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NY STATE NPA 33rd Annual ConferenceTAVR & Structural Heart
UpdateOctober 21, 2017Rose Hansen DNPStructural Heart CoordinatorGates 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
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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
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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
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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 to37% exhibit symptoms.6
Sandy Severe Aortic
Stenosis (Actual Patient)
5. Das P. European Heart Journal. 2005;26:1309-1313; 6 . Lester SJ et al. CHEST 1998;113(4):1109-1114.
Population at Risk for Aortic Stenosis is Increasing
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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 male4
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
2.6%
3.1%
2.4%2.2%
1.3%
2.8%
0.0%
1.0%
2.0%
3.0%
4.0%
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.
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Severe Aortic Stenosis Is a Life Threatening Rapidly Progressing Disease Process
After the onset of symptoms, patients with severe aortic stenosishave a survival rate as low as 50% at 2 years and 20% at 5 years without aortic valve replacement2
The PARTNER Trial demonstrated that 50% of inoperable patients died within 1 year without a valve replacement
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Otto, CM, 2000
5-YEAR SURVIVAL(Distant Metastasis)
3 4
12
2328 30
0
5
10
15
20
25
30
35
severeinoperable
AS*
lung cancer colorectalcancer
breast cancer ovariancancer
prostatecancer
Sur
viva
l (%
)
Severe aortic stenosis has a worse prognosis than many metastatic cancers
8*Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic
p
5-year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis
*
2014 AHA/ACC Valvular Heart Disease Guidelines
Symptomatic Severe Aortic Stenosis
Stage Definition Valve Hemodynamics Hemodynamic Consequences
D: Symptomatic Severe Aortic Stenosis
D1 High-gradient Aortic jet velocity ≥ 4m/s or meangradient ≥ 40 mmHg
Or aortic valve area index ≤ 0.6 cm2/m2
Left ventricular diastolic dysfunction Left ventricular hypertrophy Pulmonary hypertension may be present
D2 Low-flow/low-gradient with reduced leftventricular ejectionfraction
Resting aortic jet velocity < 4m/s ormean gradient < 40 mmHg
Dobutamine stress echocardiographyshows aortic valve area ≤ 1.0 cm2 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 orparadoxicallow-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)
Increased left ventricular relative wall thickness
Small left ventricular chamber with low stroke volume
Restrictive diastolic filling Left ventricular ejection fraction ≥
50%
NYHA Class II Symptoms include: Dyspnea, decreased exercise tolerance, CHF, angina, presyncope & syncopePatients with severe aortic stenosis typically have an aortic valve area ≤ 1.0 cm2
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A collaborative treatment decision
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Patient with severe aortic
stenosis identifiedby referring
physician
1
Patient referred tovalve clinic
2
Additional testing
completed
3
Multidisciplinaryreview and
treatment decisionby Heart Team
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Treatmentrecommendations
reviewed with referringphysician, patient
and patient’s family
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Devising a treatment plan is a collaborative process
Ultimate treatment choice is a collaborative decision between the
physicians, patient and patient’s family.
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
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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)
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Standard therapy includes medical management and BAV
ORIGINAL PARTNER Trial Significant reduction in mortality for inoperable patients with patients with the SAPIEN valve
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Of the 358patients 94% of patients in the
standard therapy group died within
5 years
21.8%absolute reduction
in mortality at 5 years
71.8%
Months
HR [95% CI] = 0.50 [0.39, 0.65]p (log rank) < 0.0001
93.6%
All-
Cau
se M
orta
lity
(%)
0 12 24 36 48 60
100
80
60
40
20
0
Standard Rx (n = 179)TAVR (n = 179)
50.7%
30.7%
All-cause mortalityinoperable cohort
The PARTNER II Trial: Intermediate-risk
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Intermediate-risk symptomatic severe aortic stenosisIntermediate-risk symptomatic severe aortic stenosis
Transapical (TA)/Transaortic (TAo)Transapical (TA)/Transaortic (TAo)Transfemoral (TF)Transfemoral (TF)
PARTNER II S3i( n = 1078 )
TA / TAo TAVRSAPIEN 3 valveTA / TAo TAVRSAPIEN 3 valve
TF TAVRSAPIEN 3 valve
TF TAVRSAPIEN 3 valve
Intermediate-risk assessment by Heart Valve Team
PARTNER IIA( n = 2032 )
Assessmenttransfemoral access
NoYeYes
1:1 Randomization
1:1 Randomization
Transapical (TA)/Transaortic (TAo)Transapical (TA)/Transaortic (TAo)Transfemoral (TF)Transfemoral (TF)
TA TAVR
SAPIEN XT
valve
TA TAVR
SAPIEN XT
valve
Surgical
AVR
Surgical
AVRvsvs
TA/TAoTAVR
SAPIEN XT
valve
TA/TAoTAVR
SAPIEN XT
valve
Surgical
AVR
Surgical
AVRvsvs
Assessment for optimalvalve delivery access
1:1 Randomization
1:1 Randomization
The most robust, rigorous study in more than 3,000 intermediate-risk patientsThe most robust, rigorous study in more than 3,000 intermediate-risk patients
Disabling Stroke*
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Months from procedure
Dis
ablin
g st
roke
(%
)
0
10
20
30
40
2.3%
5.9%
1.0%
4.4%
0 3 6 9 12
TAVR with SAPIEN 3 valve
Surgery (PIIA)
1077 1033 1008 884 953
806 778 764
*The PARTNER II trial intermediate-risk cohort unadjusted clinical event rates.
SAPIEN 3 TAVR
944 825
Number at risk:Surgery
1.0%
4.4%
Leon M et al. New England Journal of Medicine 2016
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Over 150,000 patients treated worldwide
Over 50,000 patients treated in the United States
Treating patients in Over 65 countries
Backed by unprecedented outcomes and real world results INTERMEDIATE RISK TAVR APPROVAL 8/2016
19 *As of February 2016
Gates Vascular InstituteTAVR 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
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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 forStroke Prevention during TAVRFDA Approved 8/2017
24Giustino, et al 2016
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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
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Minimally Invasive and Minimalist Approach
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 Outcomes26
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
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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
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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
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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
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11
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
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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
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Questions? Thank [email protected]
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;26:1309-13134.Giustino, Gennaro, Cerebral Embolic Protection During TAVR. JACC
Intervention DOI: 10.1016/j.jacc.2016.12.0025. 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 MitraClip13 Boston Scientific Watchman13. St Jude Amplatzer PFO/ASD Closure
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