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Figures

Figure 1

Photograph of the portable Organ Care System Lung (A) and schematic view of the perfusion module (B)

The photograph shows the device (console with perfusion module in place and donor lung on circuit) with the cover removed and the handheld control and monitoring unit, which is connected to the device via bluetooth. The disposable perfusion module integrates the low-resistance polymethylpentene membrane gas exchanger, a pulsatile pump, the fluid reservoir and tubing, an integrated ventilator, and an electric perfusate heater. Motors to drive the blood pump and ventilator are installed in the console.

Figure 2

Pulmonary vascular resistance (A) and peak airway pressure (B) with Organ Care System Lung

Pulmonary vascular resistance and peak airway pressure are continuously measured during perfusion of the donor lung with the Organ Care System Lung. Data are means. Error bars represent SD.

Figure 3

Survival of patients (A) and grafts* (B) after lung transplantation

*Patient 3 died on day 140 after transplantation because of non-graft-related reasons.

Summary

Background

Cold flush and static cold storage is the standard preservation technique for donor lungs before transplantations. Several research groups have assessed normothermic perfusion of donor lungs but all devices investigated were non-portable. We report first-in-man experience of the portable Organ Care System (OCS) Lung device for concomitant preservation, assessment, and transport of donor lungs.

Methods

Between Feb 18, and July 1, 2011, 12 patients were transplanted at two academic lung transplantation centres in Hanover, Germany and Madrid, Spain. Lungs were perfused with low-potassium dextran solution, explanted, immediately connected to the OCS Lung, perfused with Steen's solution supplemented with two red-cell concentrates. We assessed donor and recipient characteristics and monitored extended criteria donor lung scores; primary graft dysfunction scores at 0, 24, 48, and 72 h; time on mechanical ventilation after surgery; length of stays in hospital and the intensive-care unit after surgery; blood gases; and survival of grafts and patients.

Findings

Eight donors were female and four were male (mean age 44·5 years, range 14–72). Seven recipients were female and five were male (mean age 50·0 years, range 31–59). The preharvest donor ratio of partial pressure of oxyen (PaO2) to fractional concentration of oxygen in inspired air (FIO2) was 463·9 (SD 91·4). The final ratio of PaO2 to FIO2 measured with the OCS Lung was 471·58 (127·9). The difference between these ratios was not significant (p=0·72). All grafts and patients survived to 30 days; all recipients recovered and were discharged from hospital.

Interpretation

Lungs can be safely preserved with the OCS Lung, resulting in complete organ use and successful transplantation in our series of high-risk recipients. In November, 2011, we began recruitment for a prospective, randomised, multicentre trial (INSPIRE) to compare preservation with OCS Lung with standard cold storage.

Funding

TransMedics and German Federal Ministry of Education and Research.

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    DOI: http://dx.doi.org/10.1016/S0140-6736(12)61691-2
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