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Journal Article Randomized Controlled Trial Multicenter Study Comparative Study Comment Ppublish 1 citation

PubMed: 41811324 DOI: 10.1001/jamacardio.2026.0101

Conduction System vs Biventricular Pacing in Heart Failure: The PhysioSync-HF Randomized Clinical Trial.

JAMA Cardiol 11(4):360-368

Authors: André Zimerman, Alexander Dal Forno, Luis E Rohde, Caique M Ternes, Fernanda D Alves, Lucas P Damiani, Martino Martinelli-Filho, Roberto Costa, Alexsandro A Fagundes, Rodrigo M Barbosa, Eduardo B Gadelha, Carlos Eduardo Lima, Márcio A Silva, Jaime A Maldonado, Julio César de Oliveira, Fabricio Mallmann, José M Baggio Júnior, Carlos E Duarte, Liliane A de Souza, Juliana S Santos, Anderson D Silveira, Sérgio R R Decker, Leandro I Zimerman, Carisi A Polanczyk, André d'Avila

Affiliations

  • MOVE Academic Research Organization, Hospital Moinhos de Vento, Moinhos de Vento Medical School, Porto Alegre, Brazil.
  • Cardiology Division, Hospital Moinhos de Vento, Porto Alegre, Brazil.
  • Postgraduate Program in Cardiology and Cardiovascular Sciences, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
  • Research Projects Office, Hospital Moinhos de Vento, Porto Alegre, Brazil.
  • Hospital SOS Cardio, Florianópolis, Brazil.
  • Cardiology Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
  • Brazilian Clinical Research Institute, São Paulo, Brazil.
  • Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
  • Department of Cardiology, Instituto do Coração, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.
  • Cardiac Pacing Division, Department of Cardiovascular Surgery, Instituto do Coração, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.
  • Discipline of Cardiovascular Surgery, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, São Paulo, Brazil.
  • Hospital Ana Nery, Salvador, Brazil.
  • Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil.
  • Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil.
  • Hospital Universitário da Universidade Federal do Piauí, Teresina, Brazil.
  • Hospital Universitário Cassiano Antonio de Moraes, Vitória, Brazil.
  • Fundação Hospitalar do Coração Francisca Mendes, Manaus, Brazil.
  • Hospital Geral Universitário de Cuiabá, Cuiabá, Brazil.
  • Instituto de Cardiologia de Santa Catarina, São José, Brazil.
  • Instituto de Cardiologia do Distrito Federal, Brasília, Brazil.
  • Hospital Beneficência Portuguesa, São Paulo, Brazil.
  • Internal Medicine Division, Hospital Moinhos de Vento, Porto Alegre, Brazil.
  • Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
  • Harvard-Thorndike Electrophysiology Institute, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

Abstract

IMPORTANCE

Conduction system pacing (CSP) is a promising and potentially cost-effective alternative to biventricular pacing (BiVP) in patients with heart failure with reduced ejection fraction (HFrEF) and left bundle-branch block (LBBB), but its impact on heart failure (HF) outcomes remains uncertain.

OBJECTIVE

To compare CSP vs BiVP on an HF-related outcome in patients with HFrEF and LBBB.

DESIGN, SETTING, AND PARTICIPANTS

PhysioSync-HF (Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure) was an investigator-initiated, multicenter, noninferiority randomized clinical trial enrolling participants from November 2022 to December 2023 with 12 months of follow-up at 14 hospitals across all regions of Brazil. Adults with symptomatic HFrEF (New York Heart Association NYHA] classes II through III), left ventricular ejection fraction (LVEF) of 35% or less, and LBBB (QRS duration ≥130 milliseconds) were eligible for inclusion. Data were analyzed from May to August 2025.

INTERVENTION

Patients were randomized 1:1 to either CSP (preferentially left bundle-branch area pacing) or BiVP.

MAIN OUTCOMES AND MEASURES

The primary outcome was a hierarchical composite of death, HF hospitalizations, urgent HF visits, and change in LVEF at 12 months. The prespecified noninferiority margin for the odds ratio (OR) was 1.2.

RESULTS

A total of 173 patients (median [IQR] age, 62 years [56-68]; 86 female patients [49.7%]; 115 (66.5%) with dilated cardiomyopathy; median [IQR] LVEF, 26% [22%-31%]; median [IQR] QRS, 180 milliseconds [170-200]) were included. At 12 months, CSP failed to meet noninferiority and was inferior to BiVP for the primary end point (OR, 2.36; 95% CI, 1.37-4.06; P = .99 for noninferiority; P = .002 for between-group difference). The time-to-event composite of death, HF hospitalizations, or urgent HF visits was higher in CSP (hazard ratio, 2.35; 95% CI, 0.99-5.61). Mean (SD) LVEF increased to 35% (12%) with CSP and 39% (12%) with BiVP (mean difference, 3.8%; 95% CI, 0.3%-7.3%). Relative to baseline, both groups had comparable improvements in QRS duration, Kansas City Cardiomyopathy Questionnaire Overall Summary Score, NYHA class, and natriuretic peptide levels. Total direct medical cost related to the procedure and heart failure care was the equivalent of 7090 (95% CI, 5779-8648) lower in patients randomized to CSP at 12 months.

CONCLUSIONS AND RELEVANCE

In patients with HFrEF and LBBB, CSP was inferior to BiVP for a composite of death, HF hospitalizations, urgent HF visits, and change in LVEF at 12 months. These findings do not support the routine use of CSP as the first-line resynchronization strategy in this population.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05572736.

MeSH

Hospitalization, Heart Failure, Heart, Cardiovascular Diseases, Heart Failure, Systolic