Validation of the thermal stability of EMAIS-SR autonomous packaging for preservation of porcine lungs: cooling curve in an experimental model
Keywords:
Models, Animals, Monitoring, Physiologic, Cold Ischemia, Organ Preservation, Experimental Study, Lung Transplantation, Thermal Stability, Controlled Hypothermic Storage, EMAIS-SRAbstract
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.
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1. Carrel A. The preservation of tissues and its applications in surgery, 1912. Clin Orthop Relat Res. 1992 May;(278):2–8. PMID: 1563154.
2. Keshavjee SH, Yamazaki F, Cardoso PF, McRitchie DI, Patterson GA, Cooper JD. A method for safe twelve-hour pulmonary preservation. J Thorac Cardiovasc Surg. 1989 Oct;98(4):529–34. PMID: 2477644.
3. Reynolds M, Walsh MG, Cui EY, et al. Extended travel for donor organs: is cold static storage still relevant. World J Transplant. 2025 Sep 18;15(3):102150. PMID: 40881750; https://doi.org/10.5500/wjt.v15.i3.102150.
4. Date H, Lima O, Matsumura A, Tsuji H, d’Avignon DA, Cooper JD. In a canine model, lung preservation at 10°C is superior to that at 4°C: a comparison of two preservation temperatures on lung function and on adenosine triphosphate level measured by phosphorus 31-nuclear magnetic resonance. J Thorac Cardiovasc Surg. 1992 Apr;103(4):773–80. PMID: 1548920.
5. Ali A, Hoetzenecker K, Luis Campo-Cañaveral de la Cruz J, et al. Extension of cold static donor lung preservation at 10°C. NEJM Evid. 2023 Jun;2(6):EVIDoa2300008. PMID: 38320127; https://doi.org/10.1056/EVIDoa2300008.
6. Abdelnour-Berchtold E, Ali A, Baciu C, et al. Evaluation of 10°C as the optimal storage temperature for aspiration-injured donor lungs in a large animal transplant model. J Heart Lung Transplant. 2022 Dec;41(12):1679–88. PMID: 36216693; https://doi.org/10.1016/j.healun.2022.08.025.
7. Schuantes-Paim SM, Leite RF, Gonçalves VAC, et al. Static cold package for transporting organs for transplants: a validation method and pilot test. Sao Paulo Med J. 2025 Oct 27;143(6):e20252930. PMID: 41172401; https://doi.org/10.1590/1516-3180.2025.2930.29042025.
8. Hoetzenecker K, Ali A, Campo-Cañaveral de la Cruz J, et al. Prolonged preservation of up to 24 hours at 10°C does not impact outcomes after lung transplantation. Ann Surg. 2025 Apr 1;281(4):664–70. PMID: 39817344; https://doi.org/10.1097/SLA.0000000000006632.
9. Cenik I, Van Slambrouck J, Barbarossa A, et al. Temperature dynamics of donor lungs from procurement to reperfusion: static ice versus controlled hypothermic storage. J Heart Lung Transplant. 2025 Nov;44(11):1737–46. PMID: 40118306; https://doi.org/10.1016/j.healun.2025.02.1695.
10. Wang LS, Yoshikawa K, Miyoshi S, et al. The effect of ischemic time and temperature on lung preservation in a simple ex vivo rabbit model used for functional assessment. J Thorac Cardiovasc Surg. 1989 Sep;98(3):333–42. PMID: 2770316.
11. Cenik I, Van Slambrouck J, Barbarossa A, et al. Temperature dynamics of porcine and human lungs during static ice storage: ice is not 4°C. J Clin Med. 2025 Mar 20;14(6):2127. PMID: 40142935; https://doi.org/10.3390/jcm14062127.
12. Provoost AL, Novysedlak R, Van Raemdonck D, et al. Lung transplantation following controlled hypothermic storage with a portable lung preservation device: first multicenter European experience. Front Cardiovasc Med. 2024 Jun 6;11:1370543. PMID: 38903974; https://doi.org/10.3389/fcvm.2024.1370543.
13. Van Slambrouck J, Loopmans S, Prisciandaro E, et al. The effect of rewarming ischemia on tissue transcriptome and metabolome signatures: a clinical observational study in lung transplantation. J Heart Lung Transplant. 2025 Mar;44(3):437–47. PMID: 39486771; https://doi.org/10.1016/j.healun.2024.10.020.
14. Yamanashi K, Wang A, Bellissimo CA, et al. Protective effects of 10°C preservation on donor lungs with lipopolysaccharide-induced acute lung injury. J Thorac Cardiovasc Surg. 2025 Jun;169(6):E74–E87. PMID: 39321867; https://doi.org/10.1016/j.jtcvs.2024.09.022.
15. Ali A, Wang A, Ribeiro RVP, et al. Static lung storage at 10°C maintains mitochondrial health and preserves donor organ function. Sci Transl Med. 2021 Sep 15;13(611):eabf7601. PMID: 34524862; https://doi.org/10.1126/scitranslmed.abf7601.
16. Orlandi R, Brivio M, Righi I, et al. Short-term outcomes after lung transplantation using grafts preserved at 10°C: a single-centre study. Eur J Cardiothorac Surg. 2025 Nov 2;67(11):ezaf390. PMID: 41206937; https://doi.org/10.1093/ejcts/ezaf390.
17. Abramov A, Costa J, Rosen J, et al. Lung transplant outcomes after implementation of a hospital-based 10 °C controlled hypothermic organ preservation unit. J Thorac Cardiovasc Surg. 2026 Feb;171(2):532–9.e2. PMID: 41005434; https://doi.org/10.1016/j.jtcvs.2025.09.024.
18. Kukreja J, Campo-Canaveral de la Cruz JL, Van Raemdonck D, et al. The 2024 American Association for Thoracic Surgery expert consensus document: current standards in donor lung procurement and preservation. J Thorac Cardiovasc Surg. 2025 Feb;169(2):484–504. PMID: 39826938; https://doi.org/10.1016/j.jtcvs.2024.08.052.
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Copyright (c) 2026 Flavio Pola dos Reis , Matheus Werner Fantato, Pedro Henrique Andrade Guimarães, Selma Ferrer da Silva, Liliane Moreira Ruiz , Natalia Aparecida Nepumuceno, Edson Caoru Kitani, Bartira de Aguiar Roza, Paulo Manuel Pêgo Fernandes

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