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Clinical experience with the ACS RX Lifestream coronary dilatation catheter: a new low profile perfusion balloon
Insights
The ACS RX Lifestream Catheter offers improved performance in percutaneous transluminal coronary angioplasty (PTCA) and bare stent procedures. This new perfusion balloon catheter (PBC) shows promise for treating more complex coronary lesions.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
Background:
- Perfusion balloon catheters (PBCs) have limitations in percutaneous transluminal coronary angioplasty (PTCA).
- The ACS RX Lifestream Coronary Dilatation Catheter was developed to overcome these limitations with improved materials and design.
Purpose of the Study:
- To evaluate the performance of the ACS RX Lifestream Catheter in both PTCA and coronary stent implantation.
- Assess the catheter's efficacy in a diverse patient cohort with various coronary artery diseases.
Main Methods:
- A prospective study involving 45 patients undergoing PTCA or stent procedures using the ACS RX Lifestream Catheter.
- The catheter was used for predilation, stent delivery, and post-dilation in bare metal stent procedures.
- Data collected included procedural success, complications, and lesion characteristics.
Main Results:
- Successful dilation of 49 lesions across 45 cases without complications, including complex lesion types (B2, C).
- 15 successful bare metal stent implantations were performed using the catheter for predilation and post-dilation.
- Significant reduction in diameter stenosis from 81% pre-procedure to 12.8% post-procedure.
Conclusions:
- The ACS RX Lifestream Catheter is an effective device for both PTCA and bare stent procedures.
- Its design allows for expanded indications, including more challenging coronary lesions.
Background:
Although the use of the perfusion balloon catheter (PBC) has been widely accepted, there are some indicational limitations in percutaneous transluminal coronary angioplasty (PTCA). A new low profile perfusion balloon catheter, the ACS RX Lifestream Coronary Dilatation Catheter, was developed by Advanced Cardiovascular Systems, Inc. in which material and structures were improved to reduce previous limitations. PURPOSE AND STUDY DESIGN: In order to evaluate the ACS RX Lifestream 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. Exclusions included total occlusions, long diffuse and acute MI lesions. There 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 & Johnson metal stent was mounted on an ACS RX Lifestream Catheter previously used for predilation. Stent delivery and post-dilatation were performed using the same balloon.
Results:
Forty-nine lesions in 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 without any complications. Primary guiding catheter use was 6F in 40, 7F in 2 and 8F in 3 cases. The perfusion balloon was used alone in 30 cases and combined with stent placement in 15 cases. In 40 cases of 6F use, the ACS RX Lifestream Catheter could not cross the lesion in 3 cases at first attempt, of which 2 cases were successfully dilated with the balloon after predilatation with standard low-profile balloon catheters. 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 Catheters and ACS RX Flowtrack Coronary Dilatation Catheters were examined with a flow-wire in the same lesion for comparison. 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 secondary use, were successful. Percent diameter stenosis pre-dilatation was 81% and 12.8% post-procedure.
Conclusion:
ACS RX Lifestream Catheter is a useful device in both PTCA and bare stent procedures. Consequently, it is possible to expand its indications to more difficult types of lesions.