Morbidity In Patients Research Articles

Summary of clinical investigation plan for The DIATEC trial: in-hospital diabetes management by a diabetes team and continuous glucose monitoring or point of care glucose testing – a randomised controlled trial

BackgroundWorldwide, up to 20 % of hospitalised patients have diabetes mellitus. In-hospital dysglycaemia increases patient mortality, morbidity, and length of hospital stay. Improved in-hospital diabetes management strategies are needed. The DIATEC trial investigates the effects of an in-hospital diabetes team and operational insulin titration algorithms based on either continuous glucose monitoring (CGM) data or standard point-of-care (POC) glucose testing.MethodsThis is a two-armed, two-site, prospective randomised open-label blinded endpoint (PROBE) trial. We recruit non-critically ill hospitalised general medical and orthopaedic patients with type 2 diabetes treated with basal, prandial, and correctional insulin (N = 166).In both arms, patients are monitored by POC glucose testing and diabetes management is done by ward nurses guided by in-hospital diabetes teams. In one of the arms, patients are monitored in addition to POC glucose testing by telemetric CGM viewed by the in-hospital diabetes teams only. The in-hospital diabetes teams have operational algorithms to titrate insulin in both arms. Outcomes are in-hospital glycaemic and clinical outcomes.DiscussionThe DIATEC trial will show the glycaemic and clinical effects of in-hospital CGM handled by in-hospital diabetes teams with access to operational insulin titration algorithms in non-critically ill patients with type 2 diabetes. The DIATEC trial seeks to identify which hospitalised patients will benefit from CGM and in-hospital diabetes teams compared to POC glucose testing. This is essential information to optimise the use of healthcare resources before broadly implementing in-hospital CGM and diabetes teams.Trial registrationProspectively registered at ClinicalTrials.gov with identification number NCT05803473 on March 27th 2023.

Correlation between preoperative cardiopulmonary exercise testing and six-minute walk test, five-times sit to stand test and Short Form-36 physical component score in patients undergoing cytoreductive surgery

IntroductionAssessment of preoperative function is important for determining fitness for surgery, preoperative optimisation and predicting postoperative morbidity in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). This study explored correlations between preoperative cardiopulmonary exercise testing (CPET) variables, and six-minute walk test (6MWT), five-times sit to stand test (5STS) and Short Form-36 (SF-36) physical component score in patients scheduled for elective CRS-HIPEC. MethodsThis study included patients who underwent preoperative CPET, 6MWT, 5STS and responded to the SF-36 survey prior to elective CRS-HIPEC at Royal Prince Alfred Hospital in Sydney. CPET was performed using a cycle ergometer and measured peak oxygen uptake (VO2 peak) and anaerobic threshold (AT). The associations between preoperative CPET variables and preoperative 6MWT, 5STS and SF-36 were assessed using correlation test. ResultsA total of 133 patients scheduled for elective CRS-HIPEC were included in this study. The median VO2, AT and VE/VCO2 were 20.3 [6.5] ml/kg/min, 13.1 [4.9] ml/kg/min and 29 [4.5], respectively. The median 6MWT, 5STS and SF-36 physical component score were 525 m, 9.2 s and 50.2, respectively. CPET variables were significantly correlated with 6MWT (VO2 r = 0.51; AT r = 0.35; VE/VCO2 r = −0.25; p < 0.01), 5STS (VO2 r = −0.32; AT r = −0.27; VE/VCO2 r = 0.24; p < 0.01) and SF-36 (VO2 r = 0.42; AT r = 0.38; VE/VCO2 r = −0.23; p < 0.01). Conclusions6MWT, 5STS and SF-36 are at best moderately correlated with CPET variables, which suggests that these tests may serve as adjuncts rather than a replacement to CPET in the clinical setting.

Biventricular Resynchronization: Case Report and Literature Review

Cardiac resynchronization therapy (CRT) was introduced to restore left ventricular synchrony in patients with heart failure. Currently, more than 30% of patients do not respond to this therapy. CRT has proven its effectiveness in reducing morbidity and mortality in well-selected patients. A better understanding of the pathophysiological mechanisms, implantation techniques, and technological advances in devices has improved the response to this therapy. We present a case of a super-responder.

Is Steatotic Liver Disease Related to Poor Outcome in COVID-19-Hospitalized Patients?

Background: Steatotic liver disease (SLD) has been linked to more exacerbated inflammatory responses in various scenarios. The relationship between SLD and COVID-19 prognosis remains unclear. Our aim was to investigate the impact of SLD on the outcome of COVID-19. Methods: Patients hospitalized with confirmed COVID-19 and who underwent laboratory tests and chest CT scans were included. SLD was assessed by measuring the attenuation coefficient on CT scans. The relationship between SLD, the severity of COVID-19 clinical presentation and in-hospital mortality were assessed. Results: A total of 610 patients were included (mean age 62 ± 16 years, 64% male). The prevalence of SLD was 30%, and the overall in-hospital mortality rate was 19%. Patients with SLD were younger (58 ± 13 vs. 64 ± 16 years, p < 0.001) and had a higher BMI (32 ± 5 vs. 28 ± 4 kg/m2, p = 0.014). Admission AST values were higher in patients with SLD (82 ± 339 vs. 50 ± 37, p = 0.02), while D-dimer (1112 ± 2147 vs. 1959 ± 8509, p = 0.07), C-reactive protein (12 ± 9 vs. 11 ± 8, p = 0.27), ALT (67 ± 163 vs. 47 ± 90, p = 0.11), ALP (83 ± 52 vs. 102 ± 125, p = 0.27), and GGT (123 ± 125 vs. 104 ± 146, p = 0.61) did not significantly differ compared to patients without SLD. No difference was observed regarding lung parenchyma involvement >50% (20% vs. 17%, p = 0.25), hospital length of stay (14 ± 19 vs. 16 ± 23 days, p = 0.20), hemodialysis support (14% vs. 16%, p = 0.57), use of mechanical ventilation (20% vs. 20%, p = 0.96), and in-hospital mortality (17% vs. 20%, p = 0.40) when comparing patients with and without SLD. Conclusions: SLD showed no significant association with morbidity and mortality in patients with COVID-19.

Management of staple line leaks after laparoscopic sleeve gastrectomy: Single-center experience

Objective: In obesity surgery, laparoscopic sleeve gastrectomy (LSG) is a frequently applied method. However, there are certain complications. Leakage is one of the most serious complications after surgery, causing postoperative morbidity and sometimes mortality. There is no consensus about management of leaks after LSG. In our study, we aimed to present our experience on the management of LSG leaks. Patients and Methods: Patients who underwent LSG between 2010-2017 in a tertiary university hospital were analyzed retrospectively. Demographic characteristics, endoscopic and surgical interventions, morbidity, and mortality rates of patients diagnosed with LSG leak were analyzed from prospectively recorded data. Results: Leak was observed in 11 (2.15%) of a total of 510 LSG patients. Six (54%) patients were diagnosed as acute and 5 were early leaks. Stent was applied to most of the patients (72%) with or without surgical exploration. The average length of stay in hospital was 21 days. Mortality was observed in 2 patients. Conclusions: Consequently, leakage after LSG is a complication that requires multimodal therapy. Surgical treatment combined with endoscopic intervention may increase success.

Prospects of CSF shunt independence among chronically shunted patients.

CSF shunt placement for hydrocephalus and other etiologies has arguably been the most life-saving intervention in pediatric neurosurgery in the past 6 decades. Yet, chronic shunting remains a source of morbidity for patients of all ages. Neuroendoscopic surgery has made shunt independence possible for newly diagnosed hydrocephalic patients. In this study, we examine the prospects of shunt independence with or without endoscopic third ventriculostomy (ETV) in chronically shunted patients. After IRB approval, a retrospective analysis was completed on patients whose shunt was ligated or removed to achieve shunt independence, with or without ETV. Clinical and imaging data were collected. Eighty-eight patients with CSF shunts had their shunt either ligated or removed, 57 of whom had a concomitant ETV. Original reasons for shunting included: congenital hydrocephalus 20 (23%), post-hemorrhagic hydrocephalus (PHH) of prematurity 14 (16%), aqueductal stenosis 10 (11%), intracranial cyst 8 (9%), tumor 8 (9%), infantile subdural hematomas 8 (9%), myelomeningocele 7 (8%), post-traumatic hydrocephalus 7 (8%) and post-infectious hydrocephalus 6 (7%). The decision to perform a simultaneous ETV was made based on etiology. Forty-nine (56%) patients became shunt independent. The success rate was 46% in the ETV group and 73% in the no ETV group. Using multivariate analysis and Cox Proportional Hazards models, age > 4 months at shunt placement (p = 0.032), no shunt revisions (p = 0.01), select etiologies (p = 0.043), and ETVSS > 70 (in the ETV group) (p = 0.017), were protective factors for shunt independence. Considering the long-term complications of shunting, achieving shunt independence may provide hope for improved quality of life. While this study is underpowered, it provides pilot data identifying factors that predict shunt independence in chronically shunted patients, namely age, absence of prior shunt revision, etiology, and in the ETV group, the ETVSS.

Design Optimization of Printed Multi-Layered Electroactive Actuators Used for Steerable Guidewire in Micro-Invasive Surgery.

To treat cardiovascular diseases (i.e., a major cause of mortality after cancers), endovascular-technique-based guidewire has been employed for intra-arterial navigation. To date, most commercially available guidewires (e.g., Terumo, Abbott, Cordis, etc.) are non-steerable, which is poorly suited to the human arterial system with numerous bifurcations and angulations. To reach a target artery, surgeons frequently opt for several tools (guidewires with different size integrated into angulated catheters) that might provoke arterial complications such as perforation or dissection. Steerable guidewires would, therefore, be of high interest to reduce surgical morbidity and mortality for patients as well as to simplify procedure for surgeons, thereby saving time and health costs. Regarding these reasons, our research involves the development of a smart steerable guidewire using electroactive polymer (EAP) capable of bending when subjected to an input voltage. The actuation performance of the developed device is assessed through the curvature behavior (i.e., the displacement and the angle of the bending) of a cantilever beam structure, consisting of single- or multi-stack EAP printed on a substrate. Compared to the single-stack architecture, the multi-stack gives rise to a significant increase in curvature, even when subjected to a moderate control voltage. As suggested by the design framework, the intrinsic physical properties (dielectric, electrical, and mechanical) of the EAP layer, together with the nature and thickness of all materials (EAP and substrate), do have strong effect on the bending response of the device. The analyses propose a comprehensive guideline to optimize the actuator performance based on an adequate selection of the relevant materials and geometric parameters. An analytical model together with a finite element model (FEM) are investigated to validate the experimental tests. Finally, the design guideline leads to an innovative structure (composed of a 10-stack active layer screen-printed on a thin substrate) capable of generating a large range of bending angle (up to 190°) under an acceptable input level of 550 V, which perfectly matches the standard of medical tools used for cardiovascular surgery.

Abstract PO5-26-12: Optimizing Treatment Decisions in Microinvasive Ductal Carcinoma in Situ: Evaluating the Need for Surgical Axillary Staging

Abstract Background: Surgical axillary staging is often debated in patients with microinvasive ductal carcinoma in situ (T1mi) due to the low occurrence of nodal metastasis. Axillary surgery (ASx) is associated with risks like seroma, wound complications, lymphedema, and sensory deficits. This study aims to assess the utility of surgical axillary staging in clinically node-negative (cN0) T1mi breast cancer patients and provide insights for optimizing high value surgical treatment and subsequent decision-making. Methods: This retrospective cohort study analyzed data from the National Cancer Database (NCDB) to investigate axillary status of patients with cT1mi breast cancer between 2012 and 2019. Patient demographics, clinical characteristics, treatment methods and pathologic findings were collected. Comparisons were made between those who did and did not undergo ASx, and of those who did, between patients who were pathologically node-positive (pN+) vs. node-negative (pN-). Results: Of 10,843 patients analyzed, 9,220 (85.0%) underwent ASx while 1,623 (15.0%) did not. Mean age of patients undergoing ASx and those who did not was 59.2±11.2 and 66.3±12.8 years, respectively (p&amp;lt; 0.001). On univariate analysis, other factors associated with undergoing ASx were having private insurance, fewer medical comorbidities, having a HER2+ or triple negative phenotype, higher grade, presence of lymphovascular invasion and undergoing mastectomy (all p&amp;lt; 0.05). Sentinel lymphadenectomy was performed in 83% of patients while axillary lymph node dissection (ALND) was performed in 17% of patients. Final pathology demonstrated an upgrade to a true invasive cancer (T1 or greater) in 29.3% of cases. Of 9,069 patients who underwent ASx with known pathologic nodal status, 8,512 (93.9%) were pN- and 557 (6.1%) were pN+. Factors independently associated with increased odds of having positive nodes were younger age (OR 1.02, 95% CI 1.01-1.03, p&amp;lt; 0.001), Black race (OR 1.51, 95% CI 1.12-2.10, p=0.007), lymphovascular invasion (OR 13.72, 95% CI 10.25-18.36, p&amp;lt; 0.001), and undergoing mastectomy (OR 1.98, 95% CI 1.57-2.51, p&amp;lt; 0.001). Among the pN+ patients, only 64 (0.7%) had ≥3 total positive nodes and would require ALND. On subset analysis of the 4,190 patients undergoing mastectomy, 244 (5.8%) did not undergo ASx, while 3,946 (94.2%) did, of whom 373 (9%) were pN+. Regarding adjuvant treatments in this group, more patients who underwent ASx received chemotherapy (12% v. 8%, p&amp;lt; 0.001), and among those who did undergo surgery those who were pN+ were much more likely to receive chemotherapy (58% v. 12%, p&amp;lt; 0.001). However, similar proportions of patients who did and did not undergo ASx received adjuvant radiation (5% v. 4%, p=0.65), while, as expected, among those undergoing ASx, a higher proportion who were pN+ underwent radiation (32% v. 5%, p&amp;lt; 0.001). Conclusion: Surgical axillary staging for T1mi breast cancer is common, but many patients are node-negative. More patients are undergoing ALND than necessary based on pathology. Nodal status influences adjuvant therapy decisions. Identifying factors linked to upgrade and higher pN+ probabilities can enable personalized surgical treatments, reducing morbidity for most patients. Citation Format: Christian Lava, Karen Li, Lauren Berger, Daisy Spoer, Lindy Rosal, Austin Williams, Monika Masanam, Ian Greenwalt, Jennifer Son, Lucy De La Cruz. Optimizing Treatment Decisions in Microinvasive Ductal Carcinoma in Situ: Evaluating the Need for Surgical Axillary Staging [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-26-12.

Favorable impact of PD1/PD-L1 antagonists on bone remodeling: an exploratory prospective clinical study and ex vivo validation

BackgroundSkeletal morbidity in patients with cancer has a major impact on the quality of life, and preserving bone health while improving outcomes is an important goal of modern antitumor treatment...

The Effect of Preeclampsia on Adverse Maternal Outcomes in Women With Placental Abruption at a Large Urban Hospital in Tennessee From 2019 to 2022 [ID 2683655

INTRODUCTION: Placental abruption is associated with increased pregnancy-related morbidity and mortality. Few studies have explored the effect of individual risk factors for placental abruption on outcomes. Our study evaluates the association of preeclampsia and maternal morbidity in patients with placental abruption. METHODS: We conducted a retrospective case–control study to evaluate the association of preeclampsia with adverse maternal outcomes in the setting of placental abruption. Univariate analyses were used to determine the relationship between preeclampsia and known adverse maternal outcomes of placental abruption. Multivariate logistic regression was then used to evaluate the relationship between preeclampsia and each significantly associated outcome, adjusting for factors including body mass index, gestational age, mode of delivery, race, trauma, diabetes, placental location, cocaine and tobacco use, prior cesarean sections, year of delivery, and parity. Significance was assessed at an alpha of 0.05. RESULTS: Of 147 singleton pregnancies complicated by placental abruption from 2019 to 2022, 37 (25.2%) were complicated by preeclampsia. No significant differences were found between groups in incidence of acute kidney injury, disseminated intracellular coagulation, cesarean delivery, fetal demise, preterm birth, or low birth weight. On adjusted multivariable regression, we found preeclampsia increased the odds of maternal transfusion requirement (adjusted odds ratio [aOR] 3.55; 95% CI: 1.2, 10.4) and postoperative hospital stay greater than 2 days (aOR 4.05; 95% CI: 1.5, 11.2). CONCLUSION: Preeclampsia was an independent predictor of need for blood transfusion and increased duration of hospital stay in patients with placental abruption. Recognition of preeclampsia as an independent risk factor for these outcomes may allow medical optimization, increased preparedness, and lead to decreased pregnancy-related morbidity.

Cutaneous manifestations of hypothyroidism: An observational study in a tertiary care center of Eastern India

Cutaneous manifestations of hypothyroidism: An observational study in a tertiary care center of Eastern India

Positive Bacterial Cultures on Spinal Wound Closure Do Not Predict Postoperative Outcomes.

Complex surgical back wounds represent significant morbidity in patients who have undergone spinal procedures requiring closure or revision by plastic surgeons. This study aimed to assess the utility of bacterial wound culture data for predicting surgical outcomes of wound management. This study is a single-institution retrospective review of consecutive patients who required plastic surgery intervention for wound infection following spinal procedures between the years 2010 and 2021 (n = 70). Statistical analysis was performed for demographics, comorbidities, perioperative laboratory studies, and treatment methods. The primary outcomes of interest were rate of postoperative complications after soft tissue reconstruction and reconstructive failure. The secondary outcome of interest was time to healing in number of days. The overall complication rate after wound closure was 31.4%, with wound infection in 12.9%, seroma in 10%, dehiscence in 12.9%, and hematoma in 1.4%. Increasing number of debridements before wound closure increased the likelihood of a surgical complication of any kind (odds ratio [OR], 1.772; 95% confidence interval [CI], 1.045-3.002). Positive wound cultures before reconstruction were associated with development of seroma only (OR, 0.265; 95% CI, 0.078-0.893). Use of incisional vacuum-assisted closure devices significantly decreased the odds of postoperative wound dehiscence (OR, 0.179; 95% CI, 0.034-0.904) and increased odds of healing (hazard ratio, 3.638; 95% CI, 1.547-8.613). Positive wound cultures were not significantly associated with negative outcomes after complex closure or reconstruction of infected spinal surgical wounds. This finding emphasizes the importance of clinical judgment with a multidisciplinary approach to complex surgical back wounds over culture data for wound closure timing.

Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI).

Acute kidney injury (AKI) is a common and serious complication of cardiac surgery that has a significant impact on patient morbidity and mortality. The Kidney Disease Improving Global Outcomes (KDIGO) definition of AKI is widely used to classify and identify AKI associated with cardiac surgery (CSA-AKI) based on changes in serum creatinine and/or urine output. There are various pre-, intra-, and postoperative risk factors for the development of CSA-AKI which should be recognized and addressed as early as possible to expedite its diagnosis, reduce its occurrence and prevent or ameliorate its devastating complications. Crucial issues are the inaccuracy of serum creatinine as a surrogate parameter of kidney function in the perioperative setting of cardiothoracic surgery and the necessity to discover more representative markers of the pathophysiology of AKI. However, except for the tissue inhibitor of metalloproteinase-2 and insulin-like growth factor binding protein 7 ratio (TIMP2/IGFBP7), other diagnostic biomarkers with an acceptable sensitivity and specificity are still lacking. This article provides a comprehensive review of various aspects of CSA-AKI, including pathogenesis, risk factors, diagnosis, biomarkers, classification, prevention and treatment management.

Resultados de un servicio ininterrumpido de implante urgente de marcapasos permanente

Introduction and objectivesMost of the complications associated with acute and symptomatic bradyarrhythmia (ASB) occur in the time from diagnosis to permanent pacemaker implantation (PPI). We aimed to evaluate the outcomes of an urgent 24/7 PPI service (PPI-24/7) for patients with ASB. MethodsA total of 664 patients undergoing first-time PPI for ASB were prospectively assessed during 2 periods of identical length (18 months): 341 patients who underwent the procedure during working hours only (PPI-WH), and 323 patients who underwent the procedure after the implementation of the PPI-24/7 service. The primary safety endpoint was established as the cumulative 180-day incidence of complications related to the index arrhythmia and device implant. The primary efficacy endpoint was determined as the average number of hospital stays per patient. ResultsThe PPI-24/7 period was associated with a significant shortening of the time from diagnosis to implantation (median [interquartile range]): 3hours [2-6] vs 16 [5-21]). The cumulative incidence of patients with complications at 180 days was lower in the PPI-24/7 period: 9% vs 17% (adjusted odds ratio, 0.5; P=.002), due to a significant reduction in preimplant complications: 2.5% vs 12% (P <.001). The average number of hospital stays was reduced by 2 per patient in the PPI-24/7 period (nonparametric P <.001). PPI-24/7 implants performed outside working hours (n=178) were safe, with a 180-day cumulative incidence in procedure-related complications of 3.9%. ConclusionsAmong patients with ASB, PPI-24/7 was associated with a significant reduction in patient morbidity and efficient hospital resource use.Full English text available from: www.revespcardiol.org/en

Morbidity and mortality in patients with stage IV pancreatic adenocarcinoma and acute cholangitis: Outcomes and risk prognostication

BackgroundAcute cholangitis (AC) is a common complication of pancreatic ductal adenocarcinoma (PDAC). Herein, we evaluated outcomes after the first AC episode and predictors of mortality and AC recurrence in patients with stage IV PDAC. MethodsWe conducted a single-center, retrospective observational study using institutional databases. Clinical data and outcomes for patients with stage IV PDAC and at least one documented episode of AC, were assessed. Overall survival (OS) was estimated using the Kaplan-Meier method, and Cox regression model was employed to identify predictors of AC recurrence and mortality. ResultsOne hundred and twenty-four patients with stage IV PDAC and AC identified between January 01, 2014 and October 31, 2020 were included. Median OS after first episode of AC was 4.1 months (95 % CI, 4.0–5.5), and 30-day, 6, and 12-month survival was 86.2 % (95 % CI, 80.3–92.5), 37 % (95 % CI, 29.3–46.6 %) and 18.9 % (95 % CI, 13.1–27.3 %), respectively. Primary tumor in pancreatic body/tail (HR 2.29, 95 % CI: 1.26 to 4.18, p = 0.011), concomitant metastases to liver and other sites (HR 1.96, 95 % CI: 1.16 to 3.31, p = 0.003) and grade 3 AC (HR 2.26, 95 % CI: 1.45 to 3.52, p < 0.001), predicted worse outcomes. Intensive care unit admission, sepsis, systemic therapy, treatment regimen, and time to intervention did not predict survival or risk of recurrence of AC. ConclusionsAC confers significant morbidity and mortality in advanced PDAC. Worse outcomes are associated with higher grade AC, primary tumor location in pancreatic body/tail, and metastases to liver and other sites.

Sacroiliitis in inflammatory bowel disease.

This review summarizes the recent evidence regarding the epidemiology of inflammatory bowel disease (IBD) associated sacroiliitis, including the prevalence, pathogenesis, role of imaging, and therapeutic challenges. Sacroiliitis is an underappreciated musculoskeletal manifestation of IBD, a chronic inflammatory condition of the gut affecting the younger population. Untreated sacroiliitis can lead to joint destruction and chronic pain, further adding to morbidity in IBD patients. Recent publications suggest sacroiliitis can be detected on abdominal imaging obtained in IBD patients to study bowel disease, but only a small fraction of these patients were seen by rheumatologists. Early detection of IBD-associated sacroiliitis could be achieved by utilization of clinical screening tools in IBD clinics, careful examination of existing computed tomography and MRI studies, and timely referral to rheumatologist for further evaluation and treatment. Current treatment approaches for IBD and sacroiliitis include several targeted biologic therapies, but IBD-associated sacroiliitis has limited options, as these therapies may not overlap in both conditions. With the advances in imaging, sacroiliitis is an increasingly recognized comorbidity in IBD patients. Future studies focusing on this unique patient population will expand our understanding of complex pathophysiology of IBD-associated sacroiliitis and lead to identification of novel targeted therapies for this condition.

Ertugliflozin for Functional Mitral Regurgitation Associated With Heart Failure: EFFORT Trial.

The morbidity and mortality rates of patients with heart failure (HF) and functional mitral regurgitation (MR) remain substantial despite guideline-directed medical therapy for HF. We evaluated the efficacy of ertugliflozin for reduction of functional MR associated with HF with mild to moderately reduced ejection fraction. The EFFORT trial (Ertugliflozin for Functional Mitral Regurgitation) was a multicenter, double-blind, randomized trial to examine the hypothesis that the sodium-glucose cotransporter 2 inhibitor ertugliflozin is effective for improving MR in patients with HF with New York Heart Association functional class II or III, 35%≤ejection fraction<50%, and effective regurgitant orifice area of chronic functional MR >0.1 cm2 on baseline echocardiography. We randomly assigned 128 patients to receive either ertugliflozin or placebo in addition to guideline-directed medical therapy for HF. The primary end point was change in effective regurgitant orifice area of functional MR from baseline to the 12-month follow-up. Secondary end points included changes in regurgitant volume, left ventricular (LV) volume indices, left atrial volume index, LV global longitudinal strain, and NT-proBNP (N-terminal pro-B-type natriuretic peptide). The treatment groups were generally well-balanced with regard to baseline characteristics: mean age, 66±11 years; 61% men; 13% diabetes; 51% atrial fibrillation; 43% use of angiotensin receptor-neprilysin inhibitor; ejection fraction, 42±8%; and effective regurgitant orifice area, 0.20±0.12 cm2. The decrease in effective regurgitant orifice area was significantly greater in the ertugliflozin group than in the placebo group (-0.05±0.06 versus 0.03±0.12 cm2; P<0.001). Compared with placebo, ertugliflozin significantly reduced regurgitant volume by 11.2 mL (95% CI, -16.1 to -6.3; P=0.009), left atrial volume index by 6.0 mL/m2 (95% CI, -12.16 to 0.15; P=0.005), and LV global longitudinal strain by 1.44% (95% CI, -2.42% to -0.46%; P=0.004). There were no significant between-group differences regarding changes in LV volume indices, ejection fraction, or NT-proBNP levels. Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group (P=0.12). Among patients with functional MR associated with HF, ertugliflozin significantly improved LV global longitudinal strain and left atrial remodeling, and reduced functional MR. Sodium-glucose cotransporter 2 inhibitors may be considered for patients with functional MR. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04231331.

Peri-operative outcomes of pancreaticoduodenectomy comparing an isolated Roux loop or single loop for reconstruction: An ambispective observational study

BackgroundA post-operative pancreatic fistula is a major cause of morbidity and mortality in patients undergoing pancreaticoduodenectomy. We compared two methods of reconstruction of pancreaticojejunal anastomosis, an isolated loop with a single loop, to assess their effects on the incidence and severity of fistula. MethodsThe data was collected in an ambispective manner. The drain fluid was sent for amylase measurement on post-operative day 3 and a fistula was defined and classified according to the 2016 modification of the International Study Group for Pancreatic Surgery definition. The patients were divided into the isolated (Group I) and single (Group II) loop groups and compared for the incidence and severity of clinically relevant fistula along with other parameters. ResultsA total of 349 (Group I: 201, Group II: 148) patients were included in the study. The incidence of clinically relevant fistula was comparable (p = 0.206). Grade C fistula was found to be lower in the group I (7 % vs 11.6 %, p = 0.137), in patients with a soft pancreas (8.5 % vs 18.3 %, p = 0.049) and pancreatic duct diameter less than 5 mm (9.8 % vs 17.2 %, p = 0.036). The operative time was lower in Group I than in Group II (438 min vs 478, p < 0.001). ConclusionWe found that the incidence of clinically relevant fistula was similar in both the groups but the isolated reconstruction method reduced the incidence of severe fistula. In patients with a smaller pancreatic duct, soft pancreas echotexture and obesity, it provides a safer alternative and can be performed in less time than a single loop reconstruction.

Sarcopenia measured by tomography as a predictor of morbidity and mortality in thoracic surgery. A retrospective cohort study

BackgroundSarcopenia has been identified as a risk factor for perioperative adverse events. Several studies have shown that tomographic assessment of muscle mass can be an appropriate indicator of sarcopenia associated with morbidity and mortality. The aim of the study was to determine the association between height-adjusted area of ​​the pectoral and erector spinae muscles (haPMA and haESA) and perioperative morbidity and mortality in thoracic surgery. MethodsRetrospective cohort study. Measurement of muscle areas was performed by tomography. The outcomes were 30-day mortality and postoperative morbidity. The discriminative capacity of the muscle areas was evaluated with an analysis of ROC curves and the Youden index was used to establish a cut-off point. The raw morbidity and mortality risk was determined and adjusted for potential confounders. ResultsA total of 509 patients taken to thoracic surgery were included. The incidence of 30-day mortality was 7.3%. An association was found between muscle areas and 30-day mortality and pneumonia, with adequate discriminative power for mortality (AUC 0.68 for haPMA and 0.67 for haESA). An haPMA less than 10 and haESA less than 8.5 cm2/m2 were identified as a risk factor for 30-day mortality with an adjusted OR of 2.34 (95%CI 1.03 – 5.15) and 2.22 (95%CI 1.10 – 6.04) respectively. ConclusionsSarcopenia, defined as low muscle area in the pectoral and erector spinae muscles, is associated with increased morbidity and mortality in patients undergoing thoracic surgery.

Sarcopenia evaluated by EASL/AASLD computed tomography-based criteria predicts mortality in patients with cirrhosis: a systematic review and meta-analysis

Background & aimsSarcopenia is associated with increased morbidity and mortality in patients with cirrhosis, but its definition in current literature is very heterogeneous. We performed a systematic review and meta-analysis to assess the association between mortality and sarcopenia evaluated by computed tomography (CT) in patients with cirrhosis, both overall and stratified for the criteria used to define sarcopenia. MethodsMedline, Embase, Scopus, and Cochrane Library were searched up to January 2023. We included studies assessing sarcopenia presence with CT scans and providing data on the risk of mortality. Adjusted hazard ratios (HRs) and 95%-Confidence Interval (CI) were pooled using a random-effect model. ResultsThirty-nine studies comprising 12827 patients were included in the meta-analysis. The summary prevalence of sarcopenia was 44% (95%-CI: 38-50%). The presence of sarcopenia (any definition) was an independent predictor of mortality with an adjusted HR of 2.07 (95%-CI: 1.81-2.36), and the result was consistent in all subgroup analyses. The prognostic role of the EASL/AASLD criteria was confirmed for the first time with an HR of 1.86 (95%-CI: 1.53-2.26) (n=14 studies). The cut-offs used to define sarcopenia based on psoas muscle parameters varied among studies, thus, a subgroup analysis was not feasible. There was no substantial heterogeneity for the main estimates and no significant risk for publication bias. ConclusionsSarcopenia at CT is associated with a 2-fold higher risk of mortality in patients with cirrhosis. The cut-offs proposed by EASL/AASLD are prognostically relevant and should be the recommended criteria used to define sarcopenia in clinical practice. Impact and implicationsSarcopenia assessed by the reference standard (CT scan) is an independent predictor of mortality in patients with cirrhosis, with a 2-fold increase in the risk of death in all sensitivity analyses. This finding is particularly valid in patients from Europe and North America, and in transplantation candidates. Stratifying for definitions and cut-offs used, we confirmed for the first time the prognostic impact of the definition proposed by EASL/AASLD, supporting their use in clinical practice. Psoas muscle assessment is promising, but data are still limited and too heterogeneous to recommend its routine use at the time.