Medical Policy

This document addresses the use of implantable devices for remote monitoring of heart failure.

Devices addressed in this document may include, but are not limited to, the following:

• Wireless implantable hemodynamic monitoring systems for ambulatory monitoring of heart failure (the CardioMEMS^™ HF System [St. Jude Medical Inc., Atlanta, GA]) and the Cordella^® PA Pressure Sensory System [Endotronix, Inc., Lisle, IN]).
• Implantable left atrial hemodynamic monitors for monitoring of heart failure (the HeartPOD™ System [Abbott Laboratories, Abbott Park, IL, formerly by St. Jude Medical/Savacor, Inc.], Promote^® LAP System [Abbott Laboratories, Abbott Park, IL, formerly by St. Jude Medical], and V-LAP™ System [Vectorious Medical Technologies, Tel Aviv, Israel]).
• Implantable inferior vena cava sensors that measure changes in vena cava dimensions or collapsibility as indicators of intravascular volume and congestion. (The NORM Sensor [Fire1, Dublin, Ireland]).

Note: Please see the following related document for additional information

• MED.00134 Non-invasive Cardiac Management and Monitoring Systems

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

Use of implantable hemodynamic or intravascular volume-monitoring devices for remote monitoring of heart failure is considered investigational and not medically necessary.

This document describes clinical studies and expert recommendations, and explains whether use of implantable devices for remote monitoring of heart failure is considered clinically appropriate. The following summary does not replace other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Implantable devices for remote monitoring in heart failure are small devices placed in the body to track pressure or fluid changes that may suggest heart failure is getting worse. Examples include pulmonary artery pressure (PAP, pressure in the main blood vessel from the heart to the lungs) sensors or sensors placed in the inferior vena cava, which is a large vein that carries blood back to the heart, and ambulatory left atrial pressure (LAP, pressure in one of the four chambers of the heart) monitors. These devices may help doctors watch for changes from home and may lower heart failure hospital stays in some studies. However, each option has advantages and disadvantages. Some studies showed better quality of life or fewer hospital visits, but the results have been mixed, and studies have not clearly shown that these devices help people live longer. These devices also require an implantation procedure and may lead to problems related to the device or procedure, including pain, bleeding, and infection. Some options have not been studied enough.

What the Studies Show

PAP sensors are devices implanted in the pulmonary artery to measure pressure in the blood vessels going from the heart to the lungs. Some studies found fewer heart failure hospital stays and better quality of life, but some studies did not consistently show better survival or clear improvement in major health outcomes. Risks include problems from the implant procedure or device, though some studies reported low rates of these events. Better studies are needed to know if this device improves health.

Studies suggest that these devices can measure LAP and send pressure information for monitoring. Some research on implantable pressure monitoring in people with heart failure has reported fewer hospital stays or improved survival.

The studies of LAP monitoring have important limitations. Some were small, did not compare the device with standard care, or did not randomly assign people to different treatment groups. One larger study of an LAP monitor was stopped early because of complications related to the implantation procedure. Studies of the V-LAP^™ System have mainly looked at technical issues, such as whether the device could be implanted, measure pressure, and send information.

Another type of sensor device can be placed in a large vein near the heart (inferior vena cava) to track fluid changes. Early studies showed that the device could collect data and appeared safe in a small number of people, but the studies were short in duration and did not show clear improvement in health outcomes. Better studies are needed to know if this device improves health. Risks include problems related to implantation, blood vessel injury, or clotting.

Is this Clinically Appropriate?

These devices are not considered clinically appropriate for routine use because available studies have not established consistent improvement in important health outcomes with acceptable certainty and procedural risk.

(Return to Description/Scope)

Summary

This document addresses the use of implantable devices for remote monitoring of heart failure. These may include an implantable wireless pulmonary artery pressure (PAP) monitoring system, a wireless implantable hemodynamic system for ambulatory monitoring of heart failure, and a sensor implanted into the inferior vena cava to track changes in intravascular fluid volume.

While some of these types of remote monitoring systems have U.S. Food and Drug Administration (FDA) approval or clearance, others do not. For the approved devices, the approval includes individuals with New York Heart Association (NYHA) class II and III disease and the clinical evidence remains mixed: some studies and registries report reductions in heart failure, related hospitalizations and improvements in quality of life but randomized controlled trials (RCTs) have not consistently demonstrated benefit on mortality or other meaningful clinical outcomes. Limitations include short follow-up, lack of blinding, reliance on surrogate endpoints, and uncertainty regarding performance in routine clinical practice. Current guidelines acknowledge the technology as promising but emphasize that additional high-quality, long-term randomized studies are needed to establish its role in standard heart failure management.

For example, the evidence supporting the use of implantable devices for ambulatory left atrial pressure (LAP) monitoring in heart failure remains preliminary. Initial first-in-human trials, such as the Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) trial, and early HeartPOD studies support feasibility but were limited by small participant pool sizes. A subsequent, larger randomized trial (LAPTOP-HF) was terminated early due to an excess of procedural complications, although preliminary data suggested fewer heart failure hospitalizations among successfully implanted participants. More recent evidence focuses on the V-LAP system, with several small, single-arm feasibility studies consistently demonstrating procedural safety and accurate LAP measurements; however, these studies lack randomized comparative outcomes and do not establish durable clinical benefit. Broader implantable hemodynamic monitoring evidence in heart failure with reduced ejection fraction (HFrEF), together with scientific-statement discussion of V-LAP, reinforces the biologic rationale for pressure-guided heart failure management; however, the available evidence still does not establish acceptable procedural safety and clinical efficacy of implantable LAP-guided therapy. Larger controlled LAP-specific studies are needed.

Because the evidence does not consistently establish improved net health outcomes with sufficient certainty, the use of implantable hemodynamic or intravascular volume-monitoring devices for remote management of heart failure is considered investigational and not medically necessary.

Discussion

Heart failure can be defined as when the heart is not pumping blood as well as it should. This leads to a decrease in delivering oxygen and nutrient-rich blood to the body’s cells. Symptoms can include fatigue and shortness of breath.

Standard workup for heart failure includes history and physical exam which can show clinical signs such as jugular venous distention and/or orthopnea. Laboratory testing may be done. Assays for B-type natriuretic peptide (BNP) or N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) are frequently used to establish the presence and severity of heart failure. Electrocardiography is a routine part of the evaluation of a person with heart failure. It provides information regarding heart rhythm, heart rate, and duration, cause, and prognosis of heart failure. Cardiac imaging also has a key role in the initial evaluation of individuals with suspected heart failure and, when indicated, in the serial assessment of those with heart failure. After a complete history and physical examination, a comprehensive transthoracic echocardiogram (TTE) is the most useful initial diagnostic test given the vast amount of diagnostic and prognostic information provided.

Description of Devices

In May 2014, the FDA initially approved the CardioMEMS HF System through the premarket approval (PMA) process. The system utilizes a pulmonary artery sensor device and is indicated for measuring PAP and heart rate. The CardioMEMS HF System allows the hemodynamic data to be transmitted wirelessly to clinical staff that are monitoring and managing heart failure, with the specific intent to reduce hospitalizations due to heart failure. Initially approval was for individuals who have undergone hospitalization for NYHA class III heart failure in the past year. In February 2022, FDA approval was expanded to include individuals with NYHA class II (early stage) heart failure. The system is contraindicated for individuals who are unable to take antiplatelet or anticoagulants for 1 month following the implantation procedure.

In 2024, the FDA issued a premarket approval for the Cordella Pulmonary Artery Sensor System. This system utilizes a wireless pressure sensor that is permanently implanted via a right heart catheterization surgical procedure for the purpose of cardiac hemodynamic monitoring of individuals with heart failure in a non-clinical outpatient setting. The FDA approval intends for the system to measure, record, and transmit PAP data from those individuals with NYHA class III heart failure who are also taking diuretics and guideline-directed medical therapy (GMDT).

The HeartPOD System is indicated for individuals with ischemic or non-ischemic cardiomyopathy with systolic or diastolic dysfunction for at least 6 months or heart failure classified by NYHA class III. The HeartPOD system is a stand-alone device for use in individuals who do not require implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) therapy, or who have already received ICD or CRT-D therapy. The system monitors LAP with a permanently implantable sensor used in ambulatory individuals with heart failure. These implanted intracardiac sensors allow the individual to directly monitor LAP, the intracardiac electrogram, and core body temperature. The implant's readings are communicated with a hand-held computer called a patient advisor module (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 Promote LAP System is indicated for individuals diagnosed with cardiomyopathy and class III heart failure. It is a combination device for individuals who require ICD or CRT-D therapy in addition to LAP monitoring. Enrollment for an FDA investigational device exemption (IDE) study was completed in 2016; study results remain unpublished. The Promote LAP System is not available for commercial use in the U.S.

The V-LAP System is an implanted device that is placed percutaneously across the inter-atrial septum and measures LAP. Individuals with heart failure may be monitored remotely through bidirectional communication with an external unit. Data from the device are transmitted to a PAM that provides the individual with specific instructions on changes that should be made to their heart failure therapy. The changes are based on the individual’s hemodynamic measurements and the physician directions. The goal of the device is to shift from crisis management to health maintenance by detecting an impending heart failure exacerbation (i.e., before the onset of symptoms) allowing for alterations in heart failure medications and thereby, avoiding complications. The V-LAP System is limited to clinical trial use in the U.S.

The NORM Sensor is placed in the inferior vena cava (a large vein near the heart) to monitor changes in inferior vena cava (IVC) area and collapsibility as indicators of intravascular volume or congestion. There is a belt worn by users a few minutes per day to capture data. The data is then transmitted to an app which allows both individuals and their care teams to access the data. The premise is to measure changes in the inferior vena cava and collapsibility to help anticipate when heart failure events might occur.

Studies for CardioMEMS

Abraham and colleagues (2011) evaluated individuals with NYHA class III heart failure, who had been hospitalized for heart failure at least once in the previous 12 months in a prospective, single-blinded, multi-center study known as the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA class III Heart Failure Patients) trial. After implantation of the pressure sensor, study participants (n=550) were randomized either to the treatment group that consisted of wireless PAP monitoring and standard of care (n=270) or into a control group that consisted of participants who received only standard of care (n=280); the control arm’s device measurements were not made available to investigators for monitoring and management. The primary outcome measure was the rate of hospitalization due to heart failure in the first 6 months following implantation with the device. Quality of life (QOL) measures were included as secondary outcomes. Additional safety outcomes included complications associated with the device or sensor, and pressure-sensor failures. Participants were trained to take daily PAP measurements at home and were blinded to their treatment group. Follow-up assessments were scheduled at 1, 3, and 6 months, and subsequently every 6 months afterward. Study results indicated a statistically significant 30% reduction in the primary outcome of hospital readmissions for heart failure at the 6-month follow-up in the treatment group compared with the control group (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.60 to 0.85; p=0.0002). Additionally, the length of hospital stay for heart failure-related admissions was significantly shorter in the treatment group compared with the control group (2.2 days compared with 3.8 days, respectively; p=0.02). The QOL score, using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score, was significantly improved in the treatment group compared with controls (p=0.02), when assessed at 6 months follow-up. A total of 15 adverse events occurred, 8 of which were considered complications related to the device or system (n=3 treatment group; n=3 control group; n=2 not enrolled). None of the 550 participants experienced sensor-related failures during the entire follow-up period (average of 15 months).

In 2015, Abraham and colleagues published follow-up data to the CHAMPION trial. After completion of the initial randomized access period (average of 18 months), investigators were granted access to PAP for participants in both study arms (open access period) for an average of an additional 13 months of follow-up. Over the randomized access period, the reduction in hospital admission rates related to heart failure were sustained, and found to be 33% lower in the treatment group compared to the control group (HR, 0.67, 95% CI, 0.55-0.80; p<0.0001). During the open access period, rates of hospital admission related to heart failure for the former control group were reduced by 48% (HR, 0.52, 95% CI, 0.40-0.69; p<0.0001) compared to admission rates during the random access period. Heart failure-related mortality and all-cause mortality were not significantly different between the two study arms during the random access period or the open access period. No additional device-related failures were reported.

Despite the early positive results of using the outpatient wireless pressure sensor device for heart failure management, the manufacturer-sponsored RCT was hampered by methodological weaknesses. The safety and durability of treatment effect are unknown since the study's follow-up period was limited to an average of 31 months (2.6 years). In addition, the primary outcome of 6-month hospital admission rates, while important, is a surrogate measure for more clinically meaningful outcomes, such as mortality data, which the device monitoring reportedly did not significantly impact. Well-designed RCTs with extended follow-up periods and morbidity and mortality primary outcome measures are necessary to establish the safety and efficacy of outpatient cardiac hemodynamic monitoring using a wireless pressure sensor for the routine management of heart failure.

Desai (2017) published a retrospective cohort study of Medicare administrative claims data for individuals who received the CardioMEMS device following FDA approval. Out of 1935 Medicare enrollees who underwent implantation of the device, there were 1114 who were continuously enrolled and had evaluable data for at least 6 months prior to, and following, implantation (a subset of 480 enrollees had complete data for 12 months before and after implantation). There were 1020 heart failure-related hospitalizations in the 6 months before implantation, relative to 381 hospitalizations in addition to 17 ventricular assisted device (VAD) implantations or transplants, and 139 deaths in the 6-month post implantation follow-up period. The cumulative incidence of heart failure-related hospitalization was significantly lower than in the 6 months prior to implantation (HR, 0.55; 95% CI, 0.49-0.61; p<0.001). Similarly, amongst the 480 individuals with 12-month follow-up data, there were 696 heart failure-related hospitalizations in the 12 months prior to implantation, compared to 300 heart failure-related hospitalizations following implantation. There were also 15 VAD implantations or transplants, and 106 deaths. The cumulative incidence of heart failure-related hospitalizations was also significantly lower in the 12-month post implantation cohort (HR, 0.66; 95% CI, 0.57-0.76; p<0.001). Despite the trial’s positive outcomes, claims data limitations include that it is not possible to rule out confounding due to medication changes/adjustments, or correlate outcomes to direct intervention based on PAP data. The primary outcome, reduction in heart failure-related hospitalizations, may be related to the device or simply the amplified touchpoints with the healthcare system necessitated by the device’s implantation, and the limited follow-up period in addition to the lack of a control cohort leave the safety and efficacy of the CardioMEMS device still uncertain.

In 2017, Heywood and colleagues published retrospective data from a de-identified cohort of the first 2000 individuals who received the CardioMEMS device and had available follow-up data for a minimum of 6 months (general-use cohort). The primary outcome of interest was trends in remotely monitored PAPs. The mean age of the cohort enrolled was 70 years (standard deviation [SD], 12 years) and the mean follow-up period was 333 days (SD, 125 days). Relative to the previously described CHAMPION clinical trial, the general-use cohort in this study had a trend of a higher baseline mean arterial pressure (34.9 ± 10.2 mm Hg vs. 31.6 ± 10.7 mm Hg for the CHAMPION cohort; p<0.05). The PAP reductions in the general-use cohort from this study were significantly higher compared with the CHAMPION trial treatment cohort (p-value unreported) which had an area under the curve (AUC) of -150.1 mm Hg-days after 6 months of pressure-guided care whereas the general-use cohort had an AUC of -434 mm Hg-days after 6 months and mean PAP was reduced from 34.9 ± 10.2 to 31.6 ± 10.4 mm Hg after 6 months (p<0.0001). In this ‘real-world’ cohort, there was a median of 1.2 days between remote pressure transmissions and > 98% weekly use of the system, demonstrating a high-level of adherence. However, similar to the limitations cited in the CHAMPION trial, safety and efficacy conclusions are precluded by the lack of both clinically meaningful data and long-term follow-up. Further, the registry data of this study cannot rule out medication changes/adjustments as a potential confounding variable.

Shavelle and colleagues (2020) conducted a multi-center, prospective, open-label observational CardioMEMS Post-Approval Study which enrolled 1200 participants with NYHA class III heart failure and at least 1 heart failure-related hospitalization within the preceding year. At 12 months, 875 participants remained in the study. The study particularly focused on subgroups defined by sex, race and ejection fraction. The primary efficacy outcome was the difference between rates of hospitalization compared to the year prior. The rate of heart failure-related hospitalization was significantly lower at 1 year compared with the year before implantation (0.54 [628 hospitalizations] vs. 1.25 [1600 hospitalizations] events/participant-years; HR, 0.43; 95% CI, 0.39-0.47; p<0.0001). At 1 year post-implant, survival was 83.9% (95% CI, 81.7-85.8%). During the study period there were 5 (0.4%) device- or system-related complications and 1 (0.1%) pressure sensor failure. The significance of primary outcomes was robust across subgroups of gender, race and those with cardiac defibrillator devices. Study limitations include short-term follow-up and single arm, observational design. Additionally, the data source for heart failure-related hospitalizations was by self-report for the year prior to the study’s commencement, which introduces potential bias into the study’s primary efficacy outcome.

In 2020, Angermann and colleagues evaluated the safety and efficacy of the CardioMEMS in Germany, The Netherlands and Ireland to characterize the device’s performance outside of the U.S. A total of 234 individuals with NYHA class III heart failure were enrolled from 31 centers, implanted with a CardioMEMS sensor and received remote PAP-guided heart failure management. Enrollment criteria included a minimum of one heart failure-related hospitalization in the previous year. At study-end (12 months) 180 study participants remained and the study’s co-primary endpoints, device- or system-related complications and pressure sensor failure, occurred in 4 of 239 (98.3% complication free), and 1 of 234 (99.6% failure free) study participants, respectively. At 12 months, 91 study participants experienced at least 1 heart failure-related hospitalization which was a 62% decrease from the year prior (0.60 vs. 1.55 events/participant-year; HR, 0.38, 95% CI, 0.31-0.48; p<0.0001). The NYHA class improved in 35.5% of the study cohort (83 study participants) and worsened to NYHA class IV in 1.7% (4 participants) by study end. PAP decreased progressively over the course of the study. A total of 21 serious adverse events were reported during implant attempts. By study end, 31(13.8%) participants died; none were considered device, system, or protocol-procedure related. Authors concluded that remote management of heart failure using the CardioMEMS device was both safe and feasible in the health systems studied outside the U.S. Study limitations include short-term follow-up, single arm, observational design and results are not generalizable to the device’s performance within the U.S.

In 2021, Brinkley and colleagues conducted a post-hoc analysis of the CardioMEMS Post-Approval Study (see Shavelle and colleagues [2020] described above). The Brinkley study’s primary aim was to determine the impact of obesity on the safety and efficacy of CardioMEMS. At baseline, pulmonary artery diastolic pressure was higher in participants with BMI ≥ 35 kg/m² (n=358) regardless of ejection fraction. In both the obese and non-obese cohort, PAPs were significantly reduced at 12 months (p<0.0001). Heart failure-hospitalization rates were significantly reduced by > 50%: EF < 40% (BMI <35 kg/m² [HR, 0.48; 95% CI: 0.41-0.55] and ≥ 35 kg/m² [HR: 0.40; 95% CI: 0.31-0.53]) and EF ≥ 40% (BMI < 35 kg/m² [HR, 0.42; 95% CI, 0.35-0.52] and ≥ 35 kg/m² [HR, 0.34; 95% CI, 0.25-0.45]; p<0.0001). Although obesity did not appear to detrimentally affect performance of CardioMEMS relative to normal weight participants, the trial did not compare clinically relevant outcomes of CardioMEMS to standard medical care and follow-up was limited to 12 months.

In 2021, DeFelippis and colleagues conducted a post-hoc analysis of the CardioMEMS Post-Approval Study (see Shavelle and colleagues [2020] described above). The DeFelippis study’s primary objective was to examine potential gender differences in efficacy and safety of CardioMEMS. Women comprised 38% (n=452) of the study sample and were less likely to be White than men (78% of women vs. 86% of men) and more likely to have nonischemic cardiomyopathy (44% of women vs. 34% of men) and had significantly higher systolic blood pressure. Reductions in PAPA from baseline to 12 months in both men and women were similar. Both sexes experienced significant decreases in hospital-related heart failure over 12 months. There were no significant differences in change in hospital-related heart failure between men and women or all-cause mortality at 1 year. The study did not detect any efficacy or safety variations between men and women in CardioMEMS HF remote monitoring. This study shares the limitations of the CardioMEMS Post-Approval Study in that it was only 12 months in duration and did not compare this monitoring to standard medical care.

In 2021, Lindenfeld and colleagues published results from the randomized arm of the Hemodynamic-Guided Management of Heart Failure (GUIDE-HF IDE) trial (n=1000). An observational arm of the study is ongoing (n=2600). All participants in the randomized arm received CardioMEMS PAP sensor implants. Participants were then randomly assigned 1:1 to the treatment group or the control group. The treatment group received PAP-guided management and standard-of-care guideline recommended medical therapy. The control group received standard-of-care guideline directed medical therapy (GDMT) alone. The primary endpoint was a composite score of all-cause mortality and total heart failure events (heart failure hospitalizations and urgent heart failure hospital visits) at 12 months. At the randomized study’s end, there were 253 primary endpoint events among 497 participants in the treatment group and 289 out of 503 in the control group (HR, 0.88; 95% CI, 0.74-1.05; p=0.16). There was no statistically significant difference in the composite measure or in any of its components (hospitalization rate, urgent heart failure visits, mortality). Approximately 1% of those enrolled experienced device or system-related complications. All participants received an implant, and similar complication rates were seen in the treatment and control groups. The COVID-19 pandemic became a declared national emergency in the U.S. on March 13, 2020. At that time, there were 177 primary events in the intervention group and 224 events in the control group (HR, 0.81; 95% CI, 0.66-1.00; p=0.049). This statistically significant difference was due to fewer heart failure hospitalizations in the treatment group than in the control group. The rates for urgent heart failure visits and mortality were not statistically different. This difference in primary events almost disappeared during the COVID-19 pandemic and hospitalization rates decreased from a broad range of conditions. Consistent with that phenomenon, there was a 21% decrease in the control group hospitalization rate following the onset of the national emergency; conversely, the hospitalization rate for the treatment group was slightly lower, but not statistically significant. The between-group difference for heart failure hospitalization was not statistically significant after the declaration of the pandemic emergency (HR, 1.11; 95% CI, 0.80-1.55; p=0.53). Although the post-hoc analysis of pre-COVID-19 impact warrants further investigation, the a priori outcomes from the randomized arm of the GUIDE-HF trial did not demonstrate improved health outcomes from the use of hemodynamic-guided management for heart failure.

In 2022, Cowie and colleagues conducted a prospective, multicenter, open-label, post-market study to evaluate the safety, effectiveness, and feasibility of CardioMEMS in individuals with NYHA class III symptoms and a previous heart failure hospitalization (n=100). The primary endpoint was heart failure hospitalization rates 1 year post initiation of remote heart failure management relative to the year prior. Safety outcomes were evaluated at 2 years post initiation of device monitoring. At 1 year post device implantation, the annualized heart failure hospitalization rate was 82% lower (95% CI, 72-88%) than the previous 12 months (0.27 vs. 1.52 events/subject-year, respectively, p<0.0001). At 2 years, device/system-related complications and pressure sensor failure were 0% and 1%, respectively. Authors concluded that, “Hemodynamic-guided HF management was safe and significantly reduced hospitalization in a group of high-risk patients.” Confirmation is warranted in the setting of a randomized control trial with longer-term follow-up. Participants in this study did not have a period of GDMT prior to device implantation. Neither the participants nor their evaluators were blinded. It is possible that either or both factors influenced the observed difference in hospitalization rates. The design of the study does not permit reasonable conclusions about the effects of invasive monitoring relative to standard medical care.

In 2023, Burgts and colleagues published results of an open-label RCT, MONITOR-HF, conducted across 25 sites throughout the Netherlands. Eligible study participants had chronic, NYHA class III heart failure and a previous heart failure -related hospitalization. The study’s primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score at 12 months. Participants were randomly assigned in a 1:1 fashion to implantation and monitoring via CardioMEMS-HF (n=176) or standard care (n=172). Follow-up time-points were scheduled at 3 months, 6 months, and every 6 months thereafter, up to 48 months. Study participants median age was 69 years and median ejection fraction was 30% (range, 23-40). At 12 months, the KCCQ summary score was 7.13 (95% CI, 1.51-12·75; p=0.013) between groups (+7.05 in the CardioMEMS group, p=0.001, and -0.08 in the standard care group, p=0.97). Heart failure-related hospitalizations were significantly less likely in the CardioMems group (n=117) compared to the standard of care group (n=212) (HR, 0.56; 95% CI, 0.38-0.84; p=0.005). While the QOL measure and heart failure-related hospitalization favored the CardioMEMS group, remote monitoring did not affect cardiac-related mortality nor all-cause mortality. Freedom from device-related complications and sensor failure were 97.7% and 98.8%, respectively. In the Netherlands, in individuals with moderate-to-severe heart failure, hemodynamic monitoring improved subjective QOL relative to those receiving routine care; however, given the lack of blinding in this study design, study bias cannot be ruled out. Post-hoc analyses are subject to the same possibility of bias (Clephas, 2024). Further investigation is warranted.

In 2023, Heywood and colleagues published results of the previously described CardioMems post-approval study (Shavelle, 2020) through 2 years of follow-up. Of the originally enrolled 1200 participants with NYHA Class III symptoms, 710 (59%) completed the 2-year follow-up with 684 showing up for the final visit (57%). Individuals who completed the 2-year follow-up showed a sustained, but modest reduction in PA diastolic pressure (23.9 to 20.8 mmHg). The heart failure hospitalization rate was 0.37 at 2 years, with 59% of participants free of heart failure hospitalization during follow-up. Freedom from device- or system-related complications at 2 years and freedom from pressure-sensor failure at 2 years were both above 99%. The single-arm, observational design and limited follow-up period in this post-approval study, remain as significant limitations in the validity of outcomes for an implanted device.

In 2024, de Groote and colleagues reported outcomes from the French COAST cohort, a prospective, open-label, multicenter study conducted at 12 sites that implanted the CardioMEMS HF System in individuals with NYHA class III heart failure and ≥ 1 heart-failure admission in the prior year (n=103). Over 2 years, freedom from device- or system-related complications and from pressure-sensor failure was 100%, and a pre-specified effectiveness analysis comparing the year after implantation with the year before showed a 50.3% reduction in heart-failure hospitalizations (Rate Ratio, 0.50, 95% CI, 0.38-0.66). Hemodynamics and clinical status moved in the same direction: mean pulmonary-artery pressure declined (−3.7 ± 6.3 mmHg), NYHA class improved in a substantial proportion, and health-related quality of life measured by the EQ-5D-5L questionnaire increased. As a single-arm, open-label, pre-post study using each enrollee’s prior year as the comparator, findings may be influenced by care intensification and other temporal factors.

In 2023, Iaconelli and colleagues conducted a meta-analysis of both pre-print and published RCTs (four trials in total). Outcomes of interest included heart failure-related hospitalization and all-cause mortality. Hemodynamic monitoring resulted in only a small reduction in mean PAP (< 1 mmHg as a daily average), marginally significant reductions in heart failure-related hospitalizations (HR, 0.75; 95% CI 0.58-0.96; p=0.03) and no difference in mortality (Relative Risk [RR], 0.92; 95% CI, 0.68-1.26; p=0.48). The authors conclude:

Haemodynamic monitoring for patients with heart failure may reduce the risk of hospitalization for heart failure but this has not yet translated into a reduction in mortality, perhaps because the duration of trials was too short or the reduction in pulmonary artery pressure was not sufficiently large.

Additional meta-analyses similarly conclude, while continuous PAP monitoring may impact hospitalization rates, a significant reduction in mortality remains to be demonstrated (Lindenfeld, 2024; Urban, 2024).

In 2021, the European Society for Cardiology (ESC) published guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure (McDonagh, 2021). In the guidelines, wireless management in the outpatient setting are addressed:

Many implanted therapeutic devices can provide, wirelessly and remotely, information either on the device itself (generator and lead function), arrhythmias, or on patient physiology (heart rate, activity, heart sounds, bio-impedance). There is strong evidence that monitoring can detect device malfunction earlier than by conventional monitoring and that it may be useful for detecting arrhythmias such as AF. However, there is little evidence that device monitoring reduces admissions for HF or mortality

Wireless monitoring of PAP was given a IIb, B graded recommendation by the ESC (IIb: “Usefulness/efficacy is less well established by evidence/opinion”; B: “Recommendation is based on data derived from a single RCT or large, non-randomized studies”) (McDonagh, 2021).

In 2022, the ACC/AHA published guidelines on the Management of Heart Failure (Heidenrich, 2022) in which the following recommendations were made:

1. In selected adult patients with NYHA class III HF and history of a HF hospitalization in the past year or elevated natriuretic peptide levels, on maximally tolerated stable doses of GDMT with optimal device therapy, the usefulness of wireless monitoring of PA pressure by an implanted hemodynamic monitor to reduce the risk of subsequent HF hospitalizations is uncertain.
2. In patients with NYHA class III HF with a HF hospitalization within the previous year, wireless monitoring of the PA pressure by an implanted hemodynamic monitor provides uncertain value

In 2023, the ESC published a focused update to their aforementioned guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. In the guideline, class I recommendations for pre-discharge and early post-discharge follow-up of individuals hospitalized diagnosed with heart failure are listed, wireless monitoring of the PAP by an implanted hemodynamic monitor is not mentioned (McDonagh, 2023).

Systematic reviews and meta-analyses of implantable pulmonary artery pressure monitoring collectively suggest that pulmonary artery pressure functions as a dynamic prognostic biomarker, baseline values and early changes are associated with subsequent all-cause mortality, and that hemodynamic-guided care is linked to fewer heart-failure hospitalizations and improved health status, reinforcing the rationale for pulmonary artery-guided management (Kapelios, 2025; Zile, 2025). However, these conclusions rest largely on single-arm or post-hoc analyses with limited follow-up, heterogeneous care protocols, and reliance on surrogate outcomes. Randomized trials have not demonstrated a mortality benefit to date, which is consistent with previously described limitations of the primary literature on remote implantable PAP monitoring devices.

Studies for Cordella PA Sensor

In 2024, Guichard and colleagues reported results from the PROACTIVE-HF trial, a prospective, multicenter, open-label, single-arm trial conducted at 75 U.S./E.U. sites to evaluate seated mean pulmonary artery pressure (mPAP)-guided management using the Cordella PA Sensor in individuals with NYHA class III heart failure and recent heart-failure hospitalization and/or elevated natriuretic peptides. Among the modified intention-to-treat cohort successfully implanted (n=456), the prespecified primary effectiveness endpoint (a 6-month rate of heart-failure hospitalization or all-cause mortality below a performance goal of 0.43 events/participant) was met (observed 0.15; 95% CI, 0.12-0.20; p<0.0001 vs performance goal). Primary safety endpoints at 6 months were also met (freedom from device/system-related complications 99.2%; freedom from pressure-sensor failure 99.8%). Authors concluded that seated mPAP-guided remote management is safe and associated with low event rates; interpretation is limited by the single-arm design, reliance on a performance-goal comparator rather than randomization, and potential temporal/confounding effects over the 2020-2023 enrollment window.

Studies for HeartPOD

The HOMEOSTASIS trial was a multicenter, prospective trial approved by the FDA under the Investigational Devices Exemption (IDE) (Ritzema, 2007). This was the first-in-human trial of the HeartPOD System. The purpose was to evaluate the device’s safety, reliability, and functionality. Individuals with a history of NYHA functional class III to IV heart failure and at least one hospital admission, emergency department, or clinic visit for acute decompensated heart failure requiring a parenteral diuretic, vasodilator, or positive inotrope during the previous 12 months were eligible to participate. After device implantation, participants had clinic visits at 2, 6, and 12 weeks for a clinical assessment, data retrieval, and noninvasive device calibration. Concordance between pulmonary capillary wedge pressure (PCWP) and direct LAP from the device was assessed at week 12. A total of 8 individuals participated, and none experienced procedural complications. At week 12, 87% of HeartPOD LAP measurements were within ± 5 mm Hg of PCWP, and there were no device-related complications or deaths, unplanned clinic visits, or hospital admissions for heart failure. The investigators concluded that HeartPOD could be safely implanted and accurately measures LAP in the short term. They also stated that additional research is needed to determine whether direct LAP measurement can result in optimized heart failure treatment and thereby, improve clinical outcomes.

In 2010, Ritzema and colleagues reported additional results from the HOMEOSTASIS trial. This report included a total of 40 participants who were implanted with the HeartPOD System and had 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 a 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. The authors 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 2022 AHA/ACC/HFSA guideline for the Management of Heart Failure does not address the use of implantable LAP devices (Heidenreich, 2022). A scientific statement from the Heart Failure Society of America (HFSA) and the American Association of Heart Failure Nurses (AAHFN) discusses implantable digital health technologies for heart failure remote monitoring and notes that V-LAP measures left atrial pressure through a transseptal sensor. The statement cites reduced heart failure hospitalizations in the LAPTOP-HF experience but also notes early trial termination because of procedural complications. Thus, the statement establishes V-LAP as a relevant investigational implantable monitoring technology, but it does not provide a graded recommendation for routine clinical use (Cajita, 2026).

The HFSA Scientific Statements Committee published a white paper consensus statement on Remote Monitoring of Patients with Heart Failure (Dickinson, 2018). It included an assessment of the LAPTOP-HF trial, which was a prospective, multicenter, randomized, unblinded trial of individuals who had been diagnosed with NYHA class III heart failure (Maurer, 2015). Participants were randomized to LAP-guided HF therapy (treatment group) or heart failure usual standard of care (control group). The primary endpoints assessed safety and effectiveness. The safety assessment included freedom from procedure/device-related major adverse cardiovascular and neurological events (MACNE) at 12 months. The effectiveness assessment included a composite endpoint of heart failure hospitalizations and complications of heart failure therapy over the entire study period. Preliminary results were presented at the 2016 Annual Scientific Meeting of the Heart Failure Society. The investigators reported that the planned enrollment was 730 individuals however, at 486 individuals, the trial was stopped by the Data and Safety Monitoring Board due to an excess of complications from the implantation procedure. In the absence of peer-reviewed data from a completed trial, the authors of this white paper concluded that:

• The LAPTOP-HF trial of a left atrial pressure monitor failed owing to an excess of complications from the implantation procedure.
• Limited data from the trial suggest that the hemodynamic monitoring and associated management algorithm for patient-directed therapy adjustments could have been effective.

However, after enrollment was terminated, the LAPTOP-HF trial’s steering committee recommended that all randomized individuals who were implanted successfully should be followed for at least 12 months. At the 2016 Annual Scientific Meeting of the Heart Failure Society, the preliminary results reported by Abraham and colleagues (2016) showed that freedom from MACNE at 12 months was 90.6% in the LAP-guided heart failure therapy group, with a lower CI of 86.7% (the prespecified level was 80%). The annual heart failure hospital rate for the LAP-guided heart failure therapy group was 0.40 compared to. 0.68 in the control group, which represented a relative risk reduction of 41% (p=0.005). The investigators concluded that ambulatory LAP-guided heart failure therapy was safe and associated with a 41% reduction in heart failure hospital admissions, and that this data provides insight into the potential benefits of hemodynamic monitoring. Additional randomized trials are needed to assess the safety and efficacy of this technology.

Lindenfeld and colleagues (2024) published a patient-level pooled meta-analysis of three randomized implantable hemodynamic monitoring trials in HFrEF: GUIDE-HF, CHAMPION, and LAPTOP-HF. GUIDE-HF and CHAMPION evaluated PAP monitoring, while LAPTOP-HF evaluated LAP monitoring with HeartPOD and a Patient Advisory Module. Across 1350 participants with HFrEF, implantable hemodynamic monitoring-guided management was associated with reduced all-cause mortality and heart failure hospitalizations. In the LAPTOP-HF component, heart failure hospitalizations were reduced at 12 months and mortality was reduced at 24 months. However, the authors noted important limitations, including different hemodynamic measures across trials, single-blinding in GUIDE-HF and CHAMPION but unblinded treatment in LAPTOP-HF, early termination of LAPTOP-HF, shorter GUIDE-HF follow-up, and differences in contemporary GDMT. These findings strengthen the rationale for pressure-guided heart failure management, but do not resolve whether implantable LAP monitoring independently improves outcomes with acceptable procedural safety in adequately powered LAP-specific randomized studies.

Studies for V-LAP

Perl and colleagues (2022) conducted the V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF; NCT03775161) trial, the first-in-human trial of the V-LAP system. In this prospective, multicenter, open-label, single-arm trial, eligible participants were older than 18 years of age, diagnosed with chronic heart failure NYHA functional class III and had a history of at least one hospital admission due to worsening heart failure within the past year or BNP > 300 pg/mL or N-terminal pro b-type natriuretic peptide (NT-proBNP) > 1500 pg/mL. Primary outcomes included successful implantation of the device, the ability to conduct initial pressure measurements, and device safety defined as freedom from major adverse cardiovascular and neurologic events. Secondary outcomes included accurate pressure measurements, transmission of information up to 3 months after implantation, device concordance with PCWP at 3 months, admissions due to heart failure, and changes in NYHA class, 6-minute walk test, KCCQ results, and NT-proBNP levels at 6 months. A total of 24 individuals (83% were male) with a mean age of 67.4 ± 9.7 years underwent implantation with the V-LAP System.

All were successfully implanted with the device, and no device-related complications (defined as invasive treatment, device explant or death) or sensor failure occurred. Concordance between the V-LAP System and PCWP measurements showed a mean difference of -2.05 ± 3.33 mm Hg (in concordance correlation coefficient = 0.850, 95% CI, 0.676 to 0.934). At 6 months post implantation, 8 of 20 individuals experienced an improvement in NYHA class (40%, 95% CI, 16.4% to 63.5%). There was no change in 6-minute walk test distance, KCCQ scores, NT-proBNP levels, or number of hospitalizations due to heart failure. The investigators stated that these initial results demonstrate that ambulatory hemodynamic monitoring with the V-LAP system is safe and feasible. They also noted that additional well-designed randomized trials are still needed.

Restivo and colleagues (2022) reported the long-term outcomes of a subset of participants from the VECTOR-HF study. The purpose was to describe the experience of a single center with the largest number of participants (n=5) and the longest median follow-up (18 months) within the VECTOR-HF study. Individuals who underwent V-LAP System implantation showed improvements from baseline to last follow-up in their 6-minute walk test distance (from 352.5 ± 86.2 meters to 441.2 ± 125.2 meters), KCCQ overall scores (from 63.82 ± 16.36 to 81.92 ± 9.63), and KCCQ clinical scores (from 68.47 ± 19.48 to 83.70 ± 15.58). The investigators concluded that their findings were promising however, additional research to confirm the device’s reliability as well as its clinical benefit is needed.

In 2024, Meerkin and colleagues published interim findings from pooled VECTOR-HF I and VECTOR-HF IIa feasibility clinical trials. These prospective, single-arm, open-label studies evaluated the V-LAP Patient Monitoring System with a physician-directed member self-management approach. VECTOR-HF IIa used updated eligibility criteria allowing NYHA class II or III heart failure; however, the 13 participants included in this interim analysis were all NYHA class III. There were 6 participants who transitioned from VECTOR-HF I and 7 were enrolled in VECTOR-HF IIa. The studies' primary endpoints included the system's ability to perform LAP measurements and transmit data as well as safety outcomes. During the study period, no major procedural- or device-related adverse events were observed. The system successfully transmitted data as designed, and participant adherence to the monitoring system's prompts was 91.4%. The annualized heart failure hospitalization rate significantly decreased compared with an index period before V-LAP implantation (0 admissions vs. 0.69 admissions over 11.84 months, p=0.004). At 6 months, the 6-min walk test distance and KCCQ overall summary score demonstrated marginally significant improvement. However, only 10 of 13 participants were available for analysis at 6 months and 8 participants at 12 months. The small, single-arm, open-label, pooled interim design; high censoring; and underpowered enrollment preclude interpretation of clinical efficacy.

Additional V-LAP System studies remain ongoing or active in follow-up. The trials remain small and nonrandomized. They primarily evaluate feasibility, device performance, usability, and early safety. They do not provide randomized comparative evidence that LAP-guided management improves clinical outcome compared with standard heart failure care.

Studies for NORM Sensor

It has been hypothesized that the diameter of the IVC can be used to approximate right atrial pressure in persons with acute decompensated heart failure, and for those with a dilated IVC, there may be an increased risk of mortality. Renal insufficiency is also a risk factor for mortality for acute decompensated heart failure.

In 2017, Jobs reported on a retrospective chart review of individuals with acute decompensated heart failure in which they hypothesized diameter of the IVC is a marker of all-cause mortality and the prognostic impact can be influenced by kidney function. They analyzed the records of 1101 individuals with acute decompensated heart failure and who had echocardiography. The IVC was considered dilated if it was above 21 mm. Heart failure was defined as echocardiography report stating the ejection fraction was moderately or severely reduced. Renal insufficiency was classified as an estimated glomerular filtration rate below 60 ml/min/1.73 m². There were 474 (43.1%) individuals found to have IVC dilation greater than 21 mm. Overall, there were 400 (36.3%) deaths over a 3-year period. There was increased all-cause mortality for those with IVC greater than 21 mm and estimated glomerular filtration rate below 60 ml/min/1.73 m² (HR, 1.45; 95% CI, 1.21-1.74 and HR, 2.03: 95% CI, 1.67-2.48, respectively; p<0.001). The authors also noted dilation of the IVC was a high mortality risk in those with acute decompensated heart failure but only if the individuals also had renal insufficiency. There was no association of an increased risk of mortality if there was preserved kidney function.

A 2025 prospective, multicenter, single-arm feasibility study by Uriel reported on the use of an implantable sensor into the IVC of 15 individuals to monitor the area and collapse to predict congestion in heart failure. All 15 participants reached the primary safety endpoint 30 days after the procedure and the secondary endpoint of device effectiveness at 3 months following the procedure. At the 3-month follow-up, there were 7 of the 15 participants who showed an improvement in NYHA class. The other 8 participants maintained their NYHA class without deterioration. Median adherence rate of wearing the belt and home transmission data was 98%. The authors noted correlation between the sensor-derived data from the IVC cava area when compared with computed tomography (CT)-measured values. Accuracy was to within 11.15 mm². The small participant group and short follow-up period does not permit generalization and long-term efficacy. This feasibility study does not permit conclusions about improved net health outcomes.

A 2025 prospective, multicenter, nonrandomized, single-arm study by Kalra presented the evaluation of safety and feasibility of a sensor implanted into the IVC to measure changes in intravascular fluid volume. In this study, there was a blinding period of 3 months during which the clinicians did not have access to the sensor data. After 3 months, information regarding the device was obtained via CT and fluoroscopy. At that time, changes in data for the IVC were made available to clinicians. Assessments continued at 6, 12, 18, and 24 months. Study participants were those with a diagnosis of heart failure of at least 3 months who were also receiving medical treatment. Participants must have had a heart failure decompensation event (defined as either a hospital stay for heart failure, treatment in a hospital day care setting, or urgent outpatient treatment) within the previous 12 months prior to implantation and were required to have BNP levels ≥ 300 pg/mL or NT-proBNP levels ≥ 800 pg/mL (BNP ≥ 350 pg/mL and NT-proBNP ≥ 1,200 pg/mL for those who presented with atrial fibrillation). At 3 months, the primary endpoint was accurate sensor deployment without acute device or procedure-related complications and lack of sensor complications including device migration, clinically significant fracture, perforation, or symptomatic caval thrombosis. Secondary endpoints included no access-site thrombosis, significant hematoma, and successful transmission of the sensor reading to the web application. There were 49 participants who underwent sensor implant and were seen at the 3-month visit. All participants met the primary safety and technical endpoints with no serious adverse events associated with the device. With regard to sensor accuracy, the sensor measurement showed strong correlation when compared to CT measurements. There were 44 participants seen at the 6-month visit. There were 3 deaths prior to the 6-month visit (none of which were related to the device or the procedure). The median daily adherence at 6 months was 96.11%. Of the 44 participants with available data at 6 months, there was a decrease in NT-proBNP from baseline 1,629 ng/L to 1,089 ng/L at 6 months. During that time period, 12/44 participants improved from NYHA functional class III to class II. No significant differences were noted from baseline body mass index or 6-minute walk distance. While this study shows successful implantation of an IVC management system, this is an ongoing first in-human study which was not designed to demonstrate a significant clinical impact. The authors note a lack of diversity in the study population which leads to lack of generalizability. The short follow-up period and lack of information regarding improvement in net health outcomes does not permit medical necessity at this time. Further studies with larger study populations and longer follow-up periods are necessary.

The ESC guidelines for Diagnosis and Treatment of Acute and Chronic Heart Failure (McDonagh, 2023) do not discuss the use of an implanted sensor into the IVC for monitoring of heart failure.

Other implantable devices that monitor cardiac output and fluid levels through remote monitoring have been investigated in clinical trials, but thus far, none have received FDA approval.

The Centers for Disease Control and Prevention (CDC) estimates in the United States, there are nearly 6.7 million adults with heart failure. Common causes of heart failure can include ischemic heart disease, myocardial infarction, hypertension, and valvular heart disease. Symptoms of heart failure can include shortness of breath, especially during daily activities, trouble breathing when lying down, swelling of the feet and/or legs, and generalized feeling of weakness. Treatment can include medications, reducing sodium in the diet, drinking less fluids, and increasing daily physical activity.

Individuals with chronic heart failure are at increased risk of developing acute decompensated heart failure, which often requires hospitalization. Hence, early identification of individuals at greatest risk of imminent heart failure is important. Current risk management strategies involve frequent clinical assessment of signs and symptoms and continual cardiac hemodynamic monitoring in a clinical setting. Changes in cardiac hemodynamics may be indicative of change or progression of heart disease.

Several novel approaches have been investigated as techniques to measure cardiac hemodynamic variables in an outpatient setting for individuals with heart failure. One such proposed technique involves the implantation of a wireless pressure sensor in the pulmonary artery during a right heart catheterization procedure to measure pulmonary artery pressure (PAP) and heart rate in individuals with heart failure. Pressure readings are transmitted wirelessly to an external monitor and database where information may be used by clinicians and clinical staff to guide treatment decisions and monitor individuals from their home or other non-clinical setting. Another example is a sensor which is placed in the inferior vena cava (IVC) to monitor changes in vena cava dimensions or collapsibility as indicators of intravascular volume and congestion.

Cardiac catheterization: A general term describing the use of a thin catheter that is advanced into the bloodstream through an artery at the groin, arm or neck, followed by injection of a contrast agent (dye) that visualizes the coronary arteries and chambers of the heart. Cardiac catheterization, which can be done for diagnostic or therapeutic/interventional purposes or both, can be used to describe imaging of the coronary arteries, (also referred to as coronary angiography), or the heart chambers.

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:

• Dilated - This is the most common form, in which the heart cavity is enlarged and stretched (cardiac dilation). The heart is weak and doesn't pump normally, and most individuals develop congestive heart failure. Abnormal heart rhythms and disturbances in the heart's electrical conduction may also occur.
• Hypertrophic - In this condition, the muscle mass of the left ventricle enlarges or "hypertrophies." In one form of the disease, the wall between the two pumping chambers becomes enlarged, obstructing the blood flow from the left ventricle. In the other form of the disease, non-obstructive hypertrophic cardiomyopathy, the enlarged muscle doesn't obstruct blood flow.
• Restrictive - This is the least common type in the United States. The myocardium (heart muscle) of the ventricles becomes excessively "rigid," making it more difficult for the ventricles to fill with blood between heartbeats. This type of cardiomyopathy is typically caused by another underlying disease process.

Congestive heart failure (CHF), also referred to as heart failure: 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.

Hemodynamic/Haemodynamic: Study of blood flow or circulation.

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 individuals based on subjective impression of the degree of functional compromise. The four NYHA functional classes are as follows:

• Class I - individuals with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; symptoms only occur on severe exertion.
• Class II - individuals with cardiac disease resulting in slight limitation of physical activity; they are comfortable at rest; ordinary physical activity (e.g., moderate physical exertion such as carrying shopping bags up several flights of stairs) results in fatigue, palpitation, dyspnea, or anginal pain.
• Class III - individuals with cardiac disease resulting in marked limitation of physical activity; they are comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.
• Class IV - individuals with cardiac disease resulting in inability to carry on any physical activity without discomfort; symptoms of heart failure or the anginal syndrome may be present even at rest; if any physical activity is undertaken, discomfort is increased.

Right heart: Describes the two chambers on the right side of the heart; the right atrium, which receives the blood returning from the rest of the body, and the right ventricle that pumps this blood to the lungs.

Transthoracic echocardiogram: A non-invasive ultrasound of the heart.

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:
For the following procedure codes or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Associated Coding

When services are also Investigational and Not Medically Necessary for associated, secondary or subsequent procedures related to insertion/implantation codes listed above:

Peer Reviewed Publications:

1. Abraham WT, Adamson PB, Bourge RC, et al. CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized controlled trial. Lancet. 2011; 377(9766): 658-666.
2. Abraham WT, Adamson PB, Costanzo MR, et al. Hemodynamic monitoring in advanced heart failure: Results from the LAPTOP-HF trial. J Card Fail. 2016; 22(11):940.
3. Abraham WT, Stevenson LW, Bourge RC, et al. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomized trial. Lancet. 2016; 387(10017):453-461.
4. Adamson PB, Abraham WT, Bourge RC, et al. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circ Heart Fail. 2014; 7(60):935-944.
5. Adamson PB, Abraham WT, Stevenson LW, et al. Pulmonary artery pressure-guided heart failure management reduces 30-day readmissions. Circ Heart Fail. 2016; 9(6):e002600.
6. Adamson PB, Ginn G, Anker SD, et al. Remote haemodynamic-guided care for patients with chronic heart failure: a meta-analysis of completed trials. Eur J Heart Fail. 2017; 19(3):426-433.
7. Angermann CE, Assmus B, Anker SD, et al. Pulmonary artery pressure-guided therapy in ambulatory patients with symptomatic heart failure: the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF). Eur J Heart Fail. 2020; 22(10):1891-1901.
8. Brinkley DM, Guglin ME, Bennett MK, et al. Pulmonary artery pressure monitoring effectively guides management to reduce heart failure hospitalizations in obesity. JACC Heart Fail. 2021; 9(11):784-794.
9. Brugts JJ, Radhoe SP, Clephas PRD, et al. Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial. Lancet. 2023; 401(10394): 2113-2123.
10. Clephas PRD, Zwartkruis VW, Malgie J, et al. Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial. Eur Heart J. 2024; 45(32):2954-2964.
11. Costanzo MR, Stevenson LW, Adamson PB, et al. Interventions linked to decreased heart failure hospitalizations during ambulatory pulmonary artery pressure monitoring. JACC Heart Fail. 2016; 4(5):333-344.
12. Cowie MR, Flett A, Cowburn P, et al. Real-world evidence in a national health service: results of the UK CardioMEMS HF System post-market study. ESC Heart Fail. 2022; 9(1):48-56.
13. Dauw J, Sokolski M, Middleton JT, et al. Ambulatory haemodynamic-guided management reduces heart failure hospitalizations in a multicentre European heart failure cohort. ESC Heart Fail. 2022; 9(6):3858-3867.
14. DeFilippis EM, Henderson J, Axsom KM, et al. Remote hemodynamic monitoring equally reduces heart failure hospitalizations in women and men in clinical practice: a sex-specific analysis of the CardioMEMS post-approval study. Circ Heart Fail. 2021; 14(6):e007892.
15. de Groote P, Thuny F, Blanchart K, et al. Remote haemodynamic-guided heart failure management in France: results from the CardioMEMS HF System Post-Market Study (COAST) French cohort. Arch Cardiovasc Dis. 2024; 117(11):624-632.
16. Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in "real-world" clinical practice. J Am Coll Cardiol. 2017; 69(19):2357-2365.
17. Doshi RN, Carlson S, Agarwal R, et al. Association between arrhythmia and pulmonary artery pressure in heart failure patients implanted with a cardiac defibrillator and ambulatory pulmonary artery pressure sensor. J Innov Card Rhythm Manag. 2019; 10(9):3815-3821.
18. Guichard JL, Bonno EL, Nassif ME, et al. Seated pulmonary artery pressure monitoring in patients with heart failure: results of the PROACTIVE-HF Trial. JACC Heart Fail. 2024; 12(11):1879-1893.
19. Heywood JT, Jermyn R, Shavelle D, et al. Impact of practice-based management of pulmonary artery pressures in 2000 patients implanted with the CardioMEMS sensor. Circulation. 2017; 135(16):1509-1517.
20. Heywood JT, Zalawadiya S, Bourge RC, et al. Sustained reduction in pulmonary artery pressures and hospitalizations during 2 years of ambulatory monitoring. J Card Fail. 2023; 29(1):56-66.
21. Iaconelli A, Pellicori P, Caiazzo E, et al. Implanted haemodynamic telemonitoring devices to guide management of heart failure: a review and meta-analysis of randomised trials. Clin Res Cardiol. 2023; 112(8):1007-1019.
22. Jermyn R, Alam A, Kvasic J, et al. Hemodynamic-guided heart-failure management using a wireless implantable sensor: infrastructure, methods, and results in a community heart failure disease-management program. Clin Cardiol. 2017; 40(3):170-176.
23. Jobs A, Brünjes K, Katalinic A, et al. Inferior vena cava diameter in acute decompensated heart failure as predictor of all-cause mortality. Heart Vessels. 2017; 32(7):856-864.
24. Kalra PR, Gogorishvili I, Khabeishvili G, et al. First-in-human implantable inferior vena cava sensor for remote care in heart failure: FUTURE-HF. JACC Heart Fail. 2025; 13(6):1000-1010.
25. Kapelios CJ, Liori S, Bonios M, et al. Effect of pulmonary artery pressure-guided management on outcomes of patients with heart failure outside clinical trials: a systematic review and meta-analysis of real-world evidence with the CardioMEMS Heart Failure System. Eur J Heart Fail. 2025; 27(10):1857-1865.
26. Lindenfeld J, Costanzo MR, Zile MR, et al. Implantable hemodynamic monitors improve survival in patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. 2024; 83(6):682-694.
27. Lindenfeld J, Zile M, Desai AS, et al. Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021; 398 (10304): 991-1001.
28. 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.
29. Meerkin D, Perl L, Hasin T, et al. Physician-directed patient self-management in heart failure using left atrial pressure: interim insights from the VECTOR-HF I and IIa studies. Eur J Heart Fail. 2024; 26(8):1814-1823.
30. Perl L, Meerkin D, D'amario D, et al. The V-LAP System for remote left atrial pressure monitoring of patients with heart failure: Remote left atrial pressure monitoring. J Card Fail. 2022; 28(6):963-972.
31. Raina A, Abraham W, Adamson P, et al. Limitations of right heart catheterization in the diagnosis and risk stratification of patients with pulmonary hypertension related to left heart disease: insights from a wireless pulmonary artery pressure monitoring system. J Heart Lung Transplant. 2015; 34(3):438-447.
32. Restivo A, D'Amario D, Paglianiti DA, et al. A 3-year single center experience with left atrial pressure remote monitoring: The long and winding road. Front Cardiovasc Med. 2022; 9:899656.
33. 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.
34. 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.
35. Shavelle DM, Desai AS, Abraham WT, et al. Lower rates of heart failure and all-cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure: one-year outcomes from the CardioMEMS post-approval study. Circ Heart Fail. 2020; 13(8):e006863.
36. Urban S, Szymański O, Grzesiak M, et al. Effectiveness of remote pulmonary artery pressure estimating in heart failure: systematic review and meta-analysis. Sci Rep. 2024; 14(1):12929.
37. Uriel N, Bhatt K, Kahwash R, et al. Safety and feasibility of an implanted inferior vena cava sensor for accurate volume assessment: FUTURE-HF2 Trial. J Card Fail. 2025; 31(2):369-376.
38. Zile MR, Abraham WT, Stevenson LW, et al. Relationship between remote, ambulatory pulmonary artery pressures, and all-cause mortality in patients with chronic heart failure. Circ Heart Fail. 2025; 18(6):e012754.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Bashore TM, Balter S, Barac A, et al. 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions (ACCF/SCAI) expert consensus document on cardiac catheterization laboratory standards update: a report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. J Am Coll Cardiol. 2012; 59(24):2221-2305.
2. Cajita M, Peters L, Rao VN, et al. Integrated health technologies in heart failure: a scientific statement from the Heart Failure Society of America and the American Association of Heart Failure Nurses. J Card Fail. 2026; 32(3):619-632.
3. Dickinson MG, Allen LA, Albert NA, et al. Remote monitoring of patients with heart failure: a white paper from the Heart Failure Society of America Scientific Statements Committee. J Card Fail. 2018; 24(10):682-694.
4. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012; 60(24):e44-e164.
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1. American Heart Association. Classes and stages of heart failure. Last reviewed May 21, 2025. Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure. Accessed on July 16, 2026.
2. American Heart Association. Heart failure. Last reviewed May 20, 2025. Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed on July 16, 2026.
3. Centers for Disease Control and Prevention (CDC). About heart failure. May 15, 2024. Available at: https://www.cdc.gov/heart-disease/about/heart-failure.html. Accessed on July 16, 2026.
4. National Heart, Lung, and Blood Institute. What is heart failure? Last updated on March 24, 2022. Available at: https://www.nhlbi.nih.gov/health/heart-failure. Accessed on July 16, 2026.

Cardiac hemodynamic monitoring
CardioMEMS HF System
Fire1
HeartPOD System
Heart failure
Inferior vena cava sensor
Left atrial hemodynamic (LAH) monitor
Left atrial pressure (LAP) monitoring
NORM system
Promote LAP System
V-LAP System
Wireless implantable hemodynamic 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.

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