Prophylactic implantable cardioverter defibrillator therapy did not trim mortality successful patients pinch a anterior myocardial infarction, persistent mean near ventricular systolic dysfunction and abnormal ECG markers, according to late-breaking investigation presented successful a Hot Line convention coming astatine ESC Congress 2025.
An implantable cardioverter defibrillator (ICD) is simply a mini electrical instrumentality fitted successful nan thorax that detects irregular and accelerated bosom rhythms. ICD therapy is utilized successful patients pinch a anterior cardiac apprehension aliases severely impaired near ventricle (LV) pumping expertise (severe LV systolic dysfunction).
Principal Investigator, Professor Derek Exner from nan Libin Cardiovascular Institute, Calgary, Canada, explained why nan REFINE-ICD proceedings was conducted: "From earlier studies we knew that nan consequence of decease was precocious aft a myocardial infarction (MI), notably among patients pinch persistent, mean LV systolic dysfunction and ECG markers associated pinch ventricular arrhythmia risk. We tested nan presumption that an ICD whitethorn thief these patients unrecorded longer than those who person optimal aesculapian therapy alone."
The open-label, investigator-initiated REFINE-ICD proceedings was conducted successful Canada, USA, Europe, Middle East and Africa. In total, astir 2,000 patients pinch a anterior MI (≥2 months) underwent ambulatory ECG testing to measure 2 markers of ventricular arrhythmia risk: bosom complaint turbulence and T activity alternans. Of these, 597 patients pinch LVEF 36−50%, impaired bosom complaint turbulence and abnormal T activity alternans were randomized to an ICD added to aesculapian therapy aliases aesculapian therapy alone.
The mean property of nan patients was 65 years and 19% were women. Overall mortality was higher successful patients pinch some abnormal ECG markers compared pinch those without (hazard ratio [HR] 2.59; 95% assurance interval [CI] 1.97 to 3.40; p<0.001).
During mean follow-up of astir 5.7 years successful randomized patients pinch abnormal ECG markers, full mortality was not reduced pinch ICDs: 24.5% of patients died successful nan ICD group and 21.3% died successful nan power group (HR 1.07; 95% CI 0.77 to 1.50; p=0.69). Almost half of deaths (47.4%) were adjudicated arsenic non-cardiac deaths. Cardiac mortality was not reduced successful nan ICD group vs. controls (8.8% vs. 7.6%, respectively; HR 1.11; 95% CI 0.63 to 1.945). Sudden cardiac decease occurred successful 2.6% of patients successful nan ICD group and 3.8% successful nan power group (HR 0.66; 95% CI 0.27 to 1.62).
Summing up, Professor Exner said: "In this trial, patients pinch a anterior MI, persistent mean LV systolic dysfunction and ECG markers of ventricular arrhythmia consequence had doubly nan incidence of decease arsenic akin patients without these consequence markers. Although overall, nan consequence of decease was little than expected and half of each deaths were non-cardiac. Importantly, ICD therapy did not trim full mortality, cardiac decease and abrupt cardiac death. Further investigation efforts are needed to amended negociate these patients."