Transcatheter Aortic Valve Replacement (TAVR) · 2019-10-02 · 10/1/19 3 SAVR TAVR TAVI Clinical...
Transcript of Transcatheter Aortic Valve Replacement (TAVR) · 2019-10-02 · 10/1/19 3 SAVR TAVR TAVI Clinical...
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Transcatheter Aortic Valve Replacement (TAVR)
Mohammad Bashir, MD, FACSSurgical Director TAVR Program
Associate Professor of Cardiothoracic surgeryUniversity of Iowa Carver College of Medicine
Disclosures
• No Financial Disclosures• I participate in clinical trials with Edwards Lifesciences• I will discuss off label use for FDA approved devices
AS- Etiology
Etiology
Senile Calcific (60%)
Bicuspid (30%)
Rheumatic (10%)
Aortic valve Area
Normal: 3-4 cm2
Severe AS: <1.0 cm2
Aortic Stenosis Is Life Threatening and Progresses Rapidly
§ Survival after onset of symptoms is 50% at 2 years and 20% at 5 years§ Surgical intervention for severe aortic stenosis should be performed
promptly once even minor symptoms occur
Overall 3-year survival in operated and unoperated patients with severe aortic stenosis.
Andreas Auensen et al. Open Heart 2017;4:e000588
©2017 by British Cardiovascular Society
Asymptomatic Severe AS
• AVR improved survival in asymptomatic severe AS (RR 0.38 (CI 0.27–0.55; P < .001)
0102030405060708090
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Sur
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l, %
AVR, no SxAVR, SxNo AVR, no SxNo AVR, Sx
J Thorac Cardiovasc Surg. 2008 Feb;135(2):308-15
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Surgical Aortic Valve replacement (SAVR) Minimally invasive SAVR
Sapien 3Balloon-expandableEdwards Lifesciences
Evolut-RSelf-expanding
Medtronic
TAVI/TAVR
First CoreValve ImplantsLaborde, Lal, Grube | 2004
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SAVR
TAVR
TAVI Clinical Trials
Extreme Risk 2010
Foundational trials tested new TAVI therapy in patients without the option for a surgical aortic valve replacement
US CoreValve Pivotal Trial PARTNER 1B
CoreValve, N=489, STS 10.3% SAPIEN, N=179, STS 11.2%
Extreme Risk
• Conservative therapy fails• Confirmed dismal natural history of symptomatic severe AS
w/o AVR• 1 year mortality- 50.7% (All-cause); 44.5% (Cardiovascular)
• TAVR for inoperable patients• Significant benefits
• 20% absolute mortality reduction• Reduction in symptoms and improved QOL scores
• Sustained effect (2 years)
• Risks (most periprocedural)• Increased stroke risk • Increased bleed / vascular complication
TAVI Clinical TrialsHigh Risk 2011
Trials randomizing high risk patients to either TAVI or SAVR followed
US CoreValve Pivotal Trial PARTNER 1A
CoreValve, N=390, STS 7.3% vs. SAVR, N=357, STS 7.5%
SAPIEN, N=348, STS 11.8% vs. SAVR, N=351, STS 11.7%
High Risk: High Risk Patients
• TAVR vs. AVR- no difference in mortality
• TAVR – more strokes, less major bleeding
• TAVR and surgical AVR are both acceptable therapies in these high-risk patients
TAVI Clinical TrialsIntermediate Risk 2016
Randomized trial data comparing TAVI to SAVR in intermediate surgical risk patients recently became available
SURTAVI and SURTAVI CAS PARTNER 2A and PARTNER S3i
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Intermediate risk:
• The results support the use of TAVR as an alternative to surgery in intermediate risk patients.
• Patients who are candidates for transfemoral access, TAVR may result in additional clinical advantages.
• Long-term durability assessments for TAVR valves are still lacking.
TAVI Clinical TrialsLow Risk 2019
• All components of the primary endpoints and all secondary endpoints directionally favored TAVR• Results are only at one year and all patients will be followed for 10 years for
durability• TAVR is now the preferred procedure for the majority of patients with
symptomatic aortic stenosis• Short and intermediate term Hemodynamic data is very favorable in supra-
annular valves.
• More data is needed for Bicuspid, leaflet thrombosis, and younger patients
Low Risk Evolution of the Edwards Balloon-Expandable Transcatheter Valves
* Sheath compatibility for a 23 mm valve
2002Cribier-Edwards
2006SAPIEN
2009
SAPIEN XT
2013
SAPIEN 3
The University of Iowa Experience(Kafa et al. International Academy of Cardiology 2016)
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20% Increase in TAVR in 2019 Anticipated
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NEJM9 Publications
9 YearsPercutaneous Double valve in calcified native annulus(TVT 2016)
• 87-year-old woman was referred for class III heart failure management• Past medical history• Chronic kidney disease stage 3• Pulmonary hypertension• Moderate COPD • Atrial fibrillation s/p pacemaker
Percutaneous Double valve in calcified native annulus(TVT 2016)
Percutaneous Double valve in calcified native annulus(TVT 2016)
• STS for AVR/CABG 9.8%• STS score for MVR/CABG was 19%
• Valve team decision was to perform Trans catheter double valve replacement with percutaneous approach for both valves
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Percutaneous Double valve in calcified native annulus(TVT 2016)
Percutaneous Double valve in calcified native annulus(TVT 2016)
Percutaneous Double valve in calcified native annulus(TVT 2016)
Percutaneous Double valve in calcified native annulus(TVT 2016)
Percutaneous Double valve in calcified native annulus(TVT 2016)
Percutaneous Double valve in calcified native annulus(TVT 2016)
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Percutaneous Double valve in calcified native annulus(TVT 2016)
Thank you