UNOS/OPTN Oversight VCAs should be included within the
definition of organs covered by the OPTN Final Rule (42 CFR part
121) and section 301 of NOTA Planning and implementation began in
earnest in 2014 for UNOS/OPTN oversight
Slide 3
VCA participation as of February 2014 28 VCA transplant
recipients had been transplanted at 11 different transplant centers
9 patients at 6 different transplant centers were waiting for a VCA
transplant UNOS/OPTN Oversight
Slide 4
As of August 29, 2014, there were 15 OPTN approved VCA
transplant hospitals and seven VCA candidates registered on the
OPTN waiting list. OPTN changed the membership criteria to
delineate specific VCA transplant programs to upper limb, face,
lower limb, and abdominal wall.
Slide 5
UNOS/OPTN VCA Criteria That is vascularized and requires blood
flow by surgical connection of blood vessels to function after
transplantation Containing multiple tissue types Recovered from a
human donor as an anatomical/structural unit Transplanted into a
human recipient as an anatomical/structural unit
Slide 6
UNOS/OPTN VCA Criteria (continued) Minimally manipulated (i.e.,
processing that does not alter the original relevant
characteristics of the organ relating to the organ's utility for
reconstruction, repair, or replacement) For homologous use (the
replacement or supplementation of a recipient's organ with an organ
that performs the same basic function or functions in the recipient
as in the donor)
Slide 7
UNOS/OPTN VCA Criteria (continued) Not combined with another
article such as a device Susceptible to ischemia and, therefore,
only stored temporarily and not cryopreserved Susceptible to
allograft rejection, generally requiring immunosuppression that may
increase infectious disease risk to the recipient
Slide 8
UNOS/OPTN VCA Program Criteria A reconstructive surgical
director and medical director identified as responsible VCA program
staff VCA program must be at a transplant hospital Required to have
a functioning solid organ transplant program Requires a letter from
the programs local OPO
Slide 9
UNOS/OPTN VCA Program Criteria (continued) A letter of intent
from the institution signed by (chief administrative officer, a
reconstructive surgeon, and a transplant specialist) designated as
responsible for the VCA transplant program would serve as the
application for a VCA program
Slide 10
UNOS/OPTN VCA Waitlist Management Transplant programs will
register their VCA candidates in a document that they will securely
transmit to UNOS UNOS will compile all of the candidate
registrations into a master list which would be distributed to OPOs
OPOs will match VCA donors to candidates using the master list
Slide 11
UNOS/OPTN VCA Waitlist Management (continued) If an OPO
identifies a VCA donor that is suitable for more than one candidate
from the master list, allocation will first be offered to regional
candidates If the organ is not accepted regionally, allocation will
be offered to national candidates Within each classification,
waiting time will be used as the tie breaker between
candidates
Slide 12
UCLA VCA Programs UCLA Reconstructive Transplant Programs -
Hand(s)/Upper Extremity(extremities) - Face - Abdominal Wall
(always with liver or intestine transplantation)
Slide 13
Developed in conjunction with OneLegacy Consent for organ
donation Second consent for VCA ABO compatible Similar size, age,
and skin tone/hair match No identifying marks on the tissue being
transplanted Introduction of PHS High risk donor No DCD donors No
malignancies No trauma or musculoskeletal disorders of the affected
structure(s) Assessment of social/criminal history UCLA Donor
Selection Criteria
Slide 14
Policies and procedures written to meet existing solid organ
standards set by CMS and UNOS Provide prosthetic at time of
donation for limb and facial donation UCLA Policies and
Procedures
Slide 15
UCLA VCA Matching Criteria Skin Tone match and acceptable range
Relative Age Size Hair quality and quantity General features:
height, weight, hair color, eye color, ethnicity
Slide 16
UCLA Upper Limb Transplantation Standard of care prior to VCA
is prosthetics Candidates feel prosthetics do not provide adequate
replacement Currently two candidates in screening Female bilateral
upper extremity one below and one above the elbow Male unilateral
above the elbow
Slide 17
UCLA Face Transplantation Restore function oral competency,
respiratory system, and communication Regain identity and societal
acceptance Reestablish non-verbal communication Recover protection
of intact craniofacial structures
Slide 18
Standard of Care Prior to VCA
Slide 19
Univ. of Maryland Full Face Transplant
Slide 20
UCLA Face Candidate
Slide 21
Slide 22
Slide 23
UCLA Abdominal Wall Transplantation Currently finalizing
protocols and planning Identified multivisceral candidate
Candidates are unable to undergo life- saving transplant of
multivisceral organs without the abdominal wall Current candidate
unable to receive intestine, liver, and pancreas due to inadequate
soft tissue coverage
Slide 24
UCLA Abdominal Wall Transplantation
Slide 25
Slide 26
Exponential growth of VCA programs across US necessitated
standardization of practices, oversight, and a formal allocation
mechanism Keys to success are collaboration and communication
between the transplant programs, OPO, and extended care provider
network Research with each and every transplant performed
Conclusions
Slide 27
Questions?
Slide 28
References 1.Glazier, A. Regulatory Face-Off: What agency
should oversee face transplants? American Journal of
Transplantation 2008; 8: 1393-1395 2. Levi D, Tzakis A, Kato T,
Madaraga J, Mittal N, Nery J, Nishida S, Ruiz P. Transplantation of
Abdominal Wall. The Lancet Vol361 2003. 3. Petruzzo P, Lanzetta M,
Dubernard JM, Landin L, Cavadas P, Margreiter R, Schneeberger S,
Breidenbach W, Kaufman C, Jablecki J, Schuind F, Dumontier C. The
International Registry on Hand and Composite Tissue
Transplantation. Transplantation 2010; 90: 1590 4. Implement the
OPTN's Oversight of Vascularized Composite Allografts (VCAs).
http://optn.transplant.hrsa.gov/governance/public-comment/implement-the-optns-oversight-
of-vascularized-composite-allografts-vcas/ Retrieved March 9, 2015
http://optn.transplant.hrsa.gov/governance/public-comment/implement-the-optns-oversight-
