NCDR Study Shows Relationship Between ICD Reoperations and In-Hospital Complications

Undergoing repeated implantable cardioverter-defibrillator (ICD) procedures has regularly been associated with a higher risk of complications. The extent of such complications however, has never been fully determined. Shedding light on the procedural hazards, a study published May 19 in The American Journal of Cardiology,  examined a large national cohort to better understand repeat ICD outcomes, and found that higher complication rates are associated with the addition or revision of a lead with our without concurrent lead extraction, compared to the initial implants and those undergoing pocket-only procedures.

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Led by David Steckman, MD, the investigative inquiry utilized data from the NCDR's ICD Registry to compare patient characteristics, reasons for ICD implantation, and associated in-hospital adverse events among 92,751 patients receiving their first device, and 81,748 patients undergoing repeat procedures with and without lead involvement, all performed between April 1, 2010 and June 30, 2011.

The study showed that complication rates were higher in those who underwent repeat procedures involving lead implantation or revision (3.2 percent) compared to patients undergoing initial implants (2.6 percent) as well as those who had pocket only procedures (0.6 percent) accounting for a greatly likelihood of death, cardiac arrest, hematoma, lead dislodgement and infections.

Upon adjusting for baseline characteristics and medical comorbidities, Steckman et al.'s multivariable analysis revealed more than four-fold greater odds of an adverse in-hospital complication for patients undergoing a repeat procedure requiring lead implantation or revision without lead extraction, and that patients undergoing lead extraction during a reoperation procedure had more than a seven-fold increase in adverse in-hospital complications.

Further, the most common causes of a repeat ICD were from patients upgrading from a pacemaker to ICD or more complex ICD system requiring additional leads. Another cause stemmed from a device being recalled. In this particular study, a total of 787, or 2.2 percent of all device re-implants, were performed as a result of such an advisory.

"Physicians are facing complex decisions in an era of lead advisories, recalls, device infections, and upgrades to advanced devices," the authors note. "This study and others suggest that there can be significant risks to revision or addition of leads during a re-implantation procedure." They add that "although our findings may help in the process of shared decision making with regards to procedural planning, ultimately the individual choice to undergo a lead related procedure at the time of a generator replacement will depend on a discussion of risks and benefits between patients and their physicians."

Keywords: Registries, Reoperation, Decision Making, Comorbidity, Pacemaker, Artificial, Heart Arrest, Hematoma, Risk Assessment, Defibrillators, Implantable, National Cardiovascular Data Registries, ICD Registry

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