Results of aortic valve repair using decellularized bovine pericardium in congenital surgery

Nordmeyer, Sarah; Muríň, Peter; Schulz, Antonia; Danne, Friederike; Nordmeyer, Johannes; Kretzschmar, Johanna; Sumbadze, Daria; Schmitt, Katharina; Miera, Oliver; Cho, Young Min; Sinzobahamvya, Nicodème; Berger, Felix; Ovroutski, Stanislav; Photiadis, Joachim

doi:10.1093/ejcts/ezy181

Cited by 38 publications

(39 citation statements)

References 14 publications

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“…As an alternative for mechanical or biological valve substitutes, cusp replacement by means of the Ozaki operation has become more and more popular, also as an option for ACHD (23,24). The results may depend on the tissue used as cusp substitute, with autologous pericardium yielding the most promising results (25,26). Unfortunately, the quantity and the quality of autologous pericardium are limited in ACHD undergoing repeat sternotomy.…”

Section: New Techniques For Valve Replacementmentioning

confidence: 99%

Current spectrum, challenges and new developments in the surgical care of adults with congenital heart disease

Hörer

2018

Cardiovasc. Diagn. Ther

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Today, more than two thirds of patients with congenital heart disease (CHD) are adults. Cardiac surgery plays an essential role in restoring and maintaining cardiac function, aside from evolving medical treatment and catheter-based interventions. The aim of the present publication was to describe the spectrum of operations performed on adults with CHD (ACHD) by reviewing current literature. Currently, surgery for ACHD is predominantly valve surgery, since valvular pathologies are often either a part of the basic heart defect or develop as sequelae of corrective or palliative surgery. Surgical techniques for valve repair, established in patients with acquired heart disease (non-ACHD), can often be transferred to ACHD. New valve substitutes may help to reduce the number of redo operations. Most of valve operations yield good results in terms of survival and quality of life, with the precondition that the ventricular function is preserved. Heart failure due to end-stage CHD is the most frequent cause of mortality in ACHD. However, surgical treatment by means of mechanical circulatory support (MCS) is still uncommon and the mortality exceeds the one following other operations in ACHD. Currently, different devices are used and new technical developments are in progress. However, there still is no ideal assist device available. Therefore, heart transplantation remains the only valid option for end-stage CHD. Despite higher early mortality following heart transplantation in ACHD compared to non-ACHD, the long-term survival compares favorably to non-ACHD. There is room for improvement by refining the indications, the time of listing, and the perioperative care of ACHD transplant patients. Sudden death is the second most frequent cause of mortality in ACHD. Ventricular tachycardia is the most frequent cause of sudden death followed by coronary artery anomaly. Due to the increasing awareness of physicians and the improved imaging techniques, coronary artery anomalies are coming more into the focus of cardiac surgeons. However, the reported experience is limited and it is currently difficult to provide a standardized and generally applicable recommendation for the indication and the adequate surgical technique. With the increasing age and complexity of ACHD, treatment of rhythm disturbances by surgical ablation, pacemaker or implantable cardioverter defibrillator (ICD) implantation and resynchronisation gains importance. A risk score specifically designed for surgery in ACHD is among the newest developments in predicting the outcome of surgical treatment of ACHD. This evidence-based score, derived from and validated with data from the Society of Thoracic Surgeons Congenital Heart Surgery Database, enables comparison of risk-adjusted performance of the whole spectrum of procedures performed in ACHD and helps in understanding the differences in surgical outcomes. The score is thus a powerful tool for quality control and quality improvement. In conclusion, new developments in surgery for ACHD are currently made with regard to ...

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Section: New Techniques For Valve Replacementmentioning

confidence: 99%

Current spectrum, challenges and new developments in the surgical care of adults with congenital heart disease

Hörer

2018

Cardiovasc. Diagn. Ther

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“…Interestingly, all patients in this series with reoperation also had thickened leaflets on intraoperative appearance. 19 Within our cohort, two patients had complications related to the NeoAoV. Histological examination of the explanted material showed early fibrosis and calcification of the leaflets.…”

Section: Commentmentioning

confidence: 74%

The Ozaki Procedure With CardioCel Patch for Children and Young Adults With Aortic Valve Disease: Preliminary Experience – a Word of Caution

Chivers

Pavy

Vaja

et al. 2019

World J Pediatr Congenit Heart Surg

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Background: The Ozaki procedure is a surgical technique for patients with significant aortic stenosis or regurgitation or both where valve repair cannot be performed. Individual cusps are cut from glutaraldehyde-treated autologous pericardium or bovine pericardium and implanted into the aortic valve position. Encouraging results have been reported within the adult population. There are limited published data on success of this procedure in younger patients. Methods: We present a series of five children and young adults who underwent the Ozaki procedure with neoaortic valve cusps made from CardioCel, a decellularized bovine pericardial patch treated with a monomeric glutaraldehyde. Results: There were no complications in the initial postoperative period and short inpatient stay. At a mean follow-up of 29.6 months (range: 22-36 months), 4 patients had no evidence of stenosis and 3 patients had trivial or no regurgitation from the neoaortic valve. Overall, two patients had complications related to the valve and underwent reintervention during the follow-up period with a Ross procedure. One of these patients who was not taking long-term anticoagulation experienced a transient ischemic attack. Conclusions: Our experience demonstrates that the Ozaki procedure with CardioCel in pediatric and young adult patients should be approached with caution. Further research with larger groups of pediatric patients, comparison of different graft materials, and longer follow-up is required to ascertain long-term success in children.

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“…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). 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.…”

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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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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Results of aortic valve repair using decellularized bovine pericardium in congenital surgery

Abstract: AVR using decellularized bovine pericardial patch material in patients with congenital aortic valve disease show unsatisfactory results within the first 3 years of FU.

Cited by 38 publications

References 14 publications

Current spectrum, challenges and new developments in the surgical care of adults with congenital heart disease

Current spectrum, challenges and new developments in the surgical care of adults with congenital heart disease

The Ozaki Procedure With CardioCel Patch for Children and Young Adults With Aortic Valve Disease: Preliminary Experience – a Word of Caution

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

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