The management of bleeding GV is very challenging and treatment options are evolving over time. Currently, societal guidelines recommend endoscopic CYA injection or Transjugular Intrahepatic Portosystemic Shunt (TIPS) as the preferred modalities for the treatment of bleeding GV(10). However, endoscopic CYA injection may not possible if the site of the bleeding is covered with blood, in addition to being associated with a number of severe adverse events including systemic embolization and death(11). Furthermore, TIPS requires specialized interventional radiology expertise and many patients have contraindications to undergoing such procedure limiting its utility as a primary therapy for bleeding GV. More recently, EUS-guided therapy has been introduced as a new and novel endoscopic therapy for GV. This therapeutic intervention entails the delivery of endovascular coils and/or CYA into the GV under real-time ultrasound guidance.
A number of retrospective studies (mostly from North America and Europe) have shown that EUS-guided therapy is highly effective and safe option for the treatment of GV(12–13). Our study represents the first study that evaluates the safety and efficacy and EUS-guided therapy for GV specifically in Arab population. In our study, EUS-guided therapy was found to be very effective and safe in managing patients with clinically significant GV with a treatment and clinical success of 100%, yet associated with low rate of adverse events (< 10%) that were mild in severity.
In our cohort, patients were selected for EUS-guided therapy if they had clinically significant GV (actively bleeding, stigmata of recent bleed or secondary prophylaxis). One patient was selected for primary prophylaxis as he had large GV (25mm) secondary to idiopathic portal vein thrombosis. This patient underwent EUS-guided coil embolization followed by CYA injection resulting in complete obliteration after a single session. He was subsequently treated successfully with full-dose anticoagulation without bleeding. Of note, we were able to achieve high GV obliteration rate after a single session with the use of small volume CYA injection (mean 1.4ml). This was done by selectively targeting the feeder vessel when possible in addition to using combination therapy with coil embolization which lead to effective GV obliteration with minimal CYA injection. This CYA volume is significantly less than what is usually required when it is delivered by endoscopy alone as shown by Lobo et al. (1.40 ml vs. 3.07 ml, p = 0.002 for EUS-guided therapy vs. endoscopic-injection alone, respectively)(14). Since most adverse events are related to CYA injection(15), we were able to minimize adverse events by following this strategy.
When feasible, the majority of patients underwent combination coil embolization followed by CYA injection. The rationale behind the combination therapy is the coil would act as a scaffold that would concentrate the CYA in the varix increasing its effectiveness in addition to preventing CYA embolization, hence reducing the risk of adverse events. Bhat et al. has shown that this strategy can achieve GV obliteration rate of 93%(8). Furthermore, a recent meta-analysis concluded that combination EUS-coil-CYA has significantly higher technical and clinical success compared to EUS-CYA alone and EUS-coil alone strategies(16). More importantly, the same meta-analysis has shown that the adverse events were significantly lower with EUS-CYA-coil compared to EUS-CYA alone and has similar safety profile to EUS-coil alone. The only 3 patients in our cohort that underwent EUS-CYA injection alone had on average smaller GV (10mm, 15mm and 21mm) which made deployment of coils technically difficult. Therefore, when technically feasible, we prefer to use the combined-therapy approach to increase our success rate and potentially minimize adverse events.
The safety profile of EUS-guided therapy is quite remarkable in our study in concordance with previously published studies(9). We did not experience any major adverse events such as systemic embolization or infection after a mean follow-up of 174 days. One patient experienced moderate post-procedure epigastric pain that was managed with oral analgesics on outpatient basis. Interestingly, this patient had large GV (40mm) that required 4 coils and 1 ml CYA injection during the first treatment session. This pain may represent ischemia of the large GV in relation to successful obliteration of the GV. Hence larger GV and the need for multiple coils may predict which patients that are likely to experience post-procedure pain, but larger studies are needed to confirm this observation. One patient had mild puncture-site bleeding (no drop in hemoglobin or change in hemodynamics) during the procedure which ceased after coil deployment. Hence our study confirmed the safety profile of EUS-guided GV therapy and strongly favors it as an initial intervention for the management of GV over endoscopic CYA injection alone.
Our study has a number of limitations. It is a retrospective, single-center study with all the adherent potential biases that come with retrospective studies including recall bias and missing data. However, we minimized this risk by keeping a well-maintained database of all patients undergoing EUS-guided interventions. Our study is based on a small sample size (15 patients) limiting its statistical power. However, it represents our initial experience of such intervention and the first experience in Arab population increasing its clinical significance. Finally, the study was conducted in a single-center and all procedures were performed by a single endoscopist limiting the generalizability of our findings.
In summary, we report our initial experience with EUS-guided therapy for GV in Arab population. It appears to be very effective and extremely safe in patients with portal hypertension and clinically significant GV. Further multi-center prospective comparative studies are needed to compare the effectiveness of EUS-guided therapy to endoscopic-CYA injection in patients with GV. Furthermore, cost-effectiveness studies will also be of value to understand the economic value of such intervention in comparison to endoscopic therapy.