Slide 1: Primary Results from the ASSURE WCD Clinical Evaluation Post Approval Study (ACE-PAS)
Primary Results from the ASSURE WCD Clinical Evaluation Post Approval Study (ACE - PAS) Jeanne E Poole MD, University of Washington #AHA25 On Behalf of the ACE - PAS Steering & Events Committee Authors: Jeanne E. Poole, Marye J. Gleva, Kelley R. Branch, Ulrika Birgersdotter - Green, Rahul Doshi, Aru
Slide 2: Background
Background Wearable Cardioverter Defibrillator (WCD) for Sudden Cardiac Death Protection Post MI, ICD explant or Sustained VT/VF or Post PCI/CABG – Newly diagnosed HF LVEF ≤ 35% bridge to transplant SCD Survivor wait 90 days – wait 90 days – wait 40 days ICD indicated, but delayed ICD not yet indica
Slide 3: Study Device: ASSURE WCD
Study Device: ASSURE WCD 1 ASSURE WCD designed to: • Improve comfort and compliance • Provide High - Fidelity ECG recordings • Reduce the false shock alarm rate • Maintain high shock efficacy for VT/VF FDA IDE trials demonstrated: • Low false positive shock alarm rate 2 • High VF conversion rate 3 F
Slide 4: Study Device: ASSURE WCD
Study Device: ASSURE WCD 1 Episode Open VF Rate Confirm Zone Initial Detection without Shock Alert ~ 15 seconds an Alert ~ 20 seconds 200 bpm ~ 5 sec Biphasic (Nominal) Shock 170J VT Rate Zone Initial Detection Confirm without an Alert Shock Alert ~ 15 seconds ~ 45 seconds ~ 20 seconds Biphasic 170
Slide 5: Methods: Study Overview
Methods: Study Overview • Prospective, non - randomized, active surveillance registry STUDY DESIGN • Designed for safety and effectiveness in routine clinical practice • Non - inferiority trial, prespecified boundaries 1,2 • Effectiveness: All - shock conversion rate ≥ 89.0% 1 PRIMARY ENDPOINTS • Sa
Slide 6: Methods
Methods • 21,612 consecutive patients 11/2021 - 7/2025 • WCD duration determined by the healthcare provider • Data sources: WCD recorded data, medical record abstraction • Device - detected rhythm episodes: adjudicated by expert panel Analysis • Standard comparative and descriptive statistics • Kapl
Slide 7: Results: Selected Baseline Characteristics
Results: Selected Baseline Characteristics CO - MORBIDITIES N = 21,612 (%) Hypertension 72% DEMOGRAPHICS N = 21,612 (% or mean ± SD) Hyperlipidemia 61% Age (years) 64 ± 14 Coronary artery disease 58% Female sex (%) 34% Atrial Fibrillation history 37% BMI (kg/m 2) 29.5 ± 6.9 Diabetes 33% LVEF % 25.3
Slide 8: Results: WCD Prescription Indication
Results: WCD Prescription Indication N = 21,612 4% 2% Dilated Cardiomyopathy, LVEF ≤ 35% VT/VF Post - MI, LVEF ≤ 35% 12% NICM Sustained VT/VF or SCD survivor 32% ICD explant Post-MI 19% Other high - risk for SCD ICM 31% Kestra Medical Technologies —Confidential 8
Slide 9: Wear Compliance & Duration of Use
Results: Wear Compliance & Duration of Use Duration of Use 40% N = 16,441* 35% 33% Daily usage, 23.1 30% 30% Patients (%) median (IQR) hours (16.1– 23.9) 25% 20% Duration of use, 54 20% 17% median (IQR) days (20 – 97) 15% 10% Cumulative wear time 41,816 months 5% *Completed wear (n=16,441); Actively
Slide 10: Results: Primary Effectiveness Endpoint
Results: Primary Effectiveness Endpoint VT/VF All - Shock Conversion Endpoints Performance Goal VT or VF % Success events (n/N) All- shock 100% ≥ 89% 303 / 303 conversion (95% LCB: 98.9%) First shock 97% Report Only 294 / 303 conversion (95% LCB 95.7%) • 1.21% (261) patients received at least one sh
Slide 11: Results: Primary Safety Endpoint
Results: Primary Safety Endpoint Inappropriate Shock Rate Endpoints Performance Patients with Cumulative Incidence Rate Goal ≥ 1 Shock Wear Time (per patient - months) Inappropriate ≤ 0.0075 per 41,816 0.0065 patient - months 273 (1.26%) months shock rate (95% UCB: 0.0073) • 94% of patients were fre
Slide 12: Cumulative Incidence of Any VT/VF Shocked & Unshocked
Any VT/VF Shocked & Unshocked Time to First VT/VF by WCD Indication* Time to First VT/VF* 7.2% 270 55% with any VT/VF episode 240 No. of Patients p<0.0001 Cumulative Incidence of 210 180 First VT/VF 3.3% 150 3.0% 120 2.5% 19% 90 60 9% 8% 30 595 357 218 120 0 8551 4774 5645 3249 3982 2361 2582 1565 1
Slide 13: Results: Other Arrhythmias
Results: Other Arrhythmias High - rate Atrial Fibrillation Severe Brady/Asystole "Call 911 now. Begin CPR if patient is unconscious. " • 4.2% of patients had AF (>170 bpm) • At least 0.3% of patients experienced severe • 35% had no previous documented history bradycardia (<20 bpm) or asystole Kestra
Slide 14: Conclusions
Conclusions • ACE - PAS represents the largest prospective WCD study with >20,000 patients • ACE - PAS met both of its endpoints o Effectiveness: 100% all - shock VT/VF conversion o Safety: Inappropriate shock rate 0.0065 per patient - month • ACE - PAS provides contemporary data describing the risk
Slide 15: Thank You
Thank You ACE Steering Committee Dr. Jeanne E. Poole University of Washington Dr. Marye J. Gleva Washington University in St. Louis Dr. Kelley R. Branch University of Washington Dr. Ulrika Birgersdotter - Green University of California San Diego Dr. Rahul Doshi HonorHealth, Scottsdale, AZ
Slide 16: ©2025 Kestra Medical Technologies, Inc. and its affiliated companies. All rights reserved. ASSURE, Cardiac
©2025 Kestra Medical Technologies, Inc. and its affiliated companies. All rights reserved. ASSURE, Cardiac Recovery System, K EST RA, the Kestra logo, ASSURE Assist, Kestra CareStation, and the Open Heart design are Registered in the U.S. Patent and Trademark Office and Kestra Care, Adaptive Patient
Slide 17: Incidence Rate of Appropriate Shock By Indication
Incidence Rate of Appropriate Shock By Indication Number of Patients with Cumulative Months Appropriate Shock WCD Indication at least one VT/VF shock (Censored after 1st shock) (per 100 patient - years) (95% CI) 7.5 All 261 41,754 (6.6 - 8.5) 8.5 MI/ICM 150 21,109 (7.2 - 10) 3.7 NICM 41 13,464 (2.6