What is the current state of clinical evidence for static lung preservation devices, and is it sufficient to inform clinical practice?

目前静态肺保存装置的临床证据状况如何?这些证据是否足以指导临床实践?

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Abstract

INTRODUCTION: Organ preservation at low temperatures has been described since Alexis Carrel's time in 1912. Since then, organs have been stored in a mixture of frozen saline solution and liquid, with a temperature of around 4 °C. Studies suggest higher temperatures may preserve mitochondrial function, allowing for an extended ischemia time. Various systems are commercially available, each with different preservation principles. This study aims to analyze the underlying parameters of each device. MATERIALS AND METHODS: A systematic review was conducted using the following databases: PubMed, Embase, and Cochrane Library, searching for clinical trials and observational studies evaluating the use of thermal boxes for lung preservation devices in transplantation. The assessed outcomes were Primary Graft Dysfunction (PGD), ventilation time, length of hospital stay, rejection rate, and survival rate. RESULTS: The search yielded six studies selected based on title and abstract, including 519 lung transplant cases. The preservation systems evaluated were LUNGguard and MYTEMPF. Our studies assessed LUNGguard, with a total of 298 patients. This system maintained an average temperature of 6 °C (4° to 8 °C), and 51 patients developed grade 3 PGD within 72 h. The mean ventilation time was 25.2 h (25 to 25.5 h), and ICU stay ranged from 8 to 9 days. Rejection was observed in 3 out of 18 patients, and hospital survival was reported in 221 out of 231 patients. MYTEMP 65 HC was evaluated in one study with 70 patients, of whom 4 developed grade 3 PGD within 72 h. The mean ventilation time was 49 h, and the length of hospital stay was 25 days. Kaplan-Meier estimated survival was 94 % (HR = 0.65; 95 % CI 0.26 to 1.6). DISCUSSION/CONCLUSION: Preservation systems show different performances in lung preservation devices for transplantation. Across available studies, LUNGguard has been reported to maintain temperature stability with corresponding survival findings. Across studies of MYTEMP, lower grade 3 PGD rates have been reported, together with longer ventilation and hospitalization durations, and the device is described as non-transport. Other devices exist on the market, but their data remains unpublished. In summary, ongoing clinical studies with these and other preservation devices are expected to provide new evidence in the near future. As additional data become available, an updated systematic review will help clarify their comparative performance and guide clinical practice.

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