Optimal management of Riata leads with no known electrical abnormalities or externalization: a decision analysis.

Abstract

Introduction

Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA) can develop conductor cable externalization and/or electrical failure. Optimal management of these leads remains unknown.

Methods and results

A Markov model compared 4 lead management strategies: (1) routine device interrogation for electrical failure, (2) systematic yearly fluoroscopic screening and routine device interrogation, (3) implantation of new ICD lead with capping of the in situ lead, and (4) implantation of new ICD lead with extraction of the in situ lead. The base case was a 64-year-old primary prevention ICD patient. Modeling demonstrated average life expectancies as follows: capping with new lead implanted at 134.5 months, extraction with new lead implanted at 134.0 months, fluoroscopy with routine interrogation at 133.9 months, and routine interrogation at 133.5 months. One-way sensitivity analyses identified capping as the preferred strategy with only one parameter having a threshold value: when risk of nonarrhythmic death associated with lead abandonment is greater than 0.05% per year, lead extraction is preferred over capping. A second-order Monte Carlo simulation (n = 10,000), as a probabilistic sensitivity analysis, found that lead revision was favored with 100% certainty (extraction 76% and capping 24%).

Conclusions

Overall there were minimal differences in survival with monitoring versus active lead management approaches. There is no evidence to support fluoroscopic screening for externalization of Riata or Riata ST leads.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1111/jce.12563

Publication Info

Pokorney, Sean D, Ke Zhou, David B Matchar, Sean Love, Emily P Zeitler, Robert Lewis and Jonathan P Piccini (2015). Optimal management of Riata leads with no known electrical abnormalities or externalization: a decision analysis. Journal of cardiovascular electrophysiology, 26(2). pp. 184–191. 10.1111/jce.12563 Retrieved from https://hdl.handle.net/10161/22879.

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Scholars@Duke

Pokorney

Sean Pokorney

Assistant Professor of Medicine
Matchar

David Bruce Matchar

Professor of Medicine

My research relates to clinical practice improvement - from the development of clinical policies to their implementation in real world clinical settings. Most recently my major content focus has been cerebrovascular disease. Other major clinical areas in which I work include the range of disabling neurological conditions, cardiovascular disease, and cancer prevention.
Notable features of my work are: (1) reliance on analytic strategies such as meta-analysis, simulation, decision analysis and cost-effectiveness analysis; (2) a balancing of methodological rigor the needs of medical professionals; and (3) dependence on interdisciplinary groups of experts.
This approach is best illustrated by the Stroke Prevention Patient Outcome Research Team (PORT), for which I served as principal investigator. Funded by the AHCPR, the PORT involved 35 investigators at 13 institutions. The Stroke PORT has been highly productive and has led to a stroke prevention project funded as a public/private partnership by the AHCPR and DuPont Pharma, the Managing Anticoagulation Services Trial (MAST). MAST is a practice improvement trial in 6 managed care organizations, focussing on optimizing anticoagulation for individuals with atrial fibrillation.
I serve as consultant in the general area of analytic strategies for clinical policy development, as well as for specific projects related to stroke (e.g., acute stroke treatment, management of atrial fibrillation, and use of carotid endarterectomy.) I have worked with AHCPR (now AHRQ), ACP, AHA, AAN, Robert Wood Johnson Foundation, NSA, WHO, and several pharmaceutical companies.
Key Words: clinical policy, disease management, stroke, decision analysis, clinical guidelines

Robert Kenneth Lewis

Assistant Professor of Medicine
Piccini

Jonathan Paul Piccini

Professor of Medicine

Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS is a clinical cardiac electrophysiologist and Professor of Medicine at Duke University Medical Center and the Duke Clinical Research Institute. He is the Director of the Cardiac Electrophysiology section at the Duke Heart Center. His focus is on the care of patients with atrial fibrillation and complex arrhythmias, with particular emphasis on catheter ablation and lead extraction. His research interests include the development and evaluation of innovative cardiovascular interventions for the treatment heart rhythm disorders. He has served as the chairman for several national and international clinical trials and registries, including the American Heart Association-Get with the Guidelines Atrial Fibrillation program. He is an Associate Editor at JACC: Clinical Electrophysiology and is an elected member of the American Society for Clinical Investigation. Dr. Piccini has more than 550 publications in the field of heart rhythm medicine and has been the recipient of several teaching and mentorship awards.


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