The HRT Mitral Bridge Technology for Functional MR

Transcription

1 The HRT Mitral Bridge Technology for Functional MR Carlos E. Ruiz, MD, PhD, FACC, FESC, MSCAI Professor of Cardiology in Pediatrics and Medicine Director of Structural and Congenital Heart Disease Program

2 Disclosure Statement of Financial Interest Grant / Research Support Philips St Jude Medical Consulting Fees / Honoraria Valtech St. Jude Medical LivaNova V A Subramanian, MD: Inventor, Founder and CMO of HRT, Inc. Royalty / Intellectual Property Rights Stepan Gore Cerny MD PhD: P.I of the CE Mark Trial (Na Homolce Hospital, Stock Shareholder / Equity Prague, Czech Republic) Vascular Therapies MitrAssist Entourage BioInspire Cardiac Implants Valtech Pi-Cardia HRT - Medivalve

3 Repair of FMR Early increased posterior leaflet tethering Progressive (+) LV remodeling and insufficient coaptation reserve (Mihalievic T et al. J Am Coll Cardiol. 2007;49(22): ) Rate of moderate or severe MR recurrence at 2 years is 58.8% No difference with MVR in reverse LV remodeling or survival Patients in the repair group had more serious adverse events related to HF and cardiovascular readmissions (Goldstein D, Acker MA, et al. : N Engl Med J 2015, - November DOI: /NEJMoa ) CTSN (Cardiothoracic Surgical Trials Network)

4 Echocardiographic Predictors of Recurrent MR Post-Repair Systolic Tenting Area > 2.5 cm Sphericity Index > 0.7 Coaptation Height > 10 mm Interpapillary Distance (ES) > 20 mm Posterior Angle (β) > 45 o Distal Anterior Angle (α) > 25 o MR Post-repair LVEDD and LVEDV LV Dyssynchrony Lesniak-Sobelga A, et al: Int J Cardiovasc Imaging Jan; 28(1): Kongsaerepong V, et al: Am J Cardiol 2006 Aug 15;98(4): Gelsomino S, et al: Eur Heart J 2008;29: Calafiore AM et al: Ann Thorac Surg 71: , Kuwahara E et al. Circulation 2010;122:A19809 Ciarka A, et al: Heart 97: Magne et al.: Circulation. 2009;120(11 Suppl):S104 S111 Roshanali F et al.: Ann Thorac Surg 2007;84:745 9 Onorati F et al. : Thorac Cardiovasc Surg 2009; 138: Braun J et al.: Ann Thorac Surg, 2008;85: Van Garsse L et al: Circulation 2011; 124: A15266

5 Conventional wisdom for FMR Undersized Ring Annuloplasty in attempts to improve durability of MVRp RING WARS Recurrent MR rate is near 60% at 2 years post repair Progressive and augmented tethering of the PML is a major contributor to recurrence (Kuwahara E, et al. Circulation. 2006;114[suppl I]:I-529 I-534) Undersized ring annuloplasty may be a flawed concept in FMR A new and alternative concepts in Rx of FMR is warranted

6 Mitral Bridge TM Concept A2 Transannular dynamic nitinol Bridge in S-L Anchoring Pad dimension with a centered infra annular curvature Silicon-nitinol Bridge P2 Placed between A2 P2 at annular level with standard sutures Available in 5 sizes (22-30 mm)

7 Pre-Clinical Testing Confirmation of durability by bench testing 1 billion cycles (CE Mark 400M, FDA 600M) One year chronic animal studies Juvenile sheep higher tendency to produce calcification in response to injury Stable with no device migration Minimal gradient No MACE No thromboembolisms Preservation of leaflet function and architecture Histology CONFIDENTIA

8 CE Mark Clinical Trial Study Design Prospective, observational, 30 patients with mitral regurgitation Objective Evaluate the feasibility and safety of the transannular Mitral Bridge in patients with moderatesevere to severe mitral regurgitation (ASE criteria) eligible for surgical MVRp Primary endpoints Acute procedural/device success defined by 1+ MR intraoperative and off-pump Clinical success at 1,3 and 6 Mo defined MR 1+ by TEE Freedom from reoperation MACE at 1,3 and 6 Mo All-cause mortality, cardiac mortality, valve deterioration, thrombosis, thromboembolisms, SBE, etc. Secondary endpoints Preservation or improvement of LVEF LV remodeling

9 Mitral Bridge TM CE Mark Trial Pre PRE 43.9 mm POST 27.9 mm S-L Dimension Post 3 mm Coaptation Height 9.5 mm Systolic Interpapillary Distance

10 Results 34 included 26 (76.5%) Type-I (annular dilatation) 8 (23.5) Type III-b (ischemic) Chronic AF in 30/34 LVEDD > 55 mm in 9/34 Coaptation depth > 6 mm in 8/34 34 successful implants with decrease of MR to <1+ 1 pt developed a PVL and required reoperation at 7 Mo post 1 pt developed a PVL and required 100 mg Aspirin catheter closure at18 Mo Leaflet hole leak No central MR Coapt Ht > 7mm Normal leaflets Clinical Results Follow up (months) 12,8 ± 4,7 (5 22) Early and late mortality Device related AE 0 NSR Patients Coumadin 3 Mo and dual antiplatelets for 9 Mo MACE Patients Coumadin 6 Mo and dual antiplatelets for 6 Mo All Patients after 12 Mo Device explantation 0 MACE (MI, stroke, TE) 0 Reoperation* for PVL 1 Catheter* closure PVL 1 PVL 0

11 Percutaneous Peri-Bridge Leak Repair

12 Mitral Bridge Clinical Study SLD, CoaptH, MG p < 0,001 SL diameter (mm) Coaptation height (mm) Mean gradient (mmhg) p = ns p < 0,001 p = ns p = ns. Baseline (34 pts) 1 months FU (34 pts) 3 months FU (34 pts) 6 months FU (33 pts) 12 months FU (14 pts)

13 MR Severity Follow-up

14 Mitral Bridge Clinical Study MR Grade p < 0,001 MR (grade) 2.5 p = ns Preop (34 pts) 1 months FU (34 pts) 3 months FU (34 pts) 6 months FU (33 pts) 12 months FU (14 pts) * -1

15 Mitral Bridge Clinical Study MR Grade MR (grade) Central MR (grade) 4.5 p < 0, p = ns Preop (34 pts) 1 months FU (34 pts) 3 months FU (34 pts) 6 months FU (33 pts) 12 months FU (14 pts) * -1

16 LV REMODELING Echo parameters (n=34) (n=34) (n=33) PrOp 1mo 6mo LVEDD LVSED LVEDV LVESV

17 Transeptal Delivery Transapical Delivery

18 Conclusion The Mitral Bridge eliminates MR by: Direct nonplanar reduction of S-L dimension and being compliant to annular displacement Increase in coaptation height Annular saddle shape restoration Preservation of leaflet curvature and restrain of leaflet prolapse Shortens interpapillary muscle distance At 6 Mo. it produces a significant LV reverse remodeling It is safe and effective and challanges the conventional wisdom of Mitral valve repair for FMR

19 thank you

20 Mitral Bridge Sizing A B A B Dimensions Physio Ring Mitral Bridge Septo-Lateral A B A B 26 mm mm mm mm mm

21 Mitral Bridge Clinical Study MR Grade % 90% 80% 70% 60% 50% 40% 30% % 10% 0% Baseline (34 pts) 1 months FU (34 pts) 3 months FU (34 pts) 6 months FU (33 pts) 12 months FU (14 pts)

22 Inclusion/Exclusion Criteria 21 y/o Inclusion Symptomatic 3+ MR Central regurgitant jet Insignificant secondary MR jets Candidate for surgical mitral valve repair Exclusion Severe mitral and/or annular calcification SAM Emergency surgery Chronic hemodialysis Recent stroke, TIA (within last 3 months)