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

J 2023

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

SHERIDAN, Stephen William, Friedrich WETTERLING, Jeffrey Moore TESTANI, Barry A A BORLAUG, Marat FUDIM et. al.

Basic information

Original name

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

Authors

SHERIDAN, Stephen William, Friedrich WETTERLING (guarantor), Jeffrey Moore TESTANI, Barry A A BORLAUG, Marat FUDIM, Kevin DAMMAN, Alastair GRAY, Peter GAINES, Martin POLOCZEK (203 Czech Republic, belonging to the institution), Stephen MADDEN, Tucker JAMES, Teresa BUXO, Robert GAUL, Louise CORCORAN, Fiachra SWEENEY and Daniel BURKHOFF

Edition

European Journal of heart Failure, Hoboken, Wiley, 2023, 1388-9842

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 18.200 in 2022

RIV identification code

RIV/00216224:14110/23:00131029

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1002/ejhf.2822

UT WoS

000946155400001

Keywords in English

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

Abstract

V originále

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.

Citovat

SHERIDAN, Stephen William, Friedrich WETTERLING, Jeffrey Moore TESTANI, Barry A A BORLAUG, Marat FUDIM, Kevin DAMMAN, Alastair GRAY, Peter GAINES, Martin POLOCZEK, Stephen MADDEN, Tucker JAMES, Teresa BUXO, Robert GAUL, Louise CORCORAN, Fiachra SWEENEY and Daniel BURKHOFF. 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. Hoboken: Wiley, 2023, vol. 25, No 5, p. 754-763. ISSN 1388-9842. Available from: https://dx.doi.org/10.1002/ejhf.2822.

@article{2293042,
   author = {Sheridan, Stephen William and Wetterling, Friedrich and Testani, Jeffrey Moore and Borlaug, Barry A A and Fudim, Marat and Damman, Kevin and Gray, Alastair and Gaines, Peter and Poloczek, Martin and Madden, Stephen and James, Tucker and Buxo, Teresa and Gaul, Robert and Corcoran, Louise and Sweeney, Fiachra and Burkhoff, Daniel},
   article_location = {Hoboken},
   article_number = {5},
   doi = {http://dx.doi.org/10.1002/ejhf.2822},
   keywords = {Heart failure; Inferior vena cava; Right atrial pressure; Models; Animal; Chronic and acute response; Intravascular congestion},
   language = {eng},
   issn = {1388-9842},
   journal = {European Journal of heart Failure},
   title = {Safety and performance of a novel implantable sensor in the inferior vena cava under acute and chronic intravascular volume modulation},
   url = {https://onlinelibrary.wiley.com/doi/10.1002/ejhf.2822},
   volume = {25},
   year = {2023}
}

TY  - JOUR
ID  - 2293042
AU  - Sheridan, Stephen William - Wetterling, Friedrich - Testani, Jeffrey Moore - Borlaug, Barry A A - Fudim, Marat - Damman, Kevin - Gray, Alastair - Gaines, Peter - Poloczek, Martin - Madden, Stephen - James, Tucker - Buxo, Teresa - Gaul, Robert - Corcoran, Louise - Sweeney, Fiachra - Burkhoff, Daniel
PY  - 2023
TI  - Safety and performance of a novel implantable sensor in the inferior vena cava under acute and chronic intravascular volume modulation
JF  - European Journal of heart Failure
VL  - 25
IS  - 5
SP  - 754-763
EP  - 754-763
PB  - Wiley
SN  - 13889842
KW  - Heart failure
KW  - Inferior vena cava
KW  - Right atrial pressure
KW  - Models
KW  - Animal
KW  - Chronic and acute response
KW  - Intravascular congestion
UR  - https://onlinelibrary.wiley.com/doi/10.1002/ejhf.2822
N2  - 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.
ER  -

SHERIDAN, Stephen William, Friedrich WETTERLING, Jeffrey Moore TESTANI, Barry A A BORLAUG, Marat FUDIM, Kevin DAMMAN, Alastair GRAY, Peter GAINES, Martin POLOCZEK, Stephen MADDEN, Tucker JAMES, Teresa BUXO, Robert GAUL, Louise CORCORAN, Fiachra SWEENEY and Daniel BURKHOFF. Safety and performance of a novel implantable sensor in the inferior vena cava under acute and chronic intravascular volume modulation. \textit{European Journal of heart Failure}. Hoboken: Wiley, 2023, vol.~25, No~5, p.~754-763. ISSN~1388-9842. Available from: https://dx.doi.org/10.1002/ejhf.2822.

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