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521 results on '"Iwasaki, Kiyotaka"'

15. Reconstruction of a Vascular Bed with Perfusable Blood Vessels Using a Decellularized Porcine Small Intestine for Clinical Application

Author

Tobe, Yusuke, Sakaguchi, Katsuhisa, Homma, Jun, Sano, Kazunori, Kobayashi, Eiji, Sekine, Hidekazu, Iwasaki, Kiyotaka, Shimizu, Tatsuya, Umezu, Mitsuo, Magjarevic, Ratko, Series Editor, Ładyżyński, Piotr, Associate Editor, Ibrahim, Fatimah, Associate Editor, Lackovic, Igor, Associate Editor, Rock, Emilio Sacristan, Associate Editor, Shiraishi, Yasuyuki, editor, Sakuma, Ichiro, editor, Naruse, Keiji, editor, and Ueno, Akinori, editor

Published
2021
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20. Sophisticated Hydrodynamic Simulation of Pulmonary Circulation for the Preclinical Examination of Right Heart Circulatory Assist Device

Author

Tsuboko, Yusuke, Shiraishi, Yasuyuki, Yamada, Akihiro, Iwasaki, Kiyotaka, Umezu, Mitsuo, Yambe, Tomoyuki, Magjarevic, Ratko, Editor-in-Chief, Ładyżyński, Piotr, Series Editor, Ibrahim, Fatimah, Series Editor, Lacković, Igor, Series Editor, Rock, Emilio Sacristan, Series Editor, Lhotska, Lenka, editor, Sukupova, Lucie, editor, and Ibbott, Geoffrey S., editor

Published
2019
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28. Estimation Failure Risk by 0.5-mm Differences in Autologous Hamstring Graft Diameter in Anterior Cruciate Ligament Reconstruction: A Meta-analysis.

Author

Itoh, Masafumi, Itou, Junya, Okazaki, Ken, and Iwasaki, Kiyotaka

Subjects
HAMSTRING muscle surgery, ONLINE information services, MEDICAL databases, GRAFT rejection, META-analysis, MEDICAL information storage & retrieval systems, SYSTEMATIC reviews, AUTOGRAFTS, TREATMENT failure, RISK assessment, HAMSTRING muscle, DESCRIPTIVE statistics, ANTERIOR cruciate ligament surgery, ADVERSE health care events, MEDLINE, DATA analysis software, POISSON distribution, DISEASE risk factors
Abstract

Background: Because grafts are made in 0.5-mm increments clinically for anterior cruciate ligament (ACL) reconstruction, it is important to clarify how the failure rate decreases as the diameter increases. Moreover, it is important to know whether even a slight increase in the graft diameter decreases the risk of failure. Hypothesis: The risk of failure decreases significantly with each 0.5-mm increase in hamstring graft diameter. Study Design: Meta-analysis; Level of evidence, 4. Methods: The systematic review and meta-analysis have estimated the diameter-specific failure risk for each 0.5-mm increase in ACL reconstruction using autologous hamstring grafts. We searched for studies describing the relationship between graft diameter and failure rate published before December 1, 2021, in leading databases, such as PubMed, EMBASE, Cochrane Library, and Web of Science, according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We included studies using single-bundle autologous hamstring grafts to investigate the relationship between failure rate and graft diameter of 0.5-mm intervals with >1-year follow-up. Then, we calculated the failure risk caused by 0.5-mm differences in autologous hamstring graft diameter. Assuming Poisson distribution for the statistical model, we employed an extended linear mixed-effects model in the meta-analyses. Results: Five studies containing 19,333 cases were eligible. The meta-analysis revealed that the estimated value of the coefficient of diameter in the Poisson model was −0.2357 with a 95% CI of −0.2743 to −0.1971 (P <.0001). With every 1.0-mm increase in diameter, the failure rate decreased by 0.79 (0.76-0.82) times. In contrast, the failure rate increased by 1.27 (1.22-1.32) times for each 1.0-mm decrease in diameter. The failure rate significantly decreased with each 0.5-mm increase in graft diameter in the range of <7.0 to >9.0 mm from 3.63% to 1.79%. Conclusion: The risk of failure decreased correspondingly with each 0.5-mm increase in graft diameter in the range of <7.0 to >9.0 mm. Failure is multifactorial; however, increasing the graft diameter as much as possible to match each patient's anatomic space without overstuffing is an effective precaution that surgeons can take to reduce failures. [ABSTRACT FROM AUTHOR]

Published
2024
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42. A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions

Author

Iwaishi, Chie and Iwasaki, Kiyotaka

Abstract

Background:: The postmarket surveillance system plays a vital role in managing residual risks and identifying safety signals in real-world clinical practice. The Food and Drug Administration (FDA) can order postmarket surveillance studies when safety concerns are raised. We conducted a thorough investigation of device characteristics, study statuses, and the outcomes of US postmarket surveillance studies. Methods:: As of April 2017, we identified 338 orders, corresponding to 394 studies using the FDA database. Additional searches were conducted to identify safety issues or reasons for orders. Results:: Completed and active studies were limited. Fifteen of the 394 (3.8%) studies have been completed, and one study resulted in a recommendation of a labeling change. Forty-one (10.4%) studies were active. The majority of the studies (84.3%) were inactive. Three hundred fourteen (93%) orders were issued for implantable devices. The devices for use in women accounted for 144 (43%) orders. The mean from the first premarket approval or 510(k) clearance to 522 orders were 2968 days (n = 9) and 3320 days (n = 326), respectively, and the longest lag was 13,186 days. Conclusions:: Our investigation highlighted that postmarket surveillance study orders resulted in the weeding out of many of the subject medical devices. There were little clinical data produced under the program. Timely and transparent feedback from the postmarket studies are critical for informed decisions by patients and medical practitioners and in expediting patient access to innovative or advanced medical devices.

Published
2024
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46. Biomechanical Modeling to Improve Coronary Artery Bifurcation Stenting: Expert Review Document on Techniques and Clinical Implementation

Author

Antoniadis, Antonios P., Mortier, Peter, Kassab, Ghassan, Dubini, Gabriele, Foin, Nicolas, Murasato, Yoshinobu, Giannopoulos, Andreas A., Tu, Shengxian, Iwasaki, Kiyotaka, Hikichi, Yutaka, Migliavacca, Francesco, Chiastra, Claudio, Wentzel, Jolanda J., Gijsen, Frank, Reiber, Johan H.C., Barlis, Peter, Serruys, Patrick W., Bhatt, Deepak L., Stankovic, Goran, Edelman, Elazer R., Giannoglou, George D., Louvard, Yves, and Chatzizisis, Yiannis S.

Published
2015
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47. Comparison of hemodynamics and root configurations between remodeling and reimplantation methods for valve-sparing aortic root replacement: a pulsatile flow study

Author

Seki, Masahiro, primary, Kunihara, Takashi, additional, Takada, Jyunpei, additional, Sasaki, Kenichi, additional, Kumazawa, Ryo, additional, Seki, Hiroshi, additional, Sasuga, Saeko, additional, Fukuda, Hirotsugu, additional, Umezu, Mitsuo, additional, and Iwasaki, Kiyotaka, additional

Published
2022
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