Valve Replacement without a Scalpel Transcatheter Aortic Valve Replacement (TAVR) Charles T. Klodell, M.D.

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1 Valve Replacement without a Scalpel Transcatheter Aortic Valve Replacement (TAVR) Charles T. Klodell, M.D. Professor, Thoracic and Cardiovascular Surgery University of Florida klodell@surgery.ufl.edu

2 Disclosures Nothing to disclose

3 TAVR Heart Team Concept Multidisciplinary approach ensures: Patient centric care Thorough assessment by a team of specialists Collaborative treatment decision 3

4 Worse Prognosis than many Metastatic Cancers

5 Edwards Transcatheter Heart Valve Refinement Cribier-Edwards THV 23 mm Valve Stainless Steel Frame Untreated Equine Tissue Edwards SAPIEN THV 23 and 26 mm Valves Stainless Steel Frame Bovine Pericardial Tissue Carpentier-Edwards ThermaFix Process* Leaflet Matching Technology Edwards SAPIEN XT THV 23, 26, and 29 mm Valves 20mm in trial S3i Bovine Pericardial Tissue Carpentier-Edwards ThermaFix Process* Leaflet Matching Technology

6 CoreValve Bioprosthesis Outflow Orientation Maximizes Flow Constrained Portion Valve Function Supra-annular leaflet function Designed to avoid coronaries Inflow Portion Sealing Intra-annular anchoring Mitigates paravalvular aortic regurgitation

7 TAVR Patient selection Peripheral access Root/Annulus/SOV Sizing of the Valve and Valve Choice UF Health TAVR Program Future Directions

8 Patient Selection TAVR patients may present with some of the following: Severe, symptomatic native aortic valve stenosis Old age Frailty History of stroke/cva History of syncope Reduced EF Heavily calcified aorta Prior CABG History of AFib Prior open chest surgery Fatigue, slow gait Peripheral vascular disease Prior chest radiation History of CAD History of COPD History of renal insufficiency Diabetes and hypertension 8

9 Complexities of Measuring Risk While some patients may have low STS scores, certain conditions may preclude them from being suitable candidates for surgery, for example: Extensively calcified (porcelain) aorta Chest wall deformity Oxygen-dependent respiratory insufficiency Frailty 9 Example: Porcelain aorta in TAVR candidate

10 Frailty: An Important Parameter in Assessing Operative Risk Prevalence of frailty increases with aging; old does not necessarily equal frail Elderly patients achieve measurable benefit from cardiac surgery, particularly in terms of: Quality of life Increased survival Prevention of adverse cardiovascular events The Eyeball Test 10

11 Multiple Modalities for Assessing Frailty PARTNER II Trial Frailty Index Assessment 15-Foot Walk Grip strength Serum albumin Katz ADLs - (Independence in dressing, bathing, toileting, transferring, feeding, continence) 11

12 Peripheral access

13 Challenges in Percutaneous Access

14 Peripheral access Transfemoral even with use of adjuncts Additional concerns kidney transplant, renal stent with aortic protrusion, EVAR Alternative access sites Transapical Direct aortic Great vessels -? Patent IMA graft

15 Root/Annulus/SOV Size of annulus both by perimeter and area critical in valve selection Cardiac gated CTA is standard Size of SOV and coronary clearance critical Other factors may push toward balloon expandable vs self expanding valve

16 SOV/Coronaries

17 The TAVR Experience

18 UF TAVR 3/20/2012-1/30/ patients Male:Female-160:156 Average age: 79 (min: 49, max: 96) Age>=90: (8%) Age>=85: (32%)

19 UF TAVR 3/20/2012-1/30/2015 Total ICU hours: Mean:94.9 Median: 65 LOS in days (surg-dc): mean:7.25 median: 6.0

20 UF TAVR 3/20/2012-1/30/2015 Complications: Deaths at D/C: 3.5% Additional Deaths within 30 days: 0 CVA: 2.8% Renal failure: 3.1% Re-operation for bleeding: 0.3% Vascular injury: 4.6%, (60% endovascular repair) Pacemaker: 4.6% (Sapien)

21 Future Directions Progressive reduction in access size Leak mitigation systems to reduce PVL Reposition deployed valves possible Progressive use of Valve in valve deployment

22 From: Transcatheter Aortic Valve Replacement With the SAPIEN 3: A New Balloon-Expandable Transcatheter Heart Valve J Am Coll Cardiol Intv. 2013;6(3): doi: /j.jcin

23 Next Generation Devices