Complications associated with pectoral cardioverter-defibrillator implantation: comparison of subcutaneous and submuscular approaches. Worldwide Jewel Investigators.
OBJECTIVE
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.
Department of Medicine, University of Maryland School of Medicine, Baltimore, USA. MGold@Heart.ab.umd.edu
M R
MR
Gold
R W
RW
Peters
J W
JW
Johnson
S R
SR
Shorofsky
D000368:Aged; D015331:Cohort Studies; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D062109:Dermatologic Surgical Procedures; D005260:Female; D005548:Foreign-Body Migration; D006801:Humans; D008297:Male; D008722:Methods; D008875:Middle Aged; D010369:Pectoralis Muscles / Q000601:surgery; D011183:Postoperative Complications; D013997:Time Factors