First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator.

AIMS: Wearable cardioverter-defibrillators (WCDs) are indicated in patients at risk of sudden cardiac arrest who are not immediate candidates for implantable defibrillator therapy. Limitations of existing WCDs include poor compliance and high false alarm rates. The Jewel is a novel patch-WCD (P-WCD) that addresses these limitations with an adhesive-based design for near-continuous wear and a machine learning algorithm designed to minimize inappropriate detections. This was a first-in-human study of the Jewel P-WCD conducted in an electrophysiology (EP) lab to determine the safety and effectiveness of the device in terminating ventricular tachycardia/ventricular fibrillation (VT/VF) with a single shock. The aim was to evaluate the safety and effectiveness of terminating VT/VF with a single shock using the Jewel P-WCD. METHODS AND RESULTS: This was a first-in-human, prospective, single-arm, single-centre study in patients scheduled for an EP procedure in which VT/VF was expected to either spontaneously occur or be induced. The Jewel P-WCD was placed on consented patients; upon confirmation of VT/VF, a single shock (150 J) was delivered via the device. A group sequential design and Pocock alpha spending function was used to measure the observed proportion of successful VT/VF single-shock terminations. The endpoint was achieved if the lower confidence limit exceeded the performance goal of 62%, using a one-sided lower 97.4% exact confidence bound. Of 18 eligible subjects, 16 (88.9%, 97.4% confidence bound: 65.4%) were successfully defibrillated with a single shock, exceeding the primary endpoint performance goal with no adverse events. CONCLUSION: This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov/; Unique identifier: NCT05490459.

Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study.

BACKGROUND AND AIMS: Vibration-controlled transient elastography (VCTE) is a validated test for assessing liver fibrosis but may be unreliable in select patients, including those with morbid obesity. The limitations of VCTE may be overcome by EUS-guided shear wave elastography (EUS-SWE). METHODS: This single-center, prospective, nonrandomized tandem study compared the diagnostic accuracy of EUS-SWE and VCTE in consecutive patients undergoing liver biopsy sampling because of unreliable noninvasive testing. EUS-SWE of the left and right lobes were separately performed and then compared with VCTE. Liver elasticity cutoffs for different stages of fibrosis were estimated in 3 ways: optimized sensitivity and specificity using the Youden index; and with sensitivity and specificity fixed at 90% each, Diagnostic accuracy for fibrosis was compared with liver histology using the area under the receiver-operating characteristic curve (AUROC). The primary outcome was the diagnostic accuracy of EUS-SWE for advanced fibrosis. Secondary outcomes were diagnostic accuracy of VCTE, EUS-SWE for left and right hepatic lobes for significant/advanced fibrosis, and cirrhosis. RESULTS: Forty-two patients (39 men, aged 54.5 ± 12.1 years) underwent EUS-SWE, VCTE, and liver biopsy sampling. The cross-validated AUROCs for advanced fibrosis were as follows: VCTE, .87 (95% confidence interval [CI], .76-.97); EUS-SWE left lobe, .8 (95% CI, .64-.96); and EUS-SWE right lobe, .78 (95% CI, .62-.95). The corresponding AUROCs for cirrhosis were as follows: VCTE, .9 (95% CI, .83-.97); EUS-SWE left lobe, .96 (95% CI, .9-1); and EUS-SWE right lobe, .9 (95% CI, .8-1). VCTE was unreliable in 8 patients who successfully underwent EUS-SWE. There was no statistically significant difference in the AUROCs for EUS-SWE and VCTE. CONCLUSIONS: EUS-SWE correlates well with liver histology and is a safe and reliable diagnostic test for assessing liver fibrosis with accuracy comparable with VCTE. (Clinical trial registration number: NCT04533932.).

Modified design of stimulation of the left ventricular endocardium for cardiac resynchronization therapy in nonresponders, previously untreatable and high-risk upgrade patients (SOLVE-CRT) trial.

The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy were being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This article describes the revised trial and the scientific rationale for the specific changes in the protocol.

A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest.

BACKGROUND: For many patients, sudden cardiac arrest (SCA) risk is elevated temporarily. Wearable cardioverter-defibrillators (WCDs) can monitor and treat SCA during these temporary periods. Traditional WCDs can be uncomfortable, require frequent maintenance, and cannot be used when showering, resulting in poor compliance and avoidable SCA deaths. The Jewel is a novel, water-resistant patch-wearable cardioverter-defibrillator (P-WCD) with a machine learning detection algorithm designed to improve compliance and protection against SCA. OBJECTIVES: This study aims to demonstrate the safety and clinical effectiveness of a novel P-WCD. METHODS: The Jewel IDE Study, a prospective, single-arm study conducted at 30 U.S. sites, enrolled patients at SCA risk due to ventricular tachycardia/ventricular fibrillation who were not candidates for or refused an implantable defibrillator. The primary safety endpoint was <15% patients with clinically significant cutaneous adverse device effects and the primary effectiveness endpoint was <2 inappropriate shocks/100 patient-months. Secondary endpoints were ≥1 successful ventricular tachycardia/ventricular fibrillation conversion and wear time compliance of >14.1 h/d. RESULTS: A total of 305 patients (mean age: 57.9 years; 30.2% female, 27.9% non-White) were enrolled, of which 290 had available device data. The clinically significant cutaneous adverse device effect rate was 2.30% (upper 1-sided 98% CI: 4.80); none were severe. No device-related deaths or serious adverse events were reported. The inappropriate shock rate was 0.36/100 patient-months (upper 1-sided 98% CI: 1.53). Of 11 shocks in 9 patients, 9 shocks were adjudicated to be appropriate. Eight of 9 shocks were successful with a single shock. Median wear time compliance was 23.5 (20.7-23.9) h/d. CONCLUSIONS: The novel P-WCD is a safe and effective WCD with high patient compliance. There were no deaths due to noncompliance and a high number of successful conversions (Jewel IDE study [A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest]; NCT05201495).