Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: results from a multicentre international randomized trial (PREVENT‐HF)

Abstract

See page 599 for the editorial comment on this article (doi:10.1093/eurjhf/hfr058) AimsPrevious experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing (VP), however, is required, and cannot be reduced in many patients with atrioventricular (AV) block. The PREVENT-HF study was an international randomized trial that explored differences in left ventricular (LV) remodelling during RV apical vs. biventricular (BIV) pacing in patients with AV block. Methods and ResultsPatients with an expected VP prevalence ≥80% were assigned to RV apical or BIV pacing. The primary endpoint was the change in LV end-diastolic volume (EDV) .12 months. Secondary endpoints were LV end-systolic volume (ESV), LV ejection fraction (EF), mitral regurgitation (MR), and a combination of heart failure (HF) events and cardiovascular hospitalizations. Overall, 108 patients were randomized (RV: 58; BIV: 50). Intention to treat and on-treatment analyses revealed no significant differences in any of the outcomes. Analysis of covariance (ANCOVA) difference for treatment according to randomization (in mL): LVEDV 23.92 (218.71 to 10.85), P ¼ 0.6; LVESV 21.38 (212.07 to 9.31), P ¼ 0.80; LVEF 2.47 (23.00 to 7.94), P ¼ 0.37. Analysis of covariance difference for the on-treatment analysis: LVEDV 24.90 (220.02 to 10.22, PP ¼ 0.52; LVESV 26.45 (217.28 to 4.38), P ¼ 0.24, LVEF 2.18 (23.37 to 7.73), P ¼ 0.44. Furthermore, secondary endpoints did not differ significantly. ConclusionThis study did not demonstrate significant LV volume differences .12 months between RV apical and BIV pacing for AV block. Thus, BIV pacing cannot be recommended as a routine treatment for AV block in these patients. However, the results encourage and inform the design of subsequent larger trials with higher power for detecting small volume changes. ClinicalTrials.gov Identifier: NCT00170326.--

TUGENDHAT: a pilot randomized study on effects of biventricular pacing in patients with bradycardia pacing indication and normal systolic function on heart failure, atrial fibrillation and quality of life (results of 12 month follow-up)

“…Comparison with other studies is diffi cult in this case because various evaluation approaches have been used. Nevertheless, slight to moderate improvements are usually stated, particularly in the Biv mode (25,29). Other evaluation end points -pacing parameters -acted according to expectations and in agreement with published results.…”

“…The authors further suggested that EF decreases rapidly in vulnerable patients and that these patients might benefi t even more from BiV pacing. (6) No signifi cant changes in EF were found in either of the observed groups in the PREVENT-HF trial (29). Decrease of EF in BiV patients was also found (30), which supports our conclusions that change of EF in relatively healthy patients is not a reliable end point for comparison of patients with various pacing modes.…”

Six Sigma DMAIC for Shaking Stagnant Construction Cultures – A Conceptual Perspective

“…These studies have tested "de novo" CRT implantation in patients with a conventional pacing indication, both with preserved left ventricular systolic function [67][68][69] and with moderate-severe left ventricular dysfunction [70][71][72]. The results suggest that CRT plays a preventive role with regard to HF mortality/hospitalizations only in patients with left ventricular dysfunction (LVEF <40%).…”

2013 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy

“…Pequeños estudios aleatorizados han señalado que los pacientes con disfunción del VI moderada-grave podrían beneficiarse de la TRC en lugar de la estimulación apical del VD convencional (tabla 15) [123][124][125][126][127][128][129][130] . En general, los objetivos primarios de estos estudios se sustituyeron por objetivos hemodinámicos.…”