Transcatheter Aortic Replacement: Advances in Technology,

Procedure and Patient Selection

Alexander (Sandy) Dick, MD ACC Rockies, 2015

Disclosures

•   None

Smoothing out bumps

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

Partner 2 yr Follow-up

NEJM, 2012

CoreValve US Pivotal Trial

Adams et al NEJM 2014

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

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

CoreValve US Pivotal Trial Intermediate Risk ~80%

TAVR Group (N = 394)

SAVR Group (N = 401)

Adams et al NEJM 2014

CorValve - Medtronic

CT

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

Low lying coronary arteries

UK TAVR Registry

Imaging to guide prosthesis sizing

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

Bax et al Eur Hrt J 2014

Clavel et al JACC 2013 Cueff et al Heart 2011

Minimalist Approach

9:12

9:44

9:56

10:11

“Minimalist” Approach

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)

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

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

 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)  

Summary

•   Inclusion of Quality of Life measures in outcomes

•   Crucial role of CT for patient selection, valve selection, access site and outcomes

•   Minimalist approach

Questions?

Unger et al Heart 2010

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

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

Piazzo et al JACC 2014

≥2+ AR 28.4% MDCT sizing ~17%

Home?  

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…

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)…

PARTNER 2yr Follow-up

NEJM, 2012

PARTNER 2yr Follow-up

NEJM, 2012

TAVR Bus

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