Safety and acceptable initial outcomes of reused balloon catheters for percutaneous transluminal coronary angioplasty.

ABSTRACT

OBJECTIVES: This study was conducted to compare the safety and initial outcomes applying reused balloon (RB) catheters with those of attained new balloon (NB) catheters when performing percutaneous transluminal coronary angioplasty. BACKGROUND: Recently, PTCA procedures have been used increasingly for the treatment of patients with coronary heart disease. In the era of national economic constraint, reused balloon catheters will reduce the cost of expensive, imported coronary angioplasty devices. Hence, data concerning the safety and success rate of RB catheters compared with NB catheters are urgently required. METHODS: Prospective comparative study between reused and new balloon catheters for coronary angioplasty. Data forms were completed after each procedure and before the patient was discharged after an 18-month period. RESULTS: From July 1996 to December 1997, 221 cases (121-RB, 100-NB) were enrolled. Mean age, ejection fraction, diseased vessel and lesion characteristics were similar in both groups. The number of lesions was much higher performed in the RB than in the NB group (1.7 +/- 0.9 vs 1.4 +/- 0.8, p = 0.02). The RB group had more cases of acute myocardial infarction than the NB group (7.4% vs 1%, p = 0.003), however, the angiographic and case success rate were the same (99.5% vs 97.9% and 98.3% vs 97% respectively). Major adverse cardiac events in RB amounted to 1.7 per cent and for NB to 1.0 per cent (p = ns). The total amount of balloons used in RB was much higher than in the NB group (1.5 +/- 0.6 vs 1.1 +/- 0.3, p = <0.0001). There were neither infection nor positive blood cultures in either group. CONCLUSIONS: Reused balloon catheters can be safely used for percutaneous transluminal coronary angioplasty with a high success rate. The total cost of angioplasty can be reduced without a decline in efficacy.