Systematic review of first-in-human and early phase clinical trials for surgically implantable biological mitral valve substitutes.

BACKGROUND: The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research. METHODS: An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position. RESULTS: Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average. CONCLUSION: FIH clinical report is essential to assess the significance of clinical data required for a "de novo" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.

A Systematic Review of Individualized Heart Surgery with a Personalized Prosthesis.

Personalized surgery is not just a new trend but rather a patient-specific approach to therapy that makes it possible to adopt a targeted approach for a specific patient and closely mirrors the approach of personalized medicine. However, the application of tailored surgery in the context of cardiovascular replacement surgery has not been systematically reviewed. The ability to customize a device is highly dependent on the collection of radiological image data for precise prosthesis modeling. These facts are essential to "tailor-made" device design for precise prosthesis implantation. According to this study, computed tomography (CT) was the most prominent imaging modality; however, transesophageal echocardiography and echocardiography were also found to be helpful. Additionally, a dynamic finite element simulation was also found to be an attractive alternative to the finite element analysis for an in-silico experiment. Nonetheless, there is a paucity of relevant publications and only sporadic evidence. More clinical studies have been warranted, notwithstanding that the derived data and results from this insight into the use of therapeutic interventions may be evidence of multiple directives in clinical practices and beyond. This study may help the integration of personalized devices for better comprehension of predicted clinical outcomes, thus leading towards enhanced performance gains.

Polka dot cementless talar component in enhancing total ankle replacement fixation: A parametric study using the finite element analysis approach.

The primary stability of a total ankle replacement (TAR) is essential in preventing long-term aseptic loosening failure and could be quantified based on micromotion at the bone-prosthesis interface subjected to physiological loading during the normal walking. A 3D finite element analysis was conducted to investigate the current commercial STAR™ Ankle TAR bone-prosthesis interface relative micromotion (BPIRM) with addition of the talus bone minimum principal bone stresses (MPBS). Comparison was made to the proposed polka dot designs with the hemispheric feature that was demonstrated to enhance BPIRM. Parametric studies were conducted on the hemispheric features with changes in its diameter, length and shape. The FE results indicated high BPIRM at the talar component was primarily contributed by de-bonding (in the normal direction) between the talus bone and talar component. The MPBS were found to be most significant in the superior anterior and superior medial regions of the talus bone. When the pin length was increased from 1.5 to 3 mm, the BPIRM was predicted to fall below 50 µm in favour of bone in-growth. Based on the practicality of the prosthesis implantation during the surgical procedure, the final design that incorporated both the initial polka dot and 3 mm pin length in a crisscross manner was deemed to be a favorable design with reduced BPIRM and MPBS hence lowering the risk of long-term aseptic loosening.

An anatomical and biomechanical assessment of the interosseous membrane of the cadaveric forearm.

Ten cadaveric specimens underwent biomechanical assessment on a motorized jig with an in-built torque sensor. A differential variable reluctance transducer was placed on the central bundle of the interosseous membrane to detect changes in strain. Torque was measured with an intact interosseous membrane and a sectioned central bundle of the interosseous membrane. Changes in strain and torque were plotted against the degree of rotation of the cadaveric forearms. We found that the overall magnitude of strain to be greatest in pronation and smallest in supination. However, the relative displacement of the interosseous membrane between pronation and supination was minimal in absolute terms. There was no difference in torque between an intact and cut central bundle. We conclude that the interosseous membrane acts as a static longitudinal stabilizer of the forearm and less so as a rotational stabilizer.