Post on 18-Apr-2018
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Transcatheter Aortic ValveReplacement (TAVR)
Providence Heart and Vascular InstituteEric Kirker MD FACS, ABTSProvidence Valve CenterCo-Surgical DirectorOctober 20, 2012
Seldinger Technique
• Dr. Sven-Ivar Seldinger (1921-1998)• Swedish Radiologist• Introduced Technique in 1953
Structural Heart Therapy
• Surgery Based Techniques– Live real time direct visualization– Hands-on corrective therapy
• Imaging Based Techniques– Live real time indirect visualization– Tool based corrective therapy
• Hybrid Suite Concept• “Hybrid” Physician-surgical and interventional skills• Multidisciplinary TEAM
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Structural Heart HistoryBalloons, Stents, Valves• Vascular Disease
– PTA, thrombolysis, stents, embolization– Coronary Stents– Aortic Stent Grafts– Carotid Stents
• Congenital Heart Disease– Transseptal Left Heart– Balloon Atrial Septostomy– Coarctation of Aorta– Pulmonary Artery Stenosis– ASD, VSD
Structural Heart HistoryBalloons, Stents, Valves• Valvular Disease
– Valvuloplasty, BAV, MVP, PVP– Pulmonic Valve
• Medtronic Melody® (2010)– Aortic Valve
• Edwards SAPIEN®, RetroFlex3™ (2011)• Edwards SAPIEN XT®
• Medtronic CoreValve®
• St. Jude Medical Portico™
– Mitral Valve• Abbott MitraClip® System
Multiple Technologies• Edwards Sapien
– Commercial– Inoperable patients– Femoral only (for now)
• Edwards Sapien XT– Lower profile– In context of Partner II study
• Apical, transaortic, valve-in-valve
• E-Valve– Percutaneous mitral clip for
severe MR– Coapt Mitraclip study
• Medtronic Corevalve– Investigational – available at
Providence Sacred Heart,Spokane, WA
– Self-expanding– Providence Valve Center
has referred 4 patients
Available at Providence Valve Center
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7
Prevalence of Aortic Stenosis16.5 Million People in US
Over the Age of 652
7%PercentageDiagnosed withAortic Stenosis
Aortic stenosis is estimatedto be prevalent in up to 7%of the population over theage of 651
It is more likely to affectmen than women; 80% ofadults with symptomaticaortic stenosis are male3
Aortic Stenosis
Aortic Stenosis
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Aortic Stenosis Subtypes
• Congenital - before 6th decade– Bicuspid (1-2%), associated coarctation– Unicuspid (0.02%), infants, rarely adults
• Rheumatic - always associated with MV disease– Inflammatory– Commissure fusion
• Calcific, Senile - after 6th decade– No Fusion– Calcification– Atherosclerotic
Aortic StenosisSymptom Triad
• Angina• Dyspnea• Syncope
– All associated with exertion
Aortic StenosisPhysical Findings
• Murmur - crescendo, decrescendo• Upper sternal border• Radiates to carotids• Delayed carotid pulse• Diminished A2• S4
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Aortic StenosisPhysiology/Compensatory Mechanisms
• Pressure overload• Compensatory hypertrophy• Diminished coronary blood flow reserve• Increased LV diastolic pressure• Increased pulmonary pressure• Subendocardial ischemia• LV enlargement and systolic failure
1S.J. Lester et al., “The Natural History and Rate of Progression of Aortic Stenosis,” Chest 1998.2C.M. Otto, “Valve Disease: Timing of Aortic Valve Surgery,” Heart 200 Chart: Ross J Jr, Braunwald E. AorticStenosis. Circulation. 1968;38(Suppl 1):61-7.
Aortic Stenosis isLifeThreatening
Survival after onset ofsymptoms is50% at two yearsand 20% at five years1
“Surgical intervention [forsevere AS] should beperformed promptly onceeven…minor symptomsoccur”2
Valve Gradient
Gradient (mmHg) Area (cm2) CO (L/min)
2 3.0 5.0
11 2.5 5.0
16 1.25 5.0
25 1.0 5.0
45 0.75 5.0
70 0.6 5.0
100 0.5 5.0
20Yrs
5 Yrs
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• Studies show at least 40% of SAS patients are not treated with an AVR9-15
Addressing a Serious Unmet Need
0102030405060708090
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Sur
viva
l, %
AVR, no Sx
AVR, Sx
No AVR, no Sx
No AVR, Sx
Aortic Valve ReplacementGreatly Improves Survival
Years
5 year survival of breast cancer, lung cancer, prostate cancer, ovariancancer and severe inoperable aortic stenosis
Sobering Perspective
5-Year Survival8
Surv
ival,
%
BreastCancer
LungCancer
ColorectalCancer
ProstateCancer
OvarianCancer
SevereInoperable AS*
*Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic
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ASE GuidelinesECHO is Gold Standard
Providence Valve Center June 1,2011
• Options for Aortic Stenosis Patients• Transcatheter Valve Technology• Required Multidisciplinary Evaluation• Continued Growth of PHVI• Research Potential• Stature in Valve Disease Therapies• Other Valve Therapies
Transcatheter Aortic ValveImplantation/Replacement(TAVI/TAVR)
• First available in 2002 (Alain Cribier)• Rapid growth throughout the world for thetreatment of severe AS in patients who areat high surgical risk (~ 40,000)• “Additional” ~ 25% of cases in Germany• 2007-2009 Placement of AoRTicTraNscathetER Valve Trial (PARTNER TRIAL)
• November 2, 2011 FDA approval ofEdwards SAPIEN® with theRetroFlex3™(21-24Fr) for commercialrelease
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PARTNER Study Sites
IntermountainMedical CenterSalt Lake City, UT
EmoryUniversityAtlanta, GA
Univ. of MiamiMiami, FL
Univ. of VirginiaCharlottesville, VA
St. Luke’s HospitalKansas City, MO
Barnes-Jewish HospitalSt. Louis, MO
MedicalCity Dallas
Dallas, TX
St. Paul's HospitalVancouver, Canada
Univ. of WashingtonSeattle, WA
Mayo ClinicRochester, MN
StanfordUniversityPalo Alto, CA
Hospital LavalQuebec City,
Canada
Ochsner FoundationNew Orleans, LA
Scripps ClinicLa Jolla, CA
Cedars-SinaiMedical CenterLos Angeles, CA
Cleveland ClinicCleveland, OH
Columbia UniversityCornell UniversityNew York, NY
WashingtonHosp. CenterWash., DC
Univ. of PennPhila., PA
Brigham & Women’sMass GeneralBoston, MA
Northwestern Univ.Chicago, IL
Toronto Gen.Hospital
Toronto, Canada
Evanston Hospital
Leipzig Heart CenterLeipzig, Germany
n = 1,057 patients26 investigator sites22 USA, 3 Canada, 1 Germany
PHVI
TAVR Program Overview
• First TAVR in Oregon– February 1st, 2012
• First Oregon PARTNER II TAVR-TF– April 5th, 2012
• First Oregon PARTNER II TAVR-TA– August 21st, 2012
• Excellent multidisciplinary collaborationof multiple physicians, staff (eg. Echo,peripheralist, anesthesia, etc)
Patient Screening Physician Partnership Procedural Training
High Quality Imaging
Providence Valve CenterAn Integrated Approach
Multidisciplinary Treatment
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Providence Valve CenterMultidisciplinary Team• Interventional Cardiology
– Caulfield, Hodson, Korngold• Cardiac Imaging
– Walsh, Rahimtoola, Wilson– Zinck, Warfel
• Cardiac Surgery– Swanson, Kirker
• CV Anesthesia– Kelly
• Nurse Coordinator– Marla Craft
• Administrative Assistant– Kristina Wilson
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Providence Valve CenterExperience To Date September 2012
• TAVR -20 (23 through October)– Commercial - 7– PARTNER II - 13
• TF - 9• TA - 4
• SAVR - 42– PARTNER II - 6– PH&S - 36
• Referred to CoreValve in Spokane: 4– Treated - 1
• Referred to other centers: 3 (IMHC, Swedish)*As of July 2012
Data Source: PATS STS Adult Cardiac Surgery Registry ,S.Fine, RHVDS 7-2-12
PVC Opens
Symptomatic Severe Aortic StenosisSymptomatic Severe Aortic Stenosis
ASSESSMENT: High Risk AVR Candidate3105 Total Patients Screened
ASSESSMENT: High Risk AVR Candidate3105 Total Patients Screened
PARTNER Study Design
High Risk TAHigh Risk TA
ASSESSMENT:Transfemoral Access
ASSESSMENT:Transfemoral Access
TAVITrans
femoral
TAVITrans
femoral
SurgicalAVR
SurgicalAVR
High Risk TFHigh Risk TF
Primary Endpoint: All Cause Mortality (1 yr)(Non-inferiority)
Primary Endpoint: All Cause Mortality (1 yr)(Non-inferiority)
TAVITransapical
TAVITransapical
SurgicalAVR
SurgicalAVR
1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization
VSVS
StandardTherapy
(usually BAV)
StandardTherapy
(usually BAV)
ASSESSMENT:Transfemoral Access
ASSESSMENT:Transfemoral Access
Not In StudyNot In Study
TAVITrans
femoral
TAVITrans
femoral
Primary Endpoint: All Cause Mortality overlength of trial (Superiority)
Primary Endpoint: All Cause Mortality overlength of trial (Superiority)
1:1 Randomization1:1 Randomization
VS
Total = 1058 patientsTotal = 1058 patients2 Parallel Trials:
Individually Powered2 Parallel Trials:
Individually PoweredHigh RiskHigh Riskn= 700n= 700 InoperableInoperable n=358n=358
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GENERAL CLINICALINDICATIONS FOR TAVR
• Age > 75• Severe and symptomatic aortic stenosis• Moderate to high surgical risk
– PARTNER I and Commerical, STS >10%– PARTNER II, STS >4%
• Exceptions– Porcelain Aorta– Hostile Chest– Severe Pulmonary Disease– Midline LIMA/RIMA– Frailty– Severe Pulmonary Hypertension– Dementia– Cirrhosis– Severe Cerebral Vascular Disease
PARTNER Patient Population
• Severe symptomatic aortic stenosis• AVA of < 0.8 cm2
AND• Either mean AV gradient of > 40 mm Hg• Or peak aortic-jet velocity of > 4.0 m/sec
• All the patients had NYHA class II, III, or IVsymptoms
Cohort B
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Cohort B Down Side at 1 yearTAVI vs Control
• All Stroke/TIA 10.6 vs 4.5%
• Vascular Complications– All 32.4 vs 7.3%– Major 16.8 vs 2.2%– Major bleeding 22.3 vs 11.2%
Cohort A
Published CostEffectiveness Estimates
$0
$50
$100
$150
$200
$250
$300
aspirin MIprevention
rosuvastatinhigh-CRP
ICD primprev
CRT-D v.medical Rx
dabigatranAF
PARTNERCohort B
AF ablationvs. AAD
dialysis PCI stableCAD
LVADdestination
Rx
Dolla
rs p
er L
ife Y
ear o
rQAL
Y ($
thou
sand
s)
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Case Study• 83 yo female rancher, Eastern OR• Persistent AF (on dibagitran)• CRI, eGFR 56 ml/min, Cr 0.95• Moderate to severe TR• Referred to CV surgeon by PCP
for surgery eval for severe AS
GENERALNON-INDICATIONS FOR TAVR
• Age < 70• Refusal of surgery• Life expectancy < 1 yr
CLINICAL DECISION PROCESS
• Confirm Severe AS• Symptomatic• Risk Assessment• Technical feasibility
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TAVR WORK UP• Calculate risk scores• Frailty Assessment• TTE or TEE
– TEE routine part of procedure• CTA chest, abdomen, pelvis - “TAVR protocol”
– Gated– Beta-blockade issues– Contrast issues
• Coronary angio, right heart cath• PFTs, pulmonary consult• Carotid US
PVC- FacilitatedTAVR Work-up
COMMENTS•If any “NO” then considerMultidisciplinary Consult (MC)first.•If patient is likely SAVR, considerRHC/Cor first then MC beforeCTA or refer to surgeon.•If patient likely TAVR or P2, doRHC/Cor and CTA before MC.•All have an accurate STS.•All have a MC.•All are reviewed atMultidisciplinary Conference.•9/5/2012
Clinical Exam?NYHA II-IV?
Qualifying Echoor DSE?
STS>4%?
All Yes
DictateCompleteConsult
Order work up
MultidisciplinaryConsult
CTA
RHC/CorMultidisciplinaryConference
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RN Clinic Assessment
• Frailty Assessment– 15 foot timed walk
test– Grip Strength– ADL score– Albumin
• Mental Function– MMSE: mini mental
status exam
• Patient and Familymotivation andexpectations
• Quality of Life
• Social Support
• Decision MakingSupport
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ç
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LVOT 2.01 cmAnnulus 2.22 cm
Potential Recommendations:Routine Valve Surgical ValveReplacement• Aortic• Mitral, tricuspid
Percutaneous Valve Replacement• Edwards Sapien (Aortic)• Evalve Mitraclip (Mitral)
Continued Medical Therapy• Consider balloon valvuloplasty• Consider Connections consult• Continued Observation
CM 1/27/17
CATH
3/12/12
RA 10PA 44/19/31PCWP 16CO/CI3.17/1.71 (TD)2.62/1.41 (est Fick)
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CM 1/27/17
STJ 28.8Sinus 32.5Annulus 22.1
LCA height 15.5LC cusp 13.3
CM 1/27/17
11.12 x 13.82
CM 1/27/17
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RCF
REI
RCI
6.85 x 8.76 7.08 x 7.66 7.48 x 11.84
LEILCFLCI
6.31 x 8.20 6.46 x 6.96 6.35 x 9.13
Attention to detailTIMEOUTS 1,2,3
• JCAHO Timeout?• System rebooted?• Defibrillator• Conversion checklist• CPB plan
– Commercial: pt wishes (y/n)– Femoral vs. chest
• Valvuloplasty balloon• Pacer capture
• Particular concerns– Renal failure– CAD– Echo findings– Arrhythmia– Peripheral access
• If transfemoral:– Sheath sewn in?– Aortic occlusion balloon
• Valve prepped/checked• Valve positioning plan
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Trans-apical Approach
Post Operative Care
• #1 ….this is an AVR!• Potential Complications
– Vascular Access complications– Stroke– AV block– Acute MI– Acute Renal failure
TAVR patient withaortic stenosis
Incontinence
Osteoarthritis+/- joint replacement
Balance problems/immobility
Polypharmacy
Chronicbenzodiazepine
use
Alcohol dependence
Malnutrition
Renal insufficiency
Deconditioning
Depression
Constipation
Living alone
Inappropriatehousing
Lack of socialsupport
Courtesy C. Galte NP(F), MSNSt. Paul’s Hospital
Cognitive decline/dementia
CVA, PVD, CHF, COPD
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What I tell my patients
• Without surgery or TAVR ~50% mortality in 1-3 years• Calculate and discuss STS score• TAVI risks vary
– 5-10% risk of dying in first 30 days– 20-30% risk of dying in one year– Most deaths after 30 days are non-cardiac
• ~30% are pulmonary deaths– 10% risk of stroke in non-operable group– Stroke risk may be lower with surgery in high risk operable
group (5.5% TAVI vs 2.4% AVR)– 20-30% major vascular/bleeding complications
• We don’t know how long these valves will last– 5 year experience looks good
valvecenter@providence.org
THANK YOU