Multicenter Experience With 500 CardioCel Implants Used for the Repair of Congenital Heart Defects

Bell, Douglas; Betts, Kim; Justo, Robert; Forde, Nadine; Venugopal, Prem; Corno, Antonio F.; Smith, Paul D.; Caputo, Massimo; Marsico, Roberto; Karl, Tom R.; Alphonso, Nelson

doi:10.1016/j.athoracsur.2019.04.085

Cited by 18 publications

(21 citation statements)

References 17 publications

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“…On the other hand, a more promising outcome was reported by Bell et al (23) with freedom from reintervention in 135 patients (140 procedures and 195 implants) at 36 months of 94% (CI 89-97) without any evidence of calcification after echocardiographic and radiological assessment in any of these patients. Similar results were reported in a multi-center study (Brisbane, Australia; and Leicester and Bristol, United Kingdom) with an overall freedom from reintervention at 3 and 5 years after implantation of 96% (95% confidence interval, 93-98%) (24).…”

Section: Discussionsupporting

confidence: 86%

“…In addition, short to medium term retrospective studies with Cardiocel have also demonstrated positive outcomes in terms of performance, no calcification and efficacy (21)(22)(23)(24). A less favorable outcome (freedom from reoperation 57% at 36 months) was reported in a single center study of CardioCel R used in aortic valve reconstruction in young children (25).…”

Section: Discussionmentioning

confidence: 99%

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Performance of the ADAPT-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes

Neethling

Rea

Forster³

et al. 2020

Front. Pediatr.

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Background: A Phase II Clinical Trial reviewed the performance (morbidity and calcification) of the tissue-engineered ADAPT ® bovine pericardial scaffold (CardioCel ®) in pediatric patients (n = 30) with congenital cardiac defects. In that study, CardioCel ® demonstrated no graft-related morbidity and mortality in 25 patients, over 12 months. Five patients died due to non-graft-related events. Echocardiography revealed hemodynamically stable repairs with no calcification of the scaffold. Magnetic resonance imaging (MRI) at 12 months in 10 patients confirmed the absence of calcification. These patients were followed up for further up to 10 years. We present the results of this retrospective review of these patients that were followed for further medium to long-term (median 7.2 years, 25%: 3.6 years 75%: 9.25 years) postoperatively in these patients. Methods: Between April 2008 and September 2009, CardioCel ® was implanted in 30 patients with congenital cardiac defects. Efficacy measures included graft-related mortality, morbidity and haemodynamic abnormalities. Calcification was assessed by standard 2D-M mode echocardiography and MRI at 12 months. Medium to long-term assessment included routine clinical assessments and echocardiography. Results: Median age at surgery was 18 months (27 days−13 years). Twenty-five patients (142 patient years) were followed for up to 10 years. The 10-year survival rate is estimated as 86.9% (95% CI 71.4-100.0%) over the entire follow-up period. One patient was lost to follow-up. No graft-related mortality was encountered up to a median follow-up of 7.2 years. Two patients died (pacemaker complications >5 years and arrhythmia >7 years postoperatively). No graft failure, thromboembolic events, infections or device-related reinterventions were recorded. Non-significant residual leaks occurred in 3 patients. Echocardiography demonstrated the absence of calcification in all implants. Conclusion: The tissue-engineered ADAPT ® bovine pericardial scaffold demonstrated excellent medium to long-term performance (up to 10 years) when used as a scaffold for Neethling et al. Performance of CardioCel repair of congenital cardiac defects in children. Durability, acellularity, biostability and non-calcifying potential of CardioCel ® makes it a very attractive tissue for congenital cardiac repair procedures.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Performance of the ADAPT-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes

Neethling

Rea

Forster³

et al. 2020

Front. Pediatr.

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“…However, they reported one patient who underwent a Yasui operation for repair of type B interrupted aortic arch who subsequently required two balloon dilations and one reoperation for restenosis of the aortic arch. 12…”

Section: Discussionmentioning

confidence: 99%

Reconstruction of the Aortic Arch in Neonates and Infants: The Importance of Patch Material

Beynum

Kurul

Krasemann

et al. 2021

World J Pediatr Congenit Heart Surg

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Objectives: Restenosis after aortic arch reconstruction is a known complication in neonates and infants. Homograft is the most commonly used patch material for aortic arch reconstructions in our center. Since 2014, tissue-engineered bovine pericardium (CardioCel) has been used as an alternative. The aim of our study was to determine whether the choice of material affected the development of restenosis in these patients. Methods: Data of all neonates and infants who underwent aortic arch reconstruction with the use of any patch material between 2005 and 2016 were analyzed. Restenosis was defined by the need for reintervention, either percutaneous or surgical. Results: Forty-one patients underwent aortic arch repair. Excluding the 30-day mortality, 36 patients represented the study population. At primary repair, the aortic arch was reconstructed with homograft (n = 26) or CardioCel (n = 10). Restenosis was documented during the first year of life in 13 patients: Six (23%) patients in the homograft group and seven (70%) patients in the CardioCel group ( P = .01). In the homograft group, the median time from operation to first intervention for restenosis was 22.0 (range: 14-32) weeks, as compared to 14.0 (range: 7-21) weeks in the CardioCel group ( P = .04). Conclusion: We conclude that choice of patch material is likely to be an important determinant for the risk of restenosis needing reintervention following reconstruction of the aortic arch in neonates and infants.

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“…The histology of the explanted patch demonstrated acute inflammation with destruction of collagen fibers and necrosis; however, no organism was identified. 6 CardioCel is prepared through a process in which bovine pericardium is decellularized and subjected to an anticalcification proprietary tissue engineering process (ADAPT TEP) to reduce the risk of calcification and degeneration. A low concentration of monomeric glutaraldehyde is used to promote strength and elasticity.…”

Section: Discussionmentioning

confidence: 99%

Aortosubpulmonary Fistula after Konno-Rastan Aortoventriculoplasty

Mehta

Wakefield

Collier

et al. 2021

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Multicenter Experience With 500 CardioCel Implants Used for the Repair of Congenital Heart Defects

Cited by 18 publications

References 17 publications

Performance of the ADAPT-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes

Performance of the ADAPT-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes

Reconstruction of the Aortic Arch in Neonates and Infants: The Importance of Patch Material

Aortosubpulmonary Fistula after Konno-Rastan Aortoventriculoplasty

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