Three rapidly biodegradable agents used in embolization procedures appear safe and effective for reducing pain in patients with joint disorders, researchers have reported.
The finding is from a retrospective analysis in 431 patients and adds to emerging evidence that temporary agents may be effective over permanent microspheres, noted lead author Tijmen Zadelhoff, MD, of Erasmus University Medical Center in Rotterdam, the Netherlands, and colleagues.
“Pain reduction, as assessed by the [numeric pain rating scale], was achieved across all embolic agents, with a significant proportion of patients experiencing clinical success at six months post procedure,” the group wrote. The study was published March 1 in the Journal of Vascular and Interventional Radiology.
Transcatheter arterial embolization (TAE) is a minimally invasive alternative to surgery. It involves inserting a catheter into an artery and injecting embolic agents that block blood vessels that cause painful inflammation in joints. Preliminary studies have shown that permanent microspheres result in a higher rate of minor adverse events, including nerve damage, compared with temporary embolization agents, yet the studies have been limited by small numbers of patients and their safety has not been established, the researchers noted.
In this study, the group evaluated the safety and degree of pain relief patients achieved after TAE with three recently developed rapidly biodegraded embolic materials, specifically imipenem/cilastatin (IPM/CS), quick-soluble gelatin sponge particles (QS-GSPs), and resorbable microspheres (RMs).
Patients were between the ages of 18 and 80 and underwent TAEs between March 2020 and May 2023 for knee osteoarthritis, frozen shoulder, symptomatic rotator cuff tear, synovitis of the foot joints, and persistent pain after knee joint arthroplasty. IPM/CS was used in 140 patients, QS-GSPs in 136, and RMs in 155 patients, with adverse events monitored immediately after the procedure and changes in patients’ pain numeric rating scale (NRS) evaluated at one, three, six, and 20 months.
According to the analysis, no serious adverse events were observed, and all reported complications, including postprocedural pain and transient nerve-related symptoms, resolved spontaneously without long-term consequences, the researchers reported.
| Patients' self-reported joint disorder pain score changes over time after treatment with biodegraded embolic materials (scale of 0 to 10) | ||||
|---|---|---|---|---|
| Type of treatment material | Baseline score | 1-month score | 3-month score | 6-month score |
| IPM/CS | 6.9 | 4.4 | 3.6 | 3.1 |
| QS-GSPs | 6.4 | 4.3 | 3.6 | 3 |
| RMs | 7 | 4.4 | 3.2 | 2.3 |
“This study demonstrated that TAE using three different types of temporary embolic agents -- IPM/CS, QS-GSPs, and RMs – was both safe and effective for treating degenerative, inflammatory, and overuse joint disorders,” the researchers wrote.
Currently, none of the embolic materials used in the study are approved in the U.S., although South Korea-based NextBioMedical recently received an investigational device exemption from the U.S Food and Drug Administration for the RM (Nexsphere-F), the group noted. The agent is CE-certified and available in the European market, indicating its potential for future use and the development of similar products, they wrote.
“[Our study found that] QS-GSPs and RMs were safely used not only in patients with [knee osteoarthritis] but also in relatively young, active patients with overuse joint disorders, with symptom improvement,” the group wrote.
The full study is available here.
