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Coronary artery angioplasty with a helical autoperfusion balloon catheter
P A Gurbel1, R D Anderson, H O Peels
1Heart Associates Research and Education Foundation, Union Memorial Hospital, Baltimore, Maryland 21218, USA.
Insights
A novel helical autoperfusion balloon catheter enables prolonged percutaneous coronary intervention (PCI) inflations. This device demonstrated hemodynamic stability and successfully treated coronary artery disease lesions.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Percutaneous transluminal coronary angioplasty (PTCA) is a common treatment for coronary artery disease.
- Prolonged balloon inflations during PTCA can be limited by hemodynamic instability.
- A novel helical autoperfusion balloon catheter was developed to address these limitations.
Purpose of the Study:
- To report the initial clinical experience with a helical autoperfusion balloon catheter.
- To evaluate its safety and efficacy in treating coronary artery disease.
- To assess hemodynamic stability during prolonged inflations.
Main Methods:
- Twelve consecutive patients with coronary artery disease underwent PTCA using the helical autoperfusion balloon catheter.
- Hemodynamic parameters, ST monitoring, and coronary blood flow were assessed during balloon inflation.
- Luminal diameter stenosis was measured before and after PTCA.
Main Results:
- No hemodynamic changes or in-hospital adverse cardiac events were observed during balloon inflations.
- Mean inflation duration was 385 +/- 215 seconds, with 6/12 patients exceeding 7.5 minutes.
- Luminal diameter stenosis improved significantly from 61% to 29% (P < 0.05).
- TIMI flow was 1.7 +/- 0.8, and average peak distal coronary blood flow velocity was 39% of baseline during inflation.
Conclusions:
- The helical autoperfusion balloon catheter allows for safe and effective dilation of human coronary plaques.
- The device facilitates prolonged inflations with maintained hemodynamic stability.
- Further comparison with standard balloon catheters is warranted.
Abstract:
The initial in-hospital and long-term clinical experience with a helical autoperfusion balloon catheter in the treatment of coronary artery disease is reported. This new catheter design allows blood to flow passively around the inflated balloon through a protected helical channel molded into the balloon surface. Twelve consecutive patients underwent PTCA. Continuous ST monitoring, heart rate, average peak distal coronary blood flow velocity (APV), coronary blood flow (CBF), dP/dt and systemic and pulmonary arterial pressures were determined during PTCA. During balloon inflation there were no hemodynamic changes, TIMI flow was 1.7 +/- 0.8, and APV was 39% of baseline. Luminal diameter stenosis improved from 61 +/- 17 to 29 +/- 13% (P < 0.05) following PTCA. Mean continuous inflation duration was 385 +/- 215 sec and 6/12 patients had > or = 7.5-min inflations. There were no in-hospital adverse cardiac events. One patient developed recurrent angina during 8 mo of follow-up and underwent successful PTCA of a restenotic lesion. We conclude that human plaques can be successfully dilated with a helical balloon catheter that provides autoperfusion and the ability to perform prolonged inflations with hemodynamic stability. A comparison of this PTCA catheter with standard balloon catheters is warranted.