Characteristics of clinical trials evaluating cardiovascular therapies for Coronavirus Disease 2019 Registered on ClinicalTrials.gov: a cross sectional analysis.

Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described. METHODS: ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries. RESULTS: A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41). CONCLUSIONS: A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.

Outcomes of balloon-assisted maturation with large-diameter balloons.

OBJECTIVES: Balloon-assisted maturation (BAM) is a well-established technique for maturation of inadequate arteriovenous fistulas (AVF). The objective of this study was to evaluate outcomes of initial BAM using large-diameter angioplasty balloons. METHODS: Charts of patients who underwent BAM between 2018 and 2021 at a single academic institution were reviewed. AVF maturation rate was the primary outcome. Secondary outcomes included procedural complications, re-intervention rates, post-procedure vein diameter, and time to catheter-free hemodialysis (HD). Outcomes of patients that underwent initial BAM with ⩾7 mm diameter balloons (Group I) were compared to those of patients that had initial BAM with <7 mm balloons (Group II). RESULTS: Group I (n = 149) was a significantly younger cohort and had more men compared to Group II (n = 90). There were no significant differences associated with procedural details and complication rates. Median vein diameter was larger (5.9 mm, IQR: 5-6.4) in Group I compared to Group II (5.1 mm, IQR: 4.2-5.9; p = 0.03) on post-procedure Duplex ultrasound. There was also a higher incidence of vein stenosis in Group II. The overall maturation rate was higher in Group I (97% vs 88%, p = 0.003), and a larger proportion of patients in Group II required more than one BAM to achieve maturation (33% vs 16%, p = 0.002). The median time to catheter-free HD after first BAM was 29 days (IQR: 19-47) in Group I and 42 days (IQR: 24-75) in Group II (p = 0.002). At 60 days after first BAM, the incidence of catheter-free HD was 83% in Group I versus 67% in Group II (p = 0.001). CONCLUSIONS: Our study demonstrates that the ability to utilize large angioplasty balloons during initial BAM is associated with higher rates of AVF maturation with fewer re-interventions and shorter time to catheter-free dialysis. AVFs that can tolerate this procedure often have more favorable baseline characteristics.

Does Operative Time Affect Complication Rate in Laparoscopic Cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy is the most common laparoscopic procedure performed in the United States. Our aim was to determine if increased operative time (OT) is associated with increased morbidity following laparoscopic cholecystectomy. METHODS: Using ACS NSQIP from 2006 to 2015, we identified all adult (≥18 years) patients that underwent laparoscopic cholecystectomy for cholecystitis performed within 3 days of admission. Our analysis was limited to cases with OT ≥15 minutes and ≤360 minutes. Outcome variables included postoperative surgical site infections (SSI), dehiscence, pneumonia, reintubation, failure to wean from ventilator, pulmonary embolism, renal failure, urinary tract infection, cardiac arrest, myocardial infarct, bleeding, deep vein thrombosis, sepsis, septic shock, return to the operating room, and death. RESULTS: 7,031 cases met inclusion criteria. Median OT was 63 minutes, first quartile was 46 minutes and third quartile was 87 minutes. Logistic regression analysis showed that increased OT (third vs first quartile) was an independent risk factor for superficial SSI (OR 1.75, 95% CI 1.36-2.25, P < .0001), organ-space SSI (OR 1.77, 95% CI 1.33-2.35, P < .0001), dehiscence (OR 2.03, 95% CI 1.01-4.07, P = 0.0470), and septic shock (OR 1.81, 95% CI 1.06-3.09, P = 0.0286). Increased OT was independently associated with increased LOS (fourth vs 1st quartile: IRR 1.53, P < 0.0001; third vs 1st quartile: IRR 1.29, P < .0001; 2nd vs 1st quartile: IRR 1.16, P < 0.0001). CONCLUSION: Increased OT is independently associated with morbidity and increased LOS following laparoscopic cholecystectomy for cholecystitis. Prospective studies are warranted to determine which factors contribute to increased OT and why.

Systemic Determinants in Surgery: Nonclinical Factors Affecting Time to Operation for Incarcerated Ventral Hernias.

INTRODUCTION: We explore nonclinical factors affecting the amount of time from admission to the operating room for patients requiring nonelective repair of ventral hernias. METHODS: Using the 2005-2012 Nationwide Inpatient Sample, we identified adult patients with a primary diagnosis of ventral hernia without obstruction/gangrene, who underwent nonelective repair. The outcome variable of interest was time from admission to surgery. We performed univariate and multivariable analyses using negative binomial regression, adjusting for age, sex, race, income, insurance, admission day, comorbidity status (van Walraven score), diagnosis, procedure, hospital size, location/teaching status, and region. RESULTS: 7,253 patients met criteria, of which majority were women (n = 4,615) and white (n = 5,394). The majority of patients had private insurance (n = 3,015) followed by Medicare (n = 2,737). Median time to operation was 0 days. Univariate analysis comparing operation <1 day to ≥1 day identified significant differences in race, day of admission, insurance, length of stay, comorbidity status, hospital location, type, and size. Negative binomial regression showed that weekday admission (IRR 4.42, P < .0001), private insurance (IRR 1.53-2.66, P < .0001), rural location (IRR 1.39-1.76, P < .01), small hospital size (IRR 1.26-1.36, P < .05), white race (IRR 1.30-1.34, P < .01), healthier patients (van Walraven score IRR 1.05, P < .0001), and use of mesh (IRR 0.39-0.56, P < .02) were associated with shorter time until procedure. CONCLUSION: Shorter time from admission to the operating room was associated with several nonclinical factors, which suggest disparities may exist. Further prospective studies are warranted to elucidate these disparities affecting patient care.

Understanding surgical education needs in Zambian residency programs from a Resident's perspective.

INTRODUCTION: Approximately 100 surgeons in Zambia serve a population of 16 million, a severe shortage in basic surgical care. Surgical education in Zambia and other low-middle income countries has not been well characterized. The aim of this study was to evaluate surgical training resources from a resident perspective. METHODS: 6 of 8 COSECSA-accredited major medical centers were included. We developed a Surgical Education Capacity Tool to evaluate hospital characteristics including infrastructure, education, and research. The questionnaire was completed by administrators and trainees. RESULTS: 18 of 45 trainees were surveyed. Caseloads and faculty-to-trainee ratio varied by location. No sites had surgical skills, simulation, or research labs. Most had medical libraries, lecture halls, and internet. Outpatient clinics, bedside teaching, M&M conferences, and senior supervision were widely available. Despite some exposure, research mentorship, basic science, and grant application guidance were critically limited. CONCLUSIONS: Lack of access to proper infrastructure, research, and personnel all impact surgical training and education. The Surgical Education Capacity Tool offers insights into areas of potential improvement, and is applicable to other LMICs.

Association of Rankings With Cardiovascular Outcomes at Top-Ranked Hospitals vs Nonranked Hospitals in the United States.

Importance: The US News & World Report (USNWR) identifies the "Best Hospitals" for "Cardiology and Heart Surgery." These rankings may have significant influence on patients and hospitals. Objective: To determine whether USNWR top-ranked hospitals perform better than nonranked hospitals on mortality rates and readmission measures as well as patient satisfaction. Design, Setting, and Participants: This national retrospective study evaluated outcomes at 3552 US hospitals from 2014 to 2017. Exposures: US News & World Report 2018 to 2019 Cardiology and Heart Surgery rankings (top-ranked vs nonranked hospitals). Main Outcomes and Measures: Hospital-level 30-day risk-standardized mortality and readmission rates for Medicare fee-for-service beneficiaries age 65 years or older hospitalized for 3 cardiovascular conditions: acute myocardial infarction (AMI), heart failure (HF), and coronary artery bypass grafting (CABG) as well as Hospital Consumer Assessment of Healthcare Providers and Systems patient satisfaction star ratings obtained from publicly available Centers for Medicaid and Medicare Services data. Results: Thirty-day mortality rates at top-ranked hospitals (n = 50), compared with nonranked hospitals (n = 3502), were lower for AMI (11.9% vs 13.2%, P < .001), HF (9.5% vs 11.9%; P < .001), and CABG (2.3%vs 3.3%; P < .001). Thirty-day readmission rates at the top-ranked hospitals (n = 50) when compared with nonranked hospitals (n = 2841) were similar for AMI (16.7% vs 16.5%; P = .64) and CABG (14.1% vs 13.7%; P = .15) but higher for HF (21.0% vs 19.2%; P < .001), Finally, patient satisfaction was higher at top-ranked hospitals (n = 50) compared with nonranked hospitals (n = 3412) (3.9 vs 3.3; P < .001). Conclusions and Relevance: We found that USNWR top-ranked hospitals for cardiovascular care had lower 30-day mortality rates for AMI, HF, and CABG and higher patient satisfaction ratings compared with nonranked hospitals. However, 30-day readmission rates were either similar (for AMI and CABG) or higher (for HF) at top-ranked compared with nonranked hospitals. This discrepancy between readmissions and other performance measures raises concern that readmissions may not be an adequate metric of hospital care quality.

Clinical outcomes following surgically repaired bucket-handle meniscus tears.

OBJECTIVES: Meniscus tears are one of the most common knee injuries. Our goal is to investigate the failure rate for surgically repaired bucket-handle meniscus tears and compare clinical outcomes of repairs that failed versus those that did not, at a minimum 2-year follow-up interval. METHODS: 51 patients were identified in this retrospective cohort study who experienced bucket-handle meniscus tears that were isolated or with concomitant ACL injury. Inclusion criteria included age range from 13-55 years, confirmed bucket-handle meniscus tear by MRI and intraoperatively, and at least two-years of post-operative follow-up following index repair. Demographic data and outcome surveys were collected at a minimum of two-years follow-up after repair. RESULTS: Of the 51 patients that had a bucket-handle meniscal repair, 12 (23.5%) were defined as failures (return of symptoms alongside re-tear in the same zone of the repaired meniscus within two years of surgery). No demographic variables (age, sex, and BMI smoking status, location of tear, or concomitant ACL tear) significantly correlated with failure. The mean of the Sports and Recreation KOOS was significantly lower between the non-failure (87 ± 14.4) and failure (70 ± 17.2) cohorts (p = 0.0072). The Quality of Life subscale was significantly lower between the non-failure (76 ± 15.8) and failure (57 ± 18.2) groups (p = 0.0058). There was a significant difference in the post-operative Lysholm scores (p = 0.0039) with a mean of 90 ± 9.1 for the entire cohort and means of 92 ± 8.4 and 83 ± 8.6, for non-failure and failure groups, respectively. CONCLUSIONS: We found a higher failure rate (23.5%) for bucket-handle meniscus repairs at two-year follow up than has been cited in the literature, which is typically less than 20%, with significantly lower KOOS Quality of Life and Sports and Recreation subscales and Lysholm scores for the failure cohort. This is the first study to report these outcome scores solely for bucket-handle meniscus repairs, shedding light on the post-operative quality of life of patients with repair success or failure.

Intranasal Steroid Use for Otitis Media with Effusion: Ongoing Opportunities for Quality Improvement.

Objectives Our objectives were (1) to assess patterns of intranasal steroid administration when otitis media with effusion (OME) has been diagnosed in children, (2) to investigate whether usage varies according to visit setting, and (3) to determine if practice gaps are such that quality improvement could be tracked. Study Design Cross-sectional analysis of an administrative database. Subjects and Methods National Ambulatory and Hospital Ambulatory Medical Care Surveys, 2005 to 2012; univariate, multivariate, and stratified analyses of intranasal steroid usage were performed. The primary outcome was intranasal steroid administration, and the primary predictor was a diagnosis of OME. The impact of location of service was also analyzed. Results Data representing 1,943,177,903 visits demonstrated that intranasal steroids were administered in 10.0% of visits in which OME was diagnosed, in comparison to 3.5% of visits in which OME was not diagnosed (univariate odds ratio, 3.07; 95% confidence interval [CI], 1.85-5.08; P < .001). After adjusting for age, sex, race/ethnicity, and other confounding conditions, multivariate analysis demonstrated that OME remained associated with an increase in intranasal steroid usage (odds ratio, 3.58; 95% CI, 1.60-8.01; P = .002). This practice pattern was more prevalent in the ambulatory office setting (risk difference 6.6%, P < .001) and less seen in a hospital-based office or emergency department. Conclusion Despite randomized controlled trials showing a lack of efficacy for isolated OME, nasal steroids continue to be used in treating children with OME in the United States. Related quality improvement opportunities to prevent usage of an ineffective treatment exist.

Cryptosporidiosis in HIV/AIDS patients in Kenya: clinical features, epidemiology, molecular characterization and antibody responses.

We investigated the epidemiological and clinical features of cryptosporidiosis, the molecular characteristics of infecting species and serum antibody responses to three Cryptosporidium-specific antigens in human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients in Kenya. Cryptosporidium was the most prevalent enteric pathogen and was identified in 56 of 164 (34%) of HIV/AIDS patients, including 25 of 70 (36%) with diarrhea and 31 of 94 (33%) without diarrhea. Diarrhea in patients exclusively infected with Cryptosporidium was significantly associated with the number of children per household, contact with animals, and water treatment. Cryptosporidium hominis was the most prevalent species and the most prevalent subtype family was Ib. Patients without diarrhea had significantly higher serum IgG levels to Chgp15, Chgp40 and Cp23, and higher fecal IgA levels to Chgp15 and Chgp40 than those with diarrhea suggesting that antibody responses to these antigens may be associated with protection from diarrhea and supporting further investigation of these antigens as vaccine candidates.

Infectious diarrhoea in antiretroviral therapy-naive HIV/AIDS patients in Kenya.

BACKGROUND: Diarrhoea is a significant cause of morbidity and mortality in immunocompromised patients. The objectives of this study were to investigate the aetiological agents, risk factors and clinical features associated with diarrhoea in HIV/AIDS patients in Kenya. METHODS: Sociodemographic, epidemiological and clinical data were obtained for 164 HIV/AIDS patients (70 with and 94 without diarrhoea) recruited from Kenyatta National Hospital, Kenya. Stool samples were examined for enteric pathogens by microscopy and bacteriology. RESULTS: Intestinal protozoa and fungi were identified in 70% of patients, more frequently in those with diarrhoea (p<0.001). Helminths were detected in 25.6% of patients overall, and bacterial pathogens were identified in 51% of patients with diarrhoea. Polyparasitism was more common in patients with diarrhoea than those without (p<0.0001). Higher CD4(+) T-cell count (OR = 0.995, 95% CI 0.992-0.998) and water treatment (OR = 0.231, 95% CI 0.126-0.830) were associated with a lower risk of diarrhoea, while close contact with cows (OR = 3.200, 95% CI 1.26-8.13) or pigs (OR = 11.176, 95% CI 3.76-43.56) were associated with a higher risk of diarrhoea. CONCLUSIONS: Multiple enteric pathogens that are causative agents of diarrhoea were isolated from stools of antiretroviral therapy-naïve HIV/AIDS patients, indicating a need for surveillance, treatment and promotion of hygienic practices.