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Efficacy and safety of using perfusion dilatation catheter as initial balloon in coronary angioplasty
R Waksman1, Z M Ghazzal, N A Scott
1Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia 30322.
Insights
A new low-profile perfusion balloon catheter (PBC) is safe and effective for initial use in percutaneous coronary angioplasty (PTCA). This approach may reduce the number of balloons and inflations needed for successful procedures.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Percutaneous coronary angioplasty (PTCA) is a common procedure for treating coronary artery disease.
- Optimizing balloon catheter technology is crucial for improving PTCA outcomes and patient safety.
- The efficacy of novel low-profile perfusion balloon catheters (PBCs) as an initial device in PTCA requires evaluation.
Purpose of the Study:
- To assess the safety and efficacy of a new low-profile perfusion balloon catheter (PBC) as the initial balloon in percutaneous coronary angioplasty (PTCA).
- To evaluate the impact of using a PBC on procedural parameters such as balloon usage and inflation times.
- To determine the success rate and complication profile associated with the initial use of PBC in PTCA.
Main Methods:
- Retrospective analysis of 61 patients undergoing PTCA with a new low-profile perfusion balloon catheter (PBC) as the initial balloon.
- Data collection included patient demographics, lesion characteristics, procedural details (vessel treated, lesion morphology, artery size), and outcomes.
- Efficacy was defined as < 50% diameter stenosis without major complications; safety outcomes included dissection, reocclusion, and need for urgent intervention.
Main Results:
- PTCA was successful in 60 patients (98.4%), achieving a post-angioplasty diameter stenosis of 13 +/- 10.6%.
- The mean number of balloons used per procedure was 1.2, with 82% of patients requiring only one balloon.
- Complications were low, including mild intimal tear (9.8%) and stent implantation for severe dissection (4.9%); no deaths or emergency bypass surgery occurred.
Conclusions:
- A low-profile perfusion balloon catheter (PBC) is a safe and effective initial balloon choice for percutaneous coronary angioplasty (PTCA).
- The use of PBC may lead to a reduction in the number of balloons and total inflation time required during PTCA procedures.
- This technology demonstrates a favorable safety profile with a low incidence of significant complications.
Abstract:
The efficacy and safety in using a new low-profile perfusion balloon catheter (PBC) as the initial balloon in percutaneous coronary angioplasty (PTCA) was assessed retrospectively in 61 patients: 43 males, mean age 62 +/- 12 years. Thirty-three patients (54%) had unstable angina. PTCA was performed using an improved PBC in the following vessels: LAD 40%; CX 21%; RCA 24%. Lesion morphology was: Type A 21%; Type B1 18%; Type B2 40%; Type C 21%. Mean artery size was 3.01 +/- 0.53 mm. Mean PBC size was 3.14 +/- 0.45 mm. The mean number of inflations used was 2.85 +/- 2.0. The mean longest inflation was 415 +/- 213 sec and the total inflation time was 663 +/- 342 sec to a mean maximum pressure atmosphere of 7.85 +/- 2.0 bars. The number of balloons used per procedure was 1.2 +/- 0.44. In 50 patients (82%) only one balloon was used during the PTCA. PTCA was successful (< 50% diameter stenosis without major complications) in 60 patients (98.4%). Mean diameter stenosis at baseline was 82 +/- 9.5% and post-angioplasty 13 +/- 10.6%. A mild intimal tear occurred in 6 patients (9.8%). A stent was implanted in 3 patients (4.9%) due to severe dissection. In hospital reocclusion occurred in one patient (1.6%). There were no deaths or emergency bypass surgery. A low profile PBC is safe and effective as an initial balloon in PTCA. It may reduce the number of balloons used and inflations per procedure.
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