Initial Experience With an Implantable Hemodynamic Monitor

Steinhaus, David; Lemery, Robert; Bresnahan, Dennis R.; Handlin, Larry R.; Bennett, Tom; Moore, Alan; Cardinal, Debbie; Foley, Laura; Levine, Richard J.

doi:10.1161/01.cir.93.4.745

Cited by 54 publications

(25 citation statements)

References 38 publications

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“…Oxygen sensor failure may be related to thrombosis or fibrinous overgrowth and tissue/material interface but additional studies are necessary. Previous studies [5,7] using a similar oxygen sensor in 15 patients did not show similar failure rates. It is possible that the presence of two leads in the right ventricle, as opposed to the single right ventricle lead in the previous study, may produce lead-lead interaction that promotes fibrinous overgrowth.…”

Section: Discussionmentioning

confidence: 69%

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Continuous ambulatory monitoring of absolute right ventricular pressure and mixed venous oxygen saturation in patients with heart failure using an implantable haemodynamic monitor: results of a 1 year multicentre feasibility study

Ohlsson

Kubo²,

Steinhaus³

et al. 2001

European Heart Journal

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Background Implantable sensors that monitor haemodynamics over time may be useful in patients with heart failure. This multicentre study assessed the feasibility of a system that has one sensor measuring absolute pressure and another measuring mixed venous oxygen saturation (SvO 2 ). Both sensors were mounted on leads that were implanted in the right ventricle.Methods Twenty-one patients with heart failure (NYHA II-III) were included. Comparisons were made to right heart catheterizations at implant and at 2, 6 and 12 months thereafter. Patients underwent several haemodynamic provocations during the catheterizations.Results Overall, among functioning sensors, the IHM-1 values were highly correlated with reference values for all time points during all provocations, demonstrating high reproducibility and stability (r 2 =0·91, 0·79 and 0·78 for systolic, right ventricular diastolic and SvO 2 , respectively). Although IHM-1 underestimated reference pressure values by 4·5 mmHg and SvO 2 by 1·6%, this difference was consistent across provocation and stable over 12 months of follow-up. Twelve of the 21 oxygen sensors failed to function and two pressure sensors had component failures. Preliminary analysis of long-term data revealed haemodynamic patterns that may be key indicators for therapeutic interventions. ConclusionThis multicentre feasibility study demonstrated the accuracy and stability of sensors implanted in the right ventricle. The IHM-1, using right ventricular pressures and SvO 2 , with improved performance, might be useful in the study of pathophysiological mechanisms and treatment interventions in heart failure. (Eur Heart J 2001; 22: 942-954,

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Section: Discussionmentioning

confidence: 69%

“…While this study piloted the concept of continuous data trends, it did not measure absolute pressure. The second prototype implantable haemodynamic monitor was capable of measuring absolute pressure from a lead implanted in the pulmonary artery [7] but did not have data storage capability.…”

Section: Introductionmentioning

confidence: 99%

Continuous ambulatory monitoring of absolute right ventricular pressure and mixed venous oxygen saturation in patients with heart failure using an implantable haemodynamic monitor: results of a 1 year multicentre feasibility study

Ohlsson

Kubo²,

Steinhaus³

et al. 2001

European Heart Journal

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“…The system components, implantation procedure, monitoring process, storage and retrieval methods, and pressure analysis methods have previously been described. 11,[15][16][17][18][19][20][21][22] The ePAD is defined as the RV pressure at the time of pulmonary valve opening, which occurs at the time of maximum dP/dt. 18,21 A strong correlation has been shown to exist between the ePAD and actual pulmonary artery diastolic pressures measured under a variety of physiological conditions.…”

Section: Device Description and Measurementsmentioning

confidence: 99%

Transition From Chronic Compensated to Acute Decompensated Heart Failure

Zile

Bennett²,

Sutton³

et al. 2008

Circulation

488

176

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Background-Approximately half of all patients with chronic heart failure (HF) have a decreased ejection fraction (EF) (systolic HF [SHF]); the other half have HF with a normal EF (diastolic HF [DHF]). However, the underlying pathophysiological differences between DHF and SHF patients are incompletely defined. The purpose of this study was to use echocardiographic and implantable hemodynamic monitor data to examine the pathophysiology of chronic compensated and acute decompensated HF in SHF versus DHF patients. Methods and Results-Patients were divided into 2 subgroups: 204 had EF Ͻ50% (SHF) and 70 had EF Ն50% (DHF).DHF patients had EF of 58Ϯ8%, end-diastolic dimension of 50Ϯ10 mm, estimated resting pulmonary artery diastolic pressure (ePAD) of 16Ϯ9 mm Hg, and diastolic distensibility index (ratio of ePAD to end-diastolic volume) of 0.11Ϯ0.06 mm Hg/mL. In contrast, SHF patients had EF of 24Ϯ10%, end-diastolic dimension of 68Ϯ11 mm, ePAD of 18Ϯ7 mm Hg, and diastolic distensibility index of 0.06Ϯ0.04 mm Hg/mL (PϽ0.05 versus DHF for all variables except ePAD). In SHF and DHF patients who developed acute decompensated HF, these events were associated with a significant increase in ePAD, from 17Ϯ7 to 22Ϯ7 mm Hg (PϽ0.05) in DHF and from 21Ϯ9 to 24Ϯ8 mm Hg (PϽ0.05) in SHF. As a group, patients who did not have acute decompensated HF events had no significant changes in ePAD. Conclusions-Significant structural and functional differences were found between patients with SHF and those with DHF; however, elevated diastolic pressures play a pivotal role in the underlying pathophysiology of chronic compensated and acute

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“…One such device (Chronicle, Medtronic Inc., Minneapolis, Minnesota) continuously measures and stores hemodynamic information that can be reviewed remotely via a secured website. Studies comparing intracardiac pressure measurements recorded by this device with those obtained by a Swan-Ganz catheter have found the system to be accurate and stable over time [40,41]. The COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) trial was a randomized, single-blind, parallel-controlled trial designed to determine the clinical impact of an implantable hemodynamic monitoring-based management strategy in patients with advanced HF already receiving optimal medical care.…”

Section: Fluid Monitoring Devicesmentioning

confidence: 99%

Management of Advanced Heart Failure

Freudenberger

2010

Management of Heart Failure

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Initial Experience With an Implantable Hemodynamic Monitor

Cited by 54 publications

References 38 publications

Continuous ambulatory monitoring of absolute right ventricular pressure and mixed venous oxygen saturation in patients with heart failure using an implantable haemodynamic monitor: results of a 1 year multicentre feasibility study

Continuous ambulatory monitoring of absolute right ventricular pressure and mixed venous oxygen saturation in patients with heart failure using an implantable haemodynamic monitor: results of a 1 year multicentre feasibility study

Transition From Chronic Compensated to Acute Decompensated Heart Failure

Management of Advanced Heart Failure

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