Defibrillation Effectiveness and Safety of the Shock Waveform Used in a Contemporary Wearable Cardioverter Defibrillator: Results from Animal and Human Studies

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2023 Mar 14

PMID 36917566

Authors

Marye J Gleva

Joseph Sullivan

Thomas C Crawford

Greg Walcott

Ulrika Birgersdotter-Green

Kelley R Branch

Rahul N Doshi

Kaisa Kivilaid

Kelly Brennan

Ron K Rowbotham

Laura M Gustavson

Jeanne E Poole

Affiliations

Soon will be listed here.

Abstract

Introduction: The wearable cardioverter defibrillator (WCD) is used to protect patients at risk for sudden cardiac arrest. We examined defibrillation efficacy and safety of a biphasic truncated exponential waveform designed for use in a contemporary WCD in three animal studies and a human study.

Methods: Animal (swine) studies: #1: Efficacy comparison of a 170J BTE waveform (SHOCK A) to a 150J BTE waveform (SHOCK B) that approximates another commercially available waveform. Primary endpoint first shock success rate. #2: Efficacy comparison of the two waveforms at attenuated charge voltages in swine at three prespecified impedances. Primary endpoint first shock success rate. #3: Safety comparison of SHOCK A and SHOCK B in swine. Primary endpoint cardiac biomarker level changes baseline to 6 and 24 hours post-shock. Human Study: Efficacy comparison of SHOCK A to prespecified goal and safety evaluation. Primary endpoint cumulative first and second shock success rate. Safety endpoint adverse events.

Results: Animal Studies #1: 120 VF episodes in six swine. First shock success rates for SHOCK A and SHOCK B were 100%; SHOCK A non-inferior to SHOCK B (entire 95% CI of rate difference above -10% margin, p < .001). #2: 2,160 VF episodes in thirty-six swine. Attenuated SHOCK A was non-inferior to attenuated SHOCK B at each impedance (entire 95% CI of rate difference above -10% margin, p < .001). #3: Ten swine, five shocked five times each with SHOCK A, five shocked five times each with SHOCK B. No significant difference in troponin I (p = 0.658) or creatine phosphokinase (p = 0.855) changes from baseline between SHOCK A and SHOCK B. Human Study: Thirteen patients, 100% VF conversion rate. Mild skin irritation from adhesive defibrillation pads in three patients.

Conclusions: The BTE waveform effectively and safely terminated induced VF in swine and a small sample in humans.

Trial Registration: Human study clinical trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04132466.

Citing Articles

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

Chovanec M, Petru J, Hala P, Kralovec S, Thakkar A, Mathews K Europace. 2024; 26(7).

PMID: 39001864 PMC: 11282460. DOI: 10.1093/europace/euae189.

References

Panchal A, Bartos J, Cabanas J, Donnino M, Drennan I, Hirsch K . Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020; 142(16_suppl_2):S366-S468. DOI: 10.1161/CIR.0000000000000916. View

Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S . Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2020; 23(1):73-81. PMC: 7842091. DOI: 10.1093/europace/euaa268. View

Epstein A, Abraham W, Bianco N, Kern K, Mirro M, Rao S . Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post-myocardial infarction. J Am Coll Cardiol. 2013; 62(21):2000-2007. DOI: 10.1016/j.jacc.2013.05.086. View

Schneider T, Martens P, Paschen H, Kuisma M, Wolcke B, Gliner B . Multicenter, randomized, controlled trial of 150-J biphasic shocks compared with 200- to 360-J monophasic shocks in the resuscitation of out-of-hospital cardiac arrest victims. Optimized Response to Cardiac Arrest (ORCA) Investigators. Circulation. 2000; 102(15):1780-7. DOI: 10.1161/01.cir.102.15.1780. View

. Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 6: advanced cardiovascular life support: section 2: defibrillation. The American Heart Association in collaboration with the International Liaison Committee on.... Circulation. 2000; 102(8 Suppl):I90-4. View

Reek S, Geller J, Meltendorf U, Wollbrueck A, Szymkiewicz S, Klein H . Clinical efficacy of a wearable defibrillator in acutely terminating episodes of ventricular fibrillation using biphasic shocks. Pacing Clin Electrophysiol. 2003; 26(10):2016-22. DOI: 10.1046/j.1460-9592.2003.00311.x. View

Heyer Y, Baumgartner D, Baumgartner C . A Systematic Review of the Transthoracic Impedance during Cardiac Defibrillation. Sensors (Basel). 2022; 22(7). PMC: 9003563. DOI: 10.3390/s22072808. View

Killingsworth C, Melnick S, Litovsky S, Ideker R, Walcott G . Evaluation of acute cardiac and chest wall damage after shocks with a subcutaneous implantable cardioverter defibrillator in Swine. Pacing Clin Electrophysiol. 2013; 36(10):1265-72. PMC: 3796010. DOI: 10.1111/pace.12173. View

Lever N, Newall E, Larsen P . Differences in the characteristics of induced and spontaneous episodes of ventricular fibrillation. Europace. 2007; 9(11):1054-8. DOI: 10.1093/europace/eum194. View

10.

Gliner B, Lyster T, Dillion S, Bardy G . Transthoracic defibrillation of swine with monophasic and biphasic waveforms. Circulation. 1995; 92(6):1634-43. DOI: 10.1161/01.cir.92.6.1634. View

11.

Bardy G, Marchlinski F, Sharma A, Worley S, Luceri R, Yee R . Multicenter comparison of truncated biphasic shocks and standard damped sine wave monophasic shocks for transthoracic ventricular defibrillation. Transthoracic Investigators. Circulation. 1996; 94(10):2507-14. DOI: 10.1161/01.cir.94.10.2507. View

12.

Odeneg T, Ebner C, Mortl D, Keller H, Dirninger A, Stix G . Indications for and outcome in patients with the wearable cardioverter-defibrillator in a nurse-based training programme: results of the Austrian WCD Registry. Eur J Cardiovasc Nurs. 2018; 18(1):75-83. DOI: 10.1177/1474515118790365. View

13.

Achleitner U, Rheinberger K, Furtner B, Amann A, Baubin M . Waveform analysis of biphasic external defibrillators. Resuscitation. 2001; 50(1):61-70. DOI: 10.1016/s0300-9572(01)00326-4. View

14.

Higgins S, OGrady S, Banville I, Chapman F, Schmitt P, Lank P . Efficacy of lower-energy biphasic shocks for transthoracic defibrillation: a follow-up clinical study. Prehosp Emerg Care. 2004; 8(3):262-7. DOI: 10.1016/j.prehos.2004.02.002. View

15.

Sullivan J, Melnick S, Chapman F, Walcott G . Porcine defibrillation thresholds with chopped biphasic truncated exponential waveforms. Resuscitation. 2007; 74(2):325-31. DOI: 10.1016/j.resuscitation.2007.01.014. View

16.

Wassnig N, Gunther M, Quick S, Pfluecke C, Rottstadt F, Szymkiewicz S . Experience With the Wearable Cardioverter-Defibrillator in Patients at High Risk for Sudden Cardiac Death. Circulation. 2016; 134(9):635-43. PMC: 4998124. DOI: 10.1161/CIRCULATIONAHA.115.019124. View

17.

Chung M, Szymkiewicz S, Shao M, Zishiri E, Niebauer M, Lindsay B . Aggregate national experience with the wearable cardioverter-defibrillator: event rates, compliance, and survival. J Am Coll Cardiol. 2010; 56(3):194-203. PMC: 2962668. DOI: 10.1016/j.jacc.2010.04.016. View

18.

Poole J, White R, Kanz K, Hengstenberg F, Jarrard G, Robinson J . Low-energy impedance-compensating biphasic waveforms terminate ventricular fibrillation at high rates in victims of out-of-hospital cardiac arrest. LIFE Investigators. J Cardiovasc Electrophysiol. 1998; 8(12):1373-85. DOI: 10.1111/j.1540-8167.1997.tb01034.x. View

19.

Bardy G, Gliner B, Kudenchuk P, Poole J, Dolack G, Jones G . Truncated biphasic pulses for transthoracic defibrillation. Circulation. 1995; 91(6):1768-74. DOI: 10.1161/01.cir.91.6.1768. View

20.

Wilkoff B, Fauchier L, Stiles M, Morillo C, Al-Khatib S, Almendral J . 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing. Heart Rhythm. 2015; 13(2):e50-86. DOI: 10.1016/j.hrthm.2015.11.018. View