Novel Compliant Scaffold with Specific Design for Venous System: Results of a Porcine Model Study

Pierfrancesco Veroux, Alessia Giaquinta, Carla Virgilio, Davide Danilo Zani, Giuliano Ravasio, Vincenzo Ardita, Paola Secchiero, Eugenio Scanziani, Paolo Zamboni, Massimiliano Veroux, Pierfrancesco Veroux, Alessia Giaquinta, Carla Virgilio, Davide Danilo Zani, Giuliano Ravasio, Vincenzo Ardita, Paola Secchiero, Eugenio Scanziani, Paolo Zamboni, Massimiliano Veroux

Abstract

Background: Stenting has become the first-line treatment of obstructive venous disease because of poor results of balloon angioplasty. This preclinical study aimed to investigate the safety and efficacy profile of a novel compliant venous scaffold (CVS) denominated Petalo CVS, specifically designed for venous diseases.

Materials and methods: Twelve healthy pigs weighing 90 kg were used to test Petalo CVS. The devices were implanted into the internal jugular veins (IJVs) using a femoral vein percutaneous approach. The safety profile including the success rate of device releasing, anchoring, and positioning was evaluated immediately. Fracture, migration, primary patency, and endothelial response were assessed at 1, 2, 3, and 6 months after the study procedure.

Results: A total of 32 devices were successfully released in both IJVs. No procedure- or device-related complications were reported, and all pigs successfully completed the different scheduled follow-up periods. The primary patency rate was 100%, and no fracture or migration of the device into the brachiocephalic trunk was reported. Histological examination revealed only minimal lesions with minimal or absent inflammatory reaction surrounding the incorporated metallic rods.

Conclusions: This porcine model study showed a promising safety and efficacy profile of Petalo CVS, a novel endovenous device based on specific concepts.

Figures

Figure 1
Figure 1
Petalo CVS prototypes: scaffold shape evolutions. In the first prototype (a), the heads of the bridges (arrows) between the modules are directed upwards; in the second prototype (b), the heads are directed downwards; and in the final prototype (c), the heads are in a “kissing” position to minimize the risk of vein perforation and improve the collapsibility of the scaffold. Moreover, in the final prototype, the upper extremities of the modules (∗) are oriented with an external configuration to reduce the contact area and minimize the risk of migration.
Figure 2
Figure 2
Kaplan-Meier curve demonstrating excellent survival.
Figure 3
Figure 3
Kaplan-Meier analysis of 6-month freedom from inner IJV stent graft migration demonstrating a low rate of inner migration, confirming the excellent stability of the device.
Figure 4
Figure 4
Kaplan-Meier analysis of primary patency. All devices were patent at the scheduled follow-up times.
Figure 5
Figure 5
Intraoperative view showing the Petalo CVS implanted in left IJV (arrows). Note the absence of inflammatory reaction of the adventitia and tissue surrounding the vein.
Figure 6
Figure 6
Six-month follow-up. Macroscopic view of the internal surface of a small jugular vein containing Petalo CVS. The device was incorporated in the vein wall mainly at the extremities (Region 2) by a light tissue. Neointimal hyperplasia was absent. Moreover, no fracture of the support modules or transversal bridges of the scaffold were documented. Presence of thrombus was not noted. Region 1: control area; region 2: distal device area; and region 3: middle device area.
Figure 7
Figure 7
Morphological analyses of internal jugular veins implanted with Petalo CVS for 6 months. Six months after the implant, the swine were sacrificed and IJV were collected for morphological analyses. In (A), gross luminal view of the stent-grafted IJV at 6 months is shown. Representative histological images (hematoxylin-eosin stain) of control (a), distal (b), and middle (c) regions of the IJV are shown. ∗∗Empty spaces before being occupied by metallic rods. ∗Inflammatory area.

References

    1. Daugherty S. F., Gillespie D. L. Venous angioplasty and stenting improve pelvic congestion syndrome caused by venous outflow obstruction. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2015;3(3, article no. 218):283–289. doi: 10.1016/j.jvsv.2015.01.003.
    1. Seager M., Busuttil A., Dharmarajah B., Davies A. A Systematic Review of Endovenous Stenting in Chronic Venous Disease Secondary to Iliac Vein Obstruction. European Journal of Vascular and Endovascular Surgery. 2016;51(1):100–120. doi: 10.1016/j.ejvs.2015.09.002.
    1. Raju S. Treatment of iliac-caval outflow obstruction. Seminars in Vascular Surgery. 2015;28(1):47–53. doi: 10.1053/j.semvascsurg.2015.07.001.
    1. Razavi M. K., Jaff M. R., Miller L. E. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circulation: Cardiovascular Interventions. 2015;8(10) doi: 10.1161/CIRCINTERVENTIONS.115.002772.e002772
    1. Veroux P., Giaquinta A., Perricone D., et al. Internal jugular veins outflow in patients with multiple sclerosis: A catheter venography study. Journal of Vascular and Interventional Radiology. 2013;24(12):1790–1797. doi: 10.1016/j.jvir.2013.08.024.
    1. Lee B. B., Baumgartner I., Berlien P., Bianchini G., Burrows P., Gloviczki P. Guideline. Diagnosis and treatment of venous malformations. consensus document of the international union of phlebology (iup)
    1. Wittens C. H. A., Bukkems S. F. F. W., Toonder I. T. Abdominal wall venous collaterals: The latent clinical sign for central chronic venous obstruction. Circulation. 2010;122(20):2089–2090. doi: 10.1161/CIRCULATIONAHA.110.979534.
    1. Kurstjens R. L. M., de Wolf M. A. F., van Laanen J. H. H., de Haan M. W., Wittens C. H. A., de Graaf R. Hemodynamic significance of collateral blood flow in chronic venous obstruction. Phlebology. 2015;30:27–34. doi: 10.1177/0268355515569433.
    1. Lee B. B., Nicolaides A. N., Myers K., Meissner M., Kalodiki E., Allegra C. Venous hemodynamic changes in lower limb venous disease: the UIP consensus according to scientific evidence. International Angiology. 2016;35(3):236–352.
    1. Zamboni P., Consorti G., Galeotti R., et al. Venous collateral circulation of the extracranial cerebrospinal outflow routes. Current Neurovascular Research. 2009;6(3):204–212. doi: 10.2174/156720209788970054.
    1. Sarici I. S., Yanar F., Agcaoglu O., et al. Our early experience with iliofemoral vein stenting in patients with post-thrombotic syndrome. Phlebology. 2014;29(5):298–303. doi: 10.1177/0268355513477641.
    1. Titus J. M., Moise M. A., Bena J., Lyden S. P., Clair D. G. Iliofemoral stenting for venous occlusive disease. Journal of Vascular Surgery. 2011;53(3):706–712. doi: 10.1016/j.jvs.2010.09.011.
    1. Neglén P., Darcey R., Olivier J., Raju S. Bilateral stenting at the iliocaval confluence. Journal of Vascular Surgery. 2010;51(6):1457–1466. doi: 10.1016/j.jvs.2010.01.056.
    1. de Graaf R., de Wolf M., Sailer A. M., van Laanen J., Wittens C., Jalaie H. Iliocaval Confluence Stenting for Chronic Venous Obstructions. CardioVascular and Interventional Radiology. 2015;38(5):1198–1204. doi: 10.1007/s00270-015-1068-5.
    1. Caliste X. A., Clark A. L., Doyle A. J., Cullen J. P., Gillespie D. L. The incidence of contralateral iliac venous thrombosis after stenting across the iliocaval confluence in patients with acute or chronic venous outflow obstruction. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2014;2(3):253–259. doi: 10.1016/j.jvsv.2013.12.007.
    1. Haskal Z. J. Massage-induced Delayed Venous Stent Migration. Journal of Vascular and Interventional Radiology. 2008;19(6):945–949. doi: 10.1016/j.jvir.2008.03.005.
    1. Liu K. C., Starke R. M., Durst C. R., et al. Venous sinus stenting for reduction of intracranial pressure in IIH: a prospective pilot study. Journal of Neurosurgery. 2017;127(5):1126–1133. doi: 10.3171/2016.8.JNS16879.
    1. Starke R. M., Wang T., Ding D., et al. Endovascular Treatment of Venous Sinus Stenosis in Idiopathic Intracranial Hypertension: Complications, Neurological Outcomes, and Radiographic Results. The Scientific World Journal. 2015;2015 doi: 10.1155/2015/140408.140408
    1. Dake M. D. Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis: History and Background. Techniques in Vascular and Interventional Radiology. 2012;15(2):94–100. doi: 10.1053/j.tvir.2012.02.002.
    1. Salvi F., Bartolomei I., Buccellato E., Galeotti R., Zamboni P. Venous angioplasty in multiple sclerosis: Neurological outcome at two years in a cohort of relapsing-remitting patients. Functional Neurology. 2012;27(1):55–59.
    1. Hubbard D., Ponec D., Gooding J., Saxon R., Sauder H., Haacke M. Clinical improvement after extracranial venoplasty in multiple sclerosis. Journal of Vascular and Interventional Radiology. 2012;23(10):1302–1308. doi: 10.1016/j.jvir.2012.07.010.
    1. Denislic M., Milosevic Z., Zorc M., Ravnik I. Z. D., Mendiz O. Disability caused by multiple sclerosis is associated with the number of extra cranial venous stenoses: Possible improvement by venous angioplasty. Results of a prospective study. Phlebology. 2013;28(7):353–360. doi: 10.1258/phleb.2012.012065.
    1. Bavera P. M. May symptoms of chronic cerebrospinal venous insufficiency be improved by venous angioplasty? An independent 4-year follow up on 366 cases. Veins & Lymphatics. 2015;4:p. 5400. doi: 10.4081/vl.2015.5400.
    1. Zamboni P., Galeotti R., Menegatti E., et al. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. Journal of Vascular Surgery. 2009;50(6):1348.e3–1358.e3. doi: 10.1016/j.jvs.2009.07.096.
    1. Zamboni P., Galeotti R., Weinstock-Guttman B., Kennedy C., Salvi F., Zivadinov R. Venous angioplasty in patients with multiple sclerosis: Results of a pilot study. European Journal of Vascular and Endovascular Surgery. 2012;43(1):116–122. doi: 10.1016/j.ejvs.2011.03.035.

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