In a real-world population, extraction of functional but recalled ICD leads was associated with a significantly higher risk of in-hospital mortality and complications vs. lead revision, according to a study published Sept. 14 in PACE: Pacing and Clinical Electrophysiology.

Emily P. Zeitler, MD, MHS, FACC, et al., used data from ACC's EP Device Implant Registry, formerly the ICD Registry, to study patients (n=13,144) with a functioning Riata or Fidelis lead undergoing generator replacement. Patients were classified according to the fate of their recalled lead: extracted/replaced, abandoned/replaced, or reused.

Due to an excess risk of failure, the Medtronic Sprint Fidelis lead was recalled by the U.S. Food and Drug Administration in October 2007, and the Abbott Riata/Riata ST leads were formally recalled in November 2011. The ideal approach to functioning and noninfected but recalled leads remains unclear.

From 13,144 generator replacement procedures involving a recalled Riata or Fidelis lead, 414 procedures involved lead extraction and 427 abandonment; in 12,153 procedures, the lead was reused. Some important differences were noted in this all-comers population: the extraction patients were younger (mean 58 vs. 67 years) with fewer comorbidities than the reuse group. Also, compared with the reuse group, the extraction and abandonment groups had lower prevalence of heart failure, ischemic heart disease and diabetes, as well as most other reported comorbidities.

Maximum lead dwell time was similar between groups (94, 90 and 99 months on average in the extraction, abandonment and reuse groups, respectively). There were 29 in-hospital deaths: 18 in the extraction group (4.35%), two in the abandonment group (0.47%) and nine in the reuse group (0.07%). Complications were also more common with extraction (10.14% compared with 1.64% for abandonment and 0.22% for reuse).

After adjustment and compared to reuse, the odds of death or predischarge complication were significantly higher with lead extraction (adjusted odds ratio [aOR], 7.77; p<0.001), but not with lead abandonment (aOR, 1.70; p=0.38).

Lead extraction poses higher short-term risk in exchange for longer-term benefit, noted the authors, so additional study is needed to clarify whether longer term outcomes balance these periprocedural risks.

The authors conclude that this report, albeit using retrospective and limited data, “helps to clarify anticipated risks to inform decision-making at the point of care and improve understanding of the natural history of lead management following an ICD lead recall.”

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Pericardial Disease, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure

Keywords: Electrophysiology, Diabetes Mellitus, Myocardial Ischemia, Reoperation, Pericardiectomy, Heart Failure, Point-of-Care Systems, Retrospective Studies, National Cardiovascular Data Registries, EP Device Implant Registry

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