Left Atrial Appendage Closure AnchorageEpitek System SubXiphoidPericardioscopic Approach

Left Atrial Appendage Closure Anchorage/Epitek System Sub-Xiphoid/Pericardioscopic Approach Aaron V. Kaplan, M. D. , F. A. C. C. Professor of Medicine Dartmouth Medical School Director of Research, Cardiac Catheterization Lab Dartmouth-Hitchcock Medical Center Lebanon, NH AV Kaplan MD 1 Left Atrial Appendage Closure

Aaron V. Kaplan, M. D. Conflict-of -Interests • Intellectual Property: Epitek • Founder & Director: Tryton Medical • Research Support: – Abbot Vascular – Medtronic – Boston Scientific – Edwards Lifesciences • Practicing Interventional Cardiologist AV Kaplan MD 2 Left Atrial Appendage Closure

Atrial Fibrillation: A Large Unmet Clinical Need • Large Problem – >2 Million Patients (Domestic) – Increases Risk of Stroke 5 -7 x – Etiology of 10 -15% of all Strokes • Poor Options – Afib Suppression • Drugs Difficult to Take • Devices Therapy Earliest Stages – Stroke Reduction • Coumadin AV Kaplan MD 3 Left Atrial Appendage Closure

Atrial Fibrillation: The Problem is Stroke! “Approximately 35% of persons with Atrial Fibrillation will sustain a stroke with in 10 years” Kannel et al. (The Framingham Study Group) • Stroke Associated – – – AV Kaplan MD Age History of Stroke or Near Stroke (TIA) Hypertension Diabetes LV Dysfunction Rheumatic Valve Disease 4 Left Atrial Appendage Closure

90% of Thrombi in lone AFIB are found in Left Atrial Appendage Lone AFIB TEE Autopsy Surgical Total (%) Appendage Only 158 35 8 201 (91) Valvular AFIB LA 6 12 3 21 (9) TEE Autopsy Surgical Total (%) Appendage Only 30 85 139 254 (57) LA 21 84 87 192 (43) Blackshear & Odell (Mayo) Ann Thor Surg 1996; 61: 755 -9 AV Kaplan MD 5 Left Atrial Appendage Closure

Atrial Fibrillation Clot Stroke LA Atrium Aortic Valve Clot Appendage Transesophageal Echo AV Kaplan MD 6 Left Atrial Appendage Closure

Left Atrial Appendage Closure • Intracardiac • Sub-xiphoid (Epitek) – Watchman – Plato – AGA – Cath Lab – Conscious Sedation – Same Day procedure • Surgical – Removal – Ligation AV Kaplan MD 7 Left Atrial Appendage Closure

The Anchorage Sub-Xiphoid Pericardioscopic Approach AV Kaplan MD 8 Left Atrial Appendage Closure

AV Kaplan MD 9 Left Atrial Appendage Closure

Acute Canine Study AV Kaplan MD 10 Left Atrial Appendage Closure

FIM in Hamburg Prof. Karl-Heinz Kuck AV Kaplan MD 11 Left Atrial Appendage Closure

Next Steps • First In Man Studies – Prof. Karl-Heinz Kuck (Hamburg) – Prof. Vasilis Giulielmos (Greece) • Clinical Development – Expanded Study AV Kaplan MD 12 Left Atrial Appendage Closure

Thank You aaron. v. kaplan@hitchcock. org AV Kaplan MD 13 Left Atrial Appendage Closure