CLINICAL-EXPERIENCE WITH THE ACS RX LIFESTREAM(TM) CORONARY DILATATION CATHETER - A NEW LOW-PROFILE PERFUSION BALLOON CATHETER

Background: Although the use of the perfusion balloon catheter (PBC) h as been widely accepted, there are some indicational limitations in pe rcutaneous transluminal coronary angioplasty (PTCA). A new low profile perfusion balloon catheter, the ACS RX Lifestream(TM) Coronary Dilata tion Catheter, was developed by Advanced Cardiovascular Systems, Inc. in which material and structures were improved to reduce previous limi tations. Purpose and study design: In order to evaluate the ACS RX Lif estream(TM) Catheter's performance not only in PTCA but also in stent implantation, we used the catheter in 45 consecutive patients (male = 35, mean age 66 years) with combined use of 6F guiding catheter. Exclu sions included total occlusions, long diffuse and acute MI lesions. Th ere were 4 with Left Main Trunk Disease (LMTD), 15 with single vessel disease, 26 with multi-vessel disease, 20 with prior MI, 4 with prior CABG, and 10 with unstable angina. In bare stent procedures, a Johnson and Johnson metal stent was mounted on an ACS RX Lifestream(TM) Cathe ter previously used for predilation. Stent delivery and post-dilatatio n were performed using the same balloon. Results: Forty-nine lesions i n 45 cases (de novo lesion - 31) including 7 of Type A, 15 of Type B1, 19 of Type B2, and 8 of Type C lesions were successfully dilated with out any complications. Primary guiding catheter use was 6F in 40, 7F i n 2 and 8F in 3 cases. The perfusion balloon was used alone in 30 case s and combined with stent placement in 15 cases. In 40 cases of 6F use , the ACS RX Lifestream(TM) Catheter could not cross the lesion in 3 c ases at first attempt, of which 2 cases were successfully dilated with the balloon after predilatation with standard low-profile balloon cat heters. Two cases with 7F use were bail-out cases after PTCA for long diffuse lesions. In one case of 8F guide use, flow patterns of ACS RX Lifestream(TM) Catheters and ACS RX Flowtrack(TM) Coronary Dilatation Catheters were examined with a flow-wire in the same lesion for compar ison. All 15 stent cases performed using bare technique (10 with 6F, 2 with 7F and 3 with 8F guiding catheters) including 7 primary and 8 se condary use, were successful. Percent diameter stenosis pre-dilatation was 81% and 12.8% post-procedure. Conclusion: ACS RX Lifestream(TM) C atheter is a useful device in both PTCA and bare stent procedures. Con sequently, it is possible to expand its indications to more difficult types of lesions.