Predictors and 5-Year Clinical Outcomes of Pacemaker After TAVR: Analysis From the PARTNER 2 SAPIEN 3 Registries

• Published in: JACC. Cardiovascular interventions Vol. 17; no. 11; p. 1325
• Main Authors: Chen, Shmuel, Dizon, Jose M, Hahn, Rebecca T, Pibarot, Philippe, George, Isaac, Zhao, Yanglu, Blanke, Philipp, Kapadia, Samir, Babaliaros, Vasilis, Szeto, Wilson Y, Makkar, Raj, Thourani, Vinod H, Webb, John G, Mack, Michael J, Leon, Martin B, Kodali, Susheel, Nazif, Tamim M
• Format: Journal Article
• Language: English
• Published: United States 10.06.2024
• Subjects: Aged; Aged, 80 and over; Aortic Valve - diagnostic imaging; Aortic Valve - physiopathology; Aortic Valve - surgery; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Arrhythmias, Cardiac - diagnosis; Arrhythmias, Cardiac - etiology; Arrhythmias, Cardiac - mortality; Arrhythmias, Cardiac - physiopathology; Arrhythmias, Cardiac - therapy; Cardiac Pacing, Artificial; Female; Heart Valve Prosthesis; Humans; Male; Pacemaker, Artificial; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Time Factors; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - instrumentation; Transcatheter Aortic Valve Replacement - mortality; Treatment Outcome; United States - epidemiology; United States; S3; THV; conduction disturbance; balloon-expandable; transcatheter aortic valve replacement; transcatheter heart valve; PPM; SAPIEN 3; TAVR; permanent pacemaker
• ISSN: 1876-7605; 1876-7605
• DOI: 10.1016/j.jcin.2024.03.034

Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV). The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV. The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR. Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02). PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth.