2. Indication reconnue en France
• ACFA + facteurs de risque thromboembolique
et contre indication à ce traitement
(hémorragie digestive majeure, AVC
hémorragique).
3. Protect-AF trial
• 800 patients
• Randomisation: 2:1
– Suivi avec ETT à 45j, 6 mois et 1 an.
– 87% d’arrêt de la warfarin
• Critère primaire d’efficacité:
- AVC, Décés, embols systémique
• Critère primaire de sécurité:
– Migration de la prothèse
– Tamponade
– Saignement
• Resultats:
– Critère primaire:
-Reduction significative du risque de 32% (4.9%→3%=) 1
• Conclusion:
- Réduction du risque d’AVC, non infériorité sur le critère primaire
Holmes DR: ACC & i2 Summit 2009
Holmes et al., Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with
AF: a randomized non-inferiority trial, Lancet 2009; 374: 534–42
4. Proof of Concept (2)
PROTECT – AF: Updated Data (Bayesian sequential design)
Primary Safety Results
End Point Device Events Device Rate Control Event Control Rate Relative Risk
(n) (95% CI) (n) (95% CI) (95% CI)
900 pts-yr cohort 48 8.7 (6.4-11.3) 13 4.2 (2.2-6.7) 2.08 (1.18-4.13)
Primary Efficacy Results
End Point Device Events Device Rate Control Event Control Rate Relative Risk
(n) (95% CI) (n) (95% CI) (95% CI)
900 pts-yr cohort 20 3.4 (2.1-5.2) 16 5.0 (2.8-7.6) 0.68 (0.37-1.41)
All Stroke, HS, and IS by Intervention
End Point Device Event Rate (95% CI) Control Event Rate (95% CI) Relative Risk (95% CI)
All Stroke 2.6 (1.5- 4.1) 3.5 (1.7 – 5.7) 0.74 (0.36 – 1.76)
IS 2.4 (1.3 – 3.9) 1.6 (0.5 – 3.1) 1.53 (0.654 – 5.43)
HS 0.2 (0.0-0.6) 1.9 (0.7 – 3.7) 0.09 (0.00 – 0.45)
Holmes, i2 Summit - Protect AF Trial - Intermediate-Term Outcome , J. Am. Coll. Cardiol. 2010;55;A181.E1698
5.
6.
7.
8.
9. Technique
• Procédure de cardiologie interventionnelle
échoguidée par voie veineuse femorale (puis
trans-septal)
• Occlusion par prothèse autoexpendable en
nitinol adapatée à la mesure angio et ETO de
l’auricule
• Vérification par angio et ETO de l’efficacité de
la fermeture
10. Cas clinique M. B
• Homme 71 ans
• ACFA CHADS VASC >2
• Actd AVC Hémorragique 2006
• Actd Pontage aortocoronaire 1995 puis ACT+ Stent
• Fdr Cv: Diabète, Dyslipidémie, Tabac sevré
3 Serious pericardial effusions Pericardial tamponade treated by surgical intervention and device was found to have embolized on TEE at D86 and retrieved in the cath lab from the descending aortaCardiac perforation treated by pericardiocentesisPericardial effusion not intervened, pt died at D22 (NYHA III, CHADS2>5: AF/VT -> LV failure) 3 Device Embolizations (all in first series of cases, prior to retraining)2 – Surgery, pts died after surgery (1: myocardiac failure, post perfusion, 1: retroperitioneal)1 – Snared and new device implanted5 Thrombus:After 30 days1After 66 days 1After 6 months 3
The estimated stroke rate is a per patient calculation wherein each patient serves as his own control; versus the CHADS 2 score (GAGE)Despite the fact that these data are not from a randomized clinical cohort, the relative risk reduction is quite meaningful and consistent with other publications (PLAATO OSTERMAYER-2005, BLOCK,- 2009 and Watchman ASAP – REDDY, HRS, Late Breaking 2012)
