Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions.

OBJECTIVES: This study sought to examine the safety and efficacy of laser-assisted lead extraction and the indications, outcomes, and risk factors in a large series of consecutive patients. BACKGROUND: The need for lead extraction has been increasing in direct relationship to the increased numbers of cardiovascular implantable electronic devices. METHODS: Consecutive patients undergoing transvenous laser-assisted lead extraction at 13 centers were included. RESULTS: Between January 2004 and December 2007, 1,449 consecutive patients underwent laser-assisted lead extraction of 2,405 leads (20 to 270 procedures/site). Median implantation duration was 82.1 months (0.4 to 356.8 months). Leads were completely removed 96.5% of the time, with a 97.7% clinical success rate whereby clinical goals associated with the indication for lead removal were achieved. Failure to achieve clinical success was associated with body mass index <25 kg/m(2) and low extraction volume centers. Procedural failure was higher in leads implanted for >10 years and when performed in low volume centers. Major adverse events in 20 patients were directly related to the procedure (1.4%) including 4 deaths (0.28%). Major adverse effects were associated with patients with a body mass index <25 kg/m(2). Overall all-cause in-hospital mortality was 1.86%; 4.3% when associated with endocarditis, 7.9% when associated with endocarditis and diabetes, and 12.4% when associated with endocarditis and creatinine > or =2.0. Indicators of all-cause in-hospital mortality were pocket infections, device-related endocarditis, diabetes, and creatinine > or =2.0. CONCLUSIONS: Lead extraction employing laser sheaths is highly successful with a low procedural complication rate. Total mortality is substantially increased with pocket infections or device-related endocarditis, particularly in the setting of diabetes, renal insufficiency, or body mass index <25 kg/m(2). Centers with smaller case volumes tended to have a lower rate of successful extraction.

Does microvolt T-wave alternans testing predict ventricular tachyarrhythmias in patients with ischemic cardiomyopathy and prophylactic defibrillators? The MASTER (Microvolt T Wave Alternans Testing for Risk Stratification of Post-Myocardial Infarction Patients) trial.

OBJECTIVES: The purpose of this trial was to determine whether microvolt T-wave alternans (MTWA) predicts ventricular tachyarrhythmic events (VTEs) in post-myocardial infarction patients with left ventricular ejection fraction (LVEF) < or =30%. BACKGROUND: Previous studies have established MTWA as a predictor for total and arrhythmic mortality, but its ability to identify prophylactic implantable cardioverter-defibrillator (ICD) recipients most likely to experience VTEs remains uncertain. METHODS: This prospective trial was conducted at 50 U.S. centers. Patients were eligible if they met MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II) indications for device implant. All patients underwent MTWA testing followed by ICD implantation, with pre-specified programming to minimize the likelihood of therapies for non-life-threatening VTE. Minimum follow-up was 2 years with annual MTWA testing. Initially indeterminate MTWA tests were repeated. RESULTS: Analyses were conducted on 575 patients (84% male; average age +/- SD = 65 +/- 11 years; average LVEF +/- SD = 0.24 +/- 0.05). The final distribution of MTWA results were: MTWA positive in 293 (51%), MTWA negative in 214 (37%), and indeterminate in 68 patients (12%). Over an average follow-up of 2.1 +/- 0.9 years, there were 70 VTEs. A VTE occurred in 48 of 361 (13%, 6.3%/year) MTWA non-negative and 22 of 214 (10%, 5.0%/year) MTWA negative patients. A non-negative MTWA test result was not associated with VTE (hazard ratio: 1.26; 95% confidence interval: 0.76 to 2.09; p = 0.37), although total mortality was significantly increased (hazard ratio: 2.04; 95% confidence interval: 1.10 to 3.78; p = 0.02). CONCLUSIONS: In MADIT-II-indicated ICD-treated patients, the risk of VTE does not differ according to MTWA classification, despite differences in total mortality. (MASTER I-Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients; NCT00305240).

Results of catheter ablation of typical atrial flutter.

The purpose of this study was to evaluate the safety and efficacy of radiofrequency (RF) ablation of typical atrial flutter by using an 8-mm electrode catheter and a 100-W RF power generator. A limitation of previous trials of catheter ablation of atrial flutter is that the data were not collected as part of a prospective multicenter clinical trial. The study results associated catheter ablation of typical atrial flutter in a cohort of 150 patients with an 88% acute efficacy rate. At 6-month follow-up, recurrent typical atrial flutter was observed in 13% of patients. Of the 12 patients with typical atrial flutter recurrence, 4 were symptomatic and 8 were asymptomatic. Procedure duration was a significant predictor of typical atrial flutter recurrence. The 12-month rate for development of atrial fibrillation was 30%. Catheter ablation of atrial flutter was associated with significant improvements in 5 of 8 domains of the Short Form 36 Survey (quality of life) and significant decreases in 13 of the 16 symptoms of the Symptom Checklist. The device- or procedure-related complication rate was 2.7%. Skin burns occurred at the dispersive pad site due to stronger RF power in 3 patients. Use of a dual dispersive pad system mitigated this problem. Thus, the results of this study associated catheter ablation of atrial flutter with high acute efficacy, a small risk of recurrent atrial flutter, and an important risk of atrial fibrillation during follow-up.