Author’s Accepted Manuscript

Anesthesia and TEE for WATCHMAN TM Device

Implantation

Ludmil Mitrev, Natalie Trautman, Ratna

Vadlamudi, Nayan Desai, Sajjad A. Sabir

www.elsevier.com/locate/buildenv

PII: S1053-0770(16)30184-7
DOI: http://dx.doi.org/10.1053/j.jvca.2016.06.012
Reference: YJCAN3725
To appear in: Journal of Cardiothoracic and Vascular Anesthesia
Received date: 23 September 2015
Cite this article as: Ludmil Mitrev, Natalie Trautman, Ratna Vadlamudi, Nayan
Desai and Sajjad A. Sabir, Anesthesia and TEE for WATCHMAN TM Device
Implantation, Journal of Cardiothoracic and Vascular Anesthesia,
http://dx.doi.org/10.1053/j.jvca.2016.06.012
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Anesthesia and TEE for WATCHMANTM Device Implantation

Authors: 1
Ludmil Mitrev, M.D. , e-mail: Mitrev-Ludmil@cooperhealth.edu

1
Natalie Trautman, M.D. , e-mail: Trautman-Natalie@CooperHealth.edu
2
Ratna Vadlamudi, M.D. , e-mail: RVADLAM@emory.edu
3
Nayan Desai, M.D. , e-mail: Desai-Nayan@CooperHealth.edu
3
Sajjad A Sabir, M.D. , e-mail: sabir-sajjad@CooperHealth.edu

1
Department of Anesthesiology and Division of Cardiothoracic Anesthesiology, Cooper University

Hospital, One Cooper Plaza, Camden, NJ 08103, U.S.A.

2
Department of Anesthesiology, Emory University, Atlanta, GA 30322, U.S.A.
3
Department of Cardiology, Cooper University Hospital, Camden, NJ 08103, U.S.A.

Corresponding Author: Ludmil Mitrev, M.D., e-mail: Mitrev-Ludmil@cooperhealth.edu, tel. +1

(856) 968-7334

Conflicts of Interest: None

Acknowledgements

The authors wish to thank Kelly Speich, MS for his assistance with gross anatomy images.

Keywords

Watchman device; left atrial appendage closure device; atrial fibrillation; ischemic stroke.

1
Anesthesia and TEE for WATCHMANTM Device Implantation

Abstract

Only 30% to 50% of patients with non-valvular atrial fibrillation are treated with

anticoagulation to reduce the risk of thromboembolic events, due to patient

adherence and the side effect profile of such therapy.1 Several left atrial

appendage occlusion devices have been proposed as alternative approaches to

minimization of the risk of thromboembolic events. The present article reviews

the anesthetic and TEE implications of the WATCHMANTM (Boston Scientific,

Marlborough, MA, USA) Left Atrial Appendage Closure Device implantation.

Introduction

Stroke is a common cardiovascular event with significant morbidity and mortality.

A 2015 annual report from the American Heart Association estimated the annual

incidence of stoke in the United States to be approximately 795,000 2 cases, of

which 77% were new events, and the remainder – recurrent strokes. Eighty-

seven percent of all strokes are ischemic. The age-adjusted death rate per

100,000 population in 2009-2011 was 38.9, accounting for some 128,932 stroke-

related deaths in 2011. When considered separately from other cardiovascular

diseases, stroke ranked 4th among all causes of death in the United States,

behind diseases of the heart, cancer, and chronic lower respiratory diseases 2.

The global prevalence of stroke was 33 million cases in 20103, and stroke was

2
second only to ischemic heart disease in terms of mortality on a global basis,

accounting for 11.13% of total deaths worldwide.

Atrial fibrillation (AF) is an independent risk factor for stroke, increasing the risk

5-fold in all age groups. The attributable risk of stroke related to AF increases

with age, and may be substantially underestimated, due to the fact that AF can

be asymptomatic and can remain undetected4. Atrial fibrillation is said to

contribute to greater than 20% of strokes, and many efforts are directed towards

stroke prevention in AF sufferers. Historically, warfarin has been used for

anticoagulation and has been effective in reducing the risk of stroke by ~60%. 5

Recently, novel oral anticoagulants such as dabigatran, rivaroxaban, apixaban,

and edoxaban have shown comparable efficacy to warfarin with potentially better

safety profiles.6-9 Although anticoagulation can be effective in prevention of

thromboembolic events in patients with atrial fibrillation, only 30% to 50% of

patients are treated with it, due to various barriers and contraindications. Chief

among those barriers is the elevated risk of bleeding associated with warfarin or

the novel oral anticoagulants, which is reported in clinical trials to be in the

vicinity of 1.4% to > 3% per year.10 The incidence of major hemorrhage with

anticoagulation seems to be higher for patients older than 80 years of age.

In an alternative approach to stroke prevention in patients with non-valvular AF,

several implantable, self-expandable left atrial appendage (LAA) occlusion

devices have been developed. Those devices are inserted into the LAA through

3
catheter-based delivery systems, via transseptal puncture from the right to left

atrium. This group of endocardial closure devices includes the Watchman™

device (Boston Scientific Corp., Marlborough, MA), the Amplatzer™ Cardiac Plug

(ACP) and Amplatzer™ Amulet™ devices (St. Jude Medical, St. Paul, MN), and

the Coherex WaveCrest® device (Coherex Medical Inc., Salt Lake City, UT).11 A

review of the FDA device approval web pages on August 30th, 2015, revealed

that only the Watchman device had FDA approval in the United States. All of the

aforementioned devices have a CE (Conformité Européenne) mark for use in the

European Union.

The Lariat® suture delivery device (SentreHeart Inc., Redwood City, CA) deploys

a different strategy for ligation of the LAA that combines a transseptal and an

epicardial approach. Applying the Lariat suture, or snare, to the epicardial

surface of the LAA ostium requires subxiphoid pericardial access. This may not

be achievable in the presence of pericardial adhesions, can provoke pericarditis,

and is not suitable for all LAA anatomies. The Lariat device has received 510(k)

clearance by the FDA for facilitation of suture placement and knot tying in

surgical applications where soft tissues are being approximated, but essentially

all of its use has been as an LAA exclusion device.12, 13 Although case series do

exist describing results with the device both in Europe12 and the United States14,

long-term non-inferiority or superiority randomized controlled trial data vis-à-vis

anticoagulation, is lacking. A putative advantage of the Lariat suture application

is electromechanical isolation of the left atrial myocardium from the LAA, the

4
latter in itself being a known trigger for AF15, 16. A future randomized controlled

trial (AMAZE Trial) will evaluate the use of the Lariat device for the ligation of the

LAA as an adjunctive treatment to ablation in patients with persistent or

longstanding persistent AF.

Several methods for the ligation of the LAA during concomitant cardiac surgery

exist as well. Postoperative TEE data suggests that up to 60% of these closures

may be unsuccessful, as judged by the presence of LAA remnants > 1cm, flow in

the LAA remnant, or thrombi in the LAA remnant.17 Despite the uncertainty about

the efficacy of varying surgical approaches to LAA ligation and its effects on the

development of thromboembolic complications such as stroke, the 2014

guideline for the management of patients with AF from the American College of

Cardiology/American Heart Association/Heart Rhythm Society made a class IIb

recommendation to attempt excision of the LAA in patients undergoing cardiac

surgery (level of evidence C).18 In the same guideline, the percutaneous devices

such as the Watchman device were briefly described, but the authors did not find

sufficient evidence in the literature to make a formal recommendation about their

use at the time. Since the publication of that guideline, FDA has approved the

WATCHMAN device. The 2012 focused update of the European Society of

Cardiology guidelines for the management of atrial fibrillation gave class IIb (LOE

B) recommendation for use of Watchman device for patients at high risk for

stroke but long-term contra-indication to anticoagulation.19

5
In the remainder of this article, we focus on the Watchman device and the

anesthetic and TEE implications during its implantation.

Left Atrial Appendage Morphology and Its Implication for Device

Implantation and Thromboembolism

The left atrial appendage is a remnant of the primary atrium, which forms during

the third week of embryonic development. It is distinct from the main left atrial

chamber in that it is trabeculated, has increased distensibility, and, on a cellular

level, contains a high concentration of atrial natriuretic factor. The left atrium

proper forms from the outgrowth of the pulmonary veins after the 4th week of

embryonic development.20 Thrombus has a predilection for forming in the LAA

both in non-valvular AF, as well as in patients with mitral valve disease who are

either in AF or sinus rhythm. The LAA is the site of thrombus formation in more

than 90% of patients with non-valvular AF, and in 60% of patients with rheumatic

mitral valve disease (predominantly mitral stenosis).20, 21 Figure 1 shows a gross

anatomic specimen of the LAA, demonstrating its trabecular structure, in contrast

to the smooth-walled body of the left atrium.

The shape of the LAA is highly variable. Several predominant morphologies have

recently been described that have gained attention due to their association with

varying degrees of thromboembolism, as well as ease of occlusion with devices

such as the Watchman. Di Biase et al.22 examined 932 patients who were

6
scheduled to undergo AF ablation, with either cardiac CT or MRI, and

subclassified the LAA morphology into 4 types, which they termed “cactus”

(30%), “chicken wing” (48%), “windsock” (19%), and “cauliflower” (3%). The

cactus morphology was described as having a dominant central lobe with

secondary lobes extending from it in both superior and inferior directions. The

distinguishing feature of the chicken wing variety is a bend in the proximal or

middle part of the dominant lobe, or a folding back of the LAA on itself at some

distance from the perceived LAA ostium. The authors stated that this type of LAA

could have secondary lobes or twigs. The windsock morphology is characterized

by a single, elongated lobe of the LAA as the primary structure, although it, too,

can have secondary or tertiary lobes. Lastly, the cauliflower variety presented as

a LAA with limited overall length, and a variable number of lobes. The feature

distinguishing it from the cactus variety is the absence of a dominant lobe. This

subtype could also have a complex internal structure, and irregular or ovoid

shape of the LAA orifice. Some authors have referred to this anatomical variant

as a broccoli subtype.1

Using two separate multivariate logistic regression models and controlling for

CHADS2 score, gender, and AF types, Di Biase et al. demonstrated that patients

with the chicken wing LAA morphology were significantly less likely to have had a

history of stroke or TIA than those with the remaining subtypes. Although the

overall size of the LAA has been reported in autopsy studies to correlate with the

risk of stroke or TIA, this association was not corroborated in the Di Biase study.

7
Figures 2-5 demonstrate the TEE imaging equivalents of the four LAA

morphologies. Proper identification of the type of LAA by the echocardiographer

may be valuable during insertion of a transcatheter LAA occlusion device,

because the size and depth of the main lobe of the LAA relative to the LAA

ostium will determine the size of the device to be used, and the relative ease of

successful occlusion. It is worth noting that ideal images that conform to one of

the aforementioned shapes can be difficult to obtain via TEE, and may challenge

the skills of the echocardiographer.

Characteristics of the WATCHMAN™ Device

The WATCHMANTM Left Atrial Appendage Closure Device is composed of a self-

expanding central nitinol (nickel-titanium) compartment surrounded by 10 fixation

anchors, along with a fabric cap, or skirt (Figure 6).1 The cap is crafted from

polyethylene terephthalate, which at the time of implantation serves as a 160

micron filter designed to block emboli from exiting the LAA. It is available in 21,

24, 27, 30 and 33 mm sizes (device diameter). The approved indication is for

LAA occlusion in patients who are at an increased risk for stroke and systemic

embolism based on CHADS2 or CHA2DS2-VASc scores, and are recommended

for anticoagulation with warfarin, but have an appropriate rationale to seek a non-

pharmacologic alternative to warfarin. Table 1 summarizes the CHADS 2 and

CHA2DS2-VASc scoring systems for predicting the risk of stroke based on

comorbidities, age, and in the latter case also gender.18, 23-25 Intracardiac

8
thrombus, presence of ASD or PFO occlusion device, or inability to tolerate

warfarin, aspirin, or clopidogrel, are contraindications to implantation of the

device. Table 2 presents a summary of these contraindications. The Watchman

device Directions For Use document does not distinguish between absolute and

relative contraindications. Therefore, the list of contraindications should be

treated as absolute.

The patient is typically maintained on aspirin and warfarin for 45 days post

implantation. At that time, if echocardiographic surveillance does not reveal peri-

device leak jet ≥ 5mm in diameter, thrombi, dislodgement, or other device

complications, the patient is transitioned to aspirin and clopidogrel26. After 6

months, monotherapy with aspirin may be considered. In the PREVAIL trial,

warfarin was discontinued after 45 days in 92% of patients, and in > 99% after 12

months.26 Endocarditis prophylaxis should be offered during the initial 6 months

after device implantation. Longer prophylaxis is at the discretion of the treating

cardiologist.

The safety and long-term efficacy of the Watchman device has been evaluated in

a randomized, prospective pivotal study (the PROTECT AF trial)27, as well as a

follow-on prospective, randomized trial (the PREVAIL trial)26. The multi-institution

PROTECT AF trial in the United States and Europe compared LAA occlusion

with the Watchman device versus warfarin anticoagulation. Patients with non-

valvular atrial fibrillation and at least one of the following were included: previous

9
stroke or TIA, congestive heart failure, diabetes, hypertension, or age greater

than 75. The primary efficacy endpoint in this study was occurrence of ischemic

or hemorrhagic stroke, cardiovascular or unexplained death, or systemic emboli

within up to 3 years. The trial showed that at 3.8 years of follow-up, there was a

primary event rate of 2.3 events per 100 patient-years for the device group,

compared to a primary event rate of 3.8 events per 100 patient-years for the

warfarin group, thus meeting the criteria for both non-inferiority and superiority. In

the device group, there were lower rates of both cardiovascular mortality and all-

cause mortality.28 The PREVAIL trial showed that use of the Watchman device

was not inferior to warfarin therapy for ischemic stroke prevention, with a

significantly lower early safety events rate than the PROTECT AF trial (2.2%).

Registry studies seem to confirm non-inferiority to warfarin.

Device Implantation and TEE

Understanding the steps required to successfully implant the Watchman device

aids the anesthesiologist in providing the best care to the patient, and in

communicating with the invasive cardiologist or cardiac surgeon performing the

procedure. TEE is essential for identifying the morphology, size and depth of the

LAA, number and location of lobes relative to LAA ostium, and for proper

positioning of the device.1, 29 Use of fluoroscopic guidance alone may not be

sufficient, particularly in cases where the LAA anatomy is complex and involves

several lobes. Additionally, demonstrating absence of any absolute or relative

contraindication to the procedure such as LAA thrombus, prior interatrial septal

10
device, aneurysmal interatrial septum, PFO, ASD and significant mitral

regurgitation, is essential. TEE also allows for rapid recognition of any procedural

complications such as development of pericardial effusion. As the procedure

becomes more prevalent and is performed in smaller centers, cardiac

anesthesiologists may find themselves providing more perioperative TEE

services in this type of procedure, similar to the TEE services provided during

open heart surgery.

After induction of appropriate anesthesia or sedation, the TEE probe is inserted

and the LAA ostium size and usable length are measured in 4 dimensions: a) 0 –

20° in the mid-esophageal (ME) four-chamber view; b) 45–60° corresponding to

the ME aortic valve view; c) 90° in the ME two-chamber view; and d) 120 – 135°

in the aortic valve long-axis view.1, 29 One can also utilize X-plane at 0° to obtain

a simultaneous 90° orthogonal imaging plane and an X-plane from 45° will yield a

135° view. The 0° and 135° views often show the largest ostial diameter. When

using 2D multiplane TEE, the ostium diameter should be obtained from the level

of the circumflex artery or the superior edge of the mitral valve annulus to a point

2cm from the limbus of the left upper pulmonary vein. Three-dimensional TEE

can also be used to assess the size of the LAA ostium (Fig. 7).30-32 The 10 active

fixation anchors on the LAA side of the device engage the tissue to offer device

stability, but the Watchman device is kept in place largely by radial forces

generated from compression of the device. The goal, therefore, is for a 12-20%

compression of the device to be achieved once it is implanted, and the device,

11
accordingly, is selected to be some 12-20% wider than the widest measurement

of the LAA orifice. For example, for a LAA orifice of 19mm, a 21mm device will

typically be selected. The maximum LAA ostium and the LAA depth

measurements are used as a basis for selecting the device size. The length of

the Watchman device is the same as the device size. Therefore, the dominant

lobe of the LAA should ideally be at least as deep as the device size selected in

order to accommodate the device. This ‘usable depth’ of the LAA is measured

from the ostium line to the apex of the LAA or the deepest portion of its dominant

lobe (Fig. 2, 3 and 4). The maximum LAA ostium size should be between 17 to

31 mm to accommodate the currently available device sizes. Other structures to

consider during the baseline TEE exam include the pulmonary veins and flow,

the mitral valve structural integrity and function, biventricular performance,

presence of pericardial effusion, and presence of any significant aortic

atheromatous disease.

The absence of clot in the atrium or LAA must be verified. The morphology of the

LAA should also be assessed. The windsock type of LAA is easiest to occlude as

it consists of one long tube-like space. The cauliflower type LAA may be short

relative to the size of its orifice, making it hard to occlude with a Watchman

device. Likewise, the chicken wing type may have a short proximal portion, which

is less optimal for occlusion. In certain instances, device deployment may be

successful even if the protrusion of the shoulder is 40-50% of the device depth.33

12
As the Watchman device skirt covers 50% of the device surface, this protruding

area will be covered and will endothelialize, leading to successful occlusion.

Next, the echocardiographer should guide the position of the transseptal sheath

and needle. The recommended position for transseptal crossing is the

inferoposterior part of the septum.1 The catheters are more difficult to manipulate

and position if the transseptal puncture is too close to the plane of the mitral

valve orifice. In bicaval view the transseptal sheath and catheter are slowly pulled

inferiorly from SVC towards the mid portion of the septum. A leftward tenting of

the interatrial septum can be seen when the transseptal needle comes into

contact with the septum (Figure 8). Next, a modified short axis view at the aortic

valve level in the mid esophagus is used to position the transseptal access

sheath posteriorly (away from aortic valve) with a clockwise rotation. Another

useful ME TEE view for transseptal puncture guidance is the bicaval view with an

X-plane through the tented site demonstrating modified short axis view at the

aortic valve level at the same time. Live 3D or 3D zoom can also be used to

confirm the proper transseptal puncture site, although use of 3D images for this

purpose is not necessary. After crossing the interatrial septum, it is important to

measure the LA mean pressure to ensure it is ~15 mmHg to avoid under-

estimation of the LAA ostial size from hypovolemia (since the patients are NPO

prior to the procedure).33

13
After the needle and sheath are advanced into the left atrium, the sheath is

further advanced into the left upper pulmonary vein (LUPV). After administration

of 100 IU/kg heparin, the WATCHMAN access sheath is passed over a guidewire

into the LUPV. Activated clotting time is maintained at 200-300 seconds and is

checked at 30-minute intervals. A pigtail catheter is inserted through the

WATCHMAN access sheath. With the help of TEE, it is then pulled back from the

LUPV and inserted into the distal portion of the LAA. The appropriate position is

verified both angiographically and echocardiographically. A full sweep from 0 to

135° on multiplane TEE is recommended. Ongoing assessment for any evidence

of pericardial effusion is performed. The WATCHMAN access sheath is then

advanced in the correct position in the LAA over the pigtail catheter, the pigtail

catheter is removed, and, after rechecking the access sheath positioning, the

Watchman delivery system is introduced. The delivery catheter tip position in the

LAA is reconfirmed on fluoroscopy and TEE. The device is then deployed by

retracting the access sheath and delivery catheter assembly. At this point, the

device is still attached to the core wire.

A set of device release criteria should then be confirmed using fluoroscopy and

TEE. The release criteria are Position, Anchor, Size and Seal (PASS). Position is

verified by confirming that the plane of maximum diameter of the device is at or

just distal to the ostium, and that it spans the entire LAA ostium. Too distal

deployment increases the risk of uncovered LAA lobes, incomplete seal or

residual flow in the LAA. Too shallow a placement may lead to low compression

14
or unstable device. In addition, the device may protrude too far into the LA.

Three-dimensional TEE can add useful information about the fit and position of

the device.29 The invasive cardiologist or surgeon verifies the device anchoring

by using a “tug test” that involves retracting and releasing the deployment knob.

An anchored device should gently tug on the LAA. Size is verified by measuring

the maximum diameter of the Watchman device in the same 4 dimensions used

to measure the ostium size on TEE. The “threaded insert” (Fig. 9) must be visible

when measuring on echo to ensure the device was measured at its widest cross-

section in all angles. The size of the device, once deployed, should be 8 to 20%

smaller than its original dimension as this degree of compression yields adequate

radial pressure that helps keep the device in place. Finally, seal is verified using

color flow Doppler and angiography. All of the lobes of the LAA should be sealed.

Small peri-device leaks are permissible (<5mm) and may not require

repositioning of the device1. However, if gaps or leaks greater than 5mm exist,

the device should be recaptured and repositioned, or completely removed.

Recapture of the device can be achieved by advancing the delivery assembly

over the shoulders of the device until it is fully collapsed.

The procedure ends when the delivery system is removed and local hemostasis

is achieved. Once the patient is awake, a neurologic exam should be performed.

Figure 9 shows a successfully deployed Watchman device. The same device is

shown in 3D zoom in Figure 10.

15
Throughout deployment and before case completion, the echocardiographer

should also monitor for hemopericardium, device migration or dislodgement,

interference with the function of the mitral valve or pulmonary vein flow, or

thrombus formation. Typically at the end of the procedure, a small ASD can be

seen at the site of transseptal puncture, normally with left to right shunt which

can easily be identified using color flow Doppler.

Data from the PROTECT AF trial showed that the most common peri-procedural

complications were pericardial effusions and air embolism causing stroke.1 The

effusions seemed to be associated with manipulation of the device or the delivery

sheath within the LAA, the transseptal puncture, or the tug test. The air embolism

could have arisen from the large 12F transseptal access sheath. Low LAA

pressures related to dehydration from pre-procedural fasting should be avoided

in order to minimize the chances of left-sided air emboli.

General Anesthesia Vs. Monitored Anesthesia Care For Device Implantation

Due to the importance of continuous TEE monitoring, in the United States

implantation of the Watchman device is most frequently performed under general

anesthesia. Standard ASA monitors with arterial blood pressure recording are

utilized. We suggest techniques that will ensure rapid emergence and extubation

at the end of the procedure. Blood gas analysis and activated clotting time

assessment should be available. The ability to rapidly resuscitate the patient in

the event of a hemodynamic catastrophe should be present.

16
After device deployment, the ACT is allowed to drift back to the patient’s

baseline, and the patient is extubated. The patient will recover in the post-

anesthesia care unit and is then transferred to a cardiology floor bed until he or

she is ready for discharge. Select patients are transferred to the cardiology care

unit if closer monitoring is warranted. Institutional practices will often determine

the exact post-operative care arrangements.

The Watchman device can also be implanted under conscious sedation or

monitored anesthesia care. Mobius-Winkler et al.1 recommend conscious

sedation with midazolam and propofol. Chan et al.34 demonstrated eleven

successful LAA occlusion device implantations, both Watchman and ACP,

performed under conscious sedation utilizing midazolam and fentanyl, with no

complications arising from conscious sedation. If conscious sedation is chosen

as the type of anesthesia for this procedure, emergency airway devices should

be readily available.1

Conclusions

In an aging population, atrial fibrillation is a growing problem. A large percentage

of thromboembolic strokes are the result of thrombi arising in the LAA in patients

with non-valvular atrial fibrillation. Anticoagulation has been the mainstay of

therapy for those patients, but is not suitable for all due to the risk of hemorrhagic

17
complications. The WATCHMANTM Left Atrial Appendage Closure Device

(Boston Scientific, Marlborough, MA, USA) has proven to be a suitable non-

pharmacologic alternative for thromboembolism prevention in patients who are at

an increased risk for stroke and systemic embolism based on CHADS2 or

CHA2DS2-VASc scores.

Both general anesthesia and monitored anesthesia care have been used

successfully for procedural sedation. TEE is essential in guiding implantation of

the device, together with angiography. The ability to develop multiplanar images

of the LAA and an understanding of the predominant LAA morphologies, as well

as the procedural steps, aids the echocardiographer in providing the required

information to the cardiologist performing the implantation of the device.

Experience with the Watchman device and the availability of future device

alternatives will likely make percutaneous LAA occlusion more common. Use of

alternatives to TEE such as intracardiac echo to image the LAA have been

described.35 Until further experience with such methods demonstrates sufficient

and universal reliability as a peri-procedural guidance tool, TEE will likely remain

essential during Watchman device implantation.

18
Figure Legends

Figure 1. LAA - gross anatomy specimen

Figure 2. Chicken wing LAA morphology

Figure 3. Cauliflower (broccoli) LAA morphology

Figure 4. Windsock LAA morphology

Figure 5. Cactus LAA morphology

Figure 6. Watchman device

Figure 7. 3D TEE full volume multiplane reconstruction of the LAA, with diameter

measurements at the ostium

Figure 8. Transseptal needle tenting the interatrial septum before puncture

Figure 9. Watchman device post deployment

Figure 10. 3D zoom image of a successfully deployed Watchman device.

19
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Table 1. CHADS2 and CHA2DS2-VASc scoring systems

CHADS2 Score CHA2DS2VASc

Points Points
1 C Congestive Heart Failure 1
1 H Hypertension 1
1 A Age ≥75 years 2
1 D Diabetes Mellitus 1
2 S2 Stroke or Transient ischemic attack 2
V Vascular Disease (e.g. peripheral artery disease, 1
myocardial infarction, aortic plaque rupture)
A Age 65-74 years 1
Sc Sex category (female gender) 1

Score Stroke Risk Recommended Anticoagulation

0 Low No antithrombotic therapy (or Aspirin)
1 Moderate Oral anticoagulatant (or Aspirin)
2 High Oral anticoagulant

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Table 2. Contraindications to Watchman device implantation

 Intracardiac thrombus visualized by echocardiographic imaging

 An atrial septal defect repair or closure device, or a patent foramen

ovale repair or closure device

 The LAA anatomy will not accommodate a device

 Any of the customary contraindications for other percutaneous

catheterization procedures (e.g. patient size too small to
accommodate TEE probe or required catheters) or conditions (e.g.
active infection, bleeding disorder)

 Contraindications to the use of warfarin, aspirin, or clopidogrel

 Known hypersensitivity to any portion of the device material or the

individual components

®
Based on WATCHMAN Directions For Use,
https://www.bostonscientific.com/content/dam/Manuals/us/current-rev-en/90746221-
01C_Watchman%20Device_DFU_en-US_s.pdf
th
Last accessed November 28 , 2015.

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