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Subacute Subclinical Brain Infarctions after Transcatheter

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1 Subacute Subclinical Brain Infarctions after Transcatheter
Aortic Valve Implantation negatively impact Cognitive Function in Long-Term Follow-up Alexander Ghanem1,2,*, Jonas Dörner3,4,*, Leonie Schulze-Hagen2, Andreas Müller4, Marius Wilsing2, Jan-Malte Sinning2, Julian Luetkens4, Christian Frerker1, Karl-Heinz Kuck1, Hans Schild4, Nikos Werner2, Eberhard Grube2, Georg Nickenig2 1 Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany 2 Department of Cardiology, University Hospital Bonn, Germany 3 Department of Radiology, University Hospital Cologne, Germany 4 Department of Radiology, University Hospital Bonn, Germany

2 Background Incidence TAVI: AV-passage: “Silent“: 68-84 % 22 %
Pre Post Follow-up Incidence TAVI: AV-passage: “Silent“: 68-84 % 22 % Apparent : 3-10 % 3 % Ghanem et al., J Am Coll Cardiol. 2010; 55(14):

3 Outcomes Shades of Cerebral Injury disabling apparent subtle silent
Clinical Parameters Surrogate Parameters disabling 2-4% apparent 3-10% subtle 10% silent 68-84% subclinical ≈50% VARC Endpoints No VARC Endpoints Ghanem et al., Expert Rev Cardiovasc Ther ;11(10): , Ghanem et al., Curr Pharm Des 2016 (in press)

4 Prognostic value of SBIs
„Elderly people with silent brain infarcts have an increased risk of dementia and a steeper decline in cognitive function than those without such lesions.“ Vermeer et al., NEJM 2005

5 SBI - Matching Prior TAVI 3 days 3 months after TAVI
Ghanem et al., J Am Coll Cardiol. 2010; 55(14):

6 Prognostic value of DWI-CVEs
120 120 100 80 60 40 RBANS Total score RBANS Total score 100 80 60 40 E1 E2 E3 No DW-MRI Cerebral embolism in DWI No cerebral embolism in DWI E4 E5 E1 E2 E3 E4 E5 Ghanem et al., Circulation Cardiovascular Intervention, 2013

7 Endpoints Primary Secondary
Number & Volume of FLAIR-positive SBI in MRI > 2 years after TAVI Secondary DWI- / FLAIR-matched , “procedural“ SBIs DWI- / FLAIR-mismatched, “new“ SBIs Progression of total white matter hyperintensities (WMH-volume > +1,5% /y) Progression of cerebral atrophy (TBV > - 1% /a) Functional outcome (MMSE)

8 Baseline Data Atrial fibrillation or flutter, n (%) CHADS2-Score ±SD
8 (29) 2.5 ± 1.2 7 (25) 10 (36) 14 (50) 4 (14) 1 (4) Prior stroke or TIA, n (%) Baseline Data PVD, n (%) Coronary artery disease, n (%) Prior myocarial infarction, n (%) Prior PCI, n (%) Prior CABG, n (%) Clinical BL Procedural characteristics Procedure time, min ±SD Direct TAVI without predilatation, n (%) Corevalve 23/26/29/31 mm, n Edwards-Sapien 23/26 mm, n Symetis 23 mm, n Post-dilatation, n (%) Rapid pacing runs, n (%) 98 ± 54 8 (29) 0/9/12/2 2 /1 2 7(25) 1.1 ±1.0 N Age, years ±SD Male, n (%) Body mass index, kg/m2 ±SD Log EuroSCORE, % ±SD STS score: mortality, % ±SD STS score: permanent stroke, % ±SD Peak-to-peak gradient, mmHg ±SD Ejection fraction, % ±SD NYHA class ±SD Minimental state examination BL Minimental state examination FU2 28 80 ±6 14 (50) 25.6 ±5.0 24.1 ±17.9 7.5 ±6.9 3.0 ±1.8 48 ±22 49 ±15 3 ±1 26.6 ±2.8 26.7 ±3.6 Post-procedural FU 1 SIRS, n (%) Minor bleeding, n (%) Major bleeding, n (%) Stroke, n (%) 8 (29) 10 (36) 1 (4) 0 (0) 17 (61) Comorbidities Evidence of embolic events in DW-MRI, n(%) Hypertension, n (%) Diabetes, n (%) Smoking, n (%) Dyslipidemia, n (%) Creatinine, mg/dl ±SD Glomerular fibrilation rate, ml/min ±SD Hemodialysis, n (%) Atrial fibrillation or flutter, n (%) CHADS2-Score ±SD Prior stroke or TIA, n (%) PVD, n (%) Coronary artery disease, n (%) Prior myocarial infarction, n (%) Prior PCI, n (%) Prior CABG, n (%) 26 (93) 4 (14) 6 (21) 17 (61) 1.2 ± 0.4 55 ± 9 0 (0) 8 (29) 2.5 ± 1.2 7 (25) 10 (36) 14 (50) 1 (4) FU 2 Acetylsalicylic acid, n (%) Clopidogrel hydrogen sulphate, n (%) Beta-blocker, n (%) Statin, n (%) AT1 antagonist, n (%) ACE inibitor, n (%) Diuretics, n (%) 21 (75) 3 (11) 24 (86) 17 (61) 9 (32) 14 (50) 22 (79) Procedural characteristics Procedure time, min ±SD Direct TAVI without predilatation, n (%) 98 ± 54 8 (29)

9 Protocol MMSE 30DAYS 36MONTHS CVE RISK TAVI TIME
Acute Subacute Late Cerebrovascular Events (CVEs) TAVI TAVI-related Procedural embolisation NOAF Valve Thrombosis Spontaneous - Age, Comorbidities 1 30DAYS 6 12 24 36MONTHS TIME MMSE Ghanem et al., Expert Rev Cardiovasc Ther ;11(10):

10 “Biological Event Recorder“

11 “Biological Event Recorder“
“Prospective“ mismatch = No Remodeling Match = Remodeling “Retrospective“ mismatch = Non-procedural Event

12 BL FU1 FU2 DWI FLAIR TAVI FU 61 (1- 14) 14 (1-3) 32 (1-5) N=28 3d
N=11 N=17 FU2 N=28 FU 3y DWI 61 (1- 14) CVEs N=18 N=10 N=11 N=17 14 (1-3) FLAIR 32 (1-5) SBIs

13 BL FU1 FU2 DWI FLAIR TAVI FU 61 (1- 14) 14 (1-3) N=28 3d N=11 N=17
3y DWI 61 (1- 14) CVEs N=18 N=10 N=11 N=10 14 (1-3) FLAIR SBIs Patients with „new“ SBIs 5 2

14 BL FU1 FU2 DWI FLAIR TAVI FU 61 (1- 14) 14 (1-3) N=28 3d N=11 N=17
3y DWI 61 (1- 14) CVEs N=18 N=10 N=11 N=5 6 +0 14 (1-3) FLAIR 3 5 +4 SBIs + „new“ SBIs w/o DWI-Match DWI-Match 2 5 2

15 BL FU1 FU2 DWI FLAIR TAVI FU 61 (1- 14) 14 (1-3) N=28 3d N=11 N=17
3y DWI 61 (1- 14) CVEs N=18 N=10 N=11 N=5 6 +0 14 (1-3) FLAIR 3 5 +4 SBIs + „new“ SBIs w/o DWI-Match DWI-Match 2 0 +6 5 2

16 BL FU1 FU2 DWI FLAIR TAVI FU 61 (1- 14) 14 (1-3) N=28 3d N=11 N=17
3y DWI 61 (1- 14) CVEs N=18 N=10 N=11 N=5 6 +0 14 (1-3) FLAIR 3 5 +4 SBIs Without Remnnants in 1.5T-MRI + „new“ SBIs w/o DWI-Match DWI-Match 2 0 +6 5 2

17 Σ DWI 0 0 61 (1- 0 FLAIR (1-3) 0 5 +4 3 14 6 +0 N=28 N=11 N=17 N=28 BL
TAVI FU1 FU2 FU N=28 N=11 N=17 N=28 DWI (1- 0 CVEs 14) N=18 N=10 N=11 N=5 FLAIR (1-3) SBIs 0 Without + „new“ SBIs Remnnants w/o DWI-Match in 1.5T-MRI DWI-Match 5 2 3d 3y Σ 1.4 SBIs / SBI-Patient 1.06 “new“ SBI / SBI-Patient 0.5 SBIs / Patient 0.64 “new“ SBIs / Patient

18 Quantification WMH / TBV
WMH (ml) 1.500 TBV (ml) 40 1.400 1.300 30 1.200 20 1.100 1.000 10 900 800 BL FU2 BL FU2 Patients without DWI-Match Patients with DWI-Match

19 CVEs & cognitive function

20 vs. Risk vs. Fate 30DAYS 36MONTHS CVE RISK TAVI TIME
Acute Subacute Late Cerebrovascular Events (CVEs) TAVI TAVI-related - Procedural embolisation Spontaneous - Age, Comorbidities 1 30DAYS 6 12 24 36MONTHS TIME vs. Ghanem et al., Expert Rev Cardiovasc Ther ;11(10):

21 vXs. Risk vs. Fate 30DAYS 36MONTHS CVE RISK TAVI TIME
Acute Subacute Late Cerebrovascular Events (CVEs) TAVI TAVI-related - Procedural embolisation Spontaneous - Age, Comorbidities 1 30DAYS 6 12 24 36MONTHS TIME vXs. Ghanem et al., Expert Rev Cardiovasc Ther ;11(10):

22 & Risk & Fate 30DAYS 36MONTHS CVE RISK TAVI TIME
Acute Subacute Late Cerebrovascular Events (CVEs) TAVI TAVI-related Procedural embolisation NOAF Valve Thrombosis Spontaneous - Age, Comorbidities 1 30DAYS 6 12 24 36MONTHS TIME & Ghanem et al., Expert Rev Cardiovasc Ther ;11(10):

23 & Risk & Fate 30DAYS 36MONTHS CVE RISK TAVI TIME
Acute Subacute Late Cerebrovascular Events (CVEs) TAVI-relate Procedur NOAF Valve Thro TAVI d al embolisation mbosis Spontaneous - Age, Comorbidities 1 30DAYS 6 12 24 36MONTHS TIME & Ghanem et al., Expert Rev Cardiovasc Ther ;11(10): Pache et al., EHJ 2014

24 Non-procedural FLAIR:
Hypothesis Procedural DWI: 4 out of 61 Procedural FLAIR: 4 out of 18 x 3,5 Non-procedural FLAIR: 4 out of 61 x 15 Non-procedural DWI

25 Results & Conclusions Only a fraction of the cumulated embolic burden in long-term perspective has a procedural origin.  Hence, the impact of anti-thrombotic and/or anti- coagulant protocol on cerebral remodeling after TAVI is of utmost interest. FLAIR-, but not DWI- events impact cognitive function negatively.  Therefore, we need to understand which procedural DWI-events are high-risk for morphological remodeling and later functional impairment.

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