142 research outputs found

    Untreated Right Ventricle Myxoma with Pericardial Effusion in Young Men: A Case Report

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    Myxomas are benign cardiac tumors that are mostly found in the left atrium. We present a case of a 20-year-old male patient who presented with worsening dyspnea and signs of right heart failure. The echocardiography shows an untreated giant intracardiac mass in a rare place in the right ventricle, obstructing the blood flow, and massive pericardial effusion. We do a pericardiocentesis first to manage the pericardial effusion. Pericardiocentesis was done in different normal locations due to ascites permagna.  Nevertheless, our patient needs emergency surgical excision as soon as possible to prevent sudden death caused by obstruction, embolic, and other complications

    The role and essence of pilot trials and subgroup analysis in cardiovascular research: the IMPI trial experience

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    Background Randomised control trials (RCTs) are capital-intensive projects and demand substantial human and capital resources. Therefore, proper planning, precise research questions and adequate thoughts are required in areas such as acceptability of the intervention, participant recruitment, and selection of measurable outcomes. Ensuring all these are possible before delving into the main work can be forecasted through pilot trials. They help in determining the feasibility of the intended critical endpoints and ensure the applicability of the result findings. However, no matter how noble and vital the results are, improper reporting can make them unusable. The thesis brings to the fore the importance of pilot trials in low- and medium-income countries and how they can help make a case for more extensive definitive trials. It then focuses on how subgroup analysis can be used as an essential statistical tool for fully understanding clinical trial results and can be used to unearth non-apparent results in RCT. In the thesis, we highlight the need for accurate, systematic and complete reporting of pilot trials, by critically appraising the literature on abstract reporting in heart failure. The thesis discusses several aspects of pilot trial processes to understand better its unique role in helping refine the components of RCT, to make the running smooth and findings affirmative. Leveraging on the experience of working as a clinical research fellow in the second Investigation for Management of Pericarditis in Africa (IMPI-2) trial, the lessons learnt in planning, designing, implementation, recruitment and reporting of the IMPI-2 pilot forms the nucleus of this thesis. The experience acquired in the process and how they can help in planning future definitive studies are discussed in different sections of the thesis. Methodology The thesis uses the experience gained in critical appraisal of the literature, participation in preliminary planning and active participation in a multicentre randomised control trial to understand the importance of some issues during an RCT. These areas include the need for specific objective setting, identification of research participants and collaborators, the acceptability of research intervention, proper identification of possible outcome measures, retention of participants and quality reporting of research findings. It begins with an overview of pilot trials, subgroup analysis and tuberculous pericarditis which is the primary disease focus of the IMPI project. Each subsequent chapter of the thesis is presented either as a published manuscript or prepared for submission as a manuscript. The quality of reporting of pilot trials is then examined by systematically surveying the reporting of abstracts of pilot trials in heart failure using the checklist of the Consolidated standard for reporting of trials (CONSORT) extension for pilot trials. A subgroup analysis of IMPI-1 trial planned a priori on the modification of the effect of prednisolone by baseline pericardiocentesis status of trial participants is used to highlight the role subgroup analysis can play in unmasking the group effect in the randomised control trial. The thesis then goes on to present the preliminary report of the IMPI-2 pilot study, highlighting the lessons learned and aspirations in need of refining. Retention of study participants is essential to achieve success in clinical trials, one way of ensuring this is by letting the study participants understand the objectives and processes of the research and gaining their confidence. Thus, in chapter six, we piloted the use of the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), a screening tool for evaluation of informed consent (IC) comprehension as a training tool for iterative learning and evaluation of consent comprehension among IMPI-2 pilot trial participants. Results and Conclusion Enormous resources expended in clinical research can yield good returns before the main work commences, a well-planned micro trial run in the form of a pilot study is undertaken. Our systematic survey of abstracts of pilot trials in heart failure showed that reporting of abstracts of pilot trials is currently suboptimal. Deciding ahead of time on what to report by systematically identifying the different sections needed to inform the audience can improve the quality adequately. Planning subgroup analysis during the design of main studies can help reveal unsuspected findings. The subgroup analysis result showed that pericardiocentesis, despite its essential use among patients with pericardial effusion, did not significantly influence the effect of prednisolone on the primary critical outcomes among IMPI-1 participants. The preliminary report of IMPI-2 trial was designed as a two-phase study; phase 1 results showed that at 50mg, intrapericardial alteplase was safe in facilitating complete pericardiocentesis, while phase two showed that it was feasible to recruit, randomised and follow up patients in line with the study protocol. However, we identified participant retention as a considerable challenge. The result of the pilot revealed that more effort should be expended on participants’ education on the clinical condition, the reason for the trial and the need for follow-up adherence. There is also a need to make adequate provision for the use of field workers for contact tracing to reduce the dropout rate. In the main trial protocol, there may also be a need to reconsider the patient's selection and use of fibrinolysis in malignant effusion, judging from the high rate of 3 months mortality in this group of patients. The results of the informed consent study showed that an improved level of comprehension followed the use of iterative learning, a higher level of education and non-use of interpreters during informed consent delivery. These finding led us to conclude that every effort should be made to ensure that research participants entirely buy into the research they are asked to be part of through thorough information delivery. Doing so can help improve participants adherence to the trial follow-up

    Diagnostic utility of pericardial fluid pH in diagnosing infectious pericardial effusions among patients with moderate and large effusions undergoing pericardiocentesis at Groote Schuur Hospital: a subs-study of the IMPI trial

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    Diagnosis of infectious pericardial disease has been challenging in the developing world despite improvement of treatment modalities. The diagnostic utility of pH in diagnosing infectious pericardial fluid is unknown, yet this concept is well studied in pleural fluid. This cross-sectional diagnostic study evaluated the diagnostic utility of pH in infectious compared to non-infectious pericardial effusions in a high-burden setting. Methods: Patients of 18 years with moderate to large effusion between the 1st February 2016 and 31st May2018 were enrolled at Groote Schuur Hospital in Cape Town, South Africa. After safe pericardiocentesis, pH was measured with a blood gas analyzer. Mycobacterium tuberculosis culture and/or gene Xpert for TB and/or bacteria culture and/or microscopy served as the reference standard for definite infectious pericardial effusions. We calculated sensitivity, specificity, positive and negative predictive values, negative and positive likelihood ratios for an a priori pH cut off of 7.35. Receiver operating characteristic curve analysis was used for selection of ideal pH cut off. RESULTS Using a set sensitivity of 70% we estimated that we needed to recruit a sample size of 149 subjects for a 95% confidence interval and power of 80%. We screened 200 patients, and excluded 60 because they did not meet the appropriate exclusion criteria. The prevalence of infectious pericarditis was 27.1% (n/N=34/140) as confirmed by the reference standard. We found the median pH (IQR) was 7.30(7.20-7.30) for definite infection, 7.30(7.30-7.35) for probable infection and 7.50(7.40-7.55) for non-infectious effusions p value <0.01 (test for trend). At a cut off or <7.35, the sensitivity was 89.5(95%CI: 75%.5-97.1%) and the specificity was 72.5% (95% CI: 62.8%-80.9%). The ideal ROC- determined cut off for pH that would give maximum sensitivity and specificity was ≤7.30 and the maximum sensitivity and specificity at optimum cut off are 86.8% (95% CI:71.9 - 95.6) and 86.8% (95% CI:71.9 - 95.6), respectively. The area under the curve at this cut-off point is 0.86 (95% CI 0.79 to 0.9), p<0. 001. CONCLUSION: In conclusion, pericardial PH offers diagnostic utility for infectious causes of pericardial effusions using both a PH of 7.35 and an ideal cut-off of 7.30. We recommend that given the simplicity of the test it should be adopted in evaluation of patients with pericardial effusions

    Evaluation and management of cancer patients presenting with acute cardiovascular disease:a Consensus Document of the Acute CardioVascular Care (ACVC) association and the ESC council of Cardio-Oncology-Part 1: acute coronary syndromes and acute pericardial diseases

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    Advances in treatment, common cardiovascular (CV) risk factors and the ageing of the population have led to an increasing number of cancer patients presenting with acute CV diseases. These events may be related to the cancer itself or the cancer treatment. Acute cardiac care specialists must be aware of these acute CV complications and be able to manage them. This may require an individualized and multidisciplinary approach. We summarize the most common acute CV complications of cytotoxic, targeted, and immune-based therapies. This is followed by a proposal for a multidisciplinary approach where acute cardiologists work close together with the treating oncologists, haematologists, and radiation specialists, especially in situations where immediate therapeutic decisions are needed. In this first part, we further focus on the management of acute coronary syndromes and acute pericardial diseases in patients with cancer

    Current and emerging strategies for the treatment of acute pericarditis: a systematic review

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    Pericarditis is a common disorder that has multiple causes and presents in various primary-care and secondary-care settings. It is diagnosed in 0.1% of all hospital admissions and in 5% of emergency room visits for chest pain. Despite the advance of new diagnostic techniques, pericarditis is most commonly idiopathic, and radiation therapy, cardiac surgery, and percutaneous procedures have become important causes. Pericarditis is frequently benign and self-limiting. Nonsteroidal anti-inflammatory agents remain the first-line treatment for uncomplicated cases. Integrated use of new imaging methods facilitates accurate detection and management of complications such as pericardial effusion or constriction. In this article, we perform a systematic review on the etiology, clinical presentation, diagnostic evaluation, and management of acute pericarditis. We summarize current evidence on contemporary and emerging treatment strategies

    Non-invasive characterization of pleural and pericardial effusions using T1 mapping by magnetic resonance imaging

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    AIMS: Differentiating exudative from transudative effusions is clinically important and is currently performed via biochemical analysis of invasively obtained samples using Light's criteria. Diagnostic performance is however limited. Biochemical composition can be measured with T1 mapping using cardiovascular magnetic resonance (CMR) and hence may offer diagnostic utility for assessment of effusions. METHODS AND RESULTS: A phantom consisting of serially diluted human albumin solutions (25-200 g/L) was constructed and scanned at 1.5 T to derive the relationship between fluid T1 values and fluid albumin concentration. Native T1 values of pleural and pericardial effusions from 86 patients undergoing clinical CMR studies retrospectively analysed at four tertiary centres. Effusions were classified using Light's criteria where biochemical data was available (n = 55) or clinically in decompensated heart failure patients with presumed transudative effusions (n = 31). Fluid T1 and protein values were inversely correlated both in the phantom (r = -0.992) and clinical samples (r = -0.663, P < 0.0001). T1 values were lower in exudative compared to transudative pleural (3252 ± 207 ms vs. 3596 ± 213 ms, P < 0.0001) and pericardial (2749 ± 373 ms vs. 3337 ± 245 ms, P < 0.0001) effusions. The diagnostic accuracy of T1 mapping for detecting transudates was very good for pleural and excellent for pericardial effusions, respectively [area under the curve 0.88, (95% CI 0.764-0.996), P = 0.001, 79% sensitivity, 89% specificity, and 0.93, (95% CI 0.855-1.000), P < 0.0001, 95% sensitivity; 81% specificity]. CONCLUSION: Native T1 values of effusions measured using CMR correlate well with protein concentrations and may be helpful for discriminating between transudates and exudates. This may help focus the requirement for invasive diagnostic sampling, avoiding unnecessary intervention in patients with unequivocal transudative effusions

    Intracerebral Bleeding and Massive Pericardial Effusion as Presenting Symptoms of Myxedema Crisis

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    Differential Impact of Constrictive Physiology after Pericardiocentesis in Malignancy Patients with Pericardial Effusion

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    BACKGROUND: Echocardiographic signs of constrictive physiology (CP) after pericardiocentesis are frequently observed in malignancy patients. The purpose of the current study was to explore whether features of CP after pericardiocentesis have prognostic impact in malignancy patients with pericardial effusion (PE). METHODS: We retrospectively reviewed 467 consecutive patients who underwent pericardiocentesis at our institution from January 2006 to May 2014. Among them, 205 patients with advanced malignancy who underwent comprehensive echocardiography after the procedure comprised the study population. Co-primary end points were all-cause mortality (ACM) and repeated drainage (RD) for PE. Patients were divided into four subgroups according to cytologic result for malignant cells and CP (positive cytology with negative CP, both positive, both negative, and negative cytology with positive CP). RESULTS: CP after pericardiocentesis was present in 106 patients (50%) at median 4 days after the procedure. During median follow-up of 208 days, ACM and RD occurred in 162 patients (79%) and 29 patients (14%), respectively. Cox regression analysis revealed that independent predictors for ACM were male gender and positive cytology (all, p < 0.05). For RD, predictors were positive cytology, the absence of cardiac tamponade, and negative CP after pericardiocentesis (all, p < 0.05). When the patients were divided into four subgroups, patients with negative cytology and positive CP demonstrated the most favorable survival (hazard ratio [HR]: 0.39, p = 0.005) and the lowest RD rates (HR: 0.07, p = 0.012). CONCLUSION: CP after pericardiocentesis is common, but does not always imply poor survival or the need for RD in patients with advanced malignancies. On the contrary, the presence of CP in patients with negative cytology conferred the most favorable survival and the lowest rate of RD. Comprehensive echocardiographic evaluation for CP after pericardiocentesis would be helpful for predicting prognosis in patients with advanced malignancies.ope
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