Arterial Interventions and Peripheral Arterial Disease (PAD)
Bedros Taslakian, MD, EBIR
Director of VIR Research Program; Director of Clinical Research Integration
NYU Grossman School of Medicine Program
Disclosure information not submitted.
Tarub S. Mabud, MD
Resident Physician
New York University Grossman School of Medicine
Erin F. Alaia, MD
Assistant Professor
NYU Grossman School of Medicine
Richard Kijowski, MD
Professor
NYU Grossman School of Medicine
Jonathan Samuels, MD
Associate Professor of Medicine
NYU Grossman School of Medicine
Mukundan Attur, PhD
Associate Professor
NYU Grossman School of Medicine
William Macaulay, MD
Professor of Orthopaedic Surgery
NYU Grossman School of Medicine
Ryan Hickey, MD
Associate Professor
NYU Grossman School of Medicine
To evaluate the safety and effectiveness of genicular artery embolization (GAE) in reducing knee pain and improving function and quality of life in patients with knee osteoarthritis (OA), as determined by validated patient-reported outcome measures. Minimal clinically important difference (MCID) will be used to determine clinical success. Imaging data and disease-specific biomarkers will be evaluated.
Materials and Methods: This is a prospective, single-arm clinical trial. Patients with mild to severe (Kellgren-Lawrence grade 2-4) symptomatic knee OA, who failed conservative therapy for at least 3 months were enrolled. Knee imaging, patient-reported outcome measures (KOOS, WOMAC, VAS, QOL), and knee OA-specific serum biomarkers were evaluated. Each patient underwent transcatheter arterial embolization of one or more genicular arteries in the target knee using 250-μm microspheres (Embozene, Varian). Patients were followed up at 1-, 3-, and 12-month post GAE. The primary outcome was the proportion of patients with clinical success (defined as 20% decrease in WOMAC pain score at 12 months [achieving MCID]). Baseline and follow-up outcomes were compared using paired Wilcoxon signed-rank tests.
Results: A total of 13 patients (10 male; mean age 69 ± 6 years) were included. Technical success was 100%. Clinical success rate was 75%. There were no major adverse events. Transient skin changes involving the target knee were seen in 50% of cases. VAS pain scores decreased from 69.2 ± 4.8 to 33.4 ± 25.4, 21.3 ± 24.3, 9 ± 10.5 at 1, 3, 12 months follow up (P=0.0004); WOMAC pain scores decreased from 8.5 ± 3.6 to 5.1 ± 2.7, 4 ± 3.3, 4 ± 3.1 (P=0.06). WOMAC physical function scores decrease from 30.6 ± 12.8 to 11.7 ± 8.1 at 12 months. QOL index value and KOOS QOL scores improved from 0.65 ± 0.18 and 30.4 ± 14.7 at baseline to 0.88 ± 0.08 and 68.75 ± 19.8 at 12 months, respectively. Hyaluronic Acid (HA) levels decreased from 93.7 ± 65.4 to 52.5 ± 17.2 at 12 months (P=0.022).
Conclusion:
GAE is safe and efficacious treatment option for patients with knee pain secondary to OA, with high clinical success rate, no major adverse events, and significant improvement in knee pain, physical function, and quality of life.