LAA Ligation: The Watchman Device- You DON’T Wear it on Your Wrist!

Editor’s Note:

Well, I was getting my schedule the other day, a group text forum where we find out what’s in our future for the next day, and my assignment was “FA- Watchman x 2”.

So of course I followed up with- a text to the group asking: what type of surgeon IS HE- and what specialty?  Was it a Cell-Saver case or what?  I guess we all have our moments of clinical blindness,  or total lack of staying on top of current and evolving technology- so I was gently informed by my colleagues- that Watchman- is a Cath lab procedure- and NOT a doctor.   So basically- Perfusion standby- and yes- SILLY me 🙂  As such- I figured that it would be educational for all of us LESS erudite- to put down some info on this procedure-  Enjoy 🙂

 

To reduce the risk of thromboembolism from the LAA in patients with nonvalvular atrial fibrillation who:

  • Are at increased risk of stroke and systemic embolism and for whom anticoagulation therapy is recommended;
  • Have physician approval to take warfarin; and
  • Have an appropriate reason to want treatment with a non-medication alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

The WATCHMAN Device is a parachute-shaped, self-expanding device that closes the LAA. It was tested in several studies that showed the device was a good alternative treatment for patients who cannot tolerate treatment with warfarin.

The WATCHMAN device is implanted percutaneously (through the skin) in the electrophysiology (EP) lab. The implant procedure does not require surgery; however, general anesthesia may be used during the procedure. A catheter sheath is inserted into a vein near the groin and guided across the septum (muscular wall that divides the right and left sides of the heart) to the opening of the LAA. The device is placed in the opening of the LAA. This seals off the LAA and keeps it from releasing clots.

Watchman

Posted with permission from Boston Scientific

A List of LA Therapies: Pluses and Minuses 🙂

Abstract

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and has been identified as an independent risk factor for stroke. Prevention of thromboembolic events has been based on oral anticoagulation (OAC) using Vitamin K antagonists (VKA). However, long-term OAC medication is limited by an increased bleeding risk and a low patient compliance. Relying on the observation that the majority of cardiac thrombi originate from the left atrial appendage (LAA) different devices aiming for LAA closure have been proposed. This review will discuss contemporary LAA closure devices with special emphasis on procedure related complications.

Introduction

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and an independent risk factor for stroke. The prevalence of AF is approximately 1.5-2% in the general population, ranging from <0.5% at 40–50 years to 5–15% at 80 years, and is expected to double within the next 50 years as a consequence of aging societies.[] All types of AF (paroxysmal, persistent and permanent) increase the risk of ischemic stroke to a similar degree (five-fold).[,]

The CHA2DS2-VASc score has been proposed to stratify AF patients for ischemic stroke risk (Table 1, ESC[,]) with a low risk categorized as a CHA2DS2-VASc score of 0, intermediate risk as a score of 1, and high risk as a score ≥ 2.[]

Table 1

Stroke risk factors defined by CHA2DS2-VASc the scoring system.

LV= left ventricular. Vascular disease= Prior myocardial infarction, peripheral artery disease, aortic plaque. Modified from Reference.[]

CHA2DS2-VASc score
Risk Factor Score
C= Congestive heart failure/LV dysfunction 1
H= Hypertension 1
A2= Age ≥ 75years 2
D= Diabetes mellitus 1
S2= Stroke/TIA/thrombo-embolism 2
V= Vascular disease 1
A= Age 65–74 1
Sc= Sex category (i.e. female sex) 1
Maximum score 9

In patients with AF and a CHA2DS2-VASc score ≥1, long-term oral anticoagulation (OAC) is recommended irrespective of the rhythm management strategy.[,] However, in many patients, OAC can not be administered due to either a high bleeding risk (as defined by an HAS-BLED bleeding risk score ≥3),[] life-threatening bleeds, perceived frailty and/or high risk of falls, especially in very elderly patients. As a result, approximately 50% of patients eligible for OAC using Vitamin K antagonists (VKA) are not treated.[] In addition, optimal medical treatment in patients with both, a high bleeding risk and a high stroke risk remains unclear. Therefore, alternative treatment options to reduce strokes in non-valvular AF (NVAF) are warranted.

Rationale For Left Atrial Appendage Closure

Atrial fibrillation leads to loss of effective atrial contractions, promoting blood stasis and thrombus formation in the left atrial appendage (LAA).[] Therefore, the LAA has been identified as the main source of cardiac thrombi (>90%) in ischemic strokes associated with NVAF[] and has been termed the ‘most lethal human attachment’.[]

The LAA is a trabeculated, embryological remnant of the left atrium (LA) with a multilobed structure positioned anteriorly in the atrioventricular sulcus close to the left circumflex artery, the left phrenic nerve, and the left pulmonary veins.[] Recently, the shape of the LAA has been correlated with different degrees of thromboembolic risk: the “chicken wing” LAA morphology has been associated with a lower stroke risk compared to the other three main morphologies described (“cactus”, “windsock”, and “cauliflower”).[] These findings were corroborated by Khurram et al.: the presence and extent of LAA trabeculations and a small LAA orifice were independently associated with thromboembolic events.[] In addition, also the burden of silent cerebral ischemia evaluated through magnetic resonance or computed tomography resulted significantly related to LAA morphology in AF patients undergoing transcatheter ablation.[]

The pivotal role of the LAA in the genesis of ischemic strokes along with the recently published PROTECT AF trial (Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF)[] has led to a an update of the current AF guidelines[,]: percutaneous LAA closure has been introduced as a non-pharmacological option in NVAF patients with a high bleeding risk (level of recommendation: IIb).

Techniques For LAA Occlusion And Complications

Currently, three different strategies can be pursued to exclude the LAA from systemic circulation. They can be grouped into either interventional/percutaneous (endocardial, epicardial) or surgical approaches. The completeness of LAA closure as well as specific complications may be variable among different techniques. This review will focus on percutaneous LAA closure device-related complications, which will be described separately according to each different strategy.

Interventional/Percutaneous LAA Closure

Percutaneous Endocardial LAA Closure

General Considerations

The endocardial LAA closure approach via the femoral vein is based on a transseptal LA access.[] A large delivery sheath is exchanged after transseptal puncture followed by LAA visualization using angiography and transesophageal echocardiography (TEE), to define the individual LAA anatomy. Thereafter, an adequate sized device (Fig. 1) is released in the LAA landing zone after confirmation of the correct position again using TEE and fluoroscopy.

An external file that holds a picture, illustration, etc. Object name is jafib-07-01034-g01.jpg

Endocardial left atrial appendage occlusion devices: A) WATCHMAN (Boston Scientific, Maple Grove, MN); B) Amplatzer Cardiac Plug (ACP) (St. Jude Medical, Minneapolis, MN); C) WavecrestTM System (Coherex Medical, Salt Lake City, UT).

The first, randomized trial comparing percutaneous LAA occlusion (WATCHMAN, Boston Scientific, Maple Grove, MN) to OAC with warfarin, was the PROTECT AF trial (Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF).[] Importantly, this study demonstrated noninferiority of percutaneous LAA closure to OAC. However, the PROTECT AF trial was characterized by a high risk of procedure related complications in the intervention group (n=463 patients, 4.8% cardiac tamponades, 3.5% major bleeding, 1.1% stroke, 0.6% device embolization, 0.2% hemorrhagic stroke).[]

In general, complications linked to percutaneous LAA closure can be divided into:

  1. Access related
  2. Device implantation related
  3. Antithrombotic treatment related.

All types of complications are discussed in detail below along with device specific considerations (Table 2).

Table 2

Complications associated with percutaneous endocardial LAA closure
PLAATO WATCHMAN ACP ACP vs WATCHMAN
Ostermayer, 2005[] Bayard, 2010[] Block, 2009[] Protect AF[] CAP[] PREVAIL[] Park, 2011[] Asia-Pacific experience[] Plicht, 2013[] Chun, 2013[]
Patients, n 111 180 64 463 460 407 143 20 34 80 (40 vs 40)
Acute implantation success rate, % 97 90 93.85 90.9 94.3 95.1 96 95 100 95-100
Serious complications rate, % NA NA 18 (all late but PE) 39 (8.7) 23 (4.1) 12 (4.4) 10 (7%) 2 (10%) 1 4 (5%): 2 Watchman, 2 ACP
Device embolization, n (%) 0 2 (1.1%) 0 3 (0.6%) 0 NA 2 (1%) 0 0 1 ACP (1.2%)
Air embolism, n 0 0 0 3 (0.6%) 0 NA 2 (1%) 1 (5%) 0 2 (2.5%): 1 Watchman, 1 ACP
Thrombus formation, n 0 0 0 20 (4.2%)[] 0 NA NA 1 (5%) 6 (17.6%) 4 (5.1%) : 3 Watchman (7.9%) vs 1 ACP (2.5%)
Serious pericardial effusion 2 (1.8%) 6 (3.3%) 1 (1.5%) 22 (4.8%) 10 (2.2%) 1.9% 5 (4%) 0 1 (2.9%) 2 (2.5%): 1 Watchman, 1 ACP
Procedural stroke 0 NA 0 5 (0.9%) 0 (0%) NA 3 (2%) 0 0 0
Procedural-related deathe 0 2(1.1%) 0 0 0 0 0 0 0 0
Access-related complications 1 perforation Rfemoral artery; 1Right leg deep vein thrombosis 2 (1.8%) NA NA 2 hematoma, 1 arterio- venous fistula 3 (0.6%) 1 pseudoaneurysm NA NA NA NA 4 hematoma, 1 pseudoaneurysm (6.8%)

Access-Related Complications

Vascular complications such as groin hematoma, femoral arterial pseudoaneurysm or femoral arteriovenous fistula, retroperitoneal bleed, sometimes requiring transfusions and surgical interventions are the most common complications in interventional cardiology (0.6-13%).[] Patients undergoing percutaneous LAA closure are particular at risk due to the use of large delivery sheaths. Moreover, elderly patients often present with frail and tortured vascular anatomy.

Device Implantation

Different types of complications can be related to the transseptal LA access (Table 2). Large delivery sheaths increase the risk of air embolism and subsequent peri-procedural stroke/transient ischemic attack (TIA) or ST-segment elevation, and pericardial effusion with or without cardiac tamponade has been described.[] Implantation of LAA occlusion devices is associated with a learning curve that is inversely related to the complication rate of the transseptal puncture approach: the rate of serious pericardial effusion is higher in less-experienced centers and tends to decrease with the growing experience of the operators performing the procedure.[] Potential implantation-related complications may occur during the procedure and include device migration, dislodgement or embolization (Fig. 2) and cardiac perforation. In addition, traumatic damage to adjacent structures, including the pulmonary artery, left pulmonary veins and the circumflex coronary artery are possible.[,]

An external file that holds a picture, illustration, etc. Object name is jafib-07-01034-g02.jpg
Two-dimensional transesophageal echocardiography (TEE) revealing the dislocation of a 30mm-Amplatzer Cardiac Plug (ACP) device from LAA into the LA, 6 weeks after the implantation. LSPV= left superior pulmonary vein; LAA= left atrial appendage; LA= left atrium.

In complex LAA anatomies, a mismatch between device size and LAA ostium may cause incomplete LAA occlusion and residual peri-device blood flow (Fig. 3). Severity of these leaks has been classified as minor (<1mm), moderate (1 mm to 3 mm) or major (>3 mm) but a sub-study of the PROTECT AF demonstrated no adverse impact on clinical outcome even if the gap was 3mm.[] Interestingly, the role of sinus rhythm during LAA device implantation is undetermined and may need evaluation in a larger patient cohort. In our recent study the only both delayed tamponades were linked to sinus rhythm.[] In theory, sinus rhythm with enhanced LAA contractions could promote mechanical trauma.

An external file that holds a picture, illustration, etc. Object name is jafib-07-01034-g03.jpg
TEE image of incomplete LAA occlusion 6 weeks after percutaneous deployment of a WATCHMAN device (30 mm). A persistent peri-device flow (white arrow) with a blood jet size of 4.5 mm is evidenced by Color Doppler. TEE= transesophageal echocardiography; LAA= left atrial appendage.

Iatrogenic atrial septal defects following transseptal LA access usually disappeared within 6 months of the procedure or can persist in a very small proportion of patients but without any haemodynamic impairment.[]

Post Implantation Antithrombotic Treatment

Postprocedural management is not well standardized and several antithrombotic treatment algorithms have been proposed. Importantly, it has to be remembered that LAA closure is often performed in patients with contraindication to OAC. All current strategies strive for antithrombotic treatment, which allows device endothelialization without thrombus formation (Fig. 4) but, at the same time, increases the bleeding risk.

An external file that holds a picture, illustration, etc. Object name is jafib-07-01034-g04.jpg
Post-procedural TEE after 6 weeks demonstrating device-related thrombus (arrows) completely covering a 24 mm WATCHMAN device adequately occluding LAA. TEE= transesophageal echocardiography; LAA= left atrial appendage; LA= left atrium; MV= mitral valve; LV= left ventricle.

Post-procedural dual antiplatelet therapy (DPI) with aspirin (ASA) and clopidogrel has been suggested but the duration is unclear, ranging from 1 to 6 months in different studies. A consensus about the most appropriate post-procedural antithrombotic medication is still lacking.

In the PROTECT AF trial,[] patients were initially treated with warfarin for 45 days post-WATCHMAN implantation. This was followed by DPI for 6 months and thereafter by “stand alone” ASA therapy. Nevertheless, during follow-up, device related thrombus was observed in 4.2% of the patients.

A similar rate (4%) of device-related thrombus has been reported in the “ASA Plavix Registry” (ASAP).[] In this registry a WATCHMAN device was implanted as in PROTEC-AF but the target population was different. All patients in ASAP had a contraindications to OAC and after implantation, DPI was administered for 6 months followed by ASA alone. This treatment strategy resulted in a 77% reduction of expected stroke rate: stroke occurred in 4 patients (ischemic stroke in 3 patients and hemorrhagic stroke in 1 patient) with a low rate of peri-procedural pericardial effusion (5 patients, 2 requiring percutaneous drainage).[]

A significantly higher rate of device thrombi has been reported in 34 patients undergoing Amplatzer Cardiac Plug (ACP) implantation: despite DPI, thrombi on ACP were identified 6/34 (17.6%) patients (in 3 patients before discharge and in the other 3 patients at the 3-months follow-up) and Plicht et al. identified CHADS2and CHA2DS2-VASc scores, platelet count, and ejection fraction as risk factors.[] (Table 2).

Interesting data has been recently reported from our group[]: in 80 patients undergoing percutaneous LAA occlusion with either Watchman or ACP device, a short-term 6-week DPI followed by stand-alone therapy was administered in 76% of the patients, while the remaining patients continued preexisting OAC. After 6 weeks, OAC or DPI was discontinued and patients were switched to stand-alone aspirin. The overall rate of thrombus formation was comparable to previous study (5%), but interestingly, significantly lower rates of thrombus formation were observed in patients taking DPI compared to those treated with OAC (1.7% vs. 15.8%, p= 0.042), without any differences in device distribution.[] These results may suggest that short term (6 weeks) DPI may be preferable to OAC in preventing thrombus formation on LAA closure devices. Nevertheless, further studies enrolling larger numbers of patients are needed to verify the safety of this suggested post-implantation antithrombotic therapy.

Device Specific Complications

Currently, four percutaneous transcatheter devices have been investigated for LAA occlusion[]: the Percutaneous LAA Transcatheter Occlusion (PLAATO) System (eV3, Plymouth, MN); the WATCHMAN device (Boston Scientific, Maple Grove, MN); the Amplatzer Cardiac Plug (ACP) (St. Jude Medical, Minneapolis, MN) and the WavecrestTM System (Coherex Medical, Salt Lake City, UT). (Fig. 1Table 2).

The PLAATO System

The PLAATO system was the first device developed specifically for LAA occlusion. It consists of a self-expandable nitinol cage covered with an occlusive expanded polytetrafluoroethylene membrane with small anchors along the struts.[,] Acute successful LAA occlusion has been reported as higher than 90%,[,] while the annual stroke rate was 2.2%,[] with a 65% relative risk reduction compared to a CHADS2 score predicted stroke rate of 6.3%.[] Even after a long-term follow-up (5 years), the annual stroke rate was 3.8%, lower than the 6.6%/year expected with the CHADS2 score.[] In the recently published North American PLAATO long-term experience (follow-up of 3.75 years in 64 patients) only one adverse event was attributed to the device (1 cardiac tamponade requiring surgery). The other observed complications were the following: 7 deaths, 5 major strokes, 3 minor strokes, 1 probable cerebral hemorrhage/death, and 1 myocardial infarction.[] Despite initially encouraging results, the PLAATO device is no longer available due to commercial reasons.

The WATCHMAN System

The WATCHMAN system ([Fig. 1A]) is a self-expanding, nitinol device available in 5 sizes (ranging from 21 to 33mm) that has been studied in two randomized clinical trials, the PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF)[] and the PREVAIL (Prospective Randomized EVAluation of theWatchman LAA closure device In patients with atrial fibrillation vs. Long-term warfarin therapy)[] and in one registry, the CAP (The Continued Access to PROTECT AF),[] which investigated patients outcomes after the end of enrolment of PROTECT AF trial. The PROTECT AF[] is the first trial which prospectively enrolled a large number of patients (707) with NVAF to compare LAA closure using the WATCHMAN device with long-term OAC. The trial demonstrated that the percutaneous LAA closure with WATCHMAN was noninferior to OAC in preventing stroke, cardiovascular death, and systemic embolism. Patients receiving the device had fewer hemorrhagic strokes than the controls but a higher rate of adverse events, mainly due to peri-procedural complications.

Approximately 5% of patients had pericardial effusions (n=22) requiring drainage: 15 patients were treated with pericardiocentesis and 7 with surgical intervention. There were 3 device embolizations, one during the procedure and 2 during follow-up while procedure-related stroke occurred in 5 patients (Table 2). However, in the WATCHMAN group, there was a 29% reduction in stroke and 38% reduction in death compared with the warfarin control group.

A further analysis including patients undergoing WATCHMAN implantation from PROTECT AF and from a subsequent nonrandomized registry (CAP Registry) has been recently published[] showing increased implantation success rates along with decreased complications. Importantly, the rate of pericardial effusion was decreased (2.2% vs. 4.8% in PROTECT AF) and no procedure-related strokes were observed (0% vs 0.9% in PROTECT AF) (Table 2). The significant reduction of major safety events may indicate increased operators’ experience having accomplished the procedural learning curve. Preliminary data of the PREVAIL trial is in line with the CAP data.[] This second prospective, randomized study using the Watchman device also showed significantly increased success device implantation rates (95.1% vs. 94.3% in CAP and 90.9% in PROTECT AF) with a 49% reduction of safety events (4.6% vs. 8.7% in PROTECT AF; p=.004).[,] The rates of procedure-related stroke were significantly reduced compared to PROTECT AF (p=0.019) as well as the pericardial effusions requiring intervention (1.9% in PREVAIL vs. 4.0% of patients in PROTECT AF, 52% reduction) (Table 2). The decreased rate of safety events can be explained by increased overall experience. Interestingly, after appropriate training implantation success was comparable for new vs experienced operators: 93.2% vs. 96.3% (p=0.282). Also, the rate of major complications was consistently low in both groups.[]

Amplatzer Cardio Plug System

Another self-expanding endocardial device for LAA occlusion is the ACP, which is made of a disc for sealing the LAA and a body for device fixation in the LAA,[] connected by a central body (Fig. 1B). It is available in 8 different sizes (from 16 to 30mm). Initial European[] and Asia-Pacific[] experience reported similar high implantation success rates (96% and 95%) (Table 2).

Device repositioning and complete LAA closure may be facilitated by the design.[]

Serious complications were observed in 10 (7%) patients (3 ischemic stroke, 2 device embolizations and 5 significant pericardial effusions) and 3 patients in the Asia-Pacific registry (1 catheter-related thrombus formation during procedure leading to stop the implant , 1 coronary artery air embolism and 1 TEE-attributed esophageal damage), respectively.[,]

Thrombus formation on the ACP has been reported.[] A recent study[] investigated risk factors associated to this complication: despite dual antiplatelet therapy, thrombi on ACP were identified with TEE in 6 (17.6%) patients (in 3 patients before discharge and in the other 3 patients at the 3-months follow-up) (Table 2). CHADS2 and CHA2DS2-VASc scores, platelet count, and ejection fraction resulted risk factors for such thrombus formation.[] However, this data has not been replicated[] and more information is required.

Wavecrest System

The Wavecrest LAA occlusion system (Fig. 1C) recently received CE mark and has been introduced in the Europe. The device consists of a self-expanding Nitinol frame covered by ePTFE with a polyurethane rim and a distal face. This system has been designed to facilitate device deployment by allowing non-traumatic repositioning maneuvers at the LAA orifice. Two injection ports (distal and proximal) allow fluoroscopic assessment of adequate device positioning within the landing zone and device stability before release. The Wavecrest device has 20 interlocking anchors, which engage the surrounding tissue to complete the implant deployment. The cover material (ePTFE) has been clinically used before (PLAATO device) and is expected to minimize thrombus formation. There is currently no published human data available. In our own experience 12 patients were treated successfully without major complication. However, more data is certainly required to fully assess its role in LAA closure.

There are currently no studies directly comparing the three different LAA occluders and only one paper from our group,[] prospectively compared procedural data and outcome of 80 patients who underwent percutaneous LAA occlusion with either a Watchman (n=40) or an ACP device (n=40). There was no statistical difference in patients characteristics and procedure and fluoroscopy times between the two groups. The acute success rate was very high for both the LAA closure systems (95 and 100%), despite of different devices designs. Also the number of serious complications was comparable (5%): 1 air embolization and 1 delayed cardiac tamponade in each group, while minor complications occurred in 6.8% of patients (4 cases of groin hematoma, 1 case of false arterial aneurysm). At 6-weeks TEE follow-up, 1 asymptomatic ACP dislocation into the LA was observed and the device was successfully retrieved percutaneously without surgical intervention.[] Our study[] investigated alternative antithrombotic treatment regimens in high-risk patient: after device implantation, either preexisting OAC or dual platelet inhibition (DPI; Aspirin 100 mg/d + clopidogrel 75mg/d) was continued for 6 weeks; thereafter, OAC or DPI was discontinued and patients were switched to stand-alone aspirin. Interestingly, lower rates of thrombus formation were observed in patients taking DPI compared to those treated with OAC (1.7% vs 15.8%, p= 0.042), without any differences in device distribution.[]

Percutaneous Epicardial

An alternative approach to percutaneous LAA occlusion is evolving and is based on a combined epicardial/endocardial technique (LARIAT®, SentreHEART Inc., Redwood City, California, USA). This approach ligates the LAA with an epicardial suture. After obtaining percutaneous epicardial access, a magnet-tipped endocardial wire is introduced into the pericardial space. In addition, a transseptal puncture is performed introducing a 20-mm compliant occlusion balloon catheter (EndoCATH, SentreHEART, Inc., Palo Alto, CA) with a second magnet-tipped endocardial wire into the LAA. Both magnets are approximating the LAA. Then the LARIAT snare delivery system is advanced epicardially over the LAA, guided by the endocardial balloon catheter positioned inside the LAA. After correct placement verification, the snare is closed and the suture is tightened to ligate and exclude the LAA. This can result in complete LAA closure without any device “left inside the LAA”.

First experience[] reported encouraging results with complete closure in 81 of the 85 patients who successfully underwent LAA ligation with LARIAT device, and residual LAA flow ≤ 3mm only in 4 patients. No complications due to the device were observed, but there were 3 access-related complications during pericardial access and transseptal catheterization. Major complications included 2 severe pericarditis, 1 late pericardial effusion, 2 unexplained sudden death, and 2 late strokes probably non-embolic.[]

The major limitation of this technique is the need for an epicardial access. Most of the complications are related to the epicardial puncture and include possible cardiac perforation, pericardial effusion or tamponade and severe pericarditis. In some patients, the presence of pre-existing pericardial adhesions may complicate catheter manipulation. In addition, successful ligation could not be achieved inadvertent LAA anatomy (LAA size > 40 mm, posteriorly rotated LAA or lobes superiorly orientated).[]

The major advantage of this approach refers to the fact that there remains no permanent device within systemic circulation. Therefore no OAC or DPI is required after the procedure to prevent thrombus formation during endothelialization.

However, some case-reports described acute and delayed adverse events: “reopening” of the LARIAT closure device,[] LA thrombus[] and LA laceration (3/6 patients: 50%) progressing to cardiac tamponade, requiring surgery.[]

These preliminary results demonstrated feasibility of this concept but further studies are needed to validate its future clinical role in LAA closure.

Conclusions And Perspective

Percutaneous LAA closure is able to reduce the risk of stroke in NVAF and represents a treatment option for high-risk patients. The initially high procedural complication rate decreased with growing operator experience after accomplishing the learning curve and is now associated with an acceptable safety profile. Moreover, novel devices and designs are currently under evaluation, which may contribute to perform safer LAA closure in future. The important topic of optimal post-procedural antithrombotic treatment requires further investigation.

Disclosures

None.

References

1. Camm A John, Kirchhof Paulus, Lip Gregory Y H, Schotten Ulrich, Savelieva Irene, Ernst Sabine, Van Gelder Isabelle C, Al-Attar Nawwar, Hindricks Gerhard, Prendergast Bernard, Heidbuchel Hein, Alfieri Ottavio, Angelini Annalisa, Atar Dan, Colonna Paolo, De Caterina Raffaele, De Sutter Johan, Goette Andreas, Gorenek Bulent, Heldal Magnus, Hohloser Stefan H, Kolh Philippe, Le Heuzey Jean-Yves, Ponikowski Piotr, Rutten Frans H. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12 (10):1360–420.[PubMed]
2. Camm A John, Lip Gregory Y H, De Caterina Raffaele, Savelieva Irene, Atar Dan, Hohnloser Stefan H, Hindricks Gerhard, Kirchhof Paulus. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur. Heart J. 2012 Nov;33 (21):2719–47. [PubMed]
3. Stewart S, Hart C L, Hole D J, McMurray J J. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov;86 (5):516–21. [PMC free article] [PubMed]
4. Go A S, Hylek E M, Phillips K A, Chang Y, Henault L E, Selby J V, Singer D E. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285 (18):2370–5.[PubMed]
5. Miyasaka Yoko, Barnes Marion E, Gersh Bernard J, Cha Stephen S, Bailey Kent R, Abhayaratna Walter P, Seward James B, Tsang Teresa S M. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114 (2):119–25. [PubMed]
6. Heeringa Jan, van der Kuip Deirdre A M, Hofman Albert, Kors Jan A, van Herpen Gerard, Stricker Bruno H Ch, Stijnen Theo, Lip Gregory Y H, Witteman Jacqueline C M. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur. Heart J. 2006 Apr;27 (8):949–53. [PubMed]
7. Naccarelli Gerald V, Varker Helen, Lin Jay, Schulman Kathy L. Increasing prevalence of atrial fibrillation and flutter in the United States. Am. J. Cardiol. 2009 Dec 1;104 (11):1534–9. [PubMed]
8. Go Alan S, Mozaffarian Dariush, Roger Véronique L, Benjamin Emelia J, Berry Jarett D, Blaha Michael J, Dai Shifan, Ford Earl S, Fox Caroline S, Franco Sheila, Fullerton Heather J, Gillespie Cathleen, Hailpern Susan M, Heit John A, Howard Virginia J, Huffman Mark D, Judd Suzanne E, Kissela Brett M, Kittner Steven J, Lackland Daniel T, Lichtman Judith H, Lisabeth Lynda D, Mackey Rachel H, Magid David J, Marcus Gregory M, Marelli Ariane, Matchar David B, McGuire Darren K, Mohler Emile R, Moy Claudia S, Mussolino Michael E, Neumar Robert W, Nichol Graham, Pandey Dilip K, Paynter Nina P, Reeves Matthew J, Sorlie Paul D, Stein Joel, Towfighi Amytis, Turan Tanya N, Virani Salim S, Wong Nathan D, Woo Daniel, Turner Melanie B. Executive summary: heart disease and stroke statistics–2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129 (3):399–410. [PubMed]
9. Hart R G, Pearce L A, Rothbart R M, McAnulty J H, Asinger R W, Halperin J L. Stroke with intermittent atrial fibrillation: incidence and predictors during aspirin therapy. Stroke Prevention in Atrial Fibrillation Investigators. J. Am. Coll. Cardiol. 2000 Jan;35 (1):183–7. [PubMed]
10. Chao Tze-Fan, Lin Yenn-Jiang, Tsao Hsuan-Ming, Tsai Chin-Feng, Lin Wei-Shiang, Chang Shih-Lin, Lo Li-Wei, Hu Yu-Feng, Tuan Ta-Chuan, Suenari Kazuyoshi, Li Cheng-Hung, Hartono Beny, Chang Hung-Yu, Ambrose Kibos, Wu Tsu-Juey, Chen Shih-Ann. CHADS(2) and CHA(2)DS(2)-VASc scores in the prediction of clinical outcomes in patients with atrial fibrillation after catheter ablation. J. Am. Coll. Cardiol. 2011 Nov 29;58 (23):2380–5. [PubMed]
11. Pisters Ron, Lane Deirdre A, Nieuwlaat Robby, de Vos Cees B, Crijns Harry J G M, Lip Gregory Y H. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138 (5):1093–100. [PubMed]
12. Go A S, Hylek E M, Borowsky L H, Phillips K A, Selby J V, Singer D E. Warfarin use among ambulatory patients with nonvalvular atrial fibrillation: the anticoagulation and risk factors in atrial fibrillation (ATRIA) study. Ann. Intern. Med. 1999 Dec 21;131 (12):927–34. [PubMed]
13. Fatkin D, Kelly R, Feneley M P. Left atrial appendage blood velocity and thromboembolic risk in patients with atrial fibrillation. J. Am. Coll. Cardiol. 1994 Nov 1;24 (5):1429–30. [PubMed]
14. Blackshear J L, Odell J A. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann. Thorac. Surg. 1996 Feb;61 (2):755–9.[PubMed]
15. Manning WJ, Waksmonski CA, Haering JM. Sensitivity and specificity of transesophageal echo for left atrial thrombi: a prospective, consecutive surgical study. Circulation. 1994;90:1202a.
16. Aberg H. Atrial fibrillation. I. A study of atrial thrombosis and systemic embolism in a necropsy material. Acta Med Scand. 1969 May;185 (5):373–9.[PubMed]
17. Tsai L M, Chen J H, Lin L J, Yang Y J. Role of transesophageal echocardiography in detecting left atrial thrombus and spontaneous echo contrast in patients with mitral valve disease or non-rheumatic atrial fibrillation. J. Formos. Med. Assoc. 1990 Apr;89 (4):270–4. [PubMed]
18. Johnson W D, Ganjoo A K, Stone C D, Srivyas R C, Howard M. The left atrial appendage: our most lethal human attachment! Surgical implications. Eur J Cardiothorac Surg. 2000 Jun;17 (6):718–22. [PubMed]
19. Al-Saady N M, Obel O A, Camm A J. Left atrial appendage: structure, function, and role in thromboembolism. Heart. 1999 Nov;82 (5):547–54.[PMC free article] [PubMed]
20. Di Biase Luigi, Santangeli Pasquale, Anselmino Matteo, Mohanty Prasant, Salvetti Ilaria, Gili Sebastiano, Horton Rodney, Sanchez Javier E, Bai Rong, Mohanty Sanghamitra, Pump Agnes, Cereceda Brantes Mauricio, Gallinghouse G Joseph, Burkhardt J David, Cesarani Federico, Scaglione Marco, Natale Andrea, Gaita Fiorenzo. Does the left atrial appendage morphology correlate with the risk of stroke in patients with atrial fibrillation? Results from a multicenter study. J. Am. Coll. Cardiol. 2012 Aug 7;60 (6):531–8. [PubMed]
21. Khurram Irfan M, Dewire Jane, Mager Michael, Maqbool Farhan, Zimmerman Stefan L, Zipunnikov Vadim, Beinart Roy, Marine Joseph E, Spragg David D, Berger Ronald D, Ashikaga Hiroshi, Nazarian Saman, Calkins Hugh. Relationship between left atrial appendage morphology and stroke in patients with atrial fibrillation. Heart Rhythm. 2013 Dec;10 (12):1843–9. [PubMed]
22. Anselmino Matteo, Scaglione Marco, Di Biase Luigi, Gili Sebastiano, Santangeli Pasquale, Corsinovi Laura, Pianelli Martina, Cesarani Federico, Faletti Riccardo, Righi Dorico, Natale Andrea, Gaita Fiorenzo. Left atrial appendage morphology and silent cerebral ischemia in patients with atrial fibrillation. Heart Rhythm. 2014 Jan;11 (1):2–7. [PubMed]
23. Holmes David R, Reddy Vivek Y, Turi Zoltan G, Doshi Shephal K, Sievert Horst, Buchbinder Maurice, Mullin Christopher M, Sick Peter. 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. 2009 Aug 15;374 (9689):534–42. [PubMed]
24. Calkins Hugh, Kuck Karl Heinz, Cappato Riccardo, Brugada Josep, Camm A John, Chen Shih-Ann, Crijns Harry J G, Damiano Ralph J, Davies D Wyn, DiMarco John, Edgerton James, Ellenbogen Kenneth, Ezekowitz Michael D, Haines David E, Haissaguerre Michel, Hindricks Gerhard, Iesaka Yoshito, Jackman Warren, Jalife Jose, Jais Pierre, Kalman Jonathan, Keane David, Kim Young-Hoon, Kirchhof Paulus, Klein George, Kottkamp Hans, Kumagai Koichiro, Lindsay Bruce D, Mansour Moussa, Marchlinski Francis E, McCarthy Patrick M, Mont J Lluis, Morady Fred, Nademanee Koonlawee, Nakagawa Hiroshi, Natale Andrea, Nattel Stanley, Packer Douglas L, Pappone Carlo, Prystowsky Eric, Raviele Antonio, Reddy Vivek, Ruskin Jeremy N, Shemin Richard J, Tsao Hsuan-Ming, Wilber David. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14 (4):528–606.[PubMed]
25. Cappato Riccardo, Calkins Hugh, Chen Shih-Ann, Davies Wyn, Iesaka Yoshito, Kalman Jonathan, Kim You-Ho, Klein George, Packer Douglas, Skanes Allan. Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation. 2005 Mar 8;111 (9):1100–5. [PubMed]
26. Cruz-Gonzalez Ignacio, Yan Bryan P, Lam Yat-Yin. Left atrial appendage exclusion: state-of-the-art. Catheter Cardiovasc Interv. 2010 Apr 1;75 (5):806–13.[PubMed]
27. Presented by Dr. David Holmes at ACC 2013,San Francisco. (http://afibprofessional.cardiosource.org/Science-And-Quality/Clinical- Trials/P/PREVAIL.aspx?). 2013;0:0–0.
28. Onalan Orhan, Crystal Eugene. Left atrial appendage exclusion for stroke prevention in patients with nonrheumatic atrial fibrillation. Stroke. 2007 Feb;38 (2 Suppl):624–30. [PubMed]
29. Sepahpour Ali, Ng Martin K C, Storey Philip, McGuire Mark A. Death from pulmonary artery erosion complicating implantation of percutaneous left atrial appendage occlusion device. Heart Rhythm. 2013 Dec;10 (12):1810–1. [PubMed]
30. Viles-Gonzalez Juan F, Kar Saibal, Douglas Pamela, Dukkipati Srinivas, Feldman Ted, Horton Rodney, Holmes David, Reddy Vivek Y. 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. 2012 Mar 6;59 (10):923–9.[PubMed]
31. Chun K R Julian, Bordignon Stefano, Urban Verena, Perrotta Laura, Dugo Daniela, Fürnkranz Alexander, Nowak Bernd, Schmidt Boris. Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience. Heart Rhythm. 2013 Dec;10 (12):1792–9. [PubMed]
32. Reddy Vivek Y, Möbius-Winkler Sven, Miller Marc A, Neuzil Petr, Schuler Gerhard, Wiebe Jens, Sick Peter, Sievert Horst. 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 Jun 25;61 (25):2551–6. [PubMed]
33. Plicht Bjoern, Konorza Thomas F M, Kahlert Philipp, Al-Rashid Fadi, Kaelsch Hagen, Jánosi Rolf Alexander, Buck Thomas, Bachmann Hagen S, Siffert Winfried, Heusch Gerd, Erbel Raimund. Risk factors for thrombus formation on the Amplatzer Cardiac Plug after left atrial appendage occlusion. JACC Cardiovasc Interv. 2013 Jun;6 (6):606–13. [PubMed]
34. John Camm A, Colombo Antonio, Corbucci Giorgio, Padeletti Luigi. Left atrial appendage closure: a new technique for clinical practice. Heart Rhythm. 2014 Mar;11 (3):514–21. [PubMed]
35. Sievert Horst, Lesh Michael D, Trepels Thomas, Omran Heyder, Bartorelli Antonio, Della Bella Paola, Nakai Toshiko, Reisman Mark, DiMario Carlo, Block Peter, Kramer Paul, Fleschenberg Dirk, Krumsdorf Ulrike, Scherer Detlef. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105 (16):1887–9. [PubMed]
36. Nakai Toshiko, Lesh Michael D, Gerstenfeld Edward P, Virmani Renu, Jones Russell, Lee Randall J. Percutaneous left atrial appendage occlusion (PLAATO) for preventing cardioembolism: first experience in canine model. Circulation. 2002 May 7;105 (18):2217–22. [PubMed]
37. Ostermayer Stefan H, Reisman Mark, Kramer Paul H, Matthews Ray V, Gray William A, Block Peter C, Omran Heyder, Bartorelli Antonio L, Della Bella Paolo, Di Mario Carlo, Pappone Carlo, Casale Paul N, Moses Jeffrey W, Poppas Athena, Williams David O, Meier Bernhard, Skanes Allan, Teirstein Paul S, Lesh Michael D, Nakai Toshiko, Bayard Yves, Billinger Kai, Trepels Thomas, Krumsdorf Ulrike, Sievert Horst. Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials. J. Am. Coll. Cardiol. 2005 Jul 5;46 (1):9–14. [PubMed]
38. Bayard Yves-Laurent, Omran Heyder, Neuzil Petr, Thuesen Leif, Pichler Maximilian, Rowland Edward, Ramondo Angelo, Ruzyllo Witold, Budts Werner, Montalescot Gilles, Brugada Pedro, Serruys Patrick W, Vahanian Alec, Piéchaud Jean-François, Bartorelli Antonio, Marco Jean, Probst Peter, Kuck Karl-Heinz, Ostermayer Stefan H, Büscheck Franziska, Fischer Evelyn, Leetz Michaela, Sievert Horst. PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: results from the European PLAATO study. EuroIntervention. 2010 Jun;6 (2):220–6. [PubMed]
39. Block Peter C, Burstein Steven, Casale Paul N, Kramer Paul H, Teirstein Paul, Williams David O, Reisman Mark. Percutaneous left atrial appendage occlusion for patients in atrial fibrillation suboptimal for warfarin therapy: 5-year results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study. JACC Cardiovasc Interv. 2009 Jul;2 (7):594–600. [PubMed]
40. Reddy Vivek Y, Holmes David, Doshi Shephal K, Neuzil Petr, Kar Saibal. 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. 2011 Feb 1;123 (4):417–24. [PubMed]
41. Landmesser Ulf, Holmes David R. Left atrial appendage closure: a percutaneous transcatheter approach for stroke prevention in atrial fibrillation. Eur. Heart J. 2012 Mar;33 (6):698–704. [PubMed]
42. Park Jai-Wun, Bethencourt Armando, Sievert Horst, Santoro Gennaro, Meier Bernhard, Walsh Kevin, Lopez-Minguez Jose Ramon, Lopez-Minquez Jose Ramon, Meerkin David, Valdés Mariano, Ormerod Oliver, Leithäuser Boris. Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. Catheter Cardiovasc Interv. 2011 Apr 1;77 (5):700–6.[PubMed]
43. Lam Yat-Yin, Yip Gabriel W K, Yu Cheuk-Man, Chan Wilson W M, Cheng Boron C W, Yan Bryan P, Clugston Richard, Yong Gerald, Gattorna Tim, Paul Vincent. Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience. Catheter Cardiovasc Interv. 2012 Apr 1;79 (5):794–800. [PubMed]
44. Cruz-Gonzalez Ignacio, Martín Moreiras Javier, García Eulogio. Thrombus formation after left atrial appendage exclusion using an Amplatzer cardiac plug device. Catheter Cardiovasc Interv. 2011 Nov 15;78 (6):970–3. [PubMed]
45. Perrotta Laura, Bordignon Stefano, Fürnkranz Alexander, Chun Julian K R, Eggebrecht Holger, Schmidt Boris. Catch me if you can: transseptal retrieval of a dislodged left atrial appendage occluder. Circ Arrhythm Electrophysiol. 2013 Aug;6 (4):e64. [PubMed]
46. Bartus Krzysztof, Han Frederick T, Bednarek Jacek, Myc Jacek, Kapelak Boguslaw, Sadowski Jerzy, Lelakowski Jacek, Bartus Stanislaw, Yakubov Steven J, Lee Randall J. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J. Am. Coll. Cardiol. 2013 Jul 9;62 (2):108–18. [PubMed]
47. Aryana Arash, Saad Eduardo B, d’Avila André. Left atrial appendage occlusion and ligation devices: what is available, how to implement them, and how to manage and avoid complications. Curr Treat Options Cardiovasc Med. 2012 Oct;14 (5):503–19. [PubMed]
48. Di Biase Luigi, Burkhardt J David, Gibson Douglas N, Natale Andrea. 2D and 3D TEE evaluation of an early reopening of the LARIAT epicardial left atrial appendage closure device. Heart Rhythm. 2014 Jun;11 (6):1087–8. [PubMed]
49. Baker Matthew S, Paul Mounsey J, Gehi Anil K, Chung Eugene H. Left atrial thrombus after appendage ligation with LARIAT. Heart Rhythm. 2014 Aug;11 (8)[PubMed]
50. Briceno David F, Fernando Rajeev R, Laing Susan T. Left atrial appendage thrombus post LARIAT closure device. Heart Rhythm. 2014 Sep;11 (9):1600–1.[PubMed]
51. Keating Vincent P, Kolibash Christopher P, Khandheria Bijoy K, Bajwa Tanvir, Sra Jasbir, Kress David C. Left atrial laceration with epicardial ligation device. Ann Thorac Cardiovasc Surg. 2014;20 Suppl ():904–8. [PubMed]

Leave a Reply