Comprehensive and Integrative Experimentation Setup for Large Animal Hybrid Valvular Heart Surgery

Alaa, Mohamed; Tsopanomichalou, Maria; Vu, Thang Duc; Ti, Lian Kah; Lee, Chuen Neng; Kofidis, Theo

doi:10.1016/j.jss.2018.09.019

Cited by 1 publication

(1 citation statement)

References 43 publications

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“…The guidance provided by the US-FDA (United States Food and Drug Administration) in selecting appropriate animal models for cardiovascular devices is also not directed to a specific large animal. In addition, the published articles comparing swine, canine and ovine models, weighing each model’s advantages and disadvantages, are also not conclusive [ 4 - 6 ]. Therefore, pre-clinical study designs rely on the researchers’ discretion rather than a universal guideline.…”

Section: Introductionmentioning

confidence: 99%

Preclinical Large Animal In-Vivo Experiments for Surgically Implanted Atrioventricular Valve: Reappraisal and Systematic Review

Sazzad

Beverly

et al. 2023

CCR

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Background: The development of atrioventricular bioprosthesis has witnessed an increasing drive toward clinical translation over the last few decades. A significant challenge in the clinical translation of an atrioventricular bioprosthesis from bench to bedside is the appropriate choice of a large animal model to test the safety and effectiveness of the device. Methods: We conducted a systematic review of preclinical in vivo studies that would enable us to synthesize a recommended framework. PRISMA (Preferred Reporting Items for Systematic Reviews and MetaAnalyses) guidelines were followed to identify and extract relevant articles. Results: Sheep was the most common choice of animal, with nine out of the 12 included studies being conducted on sheep. There were acute and chronic studies based on our search criteria. An average of ~20 and 5 animals were used for chronic and acute studies. One out of three acute studies and eight out of nine chronic studies were on stented heart valve bioprosthesis. All analyses were conducted on the implantation of atrioventricular valves with trileaflet, except for one chronic study on unileaflet valves and one chronic and acute study on bileaflet valves. Conclusion: Understanding the variance in past preclinical study designs may increase the appropriate utilization of large animal models. This synthesized evidence provides a preclinical Invivo studies framework for future research with an atrioventricular bioprosthesis.

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Section: Introductionmentioning

confidence: 99%