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3. Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry

Author

Helge Möllmann, MD, Axel Linke, MD, Luis Nombela-Franco, MD, Martin Sluka, MD, Juan Francisco Oteo Dominguez, MD, Matteo Montorfano, MD, Won-Keun Kim, MD, Martin Arnold, MD, Mariuca Vasa-Nicotera, MD, Stephan Fichtlscherer, MD, Lenard Conradi, MD, Anthony Camuglia, MD, Francesco Bedogni, MD, Keshav Kohli, PhD, and Ganesh Manoharan, MD

Subjects
Aortic stenosis, Self-expanding, TAVI, TAVR, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: The CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. Methods: This was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. Results: We enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). Conclusions: The Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. ClinicalTrials.gov Identifier: NCT03752866.

Published
2024
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5. The Global Retinoblastoma Outcome Study: a prospective, cluster-based analysis of 4064 patients from 149 countries

Author

Fabian, Ido Didi, Abdallah, Elhassan, Abdullahi, Shehu U, Abdulqader, Rula A, Abdulrahaman, Aminatu A, Abouelnaga, Sherif, Ademola-Popoola, Dupe S, Adio, Adedayo, Afifi, Mahmoud A, Afshar, Armin R, Aggarwal, Priyanka, Aghaji, Ada E, Ahmad, Alia, Akib, Marliyanti NR, Akinsete, Adeseye, Al Harby, Lamis, Al Mesfer, Saleh, Al Ani, Mouroge H, Alarcón Portabella, Silvia, Al-Badri, Safaa AF, Alcasabas, Ana Patricia A, Al-Dahmash, Saad A, Alejos, Amanda, Alemany-Rubio, Ernesto, Alfa Bio, Amadou I, Alfonso Carreras, Yvania, Al-Haddad, Christiane E, Al-Hussaini, Hamoud HY, Ali, Amany M, Alia, Donjeta B, Al-Jadiry, Mazin F, Al-Jumaily, Usama, Alkatan, Hind M, All-Eriksson, Charlotta, Al-Mafrachi, Ali ARM, Almeida, Argentino A, Alsawidi, Khalifa M, Al-Shaheen, Athar ASM, Al-Shammary, Entissar H, Amankwaa-Frempong, Doreen, Amiruddin, Primawita O, Armytasari, Inggar, Astbury, Nicholas J, Atalay, Hatice T, Ataseven, Eda, Atchaneeyasakul, La-ongsri, Atsiaya, Rose, Autrata, Rudolf, Balaguer, Julia, Balayeva, Ruhengiz, Barranco, Honorio, Bartoszek, Paulina, Bartuma, Katarina, Bascaran, Covadonga, Bechrakis, Nikolaos E, Beck Popovic, Maja, Begimkulova, Ainura S, Benmiloud, Sarra, Berete, Rokia C, Berry, Jesse L, Bhaduri, Anirban, Bhat, Sunil, Bhattacharyya, Arpita, Biewald, Eva M, Binkley, Elaine, Blum, Sharon, Bobrova, Nadia, Boldt, H.C., Bonanomi, Maria Teresa BC, Bouda, Gabrielle C, Bouguila, Hédi, Brennan, Rachel C, Brichard, Bénédicte G, Buaboonnam, Jassada, Budiongo, Aléine, Burton, Matthew J, Calderón-Sotelo, Patricia, Calle Jara, Doris A, Camuglia, Jayne E, Cano, Miriam R, Capra, Michael, Caspi, Shani, Cassoux, Nathalie, Castela, Guilherme, Castillo, Luis, Català-Mora, Jaume, Cavieres, Isabel, Chandramohan, Arthika, Chantada, Guillermo L, Chaudhry, Shabana, Chawla, Bhavna, Chen, Wensi, Chiwanga, Faraja S, Chuluunbat, Tsengelmaa, Cieslik, Krzysztof, Clark, Antony, Cockcroft, Ruellyn L, Comsa, Codruta, Correa Llano, Maria G, Corson, Timothy W, Couitchere, Line, Cowan-Lyn, Kristin E, Csóka, Monika, Dangboon, Wantanee, Das, Anirban, Das, Pranab, Das, Sima, Davanzo, Jacquelyn M, Davidson, Alan, De Francesco, Sonia, De Potter, Patrick, Quintero D, Karina, Demirci, Hakan, Desjardins, Laurence, Díaz Coronado, Rosdali Y, Dimaras, Helen, Dodgshun, Andrew J, Donato Macedo, Carla R, Dragomir, Monica D, Du, Yi, Du Bruyn, Magritha, Du Plessis, Johannes, Dudeja, Gagan, Eerme, Katrin, Eka Sutyawan, I Wayan, El Kettani, Asmaa, Elbahi, Amal M, Elder, James E, Elhaddad, Alaa M, Elhassan, Moawia MA, Elzembely, Mahmoud M, Ericksen, Connor, Essuman, Vera A, Evina, Ted Grimbert A, Ezegwui, Ifeoma R, Fadoo, Zehra, Fandiño, Adriana C, Faranoush, Mohammad, Fasina, Oluyemi, Fernández, Delia DPG, Fernández-Teijeiro, Ana, Foster, Allen, Frenkel, Shahar, Fu, Ligia D, Fuentes-Alabi, Soad L, Garcia, Juan L, García Aldana, David, Garcia Pacheco, Henry N, Geel, Jennifer A, Ghassemi, Fariba, Girón, Ana V, Goenz, Marco A, Gold, Aaron S, Goldberg, Hila, Gole, Glen A, Gomel, Nir, Gonzalez, Efren, Gonzalez Perez, Graciela, González-Rodríguez, Liudmira, Gorfine, Malka, Graells, Jaime, Gregersen, Pernille A, Grigorovski, Nathalia DAK, Guedenon, Koffi M, Gunasekera, D Sanjeeva, Gündüz, Ahmet K, Gupta, Himika, Gupta, Sanjiv, Gupta, Vineeta, Hadjistilianou, Theodora, Hamel, Patrick, Hamid, Syed A, Hamzah, Norhafizah, Hansen, Eric D, Harbour, J William, Hartnett, M. Elizabeth, Hasanreisoglu, Murat, Muhammad, Hassan, Hassan, Sadiq, Hassan, Shadab, Hautz, Wojciech, Haydar, Huda, Hederova, Stanislava, Hessissen, Laila, Hongeng, Suradej, Hordofa, Diriba F, Hubbard, G. Baker, Hummelen, Marlies, Husakova, Kristina, Hussein Al-Janabi, Allawi N, Ibanga, Affiong, Ida, Russo, Ilic, Vesna R, Islamov, Ziyavuddin, Jairaj, Vivekaraj, Janjua, Teyyeb, Jeeva, Irfan, Ji, Xunda, Jo, Dong Hyun, Jones, Michael M, Kabesha Amani, Theophile B, Kabore, Rolande L, Kaliki, Swathi, Kalinaki, Abubakar, Kamsang, Pius, Kantar, Mehmet, Kapelushnik, Noa, Kardava, Tamar, Kebudi, Rejin, Keomisy, Jonny, Kepak, Tomas, Ketteler, Petra, Khan, Zohora J, Khaqan, Hussain A, Khetan, Vikas, Khodabande, Alireza, Khotenashvili, Zaza, Kim, Jonathan W, Kim, Jeong Hun, Kiratli, Hayyam, Kivela, Tero T., Klett, Artur, Koç, Irem, Kosh Komba Palet, Jess Elio, Krivaitiene, Dalia, Kruger, Mariana, Kulvichit, Kittisak, Kuntorini, Mayasari W, Kyara, Alice, Lam, Geoffrey C, Larson, Scott A, Latinović, Slobodanka, Laurenti, Kelly D, Lavy, Yotam, Lavric Groznik, Alenka, Leverant, Amy A, Li, Cairui, Li, Kaijun, Limbu, Ben, Liu, Chun-Hsiu, Quah, BoonLong, López, Juan P, Lukamba, Robert M, Luna-Fineman, Sandra, Lutfi, Delfitri, Lysytsia, Lesia, Madgar, Shiran, Magrath, George N, Mahajan, Amita, Maitra, Puja, Maka, Erika, Makimbetov, Emil K, Maktabi, Azza, Maldonado, Carlos, Mallipatna, Ashwin, Manudhane, Rebecca, Manzhuova, Lyazat, Martín-Begue, Nieves, Masud, Sidra, Matende, Ibrahim O, Mattosinho, Clarissa CDS, Matua, Marchelo, Mayet, Ismail, Mbumba, Freddy B, McKenzie, John D, Mehrvar, Azim, Mengesha, Aemero A, Menon, Vikas, Mercado, Gary John V, Mets, Marilyn B, Midena, Edoardo, Miller, Audra, Mishra, Divyansh KC, Mndeme, Furahini G, Mohamedani, Ahmed A, Mohammad, Mona T, Moll, Annette C, Montero, Margarita M, Moreira, Claude, Mruthyunjaya, Prithvi, Msina, Mchikirwa S, Msukwa, Gerald, Mudaliar, Sangeeta S, Muma, Kangwa I M, Munier, Francis L, Murray, Timothy G, Musa, Kareem O, Mushtaq, Asma, Musika, Anne A, Mustak, Hamzah, Mustapha, Tajudeen, Muyen, Okwen M, Myezo, Khumo H, Naidu, Gita, Naidu, Natasha, Nair, Akshay Gopinathan, Natarajan, Sundaram, Naumenko, Larisa, Ndoye Roth, Paule Aïda, Nency, Yetty M, Neroev, Vladimir, Ng, Yvonne, Nikitovic, Marina, Nkanga, Elizabeth D, Nkumbe, Henry E, Numbi, Marcel N, Nummi, Kalle, Nuruddin, Murtuza, Nyaywa, Mutale, Nyirenda, Chinsisi, Obono-Obiang, Ghislaine, Oliver, Scott CN, Oporto, Joaquin, Ortega-Hernández, Miriam, Oscar, Alexander H, Ossandon, Diego, Pagarra, Halimah, Paintsil, Vivian, Paiva, Luisa, Palanivelu, Mahesh Shanmugam, Papyan, Ruzanna, Parrozzani, Raffaele, Pascual Morales, Claudia R, Paton, Katherine E, Pe'er, Jacob, Peralta Calvo, Jesús, Perić, Sanja, Pham, Chau TM, Philbert, Remezo, Plager, David A, Pochop, Pavel, Polania, Rodrigo A., Polyakov, Vladimir, Ponce, Jimena, Qadir, Ali O, Qayyum, Seema, Qian, Jiang, Refaeli, David, Rahman, Ardizal, Rajkarnikar, Purnima, Ramanjulu, Rajesh, Ramasubramanian, Aparna, Ramirez-Ortiz, Marco A, Randhawa, Jasmeen K, Randrianarisoa, Hoby Lalaina, Raobela, Léa, Rashid, Riffat, Reddy, M.A., Renner, Lorna A, Reynders, David, Ribadu, Dahiru, Ritter-Sovinz, Petra, Rogowska, Anna, Rojanaporn, Duangnate, Romero, Livia, Roy, Soma R, Saab, Raya H, Saakyan, Svetlana, Sabhan, Ahmed H, Sagoo, Mandeep S, Said, Azza MA, Saiju, Rohit, Salas, Beatriz, San Román Pacheco, Sonsoles, Sánchez, Gissela L, Sanchez Orozco, Alma Janeth, Sayalith, Phayvanh, Scanlan, Trish A, Schlüter, Sabrina, Schwab, Christoph, Sedaghat, Ahad, Seth, Rachna, Sgroi, Mariana, Shah, Ankoor S, Shakoor, Shawkat A, Sharma, Manoj K, Sherief, Sadik T, Shields, Carol L, Sia, David, Siddiqui, Sorath Noorani, Sidi cheikh, Sidi, Silva, Sónia, Singh, Arun D, Singh, Usha, Singha, Penny, Sitorus, Rita S, Skalet, Alison H, Soebagjo, Hendrian D, Sorochynska, Tetyana, Ssali, Grace, Stacey, Andrew W, Staffieri, Sandra E, Stahl, Erin D, Steinberg, David M, Stones, David K, Strahlendorf, Caron, Suarez, Maria Estela Coleoni, Sultana, Sadia, Sun, Xiantao, Superstein, Rosanne, Supriyadi, Eddy, Surukrattanaskul, Supawan, Suzuki, Shigenobu, Svojgr, Karel, Sylla, Fatoumata, Tamamyan, Gevorg, Tan, Deborah, Tandili, Alketa, Tang, Jing, Tarrillo Leiva, Fanny F, Tashvighi, Maryam, Tateshi, Bekim, Teh, Kok Hoi, Tehuteru, Edi S, Teixeira, Luiz F, Tekavcic Pompe, Manca, Thawaba, Abdullah Dahan M, Theophile, Tuyisabe, Toledano, Helen, Trang, Doan L, Traoré, Fousseyni, Tripathy, Devjyoti, Tuncer, Samuray, Tyau-Tyau, Harba, Umar, Ali B, Unal, Emel, Uner, Ogul E, Urbak, Steen F, Ushakova, Tatiana L, Usmanov, Rustam H, Valeina, Sandra, Valente, Paola, van Hoefen Wijsard, Milo, Vasquez Anchaya, Jacqueline Karina, Vaughan, Leon O, Veleva-Krasteva, Nevyana V, Verma, Nishant, Victor, Andi A, Viksnins, Maris, Villacís Chafla, Edwin G, Villegas, Victor M, Vishnevskia-Dai, Victoria, Waddell, Keith, Wali, Amina H, Wang, Yi-Zhuo, Wangtiraumnuay, Nutsuchar, Wetter, Julie, Widiarti, Widiarti, Wilson, Matthew W, Wime, Amelia DC, Wiwatwongwana, Atchareeya, Wiwatwongwana, Damrong, Wolley Dod, Charlotte, Wong, Emily S, Wongwai, Phanthipha, Wu, Si-qi, Xiang, Daoman, Xiao, Yishuang, Xu, Bing, Xue, Kang, Yaghy, Antonio, Yam, Jason C, Yang, Huasheng, Yanga, Jenny M, Yaqub, Muhammad A, Yarovaya, Vera A, Yarovoy, Andrey A, Ye, Huijing, Yee, Roberto I, Yousef, Yacoub A, Yuliawati, Putu, Zapata López, Arturo M, Zein, Ekhtelbenina, Zhang, Yi, Zhilyaeva, Katsiaryna, Zia, Nida, Ziko, Othman AO, Zondervan, Marcia, and Bowman, Richard

Published
2022
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6. First‐in‐human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve‐in‐valve transcatheter aortic valve replacement.

Author

Mew, Christina, Dahiya, Arun, Chong, Adrian A., Hayman, Samual M., Moore, Peter T., Harrop, Danielle L., Reyaldeen, Reza, Cole, Christopher M. W., Ross, Jordan D. W., Roberts, Shaun, Korver, Kellee A., Cox, Stephen V., and Camuglia, Anthony C.

Published
2024
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9. Low content of clonogenic progenitors on day+18 is associated with acute graft-versus-host disease and predicts transplant-related mortality

Author

Milone, Giuseppe, Scirè, Paola, Camuglia, Maria Grazia, Triolo, Anna, Moschetti, Gaetano, Scuderi, Maria Grazia, Cupri, Alessandra, Milone, Giulio Antonio, Bulla, Anna, Giorgio, Mary Ann Di, Leotta, Valerio, Curtopelle, Angelo, Sciortino, Roberta, Parrinello, Laura, Crocchiolo, Roberto, and Leotta, Salvatore

Published
2021
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10. Morphogenetic forces planar polarize LGN/Pins in the embryonic head during Drosophila gastrulation

Author

Jaclyn Camuglia, Soline Chanet, and Adam C Martin

Subjects
spindle orientation, mechanics, morphogenesis, adherens junctions, Pins/LGN, Drosophila, Medicine, Science, Biology (General), QH301-705.5
Abstract

Spindle orientation is often achieved by a complex of Partner of Inscuteable (Pins)/LGN, Mushroom Body Defect (Mud)/Nuclear Mitotic Apparatus (NuMa), Gαi, and Dynein, which interacts with astral microtubules to rotate the spindle. Cortical Pins/LGN recruitment serves as a critical step in this process. Here, we identify Pins-mediated planar cell polarized divisions in several of the mitotic domains of the early Drosophila embryo. We found that neither planar cell polarity pathways nor planar polarized myosin localization determined division orientation; instead, our findings strongly suggest that Pins planar polarity and force generated from mesoderm invagination are important. Disrupting Pins polarity via overexpression of a myristoylated version of Pins caused randomized division angles. We found that disrupting forces through chemical inhibitors, depletion of an adherens junction protein, or blocking mesoderm invagination disrupted Pins planar polarity and spindle orientation. Furthermore, directional ablations that separated mesoderm from mitotic domains disrupted spindle orientation, suggesting that forces transmitted from mesoderm to mitotic domains can polarize Pins and orient division during gastrulation. To our knowledge, this is the first in vivo example where mechanical force has been shown to polarize Pins to mediate division orientation.

Published
2022
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11. The metabolic hormone leptin promotes the function of TFH cells and supports vaccine responses

Author

Jun Deng, Qian Chen, Zhian Chen, Kaili Liang, Xin Gao, Xiaohui Wang, Fadzai V. Makota, Hong Sheng Ong, Yanmin Wan, Kaiming Luo, Dongcheng Gong, Xiang Yu, Sarina Camuglia, Qunxiong Zeng, Tao Zhou, Feng Xue, Jing He, Yunbo Wei, Fan Xiao, Jianyang Ma, Danika L. Hill, Wim Pierson, Thi H. O. Nguyen, Haibo Zhou, Yan Wang, Wei Shen, Lingyun Sun, Zhanguo Li, Qiang Xia, Kun Qian, Lilin Ye, Steven Rockman, Michelle A. Linterman, Katherine Kedzierska, Nan Shen, Liwei Lu, and Di Yu

Subjects
Science
Abstract

T follicular helper (TFH) cell numbers are increased after vaccination and fewer of these cells might result in reduced vaccine responses. Here the authors show in mice and humans that leptin promotes TFH differentiation and that low leptin levels can impair TFH response to vaccines and virus protection in mice.

Published
2021
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13. Intra-arterial chemotherapy for retinoblastoma in Australia: 11-year experience

Author

Jiao, Yuanzhang, primary, O'Day, Roderick, additional, Mathew, Anu, additional, Elder, James, additional, McKenzie, John, additional, Sullivan, MIchael, additional, Campbell, Marty, additional, Mitchell, Peter, additional, Vrazas, John, additional, Bekhit, Elhamy, additional, Gole, Glen, additional, Jones, Michael, additional, Camuglia, Jayne, additional, Sia, David, additional, White, Jaclyn, additional, and Staffieri, Sandra, additional

Published
2024
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14. The metabolic hormone leptin promotes the function of TFH cells and supports vaccine responses

Author

Deng, Jun, Chen, Qian, Chen, Zhian, Liang, Kaili, Gao, Xin, Wang, Xiaohui, Makota, Fadzai V., Ong, Hong Sheng, Wan, Yanmin, Luo, Kaiming, Gong, Dongcheng, Yu, Xiang, Camuglia, Sarina, Zeng, Qunxiong, Zhou, Tao, Xue, Feng, He, Jing, Wei, Yunbo, Xiao, Fan, Ma, Jianyang, Hill, Danika L., Pierson, Wim, Nguyen, Thi H. O., Zhou, Haibo, Wang, Yan, Shen, Wei, Sun, Lingyun, Li, Zhanguo, Xia, Qiang, Qian, Kun, Ye, Lilin, Rockman, Steven, Linterman, Michelle A., Kedzierska, Katherine, Shen, Nan, Lu, Liwei, and Yu, Di

Published
2021
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18. Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry

Author

Möllmann, Helge, primary, Linke, Axel, additional, Nombela-Franco, Luis, additional, Sluka, Martin, additional, Francisco Oteo Dominguez, Juan, additional, Montorfano, Matteo, additional, Kim, Won-Keun, additional, Arnold, Martin, additional, Vasa-Nicotera, Mariuca, additional, Fichtlscherer, Stephan, additional, Conradi, Lenard, additional, Camuglia, Anthony, additional, Bedogni, Francesco, additional, Kohli, Keshav, additional, and Manoharan, Ganesh, additional

Published
2023
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19. 30-Day Outcomes With the Portico Transcatheter Heart Valve: Insights From a Multi-Centre Australian Observational Study

Author

Anthony C. Camuglia, Christopher M.W. Cole, Nicholas Boyne, Sam M. Hayman, Stephen V. Cox, Peter T. Moore, Jerrett K. Lau, Sinny Delacroix, Anna Emilie Williamson, MyNgan Duong, Nisha Schwarz, Joseph K. Montarello, and Stephen G. Worthley

Subjects
Pulmonary and Respiratory Medicine, Cardiology and Cardiovascular Medicine
Abstract

Transcatheter aortic valve implantation (TAVI) is an established therapy for the treatment of aortic valve disease in appropriately selected patients. Previous studies using the self-expanding Portico transcatheter heart valve (THV), (Abbott Structural Heart, St Paul, MN, USA) have demonstrated the technical feasibility of this system albeit in the hands of relatively inexperienced Portico users. The objective of this study was to assess the real-world safety and efficacy of the Portico THV (with and without the FlexNav delivery system, Abbott Structural Heart) at the 30-day timepoint in an Australian cohort.This study was a retrospective real-world cohort analysis of 269 consecutive patients with severe aortic valve disease who underwent TAVI at multiple centres within Australia between February 2015 and April 2021. Of the 269 patients, 51.7% were female, mean Society of Thoracic Surgeons (STS) score was 5.2 (±6.8) and 98.5% had successful implantations. Thirty (30)-day post-implantation all-cause mortality was observed in one (0.4%) patient, major vascular complications in two (0.7%) patients, more-than-mild paravalvular leak in six (2.2%) patients and requirement for new permanent pacemaker implantation in 27 (10.2%) patients. Haemodynamic parameters at 30 days included mean effective orifice area (EOA) of 2.3 (±0.9) cmThis analysis of the Portico THV in a real-world setting suggested that the system is associated with satisfactory safety and efficacy parameters. Previously published datasets may not have found similar findings owing to lower operator experience with the Portico THV system.

Published
2023

21. The Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions

Author

William T. Peverill, Alexander Incani, Stephen G. Worthley, Yash Singbal, Paul J. Garrahy, Andrew B. McCann, Stephen V. Cox, Peter T. Moore, Richard Y.Y. Lim, Taufik Fetahovic, Gerard W. Connors, Cindy Hall, Charmaine Sieg, and Anthony C. Camuglia

Subjects
Percutaneous Coronary Intervention (PCI), Stenting technique (STEC), Drug Eluting Stent (DES), Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: The present study is a prospective observational single arm clinical investigation, with parallel bench test interrogation, aimed at investigating the technical feasibility, safety and clinical outcomes with the cone flare crush modified-T (CFCT) bifurcation stenting technique. Bifurcation percutaneous coronary intervention (PCI) remains an area of ongoing procedural evolution. More widely applicable and reproducible techniques are required. Methods: From April 2018 until March 2019, 20 consecutive patients underwent bifurcation PCI using the CFCT technique with a Pt-Cr everolimus drug-eluting stent with a bioresorbable polymer. Exercise stress echocardiography was performed at 12-month follow-up. The primary outcome was a composite of cardiac related mortality, myocardial infarction, target lesion/vessel revascularization and stroke. Safety secondary endpoints included bleeding, all-cause mortality and stent thrombosis. Results: All patients underwent a successful CFCT bifurcation procedure with no complications to 30-day follow-up. One patient met the primary endpoint requiring target lesion revascularization at 9 months for stable angina. There were no other primary or secondary outcome events in the cohort. There were no strokes, deaths, stent thrombosis or myocardial infarction during the follow-up period. The mean CCS score improved from 2.25 to 0.25 (p

Published
2020
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22. Preliminary Results of a Combined Score Based on sIL2-Rα and TIM-3 Levels Assayed Early After Hematopoietic Transplantation

Author

Salvatore Leotta, Giuseppe Sapienza, Maria Grazia Camuglia, Giuseppe Avola, Annalia Di Marco, Gaetano Moschetti, Angelo Curto Pelle, Uros Markovic, Giulio Antonio Milone, Alessandra Cupri, Oriana Bianco, Viviana Frontini, Andre Spadaro, Anna Elisa Marchese, Roberto Crocchiolo, and Giuseppe Milone

Subjects
graft-vs.-host disease, Tim 3, sIL2-Rα, cytokines, hematopoietic stem cell transplantation, Immunologic diseases. Allergy, RC581-607
Abstract

Assays of cytokines in the plasma at the onset of graft-vs. -host disease (GVHD) can predict disease severity and treatment-related mortality (TRM); however, the optimal time during which cytokines should be tested and the specific panel of cytokines with the highest predictive ability remain unknown. We chose a predefined time point, 18 days after hematopoietic stem cell transplantation (HSCT), to measure the levels of six cytokines in the plasma: soluble interleukin-2 receptor alpha (sIL2-Rα), T-cell immunoglobulin domain and mucin domain-3 (TIM-3), suppression of tumorigenicity-2 (ST-2), intercellular adhesion molecule (ICAM-1), interferon-gamma (IFN-γ), and interleukin-6 (IL-6). The study included 95 patients, who underwent allogeneic hematopoietic transplantation at our institution. Plasma levels of sIL2-Rα and TIM-3, measured as continuous data, had predictive value for overall survival (sIL2-Rα, p = 0.002; TIM-3, p = 0.0007), while TRM could be predicted by sIL2-Rα (p = 0.0005), IFN-gamma (p = 0.01), and IL-6 (p = 0.0001). No cytokine was associated with the risk of relapse. Patients were categorized into groups, according to cytokine thresholds determined by receiver operating characteristic curve analysis (sIL2-Rα ≤ or > 8,100 pg/ml; TIM-3 ≤ or > 950 pg/ml) and multivariate analysis was conducted. High levels of both TIM-3 and sIL2-Rα were significant predictors of poor survival [TIM-3 > 950 pg/ml: hazard ratio (HR) = 6.214 (95% CI 1.939–19.910), p = 0.002 and sIL2-Rα > 8.100 pg/ml: HR = 2.644 (95% CI 1.308–5.347), p = 0.006]. Using these cutoff thresholds, we constructed a composite scoring system that could distinguish three different groups of patients with varying rates of TRM: high risk, 41.7%; intermediate risk, 10.8%; and low risk, 7.1% (Gray's test: p = 0.001). If confirmed in a validation cohort, this composite scoring system could be used to guide the modulation of post-transplant immune suppressive therapy.

Published
2020
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23. An RNAi based screen in Drosophila larvae identifies fascin as a regulator of myoblast fusion and myotendinous junction structure

Author

Jaclyn M. Camuglia, Torrey R. Mandigo, Richard Moschella, Jenna Mark, Christine H. Hudson, Derek Sheen, and Eric S. Folker

Subjects
Nuclear movement, Drosophila, Myoblast fusion, Myotendinous junction, Fascin, Myogenesis, Diseases of the musculoskeletal system, RC925-935
Abstract

Abstract Background A strength of Drosophila as a model system is its utility as a tool to screen for novel regulators of various functional and developmental processes. However, the utility of Drosophila as a screening tool is dependent on the speed and simplicity of the assay used. Methods Here, we use larval locomotion as an assay to identify novel regulators of skeletal muscle function. We combined this assay with muscle-specific depletion of 82 genes to identify genes that impact muscle function by their expression in muscle cells. The data from the screen were supported with characterization of the muscle pattern in embryos and larvae that had disrupted expression of the strongest hit from the screen. Results With this assay, we showed that 12/82 tested genes regulate muscle function. Intriguingly, the disruption of five genes caused an increase in muscle function, illustrating that mechanisms that reduce muscle function exist and that the larval locomotion assay is sufficiently quantitative to identify conditions that both increase and decrease muscle function. We extended the data from this screen and tested the mechanism by which the strongest hit, fascin, impacted muscle function. Compared to controls, animals in which fascin expression was disrupted with either a mutant allele or muscle-specific expression of RNAi had fewer muscles, smaller muscles, muscles with fewer nuclei, and muscles with disrupted myotendinous junctions. However, expression of RNAi against fascin only after the muscle had finished embryonic development did not recapitulate any of these phenotypes. Conclusions These data suggest that muscle function is reduced due to impaired myoblast fusion, muscle growth, and muscle attachment. Together, these data demonstrate the utility of Drosophila larval locomotion as an assay for the identification of novel regulators of muscle development and implicate fascin as necessary for embryonic muscle development.

Published
2018
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31. Intravenous Immunoglobulin Protects Against Severe Pandemic Influenza Infection

Author

Steven Rockman, Sue Lowther, Sarina Camuglia, Kirsten Vandenberg, Shirley Taylor, Lou Fabri, Sylvia Miescher, Martin Pearse, Deborah Middleton, Stephen J. Kent, and Darryl Maher

Subjects
Influenza, Passive immunotherapy, Intravenous immunoglobulin, IVIg, Plasma, Serum, Antibody, Medicine, Medicine (General), R5-920
Abstract

Influenza is a highly contagious, acute, febrile respiratory infection that can have fatal consequences particularly in individuals with chronic illnesses. Sporadic reports suggest that intravenous immunoglobulin (IVIg) may be efficacious in the influenza setting. We investigated the potential of human IVIg to ameliorate influenza infection in ferrets exposed to either the pandemic H1N1/09 virus (pH1N1) or highly pathogenic avian influenza (H5N1). IVIg administered at the time of influenza virus exposure led to a significant reduction in lung viral load following pH1N1 challenge. In the lethal H5N1 model, the majority of animals given IVIg survived challenge in a dose dependent manner. Protection was also afforded by purified F(ab′)2 but not Fc fragments derived from IVIg, supporting a specific antibody-mediated mechanism of protection. We conclude that pre-pandemic IVIg can modulate serious influenza infection-associated mortality and morbidity. IVIg could be useful prophylactically in the event of a pandemic to protect vulnerable population groups and in the critical care setting as a first stage intervention.

Published
2017
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34. Venetoclax penetrates in cerebrospinal fluid of an acute myeloid leukemia patient with leptomeningeal involvement

Author

Cristina Matteo, Giovanni Schininà, Nunziatina Laura Parrinello, Roberta Sciortino, Salvatore Leotta, Giuseppe Milone, Gianna Maria Piccolo, Massimo Zucchetti, Francesco Di Raimondo, Maria Grazia Camuglia, Annalisa Condorelli, and Maria Proietto

Subjects
Male, Oncology, Drug, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, media_common.quotation_subject, Antineoplastic Agents, Toxicology, chemistry.chemical_compound, Cerebrospinal fluid, Tandem Mass Spectrometry, Internal medicine, Meningeal Neoplasms, Humans, Medicine, Tissue Distribution, Pharmacology (medical), IC50, Chromatography, High Pressure Liquid, Bone Marrow Transplantation, media_common, Pharmacology, Sulfonamides, business.industry, Venetoclax, Myeloid leukemia, Middle Aged, Bridged Bicyclo Compounds, Heterocyclic, Radiation therapy, Leukemia, Myeloid, Acute, chemistry, Blood-Brain Barrier, Cytarabine, Methotrexate, business, medicine.drug
Abstract

Relapse at the central nervous system (CNS) in acute myeloid leukemia (AML) carries a dismal prognosis. Treatment options are limited to intrathecal therapy, high-dose cytarabine, high-dose methotrexate, and radiotherapy. Novel strategies are needed. Venetoclax has recently been approved by the FDA, in combination with hypomethylating agents or low-dose cytarabine, for elderly adults or patients ineligible for intensive chemotherapy affected by AML. However, little is known on its efficacy in patients with leptomeningeal involvement. Here, we present a case of a 52-year-old patient affected by AML relapsed at CNS after allogeneic bone marrow transplantation who was treated with venetoclax. We evaluated the concentration of the drug in cerebrospinal fluid (CSF) by HPLC MS/MS method on three different occasions to verify the penetration of the drug through the brain-blood barrier and we observed that the concentration in CSF was similar to the IC50 established in vitro.

Published
2021

38. List of Contributors

Author

Amaya, Luis, primary, Ashworth, Jane L, additional, Avery, Robert A, additional, Bartram, Jack, additional, Beres, Shannon J, additional, Binenbaum, Gil, additional, Biousse, Valérie, additional, Birch, Eileen E, additional, Biswas, Susmito, additional, Black, Graeme C M, additional, Black, Joanna, additional, Bowman, Richard J C, additional, Bradbury, John A, additional, Brodsky, Michael C, additional, Brosnahan, Donal, additional, de Alba, Alejandra, additional, Camuglia, Jayne E, additional, Carden, Susan M, additional, Castano, Giovanni, additional, Casteels, Ingele, additional, Chung, Yvonne, additional, Clarke, Michael P, additional, Coats, David K, additional, Collin, Richard, additional, Crompton, John, additional, Cunningham, Emmett T, additional, Demer, Joseph L, additional, Dollfus, Hélène, additional, Dolman, Peter J, additional, Donahue, Sean P, additional, Edelsten, Clive, additional, Fielder, Alistair R, additional, FitzPatrick, David R., additional, Fulton, Anne B, additional, Gallie, Brenda L, additional, Geloneck, Megan, additional, Gilbert, Clare E, additional, Giligson, Christy, additional, Gole, Glen A, additional, Good, William V, additional, Grigg, John R B, additional, Grossniklaus, Hans, additional, Hamel, Patrick, additional, Handler, Sheryl M, additional, Hansen, Ronald M, additional, Heidary, Gena, additional, Hertle, Richard W, additional, Hildebrand, Göran Darius, additional, Holder, Graham E, additional, Hoyt, Creig S, additional, Hubbard, G Baker, additional, Hutchinson, Amy K, additional, Jain, Saurabh, additional, Jamieson, Robyn V, additional, Jensen, Hanne, additional, Kadom, Nadja, additional, Kekunnaya, Ramesh, additional, Kersten, Robert C, additional, Kestelyn, Philippe, additional, Keunen, Jan E E, additional, Khaw, Peng Tee, additional, Kim, Chong Ae, additional, Koopman, Jan, additional, Kraft, Stephen P, additional, Kushner, Burton J, additional, Lambert, Scott R, additional, LaRoche, G Robert, additional, Larsen, Dorte Ancher, additional, Lee, Andrew G, additional, Lee, Barry, additional, Lenhart, Phoebe, additional, Liasis, Alki, additional, Liu, Grant T, additional, Lloyd, Christopher, additional, Lyons, Christopher J, additional, Matsuba, Carey A, additional, MacEwen, Caroline J, additional, McNab, Alan A, additional, Mehta, Vaishali, additional, Michaelides, Michel, additional, Mojon, Daniel, additional, Ulrik, Hans, additional, Moore, Anthony T, additional, Morris, Andrew A M, additional, Newman, Nancy J, additional, Nischal, Ken K, additional, O'Colmain, Una, additional, O'Connor, Anna R, additional, O'Keefe, Michael, additional, Olitsky, Scott E, additional, Ospina, Luis H, additional, Oystreck, Darren T, additional, Papadopoulos, Maria, additional, Park, Sunju, additional, Paysse, Evelyn A, additional, Peragallo, Jason H, additional, Pereira, Erika Mota, additional, Pilling, Rachel F, additional, Pineles, Stacy, additional, Prajna, Venkatesh, additional, Proudlock, Frank Antony, additional, Puvanachandra, Narman, additional, Quinn, Anthony G, additional, Quinn, Graham E, additional, Rahi, Jugnoo S, additional, Repka, Michael X, additional, Robinson, Joshua, additional, Russell, Buddy, additional, de Sá, Luis Carlos Ferreira, additional, Sachdeva, Virender, additional, Salchow, Daniel J, additional, Scawn, Richard L, additional, Schalij-Delfos, Nicoline, additional, van Schooneveld, Mary J, additional, Self, Jay, additional, Sergouniotis, Panagiotis I, additional, Shields, Carol L, additional, Shields, Jerry A, additional, Sloper, John J, additional, Snead, Martin P, additional, Soliman, Sameh E, additional, Sullivan, Timothy John, additional, Summers, C Gail, additional, Tan, Kimberley, additional, Taylor, David S, additional, Thompson, Dorothy A, additional, Traboulsi, Elias I, additional, Tuft, Stephen J, additional, Uddin, Jimmy M, additional, Vijayalakshmi, Perumalsamy, additional, Watts, Patrick, additional, Weakley, David R, additional, and Wells, Jill Razor, additional

Published
2017
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40. Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry

Author

Helge Mollmann, Axel Linke, Luis Nombela-Franco, Martin Sluka, Juan Francisco Oteo Dominguez, Matteo Montorfano, Won-Keun Kim, Martin Arnold, Mariuca Vasa-Nicotera, Lenard Conradi, Anthony Camuglia, Francesco Bedogni, and Ganesh Manoharan

Subjects
transcatheter aortic valve implantation, transcatheter aortic valve replacement, Portico, self-expanding, aortic stenosis, ddc:610, General Medicine
Abstract

A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected ‘standard-of-care’ clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.

Published
2022
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42. Emergency treatment of acute decompensated critical aortic stenosis with transcatheter aortic valve implantation

Author

A. Camuglia, Kuljit Singh, Sylvio Provenzano, and Kyi T H Win

Subjects
Male, medicine.medical_specialty, Transcatheter aortic, Emergency treatment, Transcatheter Aortic Valve Replacement, Ventricular Dysfunction, Left, Bicuspid aortic valve, Internal medicine, medicine, Humans, cardiovascular diseases, Cardiac skeleton, Emergency Treatment, Aged, Framingham Risk Score, business.industry, Cardiogenic shock, Aortic Valve Stenosis, medicine.disease, Stenosis, Treatment Outcome, medicine.anatomical_structure, Ventricle, Aortic Valve, cardiovascular system, Cardiology, Molecular Medicine, Cardiology and Cardiovascular Medicine, business
Abstract

Transcatheter aortic valve implantation (TAVI) is relatively contraindicated in the bicuspid aortic valve, and to our knowledge has not been tried where the true native annulus is of a size far in excess of current device capabilities. We present here a case of a successful emergency TAVI of a 73-year-old previously healthy man, who presented with cardiogenic shock, ventricular tachycardia storm and severe left ventricular dysfunction because of the underlying critical bicuspid aortic stenosis with aortic annulus area of 991.9 mm2 and associated moderate aortic incompetence (the Society of Thoracic Surgeons (STS) risk score; score mortality of 40.9%). Despite the critical condition of the patient and technically challenging anatomy, successful TAVI was performed and the patient remains well with near-normal left ventricle (LV) function at 6 months follow-up.

Published
2021

43. Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry

Author

Mollmann, Helge, primary, Linke, Axel, additional, Nombela-Franco, Luis, additional, Sluka, Martin, additional, Dominguez, Juan Francisco Oteo, additional, Montorfano, Matteo, additional, Kim, Won-Keun, additional, Arnold, Martin, additional, Vasa-Nicotera, Mariuca, additional, Conradi, Lenard, additional, Camuglia, Anthony, additional, Bedogni, Francesco, additional, and Manoharan, Ganesh, additional

Published
2022
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