Abhishek Deshmukh1, Nileshkumar Patel2, Peter A Noseworthy2, Achint A Patel2, Nilay Patel2, Shilpkumar Arora2, Suraj Kapa2, Amit Noheria2, Siva Mulpuru2, Apurva Badheka2, Avi Fischer2, James O Coffey2, Yong Mei Cha2, Paul Friedman2, Samuel Asirvatham2, Juan F Viles-Gonzalez2. 1. From Mayo Clinic, Rochester, MN (A.D., P.A.N., S.K., A.N., S.M., Y.M.C., P.F., S. Asirvatham); University of Miami Miller School of Medicine, Miami, FL (N.P., J.O.C., J.F.V.-G.); Icahn School of Medicine at Mount Sinai, New York, NY (A.A.P., S. Arora); Yale New Haven Medical Center, New Haven, CT (A.B.); St. Jude Medical, Sylmar, CA (A.F.); and Saint Peter's University Hospital/Rutgers University, New Brunswick, NJ (N.P.). deshmukh.abhishek@mayo.edu. 2. From Mayo Clinic, Rochester, MN (A.D., P.A.N., S.K., A.N., S.M., Y.M.C., P.F., S. Asirvatham); University of Miami Miller School of Medicine, Miami, FL (N.P., J.O.C., J.F.V.-G.); Icahn School of Medicine at Mount Sinai, New York, NY (A.A.P., S. Arora); Yale New Haven Medical Center, New Haven, CT (A.B.); St. Jude Medical, Sylmar, CA (A.F.); and Saint Peter's University Hospital/Rutgers University, New Brunswick, NJ (N.P.).
Abstract
BACKGROUND: Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of hospital volume on complications. METHODS AND RESULTS: Using the Nationwide Inpatient Sample, we identified 91 890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female sex and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period. CONCLUSIONS: The overall complication rate in patients undergoing TLR was higher than previously reported. Female sex and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.
BACKGROUND: Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of hospital volume on complications. METHODS AND RESULTS: Using the Nationwide Inpatient Sample, we identified 91 890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female sex and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period. CONCLUSIONS: The overall complication rate in patients undergoing TLR was higher than previously reported. Female sex and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.
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