BUDAPEST CRT Upgrade: Does an Upgrade to CRT-D Benefit Patients With HFrEF?

When compared with an ICD, an upgrade to CRT-D reduced morbidity and mortality and improved left ventricular (LV) reverse remodeling in select patients with heart failure and reduced ejection fraction (HFrEF) and intermittent or permanent right ventricular (RV) pacing, according to findings from the BUDAPEST CRT Upgrade trial presented at ESC Congress 2023.

The trial enrolled a total of 360 patients from 17 sites in seven countries and randomly assigned them 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. Patients were excluded if they were eligible for CRT according to current guidelines, had severe RV dilation, had severe valvular heart disease, had severe renal impairment, or had survived an acute myocardial infarction or coronary revascularization in the previous three months.

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 arm over a median of 12.4 months. The beneficial effect of a CRT-D upgrade was consistent across all prespecified subgroups.

In terms of secondary endpoints, the composite of HF hospitalization and all-cause mortality was lower in the CRT-D group compared with the ICD group. LV morphological and functional response based on echocardiography also favored CRT-D compared with ICD, researchers said, with 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%.

In other findings, the rate of serious adverse events was lower by nearly half in the CRT-D group (30.2%), compared with the ICD group (60%). No significant difference in the incidence of procedure- or device-related complications was observed, however, the occurrence of major ventricular arrhythmias was substantially lower in the CRT-D arm (1/215 patients) compared with the ICD arm (21/145 patients).

“The findings support performing an CRT upgrade in this patient population,” said Béla Merkely, PhD, DSc, FACC, of Semmelweis University, Budapest, Hungary. “HFrEF patients with a pacemaker or ICD should be strictly followed in clinical practice and in those with intermittent or permanent RV pacing, a CRT upgrade should be performed immediately without deferring the procedure to a later date (e.g., battery replacement) to avoid or reduce the risk of further adverse events such as mortality, HF hospitalization or LV remodeling.”