CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

Summary

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 left ventricular -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 sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (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 sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (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, Barcelona, Spain), with FDA 510(k) Clearance and European Community 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 approx. 2 years.

In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.

Conditions

• Myocardial Infarction
• Myocardial Infarction Old
• Arrhythmias, Cardiac
• Ventricular Tachycardia
• Ventricular Arrythmia
• Sudden Cardiac Death
• Sudden Cardiac Death Due to Cardiac Arrhythmia

Interventions

DIAGNOSTIC_TEST

Cardiac magnetic resonance imaging

All patients will undergo a cardiac magnetic resonance test to calculate their border zone channel (BZC) mass. This will not be used to decide further interventions, but all the patients will be treated according to standards of care.

Sponsors & Collaborators

• Centro Medico Teknon

  lead OTHER

Principal Investigators

• Antonio Berruezo, MD, PhD · Centro Médico Teknon

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-01

Primary Completion

2024-09-30

Completion

2025-09-30

Countries

• Spain

Study Locations