Author Interviews, Clots - Coagulation, NEJM, Thromboembolism / 02.04.2019 Interview with: Yaseen M. Arabi, M.D Intensive Care Department Ministry of National Guard Health Affairs Riyadh, Saudi Arabia 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 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 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. 
Annals Internal Medicine, Author Interviews, Blood Clots, Emergency Care, Kaiser Permanente, Pulmonary Disease, UC Davis / 13.11.2018 Interview with: David R. Vinson, MD Department of Emergency Medicine Kaiser Permanente Sacramento Medical Center Sacramento, CA 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, JAMA, Thromboembolism, University of Michigan / 31.05.2018 Interview with: Paul Grant, MD Associate Professor of Medicine Associate Chief Medical Information Officer Director, Perioperative and Consultative Medicine Division of Hospital Medicine Department of Internal Medicine Michigan Medicine University of Michigan What is the background for this study? What are the main findings? Response: It is well known that hospitalized medical patients are at risk for venous thromboembolism VTE, but the severity of patient risk can vary significantly. National guidelines have consistently stated that low-risk patients should not receive VTE prophylaxis beyond early ambulation. In this retrospective cohort study, we analyzed data from 52 hospitals participating in the Michigan Hospital Medicine Safety consortium. Trained medical record abstractors at each hospital collected data from 44,775 medical patients including VTE risk factors, type of VTE prophylaxis administered, and contraindications to pharmacologic prophylaxis. Individual patient risk of VTE was determined using the Padua risk assessment model. Of the 32,549 low-risk patients, 77.9% received excess venous thromboembolism prophylaxis as either pharmacologic prophylaxis (30.6%), mechanical prophylaxis (20.8%), or both (26.5%). In the 12,226 high-risk patients, VTE prophylaxis was underused in 22% of patients. The rates of inappropriate prophylaxis varied considerably by hospital.  (more…)
Author Interviews, Neurological Disorders, Pulmonary Disease / 24.10.2016 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 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, Blood Clots, CHEST, OBGYNE, Surgical Research, Thromboembolism / 27.09.2016 Interview with: Marc Blondon, MD Division of Angiology and Hemostasis, Department of Specialties of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland Seattle Epidemiologic Research and Information Center, Department of Veterans Affairs Office of Research and Development, Seattle, WA What is the background for this study? What are the main findings? Response: Venous thromboembolism, a condition including deep vein thrombosis (blood clots) and pulmonary embolism, is more common in older than younger patients. However, pregnancy and particularly the postpartum period are times at greater risk of blood clots in women. It is important to understand the risk and the risk factors for thrombosis in the postpartum period to guide the use of preventive measures such as heparin, an anticoagulant treatment, or leg compression devices. Our study summarizes the evidence on the link between C-sections and blood clots from the past 35 years. Our meta-analysis demonstrates that:
  • C-section carries a 4-fold increased risk of blood clots in the postpartum period, compared with vaginal deliveries ;
  • that this risk is most prominent but not restricted to emergency C-section ;
  • and that women who undergo elective C-section are also at higher risk than women who have a vaginal delivery.
  • Importantly, we estimated an absolute risk of blood clots after a C-section of 2-4 per 1000 pregnancies: on average, 3 out of 1000 women after C-section will develop a blood clot.
Author Interviews, CHEST, Clots - Coagulation / 13.07.2015 Interview with: David Jimenez PhD, FCCP Respiratory Department and Medicine Department Ramon y Cajal Hospital IRYCIS, and Alcala de Henares University Madrid Spain Medical Research: What is the background for this study? What are the main findings? Dr. Jimenez: Normotensive patients that have an estimated high-risk for pulmonary embolism (PE)-related complications (i.e., intermediate-risk PE) might benefit from surveillance in an intensive care setting or from the administration of specific advanced therapy. The Bova score was developed for identifying these patients. This study confirms the validity and reproducibility of the Bova score. (more…)
Author Interviews, CHEST, Critical Care - Intensive Care - ICUs, Thromboembolism / 10.07.2014

Dr. Colin Cooke MD, MSc, MS Assistant Professor, Department of Internal Medicine University of Michigan Center for Healthcare Outcomes and Policy Ann Arbor, Interview with: Dr. Colin Cooke MD, MSc, MS Assistant Professor, Department of Internal Medicine University of Michigan Center for Healthcare Outcomes and Policy Ann Arbor, MI Medical Research: What are the main findings of the study? Dr. Cooke: We determined that when patients who are hospitalized for pulmonary embolism (PE), a blood clot in the lung, approximately 1 in 5 will be admitted to an intensive care unit (ICU). However, the chances that a patient will go to an ICU is highly dependent upon which hospital they are admitted to. For example, some hospitals admitted only 3% of patients with pulmonary embolism to an ICU while others admitted almost 80%. Importantly, the differences in how hospitals use their ICU for patients with pulmonary embolism was not entirely related to the patient’s need for life support measures, the things that the ICU is designed to deliver. For example, the ICU patients in high ICU-use hospitals tended to receive fewer procedures, including mechanical ventilation, arterial catheterization, central lines, and medications to dissolve blood clots. This suggest that high utilizing hospitals are admitting patients to the ICU with weaker indications for ICU admission. (more…)
Author Interviews, Cancer, Thromboembolism / 07.07.2014 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…)
Author Interviews, JAMA, Thromboembolism / 17.06.2014

Jay Giri, MD MPH Assistant Professor, Perelman School of Medicine Director, Peripheral Intervention Interventional Cardiology & Vascular Medicine Cardiovascular Division University of PennsylvaniaMedicalResearch Interview with: Jay Giri, MD MPH Assistant Professor, Perelman School of Medicine Director, Peripheral Intervention Interventional Cardiology & Vascular Medicine Cardiovascular Division University of Pennsylvania MedicalResearch: What are the main findings of the study? Dr. Giri: Use of thrombolytics was associated with lower all-cause mortality and increased rates of intracranial hemorrhage.  These results were also seen in intermediate-risk pulmonary embolism.  Finally, it appeared that patients under age 65 might be at less bleeding risk from thrombolytics. (more…)
Blood Clots, General Medicine, UCSD / 19.05.2014 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…)
Author Interviews, Blood Clots, CHEST / 18.05.2014

Scott C. Woller, MD Co-Director Thrombosis Program Intermountain Medical Center Associate Professor of Internal Medicine University of Utah School of Medicine Murray, UT Interview with Scott C. Woller, MD Co-Director Thrombosis Program Intermountain Medical Center Associate Professor of Internal Medicine University of Utah School of Medicine Murray, UT 84157-7000 Dr. Woller: By way of background, D-dimer, a simple blood test that is used to investigate the diagnosis of suspected pulmonary embolism (PE), and it increases with age.  Recent research suggests that the use of an age-adjusted d-dimer threshold may improve diagnostic efficiency without compromising safety. We wished to assess the safety of using an age-adjusted d-dimer threshold in the work-up of patients with suspected pulmonary embolism. MedicalResearch:  What are the main findings of the study? Dr. Woller: In this retrospective cohort study we identified 923 patients age > 50 years who presented to our emergency department with suspected pulmonary embolism, and had their pretest probability of PE calculated along with a d-dimer performed. All patients underwent computed tomography pulmonary angiography (CTPA). We observed that among patients unlikely to have PE, adoption of an age-adjusted D-dimer cut-off (compared with a conventional D-dimer cut-off) reduced the need for CTPA in an additional 18.3% of patients, and was associated with a low 90-day rate of failure to diagnose PE. (more…)
Author Interviews, Biomarkers, JAMA, Thromboembolism / 19.03.2014

Marc Righini, MD Division of Angiology and Hemostasis Geneva University Hospital, Geneva, SwitzerlandMedical Interview with: Marc Righini, MD Division of Angiology and Hemostasis Geneva University Hospital, Geneva, Switzerland What are the main findings of this study? Dr. Righini: The study shows that when compared with a fixed D-Dimer cutoff of 500 ng/ml, the combination of pretest clinical probability assessment with age-adjusted D-dimer cut-off was associated  with a larger number of patients in whom Pulmonary Embolism  could be excluded, with a low likelihood of recurrent VTE. The benefit was the most important in patients  75 years or older, in whom using the age-adjusted cutoff instead of the 500 ng/ml cutoff increased five-fold the proportion of patients in whom PE could be excluded on the basis of D-dimer measurement. (more…)