Decellularization as a method to reduce calcification in bovine pericardium bioprosthetic valves

Collatusso, Claudinei; Roderjan, João Gabriel; Noronha, Lúcia de; Klosowski, Allyson; Suss, Paula Hansen; Guarita-Souza, Luiz César; Costa, Francisco Diniz Affonso da

doi:10.1093/icvts/ivz041

Cited by 21 publications

(22 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The main reason for this occurrence may be that the understanding of the calcification mechanism is not complete. We believe that the mechanisms of biological valve calcification mainly include the following: (i) glutaraldehyde aldehyde group residue [ 20 ], (ii) elastin degradation [ 21–23 ], (iii) tissue phospholipid residue [ 24 ], (iv) glycosaminoglycan degradation [ 25 , 26 ], (v) immunogenicity of heterogeneous tissues [ 27 ], (vi) residual cells [ 28 ] and (vii) difficulty in endothelialization [ 29–31 ]. Our anti-calcification strategy mainly targets the key factors of glutaraldehyde aldehyde group residue, elastin degradation and tissue phospholipid residue.…”

Section: Discussionmentioning

confidence: 99%

Preclinical study of a self-expanding pulmonary valve for the treatment of pulmonary valve disease

Kuang

Yang

et al. 2020

Regenerative Biomaterials

View full text Add to dashboard Cite

In the past decade, balloon-expandable percutaneous pulmonary valves have been developed and applied in clinical practice. However, all the existing products of pulmonary artery interventional valves in the market have a straight structure design, and they require a preset support frame and balloon expansion. This shape design of the valve limits the application range. In addition, the age of the population with pulmonary artery disease is generally low, and the existing products cannot meet the needs of anti-calcification properties and valve material durability. In this study, through optimization of the support frame and leaflet design, a self-expanding pulmonary valve product with a double bell-shaped frame was designed to improve the match of the valve and the implantation site. A loading and deployment study showed that the biomaterial of the valve was not damaged after being compressed. Pulsatile flow and fatigue in vitro tests showed that the fabricated pulmonary valve met the hydrodynamic requirements after 2 × 108 accelerated fatigue cycles. The safety and efficacy of the pulmonary valve product were demonstrated in studies of pulmonary valve implantation in 11 pigs. Angiography and echocardiography showed that the pulmonary valves were implanted in a good position, and they had normal closure and acceptable valvular regurgitation. The 180 days’ implantation results showed that the calcium content was 0.31–1.39 mg/g in the anti-calcification treatment group, which was significantly lower than that in the control valve without anti-calcification treatment (16.69 mg/g). Our new interventional pulmonary valve product was ready for clinical trials and product registration.

show abstract

Section: Discussionmentioning

confidence: 99%

Preclinical study of a self-expanding pulmonary valve for the treatment of pulmonary valve disease

Kuang

Yang

et al. 2020

Regenerative Biomaterials

View full text Add to dashboard Cite

show abstract

“…The work of Collatusso et al in Brazil ( 164 ) discusses the use of a proprietary 0.1% SDS solution, at 24 h at room temperature, followed by immersion in 70% ethanol for 24 h, then sequential washing in PBS for 10 days. This is followed by fixation in low concentration 0.1% GA for 7 days, with final storing of the manufactured valve in paraben.…”

Section: Treatment Of Xenogeneic Pericardium Before Clinical Implantationmentioning

confidence: 99%

Long-Term Stability and Biocompatibility of Pericardial Bioprosthetic Heart Valves

Williams

Bezuidenhout

Villiers

et al. 2021

Front. Cardiovasc. Med.

View full text Add to dashboard Cite

The use of bioprostheses for heart valve therapy has gradually evolved over several decades and both surgical and transcatheter devices are now highly successful. The rapid expansion of the transcatheter concept has clearly placed a significant onus on the need for improved production methods, particularly the pre-treatment of bovine pericardium. Two of the difficulties associated with the biocompatibility of bioprosthetic valves are the possibilities of immune responses and calcification, which have led to either catastrophic failure or slow dystrophic changes. These have been addressed by evolutionary trends in cross-linking and decellularization techniques and, over the last two decades, the improvements have resulted in somewhat greater durability. However, as the need to consider the use of bioprosthetic valves in younger patients has become an important clinical and sociological issue, the requirement for even greater longevity and safety is now paramount. This is especially true with respect to potential therapies for young people who are afflicted by rheumatic heart disease, mostly in low- to middle-income countries, for whom no clinically acceptable and cost-effective treatments currently exist. To extend longevity to this new level, it has been necessary to evaluate the mechanisms of pericardium biocompatibility, with special emphasis on the interplay between cross-linking, decellularization and anti-immunogenicity processes. These mechanisms are reviewed in this paper. On the basis of a better understanding of these mechanisms, a few alternative treatment protocols have been developed in the last few years. The most promising protocol here is based on a carefully designed combination of phases of tissue-protective decellularization with a finely-titrated cross-linking sequence. Such refined protocols offer considerable potential in the progress toward superior longevity of pericardial heart valves and introduce a scientific dimension beyond the largely disappointing ‘anti-calcification’ treatments of past decades.

show abstract

“…The results presented here are in agreement with the literature data, as comparable ranges were found for mechanical properties (e.g., ultimate tensile strength of $5-10 MPa or elasticity of $0.4 MPa). [38][39][40][41] The bovine pericardium is a nonlinear, anisotropic, multilaminated, and pliable material composed of a network of collagenous and elastic fibers in an amorphous matrix. 22,26 The collagen is mainly type I collagen (90%), and the matrix is made of proteoglycans, glycosaminoglycans, cells, and interstitial fluid.…”

Section: Biomechanicsmentioning

confidence: 99%

“…This reduction in DNA content may be advantageous since tissues that contain cellular debris, such as cell nuclei, are associated with increased immunogenicity, which favors calcification and premature failure of tissue-engineered heart valves. 11,39,[44][45][46] Glutaraldehyde is not as efficient in removing antigens as previously believed, 26 and therefore almost complete decellularization is extremely important. Further studies are planned to incorporate recently published successful and alternative protocols 23,25,26,47 into the SULEEI procedure described herein.…”

Section: Histomorphology and Decellularizationmentioning

confidence: 99%

Sterilization and Cross-Linking Combined with Ultraviolet Irradiation and Low-Energy Electron Irradiation Procedure: New Perspectives for Bovine Pericardial Implants in Cardiac Surgery

Walker

Dittfeld

Jakob

et al. 2020

Thorac Cardiovasc Surg

View full text Add to dashboard Cite

Background Bovine pericardium is the major natural source of patches and aortic valve substitutes in cardiac repair procedures. However, long-term tissue durability and biocompatibility issues lead to degeneration (e.g., calcification) that requires reoperation. Tissue preparation strategies, including glutaraldehyde fixation, are reasons for the deterioration of pericardial tissues. We describe a pretreatment procedure involving sterilization and cross-linking combined with ultraviolet (UV) irradiation and low-energy electron irradiation (SULEEI). This innovative, glutaraldehyde-free protocol improves the mechanical aspects and biocompatibility of porcine pericardium patches. Methods We adopted the SULEEI protocol, which combines decellularization, sterilization, and cross-linking, along with UV irradiation and low-energy electron irradiation, to pretreat bovine pericardium. Biomechanics, such as ultimate tensile strength and elasticity, were investigated by comparing SULEEI-treated tissue with glutaraldehyde-fixed analogues, clinical patch materials, and an aortic valve substitute. Histomorphological and cellular aspects were investigated by histology, DNA content analysis, and degradability. Results Mechanical parameters, including ultimate tensile strength, elasticity (Young's modulus), and suture retention strength, were similar for SULEEI-treated and clinically applied bovine pericardium. The SULEEI-treated tissues showed well-preserved histoarchitecture that resembled all pericardial tissues investigated. Fiber density did not differ significantly. DNA content after the SULEEI procedure was reduced to less than 10% of the original tissue material, and more than 50% of the SULEEI-treated pericardium was digested by collagenase. Conclusion The SULEEI procedure represents a new treatment protocol for the preparation of patches and aortic valve prostheses from bovine pericardial tissue. The avoidance of glutaraldehyde fixation may lessen the tissue degeneration processes in cardiac repair patches and valve prostheses.

show abstract

Decellularization as a method to reduce calcification in bovine pericardium bioprosthetic valves

Cited by 21 publications

References 20 publications

Preclinical study of a self-expanding pulmonary valve for the treatment of pulmonary valve disease

Preclinical study of a self-expanding pulmonary valve for the treatment of pulmonary valve disease

Long-Term Stability and Biocompatibility of Pericardial Bioprosthetic Heart Valves

Sterilization and Cross-Linking Combined with Ultraviolet Irradiation and Low-Energy Electron Irradiation Procedure: New Perspectives for Bovine Pericardial Implants in Cardiac Surgery

Contact Info

Product

Resources

About