Pulmonary arterioplasty with decellularized allogeneic patches.
BACKGROUND
Decellularized allogeneic nonvalved pulmonary artery patches for arterioplasty are a relatively new option compared with cryopreserved allogeneic, crosslinked xenogeneic bioprosthetic or synthetic materials. This study examines the midterm experience with a new decellularized allogeneic patch for congenital cardiac reconstructions.


METHODS
For this prospective postmarket approval, nonrandomized, inclusive observational study, we collected data on a consecutive cohort of 108 patients with cardiovascular reconstructions using 120 decellularized allogeneic pulmonary artery patches (MatrACELL; LifeNet Health, Inc, Virginia Beach, VA) between September 2009 and December 2012. One hundred of the patches were used for pulmonary arterioplasties. Two patients were lost early to follow-up and excluded from subsequent survival and durability analyses. Data included demographics, surgical outcomes, subsequent reoperations, and catheter reinterventions. These variables were also collected for an immediately preceding retrospective consecutive cohort of 100 patients with 101 pulmonary arterioplasty patches who received classical cryopreserved pulmonary artery allografts (n=59 patches and patients) or synthetic materials (n=41 patients with 42 patches) for pulmonary arterioplasties between 2006 and 2009.


RESULTS
In 106 patients with 118 decellularized patches, there were no device-related serious adverse events, no device failures, and no evidence of calcifications on chest roentgenograms. In contrast, the prior comparative pulmonary arterioplasty cohort of 100 patients experienced an overall 14.0% patch failure rate requiring device-related reoperations (p<0.0001) at mean duration of 194±104 days (range, 25 to 477 days).


CONCLUSIONS
The intermediate-term data obtained in this study suggest favorable performance by decellularized pulmonary artery patches, with no material failures or reoperations provoked by device failure.
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri. Electronic address: rahopkins@cmh.edu.
Richard A
RA
Hopkins
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri.
Gary K
GK
Lofland
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri.
Jennifer
J
Marshall
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri.
Diana
D
Connelly
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri.
Gayathri
G
Acharya
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri.
Pamela
P
Dennis
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri.
Richard
R
Stroup
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri.
Chris
C
McFall
The Children's Mercy Hospital, The Ward Family Heart Center, Kansas City, Missouri.
James E
JE
O'Brien
D002648:Child; D002675:Child, Preschool; D015925:Cryopreservation; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D011446:Prospective Studies; D011651:Pulmonary Artery / Q000601:surgery*; D012189:Retrospective Studies; D014184:Transplantation, Homologous; D014656:Vascular Surgical Procedures