Emily P Zeitler1, Yongfei Wang1, Kumar Dharmarajan1, Kevin J Anstrom1, Eric D Peterson1, James P Daubert1, Jeptha P Curtis1, Sana M Al-Khatib2. 1. From the Duke Clinical Research Institute, Durham, NC (E.P.Z., K.J.A., E.D.P., J.P.D., S.M.A.-K.); Department of Medicine, Duke University Medical System, Durham, NC (E.P.Z., E.D.P., J.P.D., S.M.A.-K.); Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, CT (Y.W., K.D., J.P.C.); and Department of Medicine, Yale University School of Medicine, New Haven, CT (Y.W., K.D., J.P.C.). 2. From the Duke Clinical Research Institute, Durham, NC (E.P.Z., K.J.A., E.D.P., J.P.D., S.M.A.-K.); Department of Medicine, Duke University Medical System, Durham, NC (E.P.Z., E.D.P., J.P.D., S.M.A.-K.); Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, CT (Y.W., K.D., J.P.C.); and Department of Medicine, Yale University School of Medicine, New Haven, CT (Y.W., K.D., J.P.C.). alkha001@mc.duke.edu.
Abstract
BACKGROUND: Patients with an unused or malfunctioning implantable cardioverter-defibrillator (ICD) lead may have the lead either abandoned or explanted; yet there are limited data on the comparative acute and longer-term safety of these 2 approaches. METHODS AND RESULTS: We examined in-hospital events among 24 908 subject encounters using propensity score 1:1 matching for ICD lead abandonment or explantation in the National Cardiovascular Data Registry (NCDR) ICD Registry (April 2010 to June 2014). Relative to patients undergoing lead abandonment, patients undergoing lead explantation had more in-hospital procedure-related complications: 2.19% (n=273) versus 3.77% (n=469; P<0.001), respectively. Similarly, patients undergoing lead explantation had slightly higher rates of in-hospital death: 0.21% (n=26) versus 0.64% (n=80; P<0.001), respectively. At 1 year in a Medicare subset for survival, there was a trend of increased mortality in the explantation group (11% versus 8%; P=0.06). In the Medicare subset analyzed for postprocedure complications, there was no difference with respect to 6-month bleeding (4.80% in both the groups), tamponade (0.38% versus 0.58%), infection (1.34% versus 3.07%), upper extremity thrombosis (0.77% versus 0.96%), pulmonary embolism (0.38% versus 0.96%), or urgent surgery (1.15% for both the groups; P>0.05 for all). CONCLUSIONS: After matching, patients undergoing removal of an unused or malfunctioning ICD lead had slightly higher in-hospital complications and deaths than those with a lead abandonment strategy. Although the 1-year mortality risk was slightly higher in the lead explantation group, this difference was not statistically significant and may be explained by chance.
BACKGROUND:Patients with an unused or malfunctioning implantable cardioverter-defibrillator (ICD) lead may have the lead either abandoned or explanted; yet there are limited data on the comparative acute and longer-term safety of these 2 approaches. METHODS AND RESULTS: We examined in-hospital events among 24 908 subject encounters using propensity score 1:1 matching for ICD lead abandonment or explantation in the National Cardiovascular Data Registry (NCDR) ICD Registry (April 2010 to June 2014). Relative to patients undergoing lead abandonment, patients undergoing lead explantation had more in-hospital procedure-related complications: 2.19% (n=273) versus 3.77% (n=469; P<0.001), respectively. Similarly, patients undergoing lead explantation had slightly higher rates of in-hospital death: 0.21% (n=26) versus 0.64% (n=80; P<0.001), respectively. At 1 year in a Medicare subset for survival, there was a trend of increased mortality in the explantation group (11% versus 8%; P=0.06). In the Medicare subset analyzed for postprocedure complications, there was no difference with respect to 6-month bleeding (4.80% in both the groups), tamponade (0.38% versus 0.58%), infection (1.34% versus 3.07%), upper extremity thrombosis (0.77% versus 0.96%), pulmonary embolism (0.38% versus 0.96%), or urgent surgery (1.15% for both the groups; P>0.05 for all). CONCLUSIONS: After matching, patients undergoing removal of an unused or malfunctioning ICD lead had slightly higher in-hospital complications and deaths than those with a lead abandonment strategy. Although the 1-year mortality risk was slightly higher in the lead explantation group, this difference was not statistically significant and may be explained by chance.
Authors: Christian G Wollmann; Dirk Böcker; Andreas Löher; Julia Köbe; Hans H Scheld; Günter E Breithardt; Rainer Gradaus Journal: Pacing Clin Electrophysiol Date: 2005-08 Impact factor: 1.976
Authors: Bruce L Wilkoff; Charles J Love; Charles L Byrd; Maria Grazia Bongiorni; Roger G Carrillo; George H Crossley; Laurence M Epstein; Richard A Friedman; Charles E H Kennergren; Przemyslaw Mitkowski; Raymond H M Schaerf; Oussama M Wazni Journal: Heart Rhythm Date: 2009-05-22 Impact factor: 6.343
Authors: Arthur J Moss; Wojciech Zareba; W Jackson Hall; Helmut Klein; David J Wilber; David S Cannom; James P Daubert; Steven L Higgins; Mary W Brown; Mark L Andrews Journal: N Engl J Med Date: 2002-03-19 Impact factor: 91.245
Authors: Michael P Brunner; Edmond M Cronin; Valeria E Duarte; Changhong Yu; Khaldoun G Tarakji; David O Martin; Thomas Callahan; Daniel J Cantillon; Mark J Niebauer; Walid I Saliba; Mohamed Kanj; Oussama Wazni; Bryan Baranowski; Bruce L Wilkoff Journal: Heart Rhythm Date: 2014-01-17 Impact factor: 6.343
Authors: Gust H Bardy; Kerry L Lee; Daniel B Mark; Jeanne E Poole; Douglas L Packer; Robin Boineau; Michael Domanski; Charles Troutman; Jill Anderson; George Johnson; Steven E McNulty; Nancy Clapp-Channing; Linda D Davidson-Ray; Elizabeth S Fraulo; Daniel P Fishbein; Richard M Luceri; John H Ip Journal: N Engl J Med Date: 2005-01-20 Impact factor: 91.245
Authors: Michael Glikson; Mahmoud Suleiman; David M Luria; Marjorie L Martin; David O Hodge; Win-Kuang Shen; David J Bradley; Thomas M Munger; Robert F Rea; David L Hayes; Stephen C Hammill; Paul A Friedman Journal: Heart Rhythm Date: 2008-10-11 Impact factor: 6.343
Authors: Alan Kadish; Alan Dyer; James P Daubert; Rebecca Quigg; N A Mark Estes; Kelley P Anderson; Hugh Calkins; David Hoch; Jeffrey Goldberger; Alaa Shalaby; William E Sanders; Andi Schaechter; Joseph H Levine Journal: N Engl J Med Date: 2004-05-20 Impact factor: 91.245
Authors: Frederick A Masoudi; Angelo Ponirakis; Robert W Yeh; Thomas M Maddox; Jim Beachy; Paul N Casale; Jeptha P Curtis; James De Lemos; Gregg Fonarow; Paul Heidenreich; Christina Koutras; Mark Kremers; John Messenger; Issam Moussa; William J Oetgen; Matthew T Roe; Kenneth Rosenfield; Thomas P Shields; John A Spertus; Jessica Wei; Christopher White; Christopher H Young; John S Rumsfeld Journal: J Am Coll Cardiol Date: 2013-09-18 Impact factor: 24.094