ArticleAnnals of thoracic surgery short reports2024
Early Clinical Results for a New Self-Organizing Hybrid Fabric in Congenital Cardiac Surgery.
Article in Annals of thoracic surgery short reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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.
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Who cites it
3 citing papers in PubMed.
- Early biological reactions to a novel hybrid knit fabric inducing autologous tissue ingrowth implanted in a small infant.General thoracic and cardiovascular surgery cases · 2026Article
- Early Biological Reaction to a Synthetic Hybrid Patch Inducing Tissue Ingrowth as a Senning Atrial Baffle.Annals of thoracic surgery short reports · 2026Article
- Novel transparent patch as an adjunct to adult pulmonary valve replacement.General thoracic and cardiovascular surgery · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: We have developed a new hybrid warp-knit fabric for induction of in situ tissue regeneration that has shown appropriate antideterioration properties and expandability in preclinical studies. This study was performed to assess the clinical efficacy and safety of this fabric in the early postoperative period after congenital cardiac surgery. Methods: The fabric comprises biodegradable (complete degradation period, 2-3 years) and nonbiodegradable yarns coated with cross-linked gelatin. A multicenter single-arm 3-year study was conducted. The primary end point for regulatory approval was the surgical success rate without death or reintervention related to fabric failure at 1 year after surgery. Secondary end points included the incidence of material-related secondary lesions. Results: The fabric was implanted at 41 sites (pulmonary artery, n = 18; right ventricular outflow tract, n = 12; atrial septum, n = 7; and ventricular septum, n = 4) in 34 patients of median age 1 year 11 months (range, 4 months-58 years). The surgical success rate was 100%. There were no abnormal findings for the fabric on echocardiography and no serious adverse events in a median follow-up period of 40 months (range, 36-55 months), other than 3 stenotic lesions that were due to the surgical procedure. These results permitted regulatory approval for use of the fabric in Japan. Conclusions: The new fabric promoting tissue self-organization through a novel technology showed acceptable efficacy and safety in the early postoperative period after congenital cardiac surgery.
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Registered trials
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