Mitral Valve Prolapse Arrhythmic Risk

Oslo University Hospital500 enrolled

Overview

Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited. The aim of this study is to develop and validate a risk prediction model for severe ventricular arrhythmias in patients with AMVP, with the goal of improving individualized risk stratification and identying patients who may warrant consideration for ICD therapy. This is a retrospective, multicenter longitudinal cohort study of patients with mitral valve prolapse and ventricular arrhythmias. Baseline characteristics are defined based on the clinical status at the index event and during the subsequent six months. Clinical events occurring six months or more after the index event are considered follow-up events.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Mitral Valve Prolapse Ventricular Arrhythmias and Cardiac Arrest

Interventions

Risk prediction modelOTHER

A multivariable risk prediction model will be developed and validated to estimate the individual risk of severe ventricular arrhythmias in patients with mitral valve prolapse. The model will be based on clinical, electrocardiographic, arrhythmic, echocardiographic and CMR variables. The risk prediction model is evaluated as part of this observational study and does not constitute a study-specific therapeutic or diagnostic intervention.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. MVP according to the ESC definition AND 2. Arrhythmic burden of: * A total PVC burden ≥ 0,5 % per day OR * Documentation of NSVT on any modality OR * More severe ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest) that occurred \>1 month after the beginning of follow up. AND 3. Follow up \>6 months Exclusion Criteria: * 1\. VT/VF as the initial presentation without prior cardiac evaluation (ECG, echo, Holter) 2. History of myocardial infarction 3. Obstructive coronary diseases - ≥50 % stenosis that was not treated 4. History of coronary artery bypass surgery 5. Significant valve disease other than MVP - rheumatic heart disease, severe aortic stenosis 6. LGE suggestive of probable myocarditis as the etiology. 7. Primary inherited arrhythmia - Brugada syndrome, short QT, long QT, CPVT 8. Carrier of disease causing mutation known to be associated with arrhythmia even when phenotype is negative (e.g. Lamin A/C) 9. Sustained ventricular arrhythmia clearly caused by a reversable cause

Outcomes

Primary Outcomes

Severe Ventricular Arrhythmias

Occurence of severe ventricular arrhythmias, defined as ventricullar fibrillation, sustained ventricular tachycardia, aborted cardiac arrest or appropriate implantable cardioverter-defibrillator (ICD) therapy, occuring more than 1 month after baseline.

Time frame: From >6 months after baseline until the end of available follow-up, minimum follow-up 6 months