacing wire and earlier discharge. Those patients who do require PPI should be carefully monitored for PPI-related ventricular dysfunction that may be especially deleterious in the higher risk ViV patient population and amenable to interventions like resynchronization therapy.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), EP Basic Science, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Nuclear Imaging
Keywords: Acute Kidney Injury, Anesthesia, General, Bioprosthesis, Bundle-Branch Block, Cardiac Surgical Procedures, Fluoroscopy, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Patient Discharge, Peripheral Vascular Diseases, Risk Factors, Stents, Transcatheter Aortic Valve Replacement, Vascular Diseases, Ventricular Dysfunction
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