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      An Implantable Sensorized Lead for Continuous Monitoring of Cardiac Apex Rotation

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          Abstract

          Changes in the pattern or amplitude of cardiac rotation have been associated with important cardiovascular diseases, including Heart Failure (HF) which is one of the major health problems worldwide. Recent advances in echocardiographic techniques have allowed for non-invasive quantification of cardiac rotation; however, these examinations do not address the continuous monitoring of patient status. We have presented a newly developed implantable, transvenous lead with a tri-axis (3D) MEMS gyroscope incorporated near its tip to measure cardiac apex rotation in the three-dimensional space. We have named it CardioMon for its intended use for cardiac monitoring. If compared with currently proposed implantable systems for HF monitoring based on the use of pressure sensors that can have reliability issues, an implantable motion sensor like a gyroscope holds the premise for more reliable long term monitoring. The first prototypal assembly of the CardioMon lead has been tested to assess the reliability of the 3D gyroscope readings. In vitro results showed that the novel sensorized CardioMon lead was accurate and reliable in detecting angular velocities within the range of cardiac twisting velocities. Animal experiments will be planned to further evaluate the CardioMon lead in in vivo environments and to investigate possible endocardial implantation sites.

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          Most cited references23

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          Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial.

          Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure. We undertook a single-blind trial to assess this approach. Patients with New York Heart Association (NYHA) class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. They were randomly assigned by use of a centralised electronic system to management with a wireless implantable haemodynamic monitoring (W-IHM) system (treatment group) or to a control group for at least 6 months. Only patients were masked to their assignment group. In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group. The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months. The safety endpoints assessed at 6 months were freedom from device-related or system-related complications (DSRC) and freedom from pressure-sensor failures. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661. In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (n=270) compared with 120 in the control group (n=280; rate 0·31 vs 0·44, hazard ratio [HR] 0·70, 95% CI 0·60-0·84, p<0·0001). During the entire follow-up (mean 15 months [SD 7]), the treatment group had a 39% reduction in heart-failure-related hospitalisation compared with the control group (153 vs 253, HR 0·64, 95% CI 0·55-0·75; p<0·0001). Eight patients had DSRC and overall freedom from DSRC was 98·6% (97·3-99·4) compared with a prespecified performance criterion of 80% (p<0·0001); and overall freedom from pressure-sensor failures was 100% (99·3-100·0). Our results are consistent with, and extend, previous findings by definitively showing a significant and large reduction in hospitalisation for patients with NYHA class III heart failure who were managed with a wireless implantable haemodynamic monitoring system. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management. CardioMEMS. Copyright © 2011 Elsevier Ltd. All rights reserved.
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            Comparison of a radiofrequency-based wireless pressure sensor to swan-ganz catheter and echocardiography for ambulatory assessment of pulmonary artery pressure in heart failure.

            The goal of this work was to evaluate the accuracy of a new heart failure (HF) sensor (HFS) (Heart Failure Sensor, CardioMEMS Inc., Atlanta, Georgia) pulmonary artery pressure (PAP) monitoring compared with Swan-Ganz (SG) (Hospira, Inc., Lake Forest, Illinois) catheterization and echocardiography (ECHO) in ambulatory HF patients. There is an increasing interest in the development of ambulatory monitoring devices aiming to adjust therapy and prevent hospitalizations in HF patients. Twelve patients with HF and New York Heart Association functional class II to IV were included in this study. The HFS was deployed into the pulmonary artery under angiography, allowing wireless PAP measurement. Two independent blind operators performed 3 HFS measurements at each visit, with simultaneous ECHO at 2, 14, 30, 60, and 90 days. Swan-Ganz catheterization was performed at 0 and 60 days. Linear regression was used as a measure of agreement. Variability between methods and interobserver variability were evaluated by Bland-Altman analysis. Mean age was 63 +/- 14.6 years. Systolic PAP was 64 +/- 22 mm Hg and 58 +/- 22 mm Hg for HFS and SG, respectively (p < 0.01). Both methods showed a significant correlation (r2 = 0.96 baseline, r2 = 0.90 follow-up, p < 0.01), with a mean difference of 6.2 +/- 4.5 mm Hg. Diastolic PAP was 23 +/- 14 mm Hg and 28 +/- 16 mm Hg for HFS and SG, respectively (r2 = 0.88 baseline, r2 = 0.48 follow-up, p < 0.01), with a mean difference of -1.6 +/- 6.8 mm Hg. Systolic PAP was 60 +/- 20 mm Hg and 62 +/- 12 mm Hg for HFS and ECHO, respectively (r2 = 0.75, p < 0.01), with a mean difference of -2.6 +/- 11 mm Hg. There was no significant interobserver difference. The HFS provides an accurate method for PAP assessment in the intermediate follow-up of HF patients.
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              Implantable Hemodynamic Monitoring for Heart Failure Patients

              Rates of heart failure hospitalization remain unacceptably high. Such hospitalizations are associated with substantial patient, caregiver, and economic costs. Randomized controlled trials of noninvasive telemedical systems have failed to demonstrate reduced rates of hospitalization. The failure of these technologies may be due to the limitations of the signals measured. Intracardiac and pulmonary artery pressure-guided management has become a focus of hospitalization reduction in heart failure. Early studies using implantable hemodynamic monitors demonstrated the potential of pressure-based heart failure management, whereas subsequent studies confirmed the clinical utility of this approach. One large pivotal trial proved the safety and efficacy of pulmonary artery pressure-guided heart failure management, showing a marked reduction in heart failure hospitalizations in patients randomized to active pressure-guided management. "Next-generation" implantable hemodynamic monitors are in development, and novel approaches for the use of this data promise to expand the use of pressure-guided heart failure management.
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                Author and article information

                Journal
                Sensors (Basel)
                Sensors (Basel)
                sensors
                Sensors (Basel, Switzerland)
                MDPI
                1424-8220
                30 November 2018
                December 2018
                : 18
                : 12
                : 4195
                Affiliations
                Laboratory of Bioengineering, DIMES Department, University of Bologna, S. Orsola-Malpighi Hospital, 40138 Bologna, Italy; emanuela.marcelli@ 123456unibo.it
                Author notes
                [* ]Correspondence: laura.cercenelli@ 123456unibo.it ; Tel.: +39-051-636-4603
                Author information
                https://orcid.org/0000-0001-7818-1356
                Article
                sensors-18-04195
                10.3390/s18124195
                6308825
                30513592
                d6bd9c08-accf-4a8b-8540-06240d96621a
                © 2018 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 15 October 2018
                : 28 November 2018
                Categories
                Article

                Biomedical engineering
                cardiac rotation,gyroscopes,implantable lead,heart failure,continuous monitoring

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