Citations

Controversy remains regarding which approach is better, laparoscopic appendectomy (LA) or open appendectomy (OA). A 5-year retrospective review of patients undergoing appendectomy was performed to compare the outcomes of LA and OA using standard statistical methods ( P < 0.05). LA was performed in 207 and OA in 100 patients (conversion 6.7%). Females underwent LA more frequently than males (81.7% vs 51.9%; P = 0.0001). LA patients were older (30.2 years vs 25.7 years; P = 0.03), with no differences in body mass index (BMI) (27.9 kg/m 2 vs 25.5 kg/m 2 ; P = 0.06) or operative times (51.1 minutes vs 51.5 minutes; P = 0.84).’ LA patients required less analgesics (19.2 mg vs 31.5 mg; P = 0.01), and shorter hospital stays (27.2 hours vs 53.1 hours; P = 0.0001). Operating room charges were higher for LA ($3839 vs $2528; P = 0.0001), with no difference in total hospital charges ($8801. vs $9147; P = 0.14). Complications between LA and OA were similar (3.6% vs 8%; P = 0.12). Converted patients were older, required more analgesia, and had higher morbidity, length of stay, and hospital charges. LA is the procedure of choice for appendicitis regardless of age, sex, BMI, or degree of appendiceal inflammation. LA is as safe and quick to perform as OA with lower analgesic requirements, length of stay, and no difference in total charges.

ImportanceCytokine storm due to COVID-19 can cause high morbidity and mortality and may be more common in patients with cancer treated with immunotherapy (IO) due to immune system activation.ObjectiveTo determine the association of baseline immunosuppression and/or IO-based therapies with COVID-19 severity and cytokine storm in patients with cancer.Design, Setting, and ParticipantsThis registry-based retrospective cohort study included 12 046 patients reported to the COVID-19 and Cancer Consortium (CCC19) registry from March 2020 to May 2022. The CCC19 registry is a centralized international multi-institutional registry of patients with COVID-19 with a current or past diagnosis of cancer. Records analyzed included patients with active or previous cancer who had a laboratory-confirmed infection with SARS-CoV-2 by polymerase chain reaction and/or serologic findings.ExposuresImmunosuppression due to therapy; systemic anticancer therapy (IO or non-IO).Main Outcomes and MeasuresThe primary outcome was a 5-level ordinal scale of COVID-19 severity: no complications; hospitalized without requiring oxygen; hospitalized and required oxygen; intensive care unit admission and/or mechanical ventilation; death. The secondary outcome was the occurrence of cytokine storm.ResultsThe median age of the entire cohort was 65 years (interquartile range [IQR], 54-74) years and 6359 patients were female (52.8%) and 6598 (54.8%) were non-Hispanic White. A total of 599 (5.0%) patients received IO, whereas 4327 (35.9%) received non-IO systemic anticancer therapies, and 7120 (59.1%) did not receive any antineoplastic regimen within 3 months prior to COVID-19 diagnosis. Although no difference in COVID-19 severity and cytokine storm was found in the IO group compared with the untreated group in the total cohort (adjusted odds ratio [aOR], 0.80; 95% CI, 0.56-1.13, and aOR, 0.89; 95% CI, 0.41-1.93, respectively), patients with baseline immunosuppression treated with IO (vs untreated) had worse COVID-19 severity and cytokine storm (aOR, 3.33; 95% CI, 1.38-8.01, and aOR, 4.41; 95% CI, 1.71-11.38, respectively). Patients with immunosuppression receiving non-IO therapies (vs untreated) also had worse COVID-19 severity (aOR, 1.79; 95% CI, 1.36-2.35) and cytokine storm (aOR, 2.32; 95% CI, 1.42-3.79).Conclusions and RelevanceThis cohort study found that in patients with cancer and COVID-19, administration of systemic anticancer therapies, especially IO, in the context of baseline immunosuppression was associated with severe clinical outcomes and the development of cytokine storm.Trial RegistrationClinicalTrials.gov Identifier: NCT04354701

390216 Background: CDK4/6 inhibitors have become standard of care for advanced hormone receptor positive, HER2-negative (HR+/HER2-) breast cancer in combination with endocrine therapy (ET), with one approved for high-risk patients (pts) in the adjuvant setting. The PALLAS Trial investigated the addition of palbociclib to adjuvant ET in pts with stage II-III breast cancer. Stage IIA patients were specifically enrolled to evaluate the potential benefit of using palbociclib with adjuvant ET pts diagnosed at lower risk who may have more indolent disease. Methods: In the prospective, randomized, phase III PALLAS trial, pts with HR+/HER2- early breast cancer were randomly assigned to receive adjuvant ET for at least 5 years with or without 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle). ET was of provider’s choice. Stage IIA enrollment was capped at 1,000 patients. While the primary end point of the overall study was invasive disease-free survival (iDFS) for the entire cohort, there was a preplanned analysis of recurrence and survival endpoints in the stage IIA cohort. Outcomes were compared between arms using stratified log-rank tests and Cox models (stratification factors: chemotherapy and age ≤ 50). Results: Among 5,796 pts enrolled at 406 centers in 21 countries worldwide between 9/1/2015 and 11/30/2018, a total of 1,010 stage IIA pts were enrolled. The protocol-defined number of events occurred at a median follow-up of 50 months for this subgroup (43.1 months for the overall study). Median age within this subgroup was 54 (range 29-85 yrs), and 410 (40.6%) were pre/perimenopausal, 506 (50.1%) T2/N0 (vs T0-1/N1), 272 (26.9%) grade 3 (vs. grade1/2), and 561 (55.5%) received chemotherapy. iDFS events occurred in 31 of 503 (6.2%) pts who received palbociclib plus ET and in 45 of 507 (8.9%) pts who received ET alone, resulting in a statistically nonsignificant difference in iDFS at 4 years (92.9% vs. 92.1%; hazard ratio, 0.75; CI, 0.48 to 1.19; P = .23). Nonsignificant differences were also observed for invasive breast cancer-free, distant recurrence-free, and locoregional cancer-free survival. No significant differences in iDFS were observed in subgroups including age group, receipt of chemotherapy, tumor grade, and clinical risk (T1/N1 vs. T2/N0).Conclusions: In this preplanned analysis of the stage IIA cohort of the PALLAS trial, the addition of adjuvant palbociclib to standard ET did not improve outcomes over ET alone, suggesting no benefit from the agent in reducing the incidence of early relapse in pts with lower-stage HR+/HER2- breast cancer. Future analyses will incorporate genomic risk and other molecular patterns from the extensive transPALLAS correlative program. Additional follow-up (10-year minimum) is also underway to assess the impact of palbociclib exposure on late recurrence in HR+ disease. Clinical trial information: NCT02513394.

46 Background: Tumor boards (TBs) are considered a key component for ensuring high quality cancer care. However, little is known about TB operational aspects that impact effectiveness. We aimed to understand how TBs leverage Electronic Health Record (EHR) functionalities and how pandemic-driven transitions from in-person TBs to virtual TBs impacted TB quality and effectiveness. Methods: The National Comprehensive Cancer Network (NCCN) Oncology EHR Advisory Group formed a Workgroup to assess the current state of TBs, obtain providers’ views on ideal TB state, and develop recommendations for improving TB quality and effectiveness. The Workgroup surveyed providers in various specialties at 31 NCCN Member Institutions in March 2022. Results: 846 providers from 27 institutions responded to the survey (n = 76 respondents were excluded from analysis because they reported not participating in TBs). Almost all (n = 764/767, 99%) indicated that one or more participants always or frequently attended TB meetings virtually. When comparing (newly established) virtual to (pre-pandemic) in-person TBs, 69% indicated increased attendance at virtual TBs. 65% reported no change in case volume, and 56% reported unchanged discussion quality while 19% reported increased discussion quality when comparing virtual to in-person TB meetings. In regards to EHR integration, several gaps between current and ideal state were noted. For instance, 40% always or frequently added patients to the TB roster via the EHR, but 57% reported this functionality to be very important or important for TBs. Additionally, 53% always or frequently document TB recommendations within the EHR, while 87% indicated EHR documentation of recommendations as very important or important. Respondents reported that barriers to documentation include resource constraints, concerns with patient access to documentation, legal and liability concerns, and poor EHR functionality. Conclusions: Overall, the majority of responding providers reported virtual TBs to be at least similar in quality to in-person TB meetings. A major gap identified by this study is the lack of documentation of TB recommendations in the EHR. Workflows and EHR functionalities could be improved to fully optimize the EHR for TB management and documentation.[Table: see text]

Congenital heart diseases, including single ventricle circulations, are clinically challenging due to chronic pressure overload and the inability of the myocardium to compensate for lifelong physiological demands. To determine the clinical relevance of autologous umbilical cord blood–derived mononuclear cells (UCB-MNCs) as a therapy to augment cardiac adaptation following surgical management of congenital heart disease, a validated model system of right ventricular pressure overload due to pulmonary artery banding (PAB) in juvenile pigs has been employed. PAB in a juvenile porcine model and intramyocardial delivery of UCB-MNCs was evaluated in three distinct 12-week studies utilizing serial cardiac imaging and end-of-study pathology evaluations. PAB reproducibly induced pressure overload leading to chronic right ventricular remodeling including significant myocardial fibrosis and elevation of heart failure biomarkers. High-dose UCB-MNCs (3 million/kg) delivered into the right ventricular myocardium did not cause any detectable safety issues in the context of arrhythmias or abnormal cardiac physiology. In addition, this high-dose treatment compared with placebo controls demonstrated that UCB-MNCs promoted a significant increase in Ki-67-positive cardiomyocytes coupled with an increase in the number of CD31+ endothelium. Furthermore, the incorporation of BrdU-labeled cells within the myocardium confirmed the biological potency of the high-dose UCB-MNC treatment. Finally, the cell-based treatment augmented the physiological adaptation compared with controls with a trend toward increased right ventricular mass within the 12 weeks of the follow-up period. Despite these adaptations, functional changes as measured by echocardiography and magnetic resonance imaging did not demonstrate differences between cohorts in this surgical model system. Therefore, this randomized, double-blinded, placebo-controlled pre-clinical trial establishes the safety of UCB-MNCs delivered via intramyocardial injections in a dysfunctional right ventricle and validates the induction of cardiac proliferation and angiogenesis as transient paracrine mechanisms that may be important to optimize long-term outcomes for surgically repaired congenital heart diseases.

Abstract The ongoing obesity epidemic represents a global public health crisis that contributes to poor health outcomes, reduced quality of life, and &gt;2.8 million deaths each year. Obesity is relapsing, progressive, and heterogeneous. It is considered a chronic disease by the World Obesity Federation (WOF) and a chronic condition by the World Heart Federation (WHF). People living with overweight/obesity are at greater risk for cardiovascular (CV) morbidity and mortality. Increased adiposity (body fat), particularly visceral/abdominal fat, is linked to CV risk and CV disease (CVD) via multiple direct and indirect pathophysiological mechanisms. The development of CVD is driven, in part, by obesity-related metabolic, endocrinologic, immunologic, structural, humoral, haemodynamic, and functional alterations. The complex multifaceted nature of these mechanisms can be challenging to understand and address in clinical practice. People living with obesity and CVD often have concurrent chronic physical or psychological disorders (multimorbidity) requiring multidisciplinary care pathways and polypharmacy. Evidence indicates that intentional weight loss (particularly when substantial) lowers CVD risk among people with overweight/obesity. Long-term weight loss and maintenance require ongoing commitment from both the individual and those responsible for their care. This position paper, developed by the WOF and the WHF, aims to improve understanding of the direct and indirect links between overweight/obesity and CVD, the key controversies in this area and evidence relating to cardiometabolic outcomes with available weight management options. Finally, an action plan for clinicians provides recommendations to help in identifying and addressing the risks of obesity-related CVD (recognizing resource and support variances between countries).