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Airway anastomosis complications in de novo lung transplantation with sirolimus-based immunosuppression

https://doi.org/10.1016/S1053-2498(03)00309-7Get rights and content

Abstract

A prospective, pilot trial was started to evaluate the effect of a sirolimus-based immunosuppressive regimen on acute and chronic rejection in de novo lung transplant patients. Primary lung transplant (LTx) recipients received a sirolimus- and tacrolimus-based immunosuppressive therapy immediately after transplantation. Both immunosuppressants were administered with trough level adjusted, while steroid administration was minimized. Four patients were enrolled (2 single-lung transplants, 1 double-lung transplant, 1 heart–lung transplant) in the study. Mean ischemia time was 387 ± 92 minutes. Acute rejection (at least Grade A1 ISHLT) was detected in 1 patient. Incidence of infection was 0.6 infection per 100 patient-days (3 Aspergillus infections). Until hospital discharge mean sirolimus trough level was 6.2 ± 1.2 ng/ml. Depending upon mean sirolimus trough levels of each patient, severe wound-healing complications were seen in 3 patients, resulting in bronchial airway dehiscence in 2 patients with lethal outcome in 1 patient. As a result of these complications, we revised the study design after inclusion of only 4 patients: Sirolimus administration is now started after completion of bronchial wound-healing. Sirolimus-based immunosuppressive therapy administered immediately after lung transplantation seems to be associated with severe wound-healing complications of the bronchial anastomosis.

Section snippets

Methods

In this prospective, pilot trial we studied the efficacy of the immunosuppressive combination of sirolimus, tacrolimus and corticosteroids in the prevention of acute and chronic rejection after primary lung transplantation before starting a randomized trial comparing this new regimen with our standard protocol consisting of tacrolimus, mycophenolate mofetil and corticosteroids.

All patients having undergone lung transplantation between July and September 2002 were included. Re-transplantations

Results

After enrollment of 4 patients we temporarily stopped the study due to severe adverse events suspected to be related to the use of sirolimus. Therefore, we report our preliminary results as individual case reports.

Discussion

Healing of bronchial anastomosis has been a major problem in lung transplantation.6 The main risk factors identified in the past were surgical technique, high-steroid–based immunosuppressive therapy, bronchial ischemia, acute rejection and acute fungal and bacterial infection.

The donor bronchus receives its blood supply post-operatively via low-pressure, retrograde perfusion from pulmonary artery collaterals and, consequently, is at significant risk of ischemia until neo-vascularization occurs,

Acknowledgements

The authors thank the entire transplant group without whom the transplant program would not be possible: Dept. of Cardiac Surgery: Eckart Kreuzer, Markus Mueller, Ingo Kacrzmarek, Peter Landwehr, Bruno Reichart, Heike Mellmann, Christina Raps; Dept. of General Surgery: Tim Strauss, Reinhard Kopp, Christian Mueller, Rolf Weidenhagen, Hauke Winter, Gerhard Preißler, Karl-Walter Jauch; Dept. of Anesthesia: Michael Irlbeck, Marion Weis, Florian Demetz, Barbara Korpol; Dept. of Internal Medicine:

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Supported by a grant from Wyeth-Pharma GmbH, Muenster, Germany, and Fujisawa GmbH, Munich, Germany.

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