A Novel Device for Tricuspid Regurgitation Reduction Featuring 3-Dimensional Leaflet and Atraumatic Anchor: Pivot-TR System

Min-Ku Chon; Seung-Whan Lee; Joo-Yong Hahn; Yong-Hyun Park; Hyun-Sook Kim; Sang-Hyun Lee; Dong-Hoon Shin; Pil Hyung Lee; Eun Kyoung Kim; Jae-Hwan Lee; Jae-Hyeong Park; Young Jin Choi; Markus Reinthaler; Fabian Barbieri; Jai-Wun Park; Junhui Park; June-Hong Kim

doi:10.1016/j.jacbts.2022.06.017

A Novel Device for Tricuspid Regurgitation Reduction Featuring 3-Dimensional Leaflet and Atraumatic Anchor: Pivot-TR System

JACC Basic Transl Sci. 2022 Nov 2;7(12):1249-1261. doi: 10.1016/j.jacbts.2022.06.017. eCollection 2022 Dec.

Authors

Min-Ku Chon¹, Seung-Whan Lee², Joo-Yong Hahn³, Yong-Hyun Park¹, Hyun-Sook Kim⁴, Sang-Hyun Lee¹, Dong-Hoon Shin⁵, Pil Hyung Lee², Eun Kyoung Kim³, Jae-Hwan Lee⁶, Jae-Hyeong Park⁷, Young Jin Choi⁸, Markus Reinthaler⁹, Fabian Barbieri⁹, Jai-Wun Park⁹, Junhui Park¹⁰, June-Hong Kim¹

Affiliations

¹ Department of Cardiology, School of Medicine, Pusan National University and Cardiovascular Center, Yagnas Hospital, Yangsan, South Korea.
² Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
³ Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
⁴ Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, South Korea.
⁵ Department of Pathology, School of Medicine, Pusan National University, Yangsan Hospital, Yangsan, South Korea.
⁶ Department of Cardiology, Chungnam National University Sejong Hospital, School of Medicine, Chungnam National University, Sejong, South Korea.
⁷ Department of Cardiology in Internal Medicine, Chungnam National University Hospital, School of Medicine, Chungnam National University, Daejeon, South Korea.
⁸ Department of Cardiology, Sejong General Hospital, Bucheon, South Korea.
⁹ Department of Cardiology, Campus Benjamin Franklin, Charité Berlin, Berlin, Germany.
¹⁰ Department of Statistics and Data Science, Yonsei University, South Korea.

Abstract

A new device called the Pivot-TR system was designed to treat tricuspid regurgitation with a novel spacer crossing the valve vertically. Its unique atraumatic anchoring system composed of both the elephant long nose and the inferior vena cava spiral anchor, in addition to the relatively easy implantation mechanism, enabled easy retrieval of the system later on. The system showed promising feasibility and safety results in this swine-based animal experiment, which should encourage human translation study.

Keywords: 3D leaflet; AP, anteroposterior; CT, computed tomography; CTI, cavotricuspid isthmus; IVC, inferior vena cava; Pivot-TR system; RA, right atrium; RV, right ventricle; TR, tricuspid regurgitation; TV, tricuspid valve; ePTFE, expanded polytetrafluoroethylene; tricuspid regurgitation; tricuspid valve.