Risen from the dead: Cardiac stereotactic ablative radiotherapy as last rescue in a patient with refractory ventricular fibrillation storm

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

“…However, a discussion on the proper primary endpoint of such trials is necessary. Currently, there are a growing number of case reports and small retrospective case series in the literature [19,20,[24][25][26][27][28][29][30][31], but only one "phase I/II trial", i.e., pilot-stage clinical investigation which reported results so far [22,23]. The primary endpoint of this single-center trial (NCT02919618) was safety and the authors demonstrated that RA/CRS for VT is feasible.…”

“…Finally, we added initial technical, pre-clinical, and clinical manuscripts not covered by the search based on our own experience in cardiac radiosurgery in the past 12 years. Evidence was finally extracted from the remaining 42 manuscripts, which include reports on two clinical trials [22,23], two clinical case series [24,25], eight case reports [19,20,[26][27][28][29][30][31], eight preclinical studies [18,[32][33][34][35][36][37][38][39], fourteen technical studies [40][41][42][43][44][45][46][47][48][49][50][51][52][53], and eight reviews or opinions [7,[54][55][56][57][58][59][60].…”

“…Since then, five more case reports have been published for VT RA/CRS [27][28][29][30][31] and more are likely under review. In those case reports, RA/CRS as rescue procedure for electrical storm from VT [27] or fibrillation [30] or as a treatment option for recurrent VT with high-resolution mapping [31] or secondary to a cardiac fibroma [28] or lipoma [29] have been reported. On the other hand, only one case report for RA/CRS for AF has been reported until today, and even though the results seem to indicate scarring based on late enhancement MRI, the actual AF was still persisting [20].…”

“…The target region, which basically consists of endocardial measurement points that are registered to the CCT, will then be transferred to or re-created on the primary PCT. This could either be done via dedicated registration and visualization software (if available) or done by manually re-creating the target surface region from the EPM (with registered CCT) on the co-registered PCT using 3D contouring on the segmented left ventricle in the radiation treatment planning systems (RTPS) according to the current clinical standards [19,20,[22][23][24][25][26][27][28][29][30][31]. For the latter, an in-house system available to participating centers will be used to jointly display both the target region from the EPM and the re-created surface from the RTPS.…”

“…This primary endpoint was chosen to ensure the early study termination which should be any major concern in the immediate time after radiosurgery arise. Based on the previous clinical data [19,20,[22][23][24][25][26][27][28][29][30][31] for this endpoint, we assume that RA/CRS is feasible and safe in at least 70% (study stopping rule) and ideally in ≥ 95% of the treated patients.…”