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  • Ovid Technologies (Wolters Kluwer Health)  (16)
  • Cremer, Paul  (16)
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  • Ovid Technologies (Wolters Kluwer Health)  (16)
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  • 1
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 11, No. 20 ( 2022-10-18)
    Abstract: Recurrent pericarditis is characterized by painful flares and inflammation, which negatively impact health‐related quality of life. RHAPSODY (rilonacept inhibition of interleukin‐1 alpha and beta for recurrent pericarditis: a pivotal symptomatology and outcomes study) evaluated the efficacy and safety of rilonacept (IL‐1α and ‐β cytokine trap) in recurrent pericarditis. A secondary analysis of these data evaluated the patient‐reported outcome questionnaire score change during the trial. Methods and Results Participants completed 5 patient‐reported outcome (PRO) questionnaires assessing pericarditis pain, health‐related quality of life, general health status, sleep impact, and overall symptom severity. PRO score changes during the treatment run‐in period (12 weeks) and the blinded randomized withdrawal period (up to 24 weeks) were evaluated using descriptive statistics and mixed model repeated measures analyses. Participants with PRO data from the run‐in period (n=84) and the randomized withdrawal period (n=61; 30 rilonacept, 31 placebo) were included in analyses. Run‐in baseline PRO scores indicated that pericarditis symptoms during pericarditis recurrence impacted health‐related quality of life. All PRO scores significantly improved ( P 〈 0.001) on rilonacept treatment during the run‐in period. For the randomized withdrawal period, PRO scores were maintained for participants receiving rilonacept. For those receiving placebo and who experienced a recurrence, PRO scores deteriorated at the time of recurrence and then improved following rilonacept bailout. At randomized withdrawal Week 24/End of Study, scores of participants who received bailout rilonacept were similar to those of participants who had continued rilonacept. Conclusions These results demonstrate the burden of pericarditis recurrences and the improved physical and emotional health of patients with recurrent pericarditis while on rilonacept treatment. These findings extend prior rilonacept efficacy results, demonstrating improvements in patient‐reported health‐related quality of life, sleep, pain, and global symptom severity while on treatment. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03737110.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2653953-6
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  • 2
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 144, No. Suppl_1 ( 2021-11-16)
    Abstract: Introduction: In conjunction with pericardial disease physician specialists, industry experts, and recurrent pericarditis (RP) patients the RESONANCE Registry was designed to collect retrospective and prospective, longitudinal, observational data in real-world clinical practice across the United States (US). We aimed to collect data that were complete and meaningful in terms of patient experience and health related quality of life (HRQoL). Herein, we describe a novel patient-centric research approach to obtain feedback on evaluation tools for incorporation in the RESONANCE Registry (NCT04687358). Methods: Ten adult patients with a self-reported duration of disease ranging from 8 months to 25 years participated in an advisory board during which they provided feedback through a virtual platform. Their feedback informed development of multiple registry aspects. These included selection of patient reported outcomes measures (PROMs), to be collected every three months at prospective data collection timepoints, and design of several questionnaires, including evaluation of specific RP episode characteristics. Results: Prior to finalization, registry case report forms were optimized based on feedback provided by patients. Areas of data-capture informed by patient input included selection of PROMs to be assessed and patient-centric tools used for self-assessment of disease experience and HRQoL. For example, sections of a patient questionnaire were modified to include documentation of the presenting symptom, breathlessness, fear of episodes, and patient management of each episode. Conclusions: This patient-centered research collaboration resulted in enhancements to the RESONANCE Registry that enabled capture of information meaningful to patients’ daily experiences, preferences, and expectations. Patient participation in tangible aspects of research, including registry tools and design, can increase engagement with the communities that have a vested interest in improving patient care. In addition, patient involvement can help to ensure research efforts reflect the needs of not only the healthcare community but of patients alike, with an ultimate goal of improving clinical outcomes.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1466401-X
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  • 3
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Cardiology in Review Vol. 30, No. 2 ( 2022-03), p. 59-69
    In: Cardiology in Review, Ovid Technologies (Wolters Kluwer Health), Vol. 30, No. 2 ( 2022-03), p. 59-69
    Abstract: Inflammation of the pericardium (pericarditis) is characterized by excruciating chest pain. This systematic literature review summarizes clinical, humanistic, and economic burdens in acute, especially recurrent, pericarditis, with a secondary aim of understanding United States treatment patterns and outcomes. Short-term clinical burden is well characterized, but long-term data are limited. Some studies report healthcare resource utilization and economic impact; none measure health-related quality-of-life. Pericarditis is associated with infrequent but potentially life-threatening complications, including cardiac tamponade (weighted average: 12.7% across 10 studies), constrictive pericarditis (1.84%; 9 studies), and pericardial effusion (54.7%; 16 studies). There are no approved pericarditis treatments; treatment guidelines, when available, are inconsistent on treatment course or duration. Most recommend first-line use of conventional treatments, for example, nonsteroidal antiinflammatory drugs with or without colchicine; however, 15–30% of patients experience recurrence. Second-line therapy may involve conventional therapies plus long-term utilization of corticosteroids, despite safety issues and the difficulty of tapering or discontinuation. Other exploratory therapies (eg, azathioprine, immunoglobulin, methotrexate, anakinra) present steroid-sparing options, but none are supported by robust clinical evidence, and some present tolerability challenges that may impact adherence. Pericardiectomy is occasionally pursued in treatment-refractory patients, although data are limited. This lack of an evidence-based treatment pathway for patients with recurrent disease is reflected in readmission rates, for example, 12.2% at 30 days in 1 US study. Patients with continued recurrence and inadequate treatment response need approved, safe, accessible treatments to resolve pericarditis symptoms and reduce recurrence risk without excessive treatment burden.
    Type of Medium: Online Resource
    ISSN: 1061-5377
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2081796-4
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  • 4
    In: Circulation: Cardiovascular Imaging, Ovid Technologies (Wolters Kluwer Health), Vol. 13, No. 6 ( 2020-06)
    Abstract: Infective endocarditis (IE) remains a difficult to diagnose condition associated with high mortality. 18 F-fluorodeoxyglucose positron emission tomography/computed tomography ( 18 F-FDG PET/CT) has recently emerged as another IE imaging modality, although diagnostic accuracy varies across observational studies and types of IE. This meta-analysis assessed the diagnostic performance of 18 F-FDG PET/CT for IE and its subtypes. Methods We searched Pubmed, Cochrane, and Embase from January 1980 to September 2019 for studies reporting both sensitivity and specificity of 18 F-FDG PET/CT for IE. Meta-Disc 1.4 was used to pool data for all cases of IE and its subgroups of native valve IE, prosthetic valve IE, and cardiac implantable electronic devices IE. Results We screened 2566 records from the search, assessed 52 full-text articles, and included 26 studies totaling 1358 patients (509 IE cases). Pooled sensitivity and specificity (95% CI, inconsistency I-square statistic) were 0.74 (0.70–0.77, 71.5%) and 0.88 (0.86–0.91, 78.5%) for all cases of endocarditis. Corresponding parameters for native valve IE were sensitivity 0.31 (0.21–0.41, 29.4%) and specificity 0.98 (0.95–0.99, 34.4%); for prosthetic valve IE: sensitivity 0.86 (0.81–0.89, 60.0%) and specificity 0.84 (0.79–0.88, 75.2%); and for cardiac implantable electronic devices IE: sensitivity 0.72 (0.61–0.81, 76.2%) and specificity 0.83 (0.75–0.89, 83.6%). Pooled sensitivities and specificities were higher for the 17 studies since 2015 than the 9 studies published before 2015. Conclusions 18 F-FDG PET/CT had high specificity for all IE subtypes; however, sensitivity was markedly lower for native valve IE than prosthetic valve IE and cardiac implantable electronic devices IE. It is, therefore, a useful adjunct modality for assessing endocarditis, especially in the challenging scenarios of prosthetic valve IE and cardiac implantable electronic devices IE, with improving performance over time, related to advances in 18 F-FDG PET/CT techniques.
    Type of Medium: Online Resource
    ISSN: 1941-9651 , 1942-0080
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2440475-5
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  • 5
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Circulation: Cardiovascular Imaging Vol. 12, No. 8 ( 2019-08)
    In: Circulation: Cardiovascular Imaging, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 8 ( 2019-08)
    Type of Medium: Online Resource
    ISSN: 1941-9651 , 1942-0080
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 2440475-5
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  • 6
    In: Circulation: Cardiovascular Imaging, Ovid Technologies (Wolters Kluwer Health), Vol. 15, No. 9 ( 2022-09)
    Type of Medium: Online Resource
    ISSN: 1941-9651 , 1942-0080
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2440475-5
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  • 7
    In: Circulation: Cardiovascular Imaging, Ovid Technologies (Wolters Kluwer Health), Vol. 15, No. 5 ( 2022-05)
    Abstract: Transthyretin cardiac amyloidosis (ATTR-CA) is an increasingly recognized disease, in which atrial fibrillation (AF) has been shown to be prevalent. Cardiac scintigraphy with technetium-99m-pyrophosphate (99mTc-PyP) labeled bone-seeking tracers is used to noninvasively make the diagnosis of ATTR-CA, based on ventricular myocardial uptake. Assessment of atrial wall uptake (AU) on 99mTc-PyP is currently not used in the clinical setting Methods: We analyzed a cohort of patients referred for 99mTc-PyP scan at a tertiary center to explore AU and associations between any and incident AF, ATTR-CA, and all-cause mortality. Results: Among 580 patients included, 296 patients (51%) had a diagnosis of AF; 164 patients (28%) had scans consistent with ATTR-CA while 117 patients (20%) had AU. Of 117 patients with AU, 107 (91%) had any AF. In contrast, of 463 patients without AU 191(41%) had any AF. Of those with AU, 59/117(50%) patients had a 99mTc-PyP diagnosis of ATTR-CA while 58/117(50%) patients did not have such a diagnosis ( P =1.00). Patients with AU had significantly more any AF (hazard ratio [HR], 1.03 [95% CI, 1.02–1.04] ; P 〈 0.001), independent of ATTR-CA diagnosis and sex. On multivariable Cox proportional hazards analyses adjusting for age, AU, ATTR-CA diagnosis, sex, smoking, hypertension, diabetes, left ventricular ejection fraction, and coronary artery disease, both age (HR, 1.03 [95% CI, 1.02–1.04]; P 〈 0.0001) and AU (HR, 2.68 [95% CI, 2.11–3.41]; P 〈 0.0001) were independently associated with the development of any AF. Freedom from incident AF at 1-year was significantly lower in patients with AU, both in patients with and without ATTR-CA respectively (HR, 2.27 [95% CI, 1.37–3.78]; P 〈 0.0001 versus HR, 2.21 [95% CI, 1.46–3.34]; P 〈 0.0001). Conclusions: In a consecutive cohort of patients undergoing 99mTc-PyP scans, 20% had AU, which was statistically associated with any AF, independently of ATTR-CA diagnosis and sex. AU was associated with significantly lower freedom from incident AF at 1-year. Overlooking AU on 99mTc-PyP scans could potentially miss an earlier disease manifestation, or an additional risk factor for any/incident AF.
    Type of Medium: Online Resource
    ISSN: 1941-9651 , 1942-0080
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2440475-5
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  • 8
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 144, No. Suppl_1 ( 2021-11-16)
    Abstract: Background: Staphylococcus aureus prosthetic valve endocarditis (PVE) is resistant to antimicrobial therapy and commonly associated with tissue invasion, which necessitates complex high risk surgical intervention for cure. Hypothesis: S. aureus virulence in infective endocarditis (IE) is dynamic and changes upon colonizing cardiac valves from blood stream. Methods: Six patients undergoing cardiac surgery for left-sided S. aureus IE, 3 native (NVE) and 3 PVE, were included in this study. Vegetation samples were collected during surgery as well as corresponding blood culture isolates during S. aureus bacteremia. Total RNA was extracted from all samples and underwent mRNA sequencing for transcriptomic analysis of S. aureus . Data was pooled into STAR aligner and gene expression related to virulence factors was compared between different groups (Deseq2; p-value 〈 0.05 for statistical significance). Results: In NVE vegetations, S. aureus showed an increased expression of genes associated with biofilm formation, cell division, and metabolic activity, when compared to blood culture isolates (e.g. rsmA , agrB , dnaK , clpB , ezrA , fusA , ftsZ , adh , pstS , qoxA ). S. aureus isolated from blood cultures had significantly higher expression of clfA (encoding for clumping factor A) compared to cardiac vegetations. Interestingly, in PVE vegetations, S. aureus had a significant higher expression of aur (encoding for metalloprotease aureolysin) compared to corresponding blood culture isolates or NVE vegetations. Aureolysin is an important virulence factor responsible for immune evasion and toxin production. Conclusions: In clinical IE, S. aureus up-regulates genes responsible for biofilm formation when attached to cardiac valves. Planktonic S. aureus cells in the blood stream express clfA , which could bind to fibrinogen to clump within platelet network to form vegetations. On prosthetic valves, S. aureus expresses aureolysin, which could function to evade the host immune response and promote destruction of cardiac tissues. These novel in-vivo findings provide explanations for S. aureus IE pathophysiology that warrant further investigation.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1466401-X
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  • 9
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 144, No. Suppl_1 ( 2021-11-16)
    Abstract: Introduction: The Hospital Readmissions Reduction Program (HRRP) penalizes hospitals by reducing Medicare (CMS) reimbursement for those institutions with higher rates of readmissions following hospitalizations for heart failure (HF). Understanding the contributors to readmission following HF hospitalization can identify meaningful areas for intervention. We examine whether community and patient or healthcare system factors contribute more to variability in HF readmissions. Methods: We compiled CMS hospital data on HF readmissions, CMS physician reimbursement data, and 2020-21 County Health Rankings (Credit: University of Wisconsin). The outcome was the ratio of a hospital’s HF readmissions to HF discharges. Physician/healthcare system factors included total number of cardiac subspecialists, presence of all subspecialties, and the mean proportion of reimbursed charges. Patient/community factors included mean Hierarchical Condition Category (HCC) risk score (quantifies expected healthcare costs for CMS beneficiaries based on ICD-10 coding), median household income, the proportion of residents reporting no physical activity, and access to food stores. Models were created using linear regression. Model of best fit was determined using R 2 , AIC, BIC in model training data and mean absolute prediction error (MAPE) and root mean square prediction error (RMSE) in test data. Results: The linear regression model incorporating community and patient factors explained greater variability in HF readmission rates and performed with greater accuracy in the test data (R 2 0.177; AIC -6879.1; BIC -6840.542; MAPE 0.030; RMSE 0.039) than the model incorporating physician/healthcare system factors (R 2 0.021; AIC -6566.7; BIC -6539.191; MAPE 0.032; RMSE 0.041). HCC score and level of physical activity were associated with the greatest effect sizes on the outcome. Conclusions: At a county level, community/patient factors appear to contribute more to variability in hospitals’ HF readmission rates than physician/healthcare system factors. Further analyses should explore other community, patient, and provider factors that contribute. The HRRP does not account for community or patient factors, indicating its limitations.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1466401-X
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  • 10
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 144, No. Suppl_1 ( 2021-11-16)
    Abstract: Introduction: Connective tissue disorders (CTD) play an important role in the pathogenesis of atherosclerotic heart disease with a dynamic interplay between inflammatory and traditional cardiovascular risk factors. Hypothesis: We aim to develop, validate, and compare population-level machine learning models to predict the first acute myocardial infarction (AMI) event in CTD. Methods: We extracted patient data from the Healthcare Cost and Utilization Project (HCUP) and identified 62 demographic and clinical variables. We identified those with systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, mixed connective tissue disorder, Sjogren’s syndrome, polymyositis, and dermatomyositis. We excluded those with prior history of myocardial infarction, known coronary artery disease, or missing key variables. We split the records randomly into training (70%) and testing (30%) datasets. Keras sequential model with Adadelta optimizer was used to compile the deep neural network model and scikit-learn classifiers were used for machine learning models. We estimated model performance based on the area under the receiver-operator characteristics curve (AUC). Results: 961,405 records were identified, and out of these, 14,961 (1.6%) had the first AMI event. The neural network model performed best in predicting AMI with an AUC:0.96 [A]. Classifier models had varying degrees of success range from 0.71 to 0.86 with Gradient Boosting Classifier, AUC:0.86 [B] , being the best performing classifier, followed by Decision Tree, AUC:0.85, Logistic regression, AUC:0.84, Random Forest, AUC:0.84, Naive Bayes, AUC:0.75, Stochastic Gradient Descend, AUC: 0.71. Conclusions: A neural network model was able to predict the first AMI in people with CTD accurately. Developing and implementing machine learning models can help clinicians predict individual patient risk with a high degree of success.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1466401-X
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