Noninvasive Cardioablation

Refaat, Marwan M.; Zakka, Patrick; Youssef, Bassem; Zeidan, Youssef H.; Geara, Fadi; Al‐Ahmad, Amin

doi:10.1016/j.ccep.2019.05.008

Cited by 10 publications

(11 citation statements)

References 14 publications

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“…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].…”

Section: Clinical Trial and Literature Reviewmentioning

confidence: 99%

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

et al. 2020

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Background Single-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular tachycardia (VT). In the initial single-center case studies and feasibility trials, cardiac radiosurgery has led to significant reductions of VT burden with limited toxicities. However, the full safety profile remains largely unknown. Methods/design In this multi-center, multi-platform clinical feasibility trial which we plan is to assess the initial safety profile of radiosurgery for ventricular tachycardia (RAVENTA). High-precision image-guided single-session radiosurgery with 25 Gy will be delivered to the VT substrate determined by high-definition endocardial electrophysiological mapping. The primary endpoint is safety in terms of successful dose delivery without severe treatment-related side effects in the first Jürgen Dunst and Hendrik Bonnemeier have equally contributed to this work. This is the first publication for the RAVENTA study.

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Section: Clinical Trial and Literature Reviewmentioning

confidence: 99%

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

et al. 2020

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“…On the other side, differently from standard ablation procedures, which lead to an immediate reduction of VT events, SBRT is supposed to manifest its therapeutic effects after months [29,37]. Indeed, in the 6-8 week period following SBRT, corresponding to the "blanking period," VT episodes may theoretically even be facilitated, given the complex maturation process of the lesion caused by SBRT [16][17][18]21].…”

Section: Discussionmentioning

confidence: 99%

STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study

Carbucicchio

Jereczek-Fossa

Andreini

et al. 2020

J Interv Card Electrophysiol

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Background Ventricular tachycardia (VT) is a life-threatening condition, which usually implies the need of an implantable cardioverter defibrillator in combination with antiarrhythmic drugs and catheter ablation. Stereotactic body radiotherapy (SBRT) represents a common form of therapy in oncology, which has emerged as a well-tolerated and promising alternative option for the treatment of refractory VT in patients with structural heart disease. Objective In the STRA-MI-VT trial, we will investigate as primary endpoints safety and efficacy of SBRT for the treatment of recurrent VT in patients not eligible for catheter ablation. Secondary aim will be to evaluate SBRT effects on global mortality, changes in heart function, and in the quality of life during follow-up. Methods This is a spontaneous, prospective, experimental (phase Ib/II), open-label study (NCT04066517); 15 patients with structural heart disease and intractable VT will be enrolled within a 2-year period. Advanced multimodal cardiac imaging preceding chest CT-simulation will serve to elaborate the treatment plan on different linear accelerators with target and organs-at-risk definition. SBRT will consist in a single radioablation session of 25 Gy. Follow-up will last up to 12 months. Conclusions We test the hypothesis that SBRT reduces the VT burden in a safe and effective way, leading to an improvement in quality of life and survival. If the results will be favorable, radioablation will turn into a potential alternative option for selected patients with an indication to VT ablation, based on the opportunity to treat ventricular arrhythmogenic substrates in a convenient and less-invasive manner.

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“…The source of ventricular arrhythmia often occurs in areas of myocardial scar(2,4). In general, during the invasive cardiac ablations, areas of the scar can be recognized using electroanatomic mapping systems.…”

Section: Discussionmentioning

confidence: 99%

“…The high precision with the system allows delivering a high dose to a specific target with no significant damage to the healthy tissue surrounding the target(1). Therefore, the SBRT has a high capability to be used for ablating tissue noninvasively, and, recently, the SBRT has been assessed for the treatment of malignant arrhythmias, mainly, for ventricular tachycardia (VT)(2,3).…”

Section: Introductionmentioning

confidence: 99%

“…Stereotactic arrhythmia radioablation (STAR) is a novel noninvasive SBRT application performed in an outpatient environment with no anesthesia (2,3,9). STAR is precisely direct to the VT target identified by electroanatomic mapping combined with several images and delivers high-dose radiation (usually 25- 30 Gy) to the VT target tissue point causing local tissue destruction resulting in ischemia (10,11).…”

Section: Introductionmentioning

confidence: 99%

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Stereotactic arrhythmia radioablation (STAR) in patients with ventricular tachycardia: a meta-analysis of efficacy and safety outcomes.

Viani

Pavoni²,

Fendi

2020

Preprint

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Objectives: The effectiveness and safety of STAR in patients with refractory ventricular tachycardia (VT) to catheter ablation are limited to small series. We performed a meta-analysis of observational studies to summarize existing data about efficacy and toxicity following START for VT. Methods: Eligible studies were identified on Medline, Embase, the Cochrane Library, and the proceedings of annual meetings through March 2020. We followed the PRISMA and MOOSE guidelines. An estimative of % VT burden reduction at 6 months higher than 85% was considered effective. A rate of any grade 3 or higher toxicity lower than 10% and no grade 4 or 5 were considered safe. Results: Four observational studies with a total of 39 patients treated were included. The % of VT burden reduction at 6 months was 91% (CI95% from 83 to 100%). The consumption of lower than 2 anti-arrhythmia drugs (AAD) at 6 months was 81%. The ejection fraction improved in 12.8%, unchanged 82%, and decreased by 5.2%. The overall survival (OS) was 92% and 82 % in 6 and 12 months. The cardiac death and disease-specific survival at 12 months were 12% and 88.5%. Late grade 3 toxicity 5% with no grade 4-5. Conclusion: STAR produced satisfactory % of VT burden reduction, with a significant reduction in the consumption of AAD at 6 months, and no severe toxicity. These findings support the continued work to develop new trials and to adopt STAR as a treatment option for medical practice.

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Noninvasive Cardioablation

Cited by 10 publications

References 14 publications

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

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

STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study

Stereotactic arrhythmia radioablation (STAR) in patients with ventricular tachycardia: a meta-analysis of efficacy and safety outcomes.

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