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Eric Van Belle MD-PhD, Nicolas Debry MD et al. Heart Institute

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1 Silent cerebral microbleeds during TAVR: Insight from a prospective study
Eric Van Belle MD-PhD, Nicolas Debry MD et al. Heart Institute CHRU Lille, France

2 Disclosures : no disclosures
Eric Van Belle MD-PhD Nicolas Debry MD Heart and Lung Institute, Lille, France

3 Cerebral microbleeds (CMB)
Extravasations of blood components through fragile cerebral microvascular walls Markers of risk of stroke, dementia and cognitive impairment Endovascular procedures ? Greenberg SM, Vernooij MW, Cordonnier C, Viswanathan A, Al-Shahi Salman R, Warach S, et al. Cerebral microbleeds: a guide to detection and interpretation. Lancet Neurol Feb;8(2):165–74.

4 Silent cerebral emboli
TAVR Stroke Silent cerebral emboli ≈65% Long-term cognitive performance preserved 3-5% x 3,5-10 mortality Van Belle E, Hengstenberg C, Lefevre T, Kupatt C, Debry N, Husser O, et al. Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study. J Am Coll Cardiol

5 TAVR Acute changes of haemostasis parameters
Correction of the acquired von Willebrand disease -Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, et al. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 -Van Belle E, Rauch A, Vincent F, Robin E, Kibler M, Labreuche J, et al. Von Willebrand Factor Multimers during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2016

6 Cerebral microbleeds (CMB)
Incidence ? Outcomes ? (VARC-2) Neurological trajectory ? Mortality ?

7 Methods 1 2 3 4 5 6 7 Patients referred for TAVR procedure
Pre-procedural cerebral MRI : cerebral microbleeds ? 3 Neurological assessment (baseline): NIHSS score, modified Rankin score, EQ-5D scale, MMSE score Analysis of High Molecular Weight(HMW)-multimers of VWF TAVR procedure 4 Post-procedural cerebral MRI : new cerebral microbleeds ? 5 Intrahospital outcomes : VARC-2 criteria 6 Neurological assessment (6 months): NIHSS score, modified Rankin score, EQ-5D scale, MMSE score, QVFS questionnaire 7 Mid-term survival at 12 months

8 Methods Primary endpoint : appearance and incidence of new cerebral microbleeds on the post-procedural cerebral MRI. Secondary endpoints : presence of microbleed on the preprocedural MRI and cerebral emboli (CE) at preprocedural or post-procedural MRI. Analyses : Identification of predictive factors of primary and secondary endpoints. Evaluation of their impact on early outcomes VARC-2 Impact on the neurological functions examined at 6 months Impact on the global mortality at 1 year follow-up.

9 Methods Patients referred for TAVR procedure
n= 90 patients consented and were enrolled in the study Neurological assessment (preprocedural) NIHSS score, modified Rankin score, EQ-5D scale, MMSE score n = 84 had both MRI and were included in the analysis Preprocedural cerebral MRI n= 22 (26%) patients with at least one CMB; n= 5 (5%) patients with at least one infarct TAVR procedure Postprocedural cerebral MRI n= 19 (23%) patients with at least one new CMB; n= 54 (64%) patients with at least one new infarct Intrahospital outcomes : VARC-2 criteria n= 5 (5% ) intrahospital clinical TIA/strokes Neurological assessment (6 months post TAVR) n= 75 (89%) had a neurological assessment (n= 9 were dead before) Mid-term survival at 1 year n= 73 (86%) were evaluated (n= 11 were dead before)

10 Results: baseline

11 Results: procedure and outcomes

12 Results: predictive factors of CMB
a prolonged procedure(RR=1.21 [ ] for every increased 5 min of fluoroscopy time, p=0.04) post-procedural acquired-VWD(RR 1.42 [ ] for every lower “0.1 unit” of the HMW-multimer-ratio, p=0.004) were associated with the occurrence of new post-procedural microbleed(s).

13 Results: neurological exam

14 Conclusions Occurrence of new microbleeds as measured 3 days after the procedure is high (≈20%) Presence of microbleeds as detected after the procedure is impacting the 6-month neurological outcome Procedural management and persistence of acquired-VWD are predictors of the occurrence of microbleeds. Importance of preprocedural Cerebral MRI: 6% of patients had at least one cerebral emboli

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