Innovations and brief communications
Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population
Authors
Reem Z. Sharaiha, Prashant Kedia, Nikhil Kumta, Ersilia M. DeFilippis1, Monica Gaidhane, Alpana Shukla, Louis J. Aronne, Michel Kahaleh
Institution
Division of Gastroenterology & Hepatology, Department of Medicine, Weill Cornell Medical College, New York, USA
submitted 13. July 2014 accepted after revision 2. September 2014
Background and aims: Novel endoscopic techniques have been developed as effective treatments for obesity. Recently, reduction of gastric volume via endoscopic placement of full-thickness sutures, termed endoscopic sleeve gastroplasty (ESG), has been described. Our aim was to evaluate the safety, technical feasibility, and clinical outcomes for ESG. Patient and methods: Between August 2013 and May 2014, ESG was performed on 10 patients using an endoscopic suturing device. Their weight loss, waist circumference, and clinical outcomes were assessed. Results: Mean patient age was 43.7 years and mean body mass index (BMI) was 45.2 kg/m2.
There were no significant adverse events noted. After 1 month, 3 months, and 6 months, excess weight loss of 18 %, 26 %, and 30 %, and mean weight loss of 11.5 kg, 19.4 kg, and 33.0 kg, respectively, were observed. The differences observed in mean BMI and waist circumference were 4.9 kg/m2 (P = 0.0004) and 21.7 cm (P = 0.003), respectively. Conclusions: ESG is effective in achieving weight loss with minimal adverse events. This approach may provide a cost-effective outpatient procedure to add to the steadily growing armamentarium available for treatment of this significant epidemic.
Introduction
Methods
!
!
New endoscopic bariatric techniques have been developed as standalone procedures or as adjuncts to surgery. Endoscopic procedures have the advantage of being reversible, with lower adverse events, and greater feasibility in poor surgical candidates [1 – 5]. Transoral gastroplasty (TOGA) utilizes two staple devices to create a restrictive gastric pouch or sleeve along the lesser curvature, but is limited by frequent staple-line dehiscence [5 – 7]. Other similar techniques include transoral gastric volume reduction (TGVR) with endoluminal suturing systems, such as the EndoCinch (C. R. Bard Inc., Murray Hill, New Jersey, USA) and RESTORe (Bard/Davol, Warwick, Rhode Island, USA) [2, 3, 8 – 10]. Recently, full-thickness endoscopic suturing has been shown to create a more durable sleeve with transmural tissue apposition [8]. In this case series, we describe our experience in 10 patients who underwent TGVR using the Overstitch endoscopic suturing device (Apollo Endosurgery, Austin, Texas, USA).
The Endoscopic Suturing for Gastrointestinal Tract Disorders database is a prospective multicenter registry established at Weill Cornell Medical College (IRB approval 04/26/2013). The registry’s objective is to assess the long-term efficacy, safety, and clinical outcomes of the endoscopic placement of sutures. The data is recorded and stored in a secure electronic data-capturing system (RedCap).
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1390773 Published online: 7.11.2014 Endoscopy 2015; 47: 164–166 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Michel Kahaleh, MD Division of Gastroenterology & Hepatology Department of Medicine Weill Cornell Medical College 1305 York Avenue, 4th Floor New York, NY 10021 USA Fax: +1-646-962-0110 [email protected]
Sharaiha Reem Z et al. Endoscopic sleeve gastroplasty … Endoscopy 2015; 47: 164–166
Description of technique The Overstitch endoscopic suturing device was used to perform endoscopic sleeve gastroplasty (ESG). A standard upper gastrointestinal endoscope (GIF-H180; Olympus) was used to measure the distance from the incisors of the gastroesophageal junction and the pylorus. After an esophageal overtube (Guardus; US Endoscopy, Mentor, Ohio, USA) had been inserted, two parallel anterior and posterior suture placement sites were mapped using argon plasma coagulation starting from the incisura and extending proximally to the gastroesophageal junction.
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
164
Innovations and brief communications
165
Fig. 2 Schematic illustration of the sutures placed in the endoscopic sleeve gastroplasty (ESG) procedure.
The helix device was used to ensure sequential full-thickness bites were taken. A running stitch approximated the anterior and posterior placement sites and was tightened to create a fullthickness volume-reduction plication. The suture was cut using a " Fig. 1). The suture line was created from anterior to midcinch (● line to the posterior site in an M-shaped pattern to ensure adequate plication of the folds and prevent the creation of a second " Fig. 2). A second layer of sutures was placed internal lumen (● over the length of the central sleeve in an interrupted pattern to further reduce the gastric volume and reinforce the sleeve. Repeat measurements of the distances to the gastroesophageal junction and pylorus were recorded. Ten subjects with a mean body mass index (BMI) of 45.2 ± 8.8 kg/m2 and stable weight for 3 months prior to the procedure were recruited. They underwent pre-bariatric procedure testing with psychiatric and nutritional evaluation. The procedure was performed in the endoscopy suite for nine patients. One patient’s procedure was performed in the operating room because of the need for a bariatric bed. All the procedures were performed while
Fig. 3 Image taken from an upper gastrointestinal series after endoscopic sleeve gastroplasty (ESG) showing a reduced stomach volume.
the patient’s were under general anesthesia and with the use of carbon dioxide (CO2) insufflation. As per protocol, all patients were hospitalized after the procedure for observation, management of symptoms, and to obtain an upper gastrointestinal series (UGIS) 24 hours after the proce" Fig. 3). All patients were given a 1-week course of antiedure (● metics and proton pump inhibitors to take as outpatients and were placed on a post-procedural translational diet consisting of 2 weeks of liquid protein shakes and 2 weeks of pureed diet before they transitioned to a regular diet. The post-procedural diet was designed to provide 70 g of protein and 1000 – 1200 calories per day. In addition, subjects were encouraged to drink 56 ounces of non-caloric fluids per day.
Sharaiha Reem Z et al. Endoscopic sleeve gastroplasty … Endoscopy 2015; 47: 164–166
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Fig. 1 The Overstich device attached to the endoscope with the helix that is used to ensure fullthickness suturing.
Innovations and brief communications
1
3
6
0 0
–5
–5
–10
–10
Weight loss, kg
0
–15 –20 –25 –30 –35
1
3
6
–15 –20 –25 –30 –35
Month
Fig. 4 Percentage of excess weight lost 1 month, 3 months, and 6 months after endoscopic sleeve gastroplasty (ESG).
Results !
Ten patients underwent ESG (70 % women; mean age 43.7; mean BMI 45.2 kg/m2, range 37.39 – 68.02 kg/m2). Their mean excess weight was 70.9 kg (range 43.2 – 158.2 kg). A median of eight running sutures, each with four to eight tissue stitches, was used per procedure. The mean length of the stomach decreased from 36.6 cm to 26.1 cm (P = 0.002). The median procedure time was 157 minutes (range 118 – 360 minutes). All subjects were tolerating a post-procedural oral diet by 24 hours. An UGIS in all patients demonstrated luminal narrowing. The mean length of hospital stay was 1.3 days (range 0 – 2 days). No major intraoperative adverse events occurred. Mild adverse events included abdominal pain and nausea in eight patients and chest pain in two patients. The mean percentage of excess weight lost after 1 month, 3 months, and 6 months was 18 %, 26 %, and 30 %, respectively " Fig. 4), with mean weight loss of 11.5 kg, 19.4 kg, and 33.0 kg, (● " Fig. 5). At the end of follow-up period, reductions respectively (● were observed in mean weight (from 134.2 ± 47.2 kg to 120.1 ± 38.2 kg; P = 0.002), mean BMI (from 45.2 ± 8.9 kg/m2 to 39.7 ± 7.1 kg/m2; P = 0.0004), and mean waist circumference (from 141.5 cm to 119.8 cm; P = 0.003).
Discussion !
Given the growing obesity epidemic and the rising cost of healthcare in the United States, the need for less invasive and cost-effective bariatric therapies is becoming an apparent necessity. Transoral suturing a branch of natural orifice transluminal endoscopic surgery (NOTES) allows for an incisionless procedure with a theoretical lower risk of adverse events, lower cost, and quicker recovery times compared with surgery. Previously published case series reporting on transoral suturing have demonstrated weight loss efficacy with no serious adverse events. Fogel et al. [9] demonstrated an excess weight loss at 12 months of 58.1 %, with overall 97 % of patients attaining a 30 % or greater excess weight loss after 12 months follow-up. The TRIM trial, reported by Brethaurer et al. [10], used the RESTORe suturing system in 18 patients with a preoperative BMI of 30 – 45 kg/m2 to perform anterior to posterior gastric plications using an interrupted suturing pattern. After 12 months of follow-up (n = 14), decreases were observed in the patient’s mean weight (−11.0 ± 10.0 kg; P = 0.0006), mean BMI (−4.0 ± 3.5 kg/m2;
Month
Fig. 5 Mean weight loss 1 month, 3 months, and 6 months after endoscopic sleeve gastroplasty (ESG).
P = 0.0006), and mean waist circumference (−12.6 ± 9.5 cm; P = 0.0004). Overall, 50 % of patients achieved at least 30 % excess weight loss after 12 months of follow-up. In our study, we performed ESG on 10 patients using a full-thickness endoscopic suturing system. There was a statistically significant loss of weight, and reduction in BMI and waist circumference among the patients at the end of the follow-up period. There were no serious adverse events in the study patients. While this experience relates to a small number of patients followed up over a short period, the results are encouraging. Given the growing obesity epidemic and the rising cost of healthcare in the United States, there is increased demand for less invasive and less expensive bariatric therapies. ESG with full-thickness suturing is a cost-effective, nonsurgical therapy with promising results. Investigations are underway to examine the long-term safety and efficacy data of the technique. Competing interests: None
References 1 Verdam FJ, Schouten R, Greve JW et al. An update on less invasive and endoscopic techniques mimicking the effect of bariatric surgery. J Obes 2012; 2012: 597871 2 Kumar N, Thompson CC. Endoscopic solutions for weight loss. Curr Opin Gastroenterol 2011; 27: 407 – 411 3 Jirapinyo P, Slattery J, Ryan MB et al. Evaluation of an endoscopic suturing device for transoral outlet reduction in patients with weight regain following Roux-en-Y gastric bypass. Endoscopy 2013; 45: 532 – 536 4 Espinet-Coll E, Nebreda-Duran J, Gomez-Valero JA et al. Current endoscopic techniques in the treatment of obesity. Rev Esp Enferm Dig 2012; 104: 72 – 87 5 Tsesmeli N, Coumaros D. The future of bariatrics: endoscopy, endoluminal surgery, and natural orifice transluminal endoscopic surgery. Endoscopy 2010; 42: 155 – 162 6 Familiari P, Costamagna G, Blero D et al. Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome. Gastrointest Endosc 2011; 74: 1248 – 1258 7 Majumder S, Birk J. A review of the current status of endoluminal therapy as a primary approach to obesity management. Surg Endosc 2013; 27: 2305 – 2311 8 Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc 2013; 78: 530 – 535 9 Fogel R, De Fogel J, Bonilla Y et al. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc 2008; 68: 51 – 58 10 Brethauer SA, Chand B, Schauer PR et al. Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial. Surg Obes Rel Dis 2012; 8: 296 – 303
Sharaiha Reem Z et al. Endoscopic sleeve gastroplasty … Endoscopy 2015; 47: 164–166
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
0
Excess weight loss, %
166
Copyright of Endoscopy is the property of Georg Thieme Verlag Stuttgart and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population
Authors
Reem Z. Sharaiha, Prashant Kedia, Nikhil Kumta, Ersilia M. DeFilippis1, Monica Gaidhane, Alpana Shukla, Louis J. Aronne, Michel Kahaleh
Institution
Division of Gastroenterology & Hepatology, Department of Medicine, Weill Cornell Medical College, New York, USA
submitted 13. July 2014 accepted after revision 2. September 2014
Background and aims: Novel endoscopic techniques have been developed as effective treatments for obesity. Recently, reduction of gastric volume via endoscopic placement of full-thickness sutures, termed endoscopic sleeve gastroplasty (ESG), has been described. Our aim was to evaluate the safety, technical feasibility, and clinical outcomes for ESG. Patient and methods: Between August 2013 and May 2014, ESG was performed on 10 patients using an endoscopic suturing device. Their weight loss, waist circumference, and clinical outcomes were assessed. Results: Mean patient age was 43.7 years and mean body mass index (BMI) was 45.2 kg/m2.
There were no significant adverse events noted. After 1 month, 3 months, and 6 months, excess weight loss of 18 %, 26 %, and 30 %, and mean weight loss of 11.5 kg, 19.4 kg, and 33.0 kg, respectively, were observed. The differences observed in mean BMI and waist circumference were 4.9 kg/m2 (P = 0.0004) and 21.7 cm (P = 0.003), respectively. Conclusions: ESG is effective in achieving weight loss with minimal adverse events. This approach may provide a cost-effective outpatient procedure to add to the steadily growing armamentarium available for treatment of this significant epidemic.
Introduction
Methods
!
!
New endoscopic bariatric techniques have been developed as standalone procedures or as adjuncts to surgery. Endoscopic procedures have the advantage of being reversible, with lower adverse events, and greater feasibility in poor surgical candidates [1 – 5]. Transoral gastroplasty (TOGA) utilizes two staple devices to create a restrictive gastric pouch or sleeve along the lesser curvature, but is limited by frequent staple-line dehiscence [5 – 7]. Other similar techniques include transoral gastric volume reduction (TGVR) with endoluminal suturing systems, such as the EndoCinch (C. R. Bard Inc., Murray Hill, New Jersey, USA) and RESTORe (Bard/Davol, Warwick, Rhode Island, USA) [2, 3, 8 – 10]. Recently, full-thickness endoscopic suturing has been shown to create a more durable sleeve with transmural tissue apposition [8]. In this case series, we describe our experience in 10 patients who underwent TGVR using the Overstitch endoscopic suturing device (Apollo Endosurgery, Austin, Texas, USA).
The Endoscopic Suturing for Gastrointestinal Tract Disorders database is a prospective multicenter registry established at Weill Cornell Medical College (IRB approval 04/26/2013). The registry’s objective is to assess the long-term efficacy, safety, and clinical outcomes of the endoscopic placement of sutures. The data is recorded and stored in a secure electronic data-capturing system (RedCap).
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1390773 Published online: 7.11.2014 Endoscopy 2015; 47: 164–166 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Michel Kahaleh, MD Division of Gastroenterology & Hepatology Department of Medicine Weill Cornell Medical College 1305 York Avenue, 4th Floor New York, NY 10021 USA Fax: +1-646-962-0110 [email protected]
Sharaiha Reem Z et al. Endoscopic sleeve gastroplasty … Endoscopy 2015; 47: 164–166
Description of technique The Overstitch endoscopic suturing device was used to perform endoscopic sleeve gastroplasty (ESG). A standard upper gastrointestinal endoscope (GIF-H180; Olympus) was used to measure the distance from the incisors of the gastroesophageal junction and the pylorus. After an esophageal overtube (Guardus; US Endoscopy, Mentor, Ohio, USA) had been inserted, two parallel anterior and posterior suture placement sites were mapped using argon plasma coagulation starting from the incisura and extending proximally to the gastroesophageal junction.
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
164
Innovations and brief communications
165
Fig. 2 Schematic illustration of the sutures placed in the endoscopic sleeve gastroplasty (ESG) procedure.
The helix device was used to ensure sequential full-thickness bites were taken. A running stitch approximated the anterior and posterior placement sites and was tightened to create a fullthickness volume-reduction plication. The suture was cut using a " Fig. 1). The suture line was created from anterior to midcinch (● line to the posterior site in an M-shaped pattern to ensure adequate plication of the folds and prevent the creation of a second " Fig. 2). A second layer of sutures was placed internal lumen (● over the length of the central sleeve in an interrupted pattern to further reduce the gastric volume and reinforce the sleeve. Repeat measurements of the distances to the gastroesophageal junction and pylorus were recorded. Ten subjects with a mean body mass index (BMI) of 45.2 ± 8.8 kg/m2 and stable weight for 3 months prior to the procedure were recruited. They underwent pre-bariatric procedure testing with psychiatric and nutritional evaluation. The procedure was performed in the endoscopy suite for nine patients. One patient’s procedure was performed in the operating room because of the need for a bariatric bed. All the procedures were performed while
Fig. 3 Image taken from an upper gastrointestinal series after endoscopic sleeve gastroplasty (ESG) showing a reduced stomach volume.
the patient’s were under general anesthesia and with the use of carbon dioxide (CO2) insufflation. As per protocol, all patients were hospitalized after the procedure for observation, management of symptoms, and to obtain an upper gastrointestinal series (UGIS) 24 hours after the proce" Fig. 3). All patients were given a 1-week course of antiedure (● metics and proton pump inhibitors to take as outpatients and were placed on a post-procedural translational diet consisting of 2 weeks of liquid protein shakes and 2 weeks of pureed diet before they transitioned to a regular diet. The post-procedural diet was designed to provide 70 g of protein and 1000 – 1200 calories per day. In addition, subjects were encouraged to drink 56 ounces of non-caloric fluids per day.
Sharaiha Reem Z et al. Endoscopic sleeve gastroplasty … Endoscopy 2015; 47: 164–166
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Fig. 1 The Overstich device attached to the endoscope with the helix that is used to ensure fullthickness suturing.
Innovations and brief communications
1
3
6
0 0
–5
–5
–10
–10
Weight loss, kg
0
–15 –20 –25 –30 –35
1
3
6
–15 –20 –25 –30 –35
Month
Fig. 4 Percentage of excess weight lost 1 month, 3 months, and 6 months after endoscopic sleeve gastroplasty (ESG).
Results !
Ten patients underwent ESG (70 % women; mean age 43.7; mean BMI 45.2 kg/m2, range 37.39 – 68.02 kg/m2). Their mean excess weight was 70.9 kg (range 43.2 – 158.2 kg). A median of eight running sutures, each with four to eight tissue stitches, was used per procedure. The mean length of the stomach decreased from 36.6 cm to 26.1 cm (P = 0.002). The median procedure time was 157 minutes (range 118 – 360 minutes). All subjects were tolerating a post-procedural oral diet by 24 hours. An UGIS in all patients demonstrated luminal narrowing. The mean length of hospital stay was 1.3 days (range 0 – 2 days). No major intraoperative adverse events occurred. Mild adverse events included abdominal pain and nausea in eight patients and chest pain in two patients. The mean percentage of excess weight lost after 1 month, 3 months, and 6 months was 18 %, 26 %, and 30 %, respectively " Fig. 4), with mean weight loss of 11.5 kg, 19.4 kg, and 33.0 kg, (● " Fig. 5). At the end of follow-up period, reductions respectively (● were observed in mean weight (from 134.2 ± 47.2 kg to 120.1 ± 38.2 kg; P = 0.002), mean BMI (from 45.2 ± 8.9 kg/m2 to 39.7 ± 7.1 kg/m2; P = 0.0004), and mean waist circumference (from 141.5 cm to 119.8 cm; P = 0.003).
Discussion !
Given the growing obesity epidemic and the rising cost of healthcare in the United States, the need for less invasive and cost-effective bariatric therapies is becoming an apparent necessity. Transoral suturing a branch of natural orifice transluminal endoscopic surgery (NOTES) allows for an incisionless procedure with a theoretical lower risk of adverse events, lower cost, and quicker recovery times compared with surgery. Previously published case series reporting on transoral suturing have demonstrated weight loss efficacy with no serious adverse events. Fogel et al. [9] demonstrated an excess weight loss at 12 months of 58.1 %, with overall 97 % of patients attaining a 30 % or greater excess weight loss after 12 months follow-up. The TRIM trial, reported by Brethaurer et al. [10], used the RESTORe suturing system in 18 patients with a preoperative BMI of 30 – 45 kg/m2 to perform anterior to posterior gastric plications using an interrupted suturing pattern. After 12 months of follow-up (n = 14), decreases were observed in the patient’s mean weight (−11.0 ± 10.0 kg; P = 0.0006), mean BMI (−4.0 ± 3.5 kg/m2;
Month
Fig. 5 Mean weight loss 1 month, 3 months, and 6 months after endoscopic sleeve gastroplasty (ESG).
P = 0.0006), and mean waist circumference (−12.6 ± 9.5 cm; P = 0.0004). Overall, 50 % of patients achieved at least 30 % excess weight loss after 12 months of follow-up. In our study, we performed ESG on 10 patients using a full-thickness endoscopic suturing system. There was a statistically significant loss of weight, and reduction in BMI and waist circumference among the patients at the end of the follow-up period. There were no serious adverse events in the study patients. While this experience relates to a small number of patients followed up over a short period, the results are encouraging. Given the growing obesity epidemic and the rising cost of healthcare in the United States, there is increased demand for less invasive and less expensive bariatric therapies. ESG with full-thickness suturing is a cost-effective, nonsurgical therapy with promising results. Investigations are underway to examine the long-term safety and efficacy data of the technique. Competing interests: None
References 1 Verdam FJ, Schouten R, Greve JW et al. An update on less invasive and endoscopic techniques mimicking the effect of bariatric surgery. J Obes 2012; 2012: 597871 2 Kumar N, Thompson CC. Endoscopic solutions for weight loss. Curr Opin Gastroenterol 2011; 27: 407 – 411 3 Jirapinyo P, Slattery J, Ryan MB et al. Evaluation of an endoscopic suturing device for transoral outlet reduction in patients with weight regain following Roux-en-Y gastric bypass. Endoscopy 2013; 45: 532 – 536 4 Espinet-Coll E, Nebreda-Duran J, Gomez-Valero JA et al. Current endoscopic techniques in the treatment of obesity. Rev Esp Enferm Dig 2012; 104: 72 – 87 5 Tsesmeli N, Coumaros D. The future of bariatrics: endoscopy, endoluminal surgery, and natural orifice transluminal endoscopic surgery. Endoscopy 2010; 42: 155 – 162 6 Familiari P, Costamagna G, Blero D et al. Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome. Gastrointest Endosc 2011; 74: 1248 – 1258 7 Majumder S, Birk J. A review of the current status of endoluminal therapy as a primary approach to obesity management. Surg Endosc 2013; 27: 2305 – 2311 8 Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc 2013; 78: 530 – 535 9 Fogel R, De Fogel J, Bonilla Y et al. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc 2008; 68: 51 – 58 10 Brethauer SA, Chand B, Schauer PR et al. Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial. Surg Obes Rel Dis 2012; 8: 296 – 303
Sharaiha Reem Z et al. Endoscopic sleeve gastroplasty … Endoscopy 2015; 47: 164–166
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
0
Excess weight loss, %
166
Copyright of Endoscopy is the property of Georg Thieme Verlag Stuttgart and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
