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Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to avoid complications related to transvenous implantable cardioverter-defibrillator (TV-ICD) leads. Device safety and efficacy were demonstrated previously with atypical clinical patients or limited follow-up., Objectives: The S-ICD PAS (Subcutaneous Implantable Cardioverter-Defibrillator System Post Approval Study) is a real-world, multicenter, registry of U.S. centers that was designed to assess long-term S-ICD safety and efficacy in a diverse group of patients and implantation centers., Methods: Patients were enrolled in 86 U.S. centers with standard S-ICD indications and were observed for up to 5 years. Efficacy endpoints were first and final shock efficacy. Safety endpoints were complications directly related to the S-ICD system or implantation procedure. Endpoints were assessed using prespecified performance goals., Results: A total of 1,643 patients were prospectively enrolled, with a median follow-up of 4.2 years. All prespecified safety and efficacy endpoint goals were met. Shock efficacy rates for discrete episodes of ventricular tachycardia or ventricular fibrillation were 98.4%, and they did not differ significantly across follow-up years (P = 0.68). S-ICD-related and electrode-related complication-free rates were 93.4% and 99.3%, respectively. Only 1.6% of patients had their devices replaced by a TV-ICD for a pacing need. Cumulative all-cause mortality was 21.7%., Conclusions: In the largest prospective study of the S-ICD to date, all study endpoints were met, despite a cohort with more comorbidities than in most previous trials. Complication rates were low and shock efficacy was high. These results demonstrate the 5-year S-ICD safety and efficacy for a large, diverse cohort of S-ICD recipients. (Subcutaneous Implantable Cardioverter-Defibrillator [S-ICD] System Post Approval Study [PAS]; NCT01736618)., Competing Interests: Funding Support and Author Disclosures This study was sponsored by Boston Scientific. Dr Gold has received consulting fees from Boston Scientific and Medtronic; and has participated in clinical trials with Boston Scientific, Medtronic, and Abbott. Dr El-Chami has received compensation for services from Boston Scientific and Medtronic. Dr Burke has received honoraria and research grants from AtaCor Medical, Biosense Webster, and Boston Scientific; and has held equity in AtaCor Medical. Dr Upadhyay has served on advisory boards at Abbott, BioTel, Biotronik, and Medtronic; and has served a speaker for Zoll Medical. Dr Herre has received research support from Analytics 4 Life, Boston Scientific, and EBR Systems; has received consulting fees from Medtronic; and has served as the Board Chair for LifeNet Health. Dr Kutalek has received consulting fees and compensation for services from Boston Scientific. Dr Knight has received consulting and speaker fees and investigator and/or fellowship support from Abbott, Atricure, Boston Scientific, Biosense Webster, Biotronik, CVRx, and Medtronic. Ms Leigh is a full-time employee of Boston Scientific. Ms Lucas is a full-time employee of NAMSA. Mr Carter is a full-time employee of Boston Scientific. Dr Brisben is a full-time employee of Boston Scientific. Dr Aasbo has received consulting fees from Boston Scientific and Biotronik. Dr Weiss has received compensation for services from Abbott, Boston Scientific, Biosense, Biotronik, S4, and Sanofi; has received research grants from Abbott, Boston Scientific, Biosense, and Medtronic; and has received fellowship support from Abbott, Boston Scientific, Biosense Webster, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support., Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented., Methods: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly >85% at 2 years., Results: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described., Conclusion: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety., (© 2023 Heart Rhythm Society. Published by Elsevier Inc.)

Aims: To report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices., Methods and Results: Kaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7-5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2-11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS., Conclusion: In this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.)

Background: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) 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 ≤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 and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy). 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 end points., Results: S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 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 comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02433379.

To address several fundamental questions regarding how multiwhisker tactile stimuli are integrated and processed by the trigeminal somatosensory system, a novel behavioral task was developed that required rats to discriminate the width of either a wide or narrow aperture using only their large mystacial vibrissae. Rats quickly acquired this task and could accurately discriminate between apertures of very similar width. Accurate discriminations required a large number of intact facial whiskers. Systematic removal of individual whiskers caused a decrease in performance that was directly proportional to the number of whiskers removed, indicating that tactile information from multiple whiskers is integrated as rats gauge aperture width. In different groups of rats, different sets of whiskers were removed in patterns that preferentially left whisker rows or whisker arcs intact. These different whisker removals caused similar decreases in performance, indicating that individual whiskers within the vibrissal array are functionally equivalent during performance of this task. Lesions of the barrel cortex abolished the ability of rats to discriminate, demonstrating that this region is critically involved in this tactile behavior. Interestingly, sectioning the facial nerve, which abolished whisker movements, did not affect the ability to perform accurate discriminations, indicating that active whisker movements are not necessary for accurate performance of the task. Collectively, these results indicate that the trigeminal somatosensory system forms internal representations of external stimuli (in this case, aperture width) by integrating tactile input from many functionally equivalent facial whiskers and that the vibrissal array can function as a fine-grained distance detector without active whisker movements.

A tool or probe often functions as an extension of the hand, transmitting vibrations to the hand to produce a percept of the object contacting the tool or probe. This paper reports the psychophysical results of a combined psychophysical and neurophysiological study of the perception of vibration transmitted through a cylinder grasped in the hand. In the first part of the psychophysical study, 19 subjects grasped a cylinder, 32 mm diam, with an embedded motor that caused vibration parallel to the axis of the cylinder. The relationship between threshold and frequency was the traditional U-shaped function with a minimum between 150 and 200 Hz. Except a study by Békésy in which subjects grasped a rod that vibrated parallel to the skin surface, thresholds above 20 Hz were lower and the slopes were steeper than any reported previously. Thresholds were <0.01 microm in some subjects. Data from both the psychophysical and the neurophysiological studies suggest that detection performance at frequencies >20 Hz was based on activity in Pacinian afferents. The extreme sensitivity compared with previous reports may have resulted from differences in contact area, direction of vibration, contact force, and the shape of the stimulus probe. The effects of each of these variables were studied. At 40 and 300 Hz (frequencies near the lower and upper end of the Pacinian range) thresholds were 9.8 and 18.5 dB (68 and 88%) lower, respectively, when subjects grasped the cylinder than when a 1-mm-diam probe vibrated perpendicular to the skin. These differences were accounted for as follows: 1) thresholds at a single fingerpad obtained with the large cylindrical surface were, on average, 20 and 60% lower, respectively, than thresholds with the punctate probe; 2) thresholds at the palm were, on average, 15 and 40% lower, respectively, than at the fingerpads; 3) thresholds obtained when the subjects grasped the cylinder averaged 40 and 20% less, respectively, than when the cylinder contacted only the palm; 4) thresholds with the cylinder contacting two fingers were 10 and 30% lower, respectively, than thresholds with the cylinder contacting a single finger; and 5) thresholds with vibration parallel to the skin surface were, on average, 10 and 30% lower, respectively, than thresholds with vibration perpendicular to the skin. Contact force, which was varied from 0.05 to 1.0 N, had no effect.