aMAZE

ECHONOMY
Tools for Echocardiographic Calculations
Muhamed Saric, MD, PhD
New York University

aMAZE

aMAZE Trial

Left Atrial Appendage Ligation with the LARIAT+® Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation

Primary End-Points

Freedom from episodes of AF > 30 seconds at 12 months post PVI defined as:

	No evidence of any episode of AF/AT/AFL > 30 seconds duration, as documented by holter monitoring or event monitor at any time following the 90-day blanking period post-index PVI through 12 months
	No additional catheter ablation procedures post-index PVI for treatment of AF/AT/AFL (aside from ablation for right-sided AFL); and
	No requirement for new Class I or III antiarrhythmic prescribed to treat atrial fibrillation following day 120 (90 day blanking period + 30 day window)

Inclusion Criteria

	Age ≥ 18 years and ≤ 80 years at time of screening.
	Documented diagnosis of symptomatic persistent or longstanding persistent non-valvular atrial fibrillation
	Failed at least one Class I or III antiarrhythmic
	Life expectancy ≥ 1 year;
	Willing and able to return to and comply with scheduled follow-up visits and tests; and
	Willing and able to provide written informed consent.

General Exclusion Criteria

	Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., CABG, heart transplantation, valve surgery) where adhesions are suspected
	Prior epicardial or endocardial AF ablation procedure;
	LA diameter > 6 cm as measured by CT;
	Documented embolic stroke, TIA or suspected neurologic event within 3 months prior to the planned intervention;
	Currently exhibits NYHA Class IV heart failure symptoms;
	Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
	Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
	Documented history of unstable angina within 3 months prior to the planned study intervention;
	Recent documented history of cardiogenic shock, hemodynamic instability or any medical condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated;
	Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis with symptoms;
	Diagnosed active local or systemic infection, septicemia or fever of unknown origin at time of baseline screening;
	Chronic renal insufficiency defined as eGFR < 30 mL/min/1.73m2 within 3 months prior to study treatment;
	End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
	Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
	Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer;
	Current documented use of long-term treatment with corticoid steroids, not including use of inhaled steroids for respiratory diseases;
	Active pericarditis;
	Active endocarditis;
	Any documented history or autoimmune disease associated with pericarditis;
	Evidence of pectus excavatum (documented and clinically defined by the treating physician);
	Untreated severe scoliosis (documented and clinically defined by treating physician);
	Thrombocytopenia (platelet count < 100 x 109 /L) based on most recent pre-procedure assessment within 30 days prior to planned intervention;
	Anemia with hemoglobin concentration of <8 g/dL based on most recent pre-procedure assessment (within 30 days prior to planned intervention);
	Documented Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to planned intervention;
	Known acquired or inherited propensity for forming blood clots (e.g., malignancy, Factor V leiden mutation) established by prior objective testing;
	Documented presence of implanted congenital defect closure devices, (e.g., ASD, PFO or VSD device);
	Previously attempted occlusion of the LAA (by any surgical or percutaneous method);
	Inability, unwillingness or contraindication to undergo TEE imaging;
	Body Mass Index (BMI) > 40;
	Evidence of active Graves disease;
	Current untreated hypothyroidism;
	Any contraindication to suture, endovascular device, or other minimally invasive techniques including percutaneous, transseptal, and/or sub-xiphoid access;
	Subject is pregnant or plans / desires to get pregnant within next 12 months;
	Current enrollment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow up;
	Mental impairment or other psychiatric conditions which may not allow patient to understand the nature, significance and scope of the study;
	Any other criteria, medical illness or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site Primary Investigator.

LAA Anatomic Exclusion Criteria

Based on screening / preprocedure imaging, subjects will also be excluded if they meet ANY of the following:

CT Criteria
Based on screening computed tomography angiography (CTA) performed within 90 days prior to study intervention as confirmed by the core lab:

Superior-posterior oriented LAA (i.e. superior C shape), that has:

LAA LARIAT-approach width ≥ 40 mm; or

LAA distal apex extending posterior to the ostium of the LAA.

LAA positioned behind the pulmonary artery; or

All other LAA morphology: LAA LARIAT approach width > 45 mm.

TEE Criteria
Based on TEE at time of LARIAT or catheter ablation and confirmed by institution’s designated LARIAT echocardiographer:

Intracardiac thrombus; or

Significant mitral valve stenosis (i.e., MV stenosis < 1.5 cm²)

TEE Criteria

TEE Timing

	Periprocedural TEE
	TEE at 30 days
	TEE at 1 year

Left Atrial Appendage

2D images

	AT LEAST the 70-90⁰, 135-150⁰ views should be obtained by single plane imaging.
	Identifying the circumflex artery in short-axis and the opposing ligament of Marshall (“Coumadin ridge”) should be performed (typically from 70-90⁰)
	Measurement of the maximum length of the LAA should be made (typically from 135-160⁰ view).
	Additional biplane imaging may be performed.
	In the setting of atrial fibrillation, long (preferably 5-10 second) captures should be performed to exclude thrombus

Spectral Doppler

1 cm from the ostium should be recorded, optimizing the spectral Doppler velocities for accurate measurement of ejection velocities.

3D TEE Imaging Is MANDATORY

Obtain two images of the LAA; DO NOT USE MULTI-BEAT ACQUISITION (i.e. avoid splicing images); Attempt to obtain volume rates of at least 12-15 vps ; the ENTIRE LAA ORIFICE AND BODY must be imaged

Narrow angle, single-beat of just the LAA

Full sector, full volume (may be multi-beat) to include the entire LA and LAA

Left Atrium

	From the 4Ch view, measure the LA septo-lateral dimension (figure 1)
	From the long-axis view, measure the LA antero-posterior dimension (figure 2).

Left Ventricle

Midesophageal views

Left ventricular 4Ch, 2Ch and long-axis views should be obtained from single and/or simultaneous multiplane views

Transgastric Imaging

Multiple short-axis LV imaging planes (apex, mid-papillary and basal) which should include the RV

Transseptal Imaging

	The location of the orifice of the LAA and the relationship of the long axis of the LAA to the interatrial septum can be evaluated to optimize the location of the transseptal puncture. In general, a posterior-inferior fossa ovale puncture site is ideal.
	2D imaging from a bicaval view, using the simultaneous biplane imaging mode to determine both superior-inferior (bicaval) and anterior-posterior (orthogonal AV view) may be helpful

Mitral Valve

	2D - The mitral valve should be imaged from 4Ch, 2Ch and Long-axis views.
	Color Doppler of mitral valve using appropriate sector size to image the entire jet (Note: Nyquist limit should be between 0.5-0.6 m/s).
	CW of the mitral regurgitant jet to obtain a complete spectral profile of the jet

Sponsor

SentreHEART; 300 Saginaw Drive, Redwood City, CA 94063