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Biomedical subjects

Jan Ravkilde

Publications and source records attributed to Jan Ravkilde.

7 recordsLinked to original sources
PubMed2006

Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study.

BACKGROUND: The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MV+SB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents. METHODS AND RESULTS: A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MV+SB 3.4%, MV 2.9%; P=NS). In the MV+SB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. The combined angiographic end point of diameter stenosis >50% of main vessel and occlusion of the side branch after 8 months was found in 5.3% in the MV group and 5.1% in the MV+SB group (P=NS). CONCLUSIONS: Independent of stenting strategy, excellent clinical and angiographic results were obtained with percutaneous treatment of de novo coronary artery bifurcation lesions with sirolimus-eluting stents. The simple stenting strategy used in the MV group was associated with reduced procedure and fluoroscopy times and lower rates of procedure-related biomarker elevation. Therefore, this strategy can be recommended as the routine bifurcation stenting technique.

Coronary Angiography↗
PubMed2005

Future biomarkers for detection of ischemia and risk stratification in acute coronary syndrome.

BACKGROUND: Evaluation of patients who present to the hospital with a complaint of chest pain or other signs or symptoms suggestive of acute coronary syndrome (ACS) is time-consuming, expensive, and problematic. Recent investigations have indicated that increases in biomarkers upstream from biomarkers of necrosis (cardiac troponins I and T), such as inflammatory cytokines, cellular adhesion molecules, acute-phase reactants, plaque destabilization and rupture biomarkers, biomarkers of ischemia, and biomarkers of myocardial stretch may provide earlier assessment of overall patient risk and aid in identifying patients with higher risk of an adverse event. APPROACH AND CONTENT: The purpose of this review is to provide an overview of the pathophysiology and clinical and analytical characteristics of several biomarkers that may have potential clinical utility to identify ACS patients. These biomarkers (myeloperoxidase, metalloproteinase-9, soluble CD40 ligand, pregnancy-associated plasma protein A, choline, ischemia-modified albumin, unbound free fatty acids, glycogen phosphorylase isoenzyme BB, and placental growth factor) have demonstrated promise and need to be more thoroughly evaluated for commercial development for implementation into routine clinical and laboratory practice. SUMMARY: Specifications that have been addressed for cardiac troponins and natriuretic peptides will need to be addressed with the same scrutiny for the biomarkers discussed in this review. They include validating analytical imprecision and detection limits, calibrator characterization, assay specificity and standardization, pre-analytical issues, and appropriate reference interval studies. Crossing boundaries from research to clinical application will require replication in multiple settings and experimental evidence supporting a pathophysiologic role and, ideally, interventional trials demonstrating that monitoring single or multiple biomarkers improves outcomes.

Acute Disease↗
PubMed2005

Haematoma after coronary angiography and percutaneous coronary intervention via the femoral artery frequency and risk factors.

BACKGROUND: The most common complication after coronary angiography (CA) and percutaneous coronary intervention (PCI) is the development of haematoma. Several changes in procedures regarding CA and PCI have been made in our department in recent years. The aim of this audit is to establish how many patients develop haematoma after CA/PCI via the femoral artery and subsequently to find predictors that increase the risk of developing haematoma. METHODS: We initially included 474 consecutive patients-322 patients undergoing CA and 141 patients undergoing PCI. Eleven patients were later excluded due to the absence of complete data. Thirty-three variables were registered in order to find predictors, which might increase the haematoma frequency. A univariate as well as a multivariate logistic regression analysis was performed. RESULTS: Of the 463 patients, 6 patients developed a haematoma >10 cm (1.3%) and 41 patients developed a haematoma >5 cm (8.9%). The following factors were found to be associated with the generation of haematoma: Women, systolic blood pressure >160 mm Hg, artery puncture >1, sheath time >16 min, ACT > or = 175 s, Glycoprotein (GP) IIB/IIIa inhibitors, Low Molecular Weight Heparin before procedure, personnel change during compression, and anti-coagulant-treatment before procedure. CONCLUSIONS: The frequency of haematoma was 1.3% (>10 cm) and 8.9% (>5 cm), which corresponds with reports from similar studies and departments. The factors found to increase the risk of haematoma development can provide background for procedural changes and increase the focus on patients at increased risk in order to minimize the development of haematomas.

Aged↗
PubMed2005

Biochemical diagnosis of myocardial infarction evolves towards ESC/ACC consensus: experiences from the Nordic countries.

OBJECTIVES: To investigate the diagnostic approach in Nordic hospitals receiving patients suspected of acute myocardial infarction (MI), especially focusing on implementation of the recently proposed criteria by the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) for the definition of MI. DESIGN: A survey with questionnaires of the diagnostic approach was conducted among all relevant departments (220) in the Nordic countries. RESULTS: Seventy-six percent (167) of hospitals responded. Troponins I and T (TnI and TnT) and creatinine kinase monobasic fraction (mass concentration) (CKMB(mass)) covered 93 and 65% of hospitals, respectively. Of troponin users, 34% indicated use of TnI vs 66% using TnT. Sporadic use of AST, CK, LD and myoglobin was reported. There was a tendency to lower cut-off levels in Sweden and Finland. Among troponin assays, there was considerable heterogeneity regarding cut-off levels. CONCLUSIONS: The Nordic countries are approaching ESC/ACC consensus on cardiac markers. Compared with previous national surveys (1995-1999), there is a shift towards the use of troponins. However, differences in cut-off levels of troponin emphasize the need for harmonization of assays.

Biomarkers↗
PubMed2005

Quality specifications for B-type natriuretic peptide assays.

BACKGROUND: The objective of this report is to improve the quality of immunochemical measurements of B-type natriuretic peptide (BNP) and its N-terminal propeptide (NT-proBNP). The recommendations proposed are intended for use by manufacturers of commercial assays, by clinical laboratories using those assays, by clinical trial groups and research investigators, and by regulatory agencies, such as the United States Food and Drug Administration. METHODS: A group of cardiac biomarker experts reviewed and abstracted the scientific literature to provide recommendations pertaining to the quality specifications for BNP/NT-proBNP assays. RESULTS: The evidence-based recommendations encourage manufacturers to endorse and consistently follow the proposed recommendations; encourage that all package inserts for BNP/NT-proBNP immunoassays include uniform information on assay design, preanalytical performance characteristics, analytical performance characteristics, and clinical performance; and encourage regulatory agencies to adopt a minimal and uniform set of criteria for manufacturers to provide when seeking clearance for new and/or improved assays. CONCLUSIONS: These recommendations address the use of BNP and NT-proBNP as cardiac biomarkers and not their physiologic and/or pathophysiologic relevance.

Biomarkers↗
PubMed2003

Evaluation of imprecision for cardiac troponin assays at low-range concentrations.

BACKGROUND: The European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction (MI) has recommended that an increased cardiac troponin should be defined as a measurement above the 99th percentile value of the reference group. A total imprecision (CV) at the decision limit of </=10% is recommended. However, peer-reviewed data on assay imprecision are lacking. The purpose of this study was to construct the clinically relevant imprecision profiles for each of the commercially available cardiac troponin assays. Pools of human sera containing cardiac troponin concentrations around the MI decision limit were assessed to identify the lowest concentration associated with a 10% CV. METHODS: Eight serum pools targeting different concentrations of cardiac troponin (I and T) were prepared and stored at -70 degrees C until usage. The cardiac troponin measurement protocol consisted of two replicates per specimen per run, and one run per day for 20 days, using two reagent lots and three calibrations. Manufacturers of each cardiac troponin assay directly performed the measurements. Data analysis for each assay was centralized and performed according to the NCCLS EP5-A guideline. RESULTS: The lowest concentrations (microg/L) providing a 10% CV were as follows: AxSYM, 1.22; ACS:180, 0.37; Centaur, 0.33; Immuno 1, 0.34; Access, 0.06; Vidas, 0.36; Liaison, 0.065; Dimension, 0.26; Opus, 0.90; Stratus CS, 0.10; Immulite, 0.32; Vitros ECi, 0.44; Elecsys, 0.04; AIA 21, 0.09. CONCLUSION: No cardiac troponin assay was able to achieve the 10% CV recommendation at the 99th percentile reference limit defined by the manufacturer.

Clinical Chemistry Tests↗