What question did this study set out to answer?

To evaluate the incidence, temporal trends, and risk factors of mechanical and infectious complications associated with transvenous implantable cardioverter-defibrillator leads using a large commercial claims database.

May 10, 2018Journal of the American Heart AssociationOpen Access

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

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Key result

Real-world transvenous ICD leads experience a ~25% mechanical complication rate during long-term follow-up.

Key Points

To evaluate the incidence, temporal trends, and risk factors of mechanical and infectious complications associated with transvenous implantable cardioverter-defibrillator leads using a large commercial claims database.
Retrospective analysis of claims data from the OptumLabs Data Warehouse covering patients with de novo ICD or cardiac resynchronization therapy defibrillator (CRT-D) implants between January 1, 2003, and June 30, 2015.
Included 40,837 patients with continuous insurance coverage for at least 1 year prior to implantation, with a mean follow-up of 2.3 ± 2.1 years.
Tracked mechanical and infectious complications, device reinterventions, and related clinical predictors over time.
Across 20,580 device procedures, mechanical and infectious complications occurred in 5.3% (n=2,165) and 1.9% (n=771) of cases, respectively, with up to 1 in 4 leads failing mechanically by 10 years.
The 5-year rate of freedom from mechanical complications was 92.0% for ICDs and 89.3% for CRT-D devices.
Mechanical complications were significantly associated with younger age, female sex, fewer comorbidities, and earlier implant year (2003–2008), whereas infections correlated with atrial fibrillation, diabetes, renal disease, and repeat procedures.

Structured PICO

Population

40,837 patients with a de novo implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implanted from January 1, 2003, through June 30, 2015, mean age 61.7, 73.0% male, US-based. Key inclusion: continuous insurance coverage beginning 1 year before implantation.

Intervention

Transvenous implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implantation

Outcome

Incidence of mechanical and infectious complications of transvenous ICD leads over long-term follow-upsafety

The real-world incidence of mechanical and infectious complications of transvenous ICD leads is substantially higher than reported in clinical trials, with 1 in 4 leads experiencing mechanical complications by 10 years.

Discussion

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Implication

Real-world mechanical complications with transvenous ICD leads may exceed trial rates; challenges prior estimates and leaves open need for prospective validation.

Cite This Study

Koneru et al. (2018) studied this question. 1 in 4 transvenous ICD leads experienced mechanical complications over a follow-up of up to 10 years, indicating higher real-world incidence than clinical studies.

synapsesocial.com/papers/69714deaf0a245e8b19d197a https://doi.org/10.1161/jaha.117.007691

Topics

Cardiac device therapy Persistent AF management Atrial fibrillation

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Implication

Real-world mechanical complications with transvenous ICD leads may exceed trial rates; challenges prior estimates and leaves open need for prospective validation.

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Topics

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider