Atrial septostomy in patients with end-stage pulmonary hypertension. No more needles but wires, energy and close anatomical definition.

OBJECTIVES: To assess the usefulness of a new approach to atrial septal puncture and septostomy in patients with end-stage pulmonary hypertension. BACKGROUND: Atrial septostomy in end-stage pulmonary hypertension has high mortality and morbidity rates mainly due to trans-septal catheterization. New approaches to safety during this technical step are expected. METHODS: Twelve patients with end-stage pulmonary arterial hypertension (5 males, 7 females, mean age 41, 9 ± 12, 0 years) underwent to balloon atrial septostomy. Intracardiac echography (ICE) was used to localize fossa ovalis while a radiofrequency wire was used to perforate the atrial septum. Then a septostomy was performed by progressive balloon dilatation of atrial septum. Septal perforation was successful at the first attempt in 4 patients and after 5 attempts in a single case, while Bas was successful in all. RESULTS: Pericardial effusion did not develop in any patient. Complications consisted in transient supraventricular tachyarrhythmia, transient cerebral ischemia and severe hypoxemia with ventricular tachycardia in 3 single patients. In-procedure death rate was 0%. Systemic cardiac output increased immediately, while systemic O2 saturation decreased significantly in all. Mean follow-up was 8, 2 ± 3, 8 months. Mortality was 16.6% (2 patients). NYHA class improved in the rest of patients. Four patients (33.2%) underwent to pulmonary transplant successfully. CONCLUSIONS: This novel approach for trans-septal catheterization has shown very low rate of major complication during atrial septostomy in patients with end-stage pulmonary arterial hypertension.

Left main coronary in-stent intimal hyperplasia and hemodynamics as detected by contrast-enhanced transesophageal echocardiography.

PATIENTS AND METHODS: In-stent hemodynamics were studied by transesophageal echocardiography (TEE) in a group of 54 patients after left main coronary artery stenting, during a 6-month follow-up. TEE was performed within 24 hours after stenting and at 1- and 3-month follow-up. Pulsed wave and color Doppler signals were enhanced by IV administration of Levovist. RESULTS: Angiographic immediate success was obtained in all patients. No in-hospital death occurred. Ten patients (18.4%) complained of recurrent angina at the follow-up of 4.8 ± 1.2 months. Both TEE and coronary angiography confirmed in-stent restenosis in all. Thirty-nine patients (68.5%) remained symptoms free. Mean late loss in these patients was 0.69 ± 0.20 mm. A linear significant positive relation between mean late loss values and diastolic coronary velocity (r: 0.89, P < 0.001) was found. After 3- and 6-month follow-up, PDV showed a significant increase in comparison with basal values (0.7 ± 0.3 and 0.6 ± 0.26 vs. 0.32 ± 0.2 cm/sec, P < 0.01). All patients with restenosis showed a significant increase of diastolic coronary velocity in comparison with basal values (2.89 ± 0.25 cm/sec, P < 0.001). CONCLUSION: TEE can predict the development of in-stent intimal hyperplasia in patients with unprotected left main coronary artery stenting.

Tamponade following breast augmentation.

Breast augmentation is one of most commonly performed cosmetic surgical procedures. Pneumothorax has been reported as a rare complication of breast augmentation but the incidence is not known. Our patient presented with dyspnea on exertion about 6 days following breast augmentation. She was found to have cardiac tamponade and pneumothorax. We present a case of cardiac tamponade following breast augmentation, a previously unreported complication.

Endovascular treatment of a symptomatic carotid artery aneurysm with a stent graft.

Endovascular methods have become more widespread and offer an alternative to surgery, which is often difficult in case of a hostile neck resulting from radiotherapy. Carotid pseudoaneurysm after laryngectomy is a very uncommon complication. We report a case of symptomatic carotid artery pseudoaneurysm treated using a stent graft.

Culotte bifurcation stenting with paclitaxel drug-eluting stent.

The results of using the culotte bifurcation technique have not been promising with regard to bare metal stents; however, some possible advantages with regard to drug-eluting stents (DES) must be taken into account, such as the possibility to stent provisionally, to use lower French sizes, and to completely cover the coronary wall and the new carina with a single or double stent layer. The crush technique, which aims to reach a complete coverage of the coronary wall to allow antiproliferative drugs to homogeneously distribute into the coronary walls, has been introduced. The culotte technique seems to act more physiologically, allowing the creation of a new, homogeneously covered carina, without any crushed metal inside the coronary wall. We present the case of a coronary bifurcation treated with the use of the culotte technique and paclitaxel-eluting stent deployment, with good angiographic results after 10 months of follow-up. Further data are needed to evaluate the potential utility of the culotte technique in treating bifurcation coronary lesions in the area of DES.

Downstream administration of a high-dose tirofiban bolus in high-risk patients with unstable angina undergoing early percutaneous coronary intervention.

BACKGROUND: The best treatment option for high-risk patients with unstable coronary syndrome is an early invasive strategy accompanied by intensive anti-platelet therapy. We tested the effect on clinical outcome of early coronary angioplasty using a high-dose bolus of tirofiban in patients with non-ST segment elevation acute coronary syndrome. METHODS: One hundred and forty consecutive patients with unstable coronary syndrome who underwent an immediate percutaneous coronary intervention with the administration of a high (25 microg/kg) dose bolus of tirofiban followed by an 18-h infusion of 0.15 microg kg(-1) min(-1) were compared with a matched control group of 162 patients treated with abciximab. The primary endpoint of the study was the 30-day incidence of major adverse cardiac events; the secondary endpoints were the incidence of major and minor bleeding. RESULTS: The time from admission to PCI was slightly shorter in the tirofiban group (3.9+/-4.8 vs. 4.5+/-4.4 h; P=0.26). The 30-day rate of major adverse cardiac events was similar in the two groups (6% with tirofiban and 8.6% with abciximab: OR=1.37, 95% CI=0.58-3.29, P=0.52). No major bleeding episodes were observed; the incidence of minor bleeding was 3.6% in the tirofiban group and 2.5% in the abciximab group (OR=0.68, 95% CI=0.18-2.59, P=0.74). CONCLUSIONS: In this preliminary study, the beneficial effect of the administration of a high-dose tirofiban bolus on 30-day clinical outcomes was similar to that of abciximab in high-risk patients with unstable angina undergoing immediate percutaneous coronary intervention. The results of this therapeutic strategy should be tested in a larger randomised study.

Simultaneous double-culprit in-stent thrombosis. Who is the guilty prisoner behind bars: drug-eluting stent, bare-metal stent, or indication for treatment?

BACKGROUND: The intrinsic thrombogeneity of stents was the historic limitation to their usage during the early phases of stenting. The risk of stent thrombosis has been minimized by the widespread use of platelet antiaggregation. Nowadays, the risk of subacute stent thrombosis is around 1%. Thrombotic risk depends on several factors, such as type of stent, complexity of lesion, and clinical picture. CASE REPORT: We present a case of recurrent acute in-stent thrombosis in a patient with mild antithrombin III (AT) deficiency despite the combined administration of clopidogrel and aspirin. CONCLUSION: In our patient, several factors, such as diabetes, AT deficiency, and the use of a paclitaxel-eluting stent, have contributed to the development of recurrent acute stent thrombosis. Although we were not able to identify the culprit factor, we should keep in mind that the deployment of a drug-eluting stent could be unsafe if it is not supported by a clear clinically oriented pathway that considers the overall condition of the patient since, in some cases, neither coronary lesions nor coronary stents are responsible for the negative outcome of patient therapy, which may be caused instead by incomplete or inadequate patient assessment.

Endovascular treatment of a symptomatic aneurysm of the left subclavian artery.

Upper extremity ischemia is a rare entity usually due to emboli of arterial origin. Such thromboemboli produce acute symptoms of sufficient severity as to necessitate early surgical intervention. We report the case of a patient with severe ischemia in his left hand, in whom the embolic source was a mural thrombus localized at the level of a saccular aneurysm of the subclavian artery. After having excluded the presence of a thoracic outlet syndrome, the lesion was successfully treated by means of percutaneous implantation of a stent graft with the exclusion of the aneurysm and the sealing of the thrombus.

Compression repair versus low-dose thrombin injection for the treatment of iatrogenic femoral pseudoaneurysm: a retrospective case-control study.

BACKGROUND: It has been shown that thrombin injection is a safe and effective technique for the treatment of iatrogenic femoral pseudoaneurysm. The aim of this study was to evaluate and compare the use of ultrasound-guided low-dose thrombin injections with ultrasonographically-guided compression repair in the treatment of iatrogenic femoral arterial pseudoaneurysm. METHODS: We compared two cohorts of patients treated for iatrogenic femoral pseudoaneurysm: the first included 38 patients who underwent ultrasonographically-guided compression repair as a first-step approach between January 1998 and November 2002; the second included 21 patients treated with ultrasound-guided low-dose thrombin injection between December 2002 and December 2003. RESULTS: Both groups had similar demographic characteristics and aneurysm sizes (p = 0.72). Compression was successful in 24/38 patients (63%); the 14 persistent aneurysms were surgically repaired (37%). The primary thrombin injection of a mean dose of 185+/-95 U/ml (range 100-400 U/ml) successfully obliterated all of the 21 pseudoaneurysms (success rate 100 vs 63% in the compression group, p = 0.004). Thrombosis occurred within an average of 12+/-15 s of thrombin injection. Sedation was used in 42% of the patients undergoing compression and in none of those receiving thrombin (p = 0.001). The duration of hospitalization was significantly longer in patients undergoing compression therapy (9.8+/-5.6 vs 5.6+/-1.4 days, p = 0.001). CONCLUSIONS: Ultrasound-guided low-dose thrombin injection appears to be more effective in reducing the need for surgical repair when used to treat iatrogenic femoral pseudoaneurysm, is better tolerated by the patients, and requires a shorter hospital stay.

Computational fluid dynamics simulation to evaluate aortic coarctation gradient with contrast-enhanced CT.

Coarctation of aorta (CoA) is a narrowing of the aorta leading to a pressure gradient (ΔP) across the coarctation, increased afterload and reduced peripheral perfusion pressures. Indication to invasive treatment is based on values of maximal (systolic) trans-coarctation ΔP. A computational fluid dynamic (CFD) approach is herein presented for the non-invasive haemodynamic assessment of ΔP across CoA. Patient-specific CFD simulations were created from contrast-enhanced computed tomography (CT) and appropriate flow boundary conditions. Computed ΔP was validated with invasive intravascular trans-CoA pressure measurements. Haemodynamic indices, including pressure loss coefficient (PLc), time-averaged wall shear stress (TAWSS) and oscillatory shear index (OSI), were also quantified. CFD-estimated ΔP values were comparable to the invasive ones. Moreover, the aorta proximal to CoA was exposed to altered TAWSS and OSI suggesting hypertension. PLc was found as a further geometric marker of CoA severity. Finally, CFD-estimated ΔP confirmed a significant reduction after percutaneous balloon dilatation and stenting of the CoA in one patient (e.g. from ΔP∼52 mmHg to ΔP∼3 mmHg). The validation of the ΔP computations with catheterisation measurements suggests that CFD simulation, based on CT-derived anatomical data, is a useful tool to readily quantify CoA severity.

Abciximab improves 6-month clinical outcome after rescue coronary angioplasty.

BACKGROUND: Few data are available concerning the effects on clinical outcome and left ventricular function of abciximab administration in patients undergoing rescue percutaneous transluminal coronary angioplasty (PTCA) after failed thrombolysis for acute myocardial infarction. The aim of the study was to investigate such effects. METHODS: Eighty-nine consecutive patients referred to our laboratory from other hospitals for rescue PTCA within 24 hours from the onset of chest pain were prospectively randomized before the procedure to abciximab treatment (44 patients) or placebo (45 patients). No significant differences in baseline characteristics were observed between the 2 groups. Study end points were the occurrence of major adverse cardiac events (MACE) such as death, reinfarction, congestive heart failure, target lesion revascularization, or recurrent ischemia at 30-day and 6-month follow-up and the occurrence of periprocedural bleeding. RESULTS: Mean time from symptom onset to reperfusion was 8.5 +/-5.4 hours; rescue PTCA was successful in 96% of patients. The incidence of major, moderate, and minor bleeding was similar in the 2 groups. At 30-day follow-up, the echocardiographic left ventricular wall motion score index showed a significantly higher improvement in the abciximab group versus the placebo group (P <.001). At 6-month follow-up, the incidence of MACE was 11% in the abciximab group versus 38% in the placebo group (P =.004). Abciximab administration (P =.003) and cardiogenic shock (P =.005) were the only independent predictors of the occurrence of MACE at multivariable analysis. CONCLUSION: Treatment with abciximab during rescue PTCA positively affects clinical outcome at 6-month follow-up without increasing periprocedural bleeding.

Effect of hypnotic sedation during percutaneous transluminal coronary angioplasty on myocardial ischemia and cardiac sympathetic drive.

Forty-six patients were randomized to receive drug (group 1) or hypnotic sedation (group 2) during percutaneous transluminal coronary angioplasty of the left anterior descending coronary artery. Intracoronary and standard electrocardiograms were continuously registered, and heart rate spectral variability was studied. Normalized units of low- and high-frequency components and the ratio of low to high frequency were measured during balloon inflations. The ST segment shifted at the first balloon inflation from 0.02 +/- 0.01 to 0.09 +/- 0.6 mm in group 1 and from 0.02 +/- 0.08 to 0.1 +/- 0.6 in group 2 mm (p <0.05). In group 1, the low-frequency band and the ratio of low to high frequency increased significantly during the first balloon inflation (from 59 +/- 10 to 75 +/- 10 normalized units and from 2.4 +/- 1.4 to 7.3 +/- 4.7, respectively; p <0.001). The increase of the ratio of low to high frequency was significantly related to ST shift (r = 0.706; p <0.01). In contrast, no significant variation of spectral parameters was found in group 2. The increase in cardiac sympathetic activity associated with balloon inflation and myocardial ischemia during percutaneous transluminal coronary angioplasty of the left anterior descending coronary artery was selectively eliminated by hypnosis but not by drug sedation.

Comparison in patients having primary coronary angioplasty of abciximab versus tirofiban on recovery of left ventricular function.

In patients treated with primary coronary angioplasty, the use of abciximab improves microvascular perfusion and enhances the recovery of contractile function. This study compared the effects of the new dose regimen of tirofiban (25-microg/kg bolus followed by an 18-hour infusion at 0.15 microg/kg/min) on left ventricular function with those of abciximab in patients who underwent direct angioplasty. One hundred patients who underwent primary coronary angioplasty were randomized to receive a standard dose of abciximab or a large-dose bolus of tirofiban. The primary end point of the study was change in the infarct-zone wall motion score index between the initial and 30-day follow-up echocardiographic studies. The secondary end points were procedural evaluations before and after Thrombolysis In Myocardial Infarction (TIMI) grade flow, TIMI grade myocardial perfusion, and corrected TIMI frame count. Baseline global and regional ventricular functions were similar in the 2 treatment groups. After the procedure, a TIMI grade 3 flow was obtained in 86% of patients treated with abciximab and 88% of those receiving tirofiban (p = 1.0), whereas TIMI grade 3 myocardial perfusion was present in 70% and 76%, respectively (p = 0.65); corrected TIMI frame count was 22.5 +/- 1.9 and 22.1 +/- 2.5 (p = 0.37). After 30 days, we obtained 87 paired echocardiographic studies. The infarct-zone wall motion score index decreased from 2.20 +/- 0.3 to 1.99 +/- 0.2 in the abciximab group and from 2.18 +/- 0.3 to 1.95 +/- 0.3 in the tirofiban group (p = 0.67). Thus, in patients who had primary coronary angioplasty, abciximab, and the large-dose bolus of tirofiban showed similar effects on the initial angiographic results and 30-day recovery of left ventricular function.

Preliminary experience with a high bolus dose of tirofiban during percutaneous coronary intervention.

BACKGROUND: In the TARGET study, sub-optimal platelet inhibition with tirofiban was held responsible for the higher incidence of periprocedural CK-MB release compared to abciximab. Since then, a new, higher bolus dose of tirofiban has been proposed to increase blood concentrations very soon after the start of treatment. OBJECTIVE: The aim of this study was to explore the bleeding risk and clinical outcome at 30 days in a series of patients undergoing percutaneous coronary intervention (PCI) with the new dosing regimen of tirofiban (25 microg/kg bolus followed by a 0.15 microg kg(-1) min(-1) infusion for 18 h). METHODS: A total of 133 consecutive patients underwent a PCI and received a high bolus dose of tirofiban. Platelet function inhibition was measured using the Ultegra RPFA (Accumetrics) 10 min and 8 and 24 h after the start of therapy in the first 38 cases. RESULTS: The procedural success rate was 98.5%. The mean level of platelet inhibition 10 min after the start of therapy was 94.7 +/- 5.9%. No major bleedings, no need for red blood cell transfusion and no episodes of severe thrombocytopoenia were recorded. Groin haematoma was observed in seven patients (5.3%). The cumulative incidence of 30-day major adverse cardiovascular events was 4.6% (five myocardial infarctions and one repeat PTCA for sub-acute stent thrombosis). CONCLUSIONS: The use of a high bolus dose of tirofiban in patients undergoing PCI seems to be safe and not associated with an increased risk of major bleeding. This high bolus dose may help to further reduce the rate of periprocedural adverse events.

Six-month clinical and angiographic outcomes of the Tecnic Carbostent coronary system: the phantom IV study.

The aim of this multicenter, prospective, non-randomized study was to examine the procedural, in-hospital, and mid-term clinical and angiographic outcome of patients undergoing coronary angioplasty with the Tecnic Carbostent system. Between October 2001 and March 2002, 123 consecutive patients were treated with coronary implantation of the Tecnic Carbostent. Stable angina (54%), unstable angina (37%) and silent ischemia (9%) were clinical indications for revascularisation. The baseline lesion morphology was complex (Type B2 or C) in 59% of the cases, and the mean lesion length was 15+/-8 mm. A total of 179 stents were implanted in 149 lesions. The procedural success rate was 100%. Mean percent diameter of the stenosis decreased after the intervention from 75%+/-11% to 8%+/-4%. The mean cross-sectional area stent recoil was 8.8%+/-7.3%. No in-hospital or 30-day major adverse cardiac events were observed. During the 6-month follow-up period, there were no deaths or myocardial infarctions, whereas the incidence of target lesion revascularisation was 12.7%. The angiographic restenosis rate was 14.1%: a focal or limited pattern (class I or II) was found in 83% of cases, whereas the remaining 17% had a proliferative morphology (class III or IV). In conclusion, this study indicates that a good clinical and angiographic outcome may be obtained with the Tecnic Carbostent coronary system in consecutive patients with de novo coronary lesions.

[Coronary angioplasty in women: risk factors and sex-related differences in coronary anatomy evaluated with intravascular ultrasonography]. / L'angioplastica coronarica nella donna: fattori di rischio e differenze dell'anatomia coronarica legate al sesso valutate con ecografia intravascolare.

BACKGROUND: The aim of this study was to evaluate the risk factors for cardiovascular diseases, clinical presentation and coronary anatomical size differences in women. METHODS: From January 1999 to December 2000, 244 female and 980 male patients were submitted to coronary angioplasty (PTCA). For both groups the following were considered: risk factors for cardiovascular diseases, clinical presentation and angiographic data. The clinically confirmed 6 months restenoses were evaluated. We performed intravascular ultrasound (IVUS) with three-dimensional reconstruction and quantitative coronary angiography (QCA) on the proximal left anterior descending (LAD) coronary artery segments free of significant atherosclerosis in 60 men and 50 women matched for age and clinical characteristics. The arterial and luminal areas were measured by planimetry and corrected for body surface area. We also evaluated the external elastic membrane diameter (EEMd), the minimal lumen diameter (MLD) and the intima-media thickness (IMT). RESULTS: At the time of admission, women were older than men, were shorter, weighed less, and had a smaller body surface area; they had more severe angina, diabetes mellitus and hypercholesterolemia. There was no difference between women and men in the incidence of clinical restenosis at 6 months of follow-up. At IVUS, the mean uncorrected LAD arterial area was smaller in women than in men (12.7 +/- 3 vs 15.9 +/- 3.3 mm2, p < 0.05), as was the mean LAD luminal area (9.9 +/- 3 vs 12.9 +/- 2.7 mm2, p < 0.005). Both the MLD and the EEMd as well as the IMT were smaller in women than in men (MLD 3.3 +/- 0.6 vs 3.9 +/- 0.5 mm, p < 0.05; EEMd 3.7 +/- 0.6 vs 4.2 +/- 0.4 mm, p < 0.005; IMT 0.29 +/- 0.1 vs 0.4 +/- 0.1 mm, p < 0.05). QCA confirmed the IVUS results (MLD 2.9 +/- 0.6 vs 3.5 +/- 0.8 mm, p < 0.05). After correction for body surface area, univariate associations between sex and both the arterial and luminal areas were no longer present. CONCLUSIONS: Women submitted to PTCA were older. The incidence of hypertension, diabetes mellitus and hypercholesterolemia was higher than in men. There was no sex difference in the rate of clinical restenosis at 6 months of follow-up. The LAD artery is smaller in women, independently of body size. This suggests an intrinsic sex effect on coronary dimensions.

The new patent foramen ovale occluder FIGULLA in complex septal anatomy: a case series.

BACKGROUND: The appropriate treatment strategy for secondary stroke prevention in patients with cryptogenic stroke and patent foramen ovale (PFO) remains challenging. The aim of this study was to describe a case series of patients with PFO and complex septal anatomy who underwent percutaneous correction using a FIGULLA (Occlutech) septal occluder (FSO). PATIENTS: Ten consecutive patients (6 females, 4 males, mean age 41.6 ± 16.0 years, range 17-52 years; group 1) with cryptogenetic stroke and/or transient cerebral ischemia and complex septal anatomy, as defined by intraprocedural transesophageal echocardiogram (TEE) were compared with a group of 25 patients (10 females, 15 males, mean age 43.7 ± 12.3 years; group 2) with usual tunnel-like PFO anatomy in whom PFO was closed by an Amplatzer septal occluder (ASO; AGA). RESULTS: No significant differences were noted between group 1 and group 2 for immediate success rate, residual intraprosthetic shunt at the end of the procedure, discharge, 1, 6 and 12 months follow up, number of attempts, procedure time, fluoroscopy time, or cardiac complication (atrial arrhythmias, device embolism). The only significant difference was shown for delivery sheath size (11 ± 2 versus 9 ± 1 F) and incidence of local hematoma (30% versus 12%) between group 1 and group 2, without any clinical consequence (need of transfusion) or increase in length of stay. CONCLUSION: FSO shows high performance in patients with PFO and complex septal anatomy when compared with patients with PFO and uncomplicated atrial anatomy treated by ASO. Its favorable behavior is probably related to fabric features such as the total amount of metal and the presence of titanium.

Haemodynamic predictors of a penetrating atherosclerotic ulcer rupture using fluid-structure interaction analysis.

We present preliminary data on the flow-induced haemodynamic and structural loads exerted on a penetrating atherosclerotic aortic ulcer (PAU). Specifically, one-way fluid-structure interaction analysis was performed on the aortic model reconstructed from a 66-year-old male patient with a PAU that evolved into an intramural haematoma and rupture of the thoracic aorta. The results show that elevated blood pressure (117 mmHg) and low flow velocity at the aortic wall (0.15 m/s(2)) occurred in the region of the PAU. We also found a low value of time-averaged wall shear stress (1.24 N/m(2)) and a high value of the temporal oscillation in the wall shear stress (oscillatory shear index = 0.13) in the region of the PAU. After endovascular treatment, these haemodynamic parameters were distributed uniformly on the luminal surface of the stent graft. These findings suggest that wall shear stress could be considered one of the major haemodynamic factors indicating the structural fragility of the PAU wall, which ultimately lead to PAU growth and rupture.

Can learning to interpret pump messages help lead to an early diagnosis of HeartWare ventricular assist device thrombosis?

Left ventricular assist device thrombosis is a detrimental complication that, if not properly diagnosed and treated, can lead to low output syndrome and death. When ongoing thrombus formation is caused by inappropriate anticoagulation, timely identification is possible, and could perhaps be the key to successful treatment.

Six-month echocardiographic study in patients with submassive pulmonary embolism and right ventricle dysfunction: comparison of thrombolysis with heparin.

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.