Safety and efficacy of outpatient sleeve gastrectomy: 2534 cases performed in a single free-standing ambulatory surgical center

Surgery for Obesity and Related Diseases 15 (2019) 832–836

Original article

Safety and efficacy of outpatient sleeve gastrectomy: 2534 cases performed in a single free-standing ambulatory surgical center Peter Billing, M.D., F.A.C.S.*, Josiah Billing, B.S., Eric Harris, M.D., F.A.C.S., Jedediah Kaufman, M.D., F.A.C.S., Robert Landerholm, M.D., F.A.C.S., Kurt Stewart, M.D. Eviva Bariatrics, Shoreline, Washington Received 16 November 2018; accepted 1 March 2019

Abstract

Background: Sleeve gastrectomy (SG) is currently the most widely performed operation for treatment of morbid obesity. SG leads to significant weight loss and reduction in weight related comorbidities. Procedures performed in ambulatory surgical centers (ASC) can provide several advantages over hospital-based surgery. We present results of 2,534 consecutive patients who underwent SG in an ASC. Objective: Assess the safety and efficacy of outpatient SG in a freestanding ASC. Setting: Free-standing ASC, Eviva Bariatrics, Seattle WA. Methods: Data was collected retrospectively for all patients undergoing SG from January 2008 – January 2018, n 5 2,534. Revisional procedures were not excluded from this study. Patients were excluded from the ASC if they weighed .450 pounds, if anticipated surgery time was . 2 hours, if the patient had impaired mobility limiting early ambulation, or if there were medical problems requiring postoperative monitoring beyond 23 hours. Results: Mean age was 45.9 years. Mean preoperative body mass index (BMI) was 41.9. Mean operative time was 70 minutes. 30-day complications included 3 mortalities (0.12%), 60 (2.53%) readmissions, 35 (1.42%), re-operations, and 31 (1.22%) direct transfers from the ASC to a nearby hospital. There were 25 staple line leaks (0.99%). There were no open conversions. At 6 months average excess body weight loss (EWL) was 56.3% and total weight loss (TWL) was 20.9% (n 5 1,758/2,303). At 1 year, EWL was 70.1% and TWL was 26.4% (n 5 1,199/2,125). Conclusion: With experienced surgeons, appropriate protocols, and a consistent operative team, SG can be performed safely in a free-standing ASC. (Surg Obes Relat Dis 2019;15:832– 836.) Ó 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Current published data support gastric banding procedures in free-standing ambulatory surgical centers (ASCs), but minimal data have been published regarding gastric stapling procedures in ASCs [1,2]. In 2008, we performed the first series of outpatient laparoscopic sleeve gastrecomy (SG) performed in a free-standing ASC which was published in

* Correspondence: Peter Billing, M.D., F.A.C.S., Eviva Bariatrics, 19930 Ballinger Way NE, Shoreline, Washington 98155. E-mail address: [email protected] (P. Billing).

2014 [3]. To date, we have completed over 2500 outpatient or 23-hour SGs in our free-standing ASC. Although our center is unique in that we performed the first outpatient SG case worldwide in 2008, other centers are instituting similar programs because of the lower costs, improved access to care, dedicated teams, and improved outcomes [4–8]. SG has rapidly gained interest, bridging the safety and efficacy gap in bariatric surgery between laparoscopic adjustable gastric banding (LAGB) and laparoscopic Roux-en-Y gastric bypass (RYGB). SG was originally the gastric component of the duodenal switch, employed as the first

https://doi.org/10.1016/j.soard.2019.03.003 1550-7289/Ó 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Peter Billing et al. / Surgery for Obesity and Related Diseases 15 (2019) 832–836

step in staged operations for super-obese and high-risk patients. The number of LAGB procedures has greatly diminished, and SG as a stand-alone procedure is now the most commonly performed metabolic/bariatric operation in the United States [9]. The mechanism of action of SG likely involves reduced gastric capacity, changes in enteric hormones, and changes in gastric emptying. Evidence has shown fewer complications and increased safety of the SG compared with LAGB and RYGB. With efficacy comparable to RYGB with regard to weight loss and resolution of comorbidities, SG has shorter operative time, shorter length of stay, faster recovery, lower costs, and fewer long-term complications than RYGB (e.g., internal hernia, marginal ulcer, bowel obstruction, malnutrition) or LAGB (e.g., gastric herniation or ”slip,” erosion, esophageal dilation, port leak or flip, food intolerance) [10–13]. The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program defines national accreditation standards for bariatric procedures. Recently ASCs have been under scrutiny; new standards were put in place restricting the types of procedures allowed to be performed in the outpatient setting [14]. The risk versus benefit of outpatient bariatric surgery is a topic of debate among surgeons. Many believe SG should be performed only in a fully equipped hospital. We present our experience performing outpatient SG at a single free-standing ASC. Methods Institutional review board approval was obtained to perform a retrospective analysis of patient data. We reviewed all SG procedures completed at our center from January2008 to January 2018 (n 5 2534). Revisions such as LAGB to SG and revisions to prior SG (re-sleeves) were included in this series (n 5 195; 7.7%). All cases were done in a single freestanding ASC with 23-hour stay capability. To reduce nausea, patients were given hyoscine transdermal patch the night before the procedure and aprepitant 40 mg orally within 3 hours of the procedure. Intraoperatively, patients were given 10 mg of dexamethasone and minimal use of narcotics (.5 mg or less of hydromorphone). Operative times were kept to about an hour. Five surgeons performed the SGs using a similar technique. An assistant surgeon was present for each procedure. Using a 38-French bougie, the gastric resection started approximately 2 to 6 cm from the pylorus. Concomitant hiatal hernia repairs were performed when these hernias were present. Intraoperative leak testing was not routinely performed. Oversewing the proximal 3 cm of the staple line was performed at the surgeon’s discretion. Staple line reinforcement was not used. Fibrin glue was used at the surgeon’s discretion. Patients were scheduled preoperatively for overnight (23-hr) stays if they had sleep apnea (54.5% of patients) or if they were a revisional case (7.7% of patients).

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Overnight stays in the ASC did not exceed 24 hours and met Centers for Medicare & Medicaid Services guidelines for outpatient surgery centers. Patients with obstructive sleep apnea, undergoing revisional surgery, or failing to meet ASC discharge criteria were kept overnight. All patients were given 4 to 5 L of intravenous fluids to help prevent dehydration the first week. If patients were discharged the same day, they were given 2 to3 L of fluid; these patients were routinely scheduled in the clinic (which is a separate entity) the following morning for an assessment and to receive the rest of the intravenous fluids to total 4 to 5 L. This protocol was designed to replicate the inpatient practice of seeing patients the following morning and providing overnight hydration. Patients undergoing band-to-sleeve conversion were operated on in 2 stages, with initial band removal a minimum of 4 weeks before the SG. Gastric fundoplication and removal of scar capsule anteriorly and laterally were routinely performed. Patients with a Nissen fundoplication had the fundoplication taken down before SG was performed. Attention was given to Enhanced Recovery After Bariatric Surgery criteria, and protocol-based medical and nursing care were used [15]. As such, patients were provided with preoperative counseling, early postoperative mobilization, regular antiemetics, early postoperative feeding, and avoidance of long-acting opiate analgesia. Upon discharge, patients were given narcotics, proton pump inhibitors, and occasionally ondansetron and diazepam. All patients were preoperatively educated in detail with regard to their disease process, their options, their expected surgical course, and the need for close follow-up to ensure the best outcome from their surgery. Preoperative education included discussion of risks and benefits of surgery, advantages and disadvantages of each procedure type, required lifestyle changes, and the fact that surgery is a tool to aid patients in their weight loss. Preoperative screening by a registered dietician and a mental health therapist was required. Patients were enrolled in a mandatory comprehensive aftercare program including regular follow-up with surgeons, bariatricians, dieticians, mental health therapists, and exercise physiologists over a 2-year period. Inclusion criteria (Table 1) for the ASC cases were age 18 years, weight ,450 pounds, expected operative time ,2 hours (based on patient’s surgical history, body mass index (BMI) .60 kg/m2, or need for large hiatal hernia repair), ambulatory status, low cardiac risk, sleep apnea clearance with or without continuous positive airway pressure, no nicotine use for 8 weeks preoperatively, no ongoing medical monitoring needs beyond 23 hours, nutritional and psychological clearance before surgery, and a designated support person to monitor the patient for at least the first 48 hours postoperatively. If a patient had a BMI .50, a chart review was performed by the anesthesiologist to determine appropriateness for conducting the surgery at the ASC. If BMI was .55, an in-person interview with the

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Table 1 Inclusion criteria for patients undergoing outpatient sleeve gastrectomy in a free-standing ambulatory surgical center Inclusion criteria 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.

Age 18 yr Weight ,450 pounds Expected operative time ,2 hr Patient must be ambulatory Deemed low cardiac risk by cardiologist if abnormal electrocardiogram or history of cardiac surgery Sleep apnea clearance for patients with a STOP-BANG score of 3 No nicotine use for 8 wk before surgery BMI .50; chart review by anesthesiologist is required BMI .55; in-person interview with anesthesiologist to assess the patient’s airway is required Designated support person to monitor the patient for at least the first 48 hr postsurgery No patients with a history of splenectomy No transplant patients No patients requiring dialysis treatment No patients with a pacemaker in place No patients requiring specialized equipment during surgery or recovery

STOP-BANG 5 Snoring, Tiredness, Observed Apnea, High Blood Pressure, BMI, Age, Neck Circumference, and Male Gender questionnaire; BMI 5 body mass index.

anesthesiologist was required to assess the patient’s eligibility for outpatient surgery. If a patient did not meet any of the inclusion criteria, he or she was excluded and the case was performed at a nearby hospital. However, the primary reason for surgeries being performed in a hospital was insurance requirements and not medical necessity. Results Mean age was 45.9 (18–74) years. Mean preoperative BMI was 41.9 (26.2–70.4). Mean operative time was 70 minutes (26–182). Demographic characteristics are listed in Table 2. At 6, 12, and 24 months after surgery, percent excess weight loss was 56.3%, 70.0%, and 69.2%, respectively, and percent total weight loss was 20.9%, 26.4%, and 26.9%, respectively. Percent follow-up was 69.1%, 47.3%, and 22.1% at 6, 12, and 24 months, respectively. Table 2 Demographic characteristics of patients (N 5 2534) who underwent sleeve gastrectomy in a free-standing ambulatory surgical center Demographic characteristics Age, yr BMI GERD Diabetes Hypertension Sleep apnea Hyperlipidemia Mean operative time, min

45.9 (18–74) 41.9 (28.2–70.4) 34.40% 19.60% 39.90% 54.50% 24.90% 70 (26–182)

BMI 5 body mass index; GERD 5 gastroesophageal reflux disease.

Rates of readmission were 2.53%, reoperations within 30 days were 1.38%, and transfer from the ASC to a nearby hospital were 1.22%. Three mortalities occurred within 30 days of the SG (0.12%). The mortalities that occurred within 30 days occurred on average on postoperative day (POD) 8.7 (2–21). The first occurred on POD 2 and was related to aspiration and inadequately treated sleep apnea. The second patient had a myocardial infarction 3 days after surgery. That patient’s preoperative workup included an assessment by a cardiologist, and the patient was deemed “low risk.” The third 30day mortality, occurring on POD 21, was due to sepsis and a contained leak. This patient was seen 1 week after surgery and was without pain, fever, or other symptoms. Examination results were normal. No mortalities occurred at the ASC or within 24 hours of discharge (Figure 1). There were 64 readmissions within 30 days of surgery (2.53%). The most common reasons were staple line leak (21/64; 32.8%), deep vein thrombosis (16/64; 25.0%), and surgical site infections (7/64; 10.9%). Reoperations were required in 35 patients (1.38%). The most common reasons for reoperations were postoperative bleeding (15/35; 42.9%) and staple line leaks (9/35; 25.7%). Reasons for readmissions and reoperations are listed in Table 3. Thirty-one patients (1.22%) were transferred from the ASC to a nearby hospital. The most common reason for transfer was postoperative bleeding. Complications are listed in Table 4. Discussion As we have gained experience performing outpatient SG, our protocols and procedures have gradually been refined. We aggressively screen for and treat sleep apnea. Patients with abnormal electrocardiograms or prior cardiac procedures must obtain cardiac clearance and be deemed low risk. This screening has led to improvement in complication rates and safety, with no 30-day mortalities occurring in the past 1958 cases performed including revisional and “high acuity” cases. Historically, nausea after SG is the most commonly reported reason for readmission [16]. However, early in our experience, we instituted protocols for nausea and hydration, which facilitated same-day discharge and a low readmission rate of .04% [3,14] for nausea. Logically, major complications that require a fully equipped hospital after outpatient SG are a concern. However, most major complications occur after 23 hours [14]. Postsurgical bleeding remains a legitimate concern for outpatient SG and is the main reason for transfer at our center. Resources in the ASC to assess for early bleeding include placement of intra-abdominal drains (which we did not routinely use), use of an i-STAT device to assess hematocrit level, and protocols requiring early transfer of patients with suspected bleeds. Educating ASC staff regarding the signs and symptoms of postoperative bleeding is essential, along

Peter Billing et al. / Surgery for Obesity and Related Diseases 15 (2019) 832–836

835

80.00%

Percent Weight-Loss

70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00%

6 Months, n=1,758

12 Months, n=1,199

24 Months, n=560

EWL

56.30%

70.20%

69.30%

TWL

20.90%

26.33%

26.90%

Fig. 1. Weight loss over time in the outpatient sleeve gastrectomy patient. Data was collected from a single free-standing ambulatory surgical center. N 5 2,534. Data is presented as percent excess weight loss (%EWL) and percent total weight loss (%TWL).

with close communication with the surgeon regarding any patient concerns. If appropriate protocols are in place, complications can be safely managed. Our ASC is unique in requiring all patients who do not spend the night to be seen the following morning. This protocol was designed to closely monitor patients’ safety in the ASC setting. We recommend that those who implement this type of same-day program see their patients the next day in the clinic. Table 3 Causes for readmissions and reoperations after sleeve gastrectomy in a freestanding ambulatory surgical center (N 5 2534) Category

No.

Readmission

n 5 64

Leak Deep vein thrombosis Surgical site infection Postoperative bleeding Pneumonia Pain control Diverticulitis Atelectasis Myocardial infarction Bowel obstruction Nausea Ileus Diabetic ketoacidosis Anemia

21 16 7 4 3 2 2 2 2 1 1 1 1 1

Reoperations

n 5 35

Postoperative bleeding Leak Surgical site infection Vein thrombosis Enterotomy Myocardial infarction Bowel obstruction

15 9 6 2 1 1 1

Data on visits to the emergency department were not available in this retrospective review for the entirety of the study. However, in 1 year, 11 of 335 (3.28%) had emergency room visits. This metric is currently being tracked in a prospective study. Surgeon experience and technical skill are the first step in safely performing stapled procedures in an ASC, but also required is a dedicated surgical team—anesthesiologists and nurses comfortable and skilled with the unique care of patients with obesity, as well as scrub techs and support staff working together daily. As our surgical program developed Table 4 Complications that occurred after outpatient sleeve gastrectomy (N 5 2534) Category

n

Rate (%)

Readmissions Reoperations Direct transfers Postoperative bleeding Leak Surgical site infections Vein thrombosis Pneumonia Hypoxia Mortalities Atelectasis Diverticulitis Myocardial infarction Nausea and vomiting Uncontrolled pain Diabetic ketoacidosis Renal crisis Ileus Injury of spleen Bowel obstruction Respiratory failure Enterotomy

64 35 31 29 25 25 22 5 4 3 2 2 2 2 2 1 1 1 1 1 1 1

2.53 1.38 1.22 1.14 .99 .99 .87 .20 .16 .12 .08 .08 .08 .08 .08 .04 .04 .04 .04 .04 .04 .04

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through the years, we performed increasingly complex procedures, including revisions, high BMI patients, and elderly patients. With over 2500 SG procedures performed in our ASC since 2008, our team has gained invaluable experience in patient selection, surgical technique, and an effective team approach. The benefits of ASC procedures include decreased cost, surgeon control of each step of the detailed surgical process, and increased patient satisfaction. Currently 96.5% of our stapling procedures are done in an ASC. Some patients will require a hospital setting, yet our data support that most of these patients can be safely cared for in an ASC. We acknowledge limitations to our study. As this was a retrospective review, not all variables, such as emergency department visit rate, were available. Conclusion SG can be performed safely in an outpatient setting. Patients must be carefully selected by skilled and experienced surgeons. A consistent team with strict adherence to protocols needs to be in place to ensure patient safety. With trained, dedicated teams, we believe this type of program can be duplicated. Disclosures Drs. Peter Billing and Robert Landerholm are owners of Eviva Bariatrics, where the procedures took place. References [1] Watkins BM, Ahroni JH, Michaelson R, et al. Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Relat Dis 2008;4(3):S56–62. [2] Joshi GP, Ahmad S, Riad W, Eckert S, Chung F. Selection of obese patients undergoing ambulatory surgery. Survey Anesthesiol 2014;58(2):57.

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