“There is a clear connection between the number of transvenous lead removal (TLR) procedures performed at a center and the rate of complications, such as infection,” said Juan Viles-Gonzalez, M.D., assistant professor of medicine at the University of Miami Miller School of Medicine. “Low- and intermediate-volume centers had worse safety outcomes. This is a procedure where experience clearly matters.”
Viles-Gonzalez was the lead author of the study, “Trends in Utilization and Adverse Outcomes Associated with Transvenous Lead Removal in the United States.” Miller School co-authors were Nileshkumar Patel, M.D., a cardiology fellow, and James O. Coffey, M.D., assistant professor of medicine. The multicenter study included researchers from Mayo Clinic, Icahn School of Medicine at Mount Sinai in New York, Yale New Haven Medical Center, and Saint Peter’s University Hospital/Rutgers University.
“The number of CIEDs implanted in the United States continues to grow,” said Viles-Gonzalez. “With more leads being used for longer periods of time, there has been a call for a comprehensive device and lead management approach.”
Viles-Gonzalez said the aim of the nationwide study was to examine utilization patterns, frequency of adverse events and influence of hospital volume on complications.
Using the Nationwide Inpatient Sample, the research team identified 91,890 TLR procedures, and found that the overall complication rate in patients undergoing TLR was 7.9 percent – higher than previously reported.
“Annual hospital volume emerged as an important determinant of the safety of this procedure,” Viles-Gonzalez said. “Hospitals performing more than 50 procedures per year had the best safety profile.”
He said that Rogerio G. Carrillo, M.D., associate professor of clinical surgery, who leads the UHealth surgical electrophysiology program, extracts more than 200 leads per year.
A cardiologist who focuses his research on arrhythmias in patients with cardiomyopathies, atrial fibrillation, stroke prevention and anticoagulation, Viles-Gonzalez is the author of more than 70 scientific articles, and an ad-hoc reviewer for several scientific journals, including Circulation.
In the same issue as the multicenter TLR study, Circulation published a commentary on the results, “When You Have Nowhere to Look, You Look Where You Can,” by Melanie Maytin, M.D., and Laurence M. Epstein, M.D., of Brigham and Women’s Hospital in Boston.
“Clearly what is needed are data and education, both of which are lacking,” said the authors, who noted differences between the NIS and other published datasets.
“This study highlights the need for a prospective national registry to truly know what is happening in the real world,” said the authors, who have formed a consortium of lead extraction centers to improve the care of CIED patients. “One of the major efforts of this group is to create a national registry for centers to track their own outcomes and provide pooled data to answer important questions.”
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