Subject(s)
Hypertension, Pulmonary , Ventricular Dysfunction, Right , Ventricular Function, Right , Humans , Hypertension, Pulmonary/physiopathology , Hypertension, Pulmonary/diagnosis , Ventricular Dysfunction, Right/physiopathology , Ventricular Dysfunction, Right/etiology , Chronic Disease , Male , Exercise , Female , Middle Aged , Pulmonary Embolism/physiopathology , Pulmonary Embolism/diagnosis , Risk Factors , AgedABSTRACT
Hidradenitis suppurativa (HS) presents challenges in management due to its chronic nature and high risk of recurrence. Post-surgical wound care plays a crucial role in treatment, even if standardized methods for assessing and predicting healing times are lacking. The aim of the study is to introduce the Wound Area Severity Index (WASI) as a novel tool to guide clinicians in assessing postsurgical wound progression and predicting potential healing times. A team of wound healing experts assessed 93 post-surgical HS wounds resulting from wide excision and secondary intention healing. For each wound healing time, wound area, wound bed score (WBS), and WASI were evaluated. WASI includes four parameters: area, temperature, depth and wound Bed, each with four severity levels. The total WASI score ranges from 4 to 16. Spearman correlation and Kruskal-Wallis tests were employed for statistical analysis. WASI strongly correlated with wound healing time (rho: 0.813, p < 0.001). Higher WASI scores were associated with prolonged healing, while lower scores indicated almost healed wounds. The WASI score has proven to be more highly predictive of healing times when compared to the individual parameter of the Area (moderate positive correlation, r: 0.77) and the WBS (negative correlation, r: -0.72). A total WASI score of 4 corresponded to a median healing time of 7 days, while a score exceeding 9 suggested a median healing time of 56 days. WASI has proven to be a valuable tool for assessing and predicting healing times in post-surgical HS wounds. Its simplicity, cost-effectiveness, and ability to integrate multiple parameters make it a promising addition to wound care practice.
Subject(s)
Hidradenitis Suppurativa , Severity of Illness Index , Wound Healing , Hidradenitis Suppurativa/surgery , Humans , Surgical Wound , Female , Time Factors , Male , Adult , Middle AgedABSTRACT
BACKGROUND: Thyroid diseases are one of the most common health problems worldwide. Although they represent a necessary step in order to perform thyroidectomy, hyperextension of the neck can potentially increase postoperative pain. The aim of this study is to determine a correlation between the degree of neck hyperextension on the operative table and the postoperative pain in patients undergoing open thyroidectomy. METHODS: Patients were prospectively enrolled from the cohort of patients operated at the Endocrine Surgery Unit of the University Hospital of Pisa, between May and July 2021. Both of patients who underwent total thyroidectomy or hemi-thyroidectomy were recruited. The following data were analysed in order to find a correlation with postoperative pain at 24 h: age, gender, type of surgery, BMI, operative time, and degree of neck extension. RESULTS: Overall, 195 patients were enrolled. A direct, statistically significant correlation emerged between the degree of neck hyperextension and the postoperative pain 24 h after surgery, regardless of the pain of the surgical wound (p < 0.001; beta 0.270). CONCLUSIONS: A direct correlation emerges between neck tilt angle and postoperative neck pain. Moreover, total thyroidectomy (TT) predisposes more to postoperative neck pain, considering the type of surgery.
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Background/Objectives: The surgical resection of pulmonary metastases is considered a therapeutic option in selected cases. In light of this, we present the results from a national multicenter prospective registry of lung metastasectomy. Methods: This retrospective analysis involves data collected prospectively and consecutively in a national multicentric Italian database, including patients who underwent lung metastasectomy. The primary endpoints were the analysis of morbidity and overall survival (OS), with secondary endpoints focusing on the analysis of potential risk factors affecting both morbidity and OS. Results: A total 470 lung procedures were performed (4 pneumonectomies, 46 lobectomies/bilobectomies, 13 segmentectomies and 407 wedge resections) on 461 patients (258 men and 203 women, mean age of 63.1 years). The majority of patients had metastases from colorectal cancer (45.8%). In most cases (63.6%), patients had only one lung metastasis. A minimally invasive approach was chosen in 143 cases (30.4%). The mean operative time was 118 min, with no reported deaths. Morbidity most frequently consisted of prolonged air leaking and bleeding, but no re-intervention was required. Statistical analysis revealed that morbidity was significantly affected by operative time and pulmonary comorbidities, while OS was significantly affected by disease-free interval (DFI) > 24 months (p = 0.005), epithelial histology (p = 0.001) and colorectal histology (p = 0.004) during univariate analysis. No significant correlation was found between OS and age, gender, surgical approach, surgical extent, surgical device, the number of resected metastases, lesion diameter, the site of lesions and nodal involvement. Multivariate analysis of OS confirmed that only epithelial histology and DFI were risk-factors, with p-values of 0.041 and 0.031, respectively. Conclusions: Lung metastasectomy appears to be a safe procedure, with acceptable morbidity, even with a minimally invasive approach. However, it remains a local treatment of a systemic disease. Therefore, careful attention should be paid to selecting patients who could truly benefit from surgical intervention.
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BACKGROUND AND AIMS: This paper aims to study an alternative solution to hormonal replacement therapy in specific groups of patients who underwent thyroidectomy during childhood or adulthood. After cryopreservation, thyroid autotransplantation could be an alternative solution which would allow us to use the ability of the thyroid tissue of producing hormones according to the physiological needs of the body. MATERIALS AND METHODS: A feasibility study about the effects of the most modern cryopreservation techniques on the structural and functional integrity of the follicular cells of the thyroid tissue has been carried out. Patients who could benefit from the treatment have been found for both autotransplant techniques. Additionally, a literature review has been conducted. RESULTS: The histological analysis has shown that cryopreservation does not alter the original architecture, and the culture examination that cell viability is successfully preserved. Moreover, both thyroid autotransplantation studies on animals and those on humans that were found in the literature have shown good results regarding the viability and functionality of the transplant. CONCLUSIONS: The viability of cryopreserved thyroid tissue found in this study is encouraging. Further studies to evaluate the levels of FT3, FT4 and thyroglobulin in thyroid tissue after cryopreservation are needed to verify that the secretory properties of the thyrocytes have been maintained intact. Furthermore, autotransplanted cases found in the literature do not have a long-term follow-up.
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PURPOSE: Assessing vocal cord mobility is crucial for patients undergoing thyroid surgery. We aimed to evaluate the feasibility and efficacy of surgeon-performed transcutaneous laryngeal ultrasound (TLUS) compared to flexible nasolaryngoscopy. METHOD: From February 2022 to December 2022, we conducted a prospective observational study on patients scheduled for total thyroidectomy at our Institution. All patients underwent TLUS followed by flexible nasolaryngoscopy by a blinded otolaryngologist. Findings were classified as normal or vocal cord movement impairment and then compared. Patients evaluable on TLUS were included in Group A, while those not evaluable were included in Group B, and their features were compared. RESULTS: Group A included 180 patients, while Group B included 21 patients. Male sex (p < 0.001), age (p = 0.034), BMI (p < 0.001), thyroid volume (p = 0.038), and neck circumference (p < 0.001) were associated with Group B. TLUS showed a sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 100%, 99.4%, 94.4%, 100%, and 99.4%, respectively. Cohen's K value was 0.984. CONCLUSION: TLUS is a valid, easy-to-perform, non-invasive, and painless alternative for evaluating vocal cords in selected patients. It can be used either as a first level exam and as screening tool for selecting cases for flexible nasolaryngoscopy. TLUS should be integrated into routine thyroid ultrasound examination.
Subject(s)
Laryngoscopy , Thyroidectomy , Ultrasonography , Humans , Male , Female , Prospective Studies , Middle Aged , Adult , Vocal Cords/diagnostic imaging , Aged , Feasibility Studies , Sensitivity and Specificity , Postoperative Complications/diagnostic imaging , Vocal Cord Paralysis/diagnostic imagingABSTRACT
Introduction: Carmustine (BCNU), etoposide, cytarabine, and melphalan (BEAM) are a widely used high-dose chemotherapy regimen for autologous stem cell transplantation transplant (ASCT) in lymphoid malignancies. During BCNU shortages, some centers switched to fotemustine-substituted BEAM (FEAM). Neutropenic enterocolitis (NEC) is a life-threatening complication occurring after intestinal mucosa damage related to intensive chemotherapy. NEC mortality may be up to 30%-50%. In our study, we compared NEC incidence, symptoms, mortality, and transplant outcome in terms of overall survival (OS) and progression-free survival (PFS) in the BEAM vs. FEAM groups. Furthermore, we compared the cost of hospitalization of patients who did vs. patients who did not experience a NEC episode (NECe). Methods: A total of 191 patients were enrolled in this study (N = 129 and N = 62 were conditioned with BEAM and FEAM, respectively). All patients received bed-side high-resolution ultrasound (US) for NEC diagnosis. Results and discussion: NEC incidence and NEC-related mortality were similar in the BEAM and FEAM groups (31% and 40.3%, p = 0.653, and 5% and 8%, p = 0.627, respectively). At a median follow-up of 116 months, no difference was noted between BEAM vs. FEAM groups in terms of OS and PFS (p = 0.181 and p = 0.978, respectively). BEAM appeared equivalent to FEAM in terms of NEC incidence and efficacy. The high incidence of NEC and the low mortality is related to a timely US diagnosis and prompt treatment. US knowledge in NEC diagnosis allows to have comparable days of hospitalization of patients NECpos vs. patients NECneg. The cost analysis of NECpos vs. NECneg has been also performed.
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BACKGROUND: Surgical management of parasagittal meningiomas (PMs) remains controversial in the literature. The need to pursue a resection as radical as possible and the high risk of venous injuries contribute to making the sinus opening a widely argued choice. This study aimed to analyze factors affecting the risk of recurrence and to assess clinical outcomes of patients who underwent surgical resection of PMs with conservative or aggressive management of the intrasinusal portion. METHODS: A single-institution retrospective review of all patients with PM surgically treated between January 2013 and March 2021 was conducted. RESULTS: Among 56 patients, the sinus was opened in 32 patients (57%), and a conservative approach was used in 24 patients (43%). The sinus opening was found to be a predictive factor of radical resection (Simpson grade [SG] I-II) (P = 0.007). SG was the only predictive factor of recurrence (P < 0.001). The radical resection group (SG I-II) showed recurrence-free survival at 72 months of about 90% versus 30% in the non-radical resection group (SG III-IV) (log-rank test = 14.21, P < 0.001). Aggressive management of the sinus and radical resection were not found to be related to permanent deficit (P = 0.214 and P = 0.254) or worsening of Karnofsky performance scale score (P = 0.822 and P = 0.933). CONCLUSIONS: Removal of the intrasinusal portion of the tumor using standard procedures is not associated with a higher risk of permanent deficit or worsening of Karnofsky performance scale and reduces the risk of recurrence.
Subject(s)
Cranial Sinuses , Meningeal Neoplasms , Meningioma , Neoplasm Recurrence, Local , Neurosurgical Procedures , Humans , Meningioma/surgery , Male , Female , Middle Aged , Meningeal Neoplasms/surgery , Retrospective Studies , Aged , Adult , Neurosurgical Procedures/methods , Cranial Sinuses/surgery , Treatment Outcome , Aged, 80 and overABSTRACT
Purpose: Clinical evidence suggests an association between comorbidities and outcome in patients with glioblastoma (GBM). We hypothesised that the internal carotid artery (ICA) calcium score could represent a promising prognostic biomarker in a competing risk analysis in patients diagnosed with GBM. Methods: We validated the use of the ICA calcium score as a surrogate marker of the coronary calcium score in 32 patients with lung cancer. Subsequently, we assessed the impact of the ICA calcium score on overall survival in GBM patients treated with radio-chemotherapy. Results: We analysed 50 GBM patients. At the univariate analysis, methyl-guanine-methyltransferase gene (MGMT) promoter methylation (p = 0.048), gross total tumour resection (p = 0.017), and calcium score (p = 0.011) were significant prognostic predictors in patients with GBM. These three variables also maintained statistical significance in the multivariate analysis. Conclusions: the ICA calcium score could be a promising prognostic biomarker in GBM patients.
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Ponatinib may be effective in chronic myeloid leukemia (CML) patients after failure of first/second line therapies. Although its efficacy for minimum plasma concentrations (Cmin) is >21.3 ng/mL (equal to 40 nM), ponatinib may cause adverse events (AE) that require dose optimization. The present study was aimed at investigating any possible correlations among ponatinib dose, plasma concentration, molecular response (MR), and tolerability in a real-world setting. Clinical and laboratory records (including MR and drug plasma concentrations) of 32 CML patients treated with ponatinib were harvested and analyzed. Twenty-seven patients (71%) had ponatinib Cmin values > 21.3 ng/mL, but Cmin values > 10.7 ng/mL (considered efficacious in BCR-Abl unmutated patients) were achieved by 80% of the patients receiving ≥30 mg/day and 45% of the subjects treated with 15 mg/day. No significant correlations were identified among clinical efficacy, tolerability, daily dose, and plasma concentration. Notably, patients who underwent dose tapering for tolerability or safety reasons did not experience treatment failure. In a real-world setting, adjustment of ponatinib daily doses lower than those registered may maintain therapeutic efficacy while reducing the risk of vascular events and improving tolerability. Further studies are warranted to confirm the present results in a larger cohort of patients.
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BACKGROUND: Similar to procedures requiring general anesthesia, current guidelines recommend fasting for 6 hours for solids and for 2 hours for liquids prior to coronary angiography, but without data supporting such recommendation. The CORO-NF study aimed at assessing whether a shorter fasting period prior to elective coronary angiography associates with improved patient satisfaction without more complications compared with the standard fasting approach. METHODS: We conducted a single-center, randomized, prospective, pragmatic study in 2 sequential phases: a "conventional protocol phase," continuing the usual practice (F Group); and an "experimental phase" (NF Group), reducing minimum fasting duration to 2 hours. Patients received a questionnaire to express a satisfaction score ranging from 1 (maximum complain/no approval) to 5 (minimum or no complain/full approval). All patients admitted acutely were enrolled in a control A Group registry. Fasting time and every major complication and periprocedural complications were analyzed. RESULTS: Fasting time was 821 ± 357 minutes in the F Group and 230 ± 146 minutes in the NF Group (P < .001). The satisfaction score was higher in the NF Group (4.2 ± 0.7 vs 2.9 ± 1.2, P < .001), even at multivariable analysis considering fasting time (P < .001). No intraprocedural food ingestion-related adverse events occurred in either of the 2 experimental groups, as well as in the parallel A Group, with no excess of peri- and postprocedural complications in the NF Group. CONCLUSIONS: The significantly higher satisfaction scores among patients undergoing a shorter-than-recommended fasting period prior to coronary angiography, not counterbalanced by decreased safety, underscores the potential benefits of revising the traditional 6-hour fasting protocols.
Subject(s)
Coronary Angiography , Fasting , Patient Satisfaction , Aged , Female , Humans , Male , Middle Aged , Coronary Angiography/methods , Fasting/adverse effects , Preoperative Care/methods , Prospective Studies , Time FactorsABSTRACT
Patients with amnestic mild cognitive impairment (aMCI) are at a higher risk of converting to Alzheimer's disease. The aim of this study was to examine the potential use of Verbal Fluency (VF) measures as markers for predicting the conversion to dementia. At baseline, 61 aMCI, aged 65 to 80 years, underwent a comprehensive neuropsychological assessment, including phonemic (PVF) and semantic verbal fluency (SVF) tasks. After 18 months, 14 individuals with aMCI had progressed to a diagnosis of dementia. The findings revealed that aMCI-converter group had lower Mini Mental State Examination and Rey Auditory Verbal Learning Task scores than aMCI-no converter and produced fewer clusters in both VF tasks and a lower number of switches in PVF at baseline (p < 0.05). According to receiver operating characteristic curve analysis, the number of clusters in PVF had the highest predictive value (AUC = 0.80) with a threshold of 5.510 for identifying aMCI-converter at baseline. Additionally, participants with higher levels of education exhibited more clusters and switches in VF tasks (p < 0.05). These results suggest that qualitative measures of VF could serve as neuropsychological markers for predicting cognitive decline in individuals with aMCI. Furthermore, the study highlights the potential influence of the education level on cognitive performance in neuropsychological tasks.
Subject(s)
Alzheimer Disease , Cognitive Dysfunction , Humans , Educational Status , Neuropsychological Tests , ROC CurveABSTRACT
Thymectomy is the gold standard in the treatment of thymic neoplasm and plays a key role in the therapeutic path of myasthenia gravis. For years, sternotomy has been the traditional approach for removing anterior mediastinal lesions, although the robotic thymectomy is now widely performed. The literature is still lacking in papers comparing the two approaches and evaluating long-term oncological and neurological outcomes. This study aims to analyze the postoperative results of open and robotic thymectomy for thymic neoplasms in myasthenic patients. Surgical, oncological and neurological data of myasthenic patients affected by thymic neoplasms and surgically treated with extended thymectomy, both with the open and the robotic approach, in six Italian Thoracic Centers between 2011 and 2021 were evaluated. A total of 213 patients were enrolled in the study: 110 (51.6%) were treated with the open approach, and 103 (48.4%) were treated with robotic surgery. The open surgery, compared with the robotic, presented a shorter operating time (p < 0.001), a higher number of postoperative complications (p = 0.038) and longer postoperative hospitalization (p = 0.006). No other differences were observed in terms of surgical, oncological or neurological outcomes. The robotic approach can be considered safe and feasible, comparable to the open technique, in terms of surgical, oncological and neurological outcomes.
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BACKGROUND AND AIMS: Defecation Disorders (DD) are a frequent cause of refractory chronic constipation. DD diagnosis requires anorectal physiology testing. Our aim was to evaluate the accuracy and Odds Ratio (OR) of a straining question (SQ) and a digital rectal examination (DRE) augmented by abdomen palpation on predicting a DD diagnosis in refractory CC patients. METHODS: Two hundred and thirty-eight constipated patients were enrolled. Patients underwent SQ, augmented DRE and balloon evacuation test before entering the study and after a 30-day fiber/laxative trial. All patients underwent anorectal manometry. OR and accuracy were calculated for SQ and augmented DRE for both dyssynergic defecation and inadequate propulsion. RESULTS: "Anal Muscles" response was associated to both dyssynergic defecation and inadequate propulsion, with an OR of 13.6 and 5.85 and an accuracy of 78.5% and 66.4%, respectively. "Failed anal relaxation" on augmented DRE was associated with dyssynergic defecation, with an OR of 21.4 and an accuracy of 73.1%. "Failed abdominal contraction" on augmented DRE was associated with inadequate propulsion with an OR >100 and an accuracy of 97.1%. CONCLUSIONS: Our data support screening constipated patients for DD by SQ and augmented DRE to improve management and appropriateness of referral to biofeedback.
Subject(s)
Constipation , Defecation , Humans , Defecation/physiology , Manometry , Constipation/diagnosis , Constipation/etiology , Anal Canal , Biofeedback, Psychology , Ataxia , Diagnostic Tests, Routine/adverse effectsABSTRACT
Locus coeruleus (LC) is the main noradrenergic nucleus of the brain, and degenerates early in Parkinson's disease (PD). The objective of this study is to test whether degeneration of the LC is associated with orthostatic hypotension (OH) in PD. A total of 22 cognitively intact PD patients and 52 age-matched healthy volunteers underwent 3 T magnetic resonance (MRI) with neuromelanin-sensitive T1-weighted sequences (LC-MRI). For each subject, a template space-based LC-MRI was used to calculate LC signal intensity (LC contrast ratio-LCCR) and the estimated number of voxels (LCVOX) belonging to LC. Then, we compared the LC-MRI parameters in PD patients with OH (PDOH+) versus without OH (PDOH-) (matched for sex, age, and disease duration) using one-way analysis of variance followed by multiple comparison tests. We also tested for correlations between subject's LC-MRI features and orthostatic drop in systolic blood pressure (SBP). PDOH- and PDOH+ did not differ significantly (p > 0.05) based on demographics and clinical characteristics, except for blood pressure measurements and SCOPA-AUT cardiovascular domain (p < 0.05). LCCR and LCVOX measures were significantly lower in PD compared to HC, while no differences were observed between PDOH- and PDOH+. Additionally, no correlation was found between the LC-MRI parameters and the orthostatic drop in SBP or the clinical severity of autonomic symptoms (p > 0.05). Conversely, RBD symptom severity negatively correlated with several LC-MRI parameters. Our results failed to indicate a link between the LC-MRI features and the presence of OH in PD but confirmed a marked alteration of LC signal in PD patients.
Subject(s)
Hydroxides , Hypotension, Orthostatic , Parkinson Disease , Humans , Hypotension, Orthostatic/diagnostic imaging , Hypotension, Orthostatic/etiology , Locus Coeruleus/diagnostic imaging , Parkinson Disease/complications , Parkinson Disease/diagnostic imaging , Magnetic Resonance Imaging/methodsABSTRACT
Obesity is a well-known public health concern in Western World. Accordingly, an elevated number of obese patients undergo thyroidectomy every year. We aim to assess the impact of obesity on intraoperative and postoperative outcomes of patients who undergo thyroidectomy. 1228 patients underwent thyroidectomy at our department between January 2021 and September 2021. We divided patients into two groups according to body mass index (BMI): non-obese (BMI < 30 kg/m2) and obese (BMI ≥ 30 kg/m2). A propensity score approach was performed to create 1:1 matched pairs (matching according to age, gender, diagnosis, nodule size and type of operation). After matching, the final population included 522 patients, equally divided between each group: non-obese group (Group A; n = 261) and obese group (Group B; n = 261). The primary endpoint of the study was the overall rate of postoperative complications; secondary endpoints of the study were operative time, use of energy device and length of hospital stay. The duration of hospital stay resulted longer in Group B (p = 0.002). No statistically significant differences were documented in terms of operative time (p = 0.206), use of energy devices (p = 0.855) and surgical complications (p = 0.429). Moreover, no statistically significant differences were documented considering each specific complication: transient and permanent hypocalcemia (p = 0.336; p = 0.813, respectively), transient and permanent recurrent laryngeal nerve palsy (p = 0.483; p = 0.523, respectively), hematoma (p = 0.779), bleeding (p = 0.178), wound infection (p = 0.313) and cheloid formation (p = 0.412). Thyroidectomy can safely be performed in obese patients. Outcomes resulted comparable; nonetheless, obesity correlates to longer hospital stay.
Subject(s)
Hypocalcemia , Vocal Cord Paralysis , Humans , Thyroidectomy/adverse effects , Thyroidectomy/methods , Obesity/complications , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Hypocalcemia/etiology , Vocal Cord Paralysis/etiology , Retrospective StudiesABSTRACT
In Italy, 20 minutes of continuous, flat-line electrocardiogram are required for death declaration, which significantly increases the risks of donation after circulatory death (DCD) LT. Despite prolonged warm ischemia time, Italian centers reported good outcomes in controlled donation after circulatory death LT by combining normothermic regional and end-ischemic machine perfusion. However, data on uncontrolled DCD (uDCD) LT performed by this approach are lacking. This was a multicenter, retrospective study performed at 3 large-volume centers comparing clinical outcomes of uncontrolled versus controlled DCD LT. The aim of the study was to assess outcomes of sequential normothermic regional perfusion and end-ischemic machine perfusion in uncontrolled DCD liver transplantation (LT). Of 153 DCD donors evaluated during the study period, 40 uDCD and 59 donation after circulatory death grafts were transplanted (utilization rate 52% vs. 78%, p = 0.004). Recipients of uDCD grafts had higher MEAF (4.9 vs. 3.5, p < 0.001) and CCI scores at discharge (24.4 vs. 8.7, p = 0.026), longer ICU stay (5 vs. 4 d, p = 0.047), and a trend toward more severe AKI. At multivariate analysis, 90-day graft loss was associated with recipient BMI and lactate downtrend during normothermic regional perfusion. One-year graft survival was lower in uDCD (75% vs. 90%, p = 0.007) but became comparable when non-liver-related graft losses were treated as censors (77% vs. 90%, p = 0.100). The incidence of ischemic cholangiopathy was 10% in uDCD versus 3% in donation after circulatory death, p = 0.356. uDCD LT with prolonged warm ischemia is feasible by the sequential use of normothermic regional perfusion and end-ischemic machine perfusion. Proper donor and recipient selection are key to achieving good outcomes in this setting.
Subject(s)
Liver Transplantation , Tissue and Organ Procurement , Humans , Liver Transplantation/adverse effects , Retrospective Studies , Perfusion/adverse effects , Tissue Donors , Graft Survival , Lactic Acid , Organ Preservation/adverse effectsABSTRACT
INTRODUCTION: The use of Janus Kinase Inhibitors (JAK-Is) in rheumatoid arthritis (RA) has entered in daily practice. In consideration of ORAL-Surveillance trial and the new EULAR recommendations, real-world data are needed to assess Jak-Is safety and effectiveness. The multicenter study presented here aimed to evaluate effectiveness and safety of tofacitinib in a real-life cohort. METHODS: A retrospective analysis was performed from September 2021 to December 2022. Data were collected when tofacitinib was started (T0) and after 3 (T3), 6 (T6) and 12 (T12) months of treatment. The primary objective was to analyze the efficacy and safety of tofacitinib. Safety was assessed by recording adverse events (AEs) with and without discontinuation. The secondary objective was to assess the difference between Patient-Reported Outcomes (PROs) and Physician's Global Assessment of disease activity (PhGA). RESULTS: 122 patients were included in the study from the following rheumatology Centers: Pisa, Ancona, Florence (two Centers), Siena, and Sardinia. A statistically significant improvement in DAS-28-CRP, CDAI and SDAI score was observed at T3, T6, compared to baseline (p < 0.001). Improvement was confirmed in patients who reach T12. Patients naïve to bDMARDs showed a shorter remission time and higher remission rates. There was also a statistically significant improvement in PROs compared to baseline (p < 0.001). The improvement was rapid and was consistent with PhGA. The 12-month retention rate for tofacitinib was 89.35%. Reasons to stop tofacitinib were: insufficient response (7), gastrointestinal symptoms (2), infection (1), malignancy (1), Zoster (1), pruritus sine materia (1). CONCLUSIONS: Tofacitinib is safe and effective in our RA cohort. It induces higher remission rates in patients naive to bDMARDs, suggesting that there may be a benefit using it as first-line therapy. Additionally, improvement in PROs was consistent with PhGA scores, demonstrating how tofacitinib affects both the objective and subjective components of disease activity. Key Points 1. JAK inhibitors are considered at a similar level as biologic agents in terms of effectiveness. 2. After ORAL-Surveillance results, real-world data are needed to assess the benefit/risk profile of Jaki. 3. Disagreement between patients and physicians has been previously reported with biologic therapy among patients with rheumatoid arthritis, with patients rating disease activity higher than physicians. 4. Jak inhibitors could reduce this discrepancy, due to their mechanism of action.
Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Janus Kinase Inhibitors , Piperidines , Pyrimidines , Humans , Antirheumatic Agents/adverse effects , Retrospective Studies , Janus Kinase Inhibitors/adverse effects , Arthritis, Rheumatoid/diagnosis , Pyrroles/adverse effects , Patient Reported Outcome Measures , Treatment OutcomeABSTRACT
OBJECTIVES: Lung ultrasound (LUS) and high-resolution computed tomography (HRCT) are commonly used for the evaluation of interstitial lung disease (ILD). Nintedanib (NIN) is an antifibrotic therapy approved for systemic sclerosis-associated ILD (SSc-ILD). We assessed LUS and quantitative HRCT changes in SSc-ILD patients treated with NIN during a one-year follow-up, evaluating relationships between imaging variations and functional or quality-of-life outcomes. METHODS: SSc-ILD patients who started NIN were enrolled and followed for twelve months. Pulmonary function tests and patient-reported outcome measures (PROMs) were assessed half-yearly and quarterly, respectively. LUS was performed quarterly evaluating the presence of B-lines (BL) and pleural line irregularities (PLI). HRCT was repeated after one year and quantitatively analysed with CALIPER software. RESULTS: Ten patients (70% female, mean age 62 years) were enrolled. The mean total number of both BL and PLI was constantly decreased during NIN treatment, being significantly reduced after twelve months (from 175.1 ± 66.7-120.8 ± 70.3 for BL, p= 0.005 and from 50.6 ± 32.5-37.2 ± 22.4 for PLI, p= 0.05). Male gender, smoking habit and baseline forced vital capacity <70% predicted were associated with worse LUS outcomes. A greater reduction of both BL and PLI was observed in those who improved in PROMs, especially modified Medical Research Council dyspnoea scale (p= 0.016 and p= 0.04, respectively) and Saint George's Respiratory Questionnaire (p= 0.006 and p= 0.026, respectively). No significant changes in the CALIPER percentages of normal parenchyma or ILD elements were observed after twelve months of NIN, thus paralleling the stabilization obtained at pulmonary function tests. CONCLUSIONS: We present preliminary results on NIN effects on SSc-ILD as assessed by LUS, a useful method for frequently repeated monitoring, and CALIPER, a valid implementation whenever a HRCT is performed.
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BACKGROUND AND AIM: Chronic thromboembolic pulmonary disease (CTEPD) is a progressive condition caused by fibrotic thrombi and vascular remodeling in the pulmonary circulation despite prolonged anticoagulation. We evaluated clinical factors associated with CTEPD, as well as its impact on functional capacity, pulmonary haemodynamics at rest and after exercise, and right ventricle (RV) morphology and function. METHODS: We compared 33 consecutive patients with a history of acute pulmonary embolism and either normal pulmonary vascular imaging (negative Q-scan, group 1, n = 16) or persistent defects on lung perfusion scan (positive Q-scan) despite oral anticoagulation at 4 months (group 2, n = 17). Investigations included thrombotic load, the Pulmonary Embolism Severity Index (PESI) score, functional class, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), cardiopulmonary exercise test (CPET) and echocardiographic parameters at rest and after exercise (ESE), at 4 and at 24 months. RESULTS: Compared with group 1, group 2 featured a higher PESI score (p = 0.02) and a higher thrombotic load (p = 0.004) at hospital admission. At 4 months, group 2 developed exercise-induced pulmonary hypertension (Ex-PH) at CPET (p < 0.001) and ESE (p < 0.001). At 24 months group 2 showed higher NT-proBNP (p < 0.001), WHO-FC (p < 0.001), systolic (p<0.001) and diastolic (p = 0.037) RV dysfunction and worse RV-arterial coupling (p < 0.001) despite maintaining a low or intermediate echocardiographic probability of PH. CONCLUSIONS: This is the first "proof of concept" study showing that patients with a positive Q-scan frequently develop Ex-PH and RV functional deterioration as well as reduced functional capacity, generating the hypothesis that Ex-PH could help detect the progression to CTEPD.