Subcutaneous pectoral ICD implantation had a comparable overall complication rate to the submuscular approach (4.1% vs. 2.5%, p=0.1836), but was associated with more lead dislodgments.
Cohort (n=1,000)
Yes
Does subcutaneous implantation compared to submuscular implantation reduce complications in patients receiving a pectoral ICD?
Subcutaneous pectoral ICD implantation is safe with comparable overall complication rates to the submuscular approach, though it is associated with a higher risk of early lead dislodgment.
Absolute Event Rate: 4.1% vs 2.5%
p-value: p=0.1836
OBJECTIVES: The aim of this study was to compare complications in a large cohort of patients undergoing pectoral cardioverter-defibrillator implantation with a subcutaneous or submuscular approach. BACKGROUND: Pectoral placement of implantable cardioverter-defibrillator (ICD) pulse generators is now routine because of downsizing of these devices. subcutaneous implantation has been advocated by some because it is a simple surgical procedure comparable to pacemaker insertion. Others have favored submuscular insertion to avoid wound complications. These surgical approaches have not been compared previously. METHODS: The subjects for this study were 1,000 consecutive patients receiving a Medtronic Jewel ICD at 93 centers worldwide. Cumulative follow-up for all patients was 633.7 patient-years, with 64.9% of patients followed up for > or = 6 months. The complications evaluated were erosion, pocket hematoma, seroma, wound infection, dehiscence, device migration, lead fracture and dislodgment. RESULTS: Subcutaneous implantation was performed in 604 patients and submuscular implantation in the remaining 396. The median procedural times were shorter for subcutaneous implantation (p = 0.014). In addition, the cumulative percentage of patients free from erosion was greater for subcutaneous implantations (p = 0.03, 100% vs. 99.1% at 6 months). However, lead dislodgment was more common with subcutaneous implantations (p = 0.019, 2.3% vs. 0.5% at 6 months) and occurred primarily during the first month postoperatively. Overall, there were no significant differences in cumulative freedom from complications between groups (4.1% vs. 2.5%, p = 0.1836). CONCLUSIONS: Subcutaneous pectoral implantation of this ICD can be performed safely and has a low complication rate. This approach requires a simple surgical procedure and, compared with the submuscular approach, is associated with shorter procedure times and comparable overall complication rates. However, early follow-up is important in view of the increased lead dislodgment rate.
Gold et al. (Fri,) conducted a cohort in Patients undergoing pectoral cardioverter-defibrillator implantation (n=1,000). Subcutaneous implantation vs. Submuscular implantation was evaluated on Cumulative freedom from complications (p=0.1836). Subcutaneous pectoral ICD implantation had a comparable overall complication rate to the submuscular approach (4.1% vs. 2.5%, p=0.1836), but was associated with more lead dislodgments.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: