title: Efficacy of Subcutaneous Electrocardiogram Leads for Synchronous Timing During Chronic Counterpulsation Therapy.
abstract: Counterpulsation devices (CPDs) require an accurate, reliable electrocardiogram (ECG) waveform for triggering inflation and deflation. Surface electrodes are for short-term use, and transvenous/epicardial leads require invasive implant procedure. A subcutaneous ECG lead configuration was developed as an alternative approach for long-term use with timing mechanical circulatory support (MCS) devices. In this study, efficacy testing was completed by simultaneously recording ECG waveforms from clinical-grade epicardial (control) and subcutaneous (test) leads in chronic ischemic heart failure calves implanted with CPD for up to 30 days. Sensitivity and specificity of CPD triggering by R-wave detection was quantified for each lead configuration. The subcutaneous leads provided 98.9% positive predictive value and 98.9% sensitivity compared to the epicardial ECG leads. Lead migration (n = 1) and fracture (n = 1) were observed in only 2 of 40 implanted leads, without adversely impacting triggering efficacy due to lead redundancy. These findings demonstrate the efficacy of subcutaneous ECG leads for long-term CPD timing and potential use as an alternative method for MCS device timing.
authors.affiliation: From the *Department of Bioengineering, Cardiovascular Innovation Institute, University of Louisville, Louisville, Kentucky; and †Department of Cardiovascular and Thoracic Surgery, Cardiovascular Innovation Institute, University of Louisville, Louisville, Kentucky.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Carnahan
authors.forename: Steven C
authors.initials: SC
authors.lastname: Koenig
authors.forename: Michael A
authors.initials: MA
authors.lastname: Sobieski
authors.forename: Erin M
authors.initials: EM
authors.lastname: Schumer
authors.forename: Gretel
authors.initials: G
authors.lastname: Monreal
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
authors.forename: Young
authors.initials: Y
authors.lastname: Choi
authors.forename: Brek J
authors.initials: BJ
authors.lastname: Meuris
authors.forename: Landon H
authors.initials: LH
authors.lastname: Tompkins
authors.forename: Zhongjun J
authors.initials: ZJ
authors.lastname: Wu
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.forename: Guruprasad A
authors.initials: GA
authors.lastname: Giridharan
mesh_terms: D000818:Animals; D002417:Cattle; D015908:Counterpulsation / Q000295:instrumentation; D004562:Electrocardiography / Q000379:methods; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D008297:Male