Appendage Closure. Jason Rogers, MD. Director, Interventional Cardiology UC Davis Medical Center Sacramento, California

Transcription

1 Appendage Closure Jason Rogers, MD Director, Interventional Cardiology UC Davis Medical Center Sacramento, California

2 Left Atrium: Atrial Fibrillation Left Atrial Appendage Left Atrium

3 Incidence of Atrial Fibrillation Increases with Age Adapted from Feinberg WM. Arch Intern Med. 1995;155:469-43

4 Left Atrial Appendage

5 Courtesy Mark Reisman MD

6 Cardioembolic Stroke

7 >90% of strokes in AF are caused by LAA Thrombi Thrombus in the LAA 1 Blackshear JL. Odell JA., Annals of Thoracic Surgery. 1996;61:

8 Major Bleeding Rates With Newer Anticoagulants Study Treatment Major Bleeding Hemorrhagic Stroke Dabigatran (110 mg) 2.71% 0.12% RE-LY 1 Dabigatran (150 mg) 3.11% 0.10% Warfarin 3.36% 0.38% ROCKET-AF 2 Rivaroxaban 3.6% 0.5% Warfarin 3.4% 0.7% ARISTOTLE 3 Apixaban 2.13% 0.24% Warfarin 3.09% 0.47% 1. Connelly SJ et al, NEJM 2009;361: Patel MR et al, NEJM 2011;365: Granger J. et al, NEJM 2011;365:981-92

9 Percutaneous LAA Occlusion Devices Watchman Cardiac Plug LARIAT

10 WATCHMAN Device Anchors 160 Micron Membrane Nitinol Frame Radially expands to maintain position in LAA Available sizes: 21, 24, 27, 30, 33 mm (diameter) 10 Active fixation anchors around device perimeter engage LAA tissue for stability and retention Contour shape accommodates most LAA anatomies 160 Micron Membrane Polyethyl terephthalate (PET) cap Blocks emboli from exiting the LAA Promotes healing process

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12 Case 71 year old Chronic atrial fibrillation h/o lung cancer Recurrent nosebleeds CHADS 2 = 3 CHA 2 DS 2 Vasc = 5

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22 PROTECT AF Trial 707 coumadin-eligible patients (CHADS2 1) randomized 2:1 device vs. warfarin Efficacy: CVA, CV Death, Systemic Embolism Safety: Bleeding, Procedure Complications Holmes DR et al. Lancet.2009;374:534 42

23 PROTECT-AF: Patient Demographics Adapted from HRS LBCT 2013 by Dr. Vivek Reddy SH AB- MAY 2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

24 PROTECT-AF: Patient Demographics Adapted from HRS LBCT 2013 by Dr. Vivek Reddy SH AB- MAY 2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

25 PROTECT-AF: Primary Efficacy Endpoint Adapted from HRS LBCT 2013 by Dr. Vivek Reddy SH AB- MAY 2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

26 PROTECT-AF: Primary Efficacy Endpoint Adapted from HRS LBCT 2013 by Dr. Vivek Reddy SH AB- MAY 2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

27 PROTECT-AF: Primary Efficacy Endpoint Adapted from HRS LBCT 2013 by Dr. Vivek Reddy SH AB- MAY 2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

28 PROTECT-AF: Primary Efficacy Endpoint Adapted from HRS LBCT 2013 by Dr. Vivek Reddy SH AB- MAY 2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

29 Intention-to-Treat: All-Cause Mortality Hazard Ratio with Watchman, 0.66 (95% CI, ) P = Adapted from HRS LBCT 2013 by Dr. Vivek Reddy SH AB- MAY 2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

30 PROTECT AF: Primary Safety Endpoint Adapted from HRS LBCT 2013 by Dr. Vivek Reddy SH AB- MAY 2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

31 Pericardial Effusions Requiring Intervention % of Patients 4.0% 3.0% 2.0% 1.0% 0.0% 1.6% n=7 p = P = % n=1 0.4% n=1 Cardiac perforation requiring surgical repair 2.4% PROTECT AF CAP PREVAIL 1.2% 1.5% n=11 n=7 n=4 Pericardial effusion with cardiac tamponade requiring pericardiocentesis or window Adapted from a presentation by David R. Holmes, Jr., M.D. SH AA MAR2013 PROTECT-AF and CAP data from Reddy VY et al. Circulation. 2011;123: Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

32 Stroke and Device Embolization % of Patients % of Patients 3.0% 2.0% 1.0% 0.0% 2.0% 1.0% 0.0% *1 additional device embolization was reported at 45 days PROTECT-AF and CAP data from Reddy VY et al. Circulation. 2011;123: % n=5 0.0% 0.4% n=0 n=1 Procedure/Device Related Strokes PROTECT AF CAP PREVAIL 0.4% 0.2% 0.8% n=2* n=1 n=2 Device Embolizations PROTECT AF CAP PREVAIL p = p = Procedure related strokes were reduced Device embolizations remained low Adapted from a presentation by David R. Holmes, Jr., M.D. SH AA MAR2013 Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

33 LARIAT LAA Closure Coumadin Ineligible Subjects

34 Case 81 year old Chronic atrial fibrillation h/o UGI Bleed HASBLED=9.1% yearly risk of bleeding CHADS 2 =4 CHA 2 DS 2 Vasc=6

35 LAA Baseline

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45 LA Appendage Appearance Baseline 6 week Follow Up

46 Lariat PLACE Study Permanent Ligation Approximation Closure and Exclusion Single center, non-randomized study 85 patients underwent closure of their left atrial appendage Follow up was 1 day, 30 days, 90 days and 1 year with transesophageal echocardiography Intent-to-Treat 85/89 (96%) Adverse Events (defined as access related or device failure) Closure (defined as < 1mm residual flow) 3/89 (3.3%)** Access 3/89 (3.3%) Device 0/89 (0.0%) 1 day 81/85 (95%) 30 day 81/85 (95%) 90 day 77/81 (95%) 1 year 65/66 (98%) * Bartus, Krzysztof, et al. Percutaneous Left Atrial Appendage Suture Ligation Using the LARIAT in Patients with Atrial Fibrillation: Initial Clinical Experience. J Am Coll Cardiol. ** All non-serious: 2 pericardial access related. 1 transseptal access related.

47 Thank You