Tuesday, November 27, 2018

CPT 33340 - Percutaneous Left Atrial Appendage Closure Devices

Coding Code Description CPT

33340 Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation


Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

Introduction


The heart is divided into two upper and two lower chambers. Atrial fibrillation, also called a-fib, occurs when the heart’s upper chambers beat irregularly—and often rapidly. Because blood isn’t pumped out the way that it should be, blood tends to pool in these two upper chambers. Thepooling blood increases the risk of blood clots in the area of the heart called the left atrial appendage. If a blood clot comes loose, it may travel to the brain and cause a stroke. Blood thinners are the usual method of preventing blood clots in people with a-fib. If taking a blood thinner poses too much risk or a person can’t tolerate this medication, placing a device in the heart is a different way of helping to prevent stroke. This device seals off the left atrial appendage. Should a clot develop, the device blocks it from entering the bloodstream. This policy describes when a left atrial appendage closure device is considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for  providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria Device Medical Necessity Percutaneous left atrial appendage closure device (eg, the Watchman)

The use of a device with U.S. Food and Drug Administration (FDA) approval for percutaneous left atrial appendage closure (eg, the Watchman) may be considered medically necessary for the prevention of stroke in patients with atrial fibrillation when the following criteria are met:

* There is an increased risk of stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc score and systemic anticoagulation therapy is recommended AND

* The long-term risks of systemic anticoagulation outweigh the risks of the device implantation (see Related Information) The use of a device with FDA approval for percutaneous left atrial appendage closure (eg, the Watchman) for stroke prevention in patients who do not meet the above criteria is considered investigational.

Device InvestigationalOther percutaneous left atrial appendage closure devices

The use of other percutaneous left atrial appendage closure devices, including but not limited to the Lariat and Amplatzer devices, for stroke prevention in patients with atrial fibrillation is considered investigational.

Documentation Requirements

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include ALL of the following:
* Name of the Food and Drug Administration (FDA) device to be used
* CHADS2 or CHA2DS2-VASc score documenting patient’s increased risk of stroke and systemic embolism
* Documentation that systemic anticoagulation therapy is recommended AND the long-term risks of systemic anticoagulation outweigh the risks of the device implantation



Related Information

The balance of risks and benefits associated with implantation of the Watchman device for stroke prevention, as an alternative to systemic anticoagulation with warfarin, must be made on an individual basis.

Bleeding is the primary risk associated with systemic anticoagulation. A number of risk scores have been developed to estimate the risk of significant bleeding in patients treated with systemic anticoagulation. An example is the HAS-BLED score, which has been validated to assess the annual risk of significant bleeding in patients with atrial fibrillation treated with warfarin (Pisters et al, 2010). The score ranges from 0 to 9, based on a number of clinical characteristics (see Table 1).

Table 1: Clinical Components of the HAS-BLED Bleeding Risk Score Letter Clinical Characteristic Points Awarded

H Hypertension 1
A Abnormal renal and liver function (1 point each) 1 or 2
S Stroke 1
B Bleeding 1
L Labile international normalized ratios 1
E Elderly (>65 y) 1


Letter Clinical Characteristic Points Awarded D Drugs or alcohol (1 point each) 1 or 2 Adapted from Pisters et al (2010) Risk of major bleeding in patients with scores of 3, 4, and 5 has been reported at 3.74 per 100 patient-years, 8.70 per 100 patient-years, and 12.5 per 100 patient-years, respectively. Scores of 3 or greater are considered to be associated with a high risk of bleeding, potentially signaling the need for closer monitoring of patients for adverse risks, closer monitoring of international normalized ratio, or differential dose selections of oral anticoagulants or aspirin (January et al, 2014).

Evidence Review Description

Stroke prevention in atrial fibrillation (AF) is an important goal of treatment. Treatment with anticoagulant medications is the most common approach to stroke prevention. Most embolic strokes originate from the left atrial appendage; therefore, occlusion of the left atrial appendage may offer a nonpharmacologic alternative to anticoagulant medications for this purpose. Multiple percutaneously deployed devices are being investigated for left atrial appendage closure (LAAC). One left atrial appendage device (the Watchman device) has approval from the U.S. Food and Drug Administration for stroke prevention in patients with AF.


Background

Stroke


Stroke is the most serious complication of atrial fibrillation (AF). The estimated incidence of stroke in nontreated patients with AF is 5% per year. Stroke associated with AF is primarily embolic in nature, tends to be more severe than the typical ischemic stroke, and causes higher  rates of mortality and disability. As a result, stroke prevention is one of the main goals of AF treatment.

Stroke in AF occurs primarily as a result of thromboembolism from the left atrium. The lack of atrial contractions in AF leads to blood stasis in the left atrium, and this low flow state increases the risk for thrombosis. The area of the left atrium with the lowest blood flow in AF, and, therefore, the highest risk of thrombosis, is the left atrial appendage (LAA). It has been estimated that 90% of left atrial thrombi occur in the LAA.

Treatment Pharmacologic

The main treatment for stroke prevention in AF is anticoagulation, which has proven efficacy. The risk for stroke among patients with AF is evaluated using several factors. Two commonly used scores, the CHADS2 and the CHADS2-VASc score, are described below in Table 2. Warfarin is the predominant anticoagulation agent in clinical use. A number of newer anticoagulant medications, including dabigatran, rivaroxaban, and apixaban, have recently received U.S.

Food and Drug Administration (FDA) approval for stroke prevention in nonvalvular AF and have demonstrated noninferiority to warfarin in clinical trials. While anticoagulation is effective for stroke prevention, it carries an increased risk of bleeding. Also, warfarin requires frequent monitoring and adjustments, as well as lifestyle changes. Dabigatran does not require monitoring. However, unlike warfarin, the antithrombotic effects of dabigatran are not reversible with any currently available hemostatic drugs. Guidelines from the American College of Chest Physicians (2012) have recommended the use of oral anticoagulation for patients with AF who are at high risk of stroke (ie, CHADS2 score =2), with more individualized choice of antithrombotic therapy in patients with lower stroke risk.1

Table 2. CHADS2 and CHADS2-VASc Scores to Predict Ischemic Stroke Risk in Patients with Atrial Fibrillation

Letter Clinical Characteristics Points

Awarded


C Congestive heart failure (signs/symptoms of heart failure confirmed with objective evidence of cardiac dysfunction) 1
H Hypertension (resting blood pressure >140/90 mmHg on at least 2 occasions or current antihypertensive pharmacologic treatment)
1 A Age =75 y


Bleeding is the primary risk associated with systemic anticoagulation. Risk scores have been developed to estimate the risk of significant bleeding in patients treated with systemic anticoagulation, such as the HAS-BLED score, which has been validated to assess the annual risk of significant bleeding in patients with AF treated with warfarin.3 The score ranges from 0 to 9, based on a number of clinical characteristics, including the presence of hypertension, renal and liver function, history of stroke, bleeding, labile international normalized ratios, age, and drug/alcohol use. Scores of 3 or greater are considered to be associated with high risk of bleeding, potentially signaling the need for closer monitoring of patients for adverse risks, closer monitoring of international normalized ratios, or differential dose selections of oral anticoagulants or aspirin.2

Surgery

Surgical removal, or exclusion, of the LAA is often performed in patients with AF who are undergoing open heart surgery for other reasons. Percutaneous left atrial appendage closure (LAAC) closure devices have been developed as a nonpharmacologic alternative to anticoagulation for stroke prevention in AF. The devices may prevent stroke by occluding the LAA, thus preventing thrombus formation.

Several versions of LAA occlusion devices have been developed. The Watchman Left Atrial Appendage System (Boston Scientific) is a self-expanding nickel titanium device. It has a polyester covering and fixation barbs for attachment to the endocardium. Implantation is performed percutaneously through a catheter delivery system, using venous access and transseptal puncture to enter the left atrium. Following implantation, patients receive anticoagulation with warfarin or alternative agents for approximately 1 to 2 months. After this period, patients are maintained on antiplatelet agents (ie, aspirin  and/or clopidogrel)

indefinitely. The Lariat Loop Applicator is a suture delivery device that is intended to close a variety of surgical wounds in addition to LAAC. The Cardioblate® closure device (Medtronic) is currently being tested in clinical studies. The Amplatzer cardiac plug (St. Jude Medical), is FDAapproved for closure of atrial septal defects but not for LAAC. A second-generation device, the Amplatzer Amulet, has been developed. The Percutaneous LAA Transcatheter Occlusion device (ev3) has also been evaluated in research studies but has not received FDA approval. The Occlutech® (Occlutech) Left Atrial Appendage Occluder has received a CE mark for coverage in Europe.

Outcome Measures

The optimal study design for evaluating the efficacy of percutaneous LAAC for the prevention of stroke in AF is a randomized controlled trial that includes clinically relevant measures of health outcomes. The rate of ischemic stroke during follow-up is the primary outcome of interest, along with rates of systemic embolization, cardiac events, bleeding complications, and death. For the LAAC devices, the appropriate comparison group could be oral anticoagulation, no therapy (for patients who have a prohibitive risk for oral anticoagulation), or open surgical repair.

Although the Watchman device and other LAAC devices would ideally represent an alternative to oral anticoagulation for the prevention of stroke in patients with AF, during the postimplantation period, the device may be associated with increased thrombogenicity and, therefore, anticoagulation is used during the periprocedural period. Most studies evaluating the Watchman device have included patients who are eligible for anticoagulation. Summary of Evidence

For individuals who have AF who are at increased risk for embolic stroke who receive the Watchman percutaneous LAAC device, the evidence includes 2 RCTs and meta-analyses of these trials. Relevant outcomes are overall survival, morbid events, and treatment-related morbidity.

The most relevant evidence comes from 2 industry-sponsored RCTs that compared the Watchman device with anticoagulation alone. One trial reported noninferiority on a composite outcome of stroke, cardiovascular/unexplained death, or systemic embolism after 2 years o follow-up, with continued benefits with the Watchman device after 4 years of follow-up.

The second trial did not demonstrate noninferiority for the same composite outcome but did demonstrate noninferiority of the Watchman device to warfarin for late ischemic stroke and systemic embolization. Patient-level meta-analyses at 5-year follow-up for the 2 trials reported that the Watchman device is noninferior to warfarin on the composite outcome of stroke, systemic embolism, and cardiovascular death. Also, the Watchman was associated with lower rates in major bleeding, particularly hemorrhagic stroke, and mortality over the long term. The evidence also indicates that the Watchman device is efficacious in preventing stroke in the subset of patients with AF who are at increased risk for embolic stroke. When it is determined on an individualized basis that the long-term risk of systemic anticoagulation exceeds the procedural risk of device implantation, the net health outcome will be improved. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have AF who are at increased risk for embolic stroke who receive a percutaneous LAAC device other than the Watchman device (eg, the Lariat or Amplatzer), the evidence includes uncontrolled case series. Relevant outcomes are overall survival, morbid events, and treatment-related morbidity. Case series of these devices have reported high procedural success, but also numerous complications. Also, these devices do not have Food and Drug Administration approval for LAAC. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this policy are listed in Table 3

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