CHAMPION Trial Research Articles

Abstract 15854: Pulmonary Arterial Waveform Analysis and Supervised Machine Learning Predicts Outcomes in Heart Failure: An Analysis of the CHAMPION Trial

Introduction: Pulmonary artery (PA) pressure monitors have been shown to prevent hospitalizations in heart failure patients using mean pressure values. PA waveform analysis offers an overall assessment of right ventricular load that combines resistance and compliance. Hypothesis: We hypothesised that clinical outcomes can be predicted from PA waveform analyses from patients with an implanted PA monitor. Methods: The CHAMPION trial database was analysed. Information about the demographics and data collection methods for this cohort have been published previously. All waveforms were analysed automatically using Python. Tau or RC time, respiratory rate, respiratory range, P asymptote, mean pulmonary arterial pressure (mPAP), diastolic pulmonary arterial pressure (dPAP) and systolic pulmonary arterial pressure (sPAP) were derived from the raw waveforms. Tau and P asymptote were calculated using phase plane analysis. Outcomes of hospitalization or mortality were adjudicated as part of the original trial. Statistics were performed in R. A decision tree statistical approach using the XGBoost algorithm was used. Contribution to the model was assessed using Shapley Additive Explanations (SHAP) values. The dataset was split into 70% train and 30% test sets. Results: 296,948 PA pressure traces from 547 patients were analysed. 3 patients had insufficient quality of trace to analyse. There were 1340 outcome events throughout the follow up period, median 664 days. The trained algorithm was able to predict clinical outcomes in the test dataset with 100% accuracy. The most significant contributors according the mean SHAP value were RC time (SHAP = 1.1), respiratory range (SHAP = 1.1) and heart rate (SHAP = 1.1). Conclusions: Detailed analysis of the PA waveform from PA pressure monitors is feasible and yields clinically relevant information. A supervised machine learning algorithm trained on this data can accurately predict hospitalization or mortality events in heart failure patients.

Ravulizumab (Ultomiris)


 CADTH recommends that Ultomiris should not be reimbursed by public drug plans for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody–positive generalized myasthenia gravis (gMG).
 Although evidence from a clinical trial (CHAMPION) suggested that Ultomiris contributed to improvement in activities of daily living and gMG disease severity after 26 weeks, it is uncertain if immunosuppressive therapy (IST) was optimized at the time of study enrolment. Patients in both Ultomiris and placebo groups of the CHAMPION trial received stable doses of IST; however, it was unclear if IST was optimized in both groups. The eligibility criteria for duration of IST treatment and duration of stable IST dosing in the CHAMPION trial were below the estimated range of time to maximal response according to the clinical experts consulted by CADTH. Although some evidence (mean time frame since MG diagnosis, mean corticosteroid treatment durations) was available, without dose information, it is unclear if corticosteroid was optimized for patients at the time of study enrolment.
 Feedback from patient and clinician groups identified an unmet need for patients with gMG who have symptoms but are not considered refractory to IST. There is an unmet need for effective therapy for patients with refractory gMG, but the CHAMPION trial did not require patients to be refractory. Therefore, it is unknown how many patients in the CHAMPION trial were refractory and if the results observed in the trial would be the same in these patients. As a result, the ability of Ultomiris to fill the unmet need for patients who are refractory to IST is limited by the CHAMPION trial design, which used Ultomiris earlier in the treatment paradigm for gMG and did not require participants to be refractory to IST.
 The CHAMPION trial did not provide evidence on the efficacy or harms of Ultomiris compared with other therapies used in clinical practice, such as rituximab, IV immunoglobulin, and plasma exchange. Therefore, the potential therapeutic benefit is unknown compared to what is used in clinical practice.

Heat stable carbetocin or oxytocin for prevention of postpartum hemorrhage among women at risk: A secondary analysis of the CHAMPION trial.

To examine whether the observed non-inferiority of heat-stable carbetocin (HSC), compared with oxytocin, was influenced by biologic (macrosomia, parity 3 or more, or history of postpartum hemorrhage [PPH]) and/or pharmacologic (induction or augmentation) risk factors for PPH. The present study is a secondary analysis of the CHAMPION non-inferiority randomized trial-a two-arm, double-blind, active-controlled study conducted at 23 hospitals in 10 countries, between July 2015 and January 2018. Women with singleton pregnancies, expected to deliver vaginally with cervical dilatation up to 6 cm were eligible. Randomization was stratified by country, with 1:1 assignment. Women in the intervention and control groups received a single intramuscular injection of 100 μg of HSC or 10 IU of oxytocin, respectively. The drugs were administered immediately after birth, and the third stage of labor was managed according to the WHO guidelines. Blood was collected using a plastic drape. For this analysis, we defined a woman as being at risk if she had any one or more of the biologic or pharmacologic risk factor(s). The HSC and oxytocin arms contained 14 770 and 14 768 women, respectively. The risk ratios (RR) for PPH were 1.29 (95% confidence interval [CI] 1.08-1.53) or 1.73 (95% CI 1.51-1.98) for those with only biologic (macrosomia, parity 3 or more, and PPH in the previous pregnancy) or only pharmacologic (induced or augmented) risk factors, respectively, compared with those with neither risk factors. Findings reinforce previous evidence that macrosomia, high parity, history of PPH, and induction/augmentation are risk factors for PPH. We did not find a difference in effects between HSC and oxytocin for PPH among women who were neither induced nor augmented or among those who were induced or augmented.

Abstract 008: Randomized Trial Of A Healthy Weight Intervention For Youth With Mental Illness: The Champion Trial

Introduction: Overweight and obesity in youth with serious emotional disturbance (SED) is exceedingly common. In 2015 the AHA called attention to mental illnesses in youth as important risk conditions for early CVD and the need for transformational change in management of overweight and obesity in this group. Our objective was to test a 12-month, innovative healthy weight intervention in youth with SED. Hypothesis: The active intervention is more effective than control in decreasing BMI Z-score compared at 12 m. Methods: We conducted a two-arm randomized trial in 2 outpatient pediatric mental health settings in 112 youth, ages 8-18 yrs. The active intervention group was offered 12m of in-person and virtual individual weight management sessions led by health coaches who provided guidance on improving diet and increasing physical activity, and engaged parents. Results: At baseline, mean (SD) age was 13.0 (2.7) yrs with 46% ages 8-12 and 54% 13-18; 55% were male, 46% Black, 39% had household income less than $50K/yr and 31% lived in a single-parent household. Primary diagnoses were ADHD (41%), major depression (23%), and anxiety (23%). Mean BMI Z-score (SD) was 2.0(0.4), BMI 30.4 (6.4) kg/m 2 .Mean(SD) psychotropic medications were 2.1(1.4). At 12m, 111 (99%) had a follow-up weight; 42 were collected after the onset of the COVID pandemic). The intervention group compared to the control group had 0.15 decrease in BMI Z-Score (95% CI 0.26 to 0.04), p<0.007) between baseline and 12 m (Figure) and a 1.43 kg/m 2 decrease in BMI (95% CI 2.43, 0.42, p<0.006). Estimated net effect on BMI Z-score for intervention vs. control was enhanced during the pandemic but not statistically different from net effects pre-pandemic (p=0.06). Conclusions: A weight control intervention designed for children with SED decreased BMI Z-score substantially over 12 months, including during the COVID-19 pandemic. These results provide empirical evidence in support of weight control programs in a population at high risk for early development of CVD risk factors.

Duration of third stage labour and postpartum blood loss: a secondary analysis of the WHO CHAMPION trial data

BackgroundObstetric haemorrhage continues to be a leading cause of maternal mortality, contributing to more than a quarter of the 2,443,000 maternal deaths reported between 2003 and 2009. During this period, about 70% of the haemorrhagic deaths occurred postpartum. In addition to other identifiable risk factors for greater postpartum blood loss, the duration of the third stage of labour (TSL) seems to be important, as literature shows that a longer TSL can be associated with more blood loss. To better describe the association between the duration of TSL and postpartum blood loss in women receiving active management of third stage of labour (AMTSL), this secondary analysis of the WHO CHAMPION trial data has been conducted.MethodsThis was a secondary analysis of the WHO CHAMPION trial conducted in twenty-three sites in ten countries. We studied the association between the TSL duration and blood loss in the sub cohort of women from the CHAMPION trial (all of whom received AMTSL), with TSL upto 60 min and no interventions for postpartum haemorrhage. We used a general linear model to fit blood loss as a function of TSL duration on the log scale, arm and center, using a normal distribution and the log link function. We showed this association separately for oxytocin and for Heat stable (HS) carbetocin.ResultsFor the 10,040 women analysed, blood loss rose steeply with third stage duration in the first 10 min, but more slowly after 10 min. This trend was observed for both Oxytocin and HS carbetocin and the difference in the trends for both drugs was not statistically significant (p-value = 0.2070).ConclusionsThere was a positive association between postpartum blood loss and TSL duration with either uterotonic. Blood loss rose steeply with TSL duration until 10 min, and more slowly after 10 min.Study registration The main trial was registered with Australian New Zealand Clinical Trials Registry ACTRN12614000870651 and Clinical Trial Registry of India CTRI/2016/05/006969

Effect of heat stable carbetocin vs oxytocin for preventing postpartum haemorrhage on post delivery hemoglobin–a randomized controlled trial.

Objective To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level. Setting Hospital based study in Southern India. Population Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India. WHO CHAMPION Trial was a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin with oxytocin administered immediately after vaginal birth in women across 23 sites in 10 countries. Methods This was a nested randomized controlled trial designed to compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM, administered within one minute of vaginal delivery of the baby for prevention of postpartum hemorrhage, on post-delivery 48–72 h hemoglobin level, adjusted for pre-delivery hemoglobin level. 1,799 women from one hospital in India participated in this study. Results Pre-delivery hemoglobin and postpartum blood loss were not significantly different between carbetocin and oxytocin. Post-delivery hemoglobin, unadjusted or adjusted for pre-delivery hemoglobin, was slightly lower for carbetocin (10.09 g/dL) compared to oxytocin (10.21) (p value of 0.0432). The drop in hemoglobin was slightly higher for carbetocin, although the difference was very small (1.2 g/dL for carbetocin, 1.1 g/dL for oxytocin) (p value of .0786). The proportion of participants with a drop in hemoglobin of 2 g/dL or more, adjusted for pre-delivery hemoglobin, was higher for carbetocin (RR = 1.29, 95% CI 1.02–1.63). From the regression coefficients it can be derived that post-delivery hemoglobin, adjusted for pre-delivery hemoglobin, decreases on average 0.12 g/dL for each dL of blood lost, for the two treatments combined. Conclusion The present ancillary study showed that intramuscular administration of 100 µg of heat stable carbetocin can result in a slightly lower post-delivery hemoglobin, slightly higher drop and higher percentage of women having a drop of 2 g/dL or larger, compared to 10 IU of oxytocin.

Quantification of device-related event reports associated with the CardioMEMS Heart Failure System

Abstract Introduction The CardioMEMS (Abbott) is an implantable pulmonary artery pressure monitor for heart failure patients approved by the United States Food and Drug Administration (FDA) based on the CHAMPION trial reporting a reduction in the composite outcome of heart failure hospitalizations (HFH) and all-cause mortality. The result was driven by reduction in HFH; there was no benefit on mortality. While CardioMEMS was approved by the FDA in May 2014 and received Conformitè Europënne (CE) Mark approval in December 2014, the FDA review found preferential attention towards patients in the treatment arm that may have biased results. The FDA-mandated industry-sponsored post-marketing study identified 5 device-related complications in a 1,200-patient cohort from September 2014 to October 2017. A separate review of adverse events reported to the FDA during a similar timeframe from May 2014 to May 2017 identified 155 instances of injury or death. As worldwide implantation rates of CardioMEMS have increased since 2017 to roughly 20,000, we updated device-related events reported to the FDA to aid in understanding its current real-world safety profile. Methods The FDA mandates reporting of all medical device-related events to the Manufacturer and User Facility Device Experience (MAUDE) database, a passive surveillance system. We queried all available reports from May 28, 2014 to November 28, 2020 using the unique product code for CardioMEMS (“MOM”). Almost all reports (96%) contained a narrative description, which was used to enumerate adverse events. Results A total of 2,861 MAUDE reports have been filed for CardioMEMS in the reporting period, increasing from an average of 38 reports per 6-month period from May 2014 to May 2017 to an average of 149 reports per 6-month period afterwards (Figure 1). The majority reported inaccurate measurements, which required replacement of the external unit, repeat non-invasive testing, or repeat catheterization to resolve (Table). There were 169 (5.9%) patient deaths reported; most commonly reported non-fatal safety events included hemoptysis, heart failure exacerbation, and significant bleeding at the groin site (Table 1). Conclusion We found an increased number of adverse events associated with CardioMEMS in the last 3 years compared to the first 3 years, partially coinciding with increased use. Safety of CardioMEMS should be considered along with the lack of evidence of benefit on all-cause mortality from clinical trials. MAUDE has the known limitation of incomplete adverse event reporting, thus actual adverse event rates are certainly higher. Another limitation is lack of an exact denominator as number of implantations annually is not publicly available. Our analysis demonstrates risks associated with CardioMEMS implantation that are increasing in number. These data can more accurately inform discussions regarding risks and benefits between patients, physicians, and policymakers when considering CardioMEMS. Funding Acknowledgement Type of funding sources: None. FigureTable

Patient monitoring across the spectrum of heart failure disease management 10years after the CHAMPION trial.

Despite significant advances in drug‐based and device‐based therapies, heart failure remains a major and growing public health problem associated with substantial disability, frequent hospitalizations, and high economic costs. Keeping patients well and out of the hospital has become a major focus of heart failure disease management. Achieving and maintaining such stability in heart failure patients requires a holistic approach, which includes at least the management of the underlying heart disease, the management of comorbidities and the social and psychological aspects of the disease, and the management of haemodynamic/fluid status. In this regard, accurate assessment of elevated ventricular filling pressures or volume overload, that is, haemodynamic or pulmonary congestion, respectively, before the onset of worsening heart failure symptoms represents an important management strategy. Unfortunately, conventional methods for assessing congestion, such as physical examination and monitoring of symptoms and daily weights, are insensitive markers of worsening heart failure. Assessment tools that directly measure congestion, accurately and in absolute terms, provide more actionable information that enables the application of treatment algorithms designed to restore patient stability, in a variety of clinical settings. Two such assessment tools, implantable haemodynamic monitors and remote dielectric sensing (ReDS), meet the prerequisites for useful heart failure management tools, by providing accurate, absolute, and actionable measures of congestion, to guide patient management. This review focuses on the use of such technologies, across the spectrum of heart failure treatment settings. Clinical data are presented that support the broad use of pulmonary artery pressure‐guided and/or ReDS‐guided heart failure management in heart failure patients with reduced and preserved left ventricular ejection fraction.

Procedural Safety Profile of Cardiomems Heart Failure Sensor Implantation in a Veterans Association Patient Population

<h3>Purpose</h3> Implantation of a wireless pulmonary artery pressure monitoring device [CardioMEMS] has been shown to reduce heart failure hospitalization but safety profile and peri-procedural complications have not been well described in real world practice in a Veterans Affairs (VA) patient population. <h3>Methods</h3> Electronic medical records of our single VA institution were retrospectively evaluated for device implantation procedure data and follow up clinic visits between 2017 and 2020. <h3>Results</h3> 63 patients with NYHA Class 3 heart failure were implanted with the device (Table 1A). Average procedure time was 48 minutes with average fluoroscopy time of 13 minutes. Average total volume of contrast used was 23 mL. Estimated blood loss was 10 mL. At device implantation, average right atrial mean pressures were 11 mmHg and pulmonary artery systolic, diastolic, and mean pressures were 51/24/34 mmHg. There were three peri-procedural complications. One patient developed an access related pseudoaneurysm successfully treated with surgical intervention. One patient developed a 2 cm hematoma at the access site managed conservatively. One patient developed proximal sensor migration following device deployment which was re-advanced using a Swan wedge balloon catheter and position was confirmed with chest radiograph and proper waveform analysis on device interrogation. All implants were successful and no patients were lost to follow up at clinic visits. There were no major adverse cardiovascular events (stroke, myocardial infarction and cardiovascular death) in hospital or at 30-day follow up. Procedural complications are summarized in Table 1B as compared to previously published data in the CHAMPION Trial. <h3>Conclusion</h3> This real world study demonstrates that the safety profile of pulmonary artery pressure monitoring device implantation in a single VA healthcare center serving a VA patient population is a feasible and safe management approach to patients with NYHA Class 3 heart failure.

Do chronic heart failure patients receive optimal decongestive interventions in a real‐life setting? Letter regarding the article ‘Association between loop diuretic dose changes and outcomes in chronic heart failure: observations from the ESC‐EORP Heart Failure Long‐Term Registry’

We read with interest the recent investigation by Kapelios et al.1 concerning the analysis of the European Society of Cardiology Heart Failure Long-Term (ESC-HF-LT) registry. It underscores the widespread inertia in congestion management, as only 24% of patients underwent loop diuretic (LD) dose modification in ESC-HF-LT registry. Also, guideline-directed medication was better up-titrated in patients receiving LD dose adjustment, presuming that physician's discretion may be a stronger predictor of individualised therapy than patient's clinical status. The authors also found that successful decongestion is unlikely for patients with peripheral oedema.1 Still, peripheral oedema is not the best parameter to guide decongestion, given the high prevalence of causes other than chronic heart failure (CHF). In daily practice, clinical signs and symptoms remain the cornerstone of congestion assessment, but an extensive clinical investigation is crucial.2 Given the low rate of LD adjustments, it may be speculated that clinical assessment was not sufficiently extensive, at least in some patients.1 In contrast to down-titration, up-titration was related to worse outcome. The authors noted that extensive adjustment was done to prove the independence of up-titration as a risk factor. However, (de)congestion and CHF outcome interact by means of complex and incompletely investigated mechanisms, making full adjustment almost impossible. In addition, registries contain a limited number of variables, limiting the extent of adjustment. Theoretically, LD treatment can trigger various mechanisms of harm,3 but the adaptability of the human body is likely to counterbalance these effects,4 meaning that the effective impact of LD therapy remains unclear. Also, down-titration in patients with no clinical congestion might worsen the already existing haemodynamic congestion. The ESC-HF-LT registry revealed that de-escalation was unsuccessful in 52% of the cases although it only took place in 8.3% of all patients, questioning whether the right intervention was chosen for the right patient. Despite little support by the literature and effective down-titration in only roughly 4%, the Authors suggest to attempt LD de-escalation more often. We are convinced that the target should not be the reduction of LD dose per se but the achievement of euvolaemia with full decongestion. This is supported by the findings of the CHAMPION trial, where adjustment of therapy based on invasively measured filling pressures improved outcome. Importantly, LD therapy was the most common adjustment of therapy and, in the majority, it was LD up-titration.5 Therefore, comprehensive clinical assessment is crucial, which may include additional exams, such as cardiothoracic or long ultrasound to achieve euvolaemia. Unfortunately, clinical inertia is highly prevalent,1 resulting in suboptimal treatment.

Treating PA Pressures with Use of a CardioMems Device Affects Quality of Life Measures By Improving Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6 Minute Walk Test (6mwt)

Background Projections show that the prevalence of Heart Failure (HF) will increase 46% from 2012 to 2030, resulting in >8 million people greater than 18 years of age with HF. It is the leading diagnosis for our Medicare population today. The CHAMPION trial revealed a reduction in hospitalizations in patients with a PA pressure sensor (CardioMEMS) implanted who had medication adjustments abased on pulmonary artery pressure increases/decreases without regards to symptoms. Objectives Managing PA pressures within patient's individualized thresholds with medication adjustments will improve their quality of life by improving their KCCQ scoring and their 6 minute walk distance. Methods Sanford Cardiovascular Institute in Sioux Falls, SD started implanting CardioMEMs in April 2015. Patients were treated with medication adjustments (increased or decreased) including beta-blockers, ace inhibitors, vasodilators, and diuretics to keep the patient within their individually set thresholds. Data was collected pre implant of the CardioMEMs device on KCCQ and 6mwt scoring and then again 6 to 8 months after implant. Results A total of 20 patients were given a KCCQ pre-implant and 6-8 months post implant, showing an average pre implant KCCQ of 35.5 score and a post implant average KCCQ score of 41.65, thus giving a 14.77% increase in post implant score. A total of 13 patients completed a 6mwt pre-implant and 6-8 months post implant, showing an average pre implant walk of 192.8 meters and a post implant walk average of 225.46 meters, thus giving a 14.49% increase in distance. Conclusion Implantation of a Pulmonary Artery Sensor Pressure Monitoring System can not only reduce hospital admissions, but can improve quality of life based on the improvement in KCCQ scores and 6 minute walk test distances.

Maternal characteristics and causes associated with refractory postpartum haemorrhage after vaginal birth: a secondary analysis of the WHO CHAMPION trial data.

ObjectiveTo assess the maternal characteristics and causes associated with refractory postpartum haemorrhage (PPH).DesignSecondary analysis of the WHO CHAMPION trial data.SettingTwenty‐three hospitals in ten countries.PopulationWomen from the CHAMPION trial who received uterotonics as first‐line treatment of PPH.MethodsWe assessed the association between sociodemographic, pregnancy and childbirth factors and refractory PPH, and compared the causes of PPH between women with refractory PPH and women responsive to first‐line PPH treatment.Main outcome measuresMaternal characteristics; causes of PPH.ResultsWomen with labour induced or augmented with uterotonics (adjusted odds ratio [aOR] 1.35; 95% CI 1.07–1.72), with episiotomy or tears requiring suturing (aOR 1.82; 95% CI 1.34–2.48) and who had babies with birthweights ≥3500 g (aOR 1.33; 95% CI 1.04–1.69) showed significantly higher odds of refractory PPH compared with the reference categories in the multivariate analysis adjusted by centre and trial arm. While atony was the sole PPH cause in 53.2% (116/218) of the women in the responsive PPH group, it accounted for only 31.5% (45/143) of the causes in the refractory PPH group. Conversely, tears were the sole cause in 12.8% (28/218) and 28% (40/143) of the responsive PPH and refractory PPH groups, respectively. Placental problems were the sole cause in 11 and 5.6% in the responsive and refractory PPH groups, respectively.ConclusionWomen with refractory PPH showed a different pattern of maternal characteristics and PPH causes compared with those with first‐line treatment responsive PPH.Tweetable abstractWomen with refractory postpartum haemorrhage are different from those with first‐line treatment responsive PPH.

Current Role of the CardioMEMS Device for Management of Patients with Heart Failure.

Heart failure (HF) remains a significant burden to our healthcare system and a leading cause of hospitalizations. Current reactive strategies to treat and manage HF have failed to reduce hospitalizations and improve survival. The CardioMEMS device has recently been demonstrated to improve quality of life in HF and reduce HF-related hospitalizations. Current HF management strategies are reviewed with a particular emphasis on the current role of the CardioMEMS device. The CHAMPION trial is the only randomized trial looking at the CardioMEMS device. Patients managed with targeted pulmonary artery pressures resulted in 28% reduction in the primary end-point of HF-related hospitalization at 6months (HR 0.72, 95% CI 0.60-0.85, p = 0.0002) and 37% reduction during the entire follow-up period, which averaged 15months (HR 0.63, 95% CI 0.52-0.77, p < 0.0001). The prospective open-label post-approval study recently presented a 58% reduction in HF hospitalizations per patient year (HR 0.42, 95% CI 0.38-0.47, p < 0.0001). Management of HF using the CardioMEMS device has been shown to reduce HF hospitalizations and improve quality of life regardless of ejection fraction. Patients best suited for this device are those with recurrent congestive symptoms despite optimal medical therapy.

CardioMems® device implantation reduces repeat hospitalizations in heart failure patients: A single center experience.

IntroductionHospital readmission for congestive heart failure remains one of the most important economic burdens on healthcare cost. The implantation of a wireless pressure monitoring device (CardioMEMS®) had led to nearly 40% reduction in readmission rates in the landmark CHAMPION trial. We aim to study the effectiveness of this wireless device in reducing heart failure admissions in a real-world setting.MethodsThis is a retrospective chart review of patients with recurrent admissions for heart failure implanted with the wireless pressure monitoring system (CardioMEMS®) at our institution. We studied the total number of all-cause hospital admissions as well as heart failure-related admissions pre- and post-implantation.ResultsA total of 27 patients were followed for 6–18 months. The total number of all-cause hospital admissions prior to device implantation was 61 admissions for all study patients, while the total number for the post-implantation period was 19, correlating with 2.26 + 1.06 admissions/person-year prior to device implantation versus 0.70 + 0.95 admissions/person-year post-implantation (p-value < 0.001). For heart failure-related admissions, the total number prior to device implantation was 46 compared to 9 admissions post device implantations, correlating with 1.70 + 1.07 admissions/person-years pre-implantation versus 0.33 + 0.62 admissions/person-years post-implantation (p-value < 0.001). This translates to 80.4% and 68.9% reduction in heart failure and all-cause admissions, respectively.ConclusionIn a real-world setting, the implantation of a wireless heart failure monitoring system in patients with heart failure and class III symptoms has resulted in 80.4% reduction in heart failure admissions and 69% reduction in all-cause admissions.

Pulmonary Artery Pressure Changes Detected by CardioMEMS in Temporal Relation to Hemodialysis in Heart Failure Patients with End-Stage Renal Disease

Background Cardiorenal syndrome impacts many heart failure (HF) patients, and the need for hemodialysis (HD) is associated with worsening HF and increased risk of death. The CardioMEMS system (Abbott Medical) was shown to have efficacy in the CHAMPION trial, but cardiorenal patients were excluded from enrollment. Our aim is to determine pulmonary artery (PA) pressure characteristics for HF outpatients receiving routine HD. Methods Eight HD-HF patients (54 ± 9 yrs, male =4, LVEF = 28 ± 8%) received the CardioMEMS system and were prospectively followed on an outpatient basis. PA pressures were transmitted twice on HD days (pre- and post- HD), and once on non-HD days. PA pressure was monitored weekly to observe long-term characteristics of parameter changes occurring at baseline and during meaningful clinical events (defined as emergent HD sessions or hospital encounter for volume overload). PA pressure was considered baseline if >21 days prior to clinical event or post-medication change. Paired t-test was used for comparisons; P-value Results PA pressures were elevated at implant (mean PA diastolic pressure [PADP] = 29 ± 10 mmHg), remained consistently high even though patients were at dry weight, and were highest on HD days prior to dialysis ( Figure 1 ). There were significant differences in PA pressure in temporal relation to HD schedule ( Figure 2 A), with the exception of PADP when compared between non-HD vs post-HD values. 3 patients had a HF event (3 emergent HD, 1 hospitalization) and, compared to patients without HF events, PA pressures exhibited loss of cyclical pressure variation with progressive elevation prior to decompensation ( Figure 2 B). Conclusions HF outpatients with cardiorenal syndrome demonstrate elevated PA pressures at dry weight. CardioMEMS reveals expected PA pressure changes in temporal association with HD-related fluid removal. Those experiencing HF decompensation do not demonstrate this pattern. Future studies are needed to determine if PA pressures can be used to determine HD-related fluid removal protocols to avoid HF decompensation in these patients.

Sustainable Improved Clinical Outcomes Using CardioMEMSTMHF System Remote Pulmonary Artery Pressure Monitoring in Treating Heart Failure Patients

Background CardioMEMSTMpulmonary artery pressure sensor had shown decreased rates of heart failure (HF) hospitalizations and quality of life compared to standard of care alone in the CHAMPION trial. Objective With our growing HF population, requiring CardioMEMSTM implant in our center based on the FDA approved indication, we aimed to look at the differences in HF admissions, total hospital admissions, clinic visits in all patients. We also aimed to evaluate if there was a difference in these outcomes between first 53 and second 53 patients with increasing operator and HF team experience. Time to death post-implant was also assessed. Methods We performed a retrospective analysis of 106 sequential patients who received the implant. We collected data on number of HF admissions, total hospital admissions, and clinic visits 1-year prior and 1-year post-implant. Time to death (in years) were calculated post-implant in all patients. We labeled first 53 cohort as patients who received implant before Aug 2016 and second 53 cohort who received implant after Aug 2016. Results Our study showed a significant reduction in HF admissions, total admissions and clinic visits per year in all patients who received the implant ( Table 1 ). However, further analysis did not show a significant difference in these outcomes in the first 53 patients cohort versus second 53 patients cohort despite the HF population requiring the implant are growing ( Table 2 ). The second 53 patients showed significant reduction in each individual outcome. There was no statistically significant difference in post-implant death comparing these two groups. Overall there was a significant mean (%) reduction in each clinical outcome in all patients and comparing first 53 patients versus second 53 patients. Conclusion A significant reduction in HF admissions, total admissions and clinic visits per year in all patients who received the implant, especially in the second 53 patients. However, considering post-implant results, there were no significant differences in outcomes compared to the patients who received the implant before Aug 2016 versus after Aug 2016 and our results were sustainable.

The Benefits of Ambulatory Pulmonary Artery Pressure Monitoring in Patients with Heart Failure

Purpose CHAMPION trial showed a reduction in CHF hospitalizations with the utilization of the CardioMEMS device. We hope to expand on this trial by correlating pulmonary artery pressure to other variables of volume status, such as creatinine, pro-BNP, hematocrit, iron levels, and body weight, in the patient population we currently serve to help analyze the efficiency of their current HF regimen and help formulate any required adjustments to prevent future CHF exacerbation hospitalizations. Methods We retrospectively investigated all of our CardioMEMS patients who were hospitalized after CARDIOMEMS placement over a course of 1 year for CHF exacerbation. We followed them from baseline to hospitalization to discharge to clinic follow up while monitoring several variables, including pulmonary artery pressures, creatinine, pro-BNP, hematocrit, iron levels and body weight. All data was primarily collected via the Merlin.net™ Patient Care Network - Heart Failure Management Database and EPIC EMR. Necessary diuretic regimens were adjusted according to these variables. Results Our analysis showed a direct correlation with pulmonary artery pressure with pro-BNP and body weight and an inverse relationship with creatinine, iron levels, and hematocrit at the time of admission suggesting evidence of volume overload and increased ventricular wall stress. Pro-BNP displayed a strong, positive, relative linear relationship (Pearson Correlation of 0.609 and r of 0.63) and hematocrit had a similar inverse (strong, negative, linear) (Pearson Correlation of 0.713 and r of -0.58) relationship with pulmonary artery pressure, compared to the other variables. These variables displayed a similar inverse relationship as patients were adequately diuresed during their hospitalization and subsequently discharged home. We also saw 42% reduction in length of hospital stay and 56% 30 day readmission rates in our study patient population. Conclusion Our retrospective analysis confirmed that results endorsed by the CHAMPION trial by showing a significant reduction in hospitalization of our CardioMEMS patients. Concurrently, we also advocate the benefit of Pro-BNP and hematocrit levels as strong positive correlating factors to determine volume status.

Impact of CardioMEMS device placement on lifestyle modifications: a "pseudo-placebo" effect beyond the expected?

IntroductionCongestive heart failure is a leading cause of cardiovascular mortality and morbidity in the United States and places a significant economic burden on the health care system. The CHAMPION trial showed significant reductions in heart failure hospitalizations and length of stay as well as improvements in quality of life among patients who underwent implantation of the CardioMEMS device (CardioMEMS Inc., Atlanta, GA, USA). While the benefits of the device have been well demonstrated, we explored the “pseudo-placebo” effect of device placement on patients’ lifestyle modifications.MethodsThirty patients with the CardioMEMS device were contacted for a follow-up survey that included questions about lifestyle modifications, symptomatic and dietary improvement, increased physical activity, and changes in their cardiac medication regimen.ResultsDyspnea improved in 57% of patients, 70% of patients improved their diet, and 43% increased their physical activity. Only 7% of patients found it difficult to transmit the data.DiscussionThe CHAMPION trial showed numerous benefits for patients who underwent CardioMEMS device placement. In our study, we found that device placement also resulted in a “pseudo-placebo” effect with most patients making positive lifestyle modifications.

The Utility of a Wireless Implantable Hemodynamic Monitoring System in Advanced Heart Failure Patients Needing Left Ventricular Mechanical Circulatory Support

An increase in intracardiac filling pressures is one of the primary hallmarks of progressive heart failure (HF). Multiple clinical studies have demonstrated that lowering cardiac filling pressures will alter morbidity and mortality in HF patients. Noninvasive wireless hemodynamic monitoring of cardiac output and pulmonary artery pressures in the recently published CHAMPION Trail demonstrated that careful monitoring of Class III HF patients significantly decreased in pulmonary artery mean pressures and resulted in fewer hospitalizations and more days alive outside of the hospital. We reviewed the clinical course of the subset of patients who were enrolled in the CHAMPION Trial that had further progression of their HF and required a ventricular assist device (VAD) or heart transplant.

The Benefits of Ambulatory Pulmonary Artery Pressure Monitoring in Patients With Heart Failure

CHAMPION trial showed a reduction in CHF hospitalizations with the utilization of the CardioMEMS device. We hope to expand on this trial by correlating pulmonary artery pressure to other variables of volume status, such as creatinine, pro-BNP, hematocrit, iron levels, and body weight, in the patient population we currently serve to help analyze the efficiency of their current HF regimen and help formulate any required adjustments to prevent future CHF exacerbation hospitalizations.