Cardiac Perforation From Implantable Cardioverter-Defibrillator Lead Placement: Insights From the National Cardiovascular Data Registry

Background—Cardiac perforation is a feared complication of implantable cardioverter-defibrillator (ICD) lead implantation because of the potential for significant morbidity and mortality. Predictors of perforation and the severity of associated adverse events have not been well studied. We sought to identify predictors of cardiac perforation from ICD lead implantation and subsequent outcomes. Methods and Results—We studied 440 251 first-time ICD recipients in the ICD Registry implanted between January 2006 and September 2011. Using hierarchical multivariable logistic regression adjusting for patient, implanting physician, and hospital characteristics, we examined the predictors of perforation and the association of perforation with other major complications, length of stay, and in-hospital mortality. Cardiac perforation occurred in 625 patients (0.14%). After multivariable adjustment, older age, female sex, left bundle branch block, worsened heart failure class, higher left ventricular ejection fraction, and non–single-chamber ICD implant were associated with a greater odds of perforation. Conversely, atrial fibrillation, diabetes mellitus, previous cardiac bypass surgery, and higher implanter procedural volume were associated with a lower odds of perforation (all P<0.05). After adjustment, ICD recipients with perforation had greater odds of other associated major complications (odds ratio, 27.5; 95% confidence interval, 19.9–38.0; P<0.0001), postprocedural hospital stays >3 days (odds ratio, 16.3; 95% confidence interval, 13.7–19.4; P<0.0001), and in-hospital death (odds ratio, 17.7; 95% confidence interval, 12.2–25.6; P<0.0001). Conclusions—In a large population of ICD recipients, specific patient and implanter characteristics predicted cardiac perforation risk. Cardiac perforation was associated with a substantially increased risk of other major complications, prolonged hospital stays, and death.

[1]  G. Marcus,et al.  Low Body Mass Index but Not Obesity Is Associated With In-Hospital Adverse Events and Mortality Among Implantable Cardioverter-Defibrillator Recipients: Insights From the National Cardiovascular Data Registry , 2012, Journal of the American Heart Association.

[2]  J. Messenger,et al.  The National Cardiovascular Data Registry (NCDR) Data Quality Brief: the NCDR Data Quality Program in 2012. , 2012, Journal of the American College of Cardiology.

[3]  P. Heidenreich,et al.  Physician Procedure Volume and Complications of Cardioverter-Defibrillator Implantation , 2012, Circulation.

[4]  K. Schulman,et al.  Patient and Implanting Physician Factors Associated With Mortality and Complications After Implantable Cardioverter-Defibrillator Implantation, 2002–2005 , 2008, Circulation. Arrhythmia and electrophysiology.

[5]  B. Lindsay,et al.  Review of the Registry's second year, data collected, and plans to add lead and pediatric ICD procedures. , 2008, Heart rhythm.

[6]  P. Levine,et al.  Lead Perforation: Incidence in Registries , 2007, Pacing and clinical electrophysiology : PACE.

[7]  V. Jain,et al.  Prevalence and Characterization of Asymptomatic Pacemaker and ICD Lead Perforation on CT , 2007, Pacing and clinical electrophysiology : PACE.

[8]  F. Villarreal,et al.  The pathogenesis of myocardial fibrosis in the setting of diabetic cardiomyopathy. , 2006, Journal of the American College of Cardiology.

[9]  David L Hayes,et al.  Incidence and predictors of cardiac perforation after permanent pacemaker placement. , 2005, Heart rhythm.

[10]  A. Curtis,et al.  Clinical competency statement: Training pathways for implantation of cardioverter defibrillators and cardiac resynchronization devices. , 2004, Heart rhythm.

[11]  G. Naccarelli,et al.  Complications of biventricular pacing , 2004, Current opinion in cardiology.

[12]  Mark E. Josephson,et al.  Clinical cardiac electrophysiology ; techniques and interpretations , 2001 .

[13]  I. García-Bolao,et al.  Late Fatal Right Ventricular Perforation as Complication of Permanent Pacing Leads , 2001, Pacing and clinical electrophysiology : PACE.

[14]  F. Paganelli,et al.  Incidence of Perforation and Other Mechanical Complications During Dual Active Fixation , 1996, Pacing and clinical electrophysiology : PACE.

[15]  PhilipE. Hill.  Complications of Permanent Transvenous Cardiac Pacing: A 14‐Year Review of all Transvenous Pacemakers Inserted at One Community Hospital , 1987, Pacing and clinical electrophysiology : PACE.

[16]  F. Cuoco.  Dual-Chamber Implantable Cardioverter-Defibrillator Selection Is Associated With Increased Complication Rates and Mortality Among Patients Enrolled in the NCDR Implantable Cardioverter-Defibrillator Registry , 2012 .

[17]  Randall J. Lee,et al.  Rates and severity of perforation from implantable cardioverter-defibrillator leads: A 4-year study , 2008, Journal of Interventional Cardiac Electrophysiology.

[18]  Peter C Austin,et al.  Comparing hierarchical modeling with traditional logistic regression analysis among patients hospitalized with acute myocardial infarction: should we be analyzing cardiovascular outcomes data differently? , 2003, American heart journal.