William A. Gray MD System Chief of Cardiovascular Services, Main Line Health President, Lankenau Heart Institute Wynnewood, Pennsylvania USA
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1 William A. Gray MD System Chief of Cardiovascular Services, Main Line Health President, Lankenau Heart Institute Wynnewood, Pennsylvania USA
2 Mitral Valve Disease Today Mitral regurgitation is the most common type of heart valve insufficiency in the US Prevalence increases with increasing age, from 0.5% for yr old rising to 9.3% for 75 yo Main Line Health Lankenau Heart Institute Nkomo VT et al. Lancet. 2006; 368: AHA Heart Disease and Stroke Statistics 2017 Update, Circulation 2017
3 Mitral Valve Repair Today 5-year Results of EVEREST II Primary MR Survival >50,000 Procedures worldwide The only FDA approved TMVr device High surgical risk patients Primary MR Main Line Health Lankenau Heart Institute Feldman et al, JACC 2015;66:
4 STS/ACC TVT Registry Outcomes 564 patients treated Nov 2013-Aug 2014 Primary MR 90.8% Sorajja et al, JACC 2016;67:
5 STS/ACC TVT Registry Outcomes 2,952 patients treated Nov 2013-Sep 2015 Primary MR 85.9% Presented at TCT Sorajja et al, JACC 2017;70:
6 Functional MR, unmet need with unmet evidence base Stone, TCT 2017 Enrollment complete
7
8 Stone, TCT 2017
9 Stone, TCT 2017
10 Stone, TCT 2017
11 Stone, TCT 2017
12 Stone, TCT 2017
13 Many New Technologies
14 New TMVs devices today ARTO-MVRx System Worthley et al, TCT 2017
15 Main Line Health Lankenau Heart Institute Procedural Outcomes (Phase I/II) Characteristic All Patients (N=45) Device Technical Success (MVARC)*% 100 Compression of LCX or other coronary artery n (%) 0(0) New Onset Atrial Fibrillation, n (%) 0 (0) ARTO procedure time (mins) 88.0 ± 28.7 Fluoro Time (mins) 43.5 ± 16.2 Total Contrast Vol (ml) 96.0 ± 82.0 Days in Hospital (median) (IQR) 2.0 (1-5) Device Technical success defined as: At exit from cath lab, alive, with: 1) Successful access, delivery and retrieval of the device delivery system, and 2)Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and 3)No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
16 Effective MR Reduction at 30 days (Phase I/II)
17 30 day Safety Outcomes (Phase I/II)
18 Main Line Health Lankenau Heart Institute MR Grade Reduction Maintained to 3 years (Phase I)
19 Main Line Health Lankenau Heart Institute Reduced Heart Failure Hospitalization (Phase I) P=0.01 The post ARTO number includes a hospitalization for a patient who died but was not hospitalized
20 Main Line Health Lankenau Heart Institute NYHA Class Reduction Maintained to 3 years (Phase I) *
21 New TMVs devices today HARPOON System Gammie et al, TCT 2017
22 Harpoon: Technology 21-gauge needle with pre-wound eptfe suture in preformed knot configuration Hemostatic introducer to reduce blood loss Delivered to the valve via a low profile 3mm delivery system Double helix anchor with eptfe suture as the only implant
23
24 Harpoon Procedure
25 Real-Time Titration of eptfe Cordal Length
26 Early Feasibility Study First 13 Patients Feb 2015 Feb Safe -Effective MR Reduction Circulation. 2016;134:
27 Results Technical success rate: 95 % (41/43) Two intraoperative conversions to conventional surgery -Patient #14 poor imaging, insufficient MR reduction -Patient #23 poor imaging prolonged proc, access site bleeding Both received MV repair, No MR at D/C Procedural success at 30 days: 93% (40/43) One repaired valve MSSA infective endocarditis POD #27 Preop elevated WBC, dental disease unrecognized: successful MVR
28 Results: MR Grades 100% Mass General Core Lab Adjudicated Harpoon Patients MR Grades 12.5% 80% 60% 40% 100% 100% 100% 87.5% Severe Moderate Mild or Less 20% 0% Baseline (43) Procedure (41) Discharge (38) 30-Day (40) Excludes 3 conversions to conventional surgery
29 Harpoon Annuloplasty Effect Post 5 mm P2 Pr e
30 New TMVs devices today Edwards PASCAL TMVr System 23 patients treated with compassionate use Spacer delivered via TS approach Praz et al, Lancet 2017;390:773-80
31 New TMVs devices today Edwards PASCAL TMVr System Praz et al, Lancet 2017;390:773-80
32 Ongoing Clinical Trials today Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study Multicenter, multi-national, prospective, single arm, early feasibility 60 patients, 20 sites 3 (+) to 4 (+) MR (FMR or DMR) NYHA II or greater Candidate for surgery but surgery considered not the best option
33 Ongoing Clinical Trials today The Carrillon Trial (FDA IDE) Cardioband 400 patients, 50 sites US, Canada, EU, Australia EF <50% At least 2+ MR and EORA 0.2 cm2 NYHA II, III or IV 2:1 Device vs GDMT Blinded sham-controlled 400 patients Ischemic or non-ischemic CMP 2:1 Device vs GDMT
34 Combo therapy today + = Tool Box Concept
35 TMVR Early Feasibility Study Trials today CardiaQ Tendyne Tiara Twelve Caison SAPIEN XT MAC-ViR-ViV SAPIEN 3 MAC-ViR-ViV
36
37 TMVR EFS Trials today Tendyne Feasibility Trial 30 high risk surgical patients Muller et al, J Am Coll Cardiol Dec 2016;S (16)
38 Muller, London Valves 2017 Tendyne 30-Day Outcomes Device Success at 30 Days Success 80% (60/75) Failure* 20% (15/75) Mortality 6.7% (5/75) Implant not Successful 4.0% (3/75) LVOT Obstruction 1.3% (1/75) Valve did not seat properly 1.3% (1/75) Patient became hemodynamically unstable, procedure not completed, unplanned circulatory support 1.3% (1/75) Re-intervention 2.6% (2/75) Reposition Device- resolve PVL 1.3% (1/75) Bleeding with re-operation 1.3% (1/75) Device-related performance or Adverse Events* 5.3% (6/75) Mitral valve gradient > 6 mmhg 5.3% (4/75) Paravalvular Leak 1.3% (1/75) Device Malpositioning 1.3% (1/75) Device Thrombosis 1.3% (1/75)
39 Kaplan-Meier survival curve (n=30) All-cause mortality Days
40 Main Line Health Lankenau Heart Institute Tendyne TMVR: 1yr outcomes Outcome N=30 Death (all cause) 5 (16.7%) Cardiac 4 (13.3%) Non-cardiac 1 (3.3%) CVA/TIA 0 (0%) Re-hospitalisation Heart failure 3 (10.0%) MV surgery 0 (0%) Valve performance (n=28) Malposition/PVL/hemolysis 1 (3.6%) Leaflet thrombosis 1 (3.6%)
41 MR severity 1 year post-tmvr Paired data 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Baseline 1mth 12mths N: Grade 4 Grade 3 Grade 2 Grade 1 Grade 0
42 50 LVEF (%) p<0.01 vs baseline LVEF post-tmvr Paired analysis p=ns 42.0 p=ns 38.4 Baseline 1mth 12mths N:
43 100% 90% 80% Functional capacity post-tmvr (n=30) NYHA Class % 60% 50% 40% 30% 20% 10% Class 4 Class 3 Class 2 Class 1 0% Main Line Health Lankenau Heart Institute Baseline 1month 12months N: >1 class improvement in 60%
44 KCCQ Quality of Life: KCCQ KCCQ in subjects with complete data at three timepoints (n=22) p<0.001 * p<0.001 * * vs baseline baseline 30 day 12 months
45 Intrepid Pilot study Sorajja, TCT 2017
46 Press release APOLLO Pivotal Trial 650 patients, 60 sites 2 cohorts: 1 randomized to surgery to demonstrate non-inferiority 1 single arm for high surgical patients
47 Today Conclusions Large number of patients need MV intervention The era of TMVr and TMVR has begun The is an explosion of new devices and clinical trials TMVR is developing at a lower pace than TAVR Tomorrow With aging population, more patients will need MV intervention Outcomes of TMVr & TMVR will be superior than surgical outcomes Most MV patients will be treated with transcatheter therapies Most procedures will be performed with a transseptal approach
48 The day after tomorrow Tissue engineered THV s? Bioabsorbable valve stent frames?
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