The electromagnetic navigation ultrasonography guidance for portal vein access during transjugular intrahepatic portosystemic shunt  creation

doi:10.21203/rs.3.rs-4932315/v1

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The electromagnetic navigation ultrasonography guidance for portal vein access during transjugular intrahepatic portosystemic shunt creation

https://doi.org/10.21203/rs.3.rs-4932315/v1

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Purpose

This study aims to assess the feasibility and safety of utilizing electromagnetic navigation ultrasonography (ENU) guidance during transjugular intrahepatic portosystemic shunt (TIPS) creation.

Methods

Portal vein (PV) puncture during TIPS procedures was facilitated using an ENU system device. Key procedural metrics recorded for each case included the number of needle passes, fluoroscopy time, total procedure duration, dose area product (DAP), air kerma (AK), and incidence of procedural complications.

Results

The study included six patients (five men and one woman) with a mean age of 50.6 ± 13.4 years (range, 33–72 years). With ENU guidance, the mean number of needle passes for successful PV entry was 1.7 ± 0.7 (range, 1 to 3 passes). The average fluoroscopy time for the entire TIPS procedure was 15.3 ± 2.7 minutes (range, 11–19 minutes), and the mean total procedure duration was 91.7 ± 7.8 minutes. The mean DAP associated with the procedure was 143 ± 38.5 Gy · cm2 (range, 89–196 Gy · cm2), with a median AK of 707.7 ± 212.8 mGy (range, 367–1008 mGy). Notably, no clinically significant puncture-related complications were observed.

Conclusion

Electromagnetic navigation ultrasonography (ENU) guidance demonstrates potential feasibility, safety, and effectiveness in assisting with TIPS procedures.

Health sciences/Diseases

Health sciences/Gastroenterology

Health sciences/Medical research

Electromagnetic navigation ultrasonography

Transjugular intrahepatic portosystemic shunt

Fluoroscopy time

Dose area product

Transjugular intrahepatic portosystemic shunt (TIPS) is recognized as a standard treatment for people with severe complications of portal hypertension: intractable ascites and variceal bleeding[1–3]. The procedure involves several intricate steps, with the puncture of the portal vein (PV) being particularly challenging. Difficulties in PV access can lead to procedural complications, including intraperitoneal bleeding, hepatic laceration, and damage to adjacent structures like the hepatic artery and biliary ducts [4, 5].

To mitigate this challenge, a variety of technical innovations have been proposed to provide image-guided of PV access, including alternative access options such as intracardiac echocardiography (ICE) catheter-guided portal access, wire-targeting access, and CBCT-guided access techniques, etc. Despite their promise, these techniques have limitations in clinical application.

Earlier research revealed that wedged hepatic injections of carbon dioxide (CO2) can be applied to improve the quality of the indirect portography[6, 7]. Opacification of the PV bifurcation was seen in 87% of patients in wedged hepatic venography and 25% in the iodinated-contrast images[7]. However, indirect portography with CO2 has obvious disadvantages such as air embolism with resultant microvascular insufficiency, symptomatic hypotension from pulmonary arterial hypotension, or an unusual condition involving reticular and multisystem failure that restricted the clinical application of this technique [8, 9]. Teitelbaum et al applied a wire-targeting technique to facilitate access into the portal venous system. But an additional percutaneous puncture access to the portal venous was required in this technique increasing the risk of injury to the hepatic artery and biliary system. Recently, the cone-beam CT (CBCT) guidance access technique is gaining popularity due to it provides superior visualization of the anatomy with a three-dimensional(3D) roadmap[10–12]. While using this technique, respiration and posture maintenance may affect the accuracy of the puncture of PV. In this paper, we introduce a novel PV access technique based on initial clinical experience using electromagnetic navigation ultrasonography (ENU).

Electromagnetic Navigation System(Imedis 9000, Medis Healthcare, China)

The system consists of the magnetic transmitter of navigation, the magnetic field sensor of needle and magnetic field sensor of the probe. The magnetic transmitter could generate a magnetic field. The magnetic field sensor of the needle is within the hollow core of the puncture needle and the magnetic field sensor of the probe is attached to the probe. The two sensors can receive the magnetic signal emitted by the magnetic transmitter. The system obtains and processes the space vector information from the sensors. Simultaneously, the projections of the needle body and tip on the ultrasound imaging plane, the direction of the puncture needle as well as the puncture path will be worked out and will be shown on the ultrasound image in real time fashion by the system (Fig. 1–2).

In the ultrasound image, the red cross symbol represents the estimated point (targeted point) at which the puncture needle would reach the ultrasound imaging plane if puncturing toward the direction currently indicated by the needle. The red line represents the projection of the needle body on the ultrasound imaging plane. The tip of the red line represents the projection of the needle tip.

The projections of the needle and the needle tip and the target point on the ultrasound imaging plane will change in accordance with the changing of the needle tip’s direction. So, the direction of the needle can be adjusted and the estimated point toward this direction will be real time displayed on the ultrasound imaging. If this estimated point is the desired one, the needle can be pushed toward this direction and will finally reach it.

Study design

This study was a single-center, retrospective, observational, cohort study. Ethical approvance was obtained from the Institutional Review Board of Hospital of Chengdu University of Traditional Chinese Medicine. The study was conducted in compliance with the tenets of the Declaration of Helsinki. Informed consent: Written informed consent was obtained from all study participants.

Study population

This study was performed at the Department of Interventional Oncology in our institution from October 2022 to December 2022 and followed up in the end of February 2023. This retrospective study was approved by the Ethics Committee of our institution. Six patients who underwent a TIPS procedure with the assisting of the electromagnetic navigation ultrasonography (ENU) because of complications resulting from cirrhosis-related portal hypertension. Two patients with refractory ascites and four patients who have gastro-oesophageal variceal bleeding refractory to endoscopic and drug therapy were included in the current study. Exclusion criteria included the presence of PV thrombosis, or hepatic vein occlusion or stenosis, and patient who rejected this new technique. (Table 1)

Table 1

Clinical characteristics and procedural variables of the patients.
Patient number	Sex	Age	Indication	Number of needle passes	Fluoroscopic time (min)	Cumulative DAP (Gy ∙ cm2)	Air Kerma (mGy)	Total procedure time(min)	Secondary procedure
1	Female	72	Variceal bleeding	1	16	119	767	88	Embolization
2	Male	58	Refractory ascites	2	11	89	367	99	None
3	Male	64	Refractory ascites	1	13	177	611	84	None
4	Male	65	Variceal bleeding	3	18	196	904	102	Embolization
5	Male	53	Variceal bleeding	1	15	112	589	96	Embolization
6	Male	67	Variceal bleeding	2	19	165	1008	81	Embolization
Mean	NA	63.2 ± 6.1	NA	1.7 ± 0.7	15.3 ± 2.7	143 ± 38.5	707.7 ± 212.8	91.7 ± 7.8	NA
DAP, dose area product; NA, not applicable

Procedures

TIPS were performed with the assisting of the ENU system device (Imedis 9000, Medis Healthcare). All operations were performed under general anesthesia and mechanical ventilation. All TIPS procedures were performed by the same interventional radiologist (Liu Yuan) with 20 years of experience in TIPS procedures. The localization of portal venous puncture-point on the ultrasound image for this study was performed by the sonographer (Li Xi) with 15 years of experience in interventional ultrasound. The PV is identified under ultrasound guidance with Doppler wave verification. The right internal jugular vein was punctured, and the MDS 1000B puncture system (Medis Healthcare, BeiJing, China) was delivered through the jugular vein puncture route. The ENU system (Imedis 9000, Medis Healthcare), an electromagnetic sensor device, utilized the magnetic field previously used for navigation. The sensor of puncture needle could be inserted into to the puncture needle from the hilt (Fig. 2).

Under B-mode ultrasound, the marked portal vein and needle tip were visualized in real time. Automatic calibration synchronized the needle tip with the tracking device, represented by a green solid line indicating the needle's intended direction. The puncture needle was advanced slowly under ENU guidance until entering the marked portal vein, confirmed by the red cross symbol turning green upon successful entry (Fig. 3). Following PV puncture, iodinated contrast medium injection verified portal vein identification. Subsequent portal venography and measurement of initial portal pressure were conducted, followed by collateral variceal vein embolization and dilation of the parenchymal tract using a 6-mm or 8-mm Mustang balloon catheter (Boston Scientific). Finally, an 8-mm or 10-mm Viatorr TIPS stent (W. L. Gore & Associates) was placed.

Statistics analysis

Data analysis employed SPSS 26.0 software (IBM SPSS Inc.), presenting results as frequencies, mean ± standard deviation (SD), and appropriate statistical measures. Outcome measures included technical success, number of needle passes, fluoroscopy time, total procedure duration, dose area product (DAP), air kerma (AK), and procedural complications. Technical success denoted successful shunt creation between the hepatic vein and intrahepatic branch of the portal vein. Needle passes indicated attempts to puncture the portal vein, while fluoroscopy time encompassed the duration of x-ray fluoroscopy guidance throughout the entire procedure. DAP and AK were recorded radiation exposure metrics. Procedural complications, such as intraabdominal hemorrhage, hepatic artery injury, biliary tract injury, and inadvertent puncture of extrahepatic organs, were monitored during the follow-up period.

Patient Demographics and Clinical Characteristics

Table 1 summarizes the demographic and clinical characteristics of the six patients enrolled in the study. The cohort consisted of five men and one woman, with a mean age of 63.2 ± 6.1 years (range, 53–72 years). All patients underwent successful transjugular intrahepatic portosystemic shunt (TIPS) procedures assisted by electromagnetic navigation ultrasonography (ENU). The number of needle passes required for successful portal venous (PV) entry ranged from 1 to 3 (mean ± SD, 1.7 ± 0.7). Specifically, three patients achieved successful PV puncture on the first attempt, two on the second attempt, and one on the third attempt.

Procedure Details

The mean fluoroscopy time for the entire TIPS procedure was 15.3 ± 2.7 minutes (range, 11–19 minutes), while the mean total procedure time was 91.7 ± 7.8 minutes. The dose area product (DAP) associated with the procedure averaged 143 ± 38.5 Gy · cm² (range, 89–196 Gy · cm²), and the median air kerma (AK) was 707.7 ± 212.8 mGy (range, 367–1008 mGy).

Complications and Follow-up

No puncture-related complications such as peritoneal hemorrhage, biliary tract injury, or inadvertent puncture of extrahepatic organs were observed intraoperatively or during the 2-month follow-up period. Additionally, there were no instances of hepatic encephalopathy or gastrointestinal bleeding during follow-up.

The puncture from the hepatic venous system to the portal venous system is the most technically challenging step in TIPS. The ultrasound guided PV puncture is a classic yet valuable technique, which is used in the detection of PV since 1990 by Jean-Marc Perarnau[1]. The technique dramatically reduces the overall time of the TIPS procedure at that time. With the continuous development of guiding technology, puncture guiding techniques such as ICE catheter-guided portal access, intravascular ultrasound guidance access, wire-targeting access, and 3D CBCT-guided access were widely used in targeting the PV. However, the problem of puncture still remains unresolved so far.

The advantage of this technique is that the real-time magnetic navigation ultrasonography system clearly showed the needle tip position relative to the branch of PV, the expected route of the needle, and the targeted branch of PV in real time, which improved the rate of first-pass puncture and puncture accuracy.

In our experience, the use of transabdominal US guidance will be affected by patients’ BMI, chest deformity, high abdominal pressure, patient positioning, and other factors, which may compromise ultrasound visualization[13] and hinder the speed and accuracy of puncture greatly.

Compared with the traditional ultrasonic guidance technique, the ENU avoids the impact of these disadvantages. In sum, the ENU greatly simplifies the operation process and reduces the difficulty, which is friendly to the new operator.

As a result, ENU-guided creation of TIPS in this study was associated with fewer needle passes and shorter radiographic fluoroscopy and procedural time. All surgeries were uneventful, and no intraoperative complications were observed.

Earlier research indicated that the puncture-associated complications are directly related to the number of needle passes[4]. To reduce the number of needle passes, many studies have been conducted in this field. According to our experience, when the magnetic navigation ultrasonography system was applied, the mean number of needle passes could be reduced to 1.7 passes. In the previous studies, the median number of the puncture of PV access by ultrasound-guided are 2 and 4, respectively[12, 14]. Previous study has shown that the incidence of injury to nontarget organs increase with the increase of the number of needle passes[15].Two previous studies with larger samples have shown that the median number of puncture of PV access by conventional TIPS were 4 and 6[14, 16].In recent years, new technologies, such as wire-targeting technique, ICE guidance, and CBCT-derived 3D roadmaps have significantly improved the rate of success-pass puncture. As a result, the median number of needle passes decreased, which range from 1.8 to 4 in previous studies [10, 12, 14, 16].

A retrospective study involving 264 patients has shown that patients who underwent percutaneous ultrasound-guided PV guidewire placement for fluoroscopic targeting (29.5 ± 14.6 minutes) has a shorter fluoroscopic time than those who underwent fluoroscopically guided wedged hepatic portography (38.9 ± 20.8 minutes). Several other studies have shown that the fluoroscopic times of conventional TIPS were from 34 to 48 minutes [11, 16–18]. In recent years, the 3D CT image guidance during TIPS creation reports a prospective study of 20 Patients with a mean fluoroscopic time of 11.4 ± 2.1 minutes. And in another study, the mean fluoroscopy time of 3-D CT guidance in TIPS Placement was 29 ± 14 min[11]. The mean fluoroscopy time of intravascular ultrasound guidance in TIPS Placement was reported in three studies ( 19 minutes, 27 minutes, and 28 minutes, respectively)[16–18]. Compared with conventional TIPS and 3D CT image guidance TIPS, the ENU guidance tends to reduce radiation exposure time. The possible causes for the 3D CT image guidance likelier to have longer exposure time include the patient’s body movements and respiratory action, which could influence the accuracy of the puncture. Luo et al. showed that the mean fluoroscopy time was reduced to 11.4 ± 2.1 minutes in the 3D CT image guidance group probably because the presence of PV thrombosis, medium to large ascites, or hepatic vein occlusion or stenosis were excluded from this work.

However, the present study was a single-arm trial and no control group can be compared. It demands caution to compare the results of the present study with those of other previous studies because the backgrounds of subjects, operating experience, medical equipment, and research methods were different.

Another advantage of this new technique is that its puncture procedure was wholly under ultrasound guidance which reduced the radiation dose. To assess radiation dose, the DAP and AK were usually recorded. The median dose-area product was 142 Gy · cm² in our study, and the median AK was 689 mGy. Some previous studies have reported dose differences among different PV access techniques. Ultrasonographic guidance for PV access was an important part of PV access techniques. The mean dose-area product was 62.0 ± 50.2 (SD) Gy.cm² in a retrospective study of 224 patients who underwent an ultrasound–guided technique to obtain PV access[19]. In another study, patients who underwent a transabdominal-ultrasound–guided technique to obtain PV access have lower DAP (125.60 Gy · cm² [IQR, 66.45–218.83 Gy · cm² vs. 351.72 Gy · cm²[IQR, 202.12–644.77 Gy · cm²] and AK (0.648 Gy [IQR, 0.303–1.057 Gy] vs 1.997 Gy [IQR, 0.981–3.678 Gy]) than those who underwent a fluoroscopically guided wedged hepatic portography[14]. In recent years, researchers have also tried to use intravascular-ultrasound–guided PV access in TIPS creation. A previous study has shown that DAP was not significantly different among intravascular ultrasound guidance, fluoroscopic guidance, and PV marker wire guidance[17]. Yet the fluoroscopy time and AK were reduced with intravascular ultrasound guidance compared with fluoroscopic guidance. When compared with the conventional TIPS, the intravascular ultrasound guidance was reported to reduce the DAP (3,793 µGy · m² vs 21,414 µGy · m², P < 0.01)[16]. But the intravascular ultrasound guidance requires expensive equipment.

Despite its advantages, ENU has limitations, including its inapplicability in patients with certain metal medical devices and the requirement for specialized equipment and trained personnel. Moreover, our study's retrospective design, small sample size, and lack of a control group limit definitive comparisons with other techniques. Future studies with larger cohorts and controlled designs are warranted to further validate these findings and assess long-term outcomes.

In conclusion, electromagnetic navigation ultrasonography represents a promising advancement in TIPS procedures, offering enhanced procedural efficiency, reduced radiation exposure, and excellent safety profiles. Continued research and technological refinements will likely expand its utility and refine its role in clinical practice.

Conflict of Interest

The authors declare no potential conflicts of interest in this work.

Author Contribution

All authors contributed significantly. YT and XL designed the study collected the data and did the statistical analysis. YT drafted the manuscript. WL participated in the study design, data collection, and data analysis. YL is the corresponding author and was involved in the study design, funding acquisition, data interpretation, and manuscript revision. All authors read and approved the final manuscript.

Data Availability

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

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No competing interests reported.

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You are reading this latest preprint version

The electromagnetic navigation ultrasonography guidance for portal vein access during transjugular intrahepatic portosystemic shunt creation

Status:

Version 1

Abstract

Purpose

Methods

Results

Conclusion

Figures

Introduction

Material and methods

Electromagnetic Navigation System(Imedis 9000, Medis Healthcare, China)

Study design

Study population

Procedures

Statistics analysis

Results

Patient Demographics and Clinical Characteristics

Procedure Details

Complications and Follow-up

Discussion

Conclusion

Declarations

Conflict of Interest

Author Contribution

Data Availability

References

Additional Declarations

Status:

Version 1