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
Background - The limited effectiveness of endocardial catheter ablation (CA) for persistent and long-standing persistent atrial fibrillation (Ps/LSP-AF) treatment led to the development of a minimally-invasive epicardial/endocardial ablation approach (Hybrid Convergent) to achieve a more comprehensive lesion set with durable transmural lesions. The multi-center randomized controlled CONVERGE trial (NCT01984346) evaluated the safety of Hybrid Convergent and compared its effectiveness to CA for Ps/LSP-AF treatment. Methods - One-hundred fifty-three patients were randomized 2:1 to Hybrid Convergent vs. CA. Primary effectiveness was freedom from AF/AFL/AT absent new/increased dosage of previously failed/intolerant class I/III anti-arrhythmic drugs (AADs) through 12-months. Primary safety was major adverse events through 30 days. CONVERGE permitted left atrium size up to 6cm and imposed no limits on AF duration, making it the only ablation trial to substantially include LSP-AF i.e. 42% patients with LSP-AF. Results - Of 149 evaluable patients at 12 months, primary effectiveness was achieved in 67.7% (67/99) patients with Hybrid Convergent and 50.0% (25/50) with CA (p=0.036) on/off previously failed AADs and in 53.5% (53/99) versus 32.0% (16/50) (p=0.0128) respectively off AADs. At 18-months using 7-day Holter, 74.0% (53/72) Hybrid Convergent and 55% (23/42) CA patients experienced ≥90% AF burden reduction. A total of 2.9% (3/102) patients had primary safety events within 7 days, and 4.9% (5/102) between 8-30 days post-procedure. No deaths, cardiac perforations or atrioesophageal fistulas occurred. All but one primary safety event resolved. Conclusions - The Hybrid Convergent procedure has superior effectiveness compared to the CA for the treatment of Ps/LSP-AF.
Serum S-100beta levels in healthy children have a moderate inverse correlation with age. After traumatic brain injury in children, the acute assessment of serum S-100beta levels seems to be associated with outcome.
Purpose Overnight stays associated with catheter ablation (CA) for paroxysmal atrial fibrillation (PAF) account for a significant proportion of treatment cost. Same-day discharge (SDD) after CA may be attractive to both patients and hospitals, especially in light of current restrictions on overnight stays due to COVID-19. This study reports on the selection criteria, protocol, and safety of SDD after CA of PAF. Methods Patients undergoing CA for PAF were evaluated to assess the risk of groin, respiratory, cardiac, or bleeding complications. SDD eligibility criteria were stable anticoagulation with no bleeding history, systolic heart failure, respiratory conditions, or interventional procedures within 60 days, and recommended BMI < 35. Patient proximity to the hospital was also considered. Anesthesia with propofol was used, and ablations were performed with a contact force catheter. Patients rested for 6 h postprocedure and then ambulated over 1-2 h. Discharge followed if they were stable without evidence of complications. A nurse called all patients the following morning to elicit evidence of complications. Results Of 44 planned SDD procedures between April 2017 and June 2018, 41 resulted in SDD after 7.2 ± 1.0 h, 2 patients stayed overnight for observation, and one by choice. Average age was 59 ± 10 years with CHA 2 DS 2-VASc of 1.6 ± 1.1. No SDD-related complications occurred, and no return visits resulted from the follow-up calls. Conclusion Appropriate low-risk patients identified by well-defined clinical criteria can be safely discharged the same day after CA for PAF. Evaluation in a larger population across different centers is required for generalizability of this SDD protocol.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.