An unintentional complication during an intentional procedure-Sinus of Valsalva laceration during BASILICA.
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SUBMITTER: Mangner N
PROVIDER: S-EPMC8549999 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesThe BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study.BackgroundCoronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction.MethodsSubjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images.ResultsBetween February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR.ConclusionsBASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk.
| S-EPMC6669893 | biostudies-literature
Project description:The purpose of this study is to develop a procedure for assessing unintentional overdose (OD) in opiate abusers that differentiates it from intentional OD, and provides reliable information about the incident.A sample of 121 patients in a methadone maintenance program at an urban university hospital completed a baseline assessment. A total of 70 participants completed an identical assessment at least 14 days later. The ability of an OD item to differentiate unintentional OD from intentional OD was tested, as was the test-retest reliability of questions assessing symptoms and treatment of OD.The procedure is reliable and differentiated unintentional OD from intentional OD. Questions assessing symptoms of OD were endorsed in almost every unintentional OD incident, although reliability was affected by loss of consciousness. The reliability of questions assessing emergency treatment and Narcan administration was outstanding.Our procedure for assessing OD differentiates unintentional OD from intentional OD. The use of follow-up questions assessing acute treatment for OD is recommended. Items concerning symptoms of OD are not needed to confirm the presence of an OD, but may be used to clarify whether an event was an OD.
| S-EPMC4864590 | biostudies-literature
Project description:OBJECTIVES:The aim of this study was to evaluate any potential leaflet washout benefits after bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) in transcatheter valve-in-valve (ViV) in the context of leaflet thrombosis. BACKGROUND:Leaflet thrombosis after transcatheter aortic valve replacement is secondary to flow stasis in both the sinus and neosinus. Strategies to improve washout and ameliorate neosinus and sinus flow velocities may have the potential to mitigate the occurrence of clinical and subclinical leaflet thrombosis. METHODS:A 23-mm Edwards SAPIEN 3 and a 26-mm Medtronic Evolut were deployed in a 23-mm transparent surgical aortic valve model before and after leaflet laceration. The valves were placed in the aortic position of a pulse duplicator flow loop. Particle image velocimetry was performed to quantify sinus flow hemodynamic status. A tracing fluorescent dye was injected to evaluate the number of cycles to washout in both regions of interest. RESULTS:The leaflet laceration procedure led to an increase in the velocities in the sinus and the neosinus by 50% for Evolut ViV and 61.9% for SAPIEN 3 ViV. In addition, leaflet laceration led to a reduction in overall cycles to washout in the neosinus by at least 56% with the Evolut and 54.5% with the SAPIEN 3 and in the sinus by at least 16.7% with the Evolut and 60.8% with the SAPIEN. CONCLUSIONS:Leaflet laceration using a BASILICA-type approach may hold the potential to mitigate neosinus and sinus flow stasis. Controlled in vivo trials are necessary to establish the potential benefit of BASILICA to reduce the occurrence of leaflet thrombosis.
| S-EPMC6613808 | biostudies-literature
Project description: Not available
| S-EPMC3147191 | biostudies-literature
Project description:When dogs interact with humans, they often show appropriate reactions to human intentional action. But it is unclear from these everyday observations whether the dogs simply respond to the action outcomes or whether they are able to discriminate between different categories of actions. Are dogs able to distinguish intentional human actions from unintentional ones, even when the action outcomes are the same? We tested dogs' ability to discriminate these action categories by adapting the so-called "Unwilling vs. Unable" paradigm. This paradigm compares subjects' reactions to intentional and unintentional human behaviour. All dogs received three conditions: In the unwilling-condition, an experimenter intentionally withheld a reward from them. In the two unable-conditions, she unintentionally withheld the reward, either because she was clumsy or because she was physically prevented from giving the reward to the dog. Dogs clearly distinguished in their spontaneous behaviour between unwilling- and unable-conditions. This indicates that dogs indeed distinguish intentional actions from unintentional behaviour. We critically discuss our findings with regard to dogs' understanding of human intentional action.
| S-EPMC8410798 | biostudies-literature
Project description:The safety of pericardiocentesis as a therapy for cardiac tamponade has improved since the advent of echocardiography-guided pericardiocentesis. The most life-threatening, albeit rare, complication is injury to the coronary vessels or ventricular wall resulting in recurrent tamponade. We present a rare case of acute marginal artery laceration resulting from pericardiocentesis. (Level of Difficulty: Beginner.).
| S-EPMC9044294 | biostudies-literature
Project description:Social distancing measures implemented by governments worldwide during the COVID-19 pandemic have proven an effective intervention to control the transmission of SARS-CoV-2. There is a growing literature on predictors of adherence behaviours to social distancing measures, however, there are no comprehensive insights into the nature and types of non-adherence behaviours. To address this gap in the literature, we studied non-adherence in terms of counts of infringements and people's accounts on their behaviours in a sample of North London residents. We focused on the following social distancing rules: keeping 2 mts. distancing, meeting family and friends, and going out for non-essential reasons. A mixed-methods explanatory sequential design was used comprising an online survey (May 1-31, 2020) followed by semi-structured in-depth interviews held with a purposive sample of survey respondents (August 5 -September 21, 2020). A negative binomial regression model (quantitative) and Framework Analysis (qualitative) were undertaken.681 individuals completed the survey, and 30 individuals were interviewed. We integrated survey and interview findings following three levels of the Social Ecological model: individual, interpersonal and community levels. We identified non-adherence behaviours as unintentional (barriers beyond individual's control) and intentional (deliberate decision). Unintentional adherence was reported by interviewees as, lack of controllability in keeping 2 mts. distancing, environmental constraints, social responsibility towards the community and feeling low risk. Intentional non-adherence was statistically associated with and reported as lack of trust in Government, support from friends, and lack of knowledge about rules. In addition, interviewees reported individual risk assessment and decision making on the extent to following the rules, and perceived lack of adherence in the local area. Our findings indicate that unintentional and intentional non-adherence should be improved by Government partnerships with local communities to build trust in social distancing measures; tailored messaging to young adults emphasising the need of protecting others whilst clarifying the risk of transmission; and ensuring COVID-secured environments by working with environmental health officers.
| S-EPMC8376044 | biostudies-literature
Project description:Background/purposeThis study aims at evaluating the impact of BASILICA on neo-sinus and sinus hemodynamics with and without coronary flow. Leaflet thrombosis after valve-in-valve (ViV) may compromise not only leaflet mobility but also affect valve durability and performance.Methods/materialsIn a 23?mm transparent surgical aortic valve model, a 23?mm Edwards SAPIEN 3 and a 26?mm Medtronic Evolut were deployed before and after leaflet laceration, in models with and without coronary flow. Neo-sinus and sinus hemodynamics were evaluated in the aortic position of a pulse duplicator and particle image velocimetry was performed in order to quantify sinus flow hemodynamics along with sinus and neo-sinus washout.ResultsBASILICA-type leaflet laceration procedure led to (a) an increase in the velocities in the sinus and the neo-sinus by 50% for Evolut ViV with and without coronary flow, 70% for non-coronary SAPIEN 3 ViV and 10% for coronary SAPIEN 3 ViV, and (b) an improvement in overall washout up to 2?cycles in the neo-sinus and 0.5?cycles in the sinus.ConclusionsA BASILICA-type leaflet laceration approach may improve sinus and neo-sinus hemodynamics through decreasing flow stasis and enabling less confined blood flow. BASILICA confers coronary sinus flow patterns to the non-coronary sinus.
| S-EPMC6935435 | biostudies-literature
Project description:ObjectiveTo determine the rate and differential contribution of heading vs unintentional head impacts (e.g., head to head, goal post) to CNS symptoms in adult amateur soccer players.MethodsAmateur soccer players completed baseline and serial on-line 2-week recall questionnaires (HeadCount) and reported (1) soccer practice and games, (2) heading and unintentional soccer head trauma, and (3) frequency and severity (mild to very severe) of CNS symptoms. For analysis, CNS symptoms were affirmed if one or more moderate, severe, or very severe episodes were reported in a 2-week period. Repeated measures logistic regression was used to assess if 2-week heading exposure (i.e., 4 quartiles) or unintentional head impacts (i.e., 0, 1, 2+) were associated with CNS symptoms.ResultsA total of 222 soccer players (79% male) completed 470 HeadCount questionnaires. Mean (median) heading/2 weeks was 44 (18) for men and 27 (9.5) for women. One or more unintentional head impacts were reported by 37% of men and 43% of women. Heading-related symptoms were reported in 20% (93 out of 470) of the HeadCounts. Heading in the highest quartile was significantly associated with CNS symptoms (odds ratio [OR] 3.17, 95% confidence interval [CI] 1.57-6.37) when controlling for unintentional exposure. Those with 2+ unintentional exposures were at increased risk for CNS symptoms (OR 6.09, 95% CI 3.33-11.17) as were those with a single exposure (OR 2.98, 95% CI 1.69-5.26) when controlling for heading.ConclusionsIntentional (i.e., heading) and unintentional head impacts are each independently associated with moderate to very severe CNS symptoms.
| S-EPMC5331870 | biostudies-literature
Project description:BackgroundThe patterns and risk factors of intentional injuries compared to unintentional injuries among Chinese children and adolescents have not been examined in depth. This work comprehensively describes patterns of intentional injuries in China, for which little information has been previously published.MethodsAll cases involving individuals 0-17 years old registered at emergency rooms and outpatient clinics were examined using data submitted to the National Injury Surveillance System from 2006 through 2017. A logistic regression model was performed to explore the risk factors related to intentional injuries compared to unintentional injuries.ResultsA total of 81,459 (95.1%) unintentional injuries, 4,218 (4.9%) intentional injuries (4,013 violent attacks and 205 self-mutilation/suicide) cases were identified. Blunt injuries accounted for 59.4% of violent attacks, while cuts and poisoning accounted for 37.1% and 23.4% of injuries involving self-mutilation/suicide, respectively. For unintentional injuries, falls (50.4%) ranked first. Additional risk factors for intentional injuries included being male (odds ratio [OR] 1.6), coming from rural areas (OR 1.9), being staff or workers (OR 2.2), and being a student (OR 1.8). As the age of the patients increased, so did the risk of intentional injuries (OR 5.0 in the 15-17 age group). Intentional injuries were more likely to occur at 00:00-03:00 am (OR 2.0).ConclusionsIntentional injuries affected more males, rural and older children, school students, and staff or workers. The mechanisms and occurrence times differed according to age group. Preventive measures should be taken to reduce the dropout of rural students, strengthen the school's violence prevention plan, and reduce self-harm.
| S-EPMC7661334 | biostudies-literature