Clinical Investigation
Six-Month Echocardiographic Study in Patients With Submassive Pulmonary Embolism and Right Ventricle Dysfunction: Comparison of Thrombolysis With Heparin

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Abstract

Introduction

The aim of this study was to assess the effect of thrombolysis versus heparin treatment on echocardiographic parameters and clinical outcome, during hospitalization and within the first 180 days after admission, in patients with first episode of submassive pulmonary embolism (SPE) and right ventricle dysfunction (RVD).

Methods

Consecutive patients (age, 18–75 years) with a first episode of SPE, symptoms onset since no more than 6 hours, normal blood pressure (> 100 mm Hg), echocardiographic evidence of RVD and positive lung spiral computed tomography were double-blind randomized: 1 group received 100 mg of alteplase (10-mg bolus, followed by a 90-mg intravenous infusion over a period of 2 hours), while the other group received matching placebo. In addition to alteplase or placebo, both groups received an unfractionated heparin treatment. Echocardiogram was performed at admission, at 24, 48 and 72 hours, at discharge and at 3 and at 6 months after randomization.

Results

Seventy-two patients were included into the study; 37 were assigned to thrombolysis and 35 to placebo. Both groups were well matched with regard to features and clinical presentation. Thrombolysis group showed a significant early improvement of RV function compared with heparin group, and this improvement was observed also during the follow-up (180 days). The same group also showed significant reduction in clinical events during the hospitalization and follow-up.

Conclusions

Our data suggest that, in hemodynamically stable patients with SPE, thrombolysis shows an earliest reduction of RVD and a more favorable trend in clinical outcome, so, it could merit consideration in SPE.

Section snippets

Population

From January 2005 to June 2009, we prospectively studied 72 consecutive patients aged between 18 and 75 years, with a first episode of SPE.

Inclusion Criteria

Patients had to meet all the following criteria: (1) symptoms onset since no more than 6 hours, for first episode of acute SPE; (2) normal blood pressure [systolic blood pressure (SBP) > 100 mm Hg]; (3) RVD at echocardiogram; (4) positive lung spiral computed tomography (CT) and (5) dyspnea, chest pain, tachypnea, hypoxemia PO2 75 mm Hg, PCO2 < 40 mm Hg,

RESULTS

Of the 2318 patients admitted to hospital within 6 hours from onset of sudden acute dyspnea, 1025 were patients with acute coronary syndrome (ST segment elevation myocardial infarction or non ST segment elevation myocardial infarction), 368 with severe chronic obstructive pulmonary disease, 761 with acute heart failure, 7 with recent intracranial bleeding, 5 had recent ischemic stroke (< 2 months), 4 had recent surgery (< 10 days), 6 had hemorrhagic disorder with thrombocytopenia (< 100,000), 9

DISCUSSION

Overall, the study shows the feasibility of thrombolysis treatment in patients with acute SPE and does not raise safety concerns. Moreover, this study suggests that thrombolysis could be used in patients with acute SPE. Our study suggests that thrombolysis is more effective than heparin in obtaining an early reduction of RVD in hemodynamically stable patients with acute SPE with subsequent beneficial effects in the 180-day follow-up. Probably, the beneficial effects in RVD observed may have

CONCLUSIONS

Our data suggest that, in hemodynamically stable patients with SPE, thrombolysis is associated with a more rapid reduction of RVD and this reduction shows a favorable trend in clinical outcome; however, this effect is still to be defined. The echocardiographic data of RVD might have important prognostic implications and might affect the choice of therapy. We believe that thrombolytic treatment in patients who show RVD should merit consideration and the analysis of RV function would be

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