AARHUS, DENMARK--The risk of a complication following the implantation of a cardiac device, such as an implantable cardioverter defibrillator (ICD), pacemaker, or cardiac resynchronization therapy (CRT) device, is higher than previously acknowledged, according to the results of a new Danish analysis.
Overall, one in 10 patients (9.6%) who received an implantable electronic device experienced a complication, a rate that is higher than the 5% to 6% published in previous studies. The rate of major complications was 5.6%, the most common being the need for a lead-related reintervention (2.4%).
The analysis, published December 17, 2013 in the European Heart Journal, was led by Dr Rikke Esberg Kirkfeldt (Aarhus University Hospital, Denmark) and included 5,918 consecutive patients who underwent an implantation of an electronic cardiac device. Patients who underwent a system upgrade or had a lead revision had a greater risk of complication, mainly because of infection and pocket revisions due to pain.
Women were also significantly more likely to experience a complication and had a significantly higher risk of pneumothorax and cardiac perforation than men. In addition, the risk of pneumothorax and minor hematomas was significantly more common in underweight patients. Complications were more likely to occur with dual-chamber ICD and CRT device implants than with dual-chamber pacemaker implantations.
Procedures performed at low-volume centers and by low-volume operators also carried a higher risk of complications. With low-volume operators—clinicians who performed less than 50 annual implants—the risk of cardiac perforation, infection, and minor hematomas were significantly increased. Implantations performed in an emergency or out-of-hours setting were also associated with higher complication risks.
These findings, write Kirkfeldt and colleagues, can be used to help identify patients who might be at a particularly higher risk during implantations. They also suggest that the minimum operator volume is 50 or more procedures per year, a threshold they identified in their report.
SOURCE: Michael O'Riordan, Medscape Today