TAVI After PARTNER-2 : The Hamilton Approach
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1 TAVI After PARTNER-2 : The Hamilton Approach James L. Velianou MD FRCPC Interventional Cardiology Hamilton General Hospital St Catharines General Hospital Associate Professor of Medicine McMaster University
2 Faculty/Presenter Disclosure Proctor, EdwardsLifesciences
3 Should TAVI/TAVR be available to any patient or physician that requests it? 1 YES 2 NO 3 Maybe
4 If you were 60, healthy but symptomatic and needed treatment for severe AS? 1 SAVR? 2 TAVI? 3 Medical Therapy? 4 Other?
5
6 Background In PARTNER 1, transcatheter aortic valve replacement (TAVR) was superior to standard therapy in patients with symptomatic severe aortic stenosis who were not candidates for surgery AND was equivalent to surgery in highrisk patients.
7 Background (2) However, early operator experiences using first generation TAVR systems resulted in frequent peri-procedural complications. Lower profile second generation TAVR systems have been associated with improved clinical outcomes. Recently, there has been a worldwide trend to extend TAVR therapy to lower-risk patients, but rigorous evidence-based medicine validation is lacking.
8 The PARTNER 2A Trial
9 Yes The PARTNER 2A Trial Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team Operable (STS 4%) Randomized Patients n = 2032 ASSESSMENT: Transfemoral Access No Transfemoral (TF) Transapical (TA) / TransAortic (TAo) 1:1 Randomization (n = 1550) 1:1 Randomization (n = 482) TF TAVR (n = 775) VS. Surgical AVR TA/TAo TAVR (n = 775) (n = 236) VS. Surgical AVR (n = 246) Primary Endpoint: All-Cause Mortality or Disabling Stroke at Two Years
10 Inclusion Criteria PARTNER 2A Severe AS: Echo-derived AVA 0.8 cm 2 (or AVA index < 0.5 cm 2 /m 2 ) and mean AVG > 40 mm Hg or peak jet velocity > 4.0 m/s Cardiac Symptoms: NYHA Functional Class II Intermediate Risk: 1. Determined by the multi-disciplinary Heart Team 2. Using a guideline STS 4%, and 3. Adjudicated by case review committee
11 PARTNER SAPIEN Platforms Device Evolution SAPIEN SAPIEN XT SAPIEN 3 Valve Technology Sheath Compatibility 22-24F 16-20F 14-16F Available Valve Sizes 23 mm 26 mm 23mm 26mm 29mm* 20 mm 23 mm 26 mm 29 mm *First Implant Oct 30, 2012
12 Baseline Patient Characteristics Demographics and Vascular Disease Characteristic TAVR (n = 1011) Surgery (n = 1021) p-value Age - yrs 81.5 ± ± Male - % STS Score - % 5.8 ± ± NYHA Class III or IV - % CAD - % Prior CABG - % Cerebrovascular Disease - % PVD - %
13 Baseline Patient Characteristics PARTNER 2 Other Co-morbidities Characteristic (%) TAVR (n = 1011) Surgery (n = 1021) p-value Diabetes COPD - Any O 2 dependent Creatinine > 2 mg/dl Atrial Fibrillation Permanent Pacemaker Frailty (15 ft walk > 7 s) Liver Disease
14 Procedural Characteristics (AT) PARTNER 2 Characteristic TAVR (n = 994) Surgery (n = 944) p-value Anesthesia Time (min) < Procedure Time (min) < Fluoroscopy Time (min) 20 NA NA Aortic Cross-clamp Time (min) NA 75 NA Total CPB Time (min) NA 104 NA Median ICU Stay (days) 2.0 [2, 4] 4.0 [3, 6] < Median Total Length of Stay (days) 6.0 [4, 9] 9.0 [8, 14] < Median [IQR]
15 TF Primary Endpoint (ITT) P2A All-cause Mortality or Disabling Stroke All-Cause Mortality or Disabling Stroke (%) % 4.9% TF Surgery TF TAVR 15.9% 12.3% HR: 0.79 [95% CI: 0.62, 1.00] p (log rank) = % 16.8% Number at risk: Months from Procedure TF Surgery TF TAVR
16 TF Primary Endpoint (AT) P2A 1 All-Cause Mortality or Disabling Stroke All-Cause Mortality or Disabling Stroke (%) Number at risk: TF Surgery TF TAVR 7.5% 4.5% TF Surgery TF TAVR 15.8% 11.7% HR: 0.78 [95% CI: 0.61, 0.99] p (log rank) = % 16.3% Months from Procedure
17 The PARTNER 2A and S3i Trial
18 The PARTNER 2A and S3i Trials Study Design Intermediate Risk Symptomatic Severe Aortic Stenosis Intermediate Risk ASSESSMENT by Heart Valve Team P2 S3i n = 1078 P2A n = 2032 ASSESSMENT: Optimal Valve Delivery Access Yes ASSESSMENT: Transfemoral Access No Transfemoral (TF) Transapical / Transaortic (TA/TAo) Transfemoral (TF) Transapical / TransAortic (TA/TAo) 1:1 Randomization 1:1 Randomization TF TAVR SAPIEN 3 TA/TAo TAVR SAPIEN 3 TF TAVR SAPIEN XT VS Surgical AVR TA/Tao TAVR SAPIEN 3 VS Surgical AVR Primary Endpoint: All-Cause Mortality, All Stroke, or Mod/Sev AR at One Year (Non-inferiority Propensity Score Analysis)
19 Unadjusted Time-to-Event Analysis All-Cause Mortality and All Stroke (AT) 40 P2A Surgery All-Cause Mortality / Stroke Rate (%) SAPIEN 3 TAVR 9.7% 3.7% 18.8% 10.8% Number at risk: Months from Procedure P2A Surgery S3 TAVR
20 Unadjusted Time-to-Event Analysis All-Cause Mortality (AT) 40 P2A Surgery SAPIEN 3 TAVR All-Cause Mortality (%) % 4.0% 7.4% 0 1.1% Number at risk: P2A Surgery S3 TAVR Months from Procedure
21 All-Cause Mortality at 30 Days Edwards SAPIEN Valves (As Treated Patients) PARTNER I and II Trials Overall and TF Patients SAPIEN SXT SAPIEN 3
22 TAVI and Risk..Is Tide Changing???
23 Results of AVR, AVR+CABG in Ontario Table 40 - Prevalence of Risk Factors by Hospital for Isolated AVR Surgery Risk Factor Total HHSC HSN KGH LHSC SHSC S Table Provincial distribution of risk factors by mortality for isolated CABG surgery, isolated AVR surgery Mean ± ± and 12.54combined ± CABG/AVR ± ± surgery ± for 2008/09 ± to 2010/11 Age < Isolated CABG Isolated AVR Combined CABG/AVR Surgery Surgery Surgery Sex Female In-Hospital 30-Day In-Hospital 30-Day In-Hospital 30-Day Risk Factor Mortality Mortality Mortality Mortality Mortality Mortality <25% % < BMI >30% Age Unknown Yes >75 0 < CHF % COPD % CVD LVEF % Diabetes <20% <5 <5 <5 < < LV Function <5 0 <5 <5 Hypertension Unknown <5 < <5 Unknown <5 <5 PVD % Age < LVEF Grade Source: CCN. Report On Adult Cardiac Surgery in Ontario,
24 30 day Mortality ALL ISOLATED AVR ONTARIO 2.03% (n=2609)
25 Key Points TAVI/TAVR is still rapidly changing TAVI/TAVR results appear robust in short term Application of Therapy still in flux SAVR still Gold Standard? Heart Team?
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