The Miguel Servet Hospital performs the first kidney implant with a device that improves the conditions of the organ before the transplant

This intervention, in which researchers from IIS Aragón participated, is part of a national clinical trial and the device is not available for commercial use. In Spain, this is the first case of a kidney transplant with these conditions

The Miguel Servet University Hospital in Zaragoza has performed the first kidney implant in a person from a graft maintained in optimal conditions, far superior to standards, which has been possible thanks to the use of a normothermic perfusion device, the ARK-Kidney brand.

The recipient was a patient from Aragon, who recovered kidney function early after the transplant, without additional support measures, so the process has been a success. The operation was performed last December and is part of a national clinical trial. The device that has been used is not yet available for commercial use.

Through this new maintenance device, it is possible to optimize the conservation of the pre-transplant kidney in the best physiological conditions of oxygenation, nutrients and temperature, compared to the standard of cold preservation of said organs. In Aragon, 80 to 90 kidney transplants are performed per year, all of them at the Miguel Servet Hospital, the only center where it is carried out in the Autonomous Community.

During the usual process, from the extraction of the organ to its implantation, including the determination of the recipient, the time that passes is 14 to 16 hours. During this time, the kidney is kept in small refrigerators, at a cold temperature of about 4 degrees.

The new device allows it to be kept in conditions similar to the body, at 37 degrees Celsius, oxygenated and nourished by a liquid similar to blood during the last two hours before the transplant. Thus the organ is kept in ideal conditions, something like in an incubator.

CLINICAL TRIAL

This intervention is part of a national clinical trial led by the Miguel Servet Hospital and involving five Spanish centers. Its objective is to demonstrate that this improvement in organ preservation manages to optimize the adaptation and recovery conditions of the transplanted organ to the recipient.

The beginning of the procedure that has materialized with the current implant began nine years ago, based on joint research developed mainly at the Biomedical Research Center of Aragon (CIBA-IACS) and with the collaboration between the spin-off born from the University of Zaragoza, EBERS Medical Technology SL, and the research groups of the IIS-Aragón, GIIS071-Urology Group, Miguel Servet University Hospital (URO-SERVET) and GIIS073-Research Group in Nephrology and Renal Transplantation (GINETE).

In 2015, those responsible for EBERS Medical planned to create a perfusion machine for the preservation of pre-transplant human organs in the best conditions of oxygenation, nutrients and temperature.

During this research period, the nephrologist from the Nephrology Service of the Miguel Servet University Hospital (HUMS) and principal investigator, Alex Gutiérrez Dalmau, and the urologist from the HUMS Urology Service, Ángel Borque Fernando, participated, designing and developing a phase of experimental research with different machine prototypes, kidneys of porcine origin, non-viable human kidneys for transplant and transplants in animal models.

In addition, the head of the Urology service, María Jesús Gil Sanz, has collaborated; of the previous and current head of the Nephrology Service, Luis Miguel Lou and Eduardo Parra, respectively; the urologists Ángel Roncalés, Ángel García de Jalón and José Manuel Sánchez Zalabardo; hematologist Victoria González; the pathologist, Celia del Agua, and the person responsible for coordinating transplants at HUMS, Javier Paúl.

“Through this new system, the organ is preserved in the best physiological conditions and subsequently influences the recovery and adaptation of the transplanted kidney. There is evidence of these benefits in experimental research and now efforts are being made to demonstrate that they are also achieved in clinical practice,” highlighted Dr. Alex Gutiérrez.

PIONEERS IN SPAIN

In Spain, this is the first case that has been made of a kidney transplant with these conditions. The new device has been created by an Aragonese brand, EBERS, and worldwide there is only one other device for normothermic renal perfusion.

This first intervention, which was carried out last December, was carried out by Dr. Raquel Espílez, urologist and coordinator of the clinical phase of the study and belonging to the kidney transplant Urology unit, directed by Alberto Gonzalvo; she helped by doctors Miguel Ángel Trívez and Mónica Sanz.

Along with them, Dr. Antonio Lucas, anesthesiologist in charge of the procedure, also participated; Luz Remacha, instrumentalist; doctors Antonio Ruiz, transplant coordinator; Vicky Paz, hematologist; Olga Gracia, nephrologist; Sergio Pérez and Nina Tricolici, from the IIS-A research team; Álex Gutiérrez, nephrologist, and Ángel Borque, urologist.

“We want to show our gratitude to the patients who generously decided to participate in this research and to the entire health team involved in this first case,” said doctors Alex Gutiérrez, from the Nephrology Service, and Ángel Borque, from the Urology Service.

The mechanism consists of keeping the pre-transplant kidney in the ARK-Kidney® machine for two hours, perfused at 37 degrees Celsius, producing urine and being monitored in all its perfusion and oxygenation parameters, and then transplanted into a recipient with end-stage renal failure. “This first surgical and post-operative procedure has been a success and constitutes an important milestone in biomedical research in Aragon and internationally,” highlighted doctors Alex Gutiérrez and Ángel Borque.

Source: Government of Aragon

Image: Participants in the first implant, from left to right: Ángel Borque, Luz Remacha, Mónica Sanz, Miguel Ángel Trívez, Raquel Espílez, Antonio Lucas and Álex Gutiérrez. Government of Aragon