Author Interviews, Clots - Coagulation, NEJM, Thromboembolism / 02.04.2019

MedicalResearch.com Interview with: Yaseen M. Arabi, M.D Intensive Care Department Ministry of National Guard Health Affairs Riyadh, Saudi Arabia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, is a complication of critical illness. Studies have demonstrated that despite pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular weight heparin, 5-20% of critically ill patients develop deep vein thrombosis (DVT). The PREVENT trial evaluated whether adjunctive intermittent pneumatic compression reduces incident proximal lower limb DVT as detected on twice-weekly lower limb ultrasonography in critically ill patients receiving pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular-weight heparin. The trial was conducted in 20 sites in Saudi Arabia, Canada, Australia and India and included 2003 patients. The trial found no difference in the primary end point of proximal leg DVT. The addition of intermittent pneumatic compression to pharmacologic thromboprophylaxis did not result in a lower incidence of pulmonary embolism or a composite outcome of venous thromboembolism or death from any cause at 28 days when compared to pharmacologic thromboprophylaxis alone. (more…)
Author Interviews, Clots - Coagulation, Heart Disease / 18.03.2019

MedicalResearch.com Interview with: Stavros V. Konstantinides, MD, PhD, FESC, FRCP(Glasg) Professor, Clinical Trials, and Medical Director Center for Thrombosis and Hemostasis (CTH) Johannes Gutenberg University Mainz Mainz, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: Acute pulmonary embolism (PE) is the third most frequent acute cardiovascular syndrome. It encompasses a wide spectrum of clinical symptoms and severity, ranging from massive, immediately life-threatening PE with hemodynamic collapse to the low-risk, stable patient with very few symptoms. These latter patients with acute low-risk PE may qualify for early discharge from hospital (e.g., within 48 hours) and continuation of treatment at home. This is a very promising strategy, because it may not only increase patient satisfaction and quality of life, but also help to reduce hospital-related complications and costs. However, it needed to be clearly determined, and tested in a prospective management trial, who are the appropriate candidates for an effective and safe home treatment approach. To this date, trials suggesting favorable clinical outcomes with home treatment of PE are small and date back to the era of vitamin K antagonists. Direct oral anticoagulants permitting a single drug treatment of PE are more promising in this regard, as they may make an early transition from hospital to ambulatory care both safer and more convenient. The international Home Treatment of Pulmonary Embolism (HoT-PE) phase 4 management trial tested the efficacy and safety of early discharge and ambulatory anticoagulation treatment with the direct factor Xa inhibitor rivaroxaban in patients with acute low-risk PE. Patients were identified on the basis of
  • clinical criteria or PE severity, comorbidity, and contraindications; and
  • the absence of right heart failure or intracardiac thrombi on cardiac imaging. Early termination of the study was possible following the prespecified interim analysis, which was performed after recruitment and 3-month evaluation of 525 patients (50% of the planned trial population). At the interim analysis, the primary efficacy outcome of symptomatic recurrent venous thromboembolism or PE-related death occurred in only 3 (0.6%) patients (compared to an estimated 1.7% rate based on historical data). This rate was sufficiently low to reject the primary hypothesis as predefined in the statistical analysis plan. None of the recurrent events was nonfatal.Major bleeding occurred in 6 (1.2%) patients of the safety population. The study could therefore be terminated early for efficacy. 
(more…)
Annals Internal Medicine, Author Interviews, Blood Clots, Emergency Care, Kaiser Permanente, Pulmonary Disease, UC Davis / 13.11.2018

MedicalResearch.com Interview with: David R. Vinson, MD Department of Emergency Medicine Kaiser Permanente Sacramento Medical Center Sacramento, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: At least one-third of emergency department (ED) patients with acute blood clots in the lung, or pulmonary embolism (PE), are eligible for expedited discharged to home, either directly from the ED or after a short (<24 hour) period of observation. Yet in in most hospitals in the U.S. and around the world nearly all ED patients with acute PE are hospitalized. These unnecessary hospitalizations are a poor use of health care resources, tie up inpatient beds, and expose patients to the cost, inconvenience, and risk of inpatient care. The better-performing medical centers have two characteristics in common: they help their physicians identify which PE patients are candidates for outpatient care and they facilitate timely post-discharge follow-up. At Kaiser Permanente Northern California (KPNC), we have had the follow-up system in place for some time, but didn’t have a way to help our physicians sort out which patients with acute PE would benefit from home management. To correct this, we designed a secure, web-based clinical decision support system that was integrated with the electronic health record. When activated, it presented to the emergency physician the validated PE Severity Index, which uses patient demographics, vital signs, examination findings, and past medical history to classify patients into different risk strata, correlated with eligibility for home care. To make use of the PE Severity Index easier and more streamlined for the physician, the tool drew in information from the patient’s comprehensive medical records to accurately auto-populate the PE Severity Index. The tool then calculated for the physician the patient’s risk score and estimated 30-day mortality, and also offered a site-of-care recommendation, for example, “outpatient management is often possible.” The tool also reminded the physician of relative contraindications to outpatient management. At the time, only 10 EDs in KPNC had an on-site physician researcher, who for this study served as physician educator, study promotor, and enrollment auditor to provide physician-specific feedback. These 10 EDs functioned as the intervention sites, while the other 11 EDs within KPNC served as concurrent controls. Our primary outcome was the percentage of eligible ED patients with acute PE who had an expedited discharge to home, as defined above. During the 16-month study period (8-month pre-intervention and 8-months post-intervention), we cared for 1,703 eligible ED patients with acute PE. Adjusted home discharge increased at intervention sites from 17% to 28%, a greater than 60% relative increase. There were no changes in home discharge observed at the control sites (about 15% throughout the 16-month study). The increase in home discharge was not associated with an increase in short-term return visits or major complications.  (more…)
Author Interviews, Clots - Coagulation, Emergency Care, Pulmonary Disease, Stanford / 18.08.2018

MedicalResearch.com Interview with: Joseph Bledsoe MD, FACEP Clinical Assistant Professor of Emergency Medicine Stanford Medicine Director of Research Department of Emergency Medicine Intermountain Medical Center Murray, UT 84157 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with blood clots in the lungs (pulmonary embolism) (PE) are routinely admitted to the hospital for blood thinning medications in the United States. However, evidence from other countries has shown that with appropriate risk stratification patients may be safe for outpatient treatment for their PE. Our study is the largest prospective management study in the US to evaluate home treatment of patients with acute pulmonary embolism. We enrolled 200 patients and after risk stratification with the PE severity index score, leg ultrasounds and echocardiograms performed in the emergency department, patients were treated with blood thinning medications at home with routine outpatient follow up. During the 90 day follow up period we found only one patient suffered a bleeding event after a traumatic injury, without any cases of recurrent symptomatic blood clots or death.  (more…)
Author Interviews, Emergency Care, JAMA, Pulmonary Disease / 31.01.2018

MedicalResearch.com Interview with: Giorgio Costantino MD Dipartimento di Medicina Interna Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca’ Granda Ospedale Maggiore Policlinico Università degli Studi di Milano Milan, Italy MedicalResearch.com: What is the background for this study? Response: Syncope is a common symptom that occurs in one in four people during their lifetime. Pulmonary embolism (PE) has long been recognized as an important and serious cause of syncope. PE has always been estimated a rare cause of syncope, present in less than 1.5% of patients. A recent study (PESIT), aiming at evaluating PE prevalence using a standardized algorithm in hospitalized patients after a first syncope episode, found a prevalence of PE as high as 17% in hospitalized patients. This means that patients with a first episode of syncope should be investigated with a standard diagnostic algorithm to exclude PE. However, many patients might go through useless and potentially harmful tests, such as computed tomography pulmonary angiogram. (more…)
Author Interviews, Neurological Disorders, Pulmonary Disease / 24.10.2016

MedicalResearch.com Interview with: Paolo Prandoni, M.D., Ph.D. and Department of Cardiovascular Sciences Vascular Medicine Unit University of Padua, Padua Sofia Barbar, M.D Department of Internal and Emergency Medicine Civic Hospital of Camposampiero Camposampiero MedicalResearch.com: WhaWhat are the main findings? Response: Syncope is defined as a sudden loss of consciousness due to transient global cerebral hypoperfusion characterized by rapid onset, short duration, and spontaneous complete recovery. According to the most recent guidelines, syncope can be classified as neurally-mediated, due to orthostatic hypotension and cardiovascular. Syncope is frequent in general population and represents up to 2% of all attendances in Emergency Department in Europe. The initial approach is unable to identify a plausible cause for syncope in 25-30% of cases and approximately 40% of syncope referred to an Emergency Department is then admitted to the hospital. Pulmonary embolism (PE) is an obstruction in the pulmonary arteries interfering with both blood circulation and gas exchange and therefore representing a potentially life-threatening event. Clinical features of PE are extremely variable. Available guidelines on syncope management consider PE as an infrequent cardiovascular cause of syncope. However, the true prevalence of pulmonary embolism in syncope-patients it is actually unknown. Moreover a workup for PE diagnosis in these patients is not suggested in the current guidelines. (more…)
Author Interviews, Cancer, Thromboembolism / 07.07.2014

MedicalResearch.com Interview with: Dr. Liang He Department of Anesthesiology Yan’an Hospital of Kunming City, kunming, 650051, China MedicalResearch: What are the main findings of this study? Dr. He: We evaluated the prognostic value of plasma heart-type fatty acid binding protein (H-FABP) in patients with acute pulmonary embolism (PE) with the guidelines of acute PE of European Society Cardiology (ESC). We found that higher H-FABP level (above 6 or 7 ng/ml) was associated with an increased of 30-d mortality and complicated clinical events, from six studies of 85 articles included. H-FABP has the potential to be a novel prognostic marker that can help optimize patient management strategies and risk-stratification algorithms in the population of patients with acute pulmonary embolism. However, few studies had been specifically designed to answer our research questions. (more…)
Blood Clots, General Medicine, UCSD / 19.05.2014

MedicalResearch.com Interview withTimothy Fernandes, M.D., M.P.H. University of California, San Diego - La Jolla, CA Timothy Fernandes, M.D., M.P.H. University of California, San Diego La Jolla, CA MedicalResearch: What are the main findings of this study? Dr. Fernandes: The fibrinopeptides are cleaved off of fibrinogen by thrombin during the generation of a new clot. These small molecules are excreted into the urine and we have developed a urine assay to measure the level of FPB. We examined the performance of urine FPB as a screening test for acute pulmonary embolism, blood clots that travel to the lungs. The study group consisted of 344 patients: 61 (18%) with pulmonary embolism and 283 (83%) without. At a threshold of 2.5 ng/ml, urine FPB demonstrated sensitivity of 75.4% (95% CI: 62.4-85.2%), specificity of 28.9% (95% CI: 23.8-34.7%), and negative likelihood ratio of 0.18 (0.11-0.29), weighted by prevalence in the sample population. However, the thresholds of 5 ng/ml and 7.5 ng/ml had sensitivities of only 55.7% (95% CI: 42.5-68.2%), and 42.6% (30.3-55.9%), respectively. The urine fibrinopeptide B assay at a cut-off of 2.5 ng/ml had a sensitivity of 75.4% for detecting pulmonary embolism. For diagnosis of PE, this sensitivity is comparable to previously published values for the first generation plasma latex and whole blood D-dimer assays (not as well and the D dimer ELISA assay). (more…)