Pulmonary Artery Pressure Monitoring Research Articles

Effectiveness of remote pulmonary artery pressure estimating in heart failure: systematic review and meta-analysis

Heart failure (HF) poses a significant challenge, often leading to frequent hospitalizations and compromised quality of life. Continuous pulmonary artery pressure (PAP) monitoring offers a surrogate for congestion status in ambulatory HF care. This meta-analysis examines the efficacy of PAP monitoring devices (CardioMEMS and Chronicle) in preventing adverse outcomes in HF patients, addressing gaps in prior randomized controlled trials (RCTs). Five RCTs (2572 participants) were systematically reviewed. PAP monitoring significantly reduced HF-related hospitalizations (RR 0.72 [95% CI 0.6–0.87], p = 0.0006) and HF events (RR 0.86 [95% CI 0.75–0.99], p = 0.03), with no impact on all-cause or cardiovascular mortality. Subgroup 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. PAP monitoring devices exhibit promise in diminishing HF hospitalizations and events, especially in CardioMEMS and blinded studies. However, their influence on mortality remains inconclusive. Further research, considering diverse patient populations and intervention strategies with extended follow-up, is crucial for elucidating the optimal role of PAP monitoring in HF management.

Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial.

In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups. The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronisation therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life, clinical, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented. The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were nonsignificant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = 0.03; adjusted Pinteraction = 0.33) and diabetics (Pinteraction = 0.01; adjusted Pinteraction = 0.06) were observed. However, these interaction effects did not persist after adjusting for multiple testing. This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients.

MEMS Technology in Cardiology: Advancements and Applications in Heart Failure Management Focusing on the CardioMEMS Device.

Heart failure (HF) is a complex clinical syndrome associated with significant morbidity, mortality, and healthcare costs. It is characterized by various structural and/or functional abnormalities of the heart, resulting in elevated intracardiac pressure and/or inadequate cardiac output at rest and/or during exercise. These dysfunctions can originate from a variety of conditions, including coronary artery disease, hypertension, cardiomyopathies, heart valve disorders, arrhythmias, and other lifestyle or systemic factors. Identifying the underlying cause is crucial for detecting reversible or treatable forms of HF. Recent epidemiological studies indicate that there has not been an increase in the incidence of the disease. Instead, patients seem to experience a chronic trajectory marked by frequent hospitalizations and stagnant mortality rates. Managing these patients requires a multidisciplinary approach that focuses on preventing disease progression, controlling symptoms, and preventing acute decompensations. In the outpatient setting, patient self-care plays a vital role in achieving these goals. This involves implementing necessary lifestyle changes and promptly recognizing symptoms/signs such as dyspnea, lower limb edema, or unexpected weight gain over a few days, to alert the healthcare team for evaluation of medication adjustments. Traditional methods of HF monitoring, such as symptom assessment and periodic clinic visits, may not capture subtle changes in hemodynamics. Sensor-based technologies offer a promising solution for remote monitoring of HF patients, enabling early detection of fluid overload and optimization of medical therapy. In this review, we provide an overview of the CardioMEMS device, a novel sensor-based system for pulmonary artery pressure monitoring in HF patients. We discuss the technical aspects, clinical evidence, and future directions of CardioMEMS in HF management.

Exploring the Efficacy of Pulmonary Artery Pressure Monitoring in Rural LVAD Patients: A Retrospective Cohort Study on Clinical Outcomes

Exploring the Efficacy of Pulmonary Artery Pressure Monitoring in Rural LVAD Patients: A Retrospective Cohort Study on Clinical Outcomes

Cost-effectiveness of remote haemodynamic monitoring by an implantable pulmonary artery pressure monitoring sensor (CardioMEMS-HF system) in chronic heart failure in the Netherlands.

Remote haemodynamic monitoring with an implantable pulmonary artery (PA) sensor has been shown to reduce heart failure (HF) hospitalizations and improve quality of life. Cost-effectiveness analyses studying the value of remote haemodynamic monitoring in a European healthcare system with a contemporary standard care group are lacking. A Markov model was developed to estimate the cost-effectiveness of PA-guided therapy compared to the standard of care based upon patient-level data of the MONITOR-HF trial performed in the Netherlands in patients with chronic HF (New York Heart Association class III and at least one previous HF hospitalization). Cost-effectiveness was measured as the incremental cost per quality-adjusted life year (QALY) gained from the Dutch societal perspective with a lifetime horizon which encompasses a wide variety of costs including costs of hospitalizations, monitoring time, telephone contacts, laboratory assessments, and drug changes in both treatment groups. In the base-case analysis, PA-guided therapy increased costs compared to standard of care by €12 121. The QALYs per patient for PA-guided therapy and standard of care was 4.07 and 3.481, respectively, reflecting a gain of 0.58 QALYs. The resulting incremental cost-effectiveness ratio was €20 753 per QALY, which is below the Dutch willingness-to-pay threshold of €50 000 per QALY gained for HF. The current cost-effectiveness study suggests that remote haemodynamic monitoring with PA-guided therapy on top of standard care is likely to be cost-effective for patients with symptomatic moderate-to-severe HF in the Netherlands.

Wireless Pulmonary Artery Pressure Monitor Implantation in a Patient with Duchenne Muscular Dystrophy.

Assessing heart failure progression in patients with Duchenne Muscular Dystrophy (DMD) is challenging given the multi-system nature of disease. Herein we describe the first case use of an implantable pulmonary artery pressure monitor and describe the potential clinical utility of this approach in patients with DMD.

Assessing the impact of haemodynamic monitoring with CardioMEMS on heart failure patients: a cost-benefit analysis.

The objective of this study was to perform a cost-benefit analysis of the CardioMEMS HF System (Abbott Laboratories, Abbott Park, IL, USA) in a heart failure (HF) clinic in Spain by evaluating the real-time remote monitoring of pulmonary artery pressures, which has been shown to reduce HF-related hospitalizations and improve the quality of life for selected HF patients. Particularly, the study aimed to determine the value of CardioMEMS in Southern Europe, where healthcare costs are significantly lower and its effectiveness remains uncertain. This single-centre study enrolled all consecutive HF patients (N=43) who had been implanted with a pulmonary artery pressure sensor (CardioMEMS HF System); 48.8% were females, aged 75.5±7.0years, with both reduced and preserved left ventricular ejection fraction; 67.4% of them were in New York Heart Association Class III. The number of HF hospitalizations in the year before and the year after the sensor implantation was compared. Quality-adjusted life years gained based on a literature review of previous studies were calculated. The rate of HF hospitalizations was significantly lower at 1year compared with the year before CardioMEMS implantation (0.25 vs. 1.10 events/patient-year, hazard ratio 0.22, P=0.001). At the end of the first year, the usual management outperformed the CardioMEMS HF System. By the end of the second year, the CardioMEMS system is estimated to reduce costs compared with usual management (net benefits of €346). Based on the results, we suggest that remote monitoring of pulmonary artery pressure with the CardioMEMS HF System represents a midterm and long-term efficient strategy in a healthcare setting in Southern Europe.

Fast-track extubation guided by pulmonary artery pressure monitoring after ventricular septal defect closure in infants with pulmonary hypertension

BackgroundThe fast-track extubation approach in pediatric cardiac surgery shortens hospital stays and reduces medical costs. ObjectivesThis study aims to evaluate the feasibility of the fast-track extubation approach and the role of intraoperative pulmonary artery pressure (PAP) monitoring in managing patients with preoperative pulmonary hypertension (PH) who underwent ventricular septal defect (VSD) closure. MethodsThis retrospective study included 102 infants with VSD and preoperative PH (mean PAP > 20 mmHg on cardiac catheterization). We excluded four cases that required complex procedures with long cardiopulmonary bypass time for associated lesions. Intraoperative systolic PAP monitoring was performed to evaluate the suitability of the fast-track extubation approach (<35 mmHg). We defined the fast-track extubation approach as extubation in the operation room after VSD closure. This study also aimed to assess the predictors of postoperative adverse events. Postoperative adverse events included in-hospital death, PH crisis and prolonged mechanical ventilation time, and nitric oxide (NO) administration. ResultsThe fast-track extubation approach was carried out in 39 patients (38 %). One in-hospital death (1 %) occurred in a non-fast-track patient due to postoperative PH crisis. Two patients (5.1 %) required re-intubation after the fast-track extubation approach due to upper airway issues. The frequency of NO inhalation and administration of pulmonary hypertensive medicines was significantly lower in the fast-track group than in the non-fast-track group (P < 0.001). Multivariate analysis revealed that body weight of <4 kg at surgery (P = 0.006), surgery by trainees (P = 0.003), and greater intraoperative systolic PAP (P < 0.001) were significant risk factors for postoperative adverse events. ConclusionsOur findings showed that the fast-track extubation approach after VSD closure in infants with preoperative PH was feasible, as indicated by the low frequency of re-intubation and postoperative adverse events. Intraoperative systolic PAP measurement was useful for selecting patients to be included in the fast-track extubation approach.

Remote Pulmonary Artery Pressure Monitoring: Perceived Barriers To Utilization At A Large Academic Medical Center

Remote Pulmonary Artery Pressure Monitoring: Perceived Barriers To Utilization At A Large Academic Medical Center

Anatomical characterization of pulmonary artery and implications to pulmonary artery pressure monitor implantation

In patients with heart failure, guideline directed medical therapy improves outcomes and requires close patient monitoring. Pulmonary artery pressure monitors permit remote assessment of cardiopulmonary haemodynamics and facilitate early intervention that has been shown to decrease heart failure hospitalization. Pressure sensors implanted in the pulmonary vasculature are stabilized through passive or active interaction with the anatomy and communicate with an external reader to relay invasively measured pressure by radiofrequency. A body mass index > 35 kg/m2 and chest circumference > 165 cm prevent use due to poor communication. Pulmonary vasculature anatomy is variable between patients and the pulmonary artery size, angulation of vessels and depth of sensor location from the chest wall in heart failure patients who may be candidates for pressure sensors remains largely unexamined. The present study analyses the size, angulation, and depth of the pulmonary artery at the position of implantation of two pulmonary artery pressure sensors: the CardioMEMS sensor typically implanted in the left pulmonary artery and the Cordella sensor implanted in the right pulmonary artery. Thirty-four computed tomography pulmonary angiograms from patients with heart failure were analysed using the MIMICS software. Distance from the bifurcation of the pulmonary artery to the implant site was shorter for the right pulmonary artery (4.55 ± 0.64 cm vs. 7.4 ± 1.3 cm) and vessel diameter at the implant site was larger (17.15 ± 2.87 mm vs. 11.83 ± 2.30 mm). Link distance (length of the communication path between sensor and reader) was shorter for the left pulmonary artery (9.40 ± 1.43 mm vs. 12.54 ± 1.37 mm). Therefore, the detailed analysis of pulmonary arterial anatomy using computed tomography pulmonary angiograms may alter the choice of implant location to reduce the risk of sensor migration and improve readability by minimizing sensor-to-reader link distance.

Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial (final results)

Abstract Background In heart failure (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 pulmonary artery pressure (PAP) monitoring systems. Aims We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients (V-LAP). Methods and Results The VECTOR-HF study was a first-in-human, prospective, multicenter, single-arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After three months, a right heart catheterization (RHC) was performed to correlate mean pulmonary capillary wedge pressure (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 Major Adverse Cardiac and Neurological Events (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±4.92mmHg, the correlation coefficient and the Lin’s Concordance Correlation Coefficient values were equal to 0.79 (P&amp;lt;0.0001) and 0.776 (95%CI=0.582-0.886), respectively. Preliminary experience with VLAP-based HF management was associated with significant improvements in NYHA functional class (32% of patients reached NYHA II class at 6 months, P&amp;lt;0.005; 60% of patients at 12 months, P&amp;lt;0.005) and 6-minute walk-test distance (from 244.59±119.59m at baseline to 311.78±129.88m after 6 months, P&amp;lt;0.05, and 343.95±146.15m after 12 months, P&amp;lt;0.05). Conclusion The V-LAP™ monitoring system proved to be safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms that could be associated to a better outcome. Further studies are needed to test the efficacy of the device in heart failure patients.

Novel uses for implanted haemodynamic monitoring in adults with subaortic right ventricles

BackgroundPulmonary hypertension (PH) is a common complication in patients with complete dextro-transposition of the great arteries (TGA) after atrial switch (D-TGA/AS) and congenitally corrected TGA (ccTGA). In this population with...

Abstract 18010: Trends in CardioMEMS Use Among Patients With Heart Failure in the US

Introduction: The implantable pulmonary artery pressure (PAP) monitor, CardioMEMS, has been shown to reduce heart failure (HF) hospitalizations and improve quality of life among patients with symptomatic heart failure. However, uptake of the CardioMEMS device has been limited, and its utilization across sociodemographic groups has not been studied. Methods: This was a retrospective study of commercially insured patients in the US from October 1, 2015 to October 1, 2020, using the Optum Clinformatics Data Mart. Adult patients (age &gt; 18) with heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) were included in the analysis. Multivariable logistic regression models were used to assess the factors associated with CardioMEMS placement. Results: There were 501,755 HFpEF and HFrEF patients who met inclusion criteria. Of these, 1,042 (0.002%) had CardioMEMs devices implanted. Rate of CardioMEMS implantation has increased over the last 6 years (0.04% in 2015 vs. 0.35% in 2021) but remains low, particularly among Asian and Hispanic patients (Figure 1). In a multivariable analysis, compared to patients who did not have a CardioMEMS device, those who did were more likely to have a higher income (&gt;$100,000) (Adjusted odds ratio (AOR) 1.39, 1.16-1.67, p&lt;0.001). Patients in the Southern United States (AOR 0.52, CI 0.43-0.62, p&lt;0.0001) and older patients (AOR: 0.96, CI 0.95-0.96, p &lt;0.001) were less likely to have a CardioMEMS device implanted. Patients with CardioMEMS were more likely to have chronic kidney disease, obesity, and valvular pathology (p &lt;0.0001). No gender differences were seen in CardioMEMS utilization. Conclusions: Overall utilization of the CardioMEMS device is low, but rising. CardioMEMS utilization is not distributed equally across demographic groups—younger patients and those with higher incomes were more likely to have the device implanted.

Abstract 12114: Advancing Heart Failure Knowledge and Therapies Through a Multicenter Registry and Innovative Platform for Extended Outpatient Hemodynamic Monitoring: The Hemodynamic Frontiers in Heart Failure (HF 2 )

Background: Hemodynamic Frontiers in Heart Failure (HF 2 ) is a multicenter research consortium of institutions with active remote pulmonary artery pressure monitoring programs that aims to promote research in this field. The consortium recently created a registry of patients with pulmonary artery hemodynamic (HD) monitors (HDM) to facilitate the research mission. Goals/Aims: HF 2 registry aims to collect demographic, clinical, laboratory, echocardiographic and HD data from HDM patients to create a test bed to advance scientific knowledge about ambulatory HD monitoring and quickly evaluate new therapies. Methods: HF 2 includes patients aged &gt;18 who would have been implanted with a HDM as per FDA indications of NYHA Class III HF diagnosis with a prior hospitalization or patients with NYHA Class II or BNP elevation without hospitalization. HF 2 registry data warehouse rests through University of Kansas Medical Center (KUMC) and was approved by their institutional review board (IRB) board followed by local IRBs at participating institutions with required Data use agreements. Institutions report data into the electronic registry database using REDCap, housed at KUMC. Results: This initial data set includes 254 patients implanted from 2019 until May 2023. See Table 1 for initial demographic, comorbidity, laboratory, echocardiographic, and medication data. See Table 2 for HD measurements at time of implant. Conclusion: A real-world registry/test bed of patients with HDM can evaluate long-term outcomes in such patients, provide data in unique patient groups, and provide an opportunity to evaluate HD effects of new HF therapies in rapid turnaround cross over trials.

The War Against Heart Failure Hospitalizations: Remote Monitoring and the Case for Expanding Criteria.

Successful remote patient monitoring depends on bidirectional interaction between patients and multidisciplinary clinical teams. Invasive pulmonary artery pressure monitoring has been shown to reduce heart failure (HF) hospitalizations, facilitate guideline-directed medical therapy optimization, and improve quality of life. Cardiac implantable electronic device-based multiparameter monitoring has shown encouraging results in predicting future HF-related events. Potential expanded indications for remote monitoring include guideline-directed medical therapy optimization, application to specific populations, and subclinical detection of HF. Voice analysis, inferior vena cava diameter monitoring, and artificial intelligence-based remote electrocardiogram show potential to gain some merit in remote patient monitoring in HF.

Real-time pulmonary artery pressure monitoring in heart failure patients: an updated cost-effectiveness analysis.

Previous cost-effectiveness analysis suggests that CardioMEMS is cost-effective compared with usual care for patients with persistent New York Heart Association class III symptoms and at least one heart failure (HF) hospitalization within 12months. The aim of the paper is to perform an update of the cost-effectiveness analysis of CardioMEMS using the most recent data from the published literature. A Microsoft Excel Markov model from a previous UK cost-effectiveness study of CardioMEMS was updated using the clinical effectiveness of pulmonary artery pressure (PAP)-guided treatment derived from the pivotal trials. The model included the device costs (and the implantation procedure and related complications), costs of remote monitoring, costs of HF-related hospitalizations, and costs of usual care. Quality-adjusted life years (QALYs) were estimated based on utilities from pivotal trials and published literature. Cost-effectiveness results were estimated as incremental cost per QALY gained of CardioMEMS compared with usual care. Scenario analyses were also performed using data from real-world studies that showed a significant decrease in HF-related hospitalizations. In the base case analysis over a time horizon of 10years, PAP-guided HF therapy increased cost compared with usual care by £6337 (i.e. from £22770 in usual care to £29107 in PAP-guided HF therapy) and the QALYs per patient for usual care and PAP-guided patients were 2.62 and 2.94, respectively, reflecting an increase of 0.32 QALYs with PAP-guided treatment. The resultant incremental cost-effectiveness ratio (ICER), the ratio between incremental costs and the QALYs, is estimated at £19761/QALY. Scenario analyses suggest that the ICER for CardioMEMS can range from being dominant to £27910/QALY. Probabilistic sensitivity analyses suggested that PAP-guided HF therapy has 81.9% probability of being cost-effective at a threshold of £30000/QALY. Our model suggests that CardioMEMS is likely to be cost-effective in the United Kingdom, at the currently considered thresholds of £20000-30000/QALY.

90-Day Outcomes of Pulmonary Artery Pressure Monitoring Device (CardioMEMS)

90-Day Outcomes of Pulmonary Artery Pressure Monitoring Device (CardioMEMS)

Group 2 pulmonary hypertension: from diagnosis to treatment.

Pulmonary hypertension associated with left heart disease (PHLHD) is common and associated with adverse prognosis. Proper diagnosis is critical to avoid inappropriate treatment. Practical approaches to noninvasive diagnosis are available, though invasive hemodynamics including volume loading or exercise are often necessary for definitive diagnosis. Treatment strategies and research in the field is rapidly evolving. Combined pre and post capillary pulmonary hypertension is associated with remodeling of the pulmonary vasculature that is proportional to the severity of the pulmonary hypertension. Even quite mild elevation of pulmonary vascular resistance (PVR), (greater than 2.0 Wood units (WU)) is associated with adverse outcome. Guideline-directed medical therapy (GDMT) for left heart failure has rapidly evolved, including approval of SGLT2 inhibitors for treatment of heart failure with preserved ejection fraction (HFpEF). However, full implementation of GDMT is lagging. Utilization of implanted pulmonary artery pressure monitoring can facilitate patient management in selected patient phenotypes and has been utilized to demonstrate improvement in pulmonary pressures with emerging therapies in HFpEF including SGLT2 inhibitors and sacubitril/valsartan. A variety of shunt devices to create a left-to-right shunt in order to decompress the left heart are available or undergoing clinical trials. There is concern that there could be adverse response to such devices in patients who have even mild elevation of pulmonary vascular resistance. Sleep disordered breathing is common in PHLHD and should be aggressively sought out and treated. Even mild elevation in pulmonary vascular resistance is associated with adverse outcome. A systematic approach to diagnosis of PHLHD is essential. Guideline-directed medical therapy for PHLHD prioritizes optimal management of the left heart disease. Pulmonary artery pressure sensors are useful in selected patients.

Translating Pressure Into Practice: Operational Characteristics of Ambulatory Hemodynamic Monitoring Program in the United States

BackgroundAmbulatory hemodynamic monitoring (AHM) using an implantable pulmonary artery pressure sensor (CardioMEMS) is effective in improving outcomes for patients with heart failure. The operations of AHM programs are crucial to clinical efficacy of AHM yet have not been described. Methods and ResultsAn anonymous, voluntary, web-based survey was developed and emailed to clinicians at AHM centers in the United States. Survey questions were related to program volume, staffing, monitoring practices, and patient selection criteria. Fifty-four respondents (40%) completed the survey. Respondents were 44% (n = 24) advanced HF cardiologists and 30% (n = 16) advanced nurse practitioners. Most respondents practice at a center that implants left ventricular assist devices (70%) or performs heart transplantation (54%). Advanced practice providers provide day-to-day monitoring and management in most programs (78%), and use of protocol-driven care is limited (28%). Perceived patient nonadherence and inadequate insurance coverage are cited as the primary barriers to AHM. ConclusionsDespite broad US Food and Drug Administration approval for patients with symptoms and at increased risk for worsening heart failure, the adoption of pulmonary artery pressure monitoring is concentrated at advanced heart failure centers, and modest numbers of patients are implanted at most centers. Understanding and addressing the barriers to referral of eligible patients and to broader adoption in community heart failure programs is needed to maximize the clinical benefits of AHM.

Implantable haemodynamic sensor to remotely MONITOR HF.

Results from the MONITOR-HF trial show that remote monitoring of pulmonary artery pressure using the implantable CardioMEMS sensor in patients with chronic heart failure improves quality of life and reduces hospitalizations.