Arterial Cutaneous Femoral Fistulous Tract Closure Using Surgiflo Hemostatic Matrix: A Novel Adjunct for Post-TAVR Access-Site Management

Abstract: Several options are available to address hemostasis at the end of a cardiac catheterization or percutaneous transfemoral transcatheter aortic valve replacement (TAVR) when conventional options are ineffective. To date, there have been few studies exploring the use of a topical thrombin preparation, as one of its main contraindications is that it cannot be used intravascularly due to risk of embolization. The following case shows safe utilization of Surgiflo hemostatic gel matrix under fluoroscopic guidance against an inflated balloon in order to achieve closure of a fistulous tract from a femoral artery access site during percutaneous TAVR.  

J INVASIVE CARDIOL 2017;29(8):277-279.

Key words: access-site management, embolization, hemostasis 

Arterial puncture occurs at the start of cardiac catheterization and is a critical first step in any minimally invasive process occurring in the catheterization lab or the hybrid operating room. It is not without hazards and carries its own potential for complications if hemostasis at the end of the procedure cannot be achieved. This is particularly important when large-caliber catheters are used for transfemoral access. 

There are two main categories of topical hemostatic agents: physical agents (including dry matrix compounds like gelatin matrix); and biologically active agents (including topical thrombin and fibrin sealant).¹ Recently, a newer preparation called the Surgiflo Hemostatic Matrix Kit (Ethicon) has become commercially available. The product is a gelatin-based thrombin sealant and much of the product is an evolution of Surgifoam Sponge material, which contains porcine gelatin that is rendered hardened by dry heat and then milled into a powder and mixed with a liquid to form a gelatin paste that is filled into a syringe and capped.² The Surgiflo kit also contains lyophilized human thrombin powder that can be placed in solution and used as the additional liquid to be mixed with the pre-filled gelatin matrix syringe. An alternative to using the human thrombin solution is sterile saline; however, the ancillary human thrombin provides more rapid consistent hemostasis that supports the endogenous clotting process. The gelatin matrix component provides a medium for blood platelets to adhere and aggregate, initiating the patient’s natural hemostatic cascade. Endogenous thrombin is then activated, converting endogenous fibrinogen in blood into an insoluble fibrin clot.³

The intended purpose of Surgiflo is for epilesional use in surgical procedures when control of capillary, venous, and arteriolar bleeding by pressure, ligature, or other conventional procedures is ineffective or impractical. We present here a case in which Surgiflo matrix was used against an inflated intraarterial balloon placed from the already available contralateral femoral access to achieve closure of a femoral cutaneous fistulous tract following transfemoral transcatheter aortic valve replacement (TAVR). 

Case Description

We present the case of a 76-year-old male with past medical history of hypertension, atrial fibrillation, single-vessel coronary artery disease, type-2 diabetes mellitus, and inflammatory arthropathy on hydroxychloroquine and methotrexate. The patient was sent to our institution for TAVR for his severe aortic stenosis. He had complaints of dyspnea on exertion and leg weakness walking up 1 flight of stairs. As part of his TAVR evaluation, the patient underwent computed tomography angiography, which showed a 2.5 cm right common femoral artery pseudoaneurysm likely related to his prior diagnostic catheterization 2 months earlier. Thrombin injection was done at that time with acute thrombosis of the pseudoaneurysm without any complications.⁴ A subsequent Doppler ultrasound showed thrombosed pseudoaneurysm with no internal flow. One month later, the patient underwent TAVR. Using the modified Seldinger technique and micropuncture kit, a 7 Fr sheath was inserted into the left femoral artery and a 14 Fr e-sheath was placed into the right femoral artery (RFA). Angiographic images of the RFA using crossover technique from the left femoral artery prior to accessing the RFA showed a grossly normal right common femoral lumen without angiographic evidence of aneurysmal dilation or residual pseudoaneurysm or stenosis. A 26 mm Edwards Sapien 3 stent-mounted aortic valve (Edwards Lifesciences) was positioned under fluoroscopic guidance. The valve was confirmed to be in good position with echocardiography. After valve placement, the 14 Fr sheath was removed using the existing sutures. Mild to moderate residual external bleeding was noted from the RFA access site after the Perclose suture closure devices were tied down, with subsequent angiogram from the contralateral 7 Fr access demonstrating extravasation of contrast material from the RFA into a fistulous cutaneous tract and into the adjacent soft tissue (Figure 1). No vessel aneurysm or other areas of contrast extravasation were noticed on the angiographic images. After a period of external manual compression and three subsequent attempts of internal compression with 5-min inflations, a 6 x 4 mm balloon from the contralateral access failed to resolve the bleeding and the decision was made to attempt hemostasis using Surgiflo. The Surgiflo topical sealant was injected into the femoral access tract during inflation of a 6 mm x 4 cm balloon placed at the level of persistent bleeding at the RFA access site. A multibend flex-tip catheter, provided with the hemostatic matrix kit, was used to inject Surgiflo hemostatic matrix within the access tract between the inflated balloon and the site of extravasation (Figure 2). The Surgiflo was allowed to dwell for 5 minutes with the balloon inflated, after which the balloon was deflated. Angiographic images showed no residual contrast extravasation and there was a large lumen at the puncture site with normal blood flow to the distal vessel (Figure 3). The patient tolerated the procedure well, with an estimated blood loss of <200 mL. The patient was monitored in the intensive care unit for 1 night and his length of stay in the hospital was 4 days. His only postprocedural complication was a new left bundle-branch block, which ultimately was treated with permanent pacemaker insertion. 

Discussion

Surgiflo has been used in several settings to achieve hemostasis post surgery and in cases of various vessel malformations. Karim et al retrospectively evaluated the benefits of hemostatic agents, including Surgiflo, for head and neck arteriovenous malformations in 12 patients. In those cases, Surgiflo was used as part of direct puncture sclerotherapy at the base of surgical sites, and ultimately showed that Surgiflo could safely be used to achieve hemostasis endovascularly.⁵ Slaba et al reported similar findings with the use of Surgiflo for cavernous hemangiomas.⁶

The use of Surgiflo is not without risks. Various urological and neurosurgical studies have been published regarding the potential risks of using Surgiflo from a histopathological perspective. Lipkin et al evaluated Evical (a fibrin sealant manufactured by Ethicon) and Surgiflo as an adjunct to tubeless percutaneous nephrolithotomy to determine absorption and tract closure rates. The authors concluded that although the risk of early urine leak may be reduced, these agents should be used with caution because of persistence up to 30 days for Evical and 14 days for Surgiflo and possible inhibition of wound healing.⁷ Furthermore, Altun et al evaluated 11 different hemostatic agents (including Surgiflo) in rat models post laminectomy. The hemostatic agent was applied to the epidural region after laminectomy and histopathologic sections after 12 weeks showed notable alterations such as severe fibrosis, inflammation, and increased vascularity.⁸ 

Three contraindications are listed from manufacturers when using Surgiflo. The first is that it cannot be used in the closure of skin incisions because it may interfere with the healing of skin edges. The second is that it cannot be used in patients with known allergies to porcine gelatin. The third is that it should not be used within intravascular compartments because of the risk of embolization. In our case, the Surgiflo gel matrix was used under direct fluoroscopic guidance against an inflated crossover balloon to achieve closure of the fistulous tract from the RFA access site.⁹ We believe the presence of an intraluminal balloon is critical to prevent inadvertent intraarterial injection of the Surgiflo gel matrix. The use of an intraarterial balloon and an extravascular sealant also comprises the foundation for the MynxGrip vascular closure device (Cordis Corporation); however, the MynxGrip deploys a small balloon directly through the arteriotomy access site and injects a polyethylene glycol sealant (a water-soluble, bioinert, non-thrombogenic polymer) extravascularly through a small sheath.¹⁰ Unlike the use of a crossover balloon and Surgiflo as described in this manuscript, the MynxGrip is not suitable for use with large-caliber access sheaths and requires retained wire access. Overall, in this case, good arterial flow was demonstrated distally at the end of the procedure. Our patient did not have any complications at the time of the 2-month follow-up visit. 

Conclusion

This case demonstrates a new and novel use of Surgiflo matrix as means of fistulous tract closure, as is sometimes seen following percutaneous femoral artery catheter access. 

References 

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2.     Ethicon, Inc. Surgiflo Hemostatic Matrix. 2009; 1-24. Available at https://www.ethiconinstitute.comhttps://s3.amazonaws.com/HMP/hmp_ln/imported/SFL-0389-09_Tech%20Rpt_CA.pdf. 

3.     Moss R. Management of surgical hemostasis. An independent study guide. AORN, Inc. 2013. 

4.     La Perna L, Olin JW, Goines D, Childs MB, Ouriel K. Ultrasound-guided thrombin injection for the treatment of postcatheterization pseudoaneurysms. Circulation. 2000;102:2391-2395. 

5.     Karim AB, Lindsey S, Bovino B, Berenstein A. Oral surgical procedures performed safely in patients with head and neck arteriovenous malformations: a retrospective case series of 12 patients. J Oral Maxillofac Surg. 2016;74:255.e1-255e8. Epub 2015 Oct 23. 

6.     Slaba S, Braidy C Sader RB, Hokayem N, Nassar J. Giant venous malformation of the tongue: the value of Surgiflo. J Mal Vasc. 2010;35:197-201. Epub 2010 Apr 15. 

7.     Lipkin ME, Mancini JG, Simmons WN, et al. Pathologic evaluation of hemostatic agents in percutaneous nephrolithomy tracts in a porcine model. J Endourol. 2011;25:1353-1357. Epub 2011 Jul 8.

8.     Altun I. An experimental study of histopathologic effects of hemostatic agents used in spinal surgery. World Neurosurg. 2016;90:147-153. Epub 2016 Feb 18. 

9.     Feldman T, Levisay JP, Salinger MH, Perlowski A. Femoral access for TAVR: techniques for prevention and endovascular management of complications. Endovascular Interventions: A Case-Based Approach. New York City: Springer, 2014:879-882.

10.     MYNXGRIP® Vascular Closure Device. Cordis, 2016. Available at https://www.cordisjapanjp/en_us_cardiology/close/mynxgrip-vascular-closure-device.html. Accessed Feb 12, 2017. 

From the ¹Department of Medicine, NorthShore University HealthSystem, Evanston Hospital, Evanston, Illinois; ²Department of Medicine, Division of Cardiology, NorthShore University HealthSystem, Evanston Hospital, Evanston, Illinois; and ³Department of Surgery, Division of Cardiothoracic Surgery, NorthShore University HealthSystem, Evanston Hospital, Evanston, Illinois. 

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Feldman reports research grants and consultant fees from Abbott Vascular, Boston Scientific, and Edwards Lifesciences. Dr Guerrero reports research grants and consultant/proctor fees from Edwards Lifesciences. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript submitted February 21, 2017, provisional acceptance given March 13, 2017, final version accepted March 29, 2017.

Address for correspondence: Michael H. Salinger, MD, Department of Cardiology, NorthShore University HealthSystem, Evanston, IL 60201. Email: msalinger@northshore.org