Women's Representation in RCTs Evaluating FDA-Supervised Medical Devices: A Systematic Review.

This systematic review evaluates the representation of women in randomized clinical trials (RCTs) of US Food and Drug Administration (FDA)­supervised medical devices.

Long-Term Outcomes and Characteristics Associated With Mortality of Adult Patients Post Fontan Surgery: 27-Year Single-Center Experience.

Data on the characteristics and long-term outcomes of patients who underwent Fontan surgery and surviving into adulthood are limited. We aimed to describe our center's long-term experience with this unique patient population. Included were adult patients who had undergone Fontan surgery and were followed up at our Adult Congenital Heart Disease clinic between the years 1994 and 2021. We describe cardiac and noncardiac morbidities, medical treatment, laboratory data, echocardiographic characteristics, and all-cause mortality. The primary outcome was a composite of heart failure hospitalizations or death. A total of 107 patients who underwent Fontan surgery were followed up during the study period; 46.7% were male. The mean age at time of Fontan was 7.4 ± 6.2 years and the mean age at the last follow-up or at the time of an outcome event was 35.0 ± 8.0 years (range 21.1 to 62.8). At the last documented follow-up, 74.7% of the cohort were in New York Heart Association functional class I/II. The common morbidities included atrial arrythmias (37%) and stroke (17%). The primary outcome occurred in 17.7%. By the end of the study period, 9.3% of the patients in the cohort died. In a multivariate logistic regression analysis, controlling for gender, age, and Fontan type, worse functional class at the last follow-up (New York Heart Association III/IV vs I/II) was significantly associated with the risk of the primary outcome (odds ratio 34.57, 95% confidence interval 6.728 to 177.623, p <0.001). In conclusion, long-term outcomes of patients surviving into adulthood with a Fontan circulation is encouraging. Most of these patients achieve good functional cardiovascular status, despite the complex anatomy and a substantial burden of co-morbid conditions, specifically, atrial arrythmias and thrombotic events. Functional class was independently associated with heart failure hospitalizations and mortality.

Risk Factors for Superficial Thrombophlebitis: A Retrospective Case Control Study.

BACKGROUND: Data regarding risk factors for superficial thrombophlebitis (STP) cases presenting to a hospital is limited. OBJECTIVES: To investigate and stratify clinical and laboratory risk factors for STP. METHODS: We conducted a retrospective case control study comparing patients presenting to the emergency department with STP and age- and gender-matched controls. We collected data on multiple risk factors and five blood indices. RESULTS: The study comprised 151 patients and matched controls. Patients with STP were more likely to have varicose veins (43.7% vs. 5.3%, P < 0.001), recent immobilization (14.6% vs. 1.3%, P < 0.001), obesity (36.4% vs. 18.5%, P = 0.001), a history of venous thromboembolism (VTE) or STP (27.2% vs. 0.7%, P < 0.001), and inherited thrombophilia (9.3% vs. 1.3%, P = 0.002). Following multivariate analysis, all five risk factors remained significant, with a history of VTE or STP associated with the largest risk (odds ratio [OR] 35.7), followed by immobilization (OR 22.3), varicose veins (OR 12.1), inherited thrombophilia (OR 6.1), and obesity (OR 2.7). Mean platelet volume was higher (8.5 vs 7.9 fl, P = 0.003) in STP cases. CONCLUSIONS: A history of VTE or STP, immobilization, varicose veins, inherited thrombophilia, and obesity serve as independent clinical risk factors for STP presenting to hospital.

The effect of indirect calorimetry guided isocaloric nutrition on mortality in critically ill patients-a systematic review and meta-analysis.

Indirect calorimetry (IC)-guided nutrition might positively affect the clinical outcome of critically ill patients. In this systematic review and meta-analysis, our objective was to assess the benefit of isocaloric nutrition guided by IC, compared to hypocaloric nutrition, for critically ill patients admitted to the intensive care unit (ICU). We performed a systematic review of all randomized controlled trials published through January 2021, assessing the benefit of isocaloric nutrition guided by IC. The primary outcome was 28-day all-cause mortality. Secondary outcomes were ICU and 90-day all-cause mortality, rate of nosocomial infections, and adverse events. Four trials evaluating 1052 patients were included. Patients treated with isocaloric nutrition had a lower 28-day mortality rate (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.63-0.99, P = 0.04). No between-group difference was found in ICU and 90-day mortality (RR 0.92, 95% CI 0.68-1.23, P = 0.56 and RR 0.88, 95% CI 0.72-1.07; P = 0.2, respectively) and in the rate of nosocomial infections (RR 1.15, 95% CI 0.77-1.72, P = 0.51). A pooled analysis of studies that evaluated the benefit of isocaloric nutrition guided by IC, for critically ill patients in the ICU, has shown reduced 28-day mortality. However, there was no difference in 90-day mortality and nosocomial infection rate.

A Noninvasive Stroke Volume Monitoring for Early Detection of Minimal Blood Loss: A Pilot Study.

INTRODUCTION: Alternation in traditional vital signs can only be observed during advanced stages of hypovolemia and shortly before the hemodynamic collapse. However, even minimal blood loss induces a decrease in the cardiac preload which translates to a decrease in stroke volume, but these indices are not readily monitored. We aimed to determine whether minor hemodynamic alternations induced by controlled and standardized hypovolemia can be detected by a whole-body bio-impedance technology. METHODS: This was a non-randomized controlled trial that enrolled healthy blood donors. Vital signs, as well as shock index and stroke volume (SV), were recorded using noninvasive cardiac system, a noninvasive whole-body impedance-based hemodynamic analysis system, during phlebotomy. RESULTS: Sixty subjects were included in the study group and 20 in the control group. Blood loss of 450 mL resulted in a significant decrease in systolic blood pressure (5 mm Hg; 95% CI 3, 6) and SV (5.07 mL; 95% CI 3.21, 6.92), and increase in shock index (0.03 bpm/mm Hg; 95% CI 0.01, 0.05). Clinically detectable changes (≥10%) in blood pressure and shock index were detectable in 15% and 5%, respectively. SV decreased by more than 10% in 40% of blood donors. No significant changes occurred in the control group. CONCLUSION: Continuous noninvasive monitoring of SV may be superior to conventional indices (e.g., heart rate, blood pressure, or shock index) for early identification of acute blood loss. As an operator-independent and point-of-care technology, the SV whole body bio-impedance measurement may assist in accurate monitoring of potentially bleeding patients and early identification of hemorrhage.

Accuracy of Guided Implant Surgery in 25 Edentulous Arches: A Laboratory Observational Study.

PURPOSE: To assess the accuracy of template-guided implant surgery for edentulous arches. MATERIALS AND METHODS: The stone master casts of 25 edentulous arches treated with either 4 or 6 implants with CBCT generated template-guided surgery were included in this observational cohort study. The stone casts generated from the surgical templates (group one) prior to implant placement were digitized into Standard Tesselation (STL) files with a reference scanner. For comparison, the stone master casts derived from intraoral complete-arch impressions after implant placement (group two) were also digitized. The resultant STL files were superimposed and best-fit-alignment algorithm was used to quantify the 3D deviations present between the two groups. Descriptive statistics were computed for all categorical variables. Due to the presence of nonindependent samples between maxillary and mandibular casts, a mixed-effects model was used. RESULTS: Deviations between the implant analogs of the stone casts representing digitally planned versus actually placed implants were found. The mean root-mean-square error (RMSE) between all 25 arches was found to be 0.2 mm (SD ± 0.15). The mean RMSE between presurgical and postsurgical maxillary stone casts were 0.19 ± 0.15 mm, while between mandibular stone casts were 0.21 ± 0.16 mm and were not significant (p = 0.67). The mean RMSE between presurgical and postsurgical stone casts arches with 4 versus 6 implants were found to be significant (p = 0.01). CONCLUSIONS: According to the results of the study and based on the amount of 3D deviations between the digitally planned implant positions and the actually placed implants, template-guided surgery is a safe treatment modality for implant placement in edentulous arches.

Digital Workflow: From Guided Surgery to Final Full-Arch Implant Prosthesis in Three Visits.

The purpose of this article is to report a digital workflow protocol for full-arch implant rehabilitation from guided surgery to final prosthesis in only three visits. This expedited protocol allows for implant placement with a surgical template generated from preoperative virtual planning and production of the CAD/CAM prosthodontic rehabilitation using a digital workflow. At the first visit, a guided implant placement protocol with the All-on-4 concept and immediate loading with the conversion prosthesis technique was done. At the same visit, final impression and interocclusal records, cast verification and mounting, as well as digital scanning of the conversion prosthesis were carried out. During the second visit, the framework try-in was performed. Lastly, the third visit included delivery of the final full-arch prosthesis opposed by a maxillary complete denture.

Recapitulating the clinical scenario of BRCA-associated pancreatic cancer in pre-clinical models.

Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies. BRCA-associated PDAC comprises a clinically relevant subtype. A portion of these patients are highly susceptible to DNA damaging therapeutics, however, responses are heterogeneous and clinical resistance evolves. We have developed unique patient-derived xenograft (PDX) models from metastatic lesions of germline BRCA-mutated patients obtained at distinct time points; before treatment and at progression. Thus, closely mimicking clinical scenarios, to further investigate treatment naïve and resistant patients. DNA was isolated from six BRCA-mutated PDXs and classified by whole-genome sequencing to stable-genome or homologous recombination deficient (HRD)-genome. The sensitivity to DNA-damaging agents was evaluated in vivo in three BRCA-associated PDAC PDXs models: (1) HRD-genome naïve to treatments; (2) stable-genome naïve to treatment; (3) HRD-genome resistant to treatment. Correlation between disease course at tissue acquisition and response to PARP inhibitor (PARPi)/platinum was demonstrated in PDXs in vivo. Only the HRD-genome PDX, naïve to treatment, was sensitive to PARP inhibitor/cisplatin treatments. Our results demonstrate heterogeneous responses to DNA damaging agents/PARPi in BRCA-associated PDX thus reflecting the wide clinical spectrum. An HRD-genome PDX generated from a naïve to treatment biopsy was sensitive to platinum/PARPi whereas no benefit was observed in treating a HRD-genome PDXs generated from a patient that had acquired resistance nor stable-genome PDXs.