left atrial appendage closure program › ... › uploads › 2016 › ...presentation17.pdf ·...
TRANSCRIPT
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Left Atrial Appendage ClosureAndrea Robinson, RN, MSN, ACNP
Cardiac Electrophysiology Nurse Practitioner
OhioHealth Heart & Vascular Physicians
Riverside Methodist Hospital
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Disclosures none
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Atrial Fibrillation Most common sustained arrhythmia disorder1
Affects over 5 million Americans1
Expected to affect up to 16 million Americans by 20501
Causes 460,000 hospitalizations and contributes to 80,000 deaths annually1
Responsible for 10-15% of ischemic strokes and 50% of cardioembolic strokes2
1Lip GY. J Thromb Haemost2 Hart RG, et. JACC 2000; 35:183
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2014 AHA/ACC/HRS Guidelines for Management of Patients with Atrial Fibrillation
January, CT, et al. JACC 2014: 64(21) e1-e76
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Less Than Half of Eligible Patients with Atrial Fibrillation are Anticoagulated
Hsu, et al. JAMA, April 2016.
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NOAC Discontinuation in Clinical Trials
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Common reasons for not prescribing or discontinuing anticoagulation
Advanced Age
Frailty
Falls Risk
Labile INRs
Patient Preference
Previous Bleeding or Risk Factors for Bleeding
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Risk Assessment
Stroke Risk Factors:
CHF/LV dysfunction, Diabetes, Vascular
Disease, Female Gender
Bleeding Risk Factors: Abnormal Renal/Liver,
History of Bleed, Labile INR, Alcohol,
Antiplatelet/NSAIDS
Shared Risk
Factors: HTN,
Previous stroke, TIA, TE,
and age > 65
CHA2DS2-VASc HAS-BLED
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Bleeding Risk Increases with Stroke Risk
Marcucci, M, et al. Am J Med. 2014 Oct;127(10):979-986.e2
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Stroke Pathology in Non-Valvular AtrialFibrillation
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
Blackshear, Ann Thoracic Surg 61, 1996Johnson, Eur J Cardiothoracic Surg 17, 2000Eagan: Echocardiograpgy 17, 2000
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Options for Left Atrial Appendage Closure as Alternative to Long Term Anticoagulation
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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 Closure-endocardial
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Watchman Device
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FDA Approval and LabelingFDA 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
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WATCHMAN Trials: >2000 Patients with >6000 Patient Years Follow Up
CAP2: Consistent procedural safety results5
PREVAIL: Improved implant success, procedure safety confirmed with new and experienced operators4
ASAP: Expected rate of stroke reduced by 77% in patients contraindicated to warfarin3
CAP Registry: Significantly improved safety results2 and efficacy consistent with PROTECT AF
PROTECT AF: WATCHMAN primary efficacy, CV death, and less disabling strokes superior to warfarin at 4 years1
PILOT: Early feasibility with >6 years of follow up
1Reddy, VY et al: JAMA: 312(19):1900, 20142Reddy, VY et al: Circ; 123-417, 20113Reddy, et al: JACC; 61(25);2551, 20134Holmes, DR et al: JACC 64(1):1-12, 20145FDA Panel October, 2015
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1 Reddy, J Am Coll Cardiol. 2016.10.0102 Holmes DR J Am Coll Cardiol 2015 65(24) 26143 Price, MJ JACC Cardiovasc Interv. 2015 8(15) 1925
The WATCHMAN Device can be implanted safely, enables, patients to discontinue warfarin and reduces AF stroke risk comparably to warfarin
• 95% implant success rate1
• >92% warfarin cessation after 45 days, >99% after 1 year1
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 up2.3
• 32% in all cause stroke2
• 85% in hemorrhagic stroke3
• 64% in disabling stroke2
• 56% in cardiovascular death3
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CMS National Coverage Decision CHA2DS2-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.
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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
Severe renal failure
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.
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OhioHealth Heart and Vascular Institute LAAO Program: Team Based Care
Left Atrial Appendage
Team
Implanters
(EP/IC)
Imaging (Non-Invasive)
LAA Coordinators
(RN and APN)
Anesthesia
Admin (coding,
finance, data support)
Scheduling staff
Key Factors in Successful Program: Communication, Coordination, Collaboration
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OhioHealth Heart and Vascular Institute LAAO Program
ReferralScreening/Patient Selection
SchedulingProcedure
Post Procedure
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Referral
Referral base: cardiology, neurology, internal medicine, hematology, gastrointestinal, nephrology, ophthalmology
ReferralScreening/Patient Selection
SchedulingProcedure
Post Procedure
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Screening/Patient Selection
Pre-visit Chart Review- obtain outside records
Eligibility: Review NCD requirements
Specialist consultation/collaboration (GI/Neuro/Hematology)
Shared Decision Making
AC Clinic referral
ReferralScreening/Patient Selection
SchedulingProcedure
Post Procedure
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Shared Decision Making
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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)
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Shared Decision Making
ACC AntiCoag Evaluator
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Shared Decision Tools
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SchedulingReferral
Screening/Patient Selection
SchedulingProcedure
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
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Procedure
CT/TEE images sent to company representative, physician review prior to procedure
Coordinated schedules of EP/IC implanters, Non-Invasive Cardiologist for intra-procedural TEE, Anesthesiologist, Company Representative, Hybrid Lab
INR in acceptable range, NOAC appropriately held
Type and Cross
ReferralScreening/Patient Selection
SchedulingProcedure
Post Procedure
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Post Procedure
• One night hospital stay
Limited echo prior to discharge
Start warfarin and aspirin 81 mg
30-45 day follow up with APN
45 day TEE. If no or minimal (<5mm) peridevice leak then transition to 6 months
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
ReferralScreening/Patient Selection
SchedulingProcedure Post
Procedure
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Post Approval Experience
Reddy et al. J Am Coll Cardiol. 2017;69:253-261
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ASAP TOO
Visit Interval Aspirin Clopidogrel
Discharge through 3 month visit Yes, suggested dose: 75-100 mg Yes, suggested dose 75 mg
3 month visit through 12 month visit
Yes, suggested dose: 75-100 mg No, unless other indication
Following the 12 month visit No, unless other indication No, unless other indication
ClinicalTrials.gov Identifier:NCT02928497
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
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WATCHMAN: NOACS vs WarfarinMulticenter 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
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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
Major 1 (0.5%) 1 (0.5%) 1.0Enomoto et al: Heart Rhytm Society 14:19-24, 2017
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NOAC vs Warfarin in WatchmanAdverse 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)
3 (1.4%) 2 (0.9%) 1.0
Enomoto et al: Heart Rhytm Society 14:19-24, 2017
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Case Study: JJ76 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
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Case Study: WC67 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 movies-rifles/archery on horseback. High occupational bleeding risk!
S/p successful LAAO with Watchman
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Case Study: MM69 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
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Case Study: SH71 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
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Thank You