Mortality after cardioverter-defibrillator replacement: Results of the DECODE survival score index.

BACKGROUND: Device replacement is the ideal time to reassess health care goals regarding continuing implantable cardioverter-defibrillator (ICD) therapy. Only few data are available on the decision making at this time. OBJECTIVES: The goals of this study were to identify factors associated with poor prognosis at the time of ICD replacement and to develop a prognostic index able to stratify those patients at risk of dying early. METHODS: DEtect long-term COmplications after implantable cardioverter-DEfibrillator replacement (DECODE) was a prospective, single-arm, multicenter cohort study aimed at estimating long-term complications in a large population of patients who underwent ICD/cardiac resynchronization therapy - defibrillator replacement. Potential predictors of death were investigated, and all these factors were gathered into a survival score index (SUSCI). RESULTS: We included 983 consecutive patients (median age 71 years (63-78)); 750 (76%) were men, 537 (55%) had ischemic cardiomyopathy; 460 (47%) were implanted with cardiac resynchronization therapy - defibrillator. During a median follow-up period of 761 days (interquartile range 628-904 days), 114 patients (12%) died. In multivariate Cox regression analysis, New York Heart Association class III/IV, ischemic cardiomyopathy, body mass index < 26 kg/m2, insulin administration, age ≥ 75 years, history of atrial fibrillation, and hospitalization within 30 days before ICD replacement remained associated with death. The survival score index showed a good discriminatory power with a hazard ratio of 2.6 (95% confidence interval 2.2-3.1; P < .0001). The risk of death increased according to the severity of the risk profile ranging from 0% (low risk) to 47% (high risk). CONCLUSION: A simple score that includes a limited set of variables appears to be predictive of total mortality in an unselected real-world population undergoing ICD replacement. Evaluation of the patient's profile may assist in predicting vulnerability and should prompt individualized options, especially for high-risk patients.

[Cardiac resynchronization therapy with defibrillation capability: considerations on a not yet proven therapeutic superiority]. / Terapia di risincronizzazione cardiaca in combinazione con la funzione di cardioversione-defibrillazione: considerazioni su una superiorità terapeutica ancora da dimostrare.

Cardiac resynchronization therapy (CRT) has proven a very useful tool to treat heart failure (HF). In HF patients with severely depressed left ventricular dysfunction and ventricular dyssynchrony who remain symptomatic despite optimal medical therapy, the "reverse remodeling" induced by CRT leads to a significant improvement of survival and quality of life. The addition of the cardioversion-defibrillation function to CRT (CRT-D) is considered a further beneficial effect to reduce overall mortality secondary to a decrease in sudden death rate. Unfortunately, the amount of this additional benefit is still uncertain; in particular, how much the cardioversion-defibrillation function contributes to prolong patient survival remains to be elucidated. Such uncertainty leads to a different therapeutic approach to HF patients, i.e., an extended or restricted use of CRT-D devices. Even the most recent guidelines do not provide a clear answer to this question. The present review summarizes the current evidence regarding efficacy, effectiveness, safety, and cost-effectiveness of CRT and CRT-D, and suggests some practical solutions to the appropriate use of CRT-D on the basis of clinical, ethical and socio-economic considerations.

[Prophylactic use of cardiac implantable defibrillators in patients with severe left ventricular dysfunction: how to deal with decision making among guidelines, clinical practice, ethical problems, and limited economic resources]. / Uso profilattico del cardioverter-defibrillatore impiantabile nei pazienti con grave disfunzione ventricolare sinistra: come districarsi tra linee guida, pratica clinica, problemi etici e limitazione delle risorse.

Sudden cardiac death (SCD) is usually due to ventricular tachycardia/fibrillation and represents one of the most important medical and socio-economical problems in western countries. It accounts for approximately 1 life/1000 subjects/year. New and effective treatments are necessary to reduce such dramatic event. During the last decade implantable cardioverter-defibrillators (ICDs) showed to be an effective tool to reduce both total and SCD mortality either when used for secondary or primary SCD prevention. At present, ICD implantation guidelines suggest to implant an ICD in all the patients on the basis of a left ventricular ejection fraction < or =30-35% only. This scarcely sensitive and specific criterion implies the necessity to implant very costly devices in a wide number of patients to save only few lives. A more accurate patient selection is desirable either from a clinical or ethical or economic point of view. Fortunately, this appears to be possible using well known and proven epidemiological, clinical and risk stratification data. On the basis of such data, more selective ICD implantation criteria might be used in older patients or in patients with significant comorbidity or in those patients identified at very low risk of SCD.