ArticleEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2020
Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data.
Article in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02527629 (Aortic Replacement Using Individualised Regenerative Allografts), which is not on this map. Cited by 30 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")
Who cites it
30 citing papers in PubMed, 47 citations in OpenAlex.
- Five-year results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement-the ARISE Study and ARISE Registry Data.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2024Trial
- A novel tissue-engineered stent graft combining decellularized scaffold and bioresorbable stent: a pilot feasibility study in a porcine model.Organogenesis · 2026Article
- Subcoronary Implantation of Decellularized Aortic Allografts-An Ex Vivo and In Vivo Feasibility Study.Annals of thoracic surgery short reports · 2026Article
- The molecular signature of degeneration in explanted decellularized allogeneic heart valves.Frontiers in cardiovascular medicine · 2026Article
- Phenotyping valvular heart diseases using the lens of unsupervised machine learning: a scoping review.NPJ cardiovascular health · 2025Article
- Mechanical Versus Biological Bentall Procedure: A Propensity-Score Matching Analysis of 548 Consecutive Patients.Journal of clinical medicine · 2025Article
- A novel decellularization protocol with cryopreservation of pulmonary allografts in an ovine model.Interdisciplinary cardiovascular and thoracic surgery · 2025Article
- Towards Safety and Regulation Criteria for Clinical Applications of Decellularized Organ-Derived Matrices.Bioengineering (Basel, Switzerland) · 2025Review
- Article
- Advancing Heart Valve Replacement: Risk Mitigation of Decellularized Pulmonary Valve Preparation for Its Implementation in Public Tissue Banks.Therapeutics and clinical risk management · 2025Article
- Options for pediatric heart valve replacement.Future cardiology · 2025Review
- Decellularized aortic homografts versus mechanical composite grafts for aortic root replacement.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2024Article
- Durability of transcatheter aortic valve implantation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Review
- How to counteract the lack of donor tissue in cardiac surgery? Initial experiences with a newly established homograft procurement program.Cell and tissue banking · 2024Article
- Advantages and challenges in processing and quality control of decellularized heart valves.Cell and tissue banking · 2024Article
- Aortic Valve Replacement in Adult Patients with Decellularized Homografts: A Single-Center Experience.Journal of clinical medicine · 2023Article
- Preservation of Mechanical and Morphological Properties of Porcine Cardiac Outflow Vessels after Decellularization and Wet Storage.Biomimetics (Basel, Switzerland) · 2023Article
- Growing Heart Valve Implants for Children.Journal of cardiovascular development and disease · 2023Review
- Combining Cell Technologies With Biomimetic Tissue Engineering Applications: A New Paradigm for Translational Cardiovascular Therapies.Stem cells translational medicine · 2023Review
- A European update on transcatheter aortic valve implantation (TAVI) in the COVID era.Journal of anatomy · 2023Review
Corrections and comments
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Authors and funding
24 authors at 9 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesDecellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses.
methodsA prospective, European Union-funded, single-arm, multicentre, safety study was conducted in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement.
resultsOne hundred and forty-four patients (99 male) were prospectively enrolled between October 2015 and October 2018, mean age 33.6 ± 20.8 years; 45% had undergone previous cardiac operations. Mean implanted DAH diameter 22.6 ± 2.4 mm and mean durations for the operation, cardiopulmonary bypass and cross-clamp were 341 ± 140, 174 ± 80 and 126 ± 43 min, respectively. There were 2 early deaths (1 LCA thrombus on day 3 and 1 ventricular arrhythmia 5 h postop) and 1 late death due to endocarditis 4 months postoperatively, resulting in a total mortality of 2.08%. One pacemaker implantation was necessary and 1 DAH was successfully repaired after 6 weeks for early regurgitation following subcoronary implantation. All other DAH were implanted as a free-standing root. After a mean follow-up of 1.54 ± 0.81 years, the primary efficacy end points peak gradient (mean 11.8 ± 7.5 mmHg) and regurgitation (mean 0.42 ± 0.49, grade 0-3) were excellent. At 2.5 years, freedom from explantation/endocarditis/bleeding/stroke was 98.4 ± 1.1%/99.4 ± 0.6%/99.1 ± 0.9%/99.2 ± 0.8%, respectively, with results almost identical to those in an age-matched Ross operation cohort of 212 patients (mean age 34 years) despite DAH patients having undergone >2× more previous procedures.
conclusionsThe initial results of the prospective multicentre ARISE trial show DAH to be safe for aortic valve replacement with excellent haemodynamics in the short follow-up period.
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Registered trials
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