NY STATE NPA 33 rd Annual Conference TAVR & Structural Heart Update

NY STATE NPA 33 rd Annual Conference TAVR & Structural Heart Update October 21, 2017 Rose Hansen DNP Structural Heart Coordinator Gates Vascular Institute, Buffalo NY TAVR Update: Objectives 1. Understand Aortic Stenosis disease process, prognosis and prevalence 2. Explore treatment options: TAVR, SAVR, BAV 3. Define new TAVR trends: Low Risk Patients, Carotid protection 4. Understand Patient Screening Process and Selection 5. Understand TAVR Program Challenges and Structural Heart Expansion 2 Structural Heart Update: Objectives Mitral Stenosis Prognosis and treatment options Mitral Regurgitation prognosis and treatment options Transcatheter Mitral Repair with Mitraclip for Severe Degenerative Mitral regurgitation Explore FDA Approved Watchman device for patients with Atrial Fib at high risk for CVA and Bleeding Cryptogenic Stroke associated with PFO/ASD may benefit from Closure HOCM treatment with Alcohol Septal Ablation 3 1

TAVR for Aortic Stenosis Age-related calcific aortic stenosis 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. 5 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 Aortic Stenosis is estimated to be prevalent with 12.4% of the population over the age of 75. 2 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 male 4 4.0% 3.0% 2.0% 1.0% 0.0% ELDERLY AVERAGE ANNUAL GROWTH RATE: 1910 to 2030 2.6% 3.1% 2.4% 2.2% 1.3% 2.8% 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. 6 2

Severe Aortic Stenosis Is a Life Threatening Rapidly Progressing Disease Process Otto, CM, 2000 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 replacement 2 7The PARTNER Trial demonstrated that 50% of inoperable patients died within 1 year without a valve replacement Survival (%) Severe aortic stenosis has a worse prognosis than many metastatic cancers 35 30 25 20 15 10 5 0 3 4 severe inoperable AS* 5-YEAR SURVIVAL (Distant Metastasis) lung cancer 12 colorectal cancer 23 breast cancer 28 ovarian cancer 30 prostate cancer 5-year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis 8 *Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic 2014 AHA/ACC Valvular Heart Disease Guidelines Symptomatic Severe Aortic Stenosis * NYHA Class II Symptoms include: Dyspnea, decreased exercise tolerance, CHF, angina, presyncope & syncope Patients with severe aortic stenosis typically have an aortic valve area 1.0 cm 2 Stage Definition Valve Hemodynamics Hemodynamic Consequences D: Symptomatic Severe Aortic Stenosis D1 High-gradient Aortic jet velocity 4m/s or mean gradient 40 mmhg Or aortic valve area index 0.6 cm 2 /m 2 Left ventricular diastolic dysfunction Left ventricular hypertrophy Pulmonary hypertension may be present D2 Low-flow/lowgradient 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 cm 2 with aortic jet velocity 4m/s at any flow rate Left ventricular diastolic dysfunction Left ventricular hypertrophy Left ventricular ejection fraction < 50% D3 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 cm 2 /m 2 Stroke volume index < 35 ml/m 2 measured when patient is normotensive (systolic blood pressure < 140 mmhg) Increased left ventricular relative wall thickness Small left ventricular chamber with low stroke volume Restrictive diastolic filling Left ventricular ejection fraction 50% 3

10 A collaborative treatment decision 1 Patient with severe aortic stenosis identified by referring physician 2 Patient referred to valve clinic Devising a treatment plan is a collaborative process 5 Ultimate treatment choice is a collaborative decision between the physicians, patient and patient s family. Treatment recommendations reviewed with referring physician, patient 4 and patient s family 3 Additional testing completed Multidisciplinary review and treatment decision by Heart Team 11 TAVR Pre-Operative Workup 2D Echo Right & Left Heart Cath 100cc IV Contrast CTA Torso (70cc IV contrast) PFTs Carotid Doppler Chest-X-Ray EKG Lab work/mrsa swab (TEE optional) Functional Assessment 4

TAVR Pre-Operative Workup Clinic Visit 2-3 times prior CT Surgery Consult CT Surgery Consult Second Opinion (Separate Date) Vascular Surgery Consult Anesthesia Consult Consult for all other co-morbidities Renal, Oncology, Neurology, Dental, PT, OT, ect Discussed in a multidisciplinary forum and deemed candidate for TAVR/SAVR If not a candidate: BAV or Palliative care TAVR Workup is extensive and geared to obtain mandatory registry reported data. 30 day and 1 year reports. TRANSCATHETER AORTIC VALVE REPLACEMENT TAVR Alain Cribier: First human transcatheter valve replacement (2002) 15 5

ORIGINAL PARTNER Trial Significant reduction in mortality for inoperable patients with patients with the SAPIEN valve All-Cause Mortality (%) All-cause mortality inoperable cohort 93.6% 100 Standard Rx (n = 179) TAVR (n = 179) 80 71.8% 60 50.7% 40 HR [95% CI] = 0.50 [0.39, 0.65] 20 30.7% p (log rank) < 0.0001 0 0 12 24 36 48 60 Months Of the 358 patients 94% of patients in the standard therapy group died within 5 years 21.8% absolute reduction in mortality at 5 years 16 Standard therapy includes medical management and BAV The PARTNER II Trial: Intermediate-risk Intermediate-risk symptomatic severe aortic stenosis Intermediate-risk assessment by Heart Valve Team PARTNER II S3i ( n = 1078 ) PARTNER IIA ( n = 2032 ) Assessment for optimal valve delivery access Ye s Assessment transfemoral access No Transfemoral (TF) Transapical (TA)/ Transaortic (TAo) Transfemoral (TF) 1:1 Randomization Transapical (TA)/ Transaortic (TAo) 1:1 Randomization TF TAVR SAPIEN 3 valve TA / TAo TAVR SAPIEN 3 valve TA TAVR SAPIEN XT valve vs Surgica l AVR TA/TAo TAVR SAPIEN XT valve vs Surgica l AVR The most robust, rigorous study in more than 3,000 intermediaterisk patients 17 Disabling Stroke* 40 Surgery (PIIA) TAVR with SAPIEN 3 valve Disabling stroke (%) 30 20 4.4% 1.0% 10 4.4% 5.9% 1.0% 2.3% 0 0 3 6 9 12 Number at risk: Months from procedure Surgery 944 825 806 778 764 SAPIEN 3 TAVR 1077 1033 1008 884 953 *The PARTNER II trial intermediate-risk cohort unadjusted clinical event rates. Leon M et al. New England Journal of Medicine 2016 18 6

Backed by unprecedented outcomes and real world results INTERMEDIATE RISK TAVR APPROVAL 8/2016 Over 150,000 patients treated worldwide Over 50,000 patients treated in the United States Treating patients in Over 65 countries 19 *As of February 2016 Gates Vascular Institute TAVR Program TAVR First Case 1/11/12 >675 TAVRs to date Edwards Medtronic Boston Scientific Research:Partner3, Reprise3 Transfemoral (Percutaneous 2012) MAC~ 1/1/2015 Alternate Approach 2013 >85 cases Transapical/Direct Aortic/Axillary/Subclavian Carotid Approach=14 Valve in Valve, ESRD HD, Bicuspid Valves 21 7

99 years old 5 weeks post TAVR What Else is New in the TAVR World Embolic Debris During TAVR 23 Giustino, et al 2016 Claret Sentinel Carotid Protection for Stroke Prevention during TAVR FDA Approved 8/2017 24 Giustino, et al 2016 8

LOW RISK Patients STS <3% May Now be Eligible for TAVR Partner 3 Trial 1:1 Randomization to TAVR or SAVR Bicuspid TAVR Registry pending Early TAVR TRIAL for Asymptomatic patients 25 Minimally Invasive and Minimalist Approach 26 Performed in Hybrid Cath Lab Conscious Sedation MAC Percutaneous, No Cutdown No Swan No Art Line No Foley No ICU (for select patients) Shorter LOS Less readmission Better Outcomes STRUCTURAL HEART Mitral Stenosis Severe NYHA Class CHF symptoms Poor prognosis Surgery high Risk due to calcification FDA Approval of TAVR in Mitral position ina previous place surgical valve 2017 Native TMVR in trial Balloon Mitral Valvotomy Palliative 27 9

STRUCTURAL HEART Mitral Regurgitation and Mitraclip Severe degenerative Mitral Regurgitation is a progressive disease leading to CHF and functional decline Diagnosis with TEE Right and Left Heart Cath For inoperable or high risk patients transcatheter percutaneous transeptal Mitral Valve Repair with MitraClip can decease Severe MR 28 STRUCTURAL HEART LAAO WATCHMAN DEVICE Atrial Fibrillation treatment includes anticoagulation for prevention of left atrial appendage thrombus increasing stroke risk. For Patients at high risk for Bleeding a percutaneous LAA occluder device WATCHMAN may be inserted to reduce risk Preoperative Warfarin, TEE and General anesthesia, Cath Lab or EP Lab Follow up Registry Reporting x4 29 STRUCTURAL HEART Cryptogenic CVA with PFO/ASD PFO/ASD Prevalence in 25% of population Cause shunting of right to left turbulence clotting and embolic events Causes left to right ishunting ncreasing the right atrial pressures and PHTN 2017 approval of ASD/PFO Closure in presence of cryptogenic stroke Diagnosis Bubble study echo, transcranial doppler, Rule out atrial fib holter monitor and hypercoagulable studies 30 10

Maria 103 years old 4 weeks post TAVR STRUCTURAL HEART Hypertrophic Obstructive Cardiomyopathy HOCM is an enlargement of the left ventricular outflow tract Symptoms mimic Aortic Stenosis increae risk of Sudden death, familial Diagnosis 2D Echo/ Cardiac MRI & Left heart Cath Treatment: Surgical Myectomy Open Heart Surgery Alcohol Septal ablation is performed in the Cath lab under general anesthesia Induces an infarct to the upper septal wall reducing the septum Requires ICU and post op pain management Recommend AICD 32 Structural Heart Summary Patients with Mitral Stenosis have limited treatment options and can be extremely symptomatic. Severe Mitral Regurgitation has a poor prognosis and limited treatment options Transcatheter Repair with Mitraclip is an effective option for high risk patients with Severe Mitral regurgitation Watchman device is an appropriate option for patients with Atrial Fib at high risk for CVA and Bleeding Patients with Cryptogenic Stroke and PFO/ASD may benefit from FDA Approved Closure HOCM increases risk of Sudden death an may be treated with Alcohol Septal Ablation 33 11

TAVR Summary Aortic stenosis is prevalant in elderly populations and has a poor prognosis if left untreated TAVR is effective treatment for High risk and Inoperable patients TAVR is effective treatment in Intermediate Risk Patients ALL Aortic Stenosis Patients Should Be Evaluated By the Heart Team: Low Risk Patients should be offered Trial CVA Protection is Available for at Risk patients Minimalist approach provides less complications and Shorter LOS 34 Questions? Thank You! Rhansen@Daemen.edu References 1. Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, 2014 internal estimates 2. Freed 2010, Iung 2007, Pellikka 2005; 2014 internal estimates 3. Das P. European Heart Journal. 2005;26:1309-1313 4.Giustino, Gennaro, Cerebral Embolic Protection During TAVR. JACC Intervention DOI: 10.1016/j.jacc.2016.12.002 5. Lester SJ et al. CHEST 1998;113(4):1109-1114. 5. Otto CM. Timing of aortic valve surgery. Heart. 2000;84:211-218 6. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537. 7. Dumesnil et al. European Heart Journal 2010; 31, 281-289. 8. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537. 9. National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). 2012. 10.Leon M et al. New England Journal of Medicine 2010 October 21;363(17):1597-1607. 11. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537. 12.Abbott Vascular Everest Trial MitraClip 13 Boston Scientific Watchman 13. St Jude Amplatzer PFO/ASD Closure 36 12