A simple risk model that predicts the risk of in-hospital complications and mortality associated with implantable cardioverter defibrillator(ICD) placement can be used to benchmark hospital complication rates, and potentially inform treatment decisions, according to a new NCDR report published Dec. 11 in the Journal of the American College of Cardiology.

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For the report, investigators analyzed data on 240,632 ICD implantation procedures from the ICD Registry and developed a risk score using factors independently associated with adverse events related to the procedures. The risk score characterized patients into low- and high-risk subgroups.

The investigators defined the primary outcome measure as a composite of procedure-related adverse events, including cardiac arrest, cardiac perforation, coronary venous dissection, hemothorax, infection, lead dislodgement, MI, pericardial tamponade, pneumothorax, stroke/transient ischemic attack, urgent cardiac surgery, hematoma or a set-screw problem. Mortality was included in the composite whether or not it was directly attributable to the procedure.

Among the 240,632 patients who received an ICD, 4,388 (1.8 percent) experienced an adverse event. The most common medical conditions associated with adverse events were hypertension, prior MI, heart failure, diabetes and chronic lung disease.

Those who experienced an adverse event were older (68.4 years, p < 0.0001), more often women (p < 0.0001), less likely to have ICD implantation as the primary reason for hospital admission and more likely to have been hospitalized for heart failure within the previous six months (p < 0.0001).

The most common adverse events were lead dislodgement, hematoma and pneumothorax. In-hospital mortality occurred in 637 patients (0.26 percent). Patients with a risk score of 10 or below were at very low risk of complications (0.3 percent), while those with a risk score of 30 or more had a much higher risk of complications (4.2 percent).

"Our efforts had two main purposes: First, the risk model can be used to benchmark hospital complication rates and, therefore, be a useful tool in quality-improvement efforts. Second, the risk score derived from the model can be used to facilitate shared decision-making with patients by incorporating an individual's expected risk of ICD implantation," wrote the authors.

Keywords: Hemothorax, Risk, Stroke, Ischemic Attack, Transient, Hospital Mortality, Pneumothorax, Heart Arrest, Hematoma, Registries, Heart Failure, Cardiac Surgical Procedures, Hypertension, United States, Diabetes Mellitus, Defibrillators, Implantable, Cardiac Tamponade, Lung Diseases

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