Weight Regain After Bariatric Surgery & Future Therapies Matthew Kroh, MD Assistant Professor of Surgery Cleveland Clinic Center for Surgical Innovation, Technology, and Education Digestive Disease Institute Bariatric and Metabolic Institute Disclosures Research support from and/or consultant: Covidien Ethicon Bard Gore Intuitive Objectives Examine common causes of weight regain after bariatric surgery Review current interventions for treatment Discuss innovative new approaches and future directions
Introduction Increasing numbers Number of failures & revisions increasing Initial weight Weight regain # Weight Loss Operations/Year 120000 100000 80000 60000 40000 20000 0 1992 1994 1996 1998 2000 2002 2004 Year US Bariatric Surgery 1993-2004 Introduction Weight regain after Roux en-y gastric bypass in 10-15% Inter-disciplinary evaluation including diet and exercise Causes: Behavioral Psychology Nutrutionist Anatomic Surgical Revision Revisional bariatric surgery More technically challenging Higher complication rates Often open procedures Increased laparoscopic experience increasing successful outcomes
Indications Definitions of failure Weight regain Regain medical comorbdities Failure to ameliorate co-morbidities Mechanical failure Operation Device Options for Failures Revisional procedures focus on: Stoma size Pouch size Limb lengths Variables that can be surgically altered VBG Failures Only 26% to 40% of patients maintain acceptable weight loss (>50% EWL) ten years after VBG. (Ramsey-Stewart, Aust NZ J Surg 1995; Balsiger BM, J Gastrointest Surg 2000). After VBG, staple line failure occurs in up to 48% of patients (MacLean LD, Surgery 1990) Severe GERD occurs in 30-50% of patients ( Kim CH, Mayo Clin Proc 1992; Nightengale ML, Mayo Clin Proc 1991)
Enlarged stoma Indications for Revision Indications for Revision Gastro-gastric fistula Enlarged pouch Endoscopy and Radiology Large Gastrogastric fistula Pouch Fistula Stenotic Gastrojejunostomy
What can be done surgically for patients with intact bariatric surgical procedures? Combination Surgical Therapy: Banding the Bypass Bypassing the Band Bypassing the Band
Reasons for Conversion Proportion of patients previously implanted requiring re-operation varies widely (5-58%) Usually secondary to slippage or dilation Revisions include replacement or repositioning of band May convert to another procedure Most commonly sleeve gastrectomy or RYGB Background Failure rates after banding are widely variable depending on criteria Different than RYGB Include: Poor initial EWL Long term weight regain Slippage Intolerance Esophageal dilation Infection Gastric ischemia 70 patients for failure Inadequate weight loss Reinhold criteria (<25%) Slippage Erosion Performed average 42 months after primary procedure Complication rate 14%, no mortality
Banding the Bypass Banding the Bypass- Simultaneous Procedures Usually in higher risk patients for failure High BMI (Super-obese), Men Weight regain at 3-5 years Greater experience with fixed rings Silastic, polypropylene Concern for stenosis, erosion, infection Fobi, Capela and Capela Large series of banded bypass pts, excellent results
Prospective study 90 pts, BMI >50 Randomized intra-op to banded versus non-banded RYGB 1.5 x 7cm Marlex band, sutured around proximal pouch, 5.5 cm diameter 2 cm above G-J 36 month f/u For Failure of Primary Operation Additional operation after RYGB Major complications for revision RYGB Up to 50% Requires work-up Anatomic Pouch dilation Stoma dilation Gatrogastric-fistula Exercise Diet
Surgical Options Limb-lengthening procedures Long-limb gastric bypass BPD with or without DS Revision of stoma Surgical or endoscopic Revision of pouch Surgical or endoscopic Options Limb lengthening Potentially severe metabolic problems BPD +/- DS technically difficult Excellent EWL, but malabsorption significant Endoscopic approaches Promising Durability, long term results Surgical Options Banding the bypass Fixed versus adjustable bands Interrupting propulsive wave with reduced compliance versus outlet restriction Mainly silastic or polypropylene
Pre-operative Evaluation Operative notes UGI Endoscopy Hiatal hernia, G-G fistula, ulcer E-G junction Length of pouch Width of pouch Size and characteristics of G-J Identification of and mobilization of Angle of His Left pillar visualization Often requires dissection between remnant and pouch Technique Bessler et al, SOARD, (15) 1443-48. Pars flaccida approach Small retro-gastric tunnel Gastro-gastric plication Remnant stomach Large pouch? No plication Technique
Limited data Medical therapy still limited Short and medium term outcomes Outcomes 6 pts s/p RYGB Hyperphagia and weight regain BMI at reoperation 38, initial BMI 36 Time interval 26 months from 1 st operation Placement nonadjustable silastic band (6.5-7cm) Results No complications F/U 14 months Final BMI 26 EWL 70% EWL before and after revision statistically significant
Advantages of AGB to RYGB Technically simpler Especially after lap RYGB No anastomosis Unlikely additional metabolic sequelae The Future: New Procedures and Endoluminal Therapy Laparoscopic Gastric Plication
Concept of Gastric Plication Achieve gastric restriction No Staple Line Cost Safety No Prosthesis Serosa-to-serosa apposition Reversible? Endoluminal application? Anterior Plication Greater Curvature Plication
Initial Suture Row Final Plication
Laparoscopic Gastric Plication for the Treatment of Severe Obesity IRB approval obtained for this investigational procedure 15 patients (three male) Mean preop BMI 43.5 (36.9 49.0) 9 patients underwent anterior surface plication 6 patients underwent greater curvature plication Laparoscopic Gastric Plication for the Treatment of Severe Obesity Progression of diet from liquid to solid over 4 week period postoperatively Endoscopy at 6 and 12 months postop Weight loss Adverse events Results Volume reduction achieved in all patients based on endoscopic assessment in OR Mean LOS 37 hours First 2 Greater Curvature patients with severe nausea with LOS 77 hours
Results Endoscopy 6 months Anterior Plications (n=6): One disrupted fold Greater Curve Plications (n=6): All folds intact Endoscopy 12 months Anterior Plications (n=5): Same as 6 mos Greater Curve Plications (n=6) All folds intact Anterior Plication 6 months 12 months Greater Curvature Plication 6 months 12 months
Complications No bleeding or infectious complications First GCP patient required re-operation and plication reduction on POD#2 due to gastric obstruction Mild to moderate nausea in all patients. Resolved within two weeks. 60 50 Weight Loss % EWL 40 30 20 GCP AP 10 0 0 1 3 6 12 Months Procedure Three Months Twelve Months N Δ BMI %EWL N Δ BMI %EWL Anterior 9-4.8 +/- 1.4 23.0 +/- 6.4 7* - 4.3 +/- 4.5 19.8 +/- 19.3 ** Greater Curvature 6-7.8 +/- 1.5 38.9 +/- 8.2 6-10.9 +/- 5.5 53.9 +/- 22.3 * 2 patients lost to follow-up ** Data from 2 patients collected after scheduled 12 month visit Muti-Center Trial 4 centers 45 patients 3 year follow-up All sutured Greater Curve Plication Standardized technique Enrollment nearly complete
Laparoscopic Gastric Plication Summary Anterior Plication very safe, but not effective Greater Curve Plication Technically feasible, reproducible Good short-term weight loss Low major complication rate Long-term safety and weight loss data needed Potential for shorter OR time with stapled plication Remains investigational Combination Therapy: Bandication? (D Cottam) Endoluminal Approaches for Revisional and Primary Bariatric Surgery
New Technology Platforms Instrumentation Suturing Devices Closure Devices New Technology Many obstacles to overcome before these procedures are ready for widespread use Safety Efficacy Durability Training Reimbursement Expectations should be discussed early in the development of this field
Flexible instruments Triangulation Robotics
Endoscopic Suturing Endoscopic Therapy Experimental Procedures Gastric Suturing/Partioning Similar to restrictive concept Devices and technique yet to be perfected Durability of plication is unknown Endoscopic Therapy Experimental Procedures Common features Utilize conscious or deep sedation Procedure time should be short Devices must be safe, easy to use and have reproducible outcomes Plication must have durability
Endoscopic Suturing and Partioning Devices Olympus (Eagle Claw) Endocinch (Bard Interventional Products) Spiderman (Ethicon) ESD (Wilson Cook Industries) Plicator (NDO Surgical) Syntheon (ARD) Endoscopic Devices Olympus Eagle Claw Curved needle allows larger purchase of tissue Limitations include bulky device, imprecise placement,? transmural placement Endoscopic Devices BARD Endocinch -FDA approved for GERD -Ease of use -Reproducible -?Durable Aspirate tissue just below Z- line Cinching/deployment device advanced Needle with pre loaded suture advanced Final appearance of plication in cardia
TRIM Trial Endoscopic Therapy Experimental Procedures Endoscopic Therapy Experimental Procedures Endoluminal Restriction/Conduit/Absor ption Platform that divides and limits food intake Conduit that bypasses the duodenum and decreases absorption Possible hormonal change
USGI (ROSE procedure) Platform for endoscope with multiple other channels Full thickness plication Used for Pouch and stoma reduction Endogastric Solutions (Stomaphyx) Uses endoscope and overtube Suction draws the tissue in a chamber H Fastners pleat the tissue Used for pouch and stoma reduction Limited by pouch anatomy GI Dynamics (Endobarrier) Potential Benefits May mimic the metabolic effects of Roux-en-Y gastric bypass Performed as a day procedure Delivered and removed endoscopically Is a reversible procedure
Conclusions Designed to duplicate surgical procedures Suturing devices are available and have promise Partitioning devices may have better durability Combination laparoscopic and endoscopic approaches may offer best solution Must define acceptable weight loss and durability outcomes Need prospective trials with 1-3 year f/u to start drawing these conclusions Future Directions Reinventing the wheel?