One in 25 patients experience complications after ICD implantation: ICES study

Implantable cardioverter-defibrillators (ICDs) can prevent sudden cardiac death in many patients whose hearts have weakened pumping ability, as well as for some who have suffered a past heart attack. However, new research from the Institute for Clinical Evaluative Sciences (ICES) conducted in collaboration with 18 major cardiac centres in Ontario shows that complications occur in approximately one in every 25 ICD patients who undergo battery replacement surgery within 45 days of the operation. While most of these complications are not life-threatening, some, like mechanical problems or serious surgical infections, can be serious. An estimated 2,000 Ontarians undergo this procedure annually.

“The Ontario ICD database, funded by the Ontario Ministry of Health and Long-Term care, is one of the most comprehensive ICD databases in the world. While ICDs can be life-saving devices for many patients, these data suggest that patient, operator and system factors contribute to risk of complications in patients facing ICD replacement. Identifying factors contributing to complications may permit identification of high-risk individuals that warrant incremental monitoring and therapy to attenuate risk. In addition, replacement may be a discretionary decision in the context of an advisory or borderline device performance, and risk factors that predict adverse outcome may assist in clinical decision-making,” says Dr. Andrew Krahn, principal author and Cardiologist at London Health Sciences Center.

The study of 1,081 patients undergoing ICD replacement in 18 major cardiac centres in Ontario from February 2007 to August 2009 found:

• Complications occurred in 1 out of 25 patients
• More is not necessarily better – although more complicated devices are more capable, they come at the price of more complications
• Heart failure devices, which have recently been shown to save lives and make people better, have twice the complications
• Patient, operator and system factors contribute to risk of complications, which can be used to help doctors and patients make better decisions

The most complex defibrillators may be used in some patients suffering from fluid build-up in the lungs because of a weakened heart, with the aim of improving quality of life and reducing the need for frequent hospitalizations.

“Although some complications developed immediately after defibrillator implantation, most complications tended to occur after a patient had been discharged from the hospital. The development of major complications was associated with a significantly increased risk of mortality. This highlights the critical importance for patients who have undergone a defibrillator procedure to follow-up with their physicians should they suspect they have developed a device-related complication,” says co-author and ICES Scientist, Dr. Douglas Lee.

The study “Predictors of Short Term Complications After ICD Replacement: Results from the Ontario ICD Database” is in the April 19, 2011 edition of Circulation: Arrhythmia & Electrophysiology.

The Ontario Implantable Cardioverter Database (ICD) is funded by the Ontario Ministry of Health and Long-Term (MOHLTC) and involves a collaborative effort between ICES and all 18 hospitals in Ontario involved in the implantation and follow up of patients who receive ICDs in Ontario(http://icd.ices.on.ca). The results and conclusions are those of the authors, and should not be attributed to the MOHLTC.

ICES is an independent, non-profit organization that uses population-based health information to produce knowledge on a broad range of healthcare issues. Our unbiased evidence provides measures of health system performance, a clearer understanding of the shifting healthcare needs of Ontarians, and a stimulus for discussion of practical solutions to optimize scarce resources. ICES knowledge is highly regarded in Canada and abroad, and is widely used by government, hospitals, planners, and practitioners to make decisions about care delivery and to develop policy.

FOR FURTHER INFORMATION PLEASE CONTACT:

• Deborah Creatura
• Media Advisor, ICES
• [email protected]
• 416-480-4780 or cell 647-406-5996