Aurora EV-ICDTM offers the advantages of an extravascular system while also providing ATP and Pause Prevention pacing in a device the same size as transvenous ICDs.
Antitachycardia pacing (ATP)
The only extravascular ICD to offer ATP. In studies of transvenous ICDs, even with extended detection intervals, ATP was associated with a 50% reduction in potentially unnecessary shocks.1-3. "In the EV-ICD trial, there was 67% of episodes successfully treated with ATP.4
Longevity
11.7 years projected longevity5 which is similar to other Medtronic single chamber ICDs. Greater longevity can reduce number of replacements and associated procedure risks.
Pause prevention
A pacing feature that monitors the heart for significant pauses and responds by providing temporary bradycardia pacing supports.
Size and PhysioCurveTM design
Minimizes tissue pressure and promote patient comfort6.
• Primary safety objective met: 91.9% patients free from major system or procedure-related complications at 18 months*
• Appropriate therapy: 6.8% of patients experienced appropriate therapy by 18th months
• ATP efficacy: 67% ATP-terminated episode success rate
• No major intraprocedural or unique complications due to the EV-ICD system
• No reports of mediastinitis, sepsis, or endocarditis related to the EV-ICD system
Footnotes
*
Kaplan-Meier estimate
†
The Aurora EV-ICD lead is not intended for implantation within the heart or vasculature, and, thus, Aurora is expected to avoid vascular complications associated with transvenous leads. There were no major intraprocedural complications observed in the EV ICD Pivotal Clinical study(4)
References
1
Arenal A, Proclemer A, Kloppe A, et al. Different impact of long-detection interval and anti-tachycardia pacing in reducing unnecessary shocks: data from the ADVANCE III trial. Europace. November 2016;18(11):1719-1725.
2
Lee S, Stern R, Wathen M, et al. Anti-Tachycardia Pacing Therapy Effectively Terminates Fast Ventricular Tachycardia after Longer Detection Duration in Primary Prevention Patients: Results from the PREPARE Trial. Heart Rhythm. 2008;5(5);S334-S356.
3
Brown ML, Gerritse B, Kurita T, et al. Anti-tachycardia Pacing Benefits Non-ischemic AND Ischemic Patients equally in the PainFreeSST trial. Heart Rhythm. 2018;15(5);S590-S640.
4
Friedman P, et al. Chronic Safety and Performance of the Extravascular ICD: Results from the Global EV ICD Pivotal Study. Presented as a Late Breaking Clinical Trial at HRS 2023. New Orleans LA.
5
Medtronic Aurora EV-ICDTM MRI SureScanTM DVEA3E4 Device Manual.
6
Thompson A. Lead extraction study. Medtronic data on file. November 2021.
7
Thompson AE, Atwater B, Boersma L, et al. The development of the extravascular defibrillator with substernal lead placement: A new Frontier for device-based treatment of sudden cardiac arrest. J Cardiovasc Electrophysiol. 2022;33(6):1085-1095
8
N. Leitz, Z. Khawaja, and M. Been Slow ventricular tachycardia BMJ, July 3, 2008; 337(jul03_1): a424 - a424
9
Medi C, et al. Supraventricular tachycardia. Medical Journal of Australia 190.5 (2009): 255-260.
10
Wathen MS, et al. Circulation 2004;110;2591-2596
11
Saeed M. Troubleshooting Implantable Cardioverter-Defibrillators. Tex Heart Inst J. 2011; 38(4): 355–357
12
Kim DY, Kim SH, Ryu KH. Tachycardia induced Cardiomyopathy. Korean Circ J. 2019 Sep;49(9):808-817
13
Hasdemir CAN, Yuksel A, Camli D, Kartal Y, Simsek E, et al (2012) Late Gadolinium Enhancement CMR in Patients with Tachycardia‐Induced Cardiomyopathy Caused by Idiopathic Ventricular Arrhythmias. Pacing and Clinical Electrophysiology, 35: 465-470.