Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)

Anterior chamber bleeding due to intravitreal dexamethasone implant sclerotomy without vitreous hemorrhage

Background: Anterior Chamber bleeding without vitreous hemorrhage had been described after the removal of 23G vitrectomy cannulas. We report the case of an anterior chamber bleeding after an intravitreal Dexamethasone implant. Case report: One patient with macular edema due to central retinal vein occlusion in a vitrectomized eye underwent an intravitreal Dexamethasone implant. After the injection the patient suffered from anterior chamber bleeding without signs of vitreous hemorrhage. The complication resolved with a conservative treatment. Conclusion: Anterior Chamber bleeding is a possible complication of dexamethasone implant, that can be treated in a conservative way

Short-term peripapillary structural and vascular changes following anti-VEGF vs. Dexamethasone intravitreal therapy in patients with DME

Purpose: To evaluate short-term peripapillary structural and vascular changes in DME after treatment with dexamethasone implant (DEX-I) and anti-VEGFs using OCT-A. Methods: Sixty-five patients with naïve center-involving DME were enrolled. 33 of sixty five patients (group 1) underwent with single DEX-I 0.7 mg (Ozurdex, Allergan, Inc., USA), 32 of sixty-five (group 2) underwent with intravitreal injection of aflibercept 0.5 mg (Eylea, Bayer, Genentech, San Francisco, USA). The OCT acquisition was completed at the following visits: (i) "T1 visit" corresponding to the intravitreal injection of DEX-I or aflibercept in patients with naïve center-involving DME (ii) "T2 visit" corresponding to the examination performed 2 weeks after intravitreal injection of aflibercept and 1 month after DEX-I. The parameters analyzed were: (i) RPC vasculature density (VD); (ii) peripapillary retinal nerve fiber layer (pRNFL) thickness, and (iii) intraocular pressure (IOP). Results: The RPC analysis showed a VD increase at T2 in both groups, although values did not reach statistical significance (48.12± 4.17 and 49.04 ± 4.23; P = 0.081 in Group 1 and 46.93± 3.16 and 47.17 ± 3.70; P = 0.087 in Group 2). Likewise, the pRNFL thickness and IOP fluctuations did not show statistically significant changes in in both groups among the different study visits. Conclusions: After intravitreal injection (anti-VEGF or DEX-I), no significant short-term changes were found in peripapillary microvasculature, IOP and pRNFL thickness in diabetic eyes treated with anti-VEGF or DEX-I.Purpose To evaluate short-term peripapillary structural and vascular changes in DME after treatment with dexamethasone implant (DEX-I) and anti-VEGFs using OCT-A. Methods Sixty-five patients with naive center-involving DME were enrolled. 33 of sixty five patients (group 1) underwent with single DEX-I 0.7 mg (Ozurdex, Allergan, Inc., USA), 32 of sixty-five (group 2) underwent with intravitreal injection of aflibercept 0.5 mg (Eylea, Bayer, Genentech, San Francisco, USA). The OCT acquisition was completed at the following visits: (i) "T1 visit" corresponding to the intravitreal injection of DEX-I or aflibercept in patients with naive center-involving DME (ii) "T2 visit" corresponding to the examination performed 2 weeks after intravitreal injection of aflibercept and 1 month after DEX-I. The parameters analyzed were: (i) RPC vasculature density (VD); (ii) peripapillary retinal nerve fiber layer (pRNFL) thickness, and (iii) intraocular pressure (IOP). Results The RPC analysis showed a VD increase at T2 in both groups, although values did not reach statistical significance (48.12 +/- 4.17 and 49.04 +/- 4.23; P = 0.081 in Group 1 and 46.93 +/- 3.16 and 47.17 +/- 3.70; P = 0.087 in Group 2). Likewise, the pRNFL thickness and IOP fluctuations did not show statistically significant changes in in both groups among the different study visits. Conclusions After intravitreal injection (anti-VEGF or DEX-I), no significant short-term changes were found in peripapillary microvasculature, IOP and pRNFL thickness in diabetic eyes treated with anti-VEGF or DEX-I

55. MONITORAGGIO BIOLOGICO DELL’ESPOSIZIONE PROFESSIONALE AD AS INORGANICO IN LAVORATORI DI UN IMPIANTO INDUSTRIALE DISMESSO NELL’AREA DI MANFREDONIA

Nell'ambito del programma di sorveglianza sanitaria di lavoratori potenzialmente esposti ad arsenico aerodisperso, nel luglio 2006 è stato richiesto alla Sezione di Medicina del Lavoro "B. Ramazzini" dell'Universita di Bari di determinare, in 108 campioni urinari estemporanei, i livelli di Arsenico inorganico e suoi metaboliti metilati. Poichè il 15% dei campioni ha presentato livelli superiori all'Indice Biologico di Esposizione (IBE) dell'ACGIH, è stata richiesta una consulenza scientifica sul rischio arsenico. Dopo aver raccomandato una maggiore attenzione al corretto utilizzo dei DPI e una piu attenta strategia di prevenzione della dispersione di polveri, nel periodo agosto-ottobre 2006, sono stati raccolti 108 campioni urinari e acquisite informazioni sulle variabili che possono influenzare i livelli del biomarcatore, tramite somministrazione di questionari. II valore medio di arsenico urinario e risultato a quello precedentemente osservato; nel 5% dei 108 campioni si e riscontrato il superamento dell 'IBE. Una differenza statisticamente significativa è emersa, stratificando il campione per classi d' eta ed in relazione alJ'assunzione di pesce, crostacei e molluschi. In conclusione, si è osservata una riduzione statisticamente significativa dei valori medi di escrezione urinaria di arsenico nelle due fasi di monitoraggio biologico, verosimilmente attribuibile ad una piu corretta pratica di igiene del lavoro

Long-Term Follow-Up of Catheter Ablation for Premature Ventricular Complexes in the Modern Era: The Importance of Localization and Substrate

Background: Large-scale studies evaluating long-term recurrence rates in both idiopathic and non-idiopathic PVC catheter ablation (CA) patients have not been reported. Objective: To evaluate the efficacy and safety of idiopathic and non-idiopathic PVC CA, investigating the predictors of acute and long-term efficacy. Methods: This retrospective multicentric study included 439 patients who underwent PVC CA at three institutions from April-2015 to December-2021. Clinical success at 6 months’ follow-up, defined as a reduction of at least 80% of the pre-procedural PVC burden, was deemed the primary outcome. The secondary aims of the study were: clinical success at the last available follow-up, predictors of arrhythmic recurrences at long-term follow-up, and safety outcomes. Results: The median age was 51 years, with 24.9% patients being affected suffering from structural heart disease. The median pre-procedural PVC burden was 20.1%. PVCs originating from the RVOT were the most common index PVC observed (29.1%), followed by coronary cusp (CC) and non-outflow tract (OT) LV PVCs (23.1% and 19.0%). The primary outcome at 6 months was reached in 85.1% cases, with a significant reduction in the 24 h% PVC burden (−91.4% [−83.4; −96.7], p < 0.001); long-term efficacy was observed in 82.1% of cases at almost 3-year follow-up. The presence of underlying structural heart disease and non-OT LV region origin (aHR 1.77 [1.07–2.93], p = 0.027 and aHR = 1.96 [1.22–3.14], p = 0.005) was independently associated with recurrences. Conclusion: CA of both idiopathic and non-idiopathic PVCs showed a very good acute and long-term procedural success rate, with an overall low complication. Predictors of arrhythmic recurrence at follow-up were underlying structural heart disease and non-OT LV origin

Patients with Cardiac Implantable Electronic Device Undergoing Radiation Therapy: Insights from a Ten-Year Tertiary Center Experience

Background: The number of patients with cardiac implantable electronic devices (CIEDs) receiving radiotherapy (RT) is increasing. The management of CIED-carriers undergoing RT is challenging and requires a collaborative multidisciplinary approach. Aim: The aim of the study is to report the real-world, ten-year experience of a tertiary multidisciplinary teaching hospital. Methods: We conducted an observational, real-world, retrospective, single-center study, enrolling all CIED-carriers who underwent RT at the San Raffaele University Hospital, between June 2010 and December 2021. All devices were MRI-conditional. The devices were programmed to an asynchronous pacing mode for patients who had an intrinsic heart rate of less than 40 beats per minute. An inhibited pacing mode was used for all other patients. All tachyarrhythmia device functions were temporarily disabled. After each RT session, the CIED were reprogrammed to the original settings. Outcomes included adverse events and changes in the variables that indicate lead and device functions. Results: Between June 2010 and December 2021, 107 patients were enrolled, among which 63 (58.9%) were pacemaker carriers and 44 (41.1%) were ICD carriers. Patients were subjected to a mean of 16.4 (±10.7) RT sessions. The most represented tumors in our cohort were prostate cancer (12; 11%), breast cancer (10; 9%) and lung cancer (28; 26%). No statistically significant changes in device parameters were recorded before and after radiotherapy. Generator failures, power-on resets, changes in pacing threshold or sensing requiring system revision or programming changes, battery depletions, pacing inhibitions and inappropriate therapies did not occur in our cohort of patients during a ten-year time span period. Atrial arrhythmias were recorded during RT session in 14 patients (13.1%) and ventricular arrhythmias were observed at device interrogation in 10 patients (9.9%). Conclusions: Changes in device parameters and arrhythmia occurrence were infrequent, and none resulted in a clinically significant adverse event