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National Medical Policy
Subject:
Left Atrial Appendage Devices (Watchman
Procedure, Lariat System, Cardioblate Closure
Device, Amplatzer Septal Closure Device, Atria
Clip System)
Policy Number:
NMP376
Effective Date*: October 2007
Update:
July 2016
This National Medical Policy is subject to the terms in the
IMPORTANT NOTICE
at the end of this document
For Medicaid Plans: Please refer to the appropriate State’s Medicaid
manual(s), publication(s), citation(s), and documented guidance for
coverage criteria and benefit guidelines prior to applying Health Net Medical
Policies
The Centers for Medicare & Medicaid Services (CMS)
For Medicare Advantage members please refer to the following for coverage
guidelines first:
Use
X
X
X
Source
National Coverage Determination
(NCD)
National Coverage Manual Citation
Local Coverage Determination
(LCD)*
Article (Local)*
Other
Watchman Procedure Jul 16
Reference/Website Link
Percutaneous Left Atrial Appendage Closure
(LAAC)(20.34):http://www.cms.gov/medicarecoverage-database/search/advancedsearch.aspx
Category III Codes:
http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx
CMS Manual System. Department of Health &
Human Services (DHHS). Pub 100-03 Medicare
National Coverage Determinations.
Percutaneous Left Atrial Appendage Closure
(LAAC). May 6, 2016:
https://www.cms.gov/Regulations-andGuidance/Guidance/Transmittals/Downloads/R1
1
92NCD.pdf
Medicare Learning Matters Network. MLN
Matters Number: MM9638. Effective Date:
February 8, 2016. Percutaneous Left Atrial
Appendage Closure (LAAC):
https://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNMattersArticles/downloads/MM9638.pdf
None
Use Health Net Policy
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in ALL regions.
 Medicare LCDs and Articles apply to members in specific regions. To access your
specific region, select the link provided under “Reference/Website” and follow the
search instructions. Enter the topic and your specific state to find the coverage
determinations for your region. *Note: Health Net must follow local coverage
determinations (LCDs) of Medicare Administration Contractors (MACs) located
outside their service area when those MACs have exclusive coverage of an item
or service. (CMS Manual Chapter 4 Section 90.2)
 If more than one source is checked, you need to access all sources as, on
occasion, an LCD or article contains additional coverage information than
contained in the NCD or National Coverage Manual.
 If there is no NCD, National Coverage Manual or region specific LCD/Article,
follow the Health Net Hierarchy of Medical Resources for guidance.
Current Policy Statement
Health Net, Inc. considers the FDA Approved (March 2015) Watchman Device for
occlusion of the left atrial appendage (LAA), medically necessary to reduce the risk of
stroke in adult patients with nonvalvular atrial fibrillation (NVAF)* in individuals when
the following criteria are met:
1.
Are at increased risk for stroke and systemic embolism based on CHADS2 or
CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
*Note: CHADS2 >2 score generally recommends warfarin therapy. CHADS2-VASc
score of 0: recommend no antithrombotic therapy, CHA2DS2-VASc score of 1:
recommend antithrombotic therapy with oral anticoagulation or antiplatelet therapy
but preferably oral anticoagulation, CHA2DS2-VASc score ≥2: recommend oral
anticoagulation. (AHA, August 14, 2012), AND
2.
Have appropriate rationale to seek a nonpharmaceutical alternative such as
failure and/or contraindications to warfarin, novel oral anti anticoagulants or
anti-thrombin anticoagulants, (i.e., allergic reactions, severe liver disease,
recent trauma or surgery, severely high blood pressure, active bleeding, inability
to obtain regular INR, etc.).
Health Net, Inc. considers the Left Atrial Appendage Devices (i.e., Lariat System,
Cardioblate Closure Device, Amplatzer Septal Closure Device, Atria Clip System,
etc.), investigational, since they are not U.S. F.D.A. approved specifically for
occlusion of the left atrial appendage (LAA).
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Codes Related To This Policy
NOTE:
The codes listed in this policy are for reference purposes only. Listing of a code in
this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and
medical necessity criteria. This list of codes may not be all inclusive.
On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and
inpatient procedures have been replaced by ICD-10 code sets.
ICD-9 Codes
434.91
401.9
414.9
434.00434.91
Cerebral artery occlusion, with cerebral infarction
Hypertension
Chronic ischemic heart disease
Occlusion of cerebral arteries (stroke)
ICD-10 Codes
I10
I25.9
I48.1
I48.2
I48.91
163.50
I66.01-I66.9
Essential (primary) hypertension
Chronic ischemic heart disease, unspecified
Persistent atrial fibrillation
Chronic atrial fibrillation
Unspecified atrial fibrillation
Cerebral infarction due to unspecified occlusion or stenosis of
unspecified cerebral artery
Occlusion and stenosis of cerebral arteries, not resulting in cerebral
infarction
CPT Codes
93318
93799
0281T
Echocardiography, transesophageal (TEE) for monitoring purposes,
including probe placement, real time 2-dimensional image
acquisition and interpretation leading to ongoing (continuous)
assessment of (dynamically changing) cardiac pumping function and
to evaluate therapeutic measures on an immediate time basis.
Unlisted cardiovascular service or procedure
Percutaneous transcatheter closure of the left atrial appendage with
implant, including fluoroscopy, transseptal puncture, catheter
placement(s), left atrial angiography, left atrial appendage
angiography, radiological supervision and interpretation
HCPCS Codes
N/A
Scientific Rationale – Update July 2016
The LARIAT Loop Applicator received 510K Premarket Notification on June 2, 2006
with the 510K number of K060721 for ts use to facilitate suture placement and knot
tying for use in surgical applications where soft tissue are being approximated and/or
ligated with a pre-tied polyester suture.
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The FDA has not evaluated the use of the Lariat Suture Delivery Device for LAA
closure to reduce the risk of stroke in atrial fibrillation patients. (July 13, 2016).
The FDA conducted a search of the Manufacturer and User Facility Device Experience
(MAUDE) database for reports of adverse events with the use of the LARIAT Suture
Delivery Device and its associated devices. We identified 45 adverse events through
June 30, 2015 that occurred in patients undergoing LAA closure procedures with the
LARIAT Suture Delivery Device and/or its associated devices. These reports describe
6 patient deaths and other serious medical complications including laceration and/or
perforation of the heart, complete LAA detachment from the heart, bleeding
(hemorrhage), low blood pressure (hypotension), fluid collection around the heart
(pericardial effusion), fluid collection around the heart that causes low blood pressure
and decreased heart function leading to shock (cardiac tamponade), and fluid
collection around the lung (pleural effusion). Of the 45 adverse events reported to
the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart
surgery. The FDA will continue to monitor this issue and keep the public informed if
significant new information becomes available.
The FDA, (July 13, 2015), is alerting health care providers and patients of reports of
patient deaths and other serious adverse events associated with the use of the
LARIAT Suture Delivery Device and its associated devices to close the left atrial
appendage, a pouch-like region of the left atrium in the heart, in patients with
irregular heart rhythm (atrial fibrillation) to prevent stroke. The FDA notes:




Be aware that the safety and effectiveness of the LARIAT Suture Delivery Device
to close the LAA and prevent stroke in patients with atrial fibrillation has not been
established.
To reduce the risk of stroke in patients with atrial fibrillation, consider treatment
options for which safety and effectiveness have been established.
Prior to treatment, inform your atrial fibrillation patients of the benefits and risks
of the available treatment options to help prevent stroke.
Report any adverse events associated with the use of the LARIAT Suture Delivery
Device and/or its associated devices to the FDA and the manufacturer.
There are no specific FDA approvals for the Lariat System, Cardioblate Closure
Device, Amplatzer Septal Closure Device, or the Atria Clip System, for the left atrial
appendage (LAA) closure to reduce the risk of stroke in atrial fibrillation patients.
Scientific Rationale – Update July 2015
The main goals of atrial fibrillation management are to alleviate symptoms, optimize
cardiac output by controlling rhythm, and decrease the risk of stroke and systemic
thromboembolism (TE).
The Center for Devices and Radiological Health (CDRH) of the Food and Drug
Administration (FDA) has given premarket approval (PMA) for the WATCHMAN LAA
Closure Technology on March 13, 2015. This device is indicated to reduce the risk of
thromboembolism from the left atrial appendage (LAA) in patients with non-valvular
atrial fibrillation who:

Are at increased risk for stroke and systemic embolism based on CHADS2 or
CHA2DS2-VASc scores and are recommended for anticoagulation therapy;

Are deemed by their physicians to be suitable for warfarin; and
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
Have an appropriate rationale to seek a non-pharmacologic alternative to
warfarin, taking into account the safety and effectiveness of the device
compared to warfarin.
Expiration dating for this device has been established and approved at 3 years.
Continued approval of this PMA is contingent upon the submission of periodic
reports, required under 21 CFR 814.84, at intervals of one year, unless otherwise
specified, from the date of approval of the original PMA. Two copies of this report,
identified as "Annual Report", should be submitted. This is a reminder that as of
September 24, 2014, class III devices are subject to certain provisions of the final
unique device investigation (UDI) rule. The Office of Device Evaluation (ODE) will
have the lead for this clinical study, which was initiated prior to device approval. This
study should be conducted per revision of the CAP protocol, revision of the PREVAIL
protocol, and version AF of the CAP2 protocol. The study will consist of all IDE
patients from PREVAIL, CAP, and CAP2 who are currently enrolled and alive.
The study objective is to characterize the safety and effectiveness of the WATCHMAN
LAA Closure Technology annually through 5 years post-procedure. marketing of
devices. Failure to comply with any post-approval requirement constitutes a ground
for withdrawal of approval of a PMA.
Occurrence of one of the following events between the time of implant and within
seven days of the procedure or by hospital discharge, whichever is later: all-cause
death, ischemic stroke, systemic embolism, or device or procedure-related events
requiring open cardiac surgery or major endovascular intervention such as
pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.
Percutaneous catheter drainage of pericardial effusions, snaring of an embolized
device, thrombin injection to treat femoral pseudoaneurysm, and nonsurgical
treatments of access site complications will not be included in the assessment of the
third primary endpoint, but the rates of these events should be calculated.
In addition to the condition outlined above, there is a requirement to support and
actively participate as a stakeholder in the left atrial appendage closure (LAAC)
National Cardiovascular Device Registry (NCDR) registry and undertake such
activities to ensure that surveillance occurs through 12 months post-implant within
the registry for the WATCHMAN LAAC in at least 1,000 serially implanted patients not
participating in the New Enrollment Study.
Manufacturers of medical devices, including in vitro diagnostic devices, are required
to report to FDA no later than 30 calendar days after the day they receive or
otherwise becomes aware of information, from any source, that reasonably suggests
that one of their marketed devices:


May have caused or contributed to a death or serious injury; or
Has malfunctioned and such device or similar device marketed by the
manufacturer would be likely to cause or contribute to a death or serious injury
if the malfunction you are required to submit a written report to FDA.
Clinical Trials
There is a Clinical Trial on ‘Left Atrial Appendage Closure vs. Novel Anticoagulation
Agents in Atrial Fibrillation (PRAGUE-17)’ that is ongoing but not currently recruiting
participants. The ClinicalTrials.gov Identifier is NCT02426944 and it was last updated
April 24, 2015. The aim of this trial is to compare the LAA occlusion intervention to
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novel anticoagulants (NOAC) pharmacological treatment in a randomized multicenter
study of AF patients at high risk of a cardioembolic event. The estimated study
completion date is May 2020.
There is another Clinical Trial on ‘Left Atrial Appendage Electrical Isolation and
Occlusion to Treat Persistent Atrial Fibrillation: A Safety and Feasibility Study (LEIOAF)’. The ClinicalTrials.gov Identifier is NCT02028130, and it was last updated in
June 2014. The goal of this study is to investigate whether it is safe and feasible to
ablate the LAA and to implant a Watchman device during the same procedure in
patients who are in atrial fibrillation all of the time. The estimated primary
completion date is October 2014, however it is now July 2015 and it is still ongoing.
There is a Phase II Clinical Trial on ‘Left Atrial Appendage (LAA) Occluders After
Catheter Ablation of Atrial Fibrillation’ which is currently recruiting participants. The
ClinicalTrials.gov Identifier is NCT01695824 and it was last updated on February 24,
2015. The estimated primary completion date is March 2015, however, it is already
July 2015 and it is not completed yet.
Position Statements
The current (July, 2015) ACC/AHA/HRS Guideline for the Management of Patients
with Atrial Fibrillation notes that the Watchman Device is indicated as an alternative
to long-term oral anticoagulation with warfarin in patients with nonvalvular AF who
are at increased risk of stroke.
Canadian Cardiovascular Society (CCS, 2014) guidelines for the management of
patients with AF make the following statements regarding device-mediated LAA
occlusion for stroke prevention:

There is insufficient data to recommend LAA occlusion device therapy as an
alternative to warfarin or novel oral anticoagulants (OACs).

LAA occlusion device therapy may be a reasonable option for the rare patients
with AF who are not candidates for warfarin and novel OACs because of their
very high risk of hemorrhage.

Non-approved LAA closure devices should not be used, except in research
protocols or in documented protocols used in patients at high risk of stroke
(CHADS2 score ≥ 2) and contraindications to antithrombotic therapy (a
conditional recommendation based on low-quality evidence).
European Heart Rhythm Association (EHRA) and European Association of
Percutaneous Cardiovascular Interventions (EAPCI): The EHRA/EAPCI consensus
statement on catheter-based LAA appendage occlusion state the following (Meier et
al., 2014):

The main indication for LAA occlusion is AF with a CHADS2 score ≥ 1 or CHA2DS2-VASc score ≥ 2 and a relative or absolute contraindication to prolonged
novel oral anticoagulants (OAC).

Tolerance for at minimum several weeks of dual antiplatelet therapy, usually
followed by lifelong single antiplatelet drug therapy.
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The National Institute for Health and Care Excellence (NICE, 2014) clinical guideline
on the management of AF makes the following recommendations regarding LAA
occlusion:

It should be considered only if anticoagulation is contraindicated or not
tolerated; the risks and benefits should be discussed with the patient.

Available evidence suggests that percutaneous LAA occlusion has efficacy in
reducing the risk of thromboembolic complications associated with nonvalvular
AF and is associated with a low risk of life-threatening complications. Without
mentioning specific LAA occlusion devices, this guidance notes that the different
devices used in published studies might not necessarily produce the same clinical
outcomes (NICE, 2010, p. 1).
Warfarin
Warfarin pharmacokinetics is affected by the level of vitamin K intake and production
in the gastrointestinal tract, as well as induction of hepatic cytochromes. Thus,
warfarin effect can be altered by changes in diet, administration of other
medications, gastrointestinal disorders, and reduced oral intake. Patients with
difficulty controlling the prothrombin time/international normalized ratio (PT/INR)
may benefit from a target-specific oral agent because these agents have less
variability in drug effect for a given dose than vitamin K antagonists. Affected
patients may include those with unavoidable drug-drug interactions, such as frequent
need for antibiotics or a large number of concomitant and variable medications, or
unexplained poor warfarin control.
Newer Anticoagulants
Since following implantation of the Watchman device the patients must continue on
warfarin therapy for approximately 45 days, there are very limited data on if and
how to use the Watchman device in patients with complete contraindications to
warfarin. While they do not appear to be on the horizon, the field would greatly
benefit from randomized studies that compare the newer oral anticoagulants (OACs)
versus device-mediated LAA closure and that test the use of these OACs as an
adjunct to LAA closure with Watchman or other devices.
Options for anticoagulation have been expanding over the past few decades,
providing a greater number of agents for prevention and management of
thromboembolic disease. In addition to heparins and vitamin K antagonists,
anticoagulants that directly target the enzymatic activity of thrombin and factor Xa
have been developed. Appropriate use of these agents requires knowledge of their
individual characteristics, risks, and benefits.
Newer non-vitamin K oral anticoagulants, sometimes abbreviated NOAC, (eg,
dabigatran, rivaroxaban, apixaban, or edoxaban) are preferred to warfarin for most
patients in whom oral anticoagulant therapy is chosen. However, without blinded
head-to-head trial comparisons between these newer agents, it is difficult to assert
that any of the NOAC agents is clearly superior. Each practitioner should become
familiar with and comfortable using at least one or two NOAC agents.
Studies
Lam et al. (2015) completed a study with the goal to demonstrate the feasibility,
safety, and short-term outcome of left atrial appendage (LAA) closure with a new
generation LAA closure device. The Amulet device (AGA, St Jude Medical,
Minneapolis, MN) is a new generation of the amplatzer cardiac plug (ACP),
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specifically designed for LAA closure. This new version is designed to facilitate the
implantation process and minimize procedural or device-related complications. The
device was implanted in 17 patients with nonvalvular atrial fibrillation (AF). Clinical
data were obtained at baseline, during the procedure, at discharge, at 30 and 90
days. All devices were implanted successfully. Device sizes ranged from 20 mm to 31
mm. A 12 French (Fr) or 14 Fr delivery sheath was used depending on the selected
device size. Full and partial recapture was performed in 1 case and 3 cases,
respectively. There was 1 procedure-related pericardial effusion successfully
managed with pericardiocentesis. There was no device embolization. The mean
length of stay was 2.1 ± 0.3 days. At 90 days, there were no deaths, strokes,
systemic thromboembolism, or bleeding complications. There was no device-related
thrombus or pericardial effusion at 90-day TEE. In 2 of the 17 patients minimal
peridevice flow (smaller than 2 mm) was present. The Amulet device, which has new
novel features as compared with the first generation ACP, is a feasible option for LAA
closure. From our initial experience, implantation of the Amulet is associated with
high success rate and good short-term outcome.
Patel et al. (2015) Percutaneous left atrial appendage (LAA) ligation using an
epicardial suture system (LARIAT, Sentre HEART, Palo Alto, CA) has been used in
patients with nonvalvular atrial fibrillation (AF) and contraindication to oral
anticoagulation. However, complex LAA anatomy may preclude its use. The authors
report the safety and effectiveness of compassionate use of first-generation LARIAT
device for epicardial ligation of large, complex left atrial appendages. Between
January 2010 and March 2013, 93 patients with AF, high CHADS2 score, and
contraindication(s) for oral anticoagulation therapy were evaluated for LAA ligation.
Complex anatomy detected by 3D cardiac computed tomography CT angiography led
to preclusion of 25 patients (27%). Of these, nine patients who opted for epicardial
LAA ligation on compassionate grounds were studied. Mean age was 68.1 ± 8.2
years, four females, all with large LAA width (>40 mm, 45-58 mm) and additional
anatomic complexities such as bilobed (two), long C-shaped-like (two), goose necklike (one), multilobed cauliflower-like (two), cactus-like (one), and chicken wing-like
(one) LAA. LAA ligation with LARIAT was successfully performed with surgical
standby in all patients. Seven patients (78%) were safely treated percutaneously
and only two patients required minimally invasive thoracotomy (one due to inability
to release the epicardial snare from long C-shaped LAA and other due to preexisting
adhesions precluding pericardial entry). There were no major complications. Repeat
trans-esophageal echocardiography at 3 months showed no remnant flow and none
had stroke off Coumadin at 19.3 ± 8.2 months of follow-up. Despite a high
preclusion rate, percutaneous LAA ligation may be safely and effectively performed
on compassionate grounds using the first-generation LARIAT device with surgical
standby in patients with large and complex LAA.
Reddy et al. (2014) completed the PROTECT AF, a multicenter, randomized (2:1),
unblinded, Bayesian-designed study conducted at 59 hospitals of 707 patients with
nonvalvular AF and at least 1 additional stroke risk factor (CHADS2 score ≥1).
Enrollment occurred between February 2005 and June 2008 and included 4-year
follow-up through October 2012. Noninferiority required a posterior probability
greater than 97.5% and superiority a probability of 95% or greater; the
noninferiority margin was a rate ratio of 2.0 comparing event rates between
treatment groups. Left atrial appendage closure with the device (n = 463) or
warfarin (n = 244; target international normalized ratio, 2-3). A composite efficacy
end point including stroke, systemic embolism, and cardiovascular/unexplained
death, analyzed by intention-to-treat. At a mean (SD) follow-up of 3.8 (1.7) years
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(2621 patient-years), there were 39 events among 463 patients (8.4%) in the device
group for a primary event rate of 2.3 events per 100 patient-years, compared with
34 events among 244 patients (13.9%) for a primary event rate of 3.8 events per
100 patient-years with warfarin (rate ratio, 0.60; 95% credible interval, 0.41-1.05),
meeting prespecified criteria for both noninferiority (posterior probability, >99.9%)
and superiority (posterior probability, 96.0%). Patients in the device group
demonstrated lower rates of both cardiovascular mortality (1.0 events per 100
patient-years for the device group [17/463 patients, 3.7%] vs 2.4 events per 100
patient-years with warfarin [22/244 patients, 9.0%]; hazard ratio [HR], 0.40; 95%
CI, 0.21-0.75; P = .005) and all-cause mortality (3.2 events per 100 patient-years
for the device group [57/466 patients, 12.3%] vs 4.8 events per 100 patient-years
with warfarin [44/244 patients, 18.0%]; HR, 0.66; 95% CI, 0.45-0.98; P = .04).
After 3.8 years of follow-up among patients with nonvalvular AF at elevated risk for
stroke, percutaneous LAA closure met criteria for both noninferiority and superiority,
compared with warfarin, for preventing the combined outcome of stroke, systemic
embolism, and cardiovascular death, as well as superiority for cardiovascular and allcause mortality. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00129545.
Miller et al. (2014) Pericardial suture ligation of the left atrial appendage (LAA) may
be an alternative to endoluminal devices for stroke prevention in patients with atrial
fibrillation, but multicenter safety and efficacy data in high-risk patients with
contraindications to oral anticoagulation are lacking. The purpose of this study was to
report the outcomes of consecutive cases of pericardial suture ligation of the LAA in
high-risk patients performed at 4 centers. The cohort included 41 consecutive
patients who underwent LAA closure with the LARIAT system. Epicardial and
transeptal access was obtained, and the epicardial snare was advanced over an
endo-epicardial magnetic-tipped guidewire to close the LAA. Transesophageal
echocardiography was used to confirm LAA exclusion. Mean age was 75 ± 10 years,
mean CHADS2 score was 3.0 ± 1.3, and mean HAS-BLED score was 4.4 ± 1.4.
These patients accumulated 24.6 person-years of follow-up. Acute LAA closure was
achieved in 38 patients (93%). Transesophageal echocardiography or computerized
tomographic angiography performed up to 3.3 ± 0.8 months after the procedure
demonstrated LAA leakage in 24% of patients. One patient (2%) had a transient
ischemic attack, and 8 (20%) developed pericardial effusions requiring
pericardiocentesis. Four cases (9%) were complicated by perforation of the LAA, with
2 of these patients requiring open surgical correction. This multicenter experience
revealed that pericardial suture ligation with the LARIAT system is technically
feasible and acutely efficacious. However, additional improvements are required to
minimize the rate of pericardial complications. A randomized study is warranted to
accurately define the long-term efficacy and safety profile of percutaneous epicardial
suture ligation.
Pillai et al. (2014) Left atrial appendage (LAA) ligation with the Lariat device is a
therapeutic option to prevent thromboembolic stoke in patients with nonvalvular
atrial fibrillation (AF) at high risk for systemic thromboembolization and bleeding
related to use of anticoagulation. In rare cases, this procedure could leave the LAA
incompletely ligated with continued risk of stroke. The purpose of this study was to
investigate the incidence and characteristics of LAA leak following ligation using the
Lariat device and the feasibility of leak closure with the Amplatzer septal occluder
device or a repeat Lariat application. Seventy-one consecutive patients who
underwent LAA ligation by the Lariat device were followed-up with transesophageal
echocardiography to evaluate for the presence of appendage leaks, characterization
of the leaks, and the presence of any thrombus. Patients with LAA leaks underwent
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definite closure of the leak. Six patients had LAA leaks with a mean leak size of 4.3 ±
0.6 mm. All leaks were concentric in nature. None of the patients had LAA thrombus.
Leaks in 5 of these patients were successfully closed using an Amplatzer septal
occluder device (St. Jude Medical); the leak in the sixth patient was closed using a
repeat Lariat procedure. LAA leaks from incomplete ligation of the LAA following the
Lariat procedure are not uncommon and could be successfully closed with an
Amplatzer septal occluder device or a repeat Lariat procedure.
Price et al. (2014) Transcatheter left atrial appendage (LAA) ligation may represent
an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. This
retrospective multicenter study sought to assess the early safety and efficacy of
transcatheter ligation of the LAA for stroke prevention in atrial fibrillation. This study
included consecutive patients undergoing LAA ligation with the Lariat device at 8 U.S.
sites. The primary endpoint was procedural success, defined as device success
(suture deployment and <5 mm leak by post-procedure transesophageal
echocardiography), and no major complication at discharge (death, myocardial
infarction, stroke, Bleeding Academic Research Consortium bleeding type 3 or
greater, or cardiac surgery). Post-discharge management was per operator
discretion. A total of 154 patients were enrolled. Median CHADS2 score (congestive
heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke, transient
ischemic attack, or thromboembolism [doubled]) was 3 (interquartile range: 2 to 4).
Device success was 94%, and procedural success was 86%. A major complication
occurred in 15 patients (9.7%). There were 14 major bleeds (9.1%), driven by the
need for transfusion (4.5%). Significant pericardial effusion occurred in 16 patients
(10.4%). Follow-up was available in 134 patients at a median of 112 days
(interquartile range: 50 to 270 days): Death, myocardial infarction, or stroke
occurred in 4 patients (2.9%). Among 63 patients with acute closure and
transesophageal echocardiography follow-up, there were 3 thrombi (4.8%) and 13
(20%) with residual leak. In this initial multicenter experience of LAA ligation with
the Lariat device, the rate of acute closure was high, but procedural success was
limited by bleeding. A prospective randomized trial is required to adequately define
clinical efficacy, optimal post-procedure medical therapy, and the effect of operator
experience on procedural safety.
De Backer et al. (2014) In atrial fibrillation (AF) patients with an increased stroke
risk, oral anticoagulation (OAC) is the standard treatment for stroke prevention.
However, this therapy carries a high risk of major bleeding. Percutaneous closure of
the left atrial appendage (LAA) is suggested as an alternative option for stroke
prevention in AF patients with contraindication(s) for OAC treatment. A total of 42
patients underwent percutaneous LAA closure. In this report, we describe our
experience with this procedure. The patients treated were AF patients with a high
stroke risk (CHADS-VASc 4.5±1.4) and contra-indication(s) for OAC and/or a high
bleeding risk (HAS-BLED 3.7±0.9). A history of intracerebral bleeding was the most
common reason for LAA closure. Successful implantation was obtained in 41 of 42
patients. One major peri-procedural complication occurred; a major gastrointestinal
bleeding immediately after the procedure. The mean duration of follow-up was 12.6
months. Both ischaemic stroke and bleeding occurred in one patient, resulting in an
observed annual stroke and bleeding rate of 2.3%. This rate was lower than
expected based on the CHADS-VASc (5.6%/year) and HAS-BLED (7.6%/year) for the
patient cohort. At echo follow-up, incomplete LAA closure was seen in one case;
device thrombosis was not observed. Our data confirm that percutaneous LAA
closure can be a safe and effective strategy for stroke prevention in AF patients with
an increased stroke and bleeding risk. However, long-term follow-up studies are
Watchman Procedure Jul 16
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needed before this procedure can be recommended for routine clinical use. Grant
funding was received (St Jude Medical) for research, but there are no other
competing interests.
Amorosi et al. (2014) Major practice changes require both clinical and economic
rationale, especially where a novel device replaces an established pharmaceutical
therapy. Recent studies have reported the clinical benefits of percutaneous left atrial
appendage closure (LAAC) for stroke prevention in atrial fibrillation (AF) relative to
standard warfarin anticoagulation, but little is published on the cost implications of
LAAC. This analysis sought to quantify the budget impact of LAAC compared with
warfarin and dabigatran etexilate for stroke prevention in AF. A budget impact model
was constructed from a German payer perspective across a 10-year time horizon.
Clinical event probabilities were taken from the PROTECT AF and RE-LY clinical
studies. Clinical events included stroke, major extracranial bleeding, systemic
embolism, procedure-related complications, and death. Costs for stroke included
acute, direct costs, as well as long-term disability costs. Cost inputs were taken from
German inpatient diagnosis related groups (DRGs), German pharmaceutical pricing
databases, and the literature. The findings from this model suggest that LAAC
provides long-term clinical and economic benefit while also reducing overall
mortality. At 8 years, LAAC was less expensive than dabigatran (€15 061 vs. €16
184), and at 10 years, it was only 10% more expensive than warfarin (€16 736 vs.
€15 168). The majority of LAAC costs are borne in the first year, while costs for
pharmaceutical strategies continue to accrue year on year. Thus, LAAC represents an
opportunity for savings to healthcare systems in the long term. This is an important
consideration for payers in evaluating lifetime treatment strategies in AF.
On the FDA site for the ‘Proposed Summary of Safety and Effectiveness Data’ for the
Watchman Procedure, dated 1/5/2015, under ‘Alternative Practices and Procedures’
the following information was noted:
‘The Atricure Atriclip and Terumo/LAAx Tigerpaw (indicated for the occlusion of
the left atrial appendage, under direct visualization, in conjunction with other
open cardiac surgical procedures) and the Sentre Heart Lariat (indicated for soft
tissue ligation, not specifically for the left atrial appendage) devices are
alternative devices for LAA closure using thoracoscopic and/or subxiphoid
approaches. The only alternative to using a device for closure of the LAA is openheart surgery. Cardiac surgery that is required for closure of the LAA is commonly
done following or in tandem with a MAZE procedure for atrial fibrillation or other
open heart procedures such as valve repair or replacement and is a major
procedure that may require cardiopulmonary bypass’.
The JACC (2014) notes: ‘The Lariat procedure (SentreHEART Inc., Redwood City,
California) has also gained interest lately, but early studies were concerning for high
rates of serious pericardial effusion and major bleeding. The current real-world
experience predominantly involves patients who are not long-term anticoagulation
candidates or who are perceived to have high bleeding risks’.
In 2013 the FDA is alerting health care providers and patients that in very rare
instances, tissue surrounding the Amplatzer ASO can break down (erode) and result
in life-threatening emergencies that require immediate surgery. According to
published estimates, these events occur in approximately 1 to 3 of every 1,000
patients implanted with the Amplatzer ASO. As of March 31, 2013, there have been
234,103 Amplatzer ASO devices sold worldwide. The device rubbing against the wall
of the heart can erode the tissue and create a hole. It can also lead to further
Watchman Procedure Jul 16
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scraping or erosion through tissue in the upper chambers or atria of the heart,
primarily in the top of the atria near the aorta. This scraping may also cause
separate or simultaneous holes in the aortic root, potentially leading to blood
building up in the sac surrounding the heart (cardiac tamponade). If too much blood
builds up in this sac, the heart will not be able to work properly.
CHADS2 Score
Systematic reviews demonstrate that the main risk factors for stroke in patients with
AF are previous stroke or transient ischemic attack, increasing age, hypertension,
heart failure, and diabetes mellitus. The widely used CHADS2 score (i.e., Congestive
Heart Failure, Hypertension, Age ≥75 Years, Diabetes Mellitus [1 point for presence
of each], and Stroke/TIA [2 points]; scores range from 0 to 6) was derived from the
risk factors obtained from the original, now historical, data sets from the AF
Investigators and the Stroke Prevention in AF 1 trial. Of note, the historical trials
randomized <10% of the patients who were screened, and many risk factors were
inconsistently defined or systematically recorded. Although simple, the CHADS2
score does not include many common stroke risk factors, and its limitations have
recently been highlighted. Even patients classified as low risk by CHADS2 in its
original validation study have a stroke rate of 1.9%/y, which is close to the criterion
of a cardiovascular event rate of 20% over 10 years for primary prevention
strategies (eg, the use of statins). A recent analysis also confirms that patients with
a CHADS2 score of 0 were not all low risk, and anticoagulation decisions based
simply on a CHADS2 score of 0 (the category recommended to have no
antithrombotic therapy or aspirin in some guidelines) may be insufficient to avoid
stroke/thromboembolism in patients with AF.
CHA2DS2-VASc
In the original validation, CHA2DS2- VASc was compared with 7 other contemporary
stroke risk stratification schemas in 1084 patients in the Euro Heart Survey on AF
and demonstrated reasonable predictive ability for high-risk patients but was good at
identifying low-risk patients and categorizing few patients into the moderate-risk
category. The CHA2DS2-VASc schema has subsequently been validated in numerous
AF populations, most commonly compared with CHADS2. All studies have confirmed
the ability of CHA2DS2-VASc to reliably identify ‘truly low risk' patients, who could be
managed with no antithrombotic therapy, as well as to predict stroke and
thromboembolism in high risk patients with AF, although the C statistic varies,
depending on the cohort used.
Patients who are <65 years of age with lone AF, strictly defined, irrespective of sex,
have very low absolute stroke risk, and the purpose of the CHA2DS2-VASc schema is
to aid in the identification of those other commonly encountered AF patients in
clinical practice (i.e., other than those <65 years of age and with lone AF) who are
truly low risk (CHA2DS2-VASc score of 0) who may reasonably be considered for no
antithrombotic treatment. All other AF patients, those with a CHA2DS2-VASc score of
≥1, should be considered for stroke prevention, which is essentially treatment with
OAC. One validation of CHA2DS2-VASc and CHADS2 in a Danish nationwide cohort of
73 538 AF patients not receiving vitamin K antagonists (eg, warfarin) demonstrated
that CHA2DS2-VASc performed better than CHADS2 (C statistic, 0.888 [95%
confidence interval, 0.875–0.900] and 0.812 [95% confidence interval, 0.796–
0.827], respectively) in predicting the risk of stroke and thromboembolism.
Another analysis demonstrated that patients with a CHADS2 score of 0 were not all
low risk when further categorized with the CHA2DS2-VASc score, with 1-year
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stroke/thromboembolism event rates ranging from 0.84 (CHA2DS2-VASc score=0)
to 1.75 (CHA2DS2-VASc score=1), 2.69 (CHA2DS2-VASc score=2), and 3.2
(CHA2DS2-VASc score=3). As mentioned, OAC decisions based simply on a CHADS2
score of 0 to 1 (as in some guidelines or prescribing standards) may lead to many AF
patients being provided suboptimal thromboprophylaxis and being at substantial risk
of stroke.
Assessment of Stroke (CHA2DS2-VASc) and Bleeding Risk (HAS-BLED) in
Atrial Fibrillation Patients
CHA2DS2-VASc
Score
HAS-BLED
Score
Congestive heart failure
1
1
Hypertension
1
Age ≥75 y
Diabetes mellitus
2
1
Stroke/TIA/TE
Vascular disease (prior MI,
PAD, or aortic plaque
Aged 65 to 74 y
Sex category (female)
Maximum score
2
1
Hypertension (systolic blood
pressure >160 mm Hg)
Abnormal renal and liver
function* (1 point each)
Stroke
Bleeding tendency
predisposition*
Labile INRs (if on warfarin)*
Elderly (eg, age >65 y)
Drugs or alcohol 1 point each
Maximum score
9
1
1
9
1 or 2
1
1
1
There continues to be no U.S. FDA approval for the Lariat System, Cardioblate
Closure Device, Amplatzer Septal Closure Device, and Atria Clip System, specifically
for left atrial appendage occlusion.
Scientific Rationale – Update November 2014
Anderson et al. (2013) notes ‘Management of patients with atrial fibrillation
(Compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS Recommendations).
A Report of the American College of Cardiology/American Heart Association Task
Force on Practice Guidelines. Circulation. 2013;127:1916-1926’. There is no
information at all on left atrial appendage devices in this publication.
On October 8, 2014, after reviewing updated data and analysis for the Boston
Scientific Corporation WATCHMAN Left Atrial Appendage Closure (LAAC) Device, the
U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the
Medical Devices Advisory Committee voted in favor of the Device. By a vote of 6 to 5
(with 1 abstention) the Panel concluded that the benefits of the WATCHMAN Device
outweigh the potential risks. Furthermore, the Panel voted that there is reasonable
assurance that the Device is safe (12 yes to 0 no). On the question of reasonable
assurance of effectiveness, the Panel vote was unfavorable (6 yes to 7 no). The
Panel provided substantial input and guidance related to the proposed Indications for
Use and target patient population. There was widespread agreement among the
Panel members that the Device provides a much needed alternative to long-term
anticoagulation for some patients. While not bound by this vote, the FDA takes
Advisory Panel comments and recommendations into account when reviewing the
WATCHMAN Device application. The company is committed to working with the FDA
to address the Panel's comments. The WATCHMAN Device was approved for sale in
Europe in 2005 and is currently approved in more than 70 countries across the
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globe. In the U.S., the WATCHMAN Device is an investigational device, limited to
investigational use and not available for sale.
None of the other existing available devices (eg., Lariat System, Cardioblate Closure
Device, Amplatzer Septal Closure Device, Atria Clip System, etc.) have received U.S.
FDA approval for an indication of percutaneous LAA closure. Overall, the evidence on
LAA devices is limited in quantity and quality, and device safety has not been
established.
Scientific Rationale – Update December 2013
The WATCHMAN Closure Device has received the CE Mark and is market-released
outside the United States. EWOLUTION and WASP are prospective, non-randomized,
multicenter studies and are intended to compile real-world clinical outcomes data in
patients who are implanted with the WATCHMAN device in a commercial clinical
setting and to collect real-world usage data that may be needed for reimbursement
of WATCHMAN technology. EWOLUTION is being conducted in Europe and will enroll
a maximum of 1000 patients at up to 75 sites will be enrolled with follow-up
extending to two years. WASP is being conducted in the Asia/Pacific region and will
enroll a maximum of 300 patients at up to 10 sites with two-year follow-up. This
study was noted on the FDA site dated December 11, 2013.
Per the FDA Site: There is a report that details the clinical data collected for the
study entitled, ‘Continued Access PROTECT AF Registry’ (i.e., CAP Registry), under
Atritech Clinical Protocol. The CAP Registry is conducted under Investigational
Device Exemption (IDE), and up to 30 centers and 750 patients will participate.
Enrollment commenced in August 2008, and includes preliminary data reported
through March 3, 2009. Each patient is expected to be followed for up to 5 years
post implant. The purpose of the registry is to allow continued access to the
WATCHMAN device to a subset of the pivotal study investigators and to gain further
information on the device after the conclusion of enrollment in the pivotal study and
prior to PMA approval. The CAP registry is a non-randomized study with patient
population and procedures that are similar to the PROTECT AF pivotal study data.
Per the FDA, there is a ‘Proposed Summary of Safety and Effectiveness Data’ for
‘Implantable Left Atrial Appendage Closure Devices.’ It is primarily about the
Watchman device but does mention the ‘Atricure Atriclip’ and the ‘the ‘Sentre Heart
Lariat.’ This does not mention anything about IDE.
Scientific Rationale – Update November 2013
Atrial fibrillation (AF) is an abnormal, supraventricular, accelerated heart rhythm,
known as tachyarrhythmia, which leads to worsening atrial function and irregular
ventricular conduction. Approximately one third of patients hospitalized for cardiac
arrhythmias have AF, making it the most common arrhythmia detected in clinical
practice. The form of AF seen primarily in the United States is nonvalvular AF, which
occurs without concomitant rheumatic mitral valve disease, a prosthetic heart valve,
or mitral valve repair. Patients with AF have a significantly increased risk of stroke,
heart failure, and death compared with patients with normal heart rhythms.
Ischemic stroke and other obstructions of arteries throughout the body in patients
with AF is thought to be primarily caused by emboli originating from the left atrium.
To reduce the risk of stroke, patients with AF may be treated with long-term oral
anticoagulation (e.g., warfarin) and/or antiplatelet agents (e.g., aspirin and/or
Watchman Procedure Jul 16
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clopidogrel) unless the bleeding risk posed by these medications outweighs their
benefits in stroke prevention.
While anticoagulation treatment with warfarin is more effective than antiplatelet
therapy for stroke prevention in patients with AF, its use is complicated by a limited
therapeutic range, need for frequent monitoring, presence of multiple drug and food
interactions, and risk of bleeding. Furthermore, some patients are not eligible for
warfarin therapy because of allergic reactions to warfarin, severe liver disease,
recent trauma or surgery, or active bleeding.
Problems with warfarin-based anticoagulation therapy have also spurred the
development of nonpharmaceutical approaches to stroke reduction in patients with
AF. The rationale for occluding, ligating or amputating the left atrial appendage (LAA)
as an alternative to anticoagulation therapy is based on findings that thrombi, have
been found in the LAA in approximately 90% of patients with nonvalvular or
nonrheumatic AF, and 57% of patients with valvular or rheumatic AF.
The two main approaches, as noted above, used to occlude the LAA in clinical
practice include surgical amputation or external occlusion via ligation in patients
undergoing concurrent coronary artery bypass graft, mitral valve surgery, epicardial
ablation; or endocardial occlusion using a percutaneous transcatheter closure device.
The general steps in the implantation procedure include measuring LAA dimensions
by TEE and/or angiography to select the device size and exclude the presence of
thrombi in the LAA (if present, procedure was discontinued); insertion of the device
via percutaneous catheter; positioning and expansion of the device; performance of
manual tests and/or imaging to evaluate the seal quality; release of the device from
the catheter used for implantation; and additional imaging to determine if leaks are
present. The devices are designed so that they can be recaptured for repositioning or
removal if there are any problems during implantation (e.g., LAA anatomy precludes
closure or requires use of a different size device).
Several versions of LAA closure devices have been developed, but none have
received U.S. FDA approval:




The LARIAT system, (i.e., the Lariat snare device, the Lariat procedure) is
manufactured and approved by the U.S. FDA for soft tissue closure
(“approximation”) only. It is not U.S. FDA approved for occlusion of the left
atrial appendage (LAA). The LARIAT system is a lasso type of device that is
guided into place by magnets, in order to encircle the left atrial appendage. After
the magnets attach, the device is put in place and then tightened, which
occludes the left appendage of blood flow, therefore facilitating a normalized
heart blood flow.
The WATCHMAN device, is manufactured by Atritech Inc. (Plymouth, MN). While
the U.S. FDA advisory panel for this topic voted in favor of approval, the FDA did
not grant final approval after concluding that further studies of efficacy and
safety were necessary.
The Cardioblate closure device developed by Medtronic Corp. (Minneapolis, MN)
is currently being tested in clinical studies.
The Amplatzer Cardiac Plug (ACP) septal closure device, manufactured by AGA
Medical Corp. (Plymouth, MN) is FDA-approved for closure of atrial septal
defects. This device has also been used as a LAA closure device, since this use
has not received FDA approval.
Watchman Procedure Jul 16
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

The Atria Clip is manufactured by AtriCure, Inc. (West Chester, OH). The AtriClip
is made of two parallel rigid titanium tubes with elastic nitinol springs covered
with a knit-braided polyester sheath. It is placed epicardially around the left
atrial appendage and compresses the appendage at its base, excluding blood
from entering the appendage. The FDA has cleared the AtriCure Isolator system
and AtriCure’s multifunctional pen and Coolrail linear ablation device, for the
ablation, or destruction, of cardiac tissue during surgical procedures. The FDA
has cleared AtriCure’s multifunctional pen for temporary pacing, sensing,
stimulating and recording during the evaluation of cardiac arrhythmias and
AtriCure’s Cryo1 system for the cryosurgical treatment of cardiac arrhythmias.
The U.S. FDA has not cleared or approved AtriCure’s products for the treatment
of AF.
The Percutaneous LAA Transcatheter Occlusion (PLAATO) system (ev3 Inc.) was
composed of a self-expanding nitinol cage (made in sizes ranging from 15 to 32
mm in diameter) covered by a polytetrafluoroethylene material impermeable to
blood; another component of the system was the transseptal sheath used to
deliver the device into the LAA. The size of the expanded device chosen for
insertion was usually 20% to 50% larger than the orifice of the LAA, as
measured by angiography and transesophageal echocardiography (TEE).
According to Leal et al. (2012), in 2006, the manufacturer discontinued
development of this device because of a combination of financial problems and a
concern with serious side effects reported in clinical practice (i.e., vessel
perforation during vascular access, cardiac tamponade after transseptal
puncture, and device embolization). A registry study of this device only
mentioned the financial concerns as the reason for the manufacturer
discontinuing its development.
Bartus et al. (2013) completed a single-site observational study of 89 relatively lowrisk patients with AF. The purpose of the study was to determine the efficacy and
safety of left atrial appendage (LAA) closure via a percutaneous LAA ligation
approach. Embolic stroke is the most devastating consequence of atrial fibrillation.
Exclusion of the LAA is believed to decrease the risk of embolic stroke.
Eighty-nine patients with atrial fibrillation were enrolled to undergo percutaneous
ligation of the LAA with the LARIAT device. The catheter-based LARIAT device
consists of a snare with a pre-tied suture that is guided epicardially over the LAA.
LAA closure was confirmed with transesophageal echocardiography (TEE) and
contrast fluoroscopy immediately, then with TEE at 1 day, 30 days, 90 days, and 1
year post-LAA ligation. Eighty-five (96%) of 89 patients underwent successful LAA
ligation. Eighty-one of 85 patients had complete closure immediately. Three of 85
patients had a≤2-mm residual LAA leak by TEE color Doppler evaluation. One of 85
patients had a≤3-mm jet by TEE. There were no complications due to the device.
There were 3 access-related complications (during pericardial access, n = 2; and
transseptal catheterization, n = 1). Adverse events included severe pericarditis postoperatively (n = 2), late pericardial effusion (n = 1), unexplained sudden death (n =
2), and late strokes thought to be non-embolic (n = 2). At 1 month (81 of 85) and 3
months (77 of 81) post-ligation, 95% of the patients had complete LAA closure by
TEE. Of the patients undergoing 1-year TEE (n = 65), there was 98% complete LAA
closure, including the patients with previous leaks. LAA closure with the LARIAT
device can be performed effectively with acceptably low access complications and
periprocedural adverse events in this observational study. However, at this time,
none of the LAA systems are approved by the U.S. FDA.
Watchman Procedure Jul 16
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Lee et al. (2011) A novel percutaneous approach for left atrial appendage (LAA)
ligation may be appropriate for AF patients ineligible to anticoagulation therapy.
However, the clinical applicability of the catheter-based approach is unknown.
Efficacy of complete exclusion of the LAA was correlated to the LAA anatomy defined
by contrast 3D-computer tomography (CT). A total of 79 patients between the ages
of 35 to 78 years old were evaluated by contrast 3D-CT. Morphology of the LAA was
classified by size, orientation and shape. Patients underwent percutaneous ligation of
the LAA with the LARIAT snare device. The catheter-based approach was comprised
of a .025” endocardial magnet-tipped guidewire placed in the apex of the LAA via
transseptal catherization and a .035” epicardial magnet-tipped guidewire that was
attached to the endocardial magnet-tipped guidewire via a percutaneous pericardial
approach. A 20 mm compliant occlusion balloon catheter was advanced over the
endocardial guidewire and positioned at the ostium of the LAA under
transesophageal echocardiography (TEE) guidance. An over-the-wire approach was
used to guide the LARIAT snare device over the LAA to enable ligation of the LAA.
TEE and left atriagram were used to confirm acute closure of the LAA. Follow-up TEE
was performed at 1 day and 1 month. 14 of 79 patients were excluded from
undergoing LAA ligation. 9 of 14 patients had superiorly oriented LAA. 5 of 14
patients had LAA thrombus identified by TEE prior to the procedure. 65 of 79
patients underwent successful LAA ligation. 60 of 65 patients had complete acute
closure of the LAA. 5 patients had less than a 3 mm jet identified by color flow
Doppler. Presence of an acute jet by color Doppler was correlated to LAA size and
shape. There were no device related complications. Results of 30 day TEE follow-up
by color flow Doppler is being collected. Success of percutaneous suture ligation of
the LAA is dependent on LAA morphology and can be improved with prescreening
3D-CT imaging. This catheter-based LAA ligation approach is feasible however,
further long-term follow-up is needed to confirm efficacy, as well as the approval of
the U.S. FDA.
Position Statements:
The American College of Cardiology/American Heart Association (2009) guidelines
for patients undergoing mitral valve surgery recommend left atrial appendage (LAA)
obliteration or exclusion at the time of surgical approaches for the ablation of atrial
fibrillation with the maze procedure. The American College of Cardiology/American
Heart Association Task Force (2006), did not mention the use of LAA devices to
prevent thromboembolic stroke in patients with AF.
The update of the European Society of Cardiology (2012) guidelines for the
management of AF makes a weak recommendation for the use of interventional,
percutaneous LAA closure in patients with a high stroke risk and contraindication for
long-term anticoagulation.
National Institute for Health Care Excellence (NICE, June 2010) Current evidence
suggests that percutaneous occlusion of the left atrial appendage (LAA) is efficacious
in reducing the risk of thromboembolic complications associated with non-valvular
atrial fibrillation (AF). With regard to safety, there is a risk of life-threatening
complications from the procedure, but the incidence of these is low. Therefore, this
procedure may be used provided that normal arrangements are in place for clinical
governance, consent and audit.
The LARIAT, Amplatzer, Cardiac Closure device and WATCHMAN devices have not
been specifically approved by the United States Food and Drug Administration for left
atrial appendage occlusion or ligation.
Watchman Procedure Jul 16
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Left atrial appendage (LAA) occlusion devices are nonpharmacologic alternatives to
anticoagulation for patients with atrial fibrillation. Currently, there are no devices
that have U.S. FDA approval for this indication. Overall, the evidence on LAA devices
is limited in quantity and quality, and device safety has not been established.
Given the lack of U.S. FDA approval and the limited data regarding impact on net
health outcomes, use of left atrial appendage closure devices is considered
investigational. Large, well-designed, randomized controlled trials with longer-term
follow-up are needed to determine the impact of LAA occlusion devices on net health
outcomes.
Scientific Rationale – Update October 2013
Reddy et al (2013) reported on the multicenter PROTECT AF study (Watchman Left
Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation)
conducted to determine whether percutaneous left atrial appendage closure with a
filter device (Watchman) was noninferior to warfarin for stroke prevention in atrial
fibrillation. Patients (n=707) with nonvalvular atrial fibrillation and at least 1 risk
factor (age >75 years, hypertension, heart failure, diabetes, or prior stroke/transient
ischemic attack) were randomized to either the Watchman device (n=463) or
continued warfarin (n=244) in a 2:1 ratio. After device implantation, warfarin was
continued for ≈45 days, followed by clopidogrel for 4.5 months and lifelong aspirin.
Study discontinuation rates were 15.3% (71/463) and 22.5% (55/244) for the
Watchman and warfarin groups, respectively. The time in therapeutic range for the
warfarin group was 66%. The composite primary efficacy end point included stroke,
systemic embolism, and cardiovascular death, and the primary analysis was by
intention to treat. After 1588 patient-years of follow-up (mean 2.3±1.1 years), the
primary efficacy event rates were 3.0% and 4.3% (percent per 100 patient-years) in
the Watchman and warfarin groups, respectively (relative risk, 0.71; 95% confidence
interval, 0.44%-1.30% per year), which met the criteria for noninferiority
(probability of noninferiority >0.999). There were more primary safety events in the
Watchman group (5.5% per year; 95% confidence interval, 4.2%-7.1% per year)
than in the control group (3.6% per year; 95% confidence interval, 2.2%-5.3% per
year; relative risk, 1.53; 95% confidence interval, 0.95-2.70). Investigators
concluded the "local" strategy of left atrial appendage closure is noninferior to
"systemic" anticoagulation with warfarin. PROTECT AF has, for the first time,
implicated the left atrial appendage in the pathogenesis of stroke in atrial fibrillation.
Reddy et al (2013) also assessed the safety and efficacy of left atrial appendage
(LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin
therapy. The authors reported the PROTECT AF (Watchman Left Atrial Appendage
System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated
that LAA closure with the Watchman device was noninferior to warfarin therapy.
However, the PROTECT AF trial only included patients who were candidates for
warfarin, and even patients randomly assigned to the LAA closure arm received
concomitant warfarin for 6 weeks after Watchman implantation. In this multicenter,
prospective, nonrandomized study conducted of LAA closure with the Watchman
device in 150 patients with nonvalvular AF and CHADS (congestive heart failure,
hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient
ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary
efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke,
systemic embolism, and cardiovascular/unexplained death. The mean CHADS score
and CHADS-VASc (CHADS score plus 2 points for age ≥75 years and 1 point for
vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ±
Watchman Procedure Jul 16
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1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most
common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6
months. Serious procedure- or device-related safety events occurred in 8.7% of
patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4
patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and
hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less
than that expected (7.3% per year) based on the CHADS scores of the patient
cohort. Investigators concluded LAA closure with the Watchman device can be safely
performed without a warfarin transition, and is a reasonable alternative to consider
for patients at high risk for stroke but with contraindications to systemic oral
anticoagulation. (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage
Closure Technology [ASAP].
Chun et al (2013) prospectively compared procedural data and patient outcome for
two contemporary LAA closure systems. Non-valvular atrial fibrillation (NVAF)
patients, with high risk for stroke and contraindication or not willing to accept oral
anticoagulation (OAC) were prospectively enrolled. Watchman, Boston Scientific (A)
or Amplatzer Cardiac Plug, St. Jude Medical devices (B) were implanted. All pts
received antithrombotic therapy for 6 weeks. After repeat TEE, switch to aspirin was
performed in eligible pts. 80 patients were enrolled. There was no statistical
difference in patient characteristics: CHA2DS2VASC: 4.1±1.5 vs. 4.5±1.8, HASBLED:
3.1±1.1 vs. 3.1±1.1, respectively. LAA closure was achieved in 78/80 (98%) pts (A:
38/40, 95%, B: 40/40, 100%), respectively. There was no difference in procedure
(A: 48±16 min vs. B: 47±15 min, p=0.69) and fluoroscopy time (A: 6.0±4.7 min vs.
B: 7.3± 4.4 min, p=0.25). Major complications included one air embolism and
delayed tamponade in each group. After 6 weeks one device dislodgment and four
device related thrombi were detected. Switch to aspirin was enabled in 94% (73/77
pts) after 6 weeks. During a median follow up of 364 days (Q1-Q3 283-539 days) no
systemic embolism occurred, but 3 patients died (heart failure: n=2, bleeding: n=1).
Investigators concluded implantation of both LAA closure devices can be performed
with high success rates in high-risk patients. Postprocedural 6 weeks antithrombotic
therapy followed by aspirin needs to be confirmed in a larger study.
Alli et al (2013) sought to assess quality of life parameters in a subset of patients
enrolled in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage
Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation)
trial. The PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus
Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial
demonstrated that in patients with nonvalvular atrial fibrillation (AF) and CHADS2
(congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke,
transient ischemic attack, or thromboembolism) score ≥1, a left atrial appendage
closure device is noninferior to long-term warfarin for stroke prevention. Given this
equivalency, quality of life (QOL) indicators are an important metric for evaluating
these 2 different strategies. QOL using the Short-Form 12 Health Survey, version 2,
measurement tool was obtained at baseline and 12 months in a subset of 547
patients in the PROTECT AF trial (361 device and 186 warfarin patients). The analysis
cohort consisted of patients for whom either paired quality of life data were available
after 12 months of follow-up or for patients who died. With the device, the total
physical score improved in 34.9% and was unchanged in 29.9% versus warfarin in
whom 24.7% were improved and 31.7% were unchanged (p = 0.01). Mental health
improvement occurred in 33.0% of the device group versus 22.6% in the warfarin
group (p = 0.06). There was a significant improvement in QOL in patients
randomized to device for total physical score, physical function, and in physical role
Watchman Procedure Jul 16
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limitation compared to control. There were significant differences in the change in
total physical score among warfarin naive and not-warfarin naive subgroups in the
device group compared to control, but larger gains were seen with the warfarin naive
subgroup with a 12-month change of 1.3 ± 8.8 versus -3.6 ± 6.7 (p = 0.0004)
device compared to warfarin. Investigators concluded patients with nonvalvular AF
at risk for stroke treated with left atrial appendage closure have favorable QOL
changes at 12 months versus patients treated with warfarin. (WATCHMAN Left Atrial
Appendage System for Embolic Protection in Patients With Atrial Fibrillation
[WATCHMAN PROTECT]; NCT00129545).
At this time, the Watchman Left Atrial Appendage System has not yet received FDA
approval. Clinical trials are ongoing.
Scientific Rationale – Update October 2012
The Watchman Left Atrial Appendage System continues to be investigated in several
clinical trials. Studies are ongoing but are not recruiting participants. At this time,
the device has not yet received FDA approval.
A Report of the American College of Cardiology Foundation/American Heart
Association Task Force on Practice Guidelines, “2011 ACCF/AHA/HRS Focused Update
on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline)
states:
“The 2011 Focused Update Writing Group considered the Watchman device for atrial
appendage closure in its deliberations in anticipation of FDA approval of this device.
Because the FDA has not approved clinical use of the Watchman device pending the
results of additional ongoing trials, the writing group’s deliberations and
recommendations regarding the Watchman device are not included in the final
version of this focused update. A future guideline writing committee will address this
and other evolving areas in the management of AF.”
Scientific Rationale Update – October 2011
Reddy et al. (2011) completed a randomized trial, called (PROTECT AF), in which the
’Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF’
was compared to a left atrial appendage closure against warfarin in atrial fibrillation
(AF) patients. The CHADS2 is the rating tool used for atrial fibrillation stroke risk,
(i.e. CHADS2 refers to a history of congestive heart failure, hypertension, diabetes
mellitus, age > 75, stroke symptoms previously or TIA). Although the study met the
primary efficacy end point of being noninferior to warfarin therapy for the prevention
of stroke/systemic embolism/cardiovascular death, there was a significantly higher
risk of complications, predominantly pericardial effusion and procedural stroke
related to air embolism. The authors report the influence of experience on the safety
of percutaneous left atrial appendage closure. The study cohort for this analysis
included patients in the PROTECT AF trial who underwent attempted device left atrial
appendage closure (n=542 patients) and those from a subsequent nonrandomized
registry of patients undergoing Watchman implantation (Continued Access Protocol
[CAP] Registry; n=460 patients). The safety end point included bleeding and
procedure-related events (pericardial effusion, stroke, device embolization). There
was a significant decline in the rate of procedure or device-related safety events
within 7 days of the procedure across the 2 studies, with 7.7% and 3.7% of patients,
respectively, experiencing events (P=0.007), and between the first and second
halves of PROTECT AF and CAP, with 10.0%, 5.5%, and 3.7% of patients,
respectively, experiencing events (P=0.006). The rate of serious pericardial effusion
Watchman Procedure Jul 16
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within 7 days of implantation, which had made up >50% of the safety events in
PROTECT AF, was lower in the CAP Registry (5.0% versus 2.2%, respectively;
P=0.019). There was a similar experience-related improvement in procedure-related
stroke (0.9% versus 0%, respectively; P=0.039). Finally, the functional impact of
these safety events, as defined by significant disability or death, was statistically
superior in the Watchman group compared with the warfarin group in PROTECT AF.
This remained true whether significance was defined as a change in the modified
Rankin score of ≥1, ≥2, or ≥3 (1.8 versus 4.3 events per 100 patient-years; relative
risk, 0.43; 95% confidence interval, 0.24 to 0.82; 1.5 versus 3.7 events per 100
patient-years; relative risk, 0.41; 95% confidence interval, 0.22 to 0.82; and 1.4
versus 3.3 events per 100 patient-years; relative risk, 0.43; 95% confidence
interval, 0.22 to 0.88, respectively). As with all interventional procedures, there is a
significant improvement in the safety of Watchman left atrial appendage closure with
increased operator experience.
Scientific Rational Update – January 2011
(Hundley et al. 2010) The American College of Cardiology Foundation Task Force on
expert consensus document on cardiovascular magnetic resonance stated that
standardization of protocols and further studies are needed to determine if
cardiovascular magnetic resonance provides a reliable effective method for detecting
thrombi in left atrial appendage (LAA) in patients with atrial fibrillation.
Occlusion, as opposed to ligation, of the LAA can be attempted via less invasive
percutaneous catheter-based methods. Preliminary studies of two systems
specifically designed for this purpose (PLAATO and WATCHMAN systems) have been
completed. Both systems deploy a device that is placed in the LAA via a catheter that
crosses the intraatrial septum (through a PFO or transseptal puncture). To date,
however, percutaneous LAA occlusion remains experimental and research studies are
ongoing. In addition to these two systems, the Amplatzer atrial septal occluder,
which is used for percutaneous closure of atrial septal defects, can be implanted in
the LAA. It has been evaluated for this purpose in a single small series.
The WATCHMAN device also involves an expandable device deployed in the LAA via a
transseptal catheter. The implanted device has a self-expanding nitinol frame to
secure it in the LAA. In contrast to the PLAATO device, the fabric of the WATCHMAN
device is permeable to blood. For this reason, patients require conventional
thromboembolic prophylaxis with warfarin until the device is endothelialized (eg, at
least 45 days post-implant), at which time transesophageal echocardiography is
performed to insure endothelialization. In addition, all patients are treated with both
aspirin (81 to 325 mg ) and clopidogrel (75 mg) daily for six months.
The WATCHMAN device was evaluated in the PROTECT AF non-inferiority trial in
which over 700 patients with non-valvular AF were randomly assigned in a 2:1 ratio
to either the device (with the above antithrombotic regimen) or to long-term
warfarin (international normalized ratio 2.0 to 3.0). Inclusion criteria allowed for
patients with paroxysmal, persistent, or permanent AF and all patients had a CHADS
score ≥1.
However, the Watchman procedure does not have final U.S. FDA approval at this
time. Atritech, Inc., an emerging medical device company, announced on March 18,
2010, that it has obtained clarity from the U.S. FDA on the regulatory path towards
approval of its WATCHMAN Left Atrial Appendage (LAA) Closure Technology in the
United States. In a recent letter received from the FDA, the agency requested that a
Watchman Procedure Jul 16
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confirmatory study be conducted to further substantiate the safety and effectiveness
of the WATCHMAN LAA Closure Technology in patients with atrial fibrillation at risk of
stroke and eligible for anticoagulation therapy. The FDA felt that the small study size
and safety concerns were at issue, regarding the original study.
To fulfill the post-market study requirement, the long-term safety and effectiveness
of the WATCHMAN device will be further characterized by following the subjects
successfully implanted in the PROTECT AF pivotal trial for 5 years. Atritech will
submit an Interim Post-Approval Study Status Report to FDA at 6-month intervals for
the first 2 years after market approval of the device, and annually thereafter until
the post approval study is complete. The Final Post-Approval Study Status Report will
be submitted to FDA within 3 months of collection of all study data. The Final Report
is anticipated for completion October 2013.
Scientific Rationale Initial
The ‘Watchman Left Atrial Appendage System’ is a device designed to prevent the
embolization of thrombi that may form in the left atrial appendage (LAA). This
umbrella shaped, mesh device is permanently placed just behind or at the opening of
the LAA. It is hypothesized that tissue forms over the implant, permanently closing
off the appendage. The Watchman System, therefore, may prevent ischemic stroke
and systemic thromboembolism in patients with atrial fibrillation.
(National Institute for Health and Clinical Excellence - 12-2005) The Watchman
procedure is performed in cardiac catheterization labs with fluoroscopic and
transesophageal echocardiography (TEE) guidance. During this process, the cardiac
catheter is inserted into the groin. The collapsed Watchman device is attached to the
end of a delivery catheter. Once the device is in place, it is opened, forming a
covering over the gap of the left atrial appendage. The delivery catheter is detached
and removed.
As noted previously in this policy, the Watchman implant has been specifically
designed to prevent life-threatening blood clots in patients suffering from atrial
fibrillation. Atrial fibrillation (AF) is the most common form of cardiac arrhythmia. It
occurs when electrical signals that coordinate the muscle of the atria of the heart
become rapid and disorganized, resulting in an irregular heartbeat often greater than
300 beats per minute. This causes blood to stagnate and form clots in the left atrial
appendage. The problem exists primarily in patients with hypertension, diabetes and
coronary artery diseases. AF affects about 3 million Americans, including 10 percent
who are age 75 and older.
Stroke is the third most common cause of death after heart attack and cancer, but
the number one cause of long-term adult disability. Stroke secondary to cardiogenic
embolism causes a loss of brain function because of blood clots that develop in the
heart and travel to the brain. Atrial fibrillation accounts for approximately 20-25
percent of the 750,000 people in this country who suffer from stroke.
Coumadin is highly effective in preventing blood clots, but many people cannot use
the drug or do not want to use it because of the side effects and the limitations it
places on their lives. Its use could cause untoward bleeding and requires frequent
blood tests, every one to four weeks, to determine appropriate dosage.
The Watchman, made by Atritech, is currently approved in Europe and is awaiting
FDA approval in the United States. This device is now only available in the U.S.
Watchman Procedure Jul 16
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through clinical trials, currently hosted by approximately forty hospitals nationwide.
Two thirds of participants will actually undergo the procedure to receive the device,
while one third will continue to take Coumadin as part of a control group so that their
outcomes can be compared with patients who received the implant.
This main objective of the clinical trials is to demonstrate the safety and efficacy of
the Watchman implant; another goal is to determine if this procedure may give
patients a good quality of life without a lifetime of blood thinning medications. The
primary effectiveness end point is defined as all stroke (including ischemic and
hemorrhagic), cardiovascular death (limited to any cardiovascular death or
unexplained death), systemic embolism, and documented TIA (defined as an acute
focal neurological event lasting at least 5 minutes). The primary safety end point for
the study is defined as any life threatening bleeding as determined by the ‘Clinical
Events Committee’ including pericardial effusion requiring drainage, intracranial
bleeding, or GI bleeding requiring transfusion. Event rates are defined as the number
of events per 100 patient years of follow-up.
Patients with paroxysmal, persistent, or permanent nonvalvular AF are candidates for
the clinical trials, if they meet the inclusion and exclusion criteria. The CHADS
(Congestive heart failure, Hypertension, Age, Diabetes and Stroke) score has been
developed and validated as an instrument to define stroke risk in patients with AF
and is an integral component for inclusion. To assess the CHADS score, one point is
assigned for the presence of each of the four components, and two points are
assigned for prior cerebral ischemia (stroke or TIA). A CHADS score of ≥1 is
required. Other patient selection inclusion criteria include >18 years of age, eligible
for long-term warfarin therapy, and able to discontinue warfarin therapy if the LAA is
sealed.
There is an ongoing multicenter prospective randomized study comparing the
Watchman implant to a control group taking long-term warfarin (coumadin) therapy
alone. A 2:1 randomization scheme (two Watchman implants to every control) is
used with stratification by center. The trial has been registered by Atritech on the
‘National Institute of Health (NIH) Clinical Trials’ web site. The protocol and informed
consent have been approved by each investigator's institutional review board before
initiation of the study. After informed consent and before enrollment, patients are
required to have a serum creatinine, platelet count, hemoglobin, and INR. Patients
who have fulfilled all the inclusion and clinical exclusion criteria who provide consent
have neurological and function levels assessed using the NIH Stroke Scale (NIHSS),
the Barthel Index (BI), the Modified Rankin Scale (MRS), and SF12v2 Health Survey.
The NIHSS is an acute stroke assessment tool used to assess stroke severity. The
other assessment tools (i.e., BI and MRS) are used to assess long-term function
after a stroke event. For those patients who have had a prior stroke, computed
tomography (CT) or magnetic resonance (MRI) imaging will be performed at
baseline. A transthoracic and transesophageal echocardiographic examination is
performed to further evaluate the echocardiographic exclusion criteria.
In summary, the ‘Watchman Left Atrial Appendage System’ is considered
investigational and therefore not medically necessary; this device is presently not
FDA approved in the United States. The results of the currently ongoing clinical trials
are necessary to support its efficacy and safety, and to gain approval for marketing
by the Food and Drug Administration.
Watchman Procedure Jul 16
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Review History
October 2007
January 2011
October 2011
October 2012
October 2013
November 2013
Medical Advisory Council initial approval
Update. Added Medicare Table. No revisions.
Update. Added revised Medicare Table. No revisions.
Update – no revision
Update – no revisions. Code updates.
Update. Added Lariat system, Cardioblate Closure Device,
Amplatzer Septal Closure Device, and Atria Clip System, to the
Watchman Procedure as investigational, since they are not
approved by U.S. FDA for left atrial appendage occlusion.
Changed title from ‘Watchman Procedure’ to ‘Left Atrial
Appendage Devices’.
December 2013
Reviewed FDA Investigational Device Exemption (IDE) for left
atrial appendage procedures. Discussed Medicare discrepancy for
this procedure with Medicare Compliance Supervisor, Staci
Newton. The issue is that for California, a LCD notes noncoverage
of CPT code 0218T, for left atrial appendage device, and an
Article notes coverage of this device, billed with IDE Claim, with
the QO modifier and the IDE number in the narrative field, with
same CPT code and same effective date of service of 11/2013.
Per Staci, “Since the Article indicates supplemental instruction
and specifically notes the code it would be acceptable to follow
the guidance in the Article”.
Update – no revisions. Codes updated.
Update –Added Watchman Procedure as medically necessary to
reduce the risk of stroke in adult patients with nonvalvular atrial
fibrillation (NVAF). These individuals have failed &/or have
contraindications to warfarin and other anti-thrombin
anticoagulants. The use of ChaSD2 OR CHASDS2-VASc score can
help to inform the choice of the antithrombotic agent and the
management strategy. Codes updated.
Update – no revisions. Codes updated.
November 2014
July 2015
July 2016
This policy is based on the following evidence-based guidelines:
1.
2.
3.
4.
National Institute for Health and Clinical Excellence (NICE). Interventional
procedures overview of percutaneous occlusion of the left atrial appendage.
December 2005.
American Heart Association. Atrial Fibrillation and Stroke. Hundley WG, Bluemke
DA, Finn JP, et al. American College of Cardiology Foundation Task Force on
Expert Consensus Documents, ACCF/ACR/AHA/NASCI/SCMR 2010 expert
consensus document on cardiovascular magnetic resonance: A report of the
American College of Cardiology Foundation Task Force on Expert Consensus
Documents. J Am Coll Cardiol. 2010;55(23):2614-2662.
Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS focused update
on the management of patients with atrial fibrillation (update on dabigatran): a
report of the American College of Cardiology Foundation/American Heart
Association Task Force on practice guidelines. J Am Coll Cardiol. 2011 Mar
15;57(11):1330-7. Available at:
http://content.onlinejacc.org/article.aspx?articleid=1144046
Hayes Medical Technology Directory. Percutaneous Left Atrial Appendage
Closure to Reduce Stroke Risk in Patients with Atrial Fibrillation. Jan 2, 2013.
Updated July 2, 2015.
Watchman Procedure Jul 16
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5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Hayes. Prognosis Overview. Watchman Left Atrial Appendage (LAA) Closure
Technology. Updated May 2013.
Bonow RO, Carabello BA, Chatterjee K, et al. 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 2008; 118:e523.
Fuster V, Rydén, LE, Cannom DS, et al. 2011 ACCF/AHA/HRS focused updates
incorporated into the ACC/AHA/ESC 2006 guidelines for the management of
patients with atrial fibrillation: a report of the American College of Cardiology
Foundation/American Heart Association Task Force on Practice Guidelines.
Circulation. 2011;123(10):e269-e367.
National Institute for Health and Clinical Evidence (NICE). Percutaneous
occlusion of the left atrial appendage in non-valvular atrial fibrillation for the
prevention of thromboembolism. London, UK: National Institute for Health and
Clinical Evidence; 2010. NICE Interventional Procedure Guidance No. 349.
Available at: http://publications.nice.org.uk/percutaneous-occlusion-of-the-leftatrial-appendage-in-non-valvular-atrial-fibrillation-for-the-ipg349.
Anderson JL, Halperin JL, Albert NM, et al. Management of patients with atrial
fibrillation (Compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS
Recommendations). A Report of the American College of Cardiology/American
Heart Association Task Force on Practice Guidelines. Circulation.
2013;127:1916-1926. Available at:
http://circ.ahajournals.org/content/127/18/1916.full.
January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the
management of patients with atrial fibrillation: a report of the American College
of Cardiology/American Heart Association Task Force on practice guidelines and
the Heart Rhythm Society. Circulation. 2014a;130(23):e199-e267.
January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the
management of patients with atrial fibrillation: a report of the American College
of Cardiology/American Heart Association Task Force on Practice Guidelines and
the Heart Rhythm Society. J Am Coll Cardiol. 2014b;64(21):e1-e76.
National Institute for Health and Care Excellence (NICE). Percutaneous occlusion
of the left atrial appendage in non-valvular atrial fibrillation for the prevention of
thromboembolism. National Institute for Health and Care Excellence; 2010.
Interventional Procedure Guidance No. 349. National Institute for Health and
Care Excellence. Available at: https://www.nice.org.uk/guidance/ipg349
National Institute for Health and Care Excellence (NICE). Atrial Fibrillation: The
Management of Atrial Fibrillation. National Clinical Guideline Centre (UK); 2014.
National Clinical Guidelines No. 180. Available at:
http://www.ncbi.nlm.nih.gov/books/NBK248059/.
Masoudi FA, Calkins H, Kavinsky CJ, et al. Left Atrial Appendage Occlusion
Device Societal Overview: A Professional Societal Overview from the American
College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular
Angiography and Interventions. J Am Coll Cardiol. 2015 Jun 20. pii: S07351097(15)02852-1. doi: 10.1016/j.jacc.2015.06.028. [Epub ahead of print] 2015
ACC/HRS/SCAI.
References – Update July 2016
Watchman Procedure Jul 16
25
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2.
3.
4.
5.
Couch G, Sabir I. The WATCHMAN device for stroke prophylaxis in atrial
fibrillation: An evolving niche. Hosp Pract (1995). 2015;43(1):13-21.
Ramlawi B, Bedeir K. Surgical options in atrial fibrillation. J Thorac Dis.
2015;7(2):204-213.
Stone D, Byrne T, Pershad A. 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. 2015;86(1):121-127.
Tzikas A, Shakir S, Gafoor S, et al. Left atrial appendage occlusion for stroke
prevention in atrial fibrillation: multicentre experience with the AMPLATZER
Cardiac Plug. EuroIntervention. 2015;10(10). Epub ahead of print January 22,
2015.
U.S. FDA. Use of LARIAT Suture Delivery Device for Left Atrial Appendage
Closure: FDA Safety Communication. July 13, 2015. Available at:
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm454501.htm
References – Update July 2015
1.
Afzal MR, Kanmanthareddy A, Earnest M, et al. 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
2015; 12(1):52-59.
2. Alli O, Holmes D Jr. Left atrial appendage occlusion. Heart. 2015;101(11):834841.
3. Amorosi SL, Armstrong S, Da Deppo L, et al. The budget impact of left atrial
appendage closure compared with adjusted-dose warfarin and dabigatran
etexilate for stroke prevention in atrial fibrillation. Europace. 2014
Aug;16(8):1131-6. doi: 10.1093/europace/euu038. Epub 2014 Mar 30.
4. Badheka AO, Chothani A, Mehta K, et al. Utilization and adverse outcomes of
percutaneous left atrial appendage closure for stroke prevention in atrial
fibrillation in the United States: influence of hospital volume. Circ Arrhythm
Electrophysiol. 2015;8(1):42-48.
5. Bode WD, Patel N, Gehi AK. Left atrial appendage occlusion for prevention of
stroke in nonvalvular atrial fibrillation: a meta-analysis. J Interv Card
Electrophysiol. 2015;43(1):79-89.
6. Chatterjee S, Herrmann HC, Wilensky RL, et al. Safety and procedural success of
left atrial appendage exclusion with the Lariat device: a systematic review of
published reports and analytic review of the FDA MAUDE database. JAMA Intern
Med. 2015. Epub ahead of print. May 4, 2015. Available at:
http://archinte.jamanetwork.com/article.aspx?articleid=2289126. Accessed June
25, 2015.
7. Clinicaltrials.gov. Left Atrial Appendage Closure vs. Novel Anticoagulation Agents
in Atrial Fibrillation (PRAGUE-17). ClinicalTrials.gov Identifier:NCT02426944.
April 2015.
8. Clinicaltrials.gov. Left Atrial Appendage Electrical Isolation and Occlusion to Treat
Persistent Atrial Fibrillation: A Safety and Feasibility Study (LEIO-AF).
ClinicalTrials.gov Identifier: NCT02028130. June 2014.
9. Clinicaltrials.gov. ‘Left Atrial Appendage (LAA) Occluders After Catheter Ablation
of Atrial Fibrillation’ which is currently recruiting participants. ClinicalTrials.gov
Identifier: NCT01695824. July 2015.
10. De Backer O, Loupis AM, Ihlemann N, et al. Percutaneous left atrial appendage
closure for stroke prevention. Dan Med J. 2014 Aug;61(8):A4879.
11. Gloekler S, Shakir S, Doblies J, et al. Early results of first versus second
generation Amplatzer occluders for left atrial appendage closure in patients with
Watchman Procedure Jul 16
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12.
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21.
22.
23.
24.
25.
atrial fibrillation. Clin Res Cardiol. 2015. Epub ahead of print. March 4, 2015.
Available at: http://link.springer.com/article/10.1007%2Fs00392-015-0828-1.
Lam SC, Bertog S, Gafoor S, et al. Left atrial appendage closure using the
amulet device: An initial experience with the second generation amplatzer
cardiac plug. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):297-303. doi:
10.1002/ccd.25644. Epub 2014 Sep 5.
López Mínguez JR, Nogales Asensio JM, Gragera JE, et al. Two-year clinical
outcome from the Iberian registry patients after left atrial appendage closure.
Heart. 2015;101(11):877-883.
Meier B, Winkler B, Carrel T, et al. Percutaneous Transcatheter Closure for Aortic
Puncture and Paravalvular Leak Closure With the New Amplatzer III Device. J
Am Coll Cardiol Intv. 2015;():. doi:10.1016/j.jcin.2015.02.027.
Meschia JF, Bushnell C, Boden-Albala B, et al. Guidelines for the primary
prevention of stroke: a statement for healthcare professionals from the
American Heart Association/American Stroke Association. Stroke.
2014;45(12):3754-3832.
Miller MA, Gangireddy SR, Doshi SK, et al. Multicenter study on acute and longterm safety and efficacy of percutaneous left atrial appendage closure using an
epicardial suture snaring device. Heart Rhythm. 2014;11(11):1853
Miller MA, Gangireddy SR, Doshi SK, et al. Multicenter study on acute and longterm safety and efficacy of percutaneous left atrial appendage closure using an
epicardial suture snaring device. Heart Rhythm. 2014 Nov;11(11):1853-9. doi:
10.1016/j.hrthm.2014.07.032. Epub 2014 Jul 25.
Patel MB, Rasekh A, Shuraih M, et al. Safety and effectiveness of compassionate
use of LARIAT device for epicardial ligation of anatomically complex left atrial
appendages. J Interv Card Electrophysiol. 2015 Jan 17. [Epub ahead of print].
Pillai AM, Kanmanthareddy A, Earnest M, et al. Epub 2014 Jun 30. Initial
experience with post Lariat left atrial appendage leak closure with Amplatzer
septal occluder device and repeat Lariat application. Heart Rhythm. 2014
Nov;11(11):1877-83. doi: 10.1016/j.hrthm.2014.06.035.
Price MJ, Gibson DN, Yakubov SJ, et al. Early safety and efficacy of percutaneous
left atrial appendage suture ligation: results from the U.S. transcatheter LAA
ligation consortium. J Am Coll Cardiol. 2014 Aug 12;64(6):565-72. doi:
10.1016/j.jacc.2014.03.057.
Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure
vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov
19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
Saw J, Lempereur M. Percutaneous Left Atrial Appendage Closure: Procedural
Techniques and Outcomes. J Am Coll Cardiol Intv. 2014;7(11):1205-1220.
doi:10.1016/j.jcin.2014.05.026.
U.S. FDA. WATCHMAN LAA Closure Technology - P130013. March 13, 2015.
Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=
p130013
U.S. FDA. SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED). Left Atrial
Appendage Device. Watchman LAA Closure Technology. March 13, 2015.
Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130013b.pdf
Waksman R, Pendyala LK. Overview of the Food and Drug Administration
Circulatory System Devices Panel Meetings on WATCHMAN Left Atrial Appendage
Closure Therapy. Am J Cardiol. 2015 Feb 1;115 (3):378-384. doi:
10.1016/j.amjcard.2014.11.011. Epub 2014 Nov 12.
References – Update November 2014
Watchman Procedure Jul 16
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4.
5.
6.
7.
Alli O, Doshi S, Kar S, et al. Quality of life assessment in the randomized
PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin
Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial of
patients at risk for stroke with nonvalvular atrial fibrillation. J Am Coll Cardiol.
2013;61(17):1790-1798.
Don CW, Fuller CJ, Reisman M. Transcatheter left atrial appendage occlusion.
Cardiol Clin. 2013;31(3):363-384.
Emmert MY, Puippe G, Baumüller S, et al. Safe, effective and durable epicardial
left atrial appendage clip occlusion in patients with atrial fibrillation undergoing
cardiac surgery: First long-term results from a prospective device trial. Eur J
Cardiothorac Surg. 2013 May 8. [Epub ahead of print]
Nietlispach F, Gloekler S, Krause R, et al. Amplatzer left atrial appendage
occlusion: Single center 10-year experience. Catheter Cardiovasc Interv.
2013;82(2):283-289.
Ohtsuka T, Ninomiya M, Nonaka T, et al. Thoracoscopic stand-alone left atrial
appendectomy for thromboembolism prevention in nonvalvular atrial fibrillation.
J Am Coll Cardiol. 2013;62(2):103-107.
Turi ZG. The assault on the left atrial appendage in perspective. J Am Coll
Cardiol. 2013;62(2):119-120.
Urena M, Rodes-Cabau J, Freixa X, et al. Percutaneous left atrial appendage
closure with the AMPLATZER cardiac plug device in patients with nonvalvular
atrial fibrillation and contraindications to anticoagulation therapy. J Am Coll
Cardiol. 2013;62(2):96-102.
References – Update December 2013
1.
2.
3.
4.
U.S. Food & Drug Administration (FDA). WATCHMAN Left Atrial Appendage
Closure, (LAAC). Therapy for Patients with Non-Valvular Atrial Fibrillation.
Sponsor’s Executive Summary. P130013. Circulatory System Devices Panel
Meeting. December 11, 2013. Available at:
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterial
s/medicaldevices/medicaldevicesadvisorycommittee/circulatorysystemdevicespa
nel/ucm377935.pdf
U.S. Food & Drug Administration (FDA). WATCHMAN' Left Atrial Appendage
System Continued Access PROTECT AF Registry Preliminary Clinical Report.
March 6, 2009.
U.S. FDA. Proposed Summary of Safety and Effectiveness. Implantable Left
Atrial Appendage Closure Device. Available at:
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterial
s/medicaldevices/medicaldevicesadvisorycommittee/circulatorysystemdevicespa
nel/ucm377936.pdf
Walker D, Humphries J, Philips K. Combined catheter ablation for atrial
fibrillation and WATCHMAN left atrial appendage occlusion procedures: A single
centre experience. Journal of Atrial Fibrillation. Vol 5, 2012.
References – Update November 2013
1.
2.
3.
Aryana A, Saad EB, D’Avila A. 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;14(5):503-519.
Bartus K, Han FT, Bednarek J, Myc J, et al. Percutaneous left atrial appendage
suture ligation using the LARIAT device in patients with atrial fibrillation: initial
clinical experience. Am Coll Cardiol. 2013;62(2):108.
Block PC, Burstein S, Block PC, Burstein S, Casale PN, et al. Percutaneous left
atrial appendage occlusion for patients in atrial fibrillation suboptimal for
warfarin therapy: 5-year results of the PLAATO (Percutaneous Left Atrial
Watchman Procedure Jul 16
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4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
Appendage Transcatheter Occlusion) Study. JACC Cardiovasc Interv.
2009;2(7):594-600.
Camm AJ, Lip GY, De Caterina R, et al. 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;
33:2719.
Cheng A, Hijaazi ZM. Nonpharmacologic therapy to prevent embolization in
patients with atrial fibrillation. UpToDate. September 30, 2013.
Friedman PA, Holmes DR. Non-surgical left atrial appendage closure for stroke
prevention in atrial fibrillation. J Cardiovasc Electrophysiol. 2011;22(10):11841191.
Fuller CJ, Reisman M. Stroke prevention in atrial fibrillation: atrial appendage
closure. Curr Cardiol Rep 2011;13(2):159-166.
Garcia - Fernández MA, Pérez-David E, Quiles J, et al. Role of left atrial
appendage obliteration in stroke reduction in patients with mitral valve
prosthesis: a transesophageal echocardiographic study. J Am Coll Cardiol 2003;
42:1253.
Goldstein LB, Bushnell CD, Adams RJ, et al. Guidelines for the primary
prevention of stroke: a guideline for healthcare professionals from the American
Heart Association/American Stroke Association. Stroke. 2011;42(2):517-584.
Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in
patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-992.
Gutierrez C, Blanchard DG. Atrial fibrillation: diagnosis and treatment. Am Fam
Physician. 2011;83(1):61-68.
Han J, Cheng J, Mathuria N. Pharmacologic and nonpharmacologic therapies for
stroke prevention in nonvalvular atrial fibrillation. Pacing Clin Electrophysiol.
2012;35(7):887-896.
Khattab AA, Meier B. Transcatheter left atrial appendage closure for stroke
prevention among atrial fibrillation patients. Expert Rev Cardiovasc Ther.
2012;10(7):819-821.
Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total
incremental health care costs in patients with atrial fibrillation in the United
States. Circ Cardiovasc Qual Outcomes. 2011;4(3):313-320.
Lam YY, Yip GW, Yu CM, et al. Left atrial appendage closure with AMPLATZER
cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific
experience. Catheter Cardiovasc Interv. 2012;79(5):794-800.
Lane DA, Lip GY. Use of the CHA(2)DS(2)-VASc and HAS-BLED scores to aid
decision making for thromboprophylaxis in nonvalvular atrial fibrillation. AHA.
Circulation 2012; 126:860. Available at:
http://circ.ahajournals.org/content/126/7/860.full.pdf
Leal S, Moreno R, de Sousa Almeida M, et al. Evidence-based percutaneous
closure of the left atrial appendage in patients with atrial fibrillation. Curr Cardiol
Rev. 2012;8(1):37-42.
Lee RJ, Bartus k, Bednarek J, et al. Criteria for Success of Left Atrial Appendage
Ligation By a Novel Catheter-Based Suture Ligation Procedure. Cardiac
arrhythmias. April 05, 2011. Journal of the American College of Cardiology
(JACC).
Massumi A, Chelu MG, Nazeri A, et al. 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 2013; 111:869.
Watchman Procedure Jul 16
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20. Ostermayer SH, Reisman M, Kramer PH, et al. Percutaneous left atrial
appendage transcatheter occlusion (PLAATO system) to prevent stroke in highrisk patients with non-rheumatic atrial fibrillation: results from the international
multi-center feasibility trials. J Am Coll Cardiol 2005; 46:9.
21. Shetty R, Leitner JP, Zhang M. Percutaneous catheter-based left atrial
appendage ligation and management of periprocedural left atrial appendage
perforation with the LARIAT suture delivery system. J Invasive Cardiol 2012;
24:E289.
22. U.S. Food and Drug Administration (FDA). MAUDE Adverse Event Report:
SENTROHEART INCLARIAT SUTURE DELIVERY SYSTEM. 1/10/2013. Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi_
_id=3212851
23. Viles-Gonzalez JF, Kar S, Douglas P, et al. The clinical impact of incomplete left
atrial appendage closure with the Watchman Device in patients with atrial
fibrillation: a PROTECT AF (Percutaneous Closure of the Left Atrial Appendage
Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial
Fibrillation) substudy. J Am Coll Cardiol 2012; 59:923.
References – Update October 2013
1.
2.
3.
4.
5.
6.
7.
8.
9.
Alli O, Doshi S, Kar S, et al. Quality of life assessment in the randomized
PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin
Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial of
patients at risk for stroke with nonvalvular atrial fibrillation. J Am Coll Cardiol.
2013 Apr 30;61(17):1790-8.
Chun JK, Bordignon S, Urban V, et al. Left Atrial Appendage Closure Followed
By Six Weeks Antithrombotic Therapy - A Prospective Single Center Experience.
Heart Rhythm. 2013 Aug 22.
Meincke F, Kuck KH, Bergmann MW. Interventional left atrial appendage
occlusion : alternative to oral anticoagulation for stroke prevention in atrial
fibrillation. Herz. 2013 May;38(3):239-46.
Meincke F, Schmidt-Salzmann M, Kreidel F, et al. New technical and
anticoagulation aspects for left atrial appendage closure using the WATCHMAN
device in patients not taking warfarin. EuroIntervention. 2013 Aug 22;9(4):4638.
Reddy VY, Doshi SK, Sievert H, et al. 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. 2013 Feb 12;127(6):720-9.
Reddy VY, Möbius-Winkler S, Miller MA, et al. Left atrial appendage closure with
the Watchman device in patients with a contraindication for oral anticoagulation:
the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial
Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):25516.
Swaans MJ, Alipour A, Rensing BJ, et al. Catheter ablation in combination with
left atrial appendage closure for atrial fibrillation. J Vis Exp. 2013 Feb
26;(72):e3818.
Swaans MJ, Post MC, Rensing BJ, Boersma LV. Ablation for atrial fibrillation in
combination with left atrial appendage closure: first results of a feasibility study.
J Am Heart Assoc. 2012 Oct;1(5):e002212.
Whitlock RP, Hanif H, Danter M. Nonpharmacologic approaches to stroke
prevention in atrial fibrillation. Can J Cardiol. 2013 Jul;29(7 Suppl):S79-86.
Watchman Procedure Jul 16
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References – Update October 2012
1.
2.
Landmesser U, Holmes DR Jr. Left atrial appendage closure: a percutaneous
transcatheter approach for stroke prevention in atrial fibrillation. Eur Heart J.
2012 Mar;33(6):698-704.
Möbius-Winkler S, Sandri M, Mangner N, et al. The WATCHMAN left atrial
appendage closure device for atrial fibrillation. J Vis Exp. 2012 Feb 28;(60). pii:
3671.
References Update – October 2011
1. Reddy VY, Holmes D, Doshi SK, et al. 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. Epub 2011
Jan 17.
2. Cheng J, Hijazi ZM, Fscai F. Left atrial appendage amputation, ligation, or
occlusion in patients with atrial fibrillation. June 18, 2010.
3. Holmes DR, Reddy VY, Turi ZG, et al. 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;374(9689):534-42.
References Initial
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3.
4.
5.
6.
7.
8.
STÖLLBERGER C, Rudolfstiftung K, Abteilung M, et al. Serious Complications
from Dislocation of a Watchman Left Atrial Appendage Occluder. Journal of
Cardiovascular Electrophysiology. Volume 18,Issue 8, Page 880-881, August
2007. doi:10.1111/j.1540-8167.2007.00784.x.
Stöllberger C, Finsterer J. WATCHMAN for Stroke Prevention: An Out-of-Date
Procedure. Am Coll Cardiol, 2007; 50:914, doi:10.1016/j.jacc.2007.04.077.
Fountain RB, Holmes DR, Chandrasekaran K, et al. The PROTECT AF
(WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients
with Atrial Fibrillation) Trial. American Heart Journal - Volume 151, Issue 5 (May
2006).
Stöllberger C. WATCHMAN: An effective protection against stroke? American
Heart Journal - Volume 152, Issue 4 (October 2006).
Heart Disease and Stroke Statistics—2006 Update: A Report From the American
Heart Association Statistics Committee and Stroke Statistics Subcommittee.
Circulation. 2006;113:e85-e151.
Ostermayer S, Reisman M, Kramer P, et al. Percutaneous Left Atrial Appendage
Transcatheter Occlusion (PLAATO System) to prevent stroke in high-risk patients
with non-rheumatic atrial fibrillation. J Am Coll Cardiol (2005) 46: pp 9-14.
Crystal E, Lamy A, Connolly S, et al. Left Atrial Appendage Occlusion Study
(LAAOS): a randomized clinical trial of left atrial appendage occlusion during
routine coronary artery bypass graft surgery for long-term stroke prevention.
Am Heart J (2003) 145: pp 174-178.
Stöllberger C, Schneider B, Finsterer J. Elimination of the left atrial appendage to
prevent stroke or embolism? Anatomic, physiologic, and pathophysiologic
considerations. Chest 124. 2356-2362.2003.
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