In the Journals

EMR increases risk for adverse events from radiofrequency ablation for BE dysplasia

Radiofrequency ablation for Barrett’s esophagus-related dysplasia is associated with a fourfold higher risk for adverse events when performed with endoscopic mucosal resection vs. without, according to the results of a systematic review and meta-analysis.

The study also found that BE length and baseline histology were risk factors for adverse events.

“Based on many studies, the combined use of RFA and EMR is now routinely used for treatment of BE with dysplasia in the U.S. and around the world,” the researchers wrote. “Despite the relative safety of this method, precise estimates of the rate of adverse events associated with RFA [with or without] EMR are unclear.”

To provide a better assessment of adverse event rates following RFA performed with and without EMR in patients with BE, and to identify risk factors, the researchers searched the relevant literature published or in press through 2015, and included 37 studies in their analysis, including 16 prospective studies or clinical trials (n = 791) and 21 retrospective studies (n = 8,409). RFA with EMR was performed in 73% of the studies (usually in separate endoscopic sessions), and a combination of RFA devices (focal and circumferential) were used in 77% of the studies.

The rate of overall adverse events after RFA, including perforation, bleeding, pain, hospitalization and stricture formation, served as the primary outcome of interest.

The pooled rate of overall adverse events after RFA performed with or without EMR in patients with BE was 8.8% (95% CI, 6.5-11.9). Prospective studies and clinical trials showed a nonsignificant trend towards higher adverse events vs. retrospective studies (11.3%; 95% CI, 7.5-16.9 vs. 7.8%; 95% CI, 5.4-11.3).

The pooled rates of adverse events were as follows:

  • stricture formation (5.6%; 95% CI, 4.2-7.4);
  • perforation (0.6%; 95% CI, 0.4-1);
  • bleeding (1%; 95% CI, 0.8-1.3); and
  • post-procedure pain (3.8%; 95% CI, 1.9-7.8).

Analysis of the three studies that separated outcomes in RFA with and without EMR showed a higher rate of adverse events with RFA plus EMR (22.2%; 95% CI, 16.4-29.4) compared with RFA without EMR (5%; 95% CI, 2.9-8.3). There was also a higher rate of esophageal strictures in the RFA plus EMR group (13.3%; 95% CI, 8.8-19.5) compared with the RFA without EMR group (5.1%; 95% CI, 2.5-10.1).

Further analysis showed a 25% (95% CI, 16-35) increase in the rate of adverse events with each 1 cm increase in the median BE length in a population. Meta-regression analysis also showed a positive association between the rate of adverse events and the proportion of patients with intramucosal carcinoma/high-grade dysplasia in a population, with the rate of adverse events increasing by 1.7% (95% CI, 1.4-2) as the proportion of those patients increased from 0% to 100%.

“The use of EMR to remove nodules or lesions, though essential, appears to significantly increase the risk of adverse events,” the researchers concluded. “It is critical to discuss these issues with patients prior to embarking on such treatment modalities.” – by Adam Leitenberger

Disclosure: Qumseya reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.

Radiofrequency ablation for Barrett’s esophagus-related dysplasia is associated with a fourfold higher risk for adverse events when performed with endoscopic mucosal resection vs. without, according to the results of a systematic review and meta-analysis.

The study also found that BE length and baseline histology were risk factors for adverse events.

“Based on many studies, the combined use of RFA and EMR is now routinely used for treatment of BE with dysplasia in the U.S. and around the world,” the researchers wrote. “Despite the relative safety of this method, precise estimates of the rate of adverse events associated with RFA [with or without] EMR are unclear.”

To provide a better assessment of adverse event rates following RFA performed with and without EMR in patients with BE, and to identify risk factors, the researchers searched the relevant literature published or in press through 2015, and included 37 studies in their analysis, including 16 prospective studies or clinical trials (n = 791) and 21 retrospective studies (n = 8,409). RFA with EMR was performed in 73% of the studies (usually in separate endoscopic sessions), and a combination of RFA devices (focal and circumferential) were used in 77% of the studies.

The rate of overall adverse events after RFA, including perforation, bleeding, pain, hospitalization and stricture formation, served as the primary outcome of interest.

The pooled rate of overall adverse events after RFA performed with or without EMR in patients with BE was 8.8% (95% CI, 6.5-11.9). Prospective studies and clinical trials showed a nonsignificant trend towards higher adverse events vs. retrospective studies (11.3%; 95% CI, 7.5-16.9 vs. 7.8%; 95% CI, 5.4-11.3).

The pooled rates of adverse events were as follows:

  • stricture formation (5.6%; 95% CI, 4.2-7.4);
  • perforation (0.6%; 95% CI, 0.4-1);
  • bleeding (1%; 95% CI, 0.8-1.3); and
  • post-procedure pain (3.8%; 95% CI, 1.9-7.8).

Analysis of the three studies that separated outcomes in RFA with and without EMR showed a higher rate of adverse events with RFA plus EMR (22.2%; 95% CI, 16.4-29.4) compared with RFA without EMR (5%; 95% CI, 2.9-8.3). There was also a higher rate of esophageal strictures in the RFA plus EMR group (13.3%; 95% CI, 8.8-19.5) compared with the RFA without EMR group (5.1%; 95% CI, 2.5-10.1).

Further analysis showed a 25% (95% CI, 16-35) increase in the rate of adverse events with each 1 cm increase in the median BE length in a population. Meta-regression analysis also showed a positive association between the rate of adverse events and the proportion of patients with intramucosal carcinoma/high-grade dysplasia in a population, with the rate of adverse events increasing by 1.7% (95% CI, 1.4-2) as the proportion of those patients increased from 0% to 100%.

“The use of EMR to remove nodules or lesions, though essential, appears to significantly increase the risk of adverse events,” the researchers concluded. “It is critical to discuss these issues with patients prior to embarking on such treatment modalities.” – by Adam Leitenberger

Disclosure: Qumseya reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.