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Potential Transmission of Viral Hepatitis Through Use of Stored Blood Vessels as Conduits in Organ Transplantation

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http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a3.htm?s_cid=mm6006a3_e & source=go\

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Morbidity and Mortality Weekly Report (MMWR)

Potential Transmission of Viral Hepatitis Through Use of Stored Blood Vessels as

Conduits in Organ Transplantation --- Pennsylvania, 2009

Weekly

February 18, 2011 / 60(06);172-174

Solid organ transplantation sometimes requires the use of blood vessels from a

deceased donor as conduits to connect transplanted organ vessels to recipient

vessels. Vessels not immediately used are sometimes stored for later use,

including vessels collected from hepatitis B virus (HBV) and hepatitis C virus

(HCV) seropositive donors; HBV and HCV seropositive vessels can be stored for

use in seropositive recipients. In May 2009, HCV was transmitted when a

transplant facility inadvertently used a blood vessel conduit from an

HCV-seropositive donor in a seronegative recipient. In November 2009, a second

transplant facility, the University of Pittsburgh Medical Center (UPMC),

identified two cases of potential hepatitis virus transmission from vessel

conduits. In December 2009, CDC was asked to assist the local health department

in conducting an investigation at UPMC. This report summarizes the results of

that investigation, which determined that, although neither recipient of the

vessel conduits at UPMC contracted hepatitis, these represented " near miss "

incidents in which transmission could have occurred. The storage of vessels from

hepatitis-seropositive donors at UPMC and its affiliated Department of Veterans

Affairs (VA) hospital was not necessary; vessels from seropositive donors were

infrequently used because adequate supplies of vessels from seronegative donors

were available. UPMC's prohibition of the storage of vessels from

hepatitis-seropositive donors has removed a documented risk factor for viral

transmission while not substantially affecting the transplant centers' vessel

conduit supply. Evaluation of available national data supports this prohibition.

Therefore, CDC recommends that transplant centers discontinue the practice of

storing vessel from donors with markers for viral hepatitis, including HBV

surface antigen (HBsAg), HCV antibody (anti-HCV), and HBV or HCV detectable by

nucleic acid tests.

Case Reports

In September 2009, CDC was notified of an anti-HCV negative patient who, during

liver transplantation 4 months earlier, had been given a vessel conduit

inadvertently from an anti-HCV positive donor. The potential disease

transmission was identified when the United Network for Organ Sharing (UNOS)

retrospectively recognized the serologic discordance between the

HCV-seronegative recipient and the HCV-seropositive vessel donor. The transplant

facility subsequently reported HCV infection in the patient resulting from use

of the seropositive vessel conduit.

As a result of this disease transmission, UNOS requested that all transplant

centers review HBV and HCV vessel conduit use during May 2006--May 2008. In

November 2009, a second transplant center (UPMC) identified two incidents of

conduit transplantation from hepatitis-seropositive donors into seronegative

recipients. The first was identified as a result of the UNOS inquiry, and the

second as a result of an internal audit by UPMC of its vessel conduit use during

June 2008--November 2009. CDC and the local health department subsequently were

invited to investigate the cases at UPMC. A case was defined as transplantation

of a vessel conduit from a hepatitis-seropositive donor into a seronegative

recipient at UPMC during May 2006--November 2009.

Case 1. On May 21, 2008, a woman aged 65 years received a cadaveric left kidney

transplant for end-stage renal disease secondary to diabetes and hypertension.

Pretransplantation, both the kidney donor and kidney recipient were negative

HBsAg, hepatitis B surface antibody (HBsAb), and hepatitis B core antibody

(HBcAb). However, the donor of the vessel was positive for HBcAb. Laboratory

tests on recipient specimens on November 18, 2009, included an HBV surface

antibody, surface antigen, and core antibody that were all negative, an

aspartate aminotransaminase (AST) of 13 U/dL (normal: 15--37 U/dL), and an

alanine aminotransaminase (ALT) of 21 U/dL (normal: 30--65 U/dL). On December

14, 2009, HBV DNA was undetectable at <300 copies. After the error was

discovered, hepatitis B vaccinations were administered, but antiviral therapy

was not offered because of the lack of clinical or laboratory evidence of

hepatitis transmission. More than 1 year after the transplant, the patient

remained asymptomatic for infection, and serial testing for hepatitis B markers

remained negative.

Case 2. On October 21, 2009, a man aged 64 years received a living donor kidney

transplant for end-stage renal disease secondary to diabetes and hypertension.

Pretransplantation, both the donor and recipient of the kidney were negative for

anti-HCV. The donor of the vessel, however, was positive for anti-HCV.

Subsequent testing showed the kidney recipient's serum on November 10, 2009, was

negative for anti-HCV and had undetectable (i.e., <30 IU/mL) HCV RNA on November

19. One year after transplantation, the recipient remained asymptomatic for

infection, and serial testing for hepatitis C markers remained negative.

Public Health Investigation

CDC assisted the local health department in investigating the events that

resulted in transplantation of the two vessel conduits from

hepatitis-seropositive donors into seronegative recipients at UPMC. In addition,

the effect of discontinuing the storage of hepatitis-seropositive vessels on the

availability of stored vessels for transplantation was evaluated.

At UPMC, vessels are collected and stored in a sterile fashion and refrigerated

individually in bags with an outer pocket. A donor sheet with ABO blood group

and hepatitis serologies is kept in the pocket of each bag, and examination of

this sheet before transplantation is the only way to ensure seroconcordance

between the vessel donor and organ recipient. At the time the two cases

occurred, hepatitis-seropositive vessels were stored alongside

hepatitis-seronegative vessels. According to UPMC transplant surgeons, the donor

sheet presumably was examined in both cases, but hepatitis serologies likely

were overlooked, resulting in HBV and HCV seropositive vessel conduits being

transplanted into seronegative recipients.

In a review of vessel conduit use at UPMC and its affiliated VA hospital from

January 1, 2008, to December 31, 2009, only two (0.6%) of 331 stored vessels

were found to be from hepatitis-seropositive donors at UPMC and only six (9.4%)

of 64 at the VA hospital. Two of the vessels were from donors positive for

HBsAg, five were from donors positive for anti-HCV, and one was from a donor

positive for both HBsAg and anti-HCV. UNOS collects information from all U.S.

transplant centers on donor serologic markers for all vessel conduits recovered.

According to these data, of 14,144 vessel conduits recovered nationally in 2008

and 2009, 367 (2.6%) were from donors with unknown or positive anti-HCV status,

30 (0.2%) were from donors with unknown or positive HBsAg status, and 644 (4.6%)

were from donors of unknown, indeterminate, or seropositive HBcAb status. Even

if no overlap of positive hepatitis markers among donors of these stored vessels

existed, vessels from seropositive donors would account for only 7.4% of stored

vessels nationally.

In addition to vessels from seropositive donors comprising a small proportion of

stored vessels, UNOS data indicate that only a small proportion of these stored

vessels are actually used. During 2008--2009, a total of 4,946 (72.2%) of 6,852

stored vessels with a documented disposition were not used for transplantations

and eventually were discarded. During the same period at UPMC and its affiliated

VA hospital, 275 (83.1%) of 331 and 61 (95.3%) of 64 stored vessels,

respectively, were stored but not used.

Reported by

A Humar, MD, Div of Transplantation, Univ of Pittsburgh Medical Center; J Lando,

MD, Career Epidemiology Field Officer, Office of Public Health Preparedness and

Response; V Dato, MD, Pennsylvania Dept of Health. S Holmberg, MD, National

Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; WA Bower, MD, MJ

Kuehnert, MD, Div of Healthcare Quality Promotion, National Center for Emerging

Zoonotic Infectious Disease; AK Rao, MD, EIS Officer, CDC.

Editorial Note

This investigation was triggered by the report of HCV transmission through use

of a vessel conduit from an HCV-seropositive donor during liver transplantation.

Although hepatitis transmission did not occur in the two cases described in this

report, the error of transplanting a vessel from a seropositive donor into a

seronegative recipient was the same in these cases as it was in the case where

transmission did occur; the error occurred despite appropriate labeling of

vessel seropositivity. These are thus considered important " near miss " incidents

in which transmission could have occurred despite appropriate safeguards being

in place. Although vessel conduits commonly are considered safe and reliable in

transplant surgeries (1--3), they have been linked to disease transmission,

resulting in severe illness and death (4).

Current policy regulating the storage and use of vessels is set by the Organ

Procurement and Transplantation Network (OPTN) (1),* which is overseen by UNOS

through a contract with the Health Resources and Services Administration.

Vessels can be stored for up to 14 days and used when surgical complications

arise in recipients who received an organ from the vessel donor or to facilitate

transplant in another organ recipient. Vessels designated for organ transplant

are only available for organ transplant procedures and are not used for other

vascular procedures.

OPTN permits recovery and storage of vessels from hepatitis-seropositive donors

because many transplantations occur in patients with markers for hepatitis

infection. However, CDC regards this practice as placing seronegative transplant

recipients at an unnecessary risk for exposure to viral hepatitis. Based on the

investigation of vessel conduit use at UPMC and review of available national

data from UNOS, CDC found that vessels from seropositive donors rarely were

stored, and removal of these vessels from storage would not result in lack of

vessel conduit availability. In fact, several transplant centers nationwide do

not store vessels from hepatitis-seropositive donors and have not reported

vessel shortages from this practice. Some transplant centers might remain

concerned about the potential for vessel shortages, particularly in the case of

surgical complications that arise in the recipient of the accompanying organ.

However, several acceptable alternatives to stored vessel use exist, including

use of a recipient blood vessel procured at the time of surgery, and these may

be considered if such a situation occurs. Since November 2009, UPMC has

prohibited storage of vessels from donors positive for anti-HCV, HBsAg, and

HbcAb, and no problems related to vessel availability have been noted.

Based on this investigation, CDC recommends that transplant centers discontinue

the practice of storing vessels from donors with viral hepatitis markers. These

markers include HBsAg, anti-HCV, or HBV or HCV detectable by nucleic acid tests.

This discontinuation would apply to storage of vessels from donors seropositive

or nucleic acid--positive, even if their storage was designated for use only

with the original organ, because this practice still would not remove the

potential for human error resulting in inadvertent use in a seronegative

recipient. OPTN currently is considering a binding policy prohibiting storage of

hepatitis-seropositive vessels at transplant centers.

Acknowledgments

The findings in this report are based, in part, on contributions by S Taranto,

United Network for Organ Sharing; D Maurer, MBA, and S Doloughty, Univ of

Pittsburgh Medical Center; E Lambrecht, VA Pittsburgh Healthcare System; and ND

, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB

Prevention, CDC.

References

1.Muralidharan V, Imber C, Leelaudomlipi S, et al. Arterial conduits for hepatic

artery revascularization in adult liver transplantation. Transpl Int

2004;17:163--8.

2.Goldstein RM, Secrest CL, Lintmalm GB, Husberg BS. Problematic vascular

reconstruction in liver transplantation. Part I. Arterial surgery

1990;107:540--3.

3.Sellers MT, Haustein SV, McGuire BM, et al. Use of preserved vascular

homografts in liver transplantation: hepatic artery aneurysms and other

complications. Am J Transplant 2002;2:471--5.

4.Srinivasan A, Burton EC, Kuehnert MJ, et al. Transmission of rabies virus from

an organ donor to four transplant recipients. N Engl J Med 2005;352:1103--11.

* Additional information available at

http;//optn.transplant.hrsa.gov/policesandbylaws/policies.asp.

What is already known on this topic?

Donated blood vessels are considered safe and reliable for use as conduits in

organ transplantation, but they have been linked in rare instances to disease

transmission.

What is added by this report?

Current procedures that permit the collection and storage of potentially

infectious vessels put patients at risk for hepatitis B and C infection. This

risk is avoidable by discontinuing the practice of storing vessels from

seropositive donors.

What are the implications for public health practice?

By discontinuing the storage of these potentially infectious vessels, the

potential for viral hepatitis transmission is reduced greatly without affecting

the availability of vessel conduits needed for organ transplantation.

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