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Biomedical subjects

Witold Ruzyllo

Publications and source records attributed to Witold Ruzyllo.

31 records · Page 2Linked to original sources
PubMed2004

A dose-finding study of fondaparinux in patients with non-ST-segment elevation acute coronary syndromes: the Pentasaccharide in Unstable Angina (PENTUA) Study.

OBJECTIVES: In this dose-finding study, we sought to compare fondaparinux with enoxaparin in patients with acute coronary syndromes (ACS). BACKGROUND: Fondaparinux is a synthetic pentasaccharide that selectively inhibits activated clotting factor X. It has been demonstrated as effective in preventing thromboembolic complications in orthopedic surgery. METHODS: Four doses fondaparinux (2.5, 4, 8, or 12 mg once daily) and enoxaparin (1 mg/kg twice daily) were compared, both given for three to seven days, in patients with ACS without persistent ST-segment elevation. RESULTS: The rates of the combined primary end point of death, myocardial infarction, or recurrent ischemia after nine days were 27.9%, 35.9%, 34.7%, 30.3%, and 35.7% in patients allocated to fondaparinux doses of 2.5, 4, 8, and 12 mg and enoxaparin, respectively (p = NS). In the per-protocol analysis (929 patients who received adequate study drug and had adequate ST-segment monitoring), these figures were 30.0%, 43.5%, 41.0%, 34.8%, and 40.2%. Again, no dose response was observed. The lowest event rates were observed in the 2.5-mg fondaparinux group, which had significantly lower rates than the enoxaparin group as well as for 4 and 8 mg fondaparinux in the per-protocol analysis (p < 0.05). Bleeding rates were low and not different among the patient groups. No differences were observed in fondaparinux concentrations in patients with or without death, myocardial infarction, recurrent ischemia, or bleeding events. CONCLUSIONS: This dose-finding study revealed no dose response for different fondaparinux doses ranging from 2.5 to 12 mg subcutaneously and suggests that the efficacy and safety of fondaparinux may be similar to that of enoxaparin. Further studies with fondaparinux in ACS might include the lowest dose (2.5 mg) investigated in this study.

Acute Disease↗
PubMed2004

Bleeding events with abciximab in acute coronary syndromes without early revascularization: An analysis of GUSTO IV-ACS.

BACKGROUND: The glycoprotein IIb/IIIa receptor antagonist abciximab reduces the risk of thrombotic complications with percutaneous coronary intervention, but also has been associated with higher bleeding rates. METHODS: In the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO IV-ACS) trial, abciximab (either a 24-hour or 48-hour infusion) was compared with placebo in 7800 patients with an acute coronary syndrome. During study drug administration, 2% of the patients underwent a revascularization procedure. RESULTS: In 1507 patients (19.3%), bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) classification was observed while they were hospitalized or within 7 days. Ninety-eight patients (1.2%) had a major bleed, including 8 with intracranial hemorrhages. In 215 patients (2.8%), a minor bleed was reported, and in 1194 patients (15.3%), an insignificant bleed was reported. Bleeding was more frequent in patients receiving a 48-hour infusion of abciximab. Spontaneous bleeding was seen in 911 patients (11.7%). The other 596 patients had a bleeding event in conjunction with a procedure. The most significant predictors for bleeding with multivariable analysis were: use of low-molecular weight heparin, duration of abciximab infusion, region of hospitalization, performance of coronary artery bypass grafting or percutaneous coronary intervention (PCI), advanced age, and female sex. For major bleeding, the predictors were performance of coronary artery bypass grafting or PCI, long duration of abciximab administration, and advanced age. CONCLUSION: Treatment with abciximab in patients with non-ST-elevation acute coronary syndromes is safe because major bleeding and stroke are rare, and most events are clinically manageable or have few clinical consequences. Guidelines for use of abciximab in combination with other antithrombotic agents developed for PCI should also be respected in acute coronary syndromes. Specific dosing guidelines for combination with low-molecular weight heparin must be developed for patients who subsequently will undergo a PCI.

Abciximab↗
PubMed2004

Increasing awareness and perception of heart failure in Europe and improving care--rationale and design of the SHAPE Study.

UNLABELLED: In the last decennia heart failure has become one of the most important diseases worldwide in terms of prevalence, morbidity, life expectancy, and in health care management and costs. Despite significant improvements in prevention and treatment, heart failure remains a frequently occurring disorder with increasing incidence and a high hospitalisation and death rate. As major health care problem it deserves full attention of health care authorities. Unfortunately, the seriousness of heart failure and the therapeutic possibilities are often not recognised by those directly involved, i.e. the doctor, the patient or his relatives, let alone that they are known to the general public and health care authorities. The SHAPE study aims at improving heart failure care by increasing awareness and perception of the disease in Europe. Firstly, awareness and perception of heart failure will be documented in the general public, primary care physicians and specialists (cardiologists, internists and geriatricians) in 9 European countries: France, Germany, Italy, the Netherlands, Poland, Romania, Spain, Sweden and the UK. Subsequently, the results will be used to design and carry out suitable awareness and educational programmes in these groups, aimed at improving heart failure care and research. Finally, the results of these programmes will be tested in a second documentation phase and adaptations made where needed. This manuscript describes the rationale and design of the first phase, the Documentation Phase.During the first documentation phase, 800 participants per country selected based on sex, two age groups and urban vs. rural location (100/cell) will be surveyed using a 32-question interview. Questions for the general public focus on recognition, incidence and prevalence, severity and prognosis of the disease in comparison to other disease areas, like cancer, on quality of life, therapeutic possibilities and availability of care. The primary care physician (PCP) survey aims at receiving a minimum of 300 responses. A questionnaire with 33 closed questions will be used covering the PCP's knowledge of heart failure, including prevalence, aetiology, new diagnostic and therapeutic developments and health care costs. Questions concerning diagnostic procedures and various treatments carried out by the PCP in his own practice, as well as referral patterns for diagnostic procedures and for specialist care. Questions relating to the type of practice and number of patients in each PCP's clinical practice. A minimum of 150 cardiologists and 150 internists + geriatricians will be surveyed per country. The specialist's questionnaire contains 31 questions focusing on identification of heart failure patients, patients at risk, use and availability of diagnostic tools, importance of therapies and order of treatment, perceived risks of treatment, relevance of counselling and advice, use of paramedical personnel, and questions concerning practice size, type of practice and number of patients with heart failure. CONCLUSION: This first part of the SHAPE study will provide important information about the level of knowledge and understanding of heart failure of the general public, as well as the perception of the relevance of heart failure and appropriate diagnostic and therapeutic approaches by both the primary care physician and the medical specialist. This knowledge will be extremely valuable when it comes to defining optimal educational programmes in the different target groups studied in SHAPE necessary to implement appropriate heart failure care in Europe and to obtain the means to do so.

Adult↗
PubMed2003

Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: comparison with bare metal stents by serial intravascular ultrasound analyses: data from the randomized TAXUS-II trial.

BACKGROUND: Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial. METHODS AND RESULTS: TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7+/-0.9 mm2, P<0.001) and MR (0.6+/-0.8 mm2, P<0.001) compared with BMS (1.9+/-1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5+/-1.7, 1.0+/-1.8, and 1.4+/-2.0 mm2, respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA. CONCLUSIONS: Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.

Angioplasty↗
PubMed2003

Effect of pexelizumab, an anti-C5 complement antibody, as adjunctive therapy to fibrinolysis in acute myocardial infarction: the COMPlement inhibition in myocardial infarction treated with thromboLYtics (COMPLY) trial.

BACKGROUND: Complement activation mediates myocardial damage that occurs during ischemia and reperfusion through multiple pathways. We performed 2 separate, parallel, double-blind, placebo-controlled trials to determine the effects of pexelizumab (a novel C5 complement monoclonal antibody fragment) on infarct size in patients receiving reperfusion therapy: COMPlement inhibition in myocardial infarction treated with thromboLYtics (COMPLY) and COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA). The COMPLY trial is reported here. METHODS AND RESULTS: Overall, 943 patients with acute ST-segment elevation myocardial infarction (MI) (20% with isolated inferior MI) receiving fibrinolysis were randomly assigned <6 hours after symptom onset to placebo, pexelizumab 2.0-mg/kg bolus, or pexelizumab 2.0-mg/kg bolus plus 0.05 mg/kg per h for 20 hours. Infarct size determined by creatine kinase-MB area under the curve was the primary analysis, which included patients who received at least some study drug and fibrinolysis (n=920). The median infarct size did not differ by treatment (placebo, 5230; bolus, 4952; bolus plus infusion, 5557 [ng/mL] x h; bolus versus placebo, P=0.85; bolus plus infusion versus placebo, P=0.81), nor did the 90-day composite incidence of death, new or worsening congestive heart failure, shock, or stroke (placebo, 18.6%; bolus, 18.4%; bolus plus infusion, 19.7%). Pexelizumab inhibited complement for 4 hours with bolus-only dosing and for 20 to 24 hours with bolus-plus-infusion dosing, with no increase in infections. CONCLUSIONS: When used adjunctively with fibrinolysis, pexelizumab blocked complement activity but reduced neither infarct size by creatine kinase-MB assessment nor adverse clinical outcomes.

Aged↗
PubMed2003

Pexelizumab, an anti-C5 complement antibody, as adjunctive therapy to primary percutaneous coronary intervention in acute myocardial infarction: the COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA) trial.

BACKGROUND: Complement, activated during myocardial ischemia and reperfusion, causes myocardial damage through multiple processes. The COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA) trial was performed to determine the effect of pexelizumab, a C5 complement inhibitor, on infarct size in patients with ST-segment-elevation myocardial infarction (MI) undergoing primary percutaneous coronary intervention. METHODS AND RESULTS: In COMMA, 960 patients with MI (20% isolated inferior MI) were randomized to placebo, pexelizumab 2.0-mg/kg bolus, or pexelizumab 2.0-mg/kg bolus and 0.05-mg/kg per h infusion for 20 hours. Infarct size by creatine kinase-MB area under the curve, the primary outcome, did not differ significantly between groups (placebo median, 4393; bolus pexelizumab, 4526; bolus plus infusion pexelizumab, 4713 [ng/mL] x h; P=0.89 for bolus versus placebo; P=0.76 for bolus plus infusion versus placebo), nor did the composite of 90-day death, new or worsening heart failure, shock, or stroke (placebo, 11.1%; bolus, 10.7%; bolus plus infusion, 8.5%). The ninety-day mortality rate was significantly lower with pexelizumab bolus plus infusion (1.8% versus 5.9% with placebo; nominal P=0.014); the bolus-only group had an intermediate mortality rate (4.2%). CONCLUSIONS: In patients with ST-elevation MI undergoing percutaneous coronary intervention, pexelizumab had no measurable effect on infarct size. However, the significant reduction in mortality suggests that pexelizumab may benefit patients through alternative novel mechanisms and provides impetus for additional investigation.

Aged↗
PubMed2003

Usefulness of 1H MR spectroscopy in the evaluation of myocardial metabolism in patients with dilated idiopathic cardiomyopathy: pilot study.

RATIONALE AND OBJECTIVES: Primary dilated cardiomyopathy is a disease of unknown etiology, and it leads to severe heart failure. Abnormalities of the cardiac metabolism can play an important role in prognosis and influence the symptomatology in this group. The aim of this study was to assess cardiac metabolism using proton spectroscopy magnetic resonance (1H MRS) and to examine whether there is any correlation between cardiac metabolites and functional New York Heart Association (NYHA) class and left ventricular function parameters obtained in echocardiography. MATERIALS AND METHODS: Fifteen patients with documented idiopathic dilated cardiomyopathy and 12 healthy volunteers were examined. The study protocol included clinical examination, 12-lead electrocardiogram, two-dimensional echocardiogram, and 1H MRS with voxel localized at interventricular septum area. The contents of total creatine (CR) ie, creatine + phosphocreatine, lipids (LIP), lactates (LAC) and their ratios (CR1A, CR2A, CR1/H20, CR2/H20, CR2/CR1, LIPA, LIP/H20, LIP/CR1, LACA, LAC/H20, LAC/CR1) were examined. RESULTS: Patients with dilated cardiomyopathy had significantly lower levels of creatine CRIA (5.04 +/- 0.88 vs 5.94 +/- 1.15, P < .02) and ratios LIP/H20 (4.34 +/- 2.3 vs 15.46 +/- 20.39, P < .04) and LIP/CR1 (24.49 +/- 21.26 vs 34.08 +/- 13.36, P < .05) compared with healthy volunteers. Significant correlations between NYHA functional class and the ratios CR2/CR1, CR2/H20 (r = 0.59, P < .038, r = 0.59, P < .02, respectively) and between %LVEF and LIP/CR1 (r = 0.64, P < .036), as well as between the duration of the disease (TCH) and LIP/CR1 (r = 0.67, P < .046) were found. CONCLUSION: A pilot study with proton spectroscopy magnetic resonance showed impairment of the cardiac metabolism in patients with idiopathic dilated cardiomyopathy. A trend to lower values of creatine and lipids, and to lower ratios of some of these metabolites was observed in the dilated cardiomyopathy group compared with healthy subjects. The results require further study.

Adult↗
PubMed2002

Unexpected eosinophilic myocarditis in a young woman with rapidly progressive dilated cardiomyopathy.

We present the case of 23-year-old woman with good living conditions, one year history of ventricular arrhythmia and 6 months history of decreased exercise tolerance, who was found to have dilated cardiomyopathy after aborted sudden death. Endomyocardial biopsy did not show specific findings. Within 3 months she developed profound bradycardia requiring pacemaker implantation and refractory heart failure, treated with heart transplantation. Intense eosinophilic myocarditis was found in the explanted heart. Retrospective analysis of the patient's blood count revealed mild eosinophilia (eosinophil count: 0.86 x 109/l) on one examination only. Following heart transplantation the patient had persistent eisinophilia (eosinophil count: 0.62 x 109/l). Although there was no proven parasitic infestation, based on positive family history of Enterobius vermicularis infestation she was treated with broad-spectrum antiparasitic agent: albendazole and her eosinophil count returned to normal values. This case shows that active eosinophilic myocarditis may present clinically as progressive dilated cardiomyopathy with severe involvement of conduction system. Massive myocardial tissue eosinophilia occurred in the setting of mild and transient blood eosinophilia. Favourable outcome following antiparasitic treatment suggests a potential parasitic infestation as a cause of the disease.

Adult↗
PubMed2002

Active lymphocytic myocarditis treated with murine OKT3 monoclonal antibody in a patient presenting with intractable ventricular tachycardia.

This report describes the case of a 33-year-old woman with biopsy-proven, active lymphocytic myocarditis manifested by intractable ventricular tachycardia, nonspecific intraventricular block, and myocardial dysfunction. We treated hersuccessfully with OKT3 monoclonal antibody and antiarrhythmic agents. Immunosuppression is not recommended in patients with infectious or postinfectious myocarditis. However, it may have an important role in autoimmune myocarditis. In the few reports in the medical literature that we were able to find, OKT3 monoclonal antibody was administered early in the setting of acute, fulminant autoimmune myocarditis. Our patient received OKT3 therapy in a later phase of the disease, when inflammatory infiltrates were accompanied by extensive fibrosis and severe damage of cardiomyocytes. Our patient had concomitant Helicobacter pylori infection and a strong positive family history of gastric cancer, a disease often associated with H. pylori. We discuss the possibility of a causal relationship between H. pylori infection and autoimmune myocarditis.

Adult↗
PubMed2002

Late results of percutaneous balloon mitral commissurotomy in patients with restenosis after surgical commissurotomy compared to patients with 'de-novo' stenosis.

BACKGROUND AND AIMS OF THE STUDY: The outcome of percutaneous balloon mitral commissurotomy (BMC) has been reported as poor in patients with prior surgical commissurotomy. The study aim was to evaluate immediate and long-term follow up results of BMC in patients with restenosis after surgical commissurotomy compared to patients with 'de-novo' mitral stenosis. METHODS: Between October 1988 and September 1999, a total of 1,027 patients underwent BMC. Of these patients, 169 (16.5%) were examined at 17+/-7 years (range: 2-33 years) after surgical commissurotomy (group 1), and 858 (83.5%) had de-novo mitral stenosis (group 2). RESULTS: Group 1 patients were older than group 2 patients (49.4+/-9.3 versus 47.3+/-9.6 years; p <0.05), and atrial fibrillation was seen more often in group 1 (53.9% versus 32.4%; p <0.005). Before BMC, mitral valve area (MVA) was similar in both groups (1.18+/-0.27 and 1.15+/-0.26 cm2 in groups 1 and 2 respectively; p = NS); following BMC, MVA was 1.82+/-0.3 and 1.93+/-0.40 cm2 respectively (p <0.05). Four patients (2.4%) from group 1, and 24 (2.8%) from group 2 required mitral valve replacement due to severe regurgitation (p = NS). Annual clinical and echocardiographic evaluation was completed for 950 patients (mean follow up 56.2+/-31.1 months (range: 12-132 months). Cardiac events defined as death, valve surgery or repeat BMC occurred in 16.0% of patients in group 1, and in 9.6% of those in group 2. At follow up of three, five and 10 years, actuarial event-free survival was 85.7+/-2.9%, 79.8+/-3.8% and 65.2+/-7.5% respectively in group 1, and 93.4+/-0.9%, 90.1+/-1.1% and 72.7+/-3.9% respectively in group 2 (log rank test, p = 0.02). Multivariate analysis showed MVA <1.5 cm2 after BMC, mitral regurgitation grade >2/4, Wilkins score >8, and mean transmitral gradient and left atrial mean pressure post BMC to be independent predictors of an adverse event occurring during follow up. CONCLUSION: BMC in patients with restenosis after surgical commissurotomy is an effective method of treatment, and may help to avoid valve surgery in most patients.

Adult↗
PubMed2001

Staged transcatheter closure of chronic postinfarction ventricular septal defects with the Amplatzer septal occluder.

Ventricular septal rupture is a serious complication of myocardial infarction with an extremely poor outcome. There are single reports of transcatheter closure of postmyocardial septal defects and clinical experience is limited. This paper reports on a successful staged transcatheter closure of two chronic postmyocardial defects using the Amplatzer septal occluder in a 52-year-old male.

Journal Article↗