Transcatheter Aortic Valve Replacement: Current and Future Devices: How do They Work, Eligibility, Review of Data Echo Florida 2013 Jonathan J. Passeri, M.D. Co-Director, Heart Valve Program Director, Interventional Echocardiography Disclosures Edwards LifeSciences Current and Future Devices 1
Transcatheter Aortic Valve Replacement Anderson et al, 1992 Swine model Bonhoeffer et al, 2000 First human use of stent mounted bioprosthesis for pulmonary valve regurgitation Cribier et al, 2002 First-in-man percutaneous aortic valve implantation Antegrade transvenous delivery Webb et al, 2006 Retrograde via femoral artery Also transapical LV delivery Transcatheter Valve Technology April 23, 2002 First Heart Valve Replacement Without Open Heart Surgery SOURCE: Percutaneous Valve Technologies, Inc. (PVT) Experimental Device Developed By Percutaneous Valve Technologies May Provide Alternative to Open Heart Surgery In the United States The 57 year old male patient that received the aortic valve procedure had a failing heart and was refused for surgery by three surgical teams because of his deteriorating condition and complicated vascular disease, said Dr. Alain Cribier. Lacking any other clinical solution for this patient, the PVT valve was a life saving technology. We are pleased to be the world's first clinical site to utilize this device. SAPIEN Transcatheter Heart Valve 26 mm 23 mm Collapsed Expanded 2
Percutaneous Aortic Valve Implantation Via Antegrade Approach Balloon valvuloplasty followed by stented valve deployment during rapid ventricular pacing Cribier et al, JACC 2004;43:698-703 Transfemoral Retrograde Approach for Transcatheter Aortic Valve Replacement Webb et al. Circulation 2006; 113:842-850 Alternative Mode of Transcatheter Deployment: Transapical Antegrade Approach 3
Direct Aortic Approach Sapien THV and Delivery systems Edwards SAPIEN THV 23 and 26 mm valves RetroFlex 22 and 24 F sheaths Ascendra 24 and 26 F sheaths The Next Generation: SAPIEN XT THV 4
NovaFlex Delivery System CoreValve Sapien and CoreValve Edwards Sapien CoreValve 5
CoreValve Emerging Transcatheter Heart Valves a Direct Flow Medical valve (Direct Flow Medical, Santa Rosa, CA, USA). b HLT valve (Heart Leaflet Technologies, Maple Grove, MN, USA). c Innovare valve (Braile Biomedical, São José do Rio Preto, Brazil). d JenaValve (JenaValve Technology, Munich, Germany). e Portico valve (St-Jude Medical, St Paul, MN, USA). f Sadra Lotus Medical valve (Boston Scientific SciMed Inc, Maple Grove, MN, USA). g Symetis Accurate valve (Symetis SA, Lausanne, Switzerland). h Engager valve (Medtronic Inc., Minneapolis, MN, USA). Rodés-Cabau, J. (2011) Transcatheter aortic valve implantation: current and future approaches Nat. Rev. Cardiol. doi:10.1038/nrcardio.2011.164 Who is Eligible? Medical Eligibility Anatomic Eligibility 6
PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 699 High Risk Total = 1,057 patients 2 Parallel Trials: Individually Powered Inoperable N = 358 Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR VS AVR TA TAVR VS AVR TF TAVR VS Standard Therapy Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) PARTNER Study Design: Inoperable Patients Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Inoperable N = 358 ASSESSMENT: Transfemoral Access Yes No 1:1 Randomization Not In Study N = 179 TF TAVR VS N = 179 Standard Therapy Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) Inclusion Criteria: Inoperable Group Severe Aortic Stenosis: 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/sec. Cardiac Symptoms: NYHA Functional Class II or greater Inoperable: Predicted risk of death or serious irreversible morbidity must exceed 50% 7
All Cause Mortality (%) TAVR: Transfemoral Delivery Transfemoral Transapical All Cause Mortality (ITT) Standard Rx TAVR at 1 yr = 20.0% NNT = 5.0 pts 50.7% HR [95% CI] = 0.57 [0.44, 0.75] p (log rank) < 0.0001 68.0% 30.7% 43.3% at 2 yr = 24.7% NNT = 4.0 pts Months Numbers at Risk TAVR 179 138 124 110 83 47 14 Standard Rx 179 121 85 62 42 19 5 FDA Approval November 2, 2011: Edwards SAPIEN THV via Transfemoral Delivery approved by FDA for Inoperable patients 8
Who is Eligible? Medical Eligibility Symptomatic Severe Calcific Aortic Stenosis Inoperable in estimation of two cardiac surgeons Implantation route via FDA labeling PARTNER Study Design: High Risk Surgical Group Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 699 High Risk Yes ASSESSMENT: Transfemoral Access No Transfemoral (TF) Transapical (TA) 1:1 Randomization 1:1 Randomization N = 244 N = 248 N = 104 N = 103 TF TAVR AVR TA TAVR AVR VS VS Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Inclusion Criteria: High-Risk Surgical Group Severe Aortic Stenosis: 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/sec. Cardiac Symptoms: NYHA Functional Class II or greater High Surgical Risk: Predicted risk of operative mortality 15% (determined by site surgeon and cardiologist); guideline = STS score 10 9
TAVR: Transfemoral or Transapical Delivery Transfemoral Transapical ACC 2012: All-Cause Mortality at 2 Years Kodali SK et al. N Engl J Med 2012;366:1686-1695. Who is Eligible? Medical Eligibility Symptomatic Severe Aortic Stenosis Inoperable in estimation of two cardiac surgeons Implantation route via FDA labeling High risk surgical candidates soon to come? Meets eligibility for ongoing clinical trial (PARTNER II, CoreValve U.S. Pivotal) 10
Medical Eligibility: Contraindications and Cautions Non-calcified aortic valve Bicuspid aortic valve Severe aortic regurgitation Severe mitral regurgitation Poor prognosis from non-cardiac disease (advanced malignancy, very severe COPD Transcatheter Aortic Valve Replacement: Outcomes of Patients With Moderate or Severe Mitral Regurgitation J Am Coll Cardiol. 2012;59(23):2068-2074. doi:10.1016/j.jacc.2012.02.020 Kaplan-Meier Curves for All-Cause Mortality in Patients With Mild or Less, Moderate, and Severe MR at Baseline Survival in patients with mild or less, moderate, and severe mitral regurgitation (MR) at baseline was 92.5%, 86.5%, and 83.7% at 30 days; 79.0%, 76.2%, and 64.5% at 1 year; and 66.2%, 67.9%, and 58.5% at 2 years, respectively. TAVR = transcatheter aortic va lve replacement. Source XT: Improvement in Mitral Regurgitation Presented by H Baumgartner PCR London Valves 2012 11
Medical Eligibility: Areas of Uncertainty Understanding Frailty Mild or Moderate Dementia End-Stage Renal Disease Low-gradient Aortic Stenosis (without contractile reserve) Very Low Ejection Fraction Anatomic Eligibility Aortic valve morphology Annulus size Determining route of vascular access for implantation Not always about vessel size Minimize risk of stroke and vascular complications LVOT and aortic root anatomy/pathology HOCM Narrowed and circumferentially calcified STJ Relation of Paravalvular Aortic Regurgitation to All- Cause Mortality in the TAVR As-Treated Population. Kodali SK et al. N Engl J Med 2012;366:1686-1695. 12
CTA Bicuspid Aortic Valve Bicuspid Aortic Valve: TAVR 13
Bicuspid Aortic Valve: TAVR How to Assess Eligibility Comprehensive medical evaluation Echocardiogram CTA Cardiac catheterization Transesophageal echocardiography THANK YOU! 14