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International Journal of Environmental... May 2024Although we are four years into the pandemic, there is still conflicting evidence regarding the clinical outcomes of diabetic patients hospitalized with COVID-19. The...
BACKGROUND
Although we are four years into the pandemic, there is still conflicting evidence regarding the clinical outcomes of diabetic patients hospitalized with COVID-19. The primary objective of this study was to evaluate the in-hospital mortality and morbidity of diabetic versus nondiabetic patients hospitalized with COVID-19 in the Northern UAE Emirates.
METHODS
A retrospective analysis was performed on clinical data from patients with or without diabetes mellitus (DM) who were admitted to the isolation hospital with COVID-19 during the first and second waves of the disease (March 2020 to April 2021). The assessed endpoints were all-cause in-hospital mortality, length of hospitalization, intensive care unit (ICU) admission, and mechanical ventilation.
RESULTS
A total of 427 patients were included in the analysis, of whom 335 (78.5%) had DM. Compared to nondiabetics, diabetic COVID-19 patients had a significantly longer in-hospital stay (odds ratio (OR) = 2.35; 95% confidence interval (CI) = 1.19-4.62; = 0.014), and a significantly higher frequency of ICU admission (OR = 4.50; 95% CI = 1.66-7.34; = 0.002). The need for mechanical ventilation was not significantly different between the two groups (OR: distorted estimates; = 0.996). Importantly, the overall in-hospital mortality was significantly higher among diabetic patients compared to their nondiabetic counterparts (OR = 2.26; 95% CI = 1.08-4.73; = 0.03).
CONCLUSION
DM was associated with a more arduous course of COVID-19, including a higher mortality rate, a longer overall hospital stay, and a higher frequency of ICU admission. Our results highlight the importance of DM control in COVID-19 patients to minimize the risk of detrimental clinical outcomes.
Topics: Humans; COVID-19; Hospital Mortality; United Arab Emirates; Retrospective Studies; Male; Female; Middle Aged; Diabetes Mellitus; Aged; Respiration, Artificial; Intensive Care Units; Adult; SARS-CoV-2; Length of Stay; Hospitalization
PubMed: 38928943
DOI: 10.3390/ijerph21060697 -
Cancers Jun 2024The optimal method for the second course of stereotactic body radiotherapy (SBRT) for spinal metastases remains poorly established. This single-center, single-arm, phase...
PURPOSE
The optimal method for the second course of stereotactic body radiotherapy (SBRT) for spinal metastases remains poorly established. This single-center, single-arm, phase II trial was conducted to propose a safe and effective salvage spine SBRT.
METHODS
The patients initially treated with SBRT for spine-targeted protocol treatment, or for areas adjacent to the spine, were enrolled. The second SBRT dose was 30 Gy delivered in five fractions; the spinal cord dose constraint was 15.5 Gy at the maximum point dose. The brachial or lumbosacral plexuses were dose-constrained to <30 Gy if the boundary between the nerves and tumors was detected. The primary endpoint was dose-limiting toxicity (DLT) (grade ≥ 3 severe radiation-related toxicity) within a year after the second SBRT.
RESULTS
The second SBRT was administered to the same spinal level in 12 patients and to an adjacent spinal level in 8 patients. SBRT2 was performed for 14 painful lesions, 10 MESCC, and 6 oligometastases, with some lesions having multiple indications. The median interval between SBRT sessions was 21 months (range: 6-51 months). The median follow-up duration was 14 months. No radiation myelopathy or local failure was reported during the follow-up period. DLT was confirmed in two patients (10%) within a year, both of whom developed grade 3 lumbosacral plexopathy. These two patients received SBRT twice to the S1-2 and S1-5 vertebrae, respectively, and both experienced paralysis of the tibialis anterior muscle (L5 level). Grade 3 late adverse effects (including lumbosacral plexopathy and vertebral compression fracture) were observed in 25% of the patients throughout the entire follow-up period.
CONCLUSIONS
The second spine SBRT achieved good local control without causing myelopathy. However, one-quarter of the patients experienced grade 3 late adverse effects, suggesting that the treatment protocol carries a risk of toxicity.
PubMed: 38927990
DOI: 10.3390/cancers16122286 -
Cancers Jun 2024This study aimed to examine whether the coefficient of variation (CV) in the hepatobiliary-phase (HBP) of Gd-EOB-DTPA-MRI could be an independent predictive factor for...
Prediction of Efficacy for Atezolizumab/Bevacizumab in Unresectable Hepatocellular Carcinoma with Hepatobiliary-Phase Gadolinium Ethoxybenzyl-Diethylenetriaminepentaacetic Acid MRI.
BACKGROUND
This study aimed to examine whether the coefficient of variation (CV) in the hepatobiliary-phase (HBP) of Gd-EOB-DTPA-MRI could be an independent predictive factor for tumor progression.
METHODS
Patients who underwent Gd-EOB-DTPA-MRI before Atezolizumab/bevacizumab therapy at six affiliated institutions between 2018 and 2022 were included. CV for each patient was calculated as the mean value for up to five tumors larger than 10 mm, and CV of the whole tumor was calculated using LIFEx software. The tumor response was evaluated within 6-10 weeks. The primary endpoint was to investigate the predictive factors, including CV, related to tumor progression using logistic regression analysis. The secondary endpoints were tumor response rate and progression-free survival (PFS) based on CV.
RESULTS
Of the 46 enrolled patients, 13 (28.3%) underwent early progressive disease. Multivariate analysis revealed that a high CV (≥0.22) was an independent predictive factor for tumor progression ( = 0.043). Patients with a high CV had significantly frequent PD than those with a low CV (43.5 vs. 13.0%, = 0.047). Patients with a high CV tended to have shorter PFS than those with a low CV (3.5 vs. 6.7 months, = 0.071).
CONCLUSION
Quantitative analysis using CV in the HBP of Gd-EOB-DTPA-MRI may be useful for predicting tumor progression for atezolizumab/bevacizumab therapy.
PubMed: 38927979
DOI: 10.3390/cancers16122275 -
Cancers Jun 2024Cisplatin, one of the most ototoxic anti-neoplastic agents, causes permanent hearing loss in up to 90% of patients. We assessed ototoxicity rates and prospectively...
Cisplatin, one of the most ototoxic anti-neoplastic agents, causes permanent hearing loss in up to 90% of patients. We assessed ototoxicity rates and prospectively collected audiologic outcomes of patients receiving low-dose or high-dose cisplatin with concurrent cochlear-sparing intensity-modulated radiation therapy (IMRT). Patients with head and neck squamous cell carcinoma (HNSCC) receiving definitive or adjuvant cisplatin-based chemoradiotherapy (CRT) were analyzed. Cisplatin was administered either in low doses weekly (40 mg/m) for up to seven doses or in high doses triweekly (100 mg/m) for up to three doses. Cochlear-sparing IMRT was delivered in all cases. Audiologic data were prospectively collected before, during, and after treatment completion. The primary endpoint was a hearing change grade of ≥3 after CRT completion. Of the 96 HNSCC patients evaluated, 69 received weekly cisplatin and 58 received definitive CRT. Of patients receiving weekly cisplatin, 13% developed ≥G3 ototoxicity vs. 56% of patients who received triweekly cisplatin ( < 0.001). In multivariable modeling, the cisplatin dose schedule remained significant (OR: 8.4, 95%CI: 2.8-27.8, < 0.001) for risk of severe irreversible ototoxicity. Triweekly cisplatin CRT significantly increased the ≥G3 severe irreversible ototoxicity risk compared to low-dose weekly cisplatin, irrespective of the cumulative cisplatin dose, even with the use of cochlear-sparing IMRT. No significant difference in oncologic outcomes was observed between the two schedules.
PubMed: 38927933
DOI: 10.3390/cancers16122228 -
Cancers Jun 2024Limited data exists for the efficacy and outcomes of nivolumab as a second-line treatment for unresectable hepatocellular carcinoma (uHCC). We aimed to assess the...
BACKGROUND
Limited data exists for the efficacy and outcomes of nivolumab as a second-line treatment for unresectable hepatocellular carcinoma (uHCC). We aimed to assess the efficacy and safety of nivolumab in patients with uHCC who experienced disease progression during sorafenib treatment.
METHODS
In this retrospective, observational, multicenter study, adult Child-Turcotte-Pugh A/7B patients with uHCC who tolerated sorafenib therapy but showed disease progression switched to second-line intravenous nivolumab ( = 42). A similar number of consecutive, unselected patients who were maintained on sorafenib therapy, regardless of tumoral response or progression, served as historical controls ( = 38). The primary endpoint was overall survival (OS, defined as the time from starting sorafenib in either group up to death due to any cause) and analyzed by intention-to-treat.
RESULTS
The mean age of the overall cohort was 72.4 ± 10.1 years, of whom 87.5% were males and 58.8% had underlying viral etiology. Patients in the two cohorts were similar, except those who received nivolumab had more co-morbidities (70.0% vs. 15.4%), ECOG-2 status (21.4% vs. 15.8%), BCLC stage C (81.0% vs. 47.4%), and extravascular invasion (54.4% vs. 21.8%) ( < 0.05 for all). More patients in the nivolumab arm were Child-Turcotte-Pugh B (35.7% vs. 21.1%, = 0.15). Median OS was 22.2 months (95% CI: 8.9-49.8) on second-line nivolumab and 11.0 months (95% CI: 3.6-18.4) on sorafenib alone (HR 1.93; 95% CI: 1.1-3.3, = 0.014). Median OS after starting nivolumab was 10.2 months, and time-to-progression was 4.9 months (95% CI: 3.2-6.3).
CONCLUSION
Nivolumab is an effective second-line treatment option in patients with uHCC who progress on sorafenib, with significantly improved OS. These early real-life data offer encouraging results, similar to those shown in Phase I/IIa clinical trials. Further investigations are warranted for the use of nivolumab as a monotherapy.
PubMed: 38927902
DOI: 10.3390/cancers16122196 -
Cancers Jun 2024The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk...
A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial.
The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0-72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3-82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.
PubMed: 38927884
DOI: 10.3390/cancers16122178 -
Cancers Jun 2024Recent advances in neoadjuvant systemic therapy (NST) have significantly improved pathologic complete response rates in early breast cancer, challenging the role of... (Review)
Review
Recent advances in neoadjuvant systemic therapy (NST) have significantly improved pathologic complete response rates in early breast cancer, challenging the role of axillary lymph node dissection in nose-positive patients. Targeted axillary dissection (TAD) integrates marked lymph node biopsy (MLNB) and tracer-guided sentinel lymph node biopsy (SLNB). The introduction of new wire-free localisation markers (LMs) has streamlined TAD and increased its adoption. The primary endpoints include the successful localisation and retrieval rates of LMs. The secondary endpoints include the pathological complete response (pCR), SLNB, and MLNB concordance, as well as false-negative rates. Seventeen studies encompassing 1358 TAD procedures in 1355 met the inclusion criteria. The localisation and retrieval rate of LMs were 97% and 99%. A concordance rate of 67% (95% CI: 64-70) between SLNB and MLNB was demonstrated. Notably, 49 days (range: 0-272) was the average LM deployment time to surgery. pCR was observed in 46% (95% CI: 43-49) of cases, with no significant procedure-related complications. Omitting MLNB or SLNB would have under-staged the axilla in 15.2% or 5.4% ( = 0.0001) of cases, respectively. MLNB inclusion in axillary staging post-NST for initially node-positive patients is crucial. The radiation-free Savi Scout, with its minimal MRI artefacts, is the preferred technology for TAD.
PubMed: 38927878
DOI: 10.3390/cancers16122172 -
Biomedicines Jun 2024Patients with IgA nephropathy (IgAN), a chronic kidney disease (CKD), are significantly more likely to have cardiovascular (CV) mortality and morbidity than the general...
BACKGROUND
Patients with IgA nephropathy (IgAN), a chronic kidney disease (CKD), are significantly more likely to have cardiovascular (CV) mortality and morbidity than the general population. The occurrence of metabolic syndrome (MetS) and metabolic risk factors are independent risk factors for CV disease and renal progression. The purpose of this study was to determine how metabolic characteristics in a homogeneous population of CKD patients relate to prognosis.
METHODS
A total of 145 patients with CKD stages 1-4 diagnosed with IgA nephropathy (92 men and 53 women, aged 54.7 ± 13 years) were examined and monitored for a median of 190 months. All-cause mortality and any CV event, such as stroke, myocardial infarction, revascularization (CV), end-stage renal disease, and renal replacement therapy (renal), have been included in the composite endpoints (CV and renal).
RESULTS
Patients with MetS had significantly more primary endpoint events (23/65 patients vs. 15/60 patients, < 0.001) compared to the non-MetS group. The MetS group had a statistically significant increase in both primary renal and CV endpoints (18/65 vs. 10/60, = 0.001), and in CV endpoint events (7/65 vs. 6/60, = 0.029) among the secondary endpoints (CV and renal separately). Based on Cox regression analysis, the main endpoint independent predictors of survival were dyslipidemia, eGFR, hemoglobin, urine albuminuria, and diabetes mellitus. Independent predictors of secondary renal endpoints were dyslipidemia, hemoglobin, urine albumin, and eGFR. Predictors of secondary cardiovascular endpoints were gender, BMI, and diabetes. When Kaplan-Meier curves were analyzed at the combined endpoints (CV and renal) or each endpoint independently, significant differences were seen between MetS and non-MetS. With more MetS components, the primary endpoint rate increased significantly (MetS comp. 0 vs. MetS comp. 2+, primary endpoints, = 0.012).
CONCLUSIONS
Our results show that the metabolic profile has a prognostic role not only for renal endpoints but also for CV endpoints in IgAN. BMI, hyperuricemia, hypertension, and diabetes have a predictive value for the prognosis of IgA nephropathy.
PubMed: 38927457
DOI: 10.3390/biomedicines12061250 -
Journal of Cardiothoracic Surgery Jun 2024For acute type A aortic dissection involving the aortic root with root diameter no more than 45 mm, there are various aortic root repair techniques. In this study, a...
BACKGROUND
For acute type A aortic dissection involving the aortic root with root diameter no more than 45 mm, there are various aortic root repair techniques. In this study, a novel surgical technique using a pericardial autograft for aortic root repair was introduced. We described its surgical steps in detail and compare its clinical outcomes with direct suture technique.
METHODS
Between July 2017 and August 2022, 95 patients with acute type A aortic dissection who underwent aortic root repair were enrolled, including aortic root repair using pericardial autograft (group A, n = 49) or direct suture (group B, n = 46). The patient's clinical data were retrospectively analyzed, and a 5-year follow-up was conducted.
RESULTS
The 30-day mortality, re-exploration for bleeding, postoperative new-onset renal failure requiring continuous renal replacement therapy, stroke, and paraplegia occurred in 3%, 4%, 11%, 5%, and 2% of the overall patients, respectively. There was no significant difference in the 30-day mortality and complication rate between the two groups. The 30-day mortality and re-exploration for bleeding marked the primary endpoint events. Logistic regression analysis indicated that there was a significant correlation between the primary endpoint events and surgical technique (odds ratio, 0.002; 95% confidence interval, 0-0.159; P = 0.026). The aortic valve insufficiency of the two groups were significantly improved after operation (group A, P < 0.001; group B, P < 0.001). During follow-up, there was no significant difference in short-term survival between the two groups after surgery (log-rank P = 0.75), and all patients were free from reoperation for aortic disease.
CONCLUSIONS
Patients who underwent aortic root repair using pericardial autograft tended to have reduced 30-day mortality and a lower risk of re-exploration for bleeding. Using pericardial autograft for aortic root repair is a safe and useful approach for patients with acute type A aortic dissection involving the aortic root.
Topics: Humans; Aortic Dissection; Male; Female; Retrospective Studies; Middle Aged; Pericardium; Treatment Outcome; Autografts; Aortic Aneurysm, Thoracic; Aged; Acute Disease; Postoperative Complications; Blood Vessel Prosthesis Implantation; Transplantation, Autologous; Follow-Up Studies
PubMed: 38926836
DOI: 10.1186/s13019-024-02909-2 -
Journal of Cardiothoracic Surgery Jun 2024Historically, the majority of patients admitted to inpatient exercise-based cardiac rehabilitation (EBCR) have undergone open heart surgery (OHS). However, with advances... (Comparative Study)
Comparative Study
BACKGROUND
Historically, the majority of patients admitted to inpatient exercise-based cardiac rehabilitation (EBCR) have undergone open heart surgery (OHS). However, with advances in minimally invasive cardiac surgery (MICS), these patient groups are also increasingly referred for inpatient EBCR. Herein, we aimed to compare the progress of these groups during rehabilitation.
METHODS
In this prospective, nonrandomized study, 403 inpatient EBCR patients were recruited from December 2022 until September 2023 and stratified into two groups: OHS, and MICS. Participants completed a 3-4-week certified EBCR program. The primary endpoint was defined as a change in the 6-minute walk test (6MWT). Moreover, a comprehensive panel of quality-of-life (QoL) assessments were performed at admission and discharge.
RESULTS
At baseline, patients with OHS were older (66 years [IQR 59 - 72]), more often male (83%), and underwent emergency/urgent procedures more often (20%) than patients with MICS. Furthermore, patients with MICS showed a better 6MWT at admission (426 meters [IQR 336 - 483]) compared to patients with OHS (381 meters [IQR 299 - 453]). While all patients were able to increase the distance in the 6MWT, regression analyses in fully adjusted models showed no difference in improvements between the two groups (β -5, 95% CI, -26 - 14, p = 0.58). Moreover, during EBCR, we observed significant improvements in all QoL measures in all groups.
CONCLUSIONS
In this study, improvements in fitness, as assessed by the 6WMT were observed in all groups. Furthermore, multiple QoL measures improved equally across all groups. These encouraging results emphasize the importance of EBCR.
Topics: Humans; Male; Female; Aged; Cardiac Surgical Procedures; Prospective Studies; Middle Aged; Cardiac Rehabilitation; Minimally Invasive Surgical Procedures; Quality of Life; Exercise Therapy; Walk Test
PubMed: 38926740
DOI: 10.1186/s13019-024-02871-z