SLIDE 1
Transcatheter Aortic Valve Replacement
Jesse Jorgensen, MD Medical Director, Cardiac Catheterization Laboratory Greenville Health System Greenville, South Carolina, USA January 30, 2016
SLIDE 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 occur2
Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38 (Suppl 1):61-7.
2 C.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. Heart 2000
SLIDE 3 Aortic Valve Replacement Improves Survival
10 20 30 40 50 60 70 80 90 100 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Survival, %
AVR, no Sx AVR, Sx No AVR, no Sx No AVR, Sx
Years Patient Survival
Brown ML et al. The benefits of early valve replacement in asymptomatic patients with severe aortic stenosis. J Thorac Cardiovasc Surg. 2008;2:308-315.
SLIDE 4
Surgical AVR: Not Available To All Patients
31.8% did not undergo intervention, most frequently because of comorbidities
SLIDE 5
Aortic Stenosis Undertreatment is Profound
SLIDE 6 Mortality 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.
SLIDE 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
SLIDE 8
SLIDE 9 Edwards SAPIEN Transcatheter Valve
Bovine pericardial tissue Stainless steel frame PET skirt The Carpentier-Edwards ThermaFix process* is intended to minimize the risk
preserve valve performance
SLIDE 10
Edwards SAPIEN
SLIDE 11 TAVR: Edwards Valve
NEJM 2011; 364:2187-2198
SLIDE 12
Self Expanding Technology: CoreValve (Medtronic)
2007 CE Mark 2014 FDA Approval
SLIDE 13 13
CoreValve Evolut R CE Study
MDT Confidential
Evolut R System
Transcatheter Valve (26, 29 mm)
Supra-annular design, optimized sealing
Catheter Delivery System
14Fr-equivalent profile
Loading System
Meredith EuroPCR 2015
SLIDE 14 TAVR Access
- 1. Transfemoral
- 2. Direct Aortic
- 3. Subclavian
- 4. Transapical
SLIDE 15 Agarwal S et al. Heart 2015;101:169-177
TAVR Patient Evaluation
STS Score <4 Low Risk 4-8 Intermediate Risk >8 High Risk Inoperable: >50% death or serious irreversible condition
* *
SLIDE 16 Patient-Focused Multidisciplinary Heart Team Approach
- Multidisciplinary in all aspects:
– Patient selection – Procedure Planning – Patient Treatment – Post Operative care
SLIDE 17
Valve Sizing: TEE
SLIDE 18
Valve Sizing: CT
SLIDE 19
CTA: Critical for determining Access
SLIDE 20
TAVR is the standard of care for inoperable patients with severe AS
SLIDE 21
TAVR Results: Mean Gradient & Valve Area
SLIDE 22
PARTNER Cohort B Primary Endpoint
SLIDE 23 All Cause Mortality (ITT): 5 year Follow up
Kapadia TCT Sept 2014
Median Survival
SLIDE 24 Repeat Hospitalization: TAVR vs. Standard Treatment
Kapadia TCT Sept 2014
SLIDE 25 PARTNER B Mean Gradient and Valve Area at 5 years
Kapadia TCT Sept 2014
SLIDE 26
Stroke following TAVR: Inoperable cohort
SLIDE 27
Vascular Complications: TAVR vs. Standard Treatment
SLIDE 28 Yakubov TCT 2014
SLIDE 29 CoreValve Extreme Risk
JACC 2014;63:1972-81
SLIDE 30 JACC 2014;63:1972-81
CoreValve Extreme Risk Clinical Outcomes at 1 and 12 Months
SLIDE 31 CoreValve Hemodynamics and Functional Improvement
JACC 2014;63:1972-81
SLIDE 32
CoreValve Extreme Risk 2 year Outcomes
SLIDE 33
TAVR is AT LEAST as good as Surgical AVR in High Risk patients
SLIDE 34
Echo Aortic Valve Gradients:
Sapien TAVR vs. SAVR
SLIDE 35
PARTNER A Primary Endpoint:
1 Year All-Cause Mortality TAVR vs SAVR
SLIDE 36
Cohort A Quality of Life: TAVR vs. SAVR
SLIDE 37
High Risk: TAVR vs SAVR
SLIDE 38
Paravalvular Aortic Regurgitation: Sapient TAVR vs. SAVR
SLIDE 39 CV Mortality Stratified by PV Leak (ITT)
Partner A
SLIDE 40 Corevalve High Risk
Adams ACC 2014
SLIDE 41 19.1% 4.5% Surgical 14.2% P = 0.04 for superiority 3.3% Transcatheter
Primary Endpoint: 1 Year All-cause Mortality
Adams ACC 2014
SLIDE 42 All Stroke
Adams ACC 2014
SLIDE 43 Other Endpoints
Events* 1 Month 1 Year
TAVR SAVR P Value TAVR SAVR P Value Vascular complications (major), % 5.9 1.7 0.003 6.2 2.0 0.004 Pacemaker implant, % 19.8 7.1 <0.001 22.3 11.3 <0.001 Bleeding (life threatening or disabling),% 13.6 35.0 <0.001 16.6 38.4 <0.001 New onset or worsening atrial fibrillation, % 11.7 30.5 <0.001 15.9 32.7 <0.001 Acute kidney injury, % 6.0 15.1 <0.001 6.0 15.1 <0.001
* Percentages reported are Kaplan-Meier estimates and log-rank P values
Adams ACC 2014
SLIDE 44 Echocardiographic Findings
Adams ACC 2014
SLIDE 45 Paravalvular Regurgitation
45
SLIDE 46
Vascular Safety: Get Smaller
Terumo Solopath: 15f insertion, balloon expandable to 19f. Corevalve compatible
SLIDE 47
Edwards evolution of valve design
SAPIEN SAPIEN XT SAPIEN 3
SLIDE 48 Kodali ACC 2015
Evolution of the Edwards Balloon- Expandable Transcatheter Valves
SLIDE 49 PARTNER II Study Design
Leon ACC 2013
SLIDE 50 PARTNER II Inoperable Cohort
Leon ACC 2013
SLIDE 51 PARTNER II Mortality and Stroke
Leon ACC 2013
SLIDE 52 PARTNER II: Comparison of Valve Function
Leon ACC 2013
SLIDE 53 PARTNER II: Comparison Vascular Complications
Leon ACC 2013
SLIDE 54 Partner II S3 Trial
Kodali ACC 2015
SLIDE 60 TAVR Growth in U.S.
J Am Coll Cardiol. 2015;66(25):2813-2823. Sites Enrolled in the TVT Registry
SLIDE 61 Complications in patients undergoing TAVR
Neurological Complications Bleeding and Vascular Complications
SLIDE 62
So, What’s New?
SLIDE 63 Valves Under Development
JACC 2012;60:483-92
SLIDE 64 Cerebral Emboli During TAVR and SAVR Using Transcranial Doppler
Alassar Ann Thor Surg 2015, In Press
TAVR, N=85 SAVR, N=42
1 patient in each arm suffered a stroke at 30 day follow up
SLIDE 65 Protection of cerebral events during TAVR
Freeman et al. CCI 2014;84(6):885-896
Embrella Embolic Deflector (Edwards Lifesciences) Triguard
(Keystone Heart, Herzliya Pituach, Israel)
SLIDE 66
Protection of cerebral events during TAVR
Claret Montage (Claret Medical, CA)
SLIDE 67 Valve in Valve Implantation
JACC 2011; 58 (21):2196-209
SLIDE 68 Valve in Valve Implantation
JAMA 2014; 312(2):162-70
SLIDE 69 TAVR for Pure Aortic Insufficiency
Wendt D et al. JACC Int. 2014;7(10):1159-1167.
SLIDE 70 Focus shifting from clinical outcomes to procedural efficiency
Babaliaros V et al. JACC Int 2014;7(8):898-904
SLIDE 71 Bern TAVI Registry:
The European Experience with less than high risk patients
Wenaweser P et al. Eur Heart J 2013;34:1894-1905
SLIDE 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
- perable 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
SLIDE 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
