Acute performance of a novel restorative transcatheter aortic valve: preclinical results

Miyazaki, Yosuke; Soliman, Osama Ibrahim Ibrahim; Abdelghani, Mohammad; Katsikis, Athanasios; Naz, Christophe; Lopes, Susana; Warnack, Boris; Cox, Martijn; Onuma, Yoshinobu; Serruys, Patrick W.

doi:10.4244/eij-d-17-00554

Cited by 36 publications

(15 citation statements)

References 30 publications

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“…It should be noted that this ability to learn and adapt based on clinical findings is an important and unique asset of the RestoreX TM platform, which may prove essential when expanding to larger patient groups and additional indications. For example, promising acute preclinical results using RestoreX for aortic valve restoration were previously reported (25).…”

Section: Discussionmentioning

confidence: 99%

A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials

Morales

Herrington

Bacha

et al. 2021

Front. Cardiovasc. Med.

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Objectives: We report the first use of a biorestorative valved conduit (Xeltis pulmonary valve–XPV) in children. Based on early follow-up data the valve design was modified; we report on the comparative performance of the two designs at 12 months post-implantation.Methods: Twelve children (six male) median age 5 (2 to 12) years and weight 17 (10 to 43) kg, had implantation of the first XPV valve design (XPV-1, group 1; 16 mm (n = 5), and 18 mm (n = 7). All had had previous surgery. Based on XPV performance at 12 months, the leaflet design was modified and an additional six children (five male) with complex malformations, median age 5 (3 to 9) years, and weight 21 (14 to 29) kg underwent implantation of the new XPV (XPV-2, group 2; 18 mm in all). For both subgroups, the 12 month clinical and echocardiographic outcomes were compared.Results: All patients in both groups have completed 12 months of follow-up. All are in NYHA functional class I. Seventeen of the 18 conduits have shown no evidence of progressive stenosis, dilation or aneurysm formation. Residual gradients of >40 mm Hg were observed in three patients in group 1 due to kinking of the conduit (n = 1), and peripheral stenosis of the branch pulmonary arteries (n = 2). In group 2, one patient developed rapidly progressive stenosis of the proximal conduit anastomosis, requiring conduit replacement. Five patients in group 1 developed severe pulmonary valve regurgitation (PI) due to prolapse of valve leaflet. In contrast, only one patient in group 2 developed more than mild PI at 12 months, which was not related to leaflet prolapse.Conclusions: The XPV, a biorestorative valved conduit, demonstrated promising early clinical outcomes in humans with 17 of 18 patients being free of reintervention at 1 year. Early onset PI seen in the XPV-1 version seems to have been corrected in the XPV-2, which has led to the approval of an FDA clinical trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708.

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Section: Discussionmentioning

confidence: 99%

A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials

Morales

Herrington

Bacha

et al. 2021

Front. Cardiovasc. Med.

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“…[ 83b ] Recently, a TAV version was tested in an acute animal model (sheep) where a good hemodynamic performance was reported; the mean pressure gradient, EOA, and median aortic regurgitation were 4.0 mmHg, 2.2, and 6%; respectively. [ 146 ]…”

Section: Materials Used For Thvsmentioning

confidence: 99%

Transcatheter Heart Valves: A Biomaterials Perspective

Bui

Khair

Yeats

et al. 2021

Adv Healthcare Materials

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Heart valve disease is prevalent throughout the world, and the number of heart valve replacements is expected to increase rapidly in the coming years. Transcatheter heart valve replacement (THVR) provides a safe and minimally invasive means for heart valve replacement in high‐risk patients. The latest clinical data demonstrates that THVR is a practical solution for low‐risk patients. Despite these promising results, there is no long‐term (>20 years) durability data on transcatheter heart valves (THVs), raising concerns about material degeneration and long‐term performance. This review presents a detailed account of the materials development for THVRs. It provides a brief overview of THVR, the native valve properties, the criteria for an ideal THV, and how these devices are tested. A comprehensive review of materials and their applications in THVR, including how these materials are fabricated, prepared, and assembled into THVs is presented, followed by a discussion of current and future THVR biomaterial trends. The field of THVR is proliferating, and this review serves as a guide for understanding the development of THVs from a materials science and engineering perspective.

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“…Heart valve constructs from polymer scaffolds are currently under investigation in preclinical experiments. In sheep, these scaffolds have demonstrated satisfactory durability and function on mid-term when implanted in the pulmonary position as a surgical prosthesis (55) or as a valved conduit (76), or when used as a transcatheter aortic valve (53). Based on these encouraging results, the first-in-man investigations of the polymer scaffolds has recently been started (54).…”

Section: In Situ Tissue Engineering With Polymer Scaffoldsmentioning

confidence: 99%

Tissue Engineered Materials in Cardiovascular Surgery: The Surgeon's Perspective

Durko

Yacoub

Kluin

2020

Front. Cardiovasc. Med.

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In cardiovascular surgery, reconstruction and replacement of cardiac and vascular structures are routinely performed. Prosthetic or biological materials traditionally used for this purpose cannot be considered ideal substitutes as they have limited durability and no growth or regeneration potential. Tissue engineering aims to create materials having normal tissue function including capacity for growth and self-repair. These advanced materials can potentially overcome the shortcomings of conventionally used materials, and, if successfully passing all phases of product development, they might provide a better option for both the pediatric and adult patient population requiring cardiovascular interventions. This short review article overviews the most important cardiovascular pathologies where tissue engineered materials could be used, briefly summarizes the main directions of development of these materials, and discusses the hurdles in their clinical translation. At its beginnings in the 1980s, tissue engineering (TE) was defined as "an interdisciplinary field that applies the principles of engineering and the life sciences toward the development of biological substitutes that restore, maintain, or improve tissue function" (1). Currently, the utility of TE products and materials are being investigated in several fields of human medicine, ranging from orthopedics to cardiovascular surgery (2-5). In cardiovascular surgery, reconstruction and replacement of cardiac and vascular structures are routinely performed. Considering the shortcomings of traditionally used materials, the need for advanced materials that can "restore, maintain or improve tissue function" are evident. Tissue engineered substitutes, having growth and regenerative capacity, could fundamentally change the specialty (6). This article overviews the most important cardiovascular pathologies where TE materials could be used, briefly summarizes the main directions of development of TE materials along with their advantages and shortcomings, and discusses the hurdles in their clinical translation.

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Acute performance of a novel restorative transcatheter aortic valve: preclinical results

Cited by 36 publications

References 30 publications

A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials

A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials

Transcatheter Heart Valves: A Biomaterials Perspective

Tissue Engineered Materials in Cardiovascular Surgery: The Surgeon's Perspective

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