Publications by authors named "Marek Grygier"

107 Publications

Development and Validation of a Practical Model to Identify Patients at Risk of Bleeding After TAVR.

JACC Cardiovasc Interv 2021 Jun;14(11):1196-1206

Department of Diagnostic and Interventional Cardiology, Gabriele Monasterio Tuscany Foundation, G. Pasquinucci Heart Hospital, Massa, Italy.

Objectives: No standardized algorithm exists to identify patients at risk of bleeding after transcatheter aortic valve replacement (TAVR). The aim of this study was to generate and validate a useful predictive model.

Background: Bleeding events after TAVR influence prognosis and quality of life and may be preventable.

Methods: Using machine learning and multivariate regression, more than 100 clinical variables from 5,185 consecutive patients undergoing TAVR in the prospective multicenter RISPEVA (Registro Italiano GISE sull'Impianto di Valvola Aortica Percutanea; NCT02713932) registry were analyzed in relation to Valve Academic Research Consortium-2 bleeding episodes at 1 month. The model's performance was externally validated in 5,043 TAVR patients from the prospective multicenter POL-TAVI (Polish Registry of Transcatheter Aortic Valve Implantation) database.

Results: Derivation analyses generated a 6-item score (PREDICT-TAVR) comprising blood hemoglobin and serum iron concentrations, oral anticoagulation and dual antiplatelet therapy, common femoral artery diameter, and creatinine clearance. The 30-day area under the receiver-operating characteristic curve (AUC) was 0.80 (95% confidence interval [CI]: 0.75-0.83). Internal validation by optimism bootstrap-corrected AUC was 0.79 (95% CI: 0.75-0.83). Score quartiles were in graded relation to 30-day events (0.8%, 1.1%, 2.5%, and 8.5%; overall p <0.001). External validation produced a 30-day AUC of 0.78 (95% CI: 0.72-0.82). A simple nomogram and a web-based calculator were developed to predict individual patient probabilities. Landmark cumulative event analysis showed greatest bleeding risk differences for top versus lower score quartiles in the first 30 days, when most events occurred. Predictivity was maintained when omitting serum iron values.

Conclusions: PREDICT-TAVR is a practical, validated, 6-item tool to identify patients at risk of bleeding post-TAVR that can assist in decision making and event prevention.
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http://dx.doi.org/10.1016/j.jcin.2021.03.024DOI Listing
June 2021

Feasibility of intravascular lithotripsy for calcific coronary lesions: A multi-institutional experience.

Catheter Cardiovasc Interv 2021 May 29. Epub 2021 May 29.

Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland.

Objective: We sought to determine the safety and performance of intravascular lithotripsy in the treatment of severe calcified atherosclerotic lesions.

Background: The modification of severe calcified atherosclerotic lesions with noncompliant or specialty balloons, as well as orbital or rotational atherectomy has limitations and may be ineffective, increasing the risk of periprocedural complications and worsening long-term results. Intravascular lithotripsy has recently been shown to be a safe and feasible alternative to the above methods.

Methods: All consecutive patients treated with Shockwave Medical Intravascular Lithotripsy (S-IVL) between May 2019 and June 2020 were included in current analysis. Device safety and efficacy were the critical endpoints of the study. The primary safety endpoint was 30-day major adverse cardiac events (MACE). In turn, device and clinical success were the primary performance endpoints.

Results: In total, 46 patients undergoing percutaneous coronary intervention were treated with S-IVL before stent deployment (65% male; age, 71 ± 7 years). Device success was achieved in 45 (97.8%) patients with reduction of diameter stenosis from 80% to 5.2% with an acute gain of 2.5 mm. Clinical success was demonstrated in 95.6% of cases. During the 30-day follow-up, one sudden death was recorded, regarded as probable subacute stent thrombosis. During 6-month follow up one target lesion and target vessel revascularizations occurred. The rate of MACE after 6 month was 6.2%.

Conclusions: S-IVL appears to be a safe and effective treatment modality in coronary calcium modification to optimize stent expansion. In selected cases this device obviates the need for more complex lesion preparation strategies such as atherectomy.
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http://dx.doi.org/10.1002/ccd.29792DOI Listing
May 2021

Multivessel Intervention in Myocardial Infarction with Cardiogenic Shock: CULPRIT-SHOCK Trial Outcomes in the PL-ACS Registry.

J Clin Med 2021 Apr 22;10(9). Epub 2021 Apr 22.

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, 40-752 Katowice, Poland.

Background: The aim of the study was a comparison of culprit-lesion-only (CL-PCI) with the multivessel percutaneous coronary intervention (MV-PCI) in terms of 30-day and 12-month mortality in a national registry.

Methods: Patients from the PL-ACS registry with MI and CS were analyzed. Patients meeting the criteria of the CULPRIT-SHOCK trial were divided into two groups: CL-PCI and MV-PCI groups.

Results: Of the 3265 patients in the PL-ACS registry with MI complicated by CS, the criteria of the CULPRIT-SHOCK trial were met by 2084 patients (63.8%). The CL-PCI was performed in 883 patients, and MV-PCI was performed in 1045 patients. After the propensity score matching analysis, 617 well-matched pairs were obtained. In a 30-day follow-up, death from any cause occurred in 49.3% in the CL-PCI group and 57.0% in the MV-PCI group (RR 0.86, 95% CI 0.58-0.92, = 0.0081). After 12 months, the rate of mortality was 62.5% in the CL-PCI group and 68.0% in the MV-PCI group (RR 0.92, 95% CI 0.84-1.01, = 0.066).

Conclusions: The results confirm the validity of CULPRIT-SHOCK findings in a national registry and current guideline-recommended strategy of revascularization limited to the infarct-related artery.
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http://dx.doi.org/10.3390/jcm10091832DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8122818PMC
April 2021

The impact of right coronary artery support on the outcomes of patients with unprotected left main disease undergoing percutaneous coronary intervention.

Kardiol Pol 2021 Apr 26. Epub 2021 Apr 26.

Background: Many operators are discouraged from performing left main (LM) percutaneous coronary interventions (PCI) in the absence of right coronary artery (RCA) support due to the increased procedure risk.

Aims: We aimed to assess the absent functional RCA impact on prognostic implications in patients undergoing unprotected LM PCI.

Methods: 613 patients underwent LM PCI in our department between 2015 and 2019. Consecutive 385 patients with unprotected LM and at least 1-year follow-up were included in the study. The study group consisted of 272 patients with unprotected left main coronary artery disease (ULMCAD) with dominant RCA without any significant lesions (Group 1) and 113 ULMCAD patients and with lack of RCA support (Group 2).

Results: In Group 2, 32.7% patients had a significant RCA stenosis, 48.7% chronic total occlusion (CTO) of RCA and 18.6% recessive RCA. Patients in Group 2 were older and had higher prevalence of COPD. SYNTAX Score (median (IQR) 26.0 (20.0-33.0) vs. 19.0 (13.0-25.5); P < 0.001) was higher and left ventricular ejection fraction was lower (median (IQR) 50.0 (40.0-60.0) vs. 55.0 (45.0-60.0); P = 0.01) in this group. All periprocedural complications did not differ among the groups. Long-term all-cause mortality at a median follow-up of 1149 days did not differ significantly (23% vs. 20%; P = 0.37). The long-term mortality in CTO-RCA group was also not significantly different.

Conclusions: Patients with ULMCAD who have undergone LM PCI with absent RCA support, compared with patients with ULMCAD with RCA support, differed neither in the frequency of periprocedural complications nor in long-term all-cause mortality.
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http://dx.doi.org/10.33963/KP.15972DOI Listing
April 2021

Platelet function in patients undergoing surgical and transcatheter aortic valve replacement: a comparative study.

Kardiol Pol 2021 Apr 20. Epub 2021 Apr 20.

Background: Intervention-induced platelet hypercoagulability may pose a risk of serious adverse events for patients.

Aims: The aim of this study was to assess whether surgical (SAVR) and transcatheter aortic valve replacement (TAVR) differ in periprocedural platelet activity.

Methods: The total number of 24 patients with a mean age (SD) of 71 (13) years who underwent SAVR (n=12) or TAVR (n=12) were recruited for the study. The following parameters were evaluated at four time-points: (i) platelet indices: total platelet count (PLT), platelet distribution width (PDW) and mean platelet volume (MPV), (ii) MPV/PLT ratio, (iii) platelet level of lipid peroxidation: malondialdehyde (MDA) content and MDA/PLT ratio. Eventually, percentage variations of PLT, PDW and MPV in relation to the baseline values were determined.

Results: MPV/PLT ratio increased significantly after procedures in both groups (P = 0.01 in TAVI and P = 0.01 in SAVR). MDA concentrations were significantly higher when assessed directly post-procedure (P = 0.04) as well as 24h later (P = 0.01) in the SAVR and TAVI groups. The indirect parameter of platelet activity indexed for platelet counts (MDA/PLT) was comparable between both groups before and 48 hours after procedures, but was significantly higher in SAVR patients, particularly after 24h after interventions (P = 0.04; medians TAVR vs. SAVR, respectively).

Conclusion: Standard surgical aortic valve replacement is associated with a more pronounced platelet reaction to intervention-induced injury, as compared to the transcatheter-based procedure. The importance of these laboratory findings requires further investigation focused on early and late clinical outcomes.
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http://dx.doi.org/10.33963/KP.15964DOI Listing
April 2021

Chronic total occlusion percutaneous coronary intervention in everyday clinical practice - an expert opinion of the Association of Cardiovascular Interventions of the Polish Cardiac Society.

Postepy Kardiol Interwencyjnej 2021 Mar 27;17(1):6-20. Epub 2021 Mar 27.

Second Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.

Coronary chronic total occlusions (CTO) are increasingly encountered during invasive and non-invasive coronary angiography and remain the most challenging lesions for percutaneous revascularization. During recent years success rates and safety outcomes of CTO percutaneous coronary intervention (PCI) have substantially improved, particularly due to the introduction of new techniques and dedicated equipment as well as specialized training programs of CTO operators. Significantly, the steady advances in CTO PCI techniques have coincided with the new data from randomized clinical trials supporting the role of percutaneous recanalization of CTO in relieving angina and improving the quality of life. The current expert consensus document outlines the rationale, clinical outcomes as well as technical, safety and reimbursement issues of CTO PCI. In addition, the requirements for achieving and maintaining competency in CTO PCI among interventional cardiologists are discussed. Finally, we present the modified hybrid algorithm (the so-called Polish hybrid algorithm) providing some unique refinements to the contemporary CTO PCI strategies. Continuous efforts (including active engagement with the payer) are urgently needed to increase guideline-recommended referrals to CTO PCI, and thus improve the quality of life of CTO patients in Poland.
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http://dx.doi.org/10.5114/aic.2021.104763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8039914PMC
March 2021

Peculiarities in coronary sinus anatomy: implications for successful cannulation from an autoptic study.

Europace 2021 Apr 17. Epub 2021 Apr 17.

1st Department of Cardiology, Poznan University of Medical Sciences, Dluga Street ½, 61-848 Poznan, Poland.

Aims: The number of cardiovascular procedures using the coronary sinus (CS) as a gateway is constantly increasing. The present study aimed to define specific structures within CS, which could potentially complicate CS cannulation and to develop a new Thebesian valve (TV) classification system.

Methods And Results: The study was performed on 560 consecutive unfixed cadaveric hearts during routine autopsy examination (1-3 days post-mortem). Basic CS dimensions were measured and the presence and dimensions of the TV and the Vieussens valve (VV) were assessed. Thebesian valves were classified according to their morphology into six main types: remnant fold, semilunar, fenestrated, chord, fused strands, and mixed shaped. The median age of hearts was 48 years (range 16-95 years), and 38.9% were female. Thebesian valve was present in 79.5%. The most common TV type was semilunar (54%) followed by fenestrated (8.2%), remnant fold (5.5%), fused strands (4.8%), chord (4.0%), and mixed shaped (3.0%). In 1.1% of hearts, TV totally covered the coronary sinus ostium (CSO). The VV was detected in 67.9%. Potentially occlusive VV was found in 1.1% hearts and in all of which it coexisted with obstructive TV. The median CSO area was 87.9 mm2 [interquartile range (IQR): 56.5-127.1 mm2] and median CS length was 38 mm (IQR: 29.5-45 mm). The CSO area and CS length correlated with each other and with the right atrium's dimensions.

Conclusion: We identified six types of TVs, among which only 1.1% TVs caused total occlusion of CSO. The obstructive TV co-existed with potentially occlusive VV what might hinder CS cannulation.
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http://dx.doi.org/10.1093/europace/euab108DOI Listing
April 2021

The Polish Interventional Cardiology TAVI Survey (PICTS): 10 years of transcatheter aortic valve implantation in Poland. The landscape after the first stage of the Valve for Life Initiative.

Pol Arch Intern Med 2021 05 19;131(5):413-420. Epub 2021 Mar 19.

Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

Introduction: Few studies assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008. Effects of the Valve-for-Life initiative in the country have not been reported.

Objective: To investigate TAVI adoption and practice in Poland in the years 2008-2019.

Patients And Methods: The Polish Interventional Cardiology TAVI Survey (PICTS) analysed reports of TAVI activity of all 23 TAVI centres. It consisted of 94 questions, focused on the topics: 1. characteristics of centres. 2. the annual number of TAVI in the years 2008-2019. 3. pre-, intra-, and post-procedural management, 4. a list of TAVI Team members. It was obligatory to answer all questions. The registry survey was published on-line RESULTS: Since 2008, 102 certified operators have performed a total of 6910 procedures. In 2019 the annual number of TAVI reached 1550 (40.38 implants per million inhabitants). Among patients aged ≥ 65 years, TAVI penetration rate was 18.65% in 2019. Inoperable and high-risk patients were treated in all centres, while 18 also treated medium and 5 low-risk patients. The rate of transfemoral implantations increased to 93.5% of all procedures.

Conclusions: The survey highlighted a slow, positive rate of adoption of TAVI in Poland. We found a significant treatment gap in patients with severe aortic stenosis. Remarkable regional variations in TAVI experience exist among Polish TAVI centres. Further multinational cooperation is warranted to tackle identified limitations in access to these life-saving procedures.
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http://dx.doi.org/10.20452/pamw.15887DOI Listing
May 2021

How the COVID-19 pandemic changed treatment of severe aortic stenosis: a single cardiac center experience.

J Thorac Dis 2021 Feb;13(2):906-917

Department of Cardiac Surgery and Transplantology, Poznan University of Medical Sciences, Poznan, Poland.

Background: Currently, two effective therapeutic options for severe aortic stenosis (AS) are available, one catheter-based [transcatheter aortic valve implantation (TAVI)], the other open surgical approach [surgical aortic valve replacement (SAVR)]. The COVID-19 pandemic has limited the availability of medical procedures. The purpose of this cross-sectional study was to assess if this pandemic had any impact on the treatment strategy of severe AS in a single cardiac center.

Methods: This study involved AS patients treated in 3-month periods (February through April) over 3 consecutive years 2018, 2019 [defined as COV(-) group] and 2020 [COV(+)]. We assessed if there were any differences regarding patients' clinical profile, applied therapeutic method, procedure complexity and early clinical outcomes.

Results: In the years 2018 through 2019, approximately 50% of AS patients were treated classically (SAVR) while in 2020 this rate dropped to 34%. The preoperative clinical characteristic of TAVI subjects was comparable irrespective of the year. Regarding SAVR, more patients in COV(+) underwent urgent and more complex procedures. More of them were found in NYHA class III or IV, and had lower left ventricular ejection fraction (LVEF) (51.9%±14.4% 58.3%±8.1%; P=0.021) than in COV(-) individuals. During the pandemic, a change in applied therapeutic methods and differences in patients' clinical profile did not have an unfavorable impact on in-hospital mortality (2.0% before 3.6% during pandemic) and morbidity. Of note, intubation time and in-hospital stay were significantly shorter (P<0.05) in 2020 (4.2 hours and 7.5 days) than in the previous years (7.5 hours and 9.0 days, respectively).

Conclusions: The coronavirus pandemic has changed substantially the management of severe AS. The shift into less invasive treatment method of AS patients resulted in shortening of in-hospital stay without compromise of short-term outcomes.
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http://dx.doi.org/10.21037/jtd-20-3025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7947507PMC
February 2021

Percutaneous Occlusion of the Left Atrial Appendage with Thrombus Irresponsive to Antithrombotic Therapy.

J Clin Med 2021 Feb 12;10(4). Epub 2021 Feb 12.

1st Department of Cardiology, Poznan University of Medical Sciences, Dluga1/2, 61-848 Poznan, Poland.

We analyzed clinical experience with percutaneous closure of instances of left atrial appendage with thrombus (LAAT) irresponsive to antithrombotic therapy in patients treated in three high-volume cardiology centers. Clinical and procedural data regarding consecutive patients who underwent percutaneous left atrial appendage closure (PLAAC) due to LAAT were retrospectively analyzed. The study population consisted of 17 patients (11 men; 68 ± 14 years; CHADSVASC 4.7 ± 1.9; HASBLED 3 (0-5)) with LAAT confirmed by transesophageal echocardiography, and included 5 patients with mechanical heart valves. Most of the patients (94.1%) received anticoagulation therapy before PLAAC. All LAATs were located in distal portions of the appendage and occupied less than 30% of its volume. Occluding-device implantation was successful in 17 patients; in one, a residual leak was disclosed. Appropriate positioning of occluders required more than 1 attempt in 6 individuals (35.3%); in 3 others (17.6%), the subjects' devices had contact with thrombi. No procedural complications were noted. Midterm follow-up (median: 10 months) revealed no procedure-related complications or clinically diagnosed thromboembolism. Transesophageal echocardiography (TEE) performed after six months revealed device-related thrombus in one patient. We concluded that LAAT irresponsive to antithrombotic therapy might be effectively treated with PLAAC, even in patients with mechanical-valve prostheses.
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http://dx.doi.org/10.3390/jcm10040726DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7918449PMC
February 2021

Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience.

JACC Cardiovasc Interv 2021 01 25;14(2):172-181. Epub 2020 Nov 25.

Cardiothoracic Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.

Objectives: The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system.

Background: The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device.

Methods: A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported.

Results: Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients.

Conclusions: Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.
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http://dx.doi.org/10.1016/j.jcin.2020.09.044DOI Listing
January 2021

Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device-Insights from the EWOLUTION real world registry.

Catheter Cardiovasc Interv 2021 Jun 8;97(7):E1019-E1024. Epub 2021 Jan 8.

Cardiology Department, St Antonius Hospital, Nieuwegein, the Netherlands.

Background: In this analysis of the EWOLUTION registry, we evaluated the incidence, relevance and predictors of device-related thrombus in a large multi-center real-world cohort undergoing LAAc with the WATCHMAN device.

Methods And Results: We analyzed the 835 patients who underwent percutaneous LAA closure with the WATCHMAN device in the EWOLUTION registry in whom at least one TEE follow up was performed. Patients were 74 ± 9 y/o and were at high risk for stroke and bleeding (CHA2DS2-VASC-Score 4.3 ± 1.7; HAS-BLED-Score 2.3 ± 1.2). Device-related thrombus was detected in 4.1% (34/835) after a median of 54 days (IQR 42-111 days) with 91.2% (31/34) being detected within 3 months after the procedure or at the time of first TEE. Hereby DRT occurred irrespective of postprocedural anticoagulation. Patients with DRT more frequently had long-standing, non-paroxysmal atrial fibrillation (82.4 vs. 64.9%, p < .01), evidence of dense spontaneous echo contrast (26.5 vs. 11.9%, p = .03) and larger LAA diameters at the ostium (22.8 ± 3.5 vs. 21.1 ± 3.5 mm, p < .01) compared to patients without DRT. Left ventricular ejection fraction, device compression ratio and the incidence of renal dysfunction did not differ between the two groups. In a multivariate analysis, only non-paroxysmal atrial fibrillation identified as an independent predictor of developing DRT. Specific treatment of DRT was initiated in 62% (21/34) of patients whereas resolution was confirmed in 86% (18/21) of cases. Overall, no significant differences in annual rates of stroke/TIA or systemic embolism were observed in patients with or without DRT (DRT 1.7 vs. No-DRT 2.2%/year, p = .8).

Conclusions: In real-world patients undergoing LAAc with the WATCHMAN device, DRT is rare. DRT was most frequently detected within the first 3 months after LAAc regardless of post-procedural regimen and was not associated with an increased risk of stroke or SE. While long-standing atrial fibrillation was the only independent factor associated with DRT, medical treatment of DRT resulted in a resolution of thrombi in most cases.
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http://dx.doi.org/10.1002/ccd.29458DOI Listing
June 2021

Extended cardiopulmonary resuscitation: from high fidelity simulation scenario to the first clinical applications in Poznan out-of-hospital cardiac arrest program.

Perfusion 2020 Dec 16:267659120981811. Epub 2020 Dec 16.

Department of Cardiac Surgery and Transplantology, Poznan University of Medical Sciences, Poznan, Wielkopolskie, Poland.

Background: The outcomes of out-of-hospital cardiac arrest (OHCA) patients are poor. In some OHCA cases, the reason is potentially reversible cardiac or aortic disease. It was suggested previously that high-quality cardiopulmonary resuscitation (CPR) followed by extracorporeal membrane oxygenation (ECMO) support may improve the grave prognosis of OHCA. However, extended CPR (ECPR) with ECMO application is an extremely invasive and cutting-edge procedure. The purpose of this article is to describe how high-fidelity medical simulation as a safe tool enabled implementation of the complex, multi-stage ECPR procedure.

Method: A high fidelity simulation of OHCA in street conditions was prepared and carried out as part of a ECPR procedure implemented in an in-hospital area. The simulation tested communication and collaboration of several medical teams from the pre-hospital to in-hospital phases along with optimal use of equipment in management of a sudden cardiac arrest (SCA) patient.

Results: The critical and weak points of an earlier created scenario were collected into a simulation scenario checklist of ECPR algorithm architecture. A few days later, two ECPR procedures followed by cardiologic interventions for OHCA patients (one pulmonary artery embolectomy for acute pulmonary thrombosis and one percutaneous coronary artery angioplasty with drug eluting stent implantation for acute occlusion of the left anterior descending artery), were performed for the first time in Poland. The protocol was activated five times in the first 2 months of the POHCA Program.

Conclusion: High fidelity medical simulation in real-life conditions was confirmed to be a safe, useful tool to test and then implement the novel and complex medical procedures. It enabled to find, analyze and solve the weakest points of the earlier developed theoretical protocol and eventually succeed in clinical application of complete ECPR procedure.
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http://dx.doi.org/10.1177/0267659120981811DOI Listing
December 2020

Non-calcific aortic tissue quantified from computed tomography angiography improves diagnosis and prognostication of patients referred for transcatheter aortic valve implantation.

Eur Heart J Cardiovasc Imaging 2021 May;22(6):626-635

Departments of Biomedical Sciences and Medicine, Cedars-Sinai Medical Center, Biomedical Imaging Research Institute,116N Robertson Blvd, Suite 400, Los Angeles, CA 90048, USA.

Aims: We aimed to investigate the role of aortic valve tissue composition from quantitative cardiac computed tomography angiography (CTA) in patients with severe aortic stenosis (AS) for the differentiation of disease subtypes and prognostication after transcatheter aortic valve implantation (TAVI).

Methods And Results: Our study included 447 consecutive AS patients from six high-volume centres reporting to a prospective nationwide registry of TAVI procedures (POL-TAVI), who underwent cardiac CTA before TAVI, and 224 matched controls with normal aortic valves. Components of aortic valve tissue were identified using semi-automated software as calcific and non-calcific. Volumes of each tissue component and composition [(tissue component volume/total tissue volume) × 100%] were quantified. Relationship of aortic valve composition with clinical outcomes post-TAVI was evaluated using Valve Academic Research Consortium (VARC)-2 definitions.High-gradient (HG) AS patients had significantly higher aortic tissue volume compared to low-flow low-gradient (LFLG)-AS (1672.7 vs. 1395.3 mm3, P < 0.001) as well as controls (509.9 mm3, P < 0.001), but increased non-calcific tissue was observed in LFLG compared to HG patients (1063.6 vs. 860.2 mm3, P < 0.001). Predictive value of aortic valve calcium score [area under the curve (AUC) 0.989, 95% confidence interval (CI): 0.981-0.996] for severe AS was improved after addition of non-calcific tissue volume (AUC 0.995, 95% CI: 0.991-0.999, P = 0.011). In the multivariable analysis of clinical and quantitative computed tomography parameters of aortic valve tissue, non-calcific tissue volume [odds ratio (OR) 5.2, 95% CI 1.8-15.4, P = 0.003] and history of stroke (OR 2.6, 95% CI 1.1-6.5, P = 0.037) were independent predictors of 30-day major adverse cardiovascular event (MACE).

Conclusion: Quantitative CTA assessment of aortic valve tissue volume and composition can improve detection of severe AS, differentiation between HG and LFLG-AS in patients referred for TAVI as well as prediction of 30-day MACEs post-TAVI, over the current clinical standard.
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http://dx.doi.org/10.1093/ehjci/jeaa304DOI Listing
May 2021

Procedural and Short-Term Results With the New Watchman FLX Left Atrial Appendage Occlusion Device.

JACC Cardiovasc Interv 2020 12 11;13(23):2732-2741. Epub 2020 Nov 11.

Cardiology Department, Aarhus Universitetshospital, Aarhus, Denmark.

Objectives: This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts).

Background: The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis.

Methods: A total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program.

Results: Mean age was 75.4 ± 8.9 years, and CHADS-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred.

Conclusions: LAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.
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http://dx.doi.org/10.1016/j.jcin.2020.06.056DOI Listing
December 2020

Does the operator's sex matter? An analysis based on the national interventional cardiology registry.

Kardiol Pol 2020 12 22;78(12):1221-1226. Epub 2020 Oct 22.

Background: A small number of female cardiologists work in the field of interventional cardiology. Such disparity is observed in most European countries.

Aims: We present the first national report on the practice patterns and outcomes regarding percutaneous coronary interventions (PCIs) performed by female operators (FOs) in Poland.

Methods: Data were collected from the National Registry of Invasive Cardiology Procedures (Ogólnopolski Rejestr Procedur Kardiologii Inwazyjnej [ORPKI]) between January 2014 and December 2017.

Results: A total of 31 FOs (4.1%) performed 12 935 PCIs (2.8%). The median (interquartile range [IQR]) number of PCIs performed by FOs per year was 75 (43-154), whereas that by male operators was 139 (67-216; P <0.01). Patients handled by FOs were characterized by a lower prevalence of cardiovascular risk factors and previous coronary artery interventions. Acute coronary syndrome was the main indication for treatment (74.66%). Compared with male operators, FOs handled significantly more patients with single‑vessel disease (87.02% vs 84.72%; P <0.001). They used smaller contrast doses during PCIs (median [IQR], 170.36 [77.54] cm3 vs 173.48 [77.54] cm3; P <0.001) yet higher doses of radiation exposure (median [IQR], 843 [472-1409] mGy vs 815 [458-1390] mGy; P = 0.01). There was no difference in clinical outcomes (a composite of all‑cause death, bleeding at the puncture site, or coronary artery perforation) associated with the operator's sex.

Conclusions: Women represent a minority of operators in interventional cardiology and are responsible for a low percentage of PCIs. Nonetheless, the practice patterns and outcomes of PCIs performed by FOs are similar to those of male operators.
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http://dx.doi.org/10.33963/KP.15665DOI Listing
December 2020

Percutaneous closure of atrial septal defect: a consensus document of the joint group of experts from the Association of Cardiovascular Interventions and the Grown-Up Congenital Heart Disease Section of the Polish Cardiac Society.

Kardiol Pol 2020 10 30;78(10):1066-1083. Epub 2020 Sep 30.

Department of Cardiology and Cardiovascular Interventions, Jagiellonian University Hospital in Kraków, Kraków, Poland

Atrial septal defect is the most common congenital heart lesion in adults. Although atrial septal defect closure is recommended in those with right heart enlargement or paradoxical embolism, data informing such indications in adults are quite limited. This population has many unique characteristics and needs. In recent years, significant progress has been made with regard to diagnostic modalities that facilitate the diagnostic workup of these patients. However, the decision‑making process, especially in selected adult patients population (advanced age, various concomitant diseases, poor LV function [both systolic and diastolic], pulmonary hypertension, concomitant arrhythmias or multiple defects, or deficient rims) is still not easy. Available data are predominantly focused on imaging endpoints and short‑term morbidity and mortality rather than long‑‑term. The evidence base for outcomes with or without defect closure comes from various studies with different observation periods. Moreover, the clinical experience in diagnosing and treating that subgroup of patients is inhomogeneous between individual physicians (cardiologists, imaging specialists, operators) and between small and large experience centers. In the view of the above, the joint group of experts from the Association of Cardiovascular Interventions and the Grown‑Up Congenital Heart Disease Section of the Polish Cardiac Society developed the following consensus opinion in order to standardize the principles of diagnosis, indications for treatment, methods of performing procedures, and tenets of postoperative care in Poland.
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http://dx.doi.org/10.33963/KP.15629DOI Listing
October 2020

Erysipelothrix rhusiopathiae Endocarditis in a Patient With Severe Unicuspid Aortic Valve Damage Complicated With Acquired Ventricular Septal Defect.

Can J Cardiol 2021 Mar 10;37(3):523.e1-523.e3. Epub 2020 Sep 10.

I Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.

Erysipelothrix rhusiopathiae, is an important animal pathogen, but rarely reported in humans. To date, only fa ew cases of infective E rhusiopathiae endocarditis of the aortic valve have been described. We introduce the first reported case of severe damage of the native unicuspid aortic valve complicated with acquired ventricular septal defect caused by E rhusiopathiae endocarditis. This case may provide a better understanding of the disease process and transmission and underscores the need to include this pathogen in the differential diagnosis of infective endocarditis.
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http://dx.doi.org/10.1016/j.cjca.2020.09.002DOI Listing
March 2021

Continuous Aspiration Thrombectomy in High- and Intermediate-High-Risk Pulmonary Embolism in Real-World Clinical Practice.

J Interv Cardiol 2020 21;2020:4191079. Epub 2020 Aug 21.

1 Department of Cardiology, Poznan University of Medical Sciences, 61-848 Poznan, Poland.

Objectives: We sought to assess the technical and clinical feasibility of continuous aspiration catheter-directed mechanical thrombectomy (CDT) in patients with high- or intermediate-high-risk pulmonary embolism (PE).

Methods And Results: Fourteen patients (eight women and six men; age range: 29-71 years) with high- or intermediate-high-risk PE and contraindications to or ineffective systemic thrombolysis were prospectively enrolled between October 2018 and February 2020. The Indigo Mechanical Thrombectomy System (Penumbra, Inc., Alameda, California) was used as CDT device. Low-dose local thrombolysis (alteplase, 3-12 mg) was additionally applied in three patients. Technical and procedural success was achieved in 14 patients (100%). Complete or nearly complete clearance of pulmonary arteries was achieved in nine patients (64.3%), whereas partial clearance was achieved in five (35.7%). A significant improvement in the pre- and postprocedural patients' clinical status was observed in the following fields (median; interquartile range): heart rate (110; 100-120/min vs. 85; 80-90/min; < 0.0001), systolic blood pressure (106; 90-127 mmHg vs. 123; 110-133 mmHg; = 0.049), arterial oxygen saturation (88.5; 84.2-93% vs. 95.0; 93.8-95%, = 0.0051), pulmonary artery systolic pressure (55; 44-66 mmHg vs. 42; 34-53 mmHg; = 0.0015), Miller index score (21.5; 20-23 vs. 9.5; 8-13; < 0.0001) and right ventricular/left ventricular ratio (1.3; 1.3-1.5 vs. 1.0; 0.9-1.0; < 0.0001). No major periprocedural bleeding was detected.

Conclusions: CDT is a feasible and promising technique for management of high- or intermediate-high-risk PE to decrease thrombus burden, reduce right heart strain, and improve hemodynamic and clinical status. Some patients may benefit from simultaneous local low-dose thrombolytic therapy. Nevertheless, its criteria and role in CTD-managed patients require further elucidation.
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http://dx.doi.org/10.1155/2020/4191079DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456496PMC
January 2021

Predictors of Long-Term Infections After Cardiac Implantable Electronic Device Surgery - Utility of Novel PADIT and PACE DRAP Scores.

Circ J 2020 09 5;84(10):1754-1763. Epub 2020 Sep 5.

1st Department of Cardiology, Poznan University of Medical Sciences.

Background: Cardiac implantable electronic device-related infections (CDI) are of increasing importance and involve substantial healthcare resources. This study aimed to evaluate potential CDI risk factors and the utility of the novel PADIT and PACE DRAP scores to predict CDI.Methods and Results:The study group included 1,000 consecutive patients undergoing implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) surgery. Patients' and procedural characteristics were collected. CDI occurrence was assessed during 1-year follow-up. Moreover, if periprocedural significant pocket hematoma (SPH) occurred, the maximal volume was calculated based on ultrasonographic measurements and ABC/2 formula. The overall incidence of CDI was 1.8%. In the multivariable regression analysis independent CDI risk factors were: age >75 years (odds ratio [OR]: 5.93; 95% confidence interval [CI]: 1.77-19.84), system upgrade procedure (OR: 6.46; CI: 1.94-21.44), procedure duration >1 h (OR: 13.96; CI: 4.40-44.25), presence of SPH (OR: 4.95; CI: 1.62-15.13) and reintervention within 1 month (OR: 16.29; CI: 3.14-84.50). The PACE DRAP score had higher discrimination of CDI incidence (area under curve [AUC] 0.72) as compared with the PADIT score (AUC 0.63).

Conclusions: We identified 5 independent risk factors of CDI development. Our study also showed that the PACE DRAP score was better able to identify patients at high risk of CDI than the PADIT score.
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http://dx.doi.org/10.1253/circj.CJ-20-0305DOI Listing
September 2020

Clinical and procedural characteristics of COVID-19 patients treated with percutaneous coronary interventions.

Catheter Cardiovasc Interv 2020 11 20;96(6):E568-E575. Epub 2020 Jul 20.

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland.

Background: COVID-19 pandemic has affected healthcare systems worldwide. Resources are being shifted and potentially jeopardize safety of non-COVID-19 patients with comorbidities. Our aim was to investigate the impact of national lockdown and SARS-CoV-2 pandemic on percutaneous treatment of coronary artery disease in Poland.

Methods: Data on patients who underwent percutaneous coronary procedures (angiography and/or percutaneous coronary intervention [PCI]) were extracted for March 13-May 13, 2020 from a national PCI database (ORPKI Registry) during the first month of national lockdown and compared with analogous time period in 2019.

Results: Of 163 cardiac catheterization centers in Poland, 15 (9.2%) were indefinitely or temporarily closed down due to SARS-CoV-2 pandemic. There were nine physicians (9 of 544; 1.7%) who were infected with SARS-CoV-2. There were 13,750 interventional cardiology procedures performed in Poland in the analyzed time period. In 66% of cases an acute coronary syndrome was diagnosed, and in the remaining 34% it was an elective procedure for the chronic coronary syndrome in comparison to 50% in 2019 (p < .001). There were 362 patients (2.6% of all) with COVID-19 confirmed/suspected who were treated in interventional cardiology centers and 145 with ST-Elevation Myocardial Infarction (STEMI) diagnosis (6% of all STEMIs).

Conclusions: Due to SARS-CoV-2 pandemic there was an absolute reduction in the number of interventional procedures both acute and elective in comparison to 2019 and a significant shift into acute procedures. COVID-19 confirmed/suspected patients do not differ in terms of procedural and baseline characteristics and reveal similar outcomes when treated with percutaneous coronary interventions.
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http://dx.doi.org/10.1002/ccd.29134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7405230PMC
November 2020

Thromboembolic or atherosclerotic? Optical coherence tomography in determining the cause of myocardial infarction with ST-segment elevation.

Kardiol Pol 2020 10 8;78(10):1045-1046. Epub 2020 Jul 8.

1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland

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http://dx.doi.org/10.33963/KP.15499DOI Listing
October 2020

Challenging clinical and organizational scenarios in cardiovascular diseases during the SARS-CoV-2 pandemic in Poland. Can we do better?

Postepy Kardiol Interwencyjnej 2020 Jun 27;16(2):121-122. Epub 2020 May 27.

1 Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.

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http://dx.doi.org/10.5114/aic.2020.95734DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7333210PMC
June 2020

The importance of detection and percutaneous closure of patent foramen ovale during the coronavirus disease 2019 pandemic. Authors' reply.

Kardiol Pol 2020 06 25;78(6):616-617. Epub 2020 Jun 25.

1st Department of Cardiology, Poznań University of Medical Sciences, Poznań, Poland

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http://dx.doi.org/10.33963/KP.15458DOI Listing
June 2020

A concept for the development of a pioneer regional Out-of-Hospital Cardiac Arrest Program to improve patient outcomes.

Kardiol Pol 2020 09 16;78(9):875-881. Epub 2020 Jun 16.

Department of Cardiac Surgery and Transplantology, Poznań University of Medical Sciences, Poznań, Poland

Background: Immediate initiation of cardiopulmonary resuscitation (CPR) increases chances of restoring spontaneous circulation and survival after out‑of‑hospital cardiac arrest (OHCA). For some refractory cases, extended cardiopulmonary resuscitation (ECPR) may be a promising option.

Aims: The aim of the study was to estimate the possibility of implementation of ECPR procedure to improve current early outcomes of patients after OHCA.

Methods: The medicalcharts of the Province Emergency Station in Poznań from a 12‑month periodwere assessed retrospectively. All OHCA cases were identified and the following potential inclusion criteria for ECPR were analyzed: initial defibrillation rhythm, age between 18 and 65 years, CPR conducted by bystanders, and time to hospital arrival less than 40 minutes.

Results: In 576 (46.7%) of 1233 identified OHCA cases, CPR wasinitiated by bystanders and automated external defibrillatorwas applied only 17 times. An initial defibrillation rhythm was noted in 138 individuals (11.2%). Out of 65 patients who met the ECPR age criterion, 55 underwent CPR by bystanders which lead to a no‑flow time that did not exceed 10 minutes. The additional 9 of them would be excluded due to time to hospital arrival. This means that ECPR would be applicable in 46 patients after OHCA.

Conclusions: Our analysis showed that in some patients after sudden cardiac arrest, it would have been possible to implement ECPR as a crucial part of the Regional Out-of-Hospital Cardiac Arrest (OHCA) Program, and in consequence, probably to improve early outcomes of patients with refractory and potentially reversible cardiac arrest.
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http://dx.doi.org/10.33963/KP.15433DOI Listing
September 2020