Watchman Implantation Case Presentation and Discussion

Transcription

1 Watchman Implantation Case Presentation and Discussion Walid Saliba, MD, FHRS Director Atrial Fibrillation Center Co-Director AF Stroke Prevention Center Cleveland Clinic

2 Indication FDA NonValvular AF CHADSVASC 2 Recommended for OAC Suitable for warfarin Appropriate rationale to seek non-drug alternative CMS High CHADSVASC 3 Suitable for short-term warfarin Unable to take long-term oral anticoagulation Shared decision interaction with an independent non-interventional physician

3 Case 1 60 yo woman Symptomatic Persistent AF with breakthrough on dofetilide CHADSVASC=3 for HTN, DM, Gender Intracranial Bleeding on rivaroxaban MRI revealed Cavernous malformation not amenable to surgical removal

4 Options Insurance denied Watchman implantation Options Switch to warfarin and aim for lower INRs Switch to another NOAC such as apixaban Ablate AF so she will not need anticoagulation

5 Later Appealed insurance decision Now What should we do?? Ablate AF and if she has recurrence consider Watchman Implant Watchman then Ablate 6 weeks later or Ablate AF and Implant Watchman at a later date AF ablation + Watchman implant in same setting

6 Concomitant Procedure: Compression or Hybrid Strategy AF ablation followed by Watchman implantation Decreased Risk overall and compress time periods on anticoagulation. AF free for one year on no medications and now on aspirin

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8 What is the risk of short term anticoagulation?

9 Patients Excluded from Studies Initial Experience With High-Risk Patients Excluded From Clinical Trials: Safety of Short-Term Anticoagulation After Left Atrial Appendage Closure Device. Barakat AF 1, Hussein AA 1, Saliba WI 1, Bassiouny M 1, Tarakji K 1, Kanj M 1, Jaber W 1, Rodriguez LL 1, Grimm R 1, Hussain MS 1, Russman A 1, Uchino K 1, Wisco D 1, Rasmussen P 1, Bain M 1, Vargo J 1, Zuccaro G 1, Gottesman D 1, Lindsay BD 1, Wazni OM 2. The primary outcome was spontaneous major bleeding while receiving short-term peri-procedural OAC. Circ Arrhythm Electrophysiol. 2016;9

10 Baseline Characteristics None of the patients had spontaneous major bleeding during the course of OAC after device implantation Initial Experience With High-Risk Patients Excluded From Clinical Trials: Safety of Short-Term Anticoagulation After Left

11 % without Thrombosis % Alive % without GI Bleed Warfarin therapy resumption after the index GIB was associated with a lower adjusted risk for thrombosis and death without significantly increasing the risk for recurrent GIB Arch Intern Med. 2012;172(19):

12 2415 pts with AF and ICH 1325 hemorrhagic stroke / 1090 secondary to trauma Mean age: 77.1 years; Men: 61.3%. Resuming vs. Not resuming warfarin Hemorrhagic Stroke Ischemic Stroke 0.49 ( ) Recurrent ICH 1.31 ( ) Mortality 0.51 ( ) Traumatic ICH 0.40 ( ) 0.45 ( ) 0.35 ( ) Adjusted HR (95% CI) JAMA Intern Med. Published online February 20, 2017

13 Combined Procedure

14 Combined ablation and Watchman Implant 98 patients with ablation followed by implant Complete occlusion at 12 months: 86% Device compression and position No recurrence of AF in 77% All patients discontinued OAC One stroke over 802±439 days (0.5%/yr) Journal of Arrhythmia 32 (2016)

15 62 patients (CHADS2 2.5) LAAO : complete acute closure in all. Successful sealing at f/u: 95% Discontinue OAC : 78% AF recurrence: 42%. Long-term f/u: 3 ischemic strokes (annual stroke risk of 1.7%)

16 Hybrid Approach: PVI+ LAAC Advantages Shorten Bleeding risk Lower cost Lower risk (TSP, access)?lower AF Disadvantages Reimbursement LAA access for ablation Clot in LAA post ablation Sizing? Sequence? Stability edema, scar, fluid load

17 Ostial size assessment Pre ablation Mostly unchanged. 31/98: different ostial dimensions 50% smaller dimensions (2-8 mm) 50% larger dimensions (1-3 mm) Post ablation

18 Hybrid Approach: PVI+ LAAC Advantages Shorten Bleeding risk Lower cost Lower risk (TSP, access)?lower AF Disadvantages Reimbursement LAA access for ablation Clot in LAA post ablation Sizing? Sequence? Stability edema, scar, fluid load

19 Device embolization Pre and post ablation sizing similar Compression 8-20% JCE; 2017

20 Case 2 The Lazy LAA 90 yo man persistent AF s/p two prior ablations most recent one with LAA isolation Now with paroxysmal atypical atrial flutter currently on amiodarone/warfarin Complicated with recurrent left atrial appendage thrombi with TIA in sinus rhythm

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23 Questions LAA closure?? Anticoagulation Ablation only

24 After Anticoagulation for 2 months

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27 Case 3: PFO and Stroke 74 yo man H/O stroke and recurrent TIA, DM, HTN No AF reported At another hospital PFO detected and closed? h/o DVT and filter 2 months later symptomatic PAF with post conversion pauses Started on Coumadin and PPM implanted Recurrent GI bleeding on Coumadin and NOAC

28 Access Issues

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31 Interatrial Amplatzer Device

32 Interatrial Amplatzer Device

33 Interatrial Amplatzer Device

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40 Case 4 76 yo male physician CHADSVASC = 7 for age, previous stroke, diabetes, CAD, HTN Recurrent GI bleeds due to colon angiodysplasia On apixaban No bleeding off OAC Venofer infusions ($500 each) 13 visits to infusion center since October 2015 Should he get a LAA closure device to come off OAC? Cost comparaison

41 CHA2DS2-VASc vs. HAS-BLED CHA 2 DS 2 - VASc* Score Annual % Stroke Risk HAS- BLED** Score Annual % Bleed Risk

42 WATCHMAN TM Device Reduces Ischemic Stroke Over No Therapy 8 7 Ischemic Stroke Risk (Events/100 Patient-Years) % Relative Reduction PROTECT AF 67% Relative Reduction PREVAIL Only CAP 83% Relative Reduction Imputed Ischemic Stroke Rate* Observed WATCHMAN Ischemic Stroke Rate Baseline CHA 2 DS 2 -VASc = 3.4 Baseline CHA 2 DS 2 -VASc = 3.8 Baseline CHA 2 DS 2 -VASc = 3.9 * Imputation based on published rate with adjustment for CHA 2 DS 2 -VASc score (3.0); Olesen JB. Thromb Haemost (2011)