Aortic Stenosis: Interventional Choice for a 70-year old- SAVR, TAVR or BAV? Interventional Choice for a 90-year old- SAVR, TAVR or BAV?
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1 Aortic Stenosis: Interventional Choice for a 70-year old- SAVR, TAVR or BAV? Interventional Choice for a 90-year old- SAVR, TAVR or BAV? Samin K Sharma, MD, FACC, FSCAI Director Clinical & Interventional Cardiology Zena and Michael a Weiner Professor of Medicine Mount Sinai Hospital, NY
2 Aortic Stenosis Aortic valve area: Ross J, Braunwald E. Circulation 1968; 38: Normal 3-4 cm 2 AS: - mild >1.5 cm 2 - moderate cm 2 - severe <1.0 cm 2 - critical <0.7 cm 2 Etiology: Congenital: unicuspid bicuspid tricuspid Acquired: 5% at 70 yrs 10% at 80 yrs 18% at 90 yrs rheumatic calcific cholesterolemia rheumatoid
3 Interventional Choices for AS: SAVR TAVR BAV Sapien CoreValve
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5 Summary of Recommendations for AS: Choice of Surgical or Transcatheter Intervention Nishimura et al., J Thorac Cardiovasc Surg 2014;148:e1
6 Summary of Recommendations for AS: Choice of Surgical or Transcatheter Intervention Nishimura et al., J Thorac Cardiovasc Surg 2014;148:e1
7 Summary of Recommendations for AS: Choice of Surgical or Transcatheter Intervention Nishimura et al., J Thorac Cardiovasc Surg 2014;148:e1
8 Summary of Recommendations for AS: Choice of Surgical or Transcatheter Intervention Nishimura et al., J Thorac Cardiovasc Surg 2014;148:e1
9 Summary of Recommendations for AS: Choice of Surgical or Transcatheter Intervention Nishimura et al., J Thorac Cardiovasc Surg 2014;148:e1
10 Summary of Recommendations for AS: Choice of Surgical or Transcatheter Intervention BAV may provide palliative symptomatic benefit in these pts Nishimura et al., J Thorac Cardiovasc Surg 2014;148:e1
11 Leon et al, NEJM 2010;363:1597 PARTNER US Trial: Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High Risk AVR Candidate 3105 Total Patients Screened Total = 1058 patients n= 700 High-surgical risk Gp In-operable 2 Parallel Trials STS >10% Cohort A Gp Cohort B n=358 ASSESSMENT: Transfemoral Access ASSESSMENT: Transfemoral Access High Risk TF High Risk TA Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study TAVR Trans Femoral VS Surgical AVR TAVI Trans Apical VS Surgical AVR TAVR Trans Femoral VS Standard Therapy (usually BAV) Primary Endpoint: All Cause Mortality (1 yr) (Non-inferiority) Primary Endpoint: All Cause Mortality over length of trial (Superiority)
12 PARTNER Trial Cohort B: Time-to-Event Analysis of Key Endpoints During 2 Years Follow-up Rate of Death From Any Cause 5yrs 94% Rate of Re-hospitalization 71% 20% Makkar et al., NEJM 2012;366:1696
13 PARTNER Trial Cohort A: Time-to-Event Curves for Primary Endpoints at 3-Yrs Death from Any Cause, Intention-to-Treat Population Death from Any Cause, As-Treated Population Kodali et al., NEJM 2012;366:1686
14 CoreValve Pivotal Trials Study Design CoreValve US Pivotal Trials Extreme Risk (Inoperable; STS mortality/morbidity >50%) High Risk Incremental STS mortality >15% Iliofemoral Access for 18 Fr Sheath Presented in TCT 2013 Yes No Randomization 1:1 N=790 Presented in ACC 2014 Versus CoreValve Iliofemoral CoreValve Non- Iliofemoral CoreValve SAVR N=487 N=147 N=392 N=388
15 CoreValve Extreme Risk Study: Primary Endpoints N= Year Mortality Major Stroke Popma et al, TCT 2013; JACC May 2014
16 All-cause Mortality (%) CoreValve High Risk Pivotal trial: Primary Endpoint-- 1 Year All-cause Mortality Surgical (N= 357) TAVR (N= 390) 19.1% 14.2% 4.5% P = 0.04 for superiority 3.3% Months Post-Procedure Adams et al., N Engl J Med 2014;370:1790
17 CoreValve High-risk Pivotal Trial: 1-Year Results SAVR (n=357) TAVR (n=390) p=<0.001 p=0.03 % p=0.10 p=<0.001 p=<0.001 p=0.59 p=0.004 Any stroke Major stroke AKI PPM Vasc MACCE Life-threatening/ compl disabling bleeding Adams et al., N Engl J Med 2014;370:1790
18 Mean Gradient (mmhg) PARTNER Trial: Aortic Mean Gradient & Valve Area EOA Mean Gradient Error bars = ± 1 Std Dev Valve Area (cm²) N =
19 MEAN GRADIENT (mg) Mean Gradient Aortic Valve Area ± ± ± AVA (cm 2 ) ± ± ±5.7 Baseline Post TAVR 5 Year
20 Partner Trial Cohort B: TAVR for Inoperable Severe Aortic Stenosis; Impact of Co-morbidities Makkar et al., NEJM 2012;366:1696
21 What about Intermediate risk AS patients; (defined as STS mortality risk of 4 to 8-10%) Two Trials: PARTNER IIA (completed) SURTAVI Trial (ongoing)
22 CoreValve US Pivotal SURTAVI Trial: Design Severe AS Indication for AVR Separate randomization for AS+CAD Heart Team Discussion N = 1100 Europe: STS mortality risk score > 3% and < 8% US: STS mortality risk score > 4 and < 10% 1:1 Randomization Suitable for Randomization Non-randomization Registries TAVI AVR Control TAVI VS AVR VS Yes Primary Endpoint: All cause Mortality and Stroke at 2 yrs N = 220 No Medical Management N = 1760 N = 220 Endpoint: All-cause Mortality at 2 yrs
23 The PARTNER II Trial Study Design
24 Patient History Age (years): 90 Gender: M Height (ins): 72 Weight (Ibs): 160 The patient has the following: CARDIAC STATUS NYHA Class IV RISK FACTORS AND COMORBIDITIES History of CVA, previous CABG x4, chronic persistent A-Fib, s/p PPM Chronic Lung Disease/ COPD: Moderate FEV1: 1500cc %predicted: 55 Other: Frail, history of multiple GI bleeds, hyponatremia PREVIOUS CARDIAC INTERVENTIONS: CABG x4 in 1991, PCI x3 in remote and BAV in July 2013 Creatinine (mg) /dl: 1.03 Creatinine clearance (cc/min) : 60 BNP (pg/ml): 717 Coronary Art Disease: 3 Patent grafts Aortic Calcification: Severe
25 Echo Images: Annulus Measurement Echo Image 22 Aortic annular size (mm) 0.41 Aortic valve area (cm 2 ) Aortic valve area index (cm 2 /m 2 ) 48 Mean gradient (mmhg) 4.4 Peak velocity (m/sec) 52 LVEF (%)
26 CT Images: Annulus Measurements CT Image Ao Annulus mean diameter: 28.0 mm 32.6 x 23.4 Major x Minor aortic annulus diam 89.2 Aortic Annulus perimeter (28.4 x 3.14) 32.8 Max ascending Aorta diameter Sinus of Valsalva diameter Sinus of Valsalva height Sinotubular Junction width (STJ) (all in mm)
27 CT 3D Reconstructions
28 Patient History Age (years): 90 Gender: M Height (ins): 72 Weight (Ibs): 160 Risk Summary: STS Score: 12% mortality 39% morbidity/mortality The patient has the following: CARDIAC STATUS NYHA Class IV RISK FACTORS AND COMORBIDITIES History of CVA, previous CABG x4, chronic persistent A-Fib, s/p PPM Chronic Lung Disease/ COPD: Moderate FEV1: 1500cc %predicted: 55 Other: Frail, history of multiple GI bleeds, hyponatremia PREVIOUS CARDIAC INTERVENTIONS: CABG x4 in 1991, PCI x3 in remote and BAV in July 2013 Creatinine (mg) /dl: 1.03 Creatinine clearance (cc/min) : 60 BNP (pg/ml): 717 Coronary Art Disease: 3 Patent grafts Aortic Calcification: Severe
29 Treatment of Choice in this 90 Yr old AS pt?re-bav?savr?tavr TAVR because - 12% STS risk score making him high risk for conventional SAVR Pt underwent 31mm CoreValve via RFA percutaneous approach (using 2 perclose sutures) under conscious sedation.
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36 Treatment of Choice in this 90 Yr old AS pt?re-bav?savr?tavr TAVR because - 12% STS risk score making him high risk for conventional SAVR Pt underwent 31mm CoreValve via RFA percutaneous approach (using 2 perclose sutures) under conscious sedation. No complications, out of CCU next day and discharged on post TAVR day 5.
37 Patient History Age (years): 90 Gender: M Height (ins): 72 Weight (Ibs): 160 Risk Summary: STS Score: 32% mortality 69% morbidity/mortality The patient has the following: CARDIAC STATUS NYHA Class IV RISK FACTORS AND COMORBIDITIES History of CVA, previous CABG x4, chronic persistent A-Fib, s/p PPM Chronic Lung Disease/ COPD: Severe FEV1: 500cc %predicted: 25 Other: Frail, history of multiple GI bleeds, hyponatremia PREVIOUS CARDIAC INTERVENTIONS: CABG x4 in 1991, PCI x3 in remote and BAV in July 2013 Creatinine (mg) /dl: 1.03 Creatinine clearance (cc/min) : 60 BNP (pg/ml): 717 Coronary Art Disease: 3 Patent grafts Aortic Calcification: Severe
38 Treatment of Choice in this 90 Yr old AS pt?re-bav?savr?tavr Re-BAV because - This pt with high comorbidity (FEV1 <500 cc) has extremely poor 1 year survival and TAVR is unlikely to improve the long-term survival - BAV will provide palliative symptomatic relief in these pts
39 Patient History Age (years): 71 Gender: M Height (ins): 66 Weight (Ibs): 170 The patient has the following: NYHA Class: III RISK FACTORS AND COMORBIDITIES previous CABG x4 in 2005, PAD Chronic Lung Disease/ COPD: Mild FEV1: 1900cc %predicted: 65 Other: No frailty PREVIOUS CARDIAC INTERVENTIONS PCI x2 last in 2/2013, recent cath showed patent all 3 grafts and patent PCI sites Creatinine (mg) /dl) 1.9 Creatinine clearance (cc/min) 30 BNP (pg/ml) 117 LVEF: 55% Aortic Calcification: Severe
40 Echo Images: Annulus Measurement
41 CT Images: Annulus Measurements
42 Iliofemorals
43 Patient History Age (years): 71 Gender: M Height (ins): 66 Weight (Ibs): 170 Risk Summary: STS Score: 4.5% mortality 8.2% morbidity/mortality The patient has the following: NYHA Class: III RISK FACTORS AND COMORBIDITIES previous CABG x4 in 2005, PAD Chronic Lung Disease/ COPD: Mild FEV1: 1900cc %predicted: 55 Other: No frailty PREVIOUS CARDIAC INTERVENTIONS PCI x2 last in 2/2013, recent cath showed patent all 3 grafts and patent PCI sites Creatinine (mg) /dl) 1.9 Creatinine clearance (cc/min) 30 BNP (pg/ml) 117 LVEF: 55% Aortic Calcification: Severe
44 Treatment of Choice in this 71 Yr old AS pt?bav?savr?tavr Pt was Randomized in the ongoing Intermediate risk TAVR trial (SURTAVI) because - 4.5% STS risk score makes him ideal for evaluation of TAVR vs. SAVR in these intermediate risk AS pts Pt was randomized to SAVR and underwent 21mm Pericardial valve without complications.
45 Patient History Age (years): 78 Gender: M Height (ins): 68 Weight (Ibs): 162 The patient has the following in 8/2013: NYHA Class: IV and CCS class III angina on presentation to OSH with TnI 1.2U and transferred for treatment RISK FACTORS AND COMORBIDITIES previous CABG x4 in 1999 Chronic Lung Disease/ COPD: None FEV1: 2250cc %predicted: 95 Other: No frality PREVIOUS CARDIAC INTERVENTIONS Recent cath showed patent all 4 grafts with 80% stenosis of SVG to OM, LVEF 55% Creatinine (mg) /dl) 0.9 Creatinine clearance (cc/min) 70 BNP (pg/ml) 57 LVEF: 55% Aortic Calcification: Severe
46 ECG
47 Echo Images: Annulus Measurement Site Images of AV annulus _23_ Aortic annular size (mm) _0.6_ Aortic valve area (cm 2 ) ---_ Aortic valve area index (cm 2 /m 2 ) 42.0_ Mean gradient (mmhg) _4.2_ Peak velocity (m/sec) 60_ LVEF (%)
48 CT Images: Annulus Measurements Clinical Analyst s Image Ao Annulus mean diameter 26.1 mm 30.3 X 21.8_ Major x Minor aortic annulus diameter 82.9_ Aortic Annulus perimeter (26.4 x 3.14) 33.5 Max Ascending Aorta diameter Sinus of Valsalva width Sinus of Valsalva height (all in mm) Sinotubular Junction width (STJ)
49 Hemodynamics: Baseline
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55 Patient History Age (years): 78 Gender: M Height (ins): 68 Weight (Ibs): 162 Risk Summary: STS Score: 2.8% mortality 4.2% morbidity/mortality The patient has the following in 8/2013: NYHA Class: IV and CCS class III angina on presentation to OSH and transferred for treatment RISK FACTORS AND COMORBIDITIES previous CABG x4 in 1999 Chronic Lung Disease/ COPD: None FEV1: 2250cc %predicted: 95 Other: No frality PREVIOUS CARDIAC INTERVENTIONS Recent cath showed patent all 4 grafts with 80% stenosis of SVG to OM Creatinine (mg) /dl) 0.9 Creatinine clearance (cc/min) 70 BNP (pg/ml) 57 LVEF: 55% Aortic Calcification: Severe
56 Treatment of Choice in this 78 Yr old AS pt Presenting with CHF and NSTEMI/UA?BAV+ PCI to SVG to OM?SAVR+ CABG to OM?TAVR+ PCI to SVG to OM Pt was in CHF class IV and NSTEMI/unstable angina. Had Heart Team discussion with CT surgeon and recommended percutaneous approach to stabilize the pt s condition.
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61 Treatment of Choice in this 78 Yr old AS pt Presenting with CHF and NSTEMI/UA?BAV+ PCI to SVG to OM?SAVR+ CABG to OM?TAVR+ PCI to SVG to OM Pt was in CHF class IV and NSTEMI/unstable angina. Had Heart Team discussion with CT surgeon and recommended percutaneous approach to stabilize the pt s condition. Pt then underwent BAV and BMS PCI to SVG to OM. Did well and discharged home next day.
62 Treatment of Choice in this 78 Yr old AS pt 5 mths later for CHF Class III symptom recurrence Risk Summary: STS Score: 1.8% mortality 3.2% morbidity/mortality?re-bav?savr?tavr Pt had low STS risk (<4) score and hence underwent conventional SAVR using 23mm Pericardial valve without any complications. No CABG needed as BMS to SVG to OM was patent.
63 Algorithm for Management of Severe AS: SAVR vs TAVR Severe AS AS Symptoms No Yes LVEF <50% No Physically active No Yes Exercise Test Symptoms ressure below or fall baseline blood pressure below baseline No Presence of risk factors and Presence of risk factors and low/intermediate individual surgical low/intermediate individual surgical risk risk No Yes Re-evaluate in 6 months Yes Yes SAVR No High risk for AVR Contraindication for AVR Yes Short life expectancy Serious Comorbidity STS >50% No Yes No Yes TAVR or SAVR TAVR Med Rx? BAV
64 Emerging TAVR Devices Involving Improved Technologies, Potentially Minimizing PVL/AR after TAVR
65 TAVR in Evolution (2014+) Future Clinical Indications Valve-in-valve for bio-prosthetic aortic valve failure Intermediate (moderate) risk AS patients Asymptomatic severe AS Low flow-low gradient AS impedance mismatch Aortic insufficiency; difficult with current generation which is dependent on calcified native AV to anchor the prosthesis
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