Aims: The aim of this study was to investigate the 12-month incidence, predictive factors, and prognosis of sustained ventricular tachycardia (VT) in chronic heart failure patients implanted with biventricular pacemakers without a back-up defibrillator (CRT-P), assessed by continuous intracardiac ventricular electrograms.
Methods and results: The Mona Lisa study, a prospective, multicentre, cohort study, designed to determine the incidence of sustained VT and its prognostic impact in CRT-P recipients within the year after implant enrolled 198 patients with moderate or severe chronic heart failure, despite optimal pharmacological therapy. An independent committee reviewed the data from all arrhythmic episodes as well as causes of death according to predefined criteria. During a mean follow-up of 9.8 +/- 3.1 months after implantation, 8 patients experienced at least one episode of sustained VT [4.3%; 95% confidence interval (CI), 1.1-7.5] and 21 deaths occurred, giving a 12-month mortality rate of 11.7% (95% CI, 6.4-16.9). The presence of sustained VT was associated with a high risk of sudden cardiac death (SCD) and the lowest 12-month overall survival (P < 0.0001).
Conclusion: The incidence of sustained VT remains relatively low in the first year after CRT-P implantation, but when present appears closely associated with short-term adverse outcomes, especially SCD. This emphasizes the possible value of remote monitoring to detect high-risk patients for urgent upgrading.
Trial registration: ClinicalTrials.gov NCT00180531.