Initial 2-year results of CardioCel® patch implantation in children
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Published on: March 18, 2019
Carine Pavy1, Guido Michielon1, Jan Lukas Robertus2
1Department of Cardiac Surgery, Royal Brompton Hospital, London, UK.
Insights
The CardioCel® patch shows good tolerance in pediatric congenital heart defect repairs, except for graft failures in infants when used in the aortic position. Further research is needed for aortic applications.
Area of Science:
- Cardiovascular Surgery
- Biomaterials in Medicine
Background:
- Congenital heart diseases (CHDs) are common birth defects requiring surgical intervention.
- Biologic patches are frequently used in pediatric cardiac surgery for repairs.
- Evaluating the long-term efficacy and safety of novel biomaterials is crucial.
Purpose of the Study:
- To assess the initial 2-year outcomes of CardioCel® patch implantation in pediatric patients with CHDs.
- To identify specific anatomical positions where the CardioCel® patch demonstrates optimal performance and potential limitations.
Main Methods:
- A single-center retrospective study with prospectively collected data.
- Included pediatric patients (≤18 years) undergoing surgical repair for CHDs using CardioCel® patch between March 2014 and April 2016.
- Follow-up involved clinical exams, echocardiograms, and histological examination of explanted patches.
Main Results:
- 101 pediatric patients received the CardioCel® patch, with a mean age of 22 months.
- No intraoperative difficulties or infections were reported.
- Overall 30-day mortality was 3.8%, unrelated to graft failure. Five patients required reoperation due to graft failure, predominantly in infants (<10 days old) in the aortic position.
Conclusions:
- The CardioCel® patch is well-tolerated in septal, valvar, and pulmonary artery positions for pediatric CHD repair.
- Graft failures were observed in infants when the patch was implanted in the aortic position.
- Further investigation is warranted for the use of CardioCel® patch in the aortic position in neonates and infants.
Objectives:
We present the initial 2-year results of CardioCel® patch (Admedus Regen Pty Ltd, Perth, WA, Australia) implantation in paediatric patients with congenital heart diseases.
Methods:
This was a single-centre retrospective study with prospectively collected data of all patients aged 18 years and under operated for congenital heart disease. The patch was introduced in 2014, with clinical practice committee approval and a special consent in case of an Ozaki procedure. Standard follow-up was performed with systematic clinical exams and echocardiograms. In case of reoperation or graft failure, the patch was removed and sent for a histological examination.
Results:
Between March 2014 and April 2016, 101 patients had surgical repair using a CardioCel patch. The mean age was 22 (±36.3) months, and the mean weight was 9.7 (±10.3) kg. No infections and no intraoperative implantation difficulties were associated with the patch. The median follow-up period was 212 (range 4-726) days. The overall 30-day postoperative mortality was 3.8% (n = 4), none of which were related to graft failure. Five children were reoperated because of graft failure, 4 of whom had the patch implanted for aortic and were aged less than 10 days. The indications for patch implantation in the aortic position were aortopulmonary window, truncus arteriosus, coarctation and aortic arch hypoplasia repair. The median time between the first and the second operation for graft failure was 245 (range 5-480) days.
Conclusions:
Our experience shows that the patch is well tolerated in the septal, valvar and pulmonary artery positions. However, we experienced graft failures in infants in the aortic position.
