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1. Minimum Core Data Elements for Transcatheter Mitral Therapies: Scientific Statement by PASSION CV, HVC, and TVTR

Author

Vemulapalli, Sreekanth, Simonato, Matheus, Ben Yehuda, Ori, Wu, Changfu, Feldman, Ted, Popma, Jeffrey J., Sundareswaren, Kartik, Krohn, Carole, Hardy, Karen M., Guibone, Kimberly, Christensen, Barbara, Alu, Maria C., Ng, Vivian G., Chau, Katherine H., Chen, Shmuel, Shahim, Bahira, Vincent, Flavien, MacMahon, John, James, Stefan, Mack, Michael, Leon, Martin B., Thourani, Vinod H., Carroll, John, and Krucoff, Mitchell W.

Published
2023
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2. Standardized Definitions for Bioprosthetic Valve Dysfunction Following Aortic or Mitral Valve Replacement: JACC State-of-the-Art Review

Author

Pibarot, Philippe, Herrmann, Howard C., Wu, Changfu, Hahn, Rebecca T., Otto, Catherine M., Abbas, Amr E., Chambers, John, Dweck, Marc R., Leipsic, Jonathon A., Simonato, Matheus, Rogers, Toby, Sathananthan, Janarthanan, Guerrero, Mayra, Ternacle, Julien, Wijeysundera, Harindra C., Sondergaard, Lars, Barbanti, Marco, Salaun, Erwan, Généreux, Philippe, Kaneko, Tsuyoshi, Landes, Uri, Wood, David A., Deeb, G. Michael, Sellers, Stephanie L., Lewis, John, Madhavan, Mahesh, Gillam, Linda, Reardon, Michael, Bleiziffer, Sabine, O’Gara, Patrick T., Rodés-Cabau, Josep, Grayburn, Paul A., Lancellotti, Patrizio, Thourani, Vinod H., Bax, Jeroen J., Mack, Michael J., and Leon, Martin B.

Published
2022
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3. Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps: JACC State-of-the-Art Review

Author

Herrmann, Howard C., Pibarot, Philippe, Wu, Changfu, Hahn, Rebecca T., Tang, Gilbert H.L., Abbas, Amr E., Playford, David, Ruel, Marc, Jilaihawi, Hasan, Sathananthan, Janarthanan, Wood, David A., De Paulis, Ruggero, Bax, Jeroen J., Rodes-Cabau, Josep, Cameron, Duke E., Chen, Tiffany, Del Nido, Pedro J., Dweck, Marc R., Kaneko, Tsuyoshi, Latib, Azeem, Moat, Neil, Modine, Thomas, Popma, Jeffrey J., Raben, Jamie, Smith, Robert L., Tchetche, Didier, Thomas, Martyn R., Vincent, Flavien, Yoganathan, Ajit, Zuckerman, Bram, Mack, Michael J., and Leon, Martin B.

Published
2022
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6. Definitions of adverse events associated with extracorporeal membrane oxygenation in children: results of an international Delphi process from the ECMO-CENTRAL ARC

Author

Alexander, Peta M A, Di Nardo, Matteo, Combes, Alain, Vogel, Adam M, Antonini, Marta Velia, Barrett, Nicholas, Benedetti, Giulia M, Bettencourt, Amanda, Brodie, Daniel, Gómez-Gutiérrez, René, Gorga, Stephen M, Hodgson, Carol, Kapoor, Poonam Malhotra, Le, Jennifer, MacLaren, Graeme, O’Neil, Erika R, Ostermann, Marlies, Paden, Matthew L, Patel, Neil, Rojas-Peña, Alvaro, Said, Ahmed S, Sperotto, Francesca, Willems, Ariane, Vercaemst, Leen, Yoganathan, Ajit P, Lorts, Angela, del Nido, Pedro J, Barbaro, Ryan P, Abecasis, Francisco, Al Foudri, Huda, Anders, Marc M., Angus, Derek C., Annich, Gail M., Arachchillage, Deepa J., Akcan-Arikan, Ayse, Armstrong, Aimee K., Balcells, Joan, Barrett, Meredith, Bartlett, Robert H., Belda-Hofheinz, Sylvia, Bembea, Melania M., Best, Derek J., Bonadonna, Desiree, Boonstra, Philip S., Brogan, Thomas V, Brown, Katherine L, Butragueño-Laiseca, Laura, Butt, Warwick W., Camporota, Luigi, Cardenas, Barbara, Cascarano, Maria T., Caspi, Joseph, Chen, Eric, Chiletti, Roberto, Colombo, Giovanna G., Conte, Marisa L., Crowe, Liz, Cvetkovic, Mirjana, Dalton, Heidi J., Daverio, Marco, Davidson, Mark G., Davis, Carl, DiGeronimo, Robert J., Egbunine, Ariel, Ellis, W. Cory, Fan, Eddy, Foster, Claire C, Fraser, John F., Friedman, Matthew L., Furlong-Dillard, Jamie, Fynn-Thompson, Francis, Garcia, Alejandro V., Geppert, Jeffery, Gillette, Nicole, Grazioli, Lorenzo, Greene, Christina L, Guerguerian, Anne-Marie, Guilliams, Kristin P., Haji Fortis, Jumana Y., Hao, Jianming, Heinsar, Silver, Hejduk, Mark W., Himebauch, Adam S., Horvat, Christopher M., Hoskote, Aparna, Hou, Xiaotong, Hyslop, Robert W., Ibrahim, Nicole, Ito, Takuya, Karagiannidis, Christian, Karam, Oliver, Kaushik, Shubhi, Kilbaugh, Todd J., Kim-Campbell, Nahmah, Kirsch, Roxanne E, Kormos, Robert L., Kornberger, Angela, Krucoff, Mitchell W., Lakshminrusimha, Satyan, LaRovere, Kerri L, Leger, Pierre-Louis, Levy, Philip T., Lorusso, Roberto, Lyster, Haifa, Malone, Matthew P., McMullan, D. Michael, Mečířová, Soña, Mehran, Roxana, Merz, Scott I., Mochizuki, Shuichi, Moler, Frank W., Molla, Kalkidan, Monagle, Paul, Morgan, Gareth J., Morgan, Catherine, Morice, Marie-Claude, Muszynski, Jennifer A., Najaf, Tasnim A., Nellis, Marianne E., Newburger, Jane W., O'Rourke, P. Pearl, Ostadal, Petr, Ozment, Caroline P., Pagani, Francis D., Peek, Giles J., Polito, Angelo, Priest, John R., Raman, Lakshmi, Rintoul, Natalie E., Roy, Nathalie, Rubin, Juli, Rumford, Martha, Rycus, Peter, Ryerson, Lindsay M., Sakamoto, Wakako, Segura-Matute, Susana, Shekar, Kiran, Spinella, Philip C., Spitzer, Ernest, Starr, Joanne P., Stead, Christine, Steffen, Katherine, Steiner, Marie E., Tan, Lucy, Tasker, Robert C., Taylor, J. Michael, Thiagarajan, Ravi R., Tonna, Joseph E., Ubertini, Gina M., van Leeuwen, Grace, Vang, Eric, Ventetuolo, Corey E., Venugopal, Prem S., Weinberg, Allison, Westrope, Claire, Wu, Changfu, Wylie, Gillian, Zeymer, Uwe, Zivick, Elizabeth E., and Zochios, Vasileios

Abstract

Extracorporeal membrane oxygenation (ECMO) is a high-risk and low-volume life support with increasing clinical study. However, heterogenous outcome definitions impede data assimilation into evidence to guide practice. The Academic Research Consortium (ARC), an international collaborative forum committed to facilitating the creation of stakeholder-driven consensus nomenclature and outcomes for clinical trials of medical devices, supported the ECMO Core Elements Needed for Trials Regulation And quality of Life (ECMO-CENTRAL) ARC. The ECMO-CENTRAL ARC was assembled to develop definitions of paediatric ECMO adverse events for use in clinical trials and regulatory device evaluation. An initial candidate list of ECMO adverse events derived from the mechanical circulatory support ARC was supplemented with a review of ECMO-relevant adverse event definitions collated from literature published between Jan 1, 1988, and Feb 20, 2023. Distinct teams of international topic experts drafted separate adverse event definitions that were harmonised to existing literature when appropriate. Draft definitions were revised for paediatric ECMO relevance with input from patients, families, and an international expert panel of trialists, clinicians, statisticians, biomedical engineers, device developers, and regulatory agencies. ECMO-CENTRAL ARC was revised and disseminated across research societies and professional organisations. Up to three rounds of internet-based anonymous surveys were planned as a modified Delphi process. The expert panel defined 13 adverse event definitions: neurological, bleeding, device malfunction, acute kidney injury, haemolysis, infection, vascular access-associated injury, non-CNS thrombosis, hepatic dysfunction, right heart failure, left ventricular overload, lactic acidaemia, and hypoxaemia. Definitional structure varied. Among 165 expert panel members, 114 were eligible to vote and 111 voted. Consensus was achieved for all proposed definitions. Agreement ranged from 82% to 95%. ECMO-CENTRAL ARC paired rigorous development with methodical stakeholder involvement and dissemination to define paediatric ECMO adverse events. These definitions will facilitate new research and the assimilation of data across clinical trials and ECMO device evaluation in children.

Published
2024
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21. Glaucoma in rural China (the Rural Epidemiology for Glaucoma in China (REG-China)): a national cross-sectional study

Author

Liu, Yuanyuan, primary, Yao, Baoqun, additional, Chen, Xi, additional, Yang, Xueli, additional, Liu, Yong, additional, Xie, Zhenggao, additional, Chen, Xiaofeng, additional, Yuan, Zhigang, additional, Wang, Xingrong, additional, Hu, Dan, additional, Ma, Xiang, additional, Gao, Weiqi, additional, Wang, Ruifeng, additional, Yang, Yuzhong, additional, Chen, Song, additional, Zhang, Jingkai, additional, Song, Zuoqing, additional, Wang, Junsu, additional, Wang, Jing, additional, Pei, Jinyun, additional, Wang, Weijuan, additional, Wang, Meiyan, additional, Gao, Jun, additional, Zhang, Hongwen, additional, Tan, Lian, additional, Du, Wei, additional, Pan, Xuehui, additional, Liu, Gang, additional, Du, Xiujuan, additional, Hou, Xu, additional, Gao, Xin, additional, Zhang, Zhen, additional, Shen, Zhansheng, additional, Wu, Changfu, additional, Yan, Xiaochang, additional, Bo, Shaoye, additional, Sun, Xinghuai, additional, Tang, Nai-jun, additional, Zhang, Chun, additional, and Yan, Hua, additional

Published
2022
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23. Minimum Core Data Elements for Evaluation of TAVR : A Scientific Statement by PASSION CV, HVC, and TVT Registry

Author

Simonato, Matheus, Vemulapalli, Sreekanth, Ben-Yehuda, Ori, Wu, Changfu, Wood, Larry, Popma, Jeff, Feldman, Ted, Krohn, Carole, Hardy, Karen M., Guibone, Kimberly, Christensen, Barbara, Alu, Maria C., Chen, Shmuel, Ng, Vivian G., Chau, Katherine H., Shahim, Bahira, Vincent, Flavien, MacMahon, John, James, Stefan, Mack, Michael, Leon, Martin B., Thourani, Vinod H., Carroll, John, Krucoff, Mitchell, Simonato, Matheus, Vemulapalli, Sreekanth, Ben-Yehuda, Ori, Wu, Changfu, Wood, Larry, Popma, Jeff, Feldman, Ted, Krohn, Carole, Hardy, Karen M., Guibone, Kimberly, Christensen, Barbara, Alu, Maria C., Chen, Shmuel, Ng, Vivian G., Chau, Katherine H., Shahim, Bahira, Vincent, Flavien, MacMahon, John, James, Stefan, Mack, Michael, Leon, Martin B., Thourani, Vinod H., Carroll, John, and Krucoff, Mitchell

Abstract

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Published
2022
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24. Minimum Core Data Elements for Evaluation of TAVR

Author

Simonato, Matheus, primary, Vemulapalli, Sreekanth, additional, Ben-Yehuda, Ori, additional, Wu, Changfu, additional, Wood, Larry, additional, Popma, Jeff, additional, Feldman, Ted, additional, Krohn, Carole, additional, Hardy, Karen M., additional, Guibone, Kimberly, additional, Christensen, Barbara, additional, Alu, Maria C., additional, Chen, Shmuel, additional, Ng, Vivian G., additional, Chau, Katherine H., additional, Shahim, Bahira, additional, Vincent, Flavien, additional, MacMahon, John, additional, James, Stefan, additional, Mack, Michael, additional, Leon, Martin B., additional, Thourani, Vinod H., additional, Carroll, John, additional, and Krucoff, Mitchell, additional

Published
2022
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29. Efficacy of Percutaneous Transforaminal Endoscopic Discectomy Unilateral and Bilateral Approach for Bilateral Decompression in Treatment of Degenerative Lumbar Spinal Stenosis and Their Effects on Quality of Life

Author

Wu Changfu, Xuanhuang Chen, Lin Haibin, Cai Hanhua, Feng Zheng, and Xianbin Cai

Subjects
Degenerative lumbar spinal stenosis, Endoscopic discectomy, medicine.medical_specialty, Health (social science), Percutaneous, Quality of life, Decompression, business.industry, Health Policy, Public Health, Environmental and Occupational Health, medicine, business, Surgery
Abstract

This study aimed to explore the efficacy of percutaneous transforaminal endoscopic discectomy (PTED) unilateral and bilateral approach for bilateral decompression in the treatment of degenerative lumbar spinal stenosis (DLSS) and their effects on quality of life. Altogether 119 patients with DLSS admitted to our hospital from May 2012 to February 2014 were enrolled in this study. Patients in Group A (62 cases) were treated with PTED bilateral approach for bilateral decompression, while those in Group B (57 cases) were treated with PTED unilateral approach for bilateral decompression. The therapeutic effect and incidence of complications in the two groups were observed. Visual Analogue Scale (VAS) was used to assess the pain degree of the lower limbs. Oswestry Disability Index (ODI) was used to assess the improvement of neurological function. 36-ltem Short Form Health Survey (SF-36) developed by the Institute of Medicine was used to assess the quality of life. There were no significant differences between Group A and Group B in operative time, intraoperative blood loss, hospitalization time, the effective rate of treatment, and the incidence of complications (P>0.05). The recovery time of lumbar function in Group A was significantly shorter than that in Group B (P

Published
2021

31. Glaucoma in rural China (the Rural Epidemiology for Glaucoma in China (REG-China)): a national cross-sectional study

Author

Liu, Yuanyuan, Yao, Baoqun, Chen, Xi, Yang, Xueli, Liu, Yong, Xie, Zhenggao, Chen, Xiaofeng, Yuan, Zhigang, Wang, Xingrong, Hu, Dan, Ma, Xiang, Gao, Weiqi, Wang, Ruifeng, Yang, Yuzhong, Chen, Song, Zhang, Jingkai, Song, Zuoqing, Wang, Junsu, Wang, Jing, Pei, Jinyun, Wang, Weijuan, Wang, Meiyan, Gao, Jun, Zhang, Hongwen, Tan, Lian, Du, Wei, Pan, Xuehui, Liu, Gang, Du, Xiujuan, Hou, Xu, Gao, Xin, Zhang, Zhen, Shen, Zhansheng, Wu, Changfu, Yan, Xiaochang, Bo, Shaoye, Sun, Xinghuai, Tang, Nai-jun, Zhang, Chun, and Yan, Hua

Abstract

ObjectiveThis study aimed to investigate the prevalence of glaucoma with associated factors in the rural populations of 10 provinces in China.DesignA population-based cross-sectional study.MethodsAll participants aged 6 years or older from 10 provinces completed visual acuity testing, slit-lamp examination, ophthalmoscopy and non-contact tonometry. Glaucoma suspects underwent fundus photography, Goldmann applanation tonometry, visual field testing and gonioscopy. Glaucoma was determined according to the International Society of Geographical and Epidemiological Ophthalmology classification scheme. Associations of demographics and medical factors with glaucoma were assessed using multiple logistic regression models.ResultsFrom June 2017 to October 2018, 48 398 of 52 041 participants were included in the final analyses. The age-standardised prevalence of glaucoma was 1.7% (95% CI 1.55% to 1.78%) among the participants older than 6 years, which was 2.1% (95% CI 1.93% to 2.23%) in participants aged over 40 years. The constituent ratios of glaucoma were: 44.4% primary angle-closure glaucoma (PACG), 34.7% primary open-angle glaucoma, 2.6% congenital glaucoma and 18.3% other types of glaucoma. Increasing age, smoking, cerebral stroke, type 2 diabetes, higher education (college or more) and higher personal income were significant risk factors for PACG. The unilateral and bilateral blindness rates in the entire study population were 4.692% and 1.068%, respectively. A family history of glaucoma was a significant risk factor for the prevalence of glaucoma and blindness in at least one eye.ConclusionsRural populations have a high prevalence of glaucoma, which should be included in chronic disease management programmes in China for long-term care.

Published
2023
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35. Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: Expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)–The Society of Thoracic Surgeons (STS)–American Association for Thoracic Surgery (AATS) Valve Labelling Task Force

Author

Durko, Andras P., primary, Pibarot, Philippe, additional, Atluri, Pavan, additional, Bapat, Vinayak, additional, Cameron, Duke E., additional, Casselman, Filip P.A., additional, Chen, Edward P., additional, Dahle, Gry, additional, Elefteriades, John A., additional, Lancellotti, Patrizio, additional, Prager, Richard L., additional, Rosenhek, Raphael, additional, Speir, Alan, additional, Stijnen, Marco, additional, Tasca, Giordano, additional, Yoganathan, Ajit, additional, Walther, Thomas, additional, De Paulis, Ruggero, additional, Durko, Andras P., additional, de Hart, Jurgen, additional, Ibrahim, Nicole, additional, Laschinger, John, additional, Wu, Changfu, additional, Di Rienzo, Giovanni, additional, McLaren, Alexander, additional, Randall, Hazel, additional, Becker, Lisa, additional, Capps, Scott, additional, Duncan, Brian, additional, Green, Chad, additional, Hay, John C., additional, Head, Stuart J., additional, Ieropoli, Ornella, additional, Jacob, Ashwini A., additional, Kappetein, A. Pieter, additional, Manasse, Eric, additional, Marquez, Salvador, additional, Northrup, William F., additional, Ryan, Tim, additional, and Smith, Wendel, additional

Published
2021
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41. Prevalence and Risk Factors of Glaucoma in Rural China (the Rural Epidemiology for Glaucoma in China [REG-China]): A National Cross-Sectional Study

Author

Yao, Baoqun, primary, Chen, Xi, additional, Yang, Xueli, additional, Liu, Yong, additional, Xie, Zhenggao, additional, Chen, Xiaofeng, additional, Yuan, Zhigang, additional, Wang, Xingrong, additional, Hu, Dan, additional, Ma, Xiang, additional, Gao, Weiqi, additional, Wang, Ruifeng, additional, Yang, Yuzhong, additional, Chen, Song, additional, Zhang, Jingkai, additional, Song, Zuoqing, additional, Wang, Junsu, additional, Wang, Jing, additional, Pei, Jinyun, additional, Wang, Weijuan, additional, Wang, Meiyan, additional, Gao, Jun, additional, Zhang, Hongwen, additional, Tan, Lian, additional, Du, Wei, additional, Pan, Xuehui, additional, Liu, Gang, additional, Du, Xiujuan, additional, Hou, Xu, additional, Gao, Xin, additional, Zhang, Zhen, additional, Shen, Zhansheng, additional, Wu, Changfu, additional, Yan, Xiaochang, additional, Bo, Shaoye, additional, Zhang, Chun, additional, Sun, Xinghuai, additional, Tang, Nai-Jun, additional, and Yan, Hua, additional

Published
2020
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42. Rural Glaucoma in China: Present Status and Future Directions

Author

Yao, Baoqun, primary, Chen, Xi, additional, Liu, Yong, additional, Xie, Zhenggao, additional, Chen, Xiaofeng, additional, Yuan, Zhigang, additional, Wang, Xingrong, additional, Hu, Dan, additional, Ma, Xiang, additional, Gao, Weiqi, additional, Wang, Ruifeng, additional, Yang, Yuzhong, additional, Chen, Song, additional, Zhang, Jingkai, additional, Song, Zuoqing, additional, Wang, Junsu, additional, Wang, Jing, additional, Pei, Jinyun, additional, Wang, Weijuan, additional, Wang, Meiyan, additional, Gao, Jun, additional, Zhang, Hongwen, additional, Tan, Lian, additional, Du, Wei, additional, Pan, Xuehui, additional, Liu, Gang, additional, Du, Xiujuan, additional, Hou, Xu, additional, Gao, Xin, additional, Zhang, Zhen, additional, Shen, Zhansheng, additional, Wu, Changfu, additional, Yan, Xiaochang, additional, Bo, Shaoye, additional, Zhang, Chun, additional, Sun, Xinghuai, additional, Tang, Nai-Jun, additional, and Yan, Hua, additional

Published
2020
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47. Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies

Author

Pappas, Gregory, primary, Berlin, Jesse, additional, Avila-Tang, Erika, additional, Carroll, John, additional, Drozda, Joseph, additional, Dumont, Douglas, additional, Gross, Thomas, additional, Hewitt, Kathleen, additional, Kirtane, Ajay, additional, Kong, David, additional, Krucoff, Mitchell, additional, Lashinger, John, additional, Lew, Nellie, additional, Mack, Michael, additional, Masoudi, Fred, additional, Marinac-Dabic, Danica, additional, Mehran, Roxanna, additional, Normand, Sharon-Lise, additional, Quin, Elizabeth, additional, Resnic, Fred, additional, Sedrakyan, Art, additional, Waksman, Ronald, additional, Wood, Larry, additional, Wu, Changfu, additional, and Ziegler, Tianay, additional

Published
2019
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48. Biomechanics and anterior cruciate ligament reconstruction

Author

Vercillo Fabio, Dede Ozgur, Wu Changfu, Woo Savio, and Noorani Sabrina

Subjects
Orthopedic surgery, RD701-811, Diseases of the musculoskeletal system, RC925-935
Abstract

Abstract For years, bioengineers and orthopaedic surgeons have applied the principles of mechanics to gain valuable information about the complex function of the anterior cruciate ligament (ACL). The results of these investigations have provided scientific data for surgeons to improve methods of ACL reconstruction and postoperative rehabilitation. This review paper will present specific examples of how the field of biomechanics has impacted the evolution of ACL research. The anatomy and biomechanics of the ACL as well as the discovery of new tools in ACL-related biomechanical study are first introduced. Some important factors affecting the surgical outcome of ACL reconstruction, including graft selection, tunnel placement, initial graft tension, graft fixation, graft tunnel motion and healing, are then discussed. The scientific basis for the new surgical procedure, i.e., anatomic double bundle ACL reconstruction, designed to regain rotatory stability of the knee, is presented. To conclude, the future role of biomechanics in gaining valuable in-vivo data that can further advance the understanding of the ACL and ACL graft function in order to improve the patient outcome following ACL reconstruction is suggested.

Published
2006
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