Embolic Protection Devices for Transcatheter Aortic Valve Replacement
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1 Embolic Protection Devices for Transcatheter Aortic Valve Replacement James M. McCabe, MD Medical Director, Cardiac Cath Lab University of Washington Seattle, WA
2 Disclosures Proctoring and honoraria for Edwards LifeSciences and Medtronic Valve Programs
3 Explanted Porcelain Aorta
4 Risk of Stroke TAVR vs SAVR Smith CR, et al. N Engl J Med. 2011;364: PARTNER 1 trial reported a nearly two- fold increase in the incidence of TIA and stroke associated with TAVR compared to standard surgical aortic valve replacement (SAVR)
5 Reported Stroke Rates following TAVR 6.00% 5.00% 4.00% * 3.00% 2.00% 1.00% 0.00% Smith et al. N Engl J Med. 2011;364: Eggebrecht et al. EuroIntervention. 2012;8: Adams et al. N Engl J Med. 2014;370: Linke et al. J Am Col Cardiol. 2012;59:E8. Di Mario et al. EuroIntervention. 2013;8: Holmes et al. JAMA. 2015;313: * 1 year rates
6 Percent of Patients with new ischemic lesion on DWI- MRI Daneault et al, JACC 2011;58:
7 Clinically overt stroke increases 30 day mortality following TAVR by 350% 30.00% 30 Day Mortality 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% All Patients Patients with Stroke Patients Without Stroke Eggebrecht et al. EuroIntervention. 15;8(1):129-38
8 No significant change in cognitive function pre vs post TAVR Kahlert P, et al, Circulation. 2010;121:870 8.
9 1015 patients years old Neuropsychological testing and MRI at base line in 1995 to 1996 and again in 1999 to 2000 Mean follow up 3.6 years Silent brain infarcts at base line more than doubled the risk of dementia (hazard ratio, 2.26; 95 percent confidence interval, 1.09 to 4.70).
10 Microinfarcts increase the risk of dementia by >200% Smith et al., Lancet Neurol 2012
11 Highest Risk of Stroke in TAVR is Peri- procedural Timing of Cerebrovascular Events (CVE) in FRANCE- 2 Registry (n=3,191) Tchétché et al. J Am Coll Cardiol Intv 2014; 7(10)
12 CerebroEmbolic Material Origins Following TAVR 100% 90% Cerebral embolic debris captured in TAVI patients (n=81) 80% 70% 60% 50% 40% 30% 20% 10% 0% Any debris Acute or organizing thrombus Valve leaflet Endothelium Undetermined collagenous Myocardium Foreign material Van Mieghem NM, et al. J Am Coll Cardiol Intv 2015;8:718-24
13 Valvular Calcification 13% of Surgically removed Aortic valves demonstrate mature lamellar bone with hematopoietic elements and active bone remodeling Emile R. Mohler III et al. Circulation. 2001;103:
14 Embolic Protection Technology Concepts
15 Cerebral Embolic Protection Claret Sentinel Cerebral Protection System Devices Edwards Embrella Embolic Deflector Filter capture Deflector Deflector TriGuard Cerebral Protection Device 6F (radial) 6F (radial) 9F (femoral) 140 micron pore size 100 micron pore size 130 x 250 micron pore size Brachiocephalic and LCC Aortic arch position Aortic arch position CE marked and commercialized CE marked CE marked
16 Aims: To compare the extent of cerebral ischemic injury after transcatheter aortic valve replacement (TAVR) with the use of an Embrella Embolic Deflector System versus unprotected TAVR. Study Design: 15 pts w/ severe AS underwent TAVR with use of the Embrella Embolic Deflector System for cerebral protection. Cerebral diffusion- weighted magnetic resonance imaging (DWI) was performed on day 4 after the procedure Images were retrospectively compared to 37 patients who had undergone TAVR without protection.
17 Edwards Embrella Embolic Deflector
18 Embrella Trial More new lesions in the Embrella group Mean lesion volume per patient tended to be smaller
19 TriGuard Deflector
20 Study Design: Prospective, multi- center, single- blind, randomized controlled trial ( ) 85 pts (randomized 1:1) undergoing TAVI at 13 sites in Europe and neurologic and cognitive evaluation at baseline, pre- discharge and 30 days; Cerebral DW- MRI performed pre- TAVI, 2 days post- TAVI and at 30 days.
21 TriGuard Safety Outcomes MACCE
22 TriGuard vs Non- protected Controls Freedom From Ischemic Brain Lesions
23 Neuro- cognitive outcomes TriGuard Vs Control
24 Claret Embolic Protection Device
25 Sentinel CPS - Dual filters Proximal Filter (Innominate Artery) mm Distal Filter (Left Common Carotid Artery) mm CAUTION: Investigational d evice. Limited to investigational u se b y United States law.
26 Case: 77 yo male with past medical history known AS presents w/ worsening functional status, c/o severe DOE, NYHA III symptoms. Past medical History: CAD, w/ prior NSTEMI Afib PVD Severe COPD (FEV1 37%, DLCO 31% predicted) Esophageal stricture
27 TTE Global reduced systolic function, LVEF 42%. No regional WMA Aortic Stenosis Jet Velocity 3.4 m/s Mean gradient 30 mmhg Calculated AVA 0.7 cm2 Mild AR Mild MR
28 The patient was felt to be high risk for surgical aortic valve replacement (STS 11.7%) Approved to undergo percutaneous aortic valve implantation Edwards Sapien S3 valve via the transfemoral approach.
29 3D reconstruction of the aorta and great vessels
30 CT - Aortic valve annulus
31 CT Aortic Root
32
33 Successful TAVR via a left transfemoral percutaneous approach with a 26mm Sapien S3 valve - No clinically evident neurological sequela Hemodynamics: Baseline Left ventricular pressure: 135/29 mmhg Aortic pressure: 119/65/84 mmhg Right atrial pressure: 10 mmhg PA pressure: 48/26/35 mmhg Cardiac Output: 3.5 L/min Mean aortic valve gradient: 37 mmhg Aortic Valve Area: 0.46 cm^2 Hemodynamics: Post- Valve Insertion Left ventricular pressure: 139/31 mmhg Aortic pressure: 141/66/91 mmhg Right atrial pressure: 12 mmhg PA pressure: 58/28/42 mmhg Cardiac Output: 3.8 L/min Mean aortic valve gradient: 6 mmhg Aortic Valve Area: >2 cm^2
34
35 This Patient s Post- Procedure MRI Multiple punctate foci of restricted diffusion involving the bilateral frontal lobes, right parieto- occiptal lobes and left occipital lobes. Triangular area of restricted diffusion within the left cerebellar hemisphere, measuring approx 11 x 5 mm Findings are compatible with acute ischemia of embolic etiology
36 Conclusions Rates of clinically significant stroke following TAVR have improved but remain highly mortal Silent infarcts appear to be ubiquitous and may play a role in long- term disability Embolic protection devices may help reduce the number and size of peri- procedural infarcts but require further study.
37 Thank you Jamie McCabe
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