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Distal embolization during primary percutaneous coronary intervention (PCI) occurs in at least 15% of patients and is a strong predictor of more extensive myocardial damage and a poor prognosis. Several devices are designed to evacuate the intracoronary thrombus or to prevent distal embolization. The Proxis device is a proximal embolic protection system that completely blocks antegrade flow during PCI. It may prevent distal embolization during recanalization of thrombotic coronary occlusion and thus improve outcome. We created a registry of 172 patients with ST-segment elevation myocardial infarction who underwent primary PCI with proximal embolic protection and aspiration. The mean ST-segment elevation resolution (STR) at 1 hour was 77.7%+/- 15.2; STR was greater than 50% in 94% and greater than 70% in 72% of patients. The 1-year cumulative major adverse cardiac and cerebrovascular events rate was 10.5%. The overall mortality at 1 year was 2.3%.

Background: Crossing chronic total occlusions (CTO) of coronary arteries continues to challenge interventional cardiologists. A clinical study was undertaken in four European centers to examine the feasibility of using the new CROSSER system that utilizes high-frequency mechanical vibration to penetrate atherosclerotic plaque material to cross CTOs in patients where conventional guidewire techniques had failed. The objective of the study was to determine whether the CROSSER system could safely cross such CTOs., Patients and Methods: A total of 55 CTO lesions in 53 patients were treated in two clinical phases: (1) Phase 1 feasibility study (30 CTOs), with a primary focus on device safety; and (2) Phase 2 pivotal study (25 CTOs) using an improved version of the device, with a primary focus on effectiveness., Results: The primary endpoint of device efficacy and the secondary endpoint of clinical success were both 76% (19 of 25) in the pivotal study phase. No major adverse cardiac events of death, Q-wave myocardial infarction or target lesion revascularization (by either coronary artery bypass graft surgery or percutaneous coronary intervention) were observed through 30-day follow up. No coronary perforation or pericardial tamponade occurred., Conclusions: The CROSSER system is a safe device that can cross many occlusions after a conventional guidewire failure. With additional refinement and improvements to the device, this success rate could be further increased.

We describe the case of a 45-year-old male smoker who presented with an acute anterior wall myocardial infarction and a platelet count on admission of 1030000/mm3. Emergent coronary angiography revealead left anterior wall akinesia caused by a spontaneously resolved thrombosis of the left anterior descending artery with residual stenosis. Primary percutaneous coronary angioplasty and stenting were performed. Postangioplasty course was uneventful. He was diagnosed with essential thrombocythemia based on the findings of marked thrombocytosis of 1,030,000/mm3, splenomegaly and numerous clumping giant megakaryocytes on bone marrow biopsy. In addition to standard therapy with aspirin, heparin, betablocking agent, ACE-inhibitor and statine he received additional anti-platelet therapy with Clopidogrel. Cytoreductive therapy was not necessary.

The aim of this study was to assess costs and safety of immediate femoral sheath removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial sheath removal and access site closure with a suture-mediated closure device (SMC; n = 96) or sheath removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 +/- 3.4 vs. 22.9 +/- 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients., (Copyright 2002 Wiley-Liss, Inc.)

Background: Prevention of distal embolisation during percutaneous coronary revascularisation may be necessary to reduce postinterventional morbidity and mortality., Methods and Results: We employed a newly developed emboli containment and retrieval system in native coronary arteries during percutaneous coronary angioplasty and stenting in 39 selected patients (mean age 58.9 +/- 10.1 years, 11 females) presenting with acute (n = 22; 8 LAD, 3 LCX, 11 RCA), subacute (n = 7; 2 LAD, 2 LCX, 3 RCA) or chronic (n = 6; 2 LAD, 4 RCA) total or subtotal occlusion of an infarct-related vessel, or with severe stenosis and symptoms of unstable angina (n = 4; 2 LAD, 2 RCA). Protection device-assisted angioplasty with stent implantation was uneventful in all patients with good angiographic results and normal postprocedural flow. Intermittent aggravation of anginal pain during inflation of the occlusive balloon (from 2.5 to a maximum of 25 minutes cumulative inflation time) was observed in 19 of the 36 conscious patients (7 with acute, 7 with subacute and 3 with chronic occlusion, and 2 with unstable angina), but caused neither interruption of distal occlusion nor haemodynamic instability. In 31 patients the aspirates contained visible debris. Histological analysis showed particles up to 12 mm in size, consisting of necrotic core, inflammatory cells, cholesterol debris, and old and fresh thrombi. In 8 patients the aspirated particles were too small to allow microscopic diagnosis or debris was absent., Conclusions: This preliminary report demonstrates the feasibility of using a protection device in native coronary arteries to prevent distal embolisation of particulate matter that is mobilised during percutaneous interventions. To the extent that this material contributes to the mechanisms of distal embolisation, noreflow and infarction, this device may help to reduce such complications. Appropriately designed trials are required to assess the clinical benefit of this system.

Coronary artery stenting has definitely been proven to improve results of percutaneous revascularisation in a large number of patients. Stenting reduces restenosis in large vessels above 3 mm diameter. Stenting has not solved the problem of restenosis but in spite of the inevitable in-stent restenosis due to neointimal proliferation seems to yield better long-term results than conventional PTCA. Adjunctive pharmacological treatment with aspirin and clopidogrel in combination with improved stent deployment techniques has reduced the incidence of subacute stent thrombosis. GP IIb/IIIa inhibition is a promising mean for the reduction of procedure related ischaemic events and complications not only with stent implantation but also with conventional PTCA. Other new devices may further influence the treatment choices of stenting versus conventional PTCA in the future. Novel approaches such as brachytherapy and molecular genetic approaches to reduce in-stent restenosis are currently being investigated but to date no conclusions can be drawn as to their future place in clinical practice. From a mechanistic standpoint it seems obvious to give all our efforts to protect patients with coronary atherosclerosis from loss of myocardium either with coronary artery bypass grafting or percutaneous revascularisation. As both approaches are palliative in nature, it may be useful to attempt percutaneous revascularisation in patients amenable to this therapy and thus obviate or delay the need for definitive revascularisation by coronary artery bypass grafting. At the end of this discussion we would like to remind that medical therapy for coronary artery disease is of utmost importance as all revascularisation procedures do not influence the underlying disease. Besides symptomatic relief of angina, treatment of heart failure, and other beneficial strategies to improve endothelial function, medical therapy with lipid lowering compounds together with risk factor control offers the possibility to delay progression of coronary artery disease.