Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Cancer!? I Don't Have Time for That: Impact of a Psychosocial Intervention for Young Adults with Cancer.

PURPOSE: Young adult oncology has gained momentum in recognizing the unique medical and psychosocial needs of the population of adolescents and young adults with cancer (AYAC). However, many of their psychosocial needs remain unmet and we are yet to identify how clinical or research programs can be tailored to meet these needs. The aim of the study was to evaluate the impact of a cognitive-behavioral intervention adapted to meet the psychosocial needs and issues of AYAC and delivered either through Skype or face-to-face sessions against a control condition. METHODS: A total of 113 AYAC aged between 18 and 39 years were randomly assigned to a brief three-session intervention or control/care-as-usual group. They were then assessed at three time points of baseline (time 1), post (time 2), and 3-month postintervention (time 3) using self-report questionnaires targeting overall outcomes of mood/emotional well-being and health-related quality of life (HRQOL) and specific outcomes of illness-related self-efficacy and family/social and sexual relationship well-being. RESULTS: Significant between-group differences were obtained from time 1 to time 2 on outcomes of social/family and sexual relationship well-being, whereas groups did not differ from time 2 to time 3. Within-group results from time 1 to time 2 showed significant improvements in sexual esteem for both groups, whereas only AYAC of the intervention group significantly improved on outcomes of anxiety, overall mood/emotional well-being and HRQOL. In addition, improvements in self-efficacy were obtained only for the intervention group from time 2 to time 3. CONCLUSION: When compared with a control/care-as-usual condition, the intervention had a positive impact on psychological and relationship well-being. Results suggested that the intervention was beneficial and clinically relevant to the population of AYAC.

A randomized comparison of platelet reactivity in patients after treatment with various commercial clopidogrel preparations: the CLO-CLO trial.

BACKGROUND: The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. There is a lack of information about inhibition of platelet reactivity by generic preparations. AIMS: To compare the effect of original clopidogrel (clopidogrel bisulphate [Plavix(®)]), generic clopidogrel preparations (clopidogrel hydrochloride [Clopidogrel-Mepha(®)]; clopidogrel besylate [Clopidogrel Sandoz(®)]) and prasugrel (Efient(®)) on platelet reactivity in patients with coronary artery disease. METHODS: Patients with coronary artery disease treated with stents received, in a random sequence, original clopidogrel bisulphate, clopidogrel hydrochloride and clopidogrel besylate. Platelet function was assessed with the Multiplate analyser after an initial loading dose (600 mg) and at day 10 after each treatment period. Prasugrel was given for another 10 days. An adenosine diphosphate (ADP) test value<46 antiaggregation units (U) was defined as therapeutic platelet inhibition. RESULTS: Sixty patients (mean age 69 ± 10 years; 50 men) were randomized. Original clopidogrel bisulphate, clopidogrel hydrochloride and clopidogrel besylate provided similar inhibition of platelet reactivity with values of 31 ± 25, 33 ± 28 and 28 ± 23 U, respectively (P not significant). Prasugrel provided better inhibition of platelet function (10 ± 11 vs. 31 ± 25 U for clopidogrel bisulphate; P<0.001). An ADP test value>46 U was measured in 11 patients (18%) with clopidogrel bisulphate, 13 (22%) with clopidogrel besylate and 13 (22%) with clopidogrel hydrochloride compared with only one (2%) with prasugrel. CONCLUSION: Generic clopidogrel preparations provided similar inhibition of platelet reactivity to original clopidogrel bisulphate, although prasugrel was more efficient.