A review of the LARIAT device: insights from the cumulative clinical experience
© Srivastava et al. 2015
Received: 2 July 2015
Accepted: 28 August 2015
Published: 17 September 2015
Atrial fibrillation (AF) is the most common arrhythmic disorder world-wide, accounting for 15 % of all strokes. Management of stroke risk in AF is complicated by intolerance of anti-coagulation (AC) therapy and difficulty maintaining therapeutic range in patients treated with warfarin. The left atrial appendage (LAA) is a source of thrombus in AFrelated thrombo-embolic events and surgical LAA exclusion (LAAO) is commonly performed during cardiac surgery in AF patients. Surgical approaches are limited by a high incidence of incomplete closure with a potential for consequent thrombo-embolic events as well as the morbidity of an open-heart procedure. More recently, percutaneous approaches to LAAO have been developed. The LARIAT device is an epicardial LAA exclusion system that enables percutaneous suture ligation of the LAA via combined, pericardial and trans-septal access. The device has 510k Federal Drug Administration (FDA) clearance for soft-tissue ligation and has been studied in canine models in pre-clinical studies as well as published series of clinical experience with LARIAT LAAO. The history, patient selection, procedural technique and complications of LARIAT LAAO are reviewed here. Additionally, insights and procedural improvements that have been elucidated from clinical series and outcomes from the collective experience are discussed. The LARIAT’s epicardial approach to LAA ligation is unique compared with other percutaneous LAA exclusion devices, however more data regarding device safety and efficacy is needed for the LARIAT to emerge as an established therapy for stroke prevention in AF.
KeywordsPercutaneous left atrial appendage closure devices Atrial fibrillation Embolic stroke Epicardial ligation
Atrial fibrillation (AF) is the most common arrhythmic disorder worldwide, affecting approximately 2.3 million people in the United States and 4.5 million in the European Union (January et al. 2014). With age, the prevalence and disease burden of AF increases, accounting for 15 % of all strokes and with greater associated morbidity and mortality than non-AF related strokes (January et al. 2014; Connolly et al. 2009). Oral anti-coagulation (AC) is the mainstay of stroke prevention therapy but is complicated by bleeding events and prescribing complexity, with only 50–60 % of patients treated with warfarin consistently in therapeutic range (Go et al. 1999). New oral anti-coagulants (NOACs) such as the direct thrombin inhibitor, dabigatran, and factor Xa inhibitors, rivaroxaban and apixaban, provide consistent AC compared with Coumadin but are limited by bleeding complications, expense and inability to expeditiously reverse these agents during an acute bleeding event (Connolly et al. 2009; Patel et al. 2011; Granger et al. 2011). These challenges have led to a focus on alternate therapies to reduce stroke risk in patients with AF.
The left atrial appendage (LAA) has a narrow-orifice with a tubular, trabeculated structure that fibrillates rather than contracts in AF, resulting in blood stasis and predisposition to thrombus formation (Al-Saady et al. 1999; Kanmanthareddy 2014). In a meta-analysis of 23 studies of AF patients, thrombus, when present, was localized to the LAA in 91 % of patients with non-valvular AF. The implication of the LAA as a primary source of thrombus for thrombo-embolic events in non-valvular AF has made it a veritable target for stroke reduction.
Surgical LAA exclusion by excision or ligation of the LAA, when combined with the Cox-Maze procedure, has demonstrated proficiency in reducing subsequent stroke risk (Bonow et al. 2008; Cox et al. 1999). Notably, a 36 % incidence of incomplete exclusion with surgical ligation alone has been observed and associated with thrombus formation in the partially excluded LAA as well as subsequent thrombo-embolic events (Katz et al. 2000). The flaccid state of the LAA on cardiac bypass and proximity of the circumflex artery to the base of the LAA, have been proposed etiologies of sub-optimal success with surgical approaches. Excision of the LAA provides more consistent results and the 2014 AHA/ACC/HRS Guidelines for the management of atrial fibrillation provide a Class IIB/Level of Evidence C, recommendation for surgical excision of the LAA in patients undergoing cardiac surgery (January et al. 2014). However, surgical excision remains limited by the morbidity of an open-heart procedure and lack of robust efficacy data. Surgical experience has inspired and informed the development of percutaneous left atrial appendage occlusion (LAAO) devices. The LARIAT ligation system is currently the most studied percutaneous epicardial LAAO device.
The LARIAT device was developed by a cardiothoracic surgeon and has United States Federal Drug Administration (US FDA) 510k clearance for the indication of soft-tissue approximation with greater than 2000 implants world-wide for LAA ligation (Price and Gibson 2014). A second generation of the device accommodating larger LAAs is also now commercially available. The LARIAT system accomplishes percutaneous delivery of a suture that snares the LAA epicardially, at its os, via trans-septal and pericardial access. Pre-clinical canine studies demonstrated angiographic LAA exclusion utilizing LARIAT LAAO, confirmed by macroscopic evaluation and showed progressive LAA atrophy and endothelialization of the LAA orifice in a time-dependent manner from ligation (Lee et al. 2010). The utility of an endoluminal, balloon, placed at the os of the LAA to guide LARIAT snare placement and prevent suture slippage was elucidated in an animal trial as well (Singh et al. 2010). Subsequent clinical trials have led to the use of LARIAT ligation most widely for an off-label indication of left atrial appendage ligation for stroke reduction.
LARIAT LAAO patient selection (Bartus et al. 2013)
Clinical inclusion recommendations
Clinical exclusion recommendations
Anatomical exclusion recommendations
Atrial fibrillation with CHADS2 score ≥1
History of prior cardiac surgery
Myocardial infarction within 3 months
LAA width >40 mm
Contraindication to AC therapy including:
History of pericarditis
Superiorly oriented LAA with the LAA apex directed behind the pulmonary trunk
History of thoracic radiation
Multi-lobed LAA in which lobes are oriented in different planes exceeding 40 mm
Posteriorly rotated heart
Thromboembolic event within 1 month
New York Heart Association Class IV heart failure
Recurrent CVA despite adequate AC therapy
Left ventricular function <30 %
Requirement for aspirin, thienopyridine therapy and AC therapy with high-bleed risk
Intolerance to AC therapy
Contraindications include prior pericarditis or pericardiotomy and thoracic radiation, as pericardial adhesions complicate pericardial access required for LARIAT LAAO. Due to appendage manipulation during the procedure, active thrombus within the LAA is also contraindicated. Additionally, Bartus et al. excluded patients with a myocardial infarction within 3 months, thromboembolic event within 30 days, New York Heart Association (NYHA) Class IV heart failure and left ventricular ejection fraction <30 %.
LARIAT candidates undergo an anatomical evaluation with a cardiac-gated, computed tomography (CT) scan with contrast and 3D image reconstruction to evaluate for anatomical exclusions that preclude successful device advancement. These include: (1) LAA width >40 mm, (2) superiorly oriented LAA with the apex directed behind the pulmonary artery (PA), (3) multi-lobed LAA in which lobes are oriented in different planes exceeding 40 mm, and (4) posteriorly rotated heart.
A pericardial drain is typically left in place and removed the following day if output is minimal. Patients are discharged 24–48 h after uncomplicated implantation and surveillance TEE is performed at 4–6 weeks post-implant. Pain management approaches include Tylenol as well non-steroidal anti-inflammatory agents. Scheduled colchicine for 2 weeks following LARIAT ligation has been effective in reducing the incidence of post-procedural pericarditis and pain. Anti-platelet and AC regimens following LARIAT ligation in published experience are variable with some patients continued on AC therapy if tolerated, others treated with Aspirin or Plavix or both for a period of time (Koneru et al. 2014).
Guide wire or catheter trauma to LAA after TSP
Manipulation of delivery system in pericardium
Avoidance of severe IAS tenting
Advancement of trans-septal sheath dilator into LAA under fluoroscopy over 0.32″ wire with distal curve on coronary wire
TEE surveillance for RV compression with sheath advancement to avoid RV abrasion
Micro-puncture access needle
Placement of a ‘bail out’ wire in the pericardium for quick pericardial drain placement
LAA laceration or perforation
LARIAT advancement and deployment
Cognizance of endocardial and epicardial wire forces on LAA
Minimization of LARIAT delivery system prolapse onto LA
Careful suture tightening
Careful baseline TEE
Close AC monitoring
Careful flushing of trans-septal sheath
Hematoma, arterio-venous fistula, pseudoaneurysm, bleeding, hematoma
Careful technique with ultrasound guidance as needed
Pericardial effusion and tamponade from RV puncture or abrasion during sheath advancement can complicate pericardial access. Coronary or epigastric artery laceration, trauma to intra-abdominal organs and pleural puncture have also been observed with LARIAT LAAO but should be avoidable with review of pre-procedural CT (Price and Gibson 2014; Stone et al. 2013). Utilizing a micro-puncture needle for pericardial access may mitigate the risk of significant RV laceration. When encountered, adhesions should lead to consideration for aborting ligation given low likelihood of procedural success in this setting and higher risk of complication. Effusions should be promptly treated with drainage and reversal of AC as well as consideration for surgery and can be managed anticipatorily with placement of an extra ‘bail out’ wire in the pericardial space to provide pericardial access for expedited drainage of a large effusion (Price 2014). Late pericardial effusions may develop and are hypothesized to result from inflammation related to LAA necrosis. Late pleural effusions have also been noted and may be transudative or exudative and potentially represent volume retention from reduced atrial natriuretic peptide (ANP) release after LAA ligation (Gunda et al. 2015).
Traction forces on the LA during LARIAT advancement and suture tightening can lead to LAA laceration or perforation and need for surgical rescue. Keating et al. reported LA laceration and cardiac tamponade requiring surgical intervention in 3 of 6 LARIAT ligations performed at their center (Keating et al. 2014). Reducing catheter prolapse onto the LA, particularly when the LA is enlarged, is a recommended preventative practice for LA or LAA laceration. Deployment of the LARIAT at a position with sufficient laxity such that the appendage orifice is recreated by proximal LAA tissue results in lesser traction on neighboring LA tissue. LAA perforation can occur during connection of the endo- and epi- wires, when tension imposed on the friable LAA can cause the epicardial wire to perforate. While prompt LARIAT deployment is a definitive treatment for LAA laceration or perforation, surgical readiness and a low threshold for surgical evaluation of ongoing pericardial output is recommended to avoid rapid decompensation.
Clinical experience and outcomes
Review of patient characteristics in published series of greater than ten patients of LARIAT LAAO
No. of patients with attempted ligation
No. of patients meeting clinical criteria screened
Mean/median CHADS2 Score/CHA2DS-VASC Scorea (Lip et al. 2010)
HAS-BLED Score (Lip et al. 2011)
Bartus et al. (2011)
14 screened, 2 excluded: 1 due to sub-optimal anatomy by pre-procedure CT, 1 due to presence of LAA thrombus by TEE at procedure onset
Bartus et al. (2013)
119 screened, 27 excluded: 16 due to sub-optimal anatomy by pre-procedure CT, 11 due to mobile thrombus noted by TEE at time of procedure
62 ± 10
Warfarin if tolerated, else aspirin mono-therapy. 55 % treated with warfarin post-procedure
1.9 ± 0.95/2.8 ± 1.56
2.4 ± 1.1
Massumi et al. (2013)
73 ± 8
65 % continued on Aspirin, 20 % on clopidogrel, 5 % on dual-antiplatelet therapy with Aspirin and dypyridamole, 15 % on warfarin, 5 % on rivaroxaban, 20 % on no AC
3.2 ± 1.2/4.8 ± 1.3
3.5 ± 1.0
Stone et al. (2013)
42 screened, 15 excluded; no further details
75 ± 8
Daily aspirin in all patients, dual anti-platelet therapy in 9 patients
3.5 ± 1.4/5.1 ± 1.5
4.6 ± 0.9
Price and Gibson (2014)
72 ± 9
Aspirin mono-therapy 31 %, dual anti-platelet 24 %, oral AC 23 %, clopidogrel mono-therapy 7 %, aggrenox 0.6 %
2.8 ± 1.4/4.1 ± 1.6
3.2 ± 1.2
Miller et al. (2014)
75 ± 10
At last follow-up, Aspirin 46 %, warfarin 20 %, Plavix 7 % dabigatran 7 %, rivaroxaban 7 %
3.0 ± 1.3
4.4 ± 1.4
Review of device success and peri-procedural and late complications from published clinical experience with percutaneously or minimally-invasively delivered LARIAT suture delivery device with greater than ten patients
Device success defined by <5 mm leak
Causes of failure to complete ligation
Durable ligation by follow-up TEE defined by <5 mm leak
Median or mean procedural time (min)a
Hospital LOS (days)
Bartus et al. (2011)
83 % (10/12)
1 failure to complete ligation due to inadequate TEE guidance, 1 pericardial adhesion preventing access
6/6 patients undergoing 60 days follow-up TEE had durable ligation
1 patient with pectus excavatum required thoracotomy for device removal
Bartus et al. (2013)
92 % (85/92)
3 pericardial adhesions preventing access, 1 pericardial adhesion preventing device advancement, 2 peri-procedural complications requiring termination, 1 anatomical contraindication to trans-septal puncture
85/85 patients undergoing 30 days TEE follow-up had durable ligation while 65/65 patients undergoing 1 yr TEE follow-up had durable ligation
1 epigastric artery laceration requiring cauterization, 1 RV puncture requiring pericardial drainage, 1 perforation during trans-septal access requiring pericardial drainage, 1 adhesion preventing advancement of LARIAT device, 3 adhesions preventing access, 2 severe pericarditis
2 non-embolic CVA, 2 SCD remote from procedure, 1 late effusion, 1 LA thrombus noted at 1 yr follow-up TEE resolving with warfarin therapy
Massumi et al. (2013)
100 % (20/20)
17/17 patients undergoing follow-up TEE at a mean of 96 days had durable ligation. In 6/17 patients, a residual pouch was noted with smooth walls in 5 and few pectinate muscles in 1
1 RV puncture requiring surgical intervention, 1 cardiac tamponade requiring pericardiocentesis, 1 prolonged intubation, 3 pericarditis with 1 requiring repeat pericardiocentesis
3 pericarditis, 1 death due to sepsis and pulmonary embolism occurring 50 days after ligation thought un-related to the procedure
83 ± 21
3.7 ± 3
Stone et al. (2013)
93 % (25/27)
2 peri-procedural complication requiring termination
22/22 patients undergoing TEE follow-up at a mean of 40 days had durable ligation
1 LAA laceration treated with reversal of anti-coagulation followed by surgical MAZE and appendage ligation, 1 CVA attributed to trans-septal sheath thrombus occurring in setting of sub-therapeutic ACT with no major neurologic sequelae after neurovascular rescue, 3 pericarditis
1 CVA 33 days post-procedure, thought secondary to arch atheroma, 1 pleural effusion
73 ± 18
2.8 ± 1.6
Price and Gibson (2014)
94 % 144/154
2 pericardial adhesions preventing access, 2 pericardial adhesions preventing device advancement, 2 difficult anatomy precluding ligation, 2 peri-procedural complications requiring termination
59/63 patients undergoing follow-up TEE had durable ligation with 4 having a >4 mm leak. Thrombus in the LA was noted in 3 patients undergoing TEE and 1 patient undergoing CT
3 patients required surgical exploration (2 for RV puncture, 1 for LAA perforation), 1 patient death due to nosocomial pneumonia post-procedure, 16 pericardial effusions, 4 pleural effusions
At a mean of 112 days follow-up, 2 cardiovascular deaths, 1 non-cardiovascular death, 2 CVAs, 3 pericardial effusions, 3 pleural effusions, 4 patients with thrombus noted in LA by TEE or CT
Miller et al. (2014)
95 % (39/41)
2 peri-procedure LAA perforation requiring emergent surgery
39/39 patients undergoing follow-up TEE had durable ligation
4 LAA lacerations (2 required exploratory surgery, 1 managed with pericardiocentesis, 1 managed with ligation), 13 pericardial effusions, 7 pericarditis, 4 pleural effusions
1 CVA, 5 pericardial effusions, 2 pericarditis, 2 pleural effusions
127 ± 50
Number of patients
313/334 (94 %)
222/226 (98 %)
Procedural adverse eventsc
64/334 (14.7 %)
1/334 (0.3 %)
6/334 (1.8 %)
1/334 (0.3 %)
Significant pericardial effusiond
25/334 (7.5 %)
Complication with surgical intervention
8/334 (2.4 %)
15/180 (8.3 %)
Late adverse events
33/334 (9.9 %)
6/334 (1.8 %)
6/334 (1.8 %)
6/334 (1.8 %)
10/334 (3.0 %)
Thrombus in LA or LAA by TEE/CT
5/227 (2.2 %)
The first-in-man feasibility study of the LARIAT device evaluated 13 patients undergoing LARIAT ligation either during open-heart surgery or in a closed-chest fashion. Twelve of 13 patients in this series had successful LAA ligation with 1 patient in whom the procedure was terminated due to lack of adequate echocardiographic guidance for snare advancement. Notably, a patient with pectus excavatum required a thoracoscopic procedure for device removal due to sternal compression (Bartus et al. 2011).
Bartus et al. subsequently published experience with LARIAT ligation in 92 patients from a single center, where ligation was successfully completed in 85 of 92 or 93 % of subjects. At 1-year follow-up, 65 patients underwent follow-up TEE with all patients having <5 mm leak. Notably, 55 % of the patients in this series were continued on AC therapy (Bartus et al. 2013).
Massumi et al. reported the first series of LARIAT ligation performed in the (US) in a single-center report of 20 patients. All attempted ligations were successful however peri-procedurally, 1 patient required surgical intervention for RV perforation and 1 patient was treated with pericardiocentesis for tamponade physiology. All 17 patients undergoing follow-up TEE at a mean of 96 ± 77 days had persistent LAA occlusion. However, in 6 of 17 patients, a small pouch was noted at the LAA os, containing smooth muscle tissue in 5 patients and pectinate muscles in one patient. Involution of the excluded LAA was noted in 3 patients in whom follow-up CT imaging was performed (Massumi et al. 2013).
Stone et al. reported a series of 27 US patients, selected from 42 patients being evaluated for LAAO that underwent LARIAT ligation, with 25 of 27 having successful ligation. One peri-procedure stroke was attributed to a sub-therapeutic ACT with thrombus noted on the trans-septal sheath. All 22 patients completing follow-up TEE at a mean of 45 days had durable ligation (Stone et al. 2013).
The largest US LARIAT experience studied 154 consecutive patients undergoing LAA ligation at eight centers. Device success, defined as device deployment with <5 mm residual leak by TEE, was achieved in 94 % of patients. Major bleeding occurred in 9 % of patients, and peri-procedural pericardial effusion in 16 %. Despite similar device success rates as other series, a higher rate of late-leak (20 %) and LA thrombus (4.8 %) was noted in follow-up. Of note, the patients included in this study were older and had more co-morbidities than the initial single center study of Bartus et al. (Price et al. 2014).
Miller et al. reported on an additional 41 consecutive patients undergoing LARIAT ligation with 39/41 having procedural success. A high rate of pericardial effusions requiring pericardiocentesis post-procedurally was noted (20 %), which authors attributed to operators in this series not maintaining a pericardial drain post-procedurally. Seven percent of patients required thoracentesis for late pleural effusions. Authors also noted a high rate of LAA perforation, with 2 of 4 patients with this complication requiring surgical treatment. All 4 patients with LAA perforation required multiple attempts to position the LARIAT snare, suggesting that in cases of challenging anatomy, advancement should be attempted when endocardial and epicardial wire alignment is optimal and aborted after a limited number of attempts to avert laceration and perforation (Miller et al. 2014).
Gafoor and authors evaluated the safety and efficacy of LAAO with a number of occlusion devices in a cohort of 75 octogenarians. Procedural success was noted in all 4 patients undergoing LARIAT exclusion, with no acute adverse safety events and an average hospital length of stay of 2.5 days. At 1-year, 1 LARIAT patient had an embolic stroke with thrombus originating from an incompletely ligated lobe of the appendage (Gafoor et al. 2014).
Patel et al. evaluated the compassionate use of LARIAT ligation in 9 patients who were precluded based on appendage morphology and size. Their analysis showed a LARIAT deployment success rate of 78 % utilizing strategies such as using the magnet-tipped endowire to straighten the LAA to reduce circumference and utilizing the endocath balloon to suction from the LAA, effectively reducing LAA volume (Patel et al. 2015).
Several features distinguish the LARIAT LAAO system. Compared with percutaneous endocardial LAAO devices such as the WATCHMAN (Boston Scientific Corporation, Natick, Massachusetts) and Amplatzer (St. Jude Medical, Inc., Saint Paul, Minnesota), systems, the LARIAT approach is epicardial, with only a polyester suture left behind. Device embolization, noted in 1.2 % of patients in the PREVAIL trial of the WATCHMAN device, is not observed with LARIAT LAAO and late device erosion is not a concern (Holmes et al. 2014). Intriguingly, involution of the LAA has been noted on CT imaging following LARIAT ligation and as early as 4 weeks post-implant on autopsy findings, which may have a desirable impact on the long-term durability of this approach (Massumi et al. 2013; Ellis et al. 2015). LARIAT LAAO results in electrical isolation of the LAA, with post-procedural reduction in AF burden noted as well as increased maintenance of NSR observed when performed in conjunction with pulmonary vein isolation (Han et al. 2014; Afzal et al. 2015; Badhwar et al. 2015). In the PROTECT-AF and CAP registries of the WATCHMAN device, a less than 5 mm peri-device residual leak into the appendage defined procedural success, whereas several LARIAT series demonstrate no or minimal residual jet with a similar rate of procedural success (Bartus et al. 2013; Massumi et al. 2013; Miller et al. 2014; Holmes et al. 2009; Reddy et al. 2011). In case series, 6.25–35.7 % of patients screened for LARIAT LAAO are excluded due to anatomical exclusions, while in the PROTECT-AF experience of the WATCHMAN device, 38.9 % of patients screened for device placement were excluded for clinical and echocardiographic reasons, suggesting that a complement of LAAO approaches may be suitable to serve a clinically an anatomically diverse population of AF patients (Stone et al. 2013; Bartus et al. 2011, 2013; Holmes et al. 2009).
The incidence of peri-procedural complications during LARIAT LAAO is poorly delineated and derived from one controlled trial evaluating the device in 92 subjects and experience from reported case series. A peri-procedural death rate of 0.3 % is noted in the cumulative published LARIAT experience, however the FDA’s MAUDE database reports four procedure-related deaths, likely reflecting publication bias present in reported case-series (Table 5; Fig. 5). The emergent surgery rate in the cumulative LARIAT experience was 2.4 % (8 patients) compared with 31 reports of emergent surgery in the MAUDE database. Notably, the emergency surgery rate was 1.6 % in the PROTECT-AF trial and 0.4 % in the PREVAIL trial (Holmes et al. 2009, 2014). Uniquely, LARIAT LAAO results in a high rate of pericarditis due to pericardial manipulations and appendage necrosis and is also linked to the development of pleural effusions. Long-term implications of pericardial manipulation, inflammation and adhesion formation after LARIAT LAAO are not known. Paucity of data regarding real-world rate of procedural complications and the device’s exclusively off-label use were critiqued in a recent JAMA review (Holmes et al. 2009; Chatterjee et al. 2015). The device is currently being studied in a multi-center observational trial evaluating procedural complication rate and short-term durability [ClinicalTrials.gov, NCT02059707].
A large, controlled trial of LARIAT LAAO would inform the incidence and mechanisms of various complications of LARIAT LAAO as well as possible means of improving upon these in a systematic fashion. Analysis of the PROTECT-AF trial and Continuing Access Registry of the WATCHMAN device allowed for advancements in operator training as well as device refinements and protocol modifications that resulted in significant improvement in the safety and efficacy of the device (Holmes et al. 2009; Reddy et al. 2013). Further insight into anatomical considerations that would enhance current inclusion and exclusion criteria for LARIAT LAAO could also be obtained by a large-scale trial of the device. Delineation of an optimal AC regimen would inform and standardize post-procedural practice. Establishment of efficacy in reduction of thrombo-embolic events compared with Coumadin or NOACs is an important aim for future investigations and for meaningful comparison with other LAAO systems.
The LARIAT device is an epicardial approach to LAA ligation, with safety and efficacy studied in small clinical series. Epicardial ligation may have potential advantages over endocardial occlusion such as LAA involution and electrical isolation. True complications rates and procedural strategies to prevent and manage complications, efficacy in reduction of thrombo-embolic events, optimal patient selection and post-procedural AC regimens remain to be delineated for the LARIAT ligation system.
MS conceived of the review and drafted the manuscript. VS participated in drafting the manuscript and revised it critically for intellectual content. MD participated in drafting the manuscript and revised it critically for intellectual content. MP participated in drafting the manuscript and revised it critically for intellectual content as well as provided material for Figures.
MS is a an Assistant Professor of Medicine at the University of Maryland School of Medicine (UMSOM) and is a practicing interventional cardiologist, performing coronary interventions as well as structural interventions including left atrial appendage ligation with the LARIAT device.
VS is an Assistant Professor of Medicine at the UMSOM a practices clinical electrophysiology including structural interventions such as left atrial appendage ligation with the LARIAT device.
MD is an Assistant Professor of Medicine at the UMSOM and a practicing cardiac surgeon performing left atrial appendage ligation with the AtriClip device as well as left atrial appendage ligation with the LARIAT device.
MP is an Associate Professor of Medicine at the University of San Francisco School of Medicine and a practicing interventional cardiologist performing left atrial appendage exclusion procedures.
Compliance with ethical guidelines
Competing interests MP reports receipt of consulting honoraria from St. Jude Medical, Boston Scientific, W.L. Gore and Daiichi Sankyo, Accumetrics, AstraZeneca, Janssen Pharmaceuticals. MP has also served as a proctor for Boston Scientific, St. Jude Medical, SentreHeart and W.L. Gore and has received research support from SentreHeart Inc. The other authors (MS, VS, MD) declare that they have no competing interests.
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
- Afzal MR, Kanmanthareddy A, Earnest M, Reddy M, Atkins D, Bommana S et al (2015) Impact of left atrial appendage exclusion using an epicardial ligation system (LARIAT) on atrial fibrillation burden in patients with cardiac implantable electronic devices. Heart Rhythm 12(1):52–59. doi:https://doi.org/10.1016/j.hrthm.2014.09.053 View ArticleGoogle Scholar
- Al-Saady NM, Obel OA, Camm AJ (1999) Left atrial appendage: structure, function, and role in thromboembolism. Heart 82(5):547–554View ArticleGoogle Scholar
- Badhwar N, Lakkireddy D, Kawamura M, Han FT, Iyer SK, Moyers BS et al (2015) Sequential percutaneous LAA ligation and pulmonary vein isolation in patients with persistent AF: initial results of a feasibility study. J Cardiovasc Electrophysiol. doi:https://doi.org/10.1111/jce.12655 Google Scholar
- Baker MS, Paul Mounsey J, Gehi AK, Chung EH (2013) Left atrial thrombus after appendage ligation with LARIAT. Heart Rhythm. doi:https://doi.org/10.1016/j.hrthm.2013.10.024 Google Scholar
- Bartus K, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J et al (2011) Feasibility of closed-chest ligation of the left atrial appendage in humans. Heart Rhythm 8(2):188–193. doi:https://doi.org/10.1016/j.hrthm.2010.10.040 View ArticleGoogle Scholar
- Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J et al (2013) Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol 62(2):108–118. doi:https://doi.org/10.1016/j.jacc.2012.06.046 View ArticleGoogle Scholar
- Bartus K, Morelli RL, Szczepanski W, Kapelak B, Sadowski J, Lee RJ (2014) Anatomic analysis of the left atrial appendage after closure with the LARIAT device. Circ Arrhythm Electrophysiol 7(4):764–767. doi:https://doi.org/10.1161/CIRCEP.113.001084 View ArticleGoogle Scholar
- Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD et al (2008) 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation 118(15):e523–e661. doi:https://doi.org/10.1161/CIRCULATIONAHA.108.190748 View ArticleGoogle Scholar
- Briceno DF, Fernando RR, Laing ST (2013) Left atrial appendage thrombus post LARIAT closure device. Heart Rhythm 11(9):1600–1601. doi:https://doi.org/10.1016/j.hrthm.2013.10.053 View ArticleGoogle Scholar
- Chatterjee S, Herrmann HC, Wilensky RL, Hirshfeld J, McCormick D, Frankel DS et al (2015) Safety and procedural success of left atrial appendage exclusion with the lariat device: a systematic review of published reports and analytic review of the FDA MAUDE database. JAMA Intern Med. doi:https://doi.org/10.1001/jamainternmed.2015.1513 Google Scholar
- Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A et al (2009) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361(12):1139–1151. doi:https://doi.org/10.1056/NEJMoa0905561 View ArticleGoogle Scholar
- Cox JL, Ad N, Palazzo T (1999) Impact of the maze procedure on the stroke rate in patients with atrial fibrillation. J Thorac Cardiovasc Surg 118(5):833–840View ArticleGoogle Scholar
- Di Biase L, Burkhardt JD, Gibson DN, Natale A (2013) 2D and 3D TEE evaluation of an early reopening of the LARIAT epicardial left atrial appendage closure device. Heart Rhythm 11(6):1087–1088. doi:https://doi.org/10.1016/j.hrthm.2013.08.023 View ArticleGoogle Scholar
- Ellis CR, Byrd JM, Scalf SL (2015) Ischemic necrosis of the left atrial appendage at autopsy 4 weeks following epicardial suture ligation via a sub-xiphoid approach (LARIAT). J Interv Card Electrophysiol 43(1):99–100. doi:https://doi.org/10.1007/s10840-015-9993-4 View ArticleGoogle Scholar
- Gafoor S, Franke J, Bertog S, Boehm P, Heuer L, Gonzaga M et al (2014) Left atrial appendage occlusion in octogenarians: short-term and 1-year follow-up. Catheter Cardiovasc Interv 83(5):805–810. doi:https://doi.org/10.1002/ccd.25297 View ArticleGoogle Scholar
- Giedrimas E, Lin AC, Knight BP (2013) Left atrial thrombus after appendage closure using LARIAT. Circ Arrhythm Electrophysiol 6(4):e52–e53. doi:https://doi.org/10.1161/CIRCEP.113.000532 View ArticleGoogle Scholar
- Go AS, Hylek EM, Borowsky LH, Phillips KA, Selby JV, Singer DE (1999) Warfarin use among ambulatory patients with nonvalvular atrial fibrillation: the anticoagulation and risk factors in atrial fibrillation (ATRIA) study. Ann Intern Med 131(12):927–934View ArticleGoogle Scholar
- Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M et al (2011) Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365(11):981–992. doi:https://doi.org/10.1056/NEJMoa1107039 View ArticleGoogle Scholar
- Gunda S, Kanmanthareddy A, Vallakati A, Janga P, Afzal MR, Pillarisetti J et al (2015) Characterization of pleural effusion after left atrial appendage exclusion using Lariat. J Cardiovasc Electrophysiol. doi:https://doi.org/10.1111/jce.12648 Google Scholar
- Han FT, Bartus K, Lakkireddy D, Rojas F, Bednarek J, Kapelak B et al (2014) The effects of LAA ligation on LAA electrical activity. Heart Rhythm 11(5):864–870. doi:https://doi.org/10.1016/j.hrthm.2014.01.019 View ArticleGoogle Scholar
- Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M et al (2009) Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet 374(9689):534–542. doi:https://doi.org/10.1016/S0140-6736(09)61343-X View ArticleGoogle Scholar
- Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK et al (2014) Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol 64(1):1–12. doi:https://doi.org/10.1016/j.jacc.2014.04.029 View ArticleGoogle Scholar
- Ismail TF, Panikker S, Markides V, Foran JP, Padley S, Rubens MB et al (2015) CT imaging for left atrial appendage closure: a review and pictorial essay. J Cardiovasc Comput Tomogr 9(2):89–102. doi:https://doi.org/10.1016/j.jcct.2015.01.011 View ArticleGoogle Scholar
- January CT, Wann LS, Alpert JS, Calkins H, Cleveland JC Jr, Cigarroa JE et al (2014) 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the heart rhythm society. Circulation 130(23):2071–2104. doi:https://doi.org/10.1161/CIR.0000000000000040 View ArticleGoogle Scholar
- Kanmanthareddy M, Reddy YM, Vallakati A et al (2014) Embryology and anatomy of the left atrial appendage: why does thrombus form? Interv Cardiol Clin 3:191–202Google Scholar
- Katz ES, Tsiamtsiouris T, Applebaum RM, Schwartzbard A, Tunick PA, Kronzon I (2000) Surgical left atrial appendage ligation is frequently incomplete: a transesophageal echocardiograhic study. J Am Coll Cardiol 36(2):468–471View ArticleGoogle Scholar
- Keating VP, Kolibash CP, Khandheria BK, Bajwa T, Sra J, Kress DC (2014) Left atrial laceration with epicardial ligation device. Ann Thorac Cardiovasc Surg 20(Suppl):904–908. doi:https://doi.org/10.5761/atcs.cr.13-00134 View ArticleGoogle Scholar
- Koneru JN, Badhwar N, Ellenbogen KA, Lee RJ (2014) LAA ligation using the LARIAT suture delivery device: tips and tricks for a successful procedure. Heart Rhythm. doi:https://doi.org/10.1016/j.hrthm.2014.01.022 Google Scholar
- Koranne KP, Fernando R, Laing ST (2015) Left atrial thrombus after complete left atrial appendage exclusion with LARIAT device. Catheter Cardiovasc Interv 85(2):E54–E57. doi:https://doi.org/10.1002/ccd.25549 View ArticleGoogle Scholar
- Laura DM, Chinitz LA, Aizer A, Holmes DS, Benenstein R, Freedberg RS et al (2014) The role of multimodality imaging in percutaneous left atrial appendage suture ligation with the LARIAT device. J Am Soc Echocardiogr 27(7):699–708. doi:https://doi.org/10.1016/j.echo.2014.04.014 View ArticleGoogle Scholar
- Lee RJ, Bartus K, Yakubov SJ (2010) Catheter-based left atrial appendage (LAA) ligation for the prevention of embolic events arising from the LAA: initial experience in a canine model. Circ Cardiovasc Interv 3(3):224–229. doi:https://doi.org/10.1161/CIRCINTERVENTIONS.109.914978 View ArticleGoogle Scholar
- Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ (2010) Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 137(2):263–272. doi:https://doi.org/10.1378/chest.09-1584 View ArticleGoogle Scholar
- Lip GY, Frison L, Halperin JL, Lane DA (2011) Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score. J Am Coll Cardiol 57(2):173–180. doi:https://doi.org/10.1016/j.jacc.2010.09.024 View ArticleGoogle Scholar
- Massumi A, Chelu MG, Nazeri A, May SA, Afshar-Kharaghan H, Saeed M et al (2013) Initial experience with a novel percutaneous left atrial appendage exclusion device in patients with atrial fibrillation, increased stroke risk, and contraindications to anticoagulation. Am J Cardiol 111(6):869–873. doi:https://doi.org/10.1016/j.amjcard.2012.11.061 View ArticleGoogle Scholar
- Miller MA, Gangireddy SR, Doshi SK, Aryana A, Koruth JS, Sennhauser S et al (2014a) Multicenter study on acute and long-term safety and efficacy of percutaneous left atrial appendage closure using an epicardial suture snaring device. Heart Rhythm 11(11):1853–1859. doi:https://doi.org/10.1016/j.hrthm.2014.07.032 View ArticleGoogle Scholar
- Miller MA, Gangireddy SR, Doshi SK, Aryana A, Koruth JS, Sennhauser S et al (2014b) Multicenter study on acute and long-term safety and efficacy of percutaneous left atrial appendage closure using an epicardial suture snaring device. Heart Rhythm. doi:https://doi.org/10.1016/j.hrthm.2014.07.032 Google Scholar
- Mosley WJ, Smith MR, Price MJ (2014) Percutaneous management of late leak after lariat transcatheter ligation of the left atrial appendage in patients with atrial fibrillation at high risk for stroke. Catheter Cardiovasc Interv 83(4):664–669. doi:https://doi.org/10.1002/ccd.25251 View ArticleGoogle Scholar
- Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W et al (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365(10):883–891. doi:https://doi.org/10.1056/NEJMoa1009638 View ArticleGoogle Scholar
- Patel MB, Rasekh A, Shuraih M, Chelu MG, Bartlett T, Mathuria N et al (2015) Safety and effectiveness of compassionate use of LARIAT(R) device for epicardial ligation of anatomically complex left atrial appendages. J Interv Card Electrophysiol 42(1):11–19. doi:https://doi.org/10.1007/s10840-014-9963-2 View ArticleGoogle Scholar
- Pillai AM, Kanmanthareddy A, Earnest M, Reddy M, Ferrell R, Nath J et al (2014) Initial experience with post Lariat left atrial appendage leak closure with Amplatzer septal occluder device and repeat Lariat application. Heart Rhythm 11(11):1877–1883. doi:https://doi.org/10.1016/j.hrthm.2014.06.035 View ArticleGoogle Scholar
- Pillarisetti J, Reddy YM, Gunda S, Swarup V, Lee R, Rasekh A et al (2015) Endocardial (watchman) versus epicardial (Lariat) left atrial appendage exclusion devices: understanding the differences in the location and type of leaks and their clinical implications. Heart Rhythm. doi:https://doi.org/10.1016/j.hrthm.2015.03.020 Google Scholar
- Price MJ (2014) Prevention and management of complications of left atrial appendage closure devices. Interv Cardiol Clin 3:301–311Google Scholar
- Price M, Gibson D, Yakubov S et al (2014) Early safety and efficacy of percutaneous left atrial appendage suture ligation with the Lariat device. J Am Coll Cardiol 64:565–572View ArticleGoogle Scholar
- Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S (2011) Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation 123(4):417–424. doi:https://doi.org/10.1161/CIRCULATIONAHA.110.976449 View ArticleGoogle Scholar
- Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K et al (2013) Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-year follow-up of the PROTECT AF (Watchman left atrial appendage system for embolic protection in patients with atrial fibrillation) trial. Circulation 127(6):720–729. doi:https://doi.org/10.1161/CIRCULATIONAHA.112.114389 View ArticleGoogle Scholar
- Singh SM, Dukkipati SR, d’Avila A, Doshi SK, Reddy VY (2010) Percutaneous left atrial appendage closure with an epicardial suture ligation approach: a prospective randomized pre-clinical feasibility study. Heart Rhythm 7(3):370–376. doi:https://doi.org/10.1016/j.hrthm.2009.11.010 View ArticleGoogle Scholar
- Stone D, Byrne T, Pershad A (2013) Early results with the LARIAT device for left atrial appendage exclusion in patients with atrial fibrillation at high risk for stroke and anticoagulation. Catheter Cardiovasc Interv. doi:https://doi.org/10.1002/ccd.25065 Google Scholar
- Valderrabano M (2014) Pericardial access for lariat left atrial appendage closure. Interv Cardiol Clin 3:281–289Google Scholar
- Viles-Gonzalez JF, Kar S, Douglas P, Dukkipati S, Feldman T, Horton R et al (2012) 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 Patients With Atrial Fibrillation) substudy. J Am Coll Cardiol 59(10):923–929. doi:https://doi.org/10.1016/j.jacc.2011.11.028 View ArticleGoogle Scholar
- Yeow WL, Matsumoto T, Kar S (2013) Successful closure of residual leak following LARIAT procedure in a patient with high risk of stroke and hemorrhage. Catheter Cardiovasc Interv 83(4):661–663. doi:https://doi.org/10.1002/ccd.25219 View ArticleGoogle Scholar