Introduction
Bariatric endoscopy has emerged for nonsurgical treatment of obesity, providing a
treatment option for weight loss and associated comorbidities [1].
Fogel in 2008 [2] and Brethauer in 2010 [3] showed the feasibility of endoscopic gastric volume reduction for management of
obesity using a superficial endoscopic suturing device that mimicked vertical banded
gastroplasty surgical anatomy. In 2013, Abu Dayyeh and colleagues demonstrated the
feasibility of creating a full endoscopic sleeve gastroplasty (ESG) that reduces the
entire stomach through creation of a small-diameter sleeve along the lesser curvature
of the stomach [4]. Since then, clinical experiences with ESG have been published. Outcomes of ESG
have been published at 6 months [5]
[6] and there is interest in outcomes with a longer follow-up period.
In this paper, we provide 1-year outcomes in the first 25 patients reaching this milestone
and have identified predictors of favorable weight loss response to aid patient management
moving forward.
Patients and methods
Patients
All patients had failed lifestyle modification efforts. All procedures were conducted
in accordance with good clinical practice and within the guidelines of the Declaration
of Helsinki (WMA, 2004) [7] for studies using human subjects. Written informed consent was obtained from all
patients.
The study was registered with the institutional review board of the Madrid Sanchinarro
University Hospital. The registration number of the study is 657-GHM.
Clinical Trial registration of clinical trial
The study was registered in ClinicalTrials.gov with identifier NCT02231970.
Data were collected prospectively for analysis. The specific indications for the procedure
were based on obesity parameters (body mass index [BMI] 30 – 49 kg/m2) with previous failed attempts with conventional treatment of obesity and the willingness
and ability of patients to be treated by a multidisciplinary team for at least 1 year.
The procedure was contraindicated in patients with prior gastric surgery, potentially
bleeding lesions (e. g., ulcers and acute gastritis) and neoplastic findings. Individuals
with psychiatric disorders (mental retardation, manic-depressive psychosis, severe
depression, schizophrenia, and untreated eating behavior disorders) that interfere
with their ability to actively engage with the post-procedural instruction and recommended
lifestyle adjustments were excluded. Coagulopathy and psychiatric disorders were excluded
by blood tests and interviews with a psychologist, respectively.
Endoscopic sleeve gastroplasty procedure
As we have described previously (5), we refer to the technique as endoscopic endoluminal
greater curvature plication. The procedure was performed with the patient in the left
lateral decubitus position and under general anesthesia with endotracheal intubation.
Pre-procedure antibiotics were given (Cefotaxima 2 g intravenously).
Construction of the gastroplasty was dependent on a cap-based flexible endoscopic
suturing system (OverStitch; Apollo Endosurgery, Inc., Austin, Texas, USA), which
was mounted onto a double-channel endoscope (GIF-2T160; Olympus Medical Systems Corp.,
Tokyo, Japan)placed through an esophageal overtube (US Endoscopy, Mentor, Ohio, USA)
with carbon dioxide gas insufflation.
The goal of this procedure was to reduce the gastric lumen into a tubular configuration,
with the greater curvature modified by a line of sutured plications as previously
reported.
To perform the gastroplasty we deploy interrupted sutures from distal to proximal
body. Each suture consists of six bites along the anterior/greater curvature/posterior
gastric wall before it is cinched. Because this is not a continuous staple line, but
rather, an invagination of the greater curvature of the stomach, intraluminal gaps
exist along the plication line. These gap are of no clinical consequences as far as
trapping food and are analogous to gaps seen with surgical plications of the greater
curvature for weight loss. Reinforcing stiches are usually placed in the upper body
of the stomach. The suture pattern has evolved from a very few cases addressing the
fundus to the majority in which we leave the fundus open, so the patient can have
a pouch and some accommodation ability.
Oral contrast studies assessed the gastroplasty at 24 hours for sleeve configuration
and for potential suture line leak. Bleeding complications were excluded by blood
tests at 6 hours and at 24 hours post-procedure. Post-procedure care remained unchanged
from our earlier experience and included hospitalized observation, fasting sips, a
liquid diet at 8 hours post-procedure, analgesia, and 24-hour discharge.
Adverse post-procedure events or bleeding (excluded by blood tests at 6 hours and
24 hours), were recorded as in our initial reported experience.
Follow-up multidisciplinary bariatric team
Post-procedure care with a nutritionist and a psychologist weekly or biweekly was
maintained. Patient communication included personal interviews (face-to-face), telephone
interviews, e-mails, and text messages.
The nutritional intervention changed during the course of treatment. Initially, the
focus was on a transitional diet post-intervention. After patients started on solid
food, the focus was on following the prescribed hypocaloric diet and discussing healthy
food choices and alternatives. Once the first phase was completed, nutritional support
shifted to providing patients with a workable diet program that they could follow
over the long term, which was personalized to their individual needs.
The psychologist coached patients to follow the recommended lifestyle modification
program necessary to maintain their weight loss over the long term. Furthermore, patients
were coached on how to interact with food cues and obesogenic environment stimuli.
Finally, they were taught how to recognize emotional eating cues and deal with them.
Gastric cavity restriction facilitates caloric limitation. Dietitians and psychologist
were in continuous contact to resolve problems and to design the best strategy for
treatment of each individual patient. Exercise was recommended, taking into account
each patient’s limitations and as prescribed by an exercise physiologist.
Oral contrast studies
Oral contrast studies were scheduled to assess the gastroplasty voluntarily at 3,
6, 9, or 12 months.
Endoscopic follow-up
Gastroscopy was planned voluntarily at 6 or 12 months.
The data set collected for each patient was as follows:
-
Nutrition
-
Patient contacts: The number of contacts was divided into tertiles to study its relationship
with the weight parameters. The tertiles were as follows: low adherence = T1, medium
adherence = T2, and high adherence = T3.
-
Weight parameters: Baseline and follow-up examinations included assessment of weight
and height as before, with BMI calculated as weight in kilograms divided by the square
of height in meters. Outcomes at 1, 3, 6, and 12 months were: (1) change in body weight
(TBWL); (2) percentage loss of initial body weight (%TBWL); (3) percentage of excess
body weight loss (percentage of weight lost compared with excess weight, defined as
current weight minus the weight corresponding to a BMI of 25 kg/m2) (%EWL), and (4) change in BMI.
-
Post-procedure adverse events: Nausea, constipation, abdominal pain, hematemesis,
melena, fever, reflux.
-
Psychology
-
Patient contacts: The number of contacts (face to face & telephone) was divided into
tertiles to study its relationship with the weight parameters. The tertiles were as
follows: low adherence = T1, medium adherence = T2, and high adherence = T3.
-
Behavioral measures (baseline and 1-year): (1) disorganized meals (2) “five meals
a day” compliance, (3) speed eating, (4) snaking, (5) binge eating, (6) physical activity
(PA), and (7) sleep quality.
Post-procedure program structure
Post-procedure program structure
The programmatic follow up mirrored that which was applied to the initial pilot patient
group reported earlier.
First 4 weeks
A liquid diet was started the day before the procedure and continued for 2 weeks,
followed by progression from hypocaloric liquids to small semisolid meals over 4 weeks.
Exercise initially consisted of walking, with a progressive increase in intensity
that paralleled the diet progression. Weekly contacts were made to evaluate performance
and provide solutions for problems related to compliance with lifestyle treatment
that patients may have experienced.
Months 2 – 12
Individual taste preferences were taken into account in designing hypocaloric diets.
Aerobic exercise was adjusted to patient capability and involved walking, jogging,
cycling, aerobics, or swimming for a minimum of 30 minutes, 3 times a week. Patients
were advised to add physical activity to any daily routine, (e. g. walking instead
of taking mechanized transport and climbing stairs rather than using the elevator).
Statistical analysis
Descriptive analyses of the variables were performed using the test of proportions
for qualitative variables and measurements of central tendency (mean) and measures
of dispersion (standard deviation: s.d.) for quantitative variables.
The association between changes in the initial and final values of weight parameters
used the student t test for related pairs.
For comparisons of continuous variables, the comparisons of absolute means between
groups were calculated using the student t test.
Multivariate means and the 95 % confidence interval (CI) for anthropometric measures
at baseline according to tertiles of number of nutritionist and phycologist contacts
were calculated using generalized linear models. The means were adjusted for age,
sex, and initial BMI.
Finally, univariate linear regression analyses were fit to assess the association
between %TBWL and number of nutritional controls, and between %TBWL and number of
psychological controls, both controlling for initial BMI.
All P values presented were two-tailed, and statistical significance was defined a priori
at P = 0.05. Data analyses were performed using SPSS 19.0 (SPSS Inc., Chicago, Illinois,
USA).
Results
The treatment group consisted of 25 patients (5 men, 20 women). Three patients dropped
out, one at 3 months and two at 6 months. The final sample consisted of 22 patients
with completed follow-up at 12 months.
Among the 25 patients, mean BMI was 38.5 ± 4.6 kg/m2 (range 30 – 47) and mean age 44.5 ± 8.2 years (range 29 – 60). The mean procedure
time was 80 minutes (range 50 – 120 minutes).
All patients underwent successful gastroplasty. There were no major intra-procedural,
early, or delayed adverse events. No bleeding complications were found. During this
period, patients received analgesics and antiemetics on an as-needed basis. Post-discharge
pain (2 – 4 days) and nausea (1 day) were experienced by 50 % and 20 % of the patients,
respectively. Oral contrast studies to assess the gastroplasty at 24 hours showed
no leaking contrast and intact reductions. All patients were discharged the day after
the procedure.
Weight change
[Table 1] shows the results of the evolution of the weight parameters. The initial parameters
and the values collected at the post-procedure time intervals differed significantly.
The largest decreases were seen in the first month after the procedure, when patients
were on no solid foods.
Table 1
Changes in weight-related parameters following endoscopic endolumenal greater curvature
plication for the treatment of obesity at 3 months, 6 months, and 1 year post-procedure.
|
Variable
|
1 month
mean + SD
n = 25
|
3 months
mean + SD
n = 25
|
6 months
mean + SD
n = 24
|
12 months
mean + SD
n = 22
|
|
BMI (kg/m2) loss
|
2.8 ± 0.8
|
4.9 ± 1.6
|
6.9 ± 2.9
|
7.3 ± 4.2
|
|
Total weight loss (kg)
|
7.9 ± 2.7
|
14.1 ± 5.5
|
19.6 ± 9.1
|
21.1 ± 12.6
|
|
Percentage of weight loss (%)
|
7.4 ± 2.3
|
12.9 ± 4.3
|
17.8 ± 7.5
|
18.7 ± 10.7
|
|
Percentage of excess weight loss (%)
|
24.0 ± 11.8
|
40.5 ± 16.5
|
53.9 ± 24.8
|
54.6 ± 31.9
|
BMI, body mass index
Nutritionist Follow-up
During the first year of follow-up, the mean number of nutritional contacts was 19.6 + 9.9
(range 3 – 32). [Fig. 1] shows the weight loss parameters (BMI changes, %TBWL, and %EWL) across the tertiles
of nutritional contacts. Tertiles are distributed as follows: T1 (3 – 16 contacts/year),
T2 (17 – 24 contacts/year), and T3 (24 – 32 contacts/year).
Fig. 1 Relationship between nutritional follow-up controls per year and weight loss parameters.
As shown in [Fig. 1], the magnitude of the weight loss increased significantly (P < 0.05) in individuals who had more nutritional contacts. After adjustment for age,
sex, and initial BMI, a linear trend was found for changes in %TBWL (P = 0.045) and %EWL (P = 0.013).
Psychological follow-up
During the first year of follow-up, the mean number of psychological contacts was
9.2 + 7.2 (range 0 – 23). Tertiles are distributed as follows: T1 (0 – 3 contacts/year),
T2 (4 – 12 contacts/year), and T3 (13 – 23 contacts/year).
As shown in [Fig. 2], the magnitude of the weight loss increased significantly (P < 0.05) in individuals who had more psychological contacts. After adjustment for
age, sex, and initial BMI, no linear trend was found for changes in %TBWL and %EWL.
Fig. 2 Relationship between psychological follow-up controls per year and weight loss parameters.
Changes in nutritional habits
[Fig. 3] shows initial and final values for nutritional habits. Initially, the worse habits
were “not eating 5 meals a day” (94.1 %) and “not eating slowly” (93.3 %). One year
after the procedure, the most notable changes were “not eating 5 meals a day” (from
94.1 % to 29.4 %) and binge eating (from 68.8 % to 12.5 %).
Fig. 3 Change in eating, sleep and sedentary habits: initial and 1-year prevalence.
Among the initially sedentary patients, 55.6 % began physical activity (walking or
doing cardiovascular exercises in the gym), and 75 % of those who were initially not
sedentary improved their level of physical activity (increasing walking time or doing
other activities in the gym).
Factors predictive of success
The result of the linear regression analysis, controlling for initial BMI, showed
that the number of nutritional contacts predict the %TBWL (Beta = 0.563, P = 0.014) and that the number of psychological contacts predict the %TBWL (Beta = 0.727,
P = 0.025).
Gastroplasty at 1 year
[Fig. 4] shows the radiologic images at 24 hours and 1 year post-procedure. [Fig. 5] shows the endoscopy image at 1 year post-procedure.
Fig. 4 Contrast Rx image of the endoscopic sleeve gastroplasty with the greater curvature
modified by a line of sutured plications (the arrows indicate the location of the
plications) at 1 year post-procedure
Fig. 5 Luminal endoscopic view of the gastric body reduced into a tubular configuration
at 1 year post- procedure
Gastroplasty assessment was more successful than our earlier pilot experience and
obtained in 90 % of the patients, 50 % endoscopically and 80 % by contrast study.
Based on these studies, one patient underwent a revision partial gastroplasty because
of loosened plications. A tubular configuration of the gastroplasty was otherwise
confirmed in the remaining patients.
Discussion
This extended experience demonstrates that endoscopic sleeve gastroplasty offers a
safe and effective endolumenal weight loss option with durability at 1 year. The procedure
does produce discomfort for patients in the immediate post-procedure period, with
50 % experiencing moderate abdominal pain and 20 % experiencing nausea, both of which
can be controlled pharmacologically. No long-term complications were observed. At
1-year follow-up, patients reached 54.6 % of EWL and 18.7 % of TBWL. The subgroups
with the highest number of nutritional and psychological interactions demonstrated
the most favorable weight loss. This is not surprising, given our earlier pilot experience
and general knowledge regarding the value of comprehensive supportive care post-procedure.
The study does have limitations. First, the sample size, although larger than the
originally reported pilot group, is small. In addition, there is no control group
in which the technique was not performed with which to compare results, although the
patients who were treated persistently failed lifestyle modification. Regarding the
demonstrated benefit of greater nutritional and psychological interaction, we are
uncertain as to whether that was due to patient motivation stimulated by early post-procedure
weight loss or if it is due to a unique motivational success of our nutritional and
psychological programs.
Determining how much of the contact needs to be face-face and how much electronic
is a very important area of research. In our current limited sample size, we had to
combine face-to-face and remote contacts to achieve adequate power to run the analysis.
However, we have an active prospective protocol to answer this question.
Other bariatric endoscopic interventions are available, most notably, the intragastric
balloon (IGB) [8]
[9]
[10]. The main difference between sleeve gastroplasty and IGB is treatment duration,
with IGB a defined 6-month intervention. Retrospective studies with longer follow-up
have shown maintenance of significant weight loss in only a quarter of the patients
after balloon removal. These experiences suggest that long-term weight loss maintenance
with IGB is difficult to achieve [11]
[12].
The other technique for endoscopic gastric reduction is the Primary Obesity Surgery
Endolumenal (POSE) procedure (USGI Medical, San Clemente, California, USA) [13]
[14]. The POSE method uses a per-oral Incisionless Operating Platform (IOP) for placement
of multiple isolated transmural tissue anchor plications to reduce the gastric fundus
and the gastric body. Results in 116 patients undergoing the POSE procedure with 1
year of follow-up [14] demonstrated a mean %EWL of 44.9 ± 24.4. This procedure, however, does not provide
an opportunity for reintervention as is the case with ESG
The durability of the Endoscopic Sleeve gastroplasty at 1-year, along with the weight
loss results, suggest that this endolumenal technique remains effective and helpful.
It should be noted that no irreversible anatomical alteration occurs in the gastric
cavity and the technique is reproducible and repeatable. Therefore, reintervention
in the future has the potential to achieve lasting results.
It is understood that dietary education, lifestyle modification, and physical exercise
are essential in treatment of obesity. In 2-year studies of dietary intervention for
weight weight loss through different types of diets [15], the main predictor of weight loss was the number of checkups, regardless of other
factors. Our experience confirms the findings from these prior studies. In our opinion,
the current study serves to emphasize the importance of monitoring outcomes with these
techniques and intervening when poor results in patients are associated with a low
number of visits with the multidisciplinary team.
We can conclude that after 1 year, sleeve gastroplasty is an effective, safe, and
well-tolerated procedure for treatment of patients with obesity, with regular monitoring
by a multidisciplinary team a key measure to success.
