La sténose aortique

TAVI: indications,

technique et suivi post

procédure

Dr. Christan Roguelov

Département Cœur Vaisseaux

Service de Cardiologie

CHUV

BURDEN OF VALVULAR HEART DISEASESIMPORTANT PUBLIC-HEALTH PROBLEM

Nkomo VT, Lancet 2006

DISTRIBUTION OF VALVULAR HEART DISEASESEURO HEART SURVEY

Iung B, Eur Heart J 2003

PATIENT CHARACTERISTICSEURO HEART SURVEY

Iung B, Eur Heart J 2003

AORTIC STENOSIS

AORTIC STENOSISETIOLOGIES

Baumgartner H, Eur J Echocardiogr 2009

50 % 25 %

18 %2 % 2 % 3 %

Passik CS, et al, Mayo Clin Proc 62:119, 1987

AORTIC STENOSISETIOLOGIES: PATIENTS

50 % 25 %

18 %

2 % 2 % 3 %

48 %27 %

2 %23 %

Passik CS, et al, Mayo Clin Proc 62:119, 1987

AORTIC STENOSISETIOLOGIES: PATIENTS >70 YO

Patients avec sténose aortique opérés

Patients avec sténose aortique TAVI

Patients avec sténose aortique non traités

• ANGINE DE POITRINE

• SYNCOPE

• FATIGUE, DYSPNEE

• MORT SUBITE (rare)

STENOSE AORTIQUESYMPTOMS

Ross J Jr, Circulation 1968

AORTIC STENOSISNATURAL HISTORY

Brown ML, J Thorac Cardiovasc Surg. 2008

SEVERE SYMPTOMATIC AORTIC STENOSISSURVIVAL RATES AVR vs. NO AVR

Symptoms – no AVRNo symptoms – no AVR

No or Symptoms –AVR

Définition classique de la SA sévère

Otto C et al. Circulation 1997; 95: 2262-70 Bonow R. AHA/ACC Guidelines. Circulation 2006; 48: e1-148

Sténose aortique sévère

Diamètre de la

CCVG

Flux trans-aortique

Flux de la

CCVG

A1 = × (D/2)2

• Vitesse maximale

• Gradient maximal

• Gradient moyen

Gradients et équation de continuité:

les discordances sont fréquentes!

• Retrospective characterization of 512 consecutive patients with

“severe AS” (AVA 50%.

N= 196

38%N= 316

62%

Mean gradient ≥40 mmHg Mean gradient

Le gradient dépend du débit transvalvulaire

250 ml/s = typical ejection velocity corresponding to a 80 ml stroke volume ejected within 320 ms systolic time

250

Voelker W. Circulation 1995; 91: 1196

Evaluation de la racine aortique par angio-CT

• Taille de l’anneau

• Distance anneau-coronaires

• Taille des sinus

• Pontages aorto-coronariens

• Aorte porcelaine

Kasel AM. JACC Img 2013

CT: Evaluation vasculaire / calcifications

Distribution des calcifications Accès vasculaires

Landing zone(annulus, commissures)

→ Paravalvular leak(valve undersizing/asymmetric Ca++)

LVOT

→ Annular rupture(Oversizing/ balloon expandable)

Bulky leaflet calcification

→ Coronary obstruction(low coronaries, small sinus)

Barbanti M. Circulation 2013 Ewe SH Am J Cardiol 2011 Unbehaun A. JACC 2012

•Diameter

Prise en charge du patient avec sténose aortique (ou autre

valvulopathie) au CHUV - Heart team - VALVE BOARD

• Identification du patient avec SA (adressé par cardiologue ou hospitalisé)

• Coordinatrice Valve board

• Organisation du bilan (1-2 jours)– Labo

– CT scan 3D, coro, echo, Doppler carotides

– Consultation gériatrie

– CPC (post colloque)

• Mail pour le cardiologue ttt et le Valve Board

• Discussion

• Décision: SAVR, TAVI, ttt médical, réévaluation après information complémentaires

• Planification et convocation

• Intervention

• Registre SWISS TAVI et suivi PMU CHUV.

TAVITranscatheter Aortic Valve

Implantation

17 ans d’évolution du TAVI

17 ans d’évolution du TAVI

Transcatheter aortic valve replacement in the USA 161

Cardiologie

interventionnelle

le développement des valves aortiques percutanées aux USA, et le rôle majeur joué par les

États-Unis dans cet extraordinaire aventure « process ».

© 2012 Elsevier Masson SAS.

Background

It is now 10 years since the first human transcatheter aortic

valve replacement (TAVR), a procedure performed in Rouen,

France, in a patient with severe aortic stenosis (AS) [1].

Currently, a decade after this historic event, most TAVR

procedures performed and the majority of innovations in

the field of transcatheter valve technologies occur outside

the United States of America (USA). Nevertheless, the USA

had a major role in the development and evaluation of this

technology (Fig. 1). It could be said that although TAVR

was born in France, it matured in the USA. In the following

review, we provide data on the development of TAVR in

the USA, revealing the critical role the USA played in this

extraordinary process.

The early days

In early 2004, almost 2 years after the first human TAVR

procedure, when only a total of 17 patients had been

treated by this technology, TAVR entered into the ‘major

league’ of the industry with the purchase of a small

privately held medical technology company, Percutaneous

Valve Technologies, Inc. (PVT, Caesarea, Israel), by the

American-born Edwards Lifesciences Corporation (Irvine,

CA, USA). This transaction allowed Edwards to accelerate

the development of this breakthrough technology while

providing the needed expertise and resources to ensure suc-

cessful commercialization (Fig. 2). Several months later, at

the 2004 Transcatheter Cardiovascular Therapeutics (TCT)

Figure 1. Milestones in the development of transcatheter aortic valve devices in the USA and in Europe.

meeting held in Washington, DC, TAVR attracted major

publicity as a widely discussed topic. One of the highlights

was the live introduction of a patient 1-year post-TAVR.

Feasibility evaluation of the EdwardsSAPIEN device

The USA Food and Drug Administration (FDA) had a major

influence on the evaluation of TAVR devices. The FDA, an

agency within the United States Department of Health and

Human Services, is responsible for protecting and promoting

public health through the regulation and supervision of

numerous materials, including medical devices. The Center

for Devices and Radiological Health is the branch of the

FDA responsible for the premarket approval of all medical

devices in the USA, as well as overseeing the manufactur-

ing, performance and safety of these devices. In January

2005, the FDA conditionally approved the first feasibility

trial of the Cribier-Edwards percutaneous aortic heart

valve. Six months later, Edwards Lifesciences announced a

delay in enrolment in its percutaneous aortic heart valve

clinical feasibility trials in the USA using the antegrade

transseptal delivery, in order to incorporate the retrograde

delivery system, which at that time had already been

evaluated in several cases in Canada. The company took

this action after some USA antegrade cases demonstrated

a significant degree of clinical complexity and adverse

outcomes. However, the ‘loss’ of the antegrade transseptal

approach was rapidly replaced that year by the ante-

grade transapical approach, performed using the Ascendra

Cet article est publié en Open Access sous licence CC BY-NC-ND.

Dvir D et al. Arch cardiovasc Dis 2012; 105: 160-4

Modification de la prise en charge de la sténose aortique

Différentes types de valves percutanées

TAVI « work-up »

Sévérité

Faisabilité

Chirurgie vs TAVI

STS score

STS-score

0 84Bas Intermédiaire Elevé

Evaluation du risque chirurgical d’une RVA

www.riskcalc.sts.org

Traitement

?

Traitement très haut

risque/inopérable ?

Traitement médical TAVI

Leon, NEJM, 2010

PARTNER Study Design B

Suivi à 5 ans

Kapadia, Lancet, 2015

Traitement

SAVR TAVR

PARTNER 2 (STS moyen 5.8)

TAVI équivalent au RVA chirurgical

Leon MB et al. N Engl J Med 2016; 374: 1609-20

Différence significative pour sous-groupe « trans-fémoral »

Partner 2

Death from Any Cause or Disabling Stroke(%)

STS-score = 5.8%

Leon, NEJM, 2016

SURTAVI

Death from Any Cause or Disabling Stroke(%)

STS-score = 4.5%

Reardon, NEJM, 2017

Nouvelles recommandations pour

les maladies valvulaires

TAVR vs SAVR ?

Guidelines, ESC 2017

CHIRURGIE TAVI

Risque opératoire

Contre-indications

Faisablité technique

Frailty

Futility

âge

Chirurgien

Cardiaque

Cardiologue

Invasif

Cardiologue

Non-invasif

Radiologue

Anesthésiste

Cardiaque

Gériatre

VALVE BOARD

TAVR vs SAVR ?

Guidelines, ESC 2017

Valve board connecté

CHUV

VALVE BOARD

Anesthésiste

Chirurgien cardiaque

Radiologues

Cardiologue interventionnel

Cardiologue imagerie

Coordinateur des valves

Gériatre

Application iphone « Heart Valve »

Caractéristique des patients - CHUV 2018

TOUS TF-TAVI TA/TABC-TAVI

Age (années) 82 ± 8 82 ± 8 82 ± 6

Sexe masculin (n) 43 (43%) 31 (40%) 12 (55%)

Taille (cm) 165 ± 8 165± 8 165± 9

Poids (kg) 72 ± 15 72 ±16 66 ± 15

Surface corporelle (m2) 1.7 ± 0.4 1.8± 0.2 1.7 ± 0.2

Créatinine (mcmol/l) 113 ± 78 104± 39 147 ± 148

eGFR (ml/min) 49 ± 13 50± 12 46 ± 17

Maladie coronarienne (n) 55 (55%) 42 (55%) 13 (59%)

STS-score (%) 5.9 ± 4.8 5.9 ± 5.0 6.1 ± 4.2

STS >8 : 20%

STS 4-8 : 36%

STS

Pratiquement…

TAVI

TAVI

1. Sedation

2. Intervention = 1 h

3. Soins continus

J0

TAVI

Surveillance1. Soins continus

2. Echo tt contrôle

3. Déséquipement

4. Lever

J1 TAVI

Pacemaker+

1. Mobilisation

2. RAD/transfer

CTR

J2-5

TAVI

Pacemaker -

1. Télémètrie 48

heures

BBG/BAV

2. Mobilisation

Various vascular access

approaches

Jones, Nature Cardiol Rev, 2017

EDWARDS Sapien 3 - transfémorale

TAVI: accès fémoral

TAVI: positionnement et pre-

dilatation

TAVI: implantation d’une valve

Edwards sapien 3

Suivi post TAVI

1 moisVisite

échocardiographie

+ consultation

3 moisVisite

échocardiographie

+ consultation

12 moisVisite

échocardiographie

+ consultation

Cardiologue

traitant

Prophylaxie de l’endocardite

Conclusions: TAVI

– La sténose aortique sévère est un groupe

hétérogène

• Surface, gradient et flux

– La sténose aortique sévère doit être traitée

– Le choix de traitement se décide lors un

« valve board » - équipe multidisplinaire

• < 75 ans = chirurgie

• > 75 ans = TAVI

Merci pour votre attention