OBJECTIVES: The purpose of this study was to evaluate the effectiveness of radiofrequency thermal balloon angioplasty and rescue procedure after abrupt or threatened vessel closure complicating elective percutaneous transluminal coronary angioplasty. BACKGROUND:Coronary angioplasty is an established therapy for ischemic heart disease. However, abrupt closure after successful angioplasty remains a serious problem. METHOD: We utilized a unipolar radiofrequency balloon in which a radiofrequency potential of 13.56 MHz was transmitted between the coil within the balloon and a plate electrode attached to the patient's body. The temperature within the balloon could be monitored through a thermistor within the balloon. From October 1991 through December 1993, 31 patients who had abrupt or threatened vessel closure during 1,005 consecutive elective coronary angioplasty procedures were randomly assigned to radiofrequency balloon angioplasty or to other procedures as rescue RESULTS:Fifteen patients were assigned to radiofrequency balloon angioplasty (5 with abrupt vessel closure and 10 with threatened closure). The average balloon temperature and inflation time were 62 +/- 9 degrees C and 129 +/- 62 s, respectively. Percent diameter stenosis decreased from 87 +/- 14% to 36 +/- 25% (p < 0.01). The procedure was successful in 14 patients. The rate of restenosis was 67%, but the success rate of repeat conventional coronary angioplasty for restenosed lesions was 86%. CONCLUSIONS:Radiofrequency balloon angioplasty is effective in the treatment of abrupt or threatened vessel closure complicating elective coronary angioplasty even though the procedure is associated with a relatively high rate of restenosis.
RCT Entities:
OBJECTIVES: The purpose of this study was to evaluate the effectiveness of radiofrequency thermal balloon angioplasty and rescue procedure after abrupt or threatened vessel closure complicating elective percutaneous transluminal coronary angioplasty. BACKGROUND: Coronary angioplasty is an established therapy for ischemic heart disease. However, abrupt closure after successful angioplasty remains a serious problem. METHOD: We utilized a unipolar radiofrequency balloon in which a radiofrequency potential of 13.56 MHz was transmitted between the coil within the balloon and a plate electrode attached to the patient's body. The temperature within the balloon could be monitored through a thermistor within the balloon. From October 1991 through December 1993, 31 patients who had abrupt or threatened vessel closure during 1,005 consecutive elective coronary angioplasty procedures were randomly assigned to radiofrequency balloon angioplasty or to other procedures as rescue RESULTS: Fifteen patients were assigned to radiofrequency balloon angioplasty (5 with abrupt vessel closure and 10 with threatened closure). The average balloon temperature and inflation time were 62 +/- 9 degrees C and 129 +/- 62 s, respectively. Percent diameter stenosis decreased from 87 +/- 14% to 36 +/- 25% (p < 0.01). The procedure was successful in 14 patients. The rate of restenosis was 67%, but the success rate of repeat conventional coronary angioplasty for restenosed lesions was 86%. CONCLUSIONS: Radiofrequency balloon angioplasty is effective in the treatment of abrupt or threatened vessel closure complicating elective coronary angioplasty even though the procedure is associated with a relatively high rate of restenosis.