Thorac Cardiovasc Surg 2014; 62 - OP62
DOI: 10.1055/s-0034-1367139

The INSPIRE international lung trial with the organ care system technology (OCS™) - interim report

G. Warnecke 1, D. van Raemdonck 2, G. Massard 3, N. Santelmo 3, P.-E. Falcoz 4, A. Olland 4, G. Leseche 5, H. Mal 5, P. Thomas 5, F. Rea 6, S. Nicotra 6, M. Schiavon 6, G. Marulli 6, C. Knosalla 7, R. Hetzer 7, A. Simon 8, S. Tsui 9, J. Kukreja 10, C. Bermudez 11, F.J. Moradiellos 12, A. Varela 12, K. Dhital 13, J. Nagendran 14, K. Mc Curry 15, A. Ardehali 16, A. Haverich 1
  • 1Medizinische Hochschule Hannover, THG-Chirurgie, Hannover, Germany
  • 2University Hospital, Leuven, Belgium
  • 3Hospital of the University of Strassburg, Strassburg, France
  • 4Hospital Bichat, Paris, France
  • 5University Hospital of Marseille, Marseille, France
  • 6University of Pavia, Pavia, Italy
  • 7German Heart Center, Berlin, Germany
  • 8Harefield Hospital, London, United Kingdom
  • 9Papworth Hospital, Cambridge, United Kingdom
  • 10University of California San Francisco, San Francisco, United States
  • 11University of Pittsburgh Medical Center, Pittsburgh, United States
  • 12University Hospital Puerta de Hierro, Madrid, Spain
  • 13St. Vincent's Hopital, Sydney, Australia
  • 14University of Alberta Medical Center, Edmonton, Canada
  • 15Cleveland Clinic, Cleveland, United States
  • 16University of California, Los Angeles, United States

Objectives: To assess the clinical efficacy and safety of the OCS™ device to preserve, recruit and assess donor lungs for transplantation as compared to the current cold storage technique.

Methods: INSPIRE is a prospective, international, multi-centred, randomized, controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group). A total of 264 primary lung transplant recipients will be randomized into the trial. Important donor inclusion criteria: age  < 65, normal gas exchange at time of final acceptance of donor lung. Recipient inclusion criteria: age ≥ 18 years old; primary double lung transplant candidate; Donor exclusion criteria: presence of traumatic lung injury; active pneumonia. Primary study endpoint is a composite of patient and graft survival at day 30 post transplantation and incidence of ISHLT primary graft dysfunction (PGD) Grade 3 at post-transplantation. Other endpoints: Patient survival at day 30; PGD score at T0, T24, T48 and T72 hours; duration of invasive mechanical ventilation; length of post transplant ICU stay; length of post-transplant hospital stay; additional hospital admission post initial discharge.

Results: As of September 6th, 2013, a total of 192 patients were recruited and transplanted in the INSPIRE Trial in 17 different centres in Europe, North America and Australia. We are reporting on the first 136 patients having completed the 30-day follow-up endpoint as of June 30th, 2013, including n = 59 OCS & n = 77 Control subjects. Donor and recipient characteristics/risk factors were equivalent in both groups. Patient survival on day 30 was 98% in the OCS and 95% in the Control group and at 6 months, it was OCS = 97% [n = 36] vs. Control = 87% [n = 46]. The incidence of PGD Grade 3 is summarized in the table below:

PGD Grade 3
OCS Group (n = 59) Control Group (n = 77)
T-0 5% 23%
T-24 5% 14%
T-48 7% 8%
T-72 3% 5%

Conclusion: The INSPIRE Trial's interim results are encouraging as it is demonstrating a trend towards reduction of PGD grade 3 at all time points post-lung transplantation. The data also suggests 6-month survival benefits in the OCS treated patients. INSPIRE accrual is expanding and we expect completion of the trial by end of 2013/early 2014.