Validation of the thermal stability of EMAIS-SR autonomous packaging for preservation of porcine lungs: cooling curve in an experimental model.

Abstract

Background: Intermediate temperatures (10°C) better preserve mitochondrial function and extend ischemic time, which are fundamental for lung preservation during transplantation. The EMAIS-SR device was developed as a reusable, cost-effective alternative to maintain the 10°C set-point, thereby overcoming logistical and economic barriers in organ transport.

Objective: This study aimed to validate the thermal stability of the EMAIS-SR system in a swine model by evaluating the organ-cooling curve and the time spent within the target temperature range.

Design and setting: Validation study using experimental surgery on porcine organs.

Methods: Lung blocks were harvested from two Landrace swine in independent experiments (P1, P2). The organs were placed in triple sterile packaging. Thermal stability was monitored for 48 h by using four negative temperature coefficient (NTC) thermistors (three intrapulmonary and one extrapulmonary) with data acquisition at a 0.1-s interval. Another datalogger (Hantek ® HTM208B) was used for control and validation. Thermal distribution was further characterized by infrared thermography (FLIR C3-X).

Results: In Experiment 1 (P1), intrapulmonary temperatures reached the predefined target range (≤ 12°C) approximately 1.4 h after lung extraction, and the mean temperature recorded in the container was 8.01 °C (standard deviation, 2.88°C). In Experiment 2 (P2), a mean temperature reduction of 6.6°C was observed, bringing the intrapulmonary temperature to the target range (≤ 12°C) within approximately 2 h post-extraction.

Conclusion: The EMAIS-SR device effectively maintained lung-preservation temperatures within the target 8°C-12°C range over 48 h. These results demonstrate the system's technical feasibility and its capacity to provide consistent thermal stability across intrapulmonary compartments.