Po-05-059 real-world longitudinal data evaluation of complication rates and medicare hospitalization costs between one-lead, hybrid, and two-lead icd systems

Optimal device selection between one (VR) and two-lead (DR) ICDs for patients without conventional indications for pacing remain contentious. Traditional one-lead ICDs do not provide atrial diagnostics. Alternatively, two-lead ICDs offer potential advantages over one-lead defibrillators but the addition of an atrial lead may increase procedural cost and increase the risk of lead complications. A third option, BIOTRONIK’s hybrid lead (DX) is a single-lead with a floating atrial dipole allowing for atrial sensing capabilities of a two-lead system without the need of a separate atrial lead. To evaluate lead complication rates and hospitalization costs between VR, DX, and DR ICD systems. Medicare Fee-For-Service beneficiaries with de novo BIOTRONIK VR, DX, or DR ICD systems were identified within the CERTITUDE real-world research database. Lead complications were identified from BIOTRONIK’s device tracking database and Medicare inpatient, outpatient, or carrier claims which contained combinations of ICD-9-CM, ICD-10-CM, and CPT procedure and diagnosis codes indicative of a lead-related issue (e.g., dislodgement, mechanical breakdown, etc.) requiring surgical intervention. Complications within 30-days of implant were excluded to eliminate implant procedure related issues. Estimations of hospital costs associated with device implant and lead complications were obtained from the MedPAR payment file for inpatient claims using the summation of the Diagnosis-Related Group price, outlier, and pass-through amounts as established in predicate studies. Through 3-years of follow-up, the DX cohort of 1355 patients had the lowest rate of lead complications with an incidence rate of 0.005 complications/patient-year. The VR cohort (337 patients) had the second lowest complication rate at 0.007 complications/patient-year, and the DR cohort (1743 patients) had the highest at 0.013 complications/patient-year. The survival curves for these cohorts is shown in Figure. The mean cost to Medicare for device implant at hospital was $40,233.62 and did not differ significantly between one and two-lead devices (p=0.055). The mean cost of lead complication resulting in hospitalization was $24,640.04. One-lead ICD systems, particularly DX, resulted in a lower rate of lead complications through 3-years of follow-up data. Heeding the minimal cost difference at implant, increased risk of complications, and high cost of lead complications, a one-lead system should be considered when appropriate.