Edwin McGee1, Matthew Danter2, Martin Strueber3, Claudius Mahr4, Nahush A Mokadam5, Georg Wieselthaler6, Liviu Klein7, Sangjin Lee8, Theodore Boeve9, Simon Maltais10, G Victor Pretorius11, Eric Adler12, Thomas Vassiliades13, Anson Cheung14. 1. Department of Cardiovascular and Thoracic Surgery, Loyola University Medical Center, Maywood, Illinois, USA. Electronic address: edwin.mcgee@lumc.edu. 2. Department of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, TN, USA. 3. Department of Cardiothoracic Surgery, Newark Beth Israel Medical Center, Newark, NJ, USA. 4. Department of Medicine, University of Washington Medical Center, Seattle, WA, USA. 5. Department of Cardiac Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, USA. 6. Department of Surgery, University of California San Francisco, San Francisco, CA, USA. 7. Department of Medicine, University of California San Francisco, San Francisco, CA, USA. 8. Department of Cardiovascular Medicine, Spectrum Health, Grand Rapids Michigan, MI, USA. 9. Department of Cardiac Surgery, Spectrum Health, Grand Rapids Michigan, MI, USA. 10. Department of Cardiothoracic Surgery, Mayo Clinic, Rochester, MN, USA. 11. Department of Surgery, University of California, San Diego, La Jolla, CA, USA. 12. Department of Medicine, University of California, San Diego, La Jolla, CA, USA. 13. Department of MCS Clinical and Medical Affairs, Medtronic, Framingham, MA, USA. 14. Division of Cardiothoracic Surgery, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Abstract
BACKGROUND: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches. METHODS: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada. The primary composite end-point was success at 180 days defined as alive on the originally implanted device and free from disabling stroke (modified Rankin Scale score >3), transplanted or explanted for recovery. The key secondary end-point was mean length of initial hospital stay. RESULTS: The primary end-point was successfully achieved in 88.1% of patients and was significantly greater than the pre-defined performance goal of 77.5% set from historical sternotomy data (p = 0.0012). The key secondary end-point-mean length of initial hospital stay -was 18 days and was significantly shorter than the pre-defined performance goal of 26.1 days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy approach. The overall patient survival was good, and bleeding requiring reoperation was significantly less frequent than that observed in previous studies using the sternotomy approach. CONCLUSIONS: This prospective clinical trial provides validation that implantation of the HVAD system via the thoracotomy approach used in the LATERAL study represents a safe and effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant indication.
BACKGROUND: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches. METHODS: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada. The primary composite end-point was success at 180 days defined as alive on the originally implanted device and free from disabling stroke (modified Rankin Scale score >3), transplanted or explanted for recovery. The key secondary end-point was mean length of initial hospital stay. RESULTS: The primary end-point was successfully achieved in 88.1% of patients and was significantly greater than the pre-defined performance goal of 77.5% set from historical sternotomy data (p = 0.0012). The key secondary end-point-mean length of initial hospital stay -was 18 days and was significantly shorter than the pre-defined performance goal of 26.1 days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy approach. The overall patient survival was good, and bleeding requiring reoperation was significantly less frequent than that observed in previous studies using the sternotomy approach. CONCLUSIONS: This prospective clinical trial provides validation that implantation of the HVAD system via the thoracotomy approach used in the LATERAL study represents a safe and effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant indication.
Authors: Jan F Gummert; Axel Haverich; Jan D Schmitto; Evgenij Potapov; René Schramm; Volkmar Falk Journal: Dtsch Arztebl Int Date: 2019-12-13 Impact factor: 5.594
Authors: Silvia Mariani; Tong Li; Karl Bounader; Dietmar Boethig; Alexandra Schöde; Jasmin S Hanke; Jana Michaelis; L Christian Napp; Dominik Berliner; Guenes Dogan; Roberto Lorusso; Axel Haverich; Jan D Schmitto Journal: Ann Cardiothorac Surg Date: 2021-03