Bad Oeynhausen Clinic for Thorax- and Cardiovascular Surgery Announces First Successful Beating Human Heart Transplant

At the Bad Oeynhausen Clinic for Thorax- and Cardiovascular Surgery a beating heart was transplanted for the first time ever. Prof. Dr. Dr. Reiner Körfer, medical director of the Heart and Diabetes Centre in North Rhine Westphalia, and his team Oberarzt PD Dr. Gero Tenderich, Dr. Uwe Schulz und Dr. Sebastian Schulte-Eistrup implanted the donor organ in a 3-hour operation to the 55-year old patient Margarete Wiebe on January 16th.

A new system for organ conservation, TransMedics' Organ Care System, was used for this transplantation. After removal from the donor the heart is placed into the Organ Care System, designed to maintain human organs in a functioning state outside the body. The heart is then immediately revived to a beating state, perfused with oxygen and nutrient-rich blood and maintained at the appropriate temperature. Using the System, organs are kept in their physiological, beating state during transport to the recipient and until implantation.

Prof. Dr. Reiner Körfer: "For the first time, we have successfully used the TransMedics Organ Care System to transport a donor heart. The patient is doing very well. She has already left the hospital and has resumed her everyday life. If the System continues to prove successful, it will signify the dawn of a new era in transplant medicine. With the help of the System, the time window between removal and transplantation can be extended, offering the possibility of more hearts becoming available for patients in desperate need of transplant."

Patients benefit from new conservation method
Conventional technology keeps organs waiting to be transplanted in a cold, ischemic state (with no blood circulation), which makes it impossible to keep them in a functional state. The retention of the vital organ functions offered by the Organ Care System yields several benefits. Surgeons will now have the opportunity to evaluate the organ immediately prior to transplant and to test it even more extensively for existing diseases. More comprehensive tissue matching may also be possible in the future, which could lead to an optimization of organ allocation and reduced risk of organ rejection. This new approach is designed to reduce the risk of organ damage during preservation and improve the quality of life for the patient after transplantation.

Finally, the window of time between removal and implantation could be extended with the help of the Organ Care System. This may allow organs to be transported to more distant locations, broadening the number of usable organs as well as the number of potential recipients.

Disadvantages of conventional conservation methods
Cold ischemic storage of organs can lead to substantial organ damage in isolated cases. The faster the organ reaches the patient, the better the chance for a successful transplantation. International data shows that the outcome of heart transplant patients who receive a donor heart four hours after its removal from the donor is significantly worse than those of patients who promptly receive a donor organ. If the time window between removal and implantation is too long, the organ will become unusable. The maximum storage time for a heart is only four to six hours.

Application of the TransMedics Organ Care System at Bad Oeynhausen
Performing over 80 heart and heart-lung transplants each year, Prof. Dr. Körfer and his specialist team have made the Clinic for Thorax- and Cardiovascular Surgery the leading European heart transplant center. Since 1989 more than 1,500 hearts have been transplanted at the clinic, demonstrating the great expertise the physicians of the Heart and Diabetes Centre Northrhine-Westphalia have in the treatment and after-treatment of patients with heart transplants. The number of successful operations in transplant medicine overall has risen over the years. Recent data shows that 90 percent of donor heart recipients experience no limitations in activity within a year after transplant and more than 70 percent survive for at least five years. Nevertheless, heart transplantation remains a maximally invasive intervention that always involves a certain risk for the patient.

"We are testing the Organ Care System as part of a multi-centered study that will include a total of 20 heart transplants," said PD Dr. Gero Tenderich, head of the heart transplant ward of the Heart and Diabetes Centre Northrhine-Westphalia. "Our initial experiences show that the use of the system is extremely easy and safe for the patient."

Clinical study supported by German Foundation for Organ Transplantation (DSO)
"As coordinator for organ donations, the DSO welcomes any initiative to improve organ quality and safety for patients", said Professor Dr. Günter Kirste, head of the DSO. "The DSO supports the new trial, following the approval of the permanent Committee on Organ Transplantation of the German Medical Association. Donor hearts for patients of transplantation centres will now be transported by the Organ Care System", said Kirste.

Design and functionality of the Organ Care System
The Organ Care System by TransMedics is comprised of three components operating together as an integrated technology. The core of the Organ Care System is the perfusion module, a transparent, sterile chamber protecting the organ and maintaining the appropriate temperature and level of humidity. In the case of heart transplant surgery, the organ is placed in the module and revived to a beating state immediately following its removal from the donor.

A portable platform with a wireless monitor houses all function elements of the system, including oxygen supply and a pump that is used to maintain the organ with warm, nutrient-rich blood. This monitor controls and displays the system functions. It also provides important information to allow real time, functional assessment of the organ by the physician. In the case of the heart, parameters such as aortic pressure, coronary flow, and blood temperature are monitored.

A third component is a solution set that delivers all nutrients required to replenish the organ during transport.