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Clinical Policy Bulletin:
Indirect Measurement of Left Ventricular Filling Pressure (LVFP): The VeriCor System
Number: 0704


Policy

Aetna considers indirect measurement of left ventricular filling pressure by computerized calibration of arterial waveform response to the Valsalva maneuver (e.g., the VeriCor® System) experimental and investigational because there is insufficient evidence on the clinical value of this measurement in the diagnosis and management of individuals with congestive heart failure or other indications.

See also CPB 0472 - Thoracic Electrical Bioimpedance for Cardiac Output Monitoring.



Background

Left ventricular end diastolic pressure (LVEDP), the pressure at the end of the filling phase of the heart, is elevated in congestive heart failure (CHF).  Measurement of LVEDP may be useful in the management of patients with CHF; however, it requires cardiac catheterization by (i) direct measurement via placement of a catheter in the left ventricle, or (ii) indirect measurement by placement of a catheter in the pulmonary artery to measure the pulmonary capillary wedge pressure (PCWP). 

The Vericor System (CVP Diagnostics, Boston, MA) involves the indirect measurement of left ventricular filling pressure (LVFP) by analysis of arterial waveform response to the Valsalva maneuver using a proprietary algorithm.  The Vericor System was cleared by the U.S. Food and Drug Administration based on a 510(k) premarket notification. 

To examine the relationship and the level of accuracy of a non-invasive system in directly determining LVEDP, Sharma et al (2002) assessed LVFP by measuring PCWP and LVEDP in 57 persons followed immediately by a Valsalva maneuver using the VeriCor System during elective right and left heart catheterization.  The VeriCor and PCWP measurements were then compared with results from the catheter-measured LVEDP.  VeriCor measurements correlated significantly with catheter-measured LVEDP (r = 0.86), comparable to the correlation of the PCWP with catheter-measured LVEDP (r = 0.81).  VeriCor measurements were within 4 mm Hg of direct LVEDP measurements 84 % of the time and within 6 mm Hg of these measurements 93 % of the time, whereas the corresponding values for PCWP were 41 % and 67 %, respectively.

According to the American College of Cardiology/American Heart Association (ACC/AHA) Practice Guidelines on Heart Failure (2001), the role of periodic invasive or non-invasive hemodynamic measurements in the management of heart failure remains uncertain.  The guidelines stated that, although hemodynamic measurements can be performed by non-invasive methods, these tests have not been shown to be more valuable than routine tests, including physical examination.  Moreover, it is not clear whether serial non-invasive hemodynamic measurements can be used to gauge the efficacy of treatment or to identify patients most likely to deteriorate symptomatically during long-term follow-up.

There is inadequate evidence of the clinical utility of these indirect measurements of LVFP by computerized calibration of the arterial waveform response to the Valsalva maneuver.  Clinical outcome studies published in the peer-reviewed medical literature are necessary to determine the value of this test in the clinical management of patients with CHF.

In a small, prospective study, Sharma and colleagues (2011) examined if non-invasive monitoring of LVEDP would reduce re-hospitalization rates in patients hospitalized for HF.  A total of 50 patients admitted for HF were randomized to management guided by daily non-invasive estimated LVEDP monitoring (group I, open) to a target LVEDP of less than 20 mm Hg or management based on clinical assessment alone without knowledge of the estimated LVEDP (group II, blinded).  Non-invasive estimated LVEDP was measured by the VeriCor monitor.  The primary endpoints were the reduction of estimated LVEDP at discharge and the HF re-hospitalization rate on follow-up.  Estimated LVEDP was significantly reduced at discharge in the open group compared with the blinded group (mean estimated LVEDP 19.7 +/- 1.3 mm Hg versus 25.6 +/- 1.5 mm Hg, respectively, p = 0.01).  The re-hospitalization rates for HF on follow-up were significantly improved in the open group compared with the blinded group (at 1 month: 0 % versus 25 %, respectively [p = 0.05]; at 3 months: 0 % versus 32 % [p = 0.01]; at 6 months: 4 % versus 36 % [p = 0.01]; at 1 year: 16 % versus 48 % [p = 0.03]).  The authors concluded that when HF is managed by clinical assessment only, estimated LVEDPs remain high at discharge, resulting in early and frequent re-hospitalization for HF.  Therapy guided by estimated LVEDP monitoring optimizes filling pressures and reduces HF re-hospitalization rates.  Findings of this small study need to be validated by well-designed studies.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
ICD-9 codes not covered for indications listed in the CPB:
428.0 - 429.9 Heart failure


The above policy is based on the following references:
  1. Sharma GV, Woods PA, Lambrew CT et al. Evaluation of a noninvasive system for determining left ventricular filling pressure. Arch Intern Med. 2002;162:2084-2088.
  2. Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation 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 (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). Bethesda, MD: American College of Cardiology (ACC); 2001. Available at: http://www.acc.org/clinical/guidelines/failure/hf_index.htm. Accessed March 7, 2005.
  3. Patterson RP, Zhang J. Impedance cardiographic measurement of the physiological response to the Valsalva manoeuvre. Med Biol Eng Comput. 2003;41(1):40-43.
  4. U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH). VeriCor. CVP Diagnostics, Inc. 510(k) No. K031327. Rockville, MD: FDA; June 7, 2004.
  5. CVP Diagnostics, Inc. VeriCor Monitor. Revolutionizing Heart Failure Care [website]. Boston, MA: CVP Diagnostics; 2010. Available at: http://www.cvpdiagnostics.com/. Accessed November 14, 2010.
  6. Sharma GV, Woods PA, Lindsey N, et al. Noninvasive monitoring of left ventricular end-diastolic pressure reduces rehospitalization rates in patients hospitalized for heart failure: A randomized controlled trial. J Card Fail. 2011;17(9):718-725.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna 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 Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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