Protection Devices for Stroke Prevention Do the Data support their Routine Use?

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1 ACC 2015 San Diego, March nd, 2015 Protection Devices for Stroke Prevention Do the Data support their Routine Use? Eberhard Grube MD, FACC University Hospital, Dept of Medicine II, Bonn, Germany Stanford University, Palo Alto, California, USA

2 Aortic Atheroma is Common 86 year old male Severe aortic stenosis Porcelain aorta Died 3 hours post-tavr Thoracic and abdominal aorta with iliac bifurcation Roberts WC, et al. Am J Cardiol 2013;111 (3):448

3 Stroke incidence and mortality after TAVI Meta-analysis of 10,037 published patients Stroke remains a major TAVI complication which increases 30-day mortality >3 fold 5

4 Many Strokes Occur Periprocedurally P. Kahlert et al, Circulation 2012;126:

5 Procedural Stroke Factors Presence and location of arch atheroma Micro-embolization of calcification and thrombus on valve Catheter handling and device placement technique Secondary manoeuvers Procedural duration Optimal anti-coagulation and antiaggregation Arrhythmia management

6 DW-MRI Imaging of Silent Lesions Following TAVR Can these really all be benign?

7 Second Generation Repositionable TAVR Devices Still Require Finesse All patients were assessed by a neurologist before and after TAVR 11

8 Under Reporting Remains an Issue & is Even Seen in Surgical AVR Messé SR, Acker MA, Kasner SE, et al. Stroke after aortic valve surgery: results from a prospective cohort. Circulation. 2014;Epub ahead of print 12

9 CE-marked cerebral protection devices TriGuard Cerebral Protection Device Edwards Embrella Embolic Deflector Claret Sentinel Cerebral Protection System Deflector Deflector Filter capture 9F (femoral) 6F (radial) 6F (radial) 240 micron pore size 100 micron pore size 140 micron pore size Aortic arch position Aortic arch position Brachiocephalic and LCC CE marked CE marked CE marked and commercialized

10 Conclusions Tri-Guard Embolic Deflection with the TriGuard TM during TAVR is feasible and safe (no TriGuard device related events) performed as intended in 80% of cases with complete coverage of all 3 cerebral vessels until completion of TAVR deployment DW-MRI showed that the TriGuard TM vs. historic controls Does not reduce frequency or number of new ischemic lesions (78% vs 76%) Reduces the average lesion volume (by 65%) and the total lesion volume ( by 57%) Neurocognitive assessment by MoCA in DEFLECT I showed Significant improvement in NC function after TAVI and at 30 days Cognitive impairment correlated with number of new lesions and total lesion volume

11 Claret Sentinel Cerebral Protection System (CPS) The only dual, independent filter (proximal and distal) embolic protection device with visible embolic capture The 3rd generation of the first commercially available CE Marked embolic protection device Universal size and shape Deflectable compounded curve sheath to facilitate cannulation of LCC Easy to use ergonomically designed handle 16 CAUTION: Investigational device. Limited to investigational use by U.S. law

12 Embolic Debris Captured & Retrieved During TAVR Procedures Using Claret Technology

13 Debris captured by Claret Cerebral Protection Systems in various transcatheter valve patient studies Type of Procedure, Center, Valves # of patients in series Any debris Acute Thrombus Organizing Thrombus Tissue Calcification Foreign Material TAVR 1 Rotterdam - a variety of valves TAVR 2 Hamburg - a variety of valves TAVR 3 Hamburg - using Sapien 3 TMVR 4 Aachen, Hamburg - using MitraClip n=40 75% 33% 20% 52% 20% 13% n=30 100% 90% 87% 40% 20% n=10 100% 50% 20% 40% 30% 0% n=10 100% 80% 20% 70% 0% 90% Note: Percentages reflect percent of patients in the series in which each particular tissue type was captured. Some filters captured several types of debris, so percentages will not add to 100% Van Mieghem NM, et al. Circulation 2013 Jun 4; 127(22): Schäfer U, et al., presented at DGK St. Georg Hospital. CVPath report on file at Claret Medical 4. CVPath report on file at Claret Medical

14 20 The first RCT of cerebral embolic protection in TAVI was presented in the opening session of TCT 14 late-breaking clinical trials

15 CLEAN-TAVI shows positive outcome Claret Montage Cerebral Protection System significantly reduces new cerebral lesion number and volume at 2 & 7 days, as measured by DW-MRI. 21

16 Embolic Lesion Burden of 78 Cases with Scans at all Time Points in Clean-TAVI Study Baseline FLAIR Scan 2-Day DWI Scan 7-Day DWI Scan 30-Day FLAIR Scan

17 CLEAN-TAVI sets the stage for SENTINEL study SENTINEL is a US multi-center randomized trial of the Claret Sentinel TM Cerebral Protection System in TAVR. 23

18 Sentinel IDE Study Study Sites Study Site Columbia University Medical Center Cleveland Clinic Morton Plant Hospital Emory University Hospital University of Texas Health Science Center Hospital of the University of Pennsylvania Washington Hospital Center Cedars-Sinai Health Systems Henry Ford Heart and Vascular Institute University of Washington Medical Center NY Presbyterian - Weill Cornell Medical Center University of Virginia Medical Center Barnes Jewish Hospital/Washington University Mount Sinai Principal Investigator Susheel Kodali, MD (Study Co-PI) Samir Kapadia, MD (Study Co-PI) Joshua Rovin, MD Vinod Thourani, MD Richard Smalling, MD Joseph Bavaria, MD Gus Pichard, MD Raj Makkar, MD Mayra Guerrero, MD Mark Reisman, MD S. Chiu Wong, MD D. Scott Lim, MD Alan Zajarias, MD Samir Sharma, MD 24

19 Devices Are Shown to be Effective in Extracting Debris So why would you NOT use them routinely? Van Mieghem et al, Circulation 2013;127: Debris analysis by Dr. Renu Virmani, CVPath Institute of Histopathology

20 My Conclusion Devices are Improving Procedural Techniques are improving Patient Selection is Improving Adjunctive Pharma Therapy is improving BUT: Embolic Stroke still remains an issue in TAVR is truly devastating and only poorly described by percentages!!! Cerebral Protection should become Standard of Care