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

viva

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)


• 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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Thank you

transcatheter aortic valve replacement (tavr) · 2019-10-02 · 10/1/19 3 savr tavr tavi clinical...

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