valvular interventional cardiology in perspective present and future · 2015. 10. 8. · estimated...
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Valvular Interventional Cardiology in Perspective
Present and Future
Cesar Morís
Profesor Cardiología
Director Área del Corazón
Htal Universitario Central de Asturias
Universidad de Oviedo
OVIEDO -- ESPAÑA
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MY DISCLOSURES
• Corevalve Proctor
• I serve on a Medical Advisory Board for Medtronic, Inc.
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Hospital Universitario Central de Asturias
Universidad de Oviedo
OVIEDO -- ESPAÑA
Oviedo
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World Wide Cardiology Market Trends
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Estimated Global TAVR Growth
SOURCE: Credit Suisse TAVI Comment –January 8, 2015. ASP assumption for 2024 and 2025 based on analyst model. Revenue split assumption in 2025 is 45% U.S., 35% EU, 10% Japan, 10% ROW
In the next 10 years, TAVR growth will increase X4!
M.B Leon TVT Chicago 2015
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Valvular Interventional Cardiology in Perspective
• Tricuspid
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TR is Currently Ignored !! STS Database 2009
TR cases
Annual New TR
Annual MR Surgeries
Annual TR Surgeries
1,600,000
250,000
50,000
5,500
Interventional Cardiology Perspective of Functional Tricuspid Regurgitation. Argarwal et al. Circ Cardiovasc Interv 2009;2:565-573
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…and they die! TR Increases Mortality !
Nath. JACC 2004;43:405.
5223 subjects : Mod-Sev TR increased mortality independent of
PASP, LVEF, IVC size, RV size/ function.
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OK ! Don‟t ignore TR : How to do it ?
Repair Lessons for Functional TR
Annuloplasty Rings DeVega
DeVega. Rev Esp Cardiol 1972;25:6.
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Circ Cardiovasc Interv. 2015;8:e002155. DOI: 10.1161/CIRCINTERVENTIONS.114.002155
17 percutaneous valves were implanted in 16 pts. With TV bioprosthesis dysfunction
Men follow-up: 2.1 years (3 days to 6.3 years). The percutaneous valve was performing well in 15 of 16 patients
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First-in-Human Transcatheter Tricuspid Valve Repair in
a Patient With Severely Regurgitant Tricuspid Valve
J Am Coll Cardiol. Published online March 04, 2015. doi:10.1016/j.jacc.2015.01.025
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Valvular Interventional Cardiology in Perspective
• Mitral
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Prevalence of valvular heart disease by age
Lancet 2006; 368:1005
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Complexity of aortic and mitral valve disease
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Challenges in the mitral space
• Multitude of pathologies with different etiology, mechanism, prognosis, type of repair and response to repair
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Interaction with LV function
It makes harder to predict who will benefit with mitral regurgitation
Percutaneous Treatment of Mitral Valve Disease
Aortic Stenosis
LV dysfunction
Mitral Regurgitation
LV dysfunction
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Funcional (IMF)
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Degenerativa (IMD)
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Robbins et al. Am J Cardiol 2003; 91:360 Grigioni F et al. Circulation 2001 ;103:1759-1764
Bursi F et al. Eur J Heart Fail 2010;12:382-388
Mortality and MR
MR predictor of mortality in those with
less advanced HF HR 1.23
Trichon BH. Am J Cardiol 2003;91:538
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¿Que hacer con la IM funcional?
Castleberry AW, Circulation 2014;129:2547
El tratamiento médico está asociado con las
mayores cifras de mortalidad a 20 años
N=4989
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Euro Heart Survey
surgery is often denied in the older patients
Isolated MR
(n=877)
Severe MR
(n=546)
No Severe MR
(n=331)
No Symptoms
(n=144)
Symptoms
(n=396)
No Intervention
(n=193) 49%
Intervention
(n=203) 51%
Mirabel et al, European Heart J 2007;28:1358-1365
2/3 of symptomatic MR patients >70 are
denied surgery
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Patients with secondary MR
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Duke Databank: 1,538 pts with echocardiographic 3+ - 4+ FMR and LVEF ≥20% between
2000 and 2010 not undergoing CABG
11.4% 5.9% 8.4% 11.8% 18.4%
0%
25%
50%
75%
100%
All pts 20%-30% 30%-40% 40%-50% 50%-60%
Conservative management Isolated MV surgery
LVEF
N=1538 N=440 N=298 N=313 N=479
8 other pts had LVEF >60%; none underwent MV surgery
How are Patients with Isolated FMR Treated?
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Mirabel M et al. Eur Heart J 2007;28:1358-1365
Euro Heart Survey – Conducted in 2001
Decision to operate according to comorbidity
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Muchas dudas beneficio cirugía IMF
No-MVA
MVA
Wu A, J Am Coll Cardiol 2005;45:381–7
n= 419 OP: muerte, asistencia VI, TxC a 1 año FE en CVM 23%
n=301 CABG vs CABG + MVRepair
CABG
CABG + MVR
p
Cualquier evento NRL 3.1 9.6 0.03
Ictus 1.5 5.2 0.1
Smith PK, N Engl J Med 2014, In press
Magne J, Cardiology 2009;112:244
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Unmet need in mitral regurgitation
• Similar to aortic stenosis, there are many patients
with severe MR who would benefit from mechanical
correction of the hemodynamic lesion, but are not
receiving this treatment because of high risks (real or
perceived) associated with the required surgical
procedure
Percutaneous Treatment of Mitral Valve Disease
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Mitral Valve repair
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„Alfieri‟ (edge to edge) repair
Percutaneous Treatment of Mitral Valve Disease
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The MitraClip System
Percutaneous Treatment of Mitral Valve Disease
• Take note of the clip itself, and the steering / delivery system that allows three-dimensional alignment
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CLÍNICAL EVIDENCE
Feldman T, N Engl J Med 2011; 2011;364:1395
73% Degenerative MR Stringent echo criteria Central valve pathology
Surgery is better for younger patients with degenerative MR and preserved LV function
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EFFICACY
n Acute procedural success
EVEREST II 279 77%
Franzen 2010 51 96%
Franzen 2011 50 94%
GRASP registry 117 100%
TRAMI registry 486 94%
TRAMI aged 1064 96%
ACCESS EU 567 99.6%
ESC SENTINEL 628 95.4%
Franzen O, EHJ 2010;31:1373
Franzen O, Eur J Heart Fail 2011;13:569
Grasso C, Am J Cardiol 2013;111:1482e 1487
Baldus S, Eur Jour of Heart Fail 2012; 14: 1050
Schillinger W, EuroIntervention 2013
Maisano F, J Am Coll Cardiol 2013; 62:1051
Nickenig G, J Am Coll Cardiol 2014
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MR REDUCTION
ACCESS EU ESC SENTINEL
Maisano F, J Am Coll Cardiol 2013; 62:1051 Nickenig G, Estevez-Loureiro R, J Am Coll Cardiol 2014;64:875
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VERSATILITY
IMD resultado “surgical-like” tras 2 clips
IMF resultado bueno para tipo de paciente
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Bilge M, CCI 2014;83:137 Grasso C, J Am Coll Cardiol 2014;63:834
Schäfer U, EuroIntervention 2014;In press
VERSATILITY
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Estevez-Loureiro R, Arzamendi D, Freixa X, Cardenal R, J Am Coll Cardiol 2015; in press
VERSATILITY
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ESC SENTINEL
ACCESS EU
MEJORÍA CLASE NYHA
MEJORÍA 6MWT
Maisano F, J Am Coll Cardiol 2013; 62:1051 Nickenig G, Estevez-Loureiro R, J Am Coll Cardiol 2014;64:875
MEJORÍA CALIDAD DE VIDA EVEREST HIGH RISK
Glower D, J Am Coll Cardiol 2014,64:172
FUNCTIONAL IMPROVEMENT
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MitraClip in recent valve disease guidelines
European (2012):
– Clip procedure may be considered in . . . symptomatic severe
secondary MR after optimal medical Rx (including CRT if indicated)
assuming echo criteria met and inoperable or high surgical risk (class
IIb, LOE C)
AHA / ACC (2014):
– Transcatheter MV repair may be considered for severely symptomatic
patients (NYHA class III/IV) with chronic severe primary MR (stage
D) who have . . . . prohibitive surgical risk because of severe
comorbidities (class IIb, LOE B)
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Other transcatheter techniques
Estévez-Loureiro R, PanMinerva Medica 2013;55(4):327-37
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Trans-apical beating
heart neo chordae
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Seeburger J, J Am Coll Cardiol 2014;63:914
≈50% éxito IM ≤2+ a 30 días
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Coronary Sinus Approach Cardiac Dimensions Carillon XE 2 Device
AMADEUS Trial. Circulation. 2009;120:326-333 Adapted from Hermiller TCT 2011
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Pulling tension
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Valtech Cardioband
Transeptal access super-annular implant by TEE/Fluoro guidance
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Mitralign – pledgeted annular plication
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Spiral nitinol coils – anchoring by atrial ring
and cinching of chordae by ventricular ring
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Millipede
Transcatheter mitral annular reduction with a self-
centering, positioning, and attaching device
Ring in mitral valve
Ring expanded
Adapted from Hermiller TCT 2011
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Trans-catheter Mitral
Valve Replacement
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JACC 2014; 64 , NO.17
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Transcatheter Mitral Valve Replacement
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Tendyne Valve
Self expanding trileaflet pericardial valve sewn onto a nitinol frame
Transapical
The first 2 cases of human Tendyne valve implantation were
performed in 2013 in patients going to surgical MV replacement at the French Hospital, Asuncion,
Paraguay
JACC 2015; 6 5: 2352-3
Tendyne Valve
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TIARA Valve
Self-expanding bioprosthesis with cross-linked bovine pericardial tissue leaflets mounted inside a metal
alloy frame
The first 2 cases of human Tiara valve implantation were
performed in January and February 2014 at St. Paul’s Hospital,
Vancouver, British Columbia, Canada.
Transapical
Tiara Valve
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Valvular Interventional Cardiology in Perspective
• Aortic
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Dr. Alain Cribier First-in-Man PIONEER
April 16, 2002
It was impossible
to predict the general
application of this
new procedure!
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Catheterization and Cardiovascular Interventions 2005; 66:465–469
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Bogotá 2015
> 40.000 válvulas implantadas en el mundo
> 200.000 válvulas implantadas en el mundo en 2015
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Estimated Global TAVR Procedures
SOURCE: Credit Suisse TAVI Comment –January 8, 2015. Revenue split assumption in 2025 is 45% U.S., 35% EU, 10% Japan, 10% ROW
18,000
M.B Leon TVT Chicago 2015
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Estimated Global TAVR Growth
SOURCE: Credit Suisse TAVI Comment –January 8, 2015. ASP assumption for 2024 and 2025 based on analyst model. Revenue split assumption in 2025 is 45% U.S., 35% EU, 10% Japan, 10% ROW
In the next 10 years, TAVR growth will increase X4!
M.B Leon TVT Chicago 2015
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TAVR “Underutilization” is Largely Driven by
Variation in Health Policy and Reimbursement
SOURCE: Eurostat, U.S. Census Bureau, Industry estimates
M.B Leon TVT Chicago 2015
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How is the Market developing
Source BIBA Data until dec 31 2014
Total
Transfemoral
Transapical
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2% 3% 3% 2% 2% 3% 2% 2% 2%
2% 2% 2% 2%
26% 23% 22%
21% 20% 20% 19% 17% 17% 16% 16% 16% 16%
71% 71% 73% 73% 73% 72% 72%
75% 76% 77% 78% 79% 79%
0% 2% 3%
5% 5% 5% 6% 6% 4% 4% 3% 3%
CY11 Q4 CY12 Q1 CY12 Q2 CY12 Q3 CY12 Q4 CY13 Q1 CY13 Q2 CY13 Q3 CY13 Q4 CY14 Q1 CY14 Q2 CY14 Q3 CY14 Q4
Europe Including Germany
TF
TA
SC DA
How is the Market developing
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3.2% 4.0% 3.6% 2.8% 2.6% 3.7% 2.7% 2.8% 2.2%
4.1% 3.8% 1.9%
4.0%
19.8% 18.9% 17.3%
15.3% 13.7% 14.5%
11.6% 12.3% 12.3% 10.0% 10.7% 10.5% 10.8%
77.0% 74.2%
75.7% 77.0%
79.3%
75.4% 76.2% 78.1% 78.4%
79.9% 80.3% 83.2% 82.0%
0.0% 2.9% 3.5%
4.9% 4.4% 6.4% 6.8% 7.0% 6.1% 5.1% 4.4% 3.2%
CY11 Q4 CY12 Q1 CY12 Q2 CY12 Q3 CY12 Q4 CY13 Q1 CY13 Q2 CY13 Q3 CY13 Q4 CY14 Q1 CY14 Q2 CY14 Q3 CY14 Q4
Europe Without Germany
TF
TA
SC
DA
TAVI Implants. Access route
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1.Introduction
2.Clinical research
3.Expanding indications
4.Issues
5.Adjunctive Pharmacology
6.Ideal Transcatheter Valve
7.Summary
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• Randomized clinical trials ( PARTNER and US CoreValve)
and important registries (e.g. TVT, ADVANCE)
Rigorous Clinical Research
8.494 patients included in FDA trials
( 279 ptes in EVEREST II Trial )
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PARTNER Manuscripts in NEJM (October, 2010 – May, 2012)
PARTNER B PARTNER A
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PARTNER 5-year FU in Lancet (March, 2015)
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PARTNER II
High Risk patients at 30 days
Mortality and Stroke Baseline characteristics
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PARTNER II
Intermediate Risk patients at 30 days
Mortality and Stroke Baseline characteristics
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N Engl J Med on March 29, 2014 JACC on May 20, 2014
Corevalve Trials (March 2014 – May, 2014)
PRIMARY END POINT
4.9 % Absolute risk reduction
P<0.001 for noninferiority;
P = 0.04 for superiority)
The results were similar in the intention-to-treat analysis; the event rate was 13.9% in the TAVR group, as compared with 18.7% in the surgical group (absolute risk reduction, 4.8 %)
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2 years All Cause Mortality Corevalve US Pivotal trial
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Echocardiographic valve performance Corevalve US Pivotal trial
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J Am Coll Cardiol 2015;65:2184–94
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Nordic Aortic Valve Intervention (NOTION) Trial
Objective: Compare TAVI vs. SAVR in patients >70 years eligible
for surgery (all-comers population)
Primary outcome: Composite rate of death from any cause, stroke or
myocardial infarction at 1 year (VARC II-defined)
Secondary
outcomes:
Safety and efficacy (NYHA), echocardiographic
outcomes
(VARC II-defined)
J Am Coll Cardiol 2015;65:2184–94
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Enrollment Criteria
Main inclusion criteria
•Severe AS
•Age ≥70 years
•Life expectancy ≥ 1 year
•Suitable for TAVR & SAVR
Main exclusion criteria
• Severe CAD
• Severe other valve disease
• Prior heart surgery
• Need for acute treatment
• Recent stroke or MI
• Severe lung disease
• Severe renal failure
J Am Coll Cardiol 2015;65:2184–94
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13.1 16.3
ITT
TAVI SAVR
Primary Outcome*
Death from any cause, stroke or myocardial infarction
3.2% absolute difference; p . 0.43 for superiority
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Secondary Outcomes at 2 Years
1 Year 2 Years
Outcome, % TAVI SAVR p-value TAVI SAVR p-value
Death, any cause 4.9 7.5 0.38 8.0 9.8 0.54
Death, cardiovascular 4.3 7.5 0.25 6.5 9.1 0.40
Stroke 2.9 4.6 0.44 3.6 5.4 0.46
TIA 2.1 1.6 0.71 6.0 3.3 0.30
Myocardial infarction 3.5 6.0 0.33 5.1 6.0 0.69
Atrial fibrillation 21.2 59.4 <0.001 22.7 60.2 <0.001
Pacemaker 38.0 2.4 <0.001 41.3 4.2 <0.001
Aortic valve re-intervention 0.0 0.0 na 0.0 0.0 na
J Am Coll Cardiol 2015;65:2184–94
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Aortic Valve Performance
J Am Coll Cardiol 2015;65:2184–94
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David Wood MD, FRCPC, FACC, FESC, FSCAI, FSCCT
Structural & Interventional Cardiology, VGH and SPH
Associate Clinical Professor, UBC
Centre for Heart Valve Innovation
How to TAVR Session II: Procedural Trends
Adoption of the Minimalist Approach
Williford C, Third Floor
June 4th, 2015
16:59 – 17:07
The North American 3M TAVR Study
Multidisciplinary, Multimodality, but Minimalist
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To achieve optimal results…
• Safe
• Reproducible (general anesthetic or awake)
• Reduced LOS to not only improve cost effectiveness
but also clinical outcomes
• Glimpse of the future (for both individual Heart
Teams and regional Health Authorities)…
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Considered at increased surgical risk by the Heart Team
COMPLETE REVASCULARIZATION Staged PCI of all suitable
non-culprit lesions (< 45 days)
3M TAVR Study Design To evaluate the efficacy, feasibility and safety of next day discharge home in patients undergoing balloon expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway
Patients with severe symptomatic AS undergoing elective transfemoral TAVR
Primary Outcomes: All-cause mortality and major stroke (modified Rankin Scale of 2 or
more) at 30 days AND the proportion of patients who are discharged the next day
Vancouver 3M Clinical Pathway
(n = 400)
Meets all general, anatomical, functional, and
peri-procedural exclusion criteria
Standard TAVR
(n = 800)
All remaining patients at all sites
Standard Care
Secondary Outcomes: each component of the primary endpoint; death or non-fatal stroke at 1 year; 30 day major
vascular complications/life-threatening bleed/hospital readmission/repeat procedure for valve related
dysfunction/stage 3 acute kidney injuries (AKIN classification); periprocedural MI, conversion to
GA/intubation; KCCQ and SF-12 at 2 weeks, 30 days, and 1 year
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Methods (Pilot Study)
• From a potential pool of 385 patients considered high risk for surgery, 85
(22%) were selected for the 3M protocol and underwent SAPIEN XT
(Edwards Lifesciences Inc.) valve implantation
• The Vancouver 3M Clinical Pathway was prospectively utilized for
objective anatomical and functional screening, peri-procedural
management, and to determine if next day discharge home was
appropriate
• Thirty day and one year outcomes were reported according to VARC-2
guidelines
J Am Coll Cardiol. 2014;64(11_S):. doi:10.1016/j.jacc.2014.07.773
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“Outpatient” Same-Day TAVR Sacre-Coeur Hospital; Montreal, CN
Philippe Genereux
Philippe Demers
Donald Palisaitis
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• Overall, 62/85 (73%) were discharged home one day post
TAVR with 2 readmissions (2.4%) within 30 days.
• At 30 days and 1 year, 97% (83/85) and 93% (51/55) were
NYHA class I or II with mild or less paravalvular
regurgitation.
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1.Introduction
2.Clinical research
3.Expanding indications
4.Issues
5.Adjunctive Pharmacology
6.Ideal Transcatheter Valve
7.Summary
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0%
5%
10%
15%
20%
25%
30%
35%
23 mmn=27
26 mmn=353
29 mmn=549
31 mmn=94
Sizi
ng
Rat
io (
%)
IFU Sizing Window
Mean Sizing Ratio by Valve Size
N=1023
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Sizing Ratio and Mod/Severe PVL
17.60%
9.90%
6.30% 4.90%
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
≤10% n=136
10-15%n=304
15-20%n=269
>20%n=206
[(CoreValve Perimeter – Annulus) / Annulus] x 100
N=1023
% M
od
erat
e/Se
vere
Dis
char
ge P
VL
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Permanent Pacemaker Placement
15.1%
21.6% 17.9%
24.6%
0%
5%
10%
15%
20%
25%
30%
≤ 10% n=152
10-15%n=338
15-20%n=291
>20%n=228
[(CoreValve Perimeter – Annulus) / Annulus] x 100
N=1023
Inci
den
ce o
f N
ew P
erm
anen
t Pa
cem
aker
at
30
Day
s
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Embolization Compresion Endocarditis
Conclusion: Transcatheter heart valves are susceptible to failure modes typical to those of surgical bioprostheses and unique to their specific design. Transcatheter heart valve compression and late embolization represent complications previously unreported in the surgical literature
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http://www.scai.org/TAVRCenter/Presentation.aspx?cid=da88a902-105a-401c-880d-cfae3bf9c2ab#
SCAI TAVI Center
What Happened to the Valve?
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1.Introduction
2.Clinical research
3.Expanding indications
4.Issues
5.Adjunctive Pharmacology
6.Ideal Transcatheter Valve
7.Summary
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A total of 672 TAVI patients treated: • ASA (N=415) • DAPT (N=257)
Hassell MECJ, et al. Heart 2015;0:1–8
No difference in net adverse clinical and cerebral events was observed
However, ASA was associated with a decreased tendency of life-threatening and major bleeding
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TAVR Adjunct Pharmacology
Customized Patient-Based Therapy
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New TAVR Pharmacology Trial
PIs: Dangas, G. Windecker, S.
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International Multicenter Randomized
TAVR UNLOAD
Trial
Heart Failure LVEF < 50% NYHA ≥ 2
Optimal HF therapy (OHFT)
Moderate AS
R
TAVR + OHFT
OHFT alone
Follow-up: 1 month 6 months
1 year
Clinical endpoints Symptoms
Echo QoL
Primary Endpoint
Hierarchical
occurrence of:
• All-cause death
• Disabling stroke
• Hospitalizations
for HF, aortic
valve disease, or
non-disabling
stroke
• Change in KCCQ
Reduced AFTERLOAD
Improved LV systolic
and diastolic function
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1.Introduction
2.Clinical research
3.Expanding indications
4.Issues
5.Adjunctive Pharmacology
6.Ideal Transcatheter Valve
7.Summary
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The Ideal Transcatheter Aortic Valve
MDT Evolut R Edwards Sapien 3
Significant technology differences among devices, but no major mortality/stroke
differences between Sapien vs. CV; choice determined by secondary outcomes and
anatomic considerations
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TAVR Systems with CE-Approval (2007-15)
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SUMMARY
The “IDEAL” Aortic Trans-catheter Valve should be:
• Durable
• Trans Femoral
• Sheath Outer diameter <14 French
• Precise and predictable positioning
• Low complication rates:
• Pacemaker rate < 10%
• Stroke rate lower than surgery
• Moderate or severe aortic regurgitation absent
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1.Introduction
2.Clinical research
3.Expanding indications
4.Issues
5.Adjunctive Pharmacology
6.Ideal Transcatheter Valve
7.Summary
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• Dominant technology for severe AS, supported by
rigorous clinical research.
• Further technology enhancement (including
adjunctive imaging) and procedural simplification.
• Expanded clinical indications and creative new
applications (TAVI+ PCI, LAAC, Mitraclip, etc.
• Platform extensions to treat all forms of valvular
disease
TAVI future. SUMMARY
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¿ Quienes no son buenos candidatos para cirugía?
¿ Quienes son buenos candidatos para TAVI?
Cambio de la pregunta
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In Summary
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World Wide Cardiology Market Trends
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Staged or Single-Stage Procedures are here
• Aortic valve-in-valve
• MitraClip
• LAA closure
• Coronary stent
J. Webb
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Agosto 2015 Muchas gracias