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1. 5 Year Outcomes Following Ex Vivo Lung Perfusion Using a Centralized Lung Evaluation System at a Dedicated Facility

Author

Mallea, J., primary, D'Cunha, J., additional, Sanchez, P., additional, Kon, Z., additional, Pierson, R., additional, Keller, C., additional, Erasmus, D., additional, Hartwig, M., additional, Dilling, D., additional, Brown, A., additional, Lynch, W., additional, Sketch, M.R., additional, Cella, D., additional, Roberts, M., additional, and McCurry, K., additional

Published
2024
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2. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M.A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D.M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Crestani, B., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernández Pérez, E.R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gómez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Inoue, Y., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kolb, M., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., León Jiménez, A., Luo, Q., Mageto, Y., Maher, T.M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, R., Martínez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Morrison, L., Morrow, L., Moua, T., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J.S., Patel, N., Pesci, A., Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodríguez Portal, J.A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fénero, M., Sauleda, J., Schmidt, S., Scholand, M.B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J.W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, F., Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Wells, Athol U, Flaherty, Kevin R, Brown, Kevin K, Inoue, Yoshikazu, Devaraj, Anand, Richeldi, Luca, Moua, Teng, Crestani, Bruno, Wuyts, Wim A, Stowasser, Susanne, Quaresma, Manuel, Goeldner, Rainer-Georg, Schlenker-Herceg, Rozsa, and Kolb, Martin

Published
2020
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4. Ziritaxestat, a novel autotaxin inhibitor, and lung function in idiopathic pulmonary fibrosis

Author

Maher, TM, Ford, P, Brown, KK, Costabel, U, Cottin, V, Danoff, SK, Groenveld, I, Helmer, E, Jenkins, RG, Milner, J, Molenberghs, G, Penninckx, B, Randall, MJ, Van Den Blink, B, Fieuw, A, Vandenrijn, C, Rocak, S, Seghers, I, Shao, L, Taneja, A, Jentsch, G, Watkins, TR, Wuyts, WA, Kreuter, M, Verbruggen, N, Prasad, N, Wijsenbeek, MS, Chambers, D, Chia, M, Corte, T, Glaspole, I, Goh, N, Holmes, M, Malouf, M, Thien, F, Veitch, E, Bondue, B, Dahlqvist, C, Froidure, A, Slabbynck, H, Wuyts, W, Cartagena Salinas, C, Feijoó Seoane, R, Martínez, V, Maturana, R, Pavie Gallegos, J, Rosenblut, A, Silva, R, Undurraga Pereira, A, Doubkova, M, Pauk, N, Plackova, M, Sterclova, M, Bendstrup, E, Shaker, SB, Titlestad, I, Budweiser, S, Grohé, C, Koschel, D, Prasse, A, Weber, M, Wirtz, H, Antoniou, K, Daniil, Z, Gaga, M, Papakosta, D, Izumi, S, Okamoto, M, Guerreros Benavides, A, Iberico Barrera, C, Peña Villalobos, AM, Campo Ezquibela, A, Cifrian Martinez, JM, Fernandez Fabrellas, E, Leiro, V, Molina-Molina, M, Nieto Barbero, A, Sellares Torres, J, Valenzuela, C, Cheng, S-L, Kuo, P-H, Lee, K-Y, Sheu, C-C, Gunen, H, Mogulkoc Bishop, N, Nayci, S, Adamali, H, Bianchi, S, Chaudhuri, N, Gibbons, M, Hart, S, Molyneaux, P, Parfrey, H, Saini, G, Spencer, LG, Wiscombe, S, Antin-Ozerkis, D, Bascom, R, Belperio, J, Britt, E, Fitzgerald, J, Gomez Manjarres, D, Gotfried, M, Gupta, N, Hotchkin, D, Kaye, M, Kreider, M, Kureishy, S, Lacamera, P, Lancaster, L, Lasky, J, Lorch, D, Mannem, H, Morrow, L, Moua, T, Nambiar, A, Raghu, G, Raj, R, Ramaswamy, M, Reddy, R, Russell, T, Scholand, MB, Shea, B, Suliman, S, Swigris, J, Thavarajah, K, Tolle, L, Tomic, R, Warshoff, N, Wesselius, L, Yung, G, Bergna, M, De Salvo, M, Fernandez Acquier, M, Rodriguez, A, Saez Scherbovsky, P, Assayag, D, Dhar, A, Khalil, N, Morisset, J, Provencher, S, Ryerson, C, Shapera, S, Bourdin, A, Crestani, B, Lebargy, F, Reynaud-Gaubert, M, Bonella, FT, Claussen, M, Hammerl, P, Karagiannidis, C, Keller, C, Randerath, W, Stubbe, B, Csánky, E, Medgyasszay, B, Muller, V, Adir, Y, Bar-Shai, A, Berkman, N, Fink, G, Kramer, M, Shitrit, D, Bargagli, E, Gasparini, S, Harari, S, Ravaglia, C, Richeldi, L, Vancheri, C, Ebina, M, Fujita, M, Ichikado, K, Inoue, Y, Ishikawa, N, Kato, M, Kawamura, T, Kondoh, Y, Nishioka, Y, Ogura, T, Owan, I, Saito, T, Sakamoto, N, Sakamoto, K, Shirai, M, Suda, T, Tomii, K, Chung, MP, Jeong, SH, Park, CS, Park, JS, Song, JW, Uh, S-T, Chavarria Martinez, U, Montano Gonzalez, E, Ramirez, A, Selman Lama, ME, Bresser, P, Kramer, H, Mostard, R, Nossent, E, Veltkamp, M, Wijsenbeek, M, Beckert, L, Chang, CL, Veale, A, Wilsher, M, Bednarek, M, Gasior, G, Jasieniak-Pinis, G, Jassem, E, Mroz, R, Piotrowski, W, Abdullah, I, Ambaram, A, Irusen, E, Van der Linden, M, Van Zyl-Smit, R, Williams, P, Allen, J, Averill, F, Belloli, E, Brown, A, Case, A, Chaudhary, S, Criner, G, DeBoer, K, Dilling, D, Dorf, J, Enelow, R, Ettinger, N, Feldman, J, Gibson, K, Golden, J, Hamblin, M, Hunninghake, G, Karunakara, R, Kim, H, Luckhardt, T, Menon, P, Morrison, L, Oldham, J, Patel, N, Schmidt, S, Strek, M, Summer, R, Sussman, R, Tita, J, Veeraraghavan, S, Whelan, T, and Zibrak, J

Abstract

Importance There is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF). Objective To assess the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF. Design, Setting, and Participants The 2 identically designed, phase 3, randomized clinical trials, ISABELA 1 and ISABELA 2, were conducted in Africa, Asia-Pacific region, Europe, Latin America, the Middle East, and North America (26 countries). A total of 1306 patients with IPF were randomized (525 patients at 106 sites in ISABELA 1 and 781 patients at 121 sites in ISABELA 2). Enrollment began in November 2018 in both trials and follow-up was completed early due to study termination on April 12, 2021, for ISABELA 1 and on March 30, 2021, for ISABELA 2. Interventions Patients were randomized 1:1:1 to receive 600 mg of oral ziritaxestat, 200 mg of ziritaxestat, or placebo once daily in addition to local standard of care (pirfenidone, nintedanib, or neither) for at least 52 weeks. Main Outcomes and Measures The primary outcome was the annual rate of decline for forced vital capacity (FVC) at week 52. The key secondary outcomes were disease progression, time to first respiratory-related hospitalization, and change from baseline in St George’s Respiratory Questionnaire total score (range, 0 to 100; higher scores indicate poorer health-related quality of life). Results At the time of study termination, 525 patients were randomized in ISABELA 1 and 781 patients in ISABELA 2 (mean age: 70.0 [SD, 7.2] years in ISABELA 1 and 69.8 [SD, 7.1] years in ISABELA 2; male: 82.4% and 81.2%, respectively). The trials were terminated early after an independent data and safety monitoring committee concluded that the benefit to risk profile of ziritaxestat no longer supported their continuation. Ziritaxestat did not improve the annual rate of FVC decline vs placebo in either study. In ISABELA 1, the least-squares mean annual rate of FVC decline was –124.6 mL (95% CI, −178.0 to −71.2 mL) with 600 mg of ziritaxestat vs –147.3 mL (95% CI, −199.8 to −94.7 mL) with placebo (between-group difference, 22.7 mL [95% CI, −52.3 to 97.6 mL]), and –173.9 mL (95% CI, −225.7 to −122.2 mL) with 200 mg of ziritaxestat (between-group difference vs placebo, −26.7 mL [95% CI, −100.5 to 47.1 mL]). In ISABELA 2, the least-squares mean annual rate of FVC decline was –173.8 mL (95% CI, −209.2 to −138.4 mL) with 600 mg of ziritaxestat vs –176.6 mL (95% CI, −211.4 to −141.8 mL) with placebo (between-group difference, 2.8 mL [95% CI, −46.9 to 52.4 mL]) and –174.9 mL (95% CI, −209.5 to −140.2 mL) with 200 mg of ziritaxestat (between-group difference vs placebo, 1.7 mL [95% CI, −47.4 to 50.8 mL]). There was no benefit with ziritaxestat vs placebo for the key secondary outcomes. In ISABELA 1, all-cause mortality was 8.0% with 600 mg of ziritaxestat, 4.6% with 200 mg of ziritaxestat, and 6.3% with placebo; in ISABELA 2, it was 9.3% with 600 mg of ziritaxestat, 8.5% with 200 mg of ziritaxestat, and 4.7% with placebo. Conclusions and Relevance Ziritaxestat did not improve clinical outcomes compared with placebo in patients with IPF receiving standard of care treatment with pirfenidone or nintedanib or in those not receiving standard of care treatment. Trial Registration ClinicalTrials.gov Identifiers: NCT03711162 and NCT03733444

Published
2023

9. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Wells, A. U., Flaherty, K. R., Brown, K. K., Inoue, Y., Devaraj, A., Richeldi, Luca, Moua, T., Crestani, B., Wuyts, W. A., Stowasser, S., Quaresma, M., Goeldner, R. -G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M. A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D. M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernandez Perez, E. R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gomez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., Leon Jimenez, A., Luo, Q., Mageto, Y., Maher, T. M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, Sara, Martinez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Malcolm, Joan Morrison, Morrow, L., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J. S., Patel, N., Pesci, Riccardo, Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodriguez Portal, J. A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fenero, M., Sauleda, J., Schmidt, S., Scholand, M. B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J. W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, Francesco, Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Richeldi L. (ORCID:0000-0001-8594-1448), Martinez R., Morrison L., Pesci A., Varone F., Wells, A. U., Flaherty, K. R., Brown, K. K., Inoue, Y., Devaraj, A., Richeldi, Luca, Moua, T., Crestani, B., Wuyts, W. A., Stowasser, S., Quaresma, M., Goeldner, R. -G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M. A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D. M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernandez Perez, E. R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gomez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., Leon Jimenez, A., Luo, Q., Mageto, Y., Maher, T. M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, Sara, Martinez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Malcolm, Joan Morrison, Morrow, L., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J. S., Patel, N., Pesci, Riccardo, Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodriguez Portal, J. A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fenero, M., Sauleda, J., Schmidt, S., Scholand, M. B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J. W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, Francesco, Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Richeldi L. (ORCID:0000-0001-8594-1448), Martinez R., Morrison L., Pesci A., and Varone F.

Abstract

Background: The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods: The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudo-random number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178. Findings: Participants were recruited between Feb 23, 2017, and April 27, 2018. Of 663 participants who received at least one dose of nintedanib or placebo, 173 (26%) had chronic hypersensitivity pneumonitis, 170 (26%) an autoimmune IL

Published
2020

14. 47CRT-D versus CRT-P: are we on the right track?

Author

Stassen, J, primary, Scherrenberg, M, additional, Vijgen, J, additional, Dilling, D, additional, Herbots, L, additional, Timmermans, PH J, additional, Schurmans, J, additional, Verwerft, J, additional, and Koopman, P, additional

Published
2020
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15. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Wells, Athol U, primary, Flaherty, Kevin R, additional, Brown, Kevin K, additional, Inoue, Yoshikazu, additional, Devaraj, Anand, additional, Richeldi, Luca, additional, Moua, Teng, additional, Crestani, Bruno, additional, Wuyts, Wim A, additional, Stowasser, Susanne, additional, Quaresma, Manuel, additional, Goeldner, Rainer-Georg, additional, Schlenker-Herceg, Rozsa, additional, Kolb, Martin, additional, Abe, S., additional, Aburto, M., additional, Acosta, O., additional, Andrews, C., additional, Antin-Ozerkis, D., additional, Arce, G., additional, Arias, M., additional, Avdeev, S., additional, Barczyk, A., additional, Bascom, R., additional, Bazdyrev, E., additional, Beirne, P., additional, Belloli, E., additional, Bergna, M.A., additional, Bergot, E., additional, Bhatt, N., additional, Blaas, S., additional, Bondue, B., additional, Bonella, F., additional, Britt, E., additional, Buch, K., additional, Burk, J., additional, Cai, H., additional, Cantin, A., additional, Castillo Villegas, D.M., additional, Cazaux, A., additional, Cerri, S., additional, Chaaban, S., additional, Chaudhuri, N., additional, Cottin, V., additional, Crestani, B., additional, Criner, G., additional, Dahlqvist, C., additional, Danoff, S., additional, Dematte D'Amico, J., additional, Dilling, D., additional, Elias, P., additional, Ettinger, N., additional, Falk, J., additional, Fernández Pérez, E.R., additional, Gamez-Dubuis, A., additional, Giessel, G., additional, Gifford, A., additional, Glassberg, M., additional, Glazer, C., additional, Golden, J., additional, Gómez Carrera, L., additional, Guiot, J., additional, Hallowell, R., additional, Hayashi, H., additional, Hetzel, J., additional, Hirani, N., additional, Homik, L., additional, Hope-Gill, B., additional, Hotchkin, D., additional, Ichikado, K., additional, Ilkovich, M., additional, Inoue, Y., additional, Izumi, S., additional, Jassem, E., additional, Jones, L., additional, Jouneau, S., additional, Kaner, R., additional, Kang, J., additional, Kawamura, T., additional, Kessler, R., additional, Kim, Y., additional, Kishi, K., additional, Kitamura, H., additional, Kolb, M., additional, Kondoh, Y., additional, Kono, C., additional, Koschel, D., additional, Kreuter, M., additional, Kulkarni, T., additional, Kus, J., additional, Lebargy, F., additional, León Jiménez, A., additional, Luo, Q., additional, Mageto, Y., additional, Maher, T.M., additional, Makino, S., additional, Marchand-Adam, S., additional, Marquette, C., additional, Martinez, R., additional, Martínez, M., additional, Maturana Rozas, R., additional, Miyazaki, Y., additional, Moiseev, S., additional, Molina-Molina, M., additional, Morrison, L., additional, Morrow, L., additional, Moua, T., additional, Nambiar, A., additional, Nishioka, Y., additional, Nunes, H., additional, Okamoto, M., additional, Oldham, J., additional, Otaola, M., additional, Padilla, M., additional, Park, J.S., additional, Patel, N., additional, Pesci, A., additional, Piotrowski, W., additional, Pitts, L., additional, Poonyagariyagorn, H., additional, Prasse, A., additional, Quadrelli, S., additional, Randerath, W., additional, Refini, R., additional, Reynaud-Gaubert, M., additional, Riviere, F., additional, Rodríguez Portal, J.A., additional, Rosas, I., additional, Rossman, M., additional, Safdar, Z., additional, Saito, T., additional, Sakamoto, N., additional, Salinas Fénero, M., additional, Sauleda, J., additional, Schmidt, S., additional, Scholand, M.B., additional, Schwartz, M., additional, Shapera, S., additional, Shlobin, O., additional, Sigal, B., additional, Silva Orellana, A., additional, Skowasch, D., additional, Song, J.W., additional, Stieglitz, S., additional, Stone, H., additional, Strek, M., additional, Suda, T., additional, Sugiura, H., additional, Takahashi, H., additional, Takaya, H., additional, Takeuchi, T., additional, Thavarajah, K., additional, Tolle, L., additional, Tomassetti, S., additional, Tomii, K., additional, Valenzuela, C., additional, Vancheri, C., additional, Varone, F., additional, Veeraraghavan, S., additional, Villar, A., additional, Weigt, S., additional, Wemeau, L., additional, Wuyts, W., additional, Xu, Z., additional, Yakusevich, V., additional, Yamada, Y., additional, Yamauchi, H., additional, and Ziora, D., additional

Published
2020
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20. A review of the potential applications and controversies of non-invasive testing for biomarkers of aspiration in the lung transplant population

Author

Davis, C.S., Gagermeier, J., Dilling, D., Alex, C., Lowery, E., Kovacs, E.J., Love, R.B., and Fisichella, P.M.

Subjects
Gastroesophageal Reflux, Respiratory Aspiration, Humans, respiratory system, Respiration Disorders, Bronchiolitis Obliterans, Bronchoalveolar Lavage Fluid, Article, Biomarkers, Lung Transplantation
Abstract

Despite improvements in one-yr survival following lung transplantation, five-yr survival lags significantly behind the transplantation of other solid organs. The contrast in survival persists despite advancements in anti-rejection regimens, suggesting a non-alloimmune mechanism to chronic lung transplant failure. Notably, markers of aspiration have been demonstrated in bronchoalveolar lavage (BAL) fluid concurrent with bronchiolitis obliterans syndrome (BOS). This recent evidence has underscored gastro-esophageal reflux (GER) and its associated aspiration risk as a non-alloimmune mechanism of chronic lung transplant failure. Given the suggested safety and efficacy of laparoscopic anti-reflux procedures in the lung transplant population, identifying those at risk for aspiration is of prime importance, especially concerning the potential for long-term improvements in morbidity and mortality. Conventional diagnostic methods for GER and aspiration, such as pH monitoring and detecting pepsin and bile salts in BAL fluid, have gaps in their effectiveness. Therefore, we review the applications and controversies of a non-invasive method of defining reflux injury in the lung transplant population: the detection of biomarkers of aspiration in the exhaled breath condensate. Only by means of assay standardization and directed collaboration may such a non-invasive method be a realization in lung transplantation.

Published
2010

27. Rekenmodel voor extra duinafslag ten gevolge van een gradiënt in het langstransport als gevolg van een kromming van de kustlijn

Author

Dilling, D. (author), Visser, C. (author), Dilling, D. (author), and Visser, C. (author)

Abstract

Om het toepassingsgebied van de leidraad duinafslag te vergroten wordt in deze notitie een afschatting gemaakt van een eventueel verlies aan zand ten gevolge van een kromming van de kustlijn. Dit verlies is het gevolg van een gradiënt in het langstransport tijdens een stormvloed. In het onderzoek naar de invloed van een gradiënt in het langstransport op de mate van duinafslag is in de eerste plaats getracht om door analyse van natuurraetingen tot een uitspraak te kunnen komen. Een onderzoek hiernaar door Kraayenbrink en Leeuwenstein [4] werd in 1980 afgerond. Dit onderzoek werd mede begeleid door de Adviesdienst Vlissingen van de Rijkswaterstaat. Hierbij werd getracht een verband te leggen tussen de veranderingen in zandvolumen in diverse raaien loodrecht op de kust en de opgetreden stormvloeden voor een aantal locaties waar sprake kon zijn van een mogelijke gradiënt-invloed. Uit dit onderzoek kwam naar. voren dat de kwaliteit van de beschikbare profielmetingen, alsmede de frequentie van uitvoering hiervan in feite de oorzaak waren, dat de invloed van een "gradiënt" op duinafslag kwalitatief noch kwantitatief vastgesteld kon worden., TAW/ENW

Published
1984

28. The ISHLT 2017 Updated DCD Registry Report

Author

Van Raemdonck, D. E., Keshavjee, S., Levvey, B., Snell, G., Erasmus, M. E., Cherikh, W. S., Kucheryavaya, A. Y., Stehlik, J., McCurry, K. R., Glanville, A., D'Ovidio, F., Hertz, M., Inci, I., Hopkins, P., Walia, R., Patterson, G. A., Yusen, R. D., Mason, D., Musk, M., Dilling, D. F., Camp, P., Cypel, M., Cardiovascular Centre (CVC), and Groningen Institute for Organ Transplantation (GIOT)

34. Utilization and Outcomes with Single Lung Transplantation Following Ex Vivo Lung Perfusion Using a Centralized Lung Evaluation System at a Dedicated Facility.

Author

Mallea, J., Kon, Z., Brown, A., Hartwig, M., Sanchez, P., Keller, C., Erasmus, D., Dilling, D., D'Cunha, J., Roberts, M., Sketch, M.R., Johnson, D., and McCurry, K.

Subjects
*LUNG transplantation, *LUNGS, *PERFUSION, *LUNG diseases, *STATISTICAL power analysis
Abstract

Ex vivo lung perfusion (EVLP) could impact waitlist morbidity and mortality by increasing the number of transplantable allografts, including single lungs. We previously demonstrated feasibility of remote EVLP with a centralized lung evaluation system (CLES) at a dedicated facility (NCT02234128). Despite higher rate of primary graft dysfunction grade 3 at 72 hours (PGD3-72h) in the CLES cohort, survival to 3 years was similar to controls. We performed a post hoc analysis to understand outcomes of SLT and BLT with and without the use of CLES-based EVLP. Seven US centers referred lungs for remote EVLP to a dedicated CLES facility in a non-randomized, unblinded study. Controls underwent standard cold preservation and matched to CLES cohort by transplant type, center, and lung disease diagnosis group. Recipient characteristics and outcomes are summarized across SLT and BLT recipients in CLES and control cohorts. In the control (n=49) and CLES (n=66) cohorts, 41% and 47% of recipients received a SLT, respectively. SLT recipients tended to be older. Median Lung Allocation Score (LAS) was 36 in CLES-SLT, 35 in CLES-BLT, 39 in control-SLT, and 36 in control-BLT. PGD3-72h occurred in 8/31 (26%) CLES-SLT, 8/35 (23%) CLES-BLT, 1/20 (5%) control-SLT, and 1/29 (3%) control-BLT recipients. All recipients survived to 30-days. Survival at 1-year: 29/31 (94%) in CLES-SLT, 30/35 (86%) in CLES-BLT, 19/20 (95%) in control-SLT, and 26/29 (90%) in control-BLT recipients. Survival at 3-years: 24/31 (77%) in CLES-SLT, 26/35 (74%) in CLES-BLT, 13/20 (65%) in control-SLT, and 23/29 (79%) in control-BLT recipients. PGD3-72h was similar in SLT and BLT recipients within each cohort. At 1 year, survival appeared higher in SLT than BLT groups. At 3-years, survival was similar for SLT and BLT recipients in the CLES cohort and was higher in BLT than SLT recipients in controls. These data support application of remote EVLP with a CLES at a dedicated facility as an opportunity to increase utilization of SLT. Although there is a suggestion of improved survival to 3 years for recipients who received a CLES-SLT, these data should be interpreted with caution given small patient numbers and lack of statistical power. Future research should be focused on and powered to assess differences in outcomes for SLT with and without the use of CLES. [ABSTRACT FROM AUTHOR]

Published
2023
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35. Use of Tixagevimab and Cilgavimab (Evusheld) and Subsequent Outcomes of SARS-CoV-2 Infections in Lung Transplant Recipients.

Author

Grillini, A., Stracener, P., Scarola, D., Lyons, J., and Dilling, D.

Subjects
*SARS-CoV-2, *LUNG transplantation, *LUNG infections, *COVID-19
Abstract

The protection of solid organ transplant recipients from infection has been challenging throughout the Coronavirus disease (COVID-19) pandemic. In 2022, tixagevimab and cilgavimab (Evusheld) was introduced as a means of providing passive antibodies and augmenting the vaccine immune response in immunocompromised patients. We aimed to assess the efficacy of Evusheld in reducing the incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection in lung transplant recipients. We conducted a single center, retrospective, observational cohort study examining SARS-CoV-2 incidence in 289 lung transplant recipients from January 2022 through July 2022. Manual chart extraction was utilized to collect dates of Evusheld administration, SARS-CoV-2 vaccination, and SARS-CoV-2 infection, as well as demographic and clinical data. Exact logistic regression models were used to compare incidence of SARS-CoV-2 infection and hospitalization rates between lung transplant recipients who received versus did not receive Evusheld. Of the 289 lung transplant recipients, 136 (47.1%) received Evusheld during the study period. The incidence of SARS-CoV-2 infection in transplant recipients who received Evusheld was 8.1% (or 11/136), compared to 34.0% (or 52/153) among those who did not receive Evusheld. Controlling for the number of SARS-CoV-2 vaccines received, the odds of a SARS-CoV-2 infection was approximately 83% lower for patients who received Evusheld (OR =0.18, 95% CI: 0.08 to 0.38, p<0.001). Further, the rate of hospitalization was available for 62 of 63 (98.4%) patients with a SARS-CoV-2 infection. Among these patients, no patient in the Evusheld group required hospitalization; conversely, 12 of 51 (23.5%) patients who did not receive Evusheld required hospitalization (OR =0.39, 95% CI: 0.00 to 2.38, p=0.21). Evusheld administration was associated with significant efficacy in the prevention of SARS-CoV-2 infection in lung transplant recipients. [ABSTRACT FROM AUTHOR]

Published
2023
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36. Recovery of Regional but Not Global Contractile Function by the Direct Intramyocardial Autologous Bone Marrow Transplantation

Author

Eric Bijnens, Michel Ingels, Urbain Mees, Paul Dendale, Robert Geukens, Jean-Luc Rummens, Dagmara Dilling, A. Jacobs, Hanne Jongen, Johan Vijgen, Christel Clijsters, Marc Hendrikx, Paul Steels, Karen Hensen, Remco Koninckx, HENDRIKX, Marc, HENSEN, Karen, Clijsters, C., Jongen, H., KONINCKX, Remco, Bijnens, E., Ingels, M., Jacobs, A., Geukens, R., Dendale, P., VIJGEN, Jacques, Dilling, D., STEELS, Paul, Mees, Urbain, and RUMMENS, Jean-Luc

Subjects
Male, medicine.medical_specialty, Systole, Myocardial Infarction, clinical trial, myocardial infarction, stem cells, STEM-CELL TRANSPLANTATION, MYOCARDIAL-INFARCTION, PROGENITOR CELLS, REGENERATION, SKELETAL, HUMANS, Scintigraphy, Transplantation, Autologous, Cicatrix, Cardiac magnetic resonance imaging, Physiology (medical), Internal medicine, medicine, Humans, Myocardial infarction, Coronary Artery Bypass, Radionuclide Imaging, Aged, Bone Marrow Transplantation, Ejection fraction, medicine.diagnostic_test, business.industry, Heart, Stroke Volume, Stroke volume, Middle Aged, Flow Cytometry, medicine.disease, Magnetic Resonance Imaging, Myocardial Contraction, Surgery, Transplantation, Thallium Radioisotopes, Heart failure, Cardiology, Female, Radiopharmaceuticals, Cardiology and Cardiovascular Medicine, business
Abstract

Background— Recent trials have shown that intracoronary infusion of bone marrow cells (BMCs) improves functional recovery after acute myocardial infarction. However, whether this treatment is effective in heart failure as a consequence of remodeling after organized infarcts remains unclear. In this randomized trial, we assessed the hypothesis that direct intramyocardial injection of autologous mononuclear bone marrow cells during coronary artery bypass graft (CABG) could improve global and regional left ventricular ejection fraction (LVEF) at 4-month follow-up. Methods and Results— Twenty patients (age 64.8±8.7; 17 male, 3 female) with a postinfarction nonviable scar, as assessed by thallium (Tl) scintigraphy and cardiac magnetic resonance imaging (MRI), scheduled for elective CABG, were included. They were randomized to a control group (n =10, CABG only) or a BMC group (CABG and injection of 60.10 6 ±31.10 6 BMC). Primary end points were global LVEF change and wall thickening changes in the infarct area from baseline to 4-month follow-up, as measured by MRI. Changes in metabolic activity were measured by Tl scintigraphy and expressed as a score with a range from 0 to 4, corresponding to percent of maximal myocardial Tl uptake (4 indicates 80%). Global LVEF at baseline was 39.5±5.5% in controls and 42.9±10.3% in the BMC group ( P =0.38). At 4 months, LVEF had increased to 43.1±10.9% in the control group and to 48.9±9.5% in the BMC group ( P =0.23). Systolic thickening had improved from −0.6±1.3 mm at baseline to 1.8±2.6 mm at 4 months in the cell-implanted scars, whereas nontreated scars remained largely akinetic (−0.5±2.0 mm at baseline compared with 0.4±1.7 mm at 4 months, P =0.007 control versus BMC-treated group at 4 months). Defect score decreased from 4 to 3.3±0.9 in the BMC group and to 3.7±0.4 in the control group ( P =0.18). Conclusions— At 4 months, there was no significant difference in global LVEF between both groups, but a recovery of regional contractile function in previously nonviable scar was observed in the BMC group.

Published
2006

37. The Role of Genetic Testing in Pulmonary Fibrosis: A Perspective From the Pulmonary Fibrosis Foundation Genetic Testing Work Group.

Author

Newton CA, Oldham JM, Applegate C, Carmichael N, Powell K, Dilling D, Schmidt SL, Scholand MB, Armanios M, Garcia CK, Kropski JA, and Talbert J

Subjects
Humans, United States, Genetic Testing, Idiopathic Pulmonary Fibrosis genetics
Abstract

Patients with familial pulmonary fibrosis represent a subset of patients with pulmonary fibrosis in whom inherited gene variation predisposes them to disease development. In the appropriate setting, genetic testing allows for personalized assessment of disease, recognition of clinically relevant extrapulmonary manifestations, and assessing susceptibility in unaffected relatives. However currently, the use of genetic testing is inconsistent, partly because of the lack of guidance regarding high-yield scenarios in which the results of genetic testing can inform clinical decision-making. To address this, the Pulmonary Fibrosis Foundation commissioned a genetic testing work group comprising pulmonologists, geneticists, and genetic counselors from the United States to provide guidance on genetic testing in patients with pulmonary fibrosis. This CHEST special feature presents a concise review of these proceedings and reviews pulmonary fibrosis susceptibility, clinically available genetic testing methods, and clinical scenarios in which genetic testing should be considered., (Copyright © 2022 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Published
2022
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40. Lung Transplant Pulmonologists' Views of Specialty Palliative Care for Lung Transplant Recipients.

Author

Nolley E, Fleck J, Kavalieratos D, Dew MA, Dilling D, Colman R, Crespo MM, Goldberg H, Hays S, Hachem R, Lease E, Lee J, Reynolds J, Morrell M, and Schenker Y

Subjects
Humans, Lung, Palliative Care, Pulmonologists, Quality of Life, Transplant Recipients, Lung Transplantation, Medicine
Abstract

Background: Lung transplant recipients with serious illness may benefit from but rarely receive specialty palliative care (SPC) services. Transplant pulmonologists' views of SPC may be key to understanding SPC utilization but have not been well characterized. Objectives: (1) To understand how transplant pulmonologists view SPC and decide to refer transplant recipients and (2) to identify unique aspects of lung transplantation that may influence referral decisions. Design: We conducted semistructured interviews with transplant pulmonologists at nine geographically diverse high-volume North American transplant centers with SPC services. A multidisciplinary team analyzed interview transcripts using constant comparative methods to inductively develop and refine a coding framework related to SPC views and referral decisions. Results: We interviewed 38 transplant pulmonologists; most (36/38) had referred lung transplant recipients to SPC. Participants described SPC as a medical specialty that aims to improve quality of life and distinguished SPC from hospice care, which was considered end-of-life care. Participants who viewed transplant as a temporary solution ( n  = 17/38, 45%) described earlier utilization of SPC alongside disease-directed therapies, whereas those who viewed transplant as survival-focused ( n  = 21/38, 55%) described utilization of SPC after disease-directed therapies were exhausted. Concerns about one-year survival metrics and use of addicting medications for symptom palliation were barriers to referral. Conclusions: Transplant pulmonologists' SPC referral practices may be related to their views of lung transplantation. Optimizing use of SPC in lung transplantation will require improving communication between transplant pulmonology and SPC to ensure a collaborative effort toward patient-centered goals while addressing unique barriers to SPC referral.

Published
2020
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43. ALN-RSV01 for prevention of bronchiolitis obliterans syndrome after respiratory syncytial virus infection in lung transplant recipients.

Author

Gottlieb J, Zamora MR, Hodges T, Musk AW, Sommerwerk U, Dilling D, Arcasoy S, DeVincenzo J, Karsten V, Shah S, Bettencourt BR, Cehelsky J, Nochur S, Gollob J, Vaishnaw A, Simon AR, and Glanville AR

Subjects
Adult, Bronchiolitis Obliterans etiology, Double-Blind Method, Female, Humans, Male, Middle Aged, Postoperative Complications, Syndrome, Treatment Outcome, Antiviral Agents therapeutic use, Bronchiolitis Obliterans prevention & control, Lung Transplantation, RNA, Small Interfering therapeutic use, Respiratory Syncytial Virus Infections complications
Abstract

Background: Respiratory syncytial virus (RSV) infection in lung transplant (LTx) patients is associated with an increased incidence of bronchiolitis obliterans syndrome (BOS). ALN-RSV01 is a small interfering RNA targeting RSV replication that was shown in an earlier Phase 2a trial to be safe and to reduce the incidence of BOS when compared with placebo., Methods: We performed a Phase 2b randomized, double-blind, placebo-controlled trial in RSV-infected LTx patients to examine the impact of ALN-RSV01 on the incidence of new or progressive BOS. Subjects were randomized (1:1) to receive aerosolized ALN-RSV01 or placebo daily for 5 days., Results: Of 3,985 symptomatic patients screened, 218 were RSV-positive locally, of whom 87 were randomized to receive ALN-RSV01 or placebo (modified intention-to-treat [mITT] cohort). RSV infection was confirmed by central laboratory in 77 patients (ALN-RSV01, n = 44; placebo, n = 33), which comprised the primary analysis cohort (central mITT [mITTc]). ALN-RSV01 was found to be safe and well-tolerated. At Day 180, in ALN-RSV01-treated patients, compared with placebo, in the mITTc cohort there was a trend toward a decrease in new or progressive BOS (13.6% vs 30.3%, p = 0.058), which was significant in the per-protocol cohort (p = 0.025). Treatment effect was enhanced when ALN-RSV01 was started <5 days from symptom onset, and was observed even without ribavirin treatment. There was no significant impact on viral parameters or symptom scores., Conclusions: These results confirm findings of the earlier Phase 2a trial and provide further support that ALN-RSV01 reduces the risk of BOS after RSV in LTx recipients., (Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Published
2016
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44. The prevalence and extent of gastroesophageal reflux disease correlates to the type of lung transplantation.

Author

Fisichella PM, Davis CS, Shankaran V, Gagermeier J, Dilling D, Alex CG, Kovacs EJ, Joehl RJ, and Love RB

Subjects
Adult, Aged, Barium Sulfate, Barrett Esophagus etiology, Barrett Esophagus physiopathology, Contrast Media, Female, Gastric Emptying physiology, Gastroesophageal Reflux physiopathology, Hernia, Hiatal diagnostic imaging, Hernia, Hiatal etiology, Humans, Hydrogen-Ion Concentration, Lung Transplantation methods, Male, Manometry, Middle Aged, Monitoring, Ambulatory methods, Radiography, Radiopharmaceuticals, Reoperation, Retrospective Studies, Technetium Tc 99m Sulfur Colloid, Gastroesophageal Reflux etiology, Lung Transplantation adverse effects
Abstract

Background: Evidence is increasingly convincing that lung transplantation is a risk factor of gastroesophageal reflux disease (GERD). However, it is still not known if the type of lung transplant (unilateral, bilateral, or retransplant) plays a role in the pathogenesis of GERD., Study Design: The records of 61 lung transplant patients who underwent esophageal function tests between September 2008 and May 2010, were retrospectively reviewed. These patients were divided into 3 groups based on the type of lung transplant they received: unilateral (n=25); bilateral (n=30), and retransplant (n=6). Among these groups we compared: (1) the demographic characteristics (eg, sex, age, race, and body mass index); (2) the presence of Barrett esophagus, delayed gastric emptying, and hiatal hernia; and (3) the esophageal manometric and pH-metric profile., Results: Distal and proximal reflux were more prevalent in patients with bilateral transplant or retransplant and less prevalent in patients after unilateral transplant, regardless of the cause of their lung disease. The prevalence of hiatal hernia, Barrett esophagus, and the manometric profile were similar in all groups of patients., Conclusions: Although our data show a discrepancy in prevalence of GERD in patients with different types of lung transplantation, we cannot determine the exact cause for these findings from this study. We speculate that the extent of dissection during the transplant places the patients at risk for GERD. On the basis of the results of this study, a higher level of suspicion of GERD should be held in patients after bilateral or retransplantation.

Published
2012
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45. Laparoscopic antireflux surgery for gastroesophageal reflux disease after lung transplantation.

Author

Fisichella PM, Davis CS, Gagermeier J, Dilling D, Alex CG, Dorfmeister JA, Kovacs EJ, Love RB, and Gamelli RL

Subjects
Adult, Barrett Esophagus mortality, Barrett Esophagus physiopathology, Esophagitis mortality, Esophagitis physiopathology, Esophagus physiopathology, Female, Gastroesophageal Reflux physiopathology, Hernia, Hiatal mortality, Hernia, Hiatal physiopathology, Humans, Hydrogen-Ion Concentration, Lung Diseases mortality, Lung Diseases surgery, Male, Manometry, Middle Aged, Morbidity, Postoperative Complications physiopathology, Prevalence, Retrospective Studies, Risk Factors, Gastroesophageal Reflux mortality, Gastroesophageal Reflux surgery, Laparoscopy mortality, Lung Transplantation mortality, Postoperative Complications mortality, Postoperative Complications surgery
Abstract

Background: Although gastroesophageal reflux disease (GERD) is highly prevalent in lung transplantation, the pathophysiology of GERD in these patients is unknown. We hypothesize that the pathophysiology of GERD after lung transplantation differs from that of a control population, and that the 30-d morbidity and mortality of laparoscopic antireflux surgery (LARS) are equivalent in both populations., Methods: We retrospectively compared the pathophysiology of GERD and the 30-d morbidity and mortality of 29 consecutive lung transplant patients with 23 consecutive patients without lung transplantation (control group), all of whom had LARS for GERD between November 2008 and May 2010., Results: Both groups had a similar prevalence of endoscopic esophagitis and Barrett's esophagus , comparable manometric profiles, and similar prevalence of abnormal peristalsis. However, hiatal hernia was more common in controls than in lung transplant patients (57% versus 24%; P = 0.04). Lung transplant patients had a higher prevalence and severity of proximal GERD (65% versus 33%; P = 0.04). The 30-d morbidity and mortality following LARS were similar in both groups regardless of the higher surgical risk of lung transplants (median ASA class: 3 versus 2 for controls, P < 0.001)., Conclusions: These results show that despite similar manometric profiles, lung transplant patients are more prone to proximal reflux than the general population with GERD; the prevalence of endoscopic esophagitis and Barrett's esophagus is the same in both groups of patients; a hiatal hernia is uncommon after lung transplantation; and the morbidity and mortality of LARS are the same for lung transplant patients as the general population with GERD., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Published
2011
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46. Gastroesophageal reflux disease after lung transplantation: pathophysiology and implications for treatment.

Author

Davis CS, Shankaran V, Kovacs EJ, Gagermeier J, Dilling D, Alex CG, Love RB, Sinacore J, and Fisichella PM

Subjects
Adult, Barrett Esophagus epidemiology, Female, Gastroesophageal Reflux diagnosis, Gastroesophageal Reflux etiology, Humans, Male, Middle Aged, Prevalence, Risk Factors, Young Adult, Gastroesophageal Reflux epidemiology, Gastroesophageal Reflux physiopathology, Lung Transplantation
Abstract

Background: Gastroesophageal reflux disease (GERD) is thought to be a risk factor for the development or progression of chronic rejection after lung transplantation. However, the prevalence of GERD and its risk factors, including esophageal dysmotility, hiatal hernia and delayed gastric emptying after lung transplantation, are still unknown. In addition, the prevalence of Barrett's esophagus, a known complication of GERD, has not been determined in these patients. The purpose of this study was to determine the prevalence and extent of GERD, as well as the frequency of these risk factors and complications of GERD in lung transplant patients., Methods: Thirty-five consecutive patients underwent a combination of esophageal function testing, upper endoscopy, barium swallow, and gastric emptying scan after lung transplantation., Results: In this patient population, the prevalence of GERD was 51% and 22% in those who had been retransplanted. Of patients with GERD,36% had ineffective esophageal motility (IEM), compared with 6% of patients without GERD (P = .037). No patient demonstrated hiatal hernia on barium swallow. The prevalence of delayed gastric emptying was 36%. The prevalence of biopsy-confirmed Barrett's esophagus was 12%., Conclusion: Our study shows that, after lung transplantation, more than half of patients had GERD, and that GERD was more common after retransplantation. IEM and delayed gastric emptying are frequent in patients with GERD. Hiatal hernia is rare. The prevalence of Barrett's esophagus is not negligible. We conclude that GERD is highly prevalent after lung transplantation, and that delayed gastric emptying and Barrett's esophagus should always be suspected after lung transplantation because they are common risks factors and complications of GERD., (Copyright © 2010 Mosby, Inc. All rights reserved.)

Published
2010
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48. Comparison of turbidimetric aggregation and in vitro bleeding time (PFA-100) for monitoring the platelet inhibitory profile of antiplatelet agents in patients undergoing stent implantation.

Author

Van der Planken MG, Claeys MJ, Vertessen FJ, Dilling D, Bosmans JM, Berneman ZN, Michiels JJ, and Vrints C

Subjects
Abciximab, Adenosine Diphosphate metabolism, Aged, Angina Pectoris metabolism, Antibodies, Monoclonal therapeutic use, Aspirin therapeutic use, Clopidogrel, Collagen metabolism, Female, Humans, Immunoglobulin Fab Fragments therapeutic use, Male, Middle Aged, Platelet Aggregation, Ticlopidine therapeutic use, Time Factors, Bleeding Time, Nephelometry and Turbidimetry methods, Platelet Aggregation Inhibitors pharmacology, Platelet Aggregation Inhibitors therapeutic use, Platelet Function Tests methods, Stents, Ticlopidine analogs & derivatives
Abstract

The present study compared classical ADP-induced platelet aggregation vs. PFA-100 closure times using collagen/ADP membrane cartridges to monitor the degree of platelet-inhibiting effect of three drug regimens: ticlopidin, abciximab/ticlopidin and loading dose clopidogrel, each on top of aspirin (acetylsalicylic acid, ASA) during and after elective stent placement (intervention) in a total of 31 patients with acute coronary syndrome. Ticlopidin was started directly after stent implantation, abciximab was started before coronary intervention and given intravenously for 12 h, and a clopidogrel loading dose was given before intervention. The 10 patients treated with ticlopidin (500 mg daily) showed no significant prolongation of PFA closure times and a slight increase of ADP-induced platelet aggregation shortly after intervention. In 11 patients treated with abciximab/ticlopidin, the PFA closure times were significantly prolonged, and ADP-induced platelet aggregation was reduced by more than 80% during the 12-h abciximab infusion after intervention. The 10 patients pretreated with loading dose clopidogrel (450 mg followed by 75 mg daily) showed an intermediate but significant prolongation of PFA closure times and reduction of ADP-induced platelet aggregation at levels between the ticlopidin/aspirin- and the abciximab/ticlopidin/aspirin-treated groups. At 20 h after intervention, a similar degree of PFA closure time prolongation and inhibition of ADP-induced aggregation was observed in the abciximab/ticlopidin/aspirin- and the clopidogrel/aspirin-treated patient groups. Both measurement of PFA-100 closure times and inhibition of ADP-induced platelet aggregation showed a similar degree of platelet inhibition, but had rather broad SD ranges, which limit their precision for the follow-up of individual patients. In conclusion, abciximab on top of ticlopidin/aspirin showed a stronger antiplatelet effect for only less than 20 h, as compared to loading dose clopidogrel/aspirin in acute coronary syndrome patients undergoing stent implantation. Whether such a short-term superiority of abciximab, as compared to loading dose clopidogrel, translates into an overall clinical benefit of thombotic and bleeding complications remains to be established in a randomized clinical trial.

Published
2003
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49. Unsuccessful long-term outcome after treatment of a vein graft false aneurysm with a polytetrafluoethylene-coated Jostent.

Author

Bosmans JM, Claeys MJ, Dilling D, and Vrints CJ

Subjects
Aneurysm, False diagnostic imaging, Aneurysm, False etiology, Coated Materials, Biocompatible, Coronary Angiography, Coronary Disease diagnosis, Coronary Disease surgery, Graft Occlusion, Vascular diagnostic imaging, Humans, Male, Middle Aged, Recurrence, Saphenous Vein diagnostic imaging, Saphenous Vein pathology, Time Factors, Treatment Outcome, Ultrasonography, Interventional, Aneurysm, False therapy, Angioplasty, Balloon, Coronary instrumentation, Coronary Artery Bypass adverse effects, Graft Occlusion, Vascular therapy, Polytetrafluoroethylene, Stents adverse effects
Abstract

We describe a case in which a stented ulcerated plaque in an old vein graft ruptured to a huge false aneurysm. By the use of a PTFE-coated Jostent, the false aneurysm could be percutaneously closed. However, 6 months later, a new false aneurysm, probably due to focal perforation of the covered Jostent, developed.

Published
2000
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