LEAD DAMAGE IN THE FIRST-YEAR FOLLOWING CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED) REPLACEMENT- INCIDENCE AND COSTS BASED ON DEVICE TYPE

Author(s)

Nichols CI1, Vose JG1, Mittal S2
1Medtronic Advanced Energy, Portsmouth, NH, USA, 2Valley Health System of New York and New Jersey, New York, NY, USA

OBJECTIVES: This study evaluated the incidence and costs of lead damage within one year of pacemaker (PM), implantable cardiac defibrillator (ICD), and cardiac resynchronization therapy defibrillator (CRT-D) device replacement. METHODS: Using Truven US insurance claims (1/1/2009 – 12/31/2013), we identified patients who underwent a CIED generator replacement. We excluded patients with existing lead damage or active infection. Data were analyzed for one year prior to and following the replacement procedure, with device replacement the index date for analysis. During follow-up we considered lead damage to have occurred if there was any recorded visit with a procedure code for lead revision or repair and no concurrent code for infection. A Cox model, adjusted for baseline demographics and comorbidities, was used to evaluate variables associated with risk of lead damage. RESULTS: The study cohort included 45,250 patients (72±14 years; 64% male), including 22,557 (50%) PMs, 20,632 (46%) ICDs, and 2,061 (5%) CRT-Ds. Lead damage was observed in 406 (0.90%) patients. The incidence of lead damage was significantly influenced by CIED type (PM: 0.46%; ICD: 1.27%; CRT: 1.94% p < .001). Similarly, total hospitalization cost associated with lead revision / repair was influenced by CIED type (PM: $19,959; ICD: $ 24,885; CRT: $46,229, p=0.048). As compared to PMs, ICDs (HR = 2.14, 95% CI 1.68 – 2.74) and CRTs (HR = 2.97, 95% CI 1.99 – 4.43) had a significantly higher risk of lead damage. CONCLUSIONS: This is the first nationally representative study to assess the incidence and associated costs of lead damage following CIED generator replacement in the US. Patients with an ICD or CRT have a significant 1-2% risk of lead damage, which is associated with substantial hospitalization-related costs. Strategies are needed at the time of generator replacement to minimize inadvertent lead damage.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PCV3

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Cardiovascular Disorders

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