TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio

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TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
TAVI POUR TOUS SANS COMPROMIS
   Sans compromis sur les fuites paravalvulaires : un grade 2, c’est trop !

            PR CHRISTIAN SPAULDING
            DÉPARTEMENT DE CARDIOLOGIE
            HÔPITAL EUROPÉEN GEORGES
            POMPIDOU PARIS
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
Conflits d’intérêt
Consultant: Techwald, Medtronic, Edwards

Honoraires: Zoll, Abbott, Astra-Zeneca, Boehringer Ingelheim, BMS
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
Impact of paravalvular regurgitation on the mid-term
                    outcome after transcatheter and surgical aortic valve
                    replacement

                 This multicentre study showed that both mild and
                 moderate-to-severe PVR were independent predictors of
                 worse survival after TAVI.
                 Mild and moderate-to-severe PVR are not frequent after
                 SAVR, but tend to decrease survival also in these patients.

Laakso T. et al. Impact of paravalvular regurgitation on the mid-term outcome after transcatheter and surgical aortic
 valve replacement.
Eur J Cardiothorac Surg. 2020 Dec 1;58(6):1145-1152.
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
IA Post-TAVI et Mortalité

        Kodali S et al, European Heart Journal 2015; 36, 449–456
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
Fréquence IA post-TAVI
Traces à minime (traces to mild): 40-67%
Modérée à importante (moderate to severe): 4 à 20%

                Webb JG et al Circulation 2007;116:755– 63.
                Walther T et al.Circulation 2007; 116:I240 –5.
                De Jaegere PP et al EuroIntervention 2008;4:351–7
                Takagi H et al Int I Cardiol 2016
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
SAPIEN 3 PVL ≥ 2+ rate / + moderate rate
SAPIEN 3 goes along with a PVL≥2+ rate in the range of 2,2%, weighted average
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
Paravalvular Leak: SAPIEN 3 Consistently low
over time
            p=0,85                    p=0,89

                                                            Fernandez-Santos et al analysed a subset of SAPIEN 3
                                                            recipients from the SOURCE 3 registry (n = 276)
                                                            Echocardiography was performed at baseline, post-procedure,
                                                            and at 1 year, including assessment of GLS (Global Longitudinal
                                                            Strain) using standard two-dimensional images, and core
                                                            laboratory analysis.
                                                            Paired analyses between baseline and discharge, baseline and
                                                            at 1 year were conducted
                                                            Hemodynamic parameters were improved after TAVI and
                                                            sustained to 1 year.
                                                            At 1 year, the rate of moderate to severe paravalvular leaks
                                                            (PVL) was 1.8%
                                                            The discharge GLS (–15.6 ± 5.1; p = 0.004; n = 149) improved
                                                            significantly from baseline (–15.1 ± 4.8) following TAVI.
                                                            This improvement was sustained at 1 year compared with
                                                            baseline (–17.0 ± 4.6, p < 0.001; n = 100).
 Total Aortic Regurgitation   Paravalvular Regurgitation
                                                           Fernandez-Santos S et al. Valve hemodynamic performance and myocardial strain after
                                                           implantation of a third-generation, balloon-expandable, transcatheter aortic valve. Cardiol
                                                           J. 2019 May 20
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
SURTAVI: Aortic regurgitation
TAVI POUR TOUS SANS COMPROMIS - PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS - High Tech Cardio
PVL ≥ 2+ / ≥ moderate rate in RCT, Registry, Propensity Matched
Studies and CE Mark in next generation devices
Balloon expandable valves, SAPIEN 3 / SAPIEN 3 Ultra, show very low PVL ≥ 2+ rate whereas self
expandable valve go along with higher rates

   Lotus     Portico         Evolut R /PRO                 SAPIEN 3 / 3 Ultra          Acurate NEO
Paravalvular Leak : SAPIEN 3 vs. Evolut R vs.
  Acurate NEO in a propensity matched study
                                  P
SAPIENS 3 Ultra and paravalvular leak
Fuites paravalvulaires post-TAVI : Facteurs
favorisants et prevention
Valve sous-taillée
Qualité scanner, calcul « collégiale »
Mauvaise positiondeuxième
Repositionnement, de la valve
                           valve ?
Mauvaise
Choix de la apposition   de la valve: calcifications
            valve, post-dilatation?
Paravalvular Leak: Impact of Calcification
      Severity of landing zone with Evolut R / PRO
                                                                                                                  Patients who underwent TAVR with the
                                                                                                                  CoreValve Evolut R or PRO (n=381) from
                                                                                                                  September 2015 to March 2018 were divided
                                                                                                                  by aortic valve calcification extent. Patients
                                                                                                                  with SC aortic valve anatomy (n=98; men,
                                                                                                                  >2,062 and women, >1,377 Agatston units)
                                                                                                                  were compared with those with non-severely
                                                                                                                  calcified (NCS) aortic valve anatomy after 1:2
                                                                                                                  propensity score matching
                                                                                                                  Moderate AR was present in 3.1% of SC
                                                                                                                  patients and in 0.5% of NSC patients

Piayda K et al. Performance of the CoreValve Evolut R and PRO in Severely Calcified Anatomy: A Propensity Score
Matched Analysis. Heart Lung Circ . 2020 Jun 16;S1443-9506

                                                                                                                                                14
Paravalvular Leak: Impact of Calcification Severity of
  landing zone with SAPIEN 3

                                                                                                          Aortic valve calcification severity has been
                                                                                                          associated with higher rates of aortic
                                                                                                          regurgitation (AR) following TAVR.

                                                                                                          Guimarães et al analysed in a multicenter study
                                                                                                          including 626 SAPIEN 3 recipients the impact of
                                                                                                          severe calcification. 1 group had a high index
                                                                                                          calcium score (iCS) (HCS, iCS ≥ median), and
                                                                                                          the other a low iCS (LCS, iCS < median).
                                                                                                          The mean CS was 3758 ± 1417 AU and 1616 ±
                                                                                                          691 AU in the HCS and LCS groups, respectively
                                                                                                          (p < 0.001). The incidence of moderate-severe
                                                                                                          AR post-TAVR was low in both groups
                                                                                                          (HCS:1.6%,LCS:1.6%, p = 1.0), and valve
                                                                                                          gradient and area were similar between groups.

Guimarães L et al. Transcatheter aortic valve replacement with the balloon-expandable SAPIEN 3 valve: Impact of calcium score on valve performance and clinical outcomes.
Int J Cardiol . 2020 May 1;306:20-24
IA Post-TAVI : le problème des définitions

Kappelstein PA et al, VARC 2 consensus document, JTCS 2013

                Limitation techniques
                Reproductible ?
                3, 4, 5, 7 grades ?
IA Post-TAVI: Evaluation en pratique
Une évaluation parfois subjective…
Conclusions: Fuites para-valvulaires post-TAVI
Augmente la mortalité à long terme
Nette diminution des fuites para-valvulaires avec valves de nouvelle génération
Fréquence fuites para-valvulaires > 2+: 2,2% avec Sapiens 3
Facteurs favorisants: mauvaise position valve, valve trop petite, calcifications
Prévention et traitement per-procédure:
         - Préparation procédure: Lecture « collégiale » du scanner
         - Position valve: incidence, repositionnement, (deuxième valve)
         - Calcifications : choix de la valve
Une jupe et encore plus…
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