Transcatheter Aortic Valve Replacement TAVR

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1 Transcatheter Aortic Valve Replacement TAVR Paul Gordon, MD Associate Prof of Medicine, Brown University Director, Cardiac Catheterization Laboratory The Miriam Hospital Disclosures: none

2 100 Symptomatic Aortic Stenosis is Rapidly Progressive and Life Threatening Latent Period Survival (percent) Increasing obstruction, myocardial overload Symptoms Average Age Death Age (years) Survival after onset of symptoms is 50% at 2 years and 20% at 5 years Surgical intervention for severe aortic stenosis should be performed rmed promptly once even minor symptoms occur from Ross and Braunwald, Circulation 1968;38:V-61 61

3 Aortic Valve Replacement Greatly Improves Survival Patient Survival 3 Years

4 Prompt AVR Is Indicated in Almost All Severe Symptomatic AS Patients 2008 ACC/AHA Guidelines state: In the absence of serious comorbid conditions, aortic valve replacement (AVR) is indicated in virtually all symptomatic patients with severe AS Because of the risk of sudden death, AVR should be performed promptly after the onset of symptoms Age is not a contraindication for surgery

5 Treatment for Aortic Stenosis Only treatment for aortic stenosis that improves survival is aortic valve replacement Risk of surgical AVR is low even in the very elderly However, there remain patients who are not candidates for AVR: Hostile chest (radiation, chest wall deformities) Prior median sternotomies Porcelain aorta Co-morbidities such as severe lung and/or liver disease Extreme surgical risk (STS predicted mortality/combined M&M) Dementia Frailty

6 Percutaneous Transcatheter Aortic Valve Replacement TAVR Webb et al. Circulation 2006;113:

7 PARTNER Trial Design Fully enrolled: published 2 year outcomes for both cohorts Total = 1,052 pts Yes Symptomatic Severe Aortic Stenosis Assessment High Risk AVR Candidate N=694 2 Trials Cohort A Individually Powered Cohort B N=358 (Cohorts A & B) No Yes Assessment Transfemoral Access No Yes Assessment Transfemoral Access No N=491 Cohort A TF N=203 N=491 N=203 Cohort A TA Not in Study Trans Femoral vs 1:1 Randomization AVR Control Trans Apical vs AVR Control Trans Femoral 1:1 Randomization vs Medical Management Control PRIMARY ENDPOINT All-cause mortality (1 yr) Non-inferiority PRIMARY ENDPOINT All-cause mortality (1 yr) Superiority Cohort B: inoperable patients with combined morbidity/mortality risk > 50% Transfemoral TAVR access only BAV with standard medical therapy in nearly 80% of control patients

8 Absolute Reduction in Mortality Continues to Diverge at 2 Years

9 > 30% Absolute Reduction in Cardiovascular Mortality

10 > 35% Reduction in Repeat Hospitalization

11 Higher Incidence of Stroke

12 Mortality or Stroke

13 Higher Incidence of Major Vascular Complications

14 TAVR - Current Status Over 40,000 implants outside of US over last 5 years Success rates >95% in absence of MACE FDA approval in November 2011: inoperable patients with severe AS 2 cardiac surgeons transfemoral access only Nearly 3000 commercial cases in US since approval Intense resource utilization Success of program dependent on team approach

15 Patient-Focused Multidisciplinary Heart Team Approach Multidisciplinary in all aspects: Patient selection TTE/TEE CT angiography Procedure planning Patient treatment Post-operative care Only ~1 in 5 patients refered for TAVR are candidates Some are surgical candidates for AVR Inadequate iliofemoral access (aortic valvuloplasty) Large 22 and 24F sheaths require >7-8 mm arteries futility

16 Hybrid OR A RT E V Valve prep I X-ray patient CS perfusionist P CL I SN CL IABP C CL coordinator

17 Current Investigational Technology 18F Core valve Sapien XT + NovaFlex Delivery System (PARTNERS II Trial) Transapical TAVER

18 COHORT A Predicted operative mortality 15% (STS mortality 10%)

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21 Summary In patients with symptomatic aortic stenosis: Surgical AVR is the prefered treatment TAVR is an alternative option in inoperable patients who have adequate iliofemoral access Coming 4 th quarter 2012 Transapical TAVR will be an option for high/extreme risk surgical patients or inoperable patients where femoral access is not possible Transfemoral TAVR will be an alternative option for select extreme/high risk surgical patients who have adequate femoral access