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5. Clinical and angiographic acute and follow up results of intracoronary β brachytherapy in saphenous vein bypass grafts. (Interventional Cardiology and Surgery)

Author

Schiele, T.M., Regar, E., Silber, S., Eeckhout, E., Baumgart, D., Wijns, W., Colombo, A., Rutsch, W., Meerkin, D., Gershlick, A., Bonan, R., and Urban, P.

Subjects
Coronary artery bypass -- Physiological aspects, Saphenous vein -- Physiological aspects, Radioisotope brachytherapy -- Evaluation -- Physiological aspects, Atherosclerosis -- Care and treatment -- Complications and side effects, Health
Abstract

for the RENO Investigators a subgroup analysis of the multicentre European registry of intraluminal coronary β brachytherapy (RENO) Objective: To assess clinically and angiographically the feasibility, safety, and effectiveness of [...]

Published
2003

7. The additional value of patient-reported health status in predicting 1-year mortality after invasive coronary procedures: a report from the Euro Heart Survey on Coronary Revascularisation

Author

Lenzen M. J., Scholte Op Reimer W. J. M., Pedersen S. S., Boersma E., Maier W., Widimsky P., Simoons M. L., Mercado N. F., Wijns W., Bertrand M., Meier B., Sechtem U., Sergeant P., Stahle E., Unger F., Manini M., Bramley C., Laforest V., Taylor C., Del Gaiso S., Huber K., De Backer G., Sirakova V., Cerbak R., Thayssen P., Lehto S., Blanc J. -J., Delahaye F., Kobulia B., Zeymer U., Cokkinos D., Karlocai K., Graham I., Shelley E., Behar S., Maggioni A., Grabauskiene V., Deckers J., Asmussen I., Stepinska J., Goncalves L., Mareev V., Riecansky I., Kenda M. F., Alonso A., Lopez-Sendon J. L., Rosengren A., Buser P., Okay T., Sychov O., Fox K., Wood D., Crijns H., McGregor K., Mulder B., Priori S., Ryden L., Tavazzi L., Vahanian A., Vardas P., Sarkisyan K., Glogar H. D., Frick M., Pachinger O., Zwick R., Vrints C., Van Hertbruggen E., Vercammen M., Sysmans T., Schroeder E., Domange J., De Pril H., De Vriese J., Van Hecke T., Legrand V., Gillon M. -F., Richardy M., Doneux P., Petrov I., Jorgova J., Starcevic B., Eeckhout E., Berger A., Prudent V., Camenzind E., Masson N., Zambartas C., Kleanthous H., Stellova B., Aschermann M., Simek S., Kautzner J., Karmazin V., Svab P., Indrak J., Branny M., Hladilova K., Kala P., Cappelen H., Jensen L. O., Gitt A., Gehrke K., am Rhein L., Erbel R., Gutersohn A., Eggebrecht H., Al Khani M., Rosenberger A., Vogelsberg H., Klepzig H., Schmidt A., Silber S., Mau B., Leuner C., Czyborra K., Reuschling C., Muno E., Nauheim B., Kleber F., Rux S., Saad A., Elabady M., Beiras A. C., Fernandez J. S., del Arno F. N., Romo A. I., Fernandez J. M. C., Mayoreal A. R., Rebanal F. J. R., de la Borbolla M. G., Chaparro M., Brotons C., Miralda C. P., Vila i Perez S. I., Moris C., Aviles F. F., de la Fuente Galan L., Vinuela P. T., de Torres F. M., Mora J., Rodriguez I. S., Bustamante I. P., Fernandez P. L. S., Torrent J. L. D., Diez Gil J. L., Perpinan J., Motilla V. P., Juango M. S. A., Berjon-Reyero J., Moreno R. M., Guerrero J. C. F., Savolainen K., Syvanne M., Cohen-Solal A., Oboa A. -S., Bassand J. P., Espinosa D. P., Jouet V., Cedex B., Montalescot G., Gallois V., Daubert J. C., Clerc J. M., Machecourt J., Cottin Y., Walker D., Holland F., Prosser J., Muir L., Barber K., Cleland J. G. F., Cook J., Chapichadze Z., Christos I. S. A., Tsiavou N., Chrysohoou C., Manginas A., Terrovitis J., Kanakakis J., Vavuranakis M., Drakos S., Farmakis T., Samara C., Papakosta C., Bourantas C., Michalis L. K., Christos M., Foussas S., Adamopoulou E., Vardas P. E., Marketou M., Alotti N., Basa A. M., Vigh A., Preda I., Csoti E., Keltai M., Kerkovits G., Hendler A., Blatt A., Yakov B., Beyar R., Shefer A., Halon D., Bentzvi M., Avramovitch N., Bakst A., Saba K., Cafri C., Grosbard A., Sheva B., Margolis B., Suleiman K., Banai S., Meerkin D., Mosseri M., Guita P., Jabara R., Jafari J., Shitrit D. B., Ghasan Salameh, Brezins M., van den Akker-Berman L., Guetta V., Hashomer T., Rozenman Y., Biagini A., Berti S., Ferrero M., Colombo A., Roccaforte R., Milici C., Scarpino L., Salvi A., Desideri A., Sabbadin D., Veneto C., Galassi A., Giuffrida G., Rognoni A., Vassanelli C., Paffoni P., Cioppa A., Rubino P., de Carlo M., Petronio A. S., Naccarella F., Saia F., Marzocchi A., Maranga S. S., Presbitero P., Valsecchi F., Piscione F., Esposito G., Santini N. M., Tubaro M., Erglis A., Narbute I., Kavoliuniene A., Zaliunas R., Navickas R., Luckute D., Subkovas E., Wagner D., Vermeer F., Lousberg A., Fransen H., Breeman A., Tebbe H., De Boer M. J., van der Wal M., Vos J., Leenders C. M., Veerhoek M. J., Jansen C., Bijl M., Koppelaar C., den Linden V., Brons R., Widdershofen J. W. M. G., Broers H., Kontny F., Jonzon M., Wodniecki J., Tomasik A., Trusz-Gluza M., Nowak S., Ruzyllo W., Deptuch T., Marques J., Matias F., Madeira H., Oliveira J., Sargento L., Ionac A., Dragulescu I. S., Mut-Vitcu B., Maximov D., Dorobantu M., Apetrei E., Niculescu R., Petrescu V., Bucsa A., Deleanu D., Bucharest, Benedek I. S., Hintea T., Aronov D., Tikhomirova E., Kranjec I., Prokselj K., Kanic V., Sepetoglu A., Aytekin S., Aytekin V., Catakoglu A. B., Parlar H., Tufekcioglu S., Ozyedek Z., Baltali M., Kiziltan D., Vukovic M., Neskovic A. N., Cardiology, Lenzen, M. J., Scholte Op Reimer, W. J. M., Pedersen, S. S., Boersma, E., Maier, W., Widimsky, P., Simoons, M. L., Mercado, N. F., Wijns, W., Bertrand, M., Meier, B., Sechtem, U., Sergeant, P., Stahle, E., Unger, F., Manini, M., Bramley, C., Laforest, V., Taylor, C., Del Gaiso, S., Huber, K., De Backer, G., Sirakova, V., Cerbak, R., Thayssen, P., Lehto, S., Blanc, J. -J., Delahaye, F., Kobulia, B., Zeymer, U., Cokkinos, D., Karlocai, K., Graham, I., Shelley, E., Behar, S., Maggioni, A., Grabauskiene, V., Deckers, J., Asmussen, I., Stepinska, J., Goncalves, L., Mareev, V., Riecansky, I., Kenda, M. F., Alonso, A., Lopez-Sendon, J. L., Rosengren, A., Buser, P., Okay, T., Sychov, O., Fox, K., Wood, D., Crijns, H., Mcgregor, K., Mulder, B., Priori, S., Ryden, L., Tavazzi, L., Vahanian, A., Vardas, P., Sarkisyan, K., Glogar, H. D., Frick, M., Pachinger, O., Zwick, R., Vrints, C., Van Hertbruggen, E., Vercammen, M., Sysmans, T., Schroeder, E., Domange, J., De Pril, H., De Vriese, J., Van Hecke, T., Legrand, V., Gillon, M. -F., Richardy, M., Doneux, P., Petrov, I., Jorgova, J., Starcevic, B., Eeckhout, E., Berger, A., Prudent, V., Camenzind, E., Masson, N., Zambartas, C., Kleanthous, H., Stellova, B., Aschermann, M., Simek, S., Kautzner, J., Karmazin, V., Svab, P., Indrak, J., Branny, M., Hladilova, K., Kala, P., Cappelen, H., Jensen, L. O., Gitt, A., Gehrke, K., am Rhein, L., Erbel, R., Gutersohn, A., Eggebrecht, H., Al Khani, M., Rosenberger, A., Vogelsberg, H., Klepzig, H., Schmidt, A., Silber, S., Mau, B., Leuner, C., Czyborra, K., Reuschling, C., Muno, E., Nauheim, B., Kleber, F., Rux, S., Saad, A., Elabady, M., Beiras, A. C., Fernandez, J. S., del Arno, F. N., Romo, A. I., Fernandez, J. M. C., Mayoreal, A. R., Rebanal, F. J. R., de la Borbolla, M. G., Chaparro, M., Brotons, C., Miralda, C. P., Vila i Perez, S. I., Moris, C., Aviles, F. F., de la Fuente Galan, L., Vinuela, P. T., de Torres, F. M., Mora, J., Rodriguez, I. S., Bustamante, I. P., Fernandez, P. L. S., Torrent, J. L. D., Diez Gil, J. L., Perpinan, J., Motilla, V. P., Juango, M. S. A., Berjon-Reyero, J., Moreno, R. M., Guerrero, J. C. F., Savolainen, K., Syvanne, M., Cohen-Solal, A., Oboa, A. -S., Bassand, J. P., Espinosa, D. P., Jouet, V., Cedex, B., Montalescot, G., Gallois, V., Daubert, J. C., Clerc, J. M., Machecourt, J., Cottin, Y., Walker, D., Holland, F., Prosser, J., Muir, L., Barber, K., Cleland, J. G. F., Cook, J., Chapichadze, Z., Christos, I. S. A., Tsiavou, N., Chrysohoou, C., Manginas, A., Terrovitis, J., Kanakakis, J., Vavuranakis, M., Drakos, S., Farmakis, T., Samara, C., Papakosta, C., Bourantas, C., Michalis, L. K., Christos, M., Foussas, S., Adamopoulou, E., Vardas, P. E., Marketou, M., Alotti, N., Basa, A. M., Vigh, A., Preda, I., Csoti, E., Keltai, M., Kerkovits, G., Hendler, A., Blatt, A., Yakov, B., Beyar, R., Shefer, A., Halon, D., Bentzvi, M., Avramovitch, N., Bakst, A., Saba, K., Cafri, C., Grosbard, A., Sheva, B., Margolis, B., Suleiman, K., Banai, S., Meerkin, D., Mosseri, M., Guita, P., Jabara, R., Jafari, J., Shitrit, D. B., Ghasan, Salameh, Brezins, M., van den Akker-Berman, L., Guetta, V., Hashomer, T., Rozenman, Y., Biagini, A., Berti, S., Ferrero, M., Colombo, A., Roccaforte, R., Milici, C., Scarpino, L., Salvi, A., Desideri, A., Sabbadin, D., Veneto, C., Galassi, A., Giuffrida, G., Rognoni, A., Vassanelli, C., Paffoni, P., Cioppa, A., Rubino, P., de Carlo, M., Petronio, A. S., Naccarella, F., Saia, F., Marzocchi, A., Maranga, S. S., Presbitero, P., Valsecchi, F., Piscione, F., Esposito, G., Santini, N. M., Tubaro, M., Erglis, A., Narbute, I., Kavoliuniene, A., Zaliunas, R., Navickas, R., Luckute, D., Subkovas, E., Wagner, D., Vermeer, F., Lousberg, A., Fransen, H., Breeman, A., Tebbe, H., De Boer, M. J., van der Wal, M., Vos, J., Leenders, C. M., Veerhoek, M. J., Jansen, C., Bijl, M., Koppelaar, C., den Linden, V., Brons, R., Widdershofen, J. W. M. G., Broers, H., Kontny, F., Jonzon, M., Wodniecki, J., Tomasik, A., Trusz-Gluza, M., Nowak, S., Ruzyllo, W., Deptuch, T., Marques, J., Matias, F., Madeira, H., Oliveira, J., Sargento, L., Ionac, A., Dragulescu, I. S., Mut-Vitcu, B., Maximov, D., Dorobantu, M., Apetrei, E., Niculescu, R., Petrescu, V., Bucsa, A., Deleanu, D., Bucharest, Benedek, I. S., Hintea, T., Aronov, D., Tikhomirova, E., Kranjec, I., Prokselj, K., Kanic, V., Sepetoglu, A., Aytekin, S., Aytekin, V., Catakoglu, A. B., Parlar, H., Tufekcioglu, S., Ozyedek, Z., Baltali, M., Kiziltan, D., Vukovic, M., and Neskovic, A. N.

Subjects
Male, medicine.medical_specialty, Epidemiology, medicine.medical_treatment, Health Status, Coronary Artery Disease, Revascularization, Coronary artery disease, Cohort Studies, Risk Factors, Surveys and Questionnaires, medicine, Myocardial Revascularization, Surveys and Questionnaire, Humans, Prospective Studies, Prospective cohort study, Aged, business.industry, Risk Factor, Mortality rate, Confounding, Middle Aged, medicine.disease, Surgery, Europe, Prospective Studie, Treatment Outcome, Emergency medicine, Population study, Female, Cohort Studie, Cardiology and Cardiovascular Medicine, business, Human, Cohort study
Abstract

Objective: Self-perceived health status may be helpful in identifying patients at high risk for adverse outcomes. The Euro Heart Survey on Coronary Revascularization (EHS-CR) provided an opportunity to explore whether impaired health status was a predictor of 1-year mortality in patients with coronary artery disease (CAD) undergoing angiographic procedures. Methods: Data from the EHS-CR that included 5619 patients from 31 member countries of the European Society of Cardiology were used. Inclusion criteria for the current study were completion of a self-report measure of health status, the EuroQol Questionnaire (EQ-5D) at discharge and information on 1-year follow-up, resulting in a study population of 3786 patients. Results: The 1-year mortality was 3.2% (n = 120). Survivors reported fewer problems on the five dimensions of the EQ-5D as compared with non-survivors. A broad range of potential confounders were adjusted for, which reached a p

Published
2006

8. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro Heart Survey on Coronary Revascularization

Author

Hordijk-Trion M., Lenzen M., Wijns W., De Jaegere P., Simoons M. L., Scholte Op Reimer W. J. M., Bertrand M. E., Mercado N., Boersma E., Maier W., Meier B., Moris C., Piscione F., Sechtem U., Sergeant P., Stahle E., Vos J., Widimsky P., Unger F., Manini M., Bramley C., Laforest V., Taylor C., Del Gaiso S., Huber K., De Backer G., Sirakova V., Cerbak R., Thayssen P., Lehto S., Blanc J. -J., Delahaye F., Kobulia B., Zeymer U., Cokkinos D., Karlocai K., Graham I., Shelley E., Behar S., Maggioni A., Grabauskiene V., Deckers J., Asmussen I., Stepinska J., Goncalves L., Mareev V., Riecansky I., Kenda M. F., Alonso A., Lopez-Sendon J. L., Rosengren A., Buser P., Okay T., Sychov O., Fox K., Wood D., Crijns H., McGregor K., Mulder B., Priori S., Ryden L., Tavazzi L., Vahanian A., Vardas P., Sarkisyan K., Glogar H. D., Frick M., Pachinger O., Zwick R., Vrints C., Van Hertbruggen E., Vercammen M., Sysmans T., Schroeder E., Domange J., De Pril H., De Vriese J., Van Hecke T., Legrand V., Gillon M. -F., Richardy M., Doneux P., Petrov I., Jorgova J., Starcevic B., Eeckhout E., Berger A., Prudent V., Camenzind E., Masson N., Zambartas C., Kleanthous H., Stellova B., Aschermann M., Simek S., Kautzner J., Karmazin V., Svab P., Indrak J., Branny M., Hladilova K., Kala P., Cappelen H., Jensen L. O., Gitt A., Gehrke K., am Rhein L., Erbel R., Gutersohn A., Eggebrecht H., Al Khani M., Rosenberger A., Vogelsberg H., Klepzig H., Schmidt A., Silber S., Mau B., Leuner C., Czyborra K., Reuschling C., Muno E., Nauheim B., Kleber F., Rux S., Saad A., Elabady M., Beiras A. C., Fernandez J. S., del Arno F. N., Romo A. I., Fernandez J. M. C., Mayoreal A. R., Rebanal F. J. R., de la Borbolla M. G., Chaparro M., Brotons C., Miralda C. P., Vila i Perez S. I., Aviles F. F., de la Fuente Galan L., Vinuela P. T., de Torres F. M., Mora J., Rodriguez I. S., Bustamante I. P., Fernandez P. L. S., Torrent J. L. D., Gil J. L. D., Perpinan J., Motilla V. P., Juango M. S. A., Berjon-Reyero J., Moreno R. M., Guerrero J. C. F., Savolainen K., Syvanne M., Cohen-Solal A., Oboa A. -S., Bassand J. P., Espinosa D. P., Jouet V., Cedex B., Montalescot G., Gallois V., Daubert J. C., Clerc J. M., Machecourt J., Cottin Y., Walker D., Holland F., Prosser J., Muir L., Barber K., Cleland J. G. F., Cook J., Chapichadze Z., Christos I. S. A., Tsiavou N., Chrysohoou C., Manginas A., Terrovitis J., Kanakakis J., Vavuranakis M., Drakos S., Farmakis T., Samara C., Papakosta C., Bourantas C., Michalis L. K., Christos M., Foussas S., Adamopoulou E., Marketou M., Alotti N., Basa A. M., Vigh A., Preda I., Csoti E., Keltai M., Kerkovits G., Hendler A., Blatt A., Yakov B., Beyar R., Shefer A., Halon D., Bentzvi M., Avramovitch N., Bakst A., Saba K., Cafri C., Grosbard A., Sheva B., Margolis B., Suleiman K., Banai S., Meerkin D., Mosseri M., Guita P., Jabara R., Jafari J., Shitrit D. B., Ghasan D., Salameh D., Brezins M., van den Akker-Berman L., Guetta V., Hashomer T., Rozenman Y., Biagini A., Berti S., Ferrero M., Colombo A., Roccaforte R., Milici C., Scarpino L., Salvi A., Desideri A., Sabbadin D., Veneto C., Galassi A., Giuffrida G., Rognoni A., Vassanelli C., Paffoni P., Cioppa A., Rubino P., de Carlo M., Petronio A. S., Naccarella F., Saia F., Marzocchi A., Maranga S. S., Presbitero P., Valsecchi F., Esposito G., Santini N. M., Tubaro M., Erglis A., Narbute I., Kavoliuniene A., Zaliunas R., Navickas R., Luckute D., Subkovas E., Wagner D., Vermeer F., Lousberg A., Fransen H., Breeman A., Tebbe H., De Boer M. J., van der Wal M., Leenders C. M., Veerhoek M. J., Jansen C., Bijl M., Koppelaar C., den Linden V., Brons R., Widdershofen J. W. M. G., Broers H., Kontny F., Jonzon M., Wodniecki J., Tomasik A., Trusz-Gluza M., Nowak S., Ruzyllo W., Deptuch T., Marques J., Matias F., Madeira H., Oliveira J., Sargento L., Ionac A., Dragulescu I. S., Mut-Vitcu B., Maximov D., Dorobantu M., Apetrei E., Niculescu R., Petrescu V., Bucsa A., Deleanu D., Bucharest, Benedek I. S., Hintea T., Aronov D., Tikhomirova E., Kranjec I., Prokselj K., Kanic V., Sepetoglu A., Aytekin S., Aytekin V., Catakoglu A. B., Parlar H., Tufekcioglu S., Ozyedek Z., Baltali M., Kiziltan, Vukovic M., Neskovic A. N., Cardiology, Hordijk-Trion, M., Lenzen, M., Wijns, W., De Jaegere, P., Simoons, M. L., Scholte Op Reimer, W. J. M., Bertrand, M. E., Mercado, N., Boersma, E., Maier, W., Meier, B., Moris, C., Piscione, F., Sechtem, U., Sergeant, P., Stahle, E., Vos, J., Widimsky, P., Unger, F., Manini, M., Bramley, C., Laforest, V., Taylor, C., Del Gaiso, S., Huber, K., De Backer, G., Sirakova, V., Cerbak, R., Thayssen, P., Lehto, S., Blanc, J. -J., Delahaye, F., Kobulia, B., Zeymer, U., Cokkinos, D., Karlocai, K., Graham, I., Shelley, E., Behar, S., Maggioni, A., Grabauskiene, V., Deckers, J., Asmussen, I., Stepinska, J., Goncalves, L., Mareev, V., Riecansky, I., Kenda, M. F., Alonso, A., Lopez-Sendon, J. L., Rosengren, A., Buser, P., Okay, T., Sychov, O., Fox, K., Wood, D., Crijns, H., Mcgregor, K., Mulder, B., Priori, S., Ryden, L., Tavazzi, L., Vahanian, A., Vardas, P., Sarkisyan, K., Glogar, H. D., Frick, M., Pachinger, O., Zwick, R., Vrints, C., Van Hertbruggen, E., Vercammen, M., Sysmans, T., Schroeder, E., Domange, J., De Pril, H., De Vriese, J., Van Hecke, T., Legrand, V., Gillon, M. -F., Richardy, M., Doneux, P., Petrov, I., Jorgova, J., Starcevic, B., Eeckhout, E., Berger, A., Prudent, V., Camenzind, E., Masson, N., Zambartas, C., Kleanthous, H., Stellova, B., Aschermann, M., Simek, S., Kautzner, J., Karmazin, V., Svab, P., Indrak, J., Branny, M., Hladilova, K., Kala, P., Cappelen, H., Jensen, L. O., Gitt, A., Gehrke, K., am Rhein, L., Erbel, R., Gutersohn, A., Eggebrecht, H., Al Khani, M., Rosenberger, A., Vogelsberg, H., Klepzig, H., Schmidt, A., Silber, S., Mau, B., Leuner, C., Czyborra, K., Reuschling, C., Muno, E., Nauheim, B., Kleber, F., Rux, S., Saad, A., Elabady, M., Beiras, A. C., Fernandez, J. S., del Arno, F. N., Romo, A. I., Fernandez, J. M. C., Mayoreal, A. R., Rebanal, F. J. R., de la Borbolla, M. G., Chaparro, M., Brotons, C., Miralda, C. P., Vila i Perez, S. I., Aviles, F. F., de la Fuente Galan, L., Vinuela, P. T., de Torres, F. M., Mora, J., Rodriguez, I. S., Bustamante, I. P., Fernandez, P. L. S., Torrent, J. L. D., Gil, J. L. D., Perpinan, J., Motilla, V. P., Juango, M. S. A., Berjon-Reyero, J., Moreno, R. M., Guerrero, J. C. F., Savolainen, K., Syvanne, M., Cohen-Solal, A., Oboa, A. -S., Bassand, J. P., Espinosa, D. P., Jouet, V., Cedex, B., Montalescot, G., Gallois, V., Daubert, J. C., Clerc, J. M., Machecourt, J., Cottin, Y., Walker, D., Holland, F., Prosser, J., Muir, L., Barber, K., Cleland, J. G. F., Cook, J., Chapichadze, Z., Christos, I. S. A., Tsiavou, N., Chrysohoou, C., Manginas, A., Terrovitis, J., Kanakakis, J., Vavuranakis, M., Drakos, S., Farmakis, T., Samara, C., Papakosta, C., Bourantas, C., Michalis, L. K., Christos, M., Foussas, S., Adamopoulou, E., Marketou, M., Alotti, N., Basa, A. M., Vigh, A., Preda, I., Csoti, E., Keltai, M., Kerkovits, G., Hendler, A., Blatt, A., Yakov, B., Beyar, R., Shefer, A., Halon, D., Bentzvi, M., Avramovitch, N., Bakst, A., Saba, K., Cafri, C., Grosbard, A., Sheva, B., Margolis, B., Suleiman, K., Banai, S., Meerkin, D., Mosseri, M., Guita, P., Jabara, R., Jafari, J., Shitrit, D. B., Ghasan, D., Salameh, D., Brezins, M., van den Akker-Berman, L., Guetta, V., Hashomer, T., Rozenman, Y., Biagini, A., Berti, S., Ferrero, M., Colombo, A., Roccaforte, R., Milici, C., Scarpino, L., Salvi, A., Desideri, A., Sabbadin, D., Veneto, C., Galassi, A., Giuffrida, G., Rognoni, A., Vassanelli, C., Paffoni, P., Cioppa, A., Rubino, P., de Carlo, M., Petronio, A. S., Naccarella, F., Saia, F., Marzocchi, A., Maranga, S. S., Presbitero, P., Valsecchi, F., Esposito, G., Santini, N. M., Tubaro, M., Erglis, A., Narbute, I., Kavoliuniene, A., Zaliunas, R., Navickas, R., Luckute, D., Subkovas, E., Wagner, D., Vermeer, F., Lousberg, A., Fransen, H., Breeman, A., Tebbe, H., De Boer, M. J., van der Wal, M., Leenders, C. M., Veerhoek, M. J., Jansen, C., Bijl, M., Koppelaar, C., den Linden, V., Brons, R., Widdershofen, J. W. M. G., Broers, H., Kontny, F., Jonzon, M., Wodniecki, J., Tomasik, A., Trusz-Gluza, M., Nowak, S., Ruzyllo, W., Deptuch, T., Marques, J., Matias, F., Madeira, H., Oliveira, J., Sargento, L., Ionac, A., Dragulescu, I. S., Mut-Vitcu, B., Maximov, D., Dorobantu, M., Apetrei, E., Niculescu, R., Petrescu, V., Bucsa, A., Deleanu, D., Bucharest, Benedek, I. S., Hintea, T., Aronov, D., Tikhomirova, E., Kranjec, I., Prokselj, K., Kanic, V., Sepetoglu, A., Aytekin, S., Aytekin, V., Catakoglu, A. B., Parlar, H., Tufekcioglu, S., Ozyedek, Z., Baltali, M., Kiziltan, Vukovic, M., and Neskovic, A. N.

Subjects
Male, medicine.medical_specialty, Randomization, medicine.medical_treatment, Euro Heart Survey, Coronary Artery Disease, Revascularization, law.invention, Coronary artery disease, Randomized controlled trial, law, Internal medicine, Angioplasty, medicine, Humans, cardiovascular diseases, Angioplasty, Balloon, Coronary, Coronary Artery Bypass, CABG, Aged, Randomized Controlled Trials as Topic, business.industry, Coronary Artery Bypa, Patient Selection, PCI, Health Survey, Middle Aged, medicine.disease, Health Surveys, Surgery, Clinical trial, Stenosis, surgical procedures, operative, Clinical Trials, Phase III as Topic, Conventional PCI, Female, Cardiology and Cardiovascular Medicine, business, Human
Abstract

Aims: Revascularization in patients with coronary artery disease changed over the last two decades, favouring the number of patients treated by means of percutaneous coronary interventions (PCI) when compared with coronary artery bypass grafting (CABG). Many randomized controlled trials (RCTs) have been performed to compare these two competing revascularization techniques. Because of the strict enrolment criteria of RCTs in which highly selected patients are recruited, the applicability of the results may be limited in clinical practice. The current study evaluates to what extent patients in clinical practice were similar to those who participated in RCTs comparing PCI with CABG. Methods and results: Clinical characteristics and 1-year outcome of 4713 patients enrolled in the Euro Heart Survey on Coronary Revascularization were compared with 8647 patients who participated in 14 major RCTs, comparing PCI with CABG. In addition, we analysed which proportion of survey patients would have disqualified for trial participation (n = 3033, 64%), aiming at identifying differences between trial-eligible and trial-ineligible survey patients. In general, important differences were observed between trial participants and survey patients. Patients in clinical practice were older, more often had comorbid conditions, single-vessel disease, and left main stem stenosis when compared with trial participants. Almost identical differences were observed between trial-eligible and trial-ineligible survey patients. In clinical practice, PCI was the treatment of choice, even in patients who were trial-ineligible (46% PCI, 26% CABG, 28% medical). PCI remained the preferred treatment option in patients with multi-vessel disease (57% in trial-eligible and 40% in trial-ineligible patients, respectively, P < 0.001); yet, the risk profile of patients treated by PCI was better than that for patients treated either by CABG or by medical therapy. In the RCTs, there was no mortality difference between PCI and CABG. In clinical practice, however, we observed 1-year unadjusted survival benefit for PCI vs. CABG (2.9 vs. 5.4%, P < 0.001). Survival benefit was only observed in trial-ineligible patients (3.3 vs. 6.2%, P < 0.001). Conclusion: Many patients in clinical practice were not represented in RCTs. Moreover, only 36% of these patients were considered eligible for participating in a trial comparing PCI with CABG. We demonstrated that RCTs included younger patients with a better cardiovascular risk profile when compared with patients in everyday clinical practice. This study highlights the disparity between patients in clinical practice and patients in whom the studies that provide the evidence for treatment guidelines are performed. © The European Society of Cardiology 2006. All rights reserved.

Published
2006

14. Efficacy of beta radiation in prevention of post-angioplasty restenosis

Author

Meerkin, D., Bonan, R. (Raoul), Crocker, I.R., Arsenault, A. (André), Chougule, P., Coen, V.L.M.A. (Veronique), Williams, D.O. (David), Serruys, P.W.J.C. (Patrick), King 3rd, S.B. (Spencer), Meerkin, D., Bonan, R. (Raoul), Crocker, I.R., Arsenault, A. (André), Chougule, P., Coen, V.L.M.A. (Veronique), Williams, D.O. (David), Serruys, P.W.J.C. (Patrick), and King 3rd, S.B. (Spencer)

Abstract

Restenosis remains a major limitation of coronary angioplasty in spite of major advances in techniques and technology. Recent studies have demonstrated that ionizing radiation may limit the degree of this problem. Gamma radiation has been shown to be effective in reducing in stent restenosis in humans, and beta radiation following encouraging results in animals has been shown to be feasible in humans. The objective of this study was to assess the feasibility of a 5 F non-centered catheter to deliver beta radiation emitting seeds to the lesion site post angioplasty and its effect on restenosis. Following successful angioplasty, patients were randomized to treatment with 12, 14 or 16 Gy at the angioplasty site. This was delivered with a 5 F non-centered catheter. Twelve beta radiation emitting seeds (90Sr/Y) were delivered to an area 3 cm in length to cover the angioplasty site. Angiographic follow-up was performed at 6 months. Baseline and follow-up angiograms were performed by blinded investigators at a core laboratory. This interim report comprises the first 35 patients to complete 6-month angiographic follow-up. There were no major radiation incidents. Four patients had evidence of angiographic restenosis. The MLD (mm) and percent stenosis were 0.77 +/- 0.27/72.5 +/- 8.6 pre angioplasty, 2.08 +/- 0.4/25.7 +/- 9.8 post angioplasty and radiation and 2.05 +/- 0.59/25.7 +/- 19.8 at follow-up respectively. CONCLUSION: Beta radiation can be feasibly and safely delivered post coronary angioplasty with a very encouraging reduction of restenosis.

Published
1998
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19. Reply

Author

Meerkin, D., primary and Yinnon, A. M., additional

Published
1996
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21. Clinical and angiographic acute and follow up results of intracoronary β brachytherapy in saphenous vein bypass grafts: a subgroup analysis of the multicentre European registry of intraluminal coronary β brachytherapy (RENO).

Author

Schiele, T.M., Regar, E., Silber, S., Eeckhout, E., Baumgart, D., Wijns, W., Colombo, A., Rutsch, W., Meerkin, D., Geshlick, A., Bonan, R., and Urban, P.

Subjects
VEIN surgery, SAPHENOUS vein, VEIN diseases, RADIOISOTOPE brachytherapy, ARTIFICIAL implants, DISEASES, SURGERY
Abstract

Objective: To assess clinically and angiographically the feasibility, safety, and effectiveness of vascular brachytherapy (VBT) in saphenous vein bypass grafts (SVG). Patients and methods: 67 of 1098 (6.1%) consecutive patients of the European registry of intraluminal coronary β brachytherapy underwent treatment for 68 SVG lesions by VBT using a Sr/Y90source train (BetaCath). Clinical follow up data were obtained for all of them after a mean (SD) of 6.3 (2.4) months and angiographic follow up was performed in 61 patients (91.0%) after 6.9 (2.0) months. Results: 58 (86.6%) patients were men, their mean (SD) age was 66 (10) years, 28 (41.8%) had unstable angina, and 21 (31.3%) had diabetes. Fifty three (77.9%) lesions were in-stent restenosis, 13 (19.1%) de novo lesions, and 2 (3.0%) non-stented restenotic lesions. Mean (SD) reference diameter before the intervention was 4.19 (0.52) mm, mean (SD) lesion length was 23.56 (20.38) mm, and mean (SD) minimum lumen diameter measured 0.73 (0.62) mm. Mean (SD) acute gain was 3.02 (0.88) mm. The prescribed radiation dose was 20.1 (3.2) Gy. Pullback manoeuvres were performed in 17 (25.0%) of cases. Most patients received combined aspirin and thienopyridin treatment for 6 or 12 months after the procedure. Technical success was obtained in 62 (91.2%) treated lesions and in-hospital major adverse cardiac events occurred in 4.5%. At follow up, mean (SD) reference diameter was 4.20 (0.53) mm, minimum lumen diameter 2.94 (1.50) mm, and late loss 0.86 (1.25) mm. The overall major adverse cardiac events rate was 26.7%. Conclusion: VBT of SVG is feasible and safe. At follow up the reintervention rate and cardiac morbidity and mortality seem to be favourable, considering that interventions in SVG usually are associated with the highest risks. [ABSTRACT FROM AUTHOR]

Published
2003
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27. Classification of coronary artery bifurcation lesions and treatments: time for a consensus

Author

Manuel Pan, Yves Louvard, Martyn Thomas, David Meerkin, Michael Zelizko, Peter Ludman, Philippe Brunel, Alexandra J. Lansky, Jens Flensted Lassen, Alfredo R. Galassi, Olivier Darremont, Ioannis Iakovou, Adnan Kastrati, Josef Ludwig, David Hildick-Smith, Imad Sheiban, Alfonso Medina, Francisco Burzotta, D Dudek, Victor Legrand, Vladimir Dzavik, Thierry Lefèvre, Louvard Y., Thomas M., Dzavik V., Hildick-Smith D., Galassi A.R., Pan M., Burzotta F., Zelizko M., Dudek D., Ludman P., Sheiban I., Lassen J.F., Darremont O., Kastrati A., Ludwig J., Iakovou I., Brunel P., Lansky A., Meerkin D., Legrand V., Medina A., and Lefevre T.

Subjects
medicine.medical_specialty, Bifurcation lesion, medicine.medical_treatment, Coronary Angiography, Lesion, Prosthesis Implantation, bifurcation lesions, Angioplasty, Terminology as Topic, medicine, Humans, Radiology, Nuclear Medicine and imaging, classification of bifurcation lesions, Angioplasty, Balloon, Coronary, Classification of bifurcation lesion, Bifurcation, QCA, business.industry, Coronary Stenosis, Percutaneous coronary intervention, Stent, General Medicine, Classification of treatment, medicine.anatomical_structure, Homogeneous, Conventional PCI, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Stents, Radiology, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Artery
Abstract

Background: Percutaneous coronary intervention (PCI) of coronary bifurcation lesions remains a subject of debate. Many studies have been published in this setting. They are often small scale and display methodological flaws and other shortcomings such as inaccurate designation of lesions, heterogeneity, and inadequate description of techniques implemented. Methods: The aim is to propose a consensus established by the European Bifurcation Club (EBC), on the definition and classification of bifurcation lesions and treatments implemented with the purpose of allowing comparisons between techniques in various anatomical and clinical settings. Results: A bifurcation lesion is a coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch. The simple lesion classification proposed by Medina has been adopted. To analyze the outcomes of different techniques by intention to treat, it is necessary to clearly define which vessel is the distal main branch and which is (are) the side branche(s) and give each branch a distinct name. Each segment of the bifurcation has been named following the same pattern as the Medina classification. The classification of the techniques (MADS: Main, Across, Distal, Side) is based on the manner in which the first stent has been implanted. A visual presentation of PCI techniques and devices used should allow the development of a software describing quickly and accurately the procedure performed. Conclusion: The EBC proposes a new classification of bifurcation lesions and their treatments to permit accurate comparisons of well described techniques in homogeneous lesion groups. (c) 2008 Wiley-Liss, Inc. Udgivelsesdato: 2007-Nov-5

Published
2008

28. Physician-directed patient self-management in heart failure using left atrial pressure: Interim insights from the VECTOR-HF I and IIa studies.

Author

Meerkin D, Perl L, Hasin T, Petriashvili S, Kurashvili L, Metreveli M, Ince H, Feickert S, Habib M, Caspi O, Jonas M, Amat-Santos IJ, Bayes-Genis A, Codina P, Koren O, Frydman S, Pachino RM, Anker SD, and Abraham WT

Subjects
Humans, Male, Female, Aged, Prospective Studies, Middle Aged, Hospitalization statistics & numerical data, Heart Failure therapy, Heart Failure physiopathology, Self-Management methods, Atrial Pressure physiology
Abstract

Aims: Haemodynamic monitoring using implantable pressure sensors reduces the risk of heart failure (HF) hospitalizations. Patient self-management (PSM) of haemodynamics in HF has the potential to personalize treatment, increase adherence, and reduce the risk of worsening HF, while lowering clinicians' burden., Methods and Results: The VECTOR-HF I and IIa studies are prospective, single-arm, open-label clinical trials assessing safety, usability and performance of left atrial pressure (LAP)-guided HF management using PSM in New York Heart Association class II and III HF patients. Physician-prescribed LAP thresholds trigger patient self-adjustment of diuretics. Primary endpoints include the ability to perform LAP measurements and transmit data to the healthcare provider (HCP) interface and the patient guidance application, and safety outcomes. This is an interim analysis of 13 patients using the PSM approach. Over 12 months, no procedure- or device-related major adverse cardiovascular or neurological events were observed, and there were no failures to obtain measurements from the sensor and transmit the data to the HCP interface and the patient guidance application. Patient adherence was 91.4%. Using PSM, annualized HF hospitalization rate significantly decreased compared to a similar period prior to PSM utilization (0 admissions vs. 0.69 admissions over 11.84 months, p = 0.004). At 6 months, 6-min walk test distance and the Kansas City Cardiomyopathy Questionnaire overall summary score demonstrated significant improvement., Conclusions: Interim findings suggest that PSM using a LAP monitoring system is feasible and safe. PSM is associated with high patient adherence, potentially improving HF patients' functional status, quality of life, and limiting HF hospitalizations., (© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Published
2024
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29. Early Experience With the Innovalve Transcatheter Mitral Valve Replacement System.

Author

Meerkin D, Guetta V, Shaburishvili T, Gogorishvili I, Kipiani Z, Orlov B, Zirakashvili T, Bachilava N, Butnaru A, Avner A, Goitein O, and Raanani E

Subjects
Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Cardiac Catheterization adverse effects, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Transcatheter Aortic Valve Replacement
Published
2024
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31. Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial.

Author

D'Amario D, Meerkin D, Restivo A, Ince H, Sievert H, Wiese A, Schaefer U, Trani C, Bayes-Genis A, Leyva F, Whinnett ZI, Di Mario C, Jonas M, Manhal H, Amat-Santos IJ, Del Trigo M, Gal TB, Avraham BB, Hasin T, Feickert S, D'Ancona G, Altisent OA, Koren O, Caspi O, Abraham WT, Crea F, Anker SD, Kornowski R, and Perl L

Subjects
Humans, Cardiac Catheterization methods, Prospective Studies, Pulmonary Wedge Pressure, Atrial Pressure, Heart Failure
Abstract

Aims: In heart failure (HF), implantable haemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left-sided haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems. We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients., Methods and Results: The VECTOR-HF study (NCT03775161) was a first-in-human, prospective, multicentre, single-arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After 3 months, a right heart catheterization was performed to correlate mean pulmonary capillary wedge pressure (PCWP) with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute major adverse cardiac and neurological events (MACNE). At 3 months, freedom from short-term MACNE was 97%. Agreement between sensor-calculated LAP and PCWP was consistent, with a mean difference of -0.22 ± 4.92 mmHg, the correlation coefficient and the Lin's concordance correlation coefficient values were equal to 0.79 (p < 0.0001) and 0.776 (95% confidence interval 0.582-0.886), respectively. Preliminary experience with V-LAP-based HF management was associated with significant improvements in New York Heart Association (NYHA) functional class (32% of patients reached NYHA class II at 6 months, p < 0.005; 60% of patients at 12 months, p < 0.005) and 6-min walk test distance (from 244.59 ± 119.59 m at baseline to 311.78 ± 129.88 m after 6 months, p < 0.05, and 343.95 ± 146.15 m after 12 months, p < 0.05)., Conclusion: The V-LAP™ monitoring system proved to be generally safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Published
2023
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32. The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring.

Author

Perl L, Meerkin D, D'amario D, Avraham BB, Gal TB, Weitsman T, Hasin T, Ince H, Feickert S, D'ancona G, Schaefer U, Sievert H, Leyva F, Whinnett ZI, Di Mario C, Jonas M, Glikson M, Habib M, Caspi O, Koren O, Abraham WT, Kornowski R, and Crea F

Subjects
Cardiac Catheterization, Humans, Prospective Studies, Stroke Volume, Atrial Pressure, Heart Failure
Abstract

Objective: Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF., Methods: The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes., Results: To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076)., Conclusion: The V-LAP left atrium monitoring system appears to be safe and accurate., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2022
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33. A Translational 'Humanised' Porcine Model for Trans-Septal Mitral Valve Interventions: the Right Pulmonary Vein Approach.

Author

Avner A, Sabbag I, Butnaru A, and Meerkin D

Subjects
Animals, Cardiac Catheterization, Echocardiography, Transesophageal, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Swine, Heart Valve Prosthesis Implantation methods, Mitral Valve Insufficiency surgery, Pulmonary Veins surgery
Abstract

There is an important need to develop a transcatheter/trans-septal-like model which will allow deliverability of mitral valve devices at the right angulation and height above the mitral annulus similar to the human patient. A ministernotomy allowing for TEE probe to be introduced transpericardially was performed in seven animals. In three, a standard trans-septal approach was used to attempt to deliver a device to the level of the mitral plane with a human delivery system. In four cases, a Dacron tube was connected to the RPV and the device introduced to the LA. Under TEE equivalent imaging, the device was then successfully steered to the mitral plane in all cases, having failed in all trans-septal attempts. A combination of transpericardial echocardiographic imaging (TPE) and RPV approach to the LA facilitated successful human-like mitral valve device implantation., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Published
2022
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34. Changes in High-Frequency Intracardiac Electrogram Indicate Cardiac Ischemia.

Author

Omer N, Bergman E, Ben-David T, Huri S, Beker A, Abboud S, Granot Y, and Meerkin D

Subjects
Animals, Electrocardiography, Electrophysiologic Techniques, Cardiac, Ischemia, Swine, Coronary Artery Disease, Myocardial Ischemia diagnosis
Abstract

High-frequency QRS (HFQRS) analysis of surface ECG is a reliable marker of cardiac ischemia (CI). This study aimed to assess the response of HFQRS signals from standard intracardiac electrodes (iHFQRS) to CI in swine and compare them with conventional ST-segment deviations. Devices with three intracardiac leads were implanted in three swine in a controlled environment. CI was induced by inflating a balloon in epicardial coronary arteries. A designated signal-processing algorithm was applied to quantify the iHFQRS content before, during, and after each occlusion. iHFQRS time responses were compared to conventional ST-segment deviations. Thirty-three over thirty-nine (85%) of the occlusions presented significant reduction in the iHFQRS signal, preceding ST-segment change, being the only indicator of CI in brief occlusions. iHFQRS was found to be an early indicator for the onset of CI and demonstrated superior sensitivity to conventional ST-segment deviations during brief ischemic episodes., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Published
2022
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35. Transseptal Mitral Annuloplasty With the AMEND System: First-in-Human Experience.

Author

Melica B, Braga P, Ribeiro J, Pires-Morais G, Fonte Boa A, Guerreiro C, Caeiro D, Pereira R, Meerkin D, and Fontes-Carvalho R

Subjects
Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Annuloplasty adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery
Abstract

Competing Interests: Funding Support and Author Disclosures Dr Meerkin is the medical director of Valcare Medical. All other authors have reported that they have no relationship relevant to the content of this paper to disclose.

Published
2022
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37. Transcatheter Repair of the Mitral Valve: Relevant Pathophysiology, Investigation, and Management.

Author

Levi N and Meerkin D

Subjects
Combined Modality Therapy methods, Humans, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization methods, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation methods, Mitral Valve diagnostic imaging, Mitral Valve surgery, Mitral Valve Insufficiency etiology, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency therapy
Abstract

Mitral regurgitation (MR) is a common condition causing significant morbidity and mortality in the Western world. Although surgical therapy has developed over 5 decades to provide solutions, only a minority of patients undergo surgery. The last decade has seen the emergence and application of multiple transcatheter techniques in attempts to address this undertreated population with the large clinical experience of MitraClip providing the most insight. Clear understanding of the pathophysiology of different MR types as well as the role of particularly secondary MR on patient's clinical syndrome allow for better prediction as to which patient subgroups will benefit from different repair techniques or intervention at all. Most of the techniques are based on surgical technique and are applied as single-device/technique solutions, whether leaflet, chordal, or annular solutions, but with broadening experience, combination therapies are likely to find a place in creating a more complete and surgical-like solution., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Published
2021
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38. Transapical and Transfemoral Combined Mitral Valve Repair With Annular and Leaflet Therapies.

Author

Colli A, Raanani E, Cobiella J, Wrobel K, Nombela-Franco L, Maroto L, Lipey A, and Meerkin D

Subjects
Aged, Aged, 80 and over, Echocardiography, Doppler, Color, Endovascular Procedures instrumentation, Heart Valve Prosthesis Implantation instrumentation, Humans, Male, Mitral Valve Annuloplasty instrumentation, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency etiology, Prosthesis Design, Endovascular Procedures methods, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods, Mitral Valve Annuloplasty methods, Mitral Valve Insufficiency surgery
Abstract

Two high-risk patients were successfully treated with concomitant implantation of a transapical off-pump beating heart semirigid D-shape annuloplasty device combined in 1 case with a transfemoral edge-to-edge device and in another with transapical chordal implantation. The significant anteroposterior diameter reduction offered by the annuloplasty implantation maximized the leaflet coaptation obtained by the prolapse correction performed with the leaflet devices. Combining the transcatheter annuloplasty device and leaflet/chordal repair technologies represents progress toward definitive transcatheter treatment of degenerative mitral valve disease., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Published
2020
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39. Neuroprotection by selective endovascular brain cooling - the TwinFlo™ Catheter.

Author

Solar RJ, Mattingly T, Lownie SP, and Meerkin D

Subjects
Brain, Catheters, Cold Temperature, Neuroprotection, Hypothermia, Induced
Abstract

The neuroprotective effects of hypothermia have been demonstrated in experimental models and clinical trials. Experimental studies indicate that improved efficacy and broadened indications can be achieved with moderate to deep hypothermia. The TwinFlo catheter was designed to provide very rapid, deep and selective brain cooling with faster cooling rates, and temperatures much lower than those which can be achieved by any other hypothermia device and technique. This report describes the experimental in vivo studies and initial clinical experience with the TwinFlo catheter.

Published
2020
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40. A Novel Wireless Left Atrial Pressure Monitoring System for Patients with Heart Failure, First Ex-Vivo and Animal Experience.

Author

Perl L, Soifer E, Bartunek J, Erdheim D, Köhler F, Abraham WT, and Meerkin D

Subjects
Animals, Equipment Design, Feasibility Studies, Heart Failure physiopathology, Humans, Materials Testing, Models, Animal, Predictive Value of Tests, Pulmonary Wedge Pressure, Reproducibility of Results, Sheep, Domestic, Sus scrofa, Time Factors, Atrial Function, Left, Atrial Pressure, Heart Failure diagnosis, Telemedicine instrumentation, Telemetry instrumentation, Transducers, Pressure, Wireless Technology instrumentation
Abstract

The V-LAP™ measures left atrial pressure (LAP) and enables bi-directional communications with an external unit, designed to monitor heart failure patients. We hereby describe the pre-clinical experience. Following an ex vivo phase, the system was implanted at the interatrial septum of 10 ovine subjects. LAP readouts were compared with pulmonary capillary wedge pressure (PCWP) at index procedure and 1, 2 and 3-6 months after the implantation, at rest and after volume loading. Histopathology assessment (n = 8) was performed up to 50 weeks post procedure. Procedural success was 100%. Measurements showed a mean difference of 0.19 ± 2.51 mmHg. During this period, correlation of V-LAP™ with PCWP was excellent (R 2  = 0.95, for 119 total measurements). There were no major adverse events related to the V-LAP™ system. In an animal model, the implantation of the novel wireless left atrial pressure sensor V-LAP™ was feasible, safe, and showed good accuracy and precision.

Published
2019
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41. Breastfeeding Intensity and Exclusivity of Early Term Infants at Birth and 1 Month.

Author

Noble A, Eventov-Friedman S, Hand I, Meerkin D, Gorodetsky O, and Noble L

Subjects
Female, Follow-Up Studies, Gestational Age, Hospitalization, Humans, Infant, Infant, Newborn, Logistic Models, Odds Ratio, Pregnancy, Prospective Studies, Breast Feeding statistics & numerical data, Term Birth
Abstract

Objective: To examine breastfeeding exclusivity and intensity of early term (ET) infants, born at 37-38 weeks, and term infants, born at 39-41 weeks, during the postpartum hospitalization and the first month of life. Materials and Methods: This was a prospective cohort study of 358 mothers of ET and term infants during the first 72 hours after birth and at 1 month of age. Logistic analysis was used to calculate unadjusted and adjusted odds ratios (aORs) and control for confounding variables. Results: ET infants had significantly lower breastfeeding in the first hour (aOR = 0.43, 95% confidence interval [CI] = 0.21-0.87), lower exclusive breastfeeding in the hospital and at 1 month (aOR = 0.46, 95% CI = 0.27-0.71 and aOR = 0.40, 95% CI = 0.22-0.71), and lower rates of high breastfeeding intensity in the hospital and at 1 month (aOR = 0.39, 95% CI = 0.22-0.71 and aOR = 0.33, 95% CI = 0.15-0.72), after controlling for confounding variables. ET infants had more emergency room (ER) visits in the first month (OR = 7.6, 95% CI = 1.01-60.6), and all ET infants who had ER visits were exclusively breastfed. Conclusions: ET infants had lower breastfeeding in the hospital and at 1 month. They should be regarded as a group at risk for breastfeeding challenges and infant morbidity.

Published
2019
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42. Left Circumflex Coronary Artery as the Culprit Vessel in ST-Segment-Elevation Myocardial Infarction.

Author

Ghanim D, Kusniec F, Kinany W, Qarawani D, Meerkin D, Taha K, Amir O, and Carasso S

Subjects
Aged, Coronary Angiography, Coronary Stenosis diagnosis, Coronary Stenosis surgery, Coronary Vessels diagnostic imaging, Female, Follow-Up Studies, Humans, Male, Middle Aged, Retrospective Studies, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction etiology, Coronary Stenosis complications, Coronary Vessels surgery, Electrocardiography, ST Elevation Myocardial Infarction surgery
Abstract

The prevalence of the left circumflex coronary artery (LCx) as the culprit vessel in ST-segment-elevation myocardial infarction (STEMI) is reportedly lowest among that of the 3 main epicardial arteries, and has not been described for non-STEMI (NSTEMI) and stable angina pectoris. We sought to define the distribution of culprit arteries in these clinical presentations and suggest mechanisms for the differences. We reviewed 189 coronary angiograms of patients with STEMI, 203 with NSTEMI, and 548 with stable angina (n=940), and compared distributions of stenotic and culprit coronary arteries (lesions prompting intervention). Obstructive coronary lesions (≥50% narrowing) were more prevalent in the left anterior descending coronary artery (LAD) (36%-38%) and similar in the LCx and right coronary artery (RCA) (27%-29%), regardless of clinical presentation ( P <0.01). In NSTEMI and stable angina, culprit vessels and total obstructive disease had the same distribution. In STEMI, however, a culprit LCx was significantly less prevalent (17%) than was total obstructive disease (27%; P <0.01), or a culprit LAD (47%) or RCA (34%) (both P <0.001). In our computed tomographic angiographic model of coronary longitudinal strain (percentage of shortening), LCx strain was only 1.5% ± 2.4%, versus 9.5% ± 2.9% for LAD strain and 10.1% ± 3.9% for RCA strain. In STEMI, LCx plaques seem less prone to rupturing. Culprit and total disease distributions are similar in NSTEMI and angina, suggesting a different ischemic pathophysiology in these presentations. Lower LCx longitudinal strain might contribute to reduced plaque rupture in STEMI.

Published
2017
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44. Left atrial appendage occlusion with the AMPLATZER Amulet device: an expert consensus step-by-step approach.

Author

Tzikas A, Gafoor S, Meerkin D, Freixa X, Cruz-Gonzalez I, Lewalter T, Saw J, Berti S, Nielsen-Kudsk JE, Ibrahim R, Lakkireddy D, Paul V, Arzamendi D, Nietlispach F, Worthley SG, Hildick-Smith D, Thambo JB, Tondo C, Aminian A, Kalarus Z, Schmidt B, Sondergaard L, Kefer J, Meier B, Park JW, Sievert H, and Omran H

Subjects
Atrial Appendage physiopathology, Consensus, Echocardiography, Transesophageal, Fluoroscopy methods, Humans, Punctures, Treatment Outcome, Atrial Appendage surgery, Atrial Fibrillation surgery, Cardiac Catheterization instrumentation, Equipment Design, Septal Occluder Device
Abstract

Aims: This document aims to describe a standardised methodology for performing left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device, and to provide useful tips and tricks for operators with different levels of experience., Methods and Results: Physicians who are experts in LAAO and had personal clinical experience with the AMPLATZER Amulet device were asked to contribute in the preparation of this consensus document. Twenty-seven physicians (20 interventional cardiologists and 7 electrophysiologists) from 14 different countries reviewed the manuscript. A step-by-step approach, simulating a real case, was followed. Starting with patient selection and planning, related cardiac imaging is discussed, followed by vascular access - transseptal puncture optimisation. Then, angiographic calibration/sizing and the required fluoroscopy views are explained and a device sizing strategy is proposed. Device preparation and de-airing is briefly described, followed by sheath exchange, device deployment steps, evaluation of device stability and decision for final release. The way to recapture and change a device is then shown, together with some additional tips on how to deal with challenging anatomies like "chicken wing" left atrial appendage. Finally, for operators who are switching from AMPLATZER Cardiac Plug to Amulet, the main differences between the two devices with respect to implantation technique are presented., Conclusions: In conclusion, this document reflects a consensus approach by expert implanters on the steps of LAAO technique and best practices for implantation of the AMPLATZER Amulet device, along with some practical tips to minimise the complication rate.

Published
2016
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45. Strain Analysis in the Detection of Myocardial Infarction at the Acute and Chronic Stages.

Author

Bachner-Hinenzon N, Malka A, Barac Y, Meerkin D, Ertracht O, Carasso S, Shofti R, Leitman M, Vered Z, Adam D, and Binah O

Subjects
Acute Disease, Animals, Chronic Disease, Image Enhancement methods, Male, Reproducibility of Results, Sensitivity and Specificity, Swine, Disease Progression, Echocardiography methods, Elasticity Imaging Techniques methods, Image Interpretation, Computer-Assisted methods, Myocardial Infarction diagnostic imaging, Myocardial Infarction physiopathology
Abstract

Background: Myocardial ischemia causes contractile dysfunction in ischemic, stunned, and tethered regions with larger infarcted zones having a negative prognostic impact on patients' outcomes. To distinguish the infarcted myocardium from the other regions, we investigated the diagnostic potential of circumferential strain (CS) and radial strain (RS) during the acute and chronic stages of myocardial infarction., Methods: Ten pigs underwent 90-minute occlusion of the left anterior descending artery, followed by reperfusion. Echocardiography was performed at baseline, after 90-minute occlusion, and at 2 hours, 30, and 60 days postreperfusion. CS and RS were measured using speckle tracking echocardiography. Subsequently, the pigs were sacrificed, and histological analysis for infarct size was performed., Results: After 90-minute occlusion, reduced strains were detected for all segments (infarcted anterior wall - baseline: CS: -17.6 ± 5.7%, RS: 54.4 ± 16.9%; 90 min: CS: -10.3 ± 3.0%, RS: 23.3 ± 7.0%; tethered posterior wall - baseline: CS: -18.4 ± 3.5%, RS: 68.7 ± 21.1%; 90 min: CS: -10.7 ± 6.4%, RS: 34.5 ± 14.7%, P < 0.001). However, postsystolic shortening was detected only in the infarcted segments, and the time-to-peak CS was 25% longer (P < 0.05). At 30 and 60 days postreperfusion, time-to-peak CS could only detect large scars in the anterior and anterior-septum walls (P < 0.05), while peak CS also detected smaller scars in the lateral wall (P < 0.05). RS failed to distinguish between normal, stunned/tethered, and infarcted myocardium., Conclusions: During occlusion and 2 hours postreperfusion, time-to-peak CS could distinguish between infarcted and stunned/tethered myocardial segments, while at 30 and 60 days postreperfusion, peak CS was the best detector of infarction., (© 2015, Wiley Periodicals, Inc.)

Published
2016
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46. TVP1022: A Novel Cardioprotective Drug Attenuates Left Ventricular Remodeling After Ischemia/Reperfusion in Pigs.

Author

Malka A, Meerkin D, Barac YD, Malits E, Bachner-Hinenzon N, Carasso S, Ertracht O, Angel I, Shofti R, Youdim M, Abassi Z, and Binah O

Subjects
Animals, Cardiotonic Agents pharmacology, Indans pharmacology, Myocardial Infarction pathology, Myocardial Reperfusion Injury pathology, Sus scrofa, Swine, Ventricular Remodeling physiology, Cardiotonic Agents therapeutic use, Indans therapeutic use, Myocardial Infarction drug therapy, Myocardial Reperfusion Injury drug therapy, Ventricular Remodeling drug effects
Abstract

Background: The current cornerstone treatment of myocardial infarction (MI) is restoration of coronary blood flow by means of thrombolytic therapy or primary percutaneous coronary intervention. However, reperfusion of ischemic myocardium can actually provoke tissue damage, defined as "ischemia-reperfusion (I/R) injury." TVP1022 [the S-isomer of rasagiline (Azilect), FDA-approved anti-Parkinson's drug] was found to exert cardioprotective activities against various cardiac insults, such as chronic heart failure and I/R, in rat models. Therefore, we tested the hypothesis that TVP1022 will provide cardioprotection against I/R injury and post-MI remodeling in a pig model., Methods: For inducing MI, we used an I/R model of midleft anterior descending artery occlusion for 90 minutes followed by follow-up for 8 weeks in 18 farm pigs (9 pigs in each group, MI + TVP1022 or MI + Vehicle). Echocardiographic measurements were performed and cardiac scar size was calculated using histopathological methods. For fibrosis evaluation, we measured the interstitial collagen volume fraction in the remote noninfarcted tissue., Results: TVP1022 administration significantly decreased cardiac scar size, attenuated left ventricular dilation, and improved cardiac function assessed by segmental circumferential strain analysis. Furthermore, TVP1022 significantly reduced myocardial fibrosis 8 weeks post-MI., Conclusions: Collectively, these findings indicate that TVP1022 provides prominent cardioprotection against I/R injury and post-MI remodeling in this I/R pig model.

Published
2015
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47. Predictors and outcomes associated with radial versus femoral access for intervention in patients with acute coronary syndrome in a real-world setting: results from the Acute Coronary Syndrome Israeli Survey (ACSIS) 2010.

Author

Fefer P, Matetzky S, Gannot S, Gottlieb S, Meerkin D, Bubyr L, Gavrielov N, Zahger D, Goldenberg I, Kornowski R, and Segev A

Subjects
Aged, Coronary Angiography methods, Female, Health Surveys, Humans, Israel epidemiology, Male, Middle Aged, Risk Adjustment, Risk Assessment, Acute Coronary Syndrome etiology, Acute Coronary Syndrome mortality, Acute Coronary Syndrome surgery, Catheterization, Peripheral methods, Femoral Artery surgery, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods, Postoperative Complications diagnosis, Postoperative Complications epidemiology, Postoperative Complications prevention & control, Radial Artery surgery
Abstract

Background: Use of transradial intervention (TRI) is becoming more popular, and recent studies suggest an advantage for TRI in high-risk patients presenting with acute coronary syndrome (ACS). The aim of our study was to describe current utilization and outcomes of transradial intervention (TRI) in real-world patients presenting with ACS., Methods: Data were derived from the ACS Israeli Survey (ACSIS 2010), a nationwide prospective survey of patients presenting with ACS over a 2-month period. Follow-up was continued for up to 1 year., Results: Of 1815 ACS patients undergoing coronary angiography, 613 (34%) underwent TRI, which was more likely to be employed among patients with lower-risk characteristics. Patients undergoing TRI had significantly lower 30-day mortality and in-hospital bleeding. On multivariate analysis, the risk of in-hospital major bleeding was reduced by 60% in patients undergoing TRI (P=.04). However, no significant differences in other components of major adverse cardiac events or mortality were demonstrated at 30 days. All-cause mortality at 1 year was significantly lower among patients who underwent TRI. However, after multivariate adjustment, this effect was no longer significant., Conclusions: In our study of real-world patients, better TRI outcomes are related largely to lower baseline risk of patients allocated to this approach, suggesting that TRI may be underutilized in high-risk ACS patients.

Published
2014

48. Incidence and risk factors of cerebrovascular events following cardiac catheterization.

Author

Korn-Lubetzki I, Farkash R, Pachino RM, Almagor Y, Tzivoni D, and Meerkin D

Subjects
Aged, Aged, 80 and over, Cerebrovascular Disorders diagnosis, Chi-Square Distribution, Female, Humans, Incidence, Israel epidemiology, Logistic Models, Male, Middle Aged, Multivariate Analysis, Odds Ratio, Retrospective Studies, Risk Factors, Time Factors, Cardiac Catheterization adverse effects, Cerebrovascular Disorders epidemiology, Coronary Angiography adverse effects, Percutaneous Coronary Intervention adverse effects
Abstract

Background: One of the most daunting complications of cardiac catheterization is a cerebrovascular event (CVE). We aimed to assess the real-life incidence, etiology, and risk factors of cardiac catheterization-related acute CVEs in a large cohort of patients treated in a single center., Methods and Results: We undertook a retrospective analysis of 43,350 coronary procedures performed on 30,907 procedure days over the period 1992-2011 and compared patient and procedural characteristics of procedures complicated by CVEs with the remaining cohort. CVEs occurred in 47 cases: 43 were ischemic, 3 intracerebral hemorrhages, and 1 undetermined. The overall CVE rate was 0.15%, with percutaneous coronary intervention (PCI) and diagnostic coronary angiography rates 0.23% and 0.09%, respectively. Using a forward stepwise multivariate logistic regression model including patient demographic and procedural characteristics, a total of 5 significant predictors were defined: prior stroke (OR=15.09, 95% CI [8.11 to 28.08], P<0.0001), presence of coronary arterial thrombus (OR=2.79, 95% CI [1.25 to 6.22], P=0.012), age >75 years (OR=3.33, 95% CI [1.79 to 6.19], P<0.0001), triple vessel disease (OR=2.24, 95% CI [1.20 to 4.18], P=0.011), and performance of intervention (OR=2.21, 95% CI [1.12 to 4.33], P=0.021). An additional analysis excluded any temporal change of CVE rates but demonstrated a significant increase of all high-risk patient features., Conclusion: In a single-center, retrospective assessment over nearly 20 years, cardiac catheterization-related CVEs were very rare and nearly exclusively ischemic. The independent predictors for these events were found to be the performance of an intervention and those associated with increased atherosclerotic burden, specifically older age, triple vessel disease, and prior stroke. The presence of intracoronary thrombus appears also to raise the risk of procedure-related CVE.

Published
2013
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49. Early safety of the Amplatzer Cardiac Plug™ for left atrial appendage occlusion.

Author

Meerkin D, Butnaru A, Dratva D, Bertrand OF, and Tzivoni D

Subjects
Aged, Aged, 80 and over, Cardiac Catheterization adverse effects, Female, Humans, Male, Middle Aged, Time Factors, Treatment Outcome, Ultrasonography, Atrial Appendage diagnostic imaging, Atrial Appendage surgery, Atrial Fibrillation diagnostic imaging, Atrial Fibrillation surgery, Cardiac Catheterization methods, Septal Occluder Device adverse effects
Abstract

Objective: To assess the cumulative experience of a single operator using a strict set of deployment and release criteria for the Amplatzer Cardiac Plug™ (ACP) and the impact of these criteria on procedural success and complications., Background: Following strong evidence that the left atrial appendage (LAA) is the site of the majority of thrombus formation within the left atrium in patients with non-valvular atrial fibrillation, non-pharmacological approaches to LAA exclusion have been developed and shown to be effective., Methods: Procedural and in-hospital outcomes of LAA occlusion performed by or under the supervision of a single operator using the ACP™ in 100 anticoagulant ineligible patients with a high stroke risk were assessed., Results: One hundred patients with a mean CHADS2 score of 3.21 ± 1.23 underwent catheterization for closure of LAA with the ACP™. The mean landing zone as assessed by TEE was 20.01 ± 3.21 mm, and 20.8 ± 3.19 mm by fluoroscopy. The mean difference between the TEE and the fluoroscopic measurements was 0.8 ± 1.13 mm. Device deployment was successful in 100/100 attempted cases with a mean deployed device size of 24.36 ± 3.27 mm. Procedural complications were limited to a single case of pericardial tamponade and one post-procedural pulmonary edema both of which were adequately treated with no long-term sequelae., Conclusions: In this single operator report, LAA occlusion using the double element ACP™ can be safely performed with excellent success rates. Using very specific deployment success, stability and release criteria, this device can achieve LAA occlusion with extremely low complication rates in an extremely frail oral anticoagulant ineligible population with multiple co-morbidities., (© 2013 Elsevier Ireland Ltd. All rights reserved.)

Published
2013
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50. Comparison of transradial and femoral approaches for percutaneous coronary interventions: a systematic review and hierarchical Bayesian meta-analysis.

Author

Bertrand OF, Bélisle P, Joyal D, Costerousse O, Rao SV, Jolly SS, Meerkin D, and Joseph L

Subjects
Angioplasty, Balloon, Coronary adverse effects, Humans, Treatment Outcome, Angioplasty, Balloon, Coronary methods, Cardiac Catheterization methods
Abstract

Background: Despite lower risks of access site-related complications with transradial approach (TRA), its clinical benefit for percutaneous coronary intervention (PCI) is uncertain. We conducted a systematic review and meta-analysis of clinical studies comparing TRA and transfemoral approach (TFA) for PCI., Methods: Randomized trials and observational studies (1993-2011) comparing TRA with TFA for PCI with reports of ischemic and bleeding outcomes were included. Crude and adjusted (for age and sex) odds ratios (OR) were estimated by a hierarchical Bayesian random-effects model with prespecified stratification for observational and randomized designs. The primary outcomes were rates of death, combined incidence of death or myocardial infarction, bleeding, and transfusions, early (≤ 30 days) and late after PCI., Results: We collected data from 76 studies (15 randomized, 61 observational) involving a total of 761,919 patients. Compared with TFA, TRA was associated with a 78% reduction in bleeding (OR 0.22, 95% credible interval [CrI] 0.16-0.29) and 80% in transfusions (OR 0.20, 95% CrI 0.11-0.32). These findings were consistent in both randomized and observational studies. Early after PCI, there was a 44% reduction of mortality with TRA (OR 0.56, 95% CrI 0.45-0.67), although the effect was mainly due to observational studies (OR 0.52, 95% CrI 0.40-0.63, adjusted OR 0.49 [95% CrI 0.37-0.60]), with an OR of 0.80 (95% CrI 0.49-1.23) in randomized trials., Conclusion: Our results combining observational and randomized studies show that PCI performed by TRA is associated with substantially less risks of bleeding and transfusions compared with TFA. Benefit on the incidence of death or combined death or myocardial infarction is found in observational studies but remains inconclusive in randomized trials., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Published
2012
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