Variables such as age, gender and heart failure class appear to contribute to the risk of developing cardiac perforation during first-time placement of an implantable cardioverter-defibrillator (ICD). These newfound factors were discovered in a large-scale study published Sept. 3 in Circulation: Cardiovascular Quality and Outcomes .

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The investigators looked at data from 440,251 first-time ICD recipients enrolled in the ICD Registry. Cardiac perforation occurred in 625 (0.14 percent) of these patients. Other factors associated with greater odds of cardiac perforation during first-time ICD implantation included left-bundle branch block, higher left ventricular ejection fraction (LVEF) and non-single-chamber ICD. Specifically, cardiac resynchronization therapy with a defibrillator led to a greater likelihood of cardiac perforation than single- or dual-chamber ICD implantation.

“In a large, national registry of first-time ICD recipients, specific patient and implanter characteristics predicted an increased cardiac perforation risk,” the investigators wrote. “Cardiac perforation from implantation was associated with a substantially increased risk of other major in-hospital complications, prolonged hospitalization and death.”

Previous smaller studies and registries of older lead technologies found cardiac perforation prevalence ranged from 0.6 percent to 5.2 percent for ICDs, but no data existed on the incidence of cardiac perforation from first-time ICD implantation and the extent of adverse events. Moving forward, the investigators recommended further research into mechanisms of action involved in the predictors.

“Increased risks from cardiac perforation from ICD implantation have important ramifications relevant to patients and practicing physicians, particularly as such major complications and longer hospital stays likely adversely affect patient quality of life and translate into increased health care utilization and costs,” noted lead author Jonathan Hsu, MD, MAS, Division of Cardiology, Department of Medicine, University of California, San Diego, CA. “By distinguishing easily recognizable predictors of cardiac perforation identified in this study, implanters may be better able to counsel patients regarding their risks, better able to quantify that risk, and may alter their approach (such as placing fewer total leads) in those most vulnerable.”

“Hsu and colleagues have leveraged the large volumes and broad scope of the ICD Registry to expand our understanding of the risk predictors of lead related cardiac perforation in ICD implantation,” said Mark S. Kremers, MD, FACC, chair of ICD Registry Steering Committee. “Somewhat reassuringly, the overall incidence is low, but the consequences are grave as evidenced by increased mortality, length of stay and association with other complications. While confirming several risk factors from smaller and older studies (including age, gender, and number of leads) some new and potentially puzzling elements emerged (left bundle branch block and higher ejection fraction) that merit further investigation and understanding. This data must now be incorporated into our risk/benefit algorithm and should challenge all ICD implanters to carefully weigh the pros and cons of device choice including considering, when possible, the utilization of the totally subcutaneous ICD,” he adds.

Keywords: Prevalence, Incidence, Registries, Quality of Life, Heart Failure, Bundle-Branch Block, Stroke Volume, Risk Factors, Defibrillators, Implantable, Cardiac Resynchronization Therapy, Length of Stay

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