Welcome 17 Michigan TAVR Participating Hospitals!

Transcription

1 Welcome 17 Michigan TAVR Participating Hospitals! 1

2 MICHIGAN TAVR BRIEF OVERVIEW HOW AND WHY PRE-TAVR IMAGING EVALUATION AND THE TVT Michael Grossman, MD Co-Director, BMC2 Coordinating Center

3 Why Michigan TAVR? TAVR is a truly novel technology TAVR requires technical expertise TAVR requires multidisciplinary collaboration TAVR is expensive TAVR patients have numerous co-morbidities TAVR is high-profile TAVR technology is rapidly advancing TAVR indications are rapidly expanding TAVR registry participation is required for reimbursement TAVR registry definitions are challenging TAVR registry data in TVT is less than optimal 3

4 Why Michigan TAVR? In Michigan, a unique partnership has developed between physicians, their hospitals, and Blue Cross Blue Shield of Michigan Regional collaboratives Focused on quality improvement Target clinical conditions that are common and associated with high cost Coronary intervention Cardiac surgery General surgery Peripheral vascular intervention Vascular surgery Share DA, et al. Health Aff (Millwood) Apr;30(4):

5 Michigan TAVR A partnership between MSTCVS and BMC2 Reflects the collaboration between cardiac surgery and cardiology Capitalize on the strength and experience of two of the most successful regional CQIs in the nation Collect accurate and complete data Ensure understanding of definitions Uniform collection across collaborative Organize and analyze Report in useable format Develop Quality Improvement goals/ best practices Serve as a platform for collaboration, education and exploration 5

6 Transcatheter Aortic Valve Replacement (TAVR) Overview TAVR has emerged as an alternative to surgical AVR Severe, symptomatic aortic stenosis Patients with life expectancy > 12 months Prohibitive risk for surgical AVR High risk for surgical AVR Requires a Heart Team assessment 6

7 Severe, Symptomatic Aortic Stenosis High gradient AS Vmax >4 m/s or Mean Δ >40 mmhg or AVA 1 sq cm 2 AVA index 0.6 cm 2 /m 2 Low gradient, LV dysfunction Reduced EF, dobutamine study showing: Vmax >4 m/s or Mean Δ >40 mmhg or AVA 1 cm 2 Low gradient, normal LV function Normal EF if clinical, hemodynamic and anatomic data 7

8 Symptoms: Demarcation in Course of Disease Onset of dyspnea and other heart failure symptoms foretell the worst outlook for aortic stenosis patients 1 Ross J, Braunwald E. Circulation 1968; 38: Carabello BA, Paulus WJ. Lancet 2009; 373:

9 Intervention for Severe AS Indications for TAVR vs surgical AVR: New 2014 Evaluation by a Heart Team Surgical AVR for patients at low or intermediate risk TAVR for patients with prohibitive surgical risk and life expectancy >12 months TAVR alternative for patients at high surgical risk class I class I class I class IIa 9

10 At Least 30% of Patients with Severe Symptomatic AS are Untreated! Severe Symptomatic Aortic Stenosis Percent of Cardiology Patients Treated 100% AVR No AVR 90% 80% 70% 60% 50% 40% 30% 20% Under-treatment especially prevalent among patients managed by Primary Care physicians 10% 0% Bouma 1999 Iung* 2004 Pellikka 2005 Charlson 2006 Bach 2009 Spokane (prelim) Vannan (Pub. Pending) 1. Bouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82: Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal 2003;24: (*includes both Aortic Stenosis and Mitral Regurgitation patients) 3. Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15:

11 Percent Un-Operated Severe AS Patients in Differing Hospital Systems 70 Un-operated patients with severe AS Un-operated Symptomatic, unoperated Symptomatic, unoperated with risk <10% 0 Total University VA Private Hospital Type Bach et al Circ Cardiovasc Qual Outcomes November

12 Patients with Symptomatic Aortic Stenosis Should be Evaluated by the Heart Team Cardiac surgeon Interventional cardiologist Cardiology Echocardiographer Radiology Anesthesia Nurse practitioner Cardiac rehabilitation specialist Program coordinator 12

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15 How Do We Determine Surgical Risk? STS Calculator Mortality Morbidity 24 patient variables 50 total risk factors EuroSCORE lc.html Mortality 17 patient variables Subjects at or above the 90th percentile of risk (8.38% for STS, 33.47% for logistic Euro) score are considered high risk for aortic valve replacement with average survival only two to three years 15

16 STS Risk Calculator Developed using data from STS National Adult Cardiac Surgery Database Voluntary Database Risk models updated in January 2008 using data from January 2002 to December 2006 (>109,000 patients in valve model and >101,000 in CABG/Valve model) Separate models for valve surgery and CABG/valve surgery 16

17 Characteristics Not Included in the STS or Other Risk Assessment Systems (Incremental Risk) Highly compromised respiratory disease Severe immunosuppressive diseases True porcelain aorta Chest wall radiation or deformity Multiple previous interventions in the presence of advanced multi-system dysfunction Liver disease Frailty LV diastolic dysfunction Pulmonary hypertension 17

18 Evaluation of the Patient with Aortic Stenosis Patient history and demographics Medical records Medical history Surgical history Prior imaging Echocardiogram ECG Cardiac catheterization 18

19 Patient History Symptoms Dyspnea, SOB, fatigue, change in exercise tolerance or functional capability Pre-syncope, lightheadedness, syncope Angina Detailed cardiovascular history Endocarditis Permanent pacemaker ICD Prior PCI Prior CABG Prior other cardiac surgery # previous cardiac surgeries 19

20 Patient Valve History Per TVT Prior aortic valve procedure Aortic valve surgery Bioprosthetic stentless (model and size) Bioprosthetic stented (model and size) Valve repair Balloon valvuloplasty Transcatheter replacement (TAVR) (model and size) Transcatheter valve intervention Prior non-aortic valve procedure MV Replacement Surgical Mechanical Bioprosthetic stented Bioprosthetic stentless Not Documented MV Repair Surgical 20

21 Patient Other History Per TVT Prior Stroke Transient Ischemic Attack Carotid Stenosis Prior CEA/CAS Peripheral Arterial Disease ABI < 0.9 or symptoms or prior revascularization Current/Recent Smoker (<1 Year) Hypertension Diabetes Mellitus Currently on Dialysis Chronic Lung Disease Mild Moderate Severe Home Oxygen Hostile Chest Immunocompromise Present Medications 21

22 Patient Cardiac History Per TVT CAD Presentation Angina (14 days) Sx unlikely to be ischemic (14 days) Stable angina (42 days) Unstable angina (60 days) Non-STEMI (7 days) STEMI (7 days) Prior MI < 30 Days 30 days Heart failure within 2 weeks NYHA Class within 2 weeks Cardiogenic shock within 24 hours Cardiac arrest within 24 hours Cardiac Procedure within 30 Days Porcelain aorta Atrial Fibrillation/Flutter None Persistent Paroxysmal Conduction defect 22

23 Frailty Assessment Per TVT Five meter walk Gait speed directly correlates with cardiac surgical outcome (> 6 seconds increased risk) Gait speed also correlated with remaining life years in the community Each 0.1-meter/second increment in walking speed was associated with a 12% increase in survival Walking speed of 0.8 meters/second was associated with the median life expectancy for persons in that age category. Walking speed of 0.6 meters/second would be a reasonable threshold for increased risk of early mortality A speed faster than 1.0 meters/second suggests better than average life expectancy A gait speed above 1.2 meters/second suggests exceptional life expectancy 23

24 Definition STS Risk Score Per TVT Indicate the patient's predicted risk of mortality for surgical aortic valve replacement as determined by the Heart Team and based on the Society for Thoracic Surgeon's risk model Includes incremental risk Per TVT FAQ Enter only the STS mortality score for aortic valve replacement 24

25 Functional Assessment and Quality of Life Six Minute Walk Test* Per TVT Indicate the total distance, in feet, the patient walked A performance-based measure of functional exercise capacity Scoring Predicted six-minute walk distance in healthy elderly = 631 ± 93 meters Predictive equation: 6MWDpred= (5.14 x heightcm 5.32 x age) 1.80 x weightkg x gender Note: Gender is factored into the equation by male = 1, female = 0. The change in the distance walked used to evaluate an intervention or to trace the natural history of change in exercise capacity over time The minimum clinically important difference (i.e., improvement) in the distance walked is estimated as 54 meters (with 95% confidence limits of 37 to 71 meters) KCCQ-12 Patient Questionnaire Validated QoL measure 8 questions 25

26 Clinical Data Per TVT Height cm Weight kg Hemoglobin g/dl Creatinine mg/dl Platelet count INR Albumin Bilirubin mg/dl BNP (6 months) FEV1 Predicted % DLCO (Adjusted) % 26

27 Medications within 24 Hours Per TVT Anticoagulants Including ASA Inotropes Positive 27

28 Diagnostic Cardiac Catheterization Per TVT Number of diseased vessels 50% Left main 50% Proximal LAD 70% LVEF % Cardiac output Pulmonary artery systolic pressure (RVSP)* Pulmonary artery mean pressure* PAWP* 28

29 Echocardiographic Data Per TVT Right Ventricular Systolic Pressure LVEF % Left Ventricular Internal Systolic Dimension Left Ventricular Internal Diastolic Dimension Left Ventricular End Systolic Volume Left Ventricular End Diastolic Volume Septal Wall Thickness Posterior Wall Thickness Left Atrial Volume Left Atrial Volume Index 29

30 Aortic Valve Disease Per TVT Disease Etiology Degenerative Includes calcific, senile, and leaflet prolapse Endocarditis Congenital Rheumatic fever Primary aortic Disease LV outflow tract Obstruction Supravalvular aortic Stenosis Tumor Trauma Other 30

31 Aortic Valve Disease Per TVT Aortic Regurgitation Mild Moderate Severe Valve Morphology Unicuspid Bicuspid Tricuspid Quadracuspid Uncertain Annular Calcification per echo 31

32 Aortic Measurements Per TVT AV Peak Velocity (CW) Annulus Size Assessment Method TTE TEE CTA Angiography Aortic Stenosis AV Area cm squared Aortic Stenosis - AV Mean Gradient mmhg Aortic Stenosis - AV Peak Gradient 32

33 Patient procedure forms The importance of the CT Angiogram 33

34 Patient procedure forms The importance of the CT Angiogram 34

35 Patient procedure forms The importance of the CT Angiogram 35

36 Patient procedure forms The importance of the CT Angiogram 36

37 Patient procedure forms The importance of the CT Angiogram 37

38 Patient procedure forms The importance of the CT Angiogram 38

39 Patient procedure forms The importance of the CT Angiogram 39

40 Patient procedure forms The importance of the CT Angiogram 40

41 The Final Product!! Edwards Sapien Medtronic CoreValve

42 The Reason We Are Here 47