Table 2.
Clinical effectiveness of MSA and LF pre- and post-surgery
| Measure | MSA % (n/N) [95% CI] |
LF % (n/N) [95% CI] |
|---|---|---|
| Satisfaction with current condition (from GERD-HRQL) | ||
| Baseline | 4.6% (21/460) [2.7%, 6.5%] | 3.7% (6/164) [0.8%, 6.5%] |
| 12 M | 75.3% (326/433) [71.2%, 79.4%] | 77.2% (122/158) [70.7%, 83.8%] |
| 24 M | 78.9% (254/322) [74.4%, 83.3%] | 83.3% (90/108) [76.3%, 90.4%] |
| 36 M | 78.2% (230/294) [73.5%, 82.9%] | 76.5% (65/85) [67.5%, 85.5%] |
| GERD interfering with sleep | ||
| Baseline | 73.3% (333/454) [69.3%, 77.4%] | 78.0% (128/164) [71.7%, 84.4%] |
| 12 M | 11.9% (50/419) [8.8%, 15.0%] | 9.6% (15/157) [5.0%, 14.2%] |
| 24 M | 11.7% (37/315) [8.2%, 15.3%] | 5.5% (6/109) [1.2%, 9.8%] |
| 36 M | 9.0% (26/290) [5.7%, 12.3%] | 10.7% (9/84) [4.1%, 17.3%] |
| Ability to belch | ||
| Baseline | 96.7% (441/456) [95.1%, 98.3%] | 93.9% (154/164) [90.2%, 97.6%] |
| 12 M | 96.7% (406/420) [94.9%, 98.4%] | 88.5% (138/156) [83.4%, 93.5%] |
| 24 M | 97.2% (308/317) [95.3%, 99.0%] | 92.5% (99/107) [87.5%, 97.5%] |
| 36 M | 97.6% (284/291) [95.8%, 99.4%] | 91.7% (77/84) [85.8%, 97.6%] |
| Ability to vomita | ||
| Baseline | 96.6% (343/355) [94.8%, 98.4%] | 92.0% (115/125) [87.2%, 96.8%] |
| 12 M | 89.7% (191/213) [85.6%, 93.8%] | 55.8% (29/52) [42.3%, 69.3%] |
| 24 M | 85.8% (133/155) [80.3%, 91.3%] | 52.6% (20/38) [36.7%, 68.5%] |
| 36 M | 91.2% (134/147) [86.6%, 95.8%] | 68.0% (17/25) [49.8%, 86.2%] |
| Use of PPIs | ||
| Baseline | 97.8% (453/463) [95.6%,100%] | 95.8% (158/165) [91.6%, 100%] |
| 12 M | 18.9% (81/428) [15.2%, 22.6%] | 19.7% (31/157) [13.5%, 26.0%] |
| 24 M | 21.4% (74/346) [17.1%, 25.7%] | 18.1% (21/116) [11.1%, 25.1%] |
| 36 M | 24.2% (76/314) [19.5%, 28.9%] | 19.5% (17/87) [11.2%, 27.9%] |
| Willingness to have surgery again | ||
| 12 M | 89.5% (366/409) [86.5%, 92.5%] | 91.1% (143/157) [86.6%, 95.5%] |
| 24 M | 90.6% (281/310) [87.4%, 93.9%] | 94.4% (102/108) [90.1%, 98.8%] |
| 36 M | 93.1% (270/290) [90.2%, 96.0%] | 94.0% (79/84) [89.0%, 99.1%] |
CI confidence interval, GERD gastroesophageal reflux disease, HRQL health-related quality of life, LF laparoscopic fundoplication, M months, MSA magnetic sphincter augmentation, PPI proton pump inhibitor
aData adjusted to include only those patients who found the need to vomit