Safety of Outpatient Treatment In Acute Pulmonary Embolism.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3796-3796
Author(s):  
Petra MG Erkens ◽  
Esteban Gandara ◽  
Phil Wells ◽  
Alex Yi-Hao Shen ◽  
Gauruv Bose ◽  
...  

Abstract Abstract 3796 Introduction: Systematic reviews have shown that subcutaneous low molecular weight heparins (LMWH) are at least as safe and effective in the treatment of venous thromboembolism (VTE) as intravenous unfractionated heparin (UFH). LMWH allows patients with VTE to be treated as outpatients. However, patients with pulmonary embolism (PE) are still systematically admitted to the hospital for a few days to avoid potential complications. Physicians are reluctant to discharge patients due to insufficient data supporting the safety of outpatient management of PE. This study evaluates the safety of outpatient treatment of acute PE at the Ottawa Hospital. Methods: This is a retrospective cohort study of consecutive patients presenting at the Ottawa Hospital with acute PE diagnosed between January 1, 2007 and December 31, 2008. PE was defined as an arterial filling defect on CTPA or a high probability V/Q scan. Patients diagnosed with PE during hospitalization, patients with chronic PE and patients in whom anticoagulation treatment was not initiated (e.g. palliative care patients, small clinical non-significant PE) were excluded from the analyses. Patients were managed as outpatients if they were hemodynamically stable, did not require supplemental oxygenation and did not have contraindications to low molecular weight heparin therapy. Results: In this cohort of 473 patients with acute PE, 260 (55.0%) were treated as outpatients and 213 (45.0%) were admitted to the hospital. The majority of the patients were admitted because of severe comorbidities (45.5%) or hypoxia (22.1%).No outpatient died of fatal PE during the 3 month follow-up period. At the end of follow-up, the overall mortality was 5.0% (95% CI: 2.7 to 8.4%). The rates of recurrent venous thromboembolism (VTE) in the outpatient group were 0.4% (95% CI: 0.0 to 2.1%) and 3.8% (95% CI: 1.9 to 7.0%) within 14 days and 3 months, respectively. The rates of major bleeding episodes were 0% (95% CI: 0 to 1.4%) and 1.5% (95% CI: 0.4 to 3.9%) within 14 days and 3 months, respectively. Four (1.5%) outpatients were admitted to hospital within the first 14 days because of progressive shortness of breath and pain, a pre-syncopal episode or heparin induced thrombocytopenia. Conclusion: A majority of patients with acute PE can be managed as outpatients with a low risk of mortality, recurrent VTE and major bleeding episodes. Outpatient treatment in PE is feasible and safe in uncomplicated patients. Disclosures: Rodger: Pfizer: Research Funding; Leo Pharma: Research Funding; Sanofi Aventis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Canadian Institutes of Health Research: Research Funding; Heart and Stroke Foundation: Research Funding.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. LBA-1-LBA-1
Author(s):  
Wendy Zondag ◽  
Inge Mos ◽  
Dina Creemers ◽  
Lidia Hoogerbrugge ◽  
Olaf Dekkers ◽  
...  

Abstract Abstract LBA-1 Introduction: Patients with pulmonary embolism (PE) are initially treated in the hospital with low molecular weight heparin (LMWH). The most recent guideline of the American College of Chest Physicians on Antithrombotic therapy 2008 reports some small studies on outpatient treatment in patients with pulmonary embolism, which suggest outpatient treatment in selected patients with PE is potentially effective and safe but firm recommendations for clinical practice are lacking. Clinicians urgently need reliable, easy-to-use selection criteria for selection of patients with pulmonary embolism eligible for outpatient treatment. Objective: To evaluate the efficacy and safety of outpatient treatment according to predefined criteria (Hestia criteria) in patients with acute PE. Patients and Methods: Open-label, single-arm, multicenter clinical trial of patients with objectively proven acute pulmonary embolism, conducted in twelve hospitals in the Netherlands from 2008 to 2010. Follow-up was completed in September 2010. Patients with acute PE were triaged with the predefined Hestia criteria for eligibility for outpatient treatment starting with therapeutic weight adjusted doses of LMWH (Nadroparin), followed by vitamin K antagonists. All patients eligible for outpatient treatment according to the Hestia criteria, were sent home either immediately or within 24 hours after PE was objectively diagnosed. Outcome: Outpatient treatment was evaluated with respect to recurrent venous thromboembolism (VTE), including PE or deep venous thrombosis (DVT), major haemorrhage and total mortality during initial LMWH treatment and 3 months follow up. We considered outpatient treatment to be effective if the upper limit of the 95% confidence interval of the incidence of recurrent VTE would not exceed 7%. Results: Of 297 included patients, who all completed follow-up, 6 patients (2.0%; 95% confidence interval [CI], 0.8–4.3) had recurrent VTE (5 PE (1.7%), 1 DVT (0.3 %)). Three patients (1.0%, 95% CI 0.2–2.9) died during three months follow-up, but none as a result of fatal PE. One patient died of fatal intracerebral haemorrhage, the other two patients died of progressive malignancy. In addition to the patient with intracranial bleeding, one other patient had a major bleeding event (0.7 %, 95% CI 0.08%-2.4%). Conclusion: Outpatient anticoagulant treatment is effective and safe for patients with pulmonary embolism who have been selected with the Hestia criteria. (Dutch Trial Register NTR1319). Disclosures: Huisman: GSK: Research Funding; Actelion: Research Funding; Bayer: Speakers Bureau; Boehringer Ingelheim: Speakers Bureau; Pfizer: Speakers Bureau.


VASA ◽  
2007 ◽  
Vol 36 (1) ◽  
pp. 17-22
Author(s):  
Schulz ◽  
Kesselring ◽  
Seeberger ◽  
Andresen

Background: Patients admitted to hospital for surgery or acute medical illnesses have a high risk for venous thromboembolism (VTE). Today’s widespread use of low molecular weight heparins (LMWH) for VTE prophylaxis is supposed to have reduced VTE rates substantially. However, data concerning the overall effectiveness of LMWH prophylaxis is sparse. Patients and methods: We prospectively studied all patients with symptomatic and objectively confirmed VTE seen in our hospital over a three year period. Event rates in different wards were analysed and compared. VTE prophylaxis with Enoxaparin was given to all patients at risk during their hospital stay. Results: A total of 50 464 inpatients were treated during the study period. 461 examinations were carried out for symptoms suggestive of VTE and yielded 89 positive results in 85 patients. Seventy eight patients were found to have deep vein thrombosis, 7 had pulmonary embolism, and 4 had both deep venous thrombosis and pulmonary embolism. The overall in hospital VTE event rate was 0.17%. The rate decreased during the study period from 0.22 in year one to 0,16 in year two and 0.13 % in year three. It ranged highest in neurologic and trauma patients (0.32%) and lowest (0.08%) in gynecology-obstetrics. Conclusions: With a simple and strictly applied regimen of prophylaxis with LMWH the overall rate of symptomatic VTE was very low in our hospitalized patients. Beside LMWH prophylaxis, shortening hospital stays and substantial improvements in surgical and anasthesia techniques achieved during the last decades probably play an essential role in decreasing VTE rates.


Vascular ◽  
2020 ◽  
pp. 170853812097114
Author(s):  
Mostafa El Mokadem ◽  
Ahmed Hassan ◽  
Abdulaziz Z Algaby

Objectives Low-molecular weight heparin (LMWH) has been approved for treatment of deep venous thrombosis and venous thromboembolism which are associated with cancer. The efficacy and safety of apixaban in management of acute deep venous thrombosis associated with active malignancy is still an unresolved issue. The aim of our study is to evaluate the efficacy and safety of apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous LMWH. Methods Of 138 randomized patients, 100 patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy were assigned to either oral apixaban therapy or subcutaneous low-molecular weight heparin (enoxaparin) through randomized clinical study in 1:1 ratio. All patients were followed up to six months. The primary end point was major bleeding, while secondary end points were recurrent deep venous thrombosis or venous thromboembolism, minor or non-fatal bleeding and mortality related to massive pulmonary embolism. Results Both groups were matched regarding their baseline demographic, clinical and laboratory characteristics. We had 84 patients with metastatic cancer (stage 4). The most prevalent type of malignancy was cancer colon (42% of cases). There was no significant difference between both groups regarding the incidence of primary and secondary end points. There were no reported mortality cases related to massive pulmonary embolism in both groups. Conclusion In this limited study, there was no difference in the major bleeding, recurrent deep venous thrombosis or minor bleeding in patients with active malignancy when treated with either apixaban or LMWH. Trial registration: ClinicalTrials.gov (NCT04462003). Registered 7 July 2020 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04462003


2000 ◽  
Vol 83 (02) ◽  
pp. 209-211 ◽  
Author(s):  
D. Anderson ◽  
B. Morrow ◽  
L. Gray ◽  
D. Touchie ◽  
P. S. Wells ◽  
...  

SummaryPulmonary embolism is a common complication of deep vein thrombosis. It has been established that low molecular weight heparin may be used to treat deep vein thrombosis or pulmonary embolism and randomized studies have established that outpatient management of deep vein thrombosis with low molecular weight heparin is at least as effective as in-hospital management with unfractionated heparin.This was a prospective cohort study of eligible patients with pulmonary embolism managed as outpatients using dalteparin (200 U/kg s/c daily) for a minimum of five days and warfarin for 3 months. Outpatients included those managed exclusively out of hospital and those managed initially for 1-3 days as inpatients who then completed therapy o out of hospital. Reasons for admission included hemodynamic instability; hypoxia requiring oxygen therapy; admission for another medical reason; severe pain requiring parenteral analgesia or high risk of major bleeding. Patients were followed for three months for clinically apparent recurrent venous thromboembolism and bleeding.Between three teaching hospitals, a total of 158 patients with pulmonary embolism were identified. Fifty patients were managed as inpatients and 108 as outpatients. Of the outpatients, 27 were managed for an average of 2.5 days as inpatients and then completed dalteparin therapy as outpatients. The remaining 81 patients were managed exclusively as outpatients with dalteparin. For all outpatients the overall symptomatic recurrence rate of venous thromboembolism was 5.6% (6/108) with only 1.9% (2/108) major bleeds. There were a total of four deaths with none due to pulmonary embolism or major bleed.This prospective study suggests that outpatient management of pulmonary embolism is feasible and safe for the majority of patients.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2606-2606
Author(s):  
Madhvi Rajpurkar ◽  
Indira Warrier ◽  
Meera Chitlur ◽  
Cynthia Sabo ◽  
Mary Jane Frey ◽  
...  

Abstract Pulmonary embolism (PE) is rare in children and optimal methods for diagnosis, management and treatment for children with PE are unknown. We report a case series of 13 patients (pts) with PE managed at the Thrombosis Treatment Center at Children’s Hospital of Michigan in the last 48 months and discuss their clinical characteristics. Demographics: 13 pts (7 males, 6 females; 6 African - American, 7 Caucasian) were followed for a duration of 1– 43 months (mean 16 months). Average age at presentation was 16.3 years (range 9–29 years; 11 pts were less than 18 years of age). One patient had a previous documented PE but had been lost to follow-up. Average time to diagnosis of PE was 7.7 days (1–21 days) after onset of first symptom. 3 pts diagnosed at the onset of symptoms were in the hospital at the time of the event. 1 patient was diagnosed almost a year after onset of symptoms. 8 patients (61.5%) received treatment for other respiratory illness prior to the accurate diagnosis of PE. All pts were symptomatic and had chest pain (69 %) or dyspnea on exertion (76.9%). Diagnostic Studies: Chest radiography was performed in 10 pts and was abnormal in 7 (70 %). D-Dimer was normal in 30 % of patients. All pts were diagnosed with a spiral CT. Additional clots were present in 10 pts (1 upper extremity, 1 cortical sinus, 2 superior vena caval, 6 lower extremity)and were diagnosed by ultrasonography (2), venography (5), echocardiography (2) and magnetic resonance venography (1). Risk factors: Antithrombin III, protein C and protein S were normal in all patients.1 patient was heterozygous for prothrombin G20210A mutation. None of the pts had Factor V Leiden. Six (46%) pts were heterozygous for the MTHFR C677T mutation but only one had an elevated homocysteine level. Seven (53.8 %) patients were obese. Other risk factors were systemic lupus erythematosus in 2 (15.4 %), ventriculo-atrial shunt in 3 (23.1%), inflammatory bowel disease (IBD) in 2 (23.1%) and immobilization in 4 (30.8 %) patients. No identifiable risk factor was found in one patient. A central venous line was present in one pt (7.7%). Anticardiolipin antibodies were elevated in 23.1 % and lupus anticoagulant was positive in 46.2 % Treatment: Pts received unfractionated heparin (76.9 %), catheter-directed thrombolysis (15.4%) or low molecular weight heparin (7.7 %) as initial treatment. 5 pts (38.4%) had undergone a recent (within 14 days) surgical procedure and could not receive thrombolytic therapy. 11 pts (84.6 %) received low molecular weight heparin (LMWH) and 2 (15.4%) received warfarin as follow-up treatment. 5 pts received therapy for a minimum of 12 months following the episode and none had a recurrence. 8 other pts are still on anticoagulation therapy (mean duration 4.75 months, range1–11 months) and have no recurrence. Therapy was well tolerated in pts treated with LMWH; 1 patient with IBD on warfarin had recurrent gastrointestinal bleeding necessitating blood transfusion. Summary: PE is often missed in children and should be included as a differential diagnosis in pts with chest pain or dyspnea on exertion. As diagnosis is delayed, a normal D-Dimer may not exclude the presence of PE in children. Acquired risk factors appear to play a major role in the pathogenesis of pediatric PE. As in adults, PE in children is often associated with lower extremity venous clots. Specific treatment protocols need to be developed for children with PE as most patients either cannot or do not receive thrombolyis.


1996 ◽  
Vol 75 (02) ◽  
pp. 233-238 ◽  
Author(s):  
M T Nurmohamed ◽  
A M van Riel ◽  
C M A Henkens ◽  
M M W Koopman ◽  
G T H Que ◽  
...  

SummaryPerioperative anticoagulant prophylaxis for postoperative venous thromboembolism (VTE) in neurosurgical patients has not gained wide acceptance due to the fear of intracranial bleeding. Physical methods give a worthwhile reduction of postoperative VTE but there still remains a substantial residual incidence. In other clinical indications, low molecular weight heparins have proven to be effective for prophylaxis of VTE when administered postoperatively, with the advantage of no bleeding enhancement during surgery.Therefore, we performed a multicentre, randomized, double-blind trial in neurosurgical patients to investigate the efficacy and safety of adding a low molecular weight heparin (LMWH), nadroparin, initiated postoperatively, to graduated compression stockings in the prevention of VTE. Deep-vein thrombosis was detected by mandatory venography. Bleeding was determined according to pre-defined objective criteria for major and minor episodes.An adequate bilateral venogram was obtained in 166 of 241 LMWH patients (68.9%) and 179 of 244 control patients (73.4%). A total of 31 of 166 LMWH patients (18.7%) and 47 of 179 control patients (26.3%) had VTE up to Day 10 postoperatively (p = 0.047). The relative risk reduction (RRR) was 28.9%. The rates for proximal deep-vein thrombosis/pulmonary embolism were 6.9% and 11.5% for the two groups, respectively (RRR: 40.2%; p = 0.065).Secondary analyses involved all VTE up to day 56 post-surgery which was detected in 33 patients of 241 in the LMWH group (13.7%) and 51 of 244 control patients (20.9%; RRR 34.5%; p = 0.018). The corresponding percentages for proximal deep-vein thrombosis/pulmonary embolism were 5.8% and 10.2% for the two groups, respectively, giving a RRR of 43.3%; p = 0.036. Major bleeding complications, during the treatment period, occurred in six low molecular weight heparin treated patients (2.5%) and in two control patients (0.8%); p = 0.087.A higher mortality was observed in the low molecular weight heparin group over the 56-day follow-up period (22 versus 10; p = 0.026). However, none of these deaths was judged by a blinded adjudication committee to be related to the study drug.In conclusion, this study demonstrates that the low molecular weight heparin, nadroparin, added to graduated compression stockings results in a clinically significant decrease in VTE without inducing any significant increase of major bleeding.


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