Double semilunar valve replacement in complex congenital heart disease using decellularized homografts

Bobylev, D.; Sarikouch, Samir; Tudorache, I.; Cvitkovic, Tomislav; Söylen, Bahar; Boethig, Dietmar; Theodoridis, Karolina; Bertram, Harald; Beerbaum, Philipp; Haverich, Axel; Cebotari, Serghei; Horke, Alexander

doi:10.1093/icvts/ivy212

Cited by 12 publications

(5 citation statements)

References 14 publications

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“…as a follow-up to Truncus arteriosus or after Ross procedures. In selected cases, we have performed a double semilunar valve replacement using cell-free pulmonary and aortic valves with excellent early to midterm results [19]. Long-term results for these approaches are currently pending, for example the results for a prospective study on aortic valve replacement (ARISE), which ended patient inclusion in summer 2018 [20].…”

Section: Discussionmentioning

confidence: 99%

A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†

Boethig

Horke

Hazekamp

et al. 2019

European Journal of Cardio-Thoracic Surgery

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OBJECTIVES Decellularized pulmonary homografts (DPH) have shown excellent results for pulmonary valve replacement. However, controlled multicentre studies are lacking to date. METHODS Prospective European multicentre trial evaluating DPH for pulmonary valve replacement. Matched comparison of DPH to bovine jugular vein (BJV) conduits and cryopreserved homografts (CH) considering patient age, type of heart defect and previous procedures. RESULTS In total, 121 patients (59 female) were prospectively enrolled (August 2014–December 2016), age 21.3 ± 14.4 years, DPH diameter 24.4 ± 2.8 mm. No adverse events occurred with respect to surgical handling; there were 2 early deaths (30 + 59 years) due to myocardial failure after multi-valve procedures and no late mortality (1.7% mortality). After a mean follow-up of 2.2 ± 0.6 years, the primary efficacy end points mean peak gradient (16.1 ± 12.1 mmHg) and regurgitation (mean 0.25 ± 0.48, grade 0–3) were excellent. One reoperation was required for recurrent subvalvular stenosis caused by a pericardial patch and 1 balloon dilatation was performed on a previously stented LPA. 100% follow-up for DPH patients operated before or outside the trial (n = 114) included in the ESPOIR Registry, age 16.6 ± 10.4 years, diameter 24.1 ± 4.2 mm, follow-up 5.1 ± 3.0 years. The combined DPH cohort, n = 235, comprising both Trial and Registry data showed significantly better freedom from explantation (DPH 96.7 ± 2.1%, CH 84.4 ± 3.2%, P = 0.029 and BJV 82.7 ± 3.2%, P = 0.012) and less structural valve degeneration at 10 years when matched to CH, n = 235 and BJV, n = 235 (DPH 61.4 ± 6.6%, CH 39.9 ± 4.4%, n.s., BJV 47.5 ± 4.5%, P = 0.029). CONCLUSIONS: Initial results of the prospective multicentre ESPOIR Trial showed DPH to be safe and efficient. Current DPH results including Registry data were superior to BJV and CH. Trial registration clinicaltrials.gov identifier: NCT 02035540.

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Section: Discussionmentioning

confidence: 99%

A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†

Boethig

Horke

Hazekamp

et al. 2019

European Journal of Cardio-Thoracic Surgery

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“…One arm of this approach comprises the removal of cells as they represent the bulk of antigen carriers 19 . Various decellularisation approaches have since successfully found their way into clinical implementation 20 . Concomitantly, a higher efficacy of antigen masking through improved sandwich-crosslinking was also shown to mitigate calcification significantly 14 .…”

Section: Discussionmentioning

confidence: 99%

Preclinical evaluation of a transcatheter aortic valve replacement system for patients with rheumatic heart disease

Scherman

Ofoegbu²,

Myburgh³

et al. 2019

EuroIntervention

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Aims: Cardiac surgery in middle-income countries differs significantly from that in high-income countries regarding prevailing heart valve pathologies and access to cardiac surgery. Typically, rheumatic aortic regurgitation in the absence of calcification by far outweighs stenosis. As such, entirely different transcatheter aortic valve implantation (TAVI) concepts are required for these regions. The aim of the study was to evaluate the five-month performance of the SAT (Strait Access Technologies, Cape Town, South Africa) pericardial TAVI system in the orthotopic aortic position of juvenile sheep.Methods and results: A self-homing, non-occlusive balloon-expandable TAVI system comprising a hollow balloon, stabilising locator trunks, a scalloped CoCr stent with elevating anchorage arms and decellularised, sandwich-crosslinked pericardium was compared with control surgical valves (Edwards PERIMOUNT) in sheep. The implantation period was five months. The tactile placement of the TAVI valves was accomplished without the need for rapid pacing. At termination, no structural degeneration was observed in either group. The TAVIs were well healed with the stent struts largely embedded in tissue. Correlating with sheep growth (weight gain of 40.4±13.0%) during the implantation period, mean transvalvular gradients increased from 3.08±1.95 mmHg to 8.50±5.38 mmHg (p=0.044) after five months.Conclusions: A single-stage, balloon-expandable, easy to place TAVI system with antigen-depleted and antigen-masked bioprosthetic leaflets promises to address the distinct needs of low-and middle-income countries with regard to TAVI better than conventional systems.

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“…However, despite this potential, evidence in the human setting remains preliminary ( Shirzad et al, 2017 ) and a systematical investigation in larger clinical studies are needed. Therefore, to date, precautionary anticoagulation or anti-platelet therapy would be still advisable ( Lawson et al, 2016 ; Tudorache et al, 2016 ; Bobylev et al, 2019 ; Boethig et al, 2019 ; Kirkton et al, 2019 ).…”

Section: Discussionmentioning

confidence: 99%

Endothelial Progenitor Cell-Based in vitro Pre-Endothelialization of Human Cell-Derived Biomimetic Regenerative Matrices for Next-Generation Transcatheter Heart Valves Applications

Motta

Zaytseva

Fioretta

et al. 2022

Front. Bioeng. Biotechnol.

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Hemocompatibility of cardiovascular implants represents a major clinical challenge and, to date, optimal antithrombotic properties are lacking. Next-generation tissue-engineered heart valves (TEHVs) made from human-cell-derived tissue-engineered extracellular matrices (hTEMs) demonstrated their recellularization capacity in vivo and may represent promising candidates to avoid antithrombotic therapy. To further enhance their hemocompatibility, we tested hTEMs pre-endothelialization potential using human-blood-derived endothelial-colony-forming cells (ECFCs) and umbilical vein cells (control), cultured under static and dynamic orbital conditions, with either FBS or hPL. ECFCs performance was assessed via scratch assay, thereby recapitulating the surface damages occurring in transcatheter valves during crimping procedures. Our study demonstrated: feasibility to form a confluent and functional endothelium on hTEMs with expression of endothelium-specific markers; ECFCs migration and confluency restoration after crimping tests; hPL-induced formation of neo-microvessel-like structures; feasibility to pre-endothelialize hTEMs-based TEHVs and ECFCs retention on their surface after crimping. Our findings may stimulate new avenues towards next-generation pre-endothelialized implants with enhanced hemocompatibility, being beneficial for selected high-risk patients.

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Double semilunar valve replacement in complex congenital heart disease using decellularized homografts

Abstract: A single-stage double semilunar valve replacement with DHV has shown promising early results in these 5 very complex cases, providing an additional surgical option after multiple preceding valve procedures in young patients.

Cited by 12 publications

References 14 publications

A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†

A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†

Preclinical evaluation of a transcatheter aortic valve replacement system for patients with rheumatic heart disease

Endothelial Progenitor Cell-Based in vitro Pre-Endothelialization of Human Cell-Derived Biomimetic Regenerative Matrices for Next-Generation Transcatheter Heart Valves Applications

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