BERLIN-VT: Timing of ventricular tachycardia ablation does not affect mortality in patients with MI, ICD
SAN FRANCISCO — Among patients with ventricular tachycardia indicated for an implantable cardioverter defibrillator after MI, preventive ventricular tachycardia ablation before ICD implantation did not improve mortality and HF hospitalization compared with deferred ablation, according to the results of the BERLIN-VT study.
The researchers conducted a randomized controlled trial of patients with a history of MI, left ventricular ejection fraction 30% to 50% and sustained ventricular tachycardia (VT) within 30 days before enrollment who were planned for ICD implantation.
“It has been shown in retrospective analyses that shocks are associated with increased mortality in this population compared with patients who had an ICD but no shocks,” Karl-Heinz Kuck, MD, PhD, director of cardiology at Asklepios Klinik St. Georg in Hamburg, Germany, said during a press conference at the Heart Rhythm Society Annual Scientific Sessions. “In addition, multiple observational trials have shown that catheter ablation is able to reduce ICD shocks, and preventive trials have shown that if you do an ablation in a patient with ischemic heart disease before you implant the ICD, compared with the control group, there is a significant reduction in ICD shocks, appropriate shocks, inappropriate shocks and VT/[ventricular fibrillation] recurrences. It had not been shown whether that had any effect on mortality.”
The primary outcome was time to first event including all-cause mortality, unplanned congestive HF hospitalization or unplanned hospitalization for VT/ventricular fibrillation (VF).
There were three planned interim analyses, and after the second one, the data safety and monitoring board recommended the trial be terminated for futility, Kuck said.
When the trial was stopped, 163 patients had been randomly assigned to preventive VT ablation (n = 76; mean age, 66 years; 88% men) or deferred ablation (n = 83; mean age, 66 years; 87% men), in which ablation would be administered after the third appropriate ICD shock, he said.
He noted 69 patients in the preventive group and 10 patients in the deferred group actually underwent ablation.
There was no difference between the groups in the primary endpoint (HR = 1.09; 95% CI, 0.62-1.92), according to the researchers.
The groups also did not significantly differ in all-cause death (HR = 2.97; 95% CI, 0.6-14.7) or hospitalization for VT/VF (HR = 0.69; 95% CI, 0.35-1.33), but hospitalization for worsening HF (HR = 4.37; 95% CI, 0.93-20.6) favored the deferred group when a log-rank P test was applied, Kuck said.
However, the secondary endpoints of sustained VT/VF (HR = 0.62; 95% CI, 0.38-1) and appropriate ICD therapy (HR = 0.55; 95% CI, 0.33-0.91) both favored the preventive group, he said.
“We think the optimal time for VT ablation might be later than preventive but probably prior to third appropriate shock,” Kuck said during the press conference. “Probably between the first and second shocks, because many patients and physicians feel that after one shock, patients should undergo catheter ablation.” – by Erik Swain
Kuck KH, et al. LBCT03-03. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 8-11, 2019; San Francisco.
Disclosure: The study was sponsored by Biotronik. Kuck reports he has financial ties with Abbott, Apama, Biosense Webster, Biotronik, Cardiac Implants, Cardiofocus, Edwards Lifesciences, Jena Valve, Khalila, Medtronic, MTEx, Stereotaxis, SynapticMed and Valtech.