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Severe Aortic Stenosis and TAVR Disclosures •I will not discuss off label use or investigational use in my presentation. •I have no financial relationships to disclose. •Employee of MaineHealth Cardiology Prevalence of Aortic Stenosis 16.5 Million People in US Over the Age of 652 Aortic stenosis is estimated to be prevalent in up to 7% of the population over the age of 651 Percentage Diagnosed with Aortic Stenosis It is more likely to affect men than women; 80% of adults with symptomatic aortic stenosis are male3 3 Aortic Stenosis Demographics Aortic stenosis 2% US population >65yrs old Aortic sclerosis 29% US population> 65 yrs old Aortic sclerosis 50% greater risk of mortality and myocardial infarction. Aortic sclerosis progresses to aortic stenosis in 9% over 5 years What Causes Aortic Stenosis in Adults? More Common Age-Related Calcific Aortic Stenosis Aortic stenosis in patients over the age of 65 is usually caused by calcific (calcium) deposits associated with aging Rheumatic Fever Adults who have had rheumatic fever may also be at risk for aortic stenosis Congenital Abnormality In some cases adults may develop aortic stenosis resulting from a congenital abnormality Less Common 5 3 Major Etiologies for aortic stenosis Major Risk Factors Independent clinical factors associated with degenerative aortic valve disease include the following:4 Increasing age • Male gender • Hypertension • Smoking Elevated lipoprotein A Elevated LDL cholesterol 9 Signs and Symptoms • Heart Failure • Carotid Parvus et Tardus • Angina • Laterally displaced PMI • Syncope • Soft A2 • Crescendo-Decrescendo systolic murmur • Timing of peak murmur and NOT intensity predicts severity Aortic Stenosis Is Life Threatening and Progresses Rapidly Survival after onset of symptoms is 50% at 2 years and 20% at 5 years1 Surgical intervention for severe aortic stenosis should be performed promptly once even minor symptoms occur 1 Sobering Perspective 35 5-Year Survival 8 30 30 28 Survival, % 25 20 23 15 12 10 5 4 3 0 Breast Cancer Lung Cancer Colorectal Cancer Prostate Cancer Ovarian Cancer Severe Inoperable AS* *Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic 5 year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis 12 Echocardiographic Guidelines are the Gold Standard in Assessing Severe Aortic Stenosis6 * *Doppler-Echocardiographic measurements According to the 2014 ACC/AHA guidelines, severe aortic stenosis is defined as: Aortic valve area (AVA) less than 1.0 cm2 Mean gradient greater than 40 mmHg or jet velocity greater than 4.0 m/s 13 Multiple Modalities May Be Used to 6 Diagnose Severe Aortic Stenosis Auscultation Trans-thoracic Echo (TTE) Chest Cardiac Cath. X-ray Electrocardiogram 14 Echocardiography: Continuity Equation-Conservation of Mass Echocardiography: 3D Planimetry Not so classic aortic stenosis 1. Low Flow, Low Gradient Severe AS 2. Paradoxical Low Flow, Low Gradient Severe AS Low Flow, Low Gradient AS • Low gradient with a small calculated valve area in the setting of poor systolic function. This may result in lack of referral for AVR because of the low gradient. • Dobutamine Stress Echo: – By increasing cardiac output, we can determine if the AS is severe by reassessing the gradient across the aortic valve (increases) AND the aortic valve area (decreases). – Assess myocardial contractile reserve • Does the cardiac output improve by 20% or more. – Critical for decision making regarding aortic valve replacement. Paradoxical Low Flow and/or Low Gradient Severe Aortic Stenosis1 • Some patients with severe aortic stenosis based on valve area have a lower than expected gradient (e.g. mean gradient < 30 mmHg) despite preserved LV ejection fraction (e.g. EF > 50%) – Up to 35% of patients with severe aortic stenosis present with low flow, low gradient – These low gradients often lead to an underestimation of the severity of the disease, Dobutamine stress in low gradient, low ejection fraction AS Chambers, Heart. 2006 April; 92(4): 554–558 so many of these patients do not undergo surgical aortic valve replacement 23 Stages of Valvular AS. ACC/AHA 2104 Valve Guidelines Nishimura R A et al. Circulation. 2014;129:e521-e643 Copyright © American Heart Association, Inc. All rights reserved. Summary of Recommendations for AS: Timing of Intervention. Nishimura R A et al. Circulation. 2014;129:e521-e643 Copyright © American Heart Association, Inc. All rights reserved. Aortic Valve Replacement Greatly Improves Survival Survival, % Patient Survival 100 90 80 70 60 50 40 30 20 10 0 16 AVR, noSymptoms Sx AVR, No AVR, Sx AVR, Symptoms No AVR, Symptoms No AVR,Nono Sx No AVR, No AVR,Symptoms Sx 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Years 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 26 Options for Aortic Valve Replacement Inoperable OR High Risk Transcatheter Aortic Valve Replacement (TAVR) Patients Suitable for Open Chest Surgery Surgical Aortic Valve Replacement (sAVR) Minimal Incision Valve Surgery (MIVS) Transfemoral Approach 27 Prosthetic Heart Valves Tilting Disc Valve Bio-prosthetic Valve Low Percentage of Aortic Valve Surgery Aortic Valve Replacement No Aortic Valve Replacement • Studies show at least 40% of patients with severe AS are not treated with an AVR9-15 31 Summary of Recommendations for AS: Choice of Surgical or Transcatheter Intervention. Nishimura R A et al. Circulation. 2014;129:e521-e643 Copyright © American Heart Association, Inc. All rights reserved. What is TAVR-Transcatheter Aortic Valve Replacement? • An aortic valve replacement as an alternative to traditional thoracotomy. • Less invasive than traditional thoracotomy for patients considered too high risk for traditional surgery. 33 Two TAVR Options • Edwards Sapien Valve • Medtronic CoreValve • Stainless Steel Frame • Nitinol Frame-self expanding • More Aortic Regurg, less AV • Less Aortic Regurg, More heart block/PPM • Better for severe bulky calcification. block/PPM 35 TAVR Multimodality imaging PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Cohort A Cohort B Total = 1,057 patients N = 699 High Risk ASSESSMENT: Yes 1:1 Randomization Transfemoral Access Transapical (TA) 1:1 Randomization Yes No 1:1 Randomization N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR AVR TA TAVR AVR TF TAVR Standard Therapy VS VS Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) N = 358 ASSESSMENT: No Transfemoral Access Transfemoral (TF) Inoperable 2 Parallel Trials: Individually Powered VS Not In Study Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) PARTNER Trial B • Exclusion Criteria: – bicuspid or noncalcified aortic valve – acute myocardial infarction – substantial coronary artery disease requiring revascularization – left ventricular ejection fraction of less than 20% – a diameter of the aortic annulus of less than 18 mm or more than 25 mm – severe (>3+) mitral or aortic regurgitation – a transient ischemic attack or stroke within the previous 6 months – severe renal insufficiency (creatinine greater than 3 or on dialysis). – Iliac-femoral anatomy precluding safe sheath insertion PARTNER Trial B Primary End-Points: – Death from any cause – Rate of a hierarchical composite of the time to death from any cause or the time to the first repeat hospitalization from aortic valve disease or procedure related complication PARTNER Trial B • Secondary End-Points: – the rate of death from cardiovascular causes – NYHA functional class – The distance covered during a 6-minute walk test – Valve performance (assessed by echocardiography) – The rates of myocardial infarction, stroke, acute kidney injury, vascular complications, and bleeding Characteristics of an Inoperable Patient Cohort B TAVR patients may present with some of the following: Severe, symptomatic native aortic valve stenosis Old age History of stroke/CVA Frailty History of syncope Reduced EF Heavily calcified aorta Prior CABG Prior chest radiation History of AFib Prior open chest surgery Fatigue, slow gait Peripheral vascular disease History of CAD History of COPD History of renal insufficiency Diabetes and hypertension 41 “Standard Medical Therapy” • 179 Patients assigned • Balloon Valvuloplasty perfomed in 114 (63.7%) patients in first 30 days and 36 (20.1%) additional patients 30 days after randomization. • 12 (6.7%) underwent AVR! • 5 (2.8%) LV apex to Aorta conduit TAVR Group • 179 Patients • 6 did not undergo TAVR – 2 died before implantation – 2 unsuccessful transfemoral access – 2 aortic valve annulus was to large Cohort B Survival THE PARTNER TRIAL COHORT B 44 Edwards SAPIEN THV Improved Cardiac Function Error bars = ± 1 Std Dev THE PARTNER TRIAL COHORT B 45 Cohort B HF Improvement THE PARTNER TRIAL COHORT B 46 Complications Stroke was defined as follows: Neurological deficit lasting ≥ 24 hours or lasting less than 24 hours with a brain imaging study showing an infarction. Major vascular complications were defined as any thoracic aortic dissection, access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, or hematoma) leading to either death, need for significant blood transfusion (> 3 units), or percutaneous or surgical intervention, and/or distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage. Bleeding event is defined as ≥ 2 units within the index procedure. THE PARTNER TRIAL COHORT B 47 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Cohort A Cohort B Total = 1,057 patients N = 699 High Risk ASSESSMENT: Yes 1:1 Randomization Transfemoral Access Transapical (TA) 1:1 Randomization Yes No 1:1 Randomization N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR AVR TA TAVR AVR TF TAVR Standard Therapy VS VS Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) N = 358 ASSESSMENT: No Transfemoral Access Transfemoral (TF) Inoperable 2 Parallel Trials: Individually Powered VS Not In Study Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) Cohort A: All-Cause Mortality HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = 0.483 44.8% 44.2% 34.6% 26.8% 33.7% 24.3% No. at Risk TAVR 348 298 261 239 222 187 149 AVR 351 252 236 223 202 174 142 Cohort A: Strokes HR [95% CI] = 1.09 [0.62, 1.91] p (log rank) = 0.763 9.3% 8.2% 7.7% 4.9% 6.0% 3.2% Months Post Randomization No. at Risk TAVR 348 287 250 228 211 176 139 AVR 351 246 230 217 197 169 139 CoreValve US Pivotal Trials Extreme Risk High Risk Iliofemoral Access > 18 Fr Sheath Randomization 1:1 Yes No CoreValve Iliofemoral CoreValve NonIliofemoral N=487 N=147 TCT 2013 LBCT Versus CoreValve SAVR Extreme Risk Study | Iliofemoral Pivotal 5 1 Study Purpose Study Purpose: To evaluate the safety and efficacy of the CoreValve THV for the treatment of patients with symptomatic severe aortic stenosis in whom the predicted risk of operative mortality or serious, irreversible morbidity was 50% or greater at 30 days Risk Determined by: Two Clinical Site Cardiac Surgeons and One Interventional Cardiologist Risk Confirmed by: Two Screening Committee Cardiac Surgeons and One Interventional Cardiologist Primary Endpoint: All Cause Mortality or Major Stroke at 12 Months TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal 5 2 Inclusion and Exclusion Criteria Inclusion Criteria: • Severe aortic stenosis: AVA ≤ 0.8 cm2 or AVAI ≤ 0.5 cm2/m2 AND mean gradient > 40 mm Hg or peak velocity > 4 m/sec at rest or with dobutamine stress (if LVEF < 50%) • NYHA functional class II or greater Exclusion Criteria (selected): • • • • • Recent active GI bleed (3 mos), stroke (6 mos), or MI (30 days) Creatinine clearance < 20 mL/min Significant untreated coronary artery disease LVEF < 20% Life expectancy < 1 year due to co-morbidities TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal 5 3 Primary Endpoint All Cause Mortality or Major Stroke All Cause Mortality or Major Stroke P < 0.0001 Performance Goal = 43% 9.3% [6.7,12.0] 25.5% [21.6,29.4] Months Post-Procedure TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal 54 NYHA Class Survivors 90% of Patients Improved at Least 1 NYHA Class by 1 Year Percentage of Patients 60% of Patients Improved at Least 2 NYHA Classes by 1 Year TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal 55 Secondary Endpoints Events* Any Stroke, % 1 Month 3.9 1 Year 6.7 Major, % 2.4 4.1 Minor, % 1.7 3.1 Myocardial Infarction, % 1.3 2.0 Reintervention, % 1.3 2.0 VARC Bleeding, % 35.1 41.4 Life Threatening or Disabling, % 11.7 16.6 Major, % 24.1 27.6 Major Vascular Complications, % 8.3 8.5 Permanent Pacemaker Implant, % 22.2 27.1 17.4 19.9 Per ACC Guidelines, % * Percentages obtained from Kaplan Meier estimates TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal 56 Core Valve Trial 57 Study Disposition Primary Endpoint: 1 Year All-cause Mortality ACC 2014 Surgical Transcatheter 19.1% 14.2% 4.5% P = 0.04 for superiority 3.3% 59 2-Year All-cause Mortality ACC 2014 Major Stroke 62 Other Endpoints Events* 1 Month TAV R Vascular complications (major), % 5.9 1 Year SAVR P Value TAVR SAVR P Value 6.2 2.0 0.004 Pacemaker implant, % 19.8 7.1 <0.001 22.3 Bleeding (life threatening or 13.6 35.0 <0.001 16.6 disabling),% New onset or worsening atrial fibrillation, % 11.7 30.5and log-rank <0.001P values 15.9 * Percentages reported are Kaplan-Meier estimates 11.3 <0.001 38.4 <0.001 32.7 <0.001 Acute kidney injury, % 15.1 <0.001 6.0 1.7 15.1 0.003 <0.001 6.0 63 MMC Heart Valve Clinic Marco Diaz, MD David Butzell, MD Reed Quinn, MD David Burkey, MD John Lualdi,MD Merle Kellett, MD Scott Buchanan, MD Following Patient Referral, the TAVR Team will Perform Further Evaluation 1 2 Confirm the patient is diagnosed with severe symptomatic native aortic stenosis Confirm the patient has been independently evaluated by two cardiac surgeons and meets the indication for TAVR 3 4 Evaluate the aortic valvular complex using echocardiography Evaluate the peripheral vasculature and aortic valvular complex using MDCT 5 Evaluate the peripheral vasculature and aortic valvular complex using catheterization Note: Evaluation using CT is typically not done unless the Heart Team confirms that patient is a candidate for TAVR 65 Key Takeaways • Aortic Stenosis is prevalent with a high morbidity and mortality when symptomatic and aortic valve replacement is the only treatment associated with improved outcomes. • Asymptomatic low risk patients will benefit from surgical AVR. • Low gradient does not necessarily exclude severe aortic stenosis, even when the ejection fraction is normal!! • TAVR is an excellent alternative to traditional Aortic Valve Surgery but increased risk of stroke and vascular injury and the need for a permanent pacemaker. • MMC Heart Team has performed over 100 TAVR procedures in three years with excellent outcomes. 66 Thank You!