Safety and performance of a novel implantable sensor in the inferior vena cava under acute and chronic intravascular volume modulation.

Animal Chronic and acute response Heart failure Inferior vena cava Intravascular congestion Models Right atrial pressure

Journal

European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595

Informations de publication

Date de publication:
May 2023
Historique:
revised: 10 02 2023
received: 10 10 2022
accepted: 27 02 2023
medline: 19 6 2023
pubmed: 10 3 2023
entrez: 9 3 2023
Statut: ppublish

Résumé

The management of congestion is one of the key treatment targets in heart failure. Assessing congestion is, however, difficult. The purpose of this study was to investigate the safety and dynamic response of a novel, passive, inferior vena cava (IVC) sensor in a chronic ovine model. A total of 20 sheep divided into three groups were studied in acute and chronic in vivo settings. Group I and Group II included 14 sheep in total with 12 sheep receiving the sensor and two sheep receiving a control device (IVC filter). Group III included an additional six animals for studying responses to volume challenges via infusion of blood and saline solutions. Deployment was 100% successful with all devices implanted; performing as expected with no device-related complications and signals were received at all observations. At similar volume states no significant differences in IVC area normalized to absolute area range were measured (55 ± 17% on day 0 and 62 ± 12% on day 120, p = 0.51). Chronically, the sensors were completely integrated with a thin, reendothelialized neointima with no loss of sensitivity to infused volume. Normalized IVC area changed significantly from 25 ± 17% to 43 ± 11% (p = 0.007) with 300 ml infused. In contrast, right atrial pressure required 1200 ml of infused volume prior to a statistically significant change from 3.1 ± 2.6 mmHg to 7.5 ± 2.0 mmHg (p = 0.02). In conclusion, IVC area can be measured remotely in real-time using a safe, accurate, wireless, and chronic implantable sensor promising to detect congestion with higher sensitivity than filling pressures.

Identifiants

pubmed: 36891760
doi: 10.1002/ejhf.2822
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

754-763

Informations de copyright

© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Références

Gheorghiade M, Follath F, Ponikowski P, Barsuk JH, Blair JE, Cleland JG, et al.; European Society of Cardiology; European Society of Intensive Care Medicine. Assessing and grading congestion in acute heart failure: a scientific statement from the Acute Heart Failure Committee of the Heart Failure Association of the European Society of Cardiology and endorsed by the European Society of Intensive Care Medicine. Eur J Heart Fail. 2010;12:423-33.
Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009;53:557-73.
Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart failure: problems and perspectives. J Am Coll Cardiol. 2013;61:391-403.
de la Espriella R, Cobo M, Santas E, Verbrugge FH, Fudim M, Girerd N, et al. Assessment of filling pressures and fluid overload in heart failure: an updated perspective. Rev Esp Cardiol. 2022;76:47-57.
Giamouzis G, Kalogeropoulos A, Georgiopoulou V, Laskar S, Smith AL, Dunbar S, et al. Hospitalization epidemic in patients with heart failure: risk factors, risk prediction, knowledge gaps, and future directions. J Card Fail. 2011;17:54-75.
Fonarow GCC. Overview of acutely decompensated congestive heart failure (ADHF): a report from the ADHERE registry. Heart Fail Rev. 2004;9:179-85.
Bradley SM, Levy WC, Veenstra DL. Cost-consequences of ultrafiltration for acute heart failure. Circ Cardiovasc Qual Outcomes. 2009;2:566-73.
Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, et al. CHAMPION Trial Study Group.Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011;377:658-66.
Lindenfeld J, Zile MR, Desai AS, Bhatt K, Ducharme A, Horstmanshof D, et al. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021;398:991-1001.
Rudski L, Lai W, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, et al. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010;23:685-713.
Jobs A, Brünjes K, Katalinic A, Babaev V, Desch S, Reppel M, et al. Inferior vena cava diameter in acute decompensated heart failure as predictor of all-cause mortality. Heart Vessels. 2017;32:856-64.
Pellicori P, Carubelli V, Zhang J, Castiello T, Sherwi N, Clark AL, et al. IVC diameter in patients with chronic heart failure: relationships and prognostic significance. JACC Cardiovasc Imaging. 2013;6:16-28.
Ruge M, Marhefka GD. IVC measurement for the noninvasive evaluation of central venous pressure. J Echocardiogr. 2022;20:133-43.
Narang A, Bae R, Hong H, Thomas Y, Surette S, Cadieu C, et al. Utility of a deep-learning algorithm to guide novices to acquire echocardiograms for limited diagnostic use. JAMA Cardiol. 2021;6:624-32.
Ivey-Miranda JB, Wetterling F, Gaul R, Sheridan S, Asher JL, Rao VS, et al. Changes in inferior vena cava area represent a more sensitive metric than change in filling pressures during experimental manipulation of intravascular volume and tone. Eur J Heart Fail. 2022;24:455-62.
Seo Y, Iida N, Yamamoto M, Machino-Ohtsuka T, Ishizu T, Aonuma K. Estimation of central venous pressure using the ratio of short to long diameter from cross-sectional images of the inferior vena cava. J Am Soc Echocardiogr. 2017;30:461-7.
Moreno AH, Kotz AI, Gold LD, Reddy RV, Tech M. Mechanics of distension of dog veins and other very thin-walled tubular structures. Circ Res. 1970;27:1069-81.
Gelman S. Venous function and central venous pressure: a physiologic story. Anesthesiology. 2008;108:735-48.
Yamauchi H, Biuk-Aghai EN, Yu M, Ho HC, Chapital AD, Koss W, et al. Circulating blood volume measurements correlate poorly with pulmonary artery catheter measurements. Hawaii Med J. 2008;67:8-11.
Fudim M, Kaye DM, Borlaug BA, Shah SJ, Rich S, Kapur NK, et al. Venous tone and stressed blood volume in heart failure: JACC review topic of the week. J Am Coll Cardiol. 2022;79:1858-69.
Baek SM, Makabali GG, Bryan-Brown CW, Kusek JM, Shoemaker WC. Plasma expansion in surgical patients with high central venous pressure (CVP); the relationship of blood volume to hematocrit, CVP, pulmonary wedge pressure, and cardiorespiratory changes. Surgery. 1975;78:304-15.
Yaranov DM, Jefferies JL, Silver MA, Burkhoff D, Rao VN, Fudim M. Discordance of pressure and volume: potential implications for pressure-guided remote monitoring in heart failure. J Card Fail. 2022;28:870-2.
Bendjelid K, Romand JA. Fluid responsiveness in mechanically ventilated patients: a review of indices used in intensive care. Intensive Care Med. 2003;29:352-60.
Janssens U, Graf J. Volume status and central venous pressure. Anaesthesist. 2009;58:513-9.
Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002;121:2000-8.
Noble BJ, Drinkhill MJ, Myers DS, Hainsworth R. Reflex control of splanchnic blood volume in anaesthetized dogs. J Physiol. 1998;513:263-72. 7793.1998.263by.x.
Pinsky MR, Teboul JL. Assessment of indices of preload and volume responsiveness. Curr Opin Crit Care. 2005;11:235-9.
Rex S, Brose S, Metzelder S, Huneke R, Schalte G, Autschbach R, et al. Prediction of fluid responsiveness in patients during cardiac surgery. Br J Anaesth. 2004;93:782-8.
Shoukas AA, Sagawa K. Control of total systemic vascular capacity by the carotid sinus baroreceptor reflex. Circ Res. 1973;33:22-33.
Wiesenack C, Fiegl C, Keyser A, Laule S, Prasser C, Keyl C. Continuously assessed right ventricular end-diastolic volume as a marker of cardiac preload and fluid responsiveness in mechanically ventilated cardiac surgical patients. Crit Care. 2005;9:R226-33.

Auteurs

William Stephen Sheridan (WS)

FIRE1, Foundry Innovation and Research 1 Ltd, Dublin, Ireland.

Friedrich Wetterling (F)

FIRE1, Foundry Innovation and Research 1 Ltd, Dublin, Ireland.

Jeffrey Moore Testani (JM)

Section of Cardiology, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.

Barry A Borlaug (BA)

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.

Marat Fudim (M)

Duke Clinical Research Institute, Durham, NC, USA.
Division of Cardiology, Duke University Medical Center, Durham, NC, USA.

Kevin Damman (K)

University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.

Alastair Gray (A)

Department of Cardiology, Craigavon Area Hospital, Craigavon, UK.

Peter Gaines (P)

Sheffield Hallam University, Sheffield, UK.

Martin Poloczek (M)

Department of Internal Medicine and Cardiology, University Hospital Brno and Faculty of Medicine of Masaryk University, Brno, Czech Republic.

Stephen Madden (S)

Data Science Centre, Royal College of Surgeons in Ireland, Dublin, Ireland.

James Tucker (J)

FIRE1, Foundry Innovation and Research 1 Ltd, Dublin, Ireland.

Teresa Buxo (T)

FIRE1, Foundry Innovation and Research 1 Ltd, Dublin, Ireland.

Robert Gaul (R)

FIRE1, Foundry Innovation and Research 1 Ltd, Dublin, Ireland.

Louise Corcoran (L)

FIRE1, Foundry Innovation and Research 1 Ltd, Dublin, Ireland.

Fiachra Sweeney (F)

FIRE1, Foundry Innovation and Research 1 Ltd, Dublin, Ireland.

Daniel Burkhoff (D)

Cardiovascular Research Foundation, New York, NY, USA.

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