Percutaneous ASD closure

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1 S. Hascoët Cardiologie pédiatrique et congénitale Hôpital Marie lannelongue Percutaneous ASD closure Marie Lannelongue Hospital long-term follow-up Groupe de travail sur le cathétérisme Cardiaque et congénital

2 Background 1 st procedure : King and Mills 1974 Amplatz 1997 FDA approval 2001

3 Background High success rate when anatomy is favourable Less morbidity than surgery Butera, Eurointervention 2011 Du, JACC 2002 Amplater device, Masura, 1997 First step procedure widely used

5 Hôpital Marie Lannelongue 18 mai sept PFO-A SD with Amplatzer Septal Occluder 1623 (76.1%) ASD 541 (33.3%) 18 y.o. 25 (1.5%) 4 y.o. younger 2 ans 10kgs Versus ASD < 15 kgs, n= % AE (AVB, stroke) Bartakian JACC CI 2012

6 Hôpital Marie Lannelongue Major Unexpected Events: 1623 ASD closure 1 late endocarditis (0.06% 95CI ) 2 hemo. pericardial effusion J2 / M3 (0.12% 95CI ) 1 late complete AVB (0.06% 95CI ) 0 significant Aortic/mitral Insufisiency (0.0% 95CI ) 0 late embolization (0.0% 95CI )

7 Large ASD Def: 34 mm / 15 mm/m² (balloon) n=336 (23.3%) (ASO n 38-40: n=80; 23.8%) 4 peri-procedure embolization Success rate 92.6% IC % Children 15 ans : success rate 96.1%, 95CI: % Median F.U.: 10.0 y. (range ) Losay et al. AHJ 2001; Baruteau et al., circ cardiovasc interv 2014

Children ASD 389 children f.u. 1 y. Success : 376 96.7% (IC95 94.4-98.

8 Children ASD 389 children f.u. 1 y. Success : % (IC ) 5 MAE: - 4 peri-procedure embolization 1.0% (95CI %) - 1 severe hemolysis 1.3% 95CI Baruteau, Hascoet et al., ACVD 2015

9 Children ASD 389 children f.u. 1 y. Median f.u. 7 y. (range 1-16) No delayed MAE 1 AF in a 12 y.o. young boy 5 y after closure Baruteau, Hascoet et al., ACVD 2015

10 Long-Term Follow-Up of Large Atrial Septal Occluder (Amplatzer Device) With Cardiac MRI in a Pediatric Population Chantale Lapierre, Nicolas Hugues, Nagib Dahdah, Julie Déry, Marie-Josée Raboisson, Joaquim Miró 122 patients from AJR 2012; 199: Highest quartile for device size 25 participants MRI in 2002 and 2009

Lapierre, Nicolas Hugues, Nagib Dahdah, Julie Déry, Marie-Josée

11 Long-Term Follow-Up of Large Atrial Septal Occluder (Amplatzer Device) With Cardiac MRI in a Pediatric Population Chantale Lapierre, Nicolas Hugues, Nagib Dahdah, Julie Déry, Marie-Josée Raboisson, Joaquim Miró AJR 2012; 199: : 8 yrs 2009: 15 yrs

12 Same patients but initial Echo studies reviewed retrospectively and longer follow-up

14 ASD and pregnancy 75 successful pregnancy in 67 women with ASD closure 15 y.o. 28 successful pregnancy in 20 women with large ASD 1 post-partum thrombus in out-of-hospital ASO closure Baruteau, Hascoet et al., ACVD 2015 Baruteau circ cardiovasc int 2014

15 Take-Home Message ASD closure with ASO is efficient High successful rate in selected cases MAE are rare but not nul Long-term follow-up is reassuring Losay et al. AHJ 2001 Baruteau, Hascoet et al., ACVD 2015 Baruteau circ cardiovasc int 2014

16 limits Mono-center high volume experience Large cohorts available with similar results Moore JACC 2014 But impact of volume center activity Losay et al. AHJ 2001 Baruteau, Hascoet et al., ACVD 2015 Baruteau circ cardiovasc int 2014

17 Center activity impact

18 Return from experience Good results so What are the rules to avoid complications (erosion)? - Patient criteria - Defect criteria - Procedure criteria +++ avoid oversizing - Device choice But still no perfect predictor

19 limits: calibration

20 Company Design + - statut réglementaire Amplatzer Septal Occluder Saint Jude Nitinol double disc polyester patch facilité d'utilisation, redeployable, grosse experience cable rigide, allergie nickel, érosions tardives CE FDA Helex Gore helix nitinol + PTFE membrane flexible, no erosion, faible profil maniement plus délicat, non centré, shunt résiduel CE FDA Figulla occlutech nitinol double disc dacron patch facilité d'utilisation, système de larguage moins de données CE Cera Lifetech Nitinol double disc polyester patch facilité d'utilisation, système de larguage très peu de données CE ultrasept Cardia Nitinol double disc covered with polyvnil alcohol low profile less and covered metal no published data CE cocoon Vascular Innovation Nitinol double disc covered with platinium low profile less and covered metal few published data Geva, Lancet 2014

21 Return from experience Good results so Was it possible and safe to simplify the procedure? - TTE vs TEE? - no balloon calibration? Losay et al. AHJ 2001 Baruteau, Hascoet et al., ACVD 2015 Baruteau circ cardiovasc int 2014

22 TTE vs TOE TEE : Oesophageal perforation In 2005 switch to a TTE guided procedure Similar results in children (256/389) in large ASD (219/336) Losay et al. AHJ 2001 Baruteau, Hascoet et al., ACVD 2015 Baruteau circ cardiovasc int 2014

23 New imaging modality Seo JASE 2012, Hascoet EHJ CI 2014

24 New imaging modality

25 CIA and PAH Closure criteria at Marie Lannelongue RVP < 15 UW.m² Qp/Qs > 1.5 Symptoms onset < 6 m

26 ASD closure in Eisenmenger Syndrome!!! 44 y.o. women, NYHA 3, mpap=65 mmhg PVR 22.5 UW.m² T6M 335 m, bittt PAH

28 J. Petit, J. Losay, V. Lambert, P. Brenot, A. Baruteau., S. Hascoet Thanks for your attention

Atrial Septal Defect

S. Hascoët Cardiologie pédiatrique et congénitale Hôpital Marie lannelongue Atrial Septal Defect long-term follow-up after closure Groupe de travail sur le cathétérisme Cardiaque et congénital Disclosure