Radiosurgery for ventricular tachycardia (RAVENTA): interim analysis of a multicenter multiplatform feasibility trial

Abstract

Background Single-session cardiac stereotactic radiation therapy (SBRT) has demonstrated promising results for patients with refractory ventricular tachycardia (VT). However, the full safety profile of this novel treatment remains unknown and very limited data from prospective clinical multicenter trials are available. Methods The prospective multicenter multiplatform RAVENTA (radiosurgery for ventricular tachycardia) study assesses high-precision image-guided cardiac SBRT with 25 Gy delivered to the VT substrate determined by high-definition endocardial and/or epicardial electrophysiological mapping in patients with refractory VT ineligible for catheter ablation and an implanted cardioverter defibrillator (ICD). Primary endpoint is the feasibility of full-dose application and procedural safety (defined as an incidence of serious [grade ≥ 3] treatment-related complications ≤ 5% within 30 days after therapy). Secondary endpoints comprise VT burden, ICD interventions, treatment-related toxicity, and quality of life. We present the results of a protocol-defined interim analysis. Results Between 10/2019 and 12/2021, a total of five patients were included at three university medical centers. In all cases, the treatment was carried out without complications. There were no serious potentially treatment-related adverse events and no deterioration of left ventricular ejection fraction upon echocardiography. Three patients had a decrease in VT episodes during follow-up. One patient underwent subsequent catheter ablation for a new VT with different morphology. One patient with local VT recurrence died 6 weeks after treatment in cardiogenic shock. Conclusion The interim analysis of the RAVENTA trial demonstrates early initial feasibility of this new treatment without serious complications within 30 days after treatment in five patients. Recruitment will continue as planned and the study has been expanded to further university medical centers. Trial registration number NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.

MR-LINAC, a New Partner in Radiation Oncology: Current Landscape

“…In 2017, Cuculich et al [106] published their experience with five patients treated with single-fraction SBRT (25 Gy), with a 99.9% reduction in tachycardia episodes in the following 46 months. Data from the RAVENTA trial also support this approach in a further report on its safety [107].…”

Cardiac Arrhythmias in Patients Treated for Lung Cancer: A Review

“…Meta-analysis of seven observational studies with a total of 61 patients showed that six months after STAR, the VT burden reduction was 92%, accompanied with an 86% reduction in the number of ICD shocks [62]. Several small prospective trials were recently published [63][64][65][66][67]. These studies primarily focused on safety and indicated that STAR has acceptable short-term toxicity with no significant concerns regarding acute cardiac toxicity.…”