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3. Cardiopoietic cell therapy for advanced ischemic heart failure : results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

Author

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.

Subjects
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.

Published
2017

4. Interventional treatment in diabetics in the era of drug-eluting stents and compliance to the ESC guidelines: lessons learned from the Euro Heart Survey Programme

Author

Onuma Y., Kukreja N., Ramcharitar S., Hochadel M., Gitt A., Serruys P., Marco J., Vahanian A., Weidinger F., Wijns W., Zeymer U., Silber S., Seabra-Gomez R., Eberli F., Manini M., Bramley C., Laforest V., Taylor C., Huber K., Backer G. D., Sirakova V., Cerbak R., Thayssen P., Aziz O. A., Tammam K., Lehto S., Delahaye F., Kobulia B., Cokkinos D., Kremastinos D., Karlocai K., Shelley E., Behar S., Maggioni A., Grabauskiene V., Deckers J., Asmussen I., Stepinska J., Goncalves L., Fonseca C., Mareev V., Vasilijevic Z., Riecansky M. I., Kenda M. F., Lopez-Sendon J. L., Rosengren A., Buser P., Okay T., Sychov O., Schofield P., Gitt A. K., Tavazzi L., Gomes R. S., de la Iglesia J. M., Wallentin L., Kearney P., McGregor K., Simoons M. L., Squibb B. -M., Lilly E., Margaryan K., Khachatryan S., Doerler J., Stocker E. -M., Altenberger I. J., Heigert M., Pichler M., Christ S. G., Glogar H., Lang I., Ingerle S., De Wilde P., de Marneffe M., Vrolix B. M., Dens J., Lierde J. V., De Wagter G. X., Carlier G. M., Weyne G. A., Legrand K. V., Doneux P., Gach O., Davin L., Mievis L. E., Massart P. -E., Holvoet N. G., Giunio L., Glavas D., Vukovic I., Markovic B., Duplancic D., Runjic F., Galic S. E., Mirat J., Kala P., Semenka J., Hlinomaz O., Petrikovits E., Widimsky B. P., Tousek P., Varvarovsky P. I., Cappelen H., Helqvist O. S., Kelbaek H., Jorgensen E., Engstrom T., Saunamaki K., Kastrup J., Clemmensen P., Hansen H., Al Abbadi M., Razek H. A., Aboul el Nasr G., Ragi H., Ibrihim B., Zarif B., el Banhawy N., Sorour K., Meguid M. A., Mahrous A., Al Khashab K. A., Ahmed Abd Elmoniem F., El Emry M., El Naggar A., Saad B. A., Laanmets P., Voitk J., Lutter P., Jarvekulg S., Jalakas M., Reinmets J., Marandi T., Peeba M., Serka T., Syvannne M., Kaihovirta E., Korpilahti H. K., Vaittinen M. -A., Bassand J. -P., Espinosa D. P., Cottin B. Y., Lhuillier I., Buffet P., Lorgis L., Machecourt D. J., Bertrand B., Serrano D., Bonnet G. J. -L., Steg M. P. G., Juliard J. -M., Farnoud R., Delarche P. N., Marco P. J., Petit F., Farah B., Carrie D., Galinier M., Puel J., Cahuzac J., Roncalli J., Tauzin S., Elbaz M., Schachinger V., Gitt F. A., am Rhein Ralf Zahn L., Fraiture B., Haetinger S., Klepzig N. H., Girth E., Hauber A., Firschke O. C., Widmaier J., Hofbauer F., Huttl S., Sechtem P. U., Parade U., Linnartz S. G., Andrianidis S., Tsiavou N., Papaioannou G., Deliargyris E., Attikis M., Alexopoulos D., Davlouros P., Tsikaderis D., Dardas P., Mezilis N., Istvan E., Zoltan B., Turgeman Y., Khaled S., Feldman A., Jafari J., Manevich I., Cafri C., Ilia R., Abu-Ful A., Yaroslavslev S., Wainstain J. M., Rosenchtein G., Sheva B., Krakover R., Yakov B., Halon D., Gruberg L., Markiewicz W., Grenadier E., Boulos M., Roguin A., Kerner A., Amikam S., Ben-Tzvi M., Rezmovitz J., Mosseri H. M., Lotan H., Varshizky B., Nassar H., Daninberg H., Rot D., Vais T., Benhorin J., Keren A., Medina A., Huri Z., Brandis J. S., Schoenmann G., Kornowski N. R., Assali A., Fuch S., Hasdai D., Brosh D., Sela O., Teplitski I., Tikva P., Eisenberg O., Banai S., Finkelstein A., Hasin Y., Aboud M., Nahir M., Qarwani D., Diab G., Meloni L., Lai G., Cadeddu M., Pirisi R., Bonechi F., Nassi F., Nieri M., Taiti A., Naldoni A., Calabro F., Achilli F., Maggiolini S., Piatti L., Tiberti G., Addamiano P., Berti S., Ravani M., Palmieri C., Trianni G., Cardullo S., Cioppa A., Rubino P., Ambrosini V., Salemme L., Sorropago G., Tesorio T., Geraci G., Scalise F., Mazzeti S., Auguadro C., Esposito G., Canali G., Caccia M. E., Ruggieri C., Benedetta B., de Cesare N., De Benedictis M., Coco T., Manzotti S., Fraz O. S., Marraccini P., Danesi A., Ricci R., Ferraironi A., Olivieri E., Chiera A., Garducci S., Grasseli D., McFadden E., Cahill N., Quinn M., Crean P., Caroll E., Foley D., O'Connor S., O'Hanlon R., Lynch B., O'Donnell S., Roy J., O'Brien D., Krastina A., Erglis A., Lawand S., Dorniak W., Klaudel J., Pawlowski K., Trenkner W., Janion M., Sadowski M., Janion-Sadowska A., Skorupa I., Bystryk L., Kern A., Janiak B., Szelemej R., Ruzyllo W., Witkowski A., Deptuch T., Maczynska-Mazuruk R., Budaj A., Cegieska K. L., Opolski G., Wilczyska J., Roik M., Kochman J., Martins D., Goncalves I. M. F. J., Pereira H., Faria H., Calisto J., Matos V., Leitao-Marques A., Costa M., Oliveira H., Mota P., Santos W., Brandao V., Caires F. G., Silva B., Teles F. R. C., Almeida M., Goncalves P., Raposo L., Mourao L., Bernardes L., Pedro P. G., Ferreira R., Conduto R., Quininha J., Patricio L., Cacela D., Goncalves J. M., de Sousa L., Adao M., Carvalho L. H. C., Romeira H., Sousa J. P., Garcia J. M. M., Silva J. C., Magalhaes D., Santos P. R., Mendes S. P. G., Pipa J., Nunes L., Ferreira P., Vinereanu D., Udroiu C., Florescu N., Parvu O., Stoicescu C., Dorobantu M., Balanescu S. M., Niculescu R., Calmac L., Marinescu M., Olinic B. D., Ober M., Homorodean C., Budurea C., Hij A., Anton F., Cluj-Napoca, Ortan F., Suciu C., Ursu M., Baba C., Targu-Mures, Dragulescu S. I., Petrescu L., Slovenski M., Gavrilescu D., Dina C., Mut B., Babic R., Colic M., Topic D., Vilarrasa J. B., Pont M. P., Martorell R. M., Rohlfs I., Moreno R. M., Irurita M., Irurita J., de Gran Canaria L. P., Cervantes C. E., Galvan T., Navarro J., Franco D., Rodriguez I. S., Ramirez V. H., Fernandes-Aviles F., Revilla A., Masson N., Dupertuis V., Kachboura S., Iyisoy A., Erol M. K., Ongen Z., Babalik E., Oskan M., Ozdemir N., Oto A., Aytemir K., Yavuz B., Sahin M., Durna K., Aytekin V., Demiroglu C., Gulbaran M., Aytekin S., Catakoglu A. B., Ozme B., Gemici G., Feray H., Schofield P. M., Kahn S., Clarke S., Millington H., Di Mario C., Dempster D., Henderson R. A., Burton J., Falcon-Lang D., Cardiology, Onuma, Y., Kukreja, N., Ramcharitar, S., Hochadel, M., Gitt, A., Serruys, P., Marco, J., Vahanian, A., Weidinger, F., Wijns, W., Zeymer, U., Silber, S., Seabra-Gomez, R., Eberli, F., Manini, M., Bramley, C., Laforest, V., Taylor, C., Huber, K., Backer, G. D., Sirakova, V., Cerbak, R., Thayssen, P., Aziz, O. A., Tammam, K., Lehto, S., Delahaye, F., Kobulia, B., Cokkinos, D., Kremastinos, D., Karlocai, K., Shelley, E., Behar, S., Maggioni, A., Grabauskiene, V., Deckers, J., Asmussen, I., Stepinska, J., Goncalves, L., Fonseca, C., Mareev, V., Vasilijevic, Z., Riecansky, M. I., Kenda, M. F., Lopez-Sendon, J. L., Rosengren, A., Buser, P., Okay, T., Sychov, O., Schofield, P., Gitt, A. K., Tavazzi, L., Gomes, R. S., de la Iglesia, J. M., Wallentin, L., Kearney, P., Mcgregor, K., Simoons, M. L., Squibb, B. -M., Lilly, E., Margaryan, K., Khachatryan, S., Doerler, J., Stocker, E. -M., Altenberger, I. J., Heigert, M., Pichler, M., Christ, S. G., Glogar, H., Lang, I., Ingerle, S., De Wilde, P., de Marneffe, M., Vrolix, B. M., Dens, J., Lierde, J. V., De Wagter, G. X., Carlier, G. M., Weyne, G. A., Legrand, K. V., Doneux, P., Gach, O., Davin, L., Mievis, L. E., Massart, P. -E., Holvoet, N. G., Giunio, L., Glavas, D., Vukovic, I., Markovic, B., Duplancic, D., Runjic, F., Galic, S. E., Mirat, J., Kala, P., Semenka, J., Hlinomaz, O., Petrikovits, E., Widimsky, B. P., Tousek, P., Varvarovsky, P. I., Cappelen, H., Helqvist, O. S., Kelbaek, H., Jorgensen, E., Engstrom, T., Saunamaki, K., Kastrup, J., Clemmensen, P., Hansen, H., Al Abbadi, M., Razek, H. A., Aboul el Nasr, G., Ragi, H., Ibrihim, B., Zarif, B., el Banhawy, N., Sorour, K., Meguid, M. A., Mahrous, A., Al Khashab, K. A., Ahmed Abd Elmoniem, F., El Emry, M., El Naggar, A., Saad, B. A., Laanmets, P., Voitk, J., Lutter, P., Jarvekulg, S., Jalakas, M., Reinmets, J., Marandi, T., Peeba, M., Serka, T., Syvannne, M., Kaihovirta, E., Korpilahti, H. K., Vaittinen, M. -A., Bassand, J. -P., Espinosa, D. P., Cottin, B. Y., Lhuillier, I., Buffet, P., Lorgis, L., Machecourt, D. J., Bertrand, B., Serrano, D., Bonnet, G. J. -L., Steg, M. P. G., Juliard, J. -M., Farnoud, R., Delarche, P. N., Marco, P. J., Petit, F., Farah, B., Carrie, D., Galinier, M., Puel, J., Cahuzac, J., Roncalli, J., Tauzin, S., Elbaz, M., Schachinger, V., Gitt, F. A., am Rhein Ralf Zahn, L., Fraiture, B., Haetinger, S., Klepzig, N. H., Girth, E., Hauber, A., Firschke, O. C., Widmaier, J., Hofbauer, F., Huttl, S., Sechtem, P. U., Parade, U., Linnartz, S. G., Andrianidis, S., Tsiavou, N., Papaioannou, G., Deliargyris, E., Attikis, M., Alexopoulos, D., Davlouros, P., Tsikaderis, D., Dardas, P., Mezilis, N., Istvan, E., Zoltan, B., Turgeman, Y., Khaled, S., Feldman, A., Jafari, J., Manevich, I., Cafri, C., Ilia, R., Abu-Ful, A., Yaroslavslev, S., Wainstain, J. M., Rosenchtein, G., Sheva, B., Krakover, R., Yakov, B., Halon, D., Gruberg, L., Markiewicz, W., Grenadier, E., Boulos, M., Roguin, A., Kerner, A., Amikam, S., Ben-Tzvi, M., Rezmovitz, J., Mosseri, H. M., Lotan, H., Varshizky, B., Nassar, H., Daninberg, H., Rot, D., Vais, T., Benhorin, J., Keren, A., Medina, A., Huri, Z., Brandis, J. S., Schoenmann, G., Kornowski, N. R., Assali, A., Fuch, S., Hasdai, D., Brosh, D., Sela, O., Teplitski, I., Tikva, P., Eisenberg, O., Banai, S., Finkelstein, A., Hasin, Y., Aboud, M., Nahir, M., Qarwani, D., Diab, G., Meloni, L., Lai, G., Cadeddu, M., Pirisi, R., Bonechi, F., Nassi, F., Nieri, M., Taiti, A., Naldoni, A., Calabro, F., Achilli, F., Maggiolini, S., Piatti, L., Tiberti, G., Addamiano, P., Berti, S., Ravani, M., Palmieri, C., Trianni, G., Cardullo, S., Cioppa, A., Rubino, P., Ambrosini, V., Salemme, L., Sorropago, G., Tesorio, T., Geraci, G., Scalise, F., Mazzeti, S., Auguadro, C., Esposito, G., Canali, G., Caccia, M. E., Ruggieri, C., Benedetta, B., de Cesare, N., De Benedictis, M., Coco, T., Manzotti, S., Fraz, O. S., Marraccini, P., Danesi, A., Ricci, R., Ferraironi, A., Olivieri, E., Chiera, A., Garducci, S., Grasseli, D., Mcfadden, E., Cahill, N., Quinn, M., Crean, P., Caroll, E., Foley, D., O'Connor, S., O'Hanlon, R., Lynch, B., O'Donnell, S., Roy, J., O'Brien, D., Krastina, A., Erglis, A., Lawand, S., Dorniak, W., Klaudel, J., Pawlowski, K., Trenkner, W., Janion, M., Sadowski, M., Janion-Sadowska, A., Skorupa, I., Bystryk, L., Kern, A., Janiak, B., Szelemej, R., Ruzyllo, W., Witkowski, A., Deptuch, T., Maczynska-Mazuruk, R., Budaj, A., Cegieska, K. L., Opolski, G., Wilczyska, J., Roik, M., Kochman, J., Martins, D., Goncalves, I. M. F. J., Pereira, H., Faria, H., Calisto, J., Matos, V., Leitao-Marques, A., Costa, M., Oliveira, H., Mota, P., Santos, W., Brandao, V., Caires, F. G., Silva, B., Teles, F. R. C., Almeida, M., Goncalves, P., Raposo, L., Mourao, L., Bernardes, L., Pedro, P. G., Ferreira, R., Conduto, R., Quininha, J., Patricio, L., Cacela, D., Goncalves, J. M., de Sousa, L., Adao, M., Carvalho, L. H. C., Romeira, H., Sousa, J. P., Garcia, J. M. M., Silva, J. C., Magalhaes, D., Santos, P. R., Mendes, S. P. G., Pipa, J., Nunes, L., Ferreira, P., Vinereanu, D., Udroiu, C., Florescu, N., Parvu, O., Stoicescu, C., Dorobantu, M., Balanescu, S. M., Niculescu, R., Calmac, L., Marinescu, M., Olinic, B. D., Ober, M., Homorodean, C., Budurea, C., Hij, A., Anton, F., Cluj-Napoca, Ortan, F., Suciu, C., Ursu, M., Baba, C., Targu-Mures, Dragulescu, S. I., Petrescu, L., Slovenski, M., Gavrilescu, D., Dina, C., Mut, B., Babic, R., Colic, M., Topic, D., Vilarrasa, J. B., Pont, M. P., Martorell, R. M., Rohlfs, I., Moreno, R. M., Irurita, M., Irurita, J., de Gran Canaria, L. P., Cervantes, C. E., Galvan, T., Navarro, J., Franco, D., Rodriguez, I. S., Ramirez, V. H., Fernandes-Aviles, F., Revilla, A., Masson, N., Dupertuis, V., Kachboura, S., Iyisoy, A., Erol, M. K., Ongen, Z., Babalik, E., Oskan, M., Ozdemir, N., Oto, A., Aytemir, K., Yavuz, B., Sahin, M., Durna, K., Aytekin, V., Demiroglu, C., Gulbaran, M., Aytekin, S., Catakoglu, A. B., Ozme, B., Gemici, G., Feray, H., Schofield, P. M., Kahn, S., Clarke, S., Millington, H., Di Mario, C., Dempster, D., Henderson, R. A., Burton, J., and Falcon-Lang, D.

Subjects
Registrie, Male, medicine.medical_treatment, Angiotensin-Converting Enzyme Inhibitors, Comorbidity, Coronary Artery Disease, Severity of Illness Index, Cardiovascular Disease, Hospital Mortality, Registries, Angioplasty, Balloon, Coronary, Drug-Eluting Stents, Middle Aged, Clopidogrel, Europe, Treatment Outcome, Drug-eluting stent, Cardiovascular Diseases, Practice Guidelines as Topic, Female, Guideline Adherence, Inpatient, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Diabetic Angiopathie, Adrenergic beta-Antagonists, Diabetic, SDG 3 - Good Health and Well-being, Internal medicine, Diabetes mellitus, Angioplasty, medicine, Humans, Drug eluting stent, cardiovascular diseases, Risk factor, Aged, European Heart Survey, Inpatients, Clinical Audit, business.industry, Platelet Aggregation Inhibitor, Adrenergic beta-Antagonist, Angiotensin-Converting Enzyme Inhibitor, Guideline, medicine.disease, Surgery, Health Care Survey, Health Care Surveys, Conventional PCI, Hydroxymethylglutaryl-CoA Reductase Inhibitor, Hydroxymethylglutaryl-CoA Reductase Inhibitors, business, Diabetic Angiopathies, Platelet Aggregation Inhibitors
Abstract

Aims: The objective of the study is to determine the demographics and the in-hospital outcome of diabetic and non-diabetic patients treated with percutaneous coronary interventions (PCI) in Europe, to report the type of equipment and technology used for PCI procedures in diabetics and to clarify whether the treatment of diabetic patients complies with current European Society of Cardiology (ESC) guidelines. Methods and results: A total of 14,458 patients treated with PCI were enrolled from 29 member countries of the ESC between June 2005 and January 2006. Data were collected on patient characteristics and treatment, using new Cardiology Audit and Registration Data standards. In total, 3,603 patients (24.9%) were diabetic. Diabetics were older, more often female and had a higher body mass index than non-diabetics. Diabetics had higher rates of hypercholesterolaemia and hypertension, while current smokers were more frequent in the non-diabetics. Diabetics also had significantly higher rates of previous cardiovascular events. Clopidogrel was administered only in 48.1% of diabetic patients before PCI, while IIb/IIIa inhibitors were 22.9% during PCI. At discharge, there was a major adjustment of treatment with increases in the use of Beta-blocker (80.4%), angiotensin converting enzyme inhibitor (ACEI, 71.3%) and statins (89.8%) compared with on admission (Beta-blocker 60.9%, ACEI 55.0%, statin 63.1%). Inhospital mortality was higher in diabetics (1.8% vs 1.2%) although the in-hospital MACCE rate was not significantly different (3.6% vs 3.0%, p=0.09). Conclusions: Diabetic patients treated with PCI were older with more comorbidity. According to ESC guideline, the under-usage of clopidogrel, GP IIb/IIIa inhibitors should be improved. PCI is now taken as a good opportunity to adjust the use of appropriate medication. © Europa Edition. All rights reserved.

Published
2009

7. An immunological method to combine the measurement of active and total myeloperoxidase on the same biological fluid, and its application in finding inhibitors which interact directly with the enzyme.

Author

Franck, Thierry, Minguet, G, Delporte, Cédric, Derochette, S, Zouaoui Boudjeltia, Karim, Van Antwerpen, Pierre, Gach, O, Deby-Dupont, Ginette, Mouithys-Mickalad, Ange, Serteyn, Didier, Franck, Thierry, Minguet, G, Delporte, Cédric, Derochette, S, Zouaoui Boudjeltia, Karim, Van Antwerpen, Pierre, Gach, O, Deby-Dupont, Ginette, Mouithys-Mickalad, Ange, and Serteyn, Didier

Abstract

Myeloperoxidase (MPO) is a pro-oxidant enzyme involved in inflammation, and the measurement of its activity in biological samples has emerged essential for laboratory and clinical investigations. We will describe a new method which combines the SIEFED (specific immunological extraction followed by enzymatic detection) and ELISA (ELISAcb) techniques to measure the active and total amounts of MPO on the same human sample and with the same calibration curve, as well as to define an accurate ratio between both the active and total forms of the enzyme. The SIEFED/ELISAcb method consists of the MPO extraction from aqueous or biological samples by immobilized anti-MPO antibodies coated onto microplate wells. After a washing step to eliminate unbound material, the activity of MPO is measured in situ by adding a reaction solution (SIEFED). Following aspiration of the reaction solution, a secondary anti-MPO antibody is added into the wells and the ELISAcb test is carried out in order to measure the total MPO content. To validate the combined method, a comparison was made with SIEFED and ELISA experiments performed separately on plasma samples isolated from human whole blood, after a neutrophil stimulation. The SIEFED/ELISAcb provides a suitable tool for the measurement of specific MPO activity in biological fluids and for the estimation of the inhibitory potential of a fluid. The method can also be used as a pharmacological tool to make the distinction between a catalytic inhibitor, which binds to MPO and inhibits its activity, and a steric inhibitor, which hinders the enzyme and prevents its immunodetection., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2015

8. An immunological method to combine the measurement of active and total myeloperoxidase on the same biological fluid, and its application in finding inhibitors which interact directly with the enzyme

Author

Franck, T., primary, Minguet, G., additional, Delporte, C., additional, Derochette, S., additional, Zouaoui Boudjeltia, K., additional, Van Antwerpen, P., additional, Gach, O., additional, Deby-Dupont, G., additional, Mouithys-Mickalad, A., additional, and Serteyn, D., additional

Published
2015
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10. A new easy method for specific measurement of active myeloperoxidase in human biological fluids and tissue extracts.

Author

Franck, Thierry, Kohnen, Stephan S., Zouaoui Boudjeltia, Karim, Van Antwerpen, Pierre, Bosseloir, Alain, Niesten, A, Gach, O, Nys, Marie, Deby-Dupont, Ginette, Serteyn, Didier, Franck, Thierry, Kohnen, Stephan S., Zouaoui Boudjeltia, Karim, Van Antwerpen, Pierre, Bosseloir, Alain, Niesten, A, Gach, O, Nys, Marie, Deby-Dupont, Ginette, and Serteyn, Didier

Abstract

The SIEFED ("Specific Immunological Extraction Followed by Enzymatic Detection") method already developed for the specific detection of the activity of equine myeloperoxidase (MPO) was adapted for the specific measurement of active human MPO in biological fluids or tissue extracts. The method consists of the extraction of MPO from aqueous solutions by immobilized anti-MPO antibodies followed by a washing (to eliminate the extraction medium and the biological fluid with their possible interfering molecules) and the measurement of the activity of MPO with a detection system containing a fluorogenic substrate, H(2)O(2) and nitrite ions as reaction enhancer. The SIEFED was applied to study active MPO in human biological fluids (plasma, bronchoalveolar lavage fluid and supernatant from carotids extracts). The SIEFED for human MPO has a sensitivity limit of 0.080 mU/mL and showed good precision with intra- and inter-assay coefficients of variation below 10 and 20% respectively within a broad range of MPO activities establish from 0.156 to 473 mU/mL. The SIEFED for human MPO will be useful for the specific detection of active MPO in complex fluids and can be complementary to an ELISA to determine an active/total MPO ratio in healthy volunteers and patients especially in case of chronic or acute inflammatory diseases., Journal Article, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2009

12. Economic and clinical benefit of femoral access management by vascular closure devices after percutaneous coronary interventions

Author

Gach, O., Legrand, V., Doneux, P., Martinez, Ch., and Bellekens, M.

Subjects
Heart diseases -- Research, Health, Research
Abstract

Background: Several devices have been proposed as alternatives to manual compression (MC) for femoral access management following catheterization. These devices allow earlier ambulation but don't obviate vascular complications. As a [...]

Published
2002

13. Impact of markers of myocardial damage and inflammation after Percutaneous Coronary Intervention (PCI) on late outcome

Author

Gach, O., Louis, O., Martinez, C., and Legrand, V.

Subjects
Coronary heart disease -- Prognosis, C-reactive protein -- Measurement -- Health aspects, Transluminal angioplasty -- Health aspects -- Measurement, Health, Measurement, Prognosis, Health aspects
Abstract

Background: Markers of inflammation such as high-sensitivity C-reactive protein (us CRP) or myonecrosis such as Troponin (Tn) are linked to prognosis in acute coronary syndromes. However, the prognostic value of [...]

Published
2002

18. Outcomes of Patients With Asymptomatic Aortic Stenosis Followed Up in Heart Valve Clinics

Author

Shizhen Liu, Andrea Rossi, Elena Galli, Erwan Donal, Gilbert Habib, Stefano Nistri, Thomas Modine, Augustin Coisne, Julien Magne, Raluca Elena Dulgheru, Jeroen J. Bax, Raphael Rosenhek, Madalina Garbi, Marie-Annick Clavel, Linda D. Gillam, John C. Chambers, Victoria Delgado, David Montaigne, Philippe Pibarot, Khalil Fattouch, E. Mara Vollema, Mani A. Vannan, Stella Marchetta, Romain Capoulade, Federica Ilardi, Laurent Davin, Bernard Cosyns, Olivier Gach, Guy Lloyd, Anne Bernard, Stephane Lafitte, Lionel Tastet, Luc Pierard, Patrizio Lancellotti, Cécile Oury, Marc Radermecker, Robert Zilberszac, Clinical sciences, Cardio-vascular diseases, Cardiology, Lancellotti, P., Magne, J., Dulgheru, R., Clavel, M. -A., Donal, E., Vannan, M. A., Chambers, J., Rosenhek, R., Habib, G., Lloyd, G., Nistri, S., Garbi, M., Marchetta, S., Fattouch, K., Coisne, A., Montaigne, D., Modine, T., Davin, L., Gach, O., Radermecker, M., Liu, S., Gillam, L., Rossi, A., Galli, E., Ilardi, F., Tastet, L., Capoulade, R., Zilberszac, R., Vollema, E. M., Delgado, V., Cosyns, B., Lafitte, S., Bernard, A., Pierard, L. A., Bax, J. J., Pibarot, P., Oury, C., Groupe Interdisciplinaire de Génoprotéomique Appliquée (GIGA-Research), Université de Liège, Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges], CHU Limoges, Quebec Heart and Lung Institute, Université Laval [Québec] (ULaval), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Guy's and St Thomas' Hospitals, Medizinische Universität Wien = Medical University of Vienna, Aix Marseille Université (AMU), Assistance Publique - Hôpitaux de Marseille (APHM), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), King's Health Partners, Università degli studi di Palermo - University of Palermo, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Leiden University Medical Center (LUMC), Universiteit Leiden, CHU Bordeaux [Bordeaux], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), and INSB-INSB-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, Registrie, United State, Canada, medicine.medical_specialty, 030204 cardiovascular system & hematology, Asymptomatic, Sudden death, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Aortic valve replacement, Retrospective Studie, Internal medicine, medicine, Humans, Prospective Studies, Registries, 030212 general & internal medicine, Heart valve, Watchful Waiting, Prospective cohort study, Retrospective Studies, Aged, Aged, 80 and over, Asymptomatic Disease, Ejection fraction, business.industry, Disease Management, Aortic Valve Stenosis, Middle Aged, medicine.disease, Aortic Valve Stenosi, United States, 3. Good health, Europe, Prospective Studie, Stenosis, Death, Sudden, Cardiac, medicine.anatomical_structure, Aortic valve stenosis, Asymptomatic Diseases, Cardiology, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Female, medicine.symptom, business, Cardiology and Cardiovascular Medicine, Human
Abstract

International audience; Importance - The natural history and the management of patients with asymptomatic aortic stenosis (AS) have not been fully examined in the current era. Objective - To determine the clinical outcomes of patients with asymptomatic AS using data from the Heart Valve Clinic International Database. Design, setting, and participants - This registry was assembled by merging data from prospectively gathered institutional databases from 10 heart valve clinics in Europe, Canada, and the United States. Asymptomatic patients with an aortic valve area of 1.5 cm2 or less and preserved left ventricular ejection fraction (LVEF) greater than 50% at entry were considered for the present analysis. Data were collected from January 2001 to December 2014, and data were analyzed from January 2017 to July 2018. Main outcomes and measures - Natural history, need for aortic valve replacement (AVR), and survival of asymptomatic patients with moderate or severe AS at entry followed up in a heart valve clinic. Indications for AVR were based on current guideline recommendations. Results - Of the 1375 patients included in this analysis, 834 (60.7%) were male, and the mean (SD) age was 71 (13) years. A total of 861 patients (62.6%) had severe AS (aortic valve area less than 1.0 cm2). The mean (SD) overall survival during medical management (mean [SD] follow up, 27 [24] months) was 93% (1%), 86% (2%), and 75% (4%) at 2, 4, and 8 years, respectively. A total of 104 patients (7.6%) died under observation, including 57 patients (54.8%) from cardiovascular causes. The crude rate of sudden death was 0.65% over the duration of the study. A total of 542 patients (39.4%) underwent AVR, including 388 patients (71.6%) with severe AS at study entry and 154 (28.4%) with moderate AS at entry who progressed to severe AS. Those with severe AS at entry who underwent AVR did so at a mean (SD) of 14.4 (16.6) months and a median of 8.7 months. The mean (SD) 2-year and 4-year AVR-free survival rates for asymptomatic patients with severe AS at baseline were 54% (2%) and 32% (3%), respectively. In those undergoing AVR, the 30-day postprocedural mortality was 0.9%. In patients with severe AS at entry, peak aortic jet velocity (greater than 5 m/s) and LVEF (less than 60%) were associated with all-cause and cardiovascular mortality without AVR; these factors were also associated with postprocedural mortality in those patients with severe AS at baseline who underwent AVR (surgical AVR in 310 patients; transcatheter AVR in 78 patients). Conclusions and relevance - In patients with asymptomatic AS followed up in heart valve centers, the risk of sudden death is low, and rates of overall survival are similar to those reported from previous series. Patients with severe AS at baseline and peak aortic jet velocity of 5.0 m/s or greater or LVEF less than 60% have increased risks of all-cause and cardiovascular mortality even after AVR. The potential benefit of early intervention should be considered in these high-risk patients.

Published
2018

19. Platelet reactivity and cardiovascular events after percutaneous coronary intervention in patients with stable coronary artery disease: the Stent Thrombosis In Belgium (STIB) trial

Author

Mathy C.M. Vrolix, William Wijns, Emanuele Barbato, Jean Boland, Marc J. Claeys, Olivier Gach, Julien Magne, Christophe Martinez, Thomas Cuisset, Victor Legrand, Patrick Chenu, Joseph Dens, Legrand, V, Cuisset, T, Chenu, P, Vrolix, M, Martinez, C, Dens, J, Gach, O, Boland, J, Claeys, Mj, Magne, J, Barbato, Emanuele, and Wijns, W.

Subjects
Male, Time Factors, medicine.medical_treatment, Myocardial Infarction, Coronary Artery Disease, Angina, Coronary artery disease, Belgium, Risk Factors, Odds Ratio, Clinical endpoint, Prospective Studies, Myocardial infarction, Middle Aged, Clopidogrel, Stroke, Treatment Outcome, Cardiology, Drug Therapy, Combination, Female, Stents, Cardiology and Cardiovascular Medicine, medicine.drug, Blood Platelets, medicine.medical_specialty, Ticlopidine, Platelet Function Tests, Hemorrhage, Percutaneous Coronary Intervention, Predictive Value of Tests, Internal medicine, medicine, Humans, Angina, Stable, cardiovascular diseases, Aged, Chi-Square Distribution, Aspirin, business.industry, Coronary Thrombosis, Stent, Percutaneous coronary intervention, Platelet Activation, medicine.disease, Logistic Models, Multivariate Analysis, Conventional PCI, Human medicine, business, Platelet Aggregation Inhibitors
Abstract

Aims: The Stent Thrombosis In Belgium (STIB) trial aimed to determine whether assessing platelet reactivity (PR) in patients with stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI) could predict the risk of ischaemic complications and adverse clinical events up to 30 days post PCI. Methods and results: PR before intervention was determined in 891 patients undergoing PCI for stable angina pectoris. Twelve to 24 hours before PCI, all patients received a 600 mg clopidogrel dose followed by 75 mg daily, and 500 mg of aspirin followed by 80-100 mg daily. Residual PR was assessed by VerifyNow point-of-care aspirin and P2Y12 assay before PCI. Non-responders to antiplatelet therapy were defined as aspirin reaction unit (ARU) >550 and as P2Y12 reaction unit (PRU) >230. The endpoint of the study was the composite of periprocedural myonecrosis, stent thrombosis, non-fatal myocardial infarction (MI), stroke and death at 30 days in patients with or without high PR. The endpoint was observed in 180 patients: four deaths, one stroke, 11 Q-wave MI, three non-Q-wave MI and 161 periprocedural myonecroses. At multivariate analysis, the endpoint was predicted by total stent length (OR: 1.020), GFR

Published
2014

20. The impact of the bifurcation angle for the Nano-Crush two-stent coronary bifurcation technique on long-term outcomes in a real-world clinical population.

Author

Ungureanu C, Natalis A, Cocoi M, Dumitrascu S, Noterdaeme T, Gach O, Jossart A, Soetens R, and Colletti G

Subjects
Humans, Retrospective Studies, Male, Female, Aged, Middle Aged, Time Factors, Treatment Outcome, Risk Factors, Stents, Coronary Angiography, Prosthesis Design, Angioplasty, Balloon, Coronary instrumentation, Angioplasty, Balloon, Coronary adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy
Abstract

Aim: This study aims to assess the direct impact of bifurcation angle (BA) on immediate procedural outcomes and patient prognosis post-Nano-Crush stenting for coronary bifurcation lesions., Methods: A retrospective analysis was conducted for all consecutive patients treated with the Nano-Crush technique across two high-volume interventional centers from January 2020 to October 2022., Primary Endpoint: comparison of target lesion failure rate in two cohorts based on bifurcation angle (<70° vs. ≥70°), with secondary endpoints including side branch ostium coverage, rate of successful final kissing balloon inflation (FKBI), need for conversion to another technique, and procedure length., Results: Baseline demographics included 71 patients in the BA<70° group and 49 in the BA≥70° group, with well-balanced characteristics. Angiographic characteristics revealed similar trends, including anatomic and morphological lesion characteristics (referencing Syntax score, Medina classification, and presence of calcifications). Both groups predominantly had complex coronary disease, with a baseline mean Syntax score of 24.18 ± 8.19 in the BA<70° group and 23.91 ± 7.29 in the BA≥70° group, respectively. A dedicated debulking device for lesion preparation was used in 25.35 % of patients in the first group and in 28.57 % of patients in the second group. The primary endpoint occurred in 5.63 % of patients in the BA<70° group and in 4.08 % of patients in the BA≥70° group (P = 0.7014) after ≥ 2 years of clinical follow-up. Angiographic success was achieved in 100 % of both groups, with procedural time averaging 74.99 ± 25.55 min in the BA≥70° and 76.94 ± 27.81 min in the BA<70° (P = 0.6922). The rate of successful final kissing balloon inflation was 98.59 % in the BA<70° group and 95.91 % in the BA≥70° group (P = 0.3566). The mean contrast volume was 189.54 ± 73.74 ml in BA<70° and 168.9 ± 62.77 ml in BA≥70° (P = 0.1126). Clinical follow-ups at 30 days and 2 years revealed similar outcomes and complications for each group, as summarized in Table 3., Conclusions: Our results demonstrate that the bifurcation angle does not significantly impact long-term clinical outcomes or procedural parameters, such as side branch ostium coverage, conversion to a modified DK Crush technique, FKBI success rate, and procedure length. These findings suggest that the Nano-Crush technique can be a viable option for bifurcation lesions, irrespective of the bifurcation angle, achieving optimal side branch ostium coverage while preventing excessive protrusion into the main vessel., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Published
2024
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22. Complex Percutaneous Coronary Intervention Assisted by 3-Dimensional Printing Model.

Author

Gach O, Finianos L, Palmers PJ, Testaguzza M, and Ungureanu C

Subjects
Coronary Angiography methods, Humans, Printing, Three-Dimensional, Treatment Outcome, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods
Abstract

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Published
2022
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23. Atrial fibrillation, diabetes and anticoagulation with direct oral anticoagulants: time to reconsider duration of the disease to evaluate the bleeding risk?

Author

Gach O and Pierard LA

Subjects
Administration, Oral, Anticoagulants adverse effects, Humans, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Diabetes Mellitus drug therapy, Diabetes Mellitus epidemiology, Stroke
Abstract

Atrial fibrillation and diabetes: time to reconsider duration of the disease to evaluate the bleeding risk? Impact of diabetes status in patients suffering of non-valvular atrial fibrillation requiring anticoagulation have been analysed previously and risk/benefit balance of NOACs have been confirmed in these patients. The implication of that pathology in the evaluation of the thrombotic risk is discussed but more importantly bleeding risk in this growing population is analysed, perhaps neglected until now.

Published
2021
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24. Sudden Cardiac Death Revealed by an Anomalous Origin of the Right Coronary Artery From the Left Sinus of Valsalva.

Author

Bruls S, Durieux R, Gach O, Lancellotti P, and Defraigne JO

Subjects
Adult, Death, Sudden, Cardiac, Humans, Male, Abnormalities, Multiple, Coronary Artery Bypass, Coronary Vessel Anomalies complications, Coronary Vessel Anomalies surgery, Heart Arrest etiology, Sinus of Valsalva abnormalities
Abstract

Aberrant origin of the coronary artery from the opposite sinus of Valsalva is a rare congenital coronary anomaly associated with increased risk of myocardial ischemia and sudden death in young patients. We report a case of resuscitated sudden cardiac death in a patient with an anomalous origin of the right coronary artery, arising from the left sinus of Valsalva and coursing between the ascending aorta and the pulmonary artery. Successfully coronary arterial bypass grafting using the left radial artery was performed. Despite the risk of fatal issue, surgical management of patient with this coronary anomaly still remains controversial., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Published
2020
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25. [Congenital heart disease : fistula from circumflex artery to coronary sinus].

Author

Piette C, Bernard AC, Gach O, and Lancellotti P

Subjects
Coronary Angiography, Coronary Sinus, Humans, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease surgery, Coronary Vessel Anomalies diagnostic imaging, Coronary Vessel Anomalies surgery, Vascular Fistula diagnostic imaging, Vascular Fistula surgery
Abstract

Congenital coronary artery fistulas are infrequent but sometimes hemodynamically important anomalies depending on their magnitude and the cardiac chamber or vascular site involved. Fistula from left circumflex artery to coronary sinus are potentially curable causes of ischemic heart disease.

Published
2019

26. [Percutaneous transluminal coronary angioplasty: from revolution to evolution].

Author

Gach O, Davin L, Lempereur M, Marechal P, Martinez C, and Lancellotti P

Subjects
Humans, Angioplasty, Balloon, Coronary
Abstract

In interventional cardiology, percutaneous transluminal coronary angioplasty (PTCA) definitely represents a revolution in the history of medicine, illustrating the medical community intention to replace aggressive revascularization intervention by less invasive procedure. Rapidly adopted by physicians and patients, its utilization has grown exponentially and in parallel, numerous technical progresses have pushed forward the frontiers of its indications. This article summarizes the principal evolution of this revascularization technique from its beginning until its last innovations, describing some technical characteristics and emphasizing on some changes and extension of its indications.

Published
2019

27. [Micra® leadless pacemaker].

Author

Lancellotti P, Gach O, Marechal P, and Robinet S

Subjects
Equipment Design, Humans, Treatment Outcome, Atrial Fibrillation therapy, Pacemaker, Artificial
Abstract

The Micra® leadless pacemaker has demonstrated both safety and efficacy in the short and mid-term as an alternative to conventional transvenous pacemakers. This technology provides a new solution, especially for patients without conventional venous approach and for older patients with atrial fibrillation presenting with symptomatic bradycardia. The advantages of this approach are multiple : a miniature technology therefore less invasive, short procedure, no stimulation leads, or need to create a surgical pocket with a reduced risk of infection. The pacemaker's battery has a life expectancy similar to that of a conventional transvenous pacemaker. In this article, we discuss the characteristics of Micra® versus the traditional transvenous pacemaker.

Published
2019

28. [Diagnostic coronarography].

Author

Gach O, Davin L, Lempereur M, Marechal P, Martinez C, and Lancellotti P

Subjects
Contraindications, Humans, Coronary Angiography, Heart Diseases diagnostic imaging
Abstract

Coronarography consists in selective angiography of the coronary arteries obtained invasively. It represents the gold standard for the anatomical exploration of the coronary arteries and establishes the first step for the indication of possible percutaneous or surgical revascularisation. According to substantial progress, it represents an essential diagnostic tool frequently used with, despite its invasive characteristic, a very low complication's rate. The present article describes the patient's preparation for this procedure, technical modalities, major indications, contraindications and possible complications.

Published
2019

29. Epicardial Adipose Tissue and Myocardial Fibrosis in Aortic Stenosis Relationship With Symptoms and Outcomes: A Study Using Cardiac Magnetic Resonance Imaging.

Author

Davin L, Nchimi A, Ilardi F, Dulgheru R, Marchetta S, Gach O, Marechal P, Cimino S, Bruyère PJ, Georgiopoulos A, Dibato JE, d'Amico G, Galderisi M, Parisi V, Oury C, and Lancellotti P

Subjects
Adipose Tissue pathology, Aged, Aged, 80 and over, Aortic Valve Stenosis mortality, Aortic Valve Stenosis pathology, Aortic Valve Stenosis surgery, Disease Progression, Female, Fibrosis, Heart Valve Prosthesis Implantation, Humans, Male, Middle Aged, Pericardium pathology, Predictive Value of Tests, Prognosis, Risk Factors, Time Factors, Adipose Tissue diagnostic imaging, Aortic Valve Stenosis diagnostic imaging, Magnetic Resonance Imaging, Myocardium pathology, Pericardium diagnostic imaging
Published
2019
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30. [Intracoronary imaging modalities in interventional cardiology].

Author

Gach O, Davin L, and Lancellotti P

Subjects
Angiography, Humans, Tomography, Optical Coherence, Coronary Artery Disease diagnostic imaging, Ultrasonography, Interventional
Abstract

According to technical and pharmacological innovations and to a better comprehension in pathophysiology, interventional cardiology has continuously progressed to push forward the frontiers of its indications. Despite these evolutions, it still uses an imaging modality based on X-ray, which presents numerous limitations in interpreting three-dimensional structures. The present chapter describes two available additive technologies used to optimize the resolution and the information obtained by intravascular imaging, adding key complementary information to angiography imaging : intravascular ultrasound (IVUS) and intravascular optical coherence tomography.

Published
2019

31. [The heart team : definition and organization. Point of view of the cardiologist].

Author

Lancellotti P, Ancion A, Davin L, Dulgheru R, Gach O, Lempereur M, Marchetta S, Marechal P, and Martinez C

Subjects
Cardiologists, Comorbidity, Humans, Prognosis, Cardiology, Cardiovascular Diseases surgery
Abstract

The management of complex cardiovascular disease has changed considerably with the development of new care strategies. In cardiology, the «Heart Team» or literally «Equipe du cœur» occupies a prominent place in the latest European and American recommendations, particularly in the management of complex coronary or valvular diseases and in heart failure patients. The concept of «Heart Team» is based on the need for a multidisciplinary holistic approach based on evidence (respect of the recommendations of the scientific societies), the patient as a whole (comorbidities, preferences), risks and long-term benefits of the treatment selected and performed, as well as on the level of local expertise. It aims to determine the best management strategy for the patient, and perhaps to guarantee a better result (prognosis).

Published
2019

32. [Alcohol septal ablation for obstructive hypertrophic cardiomopathy].

Author

Lancellotti P, Gach O, Davin L, Marchetta S, and Dulgheru R

Subjects
Echocardiography, Humans, Treatment Outcome, Cardiac Surgical Procedures, Cardiomyopathy, Hypertrophic therapy, Ethanol therapeutic use, Pacemaker, Artificial, Solvents therapeutic use
Abstract

Alcohol septal ablation has become an attractive alternative to surgical myomectomy in symptomatic patients with obstructive hypertrophic cardiomyopathy. Its purpose is to achieve a therapeutic infarction in the sub-aortic territory responsible of the obstruction. It is indicated in symptomatic patients resistant to optimal medical treatment and having a left intraventricular gradient equal or higher than 50 mmHg, spontaneous or with exercise. The selection of candidates must be rigorous and the procedure must be performed in an experienced center, associating interventionalists and echocardiographists. Alcohol septal ablation is preferred in cases of favourable coronary anatomy, sub-aortic obstruction and absence of associated mitral valve defect. The septal alcohol technique is fast, effective and safe. The per-procedural contrast echocardiography helps identifying whether the myocardial segment is vascularized by the septal branch to be occluded. The benefits of alcohol septal ablation are comparable to those seen with surgical myectomy in terms of functional class, exercise capacity, and gradient regression. The morbidity and mortality observed in the short and mid terms are globally equivalent to that of the surgical intervention. The major complication is dominated by the occurrence of complete atrioventricular block requiring the implantation of a definitive pacemaker, a complication in sharp decline since the contrast ultrasound-guided technique has become widespread.

Published
2019

33. [Invasive physiological evaluation of coronary artery disease].

Author

Marechal P, Lempereur M, Gach O, and Lancellotti P

Subjects
Coronary Angiography, Hemodynamics, Humans, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease physiopathology, Coronary Stenosis, Fractional Flow Reserve, Myocardial
Abstract

Percutaneous or surgical coronary revascularization must only be realized if myocardial ischemia is clearly demonstrated. In practice, this ischemia is most often seeked by non-invasive tests. These ones are unfortunately not systematically realized or may bring equivocal results compared to angiographic images. Coronary angiography remains the test of choice for the evaluation of coronary disease, but visual analysis of coronary stenosis does not confirm their hemodynamic significance. The measurement of coronary flow reserve by FFR ("fractional flow reserve") or iFR («instantaneous wave-free ratio») is a simple method to invasively assess the hemodynamic impact of a coronary lesion. Spastic angina, when suspected by clinical history, can also be confirmed during coronary angiography by the provocative methylergonovine test.

Published
2019

34. [Rotational atherectomy (Rotablator®) : complementary technique in management of undilatable coronary lesions].

Author

Gach O, Lempereur M, Marechal P, and Lancellotti P

Subjects
Coronary Angiography, Humans, Stents, Treatment Outcome, Atherectomy, Coronary, Coronary Artery Disease therapy
Abstract

In 40 years of existence, interventional cardiology has witnessed the introduction of numerous tools and techniques that have contributed to the important application's broadening of percutaneous techniques, particulary in anatomical situations previously unfavourable, and which were, at that time, subject to surgical revascularization. Among these hostiles situations, one of the principal consists in failure to adequately dilate the lesions and/or to the inability to deliver and implant a stent appropriately, situations frequently associated with a high rate of procedural complications and poor long-term clinical outcomes. Thanks to the development of complementary dedicated techniques such atherectomy device, the treatment of most fibrotic and heavily calcified lesions has become feasible and safe. The present article describes the rotational atherectomy procedure, its indications and its clinical results.

Published
2019

35. [Transcatheter aortic valve replacement : from a concept to a medical revolution].

Author

Martinez C, Gach O, Radermecker MA, and Lancellotti P

Subjects
Aortic Valve, Humans, Quality of Life, Risk Factors, Treatment Outcome, Aortic Valve Stenosis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Transcatheter Aortic Valve Replacement
Abstract

Since the first transcatheter aortic valve implantation (TAVI) in 2002, the paradigm for the treatment of severe aortic stenosis has changed. In the recent past, medical therapy with or without balloon aortic valvuloplasty was the only option for inoperable patients but now, TAVI has become the treatment of choice for these patients and the preferred alternative for high-risk operable patients. Surgical aortic valve replacement (SAVR) currently remains the gold standard for patients at low operative risk. As randomized trials have demonstrated comparable (or better results with TAVI) between TAVI and SAVR in the high-risk population, there is now a clear trend towards performing TAVI even in intermediate-risk. Nevertheless, there are still questions regarding TAVI involving paravalvular leak, stroke, pacemaker requirements, and durability, which remain to be more definitively answered before TAVI can routinely be performed in lower risk and younger population. Improvements in patient selection, multimodal imaging, and third generation devices have significantly decreased the incidence of TAVI complications. A role for post-procedure antithrombotic or anticoagulant management remains unanswered. Waiting for current studies to provide us with clear answers to these questions, it is the Heart Team's task to determine the optimal treatment for each patient based on risk scores, frailty metrics, comorbidities, patient's preference, and potential for improvement in quality of life.

Published
2019

36. Outcomes of Patients With Asymptomatic Aortic Stenosis Followed Up in Heart Valve Clinics.

Author

Lancellotti P, Magne J, Dulgheru R, Clavel MA, Donal E, Vannan MA, Chambers J, Rosenhek R, Habib G, Lloyd G, Nistri S, Garbi M, Marchetta S, Fattouch K, Coisne A, Montaigne D, Modine T, Davin L, Gach O, Radermecker M, Liu S, Gillam L, Rossi A, Galli E, Ilardi F, Tastet L, Capoulade R, Zilberszac R, Vollema EM, Delgado V, Cosyns B, Lafitte S, Bernard A, Pierard LA, Bax JJ, Pibarot P, and Oury C

Subjects
Aged, Aged, 80 and over, Canada epidemiology, Disease Management, Disease-Free Survival, Europe epidemiology, Female, Humans, Male, Middle Aged, Prospective Studies, Registries, Retrospective Studies, United States epidemiology, Aortic Valve Stenosis mortality, Asymptomatic Diseases mortality, Death, Sudden, Cardiac epidemiology, Watchful Waiting methods
Abstract

Importance: The natural history and the management of patients with asymptomatic aortic stenosis (AS) have not been fully examined in the current era., Objective: To determine the clinical outcomes of patients with asymptomatic AS using data from the Heart Valve Clinic International Database., Design, Setting, and Participants: This registry was assembled by merging data from prospectively gathered institutional databases from 10 heart valve clinics in Europe, Canada, and the United States. Asymptomatic patients with an aortic valve area of 1.5 cm2 or less and preserved left ventricular ejection fraction (LVEF) greater than 50% at entry were considered for the present analysis. Data were collected from January 2001 to December 2014, and data were analyzed from January 2017 to July 2018., Main Outcomes and Measures: Natural history, need for aortic valve replacement (AVR), and survival of asymptomatic patients with moderate or severe AS at entry followed up in a heart valve clinic. Indications for AVR were based on current guideline recommendations., Results: Of the 1375 patients included in this analysis, 834 (60.7%) were male, and the mean (SD) age was 71 (13) years. A total of 861 patients (62.6%) had severe AS (aortic valve area less than 1.0 cm2). The mean (SD) overall survival during medical management (mean [SD] follow up, 27 [24] months) was 93% (1%), 86% (2%), and 75% (4%) at 2, 4, and 8 years, respectively. A total of 104 patients (7.6%) died under observation, including 57 patients (54.8%) from cardiovascular causes. The crude rate of sudden death was 0.65% over the duration of the study. A total of 542 patients (39.4%) underwent AVR, including 388 patients (71.6%) with severe AS at study entry and 154 (28.4%) with moderate AS at entry who progressed to severe AS. Those with severe AS at entry who underwent AVR did so at a mean (SD) of 14.4 (16.6) months and a median of 8.7 months. The mean (SD) 2-year and 4-year AVR-free survival rates for asymptomatic patients with severe AS at baseline were 54% (2%) and 32% (3%), respectively. In those undergoing AVR, the 30-day postprocedural mortality was 0.9%. In patients with severe AS at entry, peak aortic jet velocity (greater than 5 m/s) and LVEF (less than 60%) were associated with all-cause and cardiovascular mortality without AVR; these factors were also associated with postprocedural mortality in those patients with severe AS at baseline who underwent AVR (surgical AVR in 310 patients; transcatheter AVR in 78 patients)., Conclusions and Relevance: In patients with asymptomatic AS followed up in heart valve centers, the risk of sudden death is low, and rates of overall survival are similar to those reported from previous series. Patients with severe AS at baseline and peak aortic jet velocity of 5.0 m/s or greater or LVEF less than 60% have increased risks of all-cause and cardiovascular mortality even after AVR. The potential benefit of early intervention should be considered in these high-risk patients.

Published
2018
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37. Defining Glycemic Variability in Very Low-Birthweight Infants: Data from a Continuous Glucose Monitoring System.

Author

Jagła M, Szymońska I, Starzec K, Gach O, Włodarczyk A, and Kwinta P

Subjects
Blood Glucose Self-Monitoring instrumentation, Female, Humans, Hyperglycemia blood, Hyperglycemia diagnosis, Hypoglycemia blood, Hypoglycemia diagnosis, Infant, Newborn, Infant, Newborn, Diseases blood, Infant, Newborn, Diseases diagnosis, Male, Prospective Studies, Reference Values, Blood Glucose analysis, Blood Glucose Self-Monitoring methods, Infant, Very Low Birth Weight blood
Abstract

Background: Glucose variability (GV) is a matter of interest for researches in recent years. It is connected with oxidative stress, which is crucial in the development of multiple complication of prematurity. However, glycemic variability in preterm infants was poorly investigated. This study aims to investigate glycemic variability obtained from a continuous glucose monitoring (CGM) system in a cohort of very low-birthweight (VLBW) infants., Methods: A prospective, single-center, open cohort study enrolled 74 VLBW infants with a mean birthweight of 1066 g and median gestational age of 28 weeks. A CGM system (Guardian Real-Time CGM ® , Medtronic, Northridge, CA) was used to measure interstitial glucose concentration. The glycemic variability was calculated using EasyGV., Results: Most glycemic variability indices in VLBW infants showed log-normal distribution and for these, geometric mean ÷/ × geometric standard deviation (GSD) was calculated: M-value 2.28 (÷/ × 1.82), mean amplitude of glycemic excursions (MAGE) 1.89 (÷/ × 1.34), average daily risk ratio (ADRR) 2.22 (÷/ × 2.56), lability index 0.46 (÷/ × 1.71), J-index 0.46 (÷/ × 1.71), low blood glucose index 2.05 (÷/ × 1.66), high blood glucose index 1.11 (÷/ × 2.44), continuous overlapping net glycemic action (CONGA) 5.54 (÷/ × 1.16), mean of daily differences (MODD) 1.23 (÷/ × 1.38), and coefficient of variation 1.15 (÷/ × 1.31). Only SD of glucose concentration showed a normal distribution: arithmetic mean 1.24 (+/-0.37). ADRR, J-index, MODD, CONGA, and MAGE are moderately to strongly correlated with SD., Conclusions: In our cohort of VLBW infants, almost all glycemic variability indices showed skewed positive distribution. The natural central tendency measure for the log-normally distributed data is the geometric mean and for statistical variation is the GSD.

Published
2018
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38. Coronary chronic total occlusion intervention: utility or futility.

Author

Marechal P, Davin L, Gach O, Martinez C, Lempereur M, Lhoest N, and Lancellotti P

Subjects
Angioplasty methods, Chronic Disease, Humans, Medical Futility, Patient Selection, Quality of Life, Treatment Outcome, Coronary Angiography methods, Coronary Occlusion therapy, Percutaneous Coronary Intervention methods
Abstract

Introduction: Despite an incidence of about 18-52% of the patients undergoing coronary angiography, chronic total occlusions (CTO) are rarely revascularised by percutaneous angioplasty (PCI). Nevertheless, current evidence suggests that successful CTO angioplasty improves symptoms, quality of life and long-term survival. During the last decade, the improvement of specific tools and techniques for these complex procedures, and the increasing experience of operators, have led to the achievement of success and complication rates almost equivalent to non-CTO angioplasty. Areas covered: This review focuses on the clinical benefits of CTO revascularization and on appropriate patient selection. Expert commentary: Current evidence suggests that successful CTO-PCI improves symptoms, quality of life and long-term survival. During the last years, the improvement of specific techniques for these complex procedures and the increasing experience of operators, have led to the achievement of success and complication rates almost equivalent to non-CTO lesion angioplasty.

Published
2018
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39. Pretreatment with P2Y12 inhibitors and outcome in patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention.

Author

Gach O, Nyssen A, Pirlet C, Magne J, Oury C, and Lancellotti P

Subjects
Aged, Belgium epidemiology, Clopidogrel therapeutic use, Female, Hemorrhage chemically induced, Humans, Male, Middle Aged, Multivariate Analysis, Percutaneous Coronary Intervention, Prasugrel Hydrochloride therapeutic use, Preoperative Care methods, Purinergic P2Y Receptor Antagonists adverse effects, Stents adverse effects, Survival Analysis, Thrombosis etiology, Ticagrelor therapeutic use, Time Factors, Treatment Outcome, Hemorrhage epidemiology, Purinergic P2Y Receptor Antagonists therapeutic use, ST Elevation Myocardial Infarction mortality, ST Elevation Myocardial Infarction therapy, Thrombosis epidemiology
Abstract

Aims: Preload with clopidogrel, ticagrelor, or prasugrel in the setting of ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI) is frequently applied. Limited data are available regarding the outcome impact of pretreatment with these drugs in the real world., Methods and Results: The outcome of 760 STEMI patients treated by primary PCI receiving clopidogrel, prasugrel, or ticagrelor (n = 269, 327, 164, respectively) was evaluated. Patients in the clopidogrel group were older, whereas those in the ticagrelor group had less hypertension but were more active smokers. Angiographic characteristics were comparable among the three groups. At 1 month, more events were observed in the clopidogrel group (11.1%) than in the ticagrelor and prasugrel groups (7.1 vs. 5.1%, P = 0.025), whereas the number of events in the ticagrelor and prasugrel groups did not differ. At 1 year, similar differences existed, mainly driven by a higher rate of death (19.5%, P = 0.008) or stent thrombosis (2 vs. 1.3% for ticagrelor, P = 0.132; vs. 0.3% for prasugrel, P = 0.07) in the clopidogrel group. In-hospital and 1-year bleeding rates were similar between groups., Conclusion: In real-world practice, pretreatment with prasugrel or ticagrelor in ongoing STEMI treated by primary PCI seems to be a well tolerated alternative strategy compared with clopidogrel but provides superior benefit in terms of outcomes.

Published
2018
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40. [Acute coronary syndrome].

Author

Gach O, El HZ, and Lancellotti P

Subjects
Chest Pain diagnosis, Chest Pain epidemiology, Chest Pain etiology, Chest Pain therapy, Electrocardiography, Emergency Medical Services, Humans, Risk Assessment, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome epidemiology, Acute Coronary Syndrome therapy
Abstract

Acute coronary syndromes represent a major cause of mortality in our country. There is a very wide spectrum of clinical presentation since the actual classification of acute coronary syndromes is based on electrocardiographic presentation, that is to say based on absence or presence of ST segment elevation. When dealing with an acute chest pain, once the probability of acute coronary syndrome is established, the emergency care must follow the scientific guidelines. One of the critical steps is represented by the evaluation of ischaemic and hemorrhagic risk in order to tailor optimally antithrombotic and anticoagulation therapies and revascularization timing. This article summarizes the main points of the emergency care from the diagnosis to risk stratification.

Published
2018

41. [Bradykinin and cardiovascular protection. Role of perindopril, an inhibitor of angiotensin conversion enzyme].

Author

Lancellotti P, Ancion A, D'Orio V, Gach O, Maréchal P, and Krzesinski JM

Subjects
Cardiovascular Diseases prevention & control, Endothelium, Vascular metabolism, Humans, Angiotensin-Converting Enzyme Inhibitors pharmacology, Bradykinin metabolism, Perindopril pharmacology
Abstract

The endothelium plays a vital role as part of the cardiovascular continuum. Risk factors such as hypertension and dyslipidemia unbalance angiotensin II - bradykinin homeostasis, leading to endothelial dysfunction and changes in vascular structure that promote atherosclerosis and thrombosis. When dealing with risk factors, treatment should focus on the prevention and restoration of endothelial function. Not all cardiovascular drugs are able to reverse vascular and structural endothelial dysfunction. Increasing levels of bradykinin is an effect of the use of angiotensin-converting enzyme inhibitors (ACE-Is), and also a fundamental part of their mode of action. The cardiovascular protection observed with ACE-I, and not with sartans, can be explained rationally by the specific effects of bradykinin on the endothelium. In the pharmacological class of ACE-Is, perindopril likely produces the strongest effects on bradykinin, which may explain, at least in part, the documented superiority of this drug in the prevention and treatment of cardiovascular disease.

Published
2018

42. Ratio of high-sensitivity troponin to creatine kinase-MB in takotsubo syndrome.

Author

Pirlet C, Pierard L, Legrand V, and Gach O

Subjects
Aged, Aged, 80 and over, Biomarkers blood, Cohort Studies, Female, Humans, Male, Middle Aged, Myocardial Infarction blood, Myocardial Infarction diagnostic imaging, Prospective Studies, Retrospective Studies, Creatine Kinase, MB Form blood, Takotsubo Cardiomyopathy blood, Takotsubo Cardiomyopathy diagnostic imaging, Troponin T blood
Abstract

Background: Takotsubo syndrome (TT) and myocardial infarction (MI) share numerous similarities in clinical presentation, ECG modifications and biomarker elevation. We sought to determine whether the ratio of high-sensitivity cardiac troponin T (hs-TnT) to the myocardial fraction of creatine kinase (CKMB) could be a potent discriminator between TT and MI patients., Methods: We separately present analysis of data from retrospective files and prospectively recruited patients presenting with TT (35 retrospective and 42 prospective), NSTEMI (48 retrospective and 75 prospective) and STEMI (20 retrospective and 39 prospective). We compared ratios of hs-TnT to CKMB on admission to the hospital between TT, NSTEMI and STEMI patients. Receiver operating characteristic (ROC) curves were analysed to determine optimal cut-off values., Results: On admission, hs-TnT/CKMB ratio was significantly higher in TT patients than in NSTEMI and STEMI patients in both the retrospective phase (median and interquartile range, TT 0.024 [0.018-0.047] vs NSTEMI 0.009 [0.006-0.022], p<0.0001; TT vs STEMI 0.011 [0.006-0.016], p=0.0002) and the prospective cohort (median and interquartile range, TT 0.032 [0.018-0.040] vs NSTEMI 0.009 [0.006-0.015], p<0.0001; TT vs STEMI 0.009 [0.005-0.017], p<0.0001). A cut-off hs-TnT/CKMB ratio of 0.015 distinguished TT from MI with a sensitivity of 85.7% and a specificity of 67.6% (AUC 0.796; 95%CI: 0.71-0.89) in the retrospective phase. In the prospective phase, a ratio of 0.017 distinguished TT from MI with a sensitivity of 83.3% and a specificity of 78.1% (AUC 0.88; 95%CI: 0.83-0.94)., Conclusion: hs-TnT/CKMB ratio is a novel, readily available parameter that could be used alongside clinical risk scores, other biomarkers and ECG findings to discriminate between TT and MI., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Published
2017
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43. [Why to treat a total chronic coronary occlusion?]

Author

Marechal P, Gach O, Davin L, Martinez C, Lempereur M, Magnee M, and Lancellotti P

Subjects
Angioplasty, Chronic Disease, Coronary Angiography, Humans, Treatment Outcome, Coronary Occlusion therapy, Percutaneous Coronary Intervention
Abstract

Despite an incidence of about 15% of the patients undergoing coronary angiography, total chronic occlusions (CTO) are rarely revascularized by percutaneous angioplasty (PCI). Nevertheless, current evidence suggest that successful CTO-PCI improve symptoms, quality of live and long-term survival. During the last years, improvement of specific techniques for these complexes procedures and increasing experience of operators allow actually to obtain success and complications rates almost equivalent to non-CTO lesions angioplasty. This review focus on the clinical benefits of CTO revascularization and on appropriate patient selection.

Published
2017

44. Duration of dual anti-platelet therapy - State of the art after the DAPT and PEGASUS-TIMI 54 trials.

Author

Pirlet C, Legrand V, Nyssen A, Pierard L, and Gach O

Subjects
Drug Therapy, Combination, Humans, Prosthesis Failure, Treatment Outcome, Coronary Restenosis prevention & control, Platelet Aggregation Inhibitors therapeutic use, Randomized Controlled Trials as Topic, Stents adverse effects, Thrombolytic Therapy methods
Abstract

Dual anti-platelet therapy is prescribed in the setting of coronary heart disease for the prevention of stent thrombosis and acute thrombotic events. The optimal duration of dual anti-platelet therapy is still under debate as numerous trials have shown non-inferiority of a strategy of early cessation of one of the agents as compared to the standard practice whereas two larger trials have demonstrated benefit of prolonging dual anti-platelet therapy.

Published
2017
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45. Belgium: coronary and structural heart interventions from 2010 to 2015.

Author

Desmet W, Aminian A, Kefer J, Dens J, Bosmans J, Claeys M, Dubois C, Gach O, Janssens L, Schroeder E, Vermeersch P, Carlier M, Benit E, and Hanet C

Subjects
Belgium, Heart physiopathology, Hospitals, Humans, Time Factors, Cardiac Surgical Procedures, Percutaneous Coronary Intervention methods, ST Elevation Myocardial Infarction surgery
Abstract

In a ranking of the gross domestic product per capita in 2015, Belgium ranked 19th in the world according to the International Monetary Fun1d and the World Bank. It has a Human Development Index of 0.890, in which it is preceded by only 20 other countries in the world. This is, at least in part, due to a well-developed social security system on which all citizens can rely. Over the last 5-10 years, however, this system has come under increasing pressure. This has resulted in insufficient, incomplete and late reimbursement of all technologies that were introduced over the last ten years in the cathlab: intracoronary imaging techniques are not reimbursed at all, and FFR only to a vastly insufficient degree. For several structural heart interventions, a system of limited and incomplete reimbursement has recently been set up, with a requirement to organise these procedures within the frames of hospital networks. Numbers of PCIs have risen by 15% over the last four years, coinciding with an increase in the number of cathlabs by 50%, aiming at better access to primary PCI for STEMI patients. This has also resulted in a decrease in the average procedure volume per centre. Two thirds of PCIs are performed via the radial access. DES penetration has increased to 74%, approaching 100% in some centres, while the uptake of BRS has been very limited so far.

Published
2017
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46. [Bipressil® : first single-pill combination of bisoprolol and perindopril arginine].

Author

Gach O, Falque B, Canivet A, Krzesinski F, Krzesinski JM, and Lancellotti P

Subjects
Drug Combinations, Humans, Antihypertensive Agents pharmacology, Bisoprolol pharmacology, Perindopril pharmacology
Abstract

In patients suffering from systemic arterial hypertension, coronary artery disease, or heart failure, beta-blockers and angiotensin-convertase enzyme inhibitors play a major therapeutic and preventive role. Coronary artery disease remains the leading cause of mortality in industrialized countries. Unless adapted preventive strategy, notably pharmacological interventions, cardiovascular events in these patients remain high. One reason for this relative failure is represented by non-adherence to treatment. A treatment consisting in an association in one pill of several different molecules should confer a higher treatment compliance and thus efficacy. This article describes the characteristics of the first available dual association between a cardioselective beta-blocker agent, bisoprolol, and an angiotensin-convertase enzyme inhibitor, perindopril arginine.

Published
2017

47. Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis: a serial follow-up at three and six months with optical coherence tomography imaging.

Author

Suwannasom P, Onuma Y, Benit E, Gach O, von Birgelen C, Hofma SH, Sotomi Y, Bo X, Zhang YJ, Gao R, García-García HM, Wykrzykowska JJ, de Winter RJ, and Serruys PW

Subjects
Adult, Aged, Aged, 80 and over, Coronary Artery Disease diagnosis, Coronary Stenosis diagnosis, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neointima pathology, Percutaneous Coronary Intervention, Polymers therapeutic use, Sirolimus administration & dosage, Tomography, Optical Coherence methods, Absorbable Implants, Cardiovascular Agents therapeutic use, Coronary Stenosis therapy, Drug-Eluting Stents, Neointima therapy, Sirolimus therapeutic use
Abstract

Aims: Our aim was to assess vascular response after polymer-free sirolimus-eluting stent (SES) implantation by using an optical coherence tomography (OCT)-derived vascular healing score (HS), quantifying the deficiency of healing., Methods and Results: In a prospective, multicentre, single-arm, open-label study, OCT examinations were performed at three months in 45 patients (47 lesions). Per protocol, 24 lesions which had not reached adequate vascular healing according to study criteria were scheduled for OCT examination at six months. The HS was calculated at two time points. Serial OCT imaging demonstrated that the proportion of covered stent struts increased from a median of 87.1% at three months to 98.6% at six months (p<0.001). The neointimal thickness increased from a median of 82.8 µm to 112.2 µm (p<0.001), whereas the median percentages of malapposed struts were 0.2% and 0.0% at the two respective time points. Neointimal volume obstruction increased from 6.3% to 12.8%, and the HS decreased from a median of 28.1 at three months to 2.4 at six months., Conclusions: In patients who had inadequate vascular healing three months after polymer-free SES implantation, serial OCT showed almost complete vascular healing at six months.

Published
2016
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48. Myocardial apical cleft.

Author

Marchetta S, Bruyere PJ, and Gach O

Subjects
Adult, Coronary Angiography methods, Coronary Artery Disease diagnosis, Diagnosis, Differential, Gated Blood-Pool Imaging methods, Humans, Male, Tomography, X-Ray Computed methods, Heart Defects, Congenital diagnosis, Heart Ventricles abnormalities
Published
2016
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49. [Image of the month. A coronary-left ventricular fistula].

Author

Marchetta S, Lempereur M, and Gach O

Subjects
Aged, 80 and over, Coronary Vessel Anomalies diagnosis, Female, Humans, Vascular Fistula diagnosis, Coronary Vessel Anomalies pathology, Heart Ventricles pathology, Vascular Fistula pathology
Published
2016

50. Active and total myeloperoxidase in coronary artery disease and relation to clinical instability.

Author

Gach O, Brogneaux C, Franck T, Serteyn D, Legrand V, Pierard LA, and Magne J

Subjects
Acute Coronary Syndrome blood, Acute Coronary Syndrome diagnostic imaging, Aged, Biomarkers blood, Chi-Square Distribution, Coronary Angiography, Coronary Artery Disease blood, Coronary Artery Disease diagnostic imaging, Disease Progression, Enzyme-Linked Immunosorbent Assay, Female, Humans, Linear Models, Male, Middle Aged, Predictive Value of Tests, Prognosis, Prospective Studies, Up-Regulation, Acute Coronary Syndrome enzymology, Coronary Artery Disease enzymology, Peroxidase blood
Abstract

Objectives: The aim of this study was to evaluate the correlation between serum total and active myeloperoxidase (MPO) levels and the presence of coronary artery disease in consecutive patients evaluated by coronary angiography and to correlate the levels of the enzyme with instability., Methods and Results: Prospective analysis of serum samples of patients before coronary angiography. Total and active MPO concentrations were assessed by the sandwich Elisa and SIEFED® methods. Stable and unstable patients were separated into two groups. Differences between groups were analysed using the Student t test, chi square test or Fisher exact test, as appropriate. The relationship between total and active MPO was assessed using linear and curvilinear regression. Two hundred and twenty patients were included (age 66±11 years, 67% male) in the study. Among these, 62% presented significant coronary artery disease. Twenty-four patients (11%) presented unstable coronary syndrome. Mean active and total MPO levels in the population were 50.1±63.5 and 147.6±223.3 ng.mL(-1), respectively. In stable patients, mean active MPO was 47.1±47.9 ng.mL(-1) and in unstable patients 75.1±135.2 ng.mL(–1) (P=0.04). Mean total MPO was 146.3±224.7 ng.mL(-1) in the stable patients and 158.2±215.8 ng.mL(-1) in the unstable patients (P=0.8). Unstable patients had a significantly higher level of active MPO than stable patients but there was no significant difference between unstable and stable patients regarding total MPO., Conclusion: A correlation was observed between active MPO and clinical instability but not with total MPO. These results suggest that this marker could be a powerful indicator of instability and could have a prognostic impact.

Published
2015
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