108 research outputs found
Considering Usual Medical Care in Clinical Trial Design
Liza Dawson and colleagues discuss the scientific and ethical issues associated with choosing clinical trial designs when there is no consensus on what constitutes usual care
Recommended from our members
Acute complications of excimer laser coronary angioplasty: a detailed analysis of multicenter results. Coinvestigators of the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) Registries.
ObjectivesThe aim of this study was to document and analyze the incidence and consequences of complications of excimer laser coronary angioplasty.BackgroundExcimer laser coronary angioplasty has been reported to be a safe and feasible alternative or adjunct to conventional balloon angioplasty, but serious and unique complications have been observed.MethodsData on 1,595 interventions of excimer laser coronary angioplasty in 1,521 patients were analyzed, using a merged data base from the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) registries.ResultsProcedural success was achieved in 89.3% of interventions. Stand-alone laser angioplasty was performed in 17.8% of interventions. Complications included dissection (22.0%), vasospasm (6.1%), filling defects (4.8%), abrupt reclosure (6.1%), embolization (2.3%), perforation (2.4%), arrhythmia (0.7%) and aneurysm formation (0.3%). Major complications were non-Q wave myocardial infarction (2.3%), Q wave myocardial infarction (1.0%), coronary artery bypass grafting (3.1%) and death (0.7%). Logistic regression analysis revealed correlation between dissections and the use of larger catheter size (p = 0.0005), high energy per pulse levels (p = 0.0001 for native vessels), lesion length > 10 mm (p = 0.001) and presence of a side branch (p = 0.01). The incidence of perforations was higher in women (p = 0.004), in treatment of total occlusions (p = 0.02) and in the presence of a side branch (p = 0.03). Fatal complications were correlated with patients with multivessel disease (p < 0.0001), patients with acute myocardial infarction (p = 0.0009) and older patients (> 70 years old, p = 0.004). The incidence of major complications decreased after performance of 50 laser angioplasty procedures at one institution (p = 0.02).ConclusionsThis analysis defines both the learning curve and the profile of complications for excimer laser angioplasty and provides insight into the selection of appropriate patients and proper performance of the procedure
Recommended from our members
Acute complications of excimer laser coronary angioplasty: a detailed analysis of multicenter results. Coinvestigators of the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) Registries.
ObjectivesThe aim of this study was to document and analyze the incidence and consequences of complications of excimer laser coronary angioplasty.BackgroundExcimer laser coronary angioplasty has been reported to be a safe and feasible alternative or adjunct to conventional balloon angioplasty, but serious and unique complications have been observed.MethodsData on 1,595 interventions of excimer laser coronary angioplasty in 1,521 patients were analyzed, using a merged data base from the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) registries.ResultsProcedural success was achieved in 89.3% of interventions. Stand-alone laser angioplasty was performed in 17.8% of interventions. Complications included dissection (22.0%), vasospasm (6.1%), filling defects (4.8%), abrupt reclosure (6.1%), embolization (2.3%), perforation (2.4%), arrhythmia (0.7%) and aneurysm formation (0.3%). Major complications were non-Q wave myocardial infarction (2.3%), Q wave myocardial infarction (1.0%), coronary artery bypass grafting (3.1%) and death (0.7%). Logistic regression analysis revealed correlation between dissections and the use of larger catheter size (p = 0.0005), high energy per pulse levels (p = 0.0001 for native vessels), lesion length > 10 mm (p = 0.001) and presence of a side branch (p = 0.01). The incidence of perforations was higher in women (p = 0.004), in treatment of total occlusions (p = 0.02) and in the presence of a side branch (p = 0.03). Fatal complications were correlated with patients with multivessel disease (p < 0.0001), patients with acute myocardial infarction (p = 0.0009) and older patients (> 70 years old, p = 0.004). The incidence of major complications decreased after performance of 50 laser angioplasty procedures at one institution (p = 0.02).ConclusionsThis analysis defines both the learning curve and the profile of complications for excimer laser angioplasty and provides insight into the selection of appropriate patients and proper performance of the procedure
The role of ischemic mitral regurgitation in the pathogenesis of acute pulmonary edema
BACKGROUND: Acute mitral regurgitation may cause pulmonary edema, but the pathogenetic role of chronic ischemic mitral regurgitation, a dynamic condition, has not yet been characterized. METHODS: We prospectively studied 28 patients (mean [+/-SD] age, 65+/-11 years) with acute pulmonary edema and left ventricular systolic dysfunction and 46 patients without a history of acute pulmonary edema. The two groups were matched for all baseline characteristics. Patients underwent quantitative Doppler echocardiography during exercise. Exercise-induced changes in the left ventricular volume, the ejection fraction, the mitral regurgitant volume, the effective regurgitant orifice area, and the transtricuspid pressure gradient were compared in patients with and without acute pulmonary edema. RESULTS: The two groups had similar clinical and baseline echocardiographic characteristics. They also had similar exercise-induced changes in heart rate, systolic blood pressure, and left ventricular volumes. In the univariate analysis, patients with recent pulmonary edema had a much higher increase than did the patients without pulmonary edema in mitral regurgitant volume (26+/-14 ml vs. 5+/-14 ml, P<0.001), the effective regurgitant orifice area (16+/-10 mm(sup 2) vs. 2+/-9 mm(sup 2), P<0.001), and the transtricuspid pressure gradient (29+/-10 mm Hg vs. 13+/-11 mm Hg, P<0.001). In the multivariate analysis, exercise-induced changes in the effective regurgitant orifice area (P<0.001), in the transtricuspid pressure gradient (P=0.001), and in the left ventricular ejection fraction (P=0.02) were independently associated with a history of recent pulmonary edema. CONCLUSIONS: In patients with left ventricular systolic dysfunction, acute pulmonary edema is associated with the dynamic changes in ischemic mitral regurgitation and the resulting increase in pulmonary vascular pressure
- …