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

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

Min-Ku Chon  1 , Seung-Whan Lee  2 , Joo-Yong Hahn  3 , Yong-Hyun Park  1 , Hyun-Sook Kim  4 , Sang-Hyun Lee  1 , Dong-Hoon Shin  5 , Pil Hyung Lee  2 , Eun Kyoung Kim  3 , Jae-Hwan Lee  6 , Jae-Hyeong Park  7 , Young Jin Choi  8 , Markus Reinthaler  9 , Fabian Barbieri  9 , Jai-Wun Park  9 , Junhui Park  10 , June-Hong Kim  1
Affiliations

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

Min-Ku Chon et al. JACC Basic Transl Sci. .

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.

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Conflict of interest statement

This work was supported by the Korea Medical Device Development Fund grant funded by the South Korean government (Ministry of Science and Information and Communication Technologies, Ministry of Trade, Industry and Energy, Ministry of Health and Welfare, and Ministry of Food and Drug Safety) (project no. RS-2020-KD000104, 1711138183). Tau-PNU Medical provided the Pivot-TR devices. Dr. J.W. Park is a medical consultant for Tau-PNU Medical. Dr. J.H. Kim is an inventor of the Pivot-TR device, is a stockholder of Tau-PNU-Medical; and is clinical director of Tau-PNU Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Structure and Mechanism of Pivot-TR Device (A) The Pivot-TR consists of 2 major parts: the pivot axis composed of the elephant nose, and the spiral anchor. (B) The C curve–shaped pivot axis (shape-memory nitinol) with the spiral anchor was designed to provide the bracing effect of the pivot system into the target site without any invasive anchoring requirement.
Figure 2
Figure 2
3D Printed Heart Bench Test for Human Translation The anteroposterior (AP) direction movement is designed to withstand well, while the lateral movement is designed to move well. The tension needed to move the 3D leaflet by 10 mm was (A) 200.5 ± 47.2 mm Hg in the AP direction and (B) 70.5 ± 32.2 mm Hg in the septolateral direction.
Figure 3
Figure 3
Procedures of the Pivot-TR (A to C) Procedural steps for Pivot-TR implantation. (D) Final position of Pivot-TR immediately postprocedure and (E) at 3-month follow-up. (F, G) Retrieval of the Pivot-TR after 2 weeks. IVC = inferior vena cava.
Figure 4
Figure 4
Echocardiographic Results (A, B) Pivot-TR device in normal valve after 24 weeks. (C to E) Tricuspid regurgitation (TR) reduction in destroyed valve: (C) baseline immediately postprocedure, (D) after 1 month, and (E) after 2 months. (F) TR reduction in normal valve (TR grade). (G) TR reduction in destroyed valve (TR grade). 1 = mild; 2 = moderate; 3 = severe; 4 = massive; 5 = torrential.
Figure 5
Figure 5
Gross and Pathology Results After 24 Weeks of Implantation in Swine (A) Pivot-TR and tricuspid valve (TV) and (B) inferior vena cava. (C) Posterior leaflet of TV, (D) anterior leaflet of TV, (E) septal leaflet of TV, (F) pulmonary valve, (G) Pulmonary artery, (H) right lung, and (I) 3D leaflet (spacer) of the Pivot-TR device (9 weeks).
Figure 6
Figure 6
Computed Tomography after 24 Weeks of Implantation in Swine Yellow arrow indicates minor nonocclusive thrombus in the pulmonary artery.
Figure 7
Figure 7
Isolated Swine Heart Pump Simulator (A) Regurgitant orifice and Pivot-TR application in functional tricuspid regurgitation model. (B) Regurgitant orifice and Pivot-TR application in destroyed tricuspid regurgitation model.
See this image and copyright information in PMC

References

    1. Asmarats L., Puri R., Latib A., Navia J.L., Rodés-Cabau J. Transcatheter tricuspid valve interventions: landscape, challenges, and future directions. J Am Coll Cardiol. 2018;71:2935–2956. - PubMed
    1. Enriquez-Sarano M., Messika-Zeitoun D., et al. Tricuspid regurgitation is a public health crisis. Prog Cardiovasc Dis. 2019;62:447–451. - PubMed
    1. Vassileva C.M., Shabosky J., Boley T., Markwell S., Hazelrigg M. Tricuspid valve surgery: the past 10 years from the Nationwide Inpatient Sample (NIS) database. J Thorac Cardiovasc Surg. 2012;143:1043–1049. - PubMed
    1. Kim J.B., Jung S.H., Choo C.H., Chung C.H., Lee D.W. Clinical and echocardiographic outcomes after surgery for severe isolated tricuspid regurgitation. J Thorac Cardiovasc Surg. 2013;146:278–284. - PubMed
    1. Curio J., Demir O.M., Pagnesi M., et al. Update on the current landscape of transcatheter options for tricuspid regurgitation treatment. Interv Cardiol. 2019;14:54–61. - PMC - PubMed

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