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Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.
Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Dysfunctional Uterine Bleeding and Uterine Fibroids- Commercial Medical Management Guideline TITLE: Electrical Bioimpedance for Cardiac Output Measurement Authorized By: Medical Management Guideline Committee
Adoption Date: 10/14/09 Revision Date:
Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.
This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.
Member benefit coverage and limitations may vary based on the member’s benefit plan.
This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.
Coverage All reviewers must first identify member eligibility, any federal or state regulatory Electrical Bioimpedance for Cardiac Output Measurement - Commercial Medical Management Guideline requirements and the plan benefit coverage prior to use of this policy.
Coverage Rationale Electrical bioimpedance is unproven for the measurement of cardiac output.
Definitive patient selection criteria for the use of electrical bioimpedance have not been established for measurement of cardiac output, primarily due to inadequate evidence regarding the impact of cardiac output monitoring on patient management or clinical outcomes. Further research is needed to confirm whether electrical bioimpedance can supply similar information regarding cardiac function, as does thermodilution catheterization (TDC).
Also see related medical policy, Plethysmography.
Benefit Considerations When deciding coverage for electrical bioimpedance for cardiac output measurement for a person who has a life threatening health condition, refer to the enrollee-specific benefit document language for further information. In some benefit documents, coverage exists for promising but unproven services for persons with life-threatening conditions, under certain circumstances.
Regulatory Requirements U.S. Food and Drug Administration (FDA): A number of devices for bioimpedance measurement of cardiac output have been approved for marketing by the FDA as Class II devices. See the following web site for more information (use product code DSB). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed August 21, 2009.
Research Evidence Background Measurement of cardiac output is used as a way to evaluate global cardiac function, based on the assumption that cardiac output is directly related to cardiac workload. Changes in cardiac output may be used to identify a change in the hemodynamic status of a patient or to confirm the need for or the efficacy of treatment, and may be routinely monitored in critically ill patients or perioperatively in high-risk patients.
The gold standard for measuring cardiac output is thermodilution catheterization; however, this is an invasive technique that poses a risk to the patient. Transthoracic electric bioimpedance (TEB), also called impedance plethysmography or impedance cardiography (ICG), is a noninvasive method for measuring cardiac output. Bioimpedance is performed by applying a small electrical current to the chest, and through electrodes placed on the neck and sides. The pulsatile flow of blood causes fluctuations in the current, and the device calculates cardiac output from the impedance waveform. TEB is used in the management of several heart-related conditions, including congestive heart failure, pacemaker calibration and heart transplant.
Clinical Evidence The available studies provide a moderate level of evidence that, in properly selected patients, electrical bioimpedance devices can provide information about changes in cardiac output similar to that provided by invasive techniques, without the risks associated with arterial or cardiac catheterization. However, a number of factors can interfere with the accuracy of electrical bioimpedance measurements, and absolute values of cardiac output may not be accurate. Moreover, patient selection criteria have not been clearly defined for measurement of cardiac output using any method, invasive or noninvasive, and unanswered questions remain regarding the appropriate role for cardiac output measurement in patient management and its impact on clinical outcomes (Hayes 2003, updated 2008).
In a literature review on impedance cardiography (ICG) for cardiac output measurement, ECRI identified 3 randomized controlled trials (RCTs), 28 comparison studies and 23 case series. The most direct measure of the clinical value of ICG Electrical Bioimpedance for Cardiac Output Measurement - Commercial Medical Management Guideline would be a controlled trial (preferably randomized) comparing clinically important outcomes, such as increased survival time and improved health; patients managed with this technology; and patients managed with the current standard of care before this technology was introduced. Only two RCTs that reported clinical outcomes were identified in the search (Stout, 2006; Smith, 2006). Several other controlled trials or comparative studies concluded that impedance cardiography cardiac output closely correlates with standard invasive cardiac output techniques (Brown, 2005; Albert, 2004; Suttner, 2006; Shoemaker, 2006; Karakitsos, 2006). Much of the clinical evidence base on ICG consists of studies comparing ICG results with thermodilution results and looking for systematic errors in the ICG results. These types of studies do not include follow-up of patient management and health after the tests (ECRI, 2009).
A randomized controlled trial (RCT) was done to compare impedance cardiography with thermodilution. Length of stay was shorter in the impedance cardiography group and change in treatment occurred in 49% of patients in the impedance cardiography group as compared to 29% of patients in the thermodilution or control group. The investigators concluded that impedance cardiography enhances clinical assessment of cardiac output and improves care of hemodynamically compromised patients (Stout, 2006) In another RCT, 164 patients with uncontrolled hypertension were randomized to a standard group (n=95) or impedance cardiography group (n=69). Systolic blood pressure and diastolic blood pressure reductions were greater in the impedance cardiography group from baseline. The impedance cardiography group achieved goal blood pressure more frequently and a more aggressive blood pressure level more frequently. The investigators concluded that antihypertensive therapy guided by impedance cardiography is more effective than standard measurements (Smith, 2006) Peacock et al. (2006) evaluated the impact of impedance cardiography in 89 dyspneic patients. Physicians documented diagnosis and treatment plans before and after seeing impedance cardiography data. Impedance cardiography data changed the working diagnosis in 12 (13%) patients and medications administered in 35 (39%) patients. The investigators concluded that impedance cardiography data result in significant changes in diagnosis and therapeutic planning during the evaluation of dyspneic patients.
Two studies compared physician assessment of hemodynamic data to values obtained using impedance cardiography and concluded that impedance cardiography has potential benefit for the assessment of cardiac output (Van De Water, 2005;
Leslie et al. (2004) compared thoracic bioimpedance with thermodilution in patients with stable chronic heart failure. A total of 282 paired measurements of cardiac output from 11 patients were evaluated. The study showed a correlation between thoracic bioimpedance and thermodilution but also demonstrated a poor level of agreement. Thoracic bioimpedance underestimated cardiac output compared with thermodilution, and this was greater with higher cardiac outputs. The investigators indicated that the study did not support the use of thoracic bioimpedance as an alternative to thermodilution in patients with stable chronic heart failure.
Cotter et al. (2004) published a prospective double-blind comparison of a noninvasive, continuous whole-body bioimpedance system (NICO system) and thermodilution cardiac output determinations in 122 cardiac patients. The overall correlation between the whole-body bioimpedance system cardiac index and the thermodilution cardiac index was r=0.886. The authors concluded that whole-body bioimpedance measurements with the NICO system are accurate in a wide range of cardiac clinical situations.
A prospective study involving 53 ICU patients found that the latest impedance cardiography technology for determining cardiac output is less variable and more reproducible in an intrapatient sense than is thermodilution. Impedance cardiography is equivalent to the average accepted thermodilution cardiac output in post-coronary artery bypass graft patients and showed marked improvement in agreement with thermodilution cardiac output compared to measurements made using previous generation impedance cardiography cardiac output equations (Van De Water, 2003).
Electrical Bioimpedance for Cardiac Output Measurement - Commercial Medical Management Guideline Kaukinen, et al. (2003) reported on the compared values obtained by continuous cardiac output monitoring with wholebody impedance cardiography after coronary artery bypass grafting with values measured using the bolus and continuous thermodilution methods. This prospective study included 20 patients in a university hospital ICU. The authors found that agreement between whole-body impedance cardiography and bolus thermodilution is slightly inferior to that between the bolus and continuous thermodilution methods.
Findings of a study by Velmahos et al. (2000) indicate that while hemodynamic status can predict clinical outcomes in critically injured patients, there is no evidence that early interventions to improve hemodynamic values lead to better outcomes.
Raajmakers et al. (1999) performed a meta-analysis of 154 studies published prior to May 1997 comparing impedance cardiography with other tests for measuring cardiac output. The authors noted that differences between impedance cardiography and other methods cannot be assumed to represent errors in the impedance measurement because the applied reference method and patient characteristics demonstrated a significant influence on the correlation coefficient.
The authors indicated that great care should be used when impedance cardiography is applied to cardiac patients.
Professional Societies/Government Organizations American College of Cardiology (ACC)/American Heart Association (AHA) A guideline on diagnosing and managing heart failure in adults states that there is no established role for periodic invasive or noninvasive hemodynamic measurements in the management of patients with heart failure (Hunt, 2009).
European Society of Cardiology (ESC) The ESC guidelines for the diagnosis and treatment of acute and chronic heart failure do not specifically address electrical bioimpedance as a technique for diagnosing heart failure (ESC, 2008).
Heart Failure Society of America (HFSA) The HFSA practice guideline on heart failure does not specifically address electrical bioimpedance as a technique for diagnosing heart failure (HFSA, 2006).