[show abstract][hide abstract] ABSTRACT: This study sought to test the hypothesis that thrombus removal, with a new manual thrombus-aspirating device, before primary percutaneous coronary intervention (PPCI) may improve myocardial reperfusion compared with standard PPCI in patients with ST-segment elevation acute myocardial infarction (STEMI).
In STEMI patients, PPCI may cause thrombus dislodgment and impaired microcirculatory reperfusion. Controversial results have been reported with different systems of distal protection or thrombus removal.
One-hundred forty-eight consecutive STEMI patients, admitted within 12 h of symptom onset and scheduled for PPCI, were randomly assigned to PPCI (group 1) or manual thrombus aspiration before standard PPCI (group 2). Patients with cardiogenic shock, previous infarction, or thrombolytic therapy were excluded. Primary end points were complete (>70%) ST-segment resolution (STR) and myocardial blush grade (MBG) 3.
Baseline clinical and angiographic characteristics were similar in the 2 groups. Comparing groups 1 and 2: complete STR 50% versus 68% (p < 0.05); MBG-3 44% versus 88% (p < 0.0001); coronary Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 78% versus 89% (p = NS); corrected TIMI frame count 21.5 +/- 12 versus 17.3 +/- 6 (p < 0.01); no reflow 15% versus 3% (p < 0.05); angiographic embolization 19% versus 5% (p < 0.05); direct stenting 24% versus 70% (p < 0.0001); and peak creatine kinase-mass band fraction 910 +/- 128 mug/l versus 790 +/- 132 mug/l (p < 0001). In-hospital clinical events were similar in the 2 groups. After adjusting for confounding factors, multivariate analysis showed thrombus aspiration to be an independent predictor of complete STR and MBG-3.
Manual thrombus aspiration before PPCI leads to better myocardial reperfusion and is associated with lower creatine kinase mass band fraction release, lower risk of distal embolization, and no reflow compared with standard PPCI. (Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction; http://clinicaltrials.gov/ct/show/NCT00257153).
Journal of the American College of Cardiology 11/2006; 48(8):1552-9. · 14.09 Impact Factor
[show abstract][hide abstract] ABSTRACT: The incidence of late severe heart failure after primary angioplasty is not clear and few data are available about the clinical prognostic predictors of this event. The aims of our study were a) to evaluate the incidence of cardiac death and heart failure after an extensive acute myocardial infarction treated with primary angioplasty, and b) to identify, among clinical, ECG, functional, and angiographic variables, the outcome predictors and their incremental prognostic value.
Two hundred and thirty-three patients with ST-segment elevation in > or = 4 leads, without cardiogenic shock, underwent primary angioplasty within 12 hours of symptom onset and were prospectively followed up for a median of 21 months for the combined endpoint of cardiac death and heart failure. The effects of clinical, ECG, functional, and angiographic data on the combined endpoint were evaluated using Cox's analysis. Separate models were developed including all variables of a given model plus significant variables of previous models to reproduce the usual clinical information flow.
Twelve (5%) deaths and 23 (10%) heart failures occurred. Diabetes (hazard ratio [HR] 6.46, 95% confidence interval [CI] 1.99-20.98) and peak creatine kinase-MB (HR 1.002, 95% CI 1.001-1.004 per unit increment), wall motion score index (HR 1.46, 95% CI 0.35-6.15 per 0.1 unit increment), and TIMI flow grade < 3 after angioplasty (HR 5.35, 95% CI 2.04-14.02) were the only significant and independent prognostic indicators. ECG information did not improve the model, whilst functional and angiographic data provided incremental prognostic value over clinical information.
At mid-term follow-up, extensive acute myocardial infarction patients undergoing primary angioplasty have a moderate heart failure event rate. The integrated evaluation of data routinely available from diagnostic work-up allows accurate prediction of the outcome; functional and angiographic data provide incremental prognostic information over clinical and ECG variables.
Italian heart journal: official journal of the Italian Federation of Cardiology 01/2005; 5(12):912-8.
[show abstract][hide abstract] ABSTRACT: Primary percutaneous intervention for acute occlusion of a native coronary artery may be complicated by distal embolization of plaque or thrombotic debris, with infarct extension. We tested the clinical application of a new therapeutic strategy combining maximal antiplatelet therapy, with glycoprotein IIb/IIIa inhibition, and adjunctive mechanical protection from distal embolization and direct aspiration of thrombus with a new balloon and catheter system (PercuSurgetrade mark). Successful aspiration of thrombus could be obtained in 7 out of 8 attempted procedures, with inability to negotiate the angulated take-off of the circumflex coronary artery in one patient. The current mechanical characteristics of the device, primarily developed for use in larger saphenous vein grafts, and certain caveats and limitations are discussed. New dedicated systems should be available in the near future for the native coronary circulation. Excellent immediate angiographic results were obtained in all treated patients, without evidence of loss of distal branches and no intraprocedural complications.
Catheterization and Cardiovascular Interventions 08/2000; 50(3):362-70. · 2.51 Impact Factor
[show abstract][hide abstract] ABSTRACT: Cardiac catheterization in a patient with recent-onset unstable angina demonstrated a suboccluded dominant right coronary artery (RCA), with angiographic evidence of a large thrombus load and a severe focal stenosis of the left anterior descending (LAD) coronary artery. After abciximab, uneventful PTCA and stenting of the LAD was performed. The thrombus containing lesion of RCA was treated with balloon predilatation and stent deployment, and the whole procedure was accomplished with protection of the distal vessel by means of PercuSurge. This device was planned to avoid distal debris migration during percutaneous interventions of saphenous bypass grafts. The system is designed to allow the placement of a temporary occlusion device, a low-profile balloon, distal to the lesion to be treated during the procedure. The occlusive balloon is kept inflated during the treatment of the lesion. Before deflating the balloon and allowing blood to reach the distal vessel, whenever it is necessary, the material proximal to the balloon is aspirated through a monorail catheter. This aspiration removes blood and thrombi proximal to the occlusive balloon from the treated coronary artery. The case we present first reports the application of the device in a large native coronary artery, with an optimal distal flow restoring and no evidence of thrombus embolization. This type of protection of distal coronary vessels towards micro- and macroembolization of thrombi is a promising system of performing safer percutaneous interventions, even in acute ischemic syndromes.
Giornale italiano di cardiologia 01/2000; 29(12):1503-7.
[show abstract][hide abstract] ABSTRACT: Coronary angioplasty (PTCA) for unstable angina is a procedure having good anatomical and clinical success. Best immediate results are achieved after a clinical "cooling" of the unstable phase, by means of intravenous heparin and acetylsalicylic acid. Coronary thrombolysis has no role in improving results of PTCA in unstable angina. Incomplete revascularization is safe and clinically effective in the acute phase, and staged procedures are recommended if two or more vessels are to be treated. Restenosis rate seems to be higher in unstable patients, especially in those who are on refractory phase.
[show abstract][hide abstract] ABSTRACT: The aim of this study was to evaluate day-hospital coronary angiography as a valid method to reduce hospital recovery costs and patient waiting lists. We evaluated its technical feasibility by randomizing sixty hospital patients. These were divided into two groups, and 6 or 8 French Judkins of Amplatz coronary angiography catheters were used for each group following the Judkins technique. Patients were invited to walk after four hours. Local complications, the number of catheters used, their stability and maneuverability, as well as the radiological resolution of the image were evaluated. No major cardiac complications occurred. One transient cerebral ischemic episode during 6F coronary angiography was quickly resolved by medical therapy. Two local haemorrhages and three cases of hypotension were observed in the 8 French group, while minor bleeding phenomena were similar in both groups (3 vs 5). Differences occurred in local haematoma incidence after 24 hours (13 in 8F vs 2 in 6F); there was no difference in the number of catheters used, the completion time of the examination, or the radiological resolution. Maneuverability and stability of the 6F group were reduced, but not so much as to compromise examination. The AA concluded that 6F catheters are useful in day-hospital coronary angiography, with a similar examination quality, and a reduction in local complication.
Giornale italiano di cardiologia 01/1991; 20(12):1118-24.