Abstract
Objectives
Selective pulmonary artery perfusion with blood flow occlusion (SPAP-BFO), an experimental endovascular technique, has shown potential to enhance pulmonary drug delivery to the lung. Therefore, it becomes a potential minimally invasive technique for lung cancer and pulmonary metastases. Prior studies predominantly used animal models which do not adequately replicate human vascular anatomy, leaving the clinical feasibility of SPAP-BFO underexplored. To address this gap, we developed a patient-specific 3D model of the human venous system to evaluate the technical feasibility of SPAP-BFO.
Methods
A 1:1 scale 3D model of the human venous system was developed and printed based on CT scans of a patient. This model was connected to a perfusion system to simulate blood flow, enabling testing of the catheterization procedure under realistic clinical conditions. Two commercially available balloon catheters, Coda (Cook) and Reliant (Medtronic), were selected based on length and balloon diameter, and their feasibility of reaching and occluding the left and right pulmonary arteries were assessed.
Results
The model effectively simulated human anatomy and blood flow, allowing for both visual and fluoroscopic assessment of the procedure. Both Coda and Reliant catheters successfully reached the target location, when introduced via the femoral vein, and occluded the left and right pulmonary arteries without physically blocking contralateral flow or extending beyond the first bifurcation.
Conclusions
This patient-specific 3D model provided a valuable platform to evaluate the clinical feasibility of SPAP-BFO. The Coda and Reliant balloon catheters demonstrated effective occlusion of the pulmonary arteries, supporting their potential use in SPAP-BFO procedures.
Keywords: 3D model, lung cancer, selective pulmonary artery perfusion, blood flow occlusion, endovascular, locoregional
Dose restrictions due to systemic toxicities remain a major limitation of standard intravenous chemotherapy in the treatment of non-small cell lung cancer (NSCLC) and pulmonary metastatic disease from sarcoma and colorectal carcinoma.
Graphical abstract
INTRODUCTION
Dose restrictions due to systemic toxicities remain a major limitation of standard intravenous chemotherapy in the treatment of non-small cell lung cancer (NSCLC) and pulmonary metastatic disease from sarcoma and colorectal carcinoma.1 Isolated lung perfusion has been successfully tested in humans but is limited by its invasive character, as it is a procedure which can only be performed once.2 Selective pulmonary artery perfusion with blood flow occlusion (SPAP-BFO) is an experimental endovascular locoregional administration technique designed to overcome this constraint, as it allows for repeated application. The method uses a balloon catheter to deliver chemotherapy directly into the pulmonary artery, accompanied by blood flow occlusion to prevent washout and enhance local drug retention. Although SPAP-BFO has shown promising results in preclinical studies using animal models (eg, rats, dogs, pigs), these models do not accurately represent human vascular anatomy.1,3–13 As a result, key technical aspects remain unexplored, limiting feasibility assessment and hindering translation to clinical practice.
Two key challenges must be addressed before SPAP-BFO can be translated into a phase I clinical study: identifying suitable surgical equipment and establishing procedural feasibility within human anatomy. The first challenge is to identify commercially available balloon catheters and compatible equipment (eg, introducers, guidewires, etc) for the implementation of SPAP-BFO. In the past, the procedure was performed by Smyth and Blades in patients using the Dotter-Lukas No. 1 catheter, which is no longer commercially available.3 The lack of contemporary patient-based studies raises the question whether new catheters must be developed or whether suitable commercial options already exist. The second challenge involves the feasibility of positioning a balloon-tipped catheter in the left pulmonary artery (LPA), where the anatomical distance between its origin and first bifurcation is relatively short. This challenge has been indirectly demonstrated by the methodologies used in previous studies. For example, the right pulmonary artery was mainly occluded in patients, and in the preclinical studies the blood flow occlusion was often achieved by external clamping of the vessel.3–5,7,9,11,12 Investigating these challenges directly in vivo in patients is not possible, and the absence of a representative human anatomy model creates a gap in translating SPAP-BFO from bench-top to bedside.
Given the growing integration of patient-derived 3D models into surgical practice,14–16 this study leverages these recent advancements to address the translational challenges of SPAP-BFO and thereby bridging the gap between preclinical research and phase I clinical trials. Specifically, we developed a customized 3D model of the human venous system to evaluate the technical and practical suitability of commercially available balloon-tipped catheters and to assess their feasibility for implementing SPAP-BFO under simulated perfusion, using both visual and fluoroscopic guidance.
METHODS
Development of the 3D model
To create an anatomically accurate 1:1 3D model of the human venous system from patient-derived imaging data, the following workflow was applied: (1) image acquisition, (2) image processing, (3) 3D printing, (4) post-processing of the printed model. All steps except image acquisition were performed in collaboration with Materialise NV (Leuven, Belgium).
Image acquisition
Medically acquired CT scans (GE healthcare, resolution: 0.625 mm) were previously obtained and provided in an anonymized form, with no biobanks involved. In accordance with the institutional guidelines approved by the local Ethics Committee, the requirement for study-specific ethical approval and informed consent was formally waived. The scans were selected based on the following criteria: clarity and visibility of the images and structures; normal vascular anatomy; the absence of diseases affecting the anatomy of the venous system (eg, hypertension).
Image processing
Retrospectively acquired contrast-enhanced whole-body CT scans from 6 patients were screened for anatomical clarity and contrast phasing. One dataset was selected to segment the venous system, including the internal jugular, brachiocephalic, subclavian, axillary, superior and inferior vena cava, common iliac, external iliac, and common femoral veins. Initially, the same dataset was also used to segment the right heart (atrium and ventricle), pulmonary trunk, and pulmonary arteries. However, these regions lacked sufficient anatomical detail required for model development. To address this, the right heart and pulmonary arteries from the first dataset were replaced by segmentations derived from an electrocardiography-gated CT scan of a second patient, which provided the required spatial and temporal resolution. The 2 segmentations were merged in Mimics Viewer software (Materialise NV, Belgium), while preserving anatomical proportions and continuity. The pulmonary arteries were segmented from their origin to the first bifurcation, representing the relevant workspace to position the balloon catheter. All structures were reviewed and approved by both a vascular (JMHH) and a cardiac surgeon before 3D printing. Following segmentation, the electronic design was adapted for experimental use. The model was designed hollow to preserve true luminal diameters, mounted on a baseplate for stability and correct installation on the surgical table, and fitted with ½-inch connectors to allow integration with a perfusion system simulating flow. Figure 1 illustrates the final electronic design.
Figure 1.
Electronic Design of the Model. (A) Frontal view; (B) left-sided view; (C) right-sided view; (D) superior view; (E) inferior view. The arrows indicate the direction of the flow
3D printing
The model was printed using TuskXC2700T, a rigid, transparent, and radiolucent material. This material was chosen for these properties which facilitate the assessment of the catheterization procedure both visually and by fluoroscopic guidance. Due to technical constraints related to the removal of support structures, the model was printed in multiple parts.
Post-processing of the printed model
The support structures, required to ensure stability during the printing process, were manually removed from the lumen and/or outside of the model. Subsequently, all parts were assembled through adhesive bonding.
The experimental setup
The model was fixed on a Maquet Magnus surgical table with a carbon fibre tabletop, providing optimal radioscopic access and unrestricted access to the surgical field. Its inlets and outlets were connected to a perfusion system comprising tubings, connectors, a pump (ECMO system: Lifebox and Revolution centrifugal pump, LivaNova, Italy), and a hardshell reservoir (VHK 71000, Getinge, Sweden) (Figure 2). Flexible silicone tubing (Raumedic, ECC Silicone Tubing, ½ inch x 3/32) was placed near the model to allow puncture access, minimize traction, and permit easy replacement after repeated use. These were connected to rigid 3/8 inch PVC tubing, which interfaced with the reservoir and pump and enabled placement of a calibrated ultrasound flow probe at the outlet of the pulmonary arteries for continuous flow monitoring before, during, and after balloon inflation. The probe could easily be switched from side to confirm and monitor flow to both sides. Demineralized water was used as perfusate to prevent material degradation and mineral deposition. During fluoroscopy-guided experiments, the model was covered with surgical drapes to obscure visual cues and simulate in vivo conditions.
Figure 2.
Experimental Setup for Both Experiments. (A, C) Pilot experiment under visual guidance: (A) the model and (C) the perfusion system. (B, D) Experiment under fluoroscopic guidance performed in the operating room: (B) the procedural setup and (D) the ECMO system used to perfuse the model
All tests were conducted under steady-flow conditions at 3 L/min. This flow rate was chosen for these experiments because the model’s operational limits were undefined, and lower flow provides minimal hydrodynamic assistance, making catheter placement more stringent than at 5 L/min. Flow rates were continuously monitored throughout the experiment, whereas pressures were not measured.
Catheterization equipment and procedure
Based on Mimics Viewer measurements, the minimal catheter requirements (75 cm length, 3 cm balloon diameter) were defined, and to reduce the risk of pulmonary artery rupture, only compliant, commercially available, intravascular approved balloon catheters were considered, resulting in the selection of the Coda (10 F, 0.035″, 140 cm, 60 cc; Cook Medical) and Reliant (8 F, 0.038″, 100 cm, 60 cc; Medtronic). Subsequently, compatible surgical equipment, such as introducers, guidewires, and catheters, were selected based on the expertise and preferences of the vascular surgeon. The following materials were selected: Brite Tip sheath introducer (4 F, 11 cm; Cordis Corporation); Check-Flo Introducer Set (14 F, 13 cm; Cook Medical); Straight Pigtail catheter (4 F, 0.038″, 90 cm; Terumo Corporation); Radifocus Guide Wire M, stiff type, angled tip (0.035″, 260 cm; Terumo Corporation); Lunderquist Extra-Stiff Wire Guide (0.035″, 260 cm; Cook Medical).
The catheterization procedure included the following steps:
Puncture of the silicone tubing at 1 of the model’s entry points.
Placement of the Brite Tip sheath introducer.
Dilation of the punctured site and replacement of the Brite Tip sheath with the Check-Flo introducer.
Insertion of the Radifocus guidewire until positioned in 1 of the pulmonary arteries.
Advancement of the Straight Pigtail catheter over the guidewire until correctly positioned.
Removal of the Radifocus guidewire.
Insertion of a Lunderquist guidewire through the Pigtail catheter.
Removal of the Pigtail catheter.
Advancement of the balloon catheter over the Lunderquist guidewire until correctly positioned.
Removal of the Lunderquist guidewire.
Verification of the balloon catheter’s position.
Inflation of the balloon until the pulmonary artery is fully occluded, as confirmed by flow measurements or by proximal injection of a contrast agent.
Confirmation that the balloon does not interfere with the flow towards the contralateral pulmonary artery.
RESULTS
Technical features and installation of the model
Technical features
The model measured 75.0 cm in length, 32.0 cm in width, and 15.0 cm in height, making it relatively large for a 3D model. The choice of TuskCX2700T as the printing material proved effective, offering 2 essential properties: transparency and radiolucency. With the addition of the baseplate, the model could be reliably positioned on a surgical table while maintaining an anatomically accurate orientation.
Installation
Attachment and replacement of the tubings was straightforward due to the design of the connectors. However, caution was required, as the connectors are a fragile component of the model. The connectors had an inner diameter of 8.0 mm and an outer diameter of 12.7 mm, allowing compatibility with standard ½-inch tubing. These dimensions supported flow rates up to 5 L/min, even when 1 of the 2 outlets was occluded. During the filling process, air trapping frequently occurred within the cardiac chambers which may interfere with the catheterization. Nevertheless, it was easily resolved by carefully tilting the model in different directions.
Evaluating the feasibility of SPAP-BFO
The evaluation of the procedural feasibility and catheter performance was conducted in 2 phases: an initial pilot experiment under direct visual guidance to assess basic feasibility, followed by a repetition of the procedure under fluoroscopic guidance to simulate the clinical environment. All experiments were performed by an experienced vascular surgeon, with a perfusionist monitoring and controlling the flow.
Assessment by visual guidance
An initial pilot experiment under direct visual guidance was conducted using the Coda balloon catheter to assess the feasibility of the procedure. This test demonstrated that the pulmonary artery could be accessed via the common femoral vein, and that the catheter effectively occluded the LPA without physically obstructing flow to the contralateral side, as confirmed by both flow measurement and visual inspection. Figure 3 displays the results of the experiment.
Figure 3.
Pilot Experiment Under Visual Guidance. (A) Advancing the pigtail catheter over the guidewire from femoral vein to left pulmonary artery (LPA); (B) The final position of the pigtail catheter in the LPA; (C) Placement of the coda cook balloon catheter; (D) full pulmonary artery occlusion, povidone-iodine was used to visualize the balloon. The arrows indicate the direction of the flow
Assessment by fluoroscopic guidance
The experiment was subsequently repeated under comparable experimental conditions, this time using fluoroscopic guidance, with the model covered to prevent direct visual assessment and more realistically simulate the clinical setting. This procedure was performed for both balloon catheters. To simplify the process, the Lunderquist guidewire was left in place between balloons, allowing for straightforward exchange without the need to repeat the entire catheterization procedure. The experimental setup, as implemented in the operating room, is shown in Figure 2, and a video fragment of the catheterization procedure under fluoroscopy is provided in Video 1. The catheterization was executed without complications and completed within approximately 10 min, even though it was only the second attempt, highlighting the procedure’s reproducibility and the model’s operational feasibility. Both the Coda and Reliant balloon catheters were successfully advanced via the common femoral vein and reached their respective target locations. They achieved complete occlusion of the left or right pulmonary arteries without physically obstructing contralateral perfusion, as confirmed by continuous flow measurements (Table 1). Additionally, no displacement of the balloon was observed during flow occlusion, indicating stability under the conditions tested.
Table 1.
Flow Measurements
| Device | Location | QTotal input (L/min) | QLPA output (L/min) | QRPA output (L/min) |
|---|---|---|---|---|
| Before/After occlusion | ||||
| Coda | LPA | 3.0 | 1.5 | 1.5 |
| RPA | 3.0 | 1.5 | 1.5 | |
| Reliant | LPA | 3.0 | 1.5 | 1.5 |
| RPA | 3.0 | 1.5 | 1.5 | |
| During occlusion | ||||
| Coda | LPA | 3.0 | 0.0 | 2.8 |
| RPA | 3.0 | 2.8 | 0.0 | |
| Reliant | LPA | 3.0 | 0.0 | 2.8 |
| RPA | 3.0 | 2.8 | 0.0 | |
Abbreviations: Q = flow; LPA = left pulmonary artery; RPA = right pulmonary artery.
Representative fluoroscopic images (Figures 4 and 5) show the balloon catheters in both deflated and inflated states, positioned within the left or right pulmonary artery. These images confirmed that the working space in both pulmonary arteries is sufficient to position the balloon tip proximal to the first bifurcation, as indicated by the location of the connector, thereby enabling unilateral occlusion without physically obstructing contralateral flow.
Figure 4.
Fluoroscopic Images Demonstrating Coda Cook Balloon Catheter Positioning and Occlusion in the Pulmonary Arteries. (A) Catheter positioned in the left pulmonary artery (LPA); (B) balloon inflated to achieve complete blood flow occlusion (BFO) in the LPA; (C) catheter positioned in the right pulmonary artery (RPA); (D) balloon inflated until complete BFO was achieved in the RPA. Dotted lines indicate the location of where the first bifurcation to the upper lobe is located
Figure 5.
Fluoroscopic Images Demonstrating Reliant Medtronic Balloon Catheter Positioning and Occlusion in the Pulmonary Arteries. (A) Catheter positioned in the left pulmonary artery (LPA); (B) balloon inflated to achieve complete blood flow occlusion (BFO) in the LPA; (C) catheter positioned in the right pulmonary artery (RPA); (D) balloon inflated until complete BFO was achieved in the RPA. Dotted lines indicate the location of where the first bifurcation to the upper lobe is located
DISCUSSION
This study presents the successful development of a patient-specific 3D model of the venous system accurately replicating human anatomy, providing a robust platform for preclinical vascular testing. Using this model, we demonstrated that both the Coda (Cook Medical) and Reliant (Medtronic) balloon catheters are effective tools to induce SPAP-BFO in either the left or right pulmonary artery. Each catheter achieved targeted vessel occlusion without impairing contralateral flow, and the model demonstrated sufficient working space to position the balloon tips proximal to the first bifurcation.
Previous studies on SPAP-BFO have primarily used animal models to investigate therapeutic outcomes such as pulmonary drug uptake, systemic exposure, and tumour response.1,3–13 While relevant, these models are anatomically distinct from human vasculature and offer limited insights into procedural feasibility. To date, only 2 clinical reports—published in the 1960s and 1980s—have described the use of SPAP-BFO in humans. Smyth and Blades used the now-obsolete Dotter-Lukas No. 1 catheter to induce occlusion of the main pulmonary arteries in 3 patients, achieving LPA occlusion in 1 case.3 However, Morris and Goldberg highlighted the technical challenge of catheterizing and occluding the LPA.17 In a subsequent study, Karakousis et al used a Swan-Ganz catheter for SPAP-BFO in 7 patients, but restricted the procedure to the segmental branches, as its 13 mm balloon diameter could not occlude the main pulmonary arteries.7 This limitations is consistent with CT angiography data from Berger et al, who reported mean diameters of 25 mm for the right and left main pulmonary arteries.18 These sparse and dated studies provide limited insights into the technical feasibility of SPAP-BFO in humans and underscore the need of anatomically accurate, patient-specific models to support clinical translation, forming the foundation of our study.
Nowadays, various types of simulation-based models exist to support the translation of vascular procedures into clinical practice, like virtual reality (VR) simulators, perfused human cadavers, and 3D-printed anatomical models.15 VR simulators have proven effective to train established procedures like angioplasty and endovascular aortic repair (EVAR), enhancing surgical efficiency. However, they are costly, time-consuming and complex to develop making them more viable for standard procedures, and not cost-effective for experimental techniques such as SPAP-BFO. Human cadavers offer anatomical realism and perfusion potential, yet are limited by availability, ethics, single-use constraints, and often lack clinical background information.19,20 In contrast, 3D-printed models provide a compelling combination of anatomical accuracy, customizability, reusability, and perfusability, making them ideal for training, feasibility studies, and equipment testing in controlled yet realistic settings. Additionally, they align with the 3R’s principle (replace, reduce, refine) by offering a repeatable, ethical alternative for early-stage testing, thereby reducing reliance on animal models. Thus, they present a practical and cost-effective platform to advance SPAP-BFO towards clinical application.
The use of 3D-printed, patient-specific vascular models has expanded rapidly in recent years, particularly for surgical planning, simulation, and training.14,16 However, venous models remain relatively underexplored and less advanced compared to arterial models. For instance, Torreggiani et al developed a perfused, patient-based model of the inferior vena cava, right heart, and pulmonary arteries.21 Similarly, Kurenov et al printed a flexible model of the pulmonary arteries for device development.22 While both models represent partial vascular systems, they are limited to specific regions and do not support the assessment of the entire catheterization procedure. In contrast, our model is, to our knowledge, the first to replicate an extended region of the venous system, enabling to study broader and more complex applications such as SPAP-BFO. More broadly, Catasta et al reviewed 22 studies involving 3D-printed arterial models published between 2015 and 2024, which demonstrated considerable variability in anatomical detail, material properties, and complexity.14 Among these, only 7 were perfused, and just 4 of these were tested under fluoroscopic guidance. These findings underscore the sophistication, uniqueness, and translational relevance of our model.
This 3D model was made as an additional safety step between the animal studies and the clinical application. SPAP-BFO has been successfully performed in patients in the past, especially in the 60s and 70s but these balloon catheters were either unspecified or no longer available.3 Therefore, the aim of this study was not to re-evaluate safety, haemodynamic effects, or efficacy—as these have already been investigated—but to determine what commercially available balloon catheters had the right properties to achieve our primary goals: being delivered to the site of interest, occluding the PA, and delivery of the drug without compromising segmental branches.
A key strength of this model is its ability to provide procedural insights that are not accessible through imaging data alone, particularly regarding catheter trackability, navigation along the tortuous route to the PA, and balloon behaviour within the limited anatomical space prior to the first segmental branches. While our model is innovative and unique, some considerations should be noted. Because of the high cost of 3D printing, a single model was deemed sufficient for this proof-of-concept study as was demonstrated in this model. In case newer, smaller balloons become available, these will be tested again but for the immediate future, this is not expected the case. While it accurately reproduces the anatomy prior to the first bifurcation and allowed us to test balloon positioning, smaller branch vessels were not included. Its rigid material also does not mimic vascular compliance, which limits physiological and haemodynamic assessment; however, based on our previous acute pig model experiments, no such alterations are expected.13 The model is therefore best viewed as a tool for technical feasibility testing and hands-on training in a risk-free environment, rather than for direct clinical risk prediction.
CONCLUSION
In conclusion, this patient-specific 3D model has demonstrated its ability to replicate the clinical conditions, providing a valuable platform to evaluate the technical feasibility of SPAP-BFO. Using this model, we identified the Coda and Reliant balloon catheters as effective tools to induce SPAP-BFO. Looking ahead, this model could play a pivotal role in training, skill development, and reducing reliance on animal models, thereby advancing both preclinical and clinical research on SPAP-BFO.
ACKNOWLEDGEMENTS
The authors thank the Materialise NV team for their support during the development and production process of the 3D model.
Contributor Information
Erik Claes, ASTARC (Antwerp Surgical Training and Anatomy Research Centre), University of Antwerp, Wilrijk 2610, Belgium; Department of Thoracic and Vascular Surgery, University Hospital Antwerp, Edegem 2650, Belgium.
Stijn E Verleden, ASTARC (Antwerp Surgical Training and Anatomy Research Centre), University of Antwerp, Wilrijk 2610, Belgium; Department of Thoracic and Vascular Surgery, University Hospital Antwerp, Edegem 2650, Belgium; Department of Pulmonology, University Hospital Antwerp, Edegem 2650, Belgium.
Annemiek Snoeckx, Department of Radiology, University Hospital Antwerp, Edegem 2650, Belgium.
Gerdy Debeuckelaere, Perfusion Department, University Hospital Antwerp, Edegem 2650, Belgium.
Joke De Raedemaecker, ASTARC (Antwerp Surgical Training and Anatomy Research Centre), University of Antwerp, Wilrijk 2610, Belgium.
Thérèse S Lapperre, Department of Pulmonology, University Hospital Antwerp, Edegem 2650, Belgium; LEMP (Laboratory of Experimental Medicine and Pediatrics), University of Antwerp, Wilrijk 2610, Belgium.
Jeroen M H Hendriks, ASTARC (Antwerp Surgical Training and Anatomy Research Centre), University of Antwerp, Wilrijk 2610, Belgium; Department of Thoracic and Vascular Surgery, University Hospital Antwerp, Edegem 2650, Belgium.
AUTHOR CONTRIBUTIONS
Conceptualization: E.C., S.E.V., J.DR., T.S.L., and J.M.H.H.; Funding acquisition: S.E.V. and J.M.H.H.; Investigation: E.C., S.E.V., G.D., J.DR., and J.M.H.H.; Methodology: E.C., S.E.V., J.DR., G.D., and J.M.H.H.; Project administration: S.E.V. and J.M.H.H.; Resources: E.C., S.E.V., A.S., G.D., and J.M.H.H.; Supervision: S.E.V. and J.M.H.H.; visualization: E.C.; Writing—original daft: E.C., S.E.V., and J.M.H.H.; writing—review & editing: E.C., S.E.V., A.S., G.D., J.DR., T.S.L., and J.M.H.H.
FUNDING
This work was supported by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society (grant number 001850494) to J.M.H.H.; and by the Collen Francqui Foundation to S.E.V.
CONFLICTS OF INTEREST
None declared.
DATA AVAILABILITY
The data underlying this article will be shared on reasonable request to the corresponding author.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data underlying this article will be shared on reasonable request to the corresponding author.