Left Atrial Appendage ClosureAndrea Robinson, RN, MSN, ACNP

Cardiac Electrophysiology Nurse Practitioner

OhioHealth Heart & Vascular Physicians

Riverside Methodist Hospital

Disclosures none

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

2014 AHA/ACC/HRS Guidelines for Management of Patients with Atrial Fibrillation

January, CT, et al. JACC 2014: 64(21) e1-e76

Less Than Half of Eligible Patients with Atrial Fibrillation are Anticoagulated

Hsu, et al. JAMA, April 2016.

NOAC Discontinuation in Clinical Trials

Common reasons for not prescribing or discontinuing anticoagulation

Advanced Age

Frailty

Falls Risk

Labile INRs

Patient Preference

Previous Bleeding or Risk Factors for Bleeding

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

Bleeding Risk Increases with Stroke Risk

Marcucci, M, et al. Am J Med. 2014 Oct;127(10):979-986.e2

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

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

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

Watchman Device

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

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

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

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.

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.

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

OhioHealth Heart and Vascular Institute LAAO Program

ReferralScreening/Patient Selection

SchedulingProcedure

Post Procedure

Referral

Referral base: cardiology, neurology, internal medicine, hematology, gastrointestinal, nephrology, ophthalmology

ReferralScreening/Patient Selection

SchedulingProcedure

Post Procedure

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

Shared Decision Making

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)

Shared Decision Making

ACC AntiCoag Evaluator

Shared Decision Tools

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

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

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

Post Approval Experience

Reddy et al. J Am Coll Cardiol. 2017;69:253-261

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

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

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

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

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

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

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

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

Thank You