Embolization of the parenchymal tract after percutaneous portal vein catheterization: a retrospective comparison of outcomes with different techniques in two centers.

doi:10.21203/rs.3.rs-1754835/v1

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Embolization of the parenchymal tract after percutaneous portal vein catheterization: a retrospective comparison of outcomes with different techniques in two centers.

https://doi.org/10.21203/rs.3.rs-1754835/v1

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Background: Embolization of the parenchymal tract is a key step after any other transhepatic or transplenic percutaneous portal vein catheterization, since eventual venous bleeding is difficult to control and may require surgical management. Different techniques have been proposed to perform tract embolization. The aim of this study is to compare the safety and efficacy of different techniques of hemostasis of the parenchymal tract.

Materials and Methods: All the interventional procedures with percutaneous transhepatic or transplenic access to the portal vein (excluding ipsilateral portal vein embolization) from January 2010 to July 2020, in two tertiary hospitals, were retrospectively analyzed. The following data were evaluated: access site, the technique of embolization, technical success in terms of immediate thrombosis of the tract, safety and clinical efficacy in terms of the absence of hemorrhagic and thrombotic complications.

Results: One-hundred-sixty-one patients underwent 220 percutaneous transhepatic or transplenic portal vein catheterization procedures. The main indications were pancreatic islet transplantation, portal anastomotic stenosis after liver transplantation, and portal vein thrombosis recanalization. As embolic materials gelfoam was used in 105 cases, metallic micro-coils in 54 cases, and cyanoacrylic glue in 44 cases; in 17 cases the parenchymal tract was not embolized. Technical success was 98% without significant difference among groups (p-value = 0.22). Eighteen post-procedural abdominal bleedings occurred, all grade 3 and were managed conservatively; difference among groups was not significant (p-value = 0.25). We detected 12 intrahepatic portal branch thromboses not related to the embolization technique; only one case of non-target embolization was documented after liver tract embolization with glue, without clinical consequences.

Conclusion: Embolization of the parenchymal tract after percutaneous portal vein catheterization is technically safe and effective. No significant differences were found between coils, glue, and gelfoam in effectiveness and complications rate.

Level of Evidence: Level 3, Cohort study.

Percutaneous portal vein catheterization

parenchymal tract embolization

glue

gelfoam

coils.

The indications for percutaneous portal vein catheterization (PPVC) have significantly grown in recent years, due to technical developments of interventional radiology and organ transplantation [1, 2]. Transhepatic and transplenic portal vein accesses are mainly performed to manage complications of liver transplant, such as stenosis and thrombosis, to induce liver hypertrophy before major resections, with portal vein embolization, and to administer autologous or heterologous cells in the setting of pancreatic islet transplantation [1, 3, 4]. Although the issue of hemostasis is considered less relevant during portal vein embolization with the ipsilateral approach [1], the embolization of the parenchymal tract should be regarded as a key step after any other transhepatic or transplenic PPVC, since eventual venous bleeding is difficult to control and may require surgical management.

Different techniques have been proposed to perform tract embolization and their use varies according to the operator experience: gelfoam, cyanoacrylates, coils, and plugs are among the most used materials [1, 5].

Several authors have already reported the safety and efficacy of parenchymal tract embolization with coils, glue, or a combination of both in after a transhepatic or transplenic approach. [2, 6–10]. In pediatric patients with orthotopic liver transplant it was reported a safe and effective use of gelfoam [11]. To our knowledge no consensus exists about the most effective and safe embolic agent nor if the tract embolization should be considered necessary.

The aim of the present study is to report the retrospective data of two tertiary referral centers that commonly perform PPVC, to compare the technical and clinical outcomes of a non-operative management in obtaining hemostasis of the portal vein access and the outcomes of the use of different embolic materials to perform parenchymal tract embolization.

2.1 Study design

This is a retrospective cohort study in patients who underwent transhepatic or transplenic PPVC procedures between January 2010 and December 2020 in two tertiary referral centers for liver and pancreatic surgery and transplantation. Patients were identified using case match search words from Institutional radiological records. Written informed consent for the interventional procedures was obtained prior to treatment from all the patients and/or from legal guardians in case of minors. Local Ethical Committees authorized this retrospective study that was conducted in respect of the principles of the Declaration of Helsinki.

Inclusion criteria were:

a radiological procedure of percutaneous portal vein catheterization, both transhepatic of transplenic
availability of procedural technical details in interventional radiology reports;
availability of periprocedural imaging for review: at least an Ultrasound (US) or Computed Tomography (CT) examination 1 week before and up to 1 month after the interventional procedure;
availability of 1-month post-procedural clinical data;

Exclusion criteria were:

PPVC for portal vein embolization with ipsilateral approach;
absence of procedural technical details in interventional radiology reports;
absence of periprocedural imaging and clinical follow-up;
tract embolization performed with unusual devices, such as vascular plugs, or a combination of materials.

Early post-procedural imaging was not routinely performed unless upon clinical indication in case of uncontrolled pain, suspected bleeding, or organ dysfunction.

2.2 Study endpoints and outcome measures

The primary objective was the technical success of the techniques, defined as the intraoperative evidence of release of embolic materials in parenchymal tract and/or the ability to remove the percutaneous sheath without any signs of bleeding.

The secondary endpoint was a clinical success in terms of the absence of post-procedural bleeding and the absence of non-target embolic complications. Post-procedural imaging bleeding was defined by the development of acute pain, a drop of hemoglobin level, and/or hemodynamic instability from 1 hour to 24-hours after the procedure, confirmed by the evidence of abdominal fluid collections or hematomas at imaging. Non-target embolization was assessed by any available post-procedural imaging study up to 1 month (or until further interventions were performed) and it was defined as the evidence of embolic material inside vessel lumen. Intrahepatic portal vein thrombosis detected at post-procedural imaging was also recorded, regardless of evidence of non-target embolization.

Bleeding, non-target embolization, and thrombotic events were considered procedure-related complications and were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

2.3 PPVC technique

All the patients were considered eligible for PPVC if no medical or technical contraindications were present. Procedures were performed in election or deferrable urgency. All available procedure data were collected. Coagulopathy (International Normalized Ratio ≥ 2 and platelet count < 50.000) and perihepatic or perisplenic ascites were considered absolute contraindications, unless corrected with transfusions or drained, respectively.

In Center 1, the main indication for PPVC was portal vein stenosis or thrombosis in liver-transplanted patients. The choice of interventional approach (transhepatic vs transplenic) was based on imaging findings, at the discretion of the interventional radiologist based on experience; the transplenic route was always considered in the second instance. In Center 2, the main indication was pancreatic islet transplantation.

All procedures in both centers were performed using fluoroscopy and digital subtraction angiography in the angiographic suite; both centers were equipped with Allura Xper FD20 (Philips Healthcare, Best, the Netherlands). Interventional radiologists had at least 5 years of experience. Conscious sedation with midazolam and fentanyl was used for adults, while general anesthesia was performed by a dedicated anesthesiologist in pediatric patients (after induction with propofol, fentanyl, and rocuronium bromide, general anesthesia was maintained with sevoflurane).

PPVC technique was the same in both centers: a parenchymal branch of the portal vein system was punctured under US guidance with a 22G Chiba needle; the guidewire was then advanced under fluoroscopic guidance and a standard coaxial 4F introducer system (Neff percutaneous access set, Cook Incorporated, Bloomington, IN; AccuStick, Boston Scientific, Marlborough, MA) was pushed over the guide. For pancreatic islet transplantation, cell infusion was performed through the 4F introducer sheath; for all the other procedures that required portal vein navigation up to 7F standard vascular introducer sheaths (Merit Medical System, South Jordan, UT) were used. Sodium heparin was administered intraoperatively for portal vein stenosis or thrombosis by intravenous boluses ranging from 50 to 80 units/kg.

The study population was divided into four groups, regardless of indication, based on the embolization technique selected by the interventional radiologist during the procedure:

Group 1: cyanoacrylate and ethiodized oil (Glubran 2, GEM, Viareggio, Italy; Lipiodol, Guerbet, Villepinte, France);
Group 2: coils 2–3 mm of diameter x 30 mm of length (MReye, Cook Incorporated, Bloomington, IN);
Group 3: gelfoam torpedoes (Johnson & Johnson Medical N.V., Belgium);
Group 4: no tract embolization performed.

Tract embolization with glue and gelfoam was performed through the introducer sheath during its retraction [1]; coil embolization was performed through standard hydrophilic 4F catheters (Terumo Corporation, Tokyo, Japan; Cordis Corporation, Miami Lakes, FL). Small contrast boluses verified positioning of the introducer or catheter tip as it pulled back from the vessel lumen into the parenchyma [1]; after flushing with dextrose 5%, 0.1–0.2 ml of 1:2 cyanoacrylate/lipiodol mixture were injected under fluoroscopic guidance (Fig. 1). In groups 2 and 3, coils or gelfoam torpedoes were pushed with the tail of a 0.035” hydrophilic guidewire (Terumo J; Terumo Corporation, Tokyo, Japan), until disappearance of blood reflux (Fig. 2). In all cases, following embolization, manual compression was applied for 1–2 minutes. When no tract embolization was performed, the introducer sheath was gradually pulled back and removed upon the disappearance of blood reflux; manual compression was then applied for 10 minutes.

2.4 Statistical Analysis

Continuous data are presented as the medians and interquartile range (IQR), categorical data as numerical values and percentages. Descriptive and analytic statistics were calculated using IBM SPSS Statistics Version 26.0 (IBM Corp., Armonk, NY). Chi-squared test and Fisher’s exact test were applied to contingency tables with the Bonferroni corrected alpha level for post-hoc pairwise comparisons.

3.1 Study population and PPVC characteristics

Extracted data that met inclusion criteria included 220 PPVC procedures performed in 161 patients (median age = 35.7 years, IQR = 40.7 years; 80 females) (Fig. 3). The mean procedures number per patient was 1.4 (range 1–6); 43 patients underwent more than one PPVC. Seventy-seven (35%) PPVCs were performed in pediatric patients, and 74 (34%) procedures were performed in orthotopic transplanted livers. Patient characteristics, indications for PPVC, and portal access features for each group are summarized in Table 1.

Table 1

Patient and PPVC baseline characteristics
Characteristics	Group 1	Group 2	Group 3	Group 4
	n = 44	n = 54	n = 105	n = 17
Sex
Female (%)	22 (50)	28 (52)	55 (52)	10 (59)
Male (%)	22 (50)	26 (48)	50 (48)	7 (41)
Age, years
Median [IQR]	13.1 [36.1]	15.9 [47.6]	44.6 [20.4]	10.9 [38.2]
Indication to PPVC
Pancreatic islet transplantation (%)	0 (0)	0 (0)	104 (99)	2 (12)
Portal anastomosis stenosis in OLT (%)	16 (36)	40 (74)	0 (0)	10 (59)
Portal vein stenosis/thrombosis (%)	7 (16)	7 (13)	0 (0)	1 (6)
TIPS creation (%)	15 (34)	3 (6)	1 (1)	3 (18)
Meso-rex anastomosis stenosis (%)	3 (7)	4 (7)	0 (0)	1 (6)
Portal varices embolization (%)	3 (7)	0 (0)	0 (0)	0 (0)
Type of approach for PPVC
Right transhepatic (%)	14 (32)	26 (48)	101 (96)	7 (41)
Left transhepatic (%)	5 (11)	6 (11)	4 (4)	1 (6)
Lateral left split liver (%)	18 (41)	19 (35)	0 (0)	7 (41)
Main portal trunk (%)	0 (0)	0 (0)	0 (0)	2 (12)
Trans-splenic (%)	7 (16)	3 (6)	0 (0)	0 (0)
Internal caliper of PPVC sheath, French
Median	6	6	4	6
IQR: Interquartile range; PPVC: Percutaneous portal vein catheterization; OLT: Orthotopic liver transplantation; TIPS: Trans-jugular intrahepatic portosystemic shunt.

At baseline, in Group 1, Group2, and Group 4 the main indication for PPVC was portal vein stenosis or thrombosis in liver transplants. In Group 3, the indication for PPVC was pancreatic islet transplantation in all but one case, with a significantly higher median age in this Group (p-value < 0.001). One-third (n = 15) of patients in Group 1 underwent PPVC in combination with trans-jugular intrahepatic portosystemic shunt (TIPS) creation.

The most common approach to the portal vein was transhepatic (n = 210/220; 95%), through the right hepatic lobe segmental branches in most cases (148/210; 70%). In pediatric patients with transplanted left lateral segments (n = 40) a segment 3 portal branch access was performed. Pediatric patients with split grafts were present in all groups, but not in Group 3 (n = 13 in Group 1; n = 17 in Group 2; n = 5 in Group 4). Transplenic PPVC was performed in 10 procedures, 7 in Groups 1 and 3 in Group 2.

The size of the introducer sheath was significantly smaller in Group 3 than in the other groups (median 4 F versus 6 F; p-value < 0.001).

3.2 Technical success and clinical outcomes

Technical success and clinical outcomes of the procedures are summarized in Table 2. Technical failure was 6% (p-value = 0.22) when tract embolization was not performed (Group 4). In all the other groups technical success was higher, without statistically significant differences (Groups 1 and 2 = 98%; Group 3 = 100%).

Table 2

Procedural technical and clinical success
	Group 1	Group 2	Group 3	Group 4	p-value
	n = 44	n = 54	n = 105	n = 17
Procedural technical success (%)	43 (98)	53 (98)	105 (100)	16 (94)	0.22
Procedural clinical success (%)	1 (2)	7 (13)	8 (8)	2 (12)	0.26
Complications Intrahepatic portal vein thrombosis (%)	3 (7)	4 (7)	1 (1)	4 (24)	0.001
Non-target embolization (%)	1 (2)	0 (0)	0 (0)	NA	0.26
NA: Not applicable.

A total of 18/220 (8%) symptomatic bleeding episodes were reported, with a higher incidence in Group 2 and Group 4, not reaching statistical significance (p-value = 0.25). Intra-procedural anticoagulants were administered only in patients in Group 1 and 2, all with no bleeding events reported. A larger introducer sheath size that was more common in groups 1, 2 and 4 was not associated with technical failure nor bleeding events.

Only one case of non-target embolization in peripheral segmental portal vein branches was documented after transhepatic tract closure with glue (Group 1), without clinical consequences.

A total of 12 (6%) cases of portal vein thrombosis were detected at imaging follow-up, with a significantly higher prevalence in Group 4 (p-value = 0.001).

Comparable technical success rates and favorable clinical outcomes were observed among the transhepatic and the transplenic approaches.

No grade 1 or 2 complications were observed. All bleeding, non-target embolization, and thrombotic events were scored grade 3 and conservatively managed.

In this study, data collected over ten years from two large tertiary liver centers specialized in diabetes, pancreatic surgery, and liver transplantation which commonly perform PPVC, was retrospectively evaluated. Standard techniques for parenchymal tract hemostasis were compared, considering clinical indications for PPVC and technical outcomes. The retrospective nature of this study over a long period made it difficult to collect more procedural details (including anticoagulation therapy) and peri-procedural clinical data.

Tract embolization with all the devices included in this cohort was technically and clinically successful, without statistical differences among groups. As expected, a slightly higher technical failure (immediate bleeding) rate was observed when no tract embolization was performed, although without statistical difference. Concerning post-procedural bleeding, it symptomatically occurred in 8% of cases, which is far below the reported rate of up to 30% [1]. This means that overall post-procedural hemostasis was effective. No statistically significant differences were found between embolization techniques in the post-procedural bleeding rate, nor when hemostasis was performed with manual compression. The lower incidence of post-procedural bleeding in this cohort was obtained when embolization was performed with glue. However, the difference didn’t reach statistical significance. In all cases, technical failures and bleeding events did not determine relevant clinical sequelae, and patients were conservatively managed. The efficacy of glue for parenchymal tract hemostasis after PPVC has been already shown by several authors: Zhang et al. [6] in a single-center retrospective comparison of glue and coils for PPVC tract embolization presented similar results. They observed a reduced rate of bleeding events when embolization was performed with glue, at the expense of an increased, though negligible, risk of non-target occlusion of intrahepatic portal branches. The authors reported the presence of fewer artifacts with glue at CT imaging, which is an advantage in patients undergoing routine CT follow-up. Also, Park et al. [7] reported favorable outcomes of tract embolization performed with glue. Our data corroborate these findings.

Concerning post-procedural thrombotic events, they were observed in a small percentage of cases, only in one determined by non-target embolization with glue, without clinical consequences. A significantly higher incidence of intrahepatic portal branches thrombosis was detected when the embolization of the parenchymal tract was not performed; this may be explained by the fact that thrombosis was already present before PPVC and the interventional radiologist did not considered necessary to perform tract embolization. Even though data confirms the low risk of non-target embolization, the technical difficulty of the procedure and the expertise of the interventional radiologist always need to be considered.

Despite a lower prevalence of transplenic approaches in the study cohort, no differences were found in terms of technical and clinical outcomes of the different modalities of tract embolization. Haddad et al. [8] and Ohm et al. [2] showed safety and efficacy of coils and a combination of glue and coils, respectively, and Zhu et al. [9] also described successful parenchymal tract embolization using glue in a cohort of patients treated with transplenic portal vein interventions. Chu et al. [10] reported the use of a combination of coils and a mixture of lipiodol and glue without bleeding complications in a small cohort of patients treated with a transplenic approach. Overall, these findings indicate the splenic vein as a safe route for percutaneous portal vein interventions.

Of note, in this study the combination of different embolic materials was not considered, in order to avoid technical bias for the heterogeneity of procedural embolization (e.g., different proportion in different materials). Although, the combination of coils and glue is reported to be effective, we consider it unnecessary and costly: indeed, we obtain an adequate hemostasis even when glue was used alone. We suggest using a lipiodol/glue ration lower that 3 to obtain a rapid polymerization and prevent non-target embolization. The performance of other devices proposed for PVCC, in particular, plugs [5], vascular closure kits [12], and microfibrillar collagen paste [13], was not assessed, as was the recently described PVCC via the mesenteric vein [14].

The study cohort includes a large number of pediatric patients with orthotopic liver transplant in which both transhepatic and exceptional transplenic accesses were used. Parenchymal tract embolization in these patients was successfully performed with coils, glue and in few isolated cases, not performed. Available data in literature in this sub-group of patients report safe and effective use of gelfoam [11].

The different indications for PPVC in this study may also have relevant clinical implications. Transplanted patients with portal vein stenosis or thrombosis usually present with portal hypertension, or a hyperdynamic circulation after a successful portal recanalization, which may increase the propensity to bleeding. Furthermore, they normally receive perioperative anticoagulation. On the contrary, patients undergoing pancreatic islet transplantation rarely suffer from portal hypertension and the portal pressure increase after islet injection is negligible [4]; moreover, they do not receive perioperative anticoagulation. In liver transplanted patients with portal vein obstruction the introducer sheath ranges up to 7F while in pancreatic islet transplanted patients it is 4F at maximum. All these factors determine a theoretical higher risk of bleeding in liver-transplanted patients. Nevertheless, bleeding events occurred in both clinical situations, without statistically significant differences, but with a trend towards more bleeding events in the lower risk population. We think this is due to the more effective hemostatic potential of glue, compared to gelfoam.

Taking into account the findings of this multicenter study, integrated with literature data, it is noteworthy that all the proposed embolization methods are valid. The embolization of the parenchymal tract after PPVC is a safe and effective procedure, useful to limit postprocedural bleeding. Based on a multicenter experience, we lean towards the use of cyanoacrylic glue for the embolization of higher caliber trans-parenchymal accesses, which is supported by a good control of hemostasis without complications compared with other materials. However, given that the difference in terms of technical success and clinical outcomes among embolization techniques did not reach statistical significance, the choice of the embolization technique could be based on the operator’s preferences and experience. The large heterogeneity of clinical conditions, indications to PPVC, access caliper and types among the groups of patients considered, and the two centers, as well as the number of interventional radiologists performing the procedure, can make this data set potentially biased. Further studies are required to prospectively investigate the reproducibility of these findings, including a cost-benefit analysis.

PPVC

percutaneous portal vein catheterization

ultrasound

computed tomography

CTCAE

common terminology criteria for adverse events

IQR

interquartile range

TIPS

transjugular intrahepatic portosystemic shunt

OLT

orthotopic liver transplantation

not applicable

Ethical approval and consent to participate: For this type of study formal consent is not required. Local Institutional Review Board authorized this retrospective study (64/INT/2021 – Vita-Salute San Raffaele Hospital, Milan. Portal-01 – Papa Giovanni XXIII Hospital, Bergamo). Informed consent was obtained from all individual participants included in the study (or their parent or legal guardian in the case of children under 18).
Consent for publication: Consent for publication was obtained for every individual person’s data included in the study.
Availability of data and material: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Competing interests: The authors declare that they have no competing interests.
Funding: This study was not supported by any funding.
Authors’ contributions: PM: conception and design of the work, interpretation of data, drafted and revised the work. FSC: acquisition, analysis, and interpretation of data; drafted and revised the work. LA: acquisition of data. LD: acquisition of data. RM: revised the work. PAB: revised the work. ADC: acquisition of data. StSt: designed and revised the work. SG: acquisition of data. GG: acquisition of data. DP: acquisition of data. MV: revised the work. FDC: revised the work. SS: revised the work.
Acknowledgements: none.

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Editorial decision: Minor revision
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You are reading this latest preprint version

Embolization of the parenchymal tract after percutaneous portal vein catheterization: a retrospective comparison of outcomes with different techniques in two centers.

Status:

Version 1

Abstract

Figures

1. Background

2. Materials And Methods

2.1 Study design

2.2 Study endpoints and outcome measures

2.3 PPVC technique

2.4 Statistical Analysis

3. Results

3.1 Study population and PPVC characteristics

3.2 Technical success and clinical outcomes

4. Discussion

5. Conclusion

Abbreviations

Declarations

References

Status:

Version 1