Impact of Practice-Based Management of Pulmonary Artery Pressures in 2000 Patients Implanted With the CardioMEMS Sensor

Heywood, J. Thomas; Jermyn, Rita; Shavelle, David M.; Abraham, William T.; Bhimaraj, Arvind; Bhatt, Kunjan; Sheikh, Fareed; Eichorn, Eric; Lamba, Sumant; Bharmi, Rupinder; Agarwal, Rahul; Kumar, Charisma; Stevenson, Lynne Warner

doi:10.1161/circulationaha.116.026184

Cited by 131 publications

(82 citation statements)

References 48 publications

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“…14,15 An innovation would be to combine two state-of-the-art strategies such as LVAD therapy and guidance by PA monitoring in order to improve the outcome in this complex patient category and reduce the high burden of complications by early detection of pressure shifts. 14,15 An innovation would be to combine two state-of-the-art strategies such as LVAD therapy and guidance by PA monitoring in order to improve the outcome in this complex patient category and reduce the high burden of complications by early detection of pressure shifts.…”

Section: Introductionmentioning

confidence: 99%

Design and rationale of haemodynamic guidance with CardioMEMS in patients with a left ventricular assist device: the HEMO‐VAD pilot study

et al. 2019

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AimsWe aim to study the feasibility and clinical value of pulmonary artery pressure monitoring with the CardioMEMS™ device in order to optimize and guide treatment in patients with a HeartMate 3 left ventricular assist device (LVAD).Methods and resultsIn this single‐centre, prospective pilot study, we will include 10 consecutive patients with New York Heart Association Class IIIb or IV with Interagency Registry for Mechanically Assisted Circulatory Support Classes 2–5 scheduled for implantation of a HeartMate 3 LVAD. Prior to LVAD implantation, patients will receive a CardioMEMS sensor, for daily pulmonary pressure readings. The haemodynamic information provided by the CardioMEMS will be used to improve haemodynamic status prior to LVAD surgery and optimize the timing of LVAD implantation. Post‐LVAD implantation, the haemodynamic changes will be assessed for additive value in detecting potential complications in an earlier stage (bleeding and tamponade). During the outpatient clinic phase, we will assess whether the haemodynamic feedback can optimize pump settings, detect potential complications, and further tailor the clinical management of these patients.ConclusionsThe HEMO‐VAD study is the first prospective pilot study to explore the safety and feasibility of using CardioMEMS for optimization of LVAD therapy with additional (remote) haemodynamic information.

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Section: Introductionmentioning

confidence: 99%

Design and rationale of haemodynamic guidance with CardioMEMS in patients with a left ventricular assist device: the HEMO‐VAD pilot study

et al. 2019

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“…27 The AUC was significantly lower in the general use cohort compared with the CHAMPION treatment group; neither sex nor baseline EF impacted this finding. Overall, patients with higher baseline pressures had larger, more negative AUC values; not surprising as the magnitude of pressure reduction has been shown to be positively correlated with baseline pressures 28.…”

Section: Real-world Clinical Experiencementioning

confidence: 78%

Chronic heart failure management and remote haemodynamic monitoring

Wolfson

Fong

Grazette

et al. 2018

Heart

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Heart failure (HF) has a large societal and economic burden and is expected to increase in magnitude and complexity over the ensuing years. A number of telemonitoring strategies exploring remote monitoring and management of clinical signs and symptoms of congestion in HF have had equivocal results. Early studies of remote haemodynamic monitoring showed promise, but issues with device integrity and implantation-associated adverse events hindered progress. Nonetheless, these early studies established that haemodynamic congestion precedes clinical congestion by several weeks and that remote monitoring of intracardiac pressures may be a viable and practical management strategy. Recently, the safety and efficacy of remote pulmonary artery pressure-guided HF management was established in a prospective, single-blind trial where randomisation to active pressure-guided HF management reduced future HF hospitalisations. Subsequent commercial use studies reinforced the utility of this technology and post hoc analyses suggest that tight haemodynamic management of patients with HF may be an additional pillar of therapy alongside established guideline-directed medical and device therapy. Currently, there is active exploration into utilisation of this technology and management paradigm for the timing of implantation of durable left ventricular assist devices (LVAD) and even optimisation of LVAD therapy. Several ongoing clinical trials will help clarify the extent and utility of this strategy along the spectrum of patient with HF from individuals with chronic, stable HF to those with more advanced disease requiring heart replacement therapy.

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“…The analysis of the first 2000 consecutive implanted patients found a population of users approximately a decade older compared with the pivotal CHAMPION clinical trial with higher baseline PAP and greater PAP reduction over time. 19 Recently, the first 5500 MEMS patients implanted in the USA over the first 3 years of the device's general use were analysed from the safety perspective: 2.8% serious complications (pulmonary artery injury, haemoptysis and death) were recorded and demonstrated the comparable estimated overall adverse event rates with the CHAMPION trial (2.6% with 575 implant attempts). 20 Similar to other interventional therapies, a learning curve for the most serious observed complications and technological refinement can be expected.…”

Section: New Approaches To Chronic Heart Failure-chronic Obstructive mentioning

confidence: 99%

It's time to move on from counting co‐morbidities to curing them: the case of chronic heart failure–chronic obstructive pulmonary disease co‐morbidity

Tavazzi

2017

European J of Heart Fail

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Impact of Practice-Based Management of Pulmonary Artery Pressures in 2000 Patients Implanted With the CardioMEMS Sensor

Cited by 131 publications

References 48 publications

Design and rationale of haemodynamic guidance with CardioMEMS in patients with a left ventricular assist device: the HEMO‐VAD pilot study

Design and rationale of haemodynamic guidance with CardioMEMS in patients with a left ventricular assist device: the HEMO‐VAD pilot study

Chronic heart failure management and remote haemodynamic monitoring

It's time to move on from counting co‐morbidities to curing them: the case of chronic heart failure–chronic obstructive pulmonary disease co‐morbidity

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