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Assessment of a percutaneous Hemopump in high risk coronary angioplasty patients
J L Dubois-Randé1, P Deleuze, P Dupouy
1Department of Cardiology and Surgical Research, CNRS URA 1431, Henri Mondor Hospital, Greteil, France.
Insights
The 14 Fr Hemopump device is safe and effective for high-risk patients undergoing percutaneous transluminal coronary angioplasty (PTCA). It successfully unloads the left ventricle, maintaining aortic pressure and cardiac output during the procedure.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- High-risk patients undergoing percutaneous transluminal coronary angioplasty (PTCA) often have compromised left ventricular function.
- Prophylactic use of circulatory support devices during high-risk PTCA is an area of ongoing research.
Purpose of the Study:
- To assess the safety and efficacy of a new 14 Fr Hemopump device in high-risk patients undergoing PTCA.
- To evaluate the Hemopump's ability to unload the left ventricle and maintain hemodynamic stability during PTCA.
Main Methods:
- Ten high-risk patients underwent PTCA with prophylactic use of the 14 Fr Hemopump, inserted percutaneously into the left ventricle.
- Hemodynamic parameters (pulmonary capillary wedge pressure, cardiac output, mean aortic pressure) were recorded before, during, and after PTCA with the Hemopump on and off.
- Device placement, procedural success, adverse events, and patient outcomes were monitored.
Main Results:
- Adequate Hemopump placement was achieved in all patients, with moderate temporary rhythm instability in some.
- Pulmonary capillary wedge pressure significantly decreased during Hemopump assist (22 +/- 8 mmHg vs. 29 +/- 7 mmHg, P < 0.05).
- Aortic blood pressure was maintained during a temporary cardiac arrest in one patient; one patient died of cardiogenic shock, while eight survived long-term.
Conclusions:
- The 14 Fr percutaneous Hemopump is a safe device for high-risk PTCA patients.
- The Hemopump effectively unloads the left ventricle during PTCA while maintaining mean aortic pressure and cardiac output.
- The device shows promise as a prophylactic measure in complex interventional cardiology procedures.
Abstract:
This study assessed the safety and efficacy of a new 14 Fr Hemopump device. Ten high risk patients requiring percutaneous transluminal coronary angioplasty (PTCA) (last remaining patent vessel or low left ventricular ejection fraction) underwent PTCA with the prophylactic use of the Hemopump. This device was inserted percutaneously through the femoral artery using a 16 Fr sheath and placed into the left ventricle. Hemodynamic parameters (pulmonary capillary wedge pressure, cardiac output, mean aortic pressure) were recorded before, during, and after PTCA when the Hemopump was on and off. Adequate placement of the Hemopump was obtained in all patients with moderate temporary rhythm instability, and PTCA was performed in all patients. Under assist, pulmonary capillary wedge pressure was 22 +/- 8 mmHg, compared with 29 +/- 7 mmHg (P < 0.05), whereas no significant change in other hemodynamic parameters was observed. One patient experienced ventricular fibrillation twice during PTCA, which was correlated by electrical cardioversion. During this temporary cardiac arrest, the aortic blood pressure was maintained at 50 mmHg with the Hemopump. For all patients, the Hemopump was withdrawn 15 min after the end of PTCA, and the sheath was removed 4-6 hr later. However, two patients required surgical sheath removal. One patient died of cardiogenic shock in the intensive care unit. Other patients were discharged 3 days after the procedure. Long-term follow-up shows eight surviving patients. These data show that 1) the 14 Fr percutaneous Hemopump is safe, and 2) can unload the left ventricle during PTCA while maintaining mean aortic pressure and cardiac output.