Transoesophageal echo-guided mitral valve repair using the Harpoon system

Transoesophageal echo-guided mitral valve repair using the Harpoon system Abstract Transapical off-pump echo-guided mitral valve repair with implantation of artificial ePTFE chordae with the Harpoon device has been proposed to treat patients presenting with severe mitral regurgitation due to posterior leaflet prolapse. The device is inserted in the left ventricle and steered to the surface of the diseased portion of the leaflet. The Harpoon device is actuated, and the leaflet is perforated by a needle that consequently releases an ePTFE chord that is fixed on the atrial surface by a double-helix coiled knot. The chord is then tensioned and fixed on the epicardial surface of the ventricle under echocardiography guidance. Mitral valve regurgitation, Mitral valve insufficiency, Mitral valve prolapse, Mitral valve flail, Mitral valve repair, Neochord, Artificial chord implantation INTRODUCTION During the last decades, minimally invasive mitral valve (MV) surgery resecting the mitral apparatus rather than the valvular tissue has been widely adopted to treat the MV. A further advancement has been the development of microinvasive mitral surgery when the mitral regurgitation is corrected not only through a small incision but also without cardiopulmonary bypass and cardioplegia [1]. Transapical off-pump MV repair with the implantation of artificial expanded polytetrafluoroethylene (ePTFE) chordae is a good example of this approach [2]. The NeoChord DS 1000 device is available in Europe and is a valuable and safe tool to treat mitral regurgitation caused by both MV prolapse and flail with good clinical results [3]. More recently, a new medical device, TSD-5, Harpoon Medical Inc. [4], has been proposed for the implantation of artificial neochordae using a similar minimally invasive transapical technique with encouraging results. Unlike the NeoChord DS100, the Harpoon device use is currently under investigation only for posterior leaflet disease. DISCUSSION In these procedures, transoesophageal echo guidance is of paramount importance for both patient selection and procedural success (Video 1). Video 1 Selected clips from the full Harpoon implantation procedure. Video 1 Selected clips from the full Harpoon implantation procedure. Close Here, we describe step by step the echo-guided surgical Harpoon procedure. Unlike the NeoChord procedure where the surgical approach is rather lateral, the apex is reached through a more anterior incision, and the device is inserted into the ventricle more closely to the left anterior descendent coronary artery [5]. Selection of the entry site of the left ventricle and navigation towards the MV apparatus is performed using biplane view at mid-commissural and long-axis views (75°–165°). After identification of the target site on the prolapsing leaflet, the device is stabilized by applying a gentle pressure on the ventricular side of the leaflet with the ‘end effector’. Further confirmation of the correct position of the device can be obtained using the 3D view from both ventricular and atrial sides, utilizing different levels of ultrasound depth that are represented by specific colours (Fig. 1A and B). Figure 1 View largeDownload slide (A and B) 2D and 3D transoesophageal echocardiography TOE showing the device stabilized to the leaflet target site by applying pressure to the ventricular side of the leaflet with the ‘end effector’. (C) 2D TOE showing the fire moment resulting in perforation of the leaflet by the 21-gauge needle wrapped with 50 coils of ePTFE in a preformed knot configuration. (D) 3D TOE showing the fire moment. (E and F) 2D-TOE and 3D TOE showing the deployed ePTFE knot on the atrial side of the diseased leaflet. AML: anterior mitral valve leaflet; PML: posterior mitral valve leaflet. Figure 1 View largeDownload slide (A and B) 2D and 3D transoesophageal echocardiography TOE showing the device stabilized to the leaflet target site by applying pressure to the ventricular side of the leaflet with the ‘end effector’. (C) 2D TOE showing the fire moment resulting in perforation of the leaflet by the 21-gauge needle wrapped with 50 coils of ePTFE in a preformed knot configuration. (D) 3D TOE showing the fire moment. (E and F) 2D-TOE and 3D TOE showing the deployed ePTFE knot on the atrial side of the diseased leaflet. AML: anterior mitral valve leaflet; PML: posterior mitral valve leaflet. At this point, the device is activated by pushing the handle fire button, and a specially designed 21-gauge needle wrapped with 50 coils of ePTFE in a preformed knot configuration perforates the leaflet (Fig. 1C and D). After needle retrieval, a double-helix ePTFE knot is formed on the atrial side of the leaflet, securing the associated pair of artificial ePTFE chords to the leaflet (Fig. 1E and F). In cases with extensive leaflet flail, stabilization of the device might be more difficult because of the limited stability offered from the floating leaflet. After knot deployment, the device is removed from the ventricle through the introducer, and the chordae are exteriorized outside the ventricular apex. To achieve the desired MV competence, the entire procedure can be repeated if additional chordae implantation is required. The desired MV coaptation is achieved by tensioning of all the chordae at the same time, under direct 2D and 3D echo guidance (Video 1). When MV coaptation and residual regurgitation are optimal, the chordae are secured on the epicardial side of the left ventricular access site in the same fashion described for the Neochord procedure [2]. Funding The present manuscript has been funded by the Harpoon Medical as part of the Mitral Trans-Apical Neochordal Echo-guided Repair (TRACER) Trial. Conflict of interest: Gino Gerosa and Augusto D’Onofrio received consulting fees from Harpoon, Inc. Andrea Colli was proctoring for NeoChord Inc. Gino Gerosa, Laura Besola and Andrea Colli received travel grants from NeoChord Inc. Andrea Colli received travel grant from Harpoon Inc. REFERENCES 1 D’Onofrio A, Gerosa G. Shifting a paradigm of cardiac surgery: from minimally invasive to micro-invasive. J Heart Valve Dis  2015; 24: 528– 30. Google Scholar PubMed  2 Colli A, Bizzotto E, Pittarello D, Gerosa G. Beating heart mitral valve repair with neochordae implantation: real-time monitoring of haemodynamic recovery. Eur J Cardiothorac Surg  2017; doi:10.1093/ejcts/ezx250. 3 Colli A, Manzan E, Zucchetta F, Bizzotto E, Besola L, Bagozzi L et al.   Transapical off-pump mitral valve repair with Neochord implantation: early clinical results. Int J Cardiol  2016; 204: 23– 8. Google Scholar CrossRef Search ADS PubMed  4 Gammie JS, Wilson P, Bartus K, Gackowski A, Hung J, D’Ambra MN et al.   Transapical beating-heart mitral valve repair with an expanded polytetrafluoroethylene cordal implantation device: initial clinical experience. Circulation  2016; 134: 189– 97. Google Scholar CrossRef Search ADS PubMed  5 Colli A, Zucchetta F, Kliger C, Bellu R, Francone M, Sedati P et al.   CT for the transapical off-pump mitral valve repair with Neochord implantation procedure. JACC Cardiovasc Imaging  2017; doi:10.1016/j.jcmg.2017.03.011. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Cardio-Thoracic Surgery Oxford University Press

Transoesophageal echo-guided mitral valve repair using the Harpoon system

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Publisher
Oxford University Press
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1010-7940
eISSN
1873-734X
D.O.I.
10.1093/ejcts/ezx365
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Abstract

Abstract Transapical off-pump echo-guided mitral valve repair with implantation of artificial ePTFE chordae with the Harpoon device has been proposed to treat patients presenting with severe mitral regurgitation due to posterior leaflet prolapse. The device is inserted in the left ventricle and steered to the surface of the diseased portion of the leaflet. The Harpoon device is actuated, and the leaflet is perforated by a needle that consequently releases an ePTFE chord that is fixed on the atrial surface by a double-helix coiled knot. The chord is then tensioned and fixed on the epicardial surface of the ventricle under echocardiography guidance. Mitral valve regurgitation, Mitral valve insufficiency, Mitral valve prolapse, Mitral valve flail, Mitral valve repair, Neochord, Artificial chord implantation INTRODUCTION During the last decades, minimally invasive mitral valve (MV) surgery resecting the mitral apparatus rather than the valvular tissue has been widely adopted to treat the MV. A further advancement has been the development of microinvasive mitral surgery when the mitral regurgitation is corrected not only through a small incision but also without cardiopulmonary bypass and cardioplegia [1]. Transapical off-pump MV repair with the implantation of artificial expanded polytetrafluoroethylene (ePTFE) chordae is a good example of this approach [2]. The NeoChord DS 1000 device is available in Europe and is a valuable and safe tool to treat mitral regurgitation caused by both MV prolapse and flail with good clinical results [3]. More recently, a new medical device, TSD-5, Harpoon Medical Inc. [4], has been proposed for the implantation of artificial neochordae using a similar minimally invasive transapical technique with encouraging results. Unlike the NeoChord DS100, the Harpoon device use is currently under investigation only for posterior leaflet disease. DISCUSSION In these procedures, transoesophageal echo guidance is of paramount importance for both patient selection and procedural success (Video 1). Video 1 Selected clips from the full Harpoon implantation procedure. Video 1 Selected clips from the full Harpoon implantation procedure. Close Here, we describe step by step the echo-guided surgical Harpoon procedure. Unlike the NeoChord procedure where the surgical approach is rather lateral, the apex is reached through a more anterior incision, and the device is inserted into the ventricle more closely to the left anterior descendent coronary artery [5]. Selection of the entry site of the left ventricle and navigation towards the MV apparatus is performed using biplane view at mid-commissural and long-axis views (75°–165°). After identification of the target site on the prolapsing leaflet, the device is stabilized by applying a gentle pressure on the ventricular side of the leaflet with the ‘end effector’. Further confirmation of the correct position of the device can be obtained using the 3D view from both ventricular and atrial sides, utilizing different levels of ultrasound depth that are represented by specific colours (Fig. 1A and B). Figure 1 View largeDownload slide (A and B) 2D and 3D transoesophageal echocardiography TOE showing the device stabilized to the leaflet target site by applying pressure to the ventricular side of the leaflet with the ‘end effector’. (C) 2D TOE showing the fire moment resulting in perforation of the leaflet by the 21-gauge needle wrapped with 50 coils of ePTFE in a preformed knot configuration. (D) 3D TOE showing the fire moment. (E and F) 2D-TOE and 3D TOE showing the deployed ePTFE knot on the atrial side of the diseased leaflet. AML: anterior mitral valve leaflet; PML: posterior mitral valve leaflet. Figure 1 View largeDownload slide (A and B) 2D and 3D transoesophageal echocardiography TOE showing the device stabilized to the leaflet target site by applying pressure to the ventricular side of the leaflet with the ‘end effector’. (C) 2D TOE showing the fire moment resulting in perforation of the leaflet by the 21-gauge needle wrapped with 50 coils of ePTFE in a preformed knot configuration. (D) 3D TOE showing the fire moment. (E and F) 2D-TOE and 3D TOE showing the deployed ePTFE knot on the atrial side of the diseased leaflet. AML: anterior mitral valve leaflet; PML: posterior mitral valve leaflet. At this point, the device is activated by pushing the handle fire button, and a specially designed 21-gauge needle wrapped with 50 coils of ePTFE in a preformed knot configuration perforates the leaflet (Fig. 1C and D). After needle retrieval, a double-helix ePTFE knot is formed on the atrial side of the leaflet, securing the associated pair of artificial ePTFE chords to the leaflet (Fig. 1E and F). In cases with extensive leaflet flail, stabilization of the device might be more difficult because of the limited stability offered from the floating leaflet. After knot deployment, the device is removed from the ventricle through the introducer, and the chordae are exteriorized outside the ventricular apex. To achieve the desired MV competence, the entire procedure can be repeated if additional chordae implantation is required. The desired MV coaptation is achieved by tensioning of all the chordae at the same time, under direct 2D and 3D echo guidance (Video 1). When MV coaptation and residual regurgitation are optimal, the chordae are secured on the epicardial side of the left ventricular access site in the same fashion described for the Neochord procedure [2]. Funding The present manuscript has been funded by the Harpoon Medical as part of the Mitral Trans-Apical Neochordal Echo-guided Repair (TRACER) Trial. Conflict of interest: Gino Gerosa and Augusto D’Onofrio received consulting fees from Harpoon, Inc. Andrea Colli was proctoring for NeoChord Inc. Gino Gerosa, Laura Besola and Andrea Colli received travel grants from NeoChord Inc. Andrea Colli received travel grant from Harpoon Inc. REFERENCES 1 D’Onofrio A, Gerosa G. Shifting a paradigm of cardiac surgery: from minimally invasive to micro-invasive. J Heart Valve Dis  2015; 24: 528– 30. Google Scholar PubMed  2 Colli A, Bizzotto E, Pittarello D, Gerosa G. Beating heart mitral valve repair with neochordae implantation: real-time monitoring of haemodynamic recovery. Eur J Cardiothorac Surg  2017; doi:10.1093/ejcts/ezx250. 3 Colli A, Manzan E, Zucchetta F, Bizzotto E, Besola L, Bagozzi L et al.   Transapical off-pump mitral valve repair with Neochord implantation: early clinical results. Int J Cardiol  2016; 204: 23– 8. Google Scholar CrossRef Search ADS PubMed  4 Gammie JS, Wilson P, Bartus K, Gackowski A, Hung J, D’Ambra MN et al.   Transapical beating-heart mitral valve repair with an expanded polytetrafluoroethylene cordal implantation device: initial clinical experience. Circulation  2016; 134: 189– 97. Google Scholar CrossRef Search ADS PubMed  5 Colli A, Zucchetta F, Kliger C, Bellu R, Francone M, Sedati P et al.   CT for the transapical off-pump mitral valve repair with Neochord implantation procedure. JACC Cardiovasc Imaging  2017; doi:10.1016/j.jcmg.2017.03.011. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Journal

European Journal of Cardio-Thoracic SurgeryOxford University Press

Published: Apr 1, 2018

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