Spectrum of issues detected by an ICD diagnostic alert that utilizes far-field electrograms: Clinical implications

Jayanthi N Koneru; Karoly Kaszala; Pierre Bordachar; Michael Shehata; Charles Swerdlow; Kenneth A Ellenbogen

doi:10.1016/j.hrthm.2015.01.047

Spectrum of issues detected by an ICD diagnostic alert that utilizes far-field electrograms: Clinical implications

Heart Rhythm. 2015 May;12(5):957-67. doi: 10.1016/j.hrthm.2015.01.047. Epub 2015 Jan 29.

Authors

Jayanthi N Koneru¹, Karoly Kaszala², Pierre Bordachar³, Michael Shehata⁴, Charles Swerdlow⁴, Kenneth A Ellenbogen⁵

Affiliations

¹ Cardiac Electrophysiology, Division of Cardiology, Virginia Commonwealth University, Richmond, Virginia. Electronic address: jkoneru@mcvh-vcu.edu.
² The Hunter Holmes McGuire VA Hospital and Virginia Commonwealth University, Richmond, Virginia.
³ Haut Leveque Hospital, LIRYC Institute, Pessac, France.
⁴ Cedars-Sinai Heart Institute and David Geffen School of Medicine at UCLA, Los Angeles, California.
⁵ Cardiac Electrophysiology, Division of Cardiology, Virginia Commonwealth University, Richmond, Virginia.

PMID: 25640632
DOI: 10.1016/j.hrthm.2015.01.047

Abstract

Background: Implantable cardioverter-defibrillator (ICD) lead failure is one of the major causes of inappropriate shocks. Algorithms have been developed by manufacturers to identify ICD lead failure and avoid inappropriate shocks. The SecureSense RV Lead Noise Discrimination (St Jude Medical, St Paul, MN) algorithm is designed to differentiate oversensing due to lead failure from ventricular arrhythmias and withhold inappropriate therapies. Several non-lead failure-related issues can trigger the SecureSense automated algorithm.

Objective: Our objective was to explain the SecureSense algorithm in a detailed fashion, highlighting examples of SecureSense alerts triggered by non-lead failure-related issues.

Methods: This is a nonrandomized observational case series. SecureSense-triggered alerts from 3 ICD device clinics were analyzed, and representative examples of SecureSense triggers due to non-lead failure-related issues were chosen to explain the function and malfunction of this algorithm.

Results: The series includes 8 cases of SecureSense alerts triggered by non-lead failure-related issues---myopotential oversensing (1), P-wave oversensing (1), T-wave oversensing (1), loss of capture (1), R-wave undersensing (1), timing cycle issues (2), and cross talk (1)---and 1 case of failure of the algorithm to appropriately identify lead failure and prevent ICD shocks.

Conclusion: Lead failure detection algorithms such as the one assessed in this study have an inherent risk of false-positive and false-negative detections. The latter might have fatal consequences. The true accuracy of these algorithms needs to be evaluated in large-scale real-life prospective clinical studies.

Keywords: Automated ICD algorithm; ICD; ICD lead failure; Implantable cardioverter-defibrillator; Inappropriate shocks; Lead failure; Lead fracture.

Publication types

Case Reports
Observational Study

MeSH terms

Adult
Aged
Aged, 80 and over
Algorithms
Arrhythmias, Cardiac* / diagnosis
Arrhythmias, Cardiac* / etiology
Arrhythmias, Cardiac* / physiopathology
Arrhythmias, Cardiac* / therapy
Brugada Syndrome
Cardiac Conduction System Disease
Defibrillators, Implantable / adverse effects*
Electric Countershock* / adverse effects
Electric Countershock* / methods
Electrocardiography / methods
Equipment Failure
Equipment Safety
Female
Heart Conduction System / abnormalities*
Heart Conduction System / physiopathology
Heart Failure* / complications
Heart Failure* / physiopathology
Heart Failure* / therapy
Humans
Male
Middle Aged
Retreatment / instrumentation
Retreatment / methods
Treatment Outcome