ABSTRACT
BACKGROUND: To lower costs, many centers around the world utilize previously used, resterilized balloon catheters to perform coronary angioplasty There are no controlled trials regarding their safety and efficacy. METHODS AND RESULTS: We performed the first randomized, double-blind, controlled, single-center clinical trial comparing the safety (clinical success) and efficacy (angiographic success) of reused versus new coronary angioplasty balloon catheters. A total of 377 procedures were included, 178 in the reused catheter arm and 199 in the new catheter arm. There were no significant differences in clinical or lesion characteristics among the two arms. The incidence of first balloon failure in the reused catheter arm was similar to that of the new catheter arm (12 cases [7%] v. 10 cases [5%], respectively). The angiographic success rate was also similar-176 cases (98.9%) in the reused catheter arm and 196 cases (98.5%) in the new catheter arm. The number of balloon catheters used per lesion, amount of contrast, and procedural and fluoroscopy time were similar in the two arms. At 30 days, the incidence of major adverse cardiac events was similar in both arms, 8 cases (4.5%) in the reused catheter arm and 10 cases (5%) in the new catheter arm. The incidence of fever was also similar. CONCLUSIONS: When performing coronary angioplasty, reused catheters are as effective (similar angiographic success) and safe (similar clinical success) as new catheters.
Subject(s)
Adult , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/instrumentation , Coronary Disease/diagnosis , Double-Blind Method , Equipment Reuse , Equipment Safety , Female , Follow-Up Studies , Humans , India , Male , Middle Aged , Probability , Reference Values , Treatment OutcomeSubject(s)
Adolescent , Adult , Aortic Valve Stenosis/physiopathology , Blood Pressure , Cardiac Output , Female , Heart Ventricles/physiopathology , Humans , Male , Methoxamine/diagnosis , Middle Aged , Systole , Vascular ResistanceABSTRACT
Os autores apresentam resultados de uma serie de 91 pacientes com hipertensao pulmonar primaria observada em area tropical.Havia predominancia de doentes do sexo masculino, ao contrario do constatado em regioes nao tropicais. Praticamente, todos os pacientes apresentavam dispneia de esforco. Alteracoes eletrocardiograficas com aumento de voltagem de onda R em V1 tinham forte correlacao positiva com o nivel de pressao arterial pulmonar. Alteracoes da conducao de estimulo eletrico eram pouco frequentes. Era destacada em 90% dos casos o aumento de tamanho das arterias pulmonares, apreciado sob o aspecto radiologico.Pressao arterial pulmonar sistolica superior a 90 mmHg foi registrada em cerca de 70% dos doentes, sendo que em cerca de 49% ela superava o nivel sistemico. De um total de 58 pacientes seguidos, 34 morreram dentro de um periodo medio de 20 meses.Nao se podem determinar as razoes para o maior grau de severidade observado nesta serie, sendo possivel a participacao de um fator etnico