Transcatheter Aortic Replacement: Advances in Technology, Procedure - - PowerPoint PPT Presentation

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Transcatheter Aortic Replacement: Advances in Technology, Procedure - - PowerPoint PPT Presentation

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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

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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,

  • r 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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9:56

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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 All N= 85 GA /TEE N=35 Awake N=50 P value Age – year 82.7+/-6.9 82.0+/-7.8 83.1+/-6.2 0.45 Male sex, n (%) 42 (50) 17 (49) 25 (50) 0.73 STS Score — % 7.9+/-3.5 8.4+/-3.4 7.5+/-3.5 0.23 NYHA III/IV – n (%) 78 (92) 31 (89) 47(95) 0.23 CCS III/IV 7 (8) 4 (11) 3 (6) 0.608 Clinical characteristics, n (%) Prior MI 18 (21) 5 (14) 13 (26) 0.19 Prior PCI 17 (20) 6 (17) 11 (22) 0.58 Prior CABG 14 (17) 6 (17) 8 (16) 0.89 Prior CVA 29 (34) 11 (31) 18 (36) 0.45 Hypertension 69 (81) 27 (77) 42 (84) 0.42 Peripheral Vascular disease 18 (21) 5 (14) 13 (26) 0.19 Diabetes 22 (26) 11 (31) 11 (22) 0.33 Severe Lung disease 23 (27) 12 (34) 11 (22) 0.21 Chronic kidney disease 51 (64) 20 (57) 31 (62) 0.44 Porcelain aorta 15 (18) 5(14) 10 (20) 0.49 Prior Pacemaker 12 (14) 4 (11) 8 (16) 0.55 Echocardiographic findings Aortic Valve Area, cm2 0.6+/-0.1 0.7 +/- 0.1 0.6 +/- 0.1 0.86 Mean 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 All N= 85 GA /TEE N=35 Awake N=50 P value Procedural Success, n (%) 82 (96.4) 33 (94.3) 49 (98.0) 0.51 Mean 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) 0.40 Death 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) 0.16 Periprosthetic regurgitation at 30 days N, (%)* Grade 0 42/82 (51) 20/35 (57) 22/47 (47) 0.03 Grade 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 days Stroke 1 (1.2) 0 (0) 1 (2.0) 0.40 Myocardial infarction 1 (1.2) 0 (0) 1 (2.0) 0.40 Bleeding Life threatening 1 (1.2) 0 (0) 1 (2.0) 0.40 Major 1 (1.2) 0 (0) 1 (2.0) 0.40 Minor 2 (2.4) 1 (2.9) 1 (2.0) 0.34 Vascular complication Major 2 (2.4) 0 (0) 2 (4.0) 0.23 Minor 4 (4.7) 1 (2.9) 3 (6.0) 0.55 New pacemaker 2 (2.4) 2 (5.7) 1 (2.0) 0.37 Early 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
  • utcomes
  • ‰ 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 Corevalv e USA N = 390 FRANCE 2 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