Reduction in 90 day readmission rates utilizing ambulatory pulmonary pressure monitoring

Introduction: Heart failure (HF) is the most frequent discharge diagnosis for hospitalized Medicare beneficiaries. Readmission after a HF hospitalization (HFH) is an important metric for quality of care. Under the Hospital Readmissions Reduction Program (HRRP), hospitals with excess all-cause 30-day readmissions may be penalized for inadequate quality of care. Results from the CHAMPION trial confirmed that HF management using pulmonary artery pressure (PAP) monitoring from an implanted sensor in patients with NYHA Class III HF reduced HFH rates compared to standard management. However, the impact of this strategy on HFH rates and all-cause 30-day readmissions in Medicare-eligible patients is unknown. Methods: Retrospective analyses of patients 65 years or older at baseline in the CHAMPION trial were performed. HFH rates and 30-day readmissions in this subgroup were compared. Excess readmission ratios reported by the HRRP were then compared with the CHAMPION readmission ratio resulting from PAP monitoring. Results: 245 patients in CHAMPION (45%) were 65 years or older at the time of PA sensor implantation (120 in the Treatment group and 125 in the Control group). Patients in the Treatment group managed with PAP monitoring had a significantly lower HFH rate (60 HFH, 0.34/year) compared to the Control group (117 HFH, 0.67/year) (IRR 0.51, 95% CI 0.37-0.70, p<0.0001). The Treatment group had a significantly reduced 30-day readmissions rate (13 readmissions, 0.07/year) compared to the Control group (31 readmissions, 0.18/year) (IRR 0.42, 95% CI 0.20-0.82, p=0.006). Using index HFH as the unit of observation for 30-day readmissions, the Treatment group ratio (13 readmissions/56 index HFH, 23.2%) was lower than the Control group ratio (31 readmissions/99 index HFH, 31.3%). PAP monitoring resulted in a CHAMPION readmission ratio (23.2%/31.3%, 0.74) that was lower than all hospital excess readmission ratios reported in the 2011 HRRP dataset. Conclusions: HF management incorporating PAP monitoring significantly reduced HFH rates and all cause 30-day readmissions in Medicare-eligible patients. Adoption of this treatment strategy at hospitals struggling with HFH and 30-day readmissions could help address an unmet need within the US health care system.

BACKGROUND:Hemodynamically guided management of patients with chronic heart failure (HF), using a remote, ambulatory pulmonary artery (PA) pressure monitor, has been shown to reduce mortality and morbidity. These improved outcomes were associated with a reduction in PA pressure. However, several pivotal questions remain unanswered: do systolic, diastolic, or mean PA pressures each predict all-cause mortality? Do PA pressures predict mortality across the ejection fraction (EF) spectrum? Do increases or decreases in PA pressure over time predict increases or decreases in mortality?METHODS:Retrospective analyses of data from CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients; n=550), GUIDE-HF (Hemodynamic-GUIDEed management of Heart Failure; n=2358), US PAS (CardioMEMS HF System Post Approval Study; n=1200), and MEMS-HF (CardioMEMS Monitoring Study for Heart Failure; n=234) were performed, including all enrolled patients regardless of treatment assignments (Total N=4342). PA systolic, PA diastolic, and PA mean pressures were examined in patients with HF and reduced EF (<50%, n=2562) and preserved EF (≥50%, n=1454). Baseline pressure (averaged over 14 days after implantation) and change in pressure (increase/decrease/no change) from baseline to 6 months (averaged over 14 days just before the 6-month time point) were related to all-cause mortality over a 2-year follow-up period.RESULTS:Baseline PA diastolic, independent of other covariates, was a significant predictor of mortality (hazard ratio, 1.04 [95% CI, 1.03–1.05]; P<0.0001). Change in PA diastolic from baseline to 6 months (assessed as a continuous variable) was an independent predictor of mortality after 6 months (landmark analysis; hazard ratio, 1.03 [95% CI, 1.01–1.05]; P=0.0042). Change in PA diastolic from baseline to 6 months(assessed as a categorical variable) decrease or increase of >2 mm Hg compared with no change predicted a 14.7% decrease and 26.7% increase in mortality, respectively (P=0.0237). PA systolic and PA mean pressures in both HF with reduced EF and HF with preserved EF patients, for both baseline and change from baseline to 6 months, were also predictive of all-cause mortality.CONCLUSIONS:Baseline PAP (systolic, diastolic, and mean) and change in PAP (systolic, diastolic, and mean) from baseline to 6 months were independent predictors of 2-year mortality in patients with chronic HF in both preserved and reduced EF.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifiers: CHAMPION, NCT00531661; GUIDE-HF, NCT03387813; USPAS, NCT02279888; MEMS-HF, NCT02693691.

MEMS stands for microelectromechanical systems and represents the devices that integrate microcomponents such as sensors and actuators on a single chip. The MEMS technology changed our world dramatically, and now MEMS can be found in many places around us including airbags, inkjet printers, game controllers, and smart phones to name a few. Integration of MEMS within biomedicine is known as Bio-MEMS,1 and its representative application is a pacemaker. More recently, by taking advantages of miniaturization, high sensitivity, wireless technology, and low energy requirement, MEMS use for implantable pressure sensor has emerged as a new approach to continuously and noninvasively monitor pressures inside the body. CardioMEMS is the first US Food and Drug Administration–approved heart failure (HF) monitoring sensor that allows ambulatory monitoring of pulmonary arterial pressure by implanting the device into the pulmonary arterial branch. See Article by Mondritzki et al CHAMPION trial (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) examined the effectiveness of CardioMEMS in chronic HF patients. In detail, the CHAMPION trial was a randomized controlled, single-blind study that investigated the benefit of ambulatory pulmonary artery pressure–guided management of HF in 550 patients with New York Heart Association functional class III HF. The study demonstrated 37% reduction in HF–related hospitalization in the CardioMEMS monitoring group compared with a matched control group during a follow-up period of 15 months.2 This study was the first to show reduction in HF events with ambulatory monitoring and prompted further development of hemodynamic monitoring devices. An implantable monitoring device that measures …

Heart Failure and Respiratory Hospitalizations Are Reduced in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease With the Use of an Implantable Pulmonary Artery Pressure Monitoring Device

CardioMEMS Pulmonary Artery Pressure Guided Management of Advanced HF Patients Supported with a HeartMate LVAD: INTELLECT 2-HF Study

To examine trends in heart failure (HF) hospitalization rates and risk of readmissions following an incident HF hospitalization. During 2000-2014, we identified in the Cardiovascular Disease in Norway Project 142 109 hospitalizations with HF as primary diagnosis. Trends of incident and total (incident and recurrent) HF hospitalization rates were analysed using negative binomial regression models. Changes over time in 30-day and 3-year risk of HF recurrences or cardiovascular disease (CVD)-related readmissions were analysed using Fine and Grey competing risk regression, with death as competing events. Age-standardized rates declined on average 1.9% per year in men and 1.8% per year in women for incident HF hospitalizations (both Ptrend < 0.001) but did not change significantly in either men or women for total HF hospitalizations. In men surviving the incident HF hospitalization, 30-day and 3-year risk of a HF recurrent event increased 1.7% and 1.2% per year, respectively. Similarly, 30-day and 3-year risk of a CVD-related hospitalization increased 1.5% and 1.0% per year, respectively (all Ptrend < 0.001). No statistically significant changes in the risk of HF recurrences or CVD-related readmissions were observed among women. In-hospital mortality for a first and recurrent HF episode declined over time in both men and women. Incident HF hospitalization rates declined in Norway during 2000-2014. An increase in the risk of recurrences in the context of reduced in-hospital mortality following an incident and recurrent HF hospitalization led to flat trends of total HF hospitalization rates.

Traditional measurement and recording methods are inadequate for continuous monitoring of ambulatory pulmonary artery pressure. Therefore a new miniaturised solid state system has been developed and assessed. A manometer tipped catheter, inserted via a subclavian or cephalic vein, was used together with an isolated amplifier and peak detectors to determine systolic and diastolic pressures. Pressures were averaged over 30 seconds and stored in digital memory. After a 24 hour recording period data were rapidly transferred to a microcomputer for numerical or graphical display. Thirteen patients had continuous ambulatory monitoring performed for between 24 and 96 hours, in seven to evaluate symptoms of dyspnoea in subjects with valvular or coronary disease (group 1), and in six to achieve optimal oral treatment for left heart failure (group 2). The catheter was calibrated before insertion and was rechecked after removal. There was less than 1% zero level drift and similar gain stability. Systolic pressures ranged from 10 to 97 (mean 39.5) mmHg, and diastolic from 1 to 46 (mean 15.3) mmHg. Four patients in group 1 had symptoms of dyspnoea associated with normal pressures, while three had raised pressures. Four of the six patients monitored in group 2 had major alterations in their treatment based on data obtained during monitoring. There were no complications. This system, which allows safe, reliable, and prolonged recording of ambulatory pulmonary artery pressure, represents a considerable advance in the ability to assess the cause of dyspnoea and to manage left heart failure.

Burden and Outcomes of Heart Failure Hospitalizations in Adults With Chronic Kidney Disease

AimsThe aim of this study was to analyse the feasibility, safety, and clinical benefit of the CardioMEMS HF System in different healthcare systems outside the United States of America.Methods and resultsProspective, open-label registry of NYHA class III patients with at least one heart failure hospitalization (HFH) within 12 months before enrolment, regardless of left ventricular ejection fraction. The primary safety endpoints assess the freedom from device/system-related complications (DSRC) and freedom from pressure sensor failure (PSF) at 2 years post-implant. The primary efficacy endpoint was the rate of HFH one year before and one year after implantation.Three hundred and four patients from 37 centres in 6 countries underwent a CardioMEMS implant procedure, which was successful in 98.3% of the cases. At 2 years, there were no DSRCs and only 1 PSF. There were 517 HFH in the year before implant compared with 144 HFH in the year post-implant (risk reduction: 69% (RR: 0.31 95% CI [0.25–0.37]; P < 0.0001). Pulmonary artery (PA) pressures were significantly lowered (mean PA pressure reduction: −3.07 ± 5.91 mmHg, P < 0.0001) with a significant improvement in functional class and quality of life (mean EQ-5D-5L visual analogue score increase 8.1 ± 22.7, P < 0.0001).ConclusionThe results of the COAST study demonstrate that the CardioMEMS HF System is a reliable device, with no device-related complications and very few pressure sensor failures. Its use is associated with a substantial HFH risk reduction, with a significant reduction in PA pressures, an improvement in NYHA classification, and an improvement in quality of life.Clinical registration numberClinicalTrials.gov Identifier: NCT02954341.

Short-term Outcomes in Ambulatory Heart Failure during the COVID-19 Pandemic: Insights from Pulmonary Artery Pressure Monitoring

Brief Report Cardiomems (CMEMS) have been demonstrated to reduce hospitalizations in symptomatic HF. The purpose of our study is to describe our experience of CMEMS in our 27 left ventricular assist device (LVAD) patients. We found that there was a 56% reduction in HF hospitalizations at 6 mo and up to 29% reduction in HF hospitalizations at 12 mo pre- and post-CMEMS placement. Further investigation is warranted in a large cohort with a particular focus on the effects on the hemocompatibility LVAD complications. Brief Communication Left ventricular assist devices are the standard of care for the treatment of patients with advanced heart failure (HF). Despite this therapy, nearly 20% of patients have residual HF symptoms resulting in increased morbidity, mortality, and decrease in quality of life. The CardioMEMS (CMEMS) pulmonary artery (PA) sensor allows for frequent collection of hemodynamic information and has been proven to reduce HF hospitalizations in chronic HF patients.1,2 Data regarding efficacy in the LVAD population is limited to small case series. We describe our single-center experience using the CMEMS system in this patient population. We performed a retrospective study of 27 LVAD patients who underwent placement of the CMEMS device between August 2018 and January 2020 at Ascension St. Vincent Data was extracted through the electronic medical record systems. Patients were selected based on high-risk features such as frequent hospitalizations pre CMEMS implant. Baseline characteristics and outcome analysis including HF hospitalizations occurring in the 1 y pre- and 6 mo and 1 y post-CMEMS implantation in these patients were collected. All implants were performed after LVAD placement without interruption of anticoagulation, with the majority (89%) performed by the right internal jugular approach without interruption of anticoagulation. Technique was similar among implanting cardiologists including gaining access with an 11 French Terumo sheath and either a 260 cm Cardiomems guidewire or 300 cm Steelcore to selectively engage the appropriately sized vessel in the left PA. A hand injection of a mixture of ~10 mL of iodinated contrast and normal saline was then used under fluoroscopy for vessel identification, followed by re-engagement of the vessel with the wire and the implant then performed as described by the IFU. At the time of implant, goal PADP was set for the patient, and subsequent PA pressure data was then used to adjust diuretics, guideline-directed medical therapy, or speed adjustments in a stepwise fashion at the discretion of the patient’s primary cardiologist or CMEMS implanter. Baseline demographics were collected and included a mean age of 56 with 71% male with all with end-stage HF with LVAD support with HM3 (55%), HM2 (9%), and HVAD (36%) with 43% as a bridge to transplant. There was no significant difference in pulmonary vascular resistance between LVAD recipients with and without CMEMS. As seen in Figure 1, there was a 58% reduction in HF hospitalizations at 6 mo and up to 29% reduction in HF hospitalizations at 12 mo pre- and post-CMEMS placement. When HF hospitalization was further delineated by primary or secondary diagnosis, this reduction was even more marked (64% at 6 mo and 47% at 1 y, respectively). The procedure was remarkably safe in this anticoagulated, continuous flow population, with only 3% of patients developing scant hemoptysis that resolved without any intervention.Figure 1.: Primary endpoint of HF hospitalizations.Major limitations to these observations exist including the limited number of patients examined in a retrospective and single-center nature. Additionally, patients were selected for PA sensor implant at the discretion of their primary cardiologist and influenced by factors such as adherence to treatment recommendations and monitoring, distance traveled to LVAD center and other clinical characteristics that may introduce significant bias. Hospitalizations remain a large burden for LVAD patients, with some reports of >70% of patients needing hospitalization within the first-year postimplant.3,4 Elevated filling pressures may not only lead to HF hospitalizations but also lead to hemocompatibility related adverse events that may further complications associated with LVADs contributing to morbidity5,6 further hospitalizations. If the signal of reduced hospitalization for HF as both a primary and secondary diagnosis can be replicated in a larger population, PA sensor monitoring may present a safe and unique opportunity to decrease morbidity in a population that often struggles with the adverse events associated with LVAD therapy. Further investigation is required to examine the generalizability of these findings and whether other adverse events such as right ventricular failure, hemocompatibility related adverse events, or infection are truly impacted by more intensive hemodynamics monitoring.

Pulmonary artery pressure-based telemedicine in heart failure: ready for Europe?

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.

158 - Heart Failure Hospitalizations in a Contemporary LVAD Population

Rafael Correo, de izquierdas, y Alvaro Noboa, magnate conservador, vencieron con un discurso clientelista en el pais mas inestable de America Latina.