advances in technology, procedure and patient selection
TRANSCRIPT
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Transcatheter Aortic Replacement: Advances in Technology,
Procedure and Patient Selection
Alexander (Sandy) Dick, MD ACC Rockies, 2015
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Disclosures
• None
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Smoothing out bumps
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Learning Objectives
• Understand current risk predictor scores and limitations in prediction of outcomes
• Importance of Quality of Life measures • Appreciate the crucial role of CT for
patient selection, valve selection, access site and outcomes
• Emphasize the future of the minimalist approach
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Partner 2 yr Follow-up
NEJM, 2012
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CoreValve US Pivotal Trial
Adams et al NEJM 2014
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Risk Score
• Society of Thoracic Surgeons-Predicted Risk of Mortality score (STS-PROM) and the European System for Cardiac Operative Risk Evaluation (EuroSCORE) – riskcalc.sts.org
• STS-PROMscore exceeds 10% or when the logistic EuroSCORE is ≥20%, referral for TAVI should be considered
Vahanian, et al Eur Hrt J 2012 Nishimura, et al Circulation 2014
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Risk Score Performance
• Specific risk factors for TAVI are not included, such as frailty, porcelain aorta, vessel tortuosity, chest wall malformation, or chest radiation
• Improved prediction with EuroSCORE II for 30 day mortality but still AOC 0.70
• Heart Team Approach Stahli, et al Cardiology 2013
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CoreValve US Pivotal Trial Intermediate Risk ~80%
TAVR Group (N = 394)
SAVR Group (N = 401)
Adams et al NEJM 2014
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CorValve - Medtronic
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CT
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Crucial role preprocedural CT
• Reduce peripheral vascular complications – Determination of access
• Anatomic assessment of valvular apparatus
• Annular sizing and device selection – Avoid complications over and undersizing
• Prediction fluoroscopic angles
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Low lying coronary arteries
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UK TAVR Registry
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Imaging to guide prosthesis sizing
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Impact CT sizing on TAVR outcomes
• 133 patients underwent TAVR with MDCT sizing algorithm and 133 without
• PVL > mild – 5.3% MDCT and 12.8% control (p=0.32)
• Composite in-hospital death, aortic annulus rupture and PVL > moderate – 3.8% MDCT and 11.3% control (p=0.020)
Leipsic, et al JACC 2013
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Bax et al Eur Hrt J 2014
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Clavel et al JACC 2013 Cueff et al Heart 2011
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Minimalist Approach
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9:12
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9:44
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10:11
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“Minimalist” Approach
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Methods • From a poten0al pool of 385 pa0ents considered high risk for surgery, 85 (22%) were selected for the 3M protocol and underwent SAPIEN XT (Edwards Lifesciences Inc.) valve implanta0on
• The Vancouver 3M Clinical Pathway was prospec0vely u0lized for objec0ve anatomical and func0onal 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
Wood DA et al. JACC 2014 (under review)
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Baseline Characteristics
Characteristic AllN= 85
GA /TEEN=35
Awake N=50
P value
Age – year 82.7+/-6.9 82.0+/-7.8 83.1+/-6.2 0.45Male sex, n (%) 42 (50) 17 (49) 25 (50) 0.73STS Score — % 7.9+/-3.5 8.4+/-3.4 7.5+/-3.5 0.23NYHA III/IV – n (%) 78 (92) 31 (89) 47(95) 0.23CCS III/IV 7 (8) 4 (11) 3 (6) 0.608Clinical characteristics, n (%)Prior MI 18 (21) 5 (14) 13 (26) 0.19Prior PCI 17 (20) 6 (17) 11 (22) 0.58Prior CABG 14 (17) 6 (17) 8 (16) 0.89Prior CVA 29 (34) 11 (31) 18 (36) 0.45Hypertension 69 (81) 27 (77) 42 (84) 0.42Peripheral Vascular disease 18 (21) 5 (14) 13 (26) 0.19Diabetes 22 (26) 11 (31) 11 (22) 0.33Severe Lung disease 23 (27) 12 (34) 11 (22) 0.21Chronic kidney disease 51 (64) 20 (57) 31 (62) 0.44Porcelain aorta 15 (18) 5(14) 10 (20) 0.49Prior Pacemaker 12 (14) 4 (11) 8 (16) 0.55Echocardiographic findingsAortic Valve Area, cm2 0.6+/-0.1 0.7 +/- 0.1 0.6 +/- 0.1 0.86Mean aortic valve gradient, mmHg
42 +/- 17 42 +/-15 42 +/- 18 0.99
Left ventricular ejection fraction, %
56 +/- 11 55 +/- 12 57 +/- 10 0.84
Mod/Severe Mitral Regurgitation, n %
5 (6) 4 (11) 1 (2) 0.25
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Clinical
Outcomes
Procedural Outcomes AllN= 85
GA /TEEN=35
Awake N=50
P value
Procedural Success, n (%) 82 (96.4) 33 (94.3) 49 (98.0) 0.51Mean Hospital length of stay, days 1.6+/-1.5 2.1+/-2 1.2+/-1 <0.01
Hospital Readmission prior to 30 days
2 (2.4) 2 (5.7) 0 (0%) 0.19
Death at 30 days, n (%) 1 (1.2) 0 (0) 1 (2.0) 0.40Death at one year 4/55 (7.3) 2/35 (5.7) 2/20(10.0) 0.24
Implantation of two valves 2 (2.4) 2 (5.7) 0 (0) 0.16Periprosthetic regurgitation at 30 days N, (%)*Grade 0 42/82 (51) 20/35 (57) 22/47 (47)
0.03Grade 1 37/82 (45) 14/35 (40) 23/47 (49)Grade 2 3/82 (4) 1/35 (3) 2/47 (4)Grade 3 0 (0) 0 (0) 0 (0)Complications at 30 daysStroke 1 (1.2) 0 (0) 1 (2.0) 0.40Myocardial infarction 1 (1.2) 0 (0) 1 (2.0) 0.40Bleeding Life threatening 1 (1.2) 0 (0) 1 (2.0) 0.40Major 1 (1.2) 0 (0) 1 (2.0) 0.40Minor 2 (2.4) 1 (2.9) 1 (2.0) 0.34Vascular complication Major 2 (2.4) 0 (0) 2 (4.0) 0.23Minor 4 (4.7) 1 (2.9) 3 (6.0) 0.55New pacemaker 2 (2.4) 2 (5.7) 1 (2.0) 0.37Early combined 30 Day VARC safety endpoint
4 (5.3) 2 (5.7) 2 (4.0) 0.89
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3M TAVR Trial • Evaluate the efficacy, feasibility and safety of next day
discharge home in high risk pa0ents undergoing TF TAVR
u0lizing Vancouver 3M Clinical Pathway & SAPIEN XT valve
• Prospec0ve mul0centre case series (10 North American sites)
• Vancouver (VGH and SPH) • Edmonton (Dr. R. Welsh) • Calgary (Dr. F. Al-‐Qoofi) • Hamilton (Dr. J. Velianou) • Sunnybrook (Dr. H. Wijeysundera/Dr. S. Radhakrishnan) • Hôpital du Sacré-‐Coeur de Montréal (Dr. JB Masson) • Centre Hospitalier de L’Universite de Montreal (Dr. P. Genereux) • Cedars-‐Sinai Medical Center (Dr. R. Makkar) • Columbia University Medical Center (Dr. M. Leon/Dr. S. Kodali)
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Summary
• Inclusion of Quality of Life measures in outcomes
• Crucial role of CT for patient selection, valve selection, access site and outcomes
• Minimalist approach
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Questions?
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Unger et al Heart 2010
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Concomitant MR
• Variable correlation to morbidity and mortality
• Independent predictors of improvement MR at 1yr – Baseline mean gradient ≥40 mmHg – Functional MR – Absence of pulmonary hypertension – Absence of atrial fibrillation
Toggweller et al JACC 2012
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Role of TAVI in Bicuspid Aortic Valve
• BAV in 1% general population – 20% elderly critical AS patients
• MRI and CT improve accuracy detect BAV • BAV excluded TAVR trials • Challenge of aortopathy, coronary ostia
location, elliptical implantation • Transcather Valve Therapy registry US
– 2% BAV, similar outcomes
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Piazzo et al JACC 2014
≥2+ AR 28.4% MDCT sizing ~17%
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Home?
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Utilizing the Vancouver 3M Clinical Pathway, in objectively screened patients with a mean age of 83±7 years and a mean STS score of
7.9±3.5%, 46 of the last 50 (24 of the last 25) have been safely discharged
home on Day 1 with no 30 day readmissions…
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To achieve the above 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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PARTNER 2yr Follow-up
NEJM, 2012
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PARTNER 2yr Follow-up
NEJM, 2012
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TAVR Bus
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3M Approach
All N = 85
3M Approach
Awake N=50
Partner TF
High risk N = 244
TVT Registry
TF High Risk N =1687
Corevalve USA
N = 390
FRANCE2 TF
N = 2361
Source XT TF
N=2688
Choice N=241
STS Score 7.9+/-3.5 7.5+/-3.5 11.8+/-3.3
7 (5-11) 7.3+/-3.0 14.5+/-11.9
7.9+/-6.6 5.6 +/-2.9
Length of hospital stay
1.6+/-1.5 1.2+/-1 8 5 (4-9) NA 10.5+/-8.1
11.1+/-9.2
NA
30-day mortality
1.4% 2.6% 3.4% 4.6% 3.3% 8.5% 4.2% 4.6%
30-day stroke
0% 0% 4.7% 3.2% 3.9% 3.7% 3.6% 4.1%
STS Score, length of hospital stay, and 30-day mortality and stroke utilizing the Vancouver 3M Clinical Pathway compared with
contemporary randomized transfemoral TAVR trials and registries