transcatheter aortic valve replacementhsc.ghs.org/wp-content/uploads/2016/01/7.-jorgensen... ·...
TRANSCRIPT
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Transcatheter Aortic Valve Replacement
Jesse Jorgensen, MD
Medical Director, Cardiac Catheterization Laboratory
Greenville Health System
Greenville, South Carolina, USA
January 30, 2016
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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
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Aortic Valve Replacement Improves
Survival
0
10
20
30
40
50
60
70
80
90
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Su
rviv
al, %
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.
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Surgical AVR:
Not Available To All Patients
31.8% did not undergo intervention, most
frequently because of comorbidities
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Aortic Stenosis Undertreatment is
Profound
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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.
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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
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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
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Edwards SAPIEN
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TAVR: Edwards Valve
NEJM 2011; 364:2187-2198
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Self Expanding Technology:
CoreValve (Medtronic)
2007 CE Mark
2014 FDA Approval
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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
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TAVR Access
1. Transfemoral
2. Direct Aortic
3. Subclavian
4. Transapical
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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
* *
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Patient-Focused Multidisciplinary
Heart Team Approach
• Multidisciplinary in all aspects:
– Patient selection
– Procedure Planning
– Patient Treatment
– Post Operative care
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Valve Sizing: TEE
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Valve Sizing: CT
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CTA: Critical for determining Access
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TAVR is the standard of care for
inoperable patients with severe AS
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TAVR Results:
Mean Gradient & Valve Area
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PARTNER Cohort B
Primary Endpoint
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All Cause Mortality (ITT):
5 year Follow up
Kapadia TCT Sept 2014
Median Survival
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Repeat Hospitalization:
TAVR vs. Standard Treatment
Kapadia TCT Sept 2014
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PARTNER B Mean Gradient and
Valve Area at 5 years
Kapadia TCT Sept 2014
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Stroke following TAVR:
Inoperable cohort
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Vascular Complications:
TAVR vs. Standard Treatment
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Yakubov TCT 2014
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CoreValve Extreme Risk
JACC 2014;63:1972-81
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JACC 2014;63:1972-81
CoreValve Extreme Risk Clinical
Outcomes at 1 and 12 Months
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CoreValve Hemodynamics and
Functional Improvement
JACC 2014;63:1972-81
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CoreValve Extreme Risk 2 year
Outcomes
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TAVR is AT LEAST as good as
Surgical AVR in High Risk patients
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Echo Aortic Valve Gradients: Sapien TAVR vs. SAVR
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PARTNER A Primary Endpoint:
1 Year All-Cause Mortality TAVR vs SAVR
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Cohort A Quality of Life:
TAVR vs. SAVR
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High Risk: TAVR vs SAVR
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Paravalvular Aortic Regurgitation:
Sapient TAVR vs. SAVR
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CV Mortality Stratified by PV
Leak (ITT)
Partner A
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Corevalve High Risk
Adams ACC 2014
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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
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All Stroke
Adams ACC 2014
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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
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Echocardiographic Findings
Adams ACC 2014
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Paravalvular Regurgitation
45
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Vascular Safety:
Get Smaller
Terumo Solopath: 15f insertion, balloon expandable to 19f.
Corevalve compatible
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Edwards evolution of valve design
SAPIEN SAPIEN XT SAPIEN 3
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Kodali ACC 2015
Evolution of the Edwards Balloon-
Expandable Transcatheter Valves
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PARTNER II Study Design
Leon ACC 2013
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PARTNER II Inoperable Cohort
Leon ACC 2013
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PARTNER II Mortality and Stroke
Leon ACC 2013
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PARTNER II:
Comparison of Valve Function
Leon ACC 2013
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PARTNER II:
Comparison Vascular Complications
Leon ACC 2013
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Partner II S3 Trial
Kodali ACC 2015
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Kodali ACC 2015
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Kodali ACC 2015
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Kodali ACC 2015
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Kodali ACC 2015
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Kodali ACC 2015
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TAVR Growth in U.S.
J Am Coll Cardiol. 2015;66(25):2813-2823.
Sites Enrolled in the TVT Registry
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Complications in patients
undergoing TAVR
Neurological Complications Bleeding and Vascular Complications
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So, What’s New?
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Valves Under Development
JACC 2012;60:483-92
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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
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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)
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Protection of cerebral events during TAVR
Claret Montage
(Claret Medical, CA)
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Valve in Valve Implantation
JACC 2011; 58 (21):2196-209
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Valve in Valve Implantation
JAMA 2014; 312(2):162-70
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TAVR for Pure Aortic Insufficiency
Wendt D et al. JACC Int. 2014;7(10):1159-1167.
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Focus shifting from clinical outcomes to
procedural efficiency
Babaliaros V et al. JACC Int 2014;7(8):898-904
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Bern TAVI Registry: The European Experience with less than high
risk patients
Wenaweser P et al. Eur Heart J 2013;34:1894-1905
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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
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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