DPYD c.1905+1G>A and c.2846 A>T and UGT1A1*28 allelic variants as predictors of toxicity: Pharmacogenetic translational analysis from the phase III TRIBE study in metastatic colorectal cancer.

Abstract not availabl

Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real-world data

Background: The TOPAZ-1 phase III trial reported a survival benefit with the anti-programmed death cell ligand 1 (anti-PD-L1) durvalumab in combination with gemcitabine and cisplatin in patients with advanced biliary tract cancer. The present study investigated the efficacy and safety of this new standard treatment in a real-world setting.Methods: The analysed population included patients with unresectable, locally advanced or metastatic adenocarcinoma of the biliary tract treated with durvalumab in combination with gemcitabine and cisplatin at 17 Italian centres. The primary endpoint of the study was progression-free survival (PFS), whereas secondary endpoints included overall survival (OS), overall response rate (ORR) and safety. Unadjusted and adjusted hazard ratios (HRs) by baseline characteristics were calculated using the Cox proportional hazards model.Results: From February 2022 to November 2022, 145 patients were enrolled. After a median follow-up of 8.5 months (95% CI: 7.9-13.6), the median PFS was 8.9 months (95% CI: 7.4-11.7). Median OS was 12.9 months (95% CI: 10.9-12.9). The investigator-assessed confirmed ORR was 34.5%, and the disease control rate was 87.6%. Any grade adverse events (AEs) occurred in 137 patients (94.5%). Grades 3-4 AEs occurred in 51 patients (35.2%). The rate of immune-mediated AEs (imAEs) was 22.7%. Grades 3-4 imAEs occurred in 2.1% of the patients. In univariate analysis, non-viral aetiology, ECOG PS >0 and NLR >= 3 correlated with shorter PFS.Conclusion: The results reported in this first real-world analysis mostly confirmed the results achieved in the TOPAZ-1 trial in terms of PFS, ORR and safety

Cardioversion safety - Are we doing enough?

There is a considerable periprocedural risk of thromboembolic events in atrial fibrillation patients undergoing cardioversion, and treatment with anticoagulants is therefore a hallmark of cardioversion safety. Based on retrospective subgroup analyses and prospective studies, non-vitamin K anticoagulants are at least as efficient as vitamin K-antagonists in preventing thromboembolic complications after cardioversion. The risk of thromboembolic complications after cardioversion very much depends on the comorbidities in a given patient, and especially heart failure, diabetes, and age >75 years carry a markedly increased risk. Cardioversion has been considered safe within a 48-h time window after onset of atrial fibrillation without prior treatment with anticoagulants, but recent studies have set this practice into question based on e.g. erratic debut assessment of atrial fibrillation. Therefore, a simple and more practical approach is here suggested, where early cardioversion is performed only in hemodynamically unstable patients

Thrombus aspiration during primary angioplasty for cardiogenic shock

We sought to assess the clinical efficacy of thrombus aspiration during primary percutaneous coronary interventions (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS). We retrospectively selected 44 patients with CS out of a population of 842 STEMI patients treated with primary PCI at our Hospital between March 2003 and October 2007. Twenty-six patients died during hospital stay (59.1%, Group 1), whereas the remaining 18 were discharged (40.9%, Group 2). Post-procedural ST-segment resolution was greater (68.0% ± 35.6 vs. 43.0% ± 35.0; p = 0.06) and in-hospital mortality was significantly lower (21.4% vs 76.6%; p < 0.01) in patients treated by TA as compared to patients undergoing standard PCI. At multivariate logistic regression analysis, TA was the only variable independently associated with survival. © 2008 Elsevier Ireland Ltd. All rights reserved

Preliminary experience with the multisensor HeartLogic algorithm for heart failure monitoring: a retrospective case series report

Aims In the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients study, a novel algorithm for heart failure (HF) monitoring was implemented. The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending HF decompensation. The remote monitoring of HF patients by means of Heartlogic has never been described in clinical practice. We report post-implantation data collected from sensors, the combined index, and their association with clinical events during follow-up in a group of patients who received a HeartLogic-enabled device in clinical practice.Methods and results Patients with ICD and cardiac resynchronization therapy ICD were remotely monitored. In December 2017, the Heartlogic feature was activated on the remote monitoring platform, and multiple ICD-based sensor data collected since device implantation were made available: Heartlogic index, heart rate, heart sounds, thoracic impedance, respiration, and activity. Their association with clinical events was retrospectively analysed. Data from 58 patients were analysed. During a mean follow-up of 5 +/- 3 months, the HeartLogic index crossed the threshold value (set by default to 16) 24 times (over 24 person-years, 0.99 alerts/patient-year) in 16 patients. HeartLogic alerts preceded five HF hospitalizations and five unplanned in-office visits for HF. Symptoms or signs of HF were also reported at the time of five scheduled visits. The median early warning time and the time spent in alert were longer in the case of hospitalizations than in the case of minor events of clinical deterioration of HF. Heartlogic contributing sensors detected changes in heart sound amplitude (increased third sound and decreased first sound) in all cases of alerts. Patients with Heartlogic alerts during the observation period had higher New York Heart Association class (P = 0.025) and lower ejection fraction (P = 0.016) at the time of activation.Conclusions Our retrospective analysis indicates that the HeartLogic algorithm might be useful to detect gradual worsening of HF and to stratify risk of HF decompensation

Radiation dose among different cardiac and vascular invasive procedures: The RODEO study

Interventional radiology and cardiology procedures contribute significantly to the collective dose of radiation exposure from medical interventions. Recent and dedicated studies comparing directly these procedures in term of patient radiation exposure are lacking. Our aim was to compare radiation exposure among different interventional procedures performed under fluoroscopic guidance. The RODEO study (NCT: 02972736) is an international observational retrospective multicenter study enrolling all patients undergoing diagnostic or interventional procedures performed by different interventional operators (i.e. radiologists, interventional cardiologists or electrophysiologists) in 6 centers, without exclusion criteria. The primary end-point of the study was the comparison of dose area product (DAP) among interventional cardiology, electrophysiology or interventional radiology procedures. A total of 17,711 procedures were included in the study: 13,522 interventional cardiology, 2352 electrophysiology and 1864 interventional radiology procedures. The highest DAP values were observed for interventional radiology procedures (74Gy∗cm2 [Interquartile range 27–178Gy∗cm2]), followed by interventional cardiology (40Gy∗cm2 [22–78Gy∗cm2]) and electrophysiology procedures (13Gy∗cm2 [4–44Gy∗cm2], p<0.0001). In term of specific procedures, the highest DAP values were observed in structural or valvular cardiac procedures (134Gy∗cm2 [51–260Gy∗cm2]) whereas the lowest DAP values in pacemaker insertion (11Gy∗cm2 [4–28Gy∗cm2]). In this large multicenter study, the highest radiation exposure was observed in procedures performed by interventional radiologists. However, among specific procedures, structural or valvular cardiac procedures were associated with the highest radiation exposure

Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real-world data

Background: The TOPAZ-1 phase III trial reported a survival benefit with the anti-programmed death cell ligand 1 (anti-PD-L1) durvalumab in combination with gemcitabine and cisplatin in patients with advanced biliary tract cancer. The present study investigated the efficacy and safety of this new standard treatment in a real-world setting. Methods: The analysed population included patients with unresectable, locally advanced or metastatic adenocarcinoma of the biliary tract treated with durvalumab in combination with gemcitabine and cisplatin at 17 Italian centres. The primary endpoint of the study was progression-free survival (PFS), whereas secondary endpoints included overall survival (OS), overall response rate (ORR) and safety. Unadjusted and adjusted hazard ratios (HRs) by baseline characteristics were calculated using the Cox proportional hazards model. Results: From February 2022 to November 2022, 145 patients were enrolled. After a median follow-up of 8.5 months (95% CI: 7.9-13.6), the median PFS was 8.9 months (95% CI: 7.4-11.7). Median OS was 12.9 months (95% CI: 10.9-12.9). The investigator-assessed confirmed ORR was 34.5%, and the disease control rate was 87.6%. Any grade adverse events (AEs) occurred in 137 patients (94.5%). Grades 3-4 AEs occurred in 51 patients (35.2%). The rate of immune-mediated AEs (imAEs) was 22.7%. Grades 3-4 imAEs occurred in 2.1% of the patients. In univariate analysis, non-viral aetiology, ECOG PS &gt;0 and NLR ≥3 correlated with shorter PFS. Conclusion: The results reported in this first real-world analysis mostly confirmed the results achieved in the TOPAZ-1 trial in terms of PFS, ORR and safety