Medical Policy: 02.02.17 

Original Effective Date: January 2016 

Reviewed: January 2019 

Revised: January 2019 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Baroreflex Activation Device

The use of baroreflex stimulation devices (also known as baroreflex activation therapy) is a potential alternative treatment for resistant hypertension and heart failure. Both hypertension and heart failure are relatively common conditions, and are initially treated with medications and lifestyle changes. A substantial portion of patients are unresponsive to conventional therapy and treating these patients is often challenging and can lead to high costs and adverse effects. As a result, there is a large unmet need for additional treatments.

 

New treatment options are being explored to treat drug-resistant hypertension. One such approach is the electrical activation of the carotid sinus baroreflex. Baroreceptors are pressure sensors contained within the walls of the carotid arteries. They are part of the autonomic nervous system that regulates basic physiologic functions such as heart rate and blood pressure (BP). When these receptors are stretched, as occurs with increases in BP, the baroreflex is activated. Activation of the baroreflex sends signals to the brain, which responds by inhibiting sympathetic nervous system output and increasing parasympathetic nervous system output. The effect of this activation is to reduce heart rate and BP, thereby helping to maintain homeostasis of the circulatory system.

 

This procedure was first introduced in the 1960s and 1970s for the treatment of drug-resistant hypertension and refractory angina pectoris. It consisted of chronically stimulating the carotid sinus nerves using implanted nerve electrodes with an implantable radiofrequency controlled receiver. At that time, this approach was not adopted as a viable treatment option for hypertension due to the development of new drugs used in the treatment of hypertension and the technical limitations of implantable medical devices during that time period. Newer devices are now being developed, first-generation and second-generation devices, which bilaterally activate the carotid sinus baroreflex by electrically stimulating the carotid sinus wall. A surgical implant procedure is used to place the device under the skin near the clavicle. The electrodes are placed on the carotid arteries and the leads run under the skin and are connected to a battery powered implanted impulse generator device.

 

Specific devices for baroreflex stimulation have been developed, but none has been approved by the U.S. Food and Drug Administration (FDA) for any indication. One device, called the Barostim neo™ (CVRx™, previously called the Rheos® Baroreflex Hypertension Therapy System) is approved for sale in Europe for hypertension and heart failure patients. The system consists of a unilateral electrode and lead that is attached to the carotid sinus and a pulse generator that is implanted subcutaneously in the chest wall. Programming is performed via radiofrequency telemetry using an external laptop computer and software.

 

There are no baroreflex activation therapy devices that have received U.S. FDA approval or clearance.

 

Clinical topic regarding diagnosis and management of resistant hypertension via the American College of Cardiology states: At this time, the benefits of renal denervation, carotid baroreceptor stimulation, and central arteriovenous anastomosis remain inconclusive, and these procedures should not be adopted in routine clinical practice.

 

Intracardiac ischemia monitor (Angelmed)

Intracardiac ischemia monitoring which utilizes an implantable electrogram device that records cardiac data and detects ischemic events using a standard pacemaker intracardiac lead positioned in the right ventricular apex. This implantable warning system emits a vibrational alarm when impending acute ischemic events are detected prior to symptom onset. The device is currently intended only for use in individuals considered high-risk for ischemic cardiac events, such as those with previous acute coronary events, diabetes, or renal insufficiency. This implantable warning system emits a vibrational alarm when impending acute ischemic events are detected prior to symptom onset. The device is currently intended only for use in individuals considered high-risk for ischemic cardiac events, such as those with previous acute coronary events, diabetes, or renal insufficiency. The proposed purpose of the device is to reduce the time from ischemic event onset to presentation in an emergency room with proposed potential clinical benefits related to faster emergent care.

 

The AngelMed Guardian® system (Angel Medical Systems, Shrewsbury, NJ) is an implantable cardiac device similar to a pacemaker but it monitors the heart’s electrical signals 24 hours a day, seven days a week. It is suggested that this device can detect rapid ST segment changes that may signify major cardiac events such as coronary artery occlusions. When an event occurs the system is designed to alert patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings. At the hospital the doctor can retrieve information collected by the implanted device to a computer to help determine a plan of treatment. The system, currently commercially available in Brazil, is the subject of a phase-II clinical study in the United States and has not received PMA or 501(k) FDA-approval at this time.

 

At the present time, there is insufficient scientific evidence to demonstrate the safety and efficacy of the Guardian System for intracardiac ischemia monitoring. The Guardian device has not been cleared by the FDA for use in the U.S. outside clinical trial settings.

 

Left atrial appendage (LAA) occlusion devices (Watchman, AtriClip and Lariat device)

LAA occlusion devices are non-pharmacologic alternatives to anticoagulation for stroke prevention in patients with atrial fibrillation. Currently, there is one device that has FDA-approval for this indication in the U.S.(Watchman), but other devices (The Lariat® Loop Applicator device, The Amplatzer Amulet® device, The AtriClip Device) have been evaluated for this purpose.

 

A Class II medical device called Lariat® (SentraHEART, Inc.) fails one out of 10 times when used “off label” in a cardiac procedure to clamp off a potential source of dangerous blood clots in high risk heart patients. Furthermore, using Lariat in this procedure often leads to urgent cardiac surgery or death and does not lower the risk of stroke in patients who undergo the procedure. The Amplatzer Amulet® device (St. Jude Medical, Plymouth, MN) has a CE approval in Europe for left atrial appendage closure, but is not currently approved in the U.S. for any indication. The main difference between the Watchman and the Lariat is that the Watchman is a metal and fabric implant placed inside the heart, blocking the opening to the appendage. The Lariat on the other hand occludes the appendage by tying off the base of the LAA from outside the heart. The approval of the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion device enhances the capability to occlude the LAA during minimally-invasive surgical procedures. Recently, the clinical trials with WaveCrest Left Atrial Appendage (LAA), Occlusion System have also been underway.

 

Published randomized, controlled trials compared the WATCHMAN™ device to warfarin, and reported non-inferiority on a composite outcome of stroke, cardiovascular/unexplained death, or systemic embolism after 2 years of follow-up. There were a higher number of complications in the LAA closure group, primarily due to early complications associated with the device placement. Additional trials are underway or awaiting published results to determine the patient population, implantation safety, non-inferiority, and long term safety.

 

The longer term data from the PREVAIL trial puts into question if noninferiority endpoints were actually reached. The concern for late ischemic stroke events remain in question at this time. The lack of including those patient ineligible for anticoagulation therapy in key trials also eliminates this population from having success with the devices in question. The introduction of new anticoagulants further complicates the questions of most efficacious, safest, and cost-effective therapy for stroke prevention.

 

American College of Cardiology, Heart Rhythm Society, et al

In 2015, the American College of Cardiology (ACC), Heart Rhythm Society (HRS), and Society for Cardiovascular Angiography and Interventions published an overview of the integration of percutaneous LAA closure devices into the clinical practice of patients with AF. The overview was organized around questions related to the sites of care delivery for LAA closure devices, training for proceduralists, necessary follow-up data collection, identification of appropriate patient cohorts, and reimbursement. The statement provides general guidelines for facility and operator requirements, including the presence of a multidisciplinary heart team, for centers performing percutaneous LAA closures. The statement does not provide specific recommendations about the indications and patient populations appropriate for percutaneous LAA closure.

 

American College of Cardiology, American Heart Association, et al

In 2014, the ACC, American Heart Association, and HRS issued guidelines on the management of patients with AF. These guidelines recommend that surgical excision of the LAA may be considered in patients undergoing cardiac surgery (class IIB recommendation; level of evidence: C), but make no specific recommendations regarding percutaneous LAA closure.

 

American College of Chest Physicians

In 2012, the American College of Chest Physicians published evidence-based clinical best practice guidelines on the use of antithrombotic therapy for prevention of stroke in AF.1 In relation to the use of LAA closure devices, the guidelines state: “At this time, we make no formal recommendations regarding LAA closure devices, pending more definitive research in this field.”

 

The Centers for Medicare & Medicaid Services (CMS)

The Centers for Medicare & Medicaid Services (CMS) covers percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development (CED) under 1862(a)(1)(E) of the Social Security Act with the following conditions:

 

Left Atrial Appendage Closure devices are covered when the device has received Food and Drug Administration (FDA) Premarket Approval (PMA) for that device’s FDA-approved indication and meet all of the conditions specified below:

  • The patient must have:
    • A CHADS2 score ≥ 2 (Congestive heart failure, Hypertension, Age >75, Diabetes, Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-VASc score ≥ 3 (Congestive heart failure, Hypertension, Age ≥ 65, Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category)
    • A formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with NVAF prior to LAAC. Additionally, the shared decision making interaction must be documented in the medical record.
    • A suitability for short-term warfarin but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making, as LAAC is only covered as a second line therapy to oral anticoagulants. The patient (preoperatively and postoperatively) is under the care of a cohesive, multidisciplinary team (MDT) of medical professionals. The procedure must be furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program.
  • The procedure must be performed by an interventional cardiologist(s), electrophysiologst(s) or cardiovascular surgeon (s) that meet the following criteria:
    • a) Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and
    • b) Has performed ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and
    • c) Continues to perform ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a two year period.
  • The patient is enrolled in, and the MDT and hospital must participate in a prospective, national, audited registry that: 1) consecutively enrolls LAAC patients and 2) tracks the following annual outcomes for each patient for a period of at least four years from the time of the LAAC:
    • a) Operator-specific complications
    • b) Device-specific complications including device thrombosis
    • c) Stroke, adjudicated, by type
    • d) Transient Ischemic Attack (TIA)
    • e) Systemic embolism
    • f) Death
    • g) Major bleeding, by site and severity
  • The registry must be designed to permit identification and analysis of patient, practitioner and facility level factors that predict patient risk for these outcomes. The registry must collect all data necessary to conduct analyses adjusted for relevant confounders and have a written executable analysis plan in place to address the following questions:
    • a) How do the outcomes listed above compare to outcomes in the pivotal clinical trials in the short term (≤12 months) and in the long term (≥ 4 years)?
    • b) What is the long term (≥ 4 year) durability of the device?
    • c) What are the short term (≤12 months) and the long term (≥4 years) device-specific complications including device thromboses?

 

To appropriately address some of these questions, Medicare claims or other outside data may be necessary.

 

Questions remain after recent recalls about the safety profile of the product. The indications and contraindications regarding the device and the use in patients unable or unwilling to use anticoagulation remain. The approval in only clinical trial settings will attempt to address value, safety, and long-term primary end point satisfaction.

 

Non-invasive assessment of central blood pressure (e.g., SphygmoCor System)/ non-invasive medical devices that provide an indication of arterial compliance

No controlled studies were found in the published literature that validates the application of non-invasive medical devices for the measuring of arterial elasticity for cardiovascular disease. No evidence was found to show that evaluation of the status of the arterial elasticity is predictive and, thus, that type of evaluation cannot be used to alter the treatment of individuals.

 

Implantable Congestive Heart Failure Monitors

Implantable pulmonary artery sensor (e.g. CardioMEMS)

A variety of outpatient cardiac hemodynamic monitoring devices have been proposed to decrease episodes of acute decompensation in patients with heart failure and thus improve quality of life and reduce morbidity.

 

The FDA approved the CardioMEMS™ Champion Heart Failure Monitoring System) through the premarket approval (PMA) process. The device consists of an implantable pulmonary artery sensor, implanted in the distal pulmonary artery, a transvenous delivery system, and an electronic sensor that processes signals from the sensor and transmits pulmonary artery pressure measurements to a secure off-site database. Several additional devices that monitor cardiac output through measurements of pressure changes in the pulmonary artery or right ventricular outflow tract have been investigated in the research setting, but have not received FDA approval.

 

The current evidence base is insufficient to support the use of ambulatory cardiac hemodynamic monitoring using an implantable pulmonary artery pressure measurement device in individuals with heart failure in an outpatient setting. Devices have not been shown to improve clinical outcomes compared to standard methods of heart failure monitoring. Additional well-designed and high quality RCTs are necessary to establish whether health outcomes are significantly improved relative to standard of care for heart failure management.

 

Implantable Congestive Heart Failure Monitors (for example, Chronicle IHM System)

The system includes an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. The device is marketed for home use.

 

Implantable Left Atrial Hemodynamic (LAH) Monitor (for example, HeartPOD™ System and Promote® LAP System)

These devices monitor left atrial pressure (LAP) with the objective of identifying pressure changes in ambulatory individuals with heart failure (HF) to potentially enable earlier intervention and prevention of clinical deterioration. The monitoring system can be used as a stand-alone or combination device with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).

 

The impact of implantable LAH monitoring on net health outcome has been evaluated through clinical trials, however the results have not been established. The effectiveness of these devices for the proposed uses has not been conclusively demonstrated. Definitive evidence that the use of these technologies improves health outcomes over standard active heart failure patient management is lacking.

 

American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)

Heart Rythm Society

The 2017 joint guidelines from the American College of Cardiology, American Heart Association, and Heart Failure Society of America on the management of heart failure offered no recommendations for the use of ambulatory monitoring devices.

 

The 2013 ACCF/AHA Guideline for the Management of Heart Failure

No recommendations were made for use of ambulatory monitoring devices.

 

National Institute for Health and Clinical Excellence

The 2010 update of the National Institute for Health and Clinical Excellence clinical guideline on chronic heart failure management does not include outpatient hemodynamic monitoring as a recommendation. This clinical guideline is scheduled for review; updates have not been published.

 

Long-Term Counterpulsation device

The aortic counterpulsation device consists of a tiny pump enclosed within a catheter-like tube that is placed through an artery (endovascular) into the heart. The pump works like an artificial heart pump to relieve the load on the left ventricle and help pump blood throughout the body to maintain oxygen saturation and organ perfusion. The indication for permanent placement in those with congestive heart failure is being studied. The device, which requires a minimally invasive surgery, provides patients an alternative to medical therapy. The devices (i.e. Symphony, iVAS, C-Pulse) are considered investigational devices at this time.

 

Prior Approval:

Not applicable

 

Policy:

Use of baroreflex stimulation implanted devices is considered investigational in all situations including but not limited to treatment of hypertension and heart failure.

 

Intracardiac ischemia monitoring is considered investigational for all indications including, but not limited to, detection of acute myocardial ischemic events.

 

Non-invasive assessment of central blood pressure (e.g., SphygmoCor System) is considered investigational.

 

The use of a cardiac device for occlusion of the left atrial appendage (e.g., Watchman, Lariat, WaveCrest Occlusion System) is considered investigational for the prevention of stroke and all other indications because their safety and effectiveness have not been established.

 

Epicardial clipping of the left atrial appendage is considered investigational.

 

Implantable Left Atrial Hemodynamic (LAH) Monitors (e.g., HeartPOD™ System and Promote® LAP System) are considered investigational.

 

In the ambulatory care and outpatient setting, cardiac hemodynamic monitoring for the management of heart failure including implantable direct pressure monitoring of the pulmonary artery (CardioMEMS) and implantable congestive heart failure monitors (e.g., the Chronicle IHM System) are considered investigational. At home devices have not been shown to improve clinical outcomes compared to standard methods of heart failure monitoring. Questions remain regarding the magnitude of benefit by these devices in the ambulatory setting. High quality trials are still lacking that show benefit to overall health outcomes.

 

The use of an implantable aortic counterpulsation system (i.e NuPulse iVAS by NuPulse, Symphony, Sunshine hearts C-Pulse) for permanent use for advanced congestive heart failure (CHF) or for any other indication is investigational.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 0266T Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed)
  • 0267T Implantation or replacement of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed)
  • 0268T Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed)
  • 0269T Revision or removal of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed)
  • 0270T Revision or removal of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed)
  • 0271T Revision or removal of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed)
  • 0272T Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day);
  • 0273T Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); with programming
  • 0451T Insertion or replacement of a permanently implantable aortic counterpulsation ventricular assist system, endovascular approach, and programming of sensing and therapeutic parameters; complete system (counterpulsation device, vascular graft, implantable vascular hemostatic seal, mechano-electrical skin interface and subcutaneous electrodes)
  • 0452T aortic counterpulsation device and vascular hemostatic seal
  • 0453T mechano-electrical skin interface
  • 0454T subcutaneous electrode
  • 0455T Removal of permanently implantable aortic counterpulsation ventricular assist system; complete system (aortic counterpulsation device, vascular hemostatic seal, mechano-electrical skin interface and electrodes
  • 0456T aortic counterpulsation device and vascular hemostatic seal
  • 0457T mechano-electrical skin interface
  • 0458T subcutaneous electrode
  • 0459T Relocation of skin pocket with replacement of implanted aortic counterpulsation ventricular assist device,mechano- electrical skin interface and electrodes
  • 0460T Repositioning of previously implanted aortic counterpulsation ventricular assist device, subcutaneous electrode;
  • 0461T aortic counterpulsation device
  • 0525T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; complete system (electrode and implantable monitor)
  • 0526T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; electrode only
  • 0527T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; implantable monitor only
  • 0528T Programming device evaluation (in person) of intracardiac ischemia monitoring system with iterative adjustment of programmed values, with analysis, review, and report   
  • 0529T Interrogation device evaluation (in person) of intracardiac ischemia monitoring system with analysis, review, and report 
  • 0530T Removal of intracardiac ischemia monitoring system, including all imaging supervision and interpretation; complete system (electrode and implantable monitor)   
  • 0531T Removal of intracardiac ischemia monitoring system, including all imaging supervision and interpretation; electrode only 
  • 0532T Removal of intracardiac ischemia monitoring system, including all imaging supervision and interpretation; implantable monitor only 
  • 33289 Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed
  • 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
  • 33999 Unlisted procedure, cardiac surgery
  • 93050 Arterial pressure waveform analysis for assessment of central arterial pressures, includes obtaining waveform(s), digitization and application of nonlinear mathematical transformations to determine central arterial pressures and augmentation index, with interpretation and report, upper extremity artery, non-invasive 
  • 93264 Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days, including at least weekly downloads of pulmonary artery pressure recordings, interpretation(s), trend analysis, and report(s) by a physician or other qualified health care professional
  • 93799 Unlisted cardiovascular service or procedure [when specified as implantation of a wireless pressure sensor in the pulmonary artery]
  • C2624 Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components

 

Selected References:

  • Bisognano JD, Bakris G, Nadim MK et al. (2011) Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled rheos pivotal trial. Journal of the American College of Cardiology 58: 765-773
  • Bakris GL, Nadim MK, Haller H et al. (2012) Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. Journal of the American Society of Hypertension 6: 152-158
  • Food and Drug Administration (FDA). FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran). Safety Announcement. November 2, 2012.
  • Bai R, Horton RP, Di Biase L, et al. Intraprocedural and long-term incomplete occlusion of the left atrial appendage following placement of the WATCHMAN device: a single center experience. J Cardiovasc Electrophysiol. 2012;23(5):455-461.
  • Scheffers IJ, Kroon AA, Schmidli J et al. (2010) Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. Journal of the American College of Cardiology 56:1254-1258
  • Hoppe UC, Brandt MC, Wachter R et al. (2012) Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. Journal of the American Society of Hypertension 6: 270-276
  • Wallbach M, Lehnig LY, Schroer C et al. (2014) Effects of baroreflex activation therapy on arterial stiffness and central hemodynamics in patients with resistant hypertension. Journal of Hypertension 32, doi: 10.1097/HJH.0000000000000361
  • Illig KA, Levy M, Sanchez L et al. (2006) An implantable carotid sinus stimulator for drug-resistant hypertension: surgical technique and short-term outcome from the multicenter phase II Rheos feasibility trial. Journal of Vascular Surgery 44: 1213-1218
  • Jacobsen JH. Implantable carotid sinus baroreflex device for the treatment of drug-resistant hypertension. Health Policy Advisory Committee onTechnology, Technology Brief Update. Adelaide, South Australia: ASERNIP-S, July 2014
  • Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. 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. Erratum in: JAMA. 2015 Mar 10;313(10):1061.
  • Alli O, Doshi S, Kar S, Reddy V, Sievert H, Mullin C, Swarup V, Whisenant B, Holmes D Jr. 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. Doi: 10.1016/j.jacc.2013.01.061. Epub 2013 Feb 28.
  • Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. 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. Doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.
  • Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. 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. Doi: 10.1161/CIRCULATIONAHA.110.976449. Epub 2011 Jan 17.
  • Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a  andomized non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. Doi: 10.1016/S0140-6736(09)61343-X. Erratum in: Lancet. 2009 Nov 7;374(9701):1596.
  • Health Policy Advisory Committee on Technology Technology Brief Update Implantable carotid sinus baroreflex device for the treatment of drug-resistant hypertension July 2014 Daskalopoulou SS, Rabi DM, Zarnke KB, et al. The 2015 Canadian Hypertension Education Program recommendations for blood pressure measurement, diagnosis, assessment of risk, prevention, and treatment of hypertension. Can J Cardiol. 2015;31(5):549-568.
  • Verdejo et al. “Comparison of a Radiofrequency-Based Wireless Pressure Sensor to Swan-Ganz Catheter and Echocardiography for Ambulatory Assessment of Pulmonary Artery Pressure in Heart Failure.” Journal of the American College of Cardiology. 50 (25) (pp 2375-2382), 2007
  • Clinical Trials AngelMed for Early Recognition and Treatment of STEMI (ALERTS). (NCT00781118) (2012 May 23). U.S. National Institutes of Health
  • Agency for Healthcare Research and Quality (AHRQ). Remote cardiac monitoring. Technology Assessment. Prepared for the AHRQ by the ECRI Evidence-based Practice Center (EPC). Contract No. 290-02-0019. Rockville, MD: AHRQ; December 12, 2007 (archived). Accessed Dec 1, 2014. Available at URL address:
  • Saurav Chatterjee, MD1; Howard C. Herrmann, MD2; Robert L. Wilensky, MD2; John Hirshfeld, MD2; Daniel McCormick, DO2; David S. Frankel, MD2; Robert W. Yeh, MD, MSc3; Ehrin J. Armstrong, MD4; Dharam J. Kumbhani, MD, SM, MRCP5; Jay Giri, MD, MPH2 JAMA Intern Med. 2015;175(7):1104-1109. Doi:10.1001/jamainternmed.2015.1513.
  • U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness: Barostim neo® Legacy System. Humanitarian Device Exemption No. H130007. Rockville, MD: December 12, 2014.
  • Institute for Clinical Systems Improvement (ICSI). Hypertension diagnosis and treatment. ICSI Health Care Guideline. 2014. American Heart Association(AHA). Resistant hypertension: diagnosis, evaluation, and treatment: A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension 2008; 51(6):1403-1419
  • Yancy CW, Jessup M, Bozkurt B, et al.; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239.
  • U.S. National Institutes of Health (NIH), National Library of Medicine. Left atrial pressure monitoring to optimize heart failure therapy (LAPTOP-HF). Clinical Trials Identifier: NCT01121107. Bethesda, MD: NIH; updated: August 26, 2011.
  • Bui AL, Fonarow GC. Home monitoring for heart failure management. J Am Coll Cardiol. 2012;59(2):97-104.
  • Bourge RC, Abraham WT, Adamson PB et al. Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. Journal of the American College of Cardiology 2008; 51(11):1073-9.
  • Heist EK, Herre JM, Binkley PF, et al. Analysis of different device-based intrathoracic impedance vectors for detection of heart failure events (from the Detect Fluid Early from Intrathoracic Impedance Monitoring study). Am J Cardiol. Oct 15 2014;114(8):1249-1256.
  • Yancy CW, Jessup M, Bozkurt B, et al.; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239.
  • Mancia G, Fagard R, Narkiewicz K, et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J. 2013;34(28):2159-2219.
  • Center for Medicare and Medicaid Services (CMS) Proposed decision memo for percutaneous left atrial appendage (LAA) closure therapy (CAG-00445N).
  • David R. Holmes, Jr., MD∗; Saibal Kar, MD†; Matthew J. Price, MD‡; Brian Whisenant, MD§; Horst Sievert, MD‖; Shephal K. Doshi, MD¶; Kenneth Huber, MD#; Vivek Y. Reddy, MD∗∗ Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy. J Am Coll Cardiol. 2014;64(1):1-12. doi:10.1016/j.jacc.2014.04.029
  • AtritechEvaluation of the WATCHMAN LAA Closure Device in Patients with Atrial Fibrillation versus Long Term Warfarin Therapy (PREVAIL). National Library of Medicine (NLM) Identifier: NCT01182441. Updated October 18, 2012a. Clinical Trials [online database].
  • Atritech. Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE). National Library of Medicine (NLM) Identifier: NCT01196897. Updated August 1, 2012c. Clinical Trials [online database].
  • Matsuo Y, Sandri M, Mangner N et al. Interventional Closure of the Left Atrial Appendage for Stroke Prevention. Circ J 2014; 78(3):619-24 
  • Butler J, Fonarow GC, Gheorghiade M. Need for increased awareness and evidence-based therapies for patients hospitalized for heart failure. JAMA. 2013;310:2035–2036.
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  • Kapelios C, Kontogiannis C, Nanas Y, Aravantinos D, Vlaras E, Tachliabouris I, Marinakis S, Charitos C, Nanas JN, Malliaras K. Profound pressure unloading induced by a novel implantable counterpulsation assist device in a porcine model of acute heart failure. Eur J Heart Fail. 2015;17(Suppl 1):120.
  • Kapelios CJ, Terrovitis JV, Siskas P, Kontogiannis C, Repasos E, Nanas JN. Counterpulsation: a concept with a remarkable past, an established present and a challenging future. Int J Cardiol. 2014;172:318–325.
  • Borlaug BA, Colucci WS. Treatment and prognosis of heart failure with preserved ejection fraction. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed March 2017.
  • Wang JT, Frishman WH. Pulmonary pressure monitoring for patients with heart failure. Cardiol Rev. 2017;25(2):53-58.
  • Martinson M, et al. Pulmonary artery pressure-guided heart failure management: US cost-effectiveness analyses using results of the CHAMPION clinical trial. Eur J Heart Fail 2017 May;19(5):652-660.
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Policy History:

  • January 2019 - Annual Review, Policy Revised
  • January 2018 - Annual Review, Policy Revised
  • January 2017 - Annual Review, Policy Revised
  • September 2016 - Interim Review, Policy Revised
  • January 2016 - New policy, Policy implemented

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.