One-Anastomosis Gastric Bypass (OABG) vs. Single Anastomosis Duodeno-Ileal Bypass (SADI) as revisional procedure following Sleeve Gastrectomy: results of a multicenter study.

PURPOSE: Sleeve Gastrectomy (SG) is the most performed bariatric surgery, but a considerable number of patients may require revisional procedures for suboptimal clinical response/recurrence of weight (SCR/RoW). Conversion options include One-Anastomosis Gastric Bypass (OAGB) and Single Anastomosis Duodeno-Ileal Bypass (SADI). The study aims to compare SADI vs. OAGB as revisional procedures in terms of early and mid-term complications, operative time, postoperative hospital stay and clinical outcomes. METHODS: All patients who underwent OAGB or SADI as revisional procedures following SG for SCR/RoW at three high-volume bariatric centers between January 2014 and April 2021 were included. Propensity score matching (PSM) analysis was performed. Demographic, operative, and postoperative outcomes of the two groups were compared. RESULTS: One hundred and sixty-eight patients were identified. After PSM, the two groups included 42 OAGB and 42 SADI patients. Early (≤ 30 days) postoperative complications rate did not differ significantly between OAGB and SADI groups (3 bleedings vs. 0, p = 0.241). Mid-term (within 2 years) complications rate was significantly higher in the OAGB group (21.4% vs. 2.4%, p = 0.007), mainly anastomotic complications and reflux disease (12% of OAGBs). Seven OAGB patients required conversion to another procedure (Roux-en-Y Gastric Bypass-RYGB) vs. none among the SADI patients (p = 0.006). CONCLUSIONS: SADI and OAGB are both effective as revisional procedures for SCR/RoW after SG. OAGB is associated with a significantly higher rate of mid-term complications and a not negligible rate of conversion (RYGB). Larger studies are necessary to draw definitive conclusions.

Fat-to-blood recirculation of partially dysfunctional PD-1+CD4 Tconv cells is associated with dysglycemia in human obesity.

Obesity is characterized by the accumulation of T cells in insulin-sensitive tissues, including the visceral adipose tissue (VAT), that can interfere with the insulin signaling pathway eventually leading to insulin resistance (IR) and type 2 diabetes. Here, we found that PD-1+CD4 conventional T (Tconv) cells, endowed with a transcriptomic and functional profile of partially dysfunctional cells, are diminished in VAT of obese patients with dysglycemia (OB-Dys), without a concomitant increase in apoptosis. These cells showed enhanced capacity to recirculate into the bloodstream and had a non-restricted TCRß repertoire divergent from that of normoglycemic obese and lean individuals. PD-1+CD4 Tconv were reduced in the circulation of OB-Dys, exhibited an altered migration potential, and were detected in the liver of patients with non-alcoholic steatohepatitis. The findings suggest a potential role for partially dysfunctional PD-1+CD4 Tconv cells as inter-organ mediators of IR in obese patients with dysglycemic.

Two clues make a proof: EUS-directed transgastric ERCP in twice-surgically altered anatomy-Roux-en-Y gastric bypass conversion of a sleeve gastrectomy.

Video 1EUS-directed transgastric ERCP in twice-surgically-altered anatomy: Roux-en-Y gastric bypass conversion of a sleeve gastrectomy.

Laparoscopic Treatment of Gastroesophageal Reflux Disease. Outcomes and Quality of Life. A Long Term Follow-Up Study.

Background: This study evaluates the feasibility, efficacy, the complications rate, and the long-term results of laparoscopic treatment of gastroesophageal reflux disease (GERD) at a dedicated center. Materials and Methods: From 01/11/1993 to 01/12/2019, we performed 620 fundoplication surgeries by laparoscopic approach according to Rossetti technique and 160 according to Toupet technique, totally 780 procedures for gastroesophageal reflux disease. The average duration of surgery was 40 minutes (range 19 - 160) for Rossetti fundoplication, 50 (range 30 - 180), and for Toupet 60 (range 45 - 190). All patients were investigated by upper digestive tract radiography, esophagogastroscopy, 24h computerized pH-metry, manometry and scintigraphy to assess esophageal clearance and gastric emptying times. In the 180 (23 %) patients with associated hiatal hernia, direct hiatoplasty was performed in 108 cases, and hiatoalloplasty in the remaining 72. Results: There were no cases of perioperative mortality; the morbidity rate was 6.28 %. We had 16.7 % long-term failures, requiring reintervention in 46 cases (6.5 %). Thirty patients (3.84 %) had to resume occasional 40 mg PPI therapy and 48 patients (6.15 %) had to resume 40 mg PPI therapy continuously. Manometry in these patients revealed lower esophageal sphincter tone between 10- and 16-mm hg with complete and coordinated relaxations. Of the 44 patients who underwent redo surgery 26 were reoperated to repackage a tighter plastic. Six patients required reoperation for dysphagia. Twelve paraesophageal hernias were recorded in the group of patients in whom only hiatoplasty without prosthesis was performed. In all cases, a hiatoplasty with prosthesis was repackaged laparoscopically. Conclusions: We emphasize the importance of accurate morphologic and functional evaluation of the esophagus preoperatively for selection of the most appropriate intervention and postoperatively for evaluation of the causes of failures. In the presence of hiatal hernia, it is always advisable to perform hiatoplasty with the placement of a prosthesis.

Could Glycated Hemoglobin be Leakage Predictor in Sleeve Gastrectomy? A Retrospective Observational Study on 4233 Patients.

PURPOSE: Diabetes increases the risks related to surgery. At the same time, bariatric surgery improves diabetes. Glycated hemoglobin (A1C) is an index of diabetes severity. The purpose of this study is to evaluate A1C as a possible predictor of postoperative complications after Sleeve Gastrectomy (SG), focusing on leakage. MATERIALS AND METHODS: Monocentric retrospective study considering all consecutive patients with obesity, with or without diabetes, who underwent bariatric surgical procedures, from January 2018 to December 2021. All patients had preoperative A1C values. RESULTS: 4233 patients were considered. 522 patients (12.33%) were diabetics (A1C ≥ 6.5%). Of these, 260 patients (6.14%) had A1C ≥ 7% and 59 (1.39%) A1C ≥ 8%. 1718 patients (40.58%) were in a pre-diabetic range (A1C 5.7%-6.5%). Higher A1C values were associated with older age, male gender, higher BMI and increased rate of comorbidities. A longer operative time was observed for patients with A1C ≥ 7%, p = 0.027 (53 ± 20 vs 51 ± 18 min). The frequency of leakage was significantly higher when A1C ≥ 7% (3.8% vs 2.0%, p = 0.026). The frequency of leakage further increased when A1C ≥ 8% (5.1%), although this difference did not reach statistical significance. CONCLUSION: Patients with obesity and A1C ≥ 7% need to be referred to a diabetologist to treat diabetes before surgery and consequently decrease the risk of leakage.

Role of Preoperative High-Resolution Manometry in the Identification of Patients at High Risk of Postoperative GERD Symptoms 1 Year After Sleeve Gastrectomy.

PURPOSE: Sleeve gastrectomy (SG) has become the most common bariatric procedure, but it is often characterized by the onset of postoperative gastroesophageal reflux disease (GERD). High-resolution manometry (HRM) is a useful tool to detect risk factors for GERD. The aim of this study was to evaluate preoperative manometric parameters as possible predictors of postoperative GERD. MATERIALS AND METHODS: This was a monocentric retrospective study. We analyzed 164 patients, with preoperative esophagitis/GERD symptoms who underwent preoperative HRM and were submitted to SG (July 2020-February 2022). RESULTS: Postoperative GERD was observed in 60 patients (36.6%): 41 of them (68%) already had preoperative GERD symptoms, whereas the remaining 19 patients (32%) developed postoperative symptoms. Female patients developed postoperative GERD in a significantly higher fraction of cases as compared to male patients (82% versus 18%; p < 0.001). DCI (distal contractile integral) was identified as the only HRM parameter correlating with the presence of GERD. Patients with DCI ≤ 1623 mmHg*cm*s developed postoperative GERD in 46% of cases (n = 43/94), as compared to 24% of cases (n = 17/70) among patients with DCI > 1623 mmHg*cm*s (p = 0.005). At multivariable analysis, female sex (OR 3.402, p = 0.002), preoperative GERD symptoms (OR 2.489, p = 0.013), and DCI ≤ 1623 mmHg*s*cm (OR 0.335, p = 0.003) were identified as independent determinants of postoperative GERD. CONCLUSION: All the patients with preoperative risk factors for reflux, such as GERD symptoms or esophagitis on EGDS (esophagogastroduodenoscopy), should be considered for an HRM. Moreover, when a DCI ≤ 1623 mmHg*s*cm is found, a bariatric procedure different from SG might be considered.

Re-sleeve gastrectomy: weight loss, comorbidities and gerd evaluation in a large series with 5 years of follow-up.

INTRODUCTION: Laparoscopic sleeve gastrectomy (SG) has rapidly become one of the most commonly performed procedures in bariatric surgery. Weight regain and insufficient weight loss are the most common causes for surgical failure. Re-sleeve gastrectomy (ReSG) can represent an option when there is evidence of a dilated gastric tube. OBJECTIVES: The aim of the study is to evaluate safety, efficacy and rate of gastro-esophageal reflux disease (GERD) after ReSG in one of the largest series present in literature with long-term follow up. METHODS AND STUDY DESIGN: Retrospective study design. From February 2010 to August 2018, 102 patients underwent ReSG at our Centre. We divided patients into two groups, according to the main reason for surgical failure: insufficient weight loss or progressive weight regain. RESULTS: One hundred-two patients (78 women, 24 men) with BMI 38 ± 6 kg/m2 underwent ReSG (mean age 44 years). Rate of postoperative complications was 3.9% (4/102). After a mean follow-up of 55 months, mean BMI decreased to 30,4 kg/m2 and the mean percentage of excess weight loss (%EWL) was 51 ± 38.6. Symptoms of GERD were present in 35/102 patients (34.3%) and the need for a new operation occurred in six patients. Forty-five patients were submitted to ReSG for progressive weight regain (group A) and 57 for insufficient weight loss (group B). No differences were found in terms of postoperative BMI and %EWL. CONCLUSION: ReSG is a feasible procedure after primary SG failure in selected patients, but its efficacy in reducing the BMI under 30 kg/m2 is still unclear. In addition, over 30% of patients suffer from long-term gastro-esophageal reflux.

Sleeve Gastrectomy with Rossetti Fundoplication Increases Lower Esophageal Sphincter Tone Preventing Gastroesophageal Reflux Disease: High-Resolution Manometry Assessment.

Background: Laparoscopic sleeve gastrectomy (LSG) is associated with the long-term development of gastroesophageal reflux disease (GERD). Recent studies on LSG with fundoplication showed a lower rate of postoperative GERD than LSG alone; however, there is a lack of objective instrumental data in the literature. This study aimed to evaluate whether and how fundoplication associated with Sleeve Gastrectomy affects the esophagogastric physiology. Materials and Methods: This prospective observational study included 20 patients with morbid obesity, GERD, and lower esophageal sphincter (LES) hypotonia. All the patients underwent LSG with Rossetti fundoplication. High-resolution manometry was performed pre- and postoperatively. All the patients completed the 6 months follow-up. Results: The fundoplication increased LES tone in all patients. The increase in the LES tone was statistically significant (330% increase). The integrated relaxation pressure and the distal contractile integral both increased accordingly, indicating an increased esophageal effort to pass through the modified esophagogastric junction. Conclusion: Rossetti fundoplication associated with LSG increased LES tone and decreased the chance of developing long-term GERD after LSG.

Laparoscopic sleeve gastrectomy with Rossetti fundoplication: long-term (5-year) follow-up.

BACKGROUND: Gastroesophageal reflux disease (GERD), including erosive esophagitis, is highly prevalent in the obese population. Barrett's esophagus is the consequence of untreated GERD. Laparoscopic sleeve gastrectomy is one of the most frequently performed bariatric procedures. This study presents results after 5 years of follow-up of combined LSG and Rossetti fundoplication for the treatment of GERD, esophagitis, and Barrett's esophagus in patients with morbid obesity. OBJECTIVE: To evaluate long-term results after sleeve gastrectomy with Rossetti fundoplication. SETTING: Public university hospital in Italy. METHODS: Since January 2015, more than 450 patients with obesity underwent sleeve gastrectomy with a Rossetti fundoplication procedure as part of prospective studies underway at our center performed by 4 different expert bariatric surgeons. Currently, 127 patients have a follow-up of 5 years or more. RESULTS: Mean patient age was 42.9 ± 10.3 years, and mean body mass index was 42.4 ± 6.1 kg/m2. In total, 74.8% of patients were experiencing GERD before surgery. In 29 of 127 patients (22.8%), preoperative gastroscopy showed signs of esophagitis and/or Barrett's esophagus. In particular, 23 of 127 patients (18.1%) had grade A esophagitis, 2 of 127 (1.6%) had grade B, 2 of 127 (1.6%) had grade C, and 2 of 127 (1.6%) had Barrett's esophagus. Mean operative time was 51 ± 21 minutes. No intraoperative complications or conversions were reported. A regular postoperative course was seen in 91.3% of patients. Sixty months after surgery, more than 95% of patients did not experience any reflux symptoms. Percent total weight loss at follow-up was comparable with that with sleeve gastrectomy. Endoscopic follow-up demonstrated improvement of esophagitis lesions (including Barrett's esophagus) present in the preoperative setting. CONCLUSION: Laparoscopic sleeve gastrectomy with Rossetti fundoplication is well tolerated, feasible, and safe in patients with obesity, providing adequate weight loss results and complete resolution of clinical signs of GERD. We have recorded an improvement in esophagitis lesions present at preoperative gastroscopy and complete resolution of Barrett's esophagus within 5 years of follow-up.

Comparison of Laparoscopic Sleeve Gastrectomy Bleeding and Leakage Rates in Four Staple-Line Reinforcement Methods: A Prospective Observational Study.

Introduction: Staple-line bleeding and gastric leakage are the most serious complications of laparoscopic sleeve gastrectomy (LSG). Reinforcement of the staple line is reported to be a method to reduce these complications rates, but the question of which method is preferable is a matter of controversy in the literature. In this study, we compared different staple-line reinforcement methods to assess their efficiency in preventing staple-line bleeding and leakage. Materials and Methods: Two hundred patients eligible for LSG were enrolled in the study and randomized into five groups based on the reinforcement method used during surgery: no reinforcement, oversewing using 3-0 polydioxanone (PDS) suture, oversewing using 4-0 barbed absorbable closure device (V-Lock), fibrin sealant glue, and buttress material. Intraoperative and postoperative complications were recorded and analyzed. Differences were considered statistically significant for P < .05. Results: The no-reinforcement group showed higher bleeding rates (20%), although only 2.5% of the patients required reintervention. All groups using staple-line reinforcement showed better outcomes in bleeding rates (P < .05). No statistically significant differences were observed among the groups in terms of the leakage rate, reintervention rate, intraoperative complications, and operative times. Conclusion: The reinforcement of the staple line decreased the bleeding rate in sleeve gastrectomy but did not affect the gastric leakage rate.

Advice of General Practitioner, of Surgeon, of Endocrinologist, and Self-determination: the Italian Road to Bariatric Surgery.

PURPOSE: Bariatric surgery (BS) is considered the most efficient treatment for severe obesity. International guidelines recommend multidisciplinary approach to BS (general practitioners, endocrinologists, surgeons, psychologists, or psychiatrists), and access to BS should be the final part of a protocol of treatment of obesity. However, there are indications that general practitioners (GPs) are not fully aware of the possible benefits of BS, that specialty physicians are reluctant to refer their patients to surgeons, and that patients with obesity choose self-management of their own obesity, including internet-based choices. There are no data on the pathways chosen by physicians and patients to undergo BS in the real world in Italy. METHODS: An exploratory exam was performed for 6 months in three pilot regions (Lombardy, Lazio, Campania) in twenty-three tertiary centers for the treatment of morbid obesity, to describe the real pathways to BS in Italy. RESULTS: Charts of 2686 patients (788 men and 1895 women, 75.5% in the age range 30-59 years) were evaluated by physicians and surgeons of the participating centers. A chronic condition of obesity was evident for the majority of patients, as indicated by duration of obesity, by presence of several associated medical problems, and by frequency of previous dietary attempts to weight loss. The vast majority (75.8%) patients were self-presenting or referred by bariatric surgeons, 24.2% patients referred by GPs and other specialists. Self-presenting patients were younger, more educated, more professional, and more mobile than patients referred by other physicians. Patients above the age of 40 years or with a duration of obesity greater than 10 years had a higher prevalence of all associated medical problems. CONCLUSIONS: The majority of patients referred to a tertiary center for the treatment of morbid obesity have a valid indication for BS. Most patients self-refer to the centers, with a minority referred by a GP or by specialists. Self-presenting patients are younger, more educated, more professional, and more mobile than patients referred by other physicians. Older patients and with a longer duration of obesity are probably representative of the conservative approach to BS, often regarded as the last resort in an endless story.

Effect of laparoscopic sleeve gastrectomy vs laparoscopic sleeve + Rossetti fundoplication on weight loss and de novo GERD in patients affected by morbid obesity: a randomized clinical study.

PURPOSE: To compare sleeve gastrectomy (SG) to SG associated with Rossetti fundoplication (SG + RF) in terms of de novo gastro-esophageal reflux disease (GERD) after surgery, weight loss, and postoperative complications. MATERIALS AND METHODS: Patients affected by morbid obesity, without symptoms of GERD, who were never in therapy with proton pump inhibitors (PPIs), were randomized into two groups. One group underwent SG and the other SG + RF. The study was stopped on February 2020 due to the COVID pandemic. RESULTS: A total of 278 patients of the programmed number of 404 patients were enrolled (68.8%). De novo esophagitis was considered in those patients who had both pre- and postoperative gastroscopy (97/278, 34.9%). Two hundred fifty-one patients (90.3%) had completed clinical follow-up at 12 months. SG + RF resulted in an adequate weight loss, similar to classic SG at 12-month follow-up (%TWL = 35. 4 ± 7.2%) with a significantly better outcome in terms of GERD development. One year after surgery, PPIs were necessary in 4.3% SG + RF patients compared to 17.1% SG patients (p = 0.001). Esophagitis was present in 2.0% of SG + RF patients versus 23.4% SG patients (p = 0.002). The main complication after SG + RF was wrap perforation (4.3%), which improved with the surgeon's learning curve. CONCLUSION: SG + RF seemed to be an effective alternative to classic SG in preventing de novo GERD. More studies are needed to establish that an adequate learning curve decreases the higher percentage of short-term complications in the SG + RF group.

An Unexpected High Rate of Internal Hernia in Our OAGB Experience as Revisional Surgery for Morbid Obesity.

Introduction: Internal hernia (IH) is a well-known complication of laparoscopic roux-en-y gastric bypass (LRYGB) with a reported incidence that ranges from 0% to 5%. In one anastomosis gastric bypass (OAGB), internal herniation is reported to be absent due to the lack of a jejuno-jejunostomy, which is present in LRYGB. Several papers reported large case series of patients undergoing OAGB with no IH through Petersen mesenteric defect. Consequently, there is no recommendation for routine closure of the mesenteric defects in OAGB. However, starting from 2015, some authors started reporting this complication in OAGB procedures. Material andMethods: The outcomes of 98 cases of revisional OAGB performed at our institution from 2014 were retrospectively collected. OAGB was secondary surgery following laparoscopic Sleeve Gastrectomy (LSG) in 96% of patients. The indications for secondary surgery were weight regain and/or severe Gastro-esophageal Reflux Disease (GERD). Outcomes of all OAGB procedures were collected at baseline and at 1, 3, 6, 12 and 24 months. Results: The rate of complications ( 30 days after discharge) requiring new surgery was 21.4% (21/98). The main causes of reintervention were the persistence of severe GERD/Biliary Reflux (14/21) and bowel obstruction due to Internal Hernia (4/21). IH was found in 4% of patients. Conclusion: Internal Hernia could be more common than reported in literature. The closure of mesenteric defects in OAGB should always be performed during revisional surgery for complicated IH.

Sleeve gastrectomy with tailored 360° fundoplication according to Rossetti in patients affected by obesity and gastroesophageal reflux: a prospective observational study.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is the most frequently performed bariatric procedure. Recent studies demonstrated the correlation between LSG and gastroesophageal reflux disease (GERD). OBJECTIVES: To evaluate the effectiveness of LSG + Rossetti antireflux fundoplication in patients affected by morbid obesity and GERD. SETTING: High-volume bariatric center, Italy. METHODS: This is a prospective, observational cohort study that enrolled 58 patients affected by obesity and GERD who underwent surgery. All the patients had a 12-month follow-up. Gastroscopies were performed preoperatively and at month 12 for 35 patients. RESULTS: At 1 year after surgery, patients had a consistent decrease in body mass index, from 41.9 ± 4.6 kg/m2 to 28.2 ± 3.7 kg/m2. GERD improved in 97.1% of patients. Co-morbidities, such as hypertension, type 2 diabetes, respiratory dysfunction, and arthropathies improved as well. The visual analogue scale score regarding the global state of health increased significantly, from 58.1 ± 17.1% before surgery to 98.8 ± 4.1% at 1 year after surgery. Two patients had a fundoplication perforation and needed reparative surgery (3.5%). One patient had anemia that needed a blood transfusion (1.7%). Complications were reduced with a learning curve. CONCLUSION: LSG + Rossetti fundoplication was shown to be a safe and effective intervention. It could be considered an option in obese patients affected by GERD. A longer follow-up is needed to establish the long-term outcomes.

Use of fibrin glue in bariatric surgery: analysis of complications after laparoscopic sleeve gastrectomy on 450 consecutive patients.

Laparoscopic Sleeve Gastrectomy (LSG) is one of the most performed surgical procedures in bariatric surgery. Staple line leak and bleeding are by far the two most feared complications after LSG. In this study, we retrospectively compared the efficacy of Fibrin Glue in preventing staple line leak and bleeding. From September 2019 to January 2020, 450 obese patients underwent elective LSG and were placed into groups with Fibrin Glue reinforcement (Group A) or without Fibrin Glue reinforcement (Group B). Primary endpoints were postoperative staple line leak and bleeding; while, secondary endpoints were reintervention rate, total operative time and mortality. Mean Body Mass Index (BMI) was 45.4 ± 7.9 kg/m2 (range: 35.1-81.8). Mean age was 43.3 ± 11.8 years (range: 18-65). No intraoperative complications or conversion to laparotomy were reported. Mean operative time was comparable between the groups (48 ± 18 min in Group A vs 48 ± 14 min in Group B; p > 0.05). No decrease in overall postoperative complications was found in Group A (5.1% vs 7.0%; p > 0.05), but after stratification according to Clavien-Dindo classification, we found a higher rate of Grade II (0.0% vs 1.6%; p < 0.05) and Grade IIIb (0.0% vs 1%; p < 0.05) complications in group B. Our study showed that Fibrin Glue as a reinforcement method during LSG is a reliable tool, without affecting the operative time of surgery and mortality. A significant reduction in complications (Clavien-Dindo grade II and grade IIIb) was observed in patients undergoing LSG with Fibrin Glue.

COVID-19 and Obesity: Is Bariatric Surgery Protective? Retrospective Analysis on 2145 Patients Undergone Bariatric-Metabolic Surgery from High Volume Center in Italy (Lombardy).

INTRODUCTION: On February 20, 2020, a severe case of pneumonia due to SARS-CoV-2 was diagnosed in northern Italy (Lombardy). Some studies have identified obesity as a risk factor for severe disease in patients with COVID-19. The purpose of this study was to investigate the incidence of SARS-CoV-2 infection and its severity in patients who have undergone bariatric surgery. MATERIAL AND METHODS: During the lockdown period (until May 2020), we contacted operated patients by phone and social networks (e.g., Facebook) to maintain constant contact with them; in addition, we gave the patients a dedicated phone number at which to call us for emergencies. We produced telemedicine and educational videos for obese and bariatric patients, and we submitted a questionnaire to patients who had undergone bariatric surgery in the past. RESULTS: A total of 2145 patients (313 male; 1832 female) replied to the questionnaire. Mean presurgical BMI: 44.5 ± 6.8 kg/m2. Mean age: 44.0 ± 10.0 year. Mean BMI after surgery: 29.3 ± 5.5 kg/m2 (p < 0.05). From February to May 2020, 8.4% of patients reported that they suffered from at least one symptom among those identified as related to SARS-CoV-2 infection. Thirteen patients (0.6%) tested positive for COVID-19. Six patients (0.3%) were admitted to the COVID Department, and 2 patients (0.1%) were admitted to the ICU. CONCLUSIONS: Although the reported rates of symptoms and fever were high, only 0.6% of patients tested positive for COVID-19. Among more than 2000 patients who underwent bariatric surgery analyzed in this study, only 0.1% needed ICU admission.