Prospective Observational Study of Pain Severity and Pain Interference Outcomes Following Percutaneous MRI-guided Laser Ablation or Cryoablation of Painful Peripheral, Soft Tissue Vascular Anomalies: 6-month Interim Analysis
Purpose: To prospectively evaluate the 6-month pain severity and pain interference outcomes following percutaneous MRI-guided laser ablation and cryoablation of focal painful, peripheral soft tissue vascular anomalies.
Materials and Methods: Patients undergoing clinically indicated MRI-guided laser ablation or cryoablation for focal painful, peripheral soft tissue vascular anomalies (VA) were enrolled in an IRB-approved prospective, observational study after giving informed consent. Patients completed the Brief Pain Inventory (BPI) prior to ablation and 6-months post-ablation. Differences in pain severity and interference outcomes on a 0 to 10 point scale (higher number meaning greater severity or interference) were compared using a paired t-test.
Results: 14 patients (12 female, 2 male; mean age 32.1 years) underwent 21 US/MRI-guided and monitored ablation sessions including laser (n=18) and cryoablation (n=3) for treatment of painful slow flow venous (n=12) or venolymphatic (n=1) malformations or hemangioma (n=1) located in the lower extremity (n=9), upper extremity (n=4) and face (n=1). Nine patients (64%) had undergone prior VA therapy including percutaneous sclerotherapy (89%) and/or surgery (44%). Median maximal VA diameter was 5.7 cm (range 1.6 to 28.6 cm). Post-ablation 3 patients were discharged same day (14%) and 18 after overnight observation (86%) Mean (±SD) pre-ablation worst pain was 8.0 ± 1.4 and average pain 5.4 ± 1.3 with a significant decrease in worst pain -4.8 ± 3.5 (p< 0.001) and average pain -3.3 ± 2.4 (p< 0.001) at 6-month post-ablation. Mean (±SD ) pre-ablation pain interference severity was as follows: general activity— 5.9 ± 2.5, mood—4.7 ± 2.2, walking ability—5.4 ± 3.9, work—6.4 ± 2.8, sleep—5.8 ± 2.8 and enjoyment of life—6.0 ± 3.1. There was a significant improvement in all pain interference outcomes at 6-months post-ablation: general activity -3.9 ± 3.0 (p< 0.001), mood -2.5 ± 3.0 (p=0.010), walking ability -3.8± 4.1 (p=0.006), work -4.5 ± 3.2 (p< 0.001), sleep -3.7 ± 3.0 (p< 0.001) and enjoyment of life -4.1 ± 3.3 (p< 0.001). There were no major and 2 minor ablation related complications.
Conclusion: These 6-month interim data suggest that MRI-guided laser ablation and cryoablation are safe and provide early significant improvements in pain severity and pain interference outcomes in patients with focal painful peripheral soft tissue vascular anomalies. Ongoing serial follow-up in this cohort will help to establish longer term outcomes