Core Facilities (IDUB):

Core Facility: Interventional Cardiology

CLinical EVidencE-based Research in HEART and Vascular Medicine

(CLEVERHEART) University Interventional Core Laboratories, Gdansk, POLAND

#CleverHeartNetwork – Actionable Understanding for Better Value in Heart and Vascular Medicine

ABOUT US

CLEVERHEART University Interventional Core Laboratories will be a unique center on a European scale conducting research on optimization and development of novel therapies in invasive cardiology, with fields of activity including:

– full range of coronary artery revascularisation using state-of-the-art intravascular imaging techniques,

– percutaneous diagnosis and treatment of structural heart diseases, including heart failure,

– (functional assessment of changes in coronary vessels and microcirculation.

The centre will be established on the basis of the long-term experience of the team working at the 1st Chair and Department of Cardiology of the University Clinical Centre of the Medical University of Gdańsk, a multi-profile clinical hospital that provides comprehensive specialist interdisciplinary care. Additionally, through close collaboration with the newly established Centre for Translational Medicine (CMT), domain-specific theoretical and scientific support, the use of artificial intelligence in the automatic interpretation of intravascular imaging, and the ability to correlate novel interventional strategies and metabolomic methods, a unique centre for individual therapy for patients with cardiovascular disease would be created. A detailed assessment of the anatomy and physiology of the coronary circulation will enable the development of both the optimal strategy of interventional and pharmacological treatment. The University Interventional Core Laboratories will work closely with the newly established the Biostatistics and Bioinformatics Core Facility.

Infrastructure intended for the establishment of the centre, with relatively small additional financial outlays will ensure access to diagnostics and therapy of cardiovascular diseases at the highest world level. The implementation involves adapting the premises (650 sq. m., Operating Theatre Cardiac Surgery/Vascular Surgery/Cardiothoracic Surgery) in order to:

– create a hybrid treatment room allowing the fusion of X-ray and tomographic imaging as well as structural and functional assessment methods,

– upgrade rooms for patients who take part in the trial to ensure the highest quality of perioperative care,

– the creation of a professional base for researchers to carry out scientific work, participate in project meetings, carry out administration, plan and analyse performed treatments.

Infrastructure will also be installed to enable 24-hour hemodynamic monitoring of patients during and after surgery and archiving perioperative data. To enable the training of investigators, a transmission facility from the treatment room will be created. In terms of infrastructure, the Base will be partly supported by the newly established Clinical Research Support Centre (CWBK). CLEVERHEART Interventional Core Laboratories will operate within IDUB (Excellence Initiative – Research University), in the Priority Research Areas (POB 2).

Planned purchase of additional equipment for the hybrid treatment room includes:

– innovative integrated intravascular imaging system that uses optical coherence tomography (OCT) and measurement of fractional flow reserve (FFR) after adenosine administration Optis I,

– CoroFlow integrated functional assessment system for lesions in coronary arteries and coronary microcirculation,

– software capable of assessing stenosis significance based on 3D quantitative coronary angiography images, an HD camera system capable of performing live procedures during scientific and training conferences conducted as part of the activities by CLEVERHEART Interventional Core Laboratories.

Aforementioned equipment will significantly increase the precision of performed procedures through the possibility of integrated analysis of stenosis and functional evaluation of coronary artery disease, assessment of coronary microcirculation and the possibility of high-resolution stent visualization that offers co-registration of X-ray and tomographic images and high-resolution 3D imaging (DynaCT Micro).

Integration of complementary imaging modalities using intravascular ultrasound (IVUS), OCT, FFR measurement and invasive microcirculation assessment will enable in-depth analysis of atherosclerotic plaque morphology, functional significance of epicardial coronary stenosis and small vessel dysfunction, invisible in standard X-ray imaging, the so-called coronary catheterization. OCT is also an established tool for optimizing percutaneous coronary intervention (PCI) and stent implantation.

System for integrated functional assessment of lesions in coronary arteries and coronary microcirculation (Coroventis CoroFlow ™, Sweden) enables FFR or instantaneous wave-free ratio (iFR), index of microcirculatory resistance (IMR), coronary flow reserve (CFR) and resistive reserve ratio (RRR), as well as an assessment of myocardial diastolic function based on relaxation time and end-diastolic pressure. Integration of data obtained from these methods will optimize the diagnosis of cardiovascular diseases, and a significant increase in therapeutic precision will not only enable the identification of patients at high risk of a coronary incident, improving significantly the prognosis.

An additional research goal of the works conducted in collaboration with recognized experts in the field of invasive cardiology is to create algorithms for the automatic detection of lesions in the highest risk coronary vessels in intravascular imaging. The fusion of angiographic and echocardiographic images will enable international research on the diagnosis and treatment of structural heart diseases, enable the creation of algorithms to support decision-making during treatment of structural heart defects using artificial intelligence, enable improvement of risk stratification strategies in patients undergoing percutaneous interventions on the heart valves, such as transcatheter aortic valve implantation (TAVI) or percutaneous mitral valve regurgitation treatment using the MitraClip system.

In terms of research and development, the team, in collaboration with Polimed, is currently participating in creating a permanent implant to connect the atria of the heart to improve symptoms of heart failure, exercise tolerance, reduce dyspnoea, optimize the quality of patients’ life, and thereby reduce the need for hospitalization. The potentially marketed new medical device – a state-of-the-art, flow-modulated atrial implant – is therefore intended for the treatment of patients diagnosed with heart failure, in particular those at an advanced stage of the disease, preventing them from normal functioning.

As far as microcirculation assessment is concerned, projects that use the Coroventis CoroFlow™ system are planned, including multicentre, randomized, double-blind, placebo-controlled trials to prove the superiority of a novel therapeutic strategy for patients with angina pectoris without significant coronary artery disease compared to the current treatment recommended in the guidelines of the European Society of Cardiology. Planned research will be conducted in cooperation with recognized experts in the field of invasive and experimental cardiology, including Prof. Juan Luis Gutierrez-Chico (Spain), Prof. Thomas Luescher (UK), Prof. Christian Templin (Switzerland), Prof. Salvatore Brugaletta (Spain), Prof. Patrick Serruys (UK), Rienk Nieuwland, PhD (The Netherlands), Prof. Jolanta Siller-Matula (Austria), Prof. Tomasz Smoleński (Poland), Prof. Shmuel Banai (Israel), Prof. Amir Lerman (USA), Prof. Richard Heuser (USA), Prof. Dagmara Hering (Poland), Prof. Łukasz Szarpak (Poland).

OUR MISSION

CLEVERHEART Interventional Core Laboratories will become a unique, full-service research and development centre offering an attractive workplace for scientists, presenting itself as a partner for scientific and implementation projects for foreign centres and equipment companies planning to design, patent and evaluate the safety and efficacy of new diagnostic and therapeutic technologies in cardiology.

Relevance to innovation and economic development. Potential of the centre

Cardiovascular diseases account for more than 30% of deaths each year, one third of which occur prematurely, i.e. in people under 70 years of age. Heart failure is the leading cause of repetitive and prolonged hospitalizations in patients over 65 years of age. The results of the planned research aim to develop new and improve and optimize the current interventional cardiology procedures for the treatment of acquired and congenital structural heart diseases, fulfilling one of the main objectives of the National Health Programme, which include the promotion of healthy and active ageing. In 2018, ~100,000 coronary angioplasties, ~1100 TAVI procedures and ~150 percutaneous mitral and tricuspid regurgitation repair procedures using the MitraClip system were performed in Poland. FFR stenosis assessment was performed in ~10,000 patients, IVUS in ~3,600, and OCT in ~380 (source: report of the Association of Cardiovascular Interventions of the Polish Cardiac Society).

Currently, the team of the Invasive Cardiology Laboratory, which is the core of planned CLEVERHEART Interventional Core Laboratories, has experience in both coronary and structural procedures; the center performs approximately 2,000 percutaneous coronary interventions (PCI), 3,500 coronary catheterizations, 100 TAVI procedures, 10 MitraClip implantations, 40 left atrial appendage closures per year. Number of procedures performed in the 1st Cardiology Department of the University Clinical Centre puts the center at the forefront of scientific and research institutions in Poland.

As cardiovascular diseases generate substantial costs due to recurrent symptoms which impair quality of life, require regular inpatient or outpatient care, leading to loss of patients’ professional productivity. The development of new solutions for the diagnosis and comprehensive treatment of these patients will enable a real reduction in premature mortality due to cardiovascular disease, enabling full recovery, improvement in health status and enhancing quality of life of Polish population, which will translate into real savings for the Polish economy, at a relatively low cost.

RESEARCH PROFILE

The planned research infrastructure supported by the experience of the team of the 1st Cardiology Department, the Invasive Cardiology Laboratory and an international panel of experts cooperating with the clinic so far within the framework of scientific projects will make it possible to conduct commercial and non-commercial research programmes of international and domestic companies that create new therapeutic devices.

Scientific and clinical capabilities of CLEVERHEART Interventional Core Laboratories, which include:

1. the infrastructure offered to be used in the project,

2. a team of cardiologists under the supervision of:

• Dariusz Ciećwierz, Ph.D., the pioneer of invasive cardiology in northern Poland,
• Prof. Miłosz Jaguszewski, the author of over 180 scientific publications in cardiology (IF 825, iH 25);
• Prof. Łukasz Szarpak (Warsaw, visiting professor), the expert in emergency and acute cardiology
• Prof. Marcin Gruchała, Head of the 1st Chair and Department of Cardiology, the expert in heart failure;
• Prof. Marcin Fijałkowski, the expert in cardiovascular imaging
• Prof. Tomasz Smoleński, the expert in experimental cardiology
• Prof. Paul Grundeman (Utrecht, visiting professor), the expert in experimental cardiac surgery,

3. cooperation with CMT, structures of the largest clinical hospital of the University Clinical Centre, Gdańsk University of Technology and equipment companies, will allow us to achieve the intended goal of building a leading research and development centre in Europe, which will simultaneously conduct over a dozen research and implementation projects annually.

Works at CLEVERHEART University Interventional Core Laboratories will be led by the CardioResearch Group team created in 2020 at the 1st Department of Cardiology. The team aims to conduct conceptual work (scientific and implementation projects) and clinical research with a focus on non-commercial clinical trials.

SCIENTIFIC COOPERATION

The team is currently involved in following non-commercial clinical trials:

1. ADONIS-PCI (Prospective, randomized, open-label, non-inferiority trial that evaluates the safety and efficacy of dual anticoagulation therapy with dabigatran and ticagrelor in patients with acute coronary syndrome and non-valvular atrial fibrillation undergoing percutaneous coronary intervention) – Prof. Miłosz Jaguszewski, Natasza Gilis-Malinowska PhD, Tomasz Figatowski, MD. The trial is developed by the team from the 1st Department of Cardiology, University Clinical Centre, funded by a grant from the Medical Research Agency (ABM);

2. ELECTRA SIRO 2 (Evaluation of safety and efficacy of two antiplatelet de-escalation strategies based on ticagrelor in acute coronary syndrome: a randomized, multicentre, double-blind ELECTRA RCT) – Prof. Miłosz Jaguszewski, Agnieszka Mickiewicz Ph.D., Marta Marcinkowska M.D.;

3. EMPATHY [randomized, double-blind, placebo-controlled trial in a population of patients with acute heart failure to compare the prognostic impact of two antidiabetic drugs from the SGLT-2 inhibitor group (dapagliflozin and empagliflozin) and placebo] – Prof. Miłosz Jaguszewski, Joanna Marlęga Ph.D.;

4. HEMOFLOW [Evaluation of the diagnostic accuracy, safety, and cost-effectiveness of the noninvasive iSIL-FFR (in SILico FFR) method to measure the fractional flow reserve in diagnostics of chronic coronary syndromes vs standard diagnostic modalities] – Prof. Miłosz Jaguszewski, Grzegorz Żuk Ph.D., Tomasz Figatowski M.D., Tomasz Michalski M.D.;

5. LEIA-HF (A multicentre, randomized, double-blind, placebo-controlled study to evaluate the efficacy of repeated infusions of levosimendan in out-patients with advanced systolic heart failure) – Prof. Miłosz Jaguszewski, Michał Bohdan Ph.D.;

6. MULTISTARS AMI (Comparison of two treatment strategies: Immediate treatment of the infarct vessel immediately followed by treatment of other significantly narrowed coronary vessels or immediate treatment of the infarct vessel and treatment of other significantly narrowed coronary vessels within the next 3-6 weeks in patients with acute myocardial infarction) – Prof. Miłosz Jaguszewski, who is the Principal Investigator for Poland, Justyna Borowiec M.D., Tomasz Figatowski M.D., Tomasz Michalski M.D.

Planned clinical projects

Apart from the above, a grant application to ABM is being prepared to obtain funding for the LevoTako Study (Effect of levosimendan on adverse events in patients with low left ventricular ejection fraction suffering from Takotsubo syndrome: a randomized, double-blind, placebo-controlled trial) developed by Prof. Miłosz Jaguszewski, Aleksandra Gąsecka Ph.D., Alicja Genc M.D., and Piotr Kasprzyk M.D. (non-commercial clinical trial). The trial will be carried out by scientists from our centre – Radosław Nowak PhD, Iwona Stopczyńska M.D., and Prof. Marcin Fijałkowski.

Conceptual, scientific and implementation work

Our team’s area of interest also includes preclinical research and the search for new medical technologies with the potential to enter routine clinical practice. One such project is led by Prof. Miłosz Jaguszewski, Tomasz Figatowski M.D., and Tomasz Michalski M.D., under the name CLEVERSTENT Project, which involves the creation of a new drug-eluting stent (DES) covered with an additional layer of silver nanoparticles and recombinant tissue plasminogen activator (rt-PA). The main assumption of this concept is to obtain a DES with anti-inflammatory properties within the coronary vessel wall, which in addition to inhibiting the phenomenon of restenosis itself, will enable causal treatment of the process leading to development of atherosclerotic lesions within it. In addition, by topical application of rt-PA, we will achieve a reduction in the duration of antiplatelet therapy. This is particularly beneficial for patients at high risk of bleeding for whom at the present, there is no optimal solution that provides a high safety and efficacy profile for the prevention of recurrent stenosis.

Another project is to develop a new version of the device that provides a permanent atrial communication (VarioFlow) to improve symptoms and prognosis in patients with advanced heart failure.

International network for scientific cooperation

Another important project is the CLEVERHEART Network being developed by Prof. Miłosz Jaguszewski, Prof. Łukasz Szarpak (Warsaw), Aleksandra Gąsecka Ph.D. (Warsaw), Natasza Gilis-Malinowska Ph.D. and Karolina Mosakowska (Co-Founders). The aim of the initiative is to accelerate the exchange of knowledge in the area of cardiovascular diseases between basic and clinical scientists, as well as between individual research centres. This collaboration will ultimately result in a personalized approach to the cardiac patient through the organization of non-commercial clinical trials and conceptual work in the field of cardiovascular diseases.

Scientific achievements of the CardioResearchGroup

Since its inception in 2020, CardioResearchGroup team members have published extensively in peer-reviewed scientific journals including Q1 journals such as European Heart Journal (IF: 22,673) and Journal of American College of Cardiology (IF: 20.589).

OUR PUBLICATIONS

Year 2021

1. Al-Jeabory M, Gasecka A, Wieczorek W, Mayer-Szary J, Jaguszewski MJ, Szarpak L. Efficacy and safety of tranexamic acid in pediatric trauma patients: Evidence from meta-analysis. Am J Emerg Med. 2021 Feb 8:S0735-6757(21)00115-7. doi: 10.1016/j.ajem.2021.02.009.

2. Borghi C, Domienik-Karłowicz J, Tykarski A, Widecka K, Filipiak KJ, Jaguszewski MJ, Narkiewicz K, Mancia G. Expert consensus for the diagnosis and treatment of patient with hyperuricemia and high cardiovascular risk: 2021 update. Cardiol J. 2021;28(1):1-14. doi: 10.5603/CJ.a2021.0001.

3. Borkowska MJ, Smereka J, Safiejko K, Nadolny K, Maslanka M, Filipiak KJ, Jaguszewski MJ, Szarpak L. Out-of-hospital cardiac arrest treated by emergency medical service teams during COVID-19 pandemic: A retrospective cohort study. Cardiol J. 2021;28(1):15-22. doi: 10.5603/CJ.a2020.0135.

4. Drozd A, Smereka J, Filipiak KJ, Jaguszewski MJ, Ładny JR, Bielski K, Nadolny K, Ruetzler K, Szarpak Ł. Intraosseous versus intravenous access while wearing personal protective equipment: a meta-analysis in the era of COVID-19.:”https://pubmed.ncbi.nlm.nih.gov/33415967/” Kardiol Pol. 2021 Jan 7. doi: 10.33963/KP.15741

5. Gasecka A, Pruc M, Kukula K, Gilis-Malinowska N, Filipiak KJ, Jaguszewski MJ, Szarpak L. Post-COVID-19 heart syndrome. Cardiol J. 2021 Mar 1. doi: 10.5603/CJ.a2021.0028.

6. Gąsecka A, Pluta K, Solarska K, Rydz B, Eyileten C, Postula M, van der Pol E, Nieuwland R, Budnik M, Kochanowski J, Jaguszewski MJ, Szarpak Ł, Mazurek T, Kapłon-Cieślicka A, Opolski G, Filipiak KJ. Plasma Concentrations of Extracellular Vesicles Are Decreased in Patients with Post-Infarct Cardiac Remodelling. Biology (Basel). 2021 Jan 30;10(2):97. doi: 10.3390/biology10020097.

7. Jaguszewski MJ, Gasecka A, Filipiak KJ, Szarpak L. Levosimendan or dobutamine in patients with low cardiac output syndrome: Results from meta-analysis. Int J Cardiol. 2021 Feb 24:S0167527300359-4. doi: 10.1016/j.ijcard.2021.02.050.

8. Jaguszewski MJ, Szarpak L, Filipiak KJ. Impact of COVID-19 pandemic on out-of-hospital cardiac arrest survival rate. Resuscitation. 2021 Feb;159:40-41. doi: 10.1016/j.resuscitation.2020.12.013.

9. Kato K, Cammann VL, Napp LC, Szawan KA, Micek J, Dreiding S, Levinson RA, Petkova V, Würdinger M, Patrascu A, Sumalinog R, Gili S, Clarenbach CF, Kohler M, Wischnewsky M, Citro R, Vecchione C, Bossone E, Neuhaus M, Franke J, Meder B, Jaguszewski MJ, Noutsias M, Knorr M, Heiner S, D’Ascenzo F, Dichtl W, Burgdorf C, Kherad B, Tschöpe C, Sarcon A, Shinbane J, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Koenig W, Pott A, Meyer P, Roffi M, Banning A, Wolfrum M, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Budnik M, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Chan C, Bridgman P, Beug D, Delmas C, Lairez O, Gilyarova E, Shilova A, Gilyarov M, El-Battrawy I, Akin I, Kozel M, Tousek P, Winchester DE, Galuszka J, Ukena C, Poglajen G, Carrilho-Ferreira P, Hauck C, Paolini C, Bilato C, Sano M, Ishibashi I, Takahara M, Himi T, Kobayashi Y, Prasad A, Rihal CS, Liu K, Schulze PC, Bianco M, Jörg L, Rickli H, Pestana G, Nguyen TH, Böhm M, Maier LS, Pinto FJ, Widimský P, Felix SB, Opolski G, Braun-Dullaeus RC, Rottbauer W, Hasenfuß G, Pieske BM, Schunkert H, Borggrefe M, Thiele H, Bauersachs J, Katus HA, Horowitz JD, Di Mario C, Münzel T, Crea F, Bax JJ, Lüscher TF, Ruschitzka F, Ghadri JR, Templin C. Prognostic impact of acute pulmonary triggers in patients with takotsubo syndrome: new insights from the International Takotsubo Registry. ESC Heart Fail. 2021 Mar 13. doi: 10.1002/ehf2.13165.

10. Kosmalska K, Rzyman M, Miękus P, Gilis-Malinowska N, Nowak R, Fijałkowski M. Usefulness of transesophageal echocardiography before cardioversion in atrial arrhythmias. Cardiol J. 2021;28(1):101-109. doi: 10.5603/CJ.a2019.0056.

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CONTACT

• Prof. Dr. Habil. Miłosz Jaguszewski
  1st Department of Cardiology
  Medical University of Gdańsk
  Phone.: 58 349 2504
  milosz.jaguszewski@gumed.edu.pl

• Karolina Mosakowska
  1st Department of Cardiology
  Medical University of Gdańsk
  Phone.: 58 349 2504
  mossmosakowska@gumed.edu.pl

photo Paweł Sudara/MUG