Long-term bio-functional performance of a novel, self-positioning balloon expandable transcatheter biological aortic valve system in the ovine aortic banding model.

BACKGROUND: The aim of the study was to evaluate bio-functionality of a novel, proprietary balloon-expandable biological transcatheter aortic valve implantation (TAVI) system (InFlow, CardValve Consortium, Poland) in an ovine model of aortic banding. METHODS: Surgical ascending aorta banding was created in 21 sheep. Two weeks later, 18 biological valves were implanted within the model using 15-16 F InFlow TAVI systems and carotid cut-down approach. Follow-up transthoracic echocardiography was performed at 30, 90, and 180-day. At designated time, animals were euthanized and valves harvested for analysis. RESULTS: All sheep survived the banding procedure. There were 4 (22%) procedure related deaths within a 7-day period. During the observation an additional 2 sheep died. In one, the valve dislocated after the procedure - the animal was excluded. Two animals completed 30-day follow up, five 90-day follow-up and four terminal follow-up of 180 days. Valves examined via transesophageal echocardiography showed proper hemodynamic parameters without evidence of structural valve deterioration. The maximum and average flow gradients at 180 days were 31.4 (23.3-37.7) and 17.5 (13.1-20.2) mmHg, respectively. There was one case of moderate insufficiency and no case of perivalvular leaks. By histopathology, there were no inflammation, thrombosis, nor calcifications in any tested valves at long-term follow-up. Neointimal coverage of stent struts increased with time from basal part in "early" groups to nearly 3/4 of stent length in the 180-day group. The pannus tissue showed maturation that increased with time with no stenotic "collar" visible in orthotopically implanted valves. CONCLUSIONS: The study showed good hemodynamic performance, durability and biocompatibility of the novel biological THV.

Actual status and future directions of cardiac telerehabilitation.

Telerehabilitation (TR) was developed to achieve the same results as would be achieved by the standard rehabilitation process and to overcome potential geographical barriers and staff deficiencies. This is especially relevant in periodic crisis situations, including the recent COVID-19 pandemic. Proper execution of TR strategy requires both well-educated staff and dedicated equipment. Various studies have shown that TR may have similar effects to traditional rehabilitation in terms of clinical outcomes and may also reduce total healthcare costs per participant, including rehospitalization costs. However, as with any method, TR has its advantages and disadvantages, including a lack of direct contact or prerequisite, rudimentary ability of the patients to handle mobile devices, among other competencies. Herein, is a discussion of the current status of TR, focusing primarily on cardiac TR, describing some technical/organizational and legal aspects, highlighting the indications, examining cost-effectiveness, as well as outlining possible future directions.

The use of modern telemedicine technologies in an innovative optimal cardiac rehabilitation program for patients after myocardial revascularization: Concept and design of RESTORE, a randomized clinical trial.

Despite proven efficacy of cardiac rehabilitation (CR) in reducing the all-cause mortality in patients after myocardial revascularization, the penetration of CR, due to patient-related factors and referral rates remains limited. To improve the outcomes, home-based tele-rehabilitation (TR) has been proposed recently. In theory TR enhances the effects of standard CR procedures due to implementation of an intelligent monitoring system designed to ensure optimal training through on-demand transmission of vital signs, aimed at motivating the patients through daily schedule reminders, setting daily goals and creating a platform for mutual feedback. Several meta-analyses assessing various studies comparing these two methods (CR and TR) have proven that they are at least equally effective, with some of the research showing superiority of TR. Although there was a small sample size, lack of long-term follow-up, reporting effects of TR itself, no integration with tools designed for coaching, motivating and promoting a healthy lifestyle constitutes an important limitation. The latter carries a hopeful prognosis for improvement when utilizing a broad-spectrum approach, especially with use of dedicated technological solutions exploiting the fact of a large and yet rapidly increasing penetration of smartphones, mobile PCs and tablets in the population. The above-mentioned findings worked as the basis and rationale for commencing the RESTORE project aimed at developing and delivering state-of-the-art, comprehensive TR for patients after myocardial revascularization and evaluating its molecular aspect in view of how it influences the atherosclerosis progression attenuation. This paper presents the current state and rationale behind the project based on up-to-date TR efficacy data.

Temporal healing patterns and coverage dynamics after new Polish transcatheter PFO occluder implantation in a swine.

BACKGROUND: Although currently used devices for interventional closure of patent foramen ovale (PFO) are widely used due to the minimally invasive nature of this technique and high success rate, there is still a need to look for new materials and designs in order to improve the treatment outcomes. AIM: To evaluate the safety, biocompatibility, temporal healing patterns, and coverage dynamics of the new Polish PFO occluder (Balton, Warsaw, Poland) in a swine model - an observation that may assist the decision with regard to its first-in-human use and duration of anticoagulation therapy. METHODS: In total, 12 pigs were scheduled for 28-day (n = 6) and 90-day follow-up (n = 6). In each animal, using a standard femoral venous approach, one PFO occluder was implanted and subsequently, in order to verify device position stability, the Minnesota manoeuvre was performed. At follow-up, all devices underwent a comprehensive evaluation with the use of high-resolution radiography (Faxitron MX-20 system), scanning electron microscopy (SEM), and standard histopathological techniques. RESULTS: All PFO occluders were implanted successfully with no complications. The Faxitron revealed that all nitinol portions of the frame appeared intact and breaks were not detected at both studied time points. Overall, the device appeared to be well deployed in the atrial septum. At 28 days the average neointimal coverage of the right side of the PFO occluder by SEM was 92%; while in contrast the left side had less coverage, at 63%. At 90 days, the coverage of the right side of the occluder was 96.8%, while the left side of the PFO occluder improved and had similar coverage of 93.3%. By histology the endothelialisation process was virtually complete at 90 days. At the early time-point the overall inflammatory infiltrate was moderate and subsequently it diminished and was only mild or occasionally moderate at 90-day follow-up. At both time points the inflammatory reaction was limited to the neointimal tissue surrounding the device. CONCLUSIONS: Our study confirmed safety and good overall biocompatibility of the new Polish PFO occluder, which is comparable to other devices available on the market - an observation that supports the decision with regard to its first-in-human application. Neoendothelialisation was virtually completed at 90 days, suggesting that similarly to other widely used devices a minimum of three to six months of anticoagulation therapy should be recommended.

State-of-the-art of transcatheter treatment of aortic valve stenosis and the overview of the InFlow project aiming at developing the first Polish TAVI system.

Initial experience of transcatheter aortic valve implantation (TAVI) or replacement (TAVR) has ap-peared as a promising minimally invasive technology for patients disqualified from surgical treatment (SAVR). Safety and efficacy of TAVI has been analyzed and assessed through numerous registries and trials. Furthermore, results obtained from comparative TAVI vs. SAVR trials proved that both treat¬ments can be considered equal in terms of post-procedural mortality and morbidity in high-risk, as well as lower risk patients. However, there are still some issues that have to be addressed, such as higher chance of paravalvular leakage, vascular injuries, conduction disturbances, malpositioning and the yet unmet problem of insufficient biological valves durability. Recent technological developments along with the learning curve of operators prove a great potential for improvement of TAVI and a chance of surpassing SAVR in various groups of patients in the near future. In pursuit of finding new solutions, the CardValve Consortium consisting of leading scientific and research institutions in Poland has been created. Under the name of InFlow and financial support from the National Center for Research and Development, they have started a project with the aim to design, create and implement into clinical practice the first, Polish, low-profile TAVI valve system, utilizing not only biological but also artificial, polymeric-based prosthesis. This review focuses on current developments in TAVI technologies including the InFlow project.

[Acute, hemorrhagic, overgrowing vaginal inflammation caused by Streptococcus agalacitae--case study]. / Ostre krwotoczne zarastajace zapalenie pochwy wywolane Streptococcus agalactiae - opis przypadku.

The aim of this study was to discuss a case of an acute, hemorrhagic, overgrowing vaginal inflammation caused by Streptococcus agalacitae. Intravaginal globules based on methylcellulose and gelatin, containing a lactic acid and chitosan complex in mole relation 1:1 to 4:1 and, in succesion, an addition of hydrophilisating substances like: PEG-200, propylene-1,2 glycol or glycerol, were applied in the treatment process. The technology was invented in Fac. of pharmacy. Dep. of Pharmaceutical Technology, Wroclaw Medical Univ, Poland (recipe patent-protected).