Clinical characteristics, mortality, cardiac hospitalization, and ventricular arrhythmias in patients undergoing CRT-D implantation: results of the ACTION-HF study.

INTRODUCTION: The characteristics and outcomes of patients who undergo cardiac resynchronization therapy (CRT) device implantation in current clinical practice may differ from those of reference trial populations. Study objectives were to assess 2-year outcomes in a population implanted with a CRT plus defibrillator device in accordance with the standard of care and to evaluate any independent association between clinical variables and outcome. METHODS AND RESULTS: A total of 406 patients enrolled at 35 centers in Italy were followed up prospectively for 2 years. All patient management decisions were left to the treating physician's discretion, in accordance with clinical practice. ACTION-HF patients had a better baseline clinical status than patients enrolled in the COMPANION study: shorter HF history (1 vs 3.5 years, P < 0.01), less advanced NYHA functional class (III-IV: 73% vs 100%, P < 0.01), higher LVEF (26% vs 21%, P < 0.01), higher SBP (122 vs 112 mmHg, P < 0.01), and less diabetes (27% vs 41%, P < 0.01). This status was reflected in lower mortality (11.5% vs 26%) and a lower incidence of appropriate ICD shocks (12.1% vs 19.3%). AF history was an independent predictor of the combination of all-cause mortality and cardiac-cause hospitalization (HR: 3.31; P < 0.001). Recurrent or new atrial arrhythmias were independently associated with the development of ventricular arrhythmias (HR: 3.4; P < 0.001). CONCLUSIONS: This population appears clinically less compromised and had a lower incidence of adverse clinical outcomes than those of reference trials. However, we recorded a substantial burden of atrial arrhythmias, which was independently associated with a higher incidence of ventricular arrhythmias.

Cardiac resynchronization therapy in patients undergoing open-chest cardiac surgery.

PURPOSE: Few data are available on the effects of cardiac resynchronization therapy (CRT) in candidates for cardiac surgery and affected by severe heart failure (HF). The aim of our analysis is to evaluate the percentage of patients who maintain indication for CRT after surgery and the efficacy of CRT in those patients subsequently implanted. METHODS: We enrolled 124 HF patients with indication both to heart surgery and to CRT. During surgery, an epicardial left ventricular lead was implanted, tunneled to a subclavear pocket, and capped. Afterward, patients were periodically reassessed to confirm indication for CRT. RESULTS: CRT indication was confirmed within 1 month from surgery in 54 patients (group A) and in 33 patients within 6 months (group B). In group A and B, 63% and 71% of patients were considered responders according to an arbitrary five-point increase of left ventricular ejection fraction (LVEF), respectively. The assessment of clinical response at 1 year, based on the definitions proposed by Packer, identified 63% and 80% of responders in group A and B, respectively. CONCLUSIONS: Our data show that a remarkable percentage of patients maintain an indication for CRT after cardiac surgery (76%), while in the remaining 24% the lack of an indication is confirmed by a higher LVEF at last follow-up. In combination with surgery, CRT proved to be an effective therapy in those patients who were subsequently implanted. The suggested method is simple, without significant adjunctive risks, and allows easier CRT implantation with stable thresholds.