The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.
Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (\>5% of the LV mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from SMVT than in matched controls for age, sex, infarct location, and LVEF. However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of SCD. (7,8) In a recent, case-control study, the investigators identified the BZC mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain), with FDA 510(k) Clearance and CE Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of time (approx. 2 years). On the other hand, catheter ablation has become an essential tool in the treatment of ventricular arrhythmias in patients with structural heart disease (SHD). VT ablation techniques have evolved towards substrate-based approaches that permit to abolish multiple VT circuits irrespective of their inducibility or hemodynamic tolerability, improving outcomes with respect to clinical VT ablation. Moreover, VT substrate ablation procedures performed during sinus rhythm and CMR-guided have proven to be safe, with very low procedure related complications. The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.
The CARTO3 electroanatomic navigation system (Biosense Webster, Diamond Bar, CA, USA) will be used for ablation. An open irrigated 3.5-mm tip ablation catheter (ThermoCool SmartTouch, Biosense Webster, Diamond Bar, CA, USA) will be used for mapping and ablation. The first step of the procedure will be the acquisition of a fast-anatomical map (FAM) of the aorta. This FAM will be then used to integrate the multi-detector cardiac tomography (MDCT) reconstruction and cardiac magnetic resonance (CMR)-derived pixel-signal intensity (PSI) maps within the spatial reference coordinates of the CARTO3 system. RF will be delivered at the entrance of the border zone channels (BZCs) identified in the PSI maps (CMR-guided scar dechanneling technique). Programmed ventricular stimulation (PVS) will be always performed after substrate elimination to test for final inducibility.
Centro Medico Teknon
Barcelona, Spain
RECRUITINGRate of sudden cardiac death or sustained ventricular tachycardia
Composite outcome of sudden cardiac death or sustained ventricular tachycardia (either treated by an ICD or documented with continuous Holter monitoring) in patients undergoing preventive ventricular tachycardia (VT) substrate ablation vs. standard of care.
Time frame: 2 years
Procedure time
Procedure time
Time frame: 2 years
Radiofrequency time
Radiofrequency time
Time frame: 2 years
Rate of achievement of complete substrate ablation
Rate of achievement of complete substrate ablation
Time frame: 2 years
VT inducibility rate
Final VT inducibility rate
Time frame: 2 years
Rate of complications
Rate of complications
Time frame: 2 years
Rate of need for anti-arrhythmic drugs
Rate of need for anti-arrhythmic drugs in both arms of the study
Time frame: 2 years
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58