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

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. 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. 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. 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. NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.

Krug D ，Zaman A ，Eidinger L ，Grehn M ，Boda-Heggemann J ，Rudic B ，Mehrhof F ，Boldt LH ，Hohmann S ，Merten R ，Buergy D ，Fleckenstein J ，Kluge A ，Rogge A ，Both M ，Rades D ，Tilz RR ，Olbrich D ，König IR ，Siebert FA ，Schweikard A ，Vonthein R ，Bonnemeier H ，Dunst J ，Blanck O ... -  《-》

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA).

Blanck O ，Buergy D ，Vens M ，Eidinger L ，Zaman A ，Krug D ，Rudic B ，Boda-Heggemann J ，Giordano FA ，Boldt LH ，Mehrhof F ，Budach V ，Schweikard A ，Olbrich D ，König IR ，Siebert FA ，Vonthein R ，Dunst J ，Bonnemeier H ... -  《-》

Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia.

Robinson CG ，Samson PP ，Moore KMS ，Hugo GD ，Knutson N ，Mutic S ，Goddu SM ，Lang A ，Cooper DH ，Faddis M ，Noheria A ，Smith TW ，Woodard PK ，Gropler RJ ，Hallahan DE ，Rudy Y ，Cuculich PS ... -  《-》

Stereotactic body radiotherapy for ventricular tachycardia (cardiac radiosurgery) : First-in-patient treatment in Germany.

Krug D ，Blanck O ，Demming T ，Dottermusch M ，Koch K ，Hirt M ，Kotzott L ，Zaman A ，Eidinger L ，Siebert FA ，Dunst J ，Bonnemeier H ... -  《-》

[Refractory ventricular tachycardia: Is there a role for radiotherapy?].

Myocardial scar-related ventricular tachycardia is a serious and potentially life-threatening arrhythmia. The prevention of sudden rhythmic death and ventricular tachycardia recurrence relies on implantable cardioverter defibrillator (ICD), anti-arrhythmic drugs and more recently on radiofrequency catheter ablation. Nevertheless, these approaches have their own risk of adverse events and complications, with a recurrence rate up to 50 % at 2 years. Stereotactic body radiotherapy, delivered in a single dose of 25Gy, has emerged as a new therapeutic tool in the management of highly refractory ventricular tachycardia. In 2017, the very first prospective 5-patient cohort suffering from recurrent ventricular tachycardia on structural heart disease (40 % of ischemic cardiomyopathy) who benefited from cardiac stereotactic body radiotherapy was published. After stereotactic body radiotherapy, the authors observed a strong ventricular tachycardia burden reduction at 12 months, with no major side effects. Since then, around 100 cases have been described in the literature, particularly in the prospective ENCORE-VT study, with positive short- and medium-term outcomes in terms of safety and ventricular tachycardia burden reduction. Recently, another American prospective 5-patient series, published in March 2020, mitigated these results since all patients presented a ventricular tachycardia recurrence at 12 months despite an initial reduction in ventricular tachycardia burden. This article describes the use of stereotactic body radiotherapy in refractory VT, the rationale of the technique, its implementation, preliminary results and potential acute and long-term consequences.

Jumeau R ，Pruvot É ，Thariat J ，Latorzeff I ，Milliez PU ，Champ-Rigot L ，De Crevoisier R ，Ferchaud V ... -  《-》