A retrospective study of 1,223 iliac vein cases performed in three office-based laboratories (OBLs) demonstrated a major complication rate of 0.41%, suggesting these procedures are safe and well-tolerated in this setting, the authors say.
According to corresponding researcher Levan Sulakvelidze, BS, from the Center for Vascular Medicine in Greenbelt, Maryland, “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.
“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 reported in the January 2022 issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders, Sulakvelidze, senior author Peter Pappas, MD, part of the leadership at the Center for Vascular Medicine, and colleagues 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 (305), pelvic symptoms alone (91) and a combination of the two (827).
Trained nursing personnel, under the supervision of the attending interventionalist, administered conscious sedation to all patients. Typical dosing involved midazolam (1mg) and fentanyl (50µg). Excluded from this setting were patients with significant cardiac/pulmonary risk, history of severe airway issues, morbid obesity and complex venous lesions (e.g., inferior vena cava [IVC] obstruction).
There were no mortalities and no complications related to the sedation rendered. The total complication rate was 7.8%, including five major complications (0.4%) and 90 minor complications.
Sulakvelidze comments: “In the study, because most of the complications were considered minor, including suspected over-reported hematomas, we have presented strong evidence that demonstrates iliac stenting performed in the OBL setting is safe. 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.”
Patient safety and quality care remain the most important goals of any procedure rendered by a vascular interventionalist, according to JVS editors. “This important study confirms that both can be achieved in the OBL setting for patients who require iliac vein stenting.”