ABSTRACT
BACKGROUND: Little is known about the ICD performance using enhanced detection algorithms in unselected, non-trial patients. Performance of recent generation ICD equipped with SmartShock™ technology (SST) for detection and conversion of ventricular tachyarrhythmias (VTA) was investigated. METHODS: 4P was a prospective, multicenter, observational study conducted in 10 Swiss implanting centers. Patients with a Class I indication according to international guidelines were included and received an ICD with SST. ICD discrimination capability was assessed by evaluating SST performance; therapy efficacy was assessed by rate of VTA conversions by ATP and by rescue shocks. RESULTS: Overall, 196 patients were included in the analysis with a mean duration of follow-up of 27.7 months (452 patient-years of observation). Patient-specific rather than recommended programming was preferred. Device-detected episodes were frequent (5147 episodes in 146 patients, 74.5%). In 44 patients (22.4%), 1274 episodes were categorized as VTA; only 215 episodes were symptomatic. ATP was the first-line therapy and highly effective (99.9% success rate at the episode level, 100.0% at the patient level). Rescue shocks were rare (66 episodes in 28 patients); 7 shocks in 5 patients (2.6%) were inappropriate. Death and hospitalization rates were low. CONCLUSIONS: In a cohort of non-trial, unselected ICD patients, VTA episodes were frequent. The 4P results confirm the robustness of VTA detection by SST and the effectiveness of ATP treatment, hence limiting overall ICD shock burden.
Subject(s)
Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Electric Countershock/instrumentation , Heart Rate , Tachycardia, Ventricular/therapy , Ventricular Fibrillation/therapy , Aged , Electric Countershock/adverse effects , Electric Countershock/mortality , Female , Hospitalization , Humans , Male , Middle Aged , Progression-Free Survival , Prospective Studies , Prosthesis Design , Prosthesis Failure , Risk Factors , Switzerland , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/mortality , Tachycardia, Ventricular/physiopathology , Time Factors , Ventricular Fibrillation/diagnosis , Ventricular Fibrillation/mortality , Ventricular Fibrillation/physiopathologyABSTRACT
BACKGROUND: Microvolt T-wave alternans (MTWA) has been proposed as a predictor of the risk of ventricular tachyarrhythmias (VT) and sudden cardiac death (SCD). Aim of this study was to perform a systematic review of the literature and a meta-analysis of MTWA in primary prevention patients with ischemic and nonischemic cardiomyopathy. METHODS: The positive predictive value (PPV), negative predictive value (NPV), and relative risk (RR) of MTWA in predicting death, cardiac death, and SCD during follow-up were reported. RESULTS: Fifteen studies involving 5681 patients (mean age 62 years, mean ejection fraction 32%) were included. The summary PPV during the average 26-month follow-up was 14% (95% CI: 13-15); NPV was 95% (95% CI: 94-96), and the univariate RR was 2.35 (95% CI: 1.68-3.28). The predictive value of MTWA was similar in patients with ischemic and nonischemic cardiomyopathy. The average RR for SCD or VT events of an abnormal MTWA was 2.40, similar to that for cardiac death. When we grouped the studies together depending upon whether beta-blockers were withheld prior to MTWA screening, the beta-blockers group showed an RR of 5.88. By contrast, the group in which beta-blocker therapy was withheld had an RR of 1.63. CONCLUSION: A positive MTWA determined an approximately 2.5-fold higher risk of cardiac death and life-threatening arrhythmia and showed a very high NPV both in ischemic and nonischemic patients. An abnormal MTWA test was associated with a 5-fold increased risk for cardiac mortality in the low-indeterminate group and about a 6-fold increased risk in beta-blockers group.
