Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial

Edwin McGee, Matthew Danter, Martin Strueber, Claudius Mahr, Nahush A. Mokadam, Georg Wieselthaler, Liviu Klein, Sangjin Lee, Theodore Boeve, Simon Maltais, G. Victor Pretorius, Eric Adler, Thomas Vassiliades, Anson Cheung

Research output: Contribution to journalArticle

24 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)344-351
Number of pages8
JournalJournal of Heart and Lung Transplantation
Volume38
Issue number4
DOIs
StatePublished - Apr 2019

Keywords

  • bridge to transplant
  • congestive heart failure
  • left ventricular assist device
  • mechanical circulatory support
  • minimally invasive

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

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    McGee, E., Danter, M., Strueber, M., Mahr, C., Mokadam, N. A., Wieselthaler, G., Klein, L., Lee, S., Boeve, T., Maltais, S., Pretorius, G. V., Adler, E., Vassiliades, T., & Cheung, A. (2019). Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial. Journal of Heart and Lung Transplantation, 38(4), 344-351. https://doi.org/10.1016/j.healun.2019.02.002