66 results on '"Tekieli, L."'
Search Results
2. Simultaneous single-stage urgent cardiac surgery and endovascular carotid revascularization under open-chest cardiopulmonary bypass in extremely high-risk, unstable patients
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Dzierwa, K, primary, Kedziora, A, additional, Mazurek, A, additional, Tekieli, L, additional, Musial, R, additional, Dobrowolska, E, additional, Pieniazek, P, additional, Sobczynski, R, additional, Kapelak, B, additional, Kwiatkowski, T, additional, Trystula, M, additional, Piatek, J, additional, and Musialek, P, additional
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- 2023
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3. Association between coronary microcirculatory resistance, left atrial strain and heart failure with preserved ejection fraction in patents with ischemia and non-obstructive coronary arteries (INOCA)
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Legutko, J, primary, Szolc, P, additional, Niewiara, L, additional, Stapor, M, additional, Kleczynski, P, additional, Tekieli, L, additional, Rzeznik, D, additional, Diachyshyn, M, additional, Bernacik, A, additional, Zmudka, K, additional, and Guzik, B, additional
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- 2023
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4. Heterogeneous and overlapping mechanisms of myocardial ischemia in patients with ischemia and non-obstructive coronary arteries. Preliminary results from the MOSAIC-COR Registry
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Szolc, P S, primary, Niewiara, L, additional, Legutko, J, additional, Kleczynski, P, additional, Rzeznik, D, additional, Tekieli, L, additional, Podolec, J, additional, Diachyshyn, M, additional, Stapor, M, additional, Zmudka, K, additional, and Guzik, B, additional
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- 2022
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5. FREQUENCY OF CERVICAL AND INTRACRANIAL ARTERIES LESIONS AND ASSOCIATED CLINICAL SYMPTOMS IN PATIENTS WITH CONFIRMED RENAL FIBROMUSCULAR DYSPLASIA - ARCADIA-POL STUDY
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Swiatlowski, L., Warchol-Celinska, E., Kowalczyk, K., Januszewicz, M., Florczak, E., Prejbisz, A., Jozwik-Plebanek, K., Michalowska, I., Witowicz, H., Kurkowska-Jastrzebska, I., Adamczak, M., Pajak, I., Kabat, M., Odrowaz-Pieniazek, P., Tekieli, L., Wozakowska-Kaplon, B., Stefanczyk, L., Przewlocki, T., Januszewicz, A., and Szczerbo-Trojanowska, M.
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- 2018
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6. Cardiology cathlab-based management of thrombotic carotid stenoses in acute ischaemic stroke: tools, techniques, local stroke unit collaboration, challenges and patient outcomes
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Musialek, P, primary, Mazurek, A, additional, Tekieli, L, additional, Tomaszewski, T, additional, Banaszkiewicz, K, additional, Urbanczyk, M, additional, Banys, R P, additional, Moczulski, Z, additional, Klecha, A, additional, Kowalczyk, T, additional, Drazkiewicz, T, additional, Trystula, M, additional, Musial, R, additional, Podolec, P, additional, and Grunwald, I Q, additional
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- 2021
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7. P769Serum biomarkers and key carotid atherosclerotic plaque morphology parameters determined in vivo using a novel, fully-quantitative virtual histology image analysis algorithm
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Musialek, P, Tekieli, L, Mazurek, A, Dabrowski, W, Stepien, E, Pieniazek, P, Kablak-Ziembicka, A, Zmudka, K, Undas, A, and Podolec, P
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- 2014
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8. A meta-analysis of the effect of stent design on clinical and radiologic outcomes of carotid artery stenting
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de Vries, Evelien E., Meershoek, Armelle J.A., Vonken, Evert J., den Ruijter, Hester M., van den Berg, Jos C., de Borst, Gert J., Bijuklic, K., Schofer, J., Bonati, L., Bosiers, M., Wauters, J., de Donato, G., Chisci, E., Setacci, C., Doig, D., Featherstone, R. L., Dobson, J., Brown, M. M., Eskandari, M. K., Giri, J., Grunwald, I. Q., Kühn, A. L., Han, D. K., Faries, P. L., Hernandez-Fernandez, F., Parrilla, G., Hornung, M., Sievert, H., Kono, K., Latacz, P., Ledwoch, J., Mudra, H., Maleux, G., Nolz, R., Ohki, T., Piazza, M., Pieniazek, P., Tekieli, L., Radak, D., Tanaskovic, S., Rasiova, M., Simonte, G., Fiorucci, B., Tietke, M. W.K., Ventoruzzo, G., de Vries, Evelien E., Meershoek, Armelle J.A., Vonken, Evert J., den Ruijter, Hester M., van den Berg, Jos C., de Borst, Gert J., Bijuklic, K., Schofer, J., Bonati, L., Bosiers, M., Wauters, J., de Donato, G., Chisci, E., Setacci, C., Doig, D., Featherstone, R. L., Dobson, J., Brown, M. M., Eskandari, M. K., Giri, J., Grunwald, I. Q., Kühn, A. L., Han, D. K., Faries, P. L., Hernandez-Fernandez, F., Parrilla, G., Hornung, M., Sievert, H., Kono, K., Latacz, P., Ledwoch, J., Mudra, H., Maleux, G., Nolz, R., Ohki, T., Piazza, M., Pieniazek, P., Tekieli, L., Radak, D., Tanaskovic, S., Rasiova, M., Simonte, G., Fiorucci, B., Tietke, M. W.K., and Ventoruzzo, G.
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- 2019
9. A meta-analysis of the effect of stent design on clinical and radiologic outcomes of carotid artery stenting
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Zorgeenheid Vaatchirurgie Medisch, MS Radiologie, Circulatory Health, Experimentele Afd. Cardiologie 1, Regenerative Medicine and Stem Cells, Brain, de Vries, Evelien E., Meershoek, Armelle J.A., Vonken, Evert J., den Ruijter, Hester M., van den Berg, Jos C., de Borst, Gert J., Bijuklic, K., Schofer, J., Bonati, L., Bosiers, M., Wauters, J., de Donato, G., Chisci, E., Setacci, C., Doig, D., Featherstone, R. L., Dobson, J., Brown, M. M., Eskandari, M. K., Giri, J., Grunwald, I. Q., Kühn, A. L., Han, D. K., Faries, P. L., Hernandez-Fernandez, F., Parrilla, G., Hornung, M., Sievert, H., Kono, K., Latacz, P., Ledwoch, J., Mudra, H., Maleux, G., Nolz, R., Ohki, T., Piazza, M., Pieniazek, P., Tekieli, L., Radak, D., Tanaskovic, S., Rasiova, M., Simonte, G., Fiorucci, B., Tietke, M. W.K., Ventoruzzo, G., Zorgeenheid Vaatchirurgie Medisch, MS Radiologie, Circulatory Health, Experimentele Afd. Cardiologie 1, Regenerative Medicine and Stem Cells, Brain, de Vries, Evelien E., Meershoek, Armelle J.A., Vonken, Evert J., den Ruijter, Hester M., van den Berg, Jos C., de Borst, Gert J., Bijuklic, K., Schofer, J., Bonati, L., Bosiers, M., Wauters, J., de Donato, G., Chisci, E., Setacci, C., Doig, D., Featherstone, R. L., Dobson, J., Brown, M. M., Eskandari, M. K., Giri, J., Grunwald, I. Q., Kühn, A. L., Han, D. K., Faries, P. L., Hernandez-Fernandez, F., Parrilla, G., Hornung, M., Sievert, H., Kono, K., Latacz, P., Ledwoch, J., Mudra, H., Maleux, G., Nolz, R., Ohki, T., Piazza, M., Pieniazek, P., Tekieli, L., Radak, D., Tanaskovic, S., Rasiova, M., Simonte, G., Fiorucci, B., Tietke, M. W.K., and Ventoruzzo, G.
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- 2019
10. A meta-analysis of the effect of stent design on clinical and radiologic outcomes of carotid artery stenting
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de Vries, Evelien E., primary, Meershoek, Armelle J.A., additional, Vonken, Evert J., additional, den Ruijter, Hester M., additional, van den Berg, Jos C., additional, de Borst, Gert J., additional, Bijuklic, K., additional, Schofer, J., additional, Bonati, L., additional, Bosiers, M., additional, Wauters, J., additional, de Donato, G., additional, Chisci, E., additional, Setacci, C., additional, Doig, D., additional, Featherstone, R.L., additional, Dobson, J., additional, Brown, M.M., additional, Eskandari, M.K., additional, Giri, J., additional, Grunwald, I.Q., additional, Kühn, A.L., additional, Han, D.K., additional, Faries, P.L., additional, Hernandez-Fernandez, F., additional, Parrilla, G., additional, Hornung, M., additional, Sievert, H., additional, Kono, K., additional, Latacz, P., additional, Ledwoch, J., additional, Mudra, H., additional, Maleux, G., additional, Nolz, R., additional, Ohki, T., additional, Piazza, M., additional, Pieniazek, P., additional, Tekieli, L., additional, Radak, D., additional, Tanaskovic, S., additional, Rasiova, M., additional, Simonte, G., additional, Fiorucci, B., additional, Tietke, M.W.K., additional, and Ventoruzzo, G., additional
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- 2019
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11. Cardiopoietic cell therapy for advanced ischemic heart failure : results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
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Bartunek, Jozef, Terzic, Andre, Davison, Beth A, Filippatos, Gerasimos S, Radovanovic, Slavica, Beleslin, Branko, Merkely, Bela, Musialek, Piotr, Wojakowski, Wojciech, Andreka, Peter, Horvath, Ivan G, Katz, Amos, Dolatabadi, Dariouch, El Nakadi, Badih, Arandjelovic, Aleksandra, Edes, Istvan, Seferovic, Petar M, Obradovic, Slobodan, Vanderheyden, Marc, Jagic, Nikola, Petrov, Ivo, Atar, Shaul, Halabi, Majdi, Gelev, Valeri L, Shochat, Michael K, Kasprzak, Jaroslaw D, Sanz Ruiz, Ricardo, Heyndrickx, Guy R, Nyolczas, Noémi, Legrand, Victor, Guédès, Antoine, Heyse, Alex, Moccetti, Tiziano, Fernandez Aviles, Francisco, Jimenez Quevedo, Pilar, Bayes Genis, Antoni, Hernandez Garcia, Jose Maria, Ribichini, Flavio, Gruchala, Marcin, Waldman, Scott A, Teerlink, John R, Gersh, Bernard J, Povsic, Thomas J, Henry, Timothy D, Metra, Marco, Hajjar, Roger J, Tendera, Michal, Behfar, Atta, Alexandre, Bertrand, Seron, Aymeric, Stough, Wendy Gattis, Sherman, Warren, Cotter, Gad, Wijns, W. i. l. l. i. a. m. Collaborators Clinical investigators, Dens, sites Belgium: Ziekenhuis Oost Limburg: J., Dupont, M., Mullens, W., Janssens, M., Dolatabadi, Hoˆpital Civil de Charleroi: D., De Bruyne, Y., Lalmand, J., Dubois, P., El Nakadi, B., Aminian, A., De Vuyst, E., Gurnet, P., Gujic, M., Blankoff, I., Guedes, CHU Mont Godinne UCL: A., Gabriel, L., Seldrum, S., Doyen, C., Andre´, M., Heyse, AZ Glorieux: A., Van Durme, F., Verschuere, J., Legrand, Domaine Universitaire du Sart Tilman: V., Gach, O., D’Orio, V., Davin, L., Lancellotti, P., Baudoux, E., Ancion, A., Dulgheru, R., Vanderheyden, OLV Ziekenhuis Aalst – Cardiologie: M., Bartunek, J., Wijns, W., Verstreken, S., Penicka, . M., Gelev, P. Meeus Bulgaria: Tokuda Hospital Sofia: V., Zheleva Kichukova, I., Parapunova, R., Melamed, R., Sardovski, S., Radev, O., Yordanov, A., Radinov, A., Nenov, D., Amine, I., Petrov, City Hospital Clinic Cardiology Center: I., Kichukov, K., Nikitasov, L., Stankov, Z., Stoyanov, H., Tasheva Dimitrova, I., Angelova, M., Dimitrov, E., Minchev, M., Garvanski, I., Botev, C., Polomski, P., Alexandrovska University Hospital, Vassilev, Sofia: D., Karamfiloff, K., Tarnovska Kadreva, R., Vladimirova, L., Dimitrov, G., Hadzhiev, E., Tzvetkova, G., Andreka, . M. Atanasova Hungary: Gottsegen Gyo¨ rgy Orszagos Kardiologiai Inte´zet: P., Fontos, G., Fabian, J., Csepregi, A., Uzonyi, G., Gelei, A., Edes, Debreceni Egyetem Orvos e´s Ege´szse´gtudomanyi Centrum Altalanos Orvostudomanyi Kar Kardiologia Inte´zet: I., Balogh, L., Vajda, G., Darago, A., Gergely, S., Fulop, T., Jenei, C., Horvath, Pe´csi Tudomanyegyetem Klinikai Ko¨zpont Szıvgyogyaszati Klinika: I., Magyari, B., Nagy, A., Cziraki, A., Faludi, R., Kittka, B., Alizadeh, H., Merkely, Semmelweis Egyetem Varosmajori Szıv e´s Ergyogyaszati Klinika: B., Geller, L., Farkas, P., Szombath, G., Foldes, G., Skopal, J., Kovacs, A., Kosztin, A., Gara, E., Sydo, N., Nyolczas, MH Ege´szse´gu¨gyi Ko¨zpont Kardiologiai Osztaly: N., Kerecsen, G., Korda, A., Kiss, . M., Borsanyi, T., Polgar, B., Muk, B., Sharif, Z. Bari Ireland: HRB Clinical Research Facility: F., Atar, Y. M. Smyth Israel:Western Galilee Hospital: S., Shturman, A., Akria, L., Kilimnik, M., Brezins, M., Halabi, Ziv Medical Center: M., Dally, N., Goldberg, A., Aehab, K., Rosenfeld, I., Levinas, T., Saleem, D., Katz, Barzilai Medical Center: A., Plaev, T., Drogenikov, T., Nemetz, A., Barshay, Y., Jafari, J., Orlov, I., Nazareth Hospital EMMS: M. Omory, N. Kogan Nielsen, Shochat, Hillel Yaffe Medical Center: M., Shotan, A., Frimerman, A., Meisel, S., Asif, A., Sofer, O., Blondheim, D. S., Vazan, A., Metra, L. Arobov Italy: A. O. Spedali Civili di Brescia: M., Bonadei, I., Inama, L., Chiari, E., Lombardi, C., Magatelli, M., Russo, D., Lazzarini, V., Carubelli, V., Vassanelli, AOUI Verona – Borgo Trento Hospital: C., Ribichini, Flavio Luciano, Bergamini, C., Krampera, Mauro, Cicoria, M. A., Zanolla, L., Dalla Mura, D., Gambaro, A., Rossi, A., Pesarini Poland: Jagiellonian University Department of Cardiac, G., Musialek, Vascular Diseases at John Paul II Hospital in Krakow: P., Mazurek, A., Drabik, L., Ka˛dzielski, A., Walter, Z., Dzieciuch Rojek, M., Rubis, P., Plazak, . W., Tekieli, L., Podolec, J., Orczyk, W., Sutor, U., Zmudka, K., Olszowska, M., Podolec, P., Gruchala, Uniwersyteckie Centrum Kliniczne: M., Ciecwierz, D., Mielczarek, M., Burakowski, S., Chmielecki, M., Zielinska, M., Frankiewicz, A., Wdowczyk, J., Stopczynska, I., Bellwon, J., Mosakowska, K., Nadolna, R., Wroblewska, J., Rozmyslowska, M., Rynkiewicz, M., Marciniak, I., Raczak, G., Tarnawska, M., Taszner, M., Kasprzak, Bieganski Hospital: J., Plewka, M., Fiutowska, D., Rechcinski, T., Lipiec, P., Sobczak, M., Weijner Mik, P., Wraga, M., Krecki, R., Markiewicz, M., Haval Qawoq, D., Wojakowski, Gornosla˛skie Centrum Medyczne Sla˛skie j. Akademii Medycznej: W., Ciosek, J., Dworowy, S., Gaszewska Zurek, E., Ochala, A., Cybulski, W., Jadczyk, T., Wanha, W., Parma, Z., Kozlowski, M., Dzierzak, M., Markiewicz Serbia: Clinical Hospital Center Zvezdara, M., Arandjelovic, Cardiology Clinic: A., Sekularac, N., Boljevic, D., Bogdanovic, A., Zivkovic, S., Cvetinovic, N., Loncar, G., Clinical Centre of Serbia, Beleslin, Cardiology Clinic: B., Nedeljkovic, M., Trifunovic, D., Giga, V., Banovic, M., Nedeljkovic, I., Stepanovic, J., Vukcevic, V., Djordjevic Dikic, A., Dobric, M., Obrenovic Kircanski, B., Seferovic, Cardiology Clinic: P., Orlic, D., Tesic, M., Petrovic, O., Milinkovic, I., Simeunovic, D., Jagic, Clinical Center of Kragujevac: N., Tasic, M., Nikolic, D., Miloradovic, V., Djurdjevic, P., Sreckovic, M., Zornic, N., Clinical Hospital Center Bezanijska Kosa, Radovanovic, Cardiology Department: S., Saric, J., Hinic, S., Djokovic, A., Ðordevic, S., Bisenic, V., Markovic, O., Stamenkovic, S., Malenkovic, V., Tresnjak, J., Misic, G., Cotra, D., Tomovic, L., Vuckovic, V., Clinic of Emergency Internal Medicine, Obradovic, Military Medical Academy: S., Jovic, Z., Vukotic, S., Markovic, D., Djenic, N., Ristic Andjelkov, A., Bayes Genis, D. Ljubinka Spain: Hospital Universitario Germans Trias I. Pujol: A., Rodriguez Leor, O., Labata, C., Vallejo, N., Ferrer, E., Batlle, M., Fernandez Aviles, Hospital General Universitario Gregorio Mara~non: F., Sanz Ruiz, R., Casado, A., Loughlin, G., Zatarain, E., Anguita, J., Ferna ndez Santos, M. E., Pascual, C., Bermejo, J., Hernandez Garcia, Hospital Clinico Universitario Virgen de la Victoria: J. M., Jimenez Navarro, M., Dominguez, A., Carrasco, F., Mu~noz, A., Garcia Pinilla, J. M., Ruiz, J., Queipo de Llano, M. P., Hernandez, A., Fernandez, A., Jimenez Quevedo, Hospital Clinico San Carlos: P., Guerra, R., Biagioni, C., Gonzalez, R. A., Gomez deDiego, J. J., Mansson Broberg, L. Perez de Isla Sweden: Karolinska University Hospital: A., Sylve´n, C., Leblanc, K., Winter, R., Blomberg, P., Gunyeli, E., Ruck, A., Silva, C., Fo¨rstedt Switzerland: CardioCentro Ticino, J., Moccetti, Switzerland: T., Rossi, M., Pasotti, E., Petrova, I., Crljenica, C., Monti, C., Murzilli, R., Su¨rder, D., Moccetti, M., Turchetto, L., Locicero, V., Chiumiento, L., Maspoli, S., Mombelli, M., Anesini, A., Biggiogero, M., Ponti, G., Camporini, C., Polledri, S., Hill, G. Dolci United Kingdom: Kings College Hospital: J., Plymen, C., Amin Youssef, G., Mcdonagh, T., Drasar, E., Mijovic, A., Jouhra, F., Mcloman, D., Dworakowski, R., Webb, I., Byrne, J., and Potter, V.
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0301 basic medicine ,Male ,Cardiopoiesis ,Cardiovascular disease ,Disease severity ,Marker ,Precision medicine ,Regenerative medicine ,Stem cell ,Target population ,Adult ,Aged ,Double-Blind Method ,Female ,Heart Failure ,Humans ,Mesenchymal Stem Cell Transplantation ,Middle Aged ,Myocardial Ischemia ,Prospective Studies ,Treatment Outcome ,Young Adult ,Cardiology and Cardiovascular Medicine ,Cell- and Tissue-Based Therapy ,mesenchymal stem-cells ,030204 cardiovascular system & hematology ,Cardiorespiratory Medicine and Haematology ,outcomes ,Fast-Track Clinical Research ,Sudden cardiac death ,0302 clinical medicine ,Ischemia ,cardiovascular disease ,Clinical endpoint ,target population ,CHART Program ,Ejection fraction ,bone-marrow ,Heart Failure/Cardiomyopathy ,3. Good health ,Cohort ,Cardiology ,Fast Track ,disease severity ,delivery ,medicine.medical_specialty ,precision medicine ,Clinical Sciences ,regenerative medicine ,03 medical and health sciences ,cardiopoiesis ,Internal medicine ,medicine ,Adverse effect ,marker ,disease ,business.industry ,medicine.disease ,mortality ,Confidence interval ,Clinical trial ,stem cell ,Editor's Choice ,030104 developmental biology ,predictors ,Cardiovascular System & Hematology ,Heart failure ,business - Abstract
Altres ajuts: This work was supported by Celyad, SA (Mont-Saint-Guibert, Belgium). Celyad has received research grants from the Walloon Region (Belgium, DG06 funding). Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.
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- 2017
12. [PP.19.10] THE ARCADIA-POL STUDY– INVOLVEMENT OF CERVICAL AND INTRACRANIAL ARTERIES IN RELATION TO VASCULAR COMPLICATIONS AND ASSOCIATED CLINICAL SYMPTOMS IN PATIENTS WITH RENAL FMD
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Swiatlowski, L., primary, Hanus, K., additional, Warchol-Celinska, E., additional, Januszewicz, M., additional, Michalowska, I., additional, Florczak, E., additional, Prejbisz, A., additional, Kadziela, J., additional, Widecka, K., additional, Soltysiak, M., additional, Rowinski, O., additional, Pajak, I., additional, Kabat, M., additional, Odrowaz-Pieniazek, P., additional, Tekieli, L., additional, Wozakowska-Kaplon, B., additional, Stefanczyk, L., additional, Przewlocki, T., additional, Januszewicz, A., additional, and Szczerbo-Trojanowska, M., additional
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- 2017
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13. P4319Carotid artery stenting simultaneous with urgent cardiac surgery as a revascularization method for patients with severe carotid and cardiac disease
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Dzierwa, K., primary, Piatek, J., additional, Konstanty-Kalandyk, J., additional, Paluszek, P., additional, Tekieli, L., additional, Trystula, M., additional, Michalski, M., additional, Musial, R., additional, Zmudka, K., additional, and Pieniazek, P., additional
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- 2017
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14. [PP.37.02] ASSOCIATION BETWEEN TWO ANGIOGRAPHIC SUBTYPES OF RENAL ARTERY FIBROMUSCULAR DYSPLASIA AND CLINICAL CHARACTERITSIC
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Florczak, E., primary, Miadziolko, M., additional, Warchol-Celinska, E., additional, Januszewicz, M., additional, Michalowska, I., additional, Hanus, K., additional, Jozwik-Plebanek, K., additional, Prejbisz, A., additional, Talarowska, P., additional, Kadziela, J., additional, Nazarewski, S., additional, Madej, K., additional, Grygiel, K., additional, Litwin, M., additional, Niemirska, A., additional, Skowronska, M., additional, Witkowski, A., additional, Odrowaz-Pieniazek, P., additional, Tekieli, L., additional, and Januszewicz, A., additional
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- 2016
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15. [PP.37.15] CLINICAL PRESENTATION OF PATIENTS WITH FIBROMUSCULAR DYSPLASIA ACCORDING TO THE NUMBER OF VASCUALR BEDS AFFECTED
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Jozwik-Plebanek, K., primary, Januszewicz, M., additional, Wojcik, W., additional, Warchol-Celinska, E., additional, Hanus, K., additional, Michalowska, I., additional, Florczak, E., additional, Prejbisz, A., additional, Kabat, M., additional, Janaszek-Sitkowska, H., additional, Andziak, P., additional, Stryczynski, L., additional, Swiatlowski, L., additional, Odrowaz-Pieniazek, P., additional, Tekieli, L., additional, Stafanczyk, L., additional, Szczerbo-Trojanowska, M., additional, Witkowski, A., additional, Tykarski, A., additional, and Januszewicz, A., additional
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- 2016
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16. Vertebral artery in-stent restenosis incidence, risk factors and treatment methods in the prospective randomized STOVAST (STenting for Ostial Vertebral Artery STenosis) trial population
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Paluszek, P., primary, Pieniazek, P., additional, Dzierwa, K., additional, Tekieli, L., additional, Musialek, P., additional, Przewlocki, T., additional, Kablak-Ziembicka, A., additional, Hlawaty, M., additional, Trystula, M., additional, and Podolec, P., additional
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- 2013
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17. Factors determining long term survival and risk of cardiovascular events in patients treated with subclavian artery angioplasty
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Wrotniak, L., primary, Przewlocki, T., additional, Kablak-Ziembicka, A., additional, Pieniazek, P., additional, Roslawiecka, A., additional, Musialek, P., additional, Kozanecki, A., additional, Tekieli, L., additional, and Podolec, P., additional
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- 2013
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18. Simultaneous or staged carotid artery stenting and coronary artery bypass grafting as the revascularization strategy for severe, concurrent carotid and coronary disease in TARGET-CAS study population
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Dzierwa, K., primary, Pieniazek, P., additional, Tekieli, L., additional, Musialek, P., additional, Przewlocki, T., additional, Piatek, J., additional, Konstanty-Kalandyk, J., additional, Trystula, M., additional, Kosobucka-Peszat, R., additional, and Podolec, P., additional
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- 2013
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19. Proximal embolic protection devices for high risk lesions/patients in "TARGET-CAS" registry of 1717 consecutive carotid artery stenting procedures
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Tekieli, L., primary, Pieniazek, P., additional, Musialek, P., additional, Przewlocki, T., additional, Kablak-Ziembicka, A., additional, Dzierwa, K., additional, Paluszek, P., additional, Hlawaty, M., additional, Zmudka, K., additional, and Podolec, P., additional
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- 2013
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20. Randomized transcoronary delivery of CD34(+) cells with perfusion versus stop-flow method in patients with recent myocardial infarction: Early cardiac retention of ⁹⁹(m)Tc-labeled cells activity.
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Musialek P, Tekieli L, Kostkiewicz M, Majka M, Szot W, Walter Z, Zebzda A, Pieniazek P, Kadzielski A, Banys RP, Olszowska M, Pasowicz M, Zmudka K, Tracz W, Musialek, Piotr, Tekieli, Lukasz, Kostkiewicz, Magdalena, Majka, Marcin, Szot, Wojciech, and Walter, Zbigniew
- Abstract
Background: For transcoronary progenitor cells' administration, injections under flow arrest (over-the-wire balloon technique, OTW) are used universally despite lack of evidence for being required for cell delivery or being effective in stimulating myocardial engraftment. Flow-mediated endothelial rolling is mandatory for subsequent cell adhesion and extravasation.Methods: To optimize cell directing toward the coronary endothelium under maintained flow, the authors developed a cell-delivery side-holed perfusion catheter (PC). Thirty-four patients (36-69 years, 30 men) with primary stent-assisted angioplasty-treated anterior MI (peak TnI 151 [53-356]ng/dL, mean[range]) were randomly assigned to OTW or PC autologous ⁹⁹Tc-extametazime-labeled bone marrow CD34(+) cells (4.34 [0.92-7.54] × 10⁶) administration at 6-14 days after pPCI (LVEF 37.1 [24-44]%). Myocardial perfusion (⁹⁹(m)Tc-MIBI) and labeled cells' activity were evaluated (SPECT) at, respectively, 36-48 h prior to and 60 min after delivery.Results: In contrast to OTW coronary occlusions, no intolerance or ventricular arrhythmia occurred with PC cells' administration (P < .001). One hour after delivery, 4.86 [1.7-7.6]% and 5.05 [2.2-9.9]% activity was detected in the myocardium (OTW and PC, respectively, P = .84). Labeled cell activity was clearly limited to the (viable) peri-infarct zone in 88% patients, indicating that the infarct core zone may be largely inaccessible to transcoronary-administered cells.Conclusions: Irrespective of the transcoronary delivery method, only ≈ 5% of native (i.e., non-engineered) CD34(+) cells spontaneously home to the injured myocardium, and cell retention occurs preferentially in the viable peri-infarct zone. Although the efficacy of cell delivery is not increased with the perfusion method, by avoiding provoking ischemic episodes PC offers a rational alternative to the OTW delivery. [ABSTRACT FROM AUTHOR]- Published
- 2011
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21. Carotid Artery Stenting With Patient- and Lesion-Tailored Selection of the Neuroprotection System and Stent Type: Early and 5-Year Results From a Prospective Academic Registry of 535 Consecutive Procedures (TARGET-CAS)
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Pieniazek P, Musialek P, Kablak-Ziembicka A, Tekieli L, Motyl R, Przewlocki T, Moczulski Z, Pasowicz M, Sokolowski A, Lesniak-Sobelga A, Zmudka K, and Tracz W
- Abstract
PURPOSE: To develop and prospectively evaluate the safety and efficacy of an algorithm for tailoring neuroprotection devices (NPD) and stent types to the patient/lesion in carotid artery stenting (CAS). METHODS: From November 2002 to October 2007, 499 patients (360 men; mean age 65.2+/-8.4 years, range 36-88) were prospectively enrolled in a safety and efficacy study of tailored CAS using proximal (flow blockade or reversal) or distal (filters or occlusion) NPDs and closed- or open-cell self-expanding stents. Of the 535 lesions treated in the study, 175 (32.7%) were 'high risk' by morphology. Half (50.1%) the patients were symptomatic. RESULTS: A quarter (137, 25.6%) of the procedures were performed under proximal protection and the remainder (398, 74.4%) with distal NPDs; the direct stenting rate was 66.9%. High-risk lesions were treated predominantly with a proximal NPD and closed-cell stent (77.1% and 82.9%, respectively) and less frequently by direct stenting (37.1%, p<0.0001 versus non-high-risk lesions). The in-hospital death/stroke rate was 2.0% (95% CI 0.85% to 3.23%), and the death/major stroke rate was 0.7% (95% CI 0.02% to 1.48%). There were no myocardial infarctions, but there was 1 (0.2%) further death within 30 days. With the tailored approach, symptom status and high-risk lesion morphology were not risk factors for an adverse outcome after CAS; only age >75 years (p<0.001) was a predictor of short-term death. Long-term survival (95.4% at 1 and 88.3% at 5 years) was similar for symptomatic versus asymptomatic patients, direct stenting versus predilation, and closed- vs. open-cell stent design; only coronary artery disease adversely impacted survival (p = 0.04). The rates of freedom from death/ipsilateral stroke were 94.9% at 1 year and 85.9% at 5 years. CONCLUSION: Tailored CAS is associated with a low complication rate and high long-term efficacy. CAS operators should have a practical knowledge of different NPDs, including at least one proximal type. [ABSTRACT FROM AUTHOR]
- Published
- 2008
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22. Percutaneous transluminal septal myocardial ablation: early results and long-term follow-up,Bezpośrednie i odległe wyniki przezskórnej ablacji alkoholowej przegrody miedzykomorowej u chorych z kardiomiopatia przerostowa zawezajaca droge wypływu
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Tekieli, L., Pieniazek, P., Podolec, P., Tomkiewicz-Pajak, L., Płazak, W., Musiałek, P., Leśniak-Sobelga, A., Przewłocki, T., Biernacka, B., Zmudka, K., and Tracz, W.
23. P769 Serum biomarkers and key carotid atherosclerotic plaque morphology parameters determined in vivo using a novel, fully-quantitative virtual histology image analysis algorithm.
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Musialek, P, Tekieli, L, Mazurek, A, Dabrowski, W, Stepien, E, Pieniazek, P, Kablak-Ziembicka, A, Zmudka, K, Undas, A, and Podolec, P
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- *
SERUM , *BIOMARKERS , *ATHEROSCLEROTIC plaque , *MORPHOLOGY , *IMAGE analysis , *ULTRASONIC imaging - Abstract
Purpose: Recent evidence shows that blood biomarkers, in isolation, are largely ineffective in risk stratification of carotid atherosclerotic plaque (CS) symptomatic transformation. Stenosis degree is a poor marker of symptom risk while plaque morphology may play a role. Intravascular ultrasound (IVUS) provides high-resolution (axial ≤0.12mm for 20MHz transducer) imaging, but conventional phenotypic virtual histology (VH-IVUS) plaque classification poor between-center/-observer reproducibility limits any wider applicability. Moreover, conventional VH-IVUS, addressing total content of eg necrotic core (NC), does not discriminate focal vs. dissociated NC that is relevant to rupture risk. We investigated whether quantitative measures of key plaque components implicated in rupture risk are related to levels of several circulating biomarkers.Methods: We developed a novel software-based algorithm for detailed, fully-quantitative VH-IVUS analysis of key plaque components known for their role in plaque rupture/thrombosis. In 21 plaques we validated inter-transducer (2 transducers) and inter-observer (3 observers) reproducibility of qVH-IVUS analysis including minimal fibrous cap (FC) thickness, and peak confluent NC area, thickness and arc. Next we employed our qVH-IVUS algorithm to evaluate CS lesions in 252 consecutive patients (age 47–83, 63.4% men, h/o CS-attributable symptoms in 50.3%) presenting for potential CS revascularization. Finally, in the first 200 subjects we determined the levels of a panel of biomarkers and preformed regression analysis in search for quantitative CS morphology/biomarker associations.Results: qVH-IVUS revealed significant differences in minimal FC thickness (0.41±0.04 v 0.34±0.05 v 0.16±0.02 v 0.19±0.03mm), peak confl NC area (3.0±0.2 v 2.5±0.3 v 4.4±0.4 v 3.4±0.5mm2), arc (87.1±6 v 67.2±6 v 121.6±9 v 94.0±9deg) and thickness (0.88±0.04 v 1.07±0.07 v 1.34±0.06 v 1.16±0.11 mm); data for asympt CS in absence of contralat symptoms, asympt CS in presence of contralat symptoms, recently symptomatic and remotely symptomatic CS, p<0.001 for all.While hsCRP was not correlated with min FC (r=-0.24, p=0.74) or NC area (r=0.05, p=0.48), TIMP correlated with min FC (r=0.34, p=0.001). Modest though highly significant correlations were identified between Lp-PLA2 and confl NC area (r=0.3, p=0.0001), HDL and confl NC thckn (r=-0.21, p=0.002). Fibrinogen level correlated with % plaque fibrotic content (r=0.19, p=0.008).Conclusion: These findings provide novel insights into circulating biomarker/quantitative plaque morphology associations that may be relevant to plaque biology and risk. [ABSTRACT FROM AUTHOR]
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- 2014
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24. MicroNET-covered stent (CGuard) routine use in acute carotid-related stroke - SAFEGUARD-STROKE Study: response to the Buffalo Group commentary.
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Tekieli L, Mazgaj M, Ruzsa Z, Janus B, Paluszek P, Sievert H, Grunwald IQ, and Musialek P
- Abstract
Competing Interests: HS has proctored and advised to manufacturers of interventional cardiovascular medicine equipment and devices. IQG was the Principal Investigator on the first study of thrombus aspiration in acute ischemic stroke and has proctored and advised to neurointerventional equipment and device manufacturers. IQG is Vice-President of the World Federation for Interventional Stroke Treatment (WIST). PM has been proctoring and/or consulting for Abbott Vascular, Balton, Gore, InspireMD, Medtronic and Penumbra. PM has served as the Polish Cardiac Society Board Representative for Stroke and Vascular Interventions and serves on the ESC Stroke Council Scientific Documents Task Force. PM is Global Co-Principal Investigator in the CGUARDIANS FDA IDE Trial of the MicroNET-covered carotid stent system. The other authors declare no conflict of interest.
- Published
- 2024
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25. Next-generation transcarotid artery revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes - TOPGUARD Study.
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Trystula M, VAN Herzeele I, Kolvenbach R, Tekieli L, Fonteyne C, Mazurek A, Dzierwa K, Chmiel J, Lindsay J, Kwiatkowski T, Hydzik A, Oplawski M, Bederski K, and Musialek P
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- Humans, Aged, Female, Male, Middle Aged, Treatment Outcome, Time Factors, Risk Factors, Cerebrovascular Circulation, Endovascular Procedures instrumentation, Endovascular Procedures adverse effects, Prospective Studies, Stroke prevention & control, Stroke etiology, Stents, Carotid Stenosis surgery, Carotid Stenosis physiopathology, Carotid Stenosis diagnostic imaging, Carotid Stenosis complications, Prosthesis Design, Intracranial Embolism prevention & control, Intracranial Embolism etiology, Embolic Protection Devices
- Abstract
Background: Stent-assisted carotid artery revascularization employing surgical cutdown for transcervical access and dynamic flow reversal (TCAR) is gaining popularity. TCAR, despite maximized intra-procedural cerebral protection, shows a marked excess of 30-day neurologic complications in symptomatic vs. asymptomatic stenoses. The TCAR conventional single-layer stent (free-cell area 5.89mm
2 ) inability to seal embologenic lesions may be particularly relevant after the flow reversal neuroprotection is terminated., Methods: We evaluated peri-procedural and 30-day major adverse cerebral and cardiac events (MACCE) of TCAR (ENROUTE, SilkRoad Medical) paired with MicroNET-covered neuroprotective stent (CGuard, InspireMD) in consecutive patients at elevated risk of complications with transfemoral/transradial filter-protected stenting (increased lesion-related and/or access-related risk). CGuard (MicroNET free cell area ≈0.02-0.03 mm2 ) has level-1 evidence for reducing intra- and abolishing post-procedural lesion-related cerebral embolism., Results: One hundred and six increased-risk patients (age 72 [61-76] years, median [Q1-Q3]; 60.4% symptomatic, 49.1% diabetic, 36.8% women, 61.3% left-sided index lesion) were enrolled in three vascular surgery centers. Angiographic stenosis severity was 81 (75-91)%, lesion length 21 (15-26)mm, increased-risk lesional characteristics 87.7%. Study stent use was 100% (no other stent types). 74.5% lesions were predilated; post-dilatation rate was 90.6%. Flow reversal duration was 8 (5-11)min. One stroke (0.9%) occurred in an asymptomatic patient prior to establishing neuroprotection (index lesion disruption with the sheath insertion wire); there were no other peri-procedural MACCE. No further adverse events occurred by 30-days. 30-day stent patency was 100% with normal velocities and absence of any in-stent material by Duplex Doppler., Conclusions: Despite a high proportion of increased-risk lesions and clinically symptomatic patients in this study, TCAR employing the MicroNET-covered anti-embolic stent showed 30-day MACCE rate <1%. This suggests a clinical role for combining maximized intra-procedural prevention of cerebral embolism by dynamic flow reversal with anti-embolic stent prevention of peri- and post-procedural cerebral embolism (TOPGUARD NCT04547387).- Published
- 2024
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26. Filter protection in contemporary carotid artery stenting: consider limited protection.
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Chmiel J, Tekieli L, Mazurek A, Czyz L, and Musialek P
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Competing Interests: PM has proctored and/or consulted for Abbott Vascular, Balton, Gore, InspireMD, and Medtronic; he has served as the Polish Cardiac Society Board Representative for Stroke and Vascular Interventions and serves on the ESC Stroke Council Scientific Documents Task Force. PM is Co-PI of the CGuardians FDA IDE Trial. Other authors declare no conflict of interest.
- Published
- 2024
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27. Outcomes in acute carotid-related stroke eligible for mechanical reperfusion: SAFEGUARD-STROKE Registry.
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Tekieli L, Dzierwa K, Grunwald IQ, Mazurek A, Urbanczyk-Zawadzka M, Wiewiorka L, Banys RP, Dabrowski W, Podlasek A, Weglarz E, Stefaniak J, Nizankowski RT, and Musialek P
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- Humans, Aged, Female, Male, Middle Aged, Aged, 80 and over, Treatment Outcome, Adult, Time Factors, Risk Factors, Thrombectomy adverse effects, Stents, Referral and Consultation, Endovascular Procedures adverse effects, Carotid Stenosis complications, Carotid Stenosis therapy, Carotid Stenosis surgery, Carotid Stenosis diagnostic imaging, Stroke etiology, Stroke therapy, Registries
- Abstract
Background: Carotid-related strokes (CRS) are largely unresponsive to intravenous thrombolysis and are often large and disabling. Little is known about contemporary CRS referral pathways and proportion of eligible patients who receive emergency mechanical reperfusion (EMR)., Methods: Referral pathways, serial imaging, treatment data, and neurologic outcomes were evaluated in consecutive CRS patients presenting over 18 months in catchment area of a major carotid disease referral center with proximal-protected CAS expertise, on-site neurology, and stroke thrombectomy capability (Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD Stent - SAFEGUARD-STROKE Registry; companion to SAFEGUARD-STROKE Study NCT05195658)., Results: Of 101 EMR-eligible patients (31% i.v.-thrombolyzed, 39.5% women, age 39-89 years, 94.1% ASPECTS 9-10, 90.1% pre-stroke mRS 0-1), 57 (56.4%) were EMR-referred. Referrals were either endovascular (Comprehensive Stroke Centre, CSC, 21.0%; Stroke Thrombectomy-Capable CAS Centre, STCC, 70.2%) or to vascular surgery (VS, 1.8%), with >1 referral attempt in 7.0% patients (CSC/VS or VS/CSC or CSC/VS/STCC). Baseline clinical and imaging characteristics were not different between EMR-treated and EMR-untreated patients. EMR was delivered to 42.6% eligible patients (emergency carotid surgery 0%; STCC rejections 0%). On multivariable analysis, non-tandem CRS was a predictor of not getting referred for EMR (OR 0.36; 95%CI 0.14-0.93, P=0.03). Ninety-day neurologic status was profoundly better in EMR-treated patients; mRS 0-2 (83.7% vs. 34.5%); mRS 3-5 (11.6% vs. 53.4%), mRS 6 (4.6% vs. 12.1%); P<0.001 for all., Conclusions: EMR-treatment substantially improves CRS neurologic outcomes but only a minority of EMR-eligible patients receive EMR. To increase the likelihood of brain-saving treatment, EMR-eligible stroke referral and management pathways, including those for CSC/VS-rejected patients, should involve stroke thrombectomy-capable centres with endovascular carotid treatment expertise.
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- 2024
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28. A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.
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Tekieli L, Afanasjev A, Mazgaj M, Borodetsky V, Sievert K, Ruzsa Z, Knapik M, Širvinskas A, Mazurek A, Dzierwa K, Sanczuk T, Mosenko V, Urbanczyk-Zawadzka M, Trystula M, Paluszek P, Wiewiorka L, Stefaniak J, Pieniazek P, Slautaitė I, Kwiatkowski T, Mackevičius A, Teitcher M, Sievert H, Grunwald IQ, and Musialek P
- Abstract
Introduction: Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism., Aim: To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm
2 ) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine., Material and Methods: Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers., Results: The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001)., Conclusions: This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658)., Competing Interests: PM has been proctoring and/or consulting for Abbott Vascular, Balton, Gore, InspireMD, and Medtronic. PM has served as the Polish Cardiac Society Board Representative for Stroke and Vascular Interventions and serves on the ESC Stroke Council Scientific Documents Task Force. PM is Global Co-Principal Investigator in the CGUARDIANS FDA IDE Trial of the MicroNET-covered carotid stent system. HS has proctored and advised to manufacturers of interventional cardiovascular medicine equipment and devices. IQG was the Principal Investigator on the first study of thrombus aspiration in acute ischemic stroke and has proctored and advised to neurointerventional equipment and device manufacturers. IQG is Vice-President of the World Federation for Interventional Stroke Treatment (WIST). The other authors report no conflicting interests., (Copyright: © 2024 Termedia Sp. z o. o.)- Published
- 2024
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29. Rare instances of concomitant acute myocardial infarction and stroke.
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Maciejewski D, Nowak K, Wawak M, Karcinska A, Tekieli L, Trystula M, Musial R, Podolec J, Pieniazek P, and Zalewski J
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- Humans, Prospective Studies, Treatment Outcome, Stents adverse effects, Cerebral Infarction complications, Risk Factors, Carotid Stenosis, Ischemic Stroke complications, Stroke complications, Stroke diagnosis, Myocardial Infarction complications, Myocardial Infarction diagnosis, Myocardial Infarction therapy
- Abstract
Cardio-cerebral infarction (CCI) is a term coined to describe concomitant myocardial infarction and acute ischemic stroke. Acute myocardial infarction and stroke, as separate events, constitute some of the most important causes for disability and mortality in aging societies. Stroke can either occur simultaneously with myocardial infarction or become a serious complication of myocardial infarction and/or its treatment. The frequency of CCI has been reported at a 0.009% incidence rate in stroke patients and is associated with an extremely high mortality. Because of the rare occurrence of CCI, there are currently no guidelines for assessing its diagnosis and optimal treatment. Therefore, currently, the management of CCI cases needs to be individualized. Hopefully, in the future, the results of large clinical trials or prospective registries are expected to enhance our understanding of managing concomitant acute MI and stroke. In this review we have focused on the current literacy in the diagnosis and treatment of CCIs. The paper illustrates potential distinct scenarios of CCI through the analysis of three patient cases (Fig. 5, Ref. 65). Text in PDF www.elis.sk Keywords: myocardial infarction, stroke, cardio-cerebral infarction, carotid artery stenting, cardiac surgery.
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- 2024
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30. Carotid artery revascularization using second generation stents versus surgery: a meta-analysis of clinical outcomes.
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Mazurek A, Malinowski K, Sirignano P, Kolvenbach R, Capoccia L, DE Donato G, VAN Herzeele I, Siddiqui AH, Castrucci T, Tekieli L, Stefanini M, Wissgott C, Rosenfield K, Metzger DC, Snyder K, Karpenko A, Kuczmik W, Stabile E, Knapik M, Casana R, Pieniazek P, Podlasek A, Taurino M, Schofer J, Cremonesi A, Sievert H, Schmidt A, Grunwald IQ, Speziale F, Setacci C, and Musialek P
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- Humans, Carotid Arteries, Constriction, Pathologic, Stents, Vascular Surgical Procedures, Randomized Controlled Trials as Topic, Endarterectomy, Carotid adverse effects, Stroke etiology, Stroke prevention & control
- Abstract
Introduction: Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA)., Evidence Acquisition: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect., Evidence Synthesis: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery., Conclusions: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).
- Published
- 2023
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31. Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study.
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Dzierwa K, Kedziora A, Tekieli L, Mazurek A, Musial R, Dobrowolska E, Stefaniak J, Pieniazek P, Paluszek P, Konstanty-Kalandyk J, Sobczynski R, Kapelak B, Kleczynski P, Brzychczy A, Kwiatkowski T, Trystula M, Piatek J, and Musialek P
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- Humans, Male, United States, Female, Heparin, Risk Factors, Treatment Outcome, Stents adverse effects, Extracorporeal Circulation adverse effects, Stroke etiology, Cardiac Surgical Procedures adverse effects, Carotid Stenosis complications, Carotid Stenosis diagnostic imaging, Carotid Stenosis surgery, Endarterectomy, Carotid adverse effects
- Abstract
Background: In patients at urgent need for cardiac surgery coexisting with increased-stroke-risk carotid stenosis, any staged intervention increases the risk of complications from the primarily unaddressed pathology. In this challenging cohort, we assessed safety and feasibility of endovascular carotid revascularization under open-chest extracorporeal circulation (ECC) combined with cardiac surgery (hybrid-room true simultaneous treatment)., Methods: Per-protocol (PP), after general anesthesia induction, chest-opening and ECC stand-by installation, carotid stenting (CAS) was performed (femoral/radial or direct carotid access) with ad-hoc/on-hand switch to ECC cardiac surgery., Results: Over 78 months, 60 patients (70.7±6.9years, 85% male, all American Society of Anesthesiology grade IV) were enrolled. All were at increased carotid-related stroke risk (ipsilateral recent stroke/transient ischemick attack, asymptomatic cerebral infarct, increased-risk lesion morphology, bilateral severe stenosis). Majority of study procedures involved CAS+coronary bypass surgery or CAS+valve replacement±coronary bypass. 45 (75%) patients were PP- and 15 (25%) not-PP (NPP-) managed (context therapy). CAS was 100% neuroprotected (transient flow reversal-64.4%, filters-35.6%) and employed micronet-covered plaque-sequestrating stents with routine post-dilatation optimization/embedding. 4 deaths (6.7%) and 7 strokes (11.7%) occurred by 30-days. Despite CAS+surgery performed on aspirin and unfractionated heparin-only (delayed clopidogrel-loading), no thrombosis occurred in the stented arteries, and 30-days stent patency was 100%. NPP-management significantly increased the risk of death/ipsilateral stroke (OR 38.5; P<0.001) and death/any stroke (OR 12.3; P=0.002) by 30-days., Conclusions: In cardiac unstable patients at increased carotid-related stroke risk who require urgent cardiac surgery, simultaneous cardiac surgery and CAS with micronet-covered stent lesion sequestration is feasible and safe and shows efficacy in minimizing stroke risk. Larger-scale, multicentric evaluation is warranted. (SIMGUARD NCT04973579).
- Published
- 2023
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32. Imaging modality-dependent carotid stenosis severity variations against intravascular ultrasound as a reference: Carotid Artery intravasculaR Ultrasound Study (CARUS).
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Tekieli L, Kablak-Ziembicka A, Dabrowski W, Dzierwa K, Moczulski Z, Urbanczyk-Zawadzka M, Mazurek A, Stefaniak J, Paluszek P, Krupinski M, Przewlocki T, Pieniazek P, and Musialek P
- Abstract
Purpose: Different non-invasive and invasive imaging modalities are used to determine carotid artery stenosis severity that remains a principal parameter in clinical decision-making. We compared stenosis degree obtained with different modalities against vascular imaging gold standard, intravascular ultrasound, IVUS., Methods: 300 consecutive patients (age 47-83 years, 192 men, 64% asymptomatic) with carotid artery stenosis of " ≥ 50%" referred for potential revascularization received as per study protocol (i) duplex ultrasound (DUS), (ii) computed tomography angiography (CTA), (iii) intraarterial quantitative angiography (iQA) and (iv) and (iv) IVUS. Correlation of measurements with IVUS (r), proportion of those concordant (within 10%) and proportion of under/overestimated were calculated along with recipient-operating-characteristics (ROC)., Results: For IVUS area stenosis (AS) and IVUS minimal lumen area (MLA), there was only a moderate correlation with DUS velocities (peak-systolic, PSV; end-diastolic, EDV; r values of 0.42-0.51, p < 0.001 for all). CTA systematically underestimated both reference area and MLA (80.4% and 92.3% cases) but CTA error was lesser for AS (proportion concordant-57.4%; CTA under/overestimation-12.5%/30.1%). iQA diameter stenosis (DS) was found concordant with IVUS in 41.1% measurements (iQA under/overestimation 7.9%/51.0%). By univariate model, PSV (ROC area-under-the-curve, AUC, 0.77, cutoff 2.6 m/s), EDV (AUC 0.72, cutoff 0.71 m/s) and CTA-DS (AUC 0.83, cutoff 59.6%) were predictors of ≥ 50% DS by IVUS (p < 0.001 for all). Best predictor, however, of ≥ 50% DS by IVUS was stenosis severity evaluation by automated contrast column density measurement on iQA (AUC 0.87, cutoff 68%, p < 0.001). Regarding non-invasive techniques, CTA was the only independent diagnostic modality against IVUS on multivariate model (p = 0.008)., Conclusion: IVUS validation shows significant imaging modality-dependent variations in carotid stenosis severity determination., (© 2023. The Author(s).)
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- 2023
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33. World Federation for Interventional Stroke Treatment (WIST) Multispecialty Training Guidelines for Endovascular Stroke Intervention.
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Grunwald IQ, Mathias K, Bertog S, Snyder KV, Sievert H, Siddiqui A, Musialek P, Hornung M, Papanagiotou P, Comelli S, Pillai S, Routledge H, Nizankowski RT, Ewart I, Fassbender K, Kühn AL, Alvarez CA, Alekyan B, Skrypnik D, Politi M, Tekieli L, Haldis T, Gaikwad S, Houston JG, Donald-Simpson H, Guyler P, Petrov I, Roffe C, Abelson M, Hargroves D, Mani S, Podlasek A, Witkowski A, Sievert K, Pawlowski K, Dziadkiewicz A, and Hopkins NL
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- Humans, Thrombectomy methods, Thrombolytic Therapy methods, Treatment Outcome, Cadaver, Stroke diagnosis, Stroke therapy, Endovascular Procedures adverse effects, Endovascular Procedures methods
- Abstract
Introduction: Today, endovascular treatment (EVT) is the therapy of choice for strokes due to acute large vessel occlusion, irrespective of prior thrombolysis. This necessitates fast, coordinated multi-specialty collaboration. Currently, in most countries, the number of physicians and centres with expertise in EVT is limited. Thus, only a small proportion of eligible patients receive this potentially life-saving therapy, often after significant delays. Hence, there is an unmet need to train a sufficient number of physicians and centres in acute stroke intervention in order to allow widespread and timely access to EVT., Aim: To provide multi-specialty training guidelines for competency, accreditation and certification of centres and physicians in EVT for acute large vessel occlusion strokes., Material and Methods: The World Federation for Interventional Stroke Treatment (WIST) consists of experts in the field of endovascular stroke treatment. This interdisciplinary working group developed competency - rather than time-based - guidelines for operator training, taking into consideration trainees' previous skillsets and experience. Existing training concepts from mostly single specialty organizations were analysed and incorporated., Results: The WIST establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in EVT. WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models., Conclusions: WIST multispecialty guidelines outline competency and quality standards for physicians and centres to perform safe and effective EVT. The role of quality control and quality assurance is highlighted., Summary: The World Federation for Interventional Stroke Treatment (WIST) establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in endovascular treatment (EVT). WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. WIST multispecialty guidelines outline competency and quality standards for physicians and centers to perform safe and effective EVT. The role of quality control and quality assurance is highlighted., Simultaneous Publication: The WIST 2023 Guidelines are published simultaneously in Europe (Adv Interv Cardiol 2023)., Competing Interests: Declaration of competing interest The authors declare no conflict of interest in relation to this manuscript., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2023
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34. First-in-Human Trial of Mechanical-Electric Thrombectomy in Acute Pulmonary Embolism.
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Andersen A, Musialek P, Araszkiewicz A, Schultz J, Nielsen-Kudsk JE, Tekieli L, Zajdel W, Sławek-Szmyt S, Taff Y, and Weinberg I
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- Humans, Treatment Outcome, Thrombectomy adverse effects, Thrombolytic Therapy, Acute Disease, Pulmonary Embolism diagnostic imaging, Pulmonary Embolism surgery
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- 2023
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35. Transcoronary stem cell transfer and evolution of infarct-related artery atherosclerosis: evaluation with conventional and novel imaging techniques including Quantitative Virtual Histology (qVH).
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Dabrowski W, Tekieli L, Mazurek A, Lanocha M, Banys RP, Zmudka K, Majka M, Wojakowski W, Tendera M, and Musialek P
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Introduction: It has been suggested that infarct-related artery (IRA) atherosclerosis progression after stem cell transcoronary administration might represent a stem-cell mediated adverse effect., Aim: To evaluate, using conventional (quantitative coronary angiography, QCA, intravascular ultrasound - IVUS) and novel (quantitative virtual histology - qVH) tools, evolution of IRA atherosclerosis following transcoronary stem cell transfer., Material and Methods: QCA, IVUS, VH-IVUS and qVH were performed in 22 consecutive patients (4 women) aged 59 years (data provided as median) undergoing a distal-to-stent infusion of 2.21 × 10
6 CD34+ CXCR4+ autologous bone marrow cells via a cell delivery-dedicated perfusion catheter at anterior AMI day 7. Imaging was repeated at 12 months. This was a substudy of Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction (REGENT) Trial (NCT00316381)., Results: 18.2% subjects showed absence of distal-to-stent angiographic/IVUS atherosclerotic lesion(s) at baseline and no new lesion(s) at 12-months. In the remaining cohort, there were 28 lesions by QCA (32 by IVUS) at baseline and no new lesion(s) at follow-up. Three fibroatheromas evolved (2 to calcified fibroatheroma and 1 to a fibrocalcific lesion); other plaques maintained their stable (low-risk) phenotypes. Diameter stenosis of QCA-identified lesions was 29.5 vs. 26.5% ( p = 0.012, baseline vs. 12-months). Gray-scale IVUS showed reduction in area stenosis (33.8 vs. 31.0%, p = 0.004) and plaque burden (66.27 vs. 64.56%, p = 0.009) at 12-months. Peak fibrotic plaque content increased from 70.41% to 75.0% ( p = 0.004). qVH peak confluent necrotic core area and minimal fibrous cap thickness remained stable (0.64 vs. 0.59 mm2 , p = 0.290, and 0.15 vs. 0.16 mm, p = 0.646)., Conclusions: This study, using a range of classic and novel imaging techniques, indicates lack of any stimulatory effect of transcoronary stem cell transfer on coronary atherosclerosis. Whether, and to what extent, a moderate reduction in plaque burden and stenosis severity at 12-months results from optimized pharmacotherapy and/or stem cell transfer requires further elucidation., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 Termedia Sp. z o. o.)- Published
- 2022
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36. Trans-endocardial delivery of progenitor cells to compromised myocardium using the "needle technique"and risk of myocardial injury.
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Drabik L, Mazurek A, Dzieciuch-Rojek M, Tekieli L, Czyż Ł, Kwiecień E, Kułaga A, Mikunda A, Chmiel J, Płazak W, Rubiś P, and Musiałek P
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Introduction: Recent analysis from CHART-1 study indicated that the therapeutic effects of trans-endocardial cardiopoetic cell transplantation in chronic ischemic heart failure (iCHF) may be lost with an increasing number of injections perfomed to deliver therapeutic cells., Aim: To evaluate global and regional contractility and diastolic function of the left ventricle of patients with iCHF who received trans-endomyocardial cardiopoietic stem cells (CSCs) delivery or sham procedures., Material and Methods: The study included patients (mean age: 60.8 ±7.1 years) with iCHF (left ventricular ejection fraction (LVEF) < 35%) and a history of hospitalization for worsening heart failure within 12 months despite optimal medical therapy. The patients underwent transmyocardial CSCs transplantation using perforated needle technique or a sham procedure. The wall motion score index (WMSI), LVEF, transmitral E-velocity, E-wave deceleration time, E/A-ratio, and E/e'-mean value were measured with two-dimensional echocardiography on days 1 and 30., Results: A total of 170 segments were analyzed, including 48 targeted segments where 92 injections of 0.5 ml of CSCs were performed. In the transendocardial injections cohort, a decrease in regional contractility was observed in 30.6% (26/85) and 18.9% (16/85) of the segments on days 1 and 30, respectively. This was accompanied by an increase in WMSI by 0.32 ±0.06 and 0.19 ±0.18 (day 1, p = 0.02, day 30, p = 0.03) and a reduction in LVEF (-3.15 ±1.23%, p = 0.065)., Conclusions: Transendocardial injections performed to deliver therapeutic cells were associated with myocardial injury. This adverse effect remained, albeit at a lesser degree, at 30-days. Mechanical injury with trans-endocardial delivery of progenitor cells using the "needle technique" may counterbalance, at least in part, any cell-related benefit(s)., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2022 Termedia Sp. z o. o.)
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- 2022
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37. Misclassification of carotid stenosis severity with area stenosis-based evaluation by computed tomography angiography: impact on erroneous indication to revascularization or patient (lesion) migration to a higher guideline recommendation class as per ESC/ESVS/ESO/SVS and CMS-FDA thresholds.
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Tekieli L, Mazurek A, Dzierwa K, Stefaniak J, Kablak-Ziembicka A, Knapik M, Moczulski Z, Banys RP, Urbanczyk-Zawadzka M, Dabrowski W, Krupinski M, Paluszek P, Weglarz E, Wiewiórka Ł, Trystula M, Przewlocki T, Pieniazek P, and Musialek P
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Intoduction: Despite a growing understanding of the role played by plaque morphology, the degree of carotid lumen reduction remains the principle parameter in decisions on revascularization in symptomatic and asymptomatic patients. Computed tomography angiography (CTA) is a widely used guideline-approved imaging modality, with "percent stenosis" commonly calculated as %area reduction (area stenosis - AS)., Aim: We evaluated the impact of the non-linear relationship between diameter stenosis (DS) and AS (area = π • (diameter/2)
2 , so that in concentric lesions 51%AS is 30%DS and 75%AS is 50%DS) on stenosis severity misclassification using calculation of area reduction., Material and Methods: CTA and catheter quantitative angiography (cQA) were performed in 300 consecutive patients referred to a tertiary vascular centre for potential carotid revascularization (age: 47-83 years, 33.7% symptomatic, 36% female; referral stenosis of ≥ "50%"). CTA-AS was determined by agreement of 2 experienced radiologists; cQA-DS (pivotal trials standard reference, NASCET method) was calculated by agreement of 2 corelab analysts., Results: For symptomatic lesion thresholds, CTA-AS-based calculation reclassified 76% of "< 50%" cQA-DS measurements to the "50-69%" group, and 58% of "50-69%" measurements to the "≥ 70%" group. For asymptomatic lesion thresholds, 78% of "< 60%" cQA-DS measurements were reclassified to the "60-79%" group, whereas 42% of "60-79%" cQA measurements crossed to the "≥ 80%" class. Overall, employing CTA-AS instead of cQA-DS enlarged the "60-79%" and "≥ 80%" lesion severity classes 1.6- and 5.8-fold, respectively, whereas the "≥ 70%" class increased 4.15-fold., Conclusions: Replacing the pivotal carotid trials reference standard cQA-DS "%stenosis" measurement with CTA-AS-based "%stenosis" results in a large-scale lesion/patient erroneous gain of an "indication" to revascularization or migration to a higher revascularization indication class. In consequence, unnecessary carotid procedures may be performed in the absence of cQA verification. Until guidelines rectify the "%stenosis" measurement methods with different guideline-approved imaging modalities (and, where needed, re-adjust decision thresholds), CTA-AS measurement should not be used as a basis for carotid revascularization., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 Termedia Sp. z o. o.)- Published
- 2022
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38. Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study.
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Mazurek A, Borratynska A, Gancarczyk U, Czyz L, Sikorska M, Tekieli L, Sobien B, Jakiel M, Trystula M, Drazkiewicz T, Podolec P, and Musialek P
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- Aged, Aged, 80 and over, Angioplasty adverse effects, Carotid Arteries, Humans, Middle Aged, Prospective Studies, Retrospective Studies, Risk Factors, Stents adverse effects, Time Factors, Treatment Outcome, Carotid Stenosis complications, Carotid Stenosis diagnostic imaging, Carotid Stenosis surgery, Diabetes Mellitus etiology, Stroke epidemiology, Stroke etiology
- Abstract
Introduction: Carotid artery stenting (CAS) using conventional (single-layer) stents is associated with worse clinical outcomes in diabetes mellitus (DM) vs. non-DM patients: an effect driven largely by lesion-related adverse events. CAS outcomes with MicroNet-covered stents (MCS) in diabetic patients have not been evaluated., Aim: To compare short- and long-term clinical outcomes and restenosis rate in DM vs. non-DM patients with carotid stenosis treated using MCS., Materials and Methods: In a prospective study in all-comer symptomatic and increased-stroke-risk asymptomatic carotid stenosis, 101 consecutive patients (age 51-86 years, 41% diabetics) underwent 106 MCS-CAS. Clinical outcomes and duplex ultrasound velocities were assessed periprocedurally and at 30 days/12 months., Results: Baseline characteristics of DM vs. non-DM patients were similar except for a higher prevalence of recent cerebral symptoms in DM. Type 1 and type 1+2 plaques were more prevalent in DM patients (26.7% vs. 9.8%, p = 0.02; 62.2% vs. 37.7%, p = 0.01). Proximal embolic protection was more prevalent in DM (60% vs. 36%; p = 0.015). 30-day clinical complications were limited to a single periprocedural minor stroke in DM (2.4% vs. 0%, p = 0.22). 12-month in-stent velocities and clinical outcomes were not different (death rate 4.8% vs. 3.3%; p = 0.69; no new strokes). Restenosis rate was not different (0% vs. 1.7%, p = 0.22)., Conclusions: MCS may offset the adverse impact of DM on periprocedural, 30-day, and 12-month clinical complications of CAS and minimize the risk of in-stent restenosis. In this increased-stroke-risk cohort, adverse event rate was low both in DM and non-DM. Further larger-scale clinical datasets including extended follow-ups are warranted., Competing Interests: PM consulted for Abbot Vascular, InspireMD, and Medtronic and is a proctor for InspireMD and Medtronic. PM was Co-Principal Investigator in the CGuard CARENET study and is currently Co-Principal Investigator in the CGUARDIANS FDA-IDE Trial. Other authors have no conflicts of interest to declare., (Copyright © 2022 Adam Mazurek et al.)
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- 2022
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39. Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis.
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Mazurek A, Malinowski K, Rosenfield K, Capoccia L, Speziale F, de Donato G, Setacci C, Wissgott C, Sirignano P, Tekieli L, Karpenko A, Kuczmik W, Stabile E, Metzger DC, Amor M, Siddiqui AH, Micari A, Pieniążek P, Cremonesi A, Schofer J, Schmidt A, and Musialek P
- Abstract
Background: Single-cohort studies suggest that second-generation stents (SGS; “mesh stents”) may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a “mesh stent” class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials., Competing Interests: Kenneth Rosenfield reports receiving fees for serving on advisory boards from Abbott Vascular, Cardinal Health, Surmodics, Inari Medical, Volcano/Philips, and Proteon; receiving fees and stock options for serving on advisory boards from Cruzar Systems, Valcare, and Eximo; receiving stock options for serving on advisory boards from Capture Vascular, Shockwave, Micell, Endospan, and Silk Road Vascular; receiving stock options for serving on the advisory boards of and the holding of equity positions in Contego, Access Vascular, and MD Insider; holding stock/stock options in Embolitech, Janacare, Primacea, and PQ Bypass; receipt of a future payout from a previous equity position in Vortex; and receiving grant support paid to his institution from Abbott Vascular, Atrium/Maquet, and Lutonix/Bard. David Christopher Metzger is Co- Principal Investigator in the CGUARDIANS FDA-IDE Trial. Adnan H. Siddiqui has consulted for Amnis Therapeutics Ltd, Cerebrotech Medical, Systems Inc, CereVasc LLC, Claret Medical Inc, Codman, Corindus Inc, GuidePoint Global Consulting, Medtronic (Formerly Covidien), MicroVention, Neuravi, Penumbra, Pulsar Vascular, Rapid Medical, Rebound Therapeutics Corporation, Silk Road Medical, Stryker, The Stroke Project Inc, Three Rivers Medical Inc, W.L. Gore & Associates, and is a Board Member of Intersocietal Accreditation Commission. He has been Principal Investigator and/or served on Steering Committees for: Codman & Shurtleff, LARGE Trial, Covidien (Now Medtronic), SWIFT PRIME and SWIFT DIRECT Trials; MicroVention, FRED Trial, CONFIDENCE Study, MUSC, POSITIVE Trial; Penumbra, 3D Separator Trial, COMPASS Trial, INVEST Trial. AHS has financial interests in BuffaloTechnology Partners Inc, Cardinal, International Medical Distribution Partners, Medina Medical Systems, Neuro Technology Investors, StimMed, and Valor Medical. Piotr Pieniazek has proctored and/or consulted for Terumo, Boston Scientific and Balton. Joachim Schofer has been Co-Principal Investigator in the CARENET Trial. Andrej Schmidt has consulted for Abbott Vascular, BD, Cook and Medtronic. Piotr Musialek has proctored and/or consulted for Abbott Vascular, InspireMD, and Medtronic. PM is Co- Principal Investigator in the CGUARDIANS FDA-IDE Trial and has been Co-Principal Investigator in the CARENET Trial; he is Principal Investigator in a series of Investigator-Initiated studies including PARADIGM/PARADIGM-Extend (NCT04271033), FLOW-GUARD (NCT04461717), OPTIMA (NCT04234854), TOP-GUARD (NCT0454738), C-HEAL (NCT04434456), SIM-GUARD (NCT04973579) and SAFEGUARD-STROKE (NCT05195658). PM is the Polish Cardiac Society Board Representative for Stroke and Vascular Interventions and serves on the European Society of Cardiology (ESC) Stroke Council Scientific Documents Task Force and on ESC Research and Grants Committee. Other author declare no conflict of interest.
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- 2022
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40. Symptomatic atherosclerotic plaque progression in a first-generation carotid stent: management and 5-year clinical and imaging outcome-a case report.
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Tekieli L, Mazurek A, Pieniazek P, and Musialek P
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Background: Restenosis in first-generation (single-layer) carotid stents (FGS) is believed to represent an exaggerated healing response of (neo)intimal hyperplasia (NIH) formation. Rather than NIH, we describe symptomatic in-FGS unstable plaque (neo)atherosclerosis mandating re-revascularization. To halt continued plaque evolution, we propose a novel treatment strategy involving a microNet-covered stent (MCS, second-generation carotid stent) to sequestrate the plaque from the vessel lumen. A durable long-term result is documented using multi-modal imaging., Case Summary: With a seemingly optimal result of FGS (Precise) symptomatic carotid lesion revascularization followed by optimal medical therapy, a late (≥3 years) progressive in-stent restenosis (ISR) arose. At Year 11, crescendo ipsilateral transient ischaemic attacks occurred. Angiography showed an ulcerated tight lesion throughout stent length. Intravascular ultrasound (IVUS) virtual histology imaging revealed thin-cap fibroatheroma. Reintervention was performed under distal protection. Undersized balloon predilatation to insert a stent caused symptomatic no-flow, and aspiration catheter was used to reduce the filter load. A MCS (CGuard) was implanted and post-dilated to ensure full lumen gain; IVUS confirmed complete plaque sequestration. The optimal anatomic result remained unchanged throughout 5 years (ultrasound and computed tomography verification); this was accompanied by clinical cure., Discussion: This is the first demonstration of in-FGS (neo)atherosclerosis resolution using an MCS to sequestrate and insulate the atherosclerotic plaque. We show that ISR may be underlined by atherosclerotic plaque progression via the FGS single-layer stent struts that may show vulnerable plaque phenotype and may be associated with cerebral ischaemia. The anatomically and clinically effective exclusion of the atherosclerotic plaque by an MCS enabled lasting, optimal endovascular reconstruction and clinical cure., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2021
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41. Novel Large-Diameter Controlled-Expansion Stentriever, Embolic-Prevention Stent and Flow Reversal in Large-Thrombus-Burden ICA Proximal Occlusion Stroke.
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Tekieli L, Banaszkiewicz K, Moczulski Z, Urbańczyk-Zawadzka M, and Musialek P
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- Carotid Artery, Internal, Humans, Stents, Thrombectomy, Treatment Outcome, Arterial Occlusive Diseases, Carotid Stenosis, Stroke diagnostic imaging, Stroke etiology, Stroke prevention & control, Thrombosis
- Abstract
Competing Interests: Funding Support and Author Disclosures This work was supported by the John Paul II Hospital in Krakow Research Fund. Dr Musialek has received proctoring and consulting fees from Abbott Vascular, InspireMD, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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- 2021
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42. One-day, sequential carotid artery stenting followed by cardiac surgery in patients with severe carotid and cardiac disease.
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Dzierwa K, Piatek J, Paluszek P, Przewlocki T, Tekieli L, Konstanty-Kalandyk J, Tomaszewski T, Drwila R, Trystula M, Musialek P, and Pieniazek P
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- Aged, Aged, 80 and over, Carotid Stenosis complications, Carotid Stenosis diagnostic imaging, Carotid Stenosis mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Feasibility Studies, Female, Heart Diseases complications, Heart Diseases diagnostic imaging, Heart Diseases mortality, Humans, Male, Middle Aged, Postoperative Complications etiology, Registries, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Carotid Artery, Internal diagnostic imaging, Carotid Stenosis therapy, Coronary Artery Bypass adverse effects, Coronary Artery Bypass mortality, Endovascular Procedures instrumentation, Heart Diseases surgery, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Stents
- Abstract
Optimal management of patients with internal carotid artery (ICA) stenosis concurrent with severe cardiac disease remains undefined. The aim of this study is to evaluate the safety and feasibility of the one-day, sequential approach by carotid artery stenting (CAS) immediately followed by cardiac surgery. The study included 70 consecutive patients with symptomatic > 50% or ⩾ 80% asymptomatic ICA stenosis coexisting with severe coronary/valve disease, who underwent one-day, sequential CAS + cardiac surgery. The majority of patients (85.7%) had CSS class III or IV angina and 10% had non-ST elevation myocardial infarction. The EuroSCORE II risk was 2.4% (IQR 1.69-3.19%). All CAS procedures were performed according to the 'tailored' algorithm with a substantial use of proximal neuroprotection devices of 44.3%. Closed-cell (75.7%) and mesh-covered (18.6%) stents were implanted in most cases. The majority of patients underwent isolated coronary artery bypass grafting (88.6%) or isolated valve replacement (7.1%). No major adverse cardiac and cerebrovascular events (MACCE) occurred at the CAS stage. There were three (4.3%) perioperative MACCE: one myocardial infarction and two deaths. All MACCE were related to cardiac surgery and were due to the high surgical risk profile of the patients. Up to 30 days, no further MACCE were observed. No perioperative or 30-day neurological complications occurred. In this patient series, one-day, sequential CAS and cardiac surgery was relatively safe and did not result in neurological complications. Thus, a strategy of preoperative CAS could be considered for patients with severe or symptomatic ICA stenosis who require urgent cardiac surgery.
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- 2019
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43. Comparison of drug-eluting and bare metal stents for extracranial vertebral artery stenting.
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Maciejewski DR, Pieniazek P, Tekieli L, Paluszek P, Przewlocki T, Tomaszewski T, Machnik R, Trystula M, Legutko J, and Kablak-Ziembicka A
- Abstract
Introduction: Drug-eluting stents of the first (DES I) and second generation (DES II) proved superior to bare metal stents (BMS) in the coronary territory. However, there are limited data on whether they have any advantage over BMS in vertebral artery stenosis (VAS)., Aim: To compare outcomes of DES (DES I, DES II) and BMS in the treatment of symptomatic extracranial VAS., Material and Methods: During 13-year study period (2003-2016), 392 consecutive patients underwent VAS angioplasty in 428 arteries, including implantation of 148 DES (DES I: 21; DES II: 127 lesions), and 280 BMS., Results: The technical success rates for DES and BMS groups were 96.7% and 94.6% ( p = 0.103), with similar periprocedural complication rates (1.4% vs. 2.2%; p = 0.565). VAS degree was reduced from 86 ±9.7 to 2.7 ±5.0% in DES ( p < 0.001) and from 84.1 ±9.4 to 4.3 ±6.9% in BMS ( p < 0.001). Angiography confirmed in-stent restenosis/occlusion (ISR/ISO) 50-99% in 53 (14.2%) and 21 (5.6%) out of 373 patients (409 arteries) with at least 6-month follow-up. ISR/ISO rates were similar in DES vs. BMS (22.8% vs. 19.4%; p = 0.635), as well as in DES I vs. DES II (6/19; 31.6% vs. 25/92; 27.2%, p = 0.325). Stainless steel (24/135; 17.8%) and cobalt-chromium (23/121;19%) BMS had significantly lower incidence of ISR/ISO, as compared to platinum-chromium (7/18; 38.9%), p = 0.034. ISR/ISO was associated with age ( p = 0.01) and CRP level > 5 mg/l ( p = 0.043), while greater stent length was associated with ISR only in the DES group ( p = 0.024)., Conclusions: Our results do not support significant differences in ISR/ISO rates between DES and BMS, although differences between particular stent types and ISR rates require further investigation., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2019 Termedia Sp. z o. o.)
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- 2019
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44. Multiterritory Atherosclerosis and Carotid Intima-Media Thickness as Cardiovascular Risk Predictors After Percutaneous Angioplasty of Symptomatic Subclavian Artery Stenosis.
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Wrotniak L, Kablak-Ziembicka A, Karch I, Pieniazek P, Rosławiecka A, Mleczko S, Tekieli L, Zmudka K, and Przewlocki T
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- Adult, Aged, Aged, 80 and over, Carotid Stenosis epidemiology, Comorbidity, Female, Humans, Male, Middle Aged, Poland epidemiology, Risk Factors, Angioplasty, Atherosclerosis epidemiology, Cardiovascular Diseases epidemiology, Carotid Intima-Media Thickness statistics & numerical data, Subclavian Steal Syndrome epidemiology, Subclavian Steal Syndrome therapy
- Abstract
Objectives: To identify independent predictors of cardiovascular events among patients with subclavian artery stenosis., Methods: Two hundred eighteen consecutive patients with subclavian artery stenosis referred to angioplasty were examined for coexistent coronary, renal, or lower extremity artery stenosis of 50% or greater. Initial carotid intima-media thickness and internal carotid artery (ICA) stenosis were assessed. Intima-media thickness was reassessed in 108 randomly chosen patients to evaluate the change over time. The incidence of cardiovascular death, myocardial infarction (MI), ischemic stroke, and symptomatic lesion progression was recorded., Results: The patients included 116 men and 102 women (mean age ± SD, 62.1 ± 8.4 years). Isolated subclavian artery stenosis and involvement of 1, 2, and 3 or 4 other territories with stenosis of 50% or greater were found in 46 (21.1%), 83 (38.1%), 55 (25.2%), and 34 (15.6%) patients, respectively. Internal carotid artery stenosis of 50% or greater (relative risk [RR], 1.54; 95% confidence interval [CI], 1.39-1.70; P < .001) and initial intima-media thickness (RR, 1.16; 95% CI, 1.05-1.28; P = .005) were identified as independent markers of multiterritory atherosclerosis. The optimal intima-media thickness cutoff for atherosclerosis extent was 1.3 mm (sensitivity, 75.6%; specificity, 76.1%). During follow-up of 57 ± 35 months, cardiovascular death, MI, and ischemic stroke occurred in 29 patients (13.3%). Those patients had significantly higher intima-media thickness progression (+0.199 ± 0.57 versus +0.008 ± 0.26 mm; P = .039) and more widespread initial atherosclerosis (mean territories, 1.8 ± 1.1 versus 1.3 ± 1.1; P = .042). Independent predictors of cardiovascular death, MI, ischemic stroke, and lesion progression were coronary artery disease (RR, 1.32; 95% CI, 1.10-1.58; P = .003) and intima-media thickness progression (RR, 1.22; 95% CI, 1.02-1.46; P = .033; sensitivity, 75.0%; specificity, 61.8%)., Conclusions: In patients with symptomatic subclavian artery stenosis, baseline carotid intima-media thickness and ICA stenosis of 50% or greater are associated with multiterritory atherosclerosis, whereas intima-media thickness progression is associated with the risk of cardiovascular events.
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- 2016
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45. Myocardial regeneration strategy using Wharton's jelly mesenchymal stem cells as an off-the-shelf 'unlimited' therapeutic agent: results from the Acute Myocardial Infarction First-in-Man Study.
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Musialek P, Mazurek A, Jarocha D, Tekieli L, Szot W, Kostkiewicz M, Banys RP, Urbanczyk M, Kadzielski A, Trystula M, Kijowski J, Zmudka K, Podolec P, and Majka M
- Abstract
Introduction: In large-animal acute myocardial infarction (AMI) models, Wharton's jelly (umbilical cord matrix) mesenchymal stem cells (WJMSCs) effectively promote angiogenesis and drive functional myocardial regeneration. Human data are lacking., Aim: To evaluate the feasibility and safety of a novel myocardial regeneration strategy using human WJMSCs as a unique, allogenic but immuno-privileged, off-the-shelf cellular therapeutic agent., Material and Methods: The inclusion criterion was first, large (LVEF ≤ 45%, CK-MB > 100 U/l) AMI with successful infarct-related artery primary percutaneous coronary intervention reperfusion (TIMI ≥ 2). Ten consecutive patients (age 32-65 years, peak hs-troponin T 17.3 ±9.1 ng/ml and peak CK-MB 533 ±89 U/l, sustained echo LVEF reduction to 37.6 ±2.6%, cMRI LVEF 40.3 ±2.7% and infarct size 20.1 ±2.8%) were enrolled., Results: 30 × 10(6) WJMSCs were administered (LAD/Cx/RCA in 6/3/1) per protocol at ≈ 5-7 days using a cell delivery-dedicated, coronary-non-occlusive method. No clinical symptoms or ECG signs of myocardial ischemia occurred. There was no epicardial flow or myocardial perfusion impairment (TIMI-3 in all; cTFC 45 ±8 vs. 44 ±9, p = 0.51), and no patient showed hs-troponin T elevation (0.92 ±0.29 ≤ 24 h before vs. 0.89 ±0.28 ≤ 24 h after; decrease, p = 0.04). One subject experienced, 2 days after cell transfer, a transient temperature rise (38.9°C); this was reactive to paracetamol with no sequel. No other adverse events and no significant arrhythmias (ECG Holter) occurred. Up to 12 months there was one new, non-index territory lethal AMI but no adverse events that might be attributable to WJMSC treatment., Conclusions: This study demonstrated the feasibility and procedural safety of WJMSC use as off-the-shelf cellular therapy in human AMI and suggested further clinical safety of WJMSC cardiac transfer, providing a basis for randomized placebo-controlled endpoint-powered evaluation.
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- 2015
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46. Double filters: a protection technique for high-risk innominate artery angioplasty.
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Pieniążek P, Tekieli L, Dzierwa K, Drwiła R, Kosobucka-Peszat R, Trystuła M, Nowak R, Moczulski Z, and Podolec P
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- Humans, Angioplasty, Balloon instrumentation, Arterial Occlusive Diseases therapy, Brachiocephalic Trunk, Cerebrovascular Disorders prevention & control, Embolic Protection Devices, Stents
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- 2014
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47. Transradial approach for carotid artery stenting in a patient with severe peripheral arterial disease.
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Maciejewski D, Pieniążek P, Tekieli L, Paluszek P, Dzierwa K, Trystuła M, Wójcik-Pędziwiatr M, and Podolec P
- Abstract
We present a case of a 73-year-old man with critical bilateral internal carotid artery stenosis, recent right-hemisphere stroke and severe peripheral artery disease in whom right internal carotid artery stenting (RICA-CAS) was performed successfully via a right transradial approach.
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- 2014
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48. Carotid artery stenting according to the "tailored CAS" algorithm performed in the very elderly patients: the thirty day outcome.
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Dzierwa K, Pieniazek P, Tekieli L, Musialek P, Przewlocki T, Kablak-Ziembicka A, Kosobucka-Peszat R, Machnik R, Trystula M, and Podolec P
- Subjects
- Age Factors, Aged, Aged, 80 and over, Angioplasty, Balloon adverse effects, Angioplasty, Balloon mortality, Asymptomatic Diseases, Carotid Stenosis complications, Carotid Stenosis diagnosis, Carotid Stenosis mortality, Comorbidity, Female, Hospitals, High-Volume, Humans, Male, Patient Selection, Poland, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Stroke etiology, Time Factors, Treatment Outcome, Algorithms, Angioplasty, Balloon instrumentation, Carotid Stenosis therapy, Decision Support Techniques, Stents
- Abstract
Objectives: To assess safety and efficacy of carotid artery stenting (CAS) according to "tailored-CAS" algorithm in the elderly (≥75 years) in relation to younger patients., Background: Although CAS has grown as an alternative to carotid endarterectomy the data on safety of CAS in the very elderly are inconsistent., Material and Methods: 1,139 patients with significant carotid stenosis underwent 1,252 CAS procedures in one high-volume center between years 2001-2011. CAS procedures were performed with lesion and patient dependent selection of neuroprotection type ("tailored-CAS"). There were 193 subjects ≥75-years-old (17%) and 946 <75-years-old. No major differences in atherosclerosis risk factors and comorbidities between groups were noted. In both groups the majority of patients were male (70.4% vs. 68.6%, P = NS) and half of the patients were symptomatic (50.2% vs. 55.2%, P = NS). Bilateral carotid stenosis was present in 25% of patients from CAS ≥75 group and 22% from CAS< 75 group, P = NS. Proximal neuroprotection devices use for high risk or symptomatic lesions accounted for 31% in CAS≥ 75 group and 32% in CAS<75 group, P = NS., Results: In symptomatic patients aged ≥75 years 30-day stroke and death rate was 7% versus 1.9% in symptomatic patients aged <75; P = 0.01 and vs. 1.8% in asymptomatic elderly, P = 0.09. No myocardial infarcts were noted., Conclusions: Symptomatic elderly is a group of highest CAS risk and the use of "tailored CAS" algorithm does not equalize CAS risk in this patients' group. "Tailored CAS" remains a safe procedure for asymptomatic elderly as well as symptomatic and asymptomatic young patients., (Copyright © 2013 Wiley Periodicals, Inc.)
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- 2013
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49. Multimarker approach in discriminating patients with symptomatic and asymptomatic atherosclerotic carotid artery stenosis.
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Musialek P, Tracz W, Tekieli L, Pieniazek P, Kablak-Ziembicka A, Przewlocki T, Stepien E, Kapusta P, Motyl R, Stepniewski J, Undas A, and Podolec P
- Abstract
Background and Purpose: Several circulating biomarkers have been implicated in carotid atherosclerotic plaque rupture and thrombosis; however, their clinical utility remains unknown. The aim of this study was to determine the role of a large biomarker panel in the discrimination of symptomatic (S) vs. asymptomatic (A/S) subjects in a contemporary population with carotid artery stenosis (CS)., Methods: Prospective sampling of circulating cytokines and blood lipids was performed in 300 unselected, consecutive patients with ≥50% CS, as assessed by duplex ultrasound (age 47-83 years; 110 with A/S and 190 with S) who were referred for potential CS revascularization., Results: CS severity and pharmacotherapy did not differ between the A/S and S patients. The median values of total cholesterol, low-density lipoprotein cholesterol, and lipoprotein(a) did not differ, but high-density lipoprotein (HDL) cholesterol was significantly higher (p<0.001) and triglycerides were lower (p=0.03) in the A/S-CS group than in the S-CS group. Interleukin-6 (IL-6) and high-sensitivity C-reactive protein were higher (p=0.04 and p=0.07, respectively) in the S-CS group. Circulating visfatin, soluble CD 40 receptor ligand, soluble vascular cell adhesion molecule, leptin, adiponectin, IL-1β, IL-8, IL-18, monocyte chemoattractant protein-1, myeloperoxidase, matrix metalloproteinases-8, -9, and -10, and fibrinogen were similar, but tissue inhibitor of matrix metalloproteinases-1 (TIMP) was reduced in S-CS compared to A/S-CS (p=0.02). Nevertheless, incorporation of TIMP and IL-6 did not improve the HDL-cholesterol receiver operating characteristics for S-CS status prediction. S-CS status was unrelated to angiographic stenosis severity or plaque burden, as assessed by intravascular ultrasound (p=0.16 and p=0.67, respectively). Multivariate logistic regression analysis revealed low HDL-cholesterol to be the only independent predictor of CS symptoms, with an odds ratio of 1.81 (95% confidence interval=1.15-2.84, p=0.01) for HDL <1.00 mmol/L (first quartile) vs. >1.37 (third quartile). In S-CS, osteoprotegerin and lipoprotein-associated phospholipase A2 (Lp-PLA2) were elevated in those with recent vs. remote symptoms (p=0.01 and p=0.02, respectively)., Conclusions: In an all-comer CS population on contemporary pharmacotherapy, low HDL-cholesterol (but not other previously implicated or several novel circulating biomarkers) is an independent predictor of S-CS status. In addition, an increase in circulating osteoprotegerin and Lp-PLA2 may transiently indicate S transformation of the carotid atherosclerotic plaque.
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- 2013
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50. Infarct size determines myocardial uptake of CD34+ cells in the peri-infarct zone: results from a study of (99m)Tc-extametazime-labeled cell visualization integrated with cardiac magnetic resonance infarct imaging.
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Musialek P, Tekieli L, Kostkiewicz M, Miszalski-Jamka T, Klimeczek P, Mazur W, Szot W, Majka M, Banys RP, Jarocha D, Walter Z, Krupinski M, Pieniazek P, Olszowska M, Zmudka K, Pasowicz M, Kereiakes DJ, Tracz W, Podolec P, and Wojakowski W
- Subjects
- Adult, Aged, Anterior Wall Myocardial Infarction blood, Anterior Wall Myocardial Infarction diagnostic imaging, Anterior Wall Myocardial Infarction immunology, Anterior Wall Myocardial Infarction pathology, Anterior Wall Myocardial Infarction physiopathology, Biomarkers metabolism, Cell Movement, Cell Survival, Cells, Cultured, Female, Humans, Male, Middle Aged, Myocardial Contraction, Myocardium immunology, Myocardium metabolism, Predictive Value of Tests, Recovery of Function, Stroke Volume, Time Factors, Transplantation, Autologous, Treatment Outcome, Troponin blood, Ventricular Function, Left, Anterior Wall Myocardial Infarction therapy, Antigens, CD34 metabolism, Bone Marrow Transplantation, Cell Tracking methods, Magnetic Resonance Imaging, Myocardial Perfusion Imaging methods, Myocardium pathology, Percutaneous Coronary Intervention, Radiopharmaceuticals, Technetium Tc 99m Exametazime, Tomography, Emission-Computed, Single-Photon
- Abstract
Background: Effective progenitor cell recruitment to the ischemic injury zone is a prerequisite for any potential therapeutic effect. Cell uptake determinants in humans with recent myocardial infarction are not defined. We tested the hypothesis that myocardial uptake of autologous CD34(+) cells delivered via an intracoronary route after recent myocardial infarction is related to left ventricular (LV) ejection fraction (LVEF) and infarct size., Methods and Results: Thirty-one subjects (age, 36-69 years; 28 men) with primary percutaneous coronary intervention-treated anterior ST-segment-elevation myocardial infarction and significant myocardial injury (median peak troponin I, 138 ng/dL [limits, 58-356 ng/dL]) and sustained LVEF depression at ≤45% were recruited. On day 10 (days 7-12), 4.3×10(6) (0.7-9.9×10(6)) (99m)Tc-extametazime-labeled autologous bone marrow CD34(+) cells (activity, 77 MBq [45.9-86.7 MBq]) were administered transcoronarily (left anterior descending coronary artery). (99m)Tc-methoxyisobutyl isonitrile (99(m)Tc-MIBI) single-photon emission computed tomography before cell delivery showed 7 (2-11) (of 17) segments with definitely abnormal/absent perfusion. Late gadolinium-enhanced infarct core mass was 21.7 g (4.4-45.9 g), and infarct border zone mass was 29.8 g (3.9-60.2 g) (full-width at half-maximum, signal intensity thresholding algorithm). One hour after administration, 5.2% (1.7%-9.9%) of labeled cell activity localized in the myocardium (whole-body planar γ scan). Image fusion of labeled cell single-photon emission computed tomography with LV perfusion single-photon emission computed tomography or with cardiac magnetic resonance infarct imaging indicated cell uptake in the peri-infarct zone. Myocardial uptake of labeled cells activity correlated in particular with late gadolinium-enhanced infarct border zone mass (r=0.84, P<0.0001) and with peak troponin I (r=0.76, P<0.001); it also correlated with severely abnormal/absent perfusion segment number (r=0.45, P=0.008) and late gadolinium-enhanced infarct core (r=0.58 and r=0.84, P<0.0001) but not with echocardiography LVEF (r=-0.07, P=0.68) or gated single-photon emission computed tomography LVEF (r=-0.28, P=0.16). The correlation with cardiac magnetic resonance imaging-LVEF was weak (r=-0.38; P=0.04)., Conclusions: This largest human study with labeled bone marrow CD34(+) cell transcoronary transplantation after recent ST-segment-elevation myocardial infarction found that myocardial cell uptake is determined by infarct size rather than LVEF and occurs preferentially in the peri-infarct zone.
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- 2013
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