Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial.

Patients on rivaroxaban requiring percutaneous coronary intervention (PCI) represent a clinical conundrum. We aimed to investigate whether rivaroxaban, with or without an additional bolus of unfractionated heparin (UFH), effectively inhibits coagulation activation during PCI. Stable patients (n=108) undergoing elective PCI and on stable dual antiplatelet therapy were randomised (2:2:2:1) to a short treatment course of rivaroxaban 10 mg (n=30), rivaroxaban 20 mg (n=32), rivaroxaban 10 mg plus UFH (n=30) or standard peri-procedural UFH (n=16). Blood samples for markers of thrombin generation and coagulation activation were drawn prior to and at 0, 0.5, 2, 6-8 and 48 hours (h) after start of PCI. In patients treated with rivaroxaban (10 or 20 mg) and patients treated with rivaroxaban plus heparin, the levels of prothrombin fragment 1 + 2 at 2 h post-PCI were 0.16 [0.1] nmol/l (median) [interquartile range, IQR] and 0.17 [0.2] nmol/l, respectively. Thrombin-antithrombin complex values at 2 h post-PCI were 3.90 [6.8]µg/l and 3.90 [10.1] µg/l, respectively, remaining below the upper reference limit (URL) after PCI and stenting. This was comparable to the control group of UFH treatment alone. However, median values for thrombin-antithrombin complex passed above the URL with increasing tendency, starting at 2 h post-PCI in the UFH-alone arm but not in rivaroxaban-treated patients. In this exploratory trial, rivaroxaban effectively suppressed coagulation activation after elective PCI and stenting.

[Implementation of reperfusion therapy in ST segment elevation myocardial infarction (STEMI). A policy statement from the Belgian Society of Cardiology and its working group of acute cardiology and interventional cardiology]. / Mise en pratique du traitement de reperfusion dans les infarctus du myocarde avec élévation du segment ST (STEMI). Recommandations actualisées de la Société Belge de Cardiologie et de ses groupes de travail: le Groupe Interdisciplinaire de Cardiologie Aiguë (BIWAC) et le Groupe de Cardiologie Interventionnelle (BWGIC).

Myocardial infarction remains a major healthcare problem. Reperfusion therapy has been shown to influence favourably short- and long-term patient survival. The authors reviewed the data of early recognition of STEMI (ST Elevation Myocardial Infarction), the reperfusion modalities including a flowchart management, as proposed by the Belgian working groups (BIWAC and BWGIC), and the lessons learned from European and American registries. Primary PCI often remains the treatment of choice. A national policy is still required to implement the guidelines and improve clinical practice for our STEMI patients.

[Implementation of reperfusion therapy in ST segment elevation myocardial infarction (STEMI). A policy statement from the Belgian Society of Cardiology and its working group of acute cardiology and interventional cardiology]. / Mise en pratique du traitement de reperfusion dans les infarctus du myocarde avec élévation du segment ST.

Myocardial infarction remains a major healthcare problem. Reperfusion therapy has been shown to influence favourably short- and long-term patient survival. The authors reviewed the data of early recognition of STEMI (ST Elevation Myocardial Infarction), the reperfusion modalities including a flowchart management, as proposed by the Belgian working groups (BIWAC and BWGIC), and the lessons learned from European and American registries. Primary PCI often remains the treatment of choice. A national policy is still required to implement the guidelines and improve clinical practice for our STEMI patients.

Femoral bifurcation infected pseudoaneurysm: a simple and quick arterial reconstruction with reversed bifurcated saphenous vein graft.

Septic endarteritis complicating arterial cannulation is an exceptional condition. The authors report a quick and feasible surgical procedure to reconstruct a femoral bifurcation with reversed bifurcated saphenous vein graft.

Biodegradable-polymer-based, paclitaxel-elutingInfinnium™ stent: 9-Month clinical and angiographic follow-up results from the SIMPLE II prospectivemulti-centre registry study

Background: SIMPLE II was a multi-centre, prospective registry study aimed at investigating the safety andefficacy of the Infinnium™ (Sahajanand Medical Technologies Pvt. Ltd, India) paclitaxel-eluting stent forthe treatment of single de novo lesions in the native coronary arteries.Methods: One hundred and three patients with symptomatic coronary artery disease were treated for singlede novo native coronary artery lesions using the Infinnium™ stent (paclitaxel concentration1.4 mcg/mm2 released over 48 days) in a multi-centre, prospective study performed on 3 continents (Asia,Europe and South America). The primary safety endpoint was major adverse cardiac events at 30 days(MACE 30d) and efficacy was assessed by in-stent binary restenosis as measured by quantitative coronaryangiography (QCA) at six-month follow-up. A clinical follow-up was scheduled at nine months.Results: The mean patient age was 58.5 years; 70.9% were males; 43.7% had unstable angina and 38.8%previous myocardial infarction. Risk factors included hypertension in 62.1%, hypercholesterolemia in52.4%, current smoking in 32.0% and diabetes in 28.2%. Stent implantation was successful in all patients,with more than one stent being implanted in 9 patients (8.7%). Hierarchical MACE 30d was 2.9%. At ninemonths, 101 patients had clinical follow-up (1 patient had died and 1 refused). There was one death(1.0%), one Q-wave myocardial infarction (Q MI) (1.0%), three non-Q MIs (2.9%), one clinically-driven targetlesion Coronary Artery Bypass Grafting (CABG) (1.0%), and one clinically-driven target lesion repeatpercutaneous coronary intervention (re-PCI) (1.0%). The overall event-free rate at nine months was 93.2%.QCA revealed in-stent and in-segment late loss of 0.38±0.49 mm and 0.18±0.46 mm, resulting in binaryrestenosis rates of 7.3% and 8.3%, respectively. There was one case of late stent thrombosis in the patientexperiencing the Q MI and subsequent re-PCI...

Clinical development of bivalirudin (Angiox): rationale for thrombin-specific anticoagulation in percutaneous coronary intervention and acute coronary syndromes.

As the pathophysiology of acute coronary syndromes (ACS) has been clarified in recent years, major advances have been made in the management of the disease. The magnitude of the thrombotic process triggered upon plaque disruption is modulated by different elements that determine plaque and blood thrombogenicity. Thrombin plays a pivotal role in ACS because of its extensive procoagulant and prothrombotic actions. Antithrombotic therapy and powerful antiplatelet therapies, in addition to early percutaneous coronary intervention (PCI), have become central in the management of ACS. A number of options for anticoagulation regimens are available. However, many agents currently used have significant limitations, recognition of which has led to the development, evaluation and clinical introduction of the class of thrombin-specific anticoagulant agents. This paper will discuss the clinical development of the direct thrombin inhibitor bivalirudin as the core anticoagulant in the contemporary PCI setting and the implications for its use in ACS.

Biodegradable-polymer-based, paclitaxel-eluting Infinnium stent: 9-Month clinical and angiographic follow-up results from the SIMPLE II prospective multi-centre registry study.

BACKGROUND: SIMPLE II was a multi-centre, prospective registry study aimed at investigating the safety and efficacy of the Infinnium (Sahajanand Medical Technologies Pvt. Ltd, India) paclitaxel-eluting stent for the treatment of single de novo lesions in the native coronary arteries. METHODS: One hundred and three patients with symptomatic coronary artery disease were treated for single de novo native coronary artery lesions using the Infinnium stent (paclitaxel concentration 1.4 mcg/mm2 released over 48 days) in a multi-centre, prospective study performed on 3 continents (Asia, Europe and South America). The primary safety endpoint was major adverse cardiac events at 30 days (MACE 30d) and efficacy was assessed by in-stent binary restenosis as measured by quantitative coronary angiography (QCA) at six-month follow-up. A clinical follow-up was scheduled at nine months. RESULTS: The mean patient age was 58.5 years; 70.9% were males; 43.7% had unstable angina and 38.8% previous myocardial infarction. Risk factors included hypertension in 62.1%, hypercholesterolemia in 52.4%, current smoking in 32.0% and diabetes in 28.2%. Stent implantation was successful in all patients, with more than one stent being implanted in 9 patients (8.7%). Hierarchical MACE 30d was 2.9%. At nine months, 101 patients had clinical follow-up (1 patient had died and 1 refused). There was one death (1.0%), one Q-wave myocardial infarction (Q MI) (1.0%), three non-Q MIs (2.9%), one clinically-driven target lesion Coronary Artery Bypass Grafting (CABG) (1.0%), and one clinically-driven target lesion repeat percutaneous coronary intervention (re-PCI) (1.0%). The overall event-free rate at nine months was 93.2%. QCA revealed in-stent and in-segment late loss of 0.38+/-0.49 mm and 0.18+/-0.46 mm, resulting in binary restenosis rates of 7.3% and 8.3%, respectively. There was one case of late stent thrombosis in the patient experiencing the Q MI and subsequent re-PCI. CONCLUSIONS: The Infinnium paclitaxel-eluting stent appears to be safe and efficacious for the treatment of single de novo lesions in coronary arteries in a patient population with symptomatic coronary artery disease (CAD).

The clinical significance of whole blood viscosity in (cardio)vascular medicine.

Whole blood is a non-Newtonian fluid, which means that its viscosity depends on shear rate. At low shear, blood cells aggregate, which induces a sharp increase in viscosity, whereas at higher shear blood cells disaggregate, deform and align in the direction of flow. Other important determinants of blood viscosity are the haematocrit, the presence of macro-molecules in the medium, temperature and, especially at high shear, the deformability of red blood cells. At the sites of severe atherosclerotic obstructions or at vasospastic locations, when change of vessel diameter is limited, blood viscosity contributes to stenotic resistance thereby jeopardising tissue perfusion. However, blood viscosity plays its most important role in the microcirculation where it contributes significantly to peripheral resistance and may cause sludging in the postcapillary venules. Apart from the direct haemodynamic significance, an increase in blood viscosity at low shear by red blood cell aggregation is also associated with increased thrombotic risk, as has been demonstrated in atrial fibrillation. Furthermore, as increased red blood cell aggregation is a reflection of inflammation, hyperviscosity has been shown to be a marker of inflammatory activity. Thus, because of its potential role in haemodynamics, thrombosis and inflammation, determination of whole blood viscosity could provide useful information for diagnostics and therapy of (cardio)vascular disease.

Pancreaticopleural fistula: diagnosis with magnetic resonance pancreatography.

Pancreaticopleural fistula secondary to chronic pancreatitis is a rare cause of recurrent pleural effusion. The demonstration of the fistula with endoscopic retrograde pancreatography and CT is invasive or limited. We report in two patients the use of magnetic resonance pancreatography as a noninvasive alternative to endoscopic retrograde pancreatography for the diagnosis of pancreaticopleural fistula.

Acute posterior cerebral circulation syndrome accompanied by serious cardiac rhythm disturbances: a rare but reversible complication following bypass graft angiography.

Cerebral events are recognized, although infrequent, complications of cardiac catheterization. We report on an exceptional case of a posterior cerebral circulation syndrome comprising a confusional state, amnestic disturbances, aphasia, and cortical blindness, accompanied by life-threatening cardiac arrhythmia after left and right internal mammary artery graft angiography, with complete recovery over 5 days. The diagnostic potential of computed tomography, magnetic resonance, and SPECT imaging of the brain in diagnosing this rare but important complication is illustrated. The need for early continuous monitoring of patients with clinically important cerebrovascular events postangiography is emphasized. Cathet. Cardiovasc. Intervent. 48:397-401, 1999.

A case of extensive pulmonary embolism presenting as an acute myocardial infarction--notes on its possible pathophysiology.

Pulmonary embolism is frequently overlooked but may be fatal. Hence, appropriate diagnosis heavily relies on clinical suspicion. Although most ECG features of pulmonary embolism lack specificity and sensitivity, especially when prior cardiopulmonary disease is present, certain ECG findings may heighten the initial clinical suspicion. This is illustrated in the following report on a case of proven pulmonary embolism complicated with cardiac arrest and prolonged shock. The electrocardiographic presentation was suggestive of an extensive acute myocardial infarction, a pattern which to our knowledge never has been reported on. However, many elements of it pointed to the diagnosis of pulmonary embolism. The multifactorial origin of the ECG findings is discussed.

Prognostic assessment of end-stage cardiac failure.

Heart failure is not a disease, but rather a complex clinical syndrome that is growing in incidence and carries a very high morbidity and mortality. Although the incidence in the general adult population in the Western world is between 1% and 2%, the frequency increases rapidly in the elderly affecting more than 10% of the individuals over the age of 75 years. The treatment of patients with end-stage chronic heart failure (CHF) is difficult. The two major goals in the treatment of heart failure are to increase the duration (slow its progression) and quality of life (relief of symptoms). Understanding the severity of the syndrome of heart failure in terms of its prognosis can be particularly important in planning long-term management and in counselling the patient. The introduction of aggressive interventional therapies such as active haemodynamic support with ventricular assist devices, or heart transplantation emphasizes the importance of quantitating the risk of death in order to properly select patients for these more aggressive treatments. In large-scale trials it has been possible to identify markers that serve as significant predictors of mortality. Of these, the detection and quantification of neurohumoral activation have gained the most recent attention. Here, we discuss some of the prognostic tools in current use for heart failure patients and their applicability to patients with advanced heart failure.

Giant left main coronary artery aneurysm in association with severe atherosclerotic coronary disease.

Aneurysms of the coronary arteries occur in 1.5-4.9% of coronary angiograms. Only a few cases of a giant aneurysm of the left main coronary artery in conjunction with severe atherosclerotic coronary disease have been reported. This report details the exceptional case of a 72-year-old patient with a giant "true saccular" aneurysm branched on the left main coronary artery. The development of an aneurysmal dilatation in conjunction with progression of coronary arteriosclerosis, observed from two different angiographic studies at an interval of 25 years, is very illustrative for evolutive atherosclerotic heart disease. This finding may support the hypothesis that atherosclerosis may be the common etiology for coronary aneurysmal dilatation.

Frequency of a positive modified Allen's test in 1,000 consecutive patients undergoing cardiac catheterization.

The modified Allen's test (A.T.) is used to prove the adequacy of the blood supply through the ulnar artery to the hand. The test is considered normal if, after compression of both the ulnar and radial arteries followed by repeated clenching of the fingers to squeeze out the blood, the normal or a slightly more pronounced red color of the palm of the hands returns within < 10 sec after release of only the ulnar artery. It is important to perform the test whenever intravascular access to the radial artery is planned. The objective of this study was to determine the percentage of patients presenting a clearly positive (< 5 sec), a moderately positive (between 5-9 sec), or a negative A.T. (10 sec and more), We performed an A.T. on 1,000 consecutive and different patients undergoing cardiac catheterization, on the right wrist, two times, each time by a different examinator trained in this test. An A.T. was performed on 1,000 patients:640 men, 360 women, mean age 62.3 yr (range 28-90 yr). In our population of patients, the relative percentages of a clearly positive (< 5 sec), moderately positive (between 5-9 sec), or negative modified Allen's test (10 sec and more) is 49%, 24%, and 27%, respectively.

[Pulmonary embolism and pregnancy: report of a case; review of the literature]. / Embolie pulmonaire et grossesse: à propos d'une observation; revue de la littérature.

Pulmonary embolism occurring during pregnancy is a rare accident but that still brings about a high mother mortality; it seems to be five to six times more frequent during the pregnancy and the post-partum than for non-parturient women who don't take any estro-progestogens, pulmonary embolism would involve complications for 0.5/1000 pregnancies before delivery. As it presents a lot of diagnostic problems, it is under-estimated. The vascular radiological examinations expose the foetus or embryo to considerable radiation and to a risk of foetal hypothyroidism leading to backwardness. The lung perfusion scanning has the advantage of not injecting iodine but is not specific. Fortunately, some medical examinations such as plethysmography or Doppler echography are safe and can also guide the clinician. As far as therapy is concerned, intravenous heparin is the first intention treatment, it can be replaced subsequently by subcutaneous heparin (low molecular weight heparin). In case of heavy pulmonary embolism endangering the vital prognosis of the patient, in case of clinical or biological resistance to the medical treatment, it could be necessary to perform a pulmonary embolectomy with, if necessary, vena cava interruption with insertion of a mechanical filter.