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Outcomes of Percutaneous Suture Mediated Vessel Closure in Venous Interventions
Allan W. Tulloch, MD, Sharon C. Kiang, MD, Daniel S. Levi, MD, Jamil Aboulhosn, MD, Brian G. DeRubertis, MD.
UCLA, Los Angeles, CA, USA.
OBJECTIVES: The safety and efficacy of vascular closure devices in the arterial system has been well documented. However, there are no reports describing the use of these devices in the venous system, despite the increasing frequency of percutaneous venous interventions, often involving large-bore sheaths in anticoagulated patients. This report describes our experience using the Perclose Proglide™ (Abbott Vascular Devices, CA) suture-mediated device in venous closure.
METHODS: Retrospective review of all patients undergoing off-label venous access closure with the Perclose was performed from 2008-2012. 70 patients (50% male, mean age 28yrs) underwent 70 femoral venous access closures for sheaths ranging from 9F-22F (mean 18F). A single Preclose device was used post-intervention for sheaths up to 12F, and two Preclose devices were used with the “Preclose” technique for sheaths > 12F. Indications for intervention included non-thrombotic May-Thurner Syndrome with leg swelling, May-Thurner Syndrome with deep vein thrombosis, and pulmonary insufficiency requiring a percutaneous pulmonic valve. All patients underwent full anticoagulation intraprocedurally (ACT >250 sec) and at the time of vessel access closure. Mean follow-up was 13 months, and consisted of physical exam (all patients) and venous duplex ultrasound (20%). Main outcome measures were DVT and access site hematoma.
RESULTS: During longitudinal follow-up, there were no documented cases of DVT or access site hematoma. Venous duplex ultrasound was performed between 1-56 months post-procedurally with normal flow documented in all studied patients. Six patients (9%) had ipsilateral leg swelling necessitating imaging that demonstrated no evidence of DVT or venous stenosis. Two deaths occurred (one <30 days, one late) due to heart failure in pulmonary insufficiency patients, but neither were procedure related.
CONCLUSIONS: The use of suture-mediated devices in the venous system appears to be well tolerated with no documented cases of deep venous thrombosis in our series. The absence of any occurrences of hematoma in these patients, despite large bore sheath access and full anticoagulation, suggests a clinical benefit for use of suture-mediated closure devices. Prospective studies with routine post-procedure duplex imaging after Perclose use in the venous system will better elucidate the long-term safety of this technique.
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