Ανεπάρκεια Τριγλώχινας Επιλογή Επεμβατικής Θεραπείας. Μ. Χρυσοχέρης Τμήμα Διαδερμικών Βαλβίδων ΔΘΚΑ ΥΓΕΙΑ

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1 Ανεπάρκεια Τριγλώχινας Επιλογή Επεμβατικής Θεραπείας Μ. Χρυσοχέρης Τμήμα Διαδερμικών Βαλβίδων ΔΘΚΑ ΥΓΕΙΑ

2 Disclosures - Proctoring activities for Abbott Vascular, Edwards Lifesciences I and the HYGEIA Hospital «Heart Team» have received research and/or travel grants and/or lecture fees from: - ABBOTT Vascular, Europe, Edwards Lifesciences, Medtronic HYGEIA Hospital Heart Team Cardiologists: G. Kourkoveli, K Papadopoulos, A Halapas, M Chrissoheris, N. Georgakopoulos, K Spargias CT Surgeons: G. Pattakos, N Bouboulis, S Skardoutsos, A Tsolakis, S Pattakos Anesthesiologist: N.Papanikolaou, I Nikolaou Pediatric and Adult Congenital Cardiology: A Tzifa Vascular Surgeons: I Belos, S Kaliafas Radiologists: F Laspas, C Mourmouris Electrophysiology: L Papavassiliou, S. Kourouklis, G Zervopoulos, T Apostolopoulos Research Nurse: E. Dafnomyli

3 Decompensated Tricuspid Regurgitation Decrease in exercise tolerance, fatigue, asthenia (low cardiac output) Elevated central venous pressures Edema, ascites, abdominal fullness, hepatic congestion, ascites, distended neck veins Atrial fibrillation often present

4 Changes in Anatomy of the Tricuspid Valve in Functional Tricuspid Regurgitation Heart 2015;101:1840

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6 Heart 2015;101:1840

7 Annuloplasty techniques

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9 Transcatheter Options for Tricuspid Valve Repair ANNULOPLASTY Cardioband TriAlign Tricinch EDGE TO EDGE MitraClip Pascal VALVE IN VALVE / RING Sapien Melody TRANSCATHETER TRICUSPID VALVE IMPLANTATION NaviGate Valve SPACER Implantation Edwards FORMA CAVAL VALVE IMPLANTATION (CAVI)

10 Transcatheter Options for Tricuspid Valve Repair Most devices are in early feasibility trials, some have progressed to CE mark trials Patient population commonly high risk, inoperable patients with functional tricuspid regurgitation, often massive or torrential TR, with advanced heart failure All devices require MULTIMODALITY imaging (TTE, TEE, 3D/4D, cardiac CT with reconstructions, occasionaly 3D printing) Encouraging results in short term, however long term efficacy and survival advantage remain to be seen

11 Interventional Tricuspid Valve Therapies: The TriValve Registry

12 TEE Imaging for Tricuspid Interventions

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15 European Heart Journal - Cardiovascular Imaging (2017) 0, 1 2 doi: /ehjci/jex139

16 Evaluation of right ventricular size and function: A critical aspect of tricuspid regurgitation J Am Soc Echocardiogr 2015;28:1 39.e14.

17 TEE Imaging for Tricuspid Interventions

18 Multimodality Imaging: Cardiac CT for Tricuspid

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21 Transcatheter Options for Tricuspid Valve Repair ANNULOPLASTY Cardioband TriAlign Tricinch EDGE TO EDGE MitraClip Pascal VALVE IN VALVE / RING Sapien Melody TRANSCATHETER TRICUSPID VALVE IMPLANTATION NaviGate Valve SPACER Implantation Edwards FORMA CAVAL VALVE IMPLANTATION (CAVI)

22 Transcatheter Valve in Valve for Severe Degeneration of Surgical Tricuspid Valve

23 Transcatheter Options for Tricuspid Valve Repair ANNULOPLASTY Cardioband TriAlign Tricinch EDGE TO EDGE MitraClip Pascal VALVE IN VALVE / RING Sapien Melody TRANSCATHETER TRICUSPID VALVE IMPLANTATION NaviGate Valve SPACER Implantation Edwards FORMA CAVAL VALVE IMPLANTATION (CAVI)

24 MitraClip for the Tricuspid Valve A S P P S A

25 N=64 patients Mean age 76 ± 10 years Functional TR in 88% Severe or massive TR in 88% Successful implant 97% TR grade reduced by at least 1 grade in 91% Significant reductions in effective regurgitant orifice area (0.9±0.3cm 2 vs.0.4±0.2cm 2 ; p<0.001), vena contracta width (1.1±0.5cm vs. 0.6±0.3cm; p=0.001) and regurgitant volume (57.2±12.8ml/beat vs. 30.8±6.9ml/beat; p<0.001) Circulation. 2017;CIRCULATIONAHA

26 Edge to Edge Tricuspid Valve Repair: MitraClip (with ICE Imaging) Pozoli A et al: Eurointervention 2017

27 Edge to Edge Tricuspid Valve Repair: PASCAL System JACC: CARDI OVASCULAR INTERVENTIONS VOL. 11, NO. 4, 2018

28 Transcatheter Options for Tricuspid Valve Repair ANNULOPLASTY Cardioband TriAlign Tricinch EDGE TO EDGE MitraClip Pascal VALVE IN VALVE / RING Sapien Melody TRANSCATHETER TRICUSPID VALVE IMPLANTATION NaviGate Valve SPACER Implantation Edwards FORMA CAVAL VALVE IMPLANTATION (CAVI)

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31 Transcatheter Options for Tricuspid Valve Repair ANNULOPLASTY Cardioband TriAlign Tricinch EDGE TO EDGE MitraClip Pascal VALVE IN VALVE / RING Sapien Melody TRANSCATHETER TRICUSPID VALVE IMPLANTATION NaviGate Valve SPACER Implantation Edwards FORMA CAVAL VALVE IMPLANTATION (CAVI)

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33 Transcatheter Options for Tricuspid Valve Repair ANNULOPLASTY Cardioband TriAlign Tricinch EDGE TO EDGE MitraClip Pascal VALVE IN VALVE / RING Sapien Melody TRANSCATHETER TRICUSPID VALVE IMPLANTATION NaviGate Valve SPACER Implantation Edwards FORMA CAVAL VALVE IMPLANTATION (CAVI)

34 Edwards FORMA Repair System Designed to improve leaflet coaptation in functional TR FORMA System consists of: 1. Spacer Positioned into the regurgitant orifice Platform for native leaflet coaptation 2. Rail Tracks spacer into position Distally and proximally anchored

35 Animation

36 N=18 patients, 3 centers, compassionate use Successful implantation in 89% One RV perforation (conversion to surgery), and one device dislocation At 1-year, no deaths, one re-hospitalization for heart failure, one device thrombosis By echocardiography TR grade decreased from severe in baseline, to less than moderate-severe in and 1-year JACC: Cardiovascular Interventions Volume 10, Issue 19, 9 October 2017, Pages

37 Compassionate use of FORMA Implantation 78 year old female, NYHA IV savr (2011), CABGx1 Severe functional TR, wide jet across coaptation zone of tricuspid valve RV dilated with systolic dysfunction Mixed mitral valve disease Normal LV systolic function Comorbities: Chronic kidney disease

38 Baseline Tricuspid Regurgitation 3D Multi-planar Reconstruction 3D Color Vena Contracta Area: 2.04cm 2 Severe functional tricuspid regurgitation Wide jet across coaptation zone of tricuspid valve Color 3D regurgitant orifice area of 2.04cm 2

39 The Working Views: Transgastric Long axis: RV inflow and outflow Simultaneous Xplane at landing zone

40 INFERIOR RV WALL ANTERI OR RV WALL RV INFLOW RVOT IV SEPTU M * ANTERI OR RV WALL

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42

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44 Anchoring of the rail, prior to FORMA spacer insertion: Stable positioning in anteroseptal groove of right ventricle

45 Anchoring of rail in position: Confirmation in Xplane

46 FORMA Spacer positioning

47 FORMA Positioning: Device is more atrial and will be advanced

48 Optimal position

49 Overview of position in Full Volume 3D: Device tends to sit more septally Aortic Mitral

50 Final 2D Color TR

51 Final 3D Color

52 Tricuspid valve with FORMA in place: 3D Multiplanar Reconstruction with color Doppler 3D Color Vena Contracta Area: 0.44cm 2

53 The FORMA Spacer Study: Assess safety and device performance Inclusion Severe functional tricuspid regurgitation Symptoms NYHA 2 High risk for traditional surgical repair Exclusion Anatomical factors (small anatomy) LVEF<25% Severe pulmonary hypertension (spap>70mmhg) Also enrolling in Greece!

54 Patient with severe TR 67 year old female, NYHA IV, fatigue Severe functional tricuspid regurgitation, RV dilated, S TDI 8cm/s LVEF 35-40% RHC: RA 23mmHg, PA 47/25mmHg, PCWP 19mmHg Multiple hospitalizations for volume overload Inotropic support, iv diuretics Ascites, hepatomegaly Referral for tricuspid valve repair

55 Severe Functional Tricuspid Regurgitation Vena contracta area 3.48cm 2

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63 In Summary Transcatheter interventions are evolving, very promising early experience Tricuspid regurgitation has prognostic significance and adverse outcomes Earlier recognition and treatment Novel imaging to better understand anatomy and pathophysiology

JOINT MEETING 2 Tricuspid club Chairpersons: G. Athanassopoulos, A. Avgeropoulou, M. Khoury, G. Stavridis

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