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

SHERIDAN, Stephen William, WETTERLING, Friedrich, TESTANI, Jeffrey Moore, BORLAUG, Barry A., FUDIM, Marat, DAMMAN, Kevin, GRAY, Alastair, GAINES, Peter, POLOCZEK, Martin, MADDEN, Stephen, TUCKER, James, BUXO, Teresa, GAUL, Robert, CORCORAN, Louise, SWEENEY, Fiachra and BURKHOFF, Daniel (2023). Safety and performance of a novel implantable sensor in the inferior vena cava under acute and chronic intravascular volume modulation. European Journal of Heart Failure.

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Aims: 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. Methods and results: 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). Conclusion: 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.

Item Type: Article
Additional Information: ** Article version: VoR ** From Wiley via Jisc Publications Router ** Licence for VoR version of this article: **Journal IDs: issn 1388-9842; issn 1879-0844 **Article IDs: publisher-id: ejhf2822 **History: published_online 09-03-2023; accepted 27-02-2023; rev-recd 10-02-2023; submitted 10-10-2022
Uncontrolled Keywords: Research Article, Research Articles, Heart failure, Inferior vena cava, Right atrial pressure, Models, Animal, Chronic and acute response, Intravascular congestion
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SWORD Depositor: Colin Knott
Depositing User: Colin Knott
Date Deposited: 10 Mar 2023 12:38
Last Modified: 11 Oct 2023 16:31

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