JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO.

12, 2017

ª 2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 2405-500X/$36.00

PUBLISHED BY ELSEVIER http://dx.doi.org/10.1016/j.jacep.2017.03.008

CONSIDERATIONS IN LA APPENDAGE CLOSURE

Angiographic Efficacy of the Atriclip

Left Atrial Appendage Exclusion
Device Placed by Minimally Invasive
Thoracoscopic Approach
Christopher R. Ellis, MD,a Sam G. Aznaurov, MD,a Neel J. Patel, MD,a Jennifer R. Williams, MD,a
Kim Lori Sandler, MD,a Steven J. Hoff, MD,b Stephen K. Ball, MD,a S. Patrick Whalen, MD,c John Jeffrey Carr, MDa

ABSTRACT

OBJECTIVES This study sought to assess long-term left atrial appendage (LAA) closure efficacy of the Atriclip applied
via totally thoracoscopic (TT) approach with computed tomographic angiography.

BACKGROUND LAA closure is associated with a low risk for atrial fibrillation–related embolic stroke. The Atriclip
exclusion device allows epicardial LAA closure, avoiding the need for post-operative oral anticoagulation. Previous data
with Atriclip during open chest procedures show a high efficacy rate of closure >95%.

METHODS Three-dimensional volumetric 2-phase computed tomographic angiography $90 days post-implantation
was independently assessed by chest radiology for complete LAA closure on all consented subjects identified
retrospectively as having had a TT-placed Atriclip at Vanderbilt University Medical Center from June 13, 2011, to
October 6, 2015.

RESULTS Complete LAA closure (defined by complete exclusion of the LAA with no exposed trabeculations, and clip within
1 cm from the left circumflex artery) was found in 61 of 65 subjects (93.9%). Four cases had incomplete closure (6.2%).
Two clips were placed too distally, leaving a large stump with exposed trabeculae. Two clips failed to address a secondary
LAA lobe. No major complications were associated with TT placement of the Atriclip. Follow-up over 183 patient-years
revealed 1 stroke in a patient with complete LAA closure and no thrombus (hypertensive cerebrovascular accident).

CONCLUSIONS Angiographic LAA closure efficacy with a TT-placed Atriclip is high (93.9%). The clinical significance of
a remnant stump is unknown. Confirmation of complete LAA occlusion should be made before cessation of systemic
anticoagulation. (J Am Coll Cardiol EP 2017;3:1356–65) © 2017 by the American College of Cardiology Foundation.

From the aVanderbilt University Medical Center, Nashville, Tennessee, USA; b Orlando Health, Cardiovascular and Thoracic, Surgery,
c
Orlando, Florida, USA; and the Wake Forest Baptist Health, Winston-Salem, North Carolina, USA. External funding for the computed
tomographic angiography scans was provided by Atricure Inc. Dr. Ellis has received research funding from Atricure, Medtronic,
and Boston Scientific; and consulting fees from Atricure, SentreHeart, and Boston Scientific. Dr. Hoff has received consulting fees
from Atricure. Dr. Whalen has received consulting fees from Atricure. All other authors have reported that they have no
relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’
institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information,
visit the JACC: Clinical Electrophysiology author instructions page.

Manuscript received December 27, 2016; revised manuscript received March 16, 2017, accepted March 28, 2017.
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 12, 2017
DECEMBER 11, 2017:1356–65
A utopsy studies have implicated the left atrial
appendage (LAA) as the source of thrombus
in >90% of atrial fibrillation (AF)-related
embolic stroke. Observation of a lower than expected
stroke rate after open chest surgery with concomitant
LAA ligation formed the scientific rationale that oblit-
eration of the LAA could potentially reduce AF-related
embolic stroke (1). In 2015, the Watchman LAA closure
device (Boston Scientific, St. Paul, Minnesota) was
approved for stroke risk reduction in patients with
nonvalvular AF who can tolerate short-term warfarin,
but who are deemed unsuitable for long-term oral
anticoagulation (OAC) treatment (2). Complete LAA
closure seems essential to provide stroke protection,
surgical data point to an increased risk for embolic
stroke in the setting of an incomplete LAA closure,
and leaks with the Lariat device (SentreHeart, Red-
wood City, California) have also been implicated in
late onset of AF-related embolic stroke (3–5). It is
unclear whether small leaks of contrast on computed
tomography (CT) or transesophageal echocardio-
graphy (TEE) with the Watchman or the Amplatz
Cardiac Plug device (St. Jude Medical, St. Paul,
Minnesota) also confer an increased embolic risk (6–9).
SEE PAGE 1366
The Atriclip and Atriclip PRO (Atricure, West Ches-
ter, Ohio) LAA occlusion devices have been evaluated
for LAA closure at the time of concomitant open heart
surgery under direct visualization, and high closure
success was demonstrated in the EXCLUDE (Exclusion
of the Left Atrial Appendage with a Novel Device: Early
Results of a Multicenter Trial) by TEE or computed
tomographic angiography (CTA) at 90-day follow-up
(10). The Atriclip can be placed by a totally thoraco-
scopic (TT) approach as a stand-alone off-label therapy
for LAA closure in absolute OAC contraindicated
patients or in a hybrid endocardial-epicardial catheter
ablation strategy mimicking the Cox-Maze IV to treat
long-standing persistent AF (11). However, LAA
closure efficacy by placement of the Atriclip device via
a TT approach has not previously been published nor
formally evaluated. We sought to confirm closure
efficacy by CT angiography in long-term follow-up
on patients who underwent a TT-placed Atriclip or
Atriclip PRO at our institution.
METHODS
The study protocol was designed as a single-arm
CTA assessment of LAA closure in patients who
had previously had placement of an Atriclip LAA
occlusion device through a completely thoracoscopic
approach. The protocol was approved by Vanderbilt
Ellis et al. 1357
Angiographic Efficacy of the Atriclip LAA Exclusion Device
University’s Institutional Review Board and ABBREVIATIONS
all subjects provided informed consent. All AND ACRONYMS
subjects undergoing LAA closure at Vanderbilt
3D = 3-dimensional
University Medical Center available for con-
AF = atrial fibrillation
sent agreed to participate in the VaLAAR
ASA = acetylsalicylic acid
(Vanderbilt LAA Registry), which is inclusive
of all LAA closure technologies. TT-placed CT = computed tomography
Atriclip subjects whose device was implan- CTA = computed tomographic
angiography
ted at Vanderbilt University Medical Center
LA = left atrium/left atrial
(operative placement of the Atriclip or Atriclip
PRO between June 13, 2011, and October 6, LAA = left atrial appendage
2015) were eligible. Eighty-one patients MRI = magnetic resonance
imaging
were identified and available for long-term
OAC = oral anticoagulation
follow-up at Vanderbilt Medical Center,
and 65 subjects consented to participate TEE = transesophageal
echocardiography
in the formal CTA study protocol. A dedicated
TT = totally thoracoscopic
3-dimensional (3D) CTA for LAA closure
assessment was then performed prospectively on
those 65 subjects alone between November 11, 2015,
and June 29, 2016 (Figure 1).
CTA was performed $90 days post-implantation.
Patients with iodine contrast allergy were pre-treated
to avoid anaphylactoid reactions in accordance with
Vanderbilt Department of Radiologic Sciences proto-
col. Then 3D volumetric 2-phase CTA was performed to
assess the presence of any contrast leak or exposed
LAA trabeculations, to define the characteristics of a
residual stump, and to objectively assess clip position
in relation to the left circumflex coronary artery. CTA
interpretation and data were independently obtained
and reviewed by Vanderbilt University Department of
Radiologic Science chest radiologists. LAA ostial
location was assigned not by any single fixed anatomic
landmark, but rather by use of multiplanar reformats
(coronal, sagittal, 3D) simultaneously to best identify
the epicardial LAA to LA body junction. All measure-
ments were made in the axial plane. Successful LAA
closure was defined as complete exclusion of the
entire trabeculated LAA. Patient demographics, base-
line medication use, and outcomes regarding stroke
and AF were obtained through direct patient interview
at the time of CTA and review of the electronic medical
record (StarPanel, Vanderbilt University Department
of Informatics, Nashville, Tennessee). The decision to
continue or withhold OAC treatment after review of
the CTA result was at the discretion of the managing
cardiac electrophysiologist. Baseline CTA, cardiac
magnetic resonance imaging (MRI), or pre-procedure
and intraoperative TEE were used to categorize LAA
anatomy before clip placement.
SURGICAL DESCRIPTION OF PLACEMENT OF THE
ATRICLIP/ATRICLIP PRO. Total thoracoscopic uni-
lateral or bilateral access was performed in a hybrid
1358 Ellis et al. JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 12, 2017

Angiographic Efficacy of the Atriclip LAA Exclusion Device DECEMBER 11, 2017:1356–65

F I G U R E 1 Study Patient Flow for Identification and Consent for CTA to Evaluate LAA Closure

Patient flow chart for subject identification and evaluation. Patients from the Vanderbilt left atrial appendage (LAA) registry with an
Atriclip were identified. Those with thoracoscopic placement only were contacted. Patients with renal failure were excluded due to contrast
load for computed tomographic angiography (CTA). A total of 65 subjects completed the formal CTA protocol. AVR ¼ aortic valve replacement;
CABG ¼ coronary artery bypass graft; GFR ¼ glomerular filtration rate; MVR ¼ mitral valve replacement; TT ¼ totally thoracoscopic.

electrophysiology lab operating room with single lung RESULTS

ventilation via a dual lumen endotracheal tube.
Dissection and direct visualization of the pulmonary
veins and LAA were accomplished in sequential
fashion (in setting of hybrid AF ablation, right thorax
followed by left-side approach). Epicardial ablation
was performed in cases undergoing hybrid AF abla-
tion before LAA closure. LAA was occluded epi-
cardially with a specially designed atrial appendage
clip and applicator (Atriclip, Atriclip PRO). Complete
LAA occlusion was confirmed using intraoperative
TEE and direct visualization at the completion of
surgery in all subjects, epicardial landmarks for
proper closure included the visible LAA neck to LA
interface and location of the ligament of Marshall,
LAA ridge to left-sided pulmonary veins,
left circumflex coronary artery. In all subjects, intra-
operative TEE was used to confirm closure of the LAA
to the satisfaction of the implanting cardiac surgeon
and cardiac anesthesiologist.
This prospective CT angiographic LAA closure
study was designed, overseen, and analyzed by the
authors as an investigator-initiated study. The pro-
tocol was approved by and reviewed by the radiation
safety committee of Vanderbilt University Institu-
tional Review Board and Department of Radiology
and Radiologic Sciences.
Patients who had previously undergone a TT-placed
Atriclip device and were followed at Vanderbilt Uni-
versity Medical Center from June 13, 2011, to October 6,
2015, were identified (n ¼ 81). All 65 subjects who
consented for the study completed a dedicated 3D CTA
assessment for efficacy of the Atriclip for LAA closure.
Demographics of the study cohort are listed in Table 1.
There were 50 male subjects (76.9%) representing a
significant sex bias as seen previously in patients
referred for AF ablation. Average LA diameter was 5.6
 7.5 mm, with LA volume 140  46.2 ml representing a
cohort with high prevalence of chronic or long-
standing AF. The mean CHADS 2-VASc score of the
and cohort was 2.48  1.54, accounted for by type I or II
diabetes (n ¼ 15), essential or malignant hypertension
(n ¼ 51), systolic or diastolic congestive heart failure
(n ¼ 8), prior stroke or transient ischemic attack (n ¼ 7),
age $65 years (n ¼ 40), age $75 years (n ¼ 6), vascular
disease (n ¼ 9), and female (n ¼ 15). Mean HAS-BLED
(Hypertension, Abnormal renal and liver function,
Stroke, Bleeding, Labile international normalized ra-
tio, Elderly, prior Drug or alcohol usage history) score
was 2.22  1.24. Mean duration from Atriclip placement
to CTA assessment was 1,029.4  375.0 days, repre-
senting a chronic stable Atriclip position. Mean
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 12, 2017 Ellis et al. 1359
DECEMBER 11, 2017:1356–65 Angiographic Efficacy of the Atriclip LAA Exclusion Device

duration of follow-up from TT Atriclip placement to

T A B L E 1 Patient Demographics (N ¼ 65)
study completion was 3.48  1.03 years.
Simultaneous or staged hybrid endocardial/ n (%) Mean  SD Median Q1

epicardial ablation for persistent AF was the indi- Age, yrs 64.54  8.75 66 61
Male 50 (76.92)
cation for initial Atriclip placement in 56 subjects
AF subtype (persistent) 53 (81.53)
(86.2%). Patients undergoing same-day hybrid AF
AF subtype (paroxysmal) 12 (18.46)
ablation remained on OAC for 90 days post- CHADS2-VASc 2.48  1.54 2 1
procedure, and staged hybrid patients remained on HAS-BLED 2.22  1.24 2 1
OAC for an additional 90 days after endocardial Concurrent AF ablation 56 (86.15)
catheter ablation. Adequate LAA closure (defined by Baseline medications
complete exclusion of the LAA with no exposed Aspirin 25 (38.46)
P2Y12 5 (7.69)
trabeculations, and clip placement within <1 cm
Warfarin 40 (61.54)
from the left circumflex artery) was found by CTA in
NOAC 17 (26.15)
61 of 65 subjects (93.9%). Closure confirmation and
AAD 26 (40.00)
detailed radiologic assessment of the clip position Follow-up, final
and atrial volume are detailed in Table 2. A smooth- Aspirin 35 (53.84)
walled residual LAA stump was noted in 35 subjects P2Y12 5 (7.69)
(54.7%) with mean dimensions of 2.1-cm width by Warfarin 6 (9.23)

1.4-cm depth. Only 2 subjects had a stump with any NOAC 6 (9.23)
AAD 6 (9.23)
visible trabeculations. There were no identified
Outcomes
thrombi in any subject regardless of stump presence.
TIA/stroke/systemic embolism 1 (1.54)
Representative cases of complete LAA closure and
ICH
no stump, or smooth-walled <2-cm stump are Major bleed, transfusion 1 (1.54)
shown in Figure 2. Typical orientation of the Atriclip Minor bleed, no transfusion 1 (1.54)
in relation to the left circumflex artery is shown Rhythm at last follow-up
in Figure 3. AF 3 (4.62)

There were 4 cases with incomplete LAA closure
(6.15%). In 2 cases, the clip was placed too distally,
leaving a large stump with exposed trabeculated
segments (Figure 4), 2 clips failed to address a sec-
ondary or posteriorly rotated LAA lobe (Figure 5).
In patients undergoing hybrid staged ablation,
electroanatomic and voltage mapping of the residual
stump demonstrated atrial electrograms present
in the stump; however, spontaneous ectopy or AF
induction was not seen. Standard intraprocedural
testing included adenosine (12- to 24-mg bolus)
and isuprel challenge (5- to 20-m g/min infusion
when tolerated hemodynamically). Endocardial
ablation at the LAA stump was not part of the
Paced rhythm 8 (12.31)
Sinus rhythm 54 (83.08)
AAD ¼ anti-arrhythmic drug; AF ¼ atrial fibrillation; CHADS2-VASc ¼ Congestive heart failure, Hypertension,
Age $75 years, Age 65 to 74 years, Diabetes mellitus, Stroke/TIA/thromboembolism, Vascular disease, Sex;
HAS-BLED ¼ Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized
ratio, Elderly, prior Drug or alcohol usage history; ICH ¼ intra-cranial hemorrhage; NOAC ¼ non-oral anti-
coagulation; Q1 ¼ first quartile; TIA ¼ transient ischemic attack.
at least to the satisfaction of the cardiac anesthesia
and cardiac surgical teams at time of implantation.
This was reviewed and confirmed, although clip
positon and LAA closure was not formally imaged at
T A B L E 2 CTA LAA Closure Data

index lesion set in the patients undergoing hybrid n (%) Mean  SD Median Q1 Q3
ablation. Days to scan 1,029.41  375.06 1,067.0 831.0 1,225.00
Of the remaining 16 subjects who did not undergo Stump, smooth-walled 35 (54.7)
the dedicated 3D CTA protocol, 12 had consented for Stump, with trabeculation 4 (6.15)

VaLAAR, but they did not consent to the additional Stump diameter, mm 20.71  6.72 19.3 16.9 25.20
Stump depth, mm 13.73  6.41 13.0 8.85 17.35
CTA to assess closure. All 12 had complete LAA
Thrombus 0 (0)
closure by previously available and clinically indi-
LA volume, cm3 139.88  46.21 133.0 112.8 156.00
cated TEE (n ¼ 5), cardiac MRI (n ¼ 2), or CT chest
LA diameter AP, mm 56.00  7.50 50.0 46.0 55.00
with contrast (n ¼ 5) performed outside of the formal LA diameter transverse, mm 69.50  11.30 69.0 61.0 77.00
CTA study protocol, but at least 90 days from TT Atriclip distance from circumflex, mm 5.84  3.33 5.1 3.5 7.80
Atriclip implantation. An additional 4 subjects did not Atriclip distance from PV, mm 6.02  3.71 5.3 3.5 7.50
provide consent for evaluation. Review of intra-
AP ¼ anterior-posterior; CTA ¼ computed tomographic angiography; LA ¼ left atrial; LAA ¼ left atrial
procedural TEE data and operative notes state all appendage; PV ¼ pulmonary vein(s); Q1 ¼ first quartile; Q3 ¼ third quartile.
subjects had complete closure by echocardiography,
1360 Ellis et al. JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 12, 2017

Angiographic Efficacy of the Atriclip LAA Exclusion Device DECEMBER 11, 2017:1356–65

F I G U R E 2 Complete LAA Closure With Atriclip Showing No Stump or a <2-cm Smooth-Walled Stump

Examples of 4 subjects with complete left atrial appendage (LAA) closure and no significant (<2 cm) LAA stump. A total of 61 of 65 subjects had
LAA closure with comparable computed tomographic angiography (CTA). See Online Videos 1 and 2.

0 , 45  , 90 , and 135  across the LAA ostium and body morphologies. The posterior rotated chicken wing case
as is now standard during percutaneous LAA closure. was a stand-alone TT Atriclip placement. Baseline
Baseline LAA anatomy was verified by CTA, cardiac anatomy of the LAA did not predict failure to
MRI, and TEE data evaluated before placement of the completely occlude the LAA with Atriclip.
Atriclip. There were 17 windsock (single dominant lobe
of sufficient length), 12 cauliflower/broccoli (complex COMPLICATIONS OF TT PLACEMENT OF THE
internal characteristics), 11 anterior rotated chicken ATRICLIP DEVICE. Placement of the Atriclip
wing, 13 posterior rotated chicken wing (behind the appeared to be safe. Major surgical complications at
pulmonary artery), and 12 superior-C loop LAA mor- 30 days after Atriclip placement were ascertained
phologies. Incomplete closure occurred in 2 superior-C retrospectively. There were no procedure-related
loop, 1 posterior rotated chicken wing, and 1 windsock myocardial infarctions, no evidence of damage or
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 12, 2017 Ellis et al. 1361
DECEMBER 11, 2017:1356–65 Angiographic Efficacy of the Atriclip LAA Exclusion Device

compression of the left circumflex coronary artery in

F I G U R E 3 Typical Orientation of the Atriclip in Relation to Left Circumflex
any subject clinically, nor in long-term follow-up by Coronary Artery
CTA. Additionally no acute pericardial effusion,
pleural effusion, myocardial perforation, or LAA
perforation occurred with Atriclip or Atriclip PRO
placement. There was 1 case of hypotension requiring
pressors post-procedure due to significant volume
shifts with hyponatremia. One subject had thoracic
bleeding within 24 h post-operatively, requiring
transfusion presumed due to bleeding from inter-
costal vessel after thoracoscopy port placement. One
subject had access site bleeding not requiring trans-
fusion or intervention (hybrid AF ablation case). For
those subjects undergoing stand-alone TT Atriclip
placement (n ¼ 9), 3 were placed in the setting of
failed subxiphoid Lariat ligation attempt, 3 were
before available percutaneous technologies in pa-
tients with contraindication to long-term OAC, and 3
in the setting of a posterior chicken wing (behind
pulmonary artery) location. The mean total procedure
time for stand-alone TT Atriclip placement was
92 min, mean anesthesia time was 207.6 min, and
average length of stay was 4.88 days. There were no Atriclip position in relation to left circumflex coronary artery. No subject had any visible
complications associated with the stand-alone TT compression of the circumflex.

Atriclip procedure. Mean length of stay was pro-

longed primarily from 2 cases of Atriclip placement
following failed Lariat placement due to availability
of CT surgeon scheduling at index hospitalization.
ANTICOAGULATION MANAGEMENT. At last follow-
up, 12 patients remained on OAC treatment
(warfarin, n ¼ 6; rivaroxaban, n ¼ 2; apixaban, n ¼ 2;
dabigatran, n ¼ 2) for a variety of clinical indications
including malpositioned Atriclip (n ¼ 3), history of
deep vein thrombosis or pulmonary embolism (n ¼ 2),
prior embolic events and thrombus on OAC therapy
(n ¼ 2), persistent arrhythmia undergoing cardiover-
sion or ablation (n ¼ 4), and patient preference (n ¼ 1).
Before placement of the Atriclip, 57 of 65 patients
were on OAC therapy. In follow-up, there was a single
stroke (n ¼ 1) over 183 patient-years that occurred in a
patient with confirmed complete closure of the LAA
by Atriclip and no cardiac thrombus at TEE. Hyper-
tensive urgency with lacunar infarct was confirmed
by cerebral diffusion-weighted brain MRI; this subject
was not on OAC therapy when the stroke occurred.
Antiplatelet therapy consisted of 81 mg daily ace-
tylsalicylic acid (ASA) in 35 subjects; no subject was
on 325-mg dose ASA; 4 patients were on long-term
clopidogrel 75 mg daily; and 1 subject was on long-
term ticlopidine. The decision to resume OAC was
made after the CTA results were evaluated in 2 of the
subjects with incomplete LAA closure. Two subjects
with incomplete LAA closure had absolute
contraindication to OAC medications and remained
on antiplatelet therapy alone.
RHYTHM MANAGEMENT. At the final follow-up, 54
patients were in sinus rhythm on electrocardiog-
raphy, 8 patients were in paced rhythm (cardiac
resynchronization therapy or right ventricular pacing
due to prior atrioventricular nodal junction ablation
with permanent AF in 3 patients, atrial paced rhythm
due to sinus node dysfunction in 5 patients). An
additional 3 patients without devices were in AF on
electrocardiography.
DISCUSSION
Evolving nonpharmacologic stroke prevention stra-
tegies in nonvalvular AF patients have become a
viable alternative to OAC treatment; however, the
U.S. Food and Drug Administration–labeled options
for patients in the United States are limited to the
Watchman LAA Occluder. The Watchman is specif-
ically not labeled for patients who are contraindicated
to OAC treatment, and thus, off-label use of the Lariat
suture ligation tool and thoracoscopic Atriclip device
have been pursued as alternatives (12–16). The
Watchman has been used clinically in patients with
contraindications to OAC therapy in the ASAP (ASA
Plavix Feasibility Study With Watchman Left Atrial
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Angiographic Efficacy of the Atriclip LAA Exclusion Device DECEMBER 11, 2017:1356–65

F I G U R E 4 Incomplete Closure in 2 Subjects Where Atriclip Was Placed Too Distally, Leaving Exposed LAA Trabeculae and Long Neck

Incomplete left atrial appendage (LAA) closure was noted in 4 subjects. Two were related to the clip being placed distal on the LAA with
exposure of proximal trabeculated LAA tissue. CX ¼ circumflex artery.

Appendage Closure Technology) and will be tested
formally in a randomized fashion against antiplatelet
therapy alone in the ASAP-TOO (Assessment of the
Watchman Device in Patients Unstable for Oral Anti-
coagulation) trial (12).
Our study represents the first formal angiographic
assessment of chronic position of the Atriclip and
evaluation for contrast leaks or ineffective LAA
closure. We found a high success rate for closure by
3D CTA with no associated thrombus or embolic
strokes in a cohort of 65 patients over 183 patient-
years. Previous published studies demonstrate peri-
device or central leaks by TEE or CTA in up to 32% of
Watchman devices, 20% of Lariat devices, and 36% of
Amplatz Cardiac Plug LAA closures (5–9). Though no
head-to-head clinical trials for LAA closure tech-
niques exist, the TT Atriclip closure efficacy compares
favorably, and our results show complete closure is
likely higher than for percutaneous device–based or
suture-based approaches.
Previously published data have established a lower
than expected rate of stroke or transient ischemic
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 12, 2017 Ellis et al. 1363
DECEMBER 11, 2017:1356–65 Angiographic Efficacy of the Atriclip LAA Exclusion Device

F I G U R E 5 Incomplete Closure in 2 Subjects Related to Failure to Ligate a Retroflexed or Posteriorly Rotated LAA Lobe

Incomplete left atrial appendage (LAA) closure due to failure to completely occlude an accessory or posterior rotated distal LAA lobe.

attack in follow-up on patients undergoing LAA
ligation at the time of cardiac surgery; however, more
recent data show that surgical closure is often
ineffective. In a recent 2016 pilot study, incomplete
LAA closure by surgical excision, stapled excision, or
internal suture ligation was 57% when formally
assessed by TEE in all subjects post-operatively (4).
A recent evaluation of LAA surgical closure at a mean
of 44 months of follow-up showed ischemic stroke
or systemic embolism occurred in 2% of patients with
complete LAA closure versus 24% with incomplete
LAA closure (all subjects had confirmed AF and were
not on systemic anticoagulation) and 0% with smooth
LAA stump (p ¼ 0.006) (17). The importance of
documentation of complete LAA closure before a
decision to stop systemic anticoagulation in patients
with known AF cannot be understated. Additionally,
failure to completely excise the LAA, when LAA
closure is performed during open chest procedures,
has been associated with increased late neurologic
events in long-term follow-up, supporting the need
for a device that can completely seal the LAA orifice
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Angiographic Efficacy of the Atriclip LAA Exclusion Device DECEMBER 11, 2017:1356–65

at the time of surgery (18). The EXCLUDE study stroke or systemic embolic events, regardless of the
used a variety of methods to assess closure during use of systemic anticoagulation therapy. Whether
concomitant or open chest placement of the clip (10). closure efficacy would be improved in a lower risk AF
However, open chest surgery solely for ligation of cohort with smaller LA volume and windsock only
the LAA likely is not a viable methodology in most LAA anatomy is unknown. Online Videos 1 and 2
cases. Additionally, the EXCLUDE study did not demonstrate a typical Atriclip TT placement from
include Atriclips placed by TT approach, and in the our series with careful identification and closure of a
verification for LAA closure assessment, there was no second LAA lobe, which was initially not appreciated
formal imaging protocol. on intraoperative TEE.
The ability to place an Atriclip through thoraco-
STUDY LIMITATIONS. Due to the retrospective nature
scopic approach alone is appealing as it can be per-
of patient selection, all subjects having a previously
formed as a stand-alone therapy with an average case
implanted Atriclip by TT approach at Vanderbilt did
time in our series of 92 min and does not mandate any
not consent to the additional CTA. There were 81
post-operative systemic anticoagulation therapy. Our
subjects identified with TT-placed Atriclip between
experience has largely been with Atriclip placement
June 13, 2011, and October 6, 2015; however, only 65 of
during thoracoscopic hybrid AF ablation or following
81 available subjects consented to study after review of
failed attempts at other LAA closure technologies
the risks and benefits of additional dedicated CTA for
(11,13). The majority of patients implanted in our
LAA closure. This may introduce bias in the results
series were challenging persistent or long-standing
given the small sample size if those subjects did not
persistent AF cases or those with LAA anatomy
follow similar trends in angiographic closure. Addi-
unsuitable for closure by subxiphoid suture ligation
tional modality imaging (MRI, TEE) was available for
in the setting of contraindications to long-term
12 of the remaining 16 subjects and supported a high
anticoagulation treatment. The experience with TT
rate of LAA closure efficacy. Stroke data were ascer-
placement during hybrid AF ablation can likely be
tained by chart review and as such are subject to po-
extrapolated to clip closure for stand-alone cases,
tential bias in reporting. Whether exposed trabeculae
with an expected reduction in overall adverse
or smooth-walled stumps after Atriclip provide a nidus
events through avoidance of entry into the right
for LAA or LA thrombus formation when subjects stop
thorax. Patient selection for LAA closure with a
OAC therapy is unknown and warrants investigation.
thoracoscopic approach is limited if the patient
The primary objective of this study was to assess LAA
cannot tolerate single lung ventilation or has under-
closure efficacy and is hypothesis-generating only, as
gone previous sternotomy or significant thoracic
there was no formal internal comparator cohort to
irradiation.
alternative methods of LAA closure.
Our study does demonstrate that despite direct
visualization of the LAA during TT placement of an
CONCLUSIONS
Atriclip, with intraoperative TEE visualization,
closure may not be completely effective. We have
Angiographic LAA closure efficacy with a TT-placed
seen that direct manual compression of a lobe of the
Atriclip is high (93.9%). The clinical significance of a
LAA using the Atriclip applicator can appear on TEE
smooth-walled remnant stump is unknown. Confir-
as complete occlusion and only after the compression
mation of complete occlusion should be made to
is released is the lobe allowed to refill with blood.
ensure effective LAA closure before cessation of sys-
Follow-up imaging with TEE or CTA will confirm
temic anticoagulation treatment.
closure was not complete (13). This may take several
minutes to hours and should warrant careful TEE ACKNOWLEDGMENT The authors acknowledge
assessment intraoperatively, likely in multiple angles Amanda Carroll, RN, who was integral in conduct of
through the LAA as with endocardial occlusion device the trial.
implantation. Additionally, the shape and application
of the Atriclip device lends itself to a closure location ADDRESS FOR CORRESPONDENCE: Dr. Christopher R.
more typically at the neck of the LAA, rather than true Ellis, Vanderbilt University Medical Center, Cardiac
ostial occlusion, as evidenced by the high prevalence Electrophysiology Laboratory, LAA Closure Program,
of a smooth-walled stump in our series (54.7%, mean Medical Center East, South Tower, Suite 5209, 1211
dimensions of 2.1-cm width by 1.4-cm depth). How- Medical Center Drive, Nashville, Tennessee 37232-8802,
ever, presence of this stump was not associated with USA. E-mail: christopher.ellis@vanderbilt.edu.
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 12, 2017 Ellis et al. 1365
DECEMBER 11, 2017:1356–65 Angiographic Efficacy of the Atriclip LAA Exclusion Device

PERSPECTIVES

COMPETENCY IN MEDICAL KNOWLEDGE: Closure TRANSLATIONAL OUTLOOK: This CTA study of

of the LAA for prevention of AF-related embolic stroke
has become a viable option for patients unsuitable for
long-term OAC therapy. Methods for ligation, occlusion,
or removal of the LAA vary in efficacy when assessed for
residual leaks into the remnant LAA and incomplete sur-
gical ligation has been associated with increased stroke
risk.
thoracoscopic-placed Atriclip device demonstrates a high
rate of effective closure (93%), but caution remains to
ensure the entire LAA is captured when the clip is
released. A decision regarding cessation of OAC following
Atriclip placement should be guided by formal imaging to
confirm complete closure of the LAA.

REFERENCES

1. Blackshear JL, Odell JA. Appendage obliteration
to reduce stroke in cardiac surgical patients with
atrial fibrillation. Ann Thorac Surg 1996;61:755–9.
2. Reddy VY, Sievert H, Halperin J, et al., for the
PROTECT AF Steering Committee and In-
vestigators. Percutaneous left atrial appendage
closure vs warfarin for atrial fibrillation: a ran-
domized clinical trial (erratum JAMA 2015;313:
1061). JAMA 2014;312:1988–98.
3. Healey JS, Crystal E, Lamy A, et al. Left Atrial
Appendage Occlusion Study (LAAOS): results of a
randomized controlled pilot study of left atrial
appendage occlusion during coronary bypass sur-
gery in patients at risk for stroke. Am Heart J
2005;150:288–93.
4. Lee R, Vassallo P, Kruse J, Malaisrie SC,
Rigolin V, Andrei AC, McCarthy P. A randomized,
prospective pilot comparison of 3 atrial appendage
elimination techniques: internal ligation, stapled
excision, and surgical excision. J Thorac Cardiovasc
Surg 2016;152:1075–80.
5. Gianni C, Di Biase L, Trivedi C, et al. Clinical
implications of leaks following left atrial
appendage ligation with the Lariat device. J Am
Coll Cardiol Intv 2016;9:1051–7.
6. Lee RJ. Clinical significance of leaks following
left atrial appendage ligation with the LARIAT
suture delivery device. J Am Coll Cardiol Intv
2016;9:1058–60.
7. Pillarisetti J, Reddy YM, Gunda S, et al. Endocar-
dial (Watchman) vs epicardial (Lariat) left atrial
appendage exclusion devices: understanding the
differences in the location and type of leaks and their
clinical implications. Heart Rhythm 2015;12:1501–7.
8. Viles-Gonzalez JF, Kar S, Douglas P, et al. The
clinical impact of incomplete left atrial appendage
closure with the Watchman Device in patients with
atrial fibrillation: a PROTECT AF (Percutaneous
Closure of the Left Atrial Appendage Versus
Warfarin Therapy for Prevention of Stroke in Pa-
tients With Atrial Fibrillation) substudy. J Am Coll
Cardiol 2012;59:923–9.
9. Jaguszewski M, Manes C, Puippe G, et al. Car-
diac CT and echocardiographic evaluation of peri-
device flow after percutaneous left atrial
appendage closure using the Amplatzer cardiac
plug device. Catheter Cardiovasc Interv 2015;85:
306–12.
10. Ailawadi G, Gerdisch MW, Harvey RL, et al.
Exclusion of the left atrial appendage with a novel
device: early results of a multicenter trial. J Thorac
Cardiovasc Surg 2011;142:1002–9.
11. Richardson TD, Shoemaker MB, Whalen SP,
Hoff SJ, Ellis CR. Staged versus simultaneous
thoracoscopic hybrid ablation for persistent atrial
fibrillation does not affect time to recurrence of
atrial arrhythmia. J Cardiovasc Electrophysiol
2016;27:428–34.
12. Reddy VY, Möbius-Winkler S, Miller MA, et al.
Left atrial appendage closure with the Watchman
device in patients with a contraindication for oral
anticoagulation: the ASAP study (ASA Plavix
Feasibility Study With Watchman Left Atrial
Appendage Closure Technology). J Am Coll Cardiol
2013;61:2551–6.
13. Aznaurov SG, Ball SK, Ellis CR. Thoracoscopic
Atriclip closure of left atrial appendage after failed
ligation via Lariat. J Am Coll Cardiol Intv 2015;8:
e265–7.
14. Lakkireddy D, Afzal MR, Lee RJ, et al. Short
and long term outcomes of percutaneous left
atrial appendage suture ligation: results from a
United States multicenter evaluation. Heart
Rhythm 2016;13:1030–6.
15. Chatterjee S, Herrmann HC, Wilensky RL, et al.
Safety and procedural success of left atrial
appendage exclusion with the lariat device: a
systematic review of published reports and ana-
lytic review of the FDA MAUDE database. JAMA
Intern Med 2015;175:1104–9.
16. Sievert H, Rasekh A, Bartus K, et al. Left atrial
appendage ligation in nonvalvular atrial fibrillation
patients at high risk for embolic events with inel-
igibility for oral anticoagulation: Initial report of
clinical outcomes. J Am Coll Cardiol EP 2015;1:
465–74.
17. Aryana A, Singh SK, Singh SM, et al. Associa-
tion between incomplete surgical ligation of left
atrial appendage and stroke and systemic embo-
lization. Heart Rhythm 2015;12:1431–7.
18. Lee R, Jivan A, Kruse J, et al. Late neurologic
events after surgery for atrial fibrillation: rare but
relevant. Ann Thorac Surg 2013;95:126–31; dis-
cussion, 131–2.
KEY WORDS anticoagulation, atrial
fibrillation, left atrial appendage, stroke,
thoracoscopy
A PPE NDI X For supplemental videos,
please see the online version of this paper.