†Deceased (see In Memoriam at the end of this document) *Representative of the Pediatric and Congenital Electrophysiology Society (PACES) ‡Representative of the European Heart Rhythm Association (EHRA) xRepresentative of the Society of Thoracic Surgeons (STS) {Representative of the American College of Cardiology (ACC) #Representative of the Latin American Heart Rhythm Society (LAHRS) **Representative of the Infectious Diseases Society of America (IDSA) ‡ ‡Representative of the American Heart Association (AHA) xxRepresentative of the American Society of Anesthesiologists (ASA) {{Representative of the Asia Pacific Heart Rhythm Society (APHRS)
Background: The Subcutaneous ICD (S-ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, less left ventricular dysfunction and received more inappropriate shocks (IAS) than in typical transvenous (TV)-ICD trials. The UNTOUCHED trial was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. Methods: Primary prevention patients with left ventricular ejection fraction (LVEF) ≤ 35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥ 250 beats per minute (bpm) and morphology discrimination for rates ≥200 and < 250 bpm. Patients were followed for 18 months. The primary endpoint was the IAS free rate compared to a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study. Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of endpoints. Results: S-ICD implant was attempted in 1116 patients and 1111 patients were included in post-implant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% women, 23.4% black race, 53.5% with ischemic heart disease, 87.7% with symptomatic heart failure and a mean LVEF of 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (Lower confidence limit LCL 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the three-incision technique, no history of atrial fibrillation, and ischemic etiology. The 18-month all cause shock free rate was 90.6% (LCL 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication free rate at 18 months was 92.7%. Conclusions: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of co-morbidities in comparison to earlier S-ICD trials. The inappropriate shock rate (3.1% at one year) is the lowest reported for the S-ICD and lower than many TV ICD studies using contemporary programming to reduce IAS. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT02433379
The rate of major complications and mortality with transvenous lead extraction is similar in the real-world outcomes to that reported in recent single-center studies from high-volume centers. There is significant risk of urgent cardiac surgery, which carries a high mortality, and planning for appropriate cardiothoracic surgery backup is imperative.
As the volume and complexity of catheter ablation of atrial fibrillation (AF) continue to rise, there is increasing attention directed at reducing exposure to ionizing radiation. This has led to the emergence of intracardiac echocardiography (ICE) as a stand-alone imaging modality guiding AF ablation. In addition to directing transseptal puncture, ICE may be used to identify left atrial structures and to guide the manipulation of catheters. ICE may also be used to visualize the esophagus in real-time and to assist with early identification of procedural complications. This review provides detailed step-by-step directions for identification of relevant structures and summarizes the use of ICE during AF ablation.
Background: The PRAETORIAN trial showed non-inferiority of the subcutaneous implantable cardioverter-defibrillator (S-ICD) compared to the transvenous ICD (TV-ICD) with regard to inappropriate shocks and complications. In contrast to the TV-ICD, the S-ICD cannot provide antitachycardia pacing (ATP) for monomorphic ventricular tachycardia (VT). This pre-specified secondary analysis evaluates appropriate therapy and whether ATP reduces the number of appropriate shocks. Methods: The PRAETORIAN trial was an international, investigator-initiated randomized trial, which included patients with an indication for ICD therapy. Patients with prior VTs below 170 bpm or refractory recurrent monomorphic VTs were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (N=426) or TV-ICD (N=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. Results: In the S-ICD group, 86/426 patients received appropriate therapy, versus 78/423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%, P=0.45). In the S-ICD group, 83 patients received at least one shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%, P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared to 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first ATP attempt successfully terminated 46% of all monomorphic VTs, but accelerated the arrhythmia in 9.4%. Ten S-ICD patients experienced 13 electrical storms, versus 18 TV-ICD patients with 19 electrical storms. Patients with appropriate therapy had an almost two-fold increased relative risk of electrical storms in the TV-ICD group compared to the S-ICD group (P=0.05). Conclusions: In this trial, no difference was observed in shock efficacy of the S-ICD compared with the TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the two groups.
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