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Concurrent bariatric surgery and paraesophageal hernia repair: an analysis of the Metabolic and Bariatric Surgery Association Quality Improvement Program (MBSAQIP) database
Surgery for Obesity and Related Diseases 15 (2019) 1746–1754
Original article
Concurrent bariatric surgery and paraesophageal hernia repair: an analysis of the Metabolic and Bariatric Surgery Association Quality Improvement Program (MBSAQIP) database Joshua Hefler, M.D.a,*, Jerry Dang, M.D.a, Valentin Mocanu, M.D.a, Noah Switzer, M.P.H., M.D., F.R.C.S.C.a,b, Daniel W. Birch, M.Sc., M.D., F.R.C.S.C.a, Shahzeer Karmali, M.P.H., M.D., F.R.C.S.C.a a
Department of Surgery, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada b Wexner Medical Center, The Ohio State University, Columbus, Ohio Received 28 April 2019; accepted 19 August 2019
Abstract
Background: Paraesophageal hernias (PEH) are common among patients with obesity. Most patients with severe obesity and a PEH will have the PEH repaired at the time of bariatric surgery. However, it is unclear whether there is increased risk when repairing a PEH during bariatric surgery. Objectives: To examine short-term outcomes of patients undergoing bariatric surgery with concurrent PEH repair versus bariatric surgery alone. Setting: Accredited bariatric centers across the United States and Canada. Methods: Patients who underwent bariatric surgery with concurrent PEH repair were identified from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program data registry. Using a propensity-score matching algorithm, these patients were matched with a cohort who underwent bariatric surgery only, controlling for age, sex, and other co-morbidities. Overall, 30-day incidence of major complications was the primary outcome. Secondary outcomes included mortality, length of operation, reoperations, and readmissions. Results: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database identified 222,320 bariatric procedures without PEH and 42,732 procedures with concurrent PEH repair. With one-to-one propensity score matching, 42,379 pairs were selected. Background characteristics, including age, sex, preoperative body mass index, and preoperative co-morbidities, did not differ statistically between matched cohorts. There was no statistically significant difference in 30-day major complications (3.5% versus 3.4%, P 5 .317). Conclusions: Our analysis indicates that the incidence of major complications for bariatric surgery with concurrent PEH repair is similar to bariatric surgery alone. Overall, this study demonstrates the safety of concurrent bariatric surgery and PEH repair. (Surg Obes Relat Dis 2019;15:1746– 1754.) Ó 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Key words:
Bariatric surgery; Sleeve gastrectomy; Gastric bypass; Paraesophageal hernia; Hiatal hernia
This project was completed with resources provided by the University of Alberta. * Correspondence: Joshua Hefler, M.D., c/o Dvorkin Lounge Mailroom, 2 G2 Walter C. Mackenzie Health Sciences Centre, 8440 - 112 ST NW, Edmonton, AB T6 G 2 B7.
E-mail address: [email protected] (J. Hefler).
https://doi.org/10.1016/j.soard.2019.08.025 1550-7289/Ó 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754
Hiatal hernias are not uncommon in the general population. A prevalence of 16.6% to 22% has been found among symptomatic individuals in Western populations [1,2]. Incidence among patients with severe obesity is thought to be much higher and has been reported to be as high as 37% in recent literature [3]. The majority of hiatus hernias (95%) are sliding hernias (type I), in which widening of the esophageal hiatus and laxity of the paraesophageal ligament allow the gastric cardia to herniate cephalad [4]. Paraesophageal hernias (PEH) make up the remaining 5% (types II–IV), including mixed types. They are associated with abnormal laxity of the gastrosplenic and gastrocolic ligaments, allowing the greater curvature of the stomach to herniate through a hiatal defect. The presence of a PEH is an important consideration for individuals undergoing bariatric surgery. PEH repair consists of the reduction of hernia contents intraabdominally, excision of the hernia sac, mobilization of the distal esophagus, and an antireflux technique [4]. The defect is closed primarily when possible but may require overlay with mesh if there is disruption of the crural fibers, the hernia defect is large, or the closure appears to be under tension. It is common practice to repair PEHs at the time of bariatric surgery because this restores normal anatomy and facilitates the success of the procedure for both laparoscopic Roux-enY gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG). However, it is unknown whether these patients are at increased risk of complications with concurrent PEH repair, nor is there consensus regarding the optimal method of repair. In this study, we used data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) data registry to evaluate 30-day postoperative outcomes for patient undergoing bariatric surgery with or without concurrent PEH repair. Our primary outcome was 30-day major complications. Secondary outcomes included 30-day mortality, length of operation, readmission, and reoperation. Secondary analyses were also performed, with patients stratified by type of bariatric surgery (LRYGB or LSG) and by use of mesh. Methods
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patients who met eligibility criteria for elective bariatric surgery, which was performed at an accredited center in the United States or Canada. Patients with a body mass index ,35 kg/m2 were excluded from our study. In addition, we excluded patients undergoing revisional or emergency surgery [6]. Data from 2015 and 2016 were available to us for this study. Patients undergoing concurrent laparoscopic PEH repair were identified on the basis of Current Procedural Terminology (CPT) codes. These patients had CPT codes of 43281 (without mesh) or 43282 (with mesh) in addition to their primary bariatric surgery (coded 43644 for LRYGB or 43775 for LSG) [7]. Note that patients undergoing hiatal hernia repair for a type I, sliding hiatal hernia were not included. Additionally, CPT code 43645 was not included because this refers laparoscopic gastric bypass that is not done in a Roux-en-Y configuration. Baseline characteristics and outcomes Demographic characteristics included age, sex, and race. Clinical characteristics included body mass index, functional status and mobility, smoking status, American Society of Anesthesiologists Physical Status Classification, and medical co-morbidities (diabetes, cardiac disease, chronic obstructive pulmonary disease, renal impairment, history of venous thromboembolism). Procedure type (LRYGB or LSG) was also included in baseline characteristics. The primary outcome was major complication within the first 30 days postoperatively. Major complications included any cardiac complications, pneumonia, acute renal failure, venous thromboembolism, cerebral vascular accident, sepsis, unplanned intubation, coma for .24 hours, deep surgical site infection, wound disruption, any postoperative bleed or leak, and the need for reoperation or reintervention within 30 days. Secondary outcomes included 30-day mortality, any complication (including superficial surgical site infection, requiring ventilator support for .48 hr, or urinary tract infection in addition to any major complication), operative time, reoperation, and readmission. Postoperative bleeding and leaks were defined as compositive variables for any patient who had a reoperation, reintervention, readmission, or death due to postoperative bleed or leak.
Data source and study population The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery maintain a national accreditation standard for bariatric surgery centers under the MBSAQIP [5]. Each of the 791 accredited centers across the United States and Canada report their outcomes, which are stored in a central database and made available to members of the associated institutions. Data have been collected annually since 2015 and include numerous variables relating to patient demographic characteristics, co-morbidities, intraoperative details, and 30-day postoperative events. The MBSAQIP database included
Statistical analysis All statistical analysis was performed using Stata 15.1 software, licensed from StataCorp LLC (College Station, TX, USA). Demographic characteristics, clinical characteristics, and outcomes were expressed as percentages (for categorical variables) or weighted means 6 standard deviation (for continuous variables). Baseline variables were compared between cohorts using either Pearson’s c2 test or Student’s t test where appropriate. Propensity score matching was applied to produce 2 groups that were similar in baseline characteristics [8].
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Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754 Table 1 Baseline characteristics of patients undergoing bariatric surgery with and without PEH repair, shown before and after propensity match Patient characteristic
Age, yr Mean 6 SD ,18 18–30 30–40 40–50 50–60 60 Female Race White Black Other BMI, kg/m2 Mean 6 SD 35–40 40–45 45–50 50–60 .60 Functional status Independent Partially dependent Fully dependent ASA classification I–II III IV–V Current smoker Diabetes No Noninsulin Insulin dependent COPD O₂ dependency Chronic steroid use Anticoagulant use CKD Dialysis dependent GERD Hyperlipidemia Hypertension OSA Previous MI Previous PCI Previous DVT Previous PE Venous stasis Procedure type LRYGB LSG
Unmatched cohort
P value
No PEH repair 222,320 (83.9%)
PEH repair 42,732 (16.1%)
44.2 6 12.0 2045 (.9) 25,395 (11.4) 58,082 (26.1) 64,273 (28.9) 61,366 (27.6) 11,159 (5.0) 173,818 (78.2)
45.1 6 11.9 222 (.5) 3555 (8.3) 9808 (23.0) 12,231 (28.6) 13,870 (32.5) 3046 (7.1) 35,584 (83.3)
163,062 (73.4) 38,495 (17.3) 20,763 (9.3)
31,884 (74.6) 7969 (18.7) 2879 (6.7)
46.2 6 8.0 47,839 (21.6) 69,262 (31.3) 48,048 (21.7) 42,856 (19.4) 13,085 (5.9)
Matched cohort
P value
No PEH repair 42,379 (50.0%)
PEH repair 42,379 (50.0%)
46.3 6 12.0 231 (.6) 3540 (8.4) 9557 (22.6) 12,367 (29.2) 13,612 (32.1) 3072 (7.3) 35,362 (83.4)
46.3 612.0 221 (.5) 3540 (8.4) 9724 (23.0) 12,141 (28.7) 13,739 (32.4) 3014 (7.1) 35,294 (83.3)
,.001
32,177 (75.9) 6841 (16.1) 3361 (7.9)
31,588 (74.5) 7935 (18.7) 2856 (6.7)
,.001
44.4 6 7.2 12,507 (29.5) 14,299 (33.7) 8109 (19.1) 6113 (14.4) 1404 (3.3)
,.001 ,.001
44.4 6 6.7 11,768 (27.9) 14,534 (34.5) 8431 (20.0) 6097 (14.5) 1295 (3.1)
44.4 6 7.2 12,401 (29.5) 14,187 (33.7) 8031 (19.1) 6063 (14.4) 1398 (3.3)
.669 ,.001
220,044 (99.0) 1575 (.7) 701 (.3)
42,315 (99.0) 225 (.5) 192 (.5)
,.001
41,962 (99.0) 252 (.6) 165 (.4)
41,965 (99.0) 222 (.5) 192 (.5)
.139
49,031 (22.1) 163,847 (74.0) 8577 (3.9) 19,869 (8.9)
11,118 (26.2) 30,044 (70.9) 1222 (2.9) 3560 (8.3)
,.001
10,870 (25.7) 30,372 (71.7) 1137 (2.7) 3506 (8.3)
11,118 (26.2) 30,039 (70.9) 1222 (2.9) 3520 (8.3)
.021
161,691 (72.7) 40,227 (18.1) 20,402 (9.2) 3951 (1.8) 1672 (.8) 3572 (1.6) 5559 (2.5) 1,507 (.7) 684 (.3) 66,628 (30.0) 54,378 (24.5) 108,031 (48.6) 85,960 (38.7) 2927 (1.3) 4686 (2.1) 3,599 (1.6) 2,585 (1.2) 2,330 (1.1)
33,377 (78.1) 6621 (15.5) 2734 (6.4) 760 (1.8) 226 (.5) 695 (1.6) 935 (2.2) 255 (.6) 91 (.2) 15,403 (36.1) 9967 (23.3) 21,084 (49.3) 15,010 (35.1) 572 (1.3) 904 (2.1) 643 (1.5) 426 (1.0) 488 (1.1)
32,969 (77.8) 6734 (15.9) 2676 (6.3) 761 (1.8) 250 (.6) 671 (1.6) 897 (2.1) 232 (.6) 101 (.2) 15,310 (36.1) 10,020 (23.6) 21,011 (49.6) 14,906 (35.2) 593 (1.4) 882 (2.1) 646 (1.5) 437 (1.0) 494 (1.2)
33,093 (78.1) 6572 (15.5) 2714 (6.4) 758 (1.8) 226 (.5) 695 (1.6) 914 (2.2) 247 (.6) 90 (.2) 15,225 (35.9) 9881 (23.3) 20,912 (49.4) 14,880 (35.1) 570 (1.4) 891 (2.1) 627 (1.5) 422 (1.0) 488 (1.2)
.290
154,281 (69.4) 68,039 (30.6)
35,279 (82.6) 7453 (17.4)
34,964 (82.5) 7415 (17.5)
34,936 (82.4) 7443 (17.6)
,.001 ,.001
,.001
,.001 ,.001
.984 ,.001 .767 ,.001 .059 .001 ,.001 ,.001 .005 ,.001 .715 .919 .085 .003 .083 ,.001
.867 .429
.531
.862
.938 .270 .513 .686 .492 .426 .543 .260 .496 .852 .497 .829 .592 .607 .847 .800
PEH 5 paraesophageal hernias; SD 5 standard deviation; BMI 5 body mass index; ASA 5 American Society of Anesthesiologists; ASA I–II 5 no/mild disturbance, ASA III 5 severe disturbance, ASA IV–V 5 life threatening/moribund; COPD 5 chronic obstructive pulmonary disease; CKD 5 chronic kidney disease; GERD 5 gastroesophageal reflux disease; OSA 5 obstructive sleep apnea; MI 5 myocardial infarction; PCI 5 percutaneous coronary intervention; DVT 5 deep vein thrombosis; PE 5 pulmonary embolism; LRYGB 5 laparoscopic Roux-en-Y gastric bypass; LSG 5 laparoscopic sleeve gastrectomy.
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Table 2 Perioperative outcomes for patients undergoing bariatric surgery with and without PEH repair, shown before and after propensity match Outcome
Mortality Major complication Leak Bleed Reoperation Reintervention Readmission Cardiac event Pneumonia AKI VTE Deep SSI Wound disruption Sepsis Unplanned intubation Coma .24 hr CVA Any complication SSI Postoperative ventilation UTI Operative time, min
Unmatched cohort
P value
No PEH repair 222,320 (83.9%)
PEH repair 42,732 (16.1%)
246 (.1) 8358 (3.8) 1073 (.5) 2132 (1.0) 2770 (1.3) 3257 (1.5) 8927 (4.0) 168 (.1) 478 (.2) 334 (.2) 574 (.3) 597 (.3) 107 (.1) 249 (.1) 379 (.2) 7 (0) 21 (0) 9832 (4.4) 1585 (.7) 199 (.1) 775 (.4) 86.8 6 47.5
24 (.1) 1489 (3.5) 166 (.4) 323 (.8) 528 (1.2) 564 (1.3) 1710 (4.0) 21 (.1) 77 (.2) 54 (.1) 129 (.3) 95 (.2) 15 (0) 44 (.1) 51 (.1) 1 (0) 6 (0) 1728 (4.0) 237 (.6) 24 (.1) 133 (.3) 87.0 6 44.3
.001 .006 .009 ,.001 .860 .021 .895 .061 .149 .237 .108 .086 .250 .607 .016 .781 .389 ,.001 ,.001 .029 .226 .417
Matched cohort
P value
No PEH repair 42,379 (50.0%)
PEH repair 42,379 (50.0%)
34 (.1) 1423 (3.4) 177 (.4) 365 (.9) 470 (1.1) 556 (1.3) 1520 (3.6) 26 (.1) 80 (.2) 41 (.1) 113 (.3) 89 (.2) 15 (0) 42 (.1) 66 (.2) 1 (0) 3 (0) 1664 (3.9) 245 (.6) 25 (.1) 134 (.3) 80.2 6 43.5
24 (.1) 1476 (3.5) 165 (.4) 321 (.8) 526 (1.2) 561 (1.3) 1692 (4.0) 21 (.1) 77 (.2) 54 (.1) 123 (.3) 95 (.2) 15 (0) 44 (.1) 51 (.1) 1 (0) 6 (0) 1710 (4.0) 235 (.6) 24 (.1) 130 (.3) 87.1 6 44.4
.189 .317 .516 .092 .074 .880 .002 .466 .811 .182 .514 .658 ..999 .829 .165 ..999 .317 .419 .647 .886 .805 ,.001
PEH 5 paraesophageal hernia; AKI 5 acute kidney injury; VTE 5 venous thromboembolism; SSI 5 surgical site infection; CVA 5 cerebral vascular accident; UTI 5 urinary tract infection.
Propensity scores were calculated using age, sex, procedure (LRYGB versus LSG), body mass index, race, gastroesophageal reflux disease, hypertension, hyperlipidemia, diabetes, chronic obstructive pulmonary disease, obstructive sleep apnea, smoking, oxygen dependency, American Society of Anesthesiologists classification, functional status, chronic steroid use, chronic kidney disease, dialysis, venous stasis, history of myocardial infarction, previous percutaneous coronary intervention, history of venous thromboembolism, and preoperative therapeutic anticoagulation. Patients who underwent concurrent PEH repair were matched 1 to 1 with patients who underwent only bariatric surgery, based on their propensity scores within a specified caliper distance of .2 standard deviations. This eliminated approximately 99% of variation due to potential confounders [9]. Univariate analysis was used to compare differences between patients undergoing bariatric surgery with and without PEH repair in both the unmatched and matched cohorts. A similar approach was used for our 2 subgroup analyses, which compared patients undergoing PEH repair with concurrent LRYGB versus LSG and mesh versus no mesh. Results Comparison of patients undergoing bariatric surgery with or without PEH repair A total of 265,052 patients undergoing bariatric surgery were included in the study. Of these, 42,732 (16.1%)
underwent concurrent PEH repair. The original cohorts differed significantly on a number of baseline variables, as seen in Table 1. For instance, there were significantly more females in the group with PEH repair (83.3% versus 78.2%, P , .001). In addition, PEH repair was more frequently performed with LSG than with LRYGB, with the former making up 82.6% of the PEH repair group compared to 69.4% of the group without PEH repair (P , .001). To control for differences in patient characteristics between groups, a propensity-matching algorithm was used to match 42,732 patients in the non-PEH repair cohort to patients who underwent concurrent repair. After propensity matching, major complications within 30 days were not significantly different between bariatric surgery only and concurrent PEH repair groups. Major complication rates were 3.4% for the bariatric surgery only cohort and 3.5% for the concurrent PEH cohort (P 5 .317). All other complications were statistically similar between groups (Table 2). Mortality was low in both cohorts and not statistically significant between groups (.1% versus .1%, P 5 .189). Operative time was slightly longer in the PEH cohort compared with the no PEH cohort (87.1 versus 80.2 min, P , .001). Readmission rates were also higher after concurrent PEH repair (4.0 versus 3.6%, P 5 .002). The most common reasons for readmission included nausea/vomiting, nonspecific abdominal pain, and unspecified, which were all more prevalent in the PEH repair group.
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Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754
Table 3 Perioperative outcomes for patients undergoing bariatric surgery with PEH repair stratified by procedure type, shown before and after propensity match Outcome
Mortality Major complication Leak Bleed Reoperation Reintervention Readmission Cardiac event Pneumonia AKI VTE Deep SSI Wound disruption Sepsis Unplanned intubation Coma .24 hr CVA Any complication SSI Postoperative ventilation UTI Operative time, min
Unmatched cohort
P value
LSG 35,279 (82.6%)
LRYGB 7453 (17.4%)
16 (.1) 968 (2.7) 107 (.3) 202 (.6) 336 (1.0) 352 (1.0) 1214 (3.4) 15 (0) 51 (.1) 34 (.1) 102 (.3) 57 (.2) 9 (0) 28 (.1) 32 (.1) 1 (0) 6 (0) 1125 (3.2) 134 (.4) 1 (0) 99 (.3) 78.1 6 36.4
8 (.1) 521 (7.0) 59 (.8) 121 (1.6) 192 (2.6) 212 (2.8) 496 (6.7) 6 (.1) 26 (.4) 20 (.3) 27 (.4) 38 (.5) 6 (.1) 16 (.2) 19 (.3) 0 (0) 0 (0) 603 (8.1) 103 (1.4) 0 (0) 34 (.5) 129.2 6 53.0
.040 ,.001 ,.001 ,.001 ,.001 ,.001 ,.001 .179 ,.001 ,.001 .296 ,.001 .021 .001 ,.001 .646 .260 ,.001 ,.001 ,.001 .013 ,.001
Matched cohort
P value
LSG 7441 (50.0%)
LRYGB 7441 (50.0%)
2 (0) 222 (3.0) 18 (.2) 49 (.7) 65 (.9) 94 (1.3) 242 (3.3) 6 (.1) 11 (.2) 11 (.2) 25 (.3) 15 (.2) 3 (0) 3 (0) 9 (.1) 0 (0) 2 (0) 262 (3.5) 39 (.5) 1 (0) 17 (.3) 80.1 6 37.3
8 (.1) 521 (7.0) 59 (.8) 121 (1.6) 192 (2.6) 212 (2.9) 495 (6.7) 6 (.1) 26 (.4) 20 (.3) 27 (.4) 38 (.5) 6 (.1) 16 (.2) 19 (.3) 0 (0) 0 (0) 603 (8.1) 103 (1.4) 13 (.2) 34 (.5) 129.3 6 53.0
.058 ,.001 ,.001 ,.001 ,.001 ,.001 ,.001 ..999 .014 .106 .781 .002 .317 .003 .059 ..999 .157 ,.001 ,.001 .001 .017 ,.001
PEH 5 paraesophageal hernia; LSG 5 laparoscopic sleeve gastrectomy; LRYGB 5 laparoscopic Roux-en-Y gastric bypass; AKI 5 acute kidney injury; VTE 5 venous thromboembolism; SSI 5 surgical site infection; CVA 5 cerebral vascular accident; UTI 5 urinary tract infection.
Stratified analysis by procedure type (LRYGB versus LSG) To assess for the potential influence of the primary bariatric procedure, a subgroup propensity-matched analysis was performed within the PEH repair cohort comparing patients undergoing LRYGB to those undergoing LSG. Of the 42,732 patients undergoing concurrent PEH repair, 7453 (17.4%) had LRYGB. Patients undergoing LRYGB and LSG were significantly different at baseline, but these differences were corrected after propensity matching. While 30-day mortality remained low and was comparable between the 2 groups (0% LSG versus .1% LRYGB, P 5 .058), the rate of major complications was significantly higher in the LRYGB subgroup (3.0% versus 7.0%, P , .001) (Table 3). This was due to higher rates of postoperative leak, bleed, reoperations, and reinterventions. These finding were consistent with patients who underwent bariatric surgery without PEH repair, among whom the rate of major complications was 3.0% for patients undergoing LSG and 6.3% for patients undergoing LRYGB (P , .001). Stratified analysis by use of mesh The method of hernia repair was then examined using a subgroup propensity-matched analysis to compare patients who had their PEH repaired with mesh versus those repaired primarily. Of the 42,732 patients undergoing concurrent PEH repair, 2569 (6.0%) were done with mesh. After
correcting for baseline differences by propensity matching, the majority of outcomes were comparable between the 2 groups (Table 4), including 30-day mortality (0% no mesh versus .1% mesh, P 5 .083) and major complications within 30 days (4.0% no mesh versus 3.9% mesh, P 5 .774) (Table 5). Unplanned intubation (0% versus .2%, P 5 .025) and operative time were significantly higher in the group with mesh (87.9 versus 107.2 min, P , .001). Discussion To our knowledge, this study presents the first analysis of the role of concurrent PEH repair at the time of bariatric surgery. Using the MBSAQIP database from 2015 to 2016, we identified a total of 265,052 patients who underwent bariatric surgery, of whom 42,732 (16.1%) underwent concurrent repair. No difference was observed in unadjusted major complications between primary bariatric surgery in comparison to concurrent PEH repair; however, readmission rates were higher after concurrent repair (4.0 versus 3.6%; P 5 .002). After correcting for baseline differences using propensity score matching, outcomes stratified by procedure type and method of repair were examined. The rate of major complications was found to be significantly higher in the concurrent repair LRYGB subgroup compared with LSG patients (3.0% versus 7.0%; P , .001) as a result of the inherent increased complication rate of the LRYGB procedure. Taken together, our findings demonstrate the safety of
Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754
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Table 4 Baseline characteristics of patients undergoing bariatric surgery with PEH repair, stratified by use of mesh Patient characteristic
Age, yr Mean 6 SD ,18 18–30 30–40 40–50 50–60 60 Female Race White Black Other BMI, kg/m2 Mean 6 SD 35–40 40–45 45–50 50–60 .60 Functional status Independent Partially dependent Fully dependent ASA classification I–II III IV–V Current smoker Diabetes No Noninsulin dependent Insulin dependent COPD O₂ dependency Chronic steroid use Anticoagulant use CKD Dialysis dependent GERD Hyperlipidemia Hypertension OSA Previous MI Previous PCI Previous DVT Previous PE Venous stasis
Unmatched cohort
P value
No mesh 40,048 (93.7%)
Mesh 2684 (6.3%)
46.2 6 12.0 211 (.5) 3381 (8.4) 9246 (23.1) 11,446 (28.6) 12,927 (32.3) 2837 (7.1) 33,255 (83.0)
47.4 6 11.8 11 (.4) 174 (6.5) 562 (20.9) 785 (29.3) 943 (35.1) 209 (7.8) 2329 (86.8)
29,824 (74.5) 7444 (18.6) 2780 (6.9)
2060 (76.8) 525 (19.6) 99 (3.7)
44.4 6 7.1 11,756 (29.6) 13,431 (33.8) 7593 (19.1) 5706 (14.4) 1280 (3.2)
Matched cohort
P value
No mesh 2569 (50.0%)
Mesh 2569 (50.0%)
47.5 6 12.2 7 (.3) 201 (7.8) 538 (20.9) 704 (27.4) 884 (34.4) 235 (9.2) 2192 (85.3)
47.3 6 11.8 11 (.4) 168 (6.5) 537 (20.9) 756 (29.4) 898 (35.0) 199 (7.8) 2228 (86.7)
,.001
1989 (77.4) 441 (17.2) 139 (5.4)
1963 (76.4) 513 (20.0) 93 (3.6)
.001
44.8 6 7.5 751 (28.2) 868 (32.6) 516 (19.4) 407 (15.3) 124 (4.7)
.001 .001
45.1 6 8.1 718 (28.2) 804 (31.6) 537 (21.1) 380 (14.9) 109 (4.3)
44.9 6 7.6 711 (27.9) 826 (32.4) 498 (19.5) 395 (15.5) 121 (4.7)
.463 .607
39,659 (99.0) 203 (.5) 186 (.5)
2656 (99.0) 22 (.8) 6 (.2)
.019
2552 (99.3) 13 (.5) 4 (.2)
2542 (99.0) 21 (.8) 6 (.2)
.316
10,553 (26.5) 28,178 (70.8) 1084 (2.7) 3345 (8.4)
565 (22.0) 1866 (72.6) 138 (5.4) 215 (8.0)
,.001
501 (19.5) 1965 (76.5) 103 (4.0) 203 (7.1)
565 (22.0) 1866 (72.6) 138 (5.4) 206 (8.0)
.003
31,323 (78.2) 6185 (15.4) 2540 (6.3) 706 (1.8) 198 (.5) 655 (1.6) 866 (2.2) 235 (.6) 83 (.21) 14,248 (35.6) 9284 (23.2) 19,569 (48.9) 14,057 (35.1) 523 (1.3) 839 (2.1) 595 (1.5) 385 (1.0) 472 (1.2)
2054 (76.5) 436 (16.2) 194 (7.2) 54 (2.0) 28 (1.0) 40 (1.5) 69 (2.6) 20 (.8) 8 (.3) 1155 (43.0) 683 (25.5) 1515 (56.5) 953 (35.5) 49 (1.8) 65 (2.4) 48 (1.8) 41 (1.5) 16 (.6)
1973 (76.8) 408 (15.9) 188 (7.3) 63 (2.5) 37 (1.4) 34 (1.3) 66 (2.6) 17 (.7) 5 (.2) 1089 (42.4) 663 (25.8) 1461 (56.9) 897 (34.9) 48 (1.9) 74 (2.9) 43 (1.7) 43 (1.7) 19 (.7)
1960 (76.3) 423 (16.5) 186 (7.2) 54 (2.1) 28 (1.1) 40 (1.6) 60 (2.3) 15 (.6) 7 (.3) 1086 (42.3) 661 (25.7) 1463 (57.0) 916 (35.7) 48 (1.9) 61 (2.4) 40 (1.6) 40 (1.6) 16 (.6)
,.001 ,.001
,.001
.535 .080
.345 ,.001 .565 .161 .302 .323 ,.001 .007 ,.001 .669 .023 .255 .212 .004 .006
.632 .118
.147
.877 0.850
.400 .261 .482 .588 .723 .563 .932 .949 .955 .579 ..999 .257 .740 .740 .611
PEH 5 paraesophageal hernia; SD 5 standard deviation; BMI 5 body mass index; ASA 5 American Society of Anesthesiologists; ASA I–II 5 no/mild disturbance, ASA III 5 severe disturbance, ASA IV–V 5 life threatening/moribund; COPD 5 chronic obstructive pulmonary disease; CKD 5 chronic kidney disease; GERD 5 gastroesophageal reflux disease; OSA 5 obstructive sleep apnea; MI 5 myocardial infarction; PCI 5 percutaneous coronary intervention; DVT 5 deep vein thrombosis; PE 5 pulmonary embolism. Cohorts shown before and after propensity match.
concurrent PEH repair and bariatric surgery compared with bariatric surgery alone. A multicenter retrospective study by Kothari et al. [10], looked at concurrent hiatus hernia repair (including both
sliding and PEH) in 644 patients undergoing specifically LRYGB and found no difference in 30-day morbidity or mortality compared with surgery without hiatus hernia repair. Ours is one of the few studies that looks specifically
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Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754 Table 5 Perioperative outcomes for patients undergoing bariatric surgery with PEH repair, stratified by use of mesh Outcome
Mortality Major complication Leak Bleed Reoperation Reintervention Readmission Cardiac event Pneumonia AKI VTE Deep SSI Wound disruption Sepsis Unplanned intubation Coma .24 hr CVA Any complication SSI Postoperative ventilation UTI Operative time, min
Unmatched cohort
P value
No mesh 40,048 (93.7%)
Mesh 2684 (6.3%)
21 (.1) 1384 (3.5) 157 (.4) 308 (.8) 498 (1.2) 526 (1.3) 1582 (4.0) 18 (0) 68 (.2) 45 (.1) 112 (.3) 86 (.2) 15 (0) 40 (.1) 46 (.1) 1 (0) 6 (0) 1608 (4.0) 219 (.6) 22 (.1) 127 (.3) 85.7 6 43.3
3 (.1) 105 (3.9) 9 (.3) 15 (.6) 30 (1.1) 38 (1.4) 127 (4.7) 3 (.1) 9 (.3) 9 (.3) 17 (.6) 9 (.3) 0 (0) 4 (.2) 5 (.2) 0 (0) 0 (0) 120 (4.5) 18 (0.7) 2 (0.1) 6 (.2) 106.2 6 54.1
.209 .212 .648 .224 .568 .653 .046 .130 .050 .002 .001 .199 .316 .442 .299 .796 .526 .246 .403 .678 .399 ,.001
Matched cohort
P value
No Mesh 2569 (50.0%)
Mesh 2569 (50.0%)
0 (0) 103 (4.0) 11 (.4) 21 (.8) 32 (1.3) 42 (1.6) 120 (4.7) 1 (0) 8 (.3) 3 (.1) 12 (.5) 10 (.4) 2 (.1) 2 (.1) 0 (0) 0 (0) 0 (0) 122 (4.8) 22 (.9) 2 (.1) 12 (.5) 87.9 6 43.7
3 (.1) 99 (3.9) 9 (.4) 15 (.6) 29 (1.1) 37 (1.4) 120 (4.7) 3 (.1) 9 (.4) 9 (.4) 13 (.5) 9 (.4) 0 (0) 4 (.2) 5 (.2) 0 (0) 0 (0) 113 (4.4) 18 (.7) 2 (.1) 5 (.2) 107.2 6 54.7
.083 .774 .654 .316 .699 .571 ..999 .317 .808 .083 .841 .818 .157 .414 .025 ..999 ..999 .548 .525 ..999 .089 ,.001
PEH 5 paraesophageal hernia; AKI 5 acute kidney injury; VTE 5 venous thromboembolism; SSI 5 surgical site infection; CVA 5 cerebral vascular accident; UTI 5 urinary tract infection. Cohorts shown before and after propensity match.
at PEH repair, excluding sliding hernias, as small sliding hernias may not require repair in patients undergoing bariatric surgery. Shada et al. [11] completed a similar analysis on concurrent bariatric surgery and PEH repair. This study included 17,856 patients using data from the National Surgical Quality Improvement Program. Consistent with our study, they found no difference in 30-day morbidity and mortality between matched cohorts and reported rates similar to those to our study (3.70% and .13% for morbidity and mortality in the PEH cohort, respectively). However, with .80,000 patients included in the final analysis, the MBSAQIP cohort is the largest retrospective study to date addressing concurrent PEH repair. To our knowledge, no comparable prospective studies have been conducted. The main finding of our subgroup analysis was a higher incidence of major complications among patients undergoing LRYGB compared with LSG with concurrent PEH repair. The 30-day mortality rate trended toward statistical significance but did not reach it (P 5 .058). This is presumably due to the greater technical complexity of LRYGB compared with LSG, with the former involving 2 enteric anastomoses in addition to a portion of stapled stomach [12]. The higher morbidity for LRYGB has been well documented in prior studies [13]. For instance, Young et al. [14] reported an odds ratio of 1.32 (95% confidence interval 1.11–1.56, P , .01) for 30-day major morbidity in LRYGB compared with LSG. Shada et al. [11] reported findings for
similar subgroups with their analysis of the National Surgical Quality Improvement Program data. They also found a statistically significant difference in 30-day overall morbidity, with rates of 6.20% and 2.69% for the LRYGB and LSG cohorts, respectively (P , .001). We found similar results when we repeated the analysis using patients from our study group who had undergone bariatric surgery without PEH repair, suggesting that the increased complication rate observed in the subgroup analysis was a result of the technical complexity of the LRYGB procedure and not due to concurrent PEH repair. Therefore, in patients undergoing concurrent PEH repair, LRYGB and LSG are both safe options, and there appears to be no inherently increased risk to performing concurrent PEH repair. The majority of concurrent PEH repairs were performed in patients who underwent LSG. Performing LSG in the presence of a PEH is controversial because LSG has the potential to dramatically worsen gastroesophageal reflux disease. Reporting results from their longitudinal database, DePree et al. [12] found 19% of patients undergoing LSG with preexisting gastroesophageal reflux disease had worsening of their symptoms postoperatively compared with only 5% of patients undergoing LRYGB. Several factors are thought to contribute to this finding, including a decrease in lower esophageal sphincter tone, sleeve size and shape (whether overly dilated or narrowed), and disruption of the antropyloric pump [15–17]. Generally, more LSGs are
Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754
performed than LRYGBs owing to the lower complexity of the procedure, but the reverse may be expected for patients with PEH in light of this finding. It is possible that LSG with concurrent PEH repair may be done only in the presence of small, asymptomatic PEHs; however, these details cannot be delineated from the MBSAQIP data set. To our knowledge, the issue of whether to use mesh has not previously been studied in this population. We found no difference in complications between patients who received mesh and those who did not, only a longer operative time, as might be expected. Caution must be taken in interpreting these results because we are unable to determine the type of mesh used (biologic versus synthetic) or the indication for its use. When the goal is solely PEH repair, use of a biologic mesh may delay, but not ultimately prevent, long-term recurrence [18]. Separate randomized trials using follow-up times of 6 months and 5 years have shown recurrence to be decreased with mesh with the former but equivalent with the latter study [19,20]. A systematic review and meta-analysis by Memon et al. [21] found 4 randomized control trials comparing primary repair with repair with synthetic mesh. They found reinforcement with synthetic mesh reduced rates of reoperation, but no statistically significant difference in recurrence or complications was noted. Understandably, the routine use of synthetic mesh is not widely practiced given its minimal benefit and the significant morbidity associated with complications such as mesh infection or erosion into the esophagus or gastric cardia [17]. Mesh is more commonly used in cases where the chance of recurrence is higher, such as with large hernia defects or significantly attenuated crura. Limitations A major limitation of using data from the MBSAQIP database is that the database only records outcomes within the first 30 days of surgery. Long-term data on the durability of the repair, including development of new or recurrent symptoms, and need for reintervention or reoperation cannot be assessed. Given this limitation, results of this study can only comment on the early implications of this added procedure and not on the success of the repair or the altered trajectory of the natural history of the hiatal hernia. Furthermore, granular details are not available from the MBSAQIP database regarding the size of the defect, extent of herniation, experience of the surgeon, and type of repair, thus restricting our ability to analyze these important factors. Rates of complications may also differ by surgical center, with higher surgical volumes potentially leading to lower complications. This would be relevant if patients undergoing concurrent PEH repair are more likely to be treated at a larger center; however, the MBSAQIP database does not contain this information. Another consideration is that we do not know whether patients not undergoing PEH repair
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had a PEH at the time of surgery. Acknowledging this limitation, there is a potential for our findings to be attributed to the presence of PEH itself rather than the surgical repair. Despite these limitations, our study presents the most robust data regarding the short-term safety of concurrent PEH repair during bariatric surgery. Conclusion Our analysis indicates that the incidence of major complications for bariatric surgery with concurrent PEH repair is similar to that with bariatric surgery alone. Overall, this study demonstrates the safety of concurrent bariatric surgery and PEH repair. Further studies are needed to identify the optimal timing and technique for concurrent repair during bariatric surgery. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Berstad A, Weberg R, Frøyshov Larsen I, Hoel B, Hauer-Jensen M. Relationship of hiatus hernia to reflux oesophagitis. A prospective study of coincidence, using endoscopy. Scand J Gastroenterol 1986;21(1):55–8. [2] Wright RA, Hurwitz AL. Relationship of hiatal hernia to endoscopically proved reflux esophagitis. Dig Dis Sci 1979;24(4):311–3. [3] Che F, Nguyen B, Cohen A, Nguyen NT. Prevalence of hiatal hernia in the morbidly obese. Surg Obes Relat Dis 2013;9(6):920–4. [4] Sutherland V, Kuwada T, Gersin K, Simms C, Stefanidis D. Impact of bariatric surgery on hiatal hernia repair outcomes. Am Surg 2016;82(8):743–7. [5] Resources for Optimal Care of the Metabolic and Bariatric Surgery Patient 2016 [homepage on the Internet]. Chicago: American College of Surgeons; c1996-2019 [updated 2016 Jan 1; cited 2019 Apr 27]. Available from: https://www.facs.org/w/media/files/quality%20programs/ bariatric/mbsaqip%20standardsmanual.ashx. [6] User Guide for the 2016 Participant Use Data File (PUF) [homepage on the Internet]. Chicago: American College of Surgeons; c19962019 [updated 2016 Jan 1; cited 2019 Apr 27]. Available from: https://www.facs.org/w/media/files/quality%20programs/bariatric/ mbsaqip_2016_puf_user_guide.ashx. [7] What is CPTÒ? [homepage on the Internet]. Salt Lake City: AAPC; c2019 [cited 2018 Oct 1. Available from: https://www.aapc.com/ resources/medical-coding/cpt.aspx. [8] Becker S, Ichino A. Estimation of average treatment effects based on propensity scores. Stata J 2002;2(4):358–77. [9] Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res 2011;46(3):399–424. [10] Kothari V, Shaligram A, Reynoso J, Schmidt E, McBride CL, Oleynikov D. Impact on perioperative outcomes of concomitant hiatal hernia repair with laparoscopic gastric bypass. Obes Surg 2012;22(10):1607–10. [11] Shada AL, Stem M, Funk LM, Greenberg JA, Lidor AO. Concurrent bariatric surgery and paraesophageal hernia repair: comparison of sleeve gastrectomy and Roux-en-Y gastric bypass. Surg Obes Relat Dis 2018;14(1):8–13.
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[12] DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease: a national analysis. JAMA Surg 2014;149(4):328–34. [13] Mocanu V, Dang J, Ladak F, Switzer N, Birch DW, Karmali S. Predictors and outcomes of leak after Roux-en-Y gastric bypass: an analysis of the MBSAQIP data registry. Surg Obes Relat Dis 2019;15(3):396– 403. [14] Young MT, Gebhart A, Phelan MJ, Nguyen NT. Use and outcomes of laparoscopic sleeve gastrectomy vs laparoscopic gastric bypass: analysis of the American College of Surgeons NSQIP. J Am Coll Surg 2015;220(5):880–5. [15] Akkary E, Duffy A, Bell R. Deciphering the sleeve: technique, indications, efficacy, and safety of sleeve gastrectomy. Obes Surg 2008;18(10):1323–9. [16] Klaus A, Weiss H. Is preoperative manometry in restrictive bariatric procedures necessary? Obes Surg 2008;18(8):1039–42.
[17] Keidar A, Appelbaum L, Schweiger C, Elazary R, Baltasar A. Dilated upper sleeve can be associated with severe postoperative gastroesophageal dysmotility and reflux. Obes Surg 2010;20(2):140–7. [18] Lebenthal A, Waterford SD, Fisichella PM. Treatment and controversies in paraesophageal hernia repair. Front Surg 2015;2:13. [19] Oelschlager BK, Pellegrini CA, Hunter JG, et al. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg 2011;213(4):461–8. [20] M€uller-Stich BP, Holzinger F, Kapp T, Klaiber C. Laparoscopic hiatal hernia repair: long-term outcome with the focus on the influence of mesh reinforcement. Surg Endosc 2006;20(3):380–4. [21] Memon MA, Memon B, Yunus RM, Khan S. Suture cruroplasty versus prosthetic hiatal herniorrhaphy for large hiatal hernia: a meta-analysis and systematic review of randomized controlled trials. Ann Surg 2016;263(2):258–66.
Original article
Concurrent bariatric surgery and paraesophageal hernia repair: an analysis of the Metabolic and Bariatric Surgery Association Quality Improvement Program (MBSAQIP) database Joshua Hefler, M.D.a,*, Jerry Dang, M.D.a, Valentin Mocanu, M.D.a, Noah Switzer, M.P.H., M.D., F.R.C.S.C.a,b, Daniel W. Birch, M.Sc., M.D., F.R.C.S.C.a, Shahzeer Karmali, M.P.H., M.D., F.R.C.S.C.a a
Department of Surgery, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada b Wexner Medical Center, The Ohio State University, Columbus, Ohio Received 28 April 2019; accepted 19 August 2019
Abstract
Background: Paraesophageal hernias (PEH) are common among patients with obesity. Most patients with severe obesity and a PEH will have the PEH repaired at the time of bariatric surgery. However, it is unclear whether there is increased risk when repairing a PEH during bariatric surgery. Objectives: To examine short-term outcomes of patients undergoing bariatric surgery with concurrent PEH repair versus bariatric surgery alone. Setting: Accredited bariatric centers across the United States and Canada. Methods: Patients who underwent bariatric surgery with concurrent PEH repair were identified from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program data registry. Using a propensity-score matching algorithm, these patients were matched with a cohort who underwent bariatric surgery only, controlling for age, sex, and other co-morbidities. Overall, 30-day incidence of major complications was the primary outcome. Secondary outcomes included mortality, length of operation, reoperations, and readmissions. Results: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database identified 222,320 bariatric procedures without PEH and 42,732 procedures with concurrent PEH repair. With one-to-one propensity score matching, 42,379 pairs were selected. Background characteristics, including age, sex, preoperative body mass index, and preoperative co-morbidities, did not differ statistically between matched cohorts. There was no statistically significant difference in 30-day major complications (3.5% versus 3.4%, P 5 .317). Conclusions: Our analysis indicates that the incidence of major complications for bariatric surgery with concurrent PEH repair is similar to bariatric surgery alone. Overall, this study demonstrates the safety of concurrent bariatric surgery and PEH repair. (Surg Obes Relat Dis 2019;15:1746– 1754.) Ó 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Key words:
Bariatric surgery; Sleeve gastrectomy; Gastric bypass; Paraesophageal hernia; Hiatal hernia
This project was completed with resources provided by the University of Alberta. * Correspondence: Joshua Hefler, M.D., c/o Dvorkin Lounge Mailroom, 2 G2 Walter C. Mackenzie Health Sciences Centre, 8440 - 112 ST NW, Edmonton, AB T6 G 2 B7.
E-mail address: [email protected] (J. Hefler).
https://doi.org/10.1016/j.soard.2019.08.025 1550-7289/Ó 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754
Hiatal hernias are not uncommon in the general population. A prevalence of 16.6% to 22% has been found among symptomatic individuals in Western populations [1,2]. Incidence among patients with severe obesity is thought to be much higher and has been reported to be as high as 37% in recent literature [3]. The majority of hiatus hernias (95%) are sliding hernias (type I), in which widening of the esophageal hiatus and laxity of the paraesophageal ligament allow the gastric cardia to herniate cephalad [4]. Paraesophageal hernias (PEH) make up the remaining 5% (types II–IV), including mixed types. They are associated with abnormal laxity of the gastrosplenic and gastrocolic ligaments, allowing the greater curvature of the stomach to herniate through a hiatal defect. The presence of a PEH is an important consideration for individuals undergoing bariatric surgery. PEH repair consists of the reduction of hernia contents intraabdominally, excision of the hernia sac, mobilization of the distal esophagus, and an antireflux technique [4]. The defect is closed primarily when possible but may require overlay with mesh if there is disruption of the crural fibers, the hernia defect is large, or the closure appears to be under tension. It is common practice to repair PEHs at the time of bariatric surgery because this restores normal anatomy and facilitates the success of the procedure for both laparoscopic Roux-enY gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG). However, it is unknown whether these patients are at increased risk of complications with concurrent PEH repair, nor is there consensus regarding the optimal method of repair. In this study, we used data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) data registry to evaluate 30-day postoperative outcomes for patient undergoing bariatric surgery with or without concurrent PEH repair. Our primary outcome was 30-day major complications. Secondary outcomes included 30-day mortality, length of operation, readmission, and reoperation. Secondary analyses were also performed, with patients stratified by type of bariatric surgery (LRYGB or LSG) and by use of mesh. Methods
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patients who met eligibility criteria for elective bariatric surgery, which was performed at an accredited center in the United States or Canada. Patients with a body mass index ,35 kg/m2 were excluded from our study. In addition, we excluded patients undergoing revisional or emergency surgery [6]. Data from 2015 and 2016 were available to us for this study. Patients undergoing concurrent laparoscopic PEH repair were identified on the basis of Current Procedural Terminology (CPT) codes. These patients had CPT codes of 43281 (without mesh) or 43282 (with mesh) in addition to their primary bariatric surgery (coded 43644 for LRYGB or 43775 for LSG) [7]. Note that patients undergoing hiatal hernia repair for a type I, sliding hiatal hernia were not included. Additionally, CPT code 43645 was not included because this refers laparoscopic gastric bypass that is not done in a Roux-en-Y configuration. Baseline characteristics and outcomes Demographic characteristics included age, sex, and race. Clinical characteristics included body mass index, functional status and mobility, smoking status, American Society of Anesthesiologists Physical Status Classification, and medical co-morbidities (diabetes, cardiac disease, chronic obstructive pulmonary disease, renal impairment, history of venous thromboembolism). Procedure type (LRYGB or LSG) was also included in baseline characteristics. The primary outcome was major complication within the first 30 days postoperatively. Major complications included any cardiac complications, pneumonia, acute renal failure, venous thromboembolism, cerebral vascular accident, sepsis, unplanned intubation, coma for .24 hours, deep surgical site infection, wound disruption, any postoperative bleed or leak, and the need for reoperation or reintervention within 30 days. Secondary outcomes included 30-day mortality, any complication (including superficial surgical site infection, requiring ventilator support for .48 hr, or urinary tract infection in addition to any major complication), operative time, reoperation, and readmission. Postoperative bleeding and leaks were defined as compositive variables for any patient who had a reoperation, reintervention, readmission, or death due to postoperative bleed or leak.
Data source and study population The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery maintain a national accreditation standard for bariatric surgery centers under the MBSAQIP [5]. Each of the 791 accredited centers across the United States and Canada report their outcomes, which are stored in a central database and made available to members of the associated institutions. Data have been collected annually since 2015 and include numerous variables relating to patient demographic characteristics, co-morbidities, intraoperative details, and 30-day postoperative events. The MBSAQIP database included
Statistical analysis All statistical analysis was performed using Stata 15.1 software, licensed from StataCorp LLC (College Station, TX, USA). Demographic characteristics, clinical characteristics, and outcomes were expressed as percentages (for categorical variables) or weighted means 6 standard deviation (for continuous variables). Baseline variables were compared between cohorts using either Pearson’s c2 test or Student’s t test where appropriate. Propensity score matching was applied to produce 2 groups that were similar in baseline characteristics [8].
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Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754 Table 1 Baseline characteristics of patients undergoing bariatric surgery with and without PEH repair, shown before and after propensity match Patient characteristic
Age, yr Mean 6 SD ,18 18–30 30–40 40–50 50–60 60 Female Race White Black Other BMI, kg/m2 Mean 6 SD 35–40 40–45 45–50 50–60 .60 Functional status Independent Partially dependent Fully dependent ASA classification I–II III IV–V Current smoker Diabetes No Noninsulin Insulin dependent COPD O₂ dependency Chronic steroid use Anticoagulant use CKD Dialysis dependent GERD Hyperlipidemia Hypertension OSA Previous MI Previous PCI Previous DVT Previous PE Venous stasis Procedure type LRYGB LSG
Unmatched cohort
P value
No PEH repair 222,320 (83.9%)
PEH repair 42,732 (16.1%)
44.2 6 12.0 2045 (.9) 25,395 (11.4) 58,082 (26.1) 64,273 (28.9) 61,366 (27.6) 11,159 (5.0) 173,818 (78.2)
45.1 6 11.9 222 (.5) 3555 (8.3) 9808 (23.0) 12,231 (28.6) 13,870 (32.5) 3046 (7.1) 35,584 (83.3)
163,062 (73.4) 38,495 (17.3) 20,763 (9.3)
31,884 (74.6) 7969 (18.7) 2879 (6.7)
46.2 6 8.0 47,839 (21.6) 69,262 (31.3) 48,048 (21.7) 42,856 (19.4) 13,085 (5.9)
Matched cohort
P value
No PEH repair 42,379 (50.0%)
PEH repair 42,379 (50.0%)
46.3 6 12.0 231 (.6) 3540 (8.4) 9557 (22.6) 12,367 (29.2) 13,612 (32.1) 3072 (7.3) 35,362 (83.4)
46.3 612.0 221 (.5) 3540 (8.4) 9724 (23.0) 12,141 (28.7) 13,739 (32.4) 3014 (7.1) 35,294 (83.3)
,.001
32,177 (75.9) 6841 (16.1) 3361 (7.9)
31,588 (74.5) 7935 (18.7) 2856 (6.7)
,.001
44.4 6 7.2 12,507 (29.5) 14,299 (33.7) 8109 (19.1) 6113 (14.4) 1404 (3.3)
,.001 ,.001
44.4 6 6.7 11,768 (27.9) 14,534 (34.5) 8431 (20.0) 6097 (14.5) 1295 (3.1)
44.4 6 7.2 12,401 (29.5) 14,187 (33.7) 8031 (19.1) 6063 (14.4) 1398 (3.3)
.669 ,.001
220,044 (99.0) 1575 (.7) 701 (.3)
42,315 (99.0) 225 (.5) 192 (.5)
,.001
41,962 (99.0) 252 (.6) 165 (.4)
41,965 (99.0) 222 (.5) 192 (.5)
.139
49,031 (22.1) 163,847 (74.0) 8577 (3.9) 19,869 (8.9)
11,118 (26.2) 30,044 (70.9) 1222 (2.9) 3560 (8.3)
,.001
10,870 (25.7) 30,372 (71.7) 1137 (2.7) 3506 (8.3)
11,118 (26.2) 30,039 (70.9) 1222 (2.9) 3520 (8.3)
.021
161,691 (72.7) 40,227 (18.1) 20,402 (9.2) 3951 (1.8) 1672 (.8) 3572 (1.6) 5559 (2.5) 1,507 (.7) 684 (.3) 66,628 (30.0) 54,378 (24.5) 108,031 (48.6) 85,960 (38.7) 2927 (1.3) 4686 (2.1) 3,599 (1.6) 2,585 (1.2) 2,330 (1.1)
33,377 (78.1) 6621 (15.5) 2734 (6.4) 760 (1.8) 226 (.5) 695 (1.6) 935 (2.2) 255 (.6) 91 (.2) 15,403 (36.1) 9967 (23.3) 21,084 (49.3) 15,010 (35.1) 572 (1.3) 904 (2.1) 643 (1.5) 426 (1.0) 488 (1.1)
32,969 (77.8) 6734 (15.9) 2676 (6.3) 761 (1.8) 250 (.6) 671 (1.6) 897 (2.1) 232 (.6) 101 (.2) 15,310 (36.1) 10,020 (23.6) 21,011 (49.6) 14,906 (35.2) 593 (1.4) 882 (2.1) 646 (1.5) 437 (1.0) 494 (1.2)
33,093 (78.1) 6572 (15.5) 2714 (6.4) 758 (1.8) 226 (.5) 695 (1.6) 914 (2.2) 247 (.6) 90 (.2) 15,225 (35.9) 9881 (23.3) 20,912 (49.4) 14,880 (35.1) 570 (1.4) 891 (2.1) 627 (1.5) 422 (1.0) 488 (1.2)
.290
154,281 (69.4) 68,039 (30.6)
35,279 (82.6) 7453 (17.4)
34,964 (82.5) 7415 (17.5)
34,936 (82.4) 7443 (17.6)
,.001 ,.001
,.001
,.001 ,.001
.984 ,.001 .767 ,.001 .059 .001 ,.001 ,.001 .005 ,.001 .715 .919 .085 .003 .083 ,.001
.867 .429
.531
.862
.938 .270 .513 .686 .492 .426 .543 .260 .496 .852 .497 .829 .592 .607 .847 .800
PEH 5 paraesophageal hernias; SD 5 standard deviation; BMI 5 body mass index; ASA 5 American Society of Anesthesiologists; ASA I–II 5 no/mild disturbance, ASA III 5 severe disturbance, ASA IV–V 5 life threatening/moribund; COPD 5 chronic obstructive pulmonary disease; CKD 5 chronic kidney disease; GERD 5 gastroesophageal reflux disease; OSA 5 obstructive sleep apnea; MI 5 myocardial infarction; PCI 5 percutaneous coronary intervention; DVT 5 deep vein thrombosis; PE 5 pulmonary embolism; LRYGB 5 laparoscopic Roux-en-Y gastric bypass; LSG 5 laparoscopic sleeve gastrectomy.
Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754
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Table 2 Perioperative outcomes for patients undergoing bariatric surgery with and without PEH repair, shown before and after propensity match Outcome
Mortality Major complication Leak Bleed Reoperation Reintervention Readmission Cardiac event Pneumonia AKI VTE Deep SSI Wound disruption Sepsis Unplanned intubation Coma .24 hr CVA Any complication SSI Postoperative ventilation UTI Operative time, min
Unmatched cohort
P value
No PEH repair 222,320 (83.9%)
PEH repair 42,732 (16.1%)
246 (.1) 8358 (3.8) 1073 (.5) 2132 (1.0) 2770 (1.3) 3257 (1.5) 8927 (4.0) 168 (.1) 478 (.2) 334 (.2) 574 (.3) 597 (.3) 107 (.1) 249 (.1) 379 (.2) 7 (0) 21 (0) 9832 (4.4) 1585 (.7) 199 (.1) 775 (.4) 86.8 6 47.5
24 (.1) 1489 (3.5) 166 (.4) 323 (.8) 528 (1.2) 564 (1.3) 1710 (4.0) 21 (.1) 77 (.2) 54 (.1) 129 (.3) 95 (.2) 15 (0) 44 (.1) 51 (.1) 1 (0) 6 (0) 1728 (4.0) 237 (.6) 24 (.1) 133 (.3) 87.0 6 44.3
.001 .006 .009 ,.001 .860 .021 .895 .061 .149 .237 .108 .086 .250 .607 .016 .781 .389 ,.001 ,.001 .029 .226 .417
Matched cohort
P value
No PEH repair 42,379 (50.0%)
PEH repair 42,379 (50.0%)
34 (.1) 1423 (3.4) 177 (.4) 365 (.9) 470 (1.1) 556 (1.3) 1520 (3.6) 26 (.1) 80 (.2) 41 (.1) 113 (.3) 89 (.2) 15 (0) 42 (.1) 66 (.2) 1 (0) 3 (0) 1664 (3.9) 245 (.6) 25 (.1) 134 (.3) 80.2 6 43.5
24 (.1) 1476 (3.5) 165 (.4) 321 (.8) 526 (1.2) 561 (1.3) 1692 (4.0) 21 (.1) 77 (.2) 54 (.1) 123 (.3) 95 (.2) 15 (0) 44 (.1) 51 (.1) 1 (0) 6 (0) 1710 (4.0) 235 (.6) 24 (.1) 130 (.3) 87.1 6 44.4
.189 .317 .516 .092 .074 .880 .002 .466 .811 .182 .514 .658 ..999 .829 .165 ..999 .317 .419 .647 .886 .805 ,.001
PEH 5 paraesophageal hernia; AKI 5 acute kidney injury; VTE 5 venous thromboembolism; SSI 5 surgical site infection; CVA 5 cerebral vascular accident; UTI 5 urinary tract infection.
Propensity scores were calculated using age, sex, procedure (LRYGB versus LSG), body mass index, race, gastroesophageal reflux disease, hypertension, hyperlipidemia, diabetes, chronic obstructive pulmonary disease, obstructive sleep apnea, smoking, oxygen dependency, American Society of Anesthesiologists classification, functional status, chronic steroid use, chronic kidney disease, dialysis, venous stasis, history of myocardial infarction, previous percutaneous coronary intervention, history of venous thromboembolism, and preoperative therapeutic anticoagulation. Patients who underwent concurrent PEH repair were matched 1 to 1 with patients who underwent only bariatric surgery, based on their propensity scores within a specified caliper distance of .2 standard deviations. This eliminated approximately 99% of variation due to potential confounders [9]. Univariate analysis was used to compare differences between patients undergoing bariatric surgery with and without PEH repair in both the unmatched and matched cohorts. A similar approach was used for our 2 subgroup analyses, which compared patients undergoing PEH repair with concurrent LRYGB versus LSG and mesh versus no mesh. Results Comparison of patients undergoing bariatric surgery with or without PEH repair A total of 265,052 patients undergoing bariatric surgery were included in the study. Of these, 42,732 (16.1%)
underwent concurrent PEH repair. The original cohorts differed significantly on a number of baseline variables, as seen in Table 1. For instance, there were significantly more females in the group with PEH repair (83.3% versus 78.2%, P , .001). In addition, PEH repair was more frequently performed with LSG than with LRYGB, with the former making up 82.6% of the PEH repair group compared to 69.4% of the group without PEH repair (P , .001). To control for differences in patient characteristics between groups, a propensity-matching algorithm was used to match 42,732 patients in the non-PEH repair cohort to patients who underwent concurrent repair. After propensity matching, major complications within 30 days were not significantly different between bariatric surgery only and concurrent PEH repair groups. Major complication rates were 3.4% for the bariatric surgery only cohort and 3.5% for the concurrent PEH cohort (P 5 .317). All other complications were statistically similar between groups (Table 2). Mortality was low in both cohorts and not statistically significant between groups (.1% versus .1%, P 5 .189). Operative time was slightly longer in the PEH cohort compared with the no PEH cohort (87.1 versus 80.2 min, P , .001). Readmission rates were also higher after concurrent PEH repair (4.0 versus 3.6%, P 5 .002). The most common reasons for readmission included nausea/vomiting, nonspecific abdominal pain, and unspecified, which were all more prevalent in the PEH repair group.
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Table 3 Perioperative outcomes for patients undergoing bariatric surgery with PEH repair stratified by procedure type, shown before and after propensity match Outcome
Mortality Major complication Leak Bleed Reoperation Reintervention Readmission Cardiac event Pneumonia AKI VTE Deep SSI Wound disruption Sepsis Unplanned intubation Coma .24 hr CVA Any complication SSI Postoperative ventilation UTI Operative time, min
Unmatched cohort
P value
LSG 35,279 (82.6%)
LRYGB 7453 (17.4%)
16 (.1) 968 (2.7) 107 (.3) 202 (.6) 336 (1.0) 352 (1.0) 1214 (3.4) 15 (0) 51 (.1) 34 (.1) 102 (.3) 57 (.2) 9 (0) 28 (.1) 32 (.1) 1 (0) 6 (0) 1125 (3.2) 134 (.4) 1 (0) 99 (.3) 78.1 6 36.4
8 (.1) 521 (7.0) 59 (.8) 121 (1.6) 192 (2.6) 212 (2.8) 496 (6.7) 6 (.1) 26 (.4) 20 (.3) 27 (.4) 38 (.5) 6 (.1) 16 (.2) 19 (.3) 0 (0) 0 (0) 603 (8.1) 103 (1.4) 0 (0) 34 (.5) 129.2 6 53.0
.040 ,.001 ,.001 ,.001 ,.001 ,.001 ,.001 .179 ,.001 ,.001 .296 ,.001 .021 .001 ,.001 .646 .260 ,.001 ,.001 ,.001 .013 ,.001
Matched cohort
P value
LSG 7441 (50.0%)
LRYGB 7441 (50.0%)
2 (0) 222 (3.0) 18 (.2) 49 (.7) 65 (.9) 94 (1.3) 242 (3.3) 6 (.1) 11 (.2) 11 (.2) 25 (.3) 15 (.2) 3 (0) 3 (0) 9 (.1) 0 (0) 2 (0) 262 (3.5) 39 (.5) 1 (0) 17 (.3) 80.1 6 37.3
8 (.1) 521 (7.0) 59 (.8) 121 (1.6) 192 (2.6) 212 (2.9) 495 (6.7) 6 (.1) 26 (.4) 20 (.3) 27 (.4) 38 (.5) 6 (.1) 16 (.2) 19 (.3) 0 (0) 0 (0) 603 (8.1) 103 (1.4) 13 (.2) 34 (.5) 129.3 6 53.0
.058 ,.001 ,.001 ,.001 ,.001 ,.001 ,.001 ..999 .014 .106 .781 .002 .317 .003 .059 ..999 .157 ,.001 ,.001 .001 .017 ,.001
PEH 5 paraesophageal hernia; LSG 5 laparoscopic sleeve gastrectomy; LRYGB 5 laparoscopic Roux-en-Y gastric bypass; AKI 5 acute kidney injury; VTE 5 venous thromboembolism; SSI 5 surgical site infection; CVA 5 cerebral vascular accident; UTI 5 urinary tract infection.
Stratified analysis by procedure type (LRYGB versus LSG) To assess for the potential influence of the primary bariatric procedure, a subgroup propensity-matched analysis was performed within the PEH repair cohort comparing patients undergoing LRYGB to those undergoing LSG. Of the 42,732 patients undergoing concurrent PEH repair, 7453 (17.4%) had LRYGB. Patients undergoing LRYGB and LSG were significantly different at baseline, but these differences were corrected after propensity matching. While 30-day mortality remained low and was comparable between the 2 groups (0% LSG versus .1% LRYGB, P 5 .058), the rate of major complications was significantly higher in the LRYGB subgroup (3.0% versus 7.0%, P , .001) (Table 3). This was due to higher rates of postoperative leak, bleed, reoperations, and reinterventions. These finding were consistent with patients who underwent bariatric surgery without PEH repair, among whom the rate of major complications was 3.0% for patients undergoing LSG and 6.3% for patients undergoing LRYGB (P , .001). Stratified analysis by use of mesh The method of hernia repair was then examined using a subgroup propensity-matched analysis to compare patients who had their PEH repaired with mesh versus those repaired primarily. Of the 42,732 patients undergoing concurrent PEH repair, 2569 (6.0%) were done with mesh. After
correcting for baseline differences by propensity matching, the majority of outcomes were comparable between the 2 groups (Table 4), including 30-day mortality (0% no mesh versus .1% mesh, P 5 .083) and major complications within 30 days (4.0% no mesh versus 3.9% mesh, P 5 .774) (Table 5). Unplanned intubation (0% versus .2%, P 5 .025) and operative time were significantly higher in the group with mesh (87.9 versus 107.2 min, P , .001). Discussion To our knowledge, this study presents the first analysis of the role of concurrent PEH repair at the time of bariatric surgery. Using the MBSAQIP database from 2015 to 2016, we identified a total of 265,052 patients who underwent bariatric surgery, of whom 42,732 (16.1%) underwent concurrent repair. No difference was observed in unadjusted major complications between primary bariatric surgery in comparison to concurrent PEH repair; however, readmission rates were higher after concurrent repair (4.0 versus 3.6%; P 5 .002). After correcting for baseline differences using propensity score matching, outcomes stratified by procedure type and method of repair were examined. The rate of major complications was found to be significantly higher in the concurrent repair LRYGB subgroup compared with LSG patients (3.0% versus 7.0%; P , .001) as a result of the inherent increased complication rate of the LRYGB procedure. Taken together, our findings demonstrate the safety of
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Table 4 Baseline characteristics of patients undergoing bariatric surgery with PEH repair, stratified by use of mesh Patient characteristic
Age, yr Mean 6 SD ,18 18–30 30–40 40–50 50–60 60 Female Race White Black Other BMI, kg/m2 Mean 6 SD 35–40 40–45 45–50 50–60 .60 Functional status Independent Partially dependent Fully dependent ASA classification I–II III IV–V Current smoker Diabetes No Noninsulin dependent Insulin dependent COPD O₂ dependency Chronic steroid use Anticoagulant use CKD Dialysis dependent GERD Hyperlipidemia Hypertension OSA Previous MI Previous PCI Previous DVT Previous PE Venous stasis
Unmatched cohort
P value
No mesh 40,048 (93.7%)
Mesh 2684 (6.3%)
46.2 6 12.0 211 (.5) 3381 (8.4) 9246 (23.1) 11,446 (28.6) 12,927 (32.3) 2837 (7.1) 33,255 (83.0)
47.4 6 11.8 11 (.4) 174 (6.5) 562 (20.9) 785 (29.3) 943 (35.1) 209 (7.8) 2329 (86.8)
29,824 (74.5) 7444 (18.6) 2780 (6.9)
2060 (76.8) 525 (19.6) 99 (3.7)
44.4 6 7.1 11,756 (29.6) 13,431 (33.8) 7593 (19.1) 5706 (14.4) 1280 (3.2)
Matched cohort
P value
No mesh 2569 (50.0%)
Mesh 2569 (50.0%)
47.5 6 12.2 7 (.3) 201 (7.8) 538 (20.9) 704 (27.4) 884 (34.4) 235 (9.2) 2192 (85.3)
47.3 6 11.8 11 (.4) 168 (6.5) 537 (20.9) 756 (29.4) 898 (35.0) 199 (7.8) 2228 (86.7)
,.001
1989 (77.4) 441 (17.2) 139 (5.4)
1963 (76.4) 513 (20.0) 93 (3.6)
.001
44.8 6 7.5 751 (28.2) 868 (32.6) 516 (19.4) 407 (15.3) 124 (4.7)
.001 .001
45.1 6 8.1 718 (28.2) 804 (31.6) 537 (21.1) 380 (14.9) 109 (4.3)
44.9 6 7.6 711 (27.9) 826 (32.4) 498 (19.5) 395 (15.5) 121 (4.7)
.463 .607
39,659 (99.0) 203 (.5) 186 (.5)
2656 (99.0) 22 (.8) 6 (.2)
.019
2552 (99.3) 13 (.5) 4 (.2)
2542 (99.0) 21 (.8) 6 (.2)
.316
10,553 (26.5) 28,178 (70.8) 1084 (2.7) 3345 (8.4)
565 (22.0) 1866 (72.6) 138 (5.4) 215 (8.0)
,.001
501 (19.5) 1965 (76.5) 103 (4.0) 203 (7.1)
565 (22.0) 1866 (72.6) 138 (5.4) 206 (8.0)
.003
31,323 (78.2) 6185 (15.4) 2540 (6.3) 706 (1.8) 198 (.5) 655 (1.6) 866 (2.2) 235 (.6) 83 (.21) 14,248 (35.6) 9284 (23.2) 19,569 (48.9) 14,057 (35.1) 523 (1.3) 839 (2.1) 595 (1.5) 385 (1.0) 472 (1.2)
2054 (76.5) 436 (16.2) 194 (7.2) 54 (2.0) 28 (1.0) 40 (1.5) 69 (2.6) 20 (.8) 8 (.3) 1155 (43.0) 683 (25.5) 1515 (56.5) 953 (35.5) 49 (1.8) 65 (2.4) 48 (1.8) 41 (1.5) 16 (.6)
1973 (76.8) 408 (15.9) 188 (7.3) 63 (2.5) 37 (1.4) 34 (1.3) 66 (2.6) 17 (.7) 5 (.2) 1089 (42.4) 663 (25.8) 1461 (56.9) 897 (34.9) 48 (1.9) 74 (2.9) 43 (1.7) 43 (1.7) 19 (.7)
1960 (76.3) 423 (16.5) 186 (7.2) 54 (2.1) 28 (1.1) 40 (1.6) 60 (2.3) 15 (.6) 7 (.3) 1086 (42.3) 661 (25.7) 1463 (57.0) 916 (35.7) 48 (1.9) 61 (2.4) 40 (1.6) 40 (1.6) 16 (.6)
,.001 ,.001
,.001
.535 .080
.345 ,.001 .565 .161 .302 .323 ,.001 .007 ,.001 .669 .023 .255 .212 .004 .006
.632 .118
.147
.877 0.850
.400 .261 .482 .588 .723 .563 .932 .949 .955 .579 ..999 .257 .740 .740 .611
PEH 5 paraesophageal hernia; SD 5 standard deviation; BMI 5 body mass index; ASA 5 American Society of Anesthesiologists; ASA I–II 5 no/mild disturbance, ASA III 5 severe disturbance, ASA IV–V 5 life threatening/moribund; COPD 5 chronic obstructive pulmonary disease; CKD 5 chronic kidney disease; GERD 5 gastroesophageal reflux disease; OSA 5 obstructive sleep apnea; MI 5 myocardial infarction; PCI 5 percutaneous coronary intervention; DVT 5 deep vein thrombosis; PE 5 pulmonary embolism. Cohorts shown before and after propensity match.
concurrent PEH repair and bariatric surgery compared with bariatric surgery alone. A multicenter retrospective study by Kothari et al. [10], looked at concurrent hiatus hernia repair (including both
sliding and PEH) in 644 patients undergoing specifically LRYGB and found no difference in 30-day morbidity or mortality compared with surgery without hiatus hernia repair. Ours is one of the few studies that looks specifically
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Joshua Hefler et al. / Surgery for Obesity and Related Diseases 15 (2019) 1746–1754 Table 5 Perioperative outcomes for patients undergoing bariatric surgery with PEH repair, stratified by use of mesh Outcome
Mortality Major complication Leak Bleed Reoperation Reintervention Readmission Cardiac event Pneumonia AKI VTE Deep SSI Wound disruption Sepsis Unplanned intubation Coma .24 hr CVA Any complication SSI Postoperative ventilation UTI Operative time, min
Unmatched cohort
P value
No mesh 40,048 (93.7%)
Mesh 2684 (6.3%)
21 (.1) 1384 (3.5) 157 (.4) 308 (.8) 498 (1.2) 526 (1.3) 1582 (4.0) 18 (0) 68 (.2) 45 (.1) 112 (.3) 86 (.2) 15 (0) 40 (.1) 46 (.1) 1 (0) 6 (0) 1608 (4.0) 219 (.6) 22 (.1) 127 (.3) 85.7 6 43.3
3 (.1) 105 (3.9) 9 (.3) 15 (.6) 30 (1.1) 38 (1.4) 127 (4.7) 3 (.1) 9 (.3) 9 (.3) 17 (.6) 9 (.3) 0 (0) 4 (.2) 5 (.2) 0 (0) 0 (0) 120 (4.5) 18 (0.7) 2 (0.1) 6 (.2) 106.2 6 54.1
.209 .212 .648 .224 .568 .653 .046 .130 .050 .002 .001 .199 .316 .442 .299 .796 .526 .246 .403 .678 .399 ,.001
Matched cohort
P value
No Mesh 2569 (50.0%)
Mesh 2569 (50.0%)
0 (0) 103 (4.0) 11 (.4) 21 (.8) 32 (1.3) 42 (1.6) 120 (4.7) 1 (0) 8 (.3) 3 (.1) 12 (.5) 10 (.4) 2 (.1) 2 (.1) 0 (0) 0 (0) 0 (0) 122 (4.8) 22 (.9) 2 (.1) 12 (.5) 87.9 6 43.7
3 (.1) 99 (3.9) 9 (.4) 15 (.6) 29 (1.1) 37 (1.4) 120 (4.7) 3 (.1) 9 (.4) 9 (.4) 13 (.5) 9 (.4) 0 (0) 4 (.2) 5 (.2) 0 (0) 0 (0) 113 (4.4) 18 (.7) 2 (.1) 5 (.2) 107.2 6 54.7
.083 .774 .654 .316 .699 .571 ..999 .317 .808 .083 .841 .818 .157 .414 .025 ..999 ..999 .548 .525 ..999 .089 ,.001
PEH 5 paraesophageal hernia; AKI 5 acute kidney injury; VTE 5 venous thromboembolism; SSI 5 surgical site infection; CVA 5 cerebral vascular accident; UTI 5 urinary tract infection. Cohorts shown before and after propensity match.
at PEH repair, excluding sliding hernias, as small sliding hernias may not require repair in patients undergoing bariatric surgery. Shada et al. [11] completed a similar analysis on concurrent bariatric surgery and PEH repair. This study included 17,856 patients using data from the National Surgical Quality Improvement Program. Consistent with our study, they found no difference in 30-day morbidity and mortality between matched cohorts and reported rates similar to those to our study (3.70% and .13% for morbidity and mortality in the PEH cohort, respectively). However, with .80,000 patients included in the final analysis, the MBSAQIP cohort is the largest retrospective study to date addressing concurrent PEH repair. To our knowledge, no comparable prospective studies have been conducted. The main finding of our subgroup analysis was a higher incidence of major complications among patients undergoing LRYGB compared with LSG with concurrent PEH repair. The 30-day mortality rate trended toward statistical significance but did not reach it (P 5 .058). This is presumably due to the greater technical complexity of LRYGB compared with LSG, with the former involving 2 enteric anastomoses in addition to a portion of stapled stomach [12]. The higher morbidity for LRYGB has been well documented in prior studies [13]. For instance, Young et al. [14] reported an odds ratio of 1.32 (95% confidence interval 1.11–1.56, P , .01) for 30-day major morbidity in LRYGB compared with LSG. Shada et al. [11] reported findings for
similar subgroups with their analysis of the National Surgical Quality Improvement Program data. They also found a statistically significant difference in 30-day overall morbidity, with rates of 6.20% and 2.69% for the LRYGB and LSG cohorts, respectively (P , .001). We found similar results when we repeated the analysis using patients from our study group who had undergone bariatric surgery without PEH repair, suggesting that the increased complication rate observed in the subgroup analysis was a result of the technical complexity of the LRYGB procedure and not due to concurrent PEH repair. Therefore, in patients undergoing concurrent PEH repair, LRYGB and LSG are both safe options, and there appears to be no inherently increased risk to performing concurrent PEH repair. The majority of concurrent PEH repairs were performed in patients who underwent LSG. Performing LSG in the presence of a PEH is controversial because LSG has the potential to dramatically worsen gastroesophageal reflux disease. Reporting results from their longitudinal database, DePree et al. [12] found 19% of patients undergoing LSG with preexisting gastroesophageal reflux disease had worsening of their symptoms postoperatively compared with only 5% of patients undergoing LRYGB. Several factors are thought to contribute to this finding, including a decrease in lower esophageal sphincter tone, sleeve size and shape (whether overly dilated or narrowed), and disruption of the antropyloric pump [15–17]. Generally, more LSGs are
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performed than LRYGBs owing to the lower complexity of the procedure, but the reverse may be expected for patients with PEH in light of this finding. It is possible that LSG with concurrent PEH repair may be done only in the presence of small, asymptomatic PEHs; however, these details cannot be delineated from the MBSAQIP data set. To our knowledge, the issue of whether to use mesh has not previously been studied in this population. We found no difference in complications between patients who received mesh and those who did not, only a longer operative time, as might be expected. Caution must be taken in interpreting these results because we are unable to determine the type of mesh used (biologic versus synthetic) or the indication for its use. When the goal is solely PEH repair, use of a biologic mesh may delay, but not ultimately prevent, long-term recurrence [18]. Separate randomized trials using follow-up times of 6 months and 5 years have shown recurrence to be decreased with mesh with the former but equivalent with the latter study [19,20]. A systematic review and meta-analysis by Memon et al. [21] found 4 randomized control trials comparing primary repair with repair with synthetic mesh. They found reinforcement with synthetic mesh reduced rates of reoperation, but no statistically significant difference in recurrence or complications was noted. Understandably, the routine use of synthetic mesh is not widely practiced given its minimal benefit and the significant morbidity associated with complications such as mesh infection or erosion into the esophagus or gastric cardia [17]. Mesh is more commonly used in cases where the chance of recurrence is higher, such as with large hernia defects or significantly attenuated crura. Limitations A major limitation of using data from the MBSAQIP database is that the database only records outcomes within the first 30 days of surgery. Long-term data on the durability of the repair, including development of new or recurrent symptoms, and need for reintervention or reoperation cannot be assessed. Given this limitation, results of this study can only comment on the early implications of this added procedure and not on the success of the repair or the altered trajectory of the natural history of the hiatal hernia. Furthermore, granular details are not available from the MBSAQIP database regarding the size of the defect, extent of herniation, experience of the surgeon, and type of repair, thus restricting our ability to analyze these important factors. Rates of complications may also differ by surgical center, with higher surgical volumes potentially leading to lower complications. This would be relevant if patients undergoing concurrent PEH repair are more likely to be treated at a larger center; however, the MBSAQIP database does not contain this information. Another consideration is that we do not know whether patients not undergoing PEH repair
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had a PEH at the time of surgery. Acknowledging this limitation, there is a potential for our findings to be attributed to the presence of PEH itself rather than the surgical repair. Despite these limitations, our study presents the most robust data regarding the short-term safety of concurrent PEH repair during bariatric surgery. Conclusion Our analysis indicates that the incidence of major complications for bariatric surgery with concurrent PEH repair is similar to that with bariatric surgery alone. Overall, this study demonstrates the safety of concurrent bariatric surgery and PEH repair. Further studies are needed to identify the optimal timing and technique for concurrent repair during bariatric surgery. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Berstad A, Weberg R, Frøyshov Larsen I, Hoel B, Hauer-Jensen M. Relationship of hiatus hernia to reflux oesophagitis. A prospective study of coincidence, using endoscopy. Scand J Gastroenterol 1986;21(1):55–8. [2] Wright RA, Hurwitz AL. Relationship of hiatal hernia to endoscopically proved reflux esophagitis. Dig Dis Sci 1979;24(4):311–3. [3] Che F, Nguyen B, Cohen A, Nguyen NT. Prevalence of hiatal hernia in the morbidly obese. Surg Obes Relat Dis 2013;9(6):920–4. [4] Sutherland V, Kuwada T, Gersin K, Simms C, Stefanidis D. Impact of bariatric surgery on hiatal hernia repair outcomes. Am Surg 2016;82(8):743–7. [5] Resources for Optimal Care of the Metabolic and Bariatric Surgery Patient 2016 [homepage on the Internet]. Chicago: American College of Surgeons; c1996-2019 [updated 2016 Jan 1; cited 2019 Apr 27]. Available from: https://www.facs.org/w/media/files/quality%20programs/ bariatric/mbsaqip%20standardsmanual.ashx. [6] User Guide for the 2016 Participant Use Data File (PUF) [homepage on the Internet]. Chicago: American College of Surgeons; c19962019 [updated 2016 Jan 1; cited 2019 Apr 27]. Available from: https://www.facs.org/w/media/files/quality%20programs/bariatric/ mbsaqip_2016_puf_user_guide.ashx. [7] What is CPTÒ? [homepage on the Internet]. Salt Lake City: AAPC; c2019 [cited 2018 Oct 1. Available from: https://www.aapc.com/ resources/medical-coding/cpt.aspx. [8] Becker S, Ichino A. Estimation of average treatment effects based on propensity scores. Stata J 2002;2(4):358–77. [9] Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res 2011;46(3):399–424. [10] Kothari V, Shaligram A, Reynoso J, Schmidt E, McBride CL, Oleynikov D. Impact on perioperative outcomes of concomitant hiatal hernia repair with laparoscopic gastric bypass. Obes Surg 2012;22(10):1607–10. [11] Shada AL, Stem M, Funk LM, Greenberg JA, Lidor AO. Concurrent bariatric surgery and paraesophageal hernia repair: comparison of sleeve gastrectomy and Roux-en-Y gastric bypass. Surg Obes Relat Dis 2018;14(1):8–13.
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[17] Keidar A, Appelbaum L, Schweiger C, Elazary R, Baltasar A. Dilated upper sleeve can be associated with severe postoperative gastroesophageal dysmotility and reflux. Obes Surg 2010;20(2):140–7. [18] Lebenthal A, Waterford SD, Fisichella PM. Treatment and controversies in paraesophageal hernia repair. Front Surg 2015;2:13. [19] Oelschlager BK, Pellegrini CA, Hunter JG, et al. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg 2011;213(4):461–8. [20] M€uller-Stich BP, Holzinger F, Kapp T, Klaiber C. Laparoscopic hiatal hernia repair: long-term outcome with the focus on the influence of mesh reinforcement. Surg Endosc 2006;20(3):380–4. [21] Memon MA, Memon B, Yunus RM, Khan S. Suture cruroplasty versus prosthetic hiatal herniorrhaphy for large hiatal hernia: a meta-analysis and systematic review of randomized controlled trials. Ann Surg 2016;263(2):258–66.