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24 results on '"Augostini, R."'

1. Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes

Author

Costanzo MR, Javaheri S, Ponikowski P, Oldenburg O, Augostini R, Goldberg LR, Stellbrink C, Fox H, Schwartz AR, Gupta S, McKane S, Meyer TE, and Abraham WT

Subjects
central sleep apnea, phrenic nerve stimulation, Psychiatry, RC435-571, Neurophysiology and neuropsychology, QP351-495
Abstract

Maria Rosa Costanzo,1 Shahrokh Javaheri,2,3 Piotr Ponikowski,4 Olaf Oldenburg,5 Ralph Augostini,3 Lee R Goldberg,6 Christoph Stellbrink,7 Henrik Fox,8 Alan R Schwartz,6 Sanjaya Gupta,9 Scott McKane,10 Timothy E Meyer,10 William T Abraham3 for the remedē®System Pivotal Trial Study Group1Advocate Heart Institute, Naperville, IL, USA; 2Bethesda North Hospital, Cincinnati, OH, USA; 3The Ohio State University, Columbus, OH, USA; 4Department of Heart Diseases, Medical University, Military Hospital, Wroclaw, Poland; 5Ludgerus-Kliniken Münster, Clemens Hospital, Münster, Germany; 6University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA; 7Bielefeld Medical Center, Bielefeld, Germany; 8Clinic for General and Interventional Cardiology Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany; 9University of Missouri-Kansas City School of Medicine, Saint Luke’s Mid-America Heart Institute, Kansas City, MO, USA; 10Respicardia, Inc., Minnetonka, MN, USACorrespondence: Maria Rosa CostanzoAdvocate Heart Institute, Naperville, IL, 60566, USAEmail mariarosa.costanzo@aah.orgBackground: The remedē System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) and improves sleep architecture and daytime sleepiness. Subsequently, the remedē System was approved by FDA in 2017. As a condition of approval, the Post Approval Study (PAS) collected clinical evidence regarding long-term safety and effectiveness in adults with moderate to severe CSA through five years post implant.Methods: Patients remaining in the Pivotal Trial at the time of FDA approval were invited to enroll in the PAS and consented to undergo sleep studies (scored by a central laboratory), complete the Epworth Sleepiness Scale (ESS) questionnaire to assess daytime sleepiness, and safety assessment. All subjects (treatment and former control group) receiving active therapy were pooled; data from both trials were combined for analysis.Results: Fifty-three of the original 151 Pivotal Trial patients consented to participate in the PAS and 52 completed the 5-year visit. Following TPNS therapy, the apnea-hypopnea index (AHI), central-apnea index (CAI), arousal index, oxygen desaturation index, and sleep architecture showed sustained improvements. Comparing 5 years to baseline, AHI and CAI decreased significantly (AHI baseline median 46 events/hour vs 17 at 5 years; CAI baseline median 23 events/hour vs 1 at 5 years), though residual hypopneas were present. In parallel, the arousal index, oxygen desaturation index and sleep architecture improved. The ESS improved by a statistically significant median reduction of 3 points at 5 years. Serious adverse events related to implant procedure, device or delivered therapy were reported by 14% of patients which include 16 (9%) patients who underwent a pulse generator reposition or lead revision (primarily in the first year). None of the events caused long-term harm. No unanticipated adverse device effects or related deaths occurred through 5 years.Conclusion: Long-term TPNS safely improves CSA, sleep architecture and daytime sleepiness through 5 years post implant.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01816776.Keywords: central sleep apnea, phrenic nerve stimulation

Published
2021

3. P985Clinical decision making for pacemaker implantation following TAVR: lessons from a large single-institution cohort

Author

Haddad, D., primary, Patel, D., additional, Afzal, M., additional, Godara, H., additional, Badin, A., additional, Hummel, J., additional, Kalbfleisch, S., additional, Houmsse, M., additional, Tyler, J., additional, Liu, Z., additional, Weiss, R., additional, Augostini, R., additional, Daoud, E., additional, and Okabe, T., additional

Published
2017
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6. Transvenous phrenic nerve stimulation for the treatment of central sleep apnoea in heart failure

Author

Ponikowski, P., primary, Javaheri, S., additional, Michalkiewicz, D., additional, Bart, B. A., additional, Czarnecka, D., additional, Jastrzebski, M., additional, Kusiak, A., additional, Augostini, R., additional, Jagielski, D., additional, Witkowski, T., additional, Khayat, R. N., additional, Oldenburg, O., additional, Gutleben, K.-J., additional, Bitter, T., additional, Karim, R., additional, Iber, C., additional, Hasan, A., additional, Hibler, K., additional, Germany, R., additional, and Abraham, W. T., additional

Published
2011
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7. Poster Session 1

Author

Deshmukh, A., primary, Sharma, S. S., additional, Gobal, F. G., additional, Singla, S. S., additional, Hebbar, P. H., additional, Paydak, H. P., additional, Igarashi, M., additional, Tada, H., additional, Sekiguchi, Y., additional, Yamasaki, H., additional, Kuroki, K., additional, Machino, T., additional, Yoshida, K., additional, Aonuma, K., additional, Shavadia, J., additional, Otieno, H., additional, Yonga, G., additional, Jinah, A., additional, Qvist, J. F., additional, Soerensen, P. H., additional, Dixen, U., additional, Ramirez-Marrero, M. A., additional, Perez-Villardon, B., additional, Gaitan-Roman, D., additional, Jimenez-Navarro, M., additional, Delgado-Prieto, J. L., additional, De Teresa-Galvan, E., additional, De Mora-Martin, M., additional, Deshmukh, A., additional, Hebbar, P. B., additional, Wei, W. X., additional, Bardari, S., additional, Zecchin, M., additional, Salame', R., additional, Vitali Serdoz, L., additional, Di Lenarda, A., additional, Guerrini, N., additional, Barbati, G., additional, Sinagra, G., additional, Hanazawa, K., additional, Kaitani, K., additional, Nakagawa, Y., additional, Lenaerts, I., additional, Driesen, R., additional, Hermida, N., additional, Heidbuchel, H., additional, Janssens, S., additional, Balligand, J. L., additional, Sipido, K. R., additional, Willems, R., additional, Sehra, R., additional, Krummen, D., additional, Briggs, C., additional, Narayan, S., additional, Tanaka, Y., additional, Hirao, K., additional, Nakamura, T., additional, Inaba, O., additional, Yagishita, A., additional, Higuchi, K., additional, Hachiya, H., additional, Isobe, M., additional, Kallergis, E., additional, Kanoupakis, E. M., additional, Mavrakis, H. E., additional, Goudis, C. A., additional, Maliaraki, N. E., additional, Vardas, P. E., additional, Kiuchi, K., additional, Piorkowski, C., additional, Kircher, S., additional, Gaspar, T., additional, Watanabe, N., additional, Bollmann, A., additional, Hindricks, G., additional, Wauters, K., additional, Grosse, A., additional, Raffa, S., additional, Brunelli, M., additional, Geller, J. C., additional, Maggioni, A. P., additional, Gonzini, L., additional, Gussoni, G., additional, Vescovo, G., additional, Gulizia, M., additional, Pirelli, S., additional, Mathieu, G., additional, Di Pasquale, G., additional, Salame, R., additional, Magnani, S., additional, Sakamoto, T., additional, Kumagai, K., additional, Fuke, E., additional, Nishiuchi, S., additional, Hayashi, T., additional, Miki, Y., additional, Naito, S., additional, Oshima, S., additional, Hof, I. E., additional, Vonken, E., additional, Velthuis, B. K., additional, Meine, M., additional, Hauer, R. N. W., additional, Loh, K. P., additional, Na, J. O., additional, Choi, C. U., additional, Kim, E. J., additional, Rha, S. W., additional, Park, C. G., additional, Seo, H. S., additional, Oh, D. J., additional, Lim, H. E., additional, Wichterle, D., additional, Bulkova, V., additional, Fiala, M., additional, Chovancik, J., additional, Simek, J., additional, Peichl, P., additional, Cihak, R., additional, Kautzner, J., additional, Glick, A., additional, Viskin, S., additional, Belhassen, B., additional, Navarrete, A., additional, Conte, F., additional, Ishti, A., additional, Sai, D., additional, Moran, M., additional, Chitovova, Z., additional, Ahmed, H., additional, Mares, K., additional, Skoda, J., additional, Sediva, L., additional, Petru, J., additional, Reddy, V. Y., additional, Neuzil, P., additional, Schmidt, M., additional, Dorwarth, U., additional, Leber, A., additional, Wankerl, M., additional, Krieg, J., additional, Straube, F., additional, Reif, S., additional, Hoffmann, E., additional, Mikhaylov, E., additional, Tikhonenko, V., additional, Lebedev, D., additional, Shin, S. Y., additional, Yong, H. S., additional, Choi, J. I., additional, Kim, S. H., additional, Matsuo, S., additional, Yamane, T., additional, Hioki, M., additional, Ito, K., additional, Narui, R., additional, Date, T., additional, Sugimoto, K., additional, Yoshimura, M., additional, Rolf, S., additional, Sommer, P., additional, Batalov, R., additional, Popov, S., additional, Antonchenko, I., additional, Suslova, T., additional, Fichtner, S., additional, Czudnochowsky, U., additional, Estner, H. L., additional, Ammar, S., additional, Reents, T., additional, Jilek, C., additional, Hessling, G., additional, Deisenhofer, I., additional, Pokushalov, E., additional, Romanov, A., additional, Corbucci, G., additional, Artemenko, S., additional, Losik, D., additional, Shabanov, V., additional, Turov, A., additional, Elesin, D., additional, Abramov, M., additional, Sanders, P., additional, Jais, P., additional, Roberts-Thomson, K., additional, Fukumoto, K., additional, Takatsuki, S., additional, Kimura, T., additional, Nishiyama, N., additional, Aizawa, Y., additional, Sato, T., additional, Miyoshi, S., additional, Fukuda, K., additional, Roux, Y., additional, Tenkorang, J., additional, Carroz, P., additional, Schlaepfer, J., additional, Pascale, P., additional, Forclaz, A., additional, Fromer, M., additional, Pruvot, E., additional, Sknouril, L., additional, Nevralova, R., additional, Dorda, M., additional, Januska, J., additional, Santi, R., additional, Geller, C., additional, Nakamura, K., additional, Kasseno, K., additional, Taniguchi, K., additional, Wutzler, A., additional, Huemer, M., additional, Parwani, A., additional, Boldt, L. H., additional, Blaschke, D., additional, Dietz, R., additional, Haverkamp, W., additional, Coutu, B., additional, Malanuk, R., additional, Ait Said, M., additional, Vicentini, A., additional, Schade, S., additional, Ando, K., additional, Rousseauplasse, A., additional, Deering, T., additional, Picarra, B. C., additional, Santos, A. R., additional, Dionisio, P., additional, Semedo, P., additional, Matos, R., additional, Leitao, M., additional, Jacinto, A., additional, Trinca, M., additional, Wan, C., additional, Glad, J., additional, Szymkiewicz, S., additional, Habibovic, M., additional, Versteeg, H., additional, Pelle, A. J. M., additional, Theuns, D. A. M. J., additional, Jordaens, L., additional, Pedersen, S. S., additional, Pakarinen, S., additional, Toivonen, L., additional, Taggeselle, J., additional, Frey, A., additional, Birkenhagen, A., additional, Kohler, S., additional, Maier, S. K. G., additional, Lobitz, N., additional, Paule, S., additional, Becher, J., additional, Mustafa, G., additional, Ibrahim, A., additional, King, G., additional, Foley, B., additional, Wilkoff, B., additional, Freedman, R., additional, Hayes, D., additional, Kalbfleisch, S., additional, Kutalek, S., additional, Schaerf, R., additional, Fazal, I. A., additional, Tynan, M., additional, Plummer, C. J., additional, Mccomb, J. M., additional, Oto, A., additional, Aytemir, K., additional, Yorgun, H., additional, Canpolat, U., additional, Kaya, E. B., additional, Tokgozoglu, L., additional, Kabakci, G., additional, Ozkutlu, H., additional, Greenberg, S., additional, Hamati, F., additional, Styperek, R., additional, Alonso, J., additional, Peress, D., additional, Bolanos, O., additional, Augostini, R., additional, Pelini, M., additional, Zhang, S., additional, Stoycos, S., additional, Witsaman, S., additional, Mowrey, K., additional, Bremer, J., additional, Oza, A., additional, Ciconte, G., additional, Mazzone, P., additional, Paglino, G., additional, Marzi, A., additional, Vergara, P., additional, Sora, N., additional, Gulletta, S., additional, Della Bella, P., additional, Nagashima, M., additional, Goya, M., additional, Soga, Y., additional, Hiroshima, K., additional, Andou, K., additional, Hayashi, K., additional, An, Y., additional, Nobuyoshi, M., additional, Kutarski, A., additional, Malecka, B., additional, Pietura, R., additional, Osmancik, P., additional, Herman, D., additional, Stros, P., additional, Kocka, V., additional, Tousek, P., additional, Linkova, H., additional, Bortnik, M., additional, Occhetta, E., additional, Dell'era, G., additional, Degiovanni, A., additional, Plebani, L., additional, Marino, P. N., additional, Gorev, M. V., additional, Alimov, D. G., additional, Raju, P., additional, Kully, S., additional, Ugni, S., additional, Furniss, S., additional, Lloyd, G., additional, Patel, N. R., additional, Richards, M. W., additional, Warren, C. E., additional, Anderson, M. H., additional, Hero, M., additional, Rey, J. L., additional, Ouali, S., additional, Azzez, S., additional, Kacem, S., additional, Hammas, S., additional, Ben Salem, H., additional, Neffeti, E., additional, Remedi, F., additional, Boughzela, E., additional, Kronborg, M. B., additional, Mortensen, P. T., additional, Poulsen, S. H., additional, Nielsen, J. C., additional, Simantirakis, E. N., additional, Kontaraki, J. E., additional, Arkolaki, E. G., additional, Chrysostomakis, S. I., additional, Nyktari, E. G., additional, Patrianakos, A. P., additional, Funck, R. C., additional, Harink, C., additional, Mueller, H. H., additional, Koelsch, S., additional, Maisch, B., additional, Bolzani, V., additional, Costandi, P., additional, Shehada, R. E., additional, Butala, N., additional, Coppola, B., additional, Taborsky, M., additional, Heinc, P., additional, Fedorco, M., additional, Doupal, V., additional, Di Cori, A., additional, Zucchelli, G., additional, Soldati, E., additional, Segreti, L., additional, De Lucia, R., additional, Viani, S., additional, Paperini, L., additional, Bongiorni, M. G., additional, Gutleben, K. J., additional, Kranig, W., additional, Barr, C., additional, Morgenstern, M. M., additional, Simon, M., additional, Dalal, Y. H., additional, Landolina, M., additional, Pierantozzi, A., additional, Agricola, T., additional, Lunati, M., additional, Pisano', E., additional, Lonardi, G., additional, Bardelli, G., additional, Zucchi, G., additional, Thibault, B., additional, Dubuc, M., additional, Karst, E., additional, Ryu, K., additional, Paiement, P., additional, Carlson, M. D., additional, Farazi, T., additional, Alhous, H., additional, Mont, L., additional, Porres, J. M., additional, Alzueta, J., additional, Beiras, X., additional, Fernandez-Lozano, I., additional, Macias, A., additional, Ruiz, R., additional, Brugada, J., additional, Viani, S. M., additional, Seifert, M., additional, Schau, T., additional, Moeller, V., additional, Meyhoefer, J., additional, Butter, C., additional, Ganiere, V., additional, Niculescu, V., additional, Domenichini, G., additional, Stettler, C., additional, Defaye, P., additional, Burri, H., additional, Stockburger, M., additional, De Teresa, E., additional, Lamas, G., additional, Desaga, M., additional, Koenig, C., additional, Cobo, E., additional, Navarro, X., additional, Wiegand, U., additional, Blich, M., additional, Carasso, S., additional, Suleiman, M., additional, Marai, I., additional, Gepstein, L., additional, Boulos, M., additional, Sasov, M., additional, Liska, B., additional, Margitfalvi, P., additional, Malacky, T., additional, Svetlosak, M., additional, Goncalvesova, E., additional, Hatala, R., additional, Takaya, Y., additional, Noda, T., additional, Yamada, Y., additional, Okamura, H., additional, Satomi, K., additional, Shimizu, W., additional, Aihara, N., additional, Kamakura, S., additional, Proclemer, A., additional, Boveda, S., additional, Oswald, H., additional, Scipione, P., additional, Da Costa, A., additional, Brzozowski, W., additional, Tomaszewski, A., additional, Wysokinski, A., additional, Arbelo, E., additional, Tamborero, D., additional, Vidal, B., additional, Tolosana, J. M., additional, Sitges, M., additional, Matas, M., additional, Botto, G. L., additional, Dicandia, C. D., additional, Mantica, M., additional, La Rosa, C., additional, D' Onofrio, A., additional, Molon, G., additional, Raciti, G., additional, Verlato, R., additional, Foley, P. W. X., additional, Chalil, S., additional, Ratib, K., additional, Smith, R. E. A., additional, Printzen, F., additional, Auricchio, A., additional, Leyva, F., additional, Abu Sham'a, R., additional, Buber, J., additional, Luria, D., additional, Kuperstein, R., additional, Feinberg, M., additional, Granit, H., additional, Eldar, M., additional, Glikson, M., additional, Vondrak, K., additional, Nof, E., additional, Lipchenca, I., additional, Vatasescu, R.- G., additional, Iorgulescu, C., additional, Caldararu, C., additional, Vasile, A., additional, Bogdan, S., additional, Constantinescu, D., additional, Dorobantu, M., additional, Sakaguchi, H., additional, Miyazaki, A., additional, Yamamoto, T., additional, Fujimoto, K., additional, Ono, S., additional, Ohuchi, H., additional, Martinelli, M., additional, Martins, S., additional, Molina, R., additional, Siqueira, S., additional, Nishioka, S. A. D., additional, Peixoto, G. L., additional, Alkmim-Teixeira, R., additional, Costa, R., additional, Meine, M. M., additional, Tuinenburg, A. E., additional, Doevendans, P. A., additional, Denollet, J., additional, Goscinska-Bis, K., additional, Zupan, I., additional, Van Der, H., additional, Anselme, F., additional, Hartog, H., additional, Block, M., additional, Borri, A., additional, Padeletti, L., additional, Toniolo, M., additional, Zanotto, G., additional, Rossi, A., additional, Raytcheva, E., additional, Tomasi, L., additional, Vassanelli, C., additional, Fernandez Lozano, I., additional, Mitroi, C., additional, Toquero Ramos, J., additional, Castro Urda, V., additional, Monivas Palomero, V., additional, Corona Figueroa, A., additional, Ruiz Bautista, L., additional, Alonso Pulpon, L., additional, Jadidi, A. S., additional, Sacher, F., additional, Shah, A. S., additional, Scherr, D., additional, Derval, N., additional, Hocini, M., additional, Haissaguerre, M., additional, Castrejon Castrejon, S., additional, Largo-Aramburu, C., additional, Sachar, J., additional, Gang, E., additional, Estrada, A., additional, Doiny, D., additional, De Miguel, E., additional, Merino, J. L., additional, Trevisi, N., additional, Ricco, A., additional, Petracca, F., additional, Baratto, F., additional, Bisceglie, A., additional, Maccabelli, G., additional, El-Damaty, A., additional, Sapp, J., additional, Warren, J., additional, Macinnis, P., additional, Horacek, M., additional, Dinov, B., additional, Schoenbauer, R., additional, Braunschweig, F., additional, Arya, A., additional, Andreu, D., additional, Berruezo, A., additional, Ortiz, J. T., additional, Silva, E., additional, De Caralt, T. M., additional, Fernandez-Armenta, J., additional, Perez-Silva, A., additional, Ortega, M., additional, Lopez-Sendon, J. L., additional, Regoli, F., additional, Faletra, F., additional, Nucifora, G., additional, Pasotti, E., additional, Moccetti, T., additional, Klersy, C., additional, Casella, M., additional, Dello Russo, A., additional, Moltrasio, M., additional, Zucchetti, M., additional, Fassini, G., additional, Di Biase, L., additional, Natale, A., additional, Tondo, C., additional, Matsuhashi, N., additional, Weig, H. J., additional, Kerst, G., additional, Weretk, S., additional, Seizer, P., additional, Gawaz, M. P., additional, Schreieck, J., additional, Sarquella-Brugada, G., additional, Prada, F., additional, Salling, C. M., additional, Kolb, C., additional, Pytkowski, M., additional, Maciag, A., additional, Farkowski, M., additional, Jankowska, A., additional, Kowalik, I., additional, Kraska, A., additional, Szwed, H., additional, Maury, P., additional, Duparc, A., additional, Mondoly, P., additional, Rollin, A., additional, Pap, R., additional, Kohari, M., additional, Bencsik, G., additional, Makai, A., additional, Saghy, L., additional, Forster, T., additional, Ebrille, E., additional, Scaglione, M., additional, Raimondo, C., additional, Caponi, D., additional, Di Donna, P., additional, Blandino, A., additional, Delcre, S. D. L., additional, Gaita, F., additional, Roca Luque, I., additional, Dos, L. D. S., additional, Rivas, N. R. G., additional, Pijuan, A. P. D., additional, Perez, J., additional, Casaldaliga, J., additional, Garcia-Dorado, D. G. D., additional, Moya, A. M. M., additional, Sato, H., additional, Yagi, T., additional, Yambe, T., additional, Streitner, F., additional, Dietrich, C., additional, Mahl, E., additional, Schoene, N., additional, Veltmann, C., additional, Borggrefe, M., additional, Kuschyk, J., additional, Sadarmin, P. P., additional, Wong, K. C. K., additional, Rajappan, K., additional, Bashir, Y., additional, Betts, T. R., additional, Leclercq, C., additional, Martins, R., additional, Daubert, J. C., additional, Mabo, P., additional, Koide, M., additional, Hamano, G., additional, Taniguchi, T., additional, Yamato, M., additional, Sasaki, N., additional, Hirooka, K., additional, Ikeda, Y., additional, Yasumura, Y., additional, Dichtl, W., additional, Wolber, T., additional, Paoli, U., additional, Bruellmann, S., additional, Berger, T., additional, Stuehlinger, M., additional, Duru, F., additional, Hintringer, F., additional, Kanoupakis, E., additional, Mavrakis, H., additional, Koutalas, E., additional, Saloustros, I., additional, Goudis, C., additional, Chlouverakis, G., additional, Vardas, P., additional, Herre, J. M., additional, Saeed, M., additional, Saberi, L., additional, Neuman, S., additional, Yamaji, K., additional, Iwabuchi, M., additional, Baranchuk, A., additional, Femenia, F., additional, Miranda Hermosilla, R., additional, Lopez Diez, J. C., additional, Serra, J. L., additional, Valentino, M., additional, Retyk, E., additional, Galizio, N., additional, Kwasniewski, W., additional, Filipecki, A., additional, Orszulak, W., additional, Urbanczyk-Swic, D., additional, Trusz - Gluza, M., additional, Piot, O., additional, Degand, B., additional, Donofrio, A., additional, Scanu, P., additional, Quesada, A., additional, Kloppe, A., additional, Mijic, D., additional, Bogossian, H., additional, Zarse, M., additional, Lemke, B., additional, Tyler, J., additional, Comfort, G., additional, Deering, T. F., additional, Epstein, A. E., additional, Greenberg, S. M. G., additional, Goldman, D. S., additional, Rhude, J., additional, Majewski, J. P., additional, Lelakowski, J., additional, Tomala, I., additional, Santos, C. M., additional, Miranda, R. S., additional, Sousa, P. J., additional, Cavaco, D. M., additional, Adragao, P. P., additional, Knops, R. E., additional, Wilde, A. A., additional, Belhameche, M., additional, Hermida, J. S., additional, Dovellini, E., additional, Frohlig, G., additional, Siot, P., additional, Duray, G. Z., additional, Israel, C. W., additional, Brachmann, J., additional, Seidl, K. H., additional, Foresti, M., additional, Birkenhauer, F., additional, Hohnloser, S. H., additional, Ferreira, C., additional, Mateus, P., additional, Ribeiro, H., additional, Carvalho, S., additional, Ferreira, A., additional, Moreira, J., additional, Kadro, W., additional, Rahim, H., additional, Turkmani, M., additional, Abu Lebdeh, M., additional, Altabban, A., additional, Cerrato, N., additional, Rivera, S., additional, Scazzuso, F., additional, Albina, G., additional, Klein, A., additional, Laino, R., additional, Sammartino, V., additional, Giniger, A., additional, Kvantaliani, T., additional, Akhvlediani, M., additional, Namdar, M., additional, Steffel, J., additional, Jetzer, S., additional, Bayrak, F., additional, Chierchia, G. B., additional, Jenni, R., additional, Brugada, P., additional, Bakos, Z., additional, Medvedev M, M. M., additional, Jonas Carlsson, J. C., additional, Fredrik Holmqvist, F. H., additional, Pyotr Platonov, P. P., additional, Nurbaev, T., additional, Pirnazarov, M., additional, Nikishin, A., additional, Aagaard, P., additional, Sahlen, A., additional, Bergfeldt, L., additional, Simeonidou, E., additional, Kastellanos, S., additional, Varounis, C., additional, Michalakeas, C., additional, Koniari, C., additional, Nikolopoulou, A., additional, Anastasiou-Nana, M., additional, Furukawa, Y., additional, Yamada, T., additional, Morita, T., additional, Tanaka, K., additional, Iwasaki, Y., additional, Kawasaki, M., additional, Kuramoto, Y., additional, Fukunami, M., additional, Blanche, C., additional, Tran, N., additional, Rigamonti, F., additional, Zimmermann, M., additional, Okisheva, E., additional, Tsaregorodtsev, D., additional, Sulimov, V., additional, Novikova, D., additional, Popkova, T., additional, Udachkina, E., additional, Korsakova, Y., additional, Volkov, A., additional, Novikov, A., additional, Alexandrova, E., additional, Nasonov, E., additional, Arsenos, P., additional, Gatzoulis, K., additional, Manis, G., additional, Dilaveris, P., additional, Gialernios, T., additional, Kartsagoulis, E., additional, Asimakopoulos, S., additional, Stefanadis, C., additional, Marocolo, M., additional, Barbosa Neto, O., additional, Carvalho, A. C., additional, Marques Neto, S. R., additional, Mota, G. R., additional, Barbosa, P. R. B., additional, Fernandez-Fernandez, A., additional, Manzano Fernandez, S., additional, Pastor-Perez, F. J., additional, Barquero-Perez, O., additional, Goya-Esteban, R., additional, Salar, M., additional, Rojo-Alvarez, J. L., additional, Garcia-Alberola, A., additional, Takigawa, M., additional, Kawamura, M., additional, Aiba, T., additional, Sakaguchi, T., additional, Itoh, H., additional, Horie, M., additional, Igarashi, T., additional, Negishi, J., additional, Toyota, N., additional, Yamada, O., additional, Papavasileiou, M., additional, Cabrera Bueno, F., additional, Molina Mora, M. J., additional, Alzueta Rodriguez, J., additional, Barrera Cordero, A., additional, De Teresa Galvan, E., additional, Revishvili, A. S., additional, Dzhordzhikiya, T., additional, Sopov, O., additional, Simonyan, G., additional, Lyadzhina, O., additional, Fetisova, E., additional, Kalinin, V., additional, Balt, J. C., additional, Steggerda, R. C., additional, Boersma, L. V. A., additional, Wijffels, M. C. E. F., additional, Wever, E. F. D., additional, Ten Berg, J. M., additional, Ricci, R. P., additional, Morichelli, L., additional, D'onofrio, A., additional, Vaccari, D., additional, Calo', L., additional, Buja, G., additional, Rovai, N., additional, Gargaro, A., additional, Sperzel, J., additional, Speca, G., additional, Santini, L., additional, Haarbo, J., additional, Dubin, K., additional, Carlson, M., additional, Garcia Quintana, A., additional, Mendoza-Lemes, H., additional, Garcia Perez, L., additional, Led Ramos, S., additional, Caballero Dorta, E., additional, Matinez De Espronceda, M., additional, Piro Mastracchio, V., additional, Serrano Arriezu, L., additional, Sciarra, L., additional, Marziali, M., additional, Marras, E., additional, Rebecchi, M., additional, Allocca, G., additional, Lioy, E., additional, Delise, P., additional, Santobuono, V. E., additional, Iacoviello, M., additional, Nacci, F., additional, Luzzi, G., additional, Puzzovivo, A., additional, Memeo, M., additional, Quadrini, F., additional, Favale, S., additional, Trucco, M. E., additional, Arce, M., additional, Palazzolo, J., additional, Uribe, W., additional, Maggi, R., additional, Furukawa, T., additional, Croci, F., additional, Solano, A., additional, Brignole, M., additional, Lebreiro, A., additional, Sousa, A., additional, Correia, A. S., additional, Lourenco, P., additional, Oliveira, S., additional, Paiva, M., additional, Freitas, J., additional, Maciel, M. J., additional, Linker, N., additional, Rieger, G., additional, Garutti, C., additional, Edvardsson, N., additional, Salguero Bodes, R., additional, De Riva Silva, M., additional, Fontenla Cerezuela, A., additional, Lopez Gil, M., additional, Mejia Martinez, E., additional, Jurado Roman, A., additional, Garcia Alvarez, S., additional, Arribas Ynsaurriaga, F., additional, Petix, N. R., additional, Del Rosso, A., additional, Guarnaccia, V., additional, Zipoli, A., additional, Rabajoli, F., additional, Foglia Manzillo, G., additional, Tolardo, C., additional, Checchinato, C., additional, Chiaravallotti, S., additional, Santarone, M., additional, Spinnler, M. T., additional, Podoleanu, C., additional, Frigy, A., additional, Dobreanu, D., additional, Ginghina, C., additional, and Carasca, E., additional

Published
2011
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8. Poster Session 1: Ablation of atrial fibrillation

Author

Marti Almor, J., primary, Bazan, V., additional, Matiello, M., additional, Cian, D., additional, Oliva, X., additional, Altaba, C., additional, Guijo, M. A., additional, Bruguera, J., additional, Fiala, M., additional, Sknouril, M., additional, Dorda, M., additional, Chovancik, J., additional, Nevralova, R., additional, Jiravsky, O., additional, Jiravska-Godula, B., additional, Branny, M., additional, Elvan, A., additional, Beukema, W. P., additional, Smit, J. J. J., additional, Delnoy, P. P. H. M., additional, Ramdat Misier, A. R., additional, Tuan, J., additional, Chung, I., additional, Jeilan, M., additional, Kundu, S., additional, Osman, F., additional, Stafford, P., additional, Ng, G. A., additional, Vergara, P., additional, Mazzone, P., additional, Paglino, G., additional, Saviano, M., additional, Crisa, S., additional, Maida, G., additional, Vicedomini, G., additional, Pappone, C., additional, Miyazaki, S., additional, Wright, M., additional, Hocini, M., additional, Jais, P., additional, Haissaguerre, M., additional, Yoshitani, K., additional, Kaitani, K., additional, Hanazawa, K., additional, Nakagawa, Y., additional, Yokokawa, M., additional, Tada, H., additional, Naito, S., additional, Oshima, S., additional, Taniguchi, K., additional, Romanov, A., additional, Pokushalov, E., additional, Shugaev, P., additional, Artemenko, S., additional, Turov, A., additional, Gindele, F. M., additional, Wiedemann, M., additional, Ewertsen, C., additional, Heiderfazel, S., additional, Andresen, D., additional, Miyake, M., additional, Motooka, M., additional, Izumi, T., additional, Izumi, C., additional, Sunthorn, H., additional, Burri, H. B., additional, Gentil, P. G., additional, Shah, D. S., additional, Sugiura, S., additional, Fujii, E., additional, Senga, M., additional, Yamazato, S., additional, Nakamura, M., additional, Ito, M., additional, Den Uijl, D. W., additional, Delgado, V., additional, Tops, L. F., additional, Trines, S. A. I. P., additional, Zeppenfeld, K., additional, Van Der Wall, E. E., additional, Schalij, M. J., additional, Bax, J. J., additional, Pappalardo, A., additional, Forleo, G. B., additional, Avella, A., additional, Bencardino, G., additional, De Girolamo, P. G., additional, Dello Russo, A., additional, Laurenzi, F., additional, Tondo, C., additional, Mueller, H., additional, Burri, H., additional, Gentil-Baron, P., additional, Lerch, R., additional, Shah, D., additional, Shirokova, N., additional, Pedrote Martinez, A. A., additional, Arana, E., additional, Garcia-Riesco, L., additional, Urbano-Moral, J. A., additional, Frutos-Lopez, M., additional, Sanchez-Brotons, J. A., additional, Torres-Llergo, J., additional, Martinez-Martinez, A., additional, Matsuda, H., additional, Harada, T., additional, Nakano, E., additional, Takai, M., additional, Fujita, S., additional, Sasaki, T., additional, Mizuno, K., additional, Miyake, F., additional, Doshi, A., additional, Hummel, J., additional, Daoud, E., additional, Augostini, R., additional, Weiss, R., additional, Hart, D., additional, Houmsse, M., additional, Kalbfleisch, S., additional, Gorzolka, J., additional, Bulkova, V., additional, Wojnarova, D., additional, Neuwirth, R., additional, Januska, J., additional, Cerrato, E., additional, Amellone, C., additional, Tizzani, E., additional, Antolini, M., additional, Massa, R., additional, Golzio, P. G., additional, Comoglio, C., additional, Rinaldi, M., additional, El-Domiaty, H. A., additional, Kamal, H. M., additional, Moubarak, A. M., additional, Mansy, M. M., additional, El-Kerdawy, H., additional, Ahmed, S., additional, Klinkenberg, T. J., additional, Ten Hagen, A., additional, Wiesfeld, A. C. P., additional, Tan, E. S., additional, and Van Gelder, I. C., additional

Published
2009
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9. Feasibility of Assessing Cryoballoon Pulmonary Vein Occlusion With Saline Injection and a Novel Mapping System.

Author

Houmsse M, Matto F, Sulkin MS, Tomaszewski DJ, Shulepov S, Glassner L, Augostini R, Kalbfleisch S, Daoud EG, and Hummel J

Subjects
Feasibility Studies, Humans, Treatment Outcome, Atrial Fibrillation surgery, Cryosurgery adverse effects, Pulmonary Veins diagnostic imaging, Pulmonary Veins surgery, Pulmonary Veno-Occlusive Disease surgery
Abstract

Thirty-eight patients had assessment of pulmonary vein occlusion with the dielectric mapping system and injection of saline as an alternative to contrast. Contrast injection was required to ascertain pulmonary vein occlusion in 31.6% (12 of 38) of subjects and 17.4% (27 of 155) of veins. No contrast was required in the last 13 subjects. In this single center study, a novel mapping-guided cryoablation approach appeared to minimize the use of contrast in pulmonary vein isolation for the treatment of atrial fibrillation., Competing Interests: Funding Support and Author Disclosures Drs Houmsse and Daoud have received research support from Medtronic. Dr Sulkin, Mr Tomaszewski, Dr Shulepov, and Mr Glassner are salaried employees of EPD Solutions. Drs Hummel and Augostini have received consulting fees from EPD Solutions and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Published
2022
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10. Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.

Author

Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Love JC, Augostini R, Faerestrand S, Wiggins SS, Healey JS, Holbrook R, Lande JD, Lexcen DR, Willey S, and Tarakji KG

Subjects
Aged, Aged, 80 and over, Anti-Bacterial Agents adverse effects, Antibiotic Prophylaxis adverse effects, Cause of Death, Defibrillators, Implantable adverse effects, Device Removal economics, Drug Costs, Fee-for-Service Plans economics, Female, Health Expenditures, Hospital Costs, Humans, Length of Stay economics, Male, Medicare economics, Middle Aged, Pacemaker, Artificial adverse effects, Patient Readmission economics, Prospective Studies, Prosthesis-Related Infections microbiology, Prosthesis-Related Infections mortality, Quality of Life, Single-Blind Method, Time Factors, Treatment Outcome, United States, Anti-Bacterial Agents economics, Anti-Bacterial Agents therapeutic use, Antibiotic Prophylaxis economics, Defibrillators, Implantable economics, Health Care Costs, Health Resources economics, Pacemaker, Artificial economics, Prosthesis-Related Infections economics, Prosthesis-Related Infections prevention & control
Abstract

Background: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system., Methods: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets., Results: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P <0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P =0.004). Quality of life was reduced ( P =0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage., Conclusions: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.

Published
2020
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11. Extreme Obesity is Associated with Low Success Rate of Atrial Fibrillation Catheter Ablation.

Author

Okabe T, Buck B, A Hayes S, T Harfi T, R Afzal M, Tyler J, Houmsse M, J Kalbfleisch S, Weiss R, D Hummel J, S Augostini R, and G Daoud E

Abstract

Background: Catheter ablation (CA) is an established treatment for patients with symptomatic atrial fibrillation (AF). The purpose of this study was to evaluate the safety and efficacy of single CA in AF patients with extreme obesity (body mass index [BMI] ≥ 40 kg/m2) and its long-term impact on body weight., Methods: Patients with BMI ≥40 kg/m2 who underwent CA at the Ohio State University between 2012 and 2016 were included. The primary efficacy endpoint was no atrial arrhythmia lasting > 30 seconds without anti-arrhythmic drugs during 1-year follow-up after a single procedure., Results: Out of 230 AF patients with BMI ≥ 40 kg/m2 undergoing CA, pulmonary vein isolation was achieved in 226 (98%) patients.Seventeen patients (7.4%) experienced acute major complications, including pericardial effusion, vascular complications and respiratory failure. Patient characteristics for 135 patients with complete 1-year follow-up were as follows: mean age 58.6 ± 9.6 years, mean BMI 44.5±4.7 kg/m2, female 63 (47%), non-paroxysmal AF 100 (74%), median CHA2DS2-VASc score 2 (IQR:1-3). In this cohort, the primary efficacy endpoint was achieved in 44 (33%) patients. Paroxysmal AF was associated with higher CA success compared to non-paroxysmal (51 vs. 26% [p < 0.01]).There was no significant weight change even in patients with successful AF CA., Conclusions: Extreme obesity is associated with low AF CA success, particularly in those with non-paroxysmal AF. Successful AF CA was not associated with long-term weight reduction. A better treatment strategy is needed in this population of AF and extreme obesity.

Published
2020
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12. Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea: A Pooled Cohort Analysis.

Author

Fudim M, Spector AR, Costanzo MR, Pokorney SD, Mentz RJ, Jagielski D, Augostini R, Abraham WT, Ponikowski PP, McKane SW, and Piccini JP

Subjects
Aged, Cohort Studies, Female, Follow-Up Studies, Humans, Male, Pilot Projects, Polysomnography, Prospective Studies, Treatment Outcome, Electric Stimulation Therapy methods, Phrenic Nerve physiopathology, Sleep Apnea, Central physiopathology, Sleep Apnea, Central therapy
Abstract

Study Objectives: Early evidence with transvenous phrenic nerve stimulation (PNS) demonstrates improved disease severity and quality of life (QOL) in patients with central sleep apnea (CSA). The goal of this analysis is to evaluate the complete prospective experience with PNS in order to better characterize its efficacy and safety, including in patients with concomitant heart failure (HF)., Methods: Using pooled individual data from the pilot (n = 57) and pivotal (n = 151) studies of the remedē System in patients with predominant moderate to severe CSA, we evaluated 12-month safety and 6- and 12-month effectiveness based on polysomnography data, QOL, and cardiac function., Results: Among 208 combined patients (June 2010 to May 2015), a remedē device implant was successful in 197 patients (95%), 50/57 pilot study patients (88%) and 147/151 pivotal trial patients (97%). The pooled cohort included patients with CSA of various etiologies, and 141 (68%) had concomitant HF. PNS reduced apnea-hypopnea index (AHI) at 6 months by a median of -22.6 episodes/h (25th and 75th percentile; -38.6 and -8.4, respectively) (median 58% reduction from baseline, P < .001). Improvement in sleep variables was maintained through 12 months of follow-up. In patients with HF and ejection fraction ≤ 45%, PNS was associated with improvement in systolic function from 27.0% (23.3, 36.0) to 31.1% (24.0, 41.5) at 12 months (P = .003). In the entire cohort, improvement in QOL was concordant with amelioration of sleep measures., Conclusions: Transvenous PNS significantly improves CSA severity, sleep quality, ventricular function, and QOL regardless of HF status. Improvements, which are independent of patient compliance, are sustained at 1 year and are associated with acceptable safety., (© 2019 American Academy of Sleep Medicine.)

Published
2019
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13. Phrenic nerve stimulation to treat patients with central sleep apnoea and heart failure.

Author

Costanzo MR, Ponikowski P, Coats A, Javaheri S, Augostini R, Goldberg LR, Holcomb R, Kao A, Khayat RN, Oldenburg O, Stellbrink C, McKane S, and Abraham WT

Subjects
Aged, Female, Follow-Up Studies, Heart Failure complications, Heart Failure physiopathology, Humans, Male, Polysomnography, Prospective Studies, Sleep Apnea, Central etiology, Sleep Apnea, Central physiopathology, Treatment Outcome, Electric Stimulation Therapy methods, Heart Failure therapy, Phrenic Nerve physiopathology, Quality of Life, Sleep Apnea, Central therapy
Abstract

Aims: The presence of central sleep apnoea (CSA) is associated with poor prognosis in patients with heart failure (HF). The aim of this analysis was to evaluate if using phrenic nerve stimulation to treat CSA in patients with CSA and HF was associated with changes in HF-specific metrics., Methods and Results: All patients randomized in the remedē System Pivotal Trial and identified at baseline with HF were included (n = 96). Effectiveness data from treatment and former control groups were pooled based on months since therapy activation. Changes from baseline to 6 and 12 months in sleep metrics, Epworth Sleepiness Scale, patient global assessment health-related quality of life, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and echocardiographic parameters are reported. HF hospitalization, cardiovascular death, and the composite of HF hospitalization or cardiovascular death within 6 months are reported by the original randomized group assignment for safety assessment. Sleep metrics and quality of life improved from baseline to 6 and 12 months. At 12 months, MLHFQ scores changed by -6.8 ± 20.0 (P = 0.005). The 6-month rate of HF hospitalization was 4.7% in treatment patients (standard error = 3.3) and 17.0% in control patients (standard error = 5.5) (P = 0.065). Reported adverse events were as expected for a transvenous implantable system., Conclusions: Phrenic nerve stimulation reduces CSA severity in patients with HF. In parallel, this CSA treatment was associated with benefits on HF quality of life., (© 2018 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Published
2018
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14. Initiation and outcomes with Class Ic antiarrhythmic drug therapy.

Author

Gao X, Guha A, Buck B, Patel D, Snider MJ, Boyd M, Afzal M, Badin A, Godara H, Liu Z, Tyler J, Weiss R, Kalbfleisch S, Hummel J, Augostini R, Houmsse M, and Daoud EG

Abstract

Background: Expert opinion recommends performing exercise testing with initiation of Class Ic antiarrhythmic medication., Objective: To evaluate the rate and reason for discontinuation of Ic agent within the first year of follow up, with particular attention to rate of proarrhythmia and the value of routine treadmill testing., Methods: This is a single center retrospective cohort study including consecutive patients with atrial arrhythmias who were initiated on a Class Ic agent from 2011 to 2016. Data was collated from chart review and pharmacy database., Results: The study population included 300 patients (55% male, mean age 61; mean ejection fraction, 56%) started on flecainide (n = 153; 51%) and propafenone (n = 147; 49%). Drug initiation was completed while hospitalized on telemetry and the staff electrophysiologists directed dosing. There was one proarrhythmic event during initiation (0.3%). The primary reason for not being discharged on Ic agent was due to detection of proarrhythmia (n = 15) or ischemia (n = 1) with treadmill testing (5.3%). Exercise testing was the single significant variable to affect the decision to discontinue Ic drug, p < 0.0001 (95% CI: 1.89-6.08%). During follow up, the primary reason for discontinuation of Ic agent was lack of efficacy, 32%., Conclusions: With proper screening, initiation of Class Ic agent is associated with very low rate of proarrhythmia. Treadmill testing is of incremental value and should be completed in all patients after loading Class Ic antiarrhythmic., (Copyright © 2017 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.)

Published
2018
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15. Successful Denovo Implantation And Explanation Of An Old Malfunctioning Micratm Leadless Pacemaker.

Author

R Afzal M, Dar T, Houmsse M, Augostini R, Daoud EG, and Hummel J

Abstract

An unknown mass in the left atrium can be challenging to differentiate, especially after previous heart transplant. A precise diagnosis is clinically crucial because of the therapeutic implications. CMR is a useful, non-invasive tool to distinguish intra-cardiac lesions, thereby enabling clinicians to initiate adequate therapy.

Published
2017
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17. Identification of Repetitive Activation Patterns Using Novel Computational Analysis of Multielectrode Recordings During Atrial Fibrillation and Flutter in Humans.

Author

Daoud EG, Zeidan Z, Hummel JD, Weiss R, Houmsse M, Augostini R, and Kalbfleisch SJ

Subjects
Aged, Atrial Fibrillation physiopathology, Atrial Flutter physiopathology, Body Surface Potential Mapping instrumentation, Catheter Ablation adverse effects, Electrocardiography instrumentation, Electrodes, Implanted trends, Electrophysiologic Techniques, Cardiac, Feasibility Studies, Female, Heart Atria physiopathology, Heart Atria surgery, Humans, Male, Middle Aged, Pulmonary Veins physiopathology, Pulmonary Veins surgery, Reproducibility of Results, Software, Atrial Fibrillation surgery, Atrial Flutter surgery, Catheter Ablation methods, Electrodes, Implanted statistics & numerical data
Abstract

Objectives: The purpose of this study was to assess computational analysis of 64-electrode basket catheter (BC) recordings of atrial fibrillation (AF) and atrial flutter using novel software, CARTOFINDER (CF)., Background: Repetitive patterns have been recorded during AF and reported to be an important mechanism of AF. CF was used to identify rotational repetitive activation patterns (RAPs) in the right (RA) and left atrium (LA)., Methods: To assess for presence of RAPs, multiple 1-min BC maps of the RA and LA were obtained before and after radiofrequency ablation (RFA) around the pulmonary veins in 14 patients undergoing AF ablation. Validation of the CF algorithm was based on analysis of BC recordings of the cavotricuspid isthmus flutter., Results: There were 2.9 rotational RAPs per patient (1.3 RA; 1.6 LA). No RAPs were noted in 2 patients. RFA was delivered on top of (n = 10), within 5 mm (n = 5), or distant (n = 10) from any RAP. Reproducibility of the BC to identify the same RAP was 82%. Post-pulmonary vein (PV) isolation, there was a 45% reduction in RAP versus pre-RFA. CF was validated by 4 electrophysiologists blindly reviewing 32 RA CF maps. Electrophysiologists correctly categorized presence/absence of RAP in 122 of 128 maps (95%)., Conclusions: CF is novel software incorporated into CARTO that identifies rotational RAP in the RA and LA with 82% reproducibility. PV RFA results in 45% reduction of RAP, suggesting that RFA beyond PV isolation is required to eliminate the bulk of RAP. Electrophysiologists who were first-time users of CF could readily identify RAPs., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Published
2017
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18. Transvenous stimulation of the phrenic nerve for the treatment of central sleep apnoea: 12 months' experience with the remedē ® System.

Author

Jagielski D, Ponikowski P, Augostini R, Kolodziej A, Khayat R, and Abraham WT

Subjects
Adult, Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Male, Middle Aged, Oximetry, Pilot Projects, Polysomnography, Prospective Studies, Sleep Apnea, Central physiopathology, Sleep, REM, Treatment Outcome, Electric Stimulation Therapy methods, Phrenic Nerve, Sleep Apnea, Central therapy
Abstract

Aims: Patients with central sleep apnoea (CSA) often have poor quality of life and are at increased risk of morbidity and mortality. This study sought to evaluate the 12-month clinical outcomes of patients with CSA treated with unilateral transvenous phrenic nerve stimulation in the prospective, multicentre, non-randomized remedē ® System pilot study., Methods and Results: Forty-seven patients with CSA were treated with the remedē ® System (Respicardia Inc., Minnetonka, MN, USA) for a minimum of 3 months. Sleep-disordered breathing parameters were evaluated by polysomnography (PSG) at 3, 6, and 12-month follow-up. Sleep symptoms and quality of life were also evaluated. Forty-one patients completed all follow-up PSGs and were included in the analysis. At 12 months, there was sustained improvement compared with baseline in the apnoea-hypopnoea index (49.9 ± 15.1 vs. 27.5 ± 18.3 events/h, P < 0.001) and central apnoea index (28.2 ± 15.0 vs. 6.0 ± 9.2 events/h, P < 0.001). Sustained improvement in the oxygen desaturation index (46.1 ± 19.1 vs. 26.9 ± 18.0 events/h, P < 0.001), rapid eye movement sleep (11.4 ± 6.1% vs. 17.1 ± 8.0%, P < 0.001), and sleep efficiency (69.3 ± 16.9% vs. 75.6 ± 17.1%, P = 0.024) were also observed. There were also continued favourable effects on sleepiness and quality of life. Three deaths unrelated to remedē ® System therapy and five serious adverse events occurred over 12 months of follow-up., Conclusion: The present study demonstrates that in patients with CSA, unilateral transvenous phrenic nerve stimulation is associated with sustained improvement in key sleep parameters, sleep symptoms, and quality of life over 12 months of follow-up., (© 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.)

Published
2016
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19. Phrenic nerve stimulation for the treatment of central sleep apnea.

Author

Abraham WT, Jagielski D, Oldenburg O, Augostini R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Harsch MR, Holcomb RG, Javaheri S, and Ponikowski P

Subjects
Aged, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Phrenic Nerve, Polysomnography, Prospective Studies, Sleep Apnea, Central physiopathology, Treatment Outcome, Quality of Life, Sleep physiology, Sleep Apnea, Central therapy, Transcutaneous Electric Nerve Stimulation methods
Abstract

Objectives: The aim of this study was to evaluate chronic, transvenous, unilateral phrenic nerve stimulation to treat central sleep apnea (CSA) in a prospective, multicenter, nonrandomized study., Background: CSA occurs predominantly in patients with heart failure and increases the risk for morbidity and mortality. Established therapies for CSA are lacking, and those available are limited by poor patient adherence., Methods: Fifty-seven patients with CSA underwent baseline polysomnography followed by transvenous phrenic nerve stimulation system implantation and follow-up. Feasibility was assessed by implantation success rate and therapy delivery. Safety was evaluated by monitoring of device- and procedure-related adverse events. Efficacy was evaluated by changes in the apnea-hypopnea index at 3 months. Quality of life at 6 months was evaluated using a sleepiness questionnaire, patient global assessment, and, in patients with heart failure at baseline, the Minnesota Living With Heart Failure Questionnaire., Results: The study met its primary end point, demonstrating a 55% reduction in apnea-hypopnea index from baseline to 3 months (49.5 ± 14.6 episodes/h vs. 22.4 ± 13.6 episodes/h of sleep; p < 0.0001; 95% confidence interval for change: -32.3 to -21.9). Central apnea index, oxygenation, and arousals significantly improved. Favorable effects on quality of life and sleepiness were noted. In patients with heart failure, the Minnesota Living With Heart Failure Questionnaire score significantly improved. Device- or procedure-related serious adverse events occurred in 26% of patients through 6 months post therapy initiation, predominantly due to lead repositioning early in the study. Therapy was well tolerated. Efficacy was maintained at 6 months., Conclusions: Transvenous, unilateral phrenic nerve stimulation appears safe and effective for treating CSA. These findings should be confirmed in a prospective, randomized, controlled trial. (Chronic Evaluation of Respicardia Therapy; NCT01124370)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Published
2015
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20. Mechanisms and clinical consequences of untreated central sleep apnea in heart failure.

Author

Costanzo MR, Khayat R, Ponikowski P, Augostini R, Stellbrink C, Mianulli M, and Abraham WT

Subjects
Brain blood supply, Cardiac Output, Comorbidity, Disease Progression, Electric Stimulation Therapy, Endothelium, Vascular physiopathology, Humans, Hyperventilation physiopathology, Oxidative Stress physiology, Phrenic Nerve physiology, Polysomnography, Quality of Life, Regional Blood Flow, Risk Factors, Severity of Illness Index, Sleep Apnea, Central epidemiology, Theophylline therapeutic use, Vasodilator Agents therapeutic use, Heart Failure epidemiology, Sleep Apnea, Central physiopathology
Abstract

Central sleep apnea (CSA) is a highly prevalent, though often unrecognized, comorbidity in patients with heart failure (HF). Data from HF population studies suggest that it may present in 30% to 50% of HF patients. CSA is recognized as an important contributor to the progression of HF and to HF-related morbidity and mortality. Over the past 2 decades, an expanding body of research has begun to shed light on the pathophysiologic mechanisms of CSA. Armed with this growing knowledge base, the sleep, respiratory, and cardiovascular research communities have been working to identify ways to treat CSA in HF with the ultimate goal of improving patient quality of life and clinical outcomes. In this paper, we examine the current state of knowledge about the mechanisms of CSA in HF and review emerging therapies for this disorder., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Published
2015
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21. Impact of international normalized ratio and activated clotting time on unfractionated heparin dosing during ablation of atrial fibrillation.

Author

Hamam I, Daoud EG, Zhang J, Kalbfleisch SJ, Augostini R, Winner M, Tsai S, Rhodes TE, Houmsse M, Liu Z, Love CJ, Tyler J, Sachdev M, Weiss R, and Hummel JD

Subjects
Adult, Aged, Atrial Fibrillation diagnosis, Catheter Ablation adverse effects, Cohort Studies, Dose-Response Relationship, Drug, Electrocardiography methods, Female, Follow-Up Studies, Humans, Intraoperative Care methods, Male, Middle Aged, Multivariate Analysis, Regression Analysis, Retrospective Studies, Risk Assessment, Time Factors, Treatment Outcome, Atrial Fibrillation drug therapy, Atrial Fibrillation surgery, Blood Coagulation drug effects, Catheter Ablation methods, Heparin administration & dosage, International Normalized Ratio
Abstract

Background: For ablation of atrial fibrillation, it is unclear how baseline international normalized ratio (INR) affects the dosing of unfractionated heparin (UFH)., Methods and Results: A retrospective review of 170 consecutive patients undergoing atrial fibrillation ablation with baseline activated clotting time (ACT) and INR values was performed. Patients were grouped according to INR <2.0 (G<2; n=129) and INR ≥2.0 (G≥2; n=41). Clinical variables, UFH doses, and ACT values were recorded. An equation was derived to calculate the first bolus of UFH required to achieve an ACT ≥300 seconds, and this was subsequently assessed in 168 patients. For the initial 170 patients, the baseline INR (2.47±0.31 versus 1.53±0.31) and ACT (185±26 versus 153±30 seconds) were significantly greater in G≥2 (P<0.001). The amount of UFH to achieve the first ACT ≥300 seconds was significantly higher for G<2 versus G≥2 (9701±2390 versus 8268±2366 U; P=0.0001). Baseline INR, ACT, and weight were predictors of the UFH dosage to achieve an ACT ≥300 seconds. An equation derived to achieve an ACT ≥300 seconds after a single bolus of UFH met this end point in 160 of 168 patients (95%)., Conclusions: Baseline INR and ACT, in addition to weight, are the only predictors of UFH dosage needed to achieve an ACT ≥300 seconds. A derived equation predicted the UFH dosage to achieve an ACT ≥300 seconds.

Published
2013
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22. Transvenous phrenic nerve stimulation for the treatment of central sleep apnoea in heart failure.

Author

Ponikowski P, Javaheri S, Michalkiewicz D, Bart BA, Czarnecka D, Jastrzebski M, Kusiak A, Augostini R, Jagielski D, Witkowski T, Khayat RN, Oldenburg O, Gutleben KJ, Bitter T, Karim R, Iber C, Hasan A, Hibler K, Germany R, and Abraham WT

Subjects
Aged, Arousal physiology, Feasibility Studies, Female, Humans, Male, Middle Aged, Oxygen blood, Phrenic Nerve, Polysomnography, Prospective Studies, Sleep Apnea, Obstructive complications, Treatment Outcome, Electric Stimulation Therapy methods, Heart Failure complications, Sleep Apnea, Obstructive therapy
Abstract

Aims: Periodic breathing with central sleep apnoea (CSA) is common in heart failure patients and is associated with poor quality of life and increased risk of morbidity and mortality. We conducted a prospective, non-randomized, acute study to determine the feasibility of using unilateral transvenous phrenic nerve stimulation for the treatment of CSA in heart failure patients., Methods and Results: Thirty-one patients from six centres underwent attempted transvenous lead placement. Of these, 16 qualified to undergo two successive nights of polysomnography-one night with and one night without phrenic nerve stimulation. Comparisons were made between the two nights using the following indices: apnoea-hypopnoea index (AHI), central apnoea index (CAI), obstructive apnoea index (OAI), hypopnoea index, arousal index, and 4% oxygen desaturation index (ODI4%). Patients underwent phrenic nerve stimulation from either the right brachiocephalic vein (n = 8) or the left brachiocephalic or pericardiophrenic vein (n = 8). Therapy period was (mean ± SD) 251 ± 71 min. Stimulation resulted in significant improvement in the AHI [median (inter-quartile range); 45 (39-59) vs. 23 (12-27) events/h, P = 0.002], CAI [27 (11-38) vs. 1 (0-5) events/h, P≤ 0.001], arousal index [32 (20-42) vs. 12 (9-27) events/h, P = 0.001], and ODI4% [31 (22-36) vs. 14 (7-20) events/h, P = 0.002]. No significant changes occurred in the OAI or hypopnoea index. Two adverse events occurred (lead thrombus and episode of ventricular tachycardia), though neither was directly related to phrenic nerve stimulation therapy., Conclusion: Unilateral transvenous phrenic nerve stimulation significantly reduces episodes of CSA and restores a more natural breathing pattern in patients with heart failure. This approach may represent a novel therapy for CSA and warrants further study.

Published
2012
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23. Ineffectiveness and potential proarrhythmia of atrial pacing for atrial fibrillation prevention after coronary artery bypass grafting.

Author

Chung MK, Augostini RS, Asher CR, Pool DP, Grady TA, Zikri M, Buehner SM, Weinstock M, and McCarthy PM

Subjects
Adrenergic beta-Antagonists therapeutic use, Aged, Atrial Fibrillation etiology, Coronary Disease surgery, Feasibility Studies, Female, Humans, Male, Middle Aged, Prospective Studies, Atrial Fibrillation prevention & control, Cardiac Pacing, Artificial, Coronary Artery Bypass adverse effects
Abstract

Background: Atrial pacing is often used empirically to suppress atrial ectopy and prevent atrial fibrillation after coronary artery bypass grafting., Methods: To determine whether atrial overdrive pacing reduces atrial fibrillation and atrial ectopy after coronary artery bypass grafting, 100 patients were randomized to no atrial pacing (Control) versus AAI pacing at 10 beats/min or more above the resting heart rate (Paced), started by postoperative day 1 and continued through day 4. Major end points were new atrial fibrillation and frequency of atrial ectopy during the first 4 days after coronary artery bypass grafting., Results: Atrial fibrillation occurred by day 4 in 13 of 51 (25.5%) Paced and in 14 of 49 (28.6%) Control patients, p = 0.90. Control patients who developed atrial fibrillation had significantly more atrial ectopy than those who did not. Atrial ectopy was paradoxically more frequent in the Paced group (2,106+/-428 versus 866+/-385 per 24 hours, p = 0.0001). Loss of capture, sensing, and consistent atrial pacing occurred frequently during atrial pacing., Conclusions: Contrary to prevailing opinion and practice, postoperative atrial overdrive pacing significantly increases atrial ectopy and does not reduce the likelihood of atrial fibrillation.

Published
2000
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24. Higher energy synchronized external direct current cardioversion for refractory atrial fibrillation.

Author

Saliba W, Juratli N, Chung MK, Niebauer MJ, Erdogan O, Trohman R, Wilkoff BL, Augostini R, Mowrey KA, Nadzam GR, and Tchou PJ

Subjects
Adult, Aged, Atrial Fibrillation diagnosis, Atrial Fibrillation physiopathology, Echocardiography, Electrocardiography, Female, Heart Rate, Humans, Male, Middle Aged, Radionuclide Ventriculography, Recurrence, Retrospective Studies, Stroke Volume, Treatment Outcome, Atrial Fibrillation therapy, Electric Countershock methods
Abstract

Objectives: We sought to evaluate the safety and efficacy of higher energy synchronized cardioversion in patients with atrial fibrillation refractory to standard energy direct current (DC) cardioversion., Background: Standard external electrical cardioversion fails to restore sinus rhythm in 5% to 30% of patients with atrial fibrillation., Methods: Patients with atrial fibrillation who failed to achieve sinus rhythm after at least two attempts at standard external cardioversion with 360 J were included in the study. Two external defibrillators, each connected to its own pair of R-2 patches in the anteroposterior position, were used to deliver a synchronized total of 720 J., Results: Fifty-five patients underwent cardioversion with 720 J. Mean weight was 117 +/- 23 kg (body mass index 48.3 +/- 4.1 kg/m2). Structural heart disease was present in 76% of patients. Mean left ventricular ejection fraction was 45 +/- 12%. Atrial fibrillation was present for over three months in 55% of the patients. Sinus rhythm was achieved in 46 (84%) of the 55 patients. No major complications were observed. No patient developed hemodynamic compromise and no documented cerebrovascular accident occurred within one month after cardioversion. Of the 46 successful cardioversions, 18 patients (39%) remained in sinus rhythm over a mean follow-up of 2.1 months., Conclusions: External higher energy cardioversion is effective in restoring sinus rhythm in patients with atrial fibrillation refractory to standard energy DC cardioversion. This method is safe and does not result in clinical evidence of myocardial impairment. It may be a useful alternative to internal cardioversion because it could be done within the same setting of the failed standard cardioversion and obviates the need to withhold protective anticoagulation for internal cardioversion.

Published
1999
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