Transcatheter Aortic Valve Replacement

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1 Transcatheter Aortic Valve Replacement Jesse Jorgensen, MD Medical Director, Cardiac Catheterization Laboratory Greenville Health System Greenville, South Carolina, USA January 30, 2016

2 Aortic Stenosis is Life Threatening and Progresses Rapidly Valvular Aortic Stenosis in Adults (Average Course) Survival after onset of symptoms 50% at 2 yrs, 20% at 5 yrs Surgical intervention should be performed promptly once even minor symptoms occur 2 Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38 (Suppl 1): C.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. Heart 2000

3 Survival, % Aortic Valve Replacement Improves Survival Patient Survival AVR, no Sx AVR, Sx No AVR, no Sx No AVR, Sx Years Brown ML et al. The benefits of early valve replacement in asymptomatic patients with severe aortic stenosis. J Thorac Cardiovasc Surg. 2008;2:

4 Surgical AVR: Not Available To All Patients 31.8% did not undergo intervention, most frequently because of comorbidities

5 Aortic Stenosis Undertreatment is Profound

6 ortality With Standard Therapy Is Worse Than With Certain Metastatic Cancers National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu.

7 Percutaneous Aortic Valve Development Professor Alain Cribier (Rouen, France) First described percutaneous aortic valve interventions in 1985 Proved that a stent could be deployed without removing the diseased native valve Implanted first percutaneous aortic valve on a patient on April 16, 2002

8

9 Edwards SAPIEN Transcatheter Valve Bovine pericardial tissue Stainless steel frame PET skirt The Carpentier-Edwards ThermaFix process* is intended to minimize the risk of calcification, helping preserve valve performance

10 Edwards SAPIEN

11 TAVR: Edwards Valve NEJM 2011; 364:

12 Self Expanding Technology: CoreValve (Medtronic) 2007 CE Mark 2014 FDA Approval

13 Evolut R System Catheter Delivery System 14Fr-equivalent profile Loading System Transcatheter Valve (26, 29 mm) Supra-annular design, optimized sealing MDT Confidential Meredith EuroPCR 2015 CoreValve Evolut R CE Study 13

14 TAVR Access 1. Transfemoral 2. Direct Aortic 3. Subclavian 4. Transapical

15 TAVR Patient Evaluation STS Score * * <4 Low Risk 4-8 Intermediate Risk >8 High Risk Inoperable: >50% death or serious irreversible condition Agarwal S et al. Heart 2015;101:

16 Patient-Focused Multidisciplinary Heart Team Approach Multidisciplinary in all aspects: Patient selection Procedure Planning Patient Treatment Post Operative care

17 Valve Sizing: TEE

18 Valve Sizing: CT

19 CTA: Critical for determining Access

20 TAVR is the standard of care for inoperable patients with severe AS

21 TAVR Results: Mean Gradient & Valve Area

22 PARTNER Cohort B Primary Endpoint

23 All Cause Mortality (ITT): 5 year Follow up Median Survival Kapadia TCT Sept 2014

24 Repeat Hospitalization: TAVR vs. Standard Treatment Kapadia TCT Sept 2014

25 PARTNER B Mean Gradient and Valve Area at 5 years Kapadia TCT Sept 2014

26 Stroke following TAVR: Inoperable cohort

27 Vascular Complications: TAVR vs. Standard Treatment

28 Yakubov TCT 2014

29 CoreValve Extreme Risk JACC 2014;63:

30 CoreValve Extreme Risk Clinical Outcomes at 1 and 12 Months JACC 2014;63:

31 CoreValve Hemodynamics and Functional Improvement JACC 2014;63:

32 CoreValve Extreme Risk 2 year Outcomes

33 TAVR is AT LEAST as good as Surgical AVR in High Risk patients

34 Echo Aortic Valve Gradients: Sapien TAVR vs. SAVR

35 PARTNER A Primary Endpoint: 1 Year All-Cause Mortality TAVR vs SAVR

36 Cohort A Quality of Life: TAVR vs. SAVR

37 High Risk: TAVR vs SAVR

38 Paravalvular Aortic Regurgitation: Sapient TAVR vs. SAVR

39 CV Mortality Stratified by PV Leak (ITT) Partner A

40 Corevalve High Risk Adams ACC 2014

41 Primary Endpoint: 1 Year All-cause Mortality Surgical Transcatheter 19.1% 14.2% 4.5% P = 0.04 for superiority 3.3% Adams ACC 2014

42 All Stroke Adams ACC 2014

43 Other Endpoints Events* 1 Month 1 Year TAVR SAVR P Value TAVR SAVR P Value Vascular complications (major), % Pacemaker implant, % < <0.001 Bleeding (life threatening or disabling),% < <0.001 New onset or worsening atrial fibrillation, % < <0.001 Acute kidney injury, % < <0.001 * Percentages reported are Kaplan-Meier estimates and log-rank P values Adams ACC 2014

44 Echocardiographic Findings Adams ACC 2014

45 Paravalvular Regurgitation 45

46 Vascular Safety: Get Smaller Terumo Solopath: 15f insertion, balloon expandable to 19f. Corevalve compatible

47 Edwards evolution of valve design SAPIEN SAPIEN XT SAPIEN 3

48 Evolution of the Edwards Balloon- Expandable Transcatheter Valves Kodali ACC 2015

49 PARTNER II Study Design Leon ACC 2013

50 PARTNER II Inoperable Cohort Leon ACC 2013

51 PARTNER II Mortality and Stroke Leon ACC 2013

52 PARTNER II: Comparison of Valve Function Leon ACC 2013

53 PARTNER II: Comparison Vascular Complications Leon ACC 2013

54 Partner II S3 Trial Kodali ACC 2015

55 Kodali ACC 2015

56 Kodali ACC 2015

57 Kodali ACC 2015

58 Kodali ACC 2015

59 Kodali ACC 2015

60 TAVR Growth in U.S. Sites Enrolled in the TVT Registry J Am Coll Cardiol. 2015;66(25):

61 Complications in patients undergoing TAVR Neurological Complications Bleeding and Vascular Complications

62 So, What s New?

63 Valves Under Development JACC 2012;60:483-92

64 Cerebral Emboli During TAVR and SAVR Using Transcranial Doppler TAVR, N=85 SAVR, N=42 1 patient in each arm suffered a stroke at 30 day follow up Alassar Ann Thor Surg 2015, In Press

65 Protection of cerebral events during TAVR Embrella Embolic Deflector (Edwards Lifesciences) Triguard (Keystone Heart, Herzliya Pituach, Israel) Freeman et al. CCI 2014;84(6):

66 Protection of cerebral events during TAVR Claret Montage (Claret Medical, CA)

67 Valve in Valve Implantation JACC 2011; 58 (21):

68 Valve in Valve Implantation JAMA 2014; 312(2):162-70

69 TAVR for Pure Aortic Insufficiency Wendt D et al. JACC Int. 2014;7(10):

70 Focus shifting from clinical outcomes to procedural efficiency Babaliaros V et al. JACC Int 2014;7(8):

71 Bern TAVI Registry: The European Experience with less than high risk patients Wenaweser P et al. Eur Heart J 2013;34:

72 Conclusions 1. TAVR (TAVI) is the current standard of care for inoperable patients with severe AS 2. TAVR is an acceptable option for high risk operable patients 3. TAVR is an acceptable option for patients with prior surgical AVR (? And MVR) 4. TAVR may soon be an option for intermediate and low risk patients

73 Conclusions Outcomes will continue to improve with smaller profile delivery systems and methods to reduce paravalvular leak Stroke prevention: embolic protection devices Dedicated valve designs for pure aortic insufficiency TMVR

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