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 Sans compromis sur les fuites paravalvulaires : un grade 2, c’est trop ! PR CHRISTIAN SPAULDING DÉPARTEMENT DE CARDIOLOGIE HÔPITAL EUROPÉEN GEORGES POMPIDOU PARIS
Conflits d’intérêt Consultant: Techwald, Medtronic, Edwards Honoraires: Zoll, Abbott, Astra-Zeneca, Boehringer Ingelheim, BMS
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.
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
SAPIEN 3 PVL ≥ 2+ rate / + moderate rate SAPIEN 3 goes along with a PVL≥2+ rate in the range of 2,2%, weighted average
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
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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