A retrospective study of 1,223 iliac vein cases performed in three office-based laboratories (OBLs) shows a major complication rate of 0.41%, suggesting these procedures are safe and well-tolerated in this setting.
“Because OBLs are not regulated to the same degree as in-patient facilities or ambulatory centres, questions have been raised regarding patient safety and outcomes in this environment,” corresponding author Levan Sulakvelidze (Center for Vascular Medicine, Greenbelt, USA) begins.
“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 and colleagues reviewed prospectively collected data from 1,104 patients who underwent a total of 1,223 iliac vein stents in OBL centres.
Three patient groups were studied based on presentation:
- Lower extremity symptoms alone: 305
- Pelvic symptoms alone: 91
- 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
- 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%), defined as requiring hospitalisation for:
- Allergic reaction (one), arrhythmia (two), chest pain (one), stent occlusion (one)
- Ninety minor complications, mainly involving:
- Minor access bleeding (39) and hematoma (31)
Sulakvelidze comments: “In the study, because most of the complications were considered minor, including suspected over-reported haematomas, 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 maximise patient safety.”
Patient safety and quality care remain the most important goals of any procedure rendered by a vascular interventionalist, said JVS editors. “This important study confirms that both can be achieved in the OBL setting for patients who require iliac vein stenting.”