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1690. A Pilot Randomized Controlled Trial of Coils Versus Plugs for Proximal Splenic Artery Embolization in High-Grade Splenic Trauma
Authors * Denotes Presenting Author
  1. Andrew Gunn *; University of Alabama at Birmingham
  2. Joel Raborn; University of Alabama at Birmingham
  3. Russell Griffin; University of Alabama at Birmingham
  4. Shannon Stephens; University of Alabama at Birmingham
  5. Joshua Richman; University of Alabama at Birmingham
  6. Jan Jansen; University of Alabama at Birmingham
Objective:
Proximal splenic artery embolization (pSAE) is used for non-operative management of high-grade splenic injuries, most often using endovascular coils (EC) or vascular plugs (VP) [1-3]. It is not known which device is superior. The purpose of this pilot trial was to evaluate the feasibility of enrolling patients in a randomized controlled trial (RCT) comparing these devices, and to collect data to inform the design of a larger clinical effectiveness trial.

Materials and Methods:
Single-center, prospective, RCT of patients with Grade 3-5 splenic injuries selected for non-operative management. Patients were randomly assigned to pSAE with EC or VP. The main outcome was feasibility. We also evaluated technical success, time-to-stasis, complications, mortality, and splenectomy rates, by estimating rates and 95% confidence intervals. As a pilot study, we did not formally test for differences between groups.

Results:
46 of 50 eligible patients were enrolled (92%, CI:90-100%). Overall, splenic salvage was 98% (45/46; CI:94-100%) as one EC patient required splenectomy. Unrelated to pSAE, one patient in each group died within 30 days. Primary technical success was observed in 22 EC patients (96%; CI:87-100%) and 20 VP patients (87%; CI:73-100%). Bayesian analysis suggests a >80% probability that primary technical success is higher for EC. One patient randomized to EC (4%; CI:0-13%), and 2 randomized to VP (9%; CI:0-20%) required additional embolic agents (e.g., gelatin sponge slurry) to achieve secondary technical success. Time-to-stasis was 7.7 (CI:5.6-9.9) min. and 7.0 (CI:4.0-10.1) min. in the EC and VP groups, respectively. Two complications (one major and one minor) occurred in the EC group (9%; CI:0-20%) and one major complication occurred in the VP group (4%; CI:0-13%).

Conclusion:
Randomized comparisons of endovascular devices used for pSAE after trauma are feasible. We observed no significant differences in outcomes between the two groups, but the trial was not powered for this purpose. High rates of splenic salvage make its use as a primary outcome in a future trial problematic. Consideration should be given to parameters such as primary technical success as a primary outcome for future trials.