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

Abstract

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.

An Era of Digital Healthcare—A Comprehensive Review of Sensor Technologies and Telehealth Advancements in Chronic Heart Failure Management

“…Chronic integration of the sensors showed a thin, re-endothelialized neointima with maintained sensitivity to infused volume. Normalized IVC area significantly changed from 25 ± 17% to 43 ± 11% ( p = 0.007) with 300 mL infused, whereas RAP required 1200 mL of infused volume before a statistically significant change from 3.1 ± 2.6 mmHg to 7.5 ± 2.0 mm Hg ( p = 0.02) [ 73 ].…”

“…This could have important clinical implications by allowing earlier detection of hypervolemia compared with pressure sensors, leading to prompt clinical intervention and positively affecting the outcomes of HF patients. Additionally, implanting the sensor in the IVC and its integration through endothelialization has shown no negative effect on long-term sensor performance in response to fluid accumulation [ 73 ]. Nevertheless, there are certain limitations to consider in both animal studies, including experiments with healthy sheep, the possibility of potential side effects in relation to the duration of experiments conducted on the same day, and ambiguity concerning the application of experimental findings to humans, especially with HF.…”

May 2023 at a glance: focus on pathophysiology, comorbidities and devices

“…A novel device, a passive, inferior vena cava sensor was tested in a chronic ovine model. The inferior vena cava area was accurately remotely measured, providing a higher sensitivity than filling pressures 42 …”

“…The inferior vena cava area was accurately remotely measured, providing a higher sensitivity than filling pressures. 42…”

Inferior vena cava monitoring in heart failure: don't wait until the last drop makes the cup run over

“…In this issue of the Journal, Sheridan and colleagues report an early pre-clinical study on a total of 20 sheep evaluating the safety and performance of the novel percutaneous, wireless, passive, radiofrequency-based, implantable FIRE1 System (Foundry Innovation & Research 1 Ltd., Dublin, Ireland), allowing real-time chronic remote monitoring of IVC CSA. 7 The device requires a transvenous insertion and deployment in the IVC and is coupled with an extracorporeal sensor incorporated in a belt. The authors found no peri-procedural complications and a good endothelialization of the device struts up to 180 days after implant.…”