ASTS creating National Registry of all living donor liver transplant procedures to help assess risk.

The American Society of Transplant Surgeons (ASTS) announced on May 15 that it is creating a National Registry to gather data that will allow potential donors and physicians to accurately assess the risks of donation and to keep track of the number of living donor liver transplants.

"The continued shortage of cadaver livers-combined with a liver transplant list hat has now climbed to more than 15,000-is leading a growing number of patients to consider living donor liver transplants," Nancy Ascher, MD, the new ASTS president, said in announcing the creation of the registry.

"While the early experience with adult-to-adult living donor transplantation at centers performing this complex procedure is encouraging, donor deaths have occurred," Ascher pointed out. "Because of the lack of data, accurate risk assessment for the donor currently is not possible." Ascher is chairman of the department of Surgery at the University of California at San Francisco.

The announcement was made at Transplant 2000, the first ever joint meeting of the ASTS and the American Society of Transplantation (AST), held May 13-17 in Chicago, IL. More than 3,600 transplant surgeons and physicians from around the world, attended the meeting, an increase of about 25% over last year.

In concert with announcing the establishment of the registry, the ASTS released a series of guidelines for living liver donation in a position paper on adult-to-adult living liver donation. The position paper was developed over the past year by the ASTS Ethics Committee chaired by Mark Adams, MD, transplant surgeon at Froedtert Memorial Lutheran Hospital in Milwaukee, WI.

The position paper lays out the rationale for performing living donor liver transplants and sets out specific guidelines for "donor and recipient selection, center criteria, and the best approach to obtaining informed consent."

Here is the section of the position paper containing the risks to the donor and the guidelines.

"Early experience with adult-to-adult living donor liver transplantation has demonstrated that the operation can be performed with a low morbidity and mortality," the paper observes. "Results re preliminary, however, and deaths have occurred. At present there is insufficient information to accurately assign risk for the donor."

"When compared to the left lateral segmentectomy, as performed for pediatric liver transplantation, a formal right or left lobectomy is a more formidable procedure that puts the donor at greater risk. The risks to the donor include:

1.Risks associated with any surgical procedure, e.g. bleeding, infection, anesthetic complications, etc.

2.The possibility that the donor will be left with insufficient hepatic function.

3.The possibility of biliary complications, both in the early and late postoperative periods.

4.The risks associated with blood transfusion.

5.Unknown, long-term risks associated with major hepatic resection.

Whether adult-to-adult living donor liver transplantation will become a widely applicable option . . . depends largely on the demonstration that the donor procedure is generally safe.

Guidelines for donor selection and evaluation

1.Potential donors should be healthy individuals who are carefully evaluated and approved by a multidisciplinary team including hepatologists and surgeons to assure that they can tolerate the procedure.

2.Potential donors should undergo evaluation to assure that they fully understand the procedure and associated risks.

3.Potential donors must be of legal age and have sufficient intellectual ability to understand the procedure and give informed consent.

4.Potential donors should be emotionally related to the recipient.

5.Potential donors who are felt or known to be coerced must be excluded.

6.Potential donors need to have the ability and willingness to comply with long-term follow-up.

Recipient Criteria

The following recipient criteria are suggested:

1.Recipients need to be medically suitable for liver transplantation by standard criteria of the transplant center.

2.Recipients need to understand and accept that the donation will put the donor at significant risk.

While it may not be possible to firmly state that adult-to-adult living donor liver transplantation should not be done in situations in which the recipient has a poor chance of overall survival, the added risk to the donor must be balanced with a realistic estimate of the chances of success.

Center Criteria

Centers preparing to perform adult-to-adult living donor liver transplantation should undergo careful institutional planning the demonstrates the following:

1.Consideration of the significant risks of the procedure to the donor.

2.Establishment of an appropriate informed consent process.

3.Surgical expertise in liver transplantation and hepatobiliary surgery.

4.An existing need for living donation versus cadaveric donation as shown by insufficient cadaver organs for transplantation resulting in potentially avoidable deaths on the waiting list.

5.Adequate resources e.g. multiple surgical teams, adequate operating room resources and institutional support.

6.Ongoing oversight.

Consent

Because of a lack of data, accurate risk assessment for the donor is currently not possible. Informed consent for the procedure should contain elements as listed below:

1.The risk of death during or after the operation.

2.The risk of liver failure resulting in the need for transplantation.

3.The risk of life-threatening infection resulting from the operation.

4.The risk of blood borne infection acquired through transfusion.

5.The risk of temporary or permanent disability.

6.The ability to withdraw from participation at any time prior to surgery.

To receive a copy of the ASTS Position Paper on Adult-to-Adult Living Donor Liver Transplantation, contact the ASTS, 1215 Jefferson Davis Highway, #1109A, Arlington, VA 22202. Phone: [phone], Fax: [phone]; website: www.asts.org