An Observational, Prospective, Non-randomized Multi-centre Cohort Feasibility Study of the Hypotension Prediction Index (HPI) in Patients Undergoing Lung Resections With the Use of One-lung Ventilation.

Perioperative hypotension is a risk factor for perioperative complications. Advances in machine learning and artificial intelligence have produced an algorithm that predicts the occurrence of hypotension episodes by analyzing an arterial pressure waveform. This technology has not been validated in thoracic surgical patients undergoing lung resections with the use of one-lung ventilation (OLV). We planned an observational, prospective multi-centre cohort validation study of the Hypotension Prediction Index (HPI) in patients undergoing lung resection procedures with the use of one-lung ventilation and a lung-protective strategy.

开始日期2023-11-11

申办/合作机构

John Paul II Hospital, Krakow

NCT06345235 / RecruitingN/AIIT

Assessment of the Association of New Biomarkers (GDF15, ST2, Galectin-3, TIMP-1, MMP-9, NfL) and Plasma Prothrombotic Potential in the Course of Cardiac Transthyretin Amyloidosis

The development of cardiac amyloidosis is caused by the deposition of misfolded, insoluble proteins in the extracellular matrix of tissues. An important element of the clinical picture of the disease is the increased risk of thromboembolic complications, independent of the occurrence of atrial fibrillation, and the presence of intracardiac thrombi. The pathomechanism may be related to an increase in filling pressure or amyloid infiltration leading to myocardial damage and endothelial dysfunction, which may activate the prothrombotic inflammatory cascade, resulting in increased thrombogenic potential. Currently, there is limited published data on the potential role of new heart failure biomarkers in the assessment of ATTR cardiomyopathy, particularly in the assessment of asymptomatic carriers of pathogenic TTR variants. Moreover, there are few literature reports on the direct assessment of the coagulation system in this group of patients, and the pathomechanism of the increased thromboembolic risk is unexplored.
Purpose of the study: To assess the diagnostic value of biomarkers related to heart failure (growth differentiation factor-15 (GDF15), soluble suppression of tumorigenicity-2 (ST2), galectin-3), amyloidosis ( TTR, tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9, matrix metalloproteinase-9), neurofilament light chain (NfL)) and the generation potential thrombin as a marker of the prothrombotic state in the course of ATTR.
Methods: This prospective, single-center study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3 , n=20). Material for research was collected and secured from all study participants. After giving informed consent, all patients will be tested using the ELISA method from peripheral blood (enzyme-linked immunosorbent assay) GDF15, ST2, TTR, TIMP-1, MMP-9, galectin-3, NfL. The values of these biomarkers will be compared in subgroups and correlated with clinical data, laboratory test results, echocardiography including analysis of left ventricular global strain (GLS), and scintigraphy. Additionally, the prothrombotic potential of plasma will be tested in both groups of patients using the calibrated automatic thrombogram (CAT) method, in accordance with the protocol previously used in the laboratory Expected results: The project will provide information on the value of biomarkers in the assessment of ATTR cardiomyopathy, especially in the assessment of asymptomatic carriers of pathogenic TTR variants, which may translate into the creation of a diagnostic algorithm for early identification of the development of the disease. Moreover, it will allow us to determine whether patients with cardiac ATTR are characterized by a prothrombotic state, which has not yet been described in the literature and may have potential clinical implications.

开始日期2023-07-11

申办/合作机构

John Paul II Hospital, Krakow

EUCTR2020-005302-26-PL / Unknown status临床3期IIT

The effect of sacubitril/valsartan versus ramipril on left ventricular function and remodeling in patients with ischemic heart failure with mid-range ejection fraction - CRACOVIA-HF

开始日期2023-01-05

申办/合作机构

John Paul II Hospital, Krakow

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2024-12-01·International Journal of Cardiology

The [99mTc]Tc-HMPAO-labelled white blood cell SPECT/CT as a novel criterion for infective endocarditis diagnosis

Article

作者: Rubiś, Paweł ; Holcman, Katarzyna ; Podolec, Piotr ; Ząbek, Andrzej ; Stępień, Agnieszka ; Szot, Wojciech ; Ćmiel, Bogdan ; Kostkiewicz, Magdalena ; Graczyk, Katarzyna ; Boczar, Krzysztof

AIMSInfective endocarditis (IE) poses a significant clinical challenge, necessitating nuanced diagnostic tools for early and accurate detection. The diagnostic role of the hybrid technique of single-photon emission tomography-computed tomography with technetium-99 m-hexamethylpropyleneamine oxime-labelled leukocytes ([^99mTc]Tc-HMPAO-SPECT/CT) has evolved in recent years. This single-center study assessed whether the recent inclusion in the 2023 European Society of Cardiology modified diagnostic criteria of IE (2023 ESC) of infectious lesions detected with [^99mTc]Tc-HMPAO-SPECT/CT affects their diagnostic performance.METHODS AND RESULTSBetween 2015 and 2019, we enrolled 205 consecutive adults with suspected IE. All participants underwent [^99mTc]Tc-HMPAO-SPECT/CT scans (370-740 MBq). Scans were deemed positive in the presence of intracardiac abnormal tracer uptake and/or within the cardiac implantable electronic device. Patients were prospectively followed-up for 12 ± 10 months. Local device infection (LDI) or IE was diagnosed in 75 (36.6 %) patients, while 72 (35.1 %) [^99mTc]Tc-HMPAO-SPECT/CT results returned positive. Moreover, extracardiac infectious foci were detected in 25 % of [^99mTc]Tc-HMPAO-SPECT/CT scans. The inclusion of both intracardiac and extracardiac lesions detected with [^99mTc]Tc-HMPAO-SPECT/CT yields significantly higher sensitivity (p = 0.003) and negative predictive value (NPV) (p = 0.009).CONCLUSIONThe inclusion of [^99mTc]Tc-HMPAO-SPECT/CT into the IE diagnostic work-up improves the appropriate classification of patients. For patients with IE, the extended inclusion of lesions detected with [^99mTc]Tc-HMPAO-SPECT/CT in the ESC 2023 diagnostic criteria significantly improves sensitivity and NPV while reducing potential IE misdiagnoses. This pioneering imaging modality is poised to become an integral component of clinical practice, promising to advance IE diagnosis and management.

2024-08-01·Thrombosis Research

Altered fibrin clot phenotype in young adults with intracerebral hemorrhage of unknown cause: A case-control study

Article

作者: Nowicki, Grzegorz ; Undas, Anetta ; Błaż, Michał ; Łopatka, Paweł

BACKGROUNDIntracerebral hemorrhage (ICH) of undetermined etiology occurs infrequently in young and middle-aged adults. We hypothesized that slight decreases in coagulation factors and formation of less compact fibrin clots prone to faster lysis predispose to this type of ICH.METHODSWe recruited 44 consecutive patients aged <50 years following ICH of unknown cause at least 3 months since the event. Subjects free of ICH (n = 47) matched for age, sex, BMI, and hypertension served as the control group. We assessed plasma fibrin clot permeability, turbidity and fibrinolytic capacity, along with thrombin generation, coagulation factors (F) II, FV, FVII, FVIII, FIX, FX, FXI, antithrombin, and fibrinolysis proteins.RESULTSICH patients (median age 41 years, 45.5 % women) had 8.4 % lower FII (p = 0.0001) and 10.1 % lower FVII activity (p = 0.0003), 9.4 % higher antithrombin activity (p = 0.0004) and 13.5 % lower platelet count (p = 0.02). Other factors and thrombin generation did not differ between the two groups. The ICH survivors were characterized by impaired fibrin polymerization reflected by 10.1 % longer lag phase of the turbidimetry curve (p = 0.0002), decreased fiber density indicated by 11.8 % lower maximum absorbance (p = 0.004), as well as 11.1 % shorter clot lysis time (p = 0.014) and 10.0 % faster increase of maximal D-Dimer levels (p = 0.000001).CONCLUSIONSWe demonstrated a prohemorrhagic fibrin clot phenotype, along with lower FII, FVII and higher antithrombin activity in adults below 50 years of age who suffered from ICH of unknown cause, which might indicate novel mechanisms contributing to ICH in younger individuals.

2024-08-01·Journal of Thoracic Disease

Comparison of four aortic bioprostheses: Hancock II vs. St Jude Trifecta vs. Carpentier-Edwards Perimount Magna vs. Magna Ease—mid-term results (COMPARE SAVR study)

Article

作者: Kędziora, Anna ; Bajorek, Natalia ; Batko, Jakub ; Deja, Marek ; Rams, Daniel J ; Tobota, Zdzisław ; Maruszewski, Bohdan J. ; Maruszewski, Bohdan J ; Rams, Daniel J. ; Widenka, Kazimierz ; Bartuś, Krzysztof ; Litwinowicz, Radoslaw ; Mazur, Piotr ; Burysz, Marian ; Filip, Grzegorz ; Ramaprabhu, Krithika ; Malinowski, Krzysztof

BackgroundIn the era of percutaneous aortic valve implantation, biological valves are the preferred prostheses implanted in patients undergoing surgical aortic valve replacement (sAVR). The aim was to present a real-life analysis of mid-term sAVR outcomes for the four aortic bioprostheses: the Hancock II, the Carpentier-Edwards Perimount Magna, the Carpentier-Edwards Perimount Magna Ease and the Trifecta valve.MethodsThis is a retrospective study based on data from the Polish National Cardiac Surgery Database. The study population comprised of 1,589 consecutive patients, of whom 432 were in the Hancock II group, 356 in the Carpentier-Edwards Perimount Magna group, 427 in the Carpentier-Edwards Magna Ease group, and 374 in the Trifecta group. A comparison of the four groups was performed using analysis of variance (ANOVA) or Kruskal-Wallis test with appropriate post hoc tests (Tukey HSD or Steel-Dwass, respectively).ResultsPatients in the Hancock II group were older, had higher New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) classes, had lower prevalence of hypertension and hyperlipidemia but higher prevalence of diabetes. The lowest mean valve size was observed in Trifecta group and the highest was in the Magna group (P<0.001). Survival analysis showed no significant differences in in-hospital mortality: 3.9% in Hancock II, 3.1% in Perimount, 3.3% in Magna and 2.1% in Trifecta group. Five-year mortality was significantly higher in Hancock II group (25.7%) compared to the other bioprostheses: 12.1% in Perimount, 9.1% in Magna and 10.70% in Trifecta group respectively.ConclusionsThe 5-year mortality rate was significantly higher in the Hancock II group compared to the other bioprostheses. In contrast, Trifecta, Perimount Magna, and Magna Ease had similar 5-year mortality rates.

项与 John Paul II Hospital, Krakow 相关的新闻（医药）

2024-05-06

·BioSpace

Thubrikar Aortic Valve Announces Clinical Success of the New Precision 2™ Delivery Catheter

COLLEGEVILLE, Pa.--(BUSINESS WIRE)-- Thubrikar Aortic Valve, Inc. today announced successful results in the first two patients implanted with the Optimum Transcatheter Aortic Valve (Optimum TAV™) using the new Precision 2™ Delivery Catheter. Interventional Cardiologist and TAVI-1 Study Principal Investigator, Jaroslaw Trebacz, MD, performed the procedures at the John Paul II Hospital in Krakow, Poland. “The first two implants with the 2nd-generation delivery catheter could not be easier or more effective. From the operator's perspective, it felt like a surprisingly mature and user-friendly device. I’m truly looking forward to the next cases,” stated Dr. Trebacz. The Precision 2 Catheter provides operators with unprecedented control during the TAVI procedure. Due to the innovative catheter design and the Optimum TAV’s short frame, the valve reorients as it is deployed resulting in automatic axial alignment with the native valve. Positioning the valve requires no complex maneuvers, and it is completely visible under fluoroscopy without the need for radiopaque markers. The Precision 2 Catheter also allows the Optimum TAV to be repositioned and recaptured for retrieval. The Company’s Medical Advisors, Dr. Susheel Kodali, Director of the Structural Heart & Valve Center at New York-Presbyterian Hospital/Columbia University Medical Center, and Dr. Mathew Williams, Director of the Heart Valve Center at NYU Langone Health, provided guidance on the development of the new catheter. In the 8 patients the Company has implanted with the Optimum TAV, valve performance has been outstanding: post-implant mean pressure gradients and effective orifice areas are superior to those published on any transcatheter aortic valve of comparable size. The Optimum TAV demonstrates pre-clinical durability surpassing that of even surgical bioprosthetic valves, which are thought to be more durable than transcatheter valves. It has a self-expanding design that is less than half the height of commercial self-expanding platforms, allowing full access for future coronary interventions. The Optimum TAV may also be used to treat patients with a failed surgical or transcatheter valve. The Optimum TAVI System, comprised of the Optimum TAV and the Precision 2 Catheter, is a true next-generation system built to address the durability vital for a younger patient population. The Company is continuing to enroll up to a total of 20 patients in Poland, and plans to expand the Optimum TAVI System CE Mark trial to two additional European countries. Dr. Mano Thubrikar, the Company’s Founder and President, stated, “The Optimum TAVI System offers patients a more durable transcatheter valve and physicians a more user-friendly delivery catheter. It will be the system of choice. We look forward to treating more patients soon.” About Thubrikar Aortic Valve Thubrikar Aortic Valve, Inc. is a privately held medical device company on a mission to revolutionize the treatment of Aortic Stenosis by bringing to the hands of physicians, and their patients, a transcatheter aortic valve durable enough for all patients. The Company was founded by Dr. Mano Thubrikar, a leading authority on the aortic valve. For more information, visit and follow the Company on LinkedIn. Drs. Williams and Kodali report disclosures with Thubrikar Aortic Valve, Inc.

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