SOLACI | Latin American Society of Interventional Cardiology

Approximately 1 million pacemakers (PM) or Implantable cardioverter-defibrillators (ICDs) are placed every year around the world, and it has been observed that 30% of these cases present left ventricular dysfunction, mainly systolic. This dysfunction is attributed to PM induced right ventricle dyssynchrony, which in time leads to hospitalization for cardiac failure and increased clinical adverse events.

In order to correct the above mentioned dyssynchrony, an upgrade was proposed from ICDs to cardiac resynchronization therapy with a defibrillator (CRT-D) via the coronary sinus.

The BUDABEST-CRT Upgrade is the first to compare the efficacy and safety of the improved CRT-D vs. ICD alone in patients with cardiac failure and reduced ejection fraction (Fey ≤35% with ICD or PM within 6 months prior procedure), with symptomatic cardiac failure and a wide paced QRS complex (≥150 ms), a high burden of RV pacing (≥20%), severe valve disease, kidney deterioration or having survived MI or revascularization within 3 months prior procedure.

Patients were randomized 3 : 2. Primary end point was a combination of events, including hospitalization for CF, all-cause mortality and reduced end systolic volume below 15%. Secondary end point included a combination of hospitalization for CF, all-cause mortality and echocardiographic assessment of response.

The study enrolled a total 360 patients from 17 centers in 7 countries. These participants were randomly assigned, leaving 215 in the CRT-D and 145 in the ICD group. Patient mean age was 72, and 11% were women. At mean 12.4 month followup, primary end point was observed in 32.4% of CRT-D patients and 78.9% in ICD patients (adjusted odds ratio 0.11; CI 95%: 0.06-0.19; P<0.001). The benefit of CRT-Ds remained constant across subgroups.