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Global 30-day outcomes after bariatric surgery during the COVID-19 pandemic (GENEVA): an international cohort study

2020; Elsevier BV; Volume: 9; Issue: 1 Linguagem: Inglês

10.1016/s2213-8587(20)30375-2

2213-8595

Rishi Singhal, Abd A. Tahrani, Christian Ludwig, Kamal Mahawar, A Abou-Mrad-Fricquegnon, A Alasfur, Andreas Alexandrou, Arnaldo Prata‐Barbosa, Amreen Bashir, Anna Bosco, Alexandros Charalabopoulos, Anna Curell, Amirhossein Davarpanah Jazi, Alfonso Diego, Abdelrahman Elghandour, Anıl Ergin, Arturo García, Ahmad Ghazal, Ashraf Haddad, Ainitze Ibarzábal, A Khazraji, Azmi Lale, André Lázaro, Adolfo Leyva‐Alvizo, Arnaud Liagre, Almantas Maleckas, Afaf Sayed Osman, Athanasios Pantelis, Abdolreza Pazouki, Andreas Plamper, Asnat Raziel, A Rizzi, Ángel Sánchez, Ankur Sharma, Antonio Spaventa, Aziz Sümer, Antonio Torres, Ahmet Gökhan Türkçapar, Ayushka Ugale, Andrey Velikorechin, Antonio Vitiello, Bilal Alkhaffaf, Benoit Bomans, BJ Ammori, B Pares, Bogdan Smeu, Bruno Zilberstein, Clara Boeker, Carl-Magnus Brodén, Cătălin Copăescu, Christian Guevara, Cem Emir Güldoğan, Cüneyt Kırkıl, Christophe Matthys, Carlo Nagliati, Chetan Parmar, Cecília de Souza Menezes Trindade, Camila Teixeira Vaz, Cácio Ricardo Wietzycoski, Carlos Zerrweck, Deepa Bedi, Domenico Marchi, Dadang Mutha Wali Faraj, Diego Foschi, David Goitein, David Hazzan, Dimitris P. Lapatsanis, Davide Mazza, D Mohammed, Diana Paola Padilla‐Armendariz, Damiano Pennisi, Dung Thi Pham, Dimitri J. Pournaras, Dingeman J. Swank, Divy Thakkar, Esther Baena, Efstratia Baili, Eduardo Lemos de Souza Bastos, Evren Dilektaşlı, Eric J. Hazebroek, Edward H. Kaplan, Edmundo Pessoa Lopes, Emilio Manno, Enrico Pinotti, Elias Sdralis, Francisco J. Barrera-Rodriguez, Francesco Cantù, Francesco Frattini, F. De Martini, Giovanna Berardi, G Cesana, Giovanni Dapri, Georgiana Dinescu, Gildas Juglard, Gabriel Martinez De Aragon, Gabriel Menaldi, Gürdal Ören, Giovanna Pavone, G. L. Rana, Gavriella Zoi Vrakopoulou, Hany Mohamed Aboshanab, Hadeel Al-Momani, Hany Balamoun, Hüseyin Çiyiltepe, H de Vasconcelos Cunha, Hosam Elghadban, H. Gislason, Hosam Hamed, Hosam Hamed, Helen Heneghan, Havidz Ibrahim, Hamid Melali, Hernán Reyes, Hugues Sebbag, Ibrahim Hakami, Ionuţ Hutopilă, José M. Balibrea, Janine Bernardo, José Luis Campos, Jean-Marie Chevallier, J. Dargent, José L. Estrada, J. S. León González, James Hewes, Jacqués Himpens, Julian W. Mall, Jerónimo Monterrubio, Jorge Pasquier, Konstadinos Albanopoulos, Katarzyna Bartosiak, Krzysztof Kaseja, K Kumar, Karl Peter Rheinwalt, Kamran Shah, Kelly van de Pas, Luigi Angrisani, Laura Benuzzi, Lynn Chong, Laurent Layani, L Lee, Luis Level, Lockwood G. Taylor, Lamia Zinaï, Murat Akbaba, Mata Mendoza Dr. Alejandro, Mohammad Altarawni, Marc Beisani, M Bertrand, Maria Grazia Cantù, Murat Dinçer, M Elbanna, Mohamad Hayssam ElFawal, M Focquet, Mauricio Forero, Matthew J. Hadad, Michael W. Hii, Michele Iovino, Md. Ariful Islam, Miguel Josa, М. Л. Каплан, Mohammad Kermansaravi, Manish Khaitan, Mehmet Kızılkaya, Maciej Kotowski, Monica Montouri, Mario Musella, Mahendra Narwaria, Manuel Navarro, Muhammad Niazi, Mehmet Mahir Özmen, Mohamed Qassem, Marleen M. Romeijn, Mohamed Said, Mohammed Salman, M Solovyeva, Mazen Takieddine, Matteo Uccelli, Murat Üstün, Mahidhar Valeti, Maciej Wałędziak, Nitin Arora, Nandkishore Dukkipati, Naomi Fearon, Nalini Kiran, Nicolás Paleari, Nasser Sakran, N Silva, Nicola Tartaglia, Ömer Önder Savaş, Ozan Şen, Octávio Viveiros, Paola Fabbri, Pablo García, Piotr Major, Patricia Beltrán Martínez, Pedro Martínez Duartez, Paulina Salminen, P Shah, Riddish Gadani, Rıdvan Gokay, Rita Gudaitytė, Radwan Kassir, Robert I. Liem, Rajeev Mohan, Rossella Palma, Reynaldo Quinino, Rui Ribeiro, Ramón Vilallonga, Sebastián Arana-Garza, Sonja Chiappetta, Spyridon Davakis, Sumaya Ghareeb, Sergio Alonso y Gregorio, Soumaya Khaldi, Sandra Santarrufina Martínez, Sietske Okkema, Stefano Olmi, S. Ortiz, Silvia Piñango, Shashank Shah, Saeed Shahabi, Safwan Taha, Surendra Ugale, Thiago Alvim Barreiro, Thorsten Beck, Tigran Poghosyan, Tarig A. Samarkandy, T. Yi̇ği̇t, V. Borrelli, Vincenzo Bottino, V. Marco, V.M. Ormando, V Pol, Valentin Sierra Esteban, Victor Valentí, Wouter K. G. Leclercq, Wanderley de Souza, Wouter Vening, Wouter Vleeschouwers, Yonta van der Burgh,

Bariatric Surgery and Outcomes

Bariatric and metabolic surgery (BMS) is the most effective intervention available for weight loss. However, the high morbidity and mortality associated with perioperative COVID-191COVIDSurg CollaborativeMortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study.Lancet. 2020; 396: 27-38Summary Full Text Full Text PDF PubMed Scopus (1220) Google Scholar has led to the cancellation of millions of surgeries including BMS procedures. There are also concerns that obesity treatment, including BMS, might be especially overlooked in the COVID-19 recovery era due to obesity stigma,2Le Brocq S Clare K Bryant M Roberts K Tahrani A on behalf of the writing group from Obesity UKthe Obesity Empowerment Networkthe UK Association for the Study of ObesityObesity and COVID-19: a call for action from people living with obesity.Lancet Diabetes Endocrinol. 2020; 8: 652-654Summary Full Text Full Text PDF PubMed Scopus (36) Google Scholar leading the BMS community to develop recommendations for the management of candidates for BMS in the context of COVID-19.3Rubino F Cohen RV Mingrone G et al.Bariatric and metabolic surgery during and after the COVID-19 pandemic: DSS recommendations for management of surgical candidates and postoperative patients and prioritisation of access to surgery.Lancet Diabetes Endocrinol. 2020; 8: 640-648Summary Full Text Full Text PDF PubMed Scopus (129) Google Scholar There is a paucity of data on the safety of BMS performed during the COVID-19 pandemic once the pandemic had become established and recognised. Therefore, we did an international cohort study (GENEVA) to investigate the 30-day morbidity and mortality of primary BMS done in adults (≥18 years) between May 1 and July 10, 2020. Complications were recorded by use of the Clavien-Dindo (CD) classification system, which is widely regarded as the accepted method for reporting surgical complications. Detailed methods are described in the appendix (pp 2–5). 2116 adult patients from 133 hospitals in 38 countries underwent primary BMS during the study period. Of these, 2001 (94·6%) patients, from 218 surgeons at 127 hospitals in 35 countries, had complete 30-day morbidity and mortality data available by Aug 15, 2020 (appendix p 6). Of the 35 countries with included patients, 12 had their peak incidence of COVID-19 before May 1, 2020 (883 patients [44·1%]); another 12 had their peak during the data collection period (811 patients [40·5%]); and the remaining 11 had their peak after Aug 10, 2020 (ie, after end of follow up; 307 patients [15·3%]; appendix p 7). Baseline demographic and clinical characteristics and types of surgery done are summarised in the appendix (pp 8). There was one death (18 days after surgery) in a patient who had a leak following sleeve gastrectomy (SG). This patient was COVID-19 negative. At 30 days, 138 complications were reported in 137 (6·8%) of 2001 patients, including ten cases of COVID-19 (table). Most complications (n=83 [60·6%]) were mild (CD grade I or II). Patients who developed complications tended to be older and were more likely to be current or ex-smokers (vs non-smokers). Fewer complications occurred with more experienced surgeons (appendix p 9).Table30-day morbidity and mortality for all patients and by bariatric procedureAll patients (n=2001)SG (n=1142 [57%])RYGB (n=557 [28%])OAGB (n=215 [11%])Other*Other procedures listed in appendix p 12. (n=87 [4%])Complications by CD classification system gradeAll complications137 (6·8%)65 (5·7%)47 (8·4%)19 (8·8%)6 (6·9%)CD grades I and II83 (4·1%)41 (3·6%)29 (5·2%)8 (3·7%)5 (5·7%)CD grades III, IV, and V54 (2·7%)24 (2·1%)18 (3·2%)11 (5·1%)1 (1·1%)CD grade I42 (2·1%)20 (1·8%)17 (3·1%)3 (1·4%)2 (2·3%)CD grade II41 (2·0%)21 (1·8%)12 (2·2%)5 (2·3%)3 (3·4%)CD grade IIIa10 (0·5%)3 (0·3%)3 (0·5%)4 (1·9%)0CD grade IIIb29 (1·4%)14 (1·2%)9 (1·6%)6 (2·8%)0CD grade IVa12 (0·6%)5 (0·4%)6 (1·1%)1 (0·5%)0CD grade IVb2 (0·1%)1 (0·1%)001 (1·1%)CD grade V (death)1 (0·05%)1 (0·1%)000COVID-19Symptomatic COVID-1910 (0·5%)8 (0·7%)1 (0·2%)01 (1·1%)Specific complicationsBleeding36 (1·8%)19 (1·7%)11 (2·0%)6 (2·8%)0Leak from gastrointestinal tract16 (0·8%)9 (0·8%)2 (0·4%)5 (2·3%)0Wound infection10 (0·5%)4 (0·4%)4 (0·7%)02 (2·3%)Postoperative pneumonia (not otherwise specified)5 (0·2%)04 (0·7%)1 (0·5%)0Deep vein thrombosis1 (0·05%)1 (0·1%)000Pulmonary embolism1 (0·05%)1 (0·1%)000Other†Other complications listed in appendix p 12.59 (2·9%)24 (2·1%)25 (4·5%)7 (3·3%)3 (3·4%)Data are number (%) of patients with at least one specified event; if a patient had more than one complication, the highest CD score is reported. Data include all adverse events from time of surgery up to 30-days postoperatively. SG=sleeve gastrectomy. RYGB= Roux-en-Y gastric bypass. OAGB=one-anastomosis gastric bypass. CD=Clavien-Dindo.* Other procedures listed in appendix p 12.† Other complications listed in appendix p 12. Open table in a new tab Data are number (%) of patients with at least one specified event; if a patient had more than one complication, the highest CD score is reported. Data include all adverse events from time of surgery up to 30-days postoperatively. SG=sleeve gastrectomy. RYGB= Roux-en-Y gastric bypass. OAGB=one-anastomosis gastric bypass. CD=Clavien-Dindo. There were ten (0·5%) symptomatic COVID-19 cases diagnosed during the 30-day follow-up. These were in Egypt (n=4), Brazil (n=2), Mexico (n=2), Argentina (n=1), and India (n=1; appendix p 10). Eight of these patients were from countries (Brazil, Egypt, and Mexico) that had their COVID-19 peak during the study period. Two of the ten patients had no preoperative testing for SARS-CoV-2, seven required no treatment, none needed intensive care or ventilation, and none died. 1593 (79·6%) of the 2001 patients in the study underwent some preoperative testing for COVID-19. Perioperative COVID-19 protocols in place during the study period are summarised in the appendix (p11). The overall 30-day mortality of 0·05% (1/2001) seen in this study is consistent with the pre-pandemic figures reported in BMS studies (0·04–0·1%)4Poelemeijer YQM Liem RSL Våge V et al.Gastric bypass versus sleeve gastrectomy: patient selection and short-term outcome of 47,101 primary operations from the Swedish, Norwegian, and Dutch national quality registries.Ann Surg. 2020; 272: 326-333Crossref PubMed Scopus (33) Google Scholar, 5Benotti P Wood GC Winegar DA et al.Risk factors associated with mortality after Roux-en-Y gastric bypass surgery.Ann Surg. 2014; 259: 123-130Crossref PubMed Scopus (107) Google Scholar, 6Stenberg E Szabo E Ågren G et al.Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial.Lancet. 2016; 387: 1397-1404Summary Full Text Full Text PDF PubMed Scopus (196) Google Scholar and the 30-day mortality of about 0·1% (1/1142) with SG in this study is similar to the figure of 0·1% reported in a study of 29 588 patients.7Alizadeh RF Li S Gambhir S et al.Laparoscopic sleeve gastrectomy or laparoscopic gastric bypass for patients with metabolic syndrome: an MBSAQIP analysis.Am Surg. 2019; 85: 1108-1112Crossref PubMed Google Scholar In a recent systematic review,8Hu Z Sun J Li R et al.A comprehensive comparison of LRYGB and LSG in obese patients including the effects on QoL, comorbidities, weight loss, and complications: a systematic review and meta-analysis.Obes Surg. 2020; 30: 819-827Crossref PubMed Scopus (42) Google Scholar 30-day complications occurred in 10·1% (319/3155) of patients who had Roux-en-Y gastric bypass (RYGB) and in 5·4% (155/2876) of patients who had SG, which is similar to the rates seen in our study (8·4% and 5·7%, respectively; table). Similarly, Stenberg and colleagues6Stenberg E Szabo E Ågren G et al.Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial.Lancet. 2016; 387: 1397-1404Summary Full Text Full Text PDF PubMed Scopus (196) Google Scholar reported 7·8% (196/2503) of patients with 30-day complications following RYGB.6Stenberg E Szabo E Ågren G et al.Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial.Lancet. 2016; 387: 1397-1404Summary Full Text Full Text PDF PubMed Scopus (196) Google Scholar The rates of 30-day severe complications (CD grade III, IV, or V) with RYGB and SG in this study (3·2% and 2·1%, respectively; table) are also similar to those reported in previous studies.4Poelemeijer YQM Liem RSL Våge V et al.Gastric bypass versus sleeve gastrectomy: patient selection and short-term outcome of 47,101 primary operations from the Swedish, Norwegian, and Dutch national quality registries.Ann Surg. 2020; 272: 326-333Crossref PubMed Scopus (33) Google Scholar, 6Stenberg E Szabo E Ågren G et al.Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial.Lancet. 2016; 387: 1397-1404Summary Full Text Full Text PDF PubMed Scopus (196) Google Scholar, 7Alizadeh RF Li S Gambhir S et al.Laparoscopic sleeve gastrectomy or laparoscopic gastric bypass for patients with metabolic syndrome: an MBSAQIP analysis.Am Surg. 2019; 85: 1108-1112Crossref PubMed Google Scholar Of the ten patients with symptomatic postoperative COVID-19, none needed ventilation and none died; all were CD grade I or II complications. This finding contrasts with data from the COVIDSurg Collaborative,1COVIDSurg CollaborativeMortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study.Lancet. 2020; 396: 27-38Summary Full Text Full Text PDF PubMed Scopus (1220) Google Scholar which reported pulmonary complications in half of patients undergoing various emergency or elective surgeries and a 30-day mortality of 23·8%. This striking difference is particularly notable given that obesity is associated with an increased risk of severe COVID-19, so the patients in our study might be at increased risk compared with other patients. However, unlike our study, the COVIDSurg analysis assessed surgeries done during a period early in the pandemic before local perioperative COVID-19 protocols were well established, which might help to account for the lower morbidity and mortality in our study. Another important factor in this regard might be the timing of the COVID-19. It is possible that those individuals with COVID-19 at the time of the surgery have a worse prognosis than do those who develop clinical disease several days later. Our study included countries with variable timing of COVID-19 peak in relation to the study period. Local heterogeneity in COVID-19 prevalence might have contributed to the small number of symptomatic COVID-19 cases among the patients in our study. Notably, the few COVID-19 cases were in countries with widespread COVID-19 and other countries with widespread COVID-19 had no symptomatic cases in the study. As such, we believe that our finding of a low number of postoperative symptomatic COVID-19 cases is likely reflective of the presence and efficacy of local perioperative COVID-19 protocols. Because of the potential for a time gap between BMS and a patient becoming infected with SARS-CoV-2, developing symptoms, requiring ventilation, and potential mortality or other outcomes, there is a possibility that some adverse outcomes that developed after 30-days might have not have been captured in the study. However, the study population was at high risk of severe COVID-19 (due to obesity, diabetes, hypertension, and cardiovascular disease) and the median incubation period for COVID-19 is about 4 days. As such, it is likely that our study identified the majority of symptomatic COVID-19 cases that developed in the study population. Unsurprisingly, SG, RYGB, and one-anastomosis gastric bypass accounted for more than 95% of all primary procedures, which is in keeping with the last two International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) global reports.9Welbourn R Hollyman M Kinsman R et al.Bariatric surgery worldwide: baseline demographic description and one-year outcomes from the fourth IFSO Global Registry report 2018.Obes Surg. 2019; 29: 782-795Crossref PubMed Scopus (504) Google Scholar, 10Angrisani L Santonicola A Iovino P et al.IFSO worldwide survey 2016: primary, endoluminal, and revisional procedures.Obes Surg. 2018; 28: 3783-3794Crossref PubMed Scopus (673) Google Scholar The mean BMI of 42·4 kg/m2 in our study cohort is also similar to the median of 41·7 kg/m2 reported in the fourth IFSO global registry report.9Welbourn R Hollyman M Kinsman R et al.Bariatric surgery worldwide: baseline demographic description and one-year outcomes from the fourth IFSO Global Registry report 2018.Obes Surg. 2019; 29: 782-795Crossref PubMed Scopus (504) Google Scholar Although we cannot rule out the possibility of selection bias caused by health-care professionals choosing lower-risk patients for BMS in view of the pandemic, the baseline characteristics of patients in our study were similar to those of other global BMS studies.9Welbourn R Hollyman M Kinsman R et al.Bariatric surgery worldwide: baseline demographic description and one-year outcomes from the fourth IFSO Global Registry report 2018.Obes Surg. 2019; 29: 782-795Crossref PubMed Scopus (504) Google Scholar, 10Angrisani L Santonicola A Iovino P et al.IFSO worldwide survey 2016: primary, endoluminal, and revisional procedures.Obes Surg. 2018; 28: 3783-3794Crossref PubMed Scopus (673) Google Scholar Our study has limitations. It only included data from participating centres and might therefore not represent the complete global picture. Furthermore, although we ensured that our collaborators knew the importance of submitting all consecutive patients during the study period, we cannot be certain that all contributors followed this instruction. Our study does not have a control cohort for statistical comparison. However, a contemporary BMS control cohort would not be possible because of the international scale of the COVID-19 pandemic and comparing the safety of BMS with other surgical procedures during the pandemic was not the aim of our study. Besides, comparisons with other surgical procedures is challenging considering the different population characteristics of patients undergoing BMS. An ideal study would collect outcomes following BMS before and through the COVID-19 pandemic from the same centres for comparison. However, this approach would have been challenging due to the unpredictability and fast spread of COVID-19. The strengths of the study include the large sample size, the global reach of the study, the high data completion rate, and extensive data profiling. Additionally, the data represented different phases of the COVID-19 pandemic across the 35 included countries (before, during, or after the COVID-19 peak). In conclusion, our study showed that 30-day morbidity and mortality following BMS during the COVID-19 pandemic with locally appropriate perioperative COVID-19 protocols in place seemed to be similar to pre-pandemic levels. However, with the evolving pandemic situation, BMS teams need to continually monitor outcome data. We declare no competing interests. RS and KM developed the concept of the study, RS and AAT were responsible for data collection, study conduct, and data analysis, CL prepared the figure, and all authors contributed to the writing and revising of the report. The study was funded by the research funds of the bariatric unit at University Hospitals Birmingham NHS Foundation Trust (Birmingham, UK). Download .pdf (2.66 MB) Help with pdf files Supplementary appendix