Background:
Gastroesophageal reflux disease is associated with Barrett esophagus, esophageal adenocarcinoma, and significantly impacts quality of life. Medical management is the first line therapy with surgical fundoplication as an alternative therapy. However, a small portion of patients who fail medical therapy are referred for surgical consultation. This creates a “gap” in therapy for those patients dissatisfied with medical therapy but are not getting referred for surgical consultation. Three procedures have been designed to address these patients. These include radiofrequency ablation (RFA) of the lower esophageal sphincter, transoral incisionless fundoplication (TIF), and magnetic sphincter augmentation.
Materials and Methods:
A Pubmed literature review was conducted of all publications for RFA, TIF, and MSA. Four most common endpoints for the 3 procedures were compared at different intervals of follow-up. These include percent of patients off proton pump inhibitors (PPIs), GERD-HRQL score, DeMeester score, and percent of time with pH <4. A second query was performed for patients treated with PPI and fundoplications to match the same 4 endpoints as a control.
Results:
Variable freedom from PPI was reported at 1 year for RFA with a weighted mean of 62%, TIF with a weighted mean of 61%, MSA with a weighted mean of 85%, and fundoplications with a weighted mean of 84%. All procedures including PPIs improved quality-of-life scores but were not equal. Fundoplication had the best improvement followed by MSA, TIF, RFA, and PPI, respectively. DeMeester scores are variable after all procedures and PPIs. All MSA studies showed normalization of pH, whereas only 4 of 17 RFA studies and 3 of 11 TIF studies reported normalization of pH.
Conclusions:
Our literature review compares 3 rival procedures to treat “gap” patients for gastroesophageal reflux disease with 4 common endpoints. Magnetic sphincter augmentation appears to have the most reproducible and linear outcomes but is the most invasive of the 3 procedures. MSA outcomes most closely mirrors that of fundoplication.
Key Words: antireflux surgery, acid normalization, MSA, radiofrequency ablation, TIF, fundoplication
Gastroesophageal reflux disease (GERD) has a major impact on quality of life and has been identified as a cause of Barrett esophagus and esophageal adenocarcinoma.1,2 GERD has an increasing incidence worldwide, particularly over the last few decades. This is especially true in the United States where it affects more than 25% of the population.3 Not only has GERD been implicated in the steady rise in the incidence of esophageal adenocarcinoma, it has been shown to be related to other cancers as well.4 Medical management with proton pump inhibitors (PPI) is the current first line of therapy for GERD.5 Despite the benefits of medical management, as many as 40% of patients are dissatisfied with their PPI management6 and up to 45% of patients can have progressive disease despite maximal treatment with PPIs.7 The usual alternative to medical treatment is surgery and the gold standard of surgical therapy since the 1950s has been a gastric fundoplication. Fundoplication has been shown to be as effective as medical management with PPIs.8 Fundoplication has been used for over 6 decades to improve the function of the lower esophageal sphincter (LES)9 but currently, only a small portion of eligible patients ever get referred for surgical treatment. This may be due to previous studies which report undesirable side effects such gas bloating and dysphagia following a fundoplication procedure.10,11 Furthermore, it has been shown that patient satisfaction with fundoplication is highest for those with severe symptoms and major anatomic derangements (hiatal hernia, strictures, etc.) and lowest for those with mild symptoms.12–17
This has created a treatment “gap” for patients who fail medical management with PPIs, but who are not unhappy enough to proceed with a fundoplication. There has been a surge of procedures directed toward treating these particular “gap patients.” These are procedures that seek to restore a mechanical barrier, as per fundoplication, but with less invasive access and with a better side-effect treatment profile. The current commercially available options for these patients include transoral incisionless fundoplication (TIF) with the EsophyX device (EndoGastric Solutions, San Mateo, CA), magnetic sphincter augmentation (MSA) with the LINX device (Torax Medical, Shoreview, MN), and radiofrequency ablation (RFA) of the LES with the Stretta device (Mederi Therapeutics Inc., Norwalk, CT).
The purpose of this review is to assess the relative effectiveness of each procedure with regard to common endpoints described in the literature.
MATERIALS AND METHODS
This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A PubMed search was performed for all published articles citing Stretta, EsophyX, or LINX as the search keyword, as well as radiofrequency ablation of lower esophageal sphincter, transoral incisionless fundoplication, endoscopic/endoluminal fundoplication, and magnetic sphincter augmentation. The search was performed for all articles before December 2019 and as far back as was reported. Only articles written in English were used. A total of 125 articles were reported for RFA of LES, 132 articles were reported for TIF, and 76 articles for MSA. Only articles that included cohorts with more than 10 patients were used. Review articles, meta-analysis, and systematic reviews were excluded from the data evaluation. There were 29 articles for RFA, 32 articles for TIF, and 22 articles for MSA that could contribute to the study. The number of patients in the study was collected as well as all subjective and objective data that were reported. Subjective data used in the study included Gastroesophageal Reflux Disease Health-related Quality of Life (GERD-HRQL) questionnaire data and percent of patients off PPI. Objective data used in the study was the DeMeester scores and percent of time with pH <4. Other endpoints, both subjective and objective, reported in the evaluated studies were not used due to the lack of their usage across all 3 procedures.
A second PubMed search was conducted looking for the same 4 endpoints for PPI use and fundoplications in the treatment for GERD. Representative studies looking at these treatment modalities were included. These endpoints will act as control values.
The studies were analyzed using weighted averages across each category of subjective and objective data. Weighting was based on the patient sample size reported in each study. The data resulting from the weighted averages was used to determine the average difference between the procedure types for the endpoints: percent of patients off of PPIs, GERD-HRQL scores, DeMeester scores, and percent of time with pH <4. The results do not represent a true random effect meta-analysis because this could not be performed on the data collected across the studies. Most studies did not disclose a SD for the endpoints reported, not all endpoints were included in each study, and the time points at which data were collected varied across studies.
RESULTS
Tables were created to show the data collected based on intervals of the common endpoints including percent of patients off PPIs, GERD-HRQL scores, and pH normalization with DeMeester scores and percent of time with pH <4. The largest amount of data available for comparison is with a 12-month follow-up for all endpoints. The tables are divided into sections representing each procedure, or PPI use, for the respective endpoints. The endpoints are shown based on intervals after the procedure or use of PPIs.
Percent of Patients off PPI
All studies that used “percent of patients off PPIs” as an endpoint are listed on Table 1 for RFA, TIF, MSA, and fundoplication. At 12 months after procedure, RFA has 15 studies with a weighted mean of 62%, TIF has 6 studies with a weighted mean of 61%, MSA has 6 studies with a weighted mean of 85%, and fundoplications have 6 studies with a weighted mean of 85%. The rest of the follow-up intervals are in Table 1 and plotted in Figure 1. Trend lines are plotted on Figure 2 with extrapolation out to 10 years.
TABLE 1.
All Studies With the Endpoint, Percent of Patients Off PPI, at Each Reported Follow-up Timepoint
| 3 mo | 6 mo | 12 mo | 2 y | 3 y | 4 y | 5 y | 6 y | 8 y | 10 y | |
|---|---|---|---|---|---|---|---|---|---|---|
| RFA | ||||||||||
| Richards et al18 | 61.5% (n=13) | |||||||||
| Triadafilopoulous et al19 | 70% (n=118) | 77% (n=118) | ||||||||
| Dibaise et al20 | 94.4% (n=18) | |||||||||
| Corley et al21 | 58% (n=35) | |||||||||
| Houston et al22 | 65% (n=31) | |||||||||
| Richards et al23 | 58% (n=65) | |||||||||
| Tam et al24 | 75% (n=20) | 65% (n=20) | ||||||||
| Go et al25 | 29% (n=50) | |||||||||
| Lufti et al26 | 43% (n=61) | |||||||||
| Torquati et al27 | 59% (n=41) | 56% (n=41) | ||||||||
| Cipoletta et al28 | 81% (n=32) | |||||||||
| Arts et al29 | 38% (n=13) | |||||||||
| Meier et al30 | 45% (n=60) | 38.3% (n=60) | ||||||||
| Noar and Lotfi-Emran31 | 82% (n=109) | 83% (n=109) | 77% (n=109) | 75% (n=109) | ||||||
| Reymunde and Santiag32 | 70.6% (n=83) | 87.9% (n=83) | 86.25% (n=80) | |||||||
| Coron et al33 | 15% (n=20) | 20% (n=20) | ||||||||
| Dundon et al34 Responsders | 15.4% (n=13) | |||||||||
| Aziz et al35 (single RFA group) | 16% (n=12) | |||||||||
| Aziz et al35 (double RFA group) | 50% (n=12) | |||||||||
| Dughera et al36 (initial 4 y study) | 72.3% (n=56) | |||||||||
| Liu et al37 | 78.9% (n=90) | 76.7% (n=90) | ||||||||
| Dughera et al38 | 80.7% (n=26) | 76.9% (n=26) | ||||||||
| Liang et al39 | 27.5% (n=138) | 42.8% (n=138) | ||||||||
| Liang et al40 | 27% (n=122) | 53.3% (n=122) | 56.6% (n=122) | |||||||
| Noar et al41 | 23% (n=99) | |||||||||
| Liang et al42 | 28.3% (n=60) | 31.7% (n=60) | ||||||||
| Yan et al43 | 68% (n=32) | 66% (n=31) | 61.7% (n=29) | |||||||
| Zhang et al44 | 74.2% (n=31) | 70.9% (n=31) | ||||||||
| Khidir et al45 | 20% (n=15) | |||||||||
| Weighted means (%) | 61.50 | 51.75 | 61.86 | 66.19 | 64.70 | 75.43 | 49.28 | 76.90 | 23.00 | |
| TIF | ||||||||||
| Cadiere et al46 | 69% (n=81) | 67% (n=79) | ||||||||
| Demyttenaere et al47 | 32% (n=26) | |||||||||
| Nguyen et al48 | 38% (n=8) | |||||||||
| Bell et al49 | 80% (n=100) | |||||||||
| Trad et al50 | 23% (n=28) | |||||||||
| Trad et al50 TEMPO | 90% (n=39) | 82% (n=39) | ||||||||
| Witteman et al51 | 66% (n=38) | 42% (n=19) | ||||||||
| Testoni et al52 | 61.2% (n=50) | 51% (n=50) | 56.1% (n=50) | 53.1% (n=50) | 45.8% (n=50) | 31.6% (n=50) | 35.7% (n=50) | |||
| Wilson et al53 | 80% (n=96) | 74% (n=96) | ||||||||
| Hakanson et al54 (TIF only) | 59% (n=22) | |||||||||
| Witteman et al55 | 74% (n=40) | |||||||||
| Witteman et al55 (TIF2 procedure) | 66% (n=53) | 39% (n=45) | ||||||||
| Trad et al56 TEMPO | 70% (n=63) | |||||||||
| Stefanidis et al57 | 72.7 (n=44) | |||||||||
| Trad et al58 TEMPO | 46% (n=44) | |||||||||
| Weighted means (%) | 32.00 | 72.88 | 60.96 | 52.22 | 62.52 | 45.80 | 31.60 | 50.78 | ||
| MSA | ||||||||||
| Bonavina et al59 | 89% (n=38) | |||||||||
| Bonavina et al60 | 90% (n=44) | 86% (n=44) | ||||||||
| Bonavina et al61 (median 3 y used) | 85% (n=95) | |||||||||
| Bonavina et al62 (update on 2010) | 90% (n=39) | 80% (n=35) | 85% (32) | 80% (n=25) | ||||||
| Ganz et al63 | 86% (n=98) | 87% (n=90) | 87% (n=85) | |||||||
| Reynolds et al64 | 76.9% (n=63) | |||||||||
| Ganz et al65 | 86% (n=85) | 87% (n=85) | 87% (n=85) | 80% (n=85) | 75.3% (n=85) | |||||
| Reynolds et al66 | 85% (n=41) | |||||||||
| Riegler et al67 | 81.8% (n=202) | |||||||||
| Saino et al68 | 87.8% (n=33) | |||||||||
| Buckley et al69 | 13% (n=200) | 94% (n=200) | ||||||||
| Broderick et al70 | 7% (n=13) | 69% (n=13) | ||||||||
| Hawasli et al71 | 54.5% (n=11) | |||||||||
| Riva et al72 | 33% (n=45) | 78% (n=45) | ||||||||
| Weighted means (%) | 25.53 | 89.90 | 84.94 | 84.68 | 84.37 | 80.00 | 78.80 | |||
| Fundoplication | ||||||||||
| Peters et al73 | 96% (n=100) | |||||||||
| Fernando et al74 | 81% (n=101) | |||||||||
| Bloomston et al75 | 81% (n=100) | 69% (n=100) | ||||||||
| Bammer et al76 | 86% (n=171) | |||||||||
| Draaisma et al77 | 86% (n=79) | |||||||||
| Kellokumpu et al78 | 88% (n=163) | |||||||||
| Reynolds et al64 (MSAvLNF) | 91% (n=117) | |||||||||
| Simorov et al79 | 82% (n=74) | 81% (n=74) | 70% (n=37) | 66% (n=50) | ||||||
| Reynolds et al66 (MSAvLNF) | 92% (n=59) | |||||||||
| Riegler et al67 | 63% (n=47) | |||||||||
| Warren et al80 | 88% (n=114) | |||||||||
| Weighted means (%) | 82.00 | 83.89 | 88.98 | 66.00 | 69.00 | 86.00 | 86.00 | 88.00 | ||
LNF indicates laparoscopic Nissen fundoplication; MSA, magnetic sphincter augmentation; RFA, radiofrequency ablation of the lower esophageal sphincter; TIF, transoral incisionless fundoplication.
FIGURE 1.
Weighted means for percent of patients off PPI therapy after MSA, RFA, TIF, and fundoplication. MSA indicates magnetic sphincter augmentation; PPI, proton pump inhibitor; RFA, radiofrequency ablation; TIF, transoral incisionless fundoplication.
FIGURE 2.
Trend lines for weighted means placed showing the overall trend of patients (%) off PPIs for MSA, RFA, TIF, and fundoplication. MSA indicates magnetic sphincter augmentation; PPI, proton pump inhibitor; RFA, radiofrequency ablation; TIF, transoral incisionless fundoplication.
GERD-HRQL
All studies that used GERD-HRQL as an endpoint are listed on Table 2 for RFA, TIF, MSA, fundoplication, and PPI use. Baseline scores are available for all studies presented. RFA studies have a baseline weighted mean of 22.57 GERD-HRQL score and has 10 studies with a weighted mean of 7.23 after 12 months. TIF studies have a baseline weight mean of 25.91 GERD-HRQL score and has 8 studies with a weighted mean of 6.11 after 12 months. MSA studies have a baseline weight mean of 23.34 GERD-HRQL score and has 6 studies with a weighted mean of 3.12 after 12 months. Fundoplication studies have a baseline weight mean of 23.1 GERD-HRQL score and has 8 studies with a weighted mean of 2.8 after 12 months. PPI studies have a baseline weight mean of 23.92 GERD-HRQL score and has 1 study with a score of 12 after 12 months. All interval follow reported scores are shown in Figure 3.
TABLE 2.
All Studies With GERD-HRQL as an Endpoint
| Prior | 3 mo | 6 mo | 12 mo | 2 y | 3 y | 4 y | 5 y | 8 y | 10 y | |
|---|---|---|---|---|---|---|---|---|---|---|
| RFA | ||||||||||
| DiBaise et al20 (on meds) | 11.5 (n=18) | 7 (n=16) | 11 (n=17) | |||||||
| Triadafilopoulos et al81 | 27 (n=118) | 10 (n=108) | 9 (n=94) | |||||||
| Corley et al21 (on meds) | 16 (n=35) | 16 (n=31) | ||||||||
| Tam et al24 | 19.5 (n=20) | 11.5 (n=20) | 7 (n=19) | |||||||
| Cipoletta et al28 (on meds) | 18 (n=32) | 16 (n=32) | ||||||||
| Meier et al30 (on meds) | 12.9 (n=60) | 6.6 (n=49) | ||||||||
| Noar and Lotfi-Emran31 (on meds) | 20.5 (n=109) | 6.8 (n=109) | 4.6 (n=109) | 6.7 (n=109) | 7.1 (n=109) | |||||
| Aziz et al35 (single RFA group) | 29.6 (n=12) | 14.4 (n=12) | ||||||||
| Aziz et al35 (double RFA group) | 31 (n=12) | 10.7 (n=12) | ||||||||
| Dughera et al36 (initial 4 y study) | 29 (n=56) | 15 (n=56) | 18 (n=56) | |||||||
| Liu et al37 | 25.6 (n=90) | 7.3 (n=90) | 8.1 (n=90) | |||||||
| Dughera et al38 (8 y data) (on PPI) | 31 (n=26) | 18 (n=26) | 20 (n=26) | |||||||
| Noar et al41 (on meds) | 21 (n=217) | 11 (n=177) | 7 (n=149) | 5 (n=98) | 7 (n=98) | 8 (n=94) | 8.55 (n=99) | |||
| Noar et al82 RLNF (on meds) | 21.5 (n=18) | 10 (n=17) | 3 (n=17) | 2 (n=12) | 4 (n=11) | 4 (n=11) | 7 (n=17) | |||
| Noar et al82 RR (on meds) | 22 (n=81) | 6.5 (n=80) | 3.5 (n=80) | 2 (n=65) | 4 (n=59) | 4 (n=58) | 3 (n=81) | |||
| Khidir et al45 | 42.7 (n=15) | 40.2 (n=15) | ||||||||
| Weighted means | 22.57 | 12.91 | 9.61 | 7.23 | 5.84 | 6.12 | 9.26 | 20.00 | 6.13 | |
| TIF | ||||||||||
| Cadiere et al46 | 24 (n=86) | 5.0 | 7.0 | |||||||
| Cadiere et al83 | 7.0 | |||||||||
| Demyttenaere et al47 | 22 (n=26) | 10.0 | ||||||||
| Testoni et al84 (on therapy) | 20 (n=20) | 16.0 | ||||||||
| Barnes et al85 | 28 (n=110) | 2.0 | ||||||||
| Bell and Cadiere86 | 16 (n=37) | 4.0 | ||||||||
| Ihde et al87 (hydrid TIF only) | 27 (n=42) | 3.0 | ||||||||
| Ihde et al87 (total patients) | 29 (n=46) | 3.0 | ||||||||
| Bell and Cadiere86 | 26 (n=100) | 4.0 | ||||||||
| Muls et al88 | 25 (n=66) | 6.0 | 6.0 | |||||||
| Testoni et al89 | 22 (n=42) | 15.0 | 17.0 | 18.0 | ||||||
| Trad et al50 | 26 (n=34) | 4.0 | ||||||||
| Trad et al50 TEMPO | 32.5 (n=39) | |||||||||
| Witteman et al51 | 33 (n=38) | 4.0 | 5.0 | |||||||
| Bell et al90 | 26 (n=127) | 4.0 | 4.0 | 5.0 | ||||||
| Hunter et al91 (on PPI) | 25 (n=87) | |||||||||
| Testoni et al52 (on PPI) | 20 (n=50) | 16.0 | 17.0 | |||||||
| Trad et al92 (crossover patients) | 26.4 (n=21) | 10.0 | ||||||||
| Trad et al92 (original cohort) | 26.3 (n=39) | 5.2 | 5.4 | |||||||
| Wilson et al53 | 24 (n=100) | 4.0 | 2.0 | |||||||
| Witteman et al55 | 26.5 (n=40) | 12.4 | ||||||||
| Witteman et al55 (TIF2 procedure) | 27.1 (n=53) | 11.1 | 10.3 | |||||||
| Trad et al56 TEMPO | 32.5 (n=63) | 5.0 | ||||||||
| Stefanidis et al57 | 27 (n=44) | 4 (n=44) | ||||||||
| Trad et al58 TEMPO | 6.8 (n=63) | |||||||||
| Weighted means | 25.91 | 10.00 | 5.97 | 6.11 | 9.82 | 8.07 | 0.00 | 5.65 | ||
| MSA | ||||||||||
| Bonavina et al59 | 26 (n=38) | 1 (n=38) | 2.5 (n=38) | |||||||
| Bonavina et al60 | 25.7 (n=44) | 4.6 (n=44) | 3.8 (n=44) | 2.4 (n=44) | ||||||
| Louie et al93 | 21 (n=34) | 5 (n=34) | ||||||||
| Reynolds et al64 | 4 (n=67) | |||||||||
| Reynolds et al64 matched Nissen study | 19.7 (n=50) | |||||||||
| Ganz et al65 | 27 (n=100) | 4.0 | ||||||||
| Reynolds et al66 | 17 (n=52) | 4 (n=52) | ||||||||
| Riegler et al67 | 20 (n=202) | 3 (n=202) | ||||||||
| Saino et al68 | 25.7 (n=44) | 2.9 | ||||||||
| Warren et al80 | 21 (n=201) | 3 (n=201) | ||||||||
| Buckley et al69 | 26 (n=200) | 3 (n=200) | 3 (n=200) | 2 (n=200) | ||||||
| Broderick et al70 | 25 (n=6) | 8.5 (n=6) | ||||||||
| Hawasli et al71 | 47 (n=11) | 12 (n=11) | ||||||||
| Riva et al72 | 19 (n=45) | 3 (n=45) | ||||||||
| Weighted means | 23.34 | 3.31 | 3.34 | 3.12 | 2.50 | 3.66 | ||||
| Fundoplication | ||||||||||
| Feldman et al94 | 20 (n=63) | 1 (n=63) | 1 (n=63) | 1 (n=63) | 1 (n=63) | 1 (n=63) | ||||
| Velanovich et al95 | 27 | 5 | ||||||||
| Bonnet et al96 | 26 (n=51) | 5 (n=51) | ||||||||
| Balci and Turkcapar et al97 | 24.2 (n=60) | 4 (n=60) | ||||||||
| Ciovica et al98 | 20 (n=326) | 1 (n=326) | ||||||||
| Balci and Turkcapar97 | 26 | 6 | ||||||||
| Hamdy et al99 | 33 (n=100) | 3 (n=100) | 0 (n=100) | |||||||
| Mark et al100 | 17 | |||||||||
| Tosato et al101 | 25 (n=36) | 7 (n=36) | 5 (n=36) | |||||||
| Reynolds et al79 (MSAvLNF) | 18.8 (n=117) | 4.3 (n=117) | ||||||||
| Rosetti et al102 | 30.4 (n=147) | 10.6 (n=147) | ||||||||
| Reynolds et al79 (MSAvLNF) | 19 (n=59) | 5 (n=59) | ||||||||
| Riegler et al67 | 23 (n=47) | 3.5 (n=47) | ||||||||
| Warren et al80 | 19 (n=114) | 5 (n=114) | ||||||||
| Koetje et al103 | 15.7 | 3.2 (n=103) | 2.6 (n=56) | 3.7 (n=26) | ||||||
| Weighted means | 23.1 | 2.3 | 6.9 | 2.8 | 1 | 1.7 | ||||
| PPI | ||||||||||
| Ciovica et al100 | 20 (n=221) | 12 (n=221) | ||||||||
| Rosetti et al103 | 29.2 (n=154) | 11.5 (n=154) | ||||||||
| Trad et al94 TEMPO | 26.4 (n=21) | 18.9 (n=21) | ||||||||
| Weighted means | 23.917 | 12.388 | 12 | |||||||
Mean scores reported at each timepoint.
LNF indicates laparoscopic Nissen fundoplication; MSA, magnetic sphincter augmentation; PPI, proton pump inhibitor; RFA, radiofrequency ablation of the lower esophageal sphincter; TIF, transoral incisionless fundoplication.
FIGURE 3.
Weighted means for Gastroesophageal Reflux Disease Health-related Quality of Life (GERD-HRQL) scores preoperatively and postoperatively. MSA indicates magnetic sphincter augmentation; PPI, proton pump inhibitor; RFA, radiofrequency ablation; TIF, transoral incisionless fundoplication.
pH Normalization
All studies that used DeMeester scores as an endpoint are listed on Table 3 for RFA, TIF, MSA, fundoplication, and PPI use. RFA has 2 studies with a weighted mean of 30.46, TIF has 4 studies with a weighted mean of 23.03, MSA has 2 studies with a weighted mean of 13.01, fundoplications have 4 studies with a weighted mean of 11.19, and PPI use has 2 studies with a weighted mean of 28.23. The rest of the follow-up intervals are in Table 3 and plotted in Figure 4.
TABLE 3.
All Studies With DeMeester Scores as an Endpoint
| Prior | 3 mo | 6 mo | 12 mo | 2 y | 3 y | 5 y | |
|---|---|---|---|---|---|---|---|
| RFA | |||||||
| Richards et al18 | 31 (n=15) | ||||||
| Triadafilopoulos et al19 | 40 (n=114) | 26.3 (n=95) | |||||
| Houston et al22 | 32.8 (n=18) | 22.9 (n=18) | |||||
| Richards et al23 | 39.4 (n=22) | 26.6 (n=22) | |||||
| Tam et al24 | 38.8 (n=20) | 22.7 (n=20) | 24.1 (n=19) | ||||
| Lufti et al26 (responders) | 40 (n=18) | 26.3 (n=18) | |||||
| Lufti et al26 (nonresponders) | 39.7 (n=6) | 40.5 (n=6) | |||||
| Arts et al29 | 46.8 (n=13) | 35.6 (n=13) | |||||
| Meier et al30 | 72.9 (n=26) | 35.1 (n=26) | |||||
| Khidir et al45 | 27.9 | ||||||
| Weighted means | 41.72 | 35.60 | 30.46 | ||||
| TIF | |||||||
| Cadiere et al46 | 34.0 | 24.0 | 28.0 | ||||
| Testoni et al86 | 20.0 | 18.0 | |||||
| Testoni et al91 | 21.0 | 18.0 | 19.0 | 20.0 | |||
| Trad et al50 TEMPO | 35.0 | 24.0 | 25.0 | ||||
| Witteman et al51 | 21.0 | 17.0 | |||||
| Bell et al92 | 34.4 | 19.0 | 20.4 | 17.2 | |||
| Hunter et al91 | 33.6 | 23.9 | |||||
| Testoni et al52 | 22.0 | 18.0 | 19.0 | ||||
| Trad et al94 (crossover patients) | 35.3 | 25.3 | |||||
| Weighted means | 30.40 | 17.00 | 21.27 | 23.03 | 18.15 | ||
| MSA | |||||||
| Bonavina et al59 | 29.3 | 4.2 | |||||
| Bonavina et al60 | 42.3 | 11.9 | 9.4 | ||||
| Bonavina et al61 (median 3 y used) | 30.1 | 11.2 | |||||
| Ganz et al104 | 36.6 | 13.5 | |||||
| Saino et al68 | 42.3 | 16.1 | |||||
| Warren et al80 | 34.0 | ||||||
| Weighted means | 32.06 | 4.20 | 13.01 | 9.40 | 11.20 | 16.10 | |
| Fundoplication | |||||||
| Peters et al73 | 50.0 | 5 | |||||
| Eubanks et al105 | 42.0 | 5.4 | |||||
| Granderath et al106 | 62.9 | 14.8 | 13.1 | 13 | |||
| Mahon et al107 | 42.7 | 8.6 | |||||
| Marano et al108 | 35.5 | 9.83 | 11.4 | 10.25 | |||
| Tosato et al101 | 30.65 | 8.05 | 7.6 | ||||
| Hamdy et al15 (PPI nonresponder) | 39.9 | 5 | |||||
| Hamdy et al15 (PPI responder) | 35.3 | 5.1 | |||||
| Weighted means | 35.69 | 9.59 | 6.05 | 10.18 | 10.25 | 13.00 | |
| PPI | |||||||
| Hunter et al91 RESPECT (Sham) | 30.9 | 32.7 | |||||
| Trad et al92 TEMPO (control) | 35.8 | 19.3 | |||||
| Weighted means | 32.53 | 28.23 | |||||
Mean scores reported at each timepoint.
MSA indicates magnetic sphincter augmentation; PPI, proton pump inhibitor; RFA, radiofrequency ablation of the lower esophageal sphincter; TIF, transoral incisionless fundoplication.
FIGURE 4.
Weighted means for DeMeester scores preoperaively and postoperatively. MSA indicates magnetic sphincter augmentation; PPI, proton pump inhibitor; RFA, radiofrequency ablation; TIF, transoral incisionless fundoplication.
All studies that used percent of time with pH <4 as an endpoint are listed on Table 4 for RFA, TIF, MSA, fundoplication, and PPI use. RFA has 6 studies with a weighted mean of 7.57, TIF has 5 studies with a weighted mean of 7.08, MSA has 2 studies with a weighted mean of 3.24, fundoplications have 4 studies with a weighted mean of 1.27, and PPI use has 1 study with a weighted mean of 4.29. The rest of the follow-up intervals are in Table 4 and plotted in Figure 5.
TABLE 4.
All Studies With Percent of Time With pH <4 as an Endpoint
| Prior | 3 mo | 6 mo | 12 mo | 2 y | 3 y | 5 y | |
|---|---|---|---|---|---|---|---|
| RFA | |||||||
| Dughera et al38 (8 y data) | 16.9 | ||||||
| Arts et al109 * | 11.3 | 11.3 | 11.3 | ||||
| Dughera et al36 (initial 4 y study) | 15.9 | ||||||
| Aziz et al35 (single RFA group) | 9.4 | 6.7 | |||||
| Aziz et al35 (double RFA group) | 8.8 | 5.2 | |||||
| Arts et al29 | 11.6 | 8.5 | |||||
| Cipoletta et al28 | 11.7 | 8.4 | |||||
| Triadafilopoulos et al110 (nonresponder) | 11.2 | 8.0 | |||||
| Triadafilopoulos et al110 (responder) | 7.8 | 4.1 | |||||
| Weighted means | 11.16 | 11.30 | 6.50 | 7.57 | |||
| TIF | |||||||
| Cadiere et al46 | 10.0 | 7.0 | 7.0 | ||||
| Muls et al90 | 9.0 | 7.0 | 3.0 | ||||
| Trad et al50 TEMPO | 10.2 | 6.8 | 7.5 | ||||
| Witteman et al51 | 7.4 | 5.5 | |||||
| Bell et al92 | 8.9 | 5.6 | 6.1 | 5.2 | |||
| Hunter et al91 | 9.3 | 6.4 | |||||
| Trad et al94 (crossover patients) | 10.2 | 7.5 | |||||
| Hakanson et al54 (TIF only) | 7.8 | 3.6 | |||||
| Witteman et al55 | 10.8 | 7.7 | |||||
| Witteman et al55 (TIF2 procedure) | 11.0 | 7.9 | 9.1 | ||||
| Trad et al56 (TEMPO) | 10.2 | 7.8 | |||||
| Weighted means | 9.78 | 5.50 | 6.54 | 7.08 | 5.20 | 5.34 | |
| MSA | |||||||
| Bonavina et al59 | 8.4 | 1.1 | |||||
| Bonavina et al60 | 11.9 | 3.1 | 2.4 | ||||
| Bonavina et al61 (median 3 y used) | 7.8 | 3.2 | |||||
| Ganz et al63 | 10.9 | 3.3 | |||||
| Riegler et al67 | 10.7 | ||||||
| Saino et al68 | 11.9 | 4.6 | |||||
| Warren et al80 | 10.0 | ||||||
| Weighted means | 10.16 | 1.10 | 3.24 | 2.40 | 3.20 | 4.60 | |
| Fundoplication | |||||||
| Anvari et al111 | 10.6 | 2.11 | |||||
| Hamdy et al15 (PPI nonresponder) | 9.7 | 0.7 | |||||
| Hamdy et al15 (PPI responder) | 11.3 | 0.9 | |||||
| Marano et al110 | 14.04 | 2.33 | 2.67 | 2.12 | |||
| Weighted means | 11.41 | 2.33 | 1.27 | 2.12 | |||
| PPI | |||||||
| Hunter et al91 RESPECT (Sham arm) | 8.6 | 8.9 | |||||
| Trad et al94 TEMPO (control arm) | 10.5 | 5 | |||||
| Anvari et al111 | 9.46 | 4.29 | |||||
| Weighted means | 9.33 | 7.60 | 4.29 | ||||
Mean scores reported at each timepoint.
Reported no significant change, no value given.
MSA indicates magnetic sphincter augmentation; PPI, proton pump inhibitor; RFA, radiofrequency ablation of the lower esophageal sphincter; TIF, transoral incisionless fundoplication.
FIGURE 5.
Weighted means for percent of time with pH <4 preoperatively and postoperatively. MSA indicates magnetic sphincter augmentation; PPI, proton pump inhibitor; RFA, radiofrequency ablation; TIF, transoral incisionless fundoplication.
DISCUSSION
TIF, MSA, and RFA are commercially available options for treating GERD. They have been proposed as being particularly suitable for the patient population that occupies a gap in therapy between the surgical gold standard of laparoscopic fundoplication and patients responsive and satisfied with medical therapy with PPI and other acid suppressing medications. All 3 procedures have different mechanisms to improve GERD symptoms and esophageal acid exposure. The ability to evaluate all 3 procedures, given those distinct differences, has made it difficult to directly compare their outcomes. However, understanding the differences in therapies, particularly their outcomes, are an important element in the patient’s workup, the recommendation of a particular procedure, and predicting the outcome of the intervention. This review compares the published data on all 3 procedures with 4 common and important endpoints.
For the purposes of this study, it was important to have a surgical control and a comparison to the gold standard surgical treatment for GERD with fundoplication. Since the 1990s long-term follow-up studies have documented the outcomes of fundoplication with regards to symptom control, percent of patients remaining on medical therapy, and the need for redo surgery. Kelly et al112 cited 84% relief of heartburn at 10 years and DeMeester et al113 documented an actuarial relief of reflux symptoms in 91% of patients at 10 years. With the improvements in laparoscopy, antireflux surgery surged with respect to case volume, and then fell in 2003,114 but reported outcomes did not seem to suffer. In 2002, Khajanchee et al115 reported at a median follow-up of 7.7 months after antireflux surgery and normal DeMeester score with 83% of patients. In longer study follow-up at 20 years by Robinson et al,116 75% of patients continue to have complete resolution of symptoms, and 19% of the remaining patients only have rare or occasional symptoms. Next came the era including the validated GERD-HRQL questionnaire that gave an objective way to quantify symptom control of reflux.117 Marano et al108 report GERD-HRQL improvement from 23 to 7, and DeMeester scores dropping from 35 to 10 at 2 years. In an another study be Koetje et al103 at 2-year follow-up GERD-HRQL scores improved from 16 to 4, and Simirov and colleagues report a 66% of patients off PPIs at 3 years. These data can validate the use of fundoplication as the control group.
Examining the data further, the longevity of these alternative procedures is somewhat defined. For fundoplications, it appears that about 1% to 18% of patients have recurrence of their symptoms and undergo redo surgery at about 10-year follow-up.18,118,119 Although this current study does not have comparable 10-year follow-up data for TIF, RFA, or MSA, except for Noar et al41 for RFA outcomes, one can extrapolate the data to get a feeling for the relative longevity of the 3 procedures. As an example, in Figure 2 for percent of patients off PPIs, it appears that both the RFA and TIF procedures have a progressive failure rate with regard to keeping patients off PPIs. The MSA data appear to be fairly consistent out to 5 years in all 4 endpoints with the limited data available. This does makes sense considering the permanent nature of the device implant, but obviously longer follow-up is needed as there may be failure related to recurrence of a hiatal hernia, dysphagia, etc. It should be noted though, these early data for MSA does rival the reported data for fundoplications if compared.
Cost is another factor needed for consideration in a patient’s choice of treatment. In the past, there has been some cost benefit to laparoscopic fundoplication over medical therapy in the long term.120,121 With availability of over the counter acid suppression, medical treatment could overcome this and become the least costly option, at least in the short term. This can also play a role for some patients and referring doctor’s consideration of a surgical option. The 3 “gap” treatments vary greatly in cost. Unfortunately, the majority of papers considered in this review did not have cost data. The studies that have addressed this issue mainly compare gap patient therapies to laparoscopic fundoplication. One study comparing MSA to laparoscopic fundoplication showed total charges around $48K compared with $50K, respectively.122 The operating room services was much lower at $16k and $19K. Funk et al123 report RFA procedure costing about $3.5K with an initial cost to purchase the generator. This covers the cost of the procedure through the hospital and the catheters. The same analysis shows TIF costing about $14K and laparoscopic fundoplication about $12.5K. There is definitely benefit for RFA with respect to overall cost mainly because it can be done in an endoscopy suite rather than an operating room. The other procedures are difficult to compare given that every facility varies, as well as within a region, or between countries.
One weakness of this study is related to the degree of variability in outcomes for each procedure. In the case of creating a fundoplication, there are several varying techniques and outcomes are very surgeon specific.124 There are also variation in outcomes with the TIF procedure, related to learning curves, volume, and patient selection philosophies. Fortunately, the data presented here for TIF is largely from high volume experts. For RFA and MSA variations in outcomes would be expected to be less as the procedures are fairly well standardized. This reinforces the reproducibility of data examined in this study.
Perhaps the major limitation of the study is variability in outcome metrics used, not only between the procedures but even between reports within the groups. As we could only compare studies which included the most common endpoints, and this led to elimination of certain studies for each outcome comparison. Overall, only 2 RFA papers, 3 TIF papers, and 4 MSA papers contained all 4 outcome measures we report on which weakens the strength of our conclusions. Another problem is the emphasis in all these studies on subjective outcomes (symptom scores) over objective outcomes (pH studies). It is a long-standing controversy as to which endpoints are best used in the reporting of GERD treatments; with some advocating objective measures and others insisting that subjective results are most relevant. For this report we included both parameters although only about one third to one half of the studies had pH data outcomes and there was bias between the techniques as well with only 1 study in the RFA group using pH as an endpoint. This may make our comparison of the pH data less reliable as a comparator, however, may be partially overcome by our use of “PPI use” as an endpoint. Although this is an objective measure, it probably is less accurate as access to PPI varies from country to country and depending on study protocols. Still, use of pH studies is important as data show that there is a risk of progression of disease if abnormal esophageal acid exposure is not stopped.7,125,126 This progression can even put the patient at risk of developing esophageal adenocarcinoma as this risk increases with development of BE and dysplasia.127 We show that TIF and Stretta failed to normalize acid exposure with regard to DeMeester score and percent of time with pH <4 in majority of studies. In regard to RFA, only 3 studies demonstrated normalization of percent of time with pH <4 at the 6-month follow-up, 1 study at the 12 months, and 1 study at 2 years. For TIF, only one study demonstrated normalization of of time with pH <4 at the 6-month follow-up, another single study demonstrated normalization at the 2 years, and finally, a single study demonstrated this at the 3-year follow-up. This indicates that the 2 endoluminal procedures are largely unable to stop abnormal esophageal acid exposure. The MSA data showed DeMeester score and percent of time with pH <4 normalization in all studies except the 5-year follow-up data where the DeMeester score mean was 16.1. Taking this endpoint into account is important especially in those patients at risk for progressive disease.
Our review of the literature on 3 different currently available rival techniques to surgical fundoplication show that, using 4 common endpoints used in assessing a patient for antireflux surgery, the MSA data appear to be the most reproducible and maintains the most linear relationship over time, albeit being the most aggressive intervention. It is evident, based on this review, that more long-term follow-up needs to be completed for all 3 procedures in order to properly see their efficacy and relative position in the treatment algorithm for GERD.
Footnotes
S.G.L. is a consultant for Ethicon and Boston Scientific. The remaining authors declare no conflicts of interest.
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