Mechanical degradation of biological heart valve tissue induced by low diameter crimping: An early assessment

Khoffi, Foued; Heim, Frédéric

doi:10.1016/j.jmbbm.2015.01.005

Cited by 33 publications

(20 citation statements)

References 11 publications

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“…Furthermore, balloon postdilation is performed in up to 13% and 29% of TAVIs with the balloon-expandable and self-expanding bioprostheses, respectively,43 44 to reduce paravalvular leak at the time of the procedure. In vitro studies showed that crimping is associated with significant alteration in structural morphology of collagen fibres45 and impairment of leaflet mechanical properties 46. Leaflet injury during valve loading and delivery processes was more important with balloon-expandable versus self-expanding bioprostheses 47.…”

Section: Durability Of Transcatheter Bioprosthesesmentioning

confidence: 99%

Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation

Salaün

Clavel

Rodés‐Cabau

et al. 2018

Heart

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The main limitation of bioprosthetic valves is their limited durability, which exposes the patient to the risk of aortic valve reintervention. Transcatheter aortic valve implantation (TAVI) is considered a reasonable alternative to surgical aortic valve replacement (SAVR) in patients with intermediate or high surgical risk. TAVI is now rapidly expanding towards the lower risk populations. Although the results of midterm durability of the transcatheter bioprostheses are encouraging, their long-term durability remains largely unknown. The objective of this review article is to present the definition, mechanisms, incidence, outcome and management of structural valve deterioration of aortic bioprostheses with specific emphasis on TAVI. The structural valve deterioration can be categorised into three stages: stage 1: morphological abnormalities (fibrocalcific remodelling and tear) of bioprosthesis valve leaflets without hemodynamic valve deterioration; stage 2: morphological abnormalities and moderate hemodynamic deterioration (increase in gradient and/or new onset of transvalvular regurgitation); and stage 3: morphological abnormalities and severe hemodynamic deterioration. Several specifics inherent to the TAVI including valve oversizing, manipulation, delivery, positioning and deployment may cause injuries to the valve leaflets and increase leaflet mechanical stress, which may limit the long-term durability of transcatheter bioprostheses. The selection of the type of aortic valve replacement and bioprosthesis should thus take into account the ratio between the demonstrated durability of the bioprostheses versus the life expectancy of the patient. Pending the publication of robust data on long-term durability of transcatheter bioprostheses, it appears reasonable to select SAVR with a bioprosthesis model that has well-established long-term durability in patients with low surgical risk and long life expectancy.

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Section: Durability Of Transcatheter Bioprosthesesmentioning

confidence: 99%

Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation

Salaün

Clavel

Rodés‐Cabau

et al. 2018

Heart

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“…Such complications are thrombosis, 22 calcific degeneration, 28 paravalvular leaks (PVL), 20 and limited durability. 36 In addition, recent evidence indicate that the tissue leaflets endure mechanical damage already during the crimping and deployment stages, even before their deployed duty cycle, 1,19 raising concerns as for their longer term durability and other ensuing complications. Improvements in performance of the latest generation of FDA-approved TAVR devices, the SAPIEN3 (Edwards Lifesciences, Irvine, CA, USA) and the Evolut PRO (Medtronic, Minneapolis, MN, USA), have gradually opened the door to expanding TAVR utility to younger and lower risk patients, 34 though raising a major concern regarding their longer term performance.…”

Section: Introductionmentioning

confidence: 99%

Novel Polymeric Valve for Transcatheter Aortic Valve Replacement Applications: In Vitro Hemodynamic Study

et al. 2018

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Transcatheter aortic valve replacement (TAVR) is a minimally-invasive approach for treating severe aortic stenosis. All clinically-used TAVR valves to date utilize chemically-fixed xenograft as the leaflet material. Inherent limitation of the tissue (e.g., calcific degeneration) motivates the search for alternative leaflet material. Here we introduce a novel polymeric TAVR valve that was designed to address the limitations of tissue-valves. In this study, we experimentally evaluated the hemodynamic performance of the valve and compared its performance to clinically-used valves: a gold standard surgical tissue valve, and a TAVR valve. Our comparative testing protocols included: (i) baseline hydrodynamics (ISO:5840-3), (ii) complementary patient-specific hydrodynamics in a dedicated system, and (iii) thrombogenicity. The patient-specific testing system facilitated comparing TAVR valves performance under more realistic conditions. Baseline hydrodynamics results at CO 4-7 L/min showed superior effective orifice area (EOA) for the polymer valve, most-notably as compared to the reference TAVR valve. Regurgitation fraction was higher in the polymeric valve, but within the ISO minimum requirements. Thrombogenicity trends followed the EOA results with the polymeric valve being the least thrombogenic, and clinical TAVR being the most. Hemodynamic-wise, the results strongly indicate that our polymeric TAVR valve can outperform tissue valves.

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“…Nevertheless, the durability of bioprosthetic leaflets is still a matter of debate [16–18]. The nonphysiological stresses, applied to the leaflets of TAVI prostheses during crimping and deployment, cause tissue dehydration and are believed to increase the risk of structural damage [19–21], affecting adversely the durability of the pericardial valves [22–26]. Polymeric heart valves could represent an attractive alternative to xenograft tissues, addressing these limitations.…”

Section: Introductionmentioning

confidence: 99%

In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE)

Rahmani

Tzamtzis

Sheridan

et al. 2016

J. of Cardiovasc. Trans. Res.

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This study presents the in vitro hydrodynamic assessment of the TRISKELE, a new system suitable for transcatheter aortic valve implantation (TAVI), aiming to mitigate the procedural challenges experienced with current technologies. The TRISKELE valve comprises three polymeric leaflet and an adaptive sealing cuff, supported by a novel fully retrievable self-expanding nitinol wire frame. Valve prototypes were manufactured in three sizes of 23, 26, and 29 mm by automated dip-coating of a biostable polymer, and tested in a hydrodynamic bench setup in mock aortic roots of 21, 23, 25, and 27 mm annulus, and compared to two reference valves suitable for equivalent implantation ranges: Edwards SAPIEN XT and Medtronic CoreValve. The TRISKELE valves demonstrated a global hydrodynamic performance comparable or superior to the controls with significant reduction in paravalvular leakage. The TRISKELE valve exhibits enhanced anchoring and improved sealing. The valve is currently under preclinical investigation.

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Mechanical degradation of biological heart valve tissue induced by low diameter crimping: An early assessment

Cited by 33 publications

References 11 publications

Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation

Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation

Novel Polymeric Valve for Transcatheter Aortic Valve Replacement Applications: In Vitro Hemodynamic Study

In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE)

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