VOL. 65, NO. 15, 2015


ISSN 0735-1097/$36.00


Letters Left Atrial Thrombus Formation After Successful Left Atrial Appendage Ligation

operators, respectively. Of the 964 patients who underwent the procedure, 19 (2%) had an LA thrombus. Table 1 lists some patient characteristics and includes follow-up data of the 19 patients. LA thrombus was detected within 90 days in 15 (79%) patients. TEEs performed in the first 6 months were negative for thrombi in 2 patients with clots

Case Series From a Nationwide Survey

discovered >200 days after the procedure. Eighteen patients received oral anticoagulants after detection

Percutaneous left atrial appendage (LAA) exclusion

of LA thrombus, whereas 1 patient received anti-

can be performed using endocardial occlusion devices

platelet therapy. Thrombus remained unchanged at

or an endoepicardially placed suture delivery device

90 days in the latter patient, requiring a switch to

(1–3). Thrombus formation on endocardial occlusion


devices (Watchman, Boston Scientific, Marlborough,

thrombus resolution. Oral anticoagulation was dis-

Massachusetts; or Amplatzer Cardiac Plug [ACP],

continued in 16 patients after clot resolution, whereas

St. Jude Medical, St. Paul, Minnesota) (1,2) has been

3 patients with unresolved thrombi remained on

attributed to platelet aggregation in the setting of a

anticoagulation (30, 58, and 80 days, respectively).

foreign body in the left atrium (LA). With the percu-

None of the patients had clinical evidence of stroke or

taneous endoepicardial ligation technique (Lariat,

peripheral embolism during follow-up.






SentreHEART, Redwood City, California), there is no

Our study highlights that the risk of LA thrombus

foreign body left behind, and the risk of thrombus

formation with the device is low (2%). Most (79%)

formation should be insignificant. This study de-

cases were detected within the first 90 days. Prompt

scribes the clinical course of LA thrombi after the

initiation of anticoagulation can lead to thrombus

Lariat procedure in 19 patients.

resolution. This is the first investigation to describe

We conducted a nationwide survey of physicians

the clinical course of LA thrombus post-procedure in

performing procedures with the Lariat device in the

a large cohort of patients receiving the Lariat device.

United States to identify patients who developed LA

In a clinical study involving 89 patients, no case of LA

thrombus after the procedure. Our study cohort

thrombus was detected on the 30-day post-procedure

comprised patients found to have LA thrombus post-

TEE. However, 1 patient had an LA thrombus


away from the site of occlusion at 1-year follow-up

Post-procedure surveillance imaging was not uniform

(3). Our study is consistent in that, although un-

across centers. Most patients underwent transesophageal

common, an LA thrombus can develop after the

echocardiogram (TEE)/computed tomography at 1 to


3 months post-procedure. Anticoagulation/antiplatelet

The pathophysiology of LA thrombus formation

therapy was initiated immediately after detection of

after the Lariat procedure remains unclear. Focal

LA thrombus. We collected demographic, clinical, and

endocardial damage and inflammation around the

pre-procedural imaging characteristics of patients.

LAA orifice secondary to tissue compression from the

Procedural variables and clinical course of patients

Lariat suture, causing edema and ischemic necrosis

after thrombus detection were recorded. Statistical

around the ligation site, can increase the propensity

analyses were performed using SPSS version 19.0 for

for LA thrombus formation. In our study, 17 of 19 (89%)

Windows (SPSS, Inc., Chicago, Illinois).

patients developed a thrombus at the ligation site.

A total of 47 operators participated in the survey.

Currently, there are no clear guidelines on LA

Routine post-procedure imaging was performed by 44


(93.6%) operators. Three (6.4%) operators performed

strongly support a follow-up TEE 30 to 90 days






imaging only if clinically indicated. Routine post-

post-procedure. Given that the risk of thrombus

procedure follow-up imaging was performed at 1 to

formation is greatest during the first 3 months post-

3 months and 3 to 6 months by 80% and 40% of the

procedure, it may be appropriate for patients to


JACC VOL. 65, NO. 15, 2015


APRIL 21, 2015:1595–604

T A B L E 1 Patient Characteristics and Follow-Up (n ¼ 19)

Age, yrs

73.6  7.4


13 (68.4)

Mean CHADS2 score

3.1  1.1

Mean CHA2DS2-VASc score

4.5  1.4

Mean HAS-BLED score

4.1  1.3

Post-Lariat anticoagulation*

1 (5.3)

Post-Lariat antiplatelet agents

4 (21.1)

Median time to clot detection, days

46 (17–428)

Location of clot Endocardial surface of the ligated site

1 (5.3)

Within the LAA through the leak into the LA

1 (5.3)

Anticoagulation started

*Center for Excellence in Atrial Fibrillation/ Complex Arrhythmia Management

17 (89.5)

Coumadin ridge Average clot size, mm

Rudolph Evonich, MD Abdi Rasekh, MD James Gray, MD Arun Mahankali Sridhar, MD Mathew Earnest, MD Ryan Ferrell, MD Jayant Nath, MD Yeruva Madhu Reddy, MD

11  10 19 (100)

Bloch Heart Rhythm Center University of Kansas Hospital KU Cardiovascular Research Institute 3901 Rainbow Boulevard MS 4023

7 (36.9)

Kansas City, Kansas 66160-7200

12 (63.2)

E-mail: [email protected]

Clot resolution‡

16 (84.2)

Mean time to clot resolution, days

91 (34–228)

Warfarin Novel oral anticoagulants†

Clinical stroke or thromboembolism

0 (0)

Major bleeding during follow-up

0 (0)

Minor bleeding during follow-up

1 (5.5)

Values are mean  SD, n (%), or median (range). *One patient was on oral anticoagulation but was noncompliant. †One patient was on antiplatelet agents but was switched to novel oral anticoagulants. ‡Three patients are still in follow-up. CHA2DS2-VASc ¼ congestive heart failure, hypertension, age $75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category; CHADS2 score ¼ congestive heart failure, hypertension, age $75 years, diabetes mellitus, stroke/transient ischemic attack; HAS-BLED ¼ hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly (>65 years), drugs/alcohol concomitantly; LA ¼ left atrium; LAA ¼ left atrial appendage.

receive antiplatelet or anticoagulant therapy during this period. The risk of LA thrombus in the absence of anticoagulation use post-procedure is low and is more

Please note: Dr. Lakkireddy has received speakers honoraria from Boehringer Ingelheim, Janssen, Pfizer, and Bristol-Myers Squibb; has served as a consultant for St. Jude Medical and BWI; and has received a research grant from SentreHEART. Drs. Gibson, Price, Valderrábano, Rasekh, and Earnest have received speakers honoraria from SentreHEART. Dr. Feldman has served as a consultant for Abbott, Boston Scientific, and Coherex; and has received research grants/honoraria from Abbott and Boston Scientific. Dr. Valderrábano has a relationship with Boston Scientific, St. Jude Medical, and Medtronic. Dr. Rasekh has served as a proctor for Lariat. Dr. Nath has received an honorarium from Lantheus Medical Imaging. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

REFERENCES 1. Gasparini M, Ceriotti C, Bragato R. Huge left atrial thrombus after left atrial appendage occlusion with a Watchman device. Eur Heart J 2012;33:1998. 2. Cruz-Gonzalez I, Martin Moreiras J, Garcia E. Thrombus formation after left atrial appendage exclusion using an Amplatzer cardiac plug device. Catheter Cardiovasc Interv 2011;78:970–3. 3. Bartus K, Han FT, Bednarek J, et al. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol 2013;62:108–18.

frequently seen during the first 3 months after LAA ligation. Periodic imaging studies are essential for early detection of an LA thrombus. With prompt initiation of anticoagulation and close supervision, an LA thrombus can be managed safely. *Dhanunjaya Lakkireddy, MD Ajay Vallakati, MD Arun Kanmanthareddy, MD Ted Feldman, MD Douglas Gibson, MD Matthew Price, MD David S. Rubenson, MD Jie Cheng, MD Miguel Valderrábano, MD Rajeev R. Fernando, MD Susan T. Laing, MD Eugene Chung, MD Sudharani Bommana, MPhil Donita Atkins, BS Jayasree Pillarisetti, MD Bradley P. Knight, MD

Do Clinical Trials In Ischemic Heart Disease Meet the Needs of Those With Ischemia? Since 1990, multiple randomized clinical trials (RCTs) and subsequent meta-analyses have compared the outcome of percutaneous coronary intervention (PCI) medical therapy for stable ischemic heart disease with no difference in primary outcome (death and/or myocardial infarction [MI]) between the 2 approaches. The reasons for this are not clear. It is certainly possible that there is no difference between the 2 strategies; alternatively, the patient populations may not have been appropriate, or the study hypothesis may not have been sufficiently focused on the right question. From 1980 until now, approximately 195,213 patients have been screened for enrollment in trials, of

Left atrial thrombus formation after successful left atrial appendage ligation: case series from a nationwide survey.

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