07 Sep ICD Implantation and Cardiac Perforation Risk
MedicalResearch.com Interview with: Jonathan Hsu, MD, MAS
Cardiac Electrophysiology, Division of Cardiology
University of California, San Diego (UCSD)
MedicalResearch.com: What are the main findings of the study?
Dr. Hsu: We found that the prevalence of cardiac perforation during modern day ICD implantation is 0.14%.
We also found that specific patient and implanter characteristics predict cardiac perforation risk: older age, female sex, left bundle branch block, worsened heart failure class, higher left ventricular ejection fraction, and non-single chamber ICD implant are associated with a greater odds of perforation, whereas atrial fibrillation, diabetes, previous cardiac bypass surgery, and higher implanter procedural volume are associated with a lower odds of perforation.
It appears that cardiac perforation from ICD implantation is associated with a substantially increased risk of other major in-hospital complications, prolonged hospitalization, and death.
In this large, national sample of first-time ICD recipients, cardiac perforation occurred in 625 out of 440,251 patients (0.14%). We identified several patient and implanter characteristics that predicted cardiac perforation risk. 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 cardiac perforation. Conversely, atrial fibrillation, diabetes, previous cardiac bypass surgery, and higher implanter procedural volume were associated with a lower odds of perforation (all p values <0.05). Patients who experienced cardiac perforation had a substantially increased risk of adverse events both before and after adjustment for potential confounders, including a greater than 26-fold increased odds of any other associated major complication, 16-fold increased odds of prolonged hospital stay > 3 days, and 15-fold increased odds of in-hospital death.
MedicalResearch.com: Were any of the findings unexpected?
Dr. Hsu: It was somewhat surprising that a higher LVEF was associated with an increased odds of cardiac perforation. It is speculative to say that perhaps more forceful contractions of the heart muscle against the lead tip may predispose to cardiac perforation. Therefore, more research in this area is necessary.
MedicalResearch.com: What should clinicians and patients take away from this study?
Dr. Hsu: 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 healthcare utilization and costs. If indeed cardiac perforation is at the core of the majority of acute complications that occur in new ICD implants and the lead characteristics influence that risk, these data may inform lead manufacturers to be even more vigilant in assuring the safety of lead implant procedures. Additionally, knowledge that cardiac perforation is associated with a considerably increased risk of adverse events may allow for more aggressive treatment in those who experience the complication to avert further morbidity and mortality. 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. Therefore our study findings would be relevant to ICD implanters and patients undergoing this cardiovascular procedure.
MedicalResearch.com: What further research do you recommend as a result of your study?
Dr. Hsu: Further research into the mechanisms of novel predictors found to be associated with cardiac perforation in our study is warranted, particularly regarding the association of LBBB and increased LVEF with a higher cardiac perforation risk, as well as the association of atrial fibrillation and diabetes with a lower cardiac perforation risk.
Specifically, now that these covariates have been identified, other device registries as well as prospective studies might consider special efforts to make sure these covariates are included on case report forms.
Cardiac Perforation From Implantable Cardioverter-Defibrillator Lead Placement: Insights From the National Cardiovascular Data Registry
Jonathan C. Hsu, Paul D. Varosy, Haikun Bao, Thomas A. Dewland, Jeptha P. Curtis, and Gregory M. Marcus
Circ Cardiovasc Qual Outcomes. 2013;CIRCOUTCOMES.113.000299published online before print September 3 2013, doi:10.1161/CIRCOUTCOMES.113.000299