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Conference proceedings ; Online: Market Launch and Regulative Assessment of ICT-Based Medical Devices

Piwowarczyk Vel Dabrowski, Maciej / Sandkuhl, Kurt

Case Study and Problem Definition

2022

Abstract: 304 ... 315 ... The market launch and regulative assessment of ICT-based medical devices in Europe is very complex due to a multitude of regulations to be considered during requirements engineering and product management. Additionally, there are no ... ...

Abstract	304 315 The market launch and regulative assessment of ICT-based medical devices in Europe is very complex due to a multitude of regulations to be considered during requirements engineering and product management. Additionally, there are no established standards, best practices or support tools how to launch medical devices on the market. The paper is part of a project aiming for methodical support for medical device launch and assessment, and is dedicated to investigating problem relevance. To understand the processes and requirements three case studies were analysed and the necessary processes and requirements were matched towards enterprise architectures (EA). Based on this finding, we argue that EA could be a suitable way to visualize and recommend required processes and structures for medical device management. The main contributions of our work are (a) a literature analysis of EA use in health care and especially for telemedicine, (b) results from use case analysis investigating the business perspective from inside three health tech companies and (c) the analysis of problems of telemedicine integration into EA.
Keywords	Assessment process ; Enterprise architecture ; Market launch ; Medical device ; DDC::600 Technik ; Medizin ; angewandte Wissenschaften::650 Management ; Öffentlichkeitsarbeit::658 Allgemeines Management
Subject code	650
Language	English
Publishing country	de
Document type	Conference proceedings ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Optical field tuning of localized plasmon modes in Ag microcrystals at the nanofemto scale.

Dai, Yanan / Dąbrowski, Maciej / Petek, Hrvoje

The Journal of chemical physics

2020 Volume 152, Issue 5, Page(s) 54201

Abstract: Nanoscale plasmonic field enhancement at sub-wavelength metallic particles is crucial for surface sensitive spectroscopy, ultrafast microscopy, and nanoscale energy transduction. Here, we demonstrate control of the spatial distribution of localized ... ...

Abstract	Nanoscale plasmonic field enhancement at sub-wavelength metallic particles is crucial for surface sensitive spectroscopy, ultrafast microscopy, and nanoscale energy transduction. Here, we demonstrate control of the spatial distribution of localized surface plasmon modes at sub-optical-wavelength crystalline silver (Ag) micropyramids grown on a Si(001) surface. We employ multiphoton photoemission electron microscopy (mP-PEEM) to image how the plasmonic field distributions vary with the photon energy, light polarization, and phase in coherent two-pulse excitation. For photon energy hυ > 2.0 eV, the mP-PEEM images show single photoemission locus, which splits into a dipolar pattern that straddles the Ag crystal at a lower energy. We attribute the variation to the migration of plasmon resonances from the Ag/vacuum to the Ag/Si interfaces by choice of the photon energy. Furthermore, the dipolar response of the Ag/Si interface follows the polarization state of light: for linearly polarized excitations, the plasmon dipole follows the in-plane electric field vector, while for circularly polarized excitations, it tilts in the direction of the handedness due to the conversion of spin angular momentum of light into orbital angular momentum of the plasmons excited in the sample. Finally, we show the coherent control of the spatial plasmon distribution by exciting the sample with two identical circularly polarized light pulses with delay defined with attosecond precision. The near field distribution wobbles at the pyramid base as the pump-probe delay is advanced due to interferences among the contributing fields. We illustrate how the frequency, polarization, and pulse structure can be used to design and control plasmon fields on the nanofemto scale for applications in chemistry and physics.
Language	English
Publishing date	2020-01-31
Publishing country	United States
Document type	Journal Article
ZDB-ID	3113-6
ISSN	1089-7690 ; 0021-9606
ISSN (online)	1089-7690
ISSN	0021-9606
DOI	10.1063/1.5139543
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Article ; Online: Properties of Non-Aminoglycoside Compounds Used to Stimulate Translational Readthrough of PTC Mutations in Primary Ciliary Dyskinesia.

Dabrowski, Maciej / Bukowy-Bieryllo, Zuzanna / Jackson, Claire L / Zietkiewicz, Ewa

International journal of molecular sciences

2021 Volume 22, Issue 9

Abstract: Primary ciliary dyskinesia (PCD) is a rare disease with autosomal recessive inheritance, caused mostly by bi-allelic gene mutations that impair motile cilia structure and function. Currently, there are no causal treatments for PCD. In many disease models, ...

Abstract	Primary ciliary dyskinesia (PCD) is a rare disease with autosomal recessive inheritance, caused mostly by bi-allelic gene mutations that impair motile cilia structure and function. Currently, there are no causal treatments for PCD. In many disease models, translational readthrough of premature termination codons (PTC-readthrough) induced by aminoglycosides has been proposed as an effective way of restoring functional protein expression and reducing disease symptoms. However, variable outcomes of pre-clinical trials and toxicity associated with long-term use of aminoglycosides prompt the search for other compounds that might overcome these problems. Because a high proportion of PCD-causing variants are nonsense mutations, readthrough therapies are an attractive option. We tested a group of chemical compounds with known PTC-readthrough potential (ataluren, azithromycin, tylosin, amlexanox, and the experimental compound TC007), collectively referred to as non-aminoglycosides (NAGs). We investigated their PTC-readthrough efficiency in six PTC mutations found in Polish PCD patients, in the context of cell and cilia health, and in comparison to the previously tested aminoglycosides. The NAGs did not compromise the viability of the primary nasal respiratory epithelial cells, and the ciliary beat frequency was retained, similar to what was observed for gentamicin. In HEK293 cells transfected with six PTC-containing inserts, the tested compounds stimulated PTC-readthrough but with lower efficiency than aminoglycosides. The study allowed us to select compounds with minimal negative impact on cell viability and function but still the potential to induce PTC-readthrough.
MeSH term(s)	Aminoglycosides/pharmacology ; Cell Death/drug effects ; Cells, Cultured ; Cilia/drug effects ; Cilia/metabolism ; Ciliary Motility Disorders/genetics ; Codon, Nonsense/genetics ; Epithelial Cells/drug effects ; Epithelial Cells/metabolism ; HEK293 Cells ; Humans ; Mutation/genetics ; Nose/pathology ; Protein Biosynthesis/drug effects ; Protein Biosynthesis/genetics
Chemical Substances	Aminoglycosides ; Codon, Nonsense
Language	English
Publishing date	2021-05-07
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms22094923
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Sudden Cardiac Death Risk over Time in HCM Patients with Implantable Cardioverter-Defibrillator.

Klopotowski, Mariusz / Kukula, Krzysztof / Jamiolkowski, Jacek / Oreziak, Artur / Dabrowski, Maciej / Chmielak, Zbigniew / Witkowski, Adam

Journal of clinical medicine

2022 Volume 11, Issue 6

Abstract: Background: In patients with HCM at high risk of SCD, an ICD should be considered as a standard of care. Current risk approximation algorithms recommended by ESC 2014 criteria indicate that SCD risk is not stable. The aim of the study was to investigate ... ...

Abstract	Background: In patients with HCM at high risk of SCD, an ICD should be considered as a standard of care. Current risk approximation algorithms recommended by ESC 2014 criteria indicate that SCD risk is not stable. The aim of the study was to investigate how the calculated SCD risk in HCM patients with an ICD implanted in the past changed over time. Methods: We analyzed 64 HCM patients with ICD for primary prevention, referred for ICD re-implantation, and 32 HCM patients referred for a first-time ICD placement during the same period. The 5-year-SCD risk was assessed for suitable patients using the recommended ESC calculator. Results: The first-time group had a higher 5-year-SCD risk than those referred for ICD re-implantation: 7.50 (IQR 5.98−10.46) vs. 4.88 (IQR 3.42−7.25), p < 0.05. Out of the patients with an initial calculated risk below 4%, the risk increased in 22% of cases, reaching the 4−6% range. In 78% of patients, the risk remained stable and low. In 31% of patients with an initial calculated SCD risk ≥ 6%, the risk decreased over time to below 6%, and in 14% of the cases, below 4%. Conclusions: SCD risk in HCM patients is usually stable or gets lower. Our data suggest it is important to re-evaluate the risk profile for patients with HCM when ICD re-implantation is considered.
Language	English
Publishing date	2022-03-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm11061633
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Article ; Online: Intravascular Ultrasound for Valve-in-Valve Guidance During Repeat Transcatheter Aortic Valve Replacement.

Kalińczuk, Łukasz / Mintz, Gary S / Zieliński, Kamil / Dąbrowski, Maciej / Witkowski, Adam

JACC. Cardiovascular interventions

2022 Volume 15, Issue 6, Page(s) e61–e62

MeSH term(s)	Aortic Valve/diagnostic imaging ; Aortic Valve/surgery ; Aortic Valve Stenosis/diagnostic imaging ; Aortic Valve Stenosis/surgery ; Heart Valve Prosthesis ; Humans ; Transcatheter Aortic Valve Replacement/adverse effects ; Treatment Outcome ; Ultrasonography, Interventional
Language	English
Publishing date	2022-02-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2021.12.040
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Article: Assessment of consistency in aortic valve sizing between surgical and transcatheter aortic valve replacement.

Jastrzebski, Jan / Dąbrowski, Maciej / Kuśmierski, Krzysztof / Kępka, Cezary / Mioduszewska, Aleksandra / Chmielak, Zbigniew / Witkowski, Adam / Kądziela, Jacek

Postepy w kardiologii interwencyjnej = Advances in interventional cardiology

2023 Volume 19, Issue 1, Page(s) 40–46

Abstract: Introduction: One of the crucial aspects of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) is the valve prosthesis selection.: Aim: To assess the consistency of the aortic valve sizing in SAVR and TAVR by ... ...

Abstract	Introduction: One of the crucial aspects of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) is the valve prosthesis selection. Aim: To assess the consistency of the aortic valve sizing in SAVR and TAVR by comparing the sizes of aortic prostheses selected based on the intraprocedural annulus measurements and simulation of the TAVR planning. Material and methods: The study comprised of 167 patients with aortic stenosis treated with SAVR. Simulation of the prosthesis sizing blinded to the SAVR results was performed based on the assessment of cardiac computed tomography (CCT) images. Results: Based on the CCT images, the average value of the aortic annulus diameter was 25.4 ±3.0 mm. Aortic valve calcifications were mild in 29 cases, moderate in 78 cases, and severe in 53 cases. The sizes of the valves recommended by the simulations were larger than valves surgically implanted in 98.6% of patients for self-expanding and in 91.7% of patients for balloon-expandable prostheses. The average difference for self-expanding prostheses was 6.4 mm and 4.5 mm for balloon expandable valves. Additionally, a negative correlation was observed for the difference in prosthesis size and size of the valve used by surgeons. Conclusions: There is a systematic difference between sizes of aortic prostheses used in SAVR and TAVR. Further studies are needed to evaluate if the difference in prosthesis size selection contributes to the frequency of prosthesis-patient mismatch phenomenon and burden of high postoperative mean transaortic gradient.
Language	English
Publishing date	2023-02-16
Publishing country	Poland
Document type	Journal Article
ISSN	1734-9338
ISSN	1734-9338
DOI	10.5114/aic.2023.125154
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Article: Objective, observer-independent evaluation of myocardial perfusion and function: role of SPECT.

Szot, Wojciech / Kwiecień, Ewa / Tekieli, Łukasz / Czyż, Łukasz / Borkowska, Eliza / Dąbrowski, Władysław / Drabik, Leszek / Dąbrowski, Maciej / Kostkiewicz, Magdalena / Musiałek, Piotr

Postepy w kardiologii interwencyjnej = Advances in interventional cardiology

2023 Volume 18, Issue 4, Page(s) 366–372

Abstract: The number of patients with coronary artery disease and ischaemic heart failure - and those with terminal heart failure - is increasing despite improvements in medical and interventional therapies of ischaemic heart disease - and, over the next decades, ... ...

Abstract	The number of patients with coronary artery disease and ischaemic heart failure - and those with terminal heart failure - is increasing despite improvements in medical and interventional therapies of ischaemic heart disease - and, over the next decades, it is projected to continue to increase further. Observer-independent, reproducible imaging techniques play a fundamental role in objective evaluation of both conventional (such as surgical or percutaneous) myocardial revascularization and novel therapeutic approaches to reduce myocardial ischaemia, improve contractility and prevent adverse myocardial remodelling. To be applicable to clinical practice, the clinical study design and data should best be rooted in everyday clinical practice. Accurate and reproducible assessment of left ventricular ejection fraction, left ventricular volumes, myocardial perfusion and function is one of the most important objectives of cardiac imaging. Current techniques used both in clinical studies and in everyday clinical practice include 2- and 3-dimensional echocardiography, magnetic resonance imaging, single-photon emission computed tomography and positron emission tomography; each of these has its strengths and limitations. We review present evidence on the role of single-photon emission computed tomography as a technique that may offer, through being observer-independent, the most objective evaluation of evolution of left ventricular perfusion, volumes and ejection fraction.
Language	English
Publishing date	2023-01-11
Publishing country	Poland
Document type	Journal Article ; Review
ISSN	1734-9338
ISSN	1734-9338
DOI	10.5114/aic.2023.124045
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Article ; Online: Intravascular Ultrasound for Valve Expansion, Orifice Dimension, and Paravalvular Leak During Transcatheter Aortic Valve Replacement.

Kalińczuk, Łukasz / Skotarczak, Wiktor / Chmielak, Zbigniew / Dąbrowski, Maciej / Stokłosa, Patrycjusz / Michałowska, Ilona / Sondergaard, Lars / Witkowski, Adam / Mintz, Gary S

JACC. Cardiovascular interventions

2023 Volume 17, Issue 1, Page(s) 111–113

MeSH term(s)	Humans ; Transcatheter Aortic Valve Replacement/adverse effects ; Transcatheter Aortic Valve Replacement/methods ; Treatment Outcome ; Aortic Valve/diagnostic imaging ; Aortic Valve/surgery ; Aortic Valve Stenosis/diagnostic imaging ; Aortic Valve Stenosis/surgery ; Ultrasonography, Interventional ; Heart Valve Prosthesis ; Aortic Valve Insufficiency/diagnostic imaging ; Aortic Valve Insufficiency/etiology ; Aortic Valve Insufficiency/surgery
Language	English
Publishing date	2023-12-06
Publishing country	United States
Document type	Letter
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2023.10.039
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Article ; Online: Coronary anomalies in patients with acquired significant aortic stenosis.

Kołsut, Piotr / Tyczyński, Paweł / Michałowska, Ilona / Leśnowolski, Łukasz / Gruczek, Justyna / Stokłosa, Patrycjusz / Zieliński, Dariusz / Litwiński, Paweł / Dębski, Artur / Dąbrowski, Maciej / Witkowski, Adam / Kuśmierczyk, Mariusz

Kardiologia polska

2024

Language	English
Publishing date	2024-02-20
Publishing country	Poland
Document type	Journal Article
ZDB-ID	411492-9
ISSN	1897-4279 ; 0022-9032
ISSN (online)	1897-4279
ISSN	0022-9032
DOI	10.33963/v.phj.99271
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Article ; Online: Transcatheter Intervention for Inoperable Tricuspid Surgical Prosthesis Dysfunction: Minimally Invasive Approach to Mitigate Heart Failure.

Rudziński, Piotr Nikodem / Henzel, Jan / Witkowski, Adam / Dąbrowski, Maciej / Huczek, Zenon / Wojakowski, Wojciech / Targoński, Radosław / Jagielak, Dariusz / Kralisz, Paweł / Demkow, Marcin

The American journal of cardiology

2024 Volume 217, Page(s) 25–28

Abstract: What is the efficacy and safety of transcatheter tricuspid valve-in-valve implantation for patients with inoperable tricuspid surgical prosthesis dysfunction? Thirty-day mortality after greatly effective transcatheter treatment is 2 times less than the ... ...

Abstract	What is the efficacy and safety of transcatheter tricuspid valve-in-valve implantation for patients with inoperable tricuspid surgical prosthesis dysfunction? Thirty-day mortality after greatly effective transcatheter treatment is 2 times less than the estimated surgical risk.
MeSH term(s)	Humans ; Heart Valve Prosthesis Implantation ; Heart Valve Prosthesis ; Prosthesis Failure ; Tricuspid Valve/surgery ; Tricuspid Valve Insufficiency ; Treatment Outcome ; Cardiac Catheterization ; Prosthesis Design ; Heart Failure/surgery
Language	English
Publishing date	2024-03-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	80014-4
ISSN	1879-1913 ; 0002-9149
ISSN (online)	1879-1913
ISSN	0002-9149
DOI	10.1016/j.amjcard.2024.02.037
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