APOLLO TMVR Trial Update: Case Presentation
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1 APOLLO TMVR Trial Update: Case Presentation Anelechi Anyanwu, MD, MSc, FRCS-CTh Professor and Vice-Chairman Department of Cardiovascular Surgery Icahn School of Medicine at Mount Sinai New York, NY
2 Disclosure I will discuss use of an investigational device (Medtronic Intrepid TMVR) I have no financial disclosures
3 Medtronic Intrepid TM TMVR Self expanding nitinol valve 27mm tri-leaflet bovine pericardium valve 43, 46 or 50 mm diameter Transapical Delivery (35 F Sheath). Medtronic Animation
4 Case Presentation 77-year-old female dyspnea on minimal exertion Two prior sternotomies CABG (2005), AVR (biological) (2013) Ischemic cardiomyopathy (LVEF 27%, AICD) Multiple hospitalizations for CHF exacerbations Other comorbidity - CKD, PVD (toe amputation), TIA, AF STS Score (MV repair) 9.21
5 Baseline Transesophageal Echocardiogram BP 106/53 Height 5ft 4in Weight 173lb LVEF 26%
6 Further Work-up RHC: PCW 34/45 mmhg, PA 64/25/38mmHg, RA 60/14mmHg, CO 4.3L/min CTA: Patent SVG s (LAD, RCA) LVEF 26% Focal ascending aorta calcification, Celiac artery occlusion (SMA collaterals)
7 Heart Team Review Declined for surgery due to prohibitive risk Enrolled in the Intrepid Global Pilot Study
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10 Preoperative Optimization 3 Days prior to procedure Myocardial Contractility: Milrinone Diuresis: Intravenous Furosemide Nutrition Physical
11 Procedure: Intrepid TM TMVR Echo guided procedure Transapical surgical access CAUTION: Investigational Device Limited by Federal (United States) Law to
12 Introducer Sheath Placed in Apex
13 Catheter Advanced and Guided Through Mitral Valve
14 Catheter in Left Atrium
15 Partial Device Release and Alignment with Annulus
16 Rapid Pacing & Implant Positioning Parallel to Mitral Plane
17 Rapid Pacing, Retraction of Device & Valve Deployment
18 Final Deployment Complete and Delivery Catheter Withdrawal
19 Final Result
20 Final Result
21 Final Result LVOT Gradient
22 Post-operative Course Extubated on POD 4 Renal failure requiring CVVH (renal recovery 10 days after the procedure) Maintained on low-dose milrinone for two weeks Discharged on POD 21 Died a year post-implant from complications of renal failure
23 APOLLO TRIAL TO EVALUATE INTREPID TMVR IN PATIENTS WITH SEVERE SYMPTOMATIC MITRAL REGURGITATION Randomized Cohort Single-arm Cohort Primary Endpoint Secondary Endpoint The rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at 1 year Composite of all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation (or reintervention) for any reason and major bleeding at 30 days or hospital discharge whichever is longer Change in NYHA at 1 year Quality of Life (QoL) Improvements at 30 days (SF-12) and 1 year (KCCQ) Echocardiographic assessments of degree of mitral valve regurgitation at 1 year Days alive out of hospital at 1 year (all hospitalizations) from index procedure Cardiovascular hospitalization through 1 year Follow-up Evaluations 30-days, 3-months, 6-months, and annually starting 1 Through 5 years 23 Medtronic APOLLO Trial Overview 2018
24 APOLLO TRIAL TRIAL OVERVIEW Principal Investigators: David Adams and Marty Leon Study Chair: Michael Mack Evaluate safety and efficacy of Medtronic Intrepid TM TMVR System in patients with symptomatic mitral regurgitation Assessment by Multidisciplinary Heart Team Ineligible for surgical procedure 1:1 Randomization Single-arm Cohort Treatment Arm TMVR Control Arm MV surgery TMVR 24 Medtronic APOLLO Trial Overview 2018
25 APOLLO TRIAL TRIAL DESIGN Randomized Cohort Single-arm Cohort Key Inclusion Criteria Subject has severe symptomatic mitral regurgitation Heart Team agrees that patient is a candidate for bioprosthetic mitral valve replacement Key Exclusion Criteria Predicted risk of operative mortality is <3% at 30 days or has 35% risk of mortality or irreversible major morbidity at 30 days Estimated life expectancy of <24 months due to associated non-cardiac comorbid conditions Subject with mitral anatomy that would preclude management of the sub-valvular apparatus and/or full chordal sparing Prior mitral valve surgery including previously implanted mitral valve, ring, or band Predicted risk of operative mortality or irreversible major morbidity < 35% and 50% 30 days Currently implanted mitral valve Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions Additional Exclusion Criteria Prior transcatheter mitral valve procedure with device currently implanted Anatomic contraindications for Intrepid TMVR system (eg., annular dimensions, high risk of LVOT obstruction, transapical access, etc.) Prohibitive mitral annular calcification Reduced ventricular function with left ventricular ejection fraction (LVEF) <25% Hemodynamic instability requiring either inotropic agents or mechanical circulatory support Need for emergent or urgent surgery 25 Medtronic APOLLO Trial Overview 2018
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28 Thank You
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