Upgrade of right ventricular pacing to cardiac resynchronisation therapy in heart failure : a randomised trial

Merkely, Béla Péter and Hatala, Robert and Wranicz, Jerzy K and Duray, Gábor and Földesi, Csaba and Som, Zoltán and Németh, Marianna and Goscinska-Bis, Kinga and Gellér, László Alajos and Zima, Endre István and Osztheimer, István and Molnár, Levente Domonkos and Karády, Júlia and Hindricks, Gerhard and Goldenberg, Ilan and Klein, Helmut and Szigeti, Mátyás and Solomon, Scott D. and Kutyifa, Valentina and Kovács, Attila and Kosztin, Annamária (2023) Upgrade of right ventricular pacing to cardiac resynchronisation therapy in heart failure : a randomised trial. EUROPEAN HEART JOURNAL, 44 (40). pp. 4259-4269. ISSN 0195-668X

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Abstract

Background and Aims: De novo implanted cardiac resynchronization therapy with defibrillator (CRT-D) reduces the risk of morbidity and mortality in patients with left bundle branch block, heart failure and reduced ejection fraction (HFrEF). However, among HFrEF patients with right ventricular pacing (RVP), the efficacy of CRT-D upgrade is uncertain. Methods: In this multicentre, randomized, controlled trial, 360 symptomatic (New York Heart Association Classes II–IVa) HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD), high RVP burden ≥ 20%, and a wide paced QRS complex duration ≥ 150 ms were randomly assigned to receive CRT-D upgrade (n = 215) or ICD (n = 145) in a 3:2 ratio. The primary outcome was the composite of all-cause mortality, heart failure hospitalization, or <15% reduction of left ventricular end-systolic volume assessed at 12 months. Secondary outcomes included all-cause mortality or heart failure hospitalization. Results: Over a median follow-up of 12.4 months, the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm vs. 101/128 (78.9%) in the ICD arm (odds ratio 0.11; 95% confidence interval 0.06–0.19; P < .001). All-cause mortality or heart failure hospitalization occurred in 22/215 (10%) in the CRT-D arm vs. 46/145 (32%) in the ICD arm (hazard ratio 0.27; 95% confidence interval 0.16–0.47; P < .001). The incidence of procedure- or device-related complications was similar between the two arms [CRT-D group 25/211 (12.3%) vs. ICD group 11/142 (7.8%)]. Conclusions: In pacemaker or ICD patients with significant RVP burden and reduced ejection fraction, upgrade to CRT-D compared with ICD therapy reduced the combined risk of all-cause mortality, heart failure hospitalization, or absence of reverse remodelling.

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