Daniel J Cantillon1, Srinivas R Dukkipati2, John H Ip3, Derek V Exner4, Imran K Niazi5, Rajesh S Banker6, Mayer Rashtian7, Kenneth Plunkitt8, Gery F Tomassoni9, Yelena Nabutovsky10, Kevin J Davis10, Vivek Y Reddy2. 1. Cleveland Clinic, Cleveland, Ohio. Electronic address: cantild@ccf.org. 2. Icahn School of Medicine at Mount Sinai, New York, New York. 3. Sparrow Clinical Research Institute, Lansing, Michigan. 4. Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada. 5. Aurora Medical Group, Milwaukee, Wisconsin. 6. Premier Cardiology, Newport Beach, California. 7. Huntington Memorial Hospital, Pasadena, California. 8. Naples Community Hospital, Naples, Florida. 9. Central Baptist Hospital, Lexington, Kentucky. 10. Abbott, Sylmar, California.
Abstract
BACKGROUND: Leadless cardiac pacemakers (LCPs) aim to mitigate lead- and pocket-related complications seen with transvenous pacemakers (TVPs). OBJECTIVE: The purpose of this study was to compare complications between the LCP cohort from the LEADLESS Pacemaker IDE Study (Leadless II) trial and a propensity score-matched real-world TVP cohort. METHODS: The multicenter LEADLESS II trial evaluated the safety and efficacy of the Nanostim LCP (Abbott, Abbott Park, IL) using structured follow-up, with serious adverse device effects independently adjudicated. TVP data were obtained from Truven Health MarketScan claims databases for patients implanted with single-chamber TVPs between April 1, 2010 and March 31, 2014 and more than 1 year of preimplant enrollment data. Comorbidities and complications were identified via International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes. Short-term (≤1 months) and mid-term (>1-18 months) complications were compared between the LCP cohort and a propensity score-matched subset of the TVP cohort. RESULTS: Among 718 patients with LCPs (mean age 75.6 ± 11.9 years; 62% men) and 1436 patients with TVPs (mean age 76.1 ± 12.3 years; 63% men), patients with LCPs experienced fewer complications (hazard ratio 0.44; 95% confidence interval 0.32-0.60; P < .001), including short-term (5.8% vs 9.4%; P = .01) and mid-term (0.56% vs 4.9%; P < .001) events. In the short-term time frame, patients with LCPs had more pericardial effusions (1.53% vs 0.35%; P = .005); similar rates of vascular events (1.11% vs 0.42%; P = .085), dislodgments (0.97% vs 1.39%; P = .54), and generator complications (0.70% vs 0.28%; P = .17); and no thoracic trauma compared to patients with TVPs (rate of thoracic trauma 3.27%). In short- and mid-term time frames, TVP events absent from the LCP group included lead-related, pocket-related, and infectious complications. CONCLUSION: Patients with LCPs experienced fewer overall short- and mid-term complications, including infectious and lead- and pocket-related events, but more pericardial effusions, which were uncommon but serious.
BACKGROUND: Leadless cardiac pacemakers (LCPs) aim to mitigate lead- and pocket-related complications seen with transvenous pacemakers (TVPs). OBJECTIVE: The purpose of this study was to compare complications between the LCP cohort from the LEADLESS Pacemaker IDE Study (Leadless II) trial and a propensity score-matched real-world TVP cohort. METHODS: The multicenter LEADLESS II trial evaluated the safety and efficacy of the Nanostim LCP (Abbott, Abbott Park, IL) using structured follow-up, with serious adverse device effects independently adjudicated. TVP data were obtained from Truven Health MarketScan claims databases for patients implanted with single-chamber TVPs between April 1, 2010 and March 31, 2014 and more than 1 year of preimplant enrollment data. Comorbidities and complications were identified via International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes. Short-term (≤1 months) and mid-term (>1-18 months) complications were compared between the LCP cohort and a propensity score-matched subset of the TVP cohort. RESULTS: Among 718 patients with LCPs (mean age 75.6 ± 11.9 years; 62% men) and 1436 patients with TVPs (mean age 76.1 ± 12.3 years; 63% men), patients with LCPs experienced fewer complications (hazard ratio 0.44; 95% confidence interval 0.32-0.60; P < .001), including short-term (5.8% vs 9.4%; P = .01) and mid-term (0.56% vs 4.9%; P < .001) events. In the short-term time frame, patients with LCPs had more pericardial effusions (1.53% vs 0.35%; P = .005); similar rates of vascular events (1.11% vs 0.42%; P = .085), dislodgments (0.97% vs 1.39%; P = .54), and generator complications (0.70% vs 0.28%; P = .17); and no thoracic trauma compared to patients with TVPs (rate of thoracic trauma 3.27%). In short- and mid-term time frames, TVP events absent from the LCP group included lead-related, pocket-related, and infectious complications. CONCLUSION:Patients with LCPs experienced fewer overall short- and mid-term complications, including infectious and lead- and pocket-related events, but more pericardial effusions, which were uncommon but serious.
Authors: Shmaila Saleem-Talib; Vincent J van Driel; Sevasti-Maria Chaldoupi; Tanja Nikolic; Harry van Wessel; C Jan Willem Borleffs; Hemanth Ramanna Journal: Pacing Clin Electrophysiol Date: 2019-02-25 Impact factor: 1.976
Authors: Jonathan P Piccini; Ryan Cunnane; Jan Steffel; Mikhael F El-Chami; Dwight Reynolds; Paul R Roberts; Kyoko Soejima; Clemens Steinwender; Christophe Garweg; Larry Chinitz; Christopher R Ellis; Kurt Stromberg; Dedra H Fagan; Lluis Mont Journal: Europace Date: 2022-07-21 Impact factor: 5.486
Authors: Jonathan P Piccini; Mikhael El-Chami; Kael Wherry; George H Crossley; Robert C Kowal; Kurt Stromberg; Colleen Longacre; Jennifer Hinnenthal; Lindsay Bockstedt Journal: JAMA Cardiol Date: 2021-10-01 Impact factor: 14.676