Prevalence of control groups in cardiovascular clinical trials: An analysis of ClinicalTrials.gov from 2009 through 2019.

Clinical trials provide the foundational evidence that guide many patient-facing decisions; however, the therapeutic effect and safety of an intervention is best evaluated when compared to a control group. We used ClinicalTrials.gov to describe the proportion of registered Phase III and IV cardiovascular clinical trials that contain a control group from 2009 through 2019. Of 1,677 registered Phase III and IV cardiovascular clinical trials, 81.2% contain a control group, and the annual prevalence remained unchanged between 2009 and 2019.

Loss of Pulsatility: Another Cause of Syncope in Patients with Left Ventricular Assist Devices.

We report a case of a 55-year-old man who presented with recurrent syncope 15 months after HeartWare left ventricular assist device (LVAD) implantation and was found to have diminished LVAD flow and pulsatility on tilt table testing leading to severe orthostatic hypotension (OH). The prevalence of OH is common, but autonomic dysfunction leading to OH has not been well described in patients with chronic LVAD support. The diagnosis of OH in this setting is challenging due to the decreased pulsatility in the flow generated by LVADs, and tilt table testing can be useful in the evaluation of OH in these patients.

Updates on Device-Based Therapies for Patients with Heart Failure.

PURPOSE OF REVIEW: Heart failure is a growing epidemic. Optimal medical therapy remains the cornerstone of heart failure management but device-based therapies have been shown to contribute to morbidity and mortality reduction. RECENT FINDINGS: Multiple investigational trials had been conducted in the past decade that helped us better understand and manage heart failure. In this manuscript, we will discuss the major device related trials of year 2017 in the fields of defibrillators, hemodynamic monitoring, remote monitoring, autonomic nervous system modulation, ventricular assist devices, and device-based valvular heart disease management. Further research and trials in device-based therapies are needed to explore their long-term reduction in mortality and morbidity along with cost-effectiveness analyses in patients living with heart failure.

Surfacing and addressing hospitalized patients' needs: Proactive nurse rounding as a tool.

AIMS: This paper reports on rounding interventions employed at high performing hospitals, and provides three case studies on how proactive nurse rounding was successfully implemented to improve patient-centredness. BACKGROUND: Proactive nurse rounding is a popular form of rounding that has shown promise for improving patient outcomes, yet, little evidence exists on how to implement it successfully. METHODS: We identified high-performing hospitals in the domains of staff responsiveness and nurse communications in the Hospital Consumer Assessment of Health Providers and Systems survey nationally, and conducted case studies at three of these hospitals exploring their implementation of proactive nurse rounding. We partnered with leaders from these hospitals to describe the associated challenges and lessons learned. RESULTS: Twenty-six high performing hospitals in the domains of staff responsiveness and/or nurse communication were identified. The majority of nursing units reported proactive nurse rounding as their main rounding intervention (96%). CONCLUSIONS: Proactive rounding interventions are a feasible approach to help surface and address hospitalized patients' needs in a timely manner. IMPLICATIONS FOR NURSING MANAGEMENT: The information and tools provided in this paper build upon the learning from high performing hospitals' experiences and are useful to nurse leaders in their efforts to improve the patient-centeredness in the hospital.

Giant left atrial appendage aneurysm: A case of mistaken identity.

Left atrial appendage (LAA) aneurysm is a rare condition that can be congenital or acquired. Most cases are discovered incidentally. However, the most frequent clinical presentations include supraventricular tachycardias and systemic embolization. Most cases in the literature were treated by resection of the LAA, and it has been recommended to perform LAA resection even in asymptomatic patients in order to prevent thromboembolic events. Here, we describe the safe, conservative management of a patient who was initially felt to have congenital partial absence of the left pericardium but at surgery the diagnosis of LAA aneurysm was established. .

Impact of the 2013 American College of Cardiology/American Heart Association cholesterol guidelines on the prescription of high-intensity statins in patients hospitalized for acute coronary syndrome or stroke.

BACKGROUND: The 2013 American College of Cardiology/American Heart Association cholesterol management guidelines represented a paradigm shift from the National Cholesterol Education Program Adult Treatment Panel III guidelines, replacing low-density lipoprotein cholesterol targets with a risk assessment model to guide statin therapy. Our objectives are to compare provider prescription of high-intensity statin therapy in patients hospitalized with acute coronary syndrome (ACS) or cerebrovascular accident (CVA) before and after the publication of the 2013 cholesterol guidelines, determine potential predictors of high-intensity statin utilization, and identify targets for improvement in cardiovascular risk reduction among these high-risk populations. METHODS: A single-center retrospective cohort study of 695 patients discharged with a diagnosis of ACS or CVA in the 6months before (n=359) and after (n=336) the release of the 2013 American College of Cardiology/American Heart Association cholesterol guidelines. Patient characteristics were compared using analysis of variance and χ2 tests. Multivariable logistic regression models were used to assess clinical predictors of provider utilization of high-intensity statins. RESULTS: After the 2013 cholesterol guidelines, the rate of prescribing high-intensity statins was greater for statin-naïve patients compared with those already on statin therapy (odds ratio [OR]0.51, P=.02). Prescription of high-intensity statins was higher for patients with ACS compared with CVA (OR 8.4, P<.001-pre-2013 guidelines; OR 4.5, P<.001-post-2013 guidelines). Prescription of high-intensity statins steadily improved over the study period, significantly among patients with CVA (P<.001). CONCLUSIONS: Physicians were more likely to prescribe high-intensity statins in statin-naïve patients as compared with intensifying existing statin therapy, and their prescription pattern was lower after CVA vs ACS.

Promising Practices for Achieving Patient-centered Hospital Care: A National Study of High-performing US Hospitals.

BACKGROUND: Patient-centered care is integral to health care quality, yet little is known regarding how to achieve patient-centeredness in the hospital setting. The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey measures patients' reports on clinician behaviors deemed by patients as key to a high-quality hospitalization experience. OBJECTIVES: We conducted a national study of hospitals that achieved the highest performance on HCAHPS to identify promising practices for improving patient-centeredness, common challenges met, and how those were addressed. RESEARCH DESIGN: We identified hospitals that achieved the top ranks or remarkable recent improvements on HCAHPS and surveyed key informants at these hospitals. Using quantitative and qualitative methods, we described the interventions used at these hospitals and developed an explanatory model for achieving patient-centeredness in hospital care. RESULTS: Fifty-two hospitals participated in this study. Hospitals used similar interventions that focused on improving responsiveness to patient needs, the discharge experience, and patient-clinician interactions. To improve responsiveness, hospitals used proactive nursing rounds (reported at 83% of hospitals) and executive/leader rounds (62%); for the discharge experience, multidisciplinary rounds (56%), postdischarge calls (54%), and discharge folders (52%) were utilized; for clinician-patient interactions, hospitals promoted specific desired behaviors (65%) and set behavioral standards (60%) for which employees were held accountable. Similar strategies were also used to achieve successful intervention implementation including HCAHPS data feedback, and employee and leader engagement and accountability. CONCLUSIONS: High-performing hospitals used a set of patient-centered care processes that involved both leaders and clinicians in ensuring that patient needs and preferences are addressed.

Neuroleptic Malignant Syndrome: A Case Aimed at Raising Clinical Awareness.

A 60-year-old man with a history of bipolar disorder on risperidone, bupropion, and escitalopram was admitted for community acquired streptococcal pneumonia. Four days later, he developed persistent hyperthermia, dysautonomia, rigidity, hyporeflexia, and marked elevation of serum creatine phosphokinase. He was diagnosed with neuroleptic malignant syndrome (NMS) and improved with dantrolene, bromocriptine, and supportive therapy. This case emphasizes the importance of considering a broad differential diagnosis for fever in the ICU, carefully reviewing the medication list for all patients, and considering NMS in patients with fever and rigidity.

Renal function decline in recipients and donors of kidney grafts: role of aortic stiffness.

BACKGROUND/AIMS: Renal function decreases over time as a result of reduction in the number of functioning nephrons with age. In recipients and donors of kidney grafts, renal function decline may be linked differently to various parameters, namely arterial stiffness. METHODS: We conducted a prospective cohort study including 101 recipients of kidney grafts and their donors aiming at determining the factors correlated to the renal function decline over time. Aortic stiffness was evaluated by the non-invasive measurement of aortic pulse wave velocity. The glomerular filtration rate was estimated using the Modification of Diet in Renal Disease (MDRD) equation and the annualized change was determined. RESULTS: Decline in renal function was estimated at 1-year post-transplantation and annually thereafter (median follow-up 8 years, range 3.6-18.3), as the mean of the annualized decrease in the glomerular filtration rate. In recipients, filtration rate decreased by 4.8 ± 19.7 ml/min/1.73 m(2) the first post-transplant year and at a yearly rate of 2.2 ± 3.8 ml/min/1.73 m(2) thereafter. The first-year decline was related to smoking and acute rejection. Later decline was significantly associated with donor age and aortic stiffness. In living donors, renal function decline after the first year corresponded to 0.7 ml/min/1.73 m(2), was significantly lower than that of recipients (p < 0.001), and was determined by donor age at nephrectomy. CONCLUSION: Recipients of kidney grafts show a glomerular filtration rate decline over time that is significantly associated with donor age and aortic stiffness after the first post-transplant year, while donors demonstrate a lower decline that is mostly determined by age at nephrectomy.

Spontaneous epidural hematoma in a child with inherited factor XIII deficiency.

We report the case of a 2-year-old Lebanese male child, known to have congenital factor XIII (FXIII) deficiency, who presented to the emergency department with somnolence and projectile vomiting without any head trauma. He has been on a prophylactic dose of 10 IU/kg of FXIII concentrate every 4 weeks since birth, but he missed his last 2 doses due to shortage of supply. Imaging studies showed an epidural hematoma with a midline shift. The child was started on 20 IU/kg of FXIII replacement, and a left parietal craniotomy was performed immediately. He tolerated the surgery well with an uneventful postoperative course. Previous DNA analysis carried out for the family members detected a small deletion (c.1475-1476delGA) in exon 12 in this child and his eldest brother. This mutation has been previously reported once in another Lebanese child with FXIII deficiency who presented with spontaneous splenic rupture. To the best of our knowledge, this is the first case of acute nontraumatic spontaneous epidural hematoma in a child with congenital FXIII deficiency. Furthermore, patients on FXIII replacement therapy have less bleeding events, thus lifelong adherence to the prophylaxis is essential to decrease the morbidities and the mortalities associated with FXIII deficiency, most notably intracranial hemorrhages.

Identification of the first mutation in a BRE motif of the ß-globin gene and its inheritance with two other α-globin gene mutations in a Lebanese family.

A 7-year old boy presented with a history of recurrent respiratory infections and hypochromic microcytic anemia. Iron profiles were normal thereby prompting genetic analysis of α- and ß-globin mutations. The first mutation in a BRE motif of the ß-globin gene in the proband, sibling and the mother was identified. The proband and his sibling also inherited common α-globin mutations from the father and mother. In all cases, no serious thalassemia disease was detected.