Congestive Heart Failure Telemonitoring:

Aetna considers home congestive heart failure telemonitoring devices experimental and investigational because such devices have not been shown to improve clinical outcomes compared to standard methods of heart failure monitoring (e.g., use of a standard scale, recording of weights in a diary that is shared with the physician, etc.).

Invasive Congestive Heart Failure Monitoring:

Aetna considers implantable congestive heart failure monitors (e.g., the Chronicle IHM System) experimental and investigational because such devices have not been shown to improve clinical outcomes compared to standard methods of heart failure monitoring.

Self-Contained Pacemaker Monitors:

Aetna considers self-contained pacemaker monitors medically necessary for members with cardiac pacemakers.  These include the following types:

1. Audible/visible signal pacemaker monitors -- these devices produce an audible and visible signal that indicates the pacemaker rate. 
2. Digital electronic pacemaker monitors -- these devices provide the member with an instantaneous digital readout of his/her pacemaker pulse rate.

A specialized telephone attachment for trans-telephonic transmission of pacemaker monitoring results is also considered medically necessary.  The Pace Trac is an example of a pacemaker monitor currently on the market.

A pacemaker controls cardiac arrhythmias by repeated electrical stimulation of the heart.  Pacemaker monitoring equipment is needed to detect impending battery failure and to monitor the performance of the pacemaker.  The design of the self-contained pacemaker monitor makes it possible for the member to monitor his or her pacemaker periodically and minimizes the need for regular visits to the outpatient department of the provider.

Pulse Tachometers:

Note: Pulse tachometers (pulse rate monitors, heart rate monitors) do not meet Aetna’s definition of covered durable medical equipment (DME) in that they are not primarily medical in nature and are normally of use in the absence of illness or injury.  Examples of brand names of pulse tachometers include the Exersentry, the Insta-Pulse, and the MacLevy Omni Pulse.

Blood Pressure Monitors and Stethoscopes:

Notes: Home blood pressure monitors (sphygmomanometers, blood pressure cuffs) and stethoscopes do not meet Aetna’s definition of covered DME in that they may be of use in the absence of illness and injury.  Following Medicare rules, Aetna covers blood pressure monitors and stethoscopes only for members receiving hemodialysis or peritoneal dialysis in the home.  In addition, blood pressure cuffs are covered for members with hypertension in pregnancy and have a DME rider.

Aetna considers automated oscillometer blood pressure monitors (e.g., Dinamap, Omron, and the BpTRU) for home use experimental and investigational because they have not been demonstrated to provide better health outcomes than conventional blood pressure monitors (see background).

AngelMed Guardian Intracardiac Ischemia Monitoring Device

Aetna considers the AngelMed Guardian intracardiac ischemia monitoring device experimental and investigational because of insufficient evidence in the peer-reviewed literature.

See also CPB 0019 - Holter Monitors and CPB 0025 - Automated Ambulatory Blood Pressure Monitoring.

Congestive Heart Failure Telemonitoring:

Non-invasive telemonitoring for congestive heart failure involves the trans-telephonic transmission of weight, blood pressure (BP), heart rate (HR) and rhythm to a remote monitoring center.  The Trans-European Network-Home-Care Management System (TEN-HMS) study is a randomized controlled clinical trial comparing home telemonitoring (HTM) to nurse telephone support (NTS) and usual care (UC) for patients with heart failure who are at high-risk of hospitalization or death.  The study found that patients assigned to HTM did not have significantly fewer days dead or hospitalized (the primary study endpoint) than patients assigned to NTS or UC.  In this study, 426 patients recruited from hospitals in the Netherlands, the United Kingdom, and Germany with a recent (within the past 6 weeks) hospital admission for heart failure and left ventricular ejection fraction (LVEF) less than 40 % were assigned randomly to HTM, NTS, or UC in a 2:2:1 ratio.  Patients were taking at least 40 mg per day of furosemide or equivalent, and at least 1 marker of increased risk.  Home telemonitoring consisted of twice-daily patient self-measurement of weight, BP, HR, and rhythm with automated devices linked to a cardiology center.  The NTS consisted of specialist nurses who were available to patients by telephone.  Primary care physicians delivered UC.  The primary end point was days dead or hospitalized with NTS versus HTM at 240 days.  The investigators reported that, during 240 days of follow-up, there was no statistically significant difference in the days that were lost as the result of death or hospitalization for UC, NTS, and HTM.  The number of admissions and mortality were similar among patients randomly assigned to NTS or HTM, but the mean duration of admission was less in patients assigned to HTM.  The investigators concluded that “[f]urther investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure.”

Heart failure guidelines from the National Institute for Clinical Excellence (2003) stated that “[m]ore complex remote monitoring (such as telemonitoring) of patients with heart failure is in its infancy, but shows promise for the future.”

In a systematic review, Chaudhry et al (2007) examined the evidence on telemonitoring in patients with chronic heart failure.  Interventions included telephone-based symptom monitoring (n = 5), automated monitoring of signs and symptoms (n = 1), and automated physiologic monitoring (n = 1).  Two studies directly compared effectiveness of 2 or more forms of telemonitoring.  Study quality and intervention type varied considerably.  Six studies suggested reduction in all-cause and heart failure hospitalizations (14 % to 55 % and 29 % to 43 %, respectively) or mortality (40 % to 56 %) with telemonitoring.  Of the 3 negative studies, 2 enrolled low-risk patients and patients with access to high quality care, whereas 1 enrolled a very high-risk Hispanic population.  Studies comparing forms of telemonitoring demonstrated similar effectiveness.  However, intervention costs were higher with more complex  programs (8,383 dollars per patient per year) versus less complex programs (1,695 dollars per patient per year).  The authors concluded that the evidence base for telemonitoring in heart failure is currently quite limited.  Furthermore, an editorial published in the British Medical Journal (Grancelli and Ferrante, 2007), which addressed another systematic evidence review found similar results with simple telephone interventions compared to complex congestive heart failure telemonitoring.

Dang et al (2009) evaluated the evidence base for the use of home telehealth remote monitoring in elderly with congestive heart failure (CHF).  The search was restricted to randomized controlled trials using either automated monitoring of signs and symptoms or automated physiologic monitoring.  For this review, telephone-based monitoring of signs and symptoms was not considered remote monitoring.  Studies were also excluded if they did not present outcomes related to healthcare utilization.  A total of 9 studies met selection criteria, with interventions that varied greatly.  Four 3-arm studies directly compared the effectiveness of 2 different interventions to usual care.  Six of the 9 studies suggested a 27 % to 40 % reduction in overall admissions.  Two 2-arm studies demonstrated a 40 % to 46 % reduction in HF-related admissions while 2 other 3-arm studies showed similar trends; however, this was not statistically significant.  Three of 9 studies suggested a significant reduction in mortality (30 % to 67 %) and 3 studies showed significant reduction in healthcare utilization costs.  Two studies suggested a 53 % to 62 % reduction in bed days of care.  Two studies showed significant reduction in the number of Emergency Department visits.  Three 2-arm studies and 1 3-arm study demonstrated significant overall improvement in outcomes with use of telemonitoring.  Available data suggest that telemonitoring is a promising strategy.  The authors stated that more data are needed to determine the ideal patient population, technology, and parameters, frequency and duration of telemonitoring, and the exact combination of case management and close monitoring that would assure consistent and improved outcomes with cost reductions in CHF.

Mortara and co-workers (2009) assessed the feasibility of a new system of HTM. The HTM system was used to monitor clinical and physiological parameters, and its effectiveness (compared with usual care) in reducing cardiac events in heart failure (HF) patients was evaluated.  Measurements were patient-managed.  From 2002 to 2004, a total of 461 HF patients (age 60 +/- 11 years, New York Heart Association class 2.4 +/- 0.6, left ventricular ejection fraction 29 +/- 7 %) were enrolled at 11 centers and randomized (1:2) to either usual outpatient care or HTM administered as 3 randomized strategies: (i) monthly telephone contact; (ii) strategy 1 plus weekly transmission of vital signs; and (iii) strategy 2 plus monthly 24-hr recording of cardiorespiratory activity.  Patients completed 81 % of vital signs transmissions, as well as 92 % of cardio-respiratory recordings.  Over a 12-month follow-up, there was no significant effect of HTM in reducing bed-days occupancy for HF or cardiac death plus HF hospitalization.  Post-hoc analysis revealed a heterogeneous effect of HTM in the 3 countries (Italy, Poland, and the United Kingdom) with a trend towards a reduction of events in Italy.  The authors concluded that Home or Hospital in Heart Failure Study indicated that self-managed HTM of clinical and physiological parameters is feasible in HF patients, with surprisingly high compliance.  Whether HTM contributes to a reduction of cardiac events requires further investigation.

Schmidt and colleagues (2010) reviewed the current status of health services research on telemonitoring, focusing on patients with chronic CHF.  The Medline database was selectively searched for articles appearing from June 2001 to May 2008, with an emphasis on randomized, controlled trials.  The available scientific data on vital signs monitoring are limited, yet there is evidence for a positive effect on some clinical endpoints, particularly mortality.  However, any possible improvement of patient-reported outcomes, such as the quality of life, still remains to be demonstrated.  The authors concluded that these findings suggested that telemonitoring is effective, yet there is no evidence for superior outcomes with any particular model of care incorporating telemonitoring (i.e., monitoring of vital signs versus structured telephone monitoring).  A valid criticism is that the individual components of HTM have not yet been separately tested in order to compare their individual effects.

Polisena and associates (2010) conducted a systematic review of the literature about HTM compared with usual care.  An electronic literature search was conducted to identify studies of HTM use in CHF patients.  A total of 21 original studies on HTM for patients with CHF were included (n = 3,082).  A random effects model was used to compute treatment effectiveness to measure the average effect of the intervention across all studies where the quantitative pooling of results was appropriate.  Home telemonitoring reduced mortality (risk ratio = 0.64; 95 % confidence interval [CI]: 0.48 to 0.85) compared with usual care.  Several studies suggested that HTM also helped to lower the number of hospitalizations and the use of other health services.  Patient quality of life and satisfaction with HTM were similar or better than with usual care.  Moreover, the authors stated that more studies of higher methodological quality are needed to provide more precise information regarding the potential clinical effectiveness of home telehealth interventions.

Koehler et al (2011) examined if physician-led remote telemedical management (RTM) compared with usual care would result in reduced mortality in ambulatory patients with CHF.  A total of 710 stable CHF patients in New York Heart Association (NYHA) functional class II or III with a LVEF of less than or equal to 35 % and a history of HF decompensation within the previous 2 years or with a LVEF of less than or equal to 25 % were enrolled in this study.  Patients were randomly assigned (1:1) to RTM or usual care.  Remote telemedical management used portable devices for ECG, BP, and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers.  The primary end point was death from any cause.  The first secondary end point was a composite of cardiovascular death and hospitalization for HF.  Baseline characteristics were similar between the RTM (n = 354) and control (n = 356) groups.  Of the patients assigned to RTM, 287 (81 %) were at least 70 % compliant with daily data transfers and no break for greater than 30 days (except during hospitalizations).  The median follow-up was 26 months (minimum 12), and was 99.9 % complete.  Compared with usual care, RTM had no significant effect on all-cause mortality (hazard ratio, 0.97; 95 % CI: 0.67 to 1.41; p = 0.87) or on cardiovascular death or HF hospitalization (hazard ratio, 0.89; 95 % CI, 0.67 to 1.19; p = 0.44).  The authors concluded that in ambulatory patients with CHF, RTM compared with usual care was not associated with a reduction in all-cause mortality.

A systematic evidence review (Molloy, et al., 2012) examined interventions to enhance adherence to medications in patients with heart failure identified randomized controlled studies of intensified interventions. The review found that all of the six studies of intensified patient care that used direct patient contact intervention showed a significant positive effect on adherence. However, of the five studies of intensified patient  that used telephone or telemonitoring programs, only one led to increased adherence.

Invasive Congestive Heart Failure Monitoring:

Implantable hemodynamic monitoring devices have features that allow remote monitoring of hemodynamic data in patients with HF.  The Chronicle Implantable Hemodynamic Monitor (IHM) is approximately the size of a pacemaker.  The device consists of an implantable monitor and a transvenous lead carrying a pressure sensor.  The pressure-sensing lead continuously measures intra-cardiac pressure, body temperature, physical activity, and HR.  It contains integrated circuitry, a lithium silver vanadium oxide battery with an approximate life of 3 years, and a bi-directional telemetry transmission coil hermetically sealed in a titanium can.  The Chronicle IHM has an investigational device exemption in the United States, which allows use of the device in clinical trials.

Bourge et al (2008) reported on the outcomes of the COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) study, a randomized, single-blinded, multi-center controlled study of the Chronicle IHM in 274 persons with NYHA class III or IV CHF.  All study subjects had an emergency room visit or at least 1 prior HF-related hospitalization within 6 months of entering the study.  The 274 successfully implanted patients were randomized to receive either optimal medical care alone (n = 140) or optimal medical care guided by results from hemodynamic measurements provided by the Chronicle IHM (n = 134).  For the first 6 months, all IHM patients transmitted monitoring data weekly.  Physicians for the control group were blocked from receiving IHM data.  After 6 months, all physicians received IHM information for patient care.  The primary end point of the study was a statistically significant reduction in treatment events, as defined by hospitalizations for HF, or emergency or urgent care center visits requiring intravenous therapy.  Patients whose physicians had access to IHM data had 22 % lower HF-related events; however this difference in the primary study end point was not statistically significant (p = 0.33).  However, in the NYHA class III subgroup, there was a statistically significant 41 % reduction in the event rate for those patients whose physicians were accessing IHM data.  The class IV (severe) subgroup did worse than the control group.  The event rate over the course of the 6 months was 0.70 for IHM-monitored patients whose physicians could see the data, compared to 0.89 for the control group.  Patients whose physicians had access to IHM data also had 21 % fewer hospitalizations.  The relative risk of HF hospitalizations was 0.79 in the group with access to IHM data compared to the blocked access group, a difference that was statistically significant.  A retrospective analysis of the time to first HF hospitalization showed a 36 % reduction (p = 0.03) in the relative risk of a HF-related hospitalization in the IHM group.  In addition, the group whose physicians had access to IHM data had a 46 % increase in the proportion of patients who improved over the 6 months and a 34 % reduction in the proportion who worsened, compared to 35 % and 51 % in the control group, respectively.  Primary safety related study end points were met, including freedom from system-related complications and freedom from pressure-sensor failure.  System-related complications occurred in 8 % of the 277 patients who underwent implantation, and all but 4 complications were successfully resolved.  There were no pressure-sensor failures after 6 months.

The Canadian Agency for Drugs and Technologies in Health's assessment on implantable hemodynamic monitoring (the Chronicle IHM System) (Ho, 2008) stated that preliminary evidence from observational studies suggested a potential for reducing hospitalizations with the use of right ventricle implantable hemodynamic monitoring (IHM).  The assessment noted, however, although a multi-center, randomized controlled trial (COMPASS-HF) showed a reduction in hospitalizations in the IHM group, the results were not statistically significant and the U.S. FDA panel concluded the trial failed to meet its primary efficacy end point.  The assessment noted that, in the COMPASS-HF study, the most common device-related complication was lead dislodgement.  The report stated that large randomized controlled trials are needed to demonstrate the clinical utility of IHM, particularly in terms of its impact on reducing hospitalization and improving patient outcomes.

Automated Oscillometer Blood Pressure Monitors:

Barker et al (2000) stated that according to the criteria of the British Hypertension Society, neither the Dinamap 8100 nor the Omron M1 can be recommended for use in children in clinical situations in which accuracy of the absolute measurement is required.

Beaubien and colleagues (2002) reported that the Dinamap yields inaccurate estimates of both systolic and diastolic BP even under standardized, and thus optimal, conditions.  This inaccuracy is exaggerated at higher BP (over 160/90 mm Hg), although the number of measurements at higher pressures was small.  The authors recommended that this device not be used when accurate BP measurement is needed for therapeutic decision-making.

Chang and colleagues (2003) evaluated the variability in observed BP associated with use of the Dinamap monitor (Dinamap PRO 100) and estimated the contributions of various factors to that variability.  In 60 volunteers (30 aged 23 to 35 years and 30 aged 54 to 82 years), the authors obtained 30 simultaneous paired BP measurements in both arms at 1-min intervals.  Variability, defined as the between-arm difference in BP measurements, was analyzed using a mixed-effects linear regression model.  A total of 1,800 paired BP measurements were obtained.  These researchers found that only 50 % of paired simultaneous BP measurements obtained were in agreement within 4 mm Hg for systolic BP or within 3 mm Hg for diastolic BP.  Residual variability, attributable to the intrinsic inaccuracy of the device, accounted for 64 to 82 % of the total systolic and diastolic BP variability.  The majority of variability in BP measurement was due to the device as used under the study conditions.

Textor et al (2003) reported that 26 % (62 of 238) potential donors with excellent kidney function were mis-classified as hypertensive with clinic oscillometric measurements (Dinamap) alone.  Ramanathan et al (2003) claimed that there is no role for standard automated oscillometric devices (Dinamap) in the calculation of ankle-brachial pressure index in the vascular clinic.

Afzali et al (2004) examined if there are differences in BP measurements taken using either automated oscillometric machines (Dinamap BP8800 and Omron Hem 713) or a random zero Hawskley sphygmomanometer in stable healthy renal transplant outpatients.  These investigators concluded that there were no significant observer bias or cardiovascular artifacts.  Intra-machine variability was small.  Blood pressure measurements using Dinamap and Omron could lead to a difference of up to 30 mm Hg higher or 15 mm Hg lower than Hawskley random zero BP readings.  Though widely used for convenience, automated oscillometric measures of BP in the renal transplant clinic are not optimal.

Dannevig et al (2005) concluded that BP should preferably be measured invasively in severely ill neonates and preterm infants, being aware of pitfalls with measurements using different oscillometer monitors and the size/arm circumference of the infant.

The BpTRU™ is an automated device that takes serial BP measurements in a physician’s office.  The Canadian Agency for Drugs and Technologies in Health (Allison, 2006) stated that preliminary data from non-randomized, uncontrolled studies suggested that the average of 5 BP measurements by means of the BpTRU, taken while the patient is alone, more reliably reflects resting BP compared to standard manual measurements taken with a stethoscope and sphygmomanometer.  Moreover, the report noted that more controlled studies are needed to compare BpTRU measurements at specific interval settings to standard measurements taken by trained clinicians across a spectrum of patients.  This evidence is needed before specific recommendations can be made in guidelines regarding which BP monitor should be used preferentially in a physician’s office.

Fischell et al (2010) conducted the first clinical studies of intracardiac ST-segment monitoring in ambulatory humans.  The authors reported that intracardiac monitoring was performed in 37 patients at high risk for acute coronary syndromes and the implanted monitor continuously evaluated ST segments as sensed by a conventional pacemaker right ventricle apical lead.  Patients were alerted to detected ischemic events.  The patients were followed for a median of 1.52 years.  Four patients had ST segment changes of greater than or equal to 3 standard deviations of their normal daily range, in the absence of an elevated heart rate.  In combination with immediate hospital monitoring, the results led to angiogram and/or intravascular ultrasonographic confirmation of thrombotic coronary occlusion/ruptured plaque.  The authors concluded that shifts exceeding 3 standard deviations from a patient’s daily intracardiac ST-segment range may be a sensitive/specific marker for thrombotic coronary occlusion and that patient alerting was associated with a median alert-to-door time of 19.5 minutes for patients at high risk of recurrent coronary syndromes, who typically present with 2 to 3 hour delays.

The AngelMed Guardian is an implantable device which records cardiac data and detects ischemic events through use of a standard pacemaker intracardiac lead placed in the right ventricular apex.  The AngelMed Guardian detects acute ischemic events by analyzing ST-segment shifts, and if a shift is detected as greater than a heart rate-dependent programmable threshold, the device will generate an emergency alert signal.  As of 2009, the AngelMed Guardian had been implanted in 55 people in the United States and Brazil (Hopenfeld et al, 2009). 

The AngelMed Guardian remains an investigational device in the United States (AngelMed, 2012).  Currently, a prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery is underway.  Subjects are being recruited in to the AngelMed for Early Recognition and Treatment of STEMI (ALERTS) Study, which has an open-label, crossover design; the primary efficacy objective is to determine whether the Guardian System reduces the composite of cardiac or unexplained death, new Q-wave MI and time-to-door for a confirmed occlusive event at a medical facility (Angel Medical Systems, 2012).