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Severe Aortic Stenosis and TAVR Joseph N. Wight, Jr, MD MaineHealth Cardiology Maine Medical Center Clinical Assistant Professor Department of Medicine Tufts University School of Medicine
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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
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What Causes Aortic Stenosis in Adults? Aortic stenosis in patients over the age of 65 is usually caused by calcific (calcium) deposits associated with aging Age-Related Calcific Aortic Stenosis Congenital Abnormality In some cases adults may develop aortic stenosis resulting from a congenital abnormality More Common Less Common Rheumatic Fever Adults who have had rheumatic fever may also be at risk for aortic stenosis 3
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3 Major Etiologies for aortic stenosis
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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 7 Major Risk Factors
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Signs and Symptoms Heart Failure Angina Syncope Carotid Parvus et Tardus Laterally displaced PMI Soft A2 Crescendo-Decrescendo systolic murmur Timing of peak murmur and NOT intensity predicts severity
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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 occur1 Aortic Stenosis Is Life Threatening and Progresses Rapidly
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5 year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis 10 Sobering Perspective 5-Year Survival8 Survival, % 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
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* 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 Echocardiographic Guidelines are the Gold Standard in Assessing Severe Aortic Stenosis6 *Doppler-Echocardiographic measurements 11
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Multiple Modalities May Be Used to Diagnose Severe Aortic Stenosis6 12
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Echocardiography: Continuity Equation-Conservation of Mass
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Echocardiography: 3D Planimetry
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Not so classic aortic stenosis
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1. Low Flow, Low Gradient Severe AS 2. Paradoxical Low Flow, Low Gradient Severe AS
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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.
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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, so many of these patients do not undergo surgical aortic valve replacement Paradoxical Low Flow and/or Low Gradient Severe Aortic Stenosis1 Dobutamine stress in low gradient, low ejection fraction AS Chambers, Heart. 2006 April; 92(4): 554–558 21
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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.
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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.
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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 24 Aortic Valve Replacement Greatly Improves Survival Patient Survival16 AVR, No Symptoms AVR, Symptoms No AVR, No Symptoms No AVR, Symptoms Years
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25 Options for Aortic Valve Replacement Transcatheter Aortic Valve Replacement (TAVR) Surgical Aortic Valve Replacement (sAVR) Minimal Incision Valve Surgery (MIVS) Inoperable OR High Risk Patients Suitable for Open Chest Surgery Transfemoral Approach
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Prosthetic Heart Valves
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Tilting Disc Valve
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Bio-prosthetic Valve
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Studies show at least 40% of patients with severe AS are not treated with an AVR9-15 29 Low Percentage of Aortic Valve Surgery Aortic Valve Replacement No Aortic Valve Replacement
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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.
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An aortic valve replacement as an alternative to traditional thoracotomy. Less invasive than traditional thoracotomy for patients considered too high risk for traditional surgery. What is TAVR-Transcatheter Aortic Valve Replacement? 31
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Two TAVR Options Edwards Sapien Valve Stainless Steel Frame More Aortic Regurg, less AV block/PPM Better for severe bulky calcification. Medtronic CoreValve Nitinol Frame-self expanding Less Aortic Regurg, More heart block/PPM
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33
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TAVR Multimodality imaging
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N = 179 N = 358 Inoperable Standard Therapy ASSESSMENT: Transfemoral Access Not In Study TF TAVR Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) 1:1 Randomization VS Yes No N = 179 TF TAVR AVR Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) TA TAVR AVR VS VS N = 248 N = 104 N = 103 N = 244 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients 2 Parallel Trials: Individually Powered N = 699 High Risk ASSESSMENT: Transfemoral Access Transapical (TA) Transfemoral (TF) 1:1 Randomization 1:1 Randomization Yes No Cohort A Cohort B
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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
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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
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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
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39 Characteristics of an Inoperable Patient Cohort B Old age Reduced EF Prior CABG History of stroke/CVA History of AFib Prior chest radiation Prior open chest surgery Heavily calcified aorta History of CAD History of COPD History of renal insufficiency Frailty History of syncope Fatigue, slow gait Peripheral vascular disease Diabetes and hypertension Severe, symptomatic native aortic valve stenosis TAVR patients may present with some of the following:
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“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
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TAVR Group 179 Patients 6 did not undergo TAVR 2 died before implantation 2 unsuccessful transfemoral access 2 aortic valve annulus was to large
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Cohort B Survival 42 THE PARTNER TRIAL COHORT B
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Edwards SAPIEN THV Improved Cardiac Function Error bars = ± 1 Std Dev 43 THE PARTNER TRIAL COHORT B
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Cohort B HF Improvement 44 THE PARTNER TRIAL COHORT B
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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. 45 THE PARTNER TRIAL COHORT B
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N = 179 N = 358 Inoperable Standard Therapy ASSESSMENT: Transfemoral Access Not In Study TF TAVR Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) 1:1 Randomization VS Yes No N = 179 TF TAVR AVR Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) TA TAVR AVR VS VS N = 248 N = 104 N = 103 N = 244 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients 2 Parallel Trials: Individually Powered N = 699 High Risk ASSESSMENT: Transfemoral Access Transapical (TA) Transfemoral (TF) 1:1 Randomization 1:1 Randomization Yes No Cohort A Cohort B
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Cohort A: All-Cause Mortality No. at Risk HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = 0.483 26.8% 24.3% 34.6% 33.7% 44.8% 44.2%
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TAVR AVR Cohort A: Strokes No. at Risk 3.2% 6.0% 9.3% 8.2% HR [95% CI] = 1.09 [0.62, 1.91] p (log rank) = 0.763 4.9% 7.7% Months Post Randomization
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CoreValve US Pivotal Trials Extreme Risk High Risk CoreValve Iliofemoral Iliofemoral Access > 18 Fr Sheath No Yes Randomization 1:1 CoreValve Non-Iliofemoral Versus SAVR CoreValve N=487 N=147 49 TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal
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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 Study Purpose Primary Endpoint: All Cause Mortality or Major Stroke at 12 Months 50 TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal
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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 Inclusion and Exclusion Criteria 51 TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal
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P < 0.0001 25.5% [21.6,29.4] All Cause Mortality or Major Stroke Months Post-Procedure 9.3% [6.7,12.0] All Cause Mortality or Major Stroke Primary Endpoint 52 Performance Goal = 43% TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal
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NYHA Class Survivors Percentage of Patients 90% of Patients Improved at Least 1 NYHA Class by 1 Year 60% of Patients Improved at Least 2 NYHA Classes by 1 Year 53 TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal
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Secondary Endpoints * Percentages obtained from Kaplan Meier estimates 54 TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal
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Core Valve Trial 55
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Study Disposition
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19.1% 4.5% Surgical 14.2% P = 0.04 for superiority 3.3% Transcatheter Primary Endpoint: 1 Year All-cause Mortality ACC 2014 57
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2-Year All-cause Mortality ACC 2014
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Major Stroke 60
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Other Endpoints * Percentages reported are Kaplan-Meier estimates and log-rank P values 61
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MMC Heart Valve Clinic Marco Diaz, MD John Lualdi,MD David Butzell, MD Merle Kellett, MD Reed Quinn, MD Scott Buchanan, MD David Burkey, MD
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Following Patient Referral, the TAVR Team will Perform Further Evaluation 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 Evaluate the aortic valvular complex using echocardiography Evaluate the peripheral vasculature and aortic valvular complex using MDCT 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 4 5 3 1 2 63
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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. Key Takeaways 64
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Thank You!