Advancements in Transcatheter Aortic Valve Implantation: A Focused Update

BackgroundThe novel Vienna TAVI system is repositionable and retrievable, already pre-mounted on the delivery system, eliminating the need for assembly and crimping of the device prior to valve implantation.AimsThe purpose of this first-in-human feasibility study was to determine the safety, feasibility, clinical and hemodynamic performance of the Vienna TAVI system at 6-month follow-up. (ClinicalTrials.gov identifier NCT04861805).MethodsThis is a prospective, non-randomized, single-arm, single-center, first-stage FIH feasibility study, which is followed by a second-stage pivotal, multicenter, multinational study in symptomatic patients with severe aortic stenosis (SAS). The first-stage FIH study evaluated the safety and feasibility, clinical and hemodynamic performance of the device in 10 patients with SAS based on recommendations by the VARC-2.ResultsAll patients were alive at 3-month follow-up. 1 non-cardiovascular mortality was reported 5 months after implantation. There were no new cerebrovascular events, life-threatening bleeding or conduction disturbances observed at 6-month follow-up. The mean AV gradient significantly decreased from 48.7 ± 10.8 to 7.32 ± 2.0 mmHg and mean AVA increased from 0.75 ± 0.18 to 2.16 ± 0.42 cm2 (p < 0.00001). There was no incidence of moderate or severe total AR observed. In the QoL questionnaires, the patients reported a significant improvement from the baseline 12-KCCQ mean score 58 ± 15 to 76 ± 20. NYHA functional class improved in two patients, remained unchanged in one patient. There was an increase in mean 6-min-walk distance from baseline 285 ± 97 to 347 ± 57 m.ConclusionsThis study demonstrates that using Vienna TAVI system has favourable and sustained 6-month safety and performance outcomes in patients with symptomatic severe aortic stenosis.

Section: Discussionmentioning

confidence: 99%

Safety and performance of the Vienna self-expandable transcatheter aortic valve system: 6-month results of the VIVA first-in-human feasibility study

Briedis

Mizarienė

Rumbinaitė

et al. 2023

“…Similarly to the use in coronary revascularization, setups for IVL have been successfully employed to facilitate the intravascular access to the aortic valve for easier insertion of large-dimension sheaths in TAVI procedures (43)(44)(45)(46). Shockwaves are delivered by a piezoelectric device to the iliac artery or the aortic wall to break up the calcifications hardening the tissue, allowing the insertion of the catheters for TAVI implantation and reducing the risks of arterial wall damage to optimize TAVI deployment (46).…”

Section: Shockwave Treatment In Minimally-invasive Aortic Valve Repla...mentioning

confidence: 99%

Shockwaves delivery for aortic valve therapy—Realistic perspective for clinical translation?

Curini

Pesce

2023

Calcific aortic valve disease (CAVD) is the most frequent valvular heart disorder, and the one with the highest impact and burden in the elderly population. While the quality and standardization of the current aortic valve replacements has reached unprecedented levels with the commercialization of minimally-invasive implants and the design of procedures for valve repair, the need of supplementary therapies able to block or retard the course of the pathology before patients need the intervention is still awaited. In this contribution, we will discuss the emerging opportunity to set up devices to mechanically rupture the calcium deposits accumulating in the aortic valve and restore, at least in part, the pliability and the mechanical function of the calcified leaflets. Starting from the evidences gained by mechanical decalcification of coronary arteries in interventional cardiology procedures, a practice already in the clinical setting, we will discuss the advantages and the potential drawbacks of valve lithotripsy devices and their potential applicability in the clinical scenario.

“…In developed countries, calcific aortic stenosis is the second-most frequent cardiovascular disease after coronary artery disease and systemic arterial hypertension with a prevalence of 0.4% in the general population ( 3 ) and 1.7% in the population over 65 years ( 4 ). Currently, there is no effective medical treatment other than surgical or transcatheter aortic valve replacement ( 5 , 6 ).…”

Section: Introductionmentioning

confidence: 99%

Shared gene characteristics and molecular mechanisms of macrophages M1 polarization in calcified aortic valve disease

Qin

Chen²,

Li³

et al. 2023

BackgroundCAVD is a common cardiovascular disease, but currently there is no drug treatment. Therefore, it is urgent to find new and effective drug therapeutic targets. Recent evidence has shown that the infiltration of M1 macrophages increased in the calcified aortic valve tissues, but the mechanism has not been fully elucidated. The purpose of this study was to explore the shared gene characteristics and molecular mechanisms of macrophages M1 polarization in CAVD, in order to provide a theoretical basis for new drugs of CAVD.MethodsThe mRNA datasets of CAVD and M1 polarization were downloaded from Gene Expression Omnibus (GEO) database. R language, String, and Cytoscape were used to analyze the functions and pathways of DEGs and feature genes. Immunohistochemical staining and Western Blot were performed to verify the selected hub genes.ResultsCCR7 and GZMB were two genes appeared together in hub genes of M1-polarized and CAVD datasets that might be involved in the process of CAVD and macrophages M1 polarization. CCR7 and CD86 were significantly increased, while CD163 was significantly decreased in the calcified aortic valve tissues. The infiltration of M1 macrophages was increased, on the contrary, the infiltration of M2 macrophages was decreased in the calcified aortic valve tissues.ConclusionThis study reveals the shared gene characteristics and molecular mechanisms of CAVD and macrophages M1 polarization. The hub genes and pathways we found may provide new ideas for the mechanisms underlying the occurrence of M1 polarization during CAVD process.