Iliac Vein Stenting in Office-Based Laboratory Setting Studied

January 25, 2022—The Society for Vascular Surgery (SVS) announced the publication of a retrospective study of 1,223 iliac vein cases performed in three office-based laboratories (OBLs). The study reported a major complication rate of 0.41%, suggesting that these procedures are safe and well tolerated in this setting. The findings were published by Ishan Satwah, BS, et al in Journal of Vascular Surgery: Venous and Lymphatic Disorders (2022;10:60-67).

The investigators are from the Center for Vascular Medicine and the Center for Vein Restoration; both are in Greenbelt, Maryland. Levan Sulakvelidze, BS, who is with the Center for Vascular Medicine, explained the background of the study in the SVS press release. He stated, “Because OBLs are not regulated to the same degree as in-patient facilities or ambulatory centers, questions have been raised regarding patient safety and outcomes in this environment.” He continued, “The safety profile of iliac vein stenting in the OBL setting has not been thoroughly evaluated. The purpose of the present study was to evaluate the complication rate and safety profile of this procedure when performed in an OBL.”

As summarized by SVS, the investigators reviewed prospectively collected data from 1,104 patients who underwent a total of 1,223 iliac vein stents in OBL centers.

Three patient groups were studied based on presentation: lower extremity symptoms alone (n = 305), pelvic symptoms alone (n = 91), and a combination of the two (n = 827). Trained nursing personnel, under the supervision of the attending interventionalist, administered conscious sedation to all patients. Typical dosing involved midazolam 1 mg and fentanyl 50 µg. Excluded from this setting were patients with significant cardiac/pulmonary risk, history of severe airway issues, morbid obesity, and complex venous lesions (eg, inferior vena cava obstruction).

There were no mortalities and no complications rendered that were related to the sedation. The total complication rate was 7.8%. There were five major complications (0.4%), defined as requiring hospitalization for allergic reaction (n = 1), arrhythmia (n = 2), chest pain (n = 1), stent occlusion (n = 1). There were 90 minor complications, mainly involving minor access bleeding (n = 39) and hematoma (n = 31).

Mr. Sulakvelidze commented on the findings, “In the study, because most of the complications were considered minor, including suspected overreported hematomas, we have presented strong evidence that demonstrates iliac stenting performed in the OBL setting is safe.”

In conclusion, Sulakvelidze stated, “Given these promising results, we recommend all OBLs become Joint Commission (formerly the Joint Commission on Accreditation of Health Care Organizations, or JCAHO)–certified and include quality assurance efforts to maximize patient safety.”

Noting that patient safety and quality care remain the most important goals of any procedure rendered by a vascular interventionalist, the JVS editors advised in the press release, “This important study confirms that both can be achieved in the OBL setting for patients who require iliac vein stenting.”