Edwards' solution for patients suffering from tricuspid valve disease

Transcription

1 Edwards' solution for patients suffering from tricuspid valve disease R. S. von Bardeleben, MD Head Structural and Heart Valve Center Heart Center Cardiology I, University Medicine Mainz Germany

2 Potential conflicts of interest Speaker's name : R. S. von Bardeleben, Mainz I have the following potential conflicts of interest to report: RCT: Speaker: TRI Repair, Triluminate, MiBand, TriBand, RESHAPE-II, EXPAND Abbott SH, Edwards, GE, Philips, Siemens

3 Tricuspid regurgitation is frequent but rarely treated 1.6M Moderate to severe TR prevalence <8k Surgical procedures annually Numbers reflective of US data. Stuge O, Liddicoat J. Journal of Thoracic and Cardiovascular Surgery Dec;132(6): McCarthy P.M., Sales V.L. Current Treatment Options in Cardiovascular Medicine Dec;12(6):

4 Tricuspid regurgitation is associated with increased mortality 5,223 patients Study shows that moderate to severe TR increases mortality* * Independent of PASP, LVEF, IVC size, RV size/function. Nath J et. al. Journal of the American College of Cardiology Feb 4;43(3):405-9.

5 Dreyfus GD et. al. Annals of Thoracic Surgery. 2005;79(1): Functional tricuspid regurgitation is predominantly a consequence of RV and annular dilatation

6 Edwards Cardioband TM Tricuspid Valve Reconstruction System First CE-mark approved transcatheter device for the treatment of tricuspid regurgitation Transcatheter transvenous technology to treat TR through annular reduction similar to surgery Shortened learning curve for users of Cardioband mitral Mitral repair Tricuspid repair

7 Cardioband Tricuspid System Procedure 1 Femoral Access 2 Implant & System Insertion Deployment 3 Implant Size Adjustment

8 Cardioband Tricuspid System Delivers a significant and consistent reduction in tricuspid regurgitation Baseline Post reduction Courtesy of Georg Nickenig, MD, Robert Schueler, MD, Heart Center University of Bonn, Germany

9 Cardioband Tricuspid System case report Baseline patient characteristics Clinical Background Baseline 80 yo male in NYHA III-IV Isolated TR III-IV No CAD Hx of Afib Mixed lung disease Dilated RV and RA, dilated annulus SL diameter 49 to 55 mm Invasive spap 60 to 65 mmhg PCWP 18 mmhg VCA 2.7cm 2 Torrential SL 5.4 cm dilated annulus

10 Cardioband Tricuspid System case report Procedure

11 Cardioband Tricuspid System case report Implant size reduction by fluoroscopy Implant original size Implant final size

12 Cardioband Tricuspid System case report Final procedural result Pre Cardioband Post Cardioband

13 Cardioband Tricuspid System case report TR reduced at 12 & 18 months Pre Cardioband Cardioband FU 12 Mo Cardioband FU 18 Mo

14 Single arm, multi-center, prospective study to evaluate the performance and safety of the Cardioband tricuspid system for reconstruction of pathological tricuspid valves Cardioband Tricuspid System TRI-REPAIR Study

15 Edwards TRI-REPAIR Study Key study admission criteria Chronic functional tricuspid regurgitation (FTR) 2+ to 4+ on a scale of 4+ (moderate to severe) with annular diameter 40 mm with valve systolic pulmonary pressure (spap) 60mmHg New York Heart Association (NYHA) Class II-IVa Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen LVEF 30% Inclusion The local site Heart Team agrees surgery will not be offered as a treatment option Exclusion Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation moderate Previous tricuspid valve repair or replacement Presence of trans-tricuspid pacemaker or defibrillator leads which cause impingement of the tricuspid valve leaflet as evaluated by echocardiography MI or known unstable angina within the 30 days prior to the index procedure Any PCI or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure Subject is on chronic dialysis and/or has anemia (Hb < 9 g/l) Life expectancy of less than 12 months Patients with cardiac cachexia

16 Edwards TRI-REPAIR Study Participating sites Heart Center, University Hospital Bonn Georg Nickenig, MD Bichat Hospital Alec Vahanian, MD Jean-Michel Juliard, MD San Raffaele Institute Azeem M. Latib, MD LMU Klinikum der Universität München, Campus Großhadern Jörg Hausleiter, MD Universitätsmedizin der Johannes Gutenberg Universität Mainz Ralph Stephan von Bardeleben, MD Universitäres Herzzentrum Hamburg GmbH (UHZ), Hamburg Ulrich Schäfer, MD Asklepios, St. Georg Hospital Karl-Heinz Kuck, MD Heart Center University of Cologne Stephan Baldus, MD Zurich University Hospital* Francesco Maisano, MD * Site activation pending approval.

17 Edwards TRI-REPAIR Study Patient FU Baseline N=30 Death n=2 (1 device related) 30 day follow up N=28 Death n=1 (not device or procedure related) Missed visit n=1 6 month follow up N=26

18 Edwards TRI-REPAIR Study Study demographics N=30 % or Mean ± SD Age (years) 75 ± 7 Female 73% EuroSCORE II 4.1% Elevated pulmonary pressure (>35mmHg by echo) 50% Mean systolic pulmonary arterial pressure (mm Hg) 37 ± 11 LVEF 58 ± 11 Baseline NYHA class III or IV 83% Diabetes 27% Atrial fibrillation 93% Prior CABG 23% Prior valve interventions 23% Valve surgery (2x mitral, 1x aortic, 1x aortic & mitral) 13% Transcatheter valve repair/replacement 10% Moderate to severe renal failure 53% Prior stroke or TIA 17% Systemic hypertension 80% Electrodes in RV 13%

19 Edwards TRI-REPAIR Study 100% technical success Successful access, deployment and positioning of the Cardioband device 100% (30/30)

20 CEC adjudicated * Defined according to MVARC Guidelines (Stone et al, 2015) MI Myocardial Infarction Edwards TRI-REPAIR Study Safety profile Adjudicated Events 30 Days n (%) Death 2 (6.7) Stroke 1 (3.3) MI 0 Bleeding complications * 4 (13.3) Fatal 1 (3.3) Life-threatening 1 (3.3) Extensive 2 (6.7) Coronary complications 3 (10.0) Device related cardiac surgery 0 Renal failure 1 (3.3) Conduction system disturbance 1 (3.3) Ventricular arrhythmia 2 (6.7) 23/30 patients (77%) had none of the above events

21 1 Rebecca T. Hahn, MD Cardiovascular Research Foundation Edwards TRI-REPAIR Study Sustained annular reduction at 6 months by core lab 1 (paired analysis)

22 1 Rebecca T. Hahn, MD Cardiovascular Research Foundation Edwards TRI-REPAIR Study Significant reduction in TR severity at 30 days and sustained at 6 months 1

23 Edwards TRI-REPAIR Study Sustained echo improvement at 6 months by core lab 1 (paired analysis) Rebecca T. Hahn, MD Cardiovascular Research Foundation

24 Edwards TRI-REPAIR Study Functional improvement at 6 months (paired analysis) 88% MWT Six Minute Walk Test; KCCQ Kansas City Cardiomyopathy Questionnaire; NYHA New York Heart Association

25 Edwards TRI-REPAIR Study Study conclusions Patients with functional tricuspid regurgitation have a large unmet need with limited safe treatment options In early experience, the Cardioband tricuspid system provides significant reduction in EROA through annular reduction and is sustained at 6 months Clinically and statistically significant improvements in functional status, quality of life and exercise capacity at 6 months 1 st CE mark Transcatheter Tricuspid Repair System Study experience has provided valuable learnings Further studies are warranted to validate these initial promising results

26 Thank you