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Women more likely than men to experience complications after ICD implantation
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Among patients who underwent implantable cardioverter defibrillator implantation, women had a higher risk for complications and were less likely to experience appropriate implantable cardioverter defibrillator-delivered therapies compared with men, according to recent study results.
Researchers in Canada conducted an analysis of 6,021 patients (21.4% women) who were referred to an electrophysiologist for possible ICD implantation between February 2007 and July 2010. To examine potential sex differences in ICD implantation and device outcomes, they measured implantation rate; complications up to 45 days; device outcomes, including appropriate shocks and therapies; and deaths up to 1 year.
Men and women had similar rates of ICD implantation (RR=0.99; 95% CI, 0.97-1.02). However, major complications after implantation were significantly more likely to occur in women by 45 days (OR=1.78; 95% CI, 1.24-2.58) and 1 year (HR=1.91; 95% CI, 1.48-2.47) after implantation. Minor, early complications were also more common in women (OR=1.55; 95% CI, 1.09-2.2).
There was no difference in total mortality between men and women who received ICDs (HR=1.0; 95% CI, 0.64-1.55).
Compared with men, women were also less likely to receive inappropriate ICD shock (HR=0.69; 95% CI, 0.51-0.93) or appropriate therapy via shock or antitachycardia pacing (HR=0.73; 95% CI, 0.59-0.9) after implantation. This finding in women "suggests that their baseline arrhythmic risk is lower under current primary and secondary prevention eligibility criteria," Derek R. MacFadden, MD, of the University of Toronto, and colleagues wrote.
In an accompanying editorial, Pamela S. Douglas, MD, of Duke University Medical Center, and Lesley H. Curtis, PhD, of Duke Clinical Research Institute, said exploring differences in men and women could lead to a deeper understanding of electrophysiology and improved care. However, researchers must look at whether ICDs are more effective than pharmacologic treatment alone in preventing sudden death in women.
"The ultimate goal of research is to better inform clinical decision-making and to provide the best possible care for every patient," Douglas and Curtis wrote. "The naturally occurring variations between the sexes represent potential opportunities to learn more about the disease and its treatments, particularly when evidence derived from studies in men do not also hold for women."
For more information:
Disclosure: Drs. Curtis, Douglas and MacFadden report no relevant financial disclosures.
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This study highlights the risks for implanting ICDs in women, and we need to think carefully about the mode of ICD required to try to minimize that risk. It also highlights the fact that we do not quite understand why this risk exists. It may reflect differences in anatomy in women vs. men - perhaps they have smaller blood vessels that increase their risk for puncturing the adjacent artery or the lung. Also, smaller blood vessels in the heart may increase the difficulty getting access to the coronary sinus and positioning the left ventricular lead, increasing the risk for coronary sinus dissection and also increasing the risk for dislodgement. If women have a thinner atrial wall there is more likelihood of perforation or dislodgement.
This is an important area for ongoing research in trying to improve our understanding of why this happens so we can develop better leads that are going to be less likely to dislodge, less likely to cause complications and improve implant outcomes.
– Anne Gillis, MD,
FHRS
President-Elect
Heart Rhythm Society
Disclosure: Dr. Gillis has received honorarium and research grants from Medtronic.
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