Prognostic importance of defibrillator shocks in patients with heart failure.

BACKGROUND: Patients with heart failure who receive an implantable cardioverter-defibrillator (ICD) for primary prevention (i.e., prevention of a first life-threatening arrhythmic event) may later receive therapeutic shocks from the ICD. Information about long-term prognosis after ICD therapy in such patients is limited. METHODS: Of 829 patients with heart failure who were randomly assigned to ICD therapy, we implanted the ICD in 811. ICD shocks that followed the onset of ventricular tachycardia or ventricular fibrillation were considered to be appropriate. All other ICD shocks were considered to be inappropriate. RESULTS: Over a median follow-up period of 45.5 months, 269 patients (33.2%) received at least one ICD shock, with 128 patients receiving only appropriate shocks, 87 receiving only inappropriate shocks, and 54 receiving both types of shock. In a Cox proportional-hazards model adjusted for baseline prognostic factors, an appropriate ICD shock, as compared with no appropriate shock, was associated with a significant increase in the subsequent risk of death from all causes (hazard ratio, 5.68; 95% confidence interval [CI], 3.97 to 8.12; P<0.001). An inappropriate ICD shock, as compared with no inappropriate shock, was also associated with a significant increase in the risk of death (hazard ratio, 1.98; 95% CI, 1.29 to 3.05; P=0.002). For patients who survived longer than 24 hours after an appropriate ICD shock, the risk of death remained elevated (hazard ratio, 2.99; 95% CI, 2.04 to 4.37; P<0.001). The most common cause of death among patients who received any ICD shock was progressive heart failure. CONCLUSIONS: Among patients with heart failure in whom an ICD is implanted for primary prevention, those who receive shocks for any arrhythmia have a substantially higher risk of death than similar patients who do not receive such shocks.

No benefit from defibrillation threshold testing in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial).

OBJECTIVES: This study investigated whether defibrillation threshold (DFT) testing during implantable cardioverter-defibrillator (ICD) implantation predicts clinical outcomes. BACKGROUND: Defibrillation testing is often performed during insertion of ICDs to confirm shock efficacy. There are no prospective data to suggest that this procedure improves outcomes when modern ICDs are implanted for primary prevention of sudden death. METHODS: The analysis included the 811 patients who were randomized to the ICD arm of the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) and had the device implanted. The DFT testing protocol in SCD-HeFT was designed to limit shock testing in a primary prevention heart failure population. RESULTS: Baseline DFT data were available for 717 patients (88.4%). All 717 patients had a DFT of < or =30 J, the maximum output of the device in this study. The DFT was < or =20 J in 97.8% of patients. There was no survival difference between patients with a lower DFT (< or =10 J, n = 547) and a higher DFT (>10 J, n = 170) (p = 0.41). First shock efficacy was 83.0% for the first clinical ventricular tachyarrhythmia event; there were no differences in shock efficacies when the cohort was subdivided by baseline DFT. CONCLUSIONS: Low baseline DFTs were obtained in patients with stable, optimally treated heart failure during ICD implantation for primary prevention of sudden death. First shock efficacy for ventricular tachyarrhythmias was high regardless of baseline DFT testing results. Baseline DFT testing did not predict long-term mortality or shock efficacy in this study.

Preliminary results of a limited thoracotomy: new approach to treat atrial fibrillation.

OBJECTIVE: To determine efficacy of a new procedure combining epicardial bipolar radiofrequency (RF) pulmonary vein (PV) antrum isolation and ganglionated plexus (GP) ablation for treatment of atrial fibrillation (AF). BACKGROUND: PV antrum electrical isolation and GP ablation have each been associated with elimination of AF. Both of these can be performed epicardially in a single combined surgical procedure, which may have advantages over endocardial ablation. METHODS AND RESULTS: Twenty-one subjects entered a prospective evaluation of limited thoracotomy epicardial bipolar PV antrum isolation, verified by PV recordings, with GP ablation, guided by GP mapping. Procedural success was defined as freedom from AF and antiarrhythmic agents during 1 year of follow-up, including evaluation by prolonged continuous monitoring capable of detecting asymptomatic arrhythmias. All subjects had recordable PV potentials and GP activity prior to ablation. Circumferential epicardial bipolar RF eliminated PV potentials in 18 of 20 right and 14 of 20 left PV antra. This concurrently eliminated 79% of GP activity (125 of 159 active sites); nearly all remaining GP activity could then be eliminated using epicardial bipolar RF forceps. Fifteen of 20 (75%) subjects overall, and 14 of 16 (87.5%) subjects with paroxysmal or persistent AF had a successful procedure. CONCLUSION: Limited thoracotomy epicardial bipolar RF antrum isolation, verified by PV recordings, with GP ablation, guided by GP mapping, is effective treatment for AF and should be considered in patients with paroxysmal or persistent AF.

Biphasic versus monophasic shock waveform for conversion of atrial fibrillation: the results of an international randomized, double-blind multicenter trial.

OBJECTIVES: This study compared a biphasic waveform with a conventional monophasic waveform for cardioversion of atrial fibrillation (AF). BACKGROUND: Biphasic shock waveforms have been demonstrated to be superior to monophasic shocks for termination of ventricular fibrillation, but data regarding biphasic shocks for conversion of AF are still emerging. METHODS: In an international, multicenter, randomized, double-blind clinical trial, we compared the effectiveness of damped sine wave monophasic versus impedance-compensated truncated exponential biphasic shocks for the cardioversion of AF. Patients received up to five shocks, as necessary for conversion: 100 J, 150 J, 200 J, a fourth shock at maximum output for the initial waveform (200 J biphasic, 360 J monophasic) and a final cross-over shock at maximum output of the alternate waveform. RESULTS: Analysis included 107 monophasic and 96 biphasic patients. The success rate was higher for biphasic than for monophasic shocks at each of the three shared energy levels (100 J: 60% vs. 22%, p < 0.0001; 150 J: 77% vs. 44%, p < 0.0001; 200 J: 90% vs. 53%, p < 0.0001). Through four shocks, at a maximum of 200 J, biphasic performance was similar to monophasic performance at 360 J (91% vs. 85%, p = 0.29). Biphasic patients required fewer shocks (1.7 +/- 1.0 vs. 2.8 +/- 1.2, p < 0.0001) and lower total energy delivered (217 +/- 176 J vs. 548 +/- 331 J, p < 0.0001). The biphasic shock waveform was also associated with a lower frequency of dermal injury (17% vs. 41%, p < 0.0001). CONCLUSIONS: For the cardioversion of AF, a biphasic shock waveform has greater efficacy, requires fewer shocks and lower delivered energy, and results in less dermal injury than a monophasic shock waveform.