Purpose: In silico trials using computational modeling and simulations can complement clinical trials to improve the time-to-market of complex cardiovascular devices in humans. This study aims to investigate the significance of synthetic data in developing in silico trials for assessing the safety and efficacy of cardiovascular devices, focusing on bioprostheses designed for transcatheter aortic valve implantation (TAVI).
Methods: A statistical shape model (SSM) was employed to extract uncorrelated shape features from TAVI patients, enabling the augmentation of the original patient population into a clinically validated synthetic cohort.
Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation.
View Article and Find Full Text PDFBackground: Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat patients with severe aortic valve stenosis. However, there is limited knowledge on the material properties of the aortic root in TAVI patients, and this can impact the credibility of computer simulations. This study aimed to develop a non-invasive inverse approach for estimating reliable material constituents for the aortic root and calcified valve leaflets in patients undergoing TAVI.
View Article and Find Full Text PDFTranscatheter aortic valve replacement (TAVR) is increasingly being considered for use in younger patients having longer life expectancy than those who were initially treated. The TAVR-in-TAVR procedure represents an appealing strategy to treat failed transcatheter heart valves (THV) likely occurring in young patients. However, the permanent displacement of first THV can potentially compromise the coronary access and ultimately inhibit the blood flow circulation.
View Article and Find Full Text PDFBackground: Volumetric Muscle Loss (VML), resulting from severe trauma or surgical ablation, is a pathological condition preventing myofibers regeneration, since skeletal muscle owns the remarkable ability to restore tissue damage, but only when limited in size. The current surgical therapies employed in the treatment of this pathology, which particularly affects military personnel, do not yet provide satisfactory results. For this reason, more innovative approaches must be sought, specifically skeletal muscle tissue engineering seems to highlight promising results obtained from preclinical studies in VML mouse model.
View Article and Find Full Text PDFMelanoma is a malignant cancer type which develops when DNA damage occurs (mainly due to environmental factors such as ultraviolet rays). Often, melanoma results in intense and aggressive cell growth that, if not caught in time, can bring one toward death. Thus, early identification at the initial stage is fundamental to stopping the spread of cancer.
View Article and Find Full Text PDFTricuspid regurgitation (TR) is a relatively common valvular disease, which can result from structural abnormalities of any anatomic part of the tricuspid valve. Severe TR is linked to congestive heart failure and hemodynamic impairment, resulting in high mortality when repaired by elective surgery. This study was undertaken to quantify the structural and hemodynamic performance of the novel Transcatheter Bicaval Valves System (TricValve) percutaneously implanted in the superior vena cava (SVC) and inferior vena cava (IVC) of two patients with severe TR and venous congestion.
View Article and Find Full Text PDFIn human dystrophies, progressive muscle wasting is exacerbated by ectopic deposition of fat and fibrous tissue originating from fibro/adipogenic progenitors (FAPs). In degenerating muscles, the ability of these cells to promote successful healing is attenuated, and FAPs aberrantly expand and differentiate into adipocytes and fibroblasts. Thus, arresting the fibro/adipogenic fate of FAPs, without affecting their physiological role, represents a valuable therapeutic strategy for patients affected by muscle diseases.
View Article and Find Full Text PDFBackground: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce.
Aims: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3).
Three-dimensional (3D) bioprinting is an emerging technology, which turned out to be an optimal tool for tissue engineering approaches. To date, different printing systems have been developed. Among them, the extrusion-based approach demonstrated to be the most suitable for skeletal muscle tissue engineering, due to its ability to produce and deposit printing fibers in a parallel pattern that well mimic the native skeletal muscle tissue architecture.
View Article and Find Full Text PDFBackground: The DISRUPT-CAD study series demonstrated feasibility and safety of intravascular lithotripsy (IVL) in selected patients, but applicability across a broad range of clinical scenarios remains unclear.
Aims: This study aims to evaluate the procedural and clinical outcomes of IVL in a high-risk real-world cohort, compared to a regulatory approval cohort.
Methods: Consecutive patients treated with IVL and percutaneous coronary intervention at our center from May 2016 to April 2020 were included.
Transcatheter mitral valve replacement (TMVR) has been used for "off-label" treatment when annuloplasty band ring for mitral repair fails. However, the complex anatomy and function of the mitral valve may lead to fatal complications as a result of the left ventricular outflow tract (LVOT) obstruction in TMVR. We report the structural and hemodynamic response of LVOT obstruction resulting from TMVR with the Edwards SAPIEN 3 Ultra (S3) device.
View Article and Find Full Text PDFBackground: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes.
Objectives: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices.
Methods: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices.
Skeletal muscle is a very dynamic and plastic tissue, being essential for posture, locomotion and respiratory movement. Muscle atrophy or genetic muscle disorders, such as muscular dystrophies, are characterized by myofiber degeneration and replacement with fibrotic tissue. Recent studies suggest that changes in muscle metabolism such as mitochondrial dysfunction and dysregulation of intracellular Ca homeostasis are implicated in many adverse conditions affecting skeletal muscle.
View Article and Find Full Text PDFBicuspid aortic valve (BAV) patients are conventionally not treated by transcathether aortic valve implantation (TAVI) because of anatomic constraint with unfavorable outcome. Patient-specific numerical simulation of TAVI in BAV may predict important clinical insights to assess the conformability of the transcathether heart valves (THV) implanted on the aortic root of members of this challenging patient population. We aimed to develop a computational approach and virtually simulate TAVI in a group of n.
View Article and Find Full Text PDFVolumetric muscle loss (VML) is the massive wasting of skeletal muscle tissue due to traumatic events or surgical ablation. This pathological condition exceeds the physiological healing process carried out by the muscle itself, which owns remarkable capacity to restore damages but only when limited in dimensions. Upon VML occurring, the affected area is severely compromised, heavily influencing the affected a person's quality of life.
View Article and Find Full Text PDFThe importance of skeletal muscle tissue is undoubted being the controller of several vital functions including respiration and all voluntary locomotion activities. However, its regenerative capability is limited and significant tissue loss often leads to a chronic pathologic condition known as volumetric muscle loss. Here, we propose a biofabrication approach to rapidly restore skeletal muscle mass, 3D histoarchitecture, and functionality.
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