Aortic Valve Disease. Aortic Valve Survival. Aortic Valve Surgery Today

Transcription

1 Aortic Valve Surgery Today Is Your Patient a Candidate for Cath or Scalpel Identifying the Patient for TAVI Aortic Valve Disease 16.5 Million People in US Over the Age of 65 2 Percentage Diagnosed with Aortic Stenosis Aortic Stenosis 86.7% Aortic Valve Survival Survival after onset of symptoms is 50% at 2 years 1

2 Survival, % Aortic Valve Survival Patient Survival Years AVR, AVR, No no Symptoms Sx AVR, Symptoms Sx No AVR, No no Symptoms Sx No No AVR, Symptoms Sx Study data demonstrate that early and late outcomes were similarly good in both symptomatic and asymptomatic patients It is important to note that among asymptomatic patients with SAS, omission of surgical treatment was the most important risk factor for late mortality Surgical Aortic Valve (SAVR) 30,000/year Aortic Stenosis 86.7% Operative Mortality 2.6% Surgical Aortic Valve (SAVR) n = 108,791 isolated AVR Aortic Stenosis 86.7% Brown et al. JCTVS 2009;137:

3 Surgical Aortic Valve (SAVR) Aortic Stenosis 86.7% Brown et al. JCTVS 2009;137:82-90 The Oldest Old: Survival of Octogenarians with Severe AS with and without AVR Aortic Stenosis 86.7% Varadarajan et al. Eur J Cardiothorac Surg. 2006; (5): Breaking Information 3

4 Surgical Aortic Valve (SAVR) 31.8% did not undergo intervention, despite NYHA class III/IV symptoms 92 hospitals from 25 countries 5,001 patients from April-July, 2001 Surgical Aortic Valve (SAVR) 31.8% did not undergo intervention, despite NYHA class III/IV symptoms 90 year old female Transcatheter Aortic Valves SAPIEN Valve CORE Valve 4

5 Transcatheter Aortic Valves FDA Approval 2011 SAPIEN Valve PARTNER I TRIAL TA, transapical; TF, transfemoral. Inclusion Criteria Partner I (Cohort B) Severe calcific aortic stenosis defined as echo derived valve area of < 0.8 cm 2 (EOA index < 0.5 cm 2 /m 2 ), mean gradient > 40 mm Hg or jet velocity > 4.0 m/s NYHA functional class II or greater Risk of death or serious irreversible morbidity of AVR as assessed by cardiologist and two surgeons must exceed 50% Surgeons must agree and attest that before The PARTNER Trial these patients would not have received AVR treatment 5

6 Partner I (Cohort B) SAPIEN Valve Standard Therapy A Seminal Date in Cardiovascular Medicine September 22, 2010 on NEJM.org Absolute Reduction in Mortality Continues to Diverge at 2 Years 6

7 37.5% Reduction in Repeat Hospitalization at 2 Years Sustained Improvement in NYHA Functional Class Higher Incidence of Stroke 7

8 TAVR CORE Valve Results TAVR CORE Valve Results TAVR CORE Valve Results 8

9 TAVR CORE Valve Results PARTNER I TRIAL (Cohort A) TA, transapical; TF, transfemoral. Partner I (Cohort A) TAVR STS>10 Mortality Risk>15% SAVR 9

10 TAVR Partner a 1 year data THE PARTNER TRIAL COHORT A Mean Gradient, mm Hg THE PARTNER TRIAL COHORT A 10

11 Partner I (Cohort A) TAVR STS>10 Mortality Risk>15% SAVR Partner II (Medium Risk) TAVR STS 4-10 SAVR Is Your Patient a Candidate for Cath or Scalpel Identifying the Patient for TAVI 11

12 Estimated Costs From The Partner Trial Procedure: $42,806 Hospitalization: $78,542 Follow-up through 12 months: $29,289 Cumulative 1-year costs: $106,076 Standard care 12 months: $53,621 Absolute Reduction in Mortality Continues to Diverge at 2 Years Absolute Reduction in Mortality Continues to Diverge at 2 Years 12

13 Estimated Costs From The Partner Trial Patients with greater surgical risk based on the Society of Thoracic Surgeons (STS) Risk Score 15% who underwent TAVR did not have a significant mortality benefit. Predictors of 2 yr mortality after TAVR include prior stroke [HR 2.99 (95% CI 1.19 to 7.51)] and O2-dependent COPD [HR 1.69 (95% CI 1.05 to 2.73)]. Aortic Stenosis Potential TAVR Population (Partner B Data) UTILITY FUTILITY LOW OR MODERATE HIGH INOPERABLE RISK RISK>15 Aortic Stenosis Potential TAVR Population 25 th percentile STS= th percentile STS=8 13

14 Aortic Stenosis Potential TAVR Population (Partner B Data) UTILITY FUTILITY LOW OR MODERATE HIGH INOPERABLE RISK 10-15% STS >10 RISK>15% Futile Care? STS > FEV1< 40% Long term O2 dependency Pulmonary hypertension with right heart failure and severe TR Chronic kidney disease Cr>3,0 Liver disease with MELD > 15 Extreme obesity Depressed affect, dementia, psychologically has given up Frailty impairment from prior CVA or neuromuscular disease Immobile wheel chair bound Very slow 5M walk test > 12 seconds or unable to walk Aortic Stenosis Potential TAVR Population (Partner B Data) UTILITY FUTILITY LOW OR MODERATE HIGH INOPERABLE RISK 10-15% RISK>15% 14

15 How Do You Define Frailty? 94 yo Yorker How Do You Define Frailty? 95 yo Texas tough TAVR 6 minute walk test 15

16 How Do You Define Frailty? 94 yo Yorker Aortic Stenosis Potential TAVR Population (Partner I and II Data) UTILITY FUTILITY LOW OR MODERATE HIGH INOPERABLE RISK 10-15% STS >10 RISK>15% Transcatheter Aortic Valve 16

17 Transcatheter Aortic Valve Aortic Valve Prostheses Transcatheter Aortic Valve 17

18 Estimated Costs From The Partner Trial Of 3105 patients screened, 12% (358 patients) were randomized to transfemoral TAVR vs Standard Rx. In Standard Rx, 82.3% underwent balloon valvuloplasty. This efficacy trial was funded by Edwards Lifesciences, the maker of the SAPIEN Despite randomization, the Standard Rx group had significantly more COPD, atrial fibrillation, and fraility. Surgical Aortic Valve (SAVR) 40% No Valve Replacement Higher Incidence of Stroke 18

19 Absolute Reduction in Mortality Continues to Diverge at 2 Years Transcatheter Aortic Valve 19