Evaluation of a Novel Endoluminal Vascular Occlusion Device in a Porcine Model: Early and Late Follow-up

Abstract

Purpose:

To evaluate the efficacy of a new vascular occlusion device (VOD) in a preclinical controlled study versus embolization coils.

Methods:

The Biomerix VOD was made from a biodurable porous polyurethane matrix in the shape of a cylinder measuring 1.5 cm long by 6.0 mm wide. Thirty-three swine were selected to undergo embolization of a 3 to 5-mm-diameter iliac artery using either a single VOD (27 animals) or sufficient Cook fibered stainless steel coils to achieve angiographic occlusion (6 controls). Test animals were assigned to undergo angiography at 1 week (n = 11), 1 month (n=6), 3 months (n=6), or 6 months (n=4). Two control animals were assigned to angiographic follow-up at 1 week, 1 month, and 3 months. Test and control animals were euthanized at each time point to explant occluded vessels for histological analysis. Study endpoints were device utilization, time to occlusion, postdeployment migration, and persistent angiographic occlusion at 7, 30, 90, and 180 days.

Results:

One VOD was deployed in each test animal, whereas a mean 3.3±0.8 coils were needed to achieve angiographic occlusion in the 6 controls (p < 0.001). The time to occlusion was significantly shorter with the VOD (1.46±0.73 versus 5.83±1.60 minutes for the coils; p < 0.001). There was no evidence of recanalization or filling defects at the site of VOD deployment, while filling defects were seen in 3 of 6 coil-treated controls. The VOD arm showed superior angiographic occlusion versus coils at the 1-week, 1-month, and 3-month angiographic follow-up time points. Histological evaluation showed that the VOD was equivalent to the embolization coils at the 1-week (n = 6) and 1-month (n=6) endpoint (100% luminal occlusion). In the 3-month group (n=6), the VOD showed 95% to 100% luminal occlusion versus 90% to 95% in the control animals. In the 6-month group, VOD showed 85% to 95% occlusion.

Conclusions:

The Biomerix VOD appears highly effective and reliable, resulting in significantly faster and longer lasting occlusion compared with fibered stainless steel embolization coils.

Keywords

experimental model swine model iliac artery occlusion transvascular occlusion device embolization coils

Get full access to this article

View all access options for this article.

References

Sato

Ogino

Hara

. Embolization of collateral vessels using mechanically detachable coils in young children with congenital heart disease. Cardiovasc Intervent Radiol. 2003; 26: 528–533.

Anjos

Menezes

Martins

. The percutaneous closure of the ductus arteriosus in adults [in Portuguese]. Rev Port Cardiol. 1999; 18: 255–259.

Inamura

Sakurai

Kawada

. Improvement of heart failure after intracardiac operation for tetralogy of Fallot by transcatheter embolization of major aortopulmonary collateral arteries [in Japanese]. Kyobu Geka. 1990; 43: 219–221.

Isokangas

Perala

. Endovascular embolization of spontaneous retroperitoneal hemorrhage secondary to anticoagulant treatment. Cardiovasc Intervent Radiol. 2004; 27: 607–611.

Faughnan

Thabet

Mei-Zahav

. Pulmonary arteriovenous malformations in children: Outcomes of transcatheter embolotherapy. J Pediatr. 2004; 145: 826–831.

Salomonowitz

Gottlob

Castaneda-Zuniga

. Work in progress: Transcatheter embolization with cyanoacrylate and nitrocellulose. Radiology. 1983; 149: 445–448.

Mori

Sugimoto

Taniguchi

. Renal arteriovenous fistula with rapid blood flow successfully treated by transcatheter arterial embolization: Application of interlocking detachable coil as coil anchor. Cardiovasc Intervent Radiol. 2004; 27: 374–376.

Ahrar

Gupta

. Hepatic artery embolization for hepatocellular carcinoma: Technique, patient selection, and outcomes. Surg Oncol Clin N Am. 2003; 12: 105–126.

Izaki

Sugimoto

Sugimura

. Transcatheter arterial embolization for advanced tumor thrombus with marked arterioportal or arteriovenous shunt complicating hepatocellular carcinoma. Radiat Med. 2004; 22: 155–162.

10.

Sharafuddin

Cervera-Ceballos

. Repositionable vascular occluder: Experimental comparison with standard Gianturco coils. J Vasc Interv Radiol. 1996; 7: 695–703.

11.

Coldwell

Stokes

Yakes

. Embolotherapy: Agents, clinical applications, and techniques. Radiographics. 1994; 14: 623–642.

12.

Raymond

Guilbert

Metcalfe

. Role of the endothelial lining in recurrences after coil embolization: Prevention of recanalization by endothelial denudation. Stroke. 2004; 35: 1471–1475.

13.

Adachi

Oyama

Kuwata

. Inadvertent coil migration that required urgent thoracotomy during embolization for the treatment of pulmonary arteriovenous fistula [in Japanese]. Kyobu Geka. 2004; 57: 867–870.

14.

Chin

Singer

Mihalov

. Superselective mesenteric embolization with microcoils in a porcine model. Dis Colon Rectum. 2002; 45: 212–218.

15.

Anderson

Wallace

Gianturco

. “Mini” Gianturco stainless steel coils for transcatheter vascular occlusion. Radiology. 1979; 132: 301–303.

16.

Chuang

Wallace

Gianturco

. A new improved coil for tapered-tip catheter for arterial occlusion. Radiology. 1980; 135: 507–509.

17.

Santoro

Bigazzi

Palladino

. Comparison of percutaneous closure of large patent ductus arteriosus by multiple coils versus the Amplatzer duct occluder device. Am J Cardiol. 2004; 94: 252–255.

18.

Akagi

Iemura

Tananari

. Simultaneous double or triple coil technique for closure of moderate sized (> or = 3.0 mm) patent ductus arteriosus. J Interv Cardiol. 2001; 14: 91–96.

19.

Hyodo

Yanaka

Kato

. Coil migration during endovascular treatment in a patient with Galenic arteriovenous malformation. J Clin Neurosci. 2002; 9: 584–585.

20.

Halloul

Burger

Grote

. Sequential coil embolization of bilateral internal iliac artery aneurysms prior to endovascular abdominal aortic aneurysm repair. J Endovasc Ther. 2001; 8: 87–92.

21.

Borisov

Tsytko

Il'in

. Failures and complications of transcatheter coil occlusion of patent ductus arteriosus [in Russian]. Vestn Khir Im I I Grek. 2004; 163: 55–58.

22.

Oishi

Okamoto

Sueda

Hashimoto

Karakawa

Akita

. Transcatheter coil embolization of large-size patent ductus arteriosus in adult patients: Usefulness and problems. Jpn Circ J. 1999; 63: 994–998.