A2ALL is a National Institute of Health funded study of adult-to-adult live liver donors collecting data from nine liver transplant programs in the US. Participation in the study is voluntary, and according to OPTN’s webpage (which may be out-of-date, not my fault), there are currently 74 transplant centers in the US that perform living liver donor transplants.
Data was collected on live liver donors from January 1, 1998 through August 31, 2009 with follow-up extended to August 31, 2010. All info from living donors prior to February 28, 2003 is retrospective, which is generally considered less reliable and valid due to subjects’ memories, lack of variable control, and loss of comprehensive medical records (other things too; that’s off the top of my head). Of that subset, 22% of the post-donation follow-up was prospective.
Median post-donation follow-up was 3.4 years for the retrospective era, and 1.8 years for the prospective liver donors, so the data says nothing about the medium or long-term risks of live liver donation. <- Just because the study includes at least one liver donor from 1998 does not mean it has 12 years of data, as some have erroneously implied.
Here’s the latest:
Among the 1870 potential LLDs evaluated across the entire observational cohort (retrospective and prospective), 760 went to the operating room with an intention to donate, 740 underwent complete donation and 738/740 grafts were transplanted into the intended recipient. There were 707 right lobe and 33 full left lobe donations.
You read that right, 20 of the donations were aborted once the liver donor was in the operating room. 12 occurred in the retrospective era and 8 in the prospective years. Unfortunately, the authors only say the procedures were stopped due to “unexpected observations” during either the donor’s or recipient’s procedure.
One or more complications were experienced by 296 donors (40%), resulting in an aggregate of 557 recorded complications; 140 donors (19%) experienced multiple complications.
Among retrospective era donors, there were four Clavien grade 3 complications, one each with intraabdominal abscess and bowel obstruction and two with complex hernias. In addition, there were three donor deaths (grade 4). One donor died as a result of sepsis and multiorgan failure in the perioperative period and two donors died relatively late following donation (1.8 and 1.9 years) from psychological complications (one accidental drug overdose and one suicide).
Among prospective era donors, there was one Clavien grade 3 complication (wound dehiscence) and no Clavien grade 4 complications.
It’s important to remember this study only captures data from liver donors until August 31, 2009, because two liver donors, Ryan Arnold and Paul Hawkes, died at separate transplant centers in 2010.
The authors mention the deaths near the end of the article here:
We should note that since the current analysis, two well publicized donor (right lobectomy) deaths have occurred in the US. One of these occurred at a center that participated in the A2ALL study, on which we currently report, but the study was closed for enrollment at the time of donor death and therefore it is not included in the analysis. The other donor death occurred at a nonparticipating center. Both centers were among the most experienced adult LLD in the US at the time of these events.
FYI: Clavien 4 complications are defined as those that “lead to transfusion or death”. Grade 3 are those complications with “residual or lasting functional disability or development of malignant disease”. Grade 2 is anything “potentially life threatening…but doesn’t result in residual disability or persistent diseases”.
The most common complications included:
– bile leak/ biloma
– pleural effusion (fluid in the lungs)
– bowel obstruction
– nerve damage
– ascites (fluid in the abdominal cavity)
– psychological difficulties
Up to 7% of donors first experienced individual types of complications more than 1 year after donation.
The only significant predictor of bile leak was body weight… Donors with higher body weight were at significantly higher risk of bile leak; each increment of 10 kg in body weight increased the risk by 22%
Older age, male gender and higher BMI were independently significant predictors of hernia formation. No other covariates among those tested (listed in methods) were significant predictors of these outcomes.
Over a follow-up period of up to 9 years [note:see my prior comment on this issue], 95% of complications were resolved, and the vast majority were resolved by 3 months post-donation. Complication types that presented later post-donation (e.g., psychological and hernia) also tended to take longer to resolve. Several cases of [nerve damage] took more than 1 year to resolve. The probability of complete resolution within 1 year after diagnosis was only 75% for hernia and 42% for psychological complications, although both probabilities increased with continued follow-up time.
…neuropraxia, which developed immediately after donation, took as long as 3 years to resolve.
The authors compared their results with that of other countries’ more extensive live liver donor studies, finding them relatively equivalent. They also confirmed that neither surgeon or center experience does anything to reduce the complication rate.
Therefore, we propose that 40% can be considered a fairly definitive assessment of the risk of complications in the first year following live donor right lobectomy
In other words, 40% of all live liver donors – yesterday, today, and tomorrow – will experience complications in the first year after right lobe living liver donation.
When composing some of these posts, I feel like I’m repeating myself. I’ve written about the risks of living liver donation multiple times, and I’ve outlined the failures of the transplant industry to ensure liver donors’ safety and well-being innumerably. It’s reasonable that someone would wonder why I continue, especially when the new reports draw the same conclusions as the old. My partial answer is just that – that confirmation, duplication and corroboration is necessary for solidifying conclusions. But there’s also the fact that the definition of an acceptable living donor has changed tremendously over the past 30 years. It’s important to keep up with the latest data* to understand how donation affects those LDs with more pre-donation risk factors. And finally, I continue to do this, hammer the point over and over again, because if I don’t, certain folks will have yet another reason to dismiss the truth. And I can’t have that.
*even though it’s invariably short-term and doesn’t address cardiovascular or renal risk.
Abecassis, M., Fisher, R., Olthoff, K., Freise, C., Rodrigo, D., Samstein, B., Kam, I., Merion, R., & , . (2012). Complications of Living Donor Hepatic Lobectomy-A Comprehensive Report American Journal of Transplantation, 12 (5), 1208-1217 DOI: 10.1111/j.1600-6143.2011.03972.x