Objective: Constriction of vein grafts with braided external nitinol meshes had previously led to the successful elimination of neointimal tissue formation. We investigated whether pulse compliance, smaller kink-free bending radius, and milder medial atrophy can be achieved by knitting the meshes rather than braiding, without losing the suppressive effect on intimal hyperplasia.
Methods: Pulse compliance, bending stiffness, and bending radius, as well as longitudinal-radial deformation-coupling and radial compression, were compared in braided and knitted nitinol meshes. Identical to previous studies with braided mesh grafts, a senescent nonhuman primate model (Chacma baboons; bilateral femoral interposition grafts/6 months) mimicking the clinical size mismatch between vein grafts and runoff arteries was used to examine the effect of knitted external meshes on vein grafts: nitinol mesh-constricted (group 1); nitinol mesh-constricted and fibrin sealant (FS) spray-coated for mesh attachment (group 2); untreated control veins (group 3), and FS spray-coated control veins (group 4).
Results: Compared with braided meshes, knitted meshes had 3.8-times higher pulse compliance (3.43 ± 0.53 vs 0.94 ± 0.12%/100 mm Hg; P = .00002); 30-times lower bending stiffness (0.015 ± 0.002 vs 0.462 ± 0.077 Nmm(2); P = .0006); 9.2-times narrower kink-free bending radius (15.3 ± 0.4 vs 140.8 ± 22.4 mm; P = .0006), and 4.3-times lower radial narrowing caused by axial distension (18.0% ± 1.0% vs 77.0% ± 3.7%; P = .00001). Compared with mesh-supported grafts, neointimal tissue was 8.5-times thicker in group I (195 ± 45 μm) vs group III (23.0 ± 21.0 μm; P < .001) corresponding with a 14.3-times larger neointimal area in group I (4330 ± 957 × 103 μm(2)) vs group III (303 ± 221× 103 μm(2); P < .00004). FS had no significant influence. Medial muscle mass remained at 43.4% in knitted meshes vs the 28.1% previously observed in braided meshes.
Conclusion: Combining the suppression of intimal hyperplasia with a more physiologic remodeling process of the media, manifold higher kink-resistance, and lower fraying than in braided meshes makes knitted nitinol an attractive concept in external vein graft protection.
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http://dx.doi.org/10.1016/j.jvs.2011.05.023 | DOI Listing |
Catheter Cardiovasc Interv
November 2023
Departments of Cardiothoracic Surgery and Pediatrics (Cardiology), Stanford University School of Medicine, Palo Alto, California, USA.
Background: The Harmony TPV25 transcatheter pulmonary valve (Medtronic Inc.) is constructed with a self-expanding stent frame comprising six zigged nitinol wires sewn together and covered with knitted polyester fabric, with flared inflow and outflow ends and a porcine pericardial valve sutured to the central portion of the device. It was approved for treatment of pulmonary regurgitation after prior right ventricular outflow tract repair in 2021.
View Article and Find Full Text PDFCatheter Cardiovasc Interv
November 2021
Department of Pediatrics, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea.
Objectives: The aim of this study is to present the mid-term outcomes of Pulsta valve.
Background: The Pulsta valve is a Self-expandable knitted nitinol-wire stent mounted with a treated tri-leaflet α-Gal-free porcine pericardial valve for percutaneous pulmonary valve implantation (PPVI) in patients with native right ventricular outflow tract (RVOT) lesions.
Methods: A multi-center clinical trial using Pulsta valve® was designed for patients with severe pulmonary regurgitation (PR) in the native RVOT in multiple centers in South Korea and 25 patients were enrolled.
J Invest Surg
October 2021
R&D Center, Kang and Park Medical Co, Ochang, Korea.
Objectives: The aim of this cohort study is to improve the procedure of fertility-sparing surgery and to assess oncological and reproductive follow-up outcomes after radical trachelectomy (RT) for cervical cancer (TNM).
Methods: We have suggested the method combining sentinel lymph nodes (SLNs) and cervicoisthmic cerclage using a superelastic knitted TiNi mesh (KTNM) implant to facilitate the primary biomechanical/retention function of the uterus. Sixty-eight consented patients, who underwent fertility-sparing surgery using both transabdominal and laparoscopic route from 2009 through 2019, were recruited in the study and prospectively followed for a mean of 69 months.
Circ Cardiovasc Interv
June 2018
Department of Thoracic and Cardiovascular Surgery, Sejong General Hospital, Bucheon, South Korea (Y.J.K.).
Background: Self-expandable percutaneous pulmonary valve implantation (PPVI) for native right ventricular outflow tract lesions is still in the clinical trial phase. The aim of this study is to present the result of feasibility study of a novel self-expandable knitted nitinol wire stent mounted with a treated trileaflet α-Gal-free porcine pericardial valve for PPVI.
Methods And Results: A feasibility study using Pulsta valve (TaeWoong Medical Co, Gyeonggi-do, South Korea) was designed for patients with severe pulmonary regurgitation in the native right ventricular outflow tract, and 6-month follow-up outcomes were reviewed.
Catheter Cardiovasc Interv
April 2017
Department of Thoracic and Cardiovascular Surgery, Seoul National University Children's Hospital, Jongno-gu, Seoul, 03080, South Korea.
Balloon-expandable percutaneous pulmonary valve systems using the Melody and Edwards SAPIEN transcatheter heart valves have been increasingly used instead of surgically implantable pulmonary valves. However, limited patients with right ventricular outflow tract (RVOT) lesions are suitable candidates for percutaneous pulmonary valve implantation (PPVI) using these systems after surgical correction of tetralogy of Fallot. Therefore, larger self-expandable valved-stents are being developed for native RVOT lesions.
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