Medical Policy

 

Subject: Implantable Left Atrial Hemodynamic Monitor
Document #: SURG.00128 Publish Date:    10/17/2018
Status: Reviewed Last Review Date:    09/13/2018

Description/Scope

This document addresses implantable left atrial hemodynamic (LAH) monitors. 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 device or in combination with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).

Note: For information regarding other technologies for cardiac disease, see:

Position Statement

Investigational and Not Medically Necessary:

Left atrial hemodynamic monitoring utilizing implantable device (for example, HeartPOD™ System and Promote® LAP System) is considered investigational and not medically necessary for all indications.

Rationale

The Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) trial was a multicenter, prospective trial approved by the U.S. Food and Drug Administration (FDA) under an Investigational Devices Exemption (IDE) and by the institutional review boards associated with each center (Ritzema, 2010). The study enrolled 40 subjects with reduced or preserved left ventricular ejection fraction (LVEF) and history of class III or ambulatory class IV HF who were implanted with an LAP monitor (HeartPOD System, Abbott, formerly St. Jude Medical/Savacor, Inc., Abbott Park, IL) for ambulatory hemodynamic monitoring. A total of 43 devices were implanted into 40 subjects with a median follow-up of 25 months (ranging from 3-38 months). Primary safety endpoint measures were met at 6 weeks with all participants free of major adverse cardiac or neurological events; the 3-year survival rate for participants without decompensation was 61%, with decrease in episodes reported after the initial 3 months. During pressure guided therapy, the reported mean daily LAP fell from 17.6 mm Hg to 14.8 mm Hg during the initial 3 months (Ritzema, 2010). The author concluded that:

The small study size, lack of a randomized design with a concurrent control group, and observer bias from lack of blinding limit the ability to reach definitive conclusions about the safety and clinical effectiveness of this heart failure management strategy.

The Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF) trial is a Phase III ongoing study evaluating the safety and clinical effectiveness of an LAP management system in those with ischemic or non-ischemic cardiomyopathy, or with NYHA Class III HF. Participants are stratified based on EF and need for cardiac rhythm management (CRM) device therapy to either an implanted left atrial pressure sensor integrated daily by the recipient using a hand-held device that also provides physician directed prescriptions based on the LAP reading, or no sensor implant with a Patient Advisor Module (PAM) for medication reminders. Results from this trial are not yet available.

The 2017 American College of Cardiology/American Heart Association/Heart Failure Society of America Focused update of the 2013 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) Guideline for the Management of Heart Failure does not address use of these implantable devices (Yancy, 2017).

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.

Background/Overview

Description of Relevant Disease

According to the Centers for Disease Control and Prevention approximately 5.7 million Americans are currently diagnosed with HF, and more than 500,000 new cases are diagnosed each year (CDC, 2016). As a result of HF, the weakened heart muscle causes inadequate filling of the left ventricle, as well as a backflow of blood into the left atrium, both resulting in decreased cardiac output and increased symptoms for the afflicted individual. Symptoms can include shortness of breath, fatigue, swelling in the ankles, feet, legs, abdomen and veins in the neck. Currently there is no cure for HF; medical therapy includes a combination of diuretics, digoxin, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), beta-blockers, and aldosterone antagonists. Some individuals may remain symptomatic, despite medical therapy. Ongoing studies evaluate other treatment options to assist physicians in the medical management of individuals with severe heart failure.

HeartPOD System:

This device is indicated for individuals with ischemic or non-ischemic cardiomyopathy with systolic or diastolic dysfunction for at least 6 months or HF classified by NYHA Class III. The HeartPOD system is a stand-alone device for use in individuals not requiring ICD or CRT-D therapy, or who already received ICD or CRT-D therapy. The system monitors LAP with a permanently implantable sensor used in ambulatory individuals with heart failure (HF). These implanted intracardiac sensors allow the individual to directly monitor left atrial pressure, the intracardiac electrogram, and core body temperature. The implant's readings are communicated with a hand-held computer called a PAM. The information is used to adjust medications on a dose-by-dose basis according to the physician's prescriptive instructions. The HeartPOD System is not available for commercial use in the U.S. The FDA investigational device exemption (IDE) study enrollment was completed in 2016, the results of the HOMEOSTASIS trial using the HeartPOD system have not yet been published.

The Promote LAP System:

The Promote LAP System (St. Jude Medical, Inc., St. Paul, MN) is indicated for individuals with ischemic or non-ischemic cardiomyopathy and Class III HF. The Promote LAP system is a combination device for individuals who require ICD or CRT-D therapy in addition to LAP monitoring. This Promote LAP System is not available for commercial use in the U.S. Enrollment for an FDA IDE study was completed in 2016; study results have not been published.

Definitions

Cardiomyopathy: A disease in which the heart muscle becomes inflamed and doesn't work as well as it should; there are three main types of cardiomyopathy:

Congestive Heart failure (CHF), also referred to as Heart Failure (HF): A condition in which the heart no longer adequately functions as a pump. As blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the lungs and other organs.

Investigational Device Exemption (IDE): Allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.

Ischemic dilated cardiomyopathy (IDCM): Left ventricular systolic dysfunction (or disease of the heart muscle) associated with at least 75 percent narrowing of at least one of the three major coronary arteries (marked stenosis) or a documented history of myocardial infarction.

New York Heart Association (NYHA) definitions: The NYHA classification of heart failure is a 4-tier system that categorizes based on subjective impression of the degree of functional compromise. The four NYHA functional classes are as follows:

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

93799

Unlisted cardiovascular service or procedure [when specified as insertion of left atrial hemodynamic monitor]

 

 

ICD-10 Procedure

 

02H700Z-02H740Z

Insertion of pressure sensor monitoring device into left atrium [by approach; includes codes 02H700Z, 02H730Z, 02H740Z]

 

For the following codes when specified as left atrial monitoring

0JH600Z-0JH630Z

Insertion of hemodynamic monitoring device into chest subcutaneous tissue and fascia [by approach; includes codes 0JH600Z, 0JH630Z]

0JH800Z-0JH830Z

Insertion of hemodynamic monitoring device into abdomen subcutaneous tissue and fascia [by approach; includes codes 0JH800Z, 0JH830Z]

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Maurer MS, Adamson PB, Costanzo MR, et al. Rationale and design of the left atrial pressure monitoring to optimize heart failure therapy study (LAPTOP-HF). J Card Fail. 2015; 21(6):479-488.
  2. Ritzema J, Melton IC, Richards AM, et al. Direct left atrial pressure monitoring in ambulatory heart failure patients: initial experience with a new permanent implantable device. Circulation. 2007; 116(25):2952-2959.
  3. Ritzema J, Troughton R, Melton I, et al.; Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) Study Group. Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure. Circulation. 2010; 121(9):1086-1095.
  4. Troughton RW, Ritzema J, Eigler NL, et al. Direct left atrial pressure monitoring in severe heart failure: long-term sensor performance. J Cardiovasc Transl Res. 2011; 4(1):3-13.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Heart Failure Society of America. 2010 Comprehensive Heart Failure Practice Guideline. Evaluation and management of patients with acute decompensated heart failure: hemodynamic monitoring. Available at: http://www.hfsa.org/wp-content/uploads/2015/04/HFSA-2010-HF-Guidelines-Section-12.pdf. Accessed on August 1, 2018.
  2. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused Update Incorporated into the ACC/AHA 2005 Guideline Update for the diagnosis and management of Chronic Heart Failure in the Adult. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2009; 119(14):e391-479. Available at: http://circ.ahajournals.org/content/119/14/e391. Accessed on August 1, 2018.
  3. St. Jude Medical. Left atrial pressure monitoring to optimize heart failure therapy (LAPTOP-HF). NLM Identifier: NCT01121107. Last updated on May 31, 2016. Available at: https://clinicaltrials.gov/ct2/results?term=NCT01121107&Search=Search. Accessed on August 1, 2018.
  4. U.S. Food and Drug Administration. The Center for Devices and Radiological Health (CDRH). Investigational Devices Exemption (IDE). Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/
    default.htm
    . Accessed on August 1, 2018.
  5. Yancy CW, Jessup M, Boxkurt B, et al.; 2017 ACC/AHA/HFSA Focused update of the 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. 2017; 136:e137-161.
Websites for Additional Information
  1. American Heart Association. Available at: http://www.americanheart.org. Accessed on August 1, 2018.
  2. Centers for Disease Control and Prevention. Heart failure fact sheet. Last updated June 16, 2016. Available at: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm. Accessed on August 1, 2018.
Index

HeartPOD System
Left atrial hemodynamic (LAH) monitor
Left atrial pressure monitoring
Promote LAP System

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

Document History

Status

Date

Action

Reviewed

09/13/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Description, Rationale, References and Websites sections.

Reviewed

11/02/2017

MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale, Background, References, and Websites sections.  Updated Coding section with 01/01/2018 CPT changes; removed 0293T, 0294T deleted 12/31/2017.

Reviewed

11/03/2016

MPTAC review. Revised title: Implantable Left Atrial Hemodynamic Monitor. Updated Description, Rationale, Background, Definitions and Reference sections.

Reviewed

11/05/2015

MPTAC review. Updated Description, Rationale, References and Websites sections. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Updated Background and References.

Reviewed

11/14/2013

MPTAC review. No Change to Position Statement. Updated Rationale, Background, References and Websites.

Reviewed

11/08/2012

MPTAC review. Updated References and Websites.

New

11/17/2011

MPTAC review. Initial document development.