Implantable Left Atrial Hemodynamic Monitor
Number: 0832
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses implantable left atrial hemodynamic monitor.
Experimental, Investigational, or Unproven
Aetna considers implantable left atrial hemodynamic monitors (e.g., the HeartPOD System, the Promote LAP System, and the V-LAP System) experimental, investigational, or unproven due to insufficient evidence in the peer-reviewed literature.
Background
The Heart Failure Society of America (2010) defines heart failure as "a syndrome caused by cardiac dysfunction, generally resulting from myocardial muscle dysfunction or loss and characterized by either left ventricular (LV) dilation or hypertrophy or both." Heart failure is a major public health problem that affects nearly 6 million Americans each year (Roger et al, 2011). Heart failure (HF) is the cause for 12 to 15 million office visits and 6.5 million hospital days per year and can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood (Hunt et al, 2009). Morbidity and mortality from HF remains high despite advances in evaluation and management with rehospitalization rates of 20% at one month and nearly 50% at 6 months (Ritzema et al, 2010). Bui et al (2012) state that the majority of these HF hospitalizations result from worsening congestion in patients previously diagnosed with HF. Arenja et al (2011) prospectively enrolled 610 consecutive patients presenting to the emergency department with acute HF and followed them for 1 year to determine risk stratification for mortality; a total of 201 patients (33%) died within 360 days and the investigators' analysis identified blood urea nitrogen and age as the best single predictors of 1-year mortality.
Kommuri et al (2012) studied the impact of prior HF hospitalizations on long-term mortality in 2,221 HF patients in a prospective cohort study. They found that in otherwise "low-risk" HF inpatients, a history of 2 or more HF hospitalizations within the prior 12 months markedly increases 1-year mortality risk. Bui et al (2012) report that "earlier identification and treatment of congestion together with improved care coordination, management of comorbid conditions, and enhanced patient self-management may help to prevent hospitalizations in patients with chronic HF. Such home monitoring extends from the promotion of self-care and home visitations to telemedicine and remote monitoring of external or implantable devices."
Giordano et al (2011) enrolled 358 HF patients in a 6 month home-based tele-management (HBT) program and observed that on re-evaluation after 6 months (238 patients) there was a general improvement in clinical, functional, and quality of life (QOL) status and a significant increase in the mean daily dosage of beta-blockers prescribed. Although Giordano et al (2011) concluded that HBT for patients with congestive HF is associated with favorable effects on hospital readmission for cardiovascular reasons and on QoL, they also noted that a more comprehensive multidisciplinary approach would probably be required to obtain favorable effects on total morbidity.
Recent research has focused on the use of ambulatory hemodynamic monitoring in chronic HF patients and continuous implantable hemodynamic monitoring devices have been introduced as a potential means to improve outcomes in these patients. The American College of Cardiology/American Heart Association Guidelines for the Diagnosis and Management of Heart Failure in Adults state that implantable hemodynamic monitors used for the chronic, remote, outpatient monitoring of ventricular filling pressures and other hemodynamic and clinical variables in HF patients are hypothesized to be of benefit as changes in therapy to optimize LV filling pressure may improve outcomes in HF patients (Hunt et al, 2009). One such device used to measure left atrial pressure (LAP) is the HeartPod® system (St Jude Medical, CRMD, Sylmar, CA), which consists of an implantable sensor lead and coil antenna; the sensor module is affixed to the atrial septum by proximal and distal folding nitinol. The implantation procedure is conducted through performing a right heart catherization with a Swan Ganz catheter. After removing the delivery sheath, the proximal lead connector is affixed to the antenna and placed in a subcutaneous pocket anchors (Troughton et al, 2010). Troughton et al. (2010) state that the handheld Patient Advisor Module device, which is used to interrogate the sensor by placing the module in proximity to the device, uses a standard algorithm to compute mean LAP.
The first reported study of an implantable left atrial hemodynamic monitor was conducted by Ritzema et al (2007) in eight male patients with established heart failure and at least 1 heart failure hospitalization or unplanned outpatient visit for parenteral therapy during the previous 12 months. The 8 subjects from this single center were enrolled in a prospective, multi-center, nonrandomized, open-label feasibility clinical trial called the Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS I). The LAP hemodynamic monitor device (HeartPOD®) was implanted in all patients without device related complications or systemic emboli. The device consisted of an implantable sensor lead coupled with a subcutaneous antenna coil, a patient advisory module (PAM), and the clinician’s personal computer software. The sensor system was implanted into the atrial septum oriented to the left atrium. Twelve-weeks post-implantation 87 % of device LAP measurements were within +/- 5 mm Hg of simultaneous pulmonary capillary wedge pressure readings over a wide range of pressures (1.6 to 71 mm Hg). Net drift corrected by calibration was -0.2 +/- 1.9 mm Hg. The authors concluded that although ambulatory monitoring of direct LAP was well tolerated, feasible, and accurate at a short-term follow-up, further follow-up and investigation were warranted to evaluate the clinical utility of LAP monitoring in patients with heart failure.
The COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) study was conducted by Bourge et al (2008). COMPASS-HF was a prospective, multi-center, randomized, single-blind, parallel-controlled trial of 274 New York Heart Association (NYHA) functional class III or IV HF patients who received an implantable continuous hemodynamic monitor. Patients were randomized to a Chronicle implantable continuous hemodynamic monitoring device (Medtronic Inc., Minneapolis, MN) (n = 134) or a control group (n = 140). The investigators concluded that, compared with control patients, the Chronicle group had a nonsignificant 21 % reduction (p = 0.33) in the rate of all HF-related events and a 36 % reduction (p = 0.03) in the relative risk of a first HF-related hospitalization. The investigators therefore recommended that additional trials be conducted to establish the clinical benefit of implantable continuous hemodynamic monitor–guided care in patients with advanced HF.
Ritzema et al (2010) conducted a physician-directed patient self-management of left atrial pressure in advanced chronic HF study in 40 patients with reduced or preserved left ventricular ejection fraction (LVEF) and acute decompensation. All enrolled patients were implanted with an investigational left atrial pressure monitor. Event-free survival was determined over a median follow-up period of 25 months. Survival without decompensation was 1 % at 3 years and events decreased in frequency at the first 3 months following implantation (p < 0.012). Mean daily left arterial pressure fell from 17.6 mm Hg during the first 3 months to 14.8 mm during pressure-guided therapy (p = 0.003). There were statistically significant improvements in NYHA class (p < 0.001) and LVEF (p < 0.001). The authors concluded that physician-directed patient self-management of left atrial pressure has the potential to improve hemodynamic, symptoms, and outcomes in advanced HF. The authors also acknowledged, however, that this was a small observational study and that these results suggest that outpatient hemodynamic monitoring linked to a self-management therapeutic strategy could change current management of advanced heart failure and potentially facilitate more optimal therapy and improved outcomes.
Troughton et al (2010) evaluated the HeartPOD® left atrial hemodynamic monitoring system in 84 advanced HF patients. The investigators conducted a prospective, multicenter, observational open-label registry study the results of which showed that comparisons of LAP with pulmonary capillary wedge pressure (PCWP) generally showed a high degree of concordance. The implanted left atrial monitor measurement of LAP differed from PCWP by > 5 mmHg in 20% of readings. However, the authors stated that these disagreements were likely miscalibration of the Swan Ganz catheter, the implanted LAP sensor, or both. Freedom from device failure was 95% at 2 years and 88% at 4 years. There were no instances of device failure or anomaly associated with clinical worsening. The authors concluded that high-fidelity LAP measurements were accurate and closely predicted PCWP over a 12-month period.
St Jude Medical is currently sponsoring a Phase III randomized, open label trial of the HeartPOD™ System or Promote® LAP System. This trial is currently recruiting participants and the primary outcome measures will be safety and efficacy. Safety will be demonstrated by evaluating the freedom from study-related major adverse cardiovascular and neurological events (MACNE) following twelve months of treatment. Effectiveness will be determined by evaluating the reduction in the relative risk of Heart Failure MACNE between the Treatment and Control groups (St. Jude Medical, 2011). The HeartPOD® and Promote® LAP System have not to date received approval for use in the United States by the Food and Drug Administration.
Walton and Krum (2005) stated that congestive HF (CHF) has been described as the new epidemic. Despite recent improvements in drug therapy, a 2-year mortality of up to 50 % persists. There are limitations to the current drug treatments and cardiac resynchronization devices. The treatment of diastolic dysfunction can be suboptimal. The Savacor Company developed the HeartPOD device to directly measure LAP in patients with CHF via an implantable device. The patient can in real time, download their intra-cardiac pressure measurements to a hand-held device. With this information, they can titrate their own treatment in a very precise manner.
The HeartPOD System (Savacor Inc., Los Angeles, CA) is used for patients with ischemic or non-ischemic cardiomyopathy with systolic or diastolic dysfunction for at least 6 months or HF classified by NYHA class III. The HeartPOD system is a standalone device for use in patients not requiring implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) therapy, or who already received ICD or CRT-D therapy. The system monitors LAP with a permanently implantable sensory sensor used in ambulatory patients with HF. These implanted intra-cardiac sensors allow the patient to directly monitor LAP, the intra-cardiac electrogram, and core body temperature. The implant's readings are communicated with a hand-held computer. 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 United States.
The Promote LAP System (St. Jude Medical, Inc., St. Paul, MN) is used for patients with ischemic or non-ischemic cardiomyopathy and class III HF. It is a combinational device for patients who require ICD or CRT-D therapy in addition to LAP monitoring. This device is not available for commercial use in the United States.
There is currently a clinical trial on “Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF)” that is currently recruiting subjects (estimated enrollment = 730; study start date was April 2010). Devices used are the HeartPOD System or the Promote LAP System (last verified May 2016).
Abraham (2013) stated that HF represents a major public health concern, associated with high rates of morbidity and mortality. A particular focus of contemporary HF management is reduction of hospital admission and re-admission rates. While optimal medical therapy favorably impacts the natural history of the disease, devices such as CRT devices and ICDs have added incremental value in improving HF outcomes. These devices also enable remote patient monitoring via device-based diagnostics. Device-based measurement of physiological parameters, such as intra-thoracic impedance and heart rate variability, provide a means to assess risk of worsening HF and the possibility of future hospitalization. Beyond this capability, implantable hemodynamic monitors have the potential to direct day-to-day management of HF patients to significantly reduce hospitalization rates. The use of a pulmonary artery pressure measurement system has been shown to significantly reduce the risk of HF hospitalization in a large randomized controlled study, the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial. Observations from a pilot study also supported the potential use of a left atrial pressure monitoring system and physician-directed patient self-management paradigm; these observations are under further investigation in the ongoing LAPTOP-HF trial.
Maurer and colleagues (2015) noted that daily measurements of LAP may be useful for guiding adjustments in medical therapy that prevent clinical decompensation in patients with severe HF. LAPTOP-HF is a prospective, multi-center, randomized, controlled clinical trial in ambulatory patients with advanced HF in which the safety and clinical effectiveness of a physician-directed patient self-management therapeutic strategy based on LAP measured twice-daily by means of an implantable sensor will be compared with a control group receiving optimal medical therapy. The trial will enroll up to 730 patients with NYHA functional class III symptoms and either a hospitalization for HF during the previous 12 months or an elevated B-type natriuretic peptide level, regardless of LVEF, at up to 75 investigational centers. Randomization to the treatment group or control group will be at a 1:1 ratio in 3 strata based on the LVEF greater than or less than or equal to 35 % and the presence of a de-novo CRT device indication. The authors stated that the LAPTOP-HF Trial will provide essential information regarding the role of implantable LAP monitoring in conjunction with a new HF treatment paradigm across the spectrum of HF patients.
Mooney and associates (2015) stated that HF is a challenging and highly prevalent medical condition. Hospitalization for acute decompensation is associated with high morbidity and mortality. Despite application of evidence-based medical therapies and technologies, HF remains a formidable challenge for virtually all healthcare systems. Repeat hospitalizations for acute decompensated HF (ADHF) can have major financial impact on institutions and resources. Early and accurate identification of impending ADHF is of paramount importance yet there is limited high quality evidence or infra-structure to guide management in the out-patient setting. Historically, ADHF was identified by physical examination or invasive hemodynamic monitoring during a hospital admission; however, advances in medical microelectronics and the advent of device-based diagnostics have enabled long-term ambulatory monitoring of HF patients in the out-patient setting. These monitors have evolved from piggybacking on cardiac implantable electrophysiological devices to stand-alone implantable hemodynamic monitors that transduce left atrial or pulmonary artery pressures as surrogate measures of left ventricular filling pressure. As technology evolves, devices will likely continue to miniaturize while their capabilities grow. The authors concluded that an important, persistent challenge that remains is developing systems to translate the large volumes of real-time data, particularly data trends, into actionable information that leads to appropriate, safe and timely interventions without overwhelming out-patient cardiology and general medical practices. They stated that future directions for implantable hemodynamic monitors beyond their utility in HF may include management of other major chronic diseases such as pulmonary hypertension, end stage renal disease and portal hypertension.
Abraham (2017) noted that HF is associated with high rates of hospitalization and re-hospitalization, resulting in substantial clinical and economic burden. Current approaches to monitoring patients with HF have done little to reduce these high rates of HF hospitalization. Implantable hemodynamic monitors have been developed to remotely provide direct measurement of intra-cardiac and pulmonary artery pressures (PAP) in ambulatory patients with HF. The authors stated that these devices have the potential to direct day-to-day management of patients with HF to reduce hospitalization rates.
Ancona and colleagues (2021) noted that HF management guided by the measurement of intra-cardiac and pulmonary pressure values obtained through innovative permanent intra-cardiac microsensors has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization. These sensors have potential to reduce patient hospitalization rates and optimize QoL. These researchers examined the usability and patients' attitudes toward a new permanent intra-cardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP) in patients with chronic HF. The V-LAP system is a miniaturized sensor implanted percutaneously across the inter-atrial septum. The system communicates wirelessly with a "companion device" (a wearable belt) that is placed on the patient's chest at the time of acquisition/transmission of left heart pressure measurements. At first follow-up after implantation, patients and health care providers were asked to fill out a questionnaire on the usability of the system, ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent). Further patient follow-ups were carried out at 3, 6, and 12 months. Use and acceptance of the first 14 patients receiving the V-LAP technology worldwide and related health care providers have been analyzed to-date. No peri-procedural morbidity/mortality was observed. Before discharge, a tailored educational session was carried out after device implantation with the patients and their health care providers. At the 1st follow-up, the mean score for overall comfort in technology use was 3.7 (SD 1.2) with 93 % (13/14) of patients succeeding in applying and operating the system independently. For health care providers, the mean score for overall ease and comfort in use of the technology was 4.2 (SD 0.8). No significant differences were observed between the patients' and health care providers' replies to the questionnaires. There was a general trend for higher scores in patients' usability reports at later follow-ups, in which the score related to overall comfort with using the technology increased from 3.0 (SD 1.4) to 4.0 (SD 0.7) (p = 0.40) and comfort with wearing and adjusting the measuring thoracic belt increased from 2.8 (SD 1.0) to 4.2 (SD 0.4) (p = 0.02). The authors concluded that despite the gravity of their HF pathology and the complexity of their co-morbid profile, patients were comfortable in using the V-LAP technology and, in the majority of cases, they could correctly and consistently acquire and transmit hemodynamic data. Moreover, these researchers stated that although the overall patient/care provider satisfaction with the V-LAP system appeared to be acceptable, improvements can be achieved after ameliorating the design of the measuring tools.
The authors stated that the main drawback of this study was the small number of patients involved at present. It should be kept into consideration that the discussed technology has been only very recently introduced and is still under evaluation in a clinical trial. In fact, the patients analyzed in this study represented the majority of all patients receiving the V-LAP device worldwide. Moreover, as emphasized above, results in terms of usability and adoption of the technology may be biased by the adequate selection of patients as part of the trial’s inclusion and exclusion protocol, which involved evaluating their psychological status, attitude toward the disease and its management, and their desire for being involved with this innovative technology. Finally, because the primary and secondary objectives of the trial were not usability and satisfaction, the sample could not be adequately sized to draw definitive conclusions on these 2 matters.
Restivo et al (2022) stated that despite continuous advancement in the field, HF remains the leading cause of hospitalization among the elderly and the overall 1st cause of hospital re-admission in developed countries. Implantable hemodynamic monitoring is being tested to anticipate the clinical exacerbation onset, potentially preventing an emergent acute decompensation. Currently, only PAP sensor received the Food and Drug Administration (FDA) approval to be implanted in symptomatic HF patients with reduced ejection fraction (EF). However, PAP's indirect estimation of LV filling pressure can be inaccurate in some contexts. The VECTOR-HF Trial is examining the safety, usability and performance of the V-LAP system, a latest-generation device capable of continuously monitoring LAP. In the authors’ center, 5 advanced HF patients have been enrolled. After confirmation of the transmitted data reliability, LAP trends and waveforms have guided therapy optimization. These researchers shared clinical insights from their center’s preliminary experience with V-LAP application. Over a median follow-up time of 18 months, LAP-based therapy optimization managed to reduce intra-cardiac pressure over time and no hospital re-admission occurred. This result was paralleled by an improvement in both functional capacity (6-minute walk test [6MWT] distance 352.5 ± 86.2 meters at baseline to 441.2 ± 125.2 meters at last follow-up) and QoL indicators (KCCQ overall score 63.82 ± 16.36 versus 81.92 ± 9.63; clinical score 68.47 ± 19.48 versus 83.70 ± 15.58). The authors concluded that preliminary evidence from V-LAP application at their center supported a promising effectiveness; however, future large studies will be important, both to confirm the clinical value of left-sided hemodynamic monitoring, and to standardize an effective LAP-guided medical management.
Clephas et al (2023) noted that adjustment of treatment based on remote monitoring of PAP may reduce the risk of hospital admission for patients with HF. In a meta-analysis, these investigators addressed this question. They carried out a systematic literature search for randomized clinical trials with PAP monitoring devices in patients with HF. The primary outcome was the total number of HF hospitalizations. Other outcomes assessed were urgent visits resulting in treatment with intravenous (IV) diuretics, all-cause mortality, and composites. Treatment effects were expressed as HRs, and pooled effect estimates were obtained applying random effects meta-analyses. A total of 3 eligible randomized clinical trials were identified that included 1,898 outpatients in NYHA functional classes II to IV, either hospitalized for HF in the prior 12 months or with elevated plasma NT-proBNP concentrations. The mean follow-up was 14.7 months, 67.8 % of the patients were men, and 65.8 % had an EF of 40 % or less. Compared to patients in the control group, the HR (95 % CI) for total HF hospitalizations in those randomized to PAP monitoring was 0.70 (0.58 to 0.86) (p = 0.0005). The corresponding HR for the composite of total HF hospitalizations, urgent visits and all-cause mortality was 0.75 (0.61 to 0.91; p = 0.0037), and for all-cause mortality 0.92 (0.73 to 1.16). Sub-group analyses, including EF phenotype, showed no evidence of heterogeneity in the treatment effect. The authors concluded that the use of remote PAP monitoring to guide treatment of patients with HF decreased episodes of worsening HF and subsequent hospitalizations.
The authors stated that this meta-analysis had several drawbacks. First, individual data were only available from MONITOR-HF, and aggregate published data from CHAMPION and GUIDE-HF were used. Second, the overall neutral results from the full data of the GUIDE-HF trial were used in this meta-analysis and not the COVID-19 sensitivity analysis. Third, the included studies were carried out in Northern America (predominantly U.S. and 4 sites in Canada) and in the Netherlands, and the technology and associated management may not be generalizable to all countries. Still, the additive effect on top of high levels of guideline-recommended medical therapy is reassuring for generalizability of these findings. Fourth, the 3 studies were under-powered to evaluate mortality, even combined in this meta-analysis. Fifth, moderate heterogeneity was present within the main and sub-group analyses. Nevertheless, the benefit of PAP monitoring remained consistent across most sub-groups. Sixth, the lack of blinding in the 3 included studies could have influenced the results via performance bias. Sixth, the successful use of the technology depends on 2 factors, namely, an adherent patient performing measurements at least several times a week; as well as an involved physician or healthcare provider responding to these pressure measurements.
Curtain et al (2024) carried out a meta-analysis of randomized controlled trials (RCTs) of implantable hemodynamic monitoring (IHM)-guided care. These investigators searched PubMed and Ovid Medline for RCTs of IHM in patients with HF; outcomes were examined in total (1st and recurrent) event analyses. A total of 5 studies comparing IHM-guided care with standard of care (SOC) alone were identified and included 2,710 patients across EF ranges. Data were available for 628 patients (23.2 %) with HF with preserved EF (HFpEF) (EF of 50 % or greater) and 2,023 patients (74.6 %) with HF with a reduced EF (HFrEF) (EF of less than 50 %). Chronicle, CardioMEMS and HeartPOD IHMs were used. In all patients, regardless of EF, IHM-guided care reduced total HF hospitalizations (HR 0.74, 95 % CI: 0.66 to 0.82) and total worsening HF events (HR 0.74, 95 % CI: 0.66 to 0.84). In patients with HFrEF, IHM-guided care reduced total worsening HF events (HR 0.75, 95 % CI: 0.66 to 0.86). The effect of IHM-guided care on total worsening HF events in patients with HFpEF was uncertain (fixed-effect model: HR 0.72, 95 % CI: 0.59 to 0.88; random-effects model: HR 0.60, 95 % CI: 0.32 to 1.14). IHM-guided care did not reduce mortality (HR 0.92, 95 % CI: 0.71 to 1.20); and IHM-guided care reduced all-cause mortality and total worsening HF events (HR 0.80, 95 % CI: 0.72 to 0.88). The authors concluded that in patients with HF across all EFs, IHM-guided care reduced total HF hospitalizations and worsening HF events. This benefit was consistent in patients with HFrEF but not consistent in HFpEF. Moreover, these researchers stated that further investigations should focus on individuals with an EF of 50 % or greater with pre-specified analyses to confirm the effectiveness of IHM-guided care in this population.
The authors stated that this meta-analysis had several drawbacks. First, only 2 studies examined an IHM that is currently available (CardioMEMS), and 3 IHMs were examined over 18 years of investigation during which time the background management of patients with HF evolved with advancements in drug and device therapies. Each IHM measured a different hemodynamic parameter. However, the IHM’s hemodynamic measures were physiologically related (e.g., ePAD (COMPASS-HF) provided a surrogate estimate for left atrial pressure (LAPTOP-HF)). Potential sources of bias exist. The REDUCE-HF Trial was terminated following concerns regarding 4-year pressure sensor failure in patients from other Chronicle device studies. A total of 400 patients from a recruitment target of 1,300 patients had enrolled at the point of study termination. Consequently, the REDUCE-HF Trial was under-powered, with only 181 events reported compared with the 648 events expected. The LAPTOP-HF Trial was also terminated early after 1 year due to peri-procedural safety concerns, and mortality data from this trial were unavailable. The meta-analysis effect estimates may have changed had both the REDUCE-HF and LAPTOP-HF Trials achieved target recruitment. However, the inclusion of these studies in the meta-analysis reduced selection bias by including at least 1 year of follow-up data on clinically relevant outcomes from these RCTs. Based on patients in the REDUCE-HF and LAPTOP-HF Trials having a mean EF of 23 % ± 7 % and 30 % ± 15 %, respectively, both studies were included in the HFrEF analysis. The initial REDUCE-HF inclusion criteria also required participants to have an ICD, favoring recruitment from a population with more severe HFrEF, the patient group in whom ICD implantation predominates. However, these researchers could not completely exclude the possibility that some patients had EFs above these ranges. Individual cohort numbers were not available from all studies for all EF groups; and these investigators did not have individual participant level data to test the interaction between EF and IHM-guided care.
Urban et al (2024) stated that HF poses a significant health challenge, often resulting in frequent hospitalizations and compromised QOL. Continuous PAP monitoring offers a surrogate for congestion status in ambulatory HF care. In a meta-analysis, these investigators examined the effectiveness of PAP monitoring devices (CardioMEMS and Chronicle) in preventing adverse outcomes in HF patients, addressing gaps in previous RCTs. A total of 5 RCTs (2,572 subjects) were systematically reviewed. PAP monitoring significantly reduced HF-related hospitalizations (RR 0.72; 95 % CI: 0.6 to 0.87, p = 0.0006) and HF events (RR 0.86; 95 % CI: 0.75 to 0.99, p = 0.03), with no impact on all-cause or cardiovascular (CV) mortality. Sub-group analyses highlighted the significance of CardioMEMS and blinded studies. Meta-regression indicated a correlation between prolonged follow-up and increased reduction in HF hospitalizations. The risk of bias was generally high, with evidence certainty ranging from low-to-moderate. The authors concluded that PAP monitoring devices exhibit promise in diminishing HF hospitalizations and events, especially in CardioMEMS and blinded studies; however, their influence on mortality remains inconclusive. These investigators stated that further research, considering diverse patient populations and intervention strategies with extended follow-up, is needed to ascertain the true clinical significance, and optimal role of PAP monitoring in HF management.
The authors stated that this study had several drawbacks. First, these investigators used only aggregated data from the included studies, and performing a patient-level analysis could potentially provide more in-depth and nuanced conclusions. Second, it is worth noting that all the studies were carried out in the U.S. and the Netherlands, which are both highly developed countries with relatively robust healthcare systems. The studies were not powered to detect the differences in mortality. Third, it is important to acknowledge that the physicians were not blinded to the allocation of patients, which inherently introduced a vulnerability to performance bias. The risk of bias remained significant, even though it is challenging to conceive a study design in which the physician would not have access to data from the implanted sensor. Fourth, the Chronicle device is presently obsolete and lacks FDA approval. Furthermore, it does not directly measure the PAP but provides estimates.
Furthermore, an UpToDate review on “Management of refractory heart failure with reduced ejection fraction” (Dunlay and Colucci, 2024) states that “Based upon the available evidence (including the ESCAPE trial described below), the routine use of pulmonary artery catheter monitoring in HF patients is not recommended … For patients with refractory HF, we recommend against routine pulmonary artery catheter monitoring. However, pulmonary artery catheter placement may be useful to guide therapy in selected patients with refractory HF when clinical assessment is inadequate to guide hemodynamic management”.
V-LAP System
The V-LAP (Vectorious Medical Technologies, Ltd) is a wireless sensor that measures LAP and transmits data to a secure cloud-based platform. It is designed to monitor patients with HF and is intended to provide detailed information on LAP in a minimally invasive way. The V-LAP System includes a leadless, non-battery operated implant that is positioned across the inter-atrial septum. It contains sensing elements and electronics, including an application-specific integrated circuit chip. The System also entails a reader device that powers the implant and collects data via radiofrequency communication.
Perl et al (2020) noted that during the coronavirus disease 2019 (COVID-19) pandemic, many patients refrained from inpatient medical care. For those inflicted with HF, the risk of repeat hospitalizations is especially high in case of infection. This presented an important opportunity for remote monitoring of hemodynamic data for these patients, in order to detect and treat accordingly. In a single-case study, these researchers reported the first measurements of a novel wireless LAP monitoring system, the V-LAP, during the COVID-19 pandemic. The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) Trial was a 1st-in-man clinical study examining the safety and feasibility of the V-LAP monitoring system. The t patient, a 59-year-old man with severe ischemic cardiomyopathy (LVEF = 30 %) was enrolled before the COVID-19 outbreak. As per protocol, both the patient and the medical team were blinded to the results in the first 3 months following implantation. They were able to witness the LAP during the pandemic, as the patient remained under-treated, demonstrating a gradual increase from a mean pressure of 6.56 to 19.4 mmHg, as well as prominent V waves, before the data became available to the medical team and the patient was treated accordingly. Thereafter, pressures have returned to low values. The authors concluded that as they awaited the full results of the 1st‐in human experience with the V‐LAP monitoring system, this case showed that remote patient management guided by invasive means has the potential to significantly improve patient management and/or outcomes, without the need for physical presence at the hospital. These researchers stated that the COVID‐19 pandemic has highlighted the importance of safe and clinically appropriate solutions for remote telemonitoring in patients with HF, and the future of this field appeared promising.
Perl et al (2022) stated that patients with HF are at an increased risk of hospital admissions. These investigators described the feasibility, safety and accuracy of a novel wireless LAP monitoring system in patients with HF. The VECTOR-HF Trial was a prospective, open-label, single-arm, multi-center, first-in-human clinical trial to examine the safety, performance, and usability of the V-LAP System in patients with NYHA class III HF. The device was implanted in the inter-atrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes. A total of 24 patients have received implants of the LAP-monitoring device; and no device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, NYHA class improved in 40 % of the patients (95 % CI: 16.4 % to 63.5 %), while the 6MWT distance had not changed significantly (313.9 ± 144.9 versus 232.5 ± 129.9 meters; p = 0.076). The authors concluded that the V-LAP left atrium monitoring system appeared to be safe and accurate. Moreover, these researchers stated that these initial promising findings of the first 24 patients from the VECTOR-HF Trial will be confirmed in future studies, including prospective RCTs.
The authors stated that this trial had several drawbacks. First, this report was an initial observation of an ongoing first-in-human clinical study; thus, both primary and secondary outcomes needed to be appraised cautiously. Second, the question of the true gold standard of left-sided pressure measurements remains. In this trial, the V-LAP measurement was compared to a Swan-Ganz catheter measurement of PCWP at implantation and after 3 months. However, Swan-Ganz catheter measurement has previously been proven to suffer from several disadvantages, limiting the authors’ ability to assess the device's accuracy and precision. Third, clinical endpoints were also compared to baseline, whereas medical changes based on the V-LAP measurements began after 3 months. Fourth, this trial was not powered to assess clinical endpoints, such as HF re-admission rates or mortality.
D'Amario et al (2023) noted that in patients with HF, implantable hemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left-sided hemodynamic sensors offer theoretical benefits beyond PAP monitoring systems. These investigators examined the safety, usability, and performance of a novel LAP monitoring system in HF patients. The VECTOR-HF Trial was a first-in-human, prospective, multi-center, single-arm, clinical trial enrolling 30 patients with HF. The device consisted of an inter-atrial positioned leadless sensor, able to transmit LAP data wirelessly. After 3 months, a right heart catheterization was carried out to correlate mean PCWP with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute MACNE. At 3 months, freedom from short-term MACNE was 97 %. Agreement between sensor-calculated LAP and PCWP was consistent, with a mean difference of -0.22 ± 4.92 mmHg, the correlation coefficient and the Lin's concordance correlation coefficient values were equal to 0.79 (p < 0.0001) and 0.776 (95 % CI: 0.582 to 0.886), respectively. Preliminary experience with V-LAP-based HF management was associated with significant improvements in NYHA functional class (32 % of patients reached NYHA class II at 6 months, p < 0.005; 60 % of patients at 12 months, p < 0.005) and 6MWT distance (from 244.59 ± 119.59 m at baseline to 311.78 ± 129.88 m after 6 months, p < 0.05, and 343.95 ± 146.15 m after 12 months, p < 0.05). The authors concluded that the V-LAP monitoring system proved to be generally safe and provided good correlation with invasive PCWP. Preliminary clinical results were encouraging, supporting a possible leading role for left-sided pressure-guided management in patients with HF. Moreover, these researchers stated that further investigations are needed to confirm the long-term safety and performance of the V-LAP device in patients with HF and, more importantly, powered enough to test the effectiveness of this strategy when compared to the current SOC in preventing HF-related re-hospitalization and major adverse cardiac events (MACE).
The authors stated that this trial had several drawbacks. First, this study was a non-randomized first-in-human clinical trial designed to prove the safety, usability and performance of the V-LAP device. It was not statistically powered to examine the clinical effectiveness of the V-LAP System-based medical management of HF patients. The small size of the study cohort might have hidden uncommon adverse events (AEs). Second, previous evidence on left-sided hemodynamic monitoring is scarce, and the comparison to the commercially available PAP sensors can generate some inconsistencies. The V-LAP accuracy assessment, conducted as a comparison between LAP and invasively measured PCWP, did not consider the possible mismatch between left- and right-sided intra-cardiac pressures. Moreover, PCWP estimation is operator-dependent and is subject to the error of the fluid-filled catheter. Direct LAP assessment through left heart catheterization could grant a more reliable comparison with V-LAP-derived LAP and a more solid LAP calibration, although at the expense of a higher invasiveness. Third, device-measured LAP and PCWP correlation was only assessed with values at rest. Exercise RHC-derived correlations would have been a further important strength, granting a full validation of V-LAP use during effort. Moreover, these investigators stated that a noteworthy temporal limitation was present. The stability of the device was only confirmed at a 3-month follow-up period; therefore, overlooking the possibility of a later material aging and pressure drift. Furthermore, over more than 3 years, technical feedback from the VECTOR-HF Trial experience has inspired corrective actions in device engineering. These changes, although minor, might have positively affected the technical performance of patients enrolled later. In addition, these investigators noted that the substantial rate of 30 % potential failure in LAP measurements within 30 months was not negligible. There were technical challenges in providing accurate long-term pressure measurements, and published data regarding the long accuracy and functionality of implantable sensors were very limited. During this study, several root causes of device deficiencies, which compromised its long-term performance, were identified and corrected. Automatic early detection of potential causes of sensor failure was developed and validated during this study, and will serve as foundation for future studies.
Schneider et al (2023) noted that there is robust evidence for the effectiveness of telemedicine in patients with HF to reduce mortality and morbidity. For the first-time, the Federal Joint Committee (G-BA) has approved telemedicine for HF patients as a digital method of care for a well-defined HF population. Patients with HF and a reduced LVEF of less than 40 % are now eligible for tele-monitoring in a real-world settings of out-patient care in Germany. The implementation of telemedicine in the German healthcare system is a complex process including the introduction of telemedical technologies, educational programs for the patients as well as the implementation of standard operating procedures (SOPs) for the staff of telemedical centers. The ongoing research in telemedicine in HF patients is focusing on 3 issues. First, research to extend the suitable HF-population for telemonitoring. Second, research on new telemedical sensor technologies (e.g. a new pulmonary pressure measurement system (Cordella) and a system for wireless measurement of left atrial pressure (V-LAP). Third, the introduction of methods of artificial intelligence (AI) (e.g. the AI-based speech analysis using a smart phone to characterize the pulmonary fluid status).
Manavi et al (2024) stated that HF is a multi-faceted, complex clinical syndrome characterized by significant morbidity, high mortality rate, reduced QOL, and rapidly increasing healthcare costs. A larger proportion of these costs comprise both ambulatory and emergency department visits, as well as hospital admissions. Despite the methods used by telehealth (TH) to improve self-care and OL, patient outcomes remain poor. Management of patients with HF is associated with numerous challenges, such as conflicting evidence from clinical trials, heterogeneity of TH devices, variability in patient inclusion and exclusion criteria, and discrepancies between healthcare systems. A growing body of evidence suggests there is an unmet need for increased individualization of in-hospital management, continuous remote monitoring of patients pre and post-hospital admission, and continuation of treatment post-discharge in order to reduce re-hospitalizations and improve long-term outcomes. The authors summarized the current state-of-the-art for HF and associated novel technologies and advancements in the most frequently used types of TH (implantable sensors), categorizing devices in their pre-clinical as well as clinical stage, bench-to-bedside implementation challenges, and future perspectives on remote HF management to improve long-term outcomes of HF patients. This review also highlighted recent advancements in non-invasive remote monitoring technologies demonstrated by a few pilot prospective, observational studies.
These investigators noted that a clinical trial demonstrated the importance of remote LAP measurements in guiding HF patient management via an advanced version of LAP monitoring, V-LAP, in the VECTOR-HF Trial. The safety, usability, and performance were assessed in 30 HF patients followed for 3-months. Post-implantation, a Swan–Ganz catheter was inserted to measure the mean PCWP invasively, and this was correlated with simultaneous mean LAP measurements obtained from the V-LAP sensor. The study showed a good correlation between invasive PCWP and its surrogate LAP and significant improvements in clinical symptoms such as NYHA class (60 % of patients improved from Class III to II) and freedom from MACNE (97 % at 3 months). The next-generation V-LAP System is a miniature, percutaneous, wireless, and leadless pressure sensor implanted permanently in the atrial septum using a trans-septal approach. It comprises 4 parts: a leadless LAP sensor with a low profile design and a novel drift compensatory mechanism, a dedicated delivery system with a re-positioning mechanism, an external reader device in the form of a wearable belt that remotely powers the sensor and a secure web-based database available to clinicians for review. The implant features a hermetically sealed body housing sensing elements and a nitinol braided double disc-anchor. The discs are deployed on both sides of the inter-atrial septum, ensuring firm positioning post-implantation while the sealed body crosses the septum. The wearable belt can be placed over the clothing around the chest for 1 to 3 mins to carry out daily measurements. The pre-clinical testing of the V-LAP monitoring system showed the safety, accuracy, and effectiveness of measurements with the wearable belt at depths of up to 30 cm. Although the experiments with the V-LAP device were a big success, the limitations include indirect measurements of LAP, i.e., PCWP, and the requirement to validate the accuracy of measurements beyond hypervolemic and hypertensive conditions. Moreover, these researchers stated that overall both the invasive and non-invasive TH platforms represent a promising avenue for improving HF management and outcomes. By promoting patient adherence and enabling more personalized and proactive care, these platforms have the potential to revolutionize HF management in the future.
Furthermore, an UpToDate review on “Treatment and prognosis of heart failure with preserved ejection fraction” (Borlaug and Colucci, 2024) states that “Remote PA pressure monitoring requires implantation of a small, remote sensor in the PA during a procedure similar to a right heart catheterization. Once home, the patient uses a pillow with a built-in receiver to obtain daily PA pressure readings, which are then transmitted and displayed to the patient's team. The goal of monitoring is to manage the patient's volume status using trends in PA pressures aѕ a surrogate measure of ventricular filling pressures. One study suggested that changes in PA pressure occurred prior to an exacerbation of HF by 19 ± 17 days for patients with НFpЕF and by 29 ± 22 days for patients with HFrEF. Trials that tested the efficacy of PA pressure monitoring show that hemodynamic monitoring may reduce НF admissions. However, these studies were not limited to patients with ΗFрΕF and had methodologic issues (e.g., enrollment and event adjudication during the coronavirus 2019 [COVID-19] pandemic, violation of trial protocols, lack of blinding) that limit their generalizability”.
References
The above policy is based on the following references:
- Abraham WT. Disease management: Remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors. Europace. 2013;15 Suppl 1:i40-i46.
- Abraham WT. The role of implantable hemodynamic monitors to manage heart failure. Heart Fail Clin. 2015;11(2):183-189.
- Abraham WT. The role of implantable hemodynamic monitors to manage heart failure. Cardiol Clin. 2017;35(2):273-279.
- Ancona GD, Murero M, Feickert S, et al. Implantation of an innovative intracardiac microcomputer system for web-based real-time monitoring of heart failure: Usability and patients' attitudes. JMIR Cardio. 2021;5(1):e21055.
- Arenja N, Breidthardt T, Socrates T, et al. Risk stratification for 1-year mortality in acute heart failure: Classification and regression tree analysis. Swiss Med Wkly. 2011;141:w13259.
- Borlaug BA, Colucci WS. Treatment and prognosis of heart failure with preserved ejection fraction. UpToDate [online serial], Waltham, MA: UpToDate; reviewed October 2024.
- Bourge RC, Abraham WT, Adamson PB e al, on behalf of the COMPASS-HF Study Group. Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: The COMPASS-HF Study. J Am Coll Card. 2008;51 (11):1073-1079.
- Bui AL, Fonarow GC. Home monitoring for heart failure management. J Am Coll Cardiol. 2012;59(2):97-104.
- Clephas PRD, Radhoe SP, Boersma E, et al. Efficacy of pulmonary artery pressure monitoring in patients with chronic heart failure: A meta-analysis of three randomized controlled trials. Eur Heart J. 2023;44(37):3658-3668.
- Curtain JP, Lee MMY, McMurray JJ, et al. Efficacy of implantable haemodynamic monitoring in heart failure across ranges of ejection fraction: A systematic review and meta-analysis. Heart. 2023;109(11):823-831.
- D'Amario D, Meerkin D, Restivo A, et al; VECTOR-HF Trial Investigators. Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: The VECTOR-HF trial. J Heart Fail. 2023;25(6):902-911.
- Dunlay SM. Colucci WS. Management of refractory heart failure with reduced ejection fraction. UpToDate [online serial], Waltham, MA: UpToDate; reviewed July 2024.
- Giordano A, Zanelli E, Scalvini S. Home-based telemanagement in chronic heart failure: An 8-year single-site experience. J Telemed Telecare. 2011;17(7):382-386.
- Hunt SA, Abraham WT, Chin MH, et al. 2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009;119(14):e391-e479.
- Ibrahim M, Rao C, Athanasiou T, et al. Mechanical unloading and cell therapy have a synergistic role in the recovery and regeneration of the failing heart. Eur J Cardiothorac Surg. 2012;42(2):312-318.
- Kommuri NV, Koelling TM, Hummel SL. The impact of prior heart failure hospitalizations on long-term mortality differs by baseline risk of death. Am J Med. 2012;125(2):209.e9-209.e15.
- Lindenfeld J, Albert NM, Boehmer JP, et al. Managing patients with hypertension and heart failure: HFSA 2010 comprehensive heart failure practice guideline. J Card Fail. 2010;16(6):e166-e168.
- Manavi T, Zafar H, Sharif F. An era of digital healthcare -- A comprehensive review of sensor technologies and telehealth advancements in chronic heart failure management. Sensors (Basel). 2024;24(8):2546.
- 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.
- Mooney DM, Fung E, Doshi RN, Shavelle DM. Evolution from electrophysiologic to hemodynamic monitoring: the story of left atrial and pulmonary artery pressure monitors. Front Physiol. 2015;6:271.
- Perl L, Avraham BB, Vaknin-Assa H, et al. A rise in left atrial pressure detected by the V-LAP™ system for patients with heart failure during the coronavirus disease 2019 pandemic. ESC Heart Fail. 2020;7(6):4361-4366.
- Perl L, Avraham BB, Vaknin-Assa H, et al. A rise in left atrial pressure detected by the V-LAP™ system for patients with heart failure during the coronavirus disease 2019 pandemic. ESC Heart Fail. 2020;7(6):4361-4366.
- 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.
- 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.
- 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.
- Roger VL, Go AS, Lloyd-Jones D, et al. Heart disease and stroke statistics -- 2011 update: A report from the American Heart Association. Circulation. 2011;123(4):e114-e118.
- Schneider D, Kohler K, Kohler F. Telemedicine in cardiology - what is new? Dtsch Med Wochenschr. 2023;148(12):767-773.
- Troughton RW, Ritzema J, Eigler NL, et al; HOMEOSTASIS Investigators. Direct left atrial pressure monitoring in severe heart failure: Long-term sensor performance. J Cardiovasc Transl Res. 2011;4(1):3-13.
- U.S. National Institutes of Health (NIH), National Library of Medicine. Left atrial pressure monitoring to optimize heart failure therapy (LAPTOP-HF). ClinicalTrials.gov Identifier: NCT01121107. Bethesda, MD: NIH; updated: August 26, 2011.
- U.S. National Institutes of Health (NIH), National Library of Medicine (NLM). Left atrial pressure monitoring to optimize heart failure therapy (LAPTOP-HF). ClinicalTrials.gov Identifier: NCT01121107. Bethesda, MD: NIH; last verified May 2016.
- 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.
- Walton AS, Krum H. The Heartpod implantable heart failure therapy system. Heart Lung Circ. 2005;14 Suppl 2:S31-S33.