Quantification of Device-Related Event Reports Associated With the CardioMEMS Heart Failure System

Lin, Anthony; Hu, Gene; Dhruva, Sanket S.; Kinard, Madris; Redberg, Rita F.

doi:10.1161/circoutcomes.122.009116

Cited by 3 publications

(3 citation statements)

References 4 publications

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“…The specific parameters measured in the study require implantation of minimally invasive devices, however, a more limited data set may be monitored using wrist worn or non-invasive technology. Both approaches have benefits and limitations: the implantation of minimally invasive devices is associated with a limited risk 30 and cost, however provides a secure reliable data collection and transfer system; wrist worn technology can provide an assessment of heart rate, heart rate variability, physical activity and derived measures, however, data collection is not secure and there are limitations with accurate heart rate/variability detection exacerbated by motion artifact, skin pigmentation and poor peripheral perfusion. 31 The most appropriate technology for the monitoring of patients with PH remains to be determined, however, a hierarchy of non-invasive, minimally invasive, and invasive technology may be appropriate when also considering patient preference, technological availability and access, and disease severity.…”

Section: Discussionmentioning

confidence: 99%

Remote monitored physiological response to therapeutic escalation and clinical worsening in patients with pulmonary arterial hypertension

Middleton

Binmahfooz

Zafar

et al. 2023

Preprint

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BackgroundInternational guidelines for the treatment of patients with pulmonary arterial hypertension (PAH) recommend the use of risk stratification to optimise therapy to achieve and maintain a low-risk profile. However, recommended methods require hospital-based investigations. We sought to develop a method for daily, remote risk evaluation.MethodsConsecutive patients (n=5820) with pulmonary hypertension (PH) were identified from the ASPIRE registry and stepwise Cox regression applied to identify parameters associated with survival. A physiological risk score was applied to all patients and survival assessed by the Kaplan-Meier method. Physical activity was measured in patients with PAH implanted with insertable cardiac monitors (ICM, n=80) to provide a remote measure of exercise capacity. In patients with PAH and implanted pulmonary artery pressure (PAP) monitor and ICM (n=28) we undertook a time-stratified bidirectional case–crossover study to determine the physiology of therapeutic escalation (TE) and clinical worsening and a remote physiological risk score applied to the data.ResultsAge, male sex, PH aetiology, WHO functional class (FC), incremental shuttle walk-distance (ISWD), heart rate reserve (HRR) and total pulmonary resistance (TPR) as independent predictors of survival. Mortality increased with each decile of baseline physiological risk (p<0.001). In patients with PAH, thresholds of physiological risk were used to classify patients into low-, intermediate-low-, intermediate-high-, and high-risk groups for one-year mortality, which were well matched to COMPERA-2.0 score-stratified groups (Cohen’s weighted Kappa 0.61). ICM-measured physical activity decreased with indicators of increased clinical risk (WHO-FC, NT-proBNP, ISWD, COMPERA-2.0, p<0.0001). Following TE, remote monitored mean PAP and TPR were reduced, and cardiac output (CO) and physical activity increased at days seven, four, 22 and 42 respectively (p<0.05). Clinical worsening events (CWE) were preceded by an increased remote monitored mean PAP and TPR and reduced CO and physical activity (p<0.05). Change in remote physiological risk score identifiable six days after TE and twelve days prior to a CWE (p<0.05).ConclusionRemote risk evaluation may facilitate personalised medicine and proactive management. The physiological risk score accurately stratifies patients with PH and may be applied to remote monitoring data for early evaluation of clinical efficacy and detection of clinical worsening.

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Section: Discussionmentioning

confidence: 99%

Remote monitored physiological response to therapeutic escalation and clinical worsening in patients with pulmonary arterial hypertension

Middleton

Binmahfooz

Zafar

et al. 2023

Preprint

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“…In the MEMS‐HF study, one patient experienced a serious infection related to the device, and there were a small number of patients who experienced serious implant procedure‐related events, including infection, hemoptysis, bleeding, abnormal heart rate/rhythm, renal failure, and lead dislodgement/migration 32 . In an analysis of data from the FDA Manufacturer and User Facility Device Experience Database, from a total of 2861 reports, hemoptysis was reported in 70 cases (2.4%), heart failure exacerbation in 43 cases (1.5%), and significant bleeding at the catheterization site in 24 cases (0.8%) 33 . CardioMEMS was associated with death or comfort care (undefined) in 167 (5.8%) of the reports.…”

Section: The Importance Of Hemodynamic Assessmentmentioning

confidence: 99%

“… 32 In an analysis of data from the FDA Manufacturer and User Facility Device Experience Database, from a total of 2861 reports, hemoptysis was reported in 70 cases (2.4%), heart failure exacerbation in 43 cases (1.5%), and significant bleeding at the catheterization site in 24 cases (0.8%). 33 CardioMEMS was associated with death or comfort care (undefined) in 167 (5.8%) of the reports.…”

Section: The Importance Of Hemodynamic Assessmentmentioning

confidence: 99%

CS1, a controlled‐release formulation of valproic acid, for the treatment of patients with pulmonary arterial hypertension: Rationale and design of a Phase 2 clinical trial

Benza,

Adamson,

Bhatt

et al. 2024

Pulm. circ.

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Although rare, pulmonary arterial hypertension (PAH) is associated with substantial morbidity and a median survival of approximately 7 years, even with treatment. Current medical therapies have a primarily vasodilatory effect and do not modify the underlying pathology of the disease. CS1 is a novel oral, controlled‐release formulation of valproic acid, which exhibits a multi‐targeted mode of action (pulmonary pressure reduction, reversal of vascular remodeling, anti‐inflammatory, anti‐fibrotic, and anti‐thrombotic) and therefore potential for disease modification and right ventricular modeling in patients with PAH. A Phase 1 study conducted in healthy volunteers indicated favorable safety and tolerability, with no increased risk of bleeding and significant reduction of plasminogen activator inhibitor 1. In an ongoing randomized Phase 2 clinical trial, three doses of open‐label CS1 administered for 12 weeks is evaluating the use of multiple outcome measures. The primary endpoint is safety and tolerability, as measured by the occurrence of adverse events. Secondary outcome measures include the use of the CardioMEMS™ HF System, which provides a noninvasive method of monitoring pulmonary artery pressure, as well as cardiac magnetic resonance imaging and echocardiography. Other outcomes include changes in risk stratification (using the REVEAL 2.0 and REVEAL Lite 2 tools), patient reported outcomes, functional capacity, 6‐min walk distance, actigraphy, and biomarkers. The pharmacokinetic profile of CS1 will also be evaluated. Overall, the novel design and unique, extensive clinical phenotyping of participants in this trial will provide ample evidence to inform the design of any future Phase 3 studies with CS1.

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Invasive Implanted Hemodynamic Monitoring in Patients With Complex Congenital Heart Disease: State-of-the-Art Review

Marshall V,

Wright,

Lampert

et al. 2024

The American Journal of Cardiology

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Quantification of Device-Related Event Reports Associated With the CardioMEMS Heart Failure System

Cited by 3 publications

References 4 publications

Remote monitored physiological response to therapeutic escalation and clinical worsening in patients with pulmonary arterial hypertension

Remote monitored physiological response to therapeutic escalation and clinical worsening in patients with pulmonary arterial hypertension

CS1, a controlled‐release formulation of valproic acid, for the treatment of patients with pulmonary arterial hypertension: Rationale and design of a Phase 2 clinical trial

Invasive Implanted Hemodynamic Monitoring in Patients With Complex Congenital Heart Disease: State-of-the-Art Review

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