Characteristics of Surgical Prosthetic Heart Valves and Problems Around Labelling: A 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

被引：2

作者：

Durko, Andras P. ^{[1
,2
]}

Head, Stuart J. ^{[1
]}

Pibarot, Philippe ^{[3
]}

Atluri, Pavan ^{[4
]}

Bapat, Vinayak ^{[5
]}

Cameron, Duke E. ^{[6
]}

Casselman, Filip P. A. ^{[7
]}

Chen, Edward P. ^{[8
]}

Dahle, Gry ^{[9
]}

Ebels, Tjark ^{[10
]}

Elefteriades, John A. ^{[11
]}

Lancellotti, Patrizio ^{[12
]}

Prager, Richard L. ^{[13
]}

Rosenhek, Raphael ^{[14
]}

Speir, Alan ^{[15
]}

Stijnen, Marco ^{[16
]}

Tasca, Giordano ^{[17
]}

Yoganathan, Ajit ^{[18
,19
]}

Walther, Thomas

De Paulis, Ruggero ^{[20
]}

机构：

[1] Erasmus MC, Dept Cardiothorac Surg, Rotterdam, Netherlands

[2] Univ Debrecen, Dept Cardiac Surg, Med & Hlth Sci Ctr, Debrecen, Hungary

[3] Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada

[4] Univ Penn, Dept Surg, Div Cardiovasc Surg, Philadelphia, PA 19104 USA

[5] Columbia Univ, New York Presbyterian, Dept Cardiovasc Surg, Med Ctr, New York, NY USA

[6] Massachusetts Gen Hosp, Dept Surg, Div Cardiac Surg, Boston, MA 02114 USA

[7] OLV Clin, Dept Cardiovasc & Thorac Surg, Aalst, Belgium

[8] Emory Univ, Sch Med, Dept Surg, Div Cardiothorac Surg, Atlanta, GA 30322 USA

[9] Oslo Univ Hosp, Rikshosp, Dept Cardiothorac & Vasc Surg, Oslo, Norway

[10] Univ Amsterdam, Dept Cardiothorac Surg, Med Ctr, Amsterdam, Netherlands

[11] Yale Univ, Dept Cardiothorac Surg, Sch Med, New Haven, CT USA

[12] Univ Liege Hosp, Dept Cardiol, GIGA Cardiovasc Sci, Liege, Belgium

[13] Univ Michigan Hosp, Dept Cardiac Surg, Ann Arbor, MI 48109 USA

[14] Med Univ Vienna, Dept Cardiol, Vienna, Austria

[15] Inova Heart & Vasc Inst, Dept Cardiac Surg, Falls Church, VA USA

[16] LifeTec Grp, Eindhoven, Netherlands

[17] Hosp A Manzoni, Cardiovasc Dept, Operat Unit Cardiac Surg, Lecce, Italy

[18] Georgia Inst Technol, Emory Sch Med, Wallace H Coulter Dept Biomed Engn, Atlanta, GA 30332 USA

[19] Goethe Univ Frankfurt, Univ Hosp Frankfurt, Dept Thorac & Cardiovasc Surg, Frankfurt, Germany

[20] European Hosp, Dept Cardiac Surg, Via Portuense 700, I-00149 Rome, Italy

来源：

ANNALS OF THORACIC SURGERY | 2019年 / 108卷 / 01期

关键词：

BIOPROSTHETIC AORTIC VALVES; SUBCLINICAL LEAFLET THROMBOSIS; PATIENT MISMATCH; HEMODYNAMIC PERFORMANCE; AMERICAN SOCIETY; REPLACEMENT; IMPACT; RECOMMENDATIONS; STENOSIS; DOPPLER;

D O I：

10.1016/j.athoracsur.2019.03.020

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labelling of SHVs rendering the comparison of different valves difficult.To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO) and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labelling of SHV size, in vivo and in vitro testing and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labelling and identifies the most important elements where further standardization is necessary. (C) 2019 by The Society of Thoracic Surgeons, The American Association for Thoracic Surgery, and the European Association for Cardio-Thoracic Surgery

引用

页码：292 / 303

页数：12

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