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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 Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members 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). Watchman Procedure Jul 16 2 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. Watchman Procedure Jul 16 3 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 Watchman Procedure Jul 16 4 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 Watchman Procedure Jul 16 5 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. Watchman Procedure Jul 16 6 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), Watchman Procedure Jul 16 7 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 Watchman Procedure Jul 16 8 (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 Watchman Procedure Jul 16 9 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 10 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 11 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 Watchman Procedure Jul 16 12 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 Watchman Procedure Jul 16 13 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 14 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 15 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 16 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 17 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 18 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 19 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 20 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 21 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 22 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 23 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 24 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 1. 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 26 12. 13. 14. 15. 16. 17. 18. 19. 20. 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. 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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 29 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 30 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 1. 2. 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. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical Watchman Procedure Jul 16 31 outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. states, prior notice or website posting is required before an amendment is deemed effective. In some No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member’s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member’s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member’s contract shall govern. The Policies do not replace or amend the Member’s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. “Reconstructive surgery” means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or Watchman Procedure Jul 16 32 (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Watchman Procedure Jul 16 33