Quality assurance process within the RAdiosurgery for VENtricular TAchycardia (RAVENTA) trial for the fusion of electroanatomical mapping and radiotherapy planning imaging data in cardiac radioablation

Mayinger, Michael; Boda-Heggemann, Judit; Mehrhof, Felix; Krug, David; Hohmann, Stephan; Xie, Jingyang; Ehrbar, Stefanie; Kovacs, Boldizsar; Merten, Roland; Grehn, Melanie; Zaman, Adrian; Fleckenstein, Jens; Kaestner, Lena; Buergy, Daniel; Rudic, Boris; Kluge, Anne; Boldt, Leif-Hendrik; Dunst, Jürgen; Bonnemeier, Hendrik; Saguner, Ardan M.; Andratschke, Nicolaus; Blanck, Oliver; Schweikard, Achim

doi:10.1016/j.phro.2022.12.003

Cited by 11 publications

(11 citation statements)

References 18 publications

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“…Two publications have elucidated pitfalls in the registration of EAM and CT images as well as in transfer of the EAM-determined target volume to the planning CT [ 22 , 33 ]. Dedicated software may bridge this gap and serve as an important tool for quality assurance [ 23 , 34 , 35 ].…”

Section: Discussionmentioning

confidence: 99%

“…Thus, an informal case review within the lead study group was established for the first five cases presented in this manuscript through anonymous data sharing prior to treatment. For additional quality assurance of the EAM-to-TPS transport process, dedicated data display software developed for the RAVENTA study was used (CARDIO-RT, University of Lübeck, Germany) [ 23 ].…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2023

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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

et al. 2023

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“…To this day, and because CR of VT is still an emerging therapy, no commercial solution provides an off -the-shelf workflow of EAM to CT data registration and CR target delineation. Several research tools have been developed to this end, [13][14][15][16][17][18] but a certified workflow that could facilitate this process is still to be proposed. The main contribution of this work was the description and the evaluation of a data integration process, that is meant to reduce the complexity and improve the accuracy and reproducibility of CR target delineation.…”

Section: Discussionmentioning

confidence: 99%

“…CR target definition is a challenging task, and prone to inaccuracies and variabilities due to the numerous data integration processes and to visualization limitations. 12 Currently, a few research tools enable visual registration of EAM data to a cardiac CT scan, [13][14][15][16][17][18] but no commercial solution exists, that is certified for clinical use. Physicians tend to overcome this limitation by performing a mental registration of the different modalities.…”

Section: Introductionmentioning

confidence: 99%

Multimodal fusion workflow for target delineation in cardiac radioablation of ventricular tachycardia

Rigal,

Benali,

Barré

et al. 2023

Medical Physics

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BackgroundCardiac radioablation (CR) is an innovative treatment to ablate cardiac arrythmia sources by radiation therapy. CR target delineation is a challenging task requiring the exploitation of highly different imaging modalities, including cardiac electro‐anatomical mapping (EAM).PurposeIn this work, a data integration process is proposed to alleviate the tediousness of CR target delineation by generating a fused representation of the heart, including all the information of interest resulting from the analysis and registration of electro‐anatomical data, PET scan and planning computed tomography (CT) scan. The proposed process was evaluated by cardiologists during delineation trials.MethodsThe data processing pipeline was composed of the following steps. The cardiac structures of interest were segmented from cardiac CT scans using a deep learning method. The EAM data was registered to the cardiac CT scan using a point cloud based registration method. The PET scan was registered using rigid image registration. The EAM and PET information, as well as the myocardium thickness, were projected on the surface of the 3D mesh of the left ventricle. The target was identified by delineating a path on this surface that was further projected to the thickness of the myocardium to create the target volume. This process was evaluated by comparison with a standard slice‐by‐slice delineation with mental EAM registration. Four cardiologists delineated targets for three patients using both methods. The variability of target volumes, and the ease of use of the proposed method, were evaluated.ResultsAll cardiologists reported being more confident and efficient using the proposed method. The inter‐clinician variability in delineated target volume was systematically lower with the proposed method (average dice score of 0.62 vs. 0.32 with a classical method). Delineation times were also improved.ConclusionsA data integration process was proposed and evaluated to fuse images of interest for CR target delineation. It effectively reduces the tediousness of CR target delineation, while improving inter‐clinician agreement on target volumes. This study is still to be confirmed by including more clinicians and patient data to the experiments.

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“… 9 Target volume transfer from the electroanatomic mapping (see Supplementary material online , Figure S2 ) to the treatment planning system was accomplished using the CARDIO-RT software. 10 Dose distribution was calculated using the AAA/Acuros AXB algorithm and cRA was performed on a Varian TrueBeam STX in four non-coplanar volumetric modulated arcs using a 6 mV flattening filter-free photon beams.…”

Section: Methodsmentioning

confidence: 99%

Cardiac radiotherapy transiently alters left ventricular electrical properties and induces cardiomyocyte-specific ventricular substrate changes in heart failure

Mehrhof,

Hüttemeister,

Tanacli

et al. 2023

Europace

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Background Ongoing clinical trials investigate the therapeutic value of stereotactic cardiac radioablation (cRA) in heart failure patients with ventricular tachycardia. Animal data indicate an effect on local cardiac conduction properties. However, the exact mechanism of cRA in patients remains elusive. Methods High-density 3D electroanatomic mapping in sinus rhythm was performed in a patient with left ventricular assist device and repeated ventricular tachycardia episodes upon several catheter-based endocardial radio-frequency ablation attempts. Subsequent to electroanatomical mapping and cRA of the left ventricular septum, two additional high-density electroanatomic maps were obtained at 2 and 4 months (M) post-cRA. Myocardial tissue samples were collected from the left ventricular septum during 4 M post-cRA from the irradiated and borderzone regions. In addition, we performed molecular biology and mitochondrial density measurements of tissue and isolated cardiomyocytes. Results Local voltage was altered in the irradiated region of the left ventricular septum during follow-up. No change of local voltage was observed in the control (i.e. borderzone) region upon irradiation. Interestingly, local activation time was significantly shortened upon irradiation (2 M post-cRA), a process that was reversible (4 M post-cRA). Molecular biology unveiled an increased expression of voltage dependent sodium channels in the irradiated region as compared to the borderzone, while Connexin43 and TGF-beta where unchanged (4 M post-cRA). Moreover, mitochondrial density was decreased in the irradiated region as compared to the borderzone. Conclusion Our study supports the notion of transiently altered cardiac conduction potentially related to structural and functional cellular changes as an underlying mechanism of cRA in patients with ventricular tachycardia.

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Quality assurance process within the RAdiosurgery for VENtricular TAchycardia (RAVENTA) trial for the fusion of electroanatomical mapping and radiotherapy planning imaging data in cardiac radioablation

Cited by 11 publications

References 18 publications

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

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

Multimodal fusion workflow for target delineation in cardiac radioablation of ventricular tachycardia

Cardiac radiotherapy transiently alters left ventricular electrical properties and induces cardiomyocyte-specific ventricular substrate changes in heart failure

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