Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial

Béla Merkely, Robert Hatala, Jerzy K Wranicz, Gábor Duray, Csaba Földesi, Zoltán Som, Marianna Németh, Kinga Goscinska-Bis, László Gellér, Endre Zima, István Osztheimer, Levente Molnár, Júlia Karády, Gerhard Hindricks, Ilan Goldenberg, Helmut Klein, Mátyás Szigeti, Scott D Solomon, Valentina Kutyifa, Attila Kovács, Annamária Kosztin, Béla Merkely, Robert Hatala, Jerzy K Wranicz, Gábor Duray, Csaba Földesi, Zoltán Som, Marianna Németh, Kinga Goscinska-Bis, László Gellér, Endre Zima, István Osztheimer, Levente Molnár, Júlia Karády, Gerhard Hindricks, Ilan Goldenberg, Helmut Klein, Mátyás Szigeti, Scott D Solomon, Valentina Kutyifa, Attila Kovács, Annamária Kosztin

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.

Keywords: Cardiac resynchronization therapy; Heart failure; Pacing-induced cardiomyopathy; Right ventricular pacing; Upgrade.

© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Structured Graphical Abstract
Structured Graphical Abstract
Main inclusion criteria and randomization by arms showing the result of 360 patients (215 CRT-D vs. 145 ICD) analysed by intention to treat. Primary and secondary outcomes showing a substantial treatment effect of CRT-D compared with ICD alone. Among patients with HF and reduced LVEF with intermittent or permanent RV pacing, CRT-D upgrade resulted in a lower incidence of the composite of all-cause mortality, HF hospitalization, or

Figure 1

Event rate of the primary…

Figure 1

Event rate of the primary composite outcome in the implantable cardioverter defibrillator and…

Figure 1
Event rate of the primary composite outcome in the implantable cardioverter defibrillator and cardiac resynchronization therapy with defibrillator arms and its components: first occurrence of heart failure hospitalization with or without subsequent all-cause death, all-cause death without previous heart failure hospitalization, and

Figure 2

( A ) All-cause mortality…

Figure 2

( A ) All-cause mortality and heart failure hospitalization. ( B ) All-cause…

Figure 2
(A) All-cause mortality and heart failure hospitalization. (B) All-cause mortality. (C) Heart failure hospitalization. Kaplan–Meier estimates for secondary outcomes. (A) The Kaplan–Meier curves for the secondary composite outcome of first occurrence of all-cause mortality or heart failure hospitalization. (B) The Kaplan–Meier curves for death from any cause. (C) The Kaplan–Meier curves for heart failure hospitalization. CI, confidence interval; CRT-D, cardiac resynchronization therapy with defibrillator; ICD, implantable cardioverter defibrillator.

Figure 3

Primary composite outcome, according to…

Figure 3

Primary composite outcome, according to prespecified subgroups.

Figure 3
Primary composite outcome, according to prespecified subgroups.
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References
    1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009—a World Society of Arrhythmia’s project. Pacing Clin Electrophysiol 2011;34:1013–27. 10.1111/j.1540-8159.2011.03150.x - DOI - PubMed
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Figure 1
Figure 1
Event rate of the primary composite outcome in the implantable cardioverter defibrillator and cardiac resynchronization therapy with defibrillator arms and its components: first occurrence of heart failure hospitalization with or without subsequent all-cause death, all-cause death without previous heart failure hospitalization, and

Figure 2

( A ) All-cause mortality…

Figure 2

( A ) All-cause mortality and heart failure hospitalization. ( B ) All-cause…

Figure 2
(A) All-cause mortality and heart failure hospitalization. (B) All-cause mortality. (C) Heart failure hospitalization. Kaplan–Meier estimates for secondary outcomes. (A) The Kaplan–Meier curves for the secondary composite outcome of first occurrence of all-cause mortality or heart failure hospitalization. (B) The Kaplan–Meier curves for death from any cause. (C) The Kaplan–Meier curves for heart failure hospitalization. CI, confidence interval; CRT-D, cardiac resynchronization therapy with defibrillator; ICD, implantable cardioverter defibrillator.

Figure 3

Primary composite outcome, according to…

Figure 3

Primary composite outcome, according to prespecified subgroups.

Figure 3
Primary composite outcome, according to prespecified subgroups.
Figure 2
Figure 2
(A) All-cause mortality and heart failure hospitalization. (B) All-cause mortality. (C) Heart failure hospitalization. Kaplan–Meier estimates for secondary outcomes. (A) The Kaplan–Meier curves for the secondary composite outcome of first occurrence of all-cause mortality or heart failure hospitalization. (B) The Kaplan–Meier curves for death from any cause. (C) The Kaplan–Meier curves for heart failure hospitalization. CI, confidence interval; CRT-D, cardiac resynchronization therapy with defibrillator; ICD, implantable cardioverter defibrillator.
Figure 3
Figure 3
Primary composite outcome, according to prespecified subgroups.

References

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