Left Atrial Appendage Closure Andrea Robinson, RN, MSN, ACNP

Transcription

1 Left Atrial Appendage Closure Andrea Robinson, RN, MSN, ACNP Cardiac Electrophysiology Nurse Practitioner OhioHealth Heart & Vascular Physicians Riverside Methodist Hospital

2 none Disclosures

3 Atrial Fibrillation Most common sustained arrhythmia disorder 1 Affects over 5 million Americans 1 Expected to affect up to 16 million Americans by Causes 460,000 hospitalizations and contributes to 80,000 deaths annually 1 Responsible for 10-15% of ischemic strokes and 50% of cardioembolic strokes 2 1 Lip GY. J Thromb Haemost 2

4 2014 AHA/ACC/HRS Guidelines for Management of Patients with Atrial Fibrillation January, CT, et al. JACC 2014: 64(21) e1-e76

5 Less Than Half of Eligible Patients with Atrial Fibrillation are Anticoagulated Hsu, et al. JAMA, April 2016.

6 NOAC Discontinuation in Clinical Trials

7 Common reasons for not prescribing or discontinuing anticoagulation Advanced Age Frailty Falls Risk Labile INRs Patient Preference Previous Bleeding or Risk Factors for Bleeding

8 Risk Assessment CHA 2 DS 2 -VASc Shared Risk Factors: HTN, Previous stroke, TIA, TE, and age > 65 Stroke Risk Factors: CHF/LV dysfunction, Diabetes, Vascular Disease, Female Gender HAS-BLED Bleeding Risk Factors: Abnormal Renal/Liver, History of Bleed, Labile INR, Alcohol, Antiplatelet/NSAIDS

9 Bleeding Risk Increases with Stroke Risk Marcucci, M, et al. Am J Med Oct;127(10): e2

10 Blackshear, Ann Thoracic Surg 61, 1996 Johnson, Eur J Cardiothoracic Surg 17, 2000 Eagan: Echocardiograpgy 17, 2000 Stroke Pathology in Non-Valvular Atrial Fibrillation Insufficient LAA contraction leads to stagnant blood flow Most likely culprit: embolization of LAA clot 90% of thrombus found in LAA Risk factors identifiable on TEE include Enlarged LAA Spontaneous echo contrast Reduced LAA flow velocities

11 Options for Left Atrial Appendage Closure as Alternative to Long Term Anticoagulation

12 Devices Currently Available in US for Commercial Use Lariat- FDA approved for soft tissue closure- epicardial Atri-Clip- FDA Approved for LAA Closure in conjunction with other open cardiac procedures- epicardial Watchman Device- First FDA Approved for LAA Closureendocardial

13 Watchman Device

14 FDA Approval and Labeling FDA Approval in March 2015 with an indication to reduce the risk of thromboembolism from the left atrial appendage in patients 1.) with non valvular atrial fibrillation 2.) who are recommended anticoagulation based on their CHADS2 or CHADS VASC score to decrease stroke risk 3.) are deemed suitable for warfarin 4.) who have an appropriate rationale to seek a non pharmacologic alternative to warfarin

15 WATCHMAN Trials: >2000 Patients with >6000 Patient Years Follow Up PILOT: Early feasibility with >6 years of follow up PROTECT AF: WATCHMAN primary efficacy, CV death, and less disabling strokes superior to warfarin at 4 years 1 CAP Registry: Significantly improved safety results 2 and efficacy consistent with PROTECT AF ASAP: Expected rate of stroke reduced by 77% in patients contraindicated to warfarin 3 PREVAIL: Improved implant success, procedure safety confirmed with new and experienced operators 4 CAP2: Consistent procedural safety results 5 1 Reddy, VY et al: JAMA: 312(19):1900, Reddy, VY et al: Circ; , Reddy, et al: JACC; 61(25);2551, Holmes, DR et al: JACC 64(1):1-12, 2014

16 The WATCHMAN Device can be implanted safely, enables, patients to discontinue warfarin and reduces AF stroke risk comparably to warfarin 95% implant success rate 1 >92% warfarin cessation after 45 days, >99% after 1 year 1 WATCHMAN therapy demonstrated comparable stroke risk reduction, and statistically superior reductions in hemorrhagic stroke, disabling stroke and cardiovascular death compared to warfarin over long term follow up % in all cause stroke 2 85% in hemorrhagic stroke 3 64% in disabling stroke 2 56% in cardiovascular death 3 1 Reddy, J Am Coll Cardiol Holmes DR J Am Coll Cardiol (24) Price, MJ JACC Cardiovasc Interv (15)

17 CMS National Coverage Decision CHA 2 DS 2 -VASc of 3 or CHADS2 2. Formal shared decision making (SDM) interaction utilizing an independent, non-interventional physician whose opinion must be written in the medical record. Suitability for short-term warfarin, but deemed unable to take long-term anticoagulation, after the conclusion of SDM, as LAAC is only covered as second line to oral anticoagulation Procedure must be performed in a hospital with an established structural heart disease or electrophysiology program. Procedure must be performed by an interventional cardiologist, electrophysiologist or cardiovascular surgeon, who must have received formal training by the manufacturer, have performed 25 transeptal procedures, and continue to perform 25 transeptal procedures, including 12 of which are LAA occlusion, over a two year period. Patient is enrolled, and physicians and hospital participate in a prospective, national, audited registry for at least four years from the time of implantation.

18 Suggested Contraindications to Long Term Warfarin Use History of intracranial bleeding, or other spontaneous or non ICH bleeding such as GI or retroperitoneal bleeding Documented poor compliance with AC or labile INRs Intolerance of warfarin or new oral anticoagulants High risk of recurrent falls Cognitive impairment Occupation related high bleeding risk Need for prolonged dual antiplatelet therapy Increased bleeding risk not reflected by the HAS-BLED score (e.g. thrombocytopenia, cancer, or risk of tumor associated bleeding in case of systemic anticoagulation) Other situations for which anticoagulation is inappropriate. Severe renal failure

19 OhioHealth Heart and Vascular Institute LAAO Program: Team Based Care Implanters (EP/IC) Scheduling staff Admin (coding, finance, data support) Left Atrial Appendage Team Imaging (Non- Invasive) LAA Coordinators (RN and APN) Anesthesia Key Factors in Successful Program: Communication, Coordination, Collaboration

20 OhioHealth Heart and Vascular Institute LAAO Program Referral Screening/Pat ient Selection Scheduling Procedure Post Procedure

21 Referral Referral Screening/Pat ient Selection Scheduling Procedure Post Procedure Referral base: cardiology, neurology, internal medicine, hematology, gastrointestinal, nephrology, ophthalmology

22 Screening/Patient Selection Referral Screening/Pat ient Selection Scheduling Procedure Post Procedure Pre-visit Chart Review- obtain outside records Eligibility: Review NCD requirements Specialist consultation/collaboration (GI/Neuro/Hematology) Shared Decision Making AC Clinic referral

23 Shared Decision Making

24 Shared Decision Making The process by which the optimal decision may be reached for a patient at a fateful health crossroads is called shared decision making and involves, at minimum, a clinician and the patient, although other members of the health care team or friends and family members may be invited to participate. In shared decision making, both parties share information: the clinician offers options and describes their risks and benefits, and the patient expresses his or her preferences and values. Each participant is thus armed with a better understanding of the relevant factors and shares responsibility in the decision about how to proceed. Barry and Edgman-Levitan (2012)

25 ACC AntiCoag Evaluator Shared Decision Making

26 Shared Decision Tools

27 Scheduling Referral Screening/Pat ient Selection Scheduling Procedure Post Procedure Start or continue anticoagulation 3 weeks prior to scheduled implant Start working on prior authorization for commercial insurance payers. NCD established uniform coverage for Medicare. For Commercial can leverage NCD. May need peer-peer review or letter Obtain CCTA or TEE prior to implant to assess LAA anatomy and evaluate for thrombus

28 Procedure Referral Screening/Pat ient Selection Scheduling Procedure Post Procedure CT/TEE images sent to company representative, physician review prior to procedure Coordinated schedules of EP/IC implanters, Non-Invasive Cardiologist for intraprocedural TEE, Anesthesiologist, Company Representative, Hybrid Lab INR in acceptable range, NOAC appropriately held Type and Cross

29 Post Procedure Referral Screening/Pat ient Selection One night hospital stay Limited echo prior to discharge Start warfarin and aspirin 81 mg day follow up with APN 45 day TEE. If no or minimal (<5mm) peridevice leak then transition to 6 months Scheduling Procedure Post Procedure Clopidogrel/aspirin. Aspirin to continue indefinitely. If inadequate closure, continue warfarin and repeat TEE at 6 months Antibiotic endocarditis prophylaxis for 6 months 4 years data collection as specified by NCDR Registry

30 Post Approval Experience Reddy et al. J Am Coll Cardiol. 2017;69:

31 ASAP TOO Purpose: US indication expansion for patients deemed contraindicated to oral anticoagulation 888 subjects, 100 sites, Global and multi center Randomized 2:1 WATCHMAN +DAPT vs Single antiplatelet or no therapy Primary Effectiveness endpoint: Ischemic stroke/systemic embolism 5 year follow up Status: Enrolling Visit Interval Aspirin Clopidogrel Discharge through 3 month visit Yes, suggested dose: mg Yes, suggested dose 75 mg 3 month visit through 12 month visit Yes, suggested dose: mg No, unless other indication Following the 12 month visit No, unless other indication No, unless other indication ClinicalTrials.gov Identifier:NCT

32 WATCHMAN: NOACS vs Warfarin Multicenter Registry 214 patients undergoing Watchman implant treated with NOAC 212 patients undergoing Watchman implant treated with standard post warfarin regimen as per IFU Enomoto et al: Heart Rhythm Society 14:19-24, 2017

33 NOACs vs Warfarin in Watchman Adverse Events NOACS (n=214) Warfarin (n=212) P Overall complications no (%) Periprocedure 6 (2.8%) 5 (2.4%) 1.0 Postprocedure 2 (0.9%) 5 (2.4%) 0.3 Bleeding complications Periprocedure 4 (1.9%) 4 (1.9%) 1.0 Major 2 (0.9%) 3 (1.4%) 0.7 Postprocedure 1 (0.5%) 2 (0.9%) 0.6 Enomoto Major et al: Heart Rhytm Society 14:19-24, 1 (0.5%) 1 (0.5%)

34 NOAC vs Warfarin in Watchman Adverse events NOACS (n=214) Warfarin (n=212) P Stroke, TIA, or Systemic Embolism Periprocedure 0 (0%) 0 (0%) 1.0 Postprocedure 1 (0.5%) 1 (0.5%) 1.0 Other Complications Periprocedure 2 (0.9%) 1 (0.5%) 1.0 Postprocedure 0 (0%) 2 (0.9%) 0.3 LAA thrombosis 2 (0.9%) 1 (0.5%) 1.0 LAA thrombosis or other embolic event (including stroke TIA, or systemic embolism) Enomoto et al: Heart Rhytm Society 14:19-24, (1.4%) 2 (0.9%) 1.0

35 Case Study: JJ 76 y/o female with PMH of PAF, stroke, HTN, HLD, severe anemia related to ongoing GI bleeding from GAVE (gastric antral vascular ectasia). First stroke in 2013 (RMCA) in setting of subtherapeutic warfarin. Continued on Warfarin. Major GI Bleed in 2015 and AC stopped. Second Stroke 2015 (Left frontal). Eliquis 5 mg bid started. Became transfusion dependent via chest wall porta cath due to ongoing slow bleeding on AC. Third stroke (RMCA) 2016 on Eliquis. Referred for LAAO. Candidate? CHADS VASC 6 (htn,age2,stroke2,gender, HAS BLED 3 (stroke,bleed,age) Collaboration with GI/ Neuro/ Hematology and SDM S/p successful LAAO with Watchman

36 Case Study: WC 67 y/o male with PMH AFL s/p CTI RFA, PAF, stroke, HTN, GERD S/p CTI RFA, AC for 4 weeks then aspirin. PAF diagnosed in setting of admission for acute RMCA stroke. Started on Pradaxa 150 mg bid with no reported intolerance or bleeding. Referred for LAAO. Candidate? CHADS VASC 4 (htn,age,stroke2) HAS BLED 2 (stroke,age) Occupation: dramatic reenactments for Native American moviesrifles/archery on horseback. High occupational bleeding risk! S/p successful LAAO with Watchman

37 Case Study: MM 69 y/o male with PMH ESRD on HD, PAF, SAH, HTN, CAD s/p PCI AC discontinued in 2010 after SAH. Tolerating aspirin 81mg. Referred for LAAO. Candidate? CHADS VASC 3 (htn,vasc,age), HAS BLED 6 (htn,renal,bleed,labile INR,age,aspirin) After consultation with neurosurgery, felt to be acceptable risk for short term AC. Started on warfarin and scheduled for Watchman. Admitted the next week with supratherapeutic INR, uncontrolled HTN with BP 180/100 mmhg, and scleral hemorrhage. Medication compliance questioned After SDM interaction, referred for Lariat as deemed unsuitable for short term AC. Attempt at Lariat unsuccessful due to pericardial adhesions Decision made to implant Watchman device with post DAPT

38 Case Study: SH 71 y/o male with PMH CAD s/p PCI, ICM w/hfpef (improved), AFL s/p CTI RFA, PAF on Sotalol, HTN, DM, CKD Previously on Xarelto 20 mg. Developed acute melena with symptomatic anemia requiring transfusion. Evaluated with EGD/colonoscopy/capsule enteroscopy with no source of bleeding identified. Changed to Eliquis 5 mg bid with no further melena. Referred for LAAO. Candidate? CHADS VASC 5 (chf,htn,dm,vasc,age) HAS BLED 2 (bleed,age) After SDM interaction, decision to remain on current Eliquis 5 mg bid with close monitoring for recurrent bleeding

39 Thank You