Name of the Study: BUDAPEST CRT Upgrade: Does an Upgrade to CRT-D Benefit Patients with HFrEF?

Reviwer: Dr. Tuğba ÇETİN

Published Congress: ESC 2023

Link: https://www.acc.org/latest-in-cardiology/articles/2023/08/23/19/16/sat-252am-budapest-crt-esc-2023

Background:

Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in patients with heart failure (HF) with reduced ejection fraction (HFrEF) and electrical dyssynchrony but outcome effects of CRT in pacing -induced HF have not been studied in a large randomized controlled trial (RCT). The study shows impressive and significant reductions in the primary combined endpoint of time to first HF hospitalizations and mortality or more than 15% reduction in left ventricular (LV) volume (LVESV) in patients randomized from previous pacemaker (PM) or implantable cardioverter defibrillator (ICD) to upgrading to CRT-D or ICD.

Objective:

The purpose of this study is to evaluate the efficacy and safety of a CRT upgrade, compared to ICD alone, in HFrEF patients with a pacemaker or ICD and intermittent or permanent RV pacing.

Methods:

A total of 360 patients were enrolled from 17 sites in seven countries and randomly assigned to receive a CRT-D (n=215) or an ICD (n=145). The mean age was 72.8 years and 11.1% were women. All patients had HF symptoms, reduced ejection fraction (≤35%), wide paced QRS complex (≥150 ms), and a high burden of RV pacing (≥20%). They had also received a pacemaker or ICD at least six months previously and were being treated with guideline-directed medical therapy.

Results:

In total 360 HF patients, (most commonly NYHA II-III), with low mean LVEF (25%) and well-treated with GDMT for HF were included. Many (54-60%) had atrial fibrillation at baseline and more than 50% had experienced a HF hospitalization (HFH) within the preceding year. The primary outcome was the composite of HF hospitalization, all-cause mortality, or < 15% reduction of LV end-systolic volume. In overall findings, this primary outcome occurred in 58 of the 179 patients (32.4%) in the CRT-D arm and 101 of the 128 patients (78.9%) in the ICD. Over a mean of 12.8 months the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm and in 101/128 (78.9%) in the ICD arm [adjusted odds ratio (OR) 0.11; 95% confidence interval (CI), 0.06 to 0.19; p<0.001]. LV morphological and functional response based on echocardiography also favoured CRT-D compared with ICD and this study showed a difference at 12 months in LV end-diastolic volume of -39.00 mL and a difference at 12 months in LV ejection fraction of 9.76%. Despite of a high rate of serious adverse events was reported in the BUDAPEST CRT Upgrade study, they were not restricted to device or procedure related complications. Lead extractions were somewhat higher in the CRT- than in the ICD group (15,1% vs 18 11.3%), procedure or device related complications were indeed higher in the CRT group (12.3% 19 vs 7.8%). The rate of serious adverse events was lower by nearly half in the CRT-D group (30.2%), compared with the ICD group (60%).

Conclusion:

Until now because of its complications upgrading to CRT has been postponed or not considered suitable. Such a delay is associated with risk of unnecessary aggravation of the HF condition. The results of the BUDAPEST-CRT Upgrade study call for careful monitoring of LV function, RV pacing and HF symptoms to identify patients in need for upgrading to CRT.

Interpretations:

Although a high rate of serious adverse events was reported in CRT-D upgrade, complications should not defer from CRT upgrading that holds the promise of improving outcomes in patients with heart failure.