Evaluation of an active coronary perfusion balloon device using Doppler flow wire during PTCA

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Percutaneous transluminal coronary angioplasty (PTCA) risks myocardial ischemia during balloon inflation.
• Active coronary perfusion catheters (APC) are proposed to prevent ischemia by maintaining coronary flow.
• The efficacy of APC in providing sufficient flow in large coronary vessels during PTCA remains under investigation.

Purpose of the Study:

• To evaluate if active coronary perfusion catheters (APC) can deliver adequate coronary blood flow during balloon inflation in large caliber vessels.
• To compare the active perfusion rate of APC with pre-PTCA flow rates.
• To assess the safety and clinical outcomes associated with APC use during PTCA.

Main Methods:

• Conducted a study on 12 patients with stenosed large caliber coronary vessels (average diameter 3.4 mm).
• Measured coronary flow velocity using a Doppler guidewire placed distally to the APC balloon.
• Calculated intracoronary flow rate using Doppler velocity and quantitative coronary angiography, with pump rates set between 30-60 ml/min.

Main Results:

• Pre-PTCA flow rates were achieved in 92% of patients during balloon inflation (mean flow 43 ml/min vs. 55 ml/min during PTCA).
• A strong correlation (r=0.92) was observed between preset pump rates and actual coronary flow.
• No significant decrease in arterial pressure or major ECG changes occurred; only 8% experienced restenosis at follow-up.

Conclusions:

• Active coronary perfusion catheters (APC) can maintain sufficient distal coronary flow during PTCA balloon inflation, even in large vessels.
• This method is minimally invasive compared to circulatory assist devices and appears effective for high-risk patients.
• Combining Doppler velocity and quantitative coronary angiography allows precise online flow monitoring during angioplasty.