Introduction
Patients and methods
Patient selection
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Grade I valves: presence of a prominent tissue fold surrounding the endoscopic shaft
-
Grade II valves: presence of a moderately prominent tissue fold; rarely opens with respiration and closes promptly
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Grade III valves: a barely present fold; fails to close around the endoscope
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Grade IV valves: lack of a muscular fold; lumen of esophagus stays open all the time, allowing the squamous epithelium to be viewed from below
Procedure details
Safety assessment
Effectiveness assessment
Statistical analysis
Results
Patient characteristics
No. patients | 86 |
Female/male | 29/57 (34%/66%) |
Age (years) | 44 (19–73) |
BMI (kg m−2) | 25.2 (17.1–36.1) |
Hiatal hernia | 49/85 (58%) |
Esophagitis | 70 (81%) |
Gastritis | 21/45 (47%) |
GERD history | |
GERD duration (years) | 6 (1–33) |
>11 years | 11 (13%) |
6–10 years | 34 (40%) |
3–5 years | 27 (31%) |
6 months to 2 years | 14 (16%) |
No. Patients on PPIs | 86 (100%) |
PPI use duration (years) | 4 (1–14) |
>11 years | 4 (5%) |
6–10 years | 21 (24%) |
3–5 years | 41 (48%) |
<2 years | 20 (23%) |
Procedure details
Safety assessment
Adverse event | ≤1 Week | 1 Week to 1 month | >1 Month |
---|---|---|---|
Musculoskeletal pain | 8 (9%) | 8 (9%) | |
Abdominal pain upper | 8 (9%) | 4 (5%) | 1 (1%) |
Pharyngolaryngeal pain | 6 (7%) | 1 (1%) | |
Nausea | 6 (7%) | 1 (1%) | |
Epigastric pain | 4 (5%) | 2 (2%) | |
Application site bleeding | 5 (6%) | ||
Pyrexia | 3 (4%) | ||
Dysphagia | 3 (4%) | ||
Diarrhea | 2 (2%) | ||
Vomiting | 2 (2%) |
Clinical effectiveness at 12 months
Parameter | Pre–TIF (n = 82) | 6 Months Post-TIF (n = 81) | 12 Months Post-TIF (n = 79) |
---|---|---|---|
GERD-HRQL score | |||
Median (range) off PPIs | 24 (11–38) | 5 (0–24) | 7 (0–30) |
Median % reduction vs. pre-TIF off PPIs | 80% | 68% | |
p
| <0.0001 | <0.0001 | |
No. reduced by ≥50% | 62 (77%) | 58 (73%) | |
No. eliminated | 65 (80%) | 59 (75%) | |
Median (range) on PPIs | 9 (0–22) | – | – |
Median % reduction vs. pre-TIF on PPIs | 50% | 22% | |
p
| <0.05 | >0.05 | |
Heartburn score | |||
Median (range) off PPIs | 21 (10–30) | 4 (0–19) | 6 (0–26) |
Median % reduction vs. pre-TIF off PPIs | 79% | 67% | |
p
| <0.0001 | <0.0001 | |
No. reduced by ≥50% | 62 (77%) | 59 (75%) | |
No. eliminated
a
| 70 (86%) | 61 (77%) | |
Median (range) on PPIs | 7 (0–19) | – | – |
Median % reduction vs. pre-TIF on PPIs | 43% | 22% | |
p
| <0.05 | >0.05 | |
Regurgitation | |||
No. off PPIs | 60 (74%) | 24 (30%) | 25 (32%) |
No. eliminated | 37 (62%) | 34 (59%) |
Medication | No. | Daily | Occasional | None |
---|---|---|---|---|
PPIs | ||||
Pre-TIF | 86 | 86 (100%) | 0 | 0 |
6 Months | 81 | 14 (17%) | 11 (14%) | 56 (69%) |
12 Months | 79 | 12 (15%) | 13 (16%) | 54 (68%) |
H2RA | ||||
Pre-TIF | 86 | 3 (3%) | 1 (1%) | 82 (95%) |
6 Months | 81 | 0 | 1 (1%) | 80 (99%) |
12 Months | 79 | 0 | 5 (6%) | 74 (94%) |
Antacids | ||||
Pre-TIF | 86 | 0 | 18 (21%) | 68 (79%) |
6 Months | 81 | 0 | 21 (26%) | 60 (74%) |
12 Months | 79 | 0 | 23 (29%) | 56 (71%) |
Any GERD medication | ||||
Pre-TIF | 86 | 86 (100%) | 0 | 0 |
6 Months | 81 | 14 (17%) | 25 (31%) | 42 (52%) |
12 Months | 79 | 12 (15%) | 29 (37%) | 38 (48%) |
Parameter | Pre-TIF (n = 82) | 6 Months Post-TIF (n = 81) | 12 Months Post-TIF (n = 71)a
|
---|---|---|---|
Percentage of time pH < 4 | |||
Median (range) | 10 (3–67) | 7 (1–29) | 7 (0–22) |
Median % reduction | 31 | 33 | |
p
| <0.001 | 0.02 | |
Normalizedb
| 33 (41%) | 26 (37%) | |
Significantly reducedc or normalized | 46 (57%) | 43 (61%) | |
DeMeester score | |||
Median (range) | 34 (11–222) | 24 (4–107) | 28 (1–76) |
Median % reduction | 28 | 24 | |
p
| <0.001 | <0.001 |
Parameter | Pre-TIF (n = 82) | 6 Months Post-TIF (n = 81) | 12 Months Post-TIF (n = 77)a
|
---|---|---|---|
Hill grade | |||
I | 0 | 22 (29%) | 24 (33%) |
II | 35 (45%) | 42 (55%) | 26 (36%) |
III | 34 (44%) | 10 (13%) | 18 (25%) |
IV | 9 (12%) | 3 (4%) | 5 (7%) |
Hiatal hernia | |||
None | 33 (41%) | 58 (72%) | 49 (64%) |
1 cm | 11 (14%) | 7 (9%) | 12 (16%) |
2 cm | 33 (41%) | 14 (17%) | 10 (13%) |
3 cm | 4 (5%) | 2 (3%) | 6 (8%) |
Reduced | 35/47 (74%) p < 0.001 | 27/45 (60%) p < 0.001 | |
Eliminated | 29/47 (62%) | 22/45 (49%) | |
Esophagitis | |||
None | 14 (17%) | 37 (46%) | 35 (45%) |
Grade A | 31 (38%) | 26 (32%) | 22 (29%) |
Grade B | 27 (33%) | 14 (17%) | 14 (18%) |
Grade C | 10 (12%) | 3 (4%) | 5 (6%) |
Grade D | 0 | 1 (1%) | 1 (1%) |
Reducedb
| 42/67 (63%) p < 0.001 | 39/63 (62%) p < 0.001 | |
Eliminatedb
| 26/67 (39%) | 25/63 (40%) |
Parameter | Hill grade I tight (n = 21) | Hill grade II moderate (n = 21) | Hill grade III/IV loose (n = 14) | p* |
---|---|---|---|---|
GERD-HRQL scores—improved by ≥ 50% | 18 (86%) | 17 (81%) | 11 (79%) | 0.330 |
Heartburn—eliminated | 19 (90%) | 17 (81%) | 10 (71%) | 0.122 |
PPI use—none | 17 (81%) | 18 (86%) | 7 (50%) | 0.091 |
Esophageal pH—normalized | 48% | 25% | 33% | 0.014 |
Hiatal hernia | ||||
None post-TIF | 18 (86%) | 14 (67%) | 5 (36%) | 0.002 |
None pre-TIF | 12 (56%) | 7 (33%) | 4 (29%) | 0.014 |
Reduced | 8/9 (89%) | 10/14 (71%) | 3/10 (30%) | 0.250 |
Eliminated | 7/9 (78%) | 7/14 (50%) | 3/10 (30%) | 0.290 |
Esophagitis | ||||
None post-TIF | 15 (71%) | 9 (43%) | 5 (36%) | 0.001 |
None pre-TIF | 3 (14%) | 2 (10%) | 3 (21%) | 0.400 |
Reducedb
| 12/15 (80%) | 14/19 (74%) | 4/11 (36%) | 0.010 |
Eliminatedb
| 9/15 (60%) | 7/19 (37%) | 3/11 (27%) | 0.002 |
Cardia circumference (mm) | ||||
Post-TIF | 32.8 | 37.5 | 40.4 | 0.001 |
Pre-TIF | 43.3 | 46.8 | 41.3 | 0.050 |
Normalizedc
| 9/16 (56%) | 4/12 (33%) | 1/12 (8%) | 0.040 |
Parameter | GERD-HRQL score | Esophageal acid exposure | Hill grade | Hiatal hernia size | Esophagitis grade | LES resting pressure |
---|---|---|---|---|---|---|
Esophageal acid exposure | 0.259 | |||||
p = 0.061 | ||||||
Hill grade | 0.275 | 0.434 | ||||
p = 0.040 | p = 0.048 | |||||
Hiatal hernia size | 0.341 | 0.754 | 0.754 | |||
p = 0.111 | p = 0.000 | p = 0 | ||||
Esophagitis grade | 0.400 | 0.266 | 0.628 | 0.495 | ||
p = 0.000 | p = 0.054 | p = 0 | p = 0.016 | |||
LES resting pressure | −0.298 | −0.396 | −0.533 | −0.125 | −0.411 | |
p = 0.185 | p = 0.061 | p = 0.009 | p = 0.185 | p = 0.014 | ||
Cardia circumference | 0.362 | 0.287 | 0.803 | 0.704 | 0.530 | −0.280 |
p = 0.049 | p = 0.043 | p = 0 | p = 0 | p = 0 | p = 0.133 |