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Transcatheter Aortic Valve Replacement(TAVR) NCVH - 2016 Update Rodney Reeves, MD • Disclosures: none Current State of TAVR - 2016 » ~350 US Centers performing TAVR » WKHS currently only local institution performing TAVR(2 ICs, 2 cardiac surgeons) » 2 valve options are currently FDA approved(Edwards, Medtronic) » Numerous other valves in pipeline/ approval process 3 Current FDA Approved Valves » Edwards Sapien 3 - balloon expandable » Medtronic Corevalve Evolut R- selfexpanding » Both are excellent valves!!! Both are reasonable options for the majority of patients. » Advantages and disadvantages to each….we are still learning best way to individualize choice for each patient 4 Pre TAVR workup » Meet the patient and family(discuss goals/ expectations) » CT » RHC/LHC » Assess risk(PFTs, frailty index, comorbidities, STS score, etc.) » Surgical Consultation 5 Day of TAVR » Team Approach - heart surgeon and interventional cardiologist work together on procedure, both scrubbed » Lots of help and support!!!(cath lab RNs, rad techs, OR staff, perfusionist on standby, etc.) » Typically ~ 1 hr, most still general anesthesia, extubate in OR 6 Post-op till Discharge » » » » Early ambulation Lines out quickly Avoidance of sedatives/narcotics Aspirin/Plavix 7 TAVR Heart Team Concept 2014 Valvular Disease Guidelines Cohesive, Multi-disciplinary Approach Embodies ▪ Optimal patient centric care ▪ Dedication across medical specialties ▪ Collaborative treatment decision Interventional Cardiologist Imaging Specialists AHA / ACC Cardiologist Surgeon TAVR Valve Clinic Coordinator Heart Team National Coverage Determination18 The patient (preoperatively and postoperatively) is under the care of a heart team Cardiac CATH Lab and O.R. Staff Referring Cardiologist Anesthe- siologist 18. National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). 2012. 8 TAVR Evaluation Pathway Pre-screening Review of Records Clinical Evaluation Gated CTA (Chest / Abdomen / Pelvis) RHC / LHC Coronary Angiography Functional Status Assessment (Cognitive Function, Frailty, etc.) STS Score Calculation Treatment Plan Note: The above is a suggested flow for the patient screening process, however, the order in which screening tests are conducted varies depending on the patient’s profile and should be at the discretion of the Heart Team. 9 Characteristics of a TAVR Patient19 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 19. Leon M et al. New England Journal of Medicine 2010 October 21;363(17):1597-1607. 10 Alain Cribier: First Human Transcatheter Valve Replacement (2002) 11 What Causes Aortic Stenosis in Adults? Less Common Congenital Abnormality More Common Rheumatic Fever Age-Related Calcific Aortic Stenosis Images courtesy of John Webb, MD at St. Paul’s Hospital and Renu Virmani, MD at the CVPath Institute 12 Population at Risk for Aortic Stenosis is Increasing Approx. 2.5 Million People in the U.S. Over the Age of 75 suffer from this disease.1 ELDERLY AVERAGE ANNUAL GROWTH RATE: 1910 to 2030 4.0% 3.1% ▪ Aortic Stenosis is estimated to be prevalent with 12.4% of the population over the age of 75.2 2.6% 2.8% 2.4% ▪ The elderly population will more than double between now and the year 2050, to 80 million.3 ▪ 80% of adults with symptomatic aortic stenosis are male4 2.2% 1.3% 0.0% 1910-1930 1950-1970 1990-2010 1. U.S. Census Bureau, Population Division. June 2015; 2. Ruben L.J.et al. Heart. 2000;84:211-21; 3. U.S. Census Bureau Statistical Brief. May 1995; 4. Ramaraj R, Sorrell VL. Br Med J 2008;336: 550–5. 13 Symptoms of Aortic Stenosis ▪ ▪ ▪ ▪ ▪ Shortness of breath Angina Fatigue Syncope or Presyncope Other ▪ Rapid or irregular heartbeat ▪ Palpitations Sandy Severe Aortic Stenosis (Actual Patient) The symptoms of aortic disease are commonly misunderstood by patients as ‘normal’ signs of aging.5 Many patients initially appear asymptomatic, but on closer examination up to 37% exhibit symptoms.6 5. Das P. European Heart Journal. 2005;26:1309-1313; 6 . Lester SJ et al. CHEST 1998;113(4):1109-1114. 14 Severe Aortic Stenosis is Life Threatening and Treatment is Critical6 ADULTS AVERAGE COURSE WITH VALVULAR AORTIC STENOSIS 100% Onset Severe Symptoms 80% Angina Survival, % After the onset of symptoms, patients with severe aortic stenosis have a survival rate as low as 50% at 2 years and 20% at 5 years without aortic valve replacement7 60% 40% Syncope Latent Period Failure (Increasing Obstruction, Myocardial Overload) 0 20% 2 4 6 Average Survival, y 0 0 40 50 Age, Years 60 70 50% of patients died within 1 year without valve replacement Per the Inoperable Cohort of the PARTNER Trial 6. Lester SJ et al. CHEST 1998;113(4):1109-1114; 7. Otto CM. Heart. 2000:84:211-218. 15 Worse Prognosis than Many Metastatic Cancers 5-YEAR SURVIVAL 8 (Distant Metastasis) 35 30 Survival, % 30 25 28 23 20 15 12 10 4 5 0 Breast Cancer Lung Cancer 3 Colorectal Cancer Prostate Cancer Ovarian Cancer Severe Inoperable AS* 5 year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis *Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic 8. National Institutes of Health. http://seer.cancer.gov/statfacts/. Accessed Nov. 2010. 16 Timely Intervention is Critical for Patients with Symptoms9 ▪ In the absence of serious comorbid conditions, aortic valve replacement (AVR) is indicated in the majority of symptomatic patients with severe aortic stenosis ▪ Consultation with or referral to a Heart Valve Center of Excellence is reasonable when discussing treatment options for: 2014 Valvular Disease Guidelines AHA / ACC ▪ Asymptomatic patients with severe valvular heart disease ▪ Patients with multiple comorbidities for whom valve intervention is considered ▪ Because of the risk of sudden death, replacing the aortic valve should be performed promptly after the onset of symptoms ▪ Age is not a contraindication to surgery 9. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537. 17 Definition of Severe Aortic Stenosis9 Patients with severe aortic stenosis typically have an aortic valve area ≤ 1.0 cm2 Definition 2014 Valvular Disease Guidelines AHA / ACC Valve Hemodynamics High-gradient severe aortic stenosis ▪ Aortic jet velocity ≥ 4 m/s or mean gradient ≥ 40 mmHg ▪ Or aortic valve area index ≤ 0.6 cm2/m2 Low-flow/low-gradient with reduced left ventricular ejection fraction ▪ Resting aortic jet velocity < 4m/s or mean gradient < 40 mmHg ▪ Dobutamine stress echocardiography shows aortic valve area ≤ 1.0 cm2 with aortic jet velocity ≥ 4m/s at any flow rate ▪ Left ventricular ejection fraction < 50% Low-gradient with normal left ventricular ejection fraction or paradoxical low-flow ▪ Aortic jet velocity < 4m/s or mean gradient < 40 mmHg ▪ Indexed aortic valve area ≤ 0.6 cm2/m2 ▪ Stroke volume index < 35 mL/m2 measured when patient is normotensive (systolic blood pressure < 140 mmHg) ▪ Left ventricular ejection fraction ≥ 50% Symptoms: Dyspnea or decreased exercise tolerance, heart failure, angina, syncope and presyncope 9. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537. 18 Paradoxical Low Flow and/or Low Gradient Severe Aortic Stenosis10 ▪ Dobutamine stress echocardiography can be used to differentiate between true and pseudo severe aortic stenosis ▪ Better define the severity of the aortic stenosis ▪ Accurately assess contractile / pump reserve ▪ 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 under estimation of the severity of the disease, so many of these patients do not undergo surgical aortic valve replacement Dobutamine stress in low gradient, low ejection fraction AS Chambers, Heart. 2006 April; 92(4): 554–558 10. Dumesnil et al. European Heart Journal 2010; 31, 281-289. 19 At Least 40% of Patients Who Need Valve Replacement Do Not Get Treatment11-17 UNDERTREATEMENT OF AORTIC STENOSIS 100% 80% 54% 43% 60% 61% 40% 39% Patients, % 60% 52% 74% 69% 40% 20% 46% 57% 48% 26% 31% 0% Bouma 1999 Pellikka 2005 Charison 2006 Varadarajan 2006 January 2009 Aortic Valve Replacement (AVR) Bach 2009 Freed 2010 No AVR Studies show that patients with severe aortic stenosis are under-diagnosed and under-treated 11. Bouma BJ et al. Heart. 1999;82:143-148; 12. Pellikka PA et al. Circulation. 2005;111:3290-3295; 13. Charlson E et al. J Heart Valve Dis. 2006;15:312-321; 14. Varadarajan P et al. Ann Thorac Surg. 2006;82:2111-2115; 15. Jan F et al. Circulation. 2009;120;S753; 16. Bach DS et al. Circ Cardiovasc Qual Outcomes. 2009;2:533-539; 17. Freed BH et al. Am J Cardiol. 2010;105:1339-1342. 20 Medical Management and BAV are Inadequate Therapies for Inoperable Patients T H E PA R T N E R T R I A L Control Group (Med Rx and BAV) (n = 179) 80.9% 87.5% 93.6% All-Cause Mortality (%) 68.0% 50.7% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < 0.0001 Months * In an age and gender matched US population without comorbidities, the mortality at 5 years is 40.5%. ▪ Despite frequent BAV, standard therapy did not alter the dismal course of disease for inoperable patients in the PARTNER Trial ▪ 51% died within 1 year ▪ 94% died within 5 years 21 Options for Aortic Valve Replacement per Guidelines9 Severe Aortic Stenosis is Defined as: Valve Area < 1.0 cm2 Mean Gradient > 40 mmHg OR Jet Velocity > 4.0 m/s Therapy Transcatheter Heart Valve Low- to Moderate-Risk High Risk Greater Risk Transcatheter Aortic Valve Replacement (TAVR) Open-Heart Surgery (AVR) Surgical Heart Valve High Risk Patients Defined by STS Risk Score > 8% 9. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537. 22 Edwards SAPIEN 3 Transcatheter Heart Valve For relief of aortic stenosis in patients with ▪ Symptomatic heart disease due to severe native calcific aortic stenosis ▪ Have native anatomy appropriate for the valve delivery system ▪ Evaluated by a Heart Team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy Society of Thoracic Surgeons operative risk score ≥ 8% OR at a ≥ 15% risk of mortality (at 30 days) 23 24 25 26 TAVR is Better than Medical Management for Inoperable Patients Edwards SAPIEN Valves Significantly Improve Survival 27 TAVR is Better than Medical Management for Inoperable Patients Edwards SAPIEN is superior to medical management in inoperable patients TAVR with Edwards SAPIEN valves is a reasonable alternative to surgery Edwards SAPIEN 3 valve: Transformational design Edwards SAPIEN Valves Significantly Improve Survival 27 TAVR is Better than Medical Management for Inoperable Patients TAVR is superior Edwards SAPIEN is superior to medical to medical management for management Inoperable in inoperable Patients patients TAVR with Edwards SAPIEN valves is a reasonable alternative to surgery Edwards SAPIEN 3 valve: Transformational design Edwards SAPIEN Valves Significantly Improve Survival 27 Standard Therapy is an Ineffective Treatment for Severe Aortic Stenosis Patients A L L - C A U S E M O R TA L I T Y Inoperable Cohort 100% 93.6% Standard Rx (n = 179) TAVR (n = 179) All-Cause Mortality (%) 80% 71.8% 50.7% 60% 21.8% absolute reduction in mortality at 5 years 40% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < 0.0001 30.7% 20% Without treatment 94% of patients in the standard therapy group died within 5 years 0% 0 12 24 36 48 60 Months Standard therapy includes medical management and BAV 28 Standard Therapy Patients Were Rehospitalized Twice as Often as TAVR Patients R E H O S P I TA L I Z AT I O N Inoperable Cohort 100% Standard Rx (n = 179) TAVR (n = 179) 87.3% Hospitality (%) 80% 60% 47.6% 39.7% absolute reduction of rehospitilization 40% HR [95% CI] = 0.40 [0.29, 0.55] p (log rank) < 0.0001 20% 87.3% of patients with standard therapy were rehospitalized for cardiac issues at 5 years 0% 0 12 24 36 48 60 Months Standard therapy includes medical management and BAV 29 TAVR with Edwards SAPIEN Valves is Equivalent to Surgery With the Benefits of a Less Invasive Procedure 30 TAVR with Edwards SAPIEN Valves is Equivalent to Surgery TAVR is superior to medical management for Inoperable Patients Edwards SAPIEN valve is a reasonable alternative to surgery in highrisk patients Edwards SAPIEN 3 valve: Transformational design With the Benefits of a Less Invasive Procedure 30 TAVR with Edwards SAPIEN Valves is Equivalent to Surgery TAVR is superior to medical management for Inoperable Patients TAVR Edwards withSAPIEN Edwards valve is aSAPIEN valves reasonable is a reasonable alternative to alternative surgery in to highsurgery risk patients Edwards SAPIEN 3 valve: Transformational design With the Benefits of a Less Invasive Procedure 30 TAVR is Equivalent to Surgery in High-Risk Patients A L L C A U S E M O R TA L I T Y A t 5 Ye a r s 100% SAVR Error Bars Represent 95% Confidence Limits TAVR 67.8% All-Cause Mortality (%) 80% 60% 62.4% 40% HR [95% CI] = 1.04 [0.86, 1.24] p (log rank) = 0.76 20% 0% 0 12 No. at Risk TAVR 348 SAVR 351 24 36 Months Post Randomization 48 60 262 228 191 154 61 236 210 174 131 64 At 5 Years Patients that had TAVR with the Edwards SAPIEN valve showed survival equivalent to SAVR Per ACC / AHA Guidelines, TAVR is a reasonable alternative to surgery in patients who meet an indication for AVR and who have high surgical risk for surgical AVR9 9. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537. 31 Patients Continued to Show Improved Symptom Relief 5 Years After TAVR NYHA CLASS OVER TIME 100% I p = 0.91 p = 0.64 II III IV p = 0.35 13% 15% p = 0.93 14% 15% 20% Percent of Evaluable Echoes At both 1 year and 5 year follow up, 85% of Patients treated with the Edwards SAPIEN valve were in NYHA Class I or II compared to only 6% at baseline. 19% 80% 60% 94% 94% 40% 20% 0% TAVR SAVR 348 349 Baseline TAVR SAVR 250 226 1 Year TAVR SAVR 165 145 3 Years TAVR SAVR 100 97 5 Years 32 Longest Follow-Up in Any TAVR Randomized Study The PARTNER Trial 5-Year Results TAVR vs. Standard Therapy in Inoperable Patients ▪ Significant mortality benefit ▪ Statistically significant reduction in hospitalization ▪ NNT is 5 patients to save a life TAVR vs. Surgical AVR in HighRisk Patients ▪ Equivalent mortality benefit ▪ Persistent symptom relief 5 YEARS of PROVEN VALVE DURABILITY ▪ Sustained hemodynamic performance ▪ No incidence of structural valve deterioration requiring surgical valve replacement20 ▪ Significant and sustained improvement in functional heart class 20. Lancet. 2015 Jun 20;385(9986):2477-84. doi: 10.1016/S0140-6736(15)60308-7. Epub 2015 Mar 15. 33 Now Approved: The Edwards SAPIEN 3 Valve 34 Now Approved: The Edwards SAPIEN 3 Valve TAVR is superior to medical management for inoperable patients TAVR is a reasonable alternative to surgery for highrisk patients Transformational advance in valve design: Edwards SAPIEN 3 Valve 34 Now Approved: The Edwards SAPIEN 3 Valve TAVR is superior to medical management for inoperable patients TAVR is a reasonable alternative to surgery for highrisk patients Edwards Transformational advance3invalve: SAPIEN valve design: Edwards Transformational SAPIEN 3 Valve design Unprecedented Clinical Outcomes 34 Low Mortality at 30 Days The PARTNER II Trial: SAPIEN 3 Valve High-Risk MORTALITY (As Treated Patients) 100% All-Cause Mortality of the 491 patients in the PARTNER II Trial was 1.6% at 30 days Cardiovascular Mortality was 1.0% All-Cause Cardiovascular 75% 50% 26% 1% 1.60% 1% High-Risk (TF) 35 All-Cause Mortality Has Decreased Overall A L L - C A U S E M O R TA L I T Y a t 3 0 D AY S 20% PARTNER I Trial and PARTNER II Trial 6% 5% 4% 5% 4% 2% 0% PARTNER I B (TF) 175 PARTNER I A (All) PARTNER I A (TF) 344 SAPIEN Valve 240 PARTNER II B (TF) 271 PARTNER II B (TF) PARTNER II HR (TF) 282 491 SAPIEN XT Valve SAPIEN 3 Valve 36 Low Stroke at 30 Days The PARTNER II Trial: SAPIEN 3 Valve HR DISABLING STROKE ( A s Tr e a t e d P a t i e n t s ) Of the 491 Patients in the PARTNER II Trial: Disabling Stroke was 0.8% at 30 days 100% Disabling 75% 50% 25% 0% 0.8% High-Risk (TF) 37 Other Clinical Events at 30 Days (as Treated Patients)* SAPIEN 3 Valve HR TF Events (%) Major Vascular Comps. Bleeding – Life Threatening *PARTNER II Trial high-risk TF SAPIEN 3 valve cohort 30-day results. (n = 491) 5.3 5.5 Femoral Case Example 39 40 40 41 41 42 42 Transapical Case Example 43 Where is all this going? » Number and indication for procedure is growing » Moving towards a “minimalist” approach » Eventually, the great, great majority of these Aortic Stenosis cases will be done via TAVR(as opposed to traditional surgery) » Therapies for Mitral and Tricuspid Valves is evolving quickly 47 Case Examples: 48 Valve in Valve with Corevalve Evolut R » 86 yo male » History of 23mm Medtronic Mosaic Valve ~ 15 years ago » Now with bioprosthetic valve stenosis » 3 recent CHF admits » Mean gradient ~35, EF 15% 49 50 50 51 51 52 52 Edwards Sapien 3 » 88 yo WM » NYHA Class III » Good functional capacity 53 54 54 55 55 56 56 57