Interventional procedure overview of laparoscopic insertion of a magnetic ring for gastro-oesophageal reflux disease

GORD-HRQL

In a systematic review and meta-analysis of 15 studies (n=1,138), the pooled rate of GORD-HRQL improvement (at least 50% reduction) was 88% (95% confidence interval [CI] 83% to 93%, Cochrane Q P=0.11, I²= 55%; 3 studies) within 1 year, and 85% (95% CI 78% to 91%, Cochrane Q P=0.52, I²=0%; 2 studies) within 5 years. The total pooled rate was 88% (95% CI 84% to 92%; Cochrane Q P=0.17, I²=40%; 4 studies). When comparing laparoscopic insertion of a magnetic ring with laparoscopic Nissen fundoplication (LNF), the weighted mean difference (WMD) in GORD-HRQL score was 0.20 (95% CI -1.60 to 2.00, p=0.83; Cochrane Q P=0.79, I²=0%; 3 studies; Zhuang 2021).

In a systematic review and meta-analysis of 19 studies (n=12,697), when comparing laparoscopic insertion of a magnetic ring with fundoplication, the WMD in postoperative GORD-HRQL score was 0.34 (95% CI −0.70 to 1.37, p=0.525, I²=70.6%; 3 studies; Guidozzi 2019).

In a systematic review and meta-analysis of 7 studies (n=1,211), the estimated pooled mean difference in postoperative GORD-HRQL score was −0.48 (95% CI -1.05 to 0.09, p=0.101, I²=0.0%; 6 studies) between laparoscopic insertion of a magnetic ring and fundoplication (Aiolfi 2018).

In a randomised controlled trial (RCT) of 134 patients, the proportion of patients who had an at least 50% reduction in GORD-HRQL score was 81% (38/47) in the laparoscopic insertion of a magnetic ring group and 8% (7/87) in the twice-daily proton pump inhibitor (PPI) group (p<0.001) at 6-month follow up (Bell 2019). For all patients who had laparoscopic insertion of a magnetic ring (both primary and crossover groups) the mean GORD-HRQL score was 30±10 off PPIs and 24±10 on daily PPIs at baseline, and statistically significantly improved to 6 at 6 months and to 5 at 12 months (p<0.001). The proportion of patients who had an at least 50% reduction in GORD-HRQL score on PPIs was 81% (61/75). For the group who had medical treatment, no improvement in GORD-HRQL score was seen at study completion (exact data was not reported; Bell 2020).

In a non-randomised comparative study of 631 patients with GORD, there was a statistically significantly improvement in mean GORD-HRQL score at 3 years after treatment in both laparoscopic insertion of a magnetic ring (baseline, 22.0±9.1; 3 years, 4.6±6.0; mean change, -16.6±10.2, p<0.001) and fundoplication groups (baseline, 23.6±9.8; 3 years, 4.9±7.1; mean change, -17.8±10.6, p<0.001; Bonavina 2020).

In a case series of 553 patients with GORD, the mean GORD-HRQL total score statistically significantly improved from 33.8±18.7 at baseline to 7.2±9.0 (p<0.001) at a mean follow up of 10.3 months. The proportion of patients who had an at least 50% improvement in their GORD-HRQL total score was 84% (Ayazi 2020a).

In a case series of 124 patients with GORD who were followed up for 6 to 12 years after laparoscopic insertion of a magnetic ring, the mean total GORD-HRQL score statistically significantly improved from 19.9 at baseline to 4.01 (p<0.001) at a median follow up of 9 years. Clinically significant improvement in GORD-HRQL (>50% improvement) occurred in 93% of patients (Ferrari 2020).

In a non-randomised comparative study of 336 patients, the mean GORD-HRQL score statistically significantly improved from 19.2±7.7 at baseline to 3.8±5.7 at a mean follow up of 50.8 months in the non-severe GORD group and from 21.0±7.5 to 3.9±4.8 in the severe GORD group (all p<0.05). Comparison between groups showed that the mean score was statistically significantly higher in the severe GORD group than the non-severe GORD group at baseline (p=0.0479) but not at the final follow up (p=0.8870; Ferrari 2021).

In a non-randomised comparative study of 350 patients with GORD, the proportion of patients who had an at least 50% reduction in GORD-HRQL total score was 79% in the no hiatal hernia group, 78% in the small hiatal hernia group, 82% in the large hiatal hernia group, and 88% in the paraesophageal hernia group (p=0.77). The overall rate of clinical improvement in GORD-HRQL total score was 79% at a mean follow up of 13.6 months (Ayazi 2020b).

PPI use

In the systematic review and meta-analysis of 15 studies, the pooled rate of postoperative PPI use was 13% (95% CI 9.9% to 17.4%; Cochrane Q P =0.12, I²=43%; 6 studies) within 1 year, 14% (95% CI 8.3% to 20.6%; Cochrane Q P=0.89, I²=0%; 2 studies) within 2 years, and 19% (95% CI 9.9% to 35.9%; Cochrane Q P=0.13, I²=55%; 2 studies) within 5 years. When comparing laparoscopic insertion of a magnetic ring with LNF, there was no statistically significant difference in postoperative PPI use (risk ratio [RR] 1.55, 95% CI 0.49 to 4.94, p=0.46, Cochrane Q P=0.27, I²=19%; 2 studies; Zhuang 2021).

In the systematic review and meta-analysis of 19 studies, analysis of 13 single-cohort studies showed that the proportion of patients who needed postoperative PPI therapy was 13% (138/1,043). When comparing laparoscopic insertion of a magnetic ring with fundoplication, there was no statistically significant difference in postoperative PPI therapy (pooled odds ratio [OR] 1.08, 95% CI 0.40 to 2.95, p=0.877, I²=72%; 5 studies; Guidozzi 2019).

In the systematic review and meta-analysis of 7 studies, there was no statistically significant difference in PPI suspension (pooled OR 0.81, 95% CI 0.42 to 1.58, p=0.548, I²=63.9%; 6 studies) between the laparoscopic insertion of a magnetic ring group and the fundoplication group (Aiolfi 2018).

In the RCT of 134 patients, 91% (43/47) of patients in the laparoscopic insertion of a magnetic ring group discontinued PPIs at 6-month follow up (Bell 2019). At study completion (12 months), 91% (68/75) of patients who had laparoscopic insertion of a magnetic ring (both primary and crossover groups) stopped PPIs (Bell 2020).

In the non-randomised comparative study of 631 patients, the proportion of patients who used PPIs reduced from 98% (453/463) at baseline to 24% (76/314) at 3 years after laparoscopic insertion of a magnetic ring group and from 96% (158/165) to 20% (17/87) after fundoplication (Bonavina 2020).

In the case series of 553 patients, the proportion of patients who were free from PPI use was 93% at a mean follow up of 10.3 months (Ayazi 2020a).

In the case series of 124 patients, complete or at least 50% reduction in the average daily dose of PPI occurred in 79% and 90% of patients, respectively, at a median follow up of 9 years (Ferrari 2020).

In the non-randomised comparative study of 336 patients, use of PPI statistically significantly reduced from 71% (167/234) of patients at baseline to 13% (31/234) of patients at a mean follow up of 50.8 months in the non-severe GORD group and from 86% (88/102) to 16% (16/102) in the severe GORD group (all p<0.05). Comparison between groups showed that PPI use was statistically significantly higher in patients with severe GORD than patients with non-severe GORD at baseline but not at the final follow up (Ferrari 2021).

In the non-randomised comparative study of 350 patients, the proportion of patients who were free from PPI use was 93% in the no hiatal hernia group, 92% in the small hiatal hernia group, 90% in the large hiatal hernia group and 94% in the paraesophageal hernia group (p=0.96). Overall, 92% of patients were free from PPI use at a mean follow up of 13.6 months (Ayazi 2020b).

DeMeester score

In the RCT of 134 patients, the median DeMeester score at baseline was 40.3 (interquartile range [IQR] 28.1 to 53.0) in patients who had laparoscopic insertion of a magnetic ring compared with 30.9 (IQR 24.3 to 39.5) in patients who had twice-daily PPIs. The mean score changed to 8 compared with 18 (p=0.059) at 6 months (Bell 2019). For patients who had laparoscopic insertion of a magnetic ring (both primary and crossover patients), the median DeMeester score improved from 40.5 (IQR 25.7 to 49.5) at baseline to 5.3 (IQR 1.2 to 18.5) at study completion (12 months), and DeMeester scores were normalised in 70% (48/69) of patients. For the step-down PPI patients, the median score remained elevated at 16.7 (IQR 1.9 to 164; exact baseline data was not reported) and scores were normal in 54% of patients at study completion (Bell 2020).

In the case series of 553 patients, the mean DeMeester score was 33.9±29.4 in all patients at baseline. At 1 year after the procedure, the score improved to 7.2±10.2 in patients (n=327) who had a small implant (sizes 13 and 14), 18.8±33.2 in patients (n=138) who had a medium implant (size 15) and 21.0±42.8 in patients (n=85) who had a large implant (sizes 16 and 17; between groups, p<0.0001). DeMeester scores were normalised in 82%, 69% and 66% respectively (p=0.0349; Ayazi 2020a).

In the case series of 124 patients with GORD, the mean DeMeester scorestatistically significantly improved from 40.7±26.5 at baseline to 16.3±18.8 at a median follow up of 9 years (p<0.001; Ferrari 2020).

In the non-randomised comparative study of 336 patients, the mean DeMeester score statistically significantly improved from 26.2±12 at baseline to 13.4±15.9 at a mean follow up of 50.8 months in the non-severe GORD group and from 58.3±33.5 to 17±16.3 in the severe GORD group (all p<0.05). Comparison between groups showed that the mean score was statistically significantly higher in the severe GORD group than the non-severe GORD group at baseline (p<0.0001) but not at the final follow up (p=0.0591). The proportion of patients with abnormal DeMeester scores was 28% in the non-severe GORD group and 42% in the severe GORD group at the final follow up (p=0.1476; Ferrari 2021).

In the non-randomised comparative study of 350 patients, DeMeester scores were normalised in 71% of patients without hiatal hernia, 79% of patients with small hiatal hernias, 66% of patients with large hiatal hernias, and 58% of patients with paraesophageal hernias (p=0.21). Overall, DeMeester scores were normal in 74% of patients at a mean follow up of 13.6 months (Ayazi 2020b).

Regurgitation

In the RCT of 134 patients, per protocol analysis showed that the proportion of patients who reported resolution of moderate-to-severe regurgitation was 89% (42/47) in the laparoscopic insertion of a magnetic ring group and 10% (10/101) in the twice-daily PPI group (p<0.001) at 6-month follow up. Intention-to-treat analysis revealed that relief of moderate-to-severe regurgitation occurred in 84% (42/50) and 10% (10/102), respectively (p<0.001). At 12 months, the proportion of patients who reported resolution of moderate-to-severe regurgitation was 96% (72/75) in the laparoscopic insertion of a magnetic ring group (both primary and crossover patients) and 19% (8/43) in the step-down PPI group. At the same end point, complete elimination of regurgitation was reported in 73% and 2%, respectively (p<0.001; Bell 2020).

In the case series of 124 patients with GORD, the proportion of patients with grade 2 to 4 regurgitation statistically significantly decreased from 60% at baseline to 10% postoperatively (p<0.01; Ferrari 2020).

Ability to belch

In the systematic review and meta-analysis of 15 studies, when comparing laparoscopic insertion of a magnetic ring and LNF, there was no statistically significant difference in ability to belch (RR 1.48, 95% CI 0.76 to 2.86, p=0.25; Cochrane Q P<0.00001, I²=92%; 3 studies; Zhuang 2021).

In the systematic review and meta-analysis of 19 studies, laparoscopic insertion of a magnetic ring was associated with statistically significantly greater ability to belch compared with fundoplication (pooled OR 12.34, 95% CI 6.43 to 23.7; p<0.001; I²=0%; 4 studies; Guidozzi 2019).

In the systematic review and meta-analysis of 7 studies (n=1,211), laparoscopic insertion of a magnetic ring was associated with statistically significantly greater ability to belch compared with fundoplication (pooled OR 5.53, 95% CI 3.73 to 8.19, p<0.001, I²=8.2%; 7 studies; Aiolfi 2018).

In the non-randomised comparative study of 631 patients, the proportion of patients who appeared to be able to belch as needed changed from 97% (441/456) at baseline to 98% (284/291) at 3 years after laparoscopic insertion of a magnetic ring and from 94% (154/164) to 92% (77/84) after fundoplication (Bonavina 2020).

Ability to vomit

In the systematic review and meta-analysis of 7 studies, the estimated pooled OR of ability to vomit was 10.10 (95% CI 5.33 to 19.15, p<0.001, I²=44%; 6 studies) between laparoscopic insertion of a magnetic ring and fundoplication (Aiolfi 2018).

In the non-randomised comparative study of 631 patients, the proportion of patients who reserved the ability to vomit decreased from 97% (343/355) at baseline to 91% (134/147) at 3 years after laparoscopic insertion of a magnetic ring and from 92% (115/125) to 68% (17/25) after fundoplication (Bonavina 2020).

Gas bloating

In the systematic review and meta-analysis of 15 studies, there was a statistically significantly lower risk of gas-bloat syndrome in the laparoscopic insertion of a magnetic ring group than the LNF group (RR 0.69, 95% CI 0.51 to 0.93, p=0.01; Cochrane Q P=0.39, I²=0%; 2 studies; Zhuang 2021).

In the systematic review and meta-analysis of 19 studies, laparoscopic insertion of a magnetic ring was associated with statistically significantly less gas bloating compared with fundoplication (pooled OR 0.34, 95% CI 0.16 to 0.71, p=0.004; I²=62.8%; 5 studies; Guidozzi 2019).

In the systematic review and meta-analysis of 7 studies, laparoscopic insertion of a magnetic ring was associated with statistically significantly fewer gas-bloat symptoms compared with fundoplication (pooled OR 0.39, 95% CI 0.25 to 0.61, p<0.001, I²=49.6%; 5 studies, n=1,042; Aiolfi 2018).

In the RCT of 134 patients, frequent or continuous bloating was present in 58% of patients off PPIs and 55% of patients on PPIs at baseline. After the procedure, this statistically significantly reduced to 15% (11/75) of patients (both primary and crossover patients) and 27% of primary patients who had laparoscopic insertion of a magnetic ring at study completion (p=0.0416). No change was seen in the patients who had medical treatment (exact data was not reported; Bell 2020).

Patient satisfaction

In the non-randomised comparative study of 631 patients, patient satisfaction (GORD-HRQL satisfaction with present condition) increased from 5% to 78% in the laparoscopic insertion of a magnetic ring group and from 4% to 77% in the fundoplication group (Bonavina 2020).

In the case series of 553 patients, 87% of patients were satisfied with the outcomes of the procedure (Ayazi 2020a).

In the case series of 124 patients, overall patient satisfaction was reported in 94% of patients who were followed up for more than 10 years (Ferrari 2020).

In the non-randomised comparative study of 350 patients, there was no statistically significant difference in patient satisfaction between groups (no hiatal hernia, 87%; small hiatal hernia, 88%; large hiatal hernia, 92%; paraesophageal hernia, 94%; p=0.73). The overall rate of patient satisfaction was 89% at a mean follow up of 13.6 months (Ayazi 2020b).