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

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

Background: Novel sirolimus eluting stents (SES) have shown non-inferior clinical outcomes when compared to everolimus eluting stents (EES), however only limited preclinical data have been published. Therefore, we evaluate vascular response of a new generation biodegradable polymer SES (BP-SES: Alex Plus, Balton) and fluoropolymer EES (EES: Xience Pro, Abbott) in the porcine coronary restenosis model.Methods: A total of 40 stents were implanted with 120% overstretch in coronaries of 17 domestic swine: 16 BP-SES, 16 EES and 8 bare metal controls (BMS). Following 28 and 90 days, coronary angiography and optical coherence tomography (OCT) was performed, animals sacrificed and stented segments harvested for pathological evaluation.Results: At 28 days neointimal thickness in OCT was lowest in the BP-SES when compared to EES and BMS (0.18 ± 0.1 vs. 0.39 ± 0.1 vs. 0.34 ± 0.2 mm, respectively; p = 0.04). There was no difference in the proportion of malapposed or uncovered struts, although protruding covered struts were more common in BP-SES (14.8 ± 10% vs. 4.1 ± 4% vs. 3.7 ± 6%; p = 0.03). In pathology, the lowest neointimal thickness was confirmed in BP-SES (p < 0.05). The inflammation score was significantly lower in BP-SES and EES when compared to BMS (0.24 ± 0.1 vs. 0.4 ± 0.1 vs. 0.77 ± 0.4; p < 0.01) whilst EES and BP-SES had higher fibrin scores than BMS (1.2 ± 0.4 vs. 1.3 ± 0.3 vs. 0.17 ± 0.2; p < 0.01). At 90 days neointimal coverage and thickness in OCT was comparable between groups and healing in histopathology was complete.Conclusions: New generation, BP-SES show similar vascular healing and biocompatibility profile with marginally higher degree of restenosis inhibition, when compared to fluoropolymer EES in the porcine coronary restenosis model

Early and Long-Term Results of Unprotected Left Main Coronary Artery Stenting The LE MANS (Left Main Coronary Artery Stenting) Registry

ObjectivesThe aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups.BackgroundPCI is an increasingly utilized method of revascularization in patients with ULMCA.MethodsThis multicenter prospective registry included 252 patients after ULMCA stenting enrolled between March 1997 and February 2008. Non–ST-segment elevation acute coronary syndrome was diagnosed in 58% of patients; ST-segment elevation myocardial infarction cases were excluded. Drug-eluting stents were implanted in 36.2% of patients.ResultsMajor adverse cardiovascular and cerebral events (MACCE) occurred in 12 (4.8%) patients during the 30-day period, which included 4 (1.5%) deaths. After 12 months there were 17 (12.1%) angiographically confirmed cases of restenosis. During long-term follow-up (1 to 11 years, mean 3.8 years) there were 64 (25.4%) MACCE and 35 (13.9%) deaths. The 5- and 10-year survival rates were 78.1% and 68.9%, respectively. Despite differences in demographical and clinical data in favor of BMS patients, unmatched analysis showed a significantly lower MACCE rate in DES patients (25.9% vs. 14.9%, p = 0.039). This difference was strengthened after propensity score matching. The DES lowered both mortality and MACCE for distal ULMCA lesions when compared with BMS. Ejection fraction <50% was the only independent risk factor influencing long-term survival.ConclusionsStenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease

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

Bioresorbable scaffolds in the treatment of coronary artery disease : expert consensus statement of the association of cardiovascular interventions of the Polish Cardiac Society (ACVI PCS)

Bioresorbable scaffold coated with antimitotic drug is the latest development in the coronary stents technology. The concept of temporary scaffolding and natural vessel healing after angioplasty is a very attractive alternative to conventional metal stents. The results of the first observational studies have confirmed their ultimate biodegradation. Newest results of randomised trials and registries in broader clinical and anatomical indications also revealed the limitations of the first generation of scaffolds. The relatively thick polymeric struts and compliance with specific implantation protocol may influence the results. In this document, the group of experts presents the current state of knowledge, with a particular focus on the advantages and limitations of the new technology; it presents practical guidelines for optimal implantation techniques and clarifies documented indications for patients and lesions selection

Small Inductive Dimension of Topological Spaces. Part II

In this paper we present basic properties of n-dimensional topological spaces according to the book [10]. In the article the formalization of Section 1.5 is completed.Institute of Computer Science, University of Białystok, PolandGrzegorz Bancerek. Cardinal numbers. Formalized Mathematics, 1(2):377-382, 1990.Grzegorz Bancerek. The fundamental properties of natural numbers. Formalized Mathematics, 1(1):41-46, 1990.Grzegorz Bancerek. König's theorem. Formalized Mathematics, 1(3):589-593, 1990.Grzegorz Bancerek. The ordinal numbers. Formalized Mathematics, 1(1):91-96, 1990.Grzegorz Bancerek and Krzysztof Hryniewiecki. Segments of natural numbers and finite sequences. Formalized Mathematics, 1(1):107-114, 1990.Leszek Borys. Paracompact and metrizable spaces. Formalized Mathematics, 2(4):481-485, 1991.Agata Darmochwał. Families of subsets, subspaces and mappings in topological spaces. Formalized Mathematics, 1(2):257-261, 1990.Agata Darmochwał. Finite sets. Formalized Mathematics, 1(1):165-167, 1990.Agata Darmochwał. The Euclidean space. Formalized Mathematics, 2(4):599-603, 1991.Ryszard Engelking. Teoria wymiaru. PWN, 1981.Robert Milewski. Bases of continuous lattices. Formalized Mathematics, 7(2):285-294, 1998.Beata Padlewska. Families of sets. Formalized Mathematics, 1(1):147-152, 1990.Beata Padlewska and Agata Darmochwał. Topological spaces and continuous functions. Formalized Mathematics, 1(1):223-230, 1990.Karol Pąk. Small inductive dimension of topological spaces. Formalized Mathematics, 17(3):207-212, 2009, doi: 10.2478/v10037-009-0025-7.Andrzej Trybulec. A Borsuk theorem on homotopy types. Formalized Mathematics, 2(4):535-545, 1991.Michał J. Trybulec. Integers. Formalized Mathematics, 1(3):501-505, 1990.Zinaida Trybulec. Properties of subsets. Formalized Mathematics, 1(1):67-71, 1990.Mirosław Wysocki and Agata Darmochwał. Subsets of topological spaces. Formalized Mathematics, 1(1):231-237, 1990

Basel Problem – Preliminaries

SummaryIn the article we formalize in the Mizar system [4] preliminary facts needed to prove the Basel problem [7, 1]. Facts that are independent from the notion of structure are included here.Korniłowicz Artur - Institute of Informatics, University of Białystok, PolandPąk Karol - Institute of Informatics, University of Białystok, PolandM. Aigner and G. M. Ziegler. Proofs from THE BOOK. Springer-Verlag, Berlin Heidelberg New York, 2004.Grzegorz Bancerek. The fundamental properties of natural numbers. Formalized Mathematics, 1(1):41–46, 1990.Grzegorz Bancerek and Krzysztof Hryniewiecki. Segments of natural numbers and finite sequences. Formalized Mathematics, 1(1):107–114, 1990.Grzegorz Bancerek, Czesław Byliński, Adam Grabowski, Artur Korniłowicz, Roman Matuszewski, Adam Naumowicz, Karol Pąk, and Josef Urban. Mizar: State-of-the-art and beyond. In Manfred Kerber, Jacques Carette, Cezary Kaliszyk, Florian Rabe, and Volker Sorge, editors, Intelligent Computer Mathematics, volume 9150 of Lecture Notes in Computer Science, pages 261–279. Springer International Publishing, 2015. ISBN 978-3-319-20614-1. doi: 10.1007/978-3-319-20615-817.Czesław Byliński. Finite sequences and tuples of elements of a non-empty sets. Formalized Mathematics, 1(3):529–536, 1990.Czesław Byliński. Functions and their basic properties. Formalized Mathematics, 1(1): 55–65, 1990.Augustin Louis Cauchy. Cours d’analyse de l’Ecole royale polytechnique. de l’Imprimerie royale, 1821.Wenpai Chang, Yatsuka Nakamura, and Piotr Rudnicki. Inner products and angles of complex numbers. Formalized Mathematics, 11(3):275–280, 2003.Wenpai Chang, Hiroshi Yamazaki, and Yatsuka Nakamura. The inner product and conjugate of finite sequences of complex numbers. Formalized Mathematics, 13(3):367–373, 2005.Noboru Endou. Double series and sums. Formalized Mathematics, 22(1):57–68, 2014. doi: 10.2478/forma-2014-0006.Noboru Endou, Katsumi Wasaki, and Yasunari Shidama. Definition of integrability for partial functions from ℝ to ℝ and integrability for continuous functions. Formalized Mathematics, 9(2):281–284, 2001.Adam Grabowski and Yatsuka Nakamura. Some properties of real maps. Formalized Mathematics, 6(4):455–459, 1997.Artur Korniłowicz and Yasunari Shidama. Inverse trigonometric functions arcsin and arccos. Formalized Mathematics, 13(1):73–79, 2005.Jarosław Kotowicz. Partial functions from a domain to the set of real numbers. Formalized Mathematics, 1(4):703–709, 1990.Xiquan Liang and Bing Xie. Inverse trigonometric functions arctan and arccot. Formalized Mathematics, 16(2):147–158, 2008. doi: 10.2478/v10037-008-0021-3.Robert Milewski. Trigonometric form of complex numbers. Formalized Mathematics, 9 (3):455–460, 2001.Keiichi Miyajima and Takahiro Kato. The sum and product of finite sequences of complex numbers. Formalized Mathematics, 18(2):107–111, 2010. doi: 10.2478/v10037-010-0014-x.Cuiying Peng, Fuguo Ge, and Xiquan Liang. Several integrability formulas of special functions. Formalized Mathematics, 15(4):189–198, 2007. doi: 10.2478/v10037-007-0023-6.Konrad Raczkowski. Integer and rational exponents. Formalized Mathematics, 2(1):125–130, 1991.Konrad Raczkowski and Paweł Sadowski. Real function continuity. Formalized Mathematics, 1(4):787–791, 1990.Piotr Rudnicki and Andrzej Trybulec. Abian’s fixed point theorem. Formalized Mathematics, 6(3):335–338, 1997.Yasunari Shidama, Noboru Endou, and Katsumi Wasaki. Riemann indefinite integral of functions of real variable. Formalized Mathematics, 15(2):59–63, 2007. doi: 10.2478/v10037-007-0007-6.Andrzej Trybulec and Czesław Byliński. Some properties of real numbers. Formalized Mathematics, 1(3):445–449, 1990.Michał J. Trybulec. Integers. Formalized Mathematics, 1(3):501–505, 1990.Edmund Woronowicz. Relations and their basic properties. Formalized Mathematics, 1 (1):73–83, 1990.Yuguang Yang and Yasunari Shidama. Trigonometric functions and existence of circle ratio. Formalized Mathematics, 7(2):255–263, 1998.25214114

Przezcewnikowa implantacja zastawki aortalnej w leczeniu dysfunkcyjnych bioprotez chirurgicznych i przezcewnikowych. Opinia ekspertów Asocjacji Interwencji Sercowo-Naczyniowych Polskiego Towarzystwa Kardiologicznego

Ponad 15-letnie doświadczenie i wyniki dużych badań obserwacyjnych, na podstawie których tworzone są wytyczne, wskazują na bezpieczeństwo i skuteczność zabiegów przezcewnikowej implantacji „zastawki w zastawkę” (ViV-TAVI, valve-in-valve transcatheter aortic valve implantation), zmniejszając tym samym potrzebę reoperacji u pacjentów wysokiego ryzyka. Oczekuje się, że liczba zabiegów ViV-TAVI w Polsce, szacowana na około 2% wszystkich przezcewnikowej implantacji zastawki aortalnej w 2020 roku, będzie rosła. Niniejszy dokument ma na celu przegląd aspektów proceduralnych ViV-TAVI, w tym odpowiednich metod planowania przedzabiegowego, sposobów optymalizacji wyników hemodynamicznych i ograniczania ryzyka okluzji tętnic wieńcowych. Dokument zawiera również wstępny przegląd wskazań i wytycznych dotyczących ponownego zabiegu TAVI (re-do TAVI) u pacjentów ze zdegenerowanymi zastawkami przezcewnikowymi