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The Sternotomy Hemopump. A second generation intraarterial ventricular assist device
R K Wampler1, W Aboul-Hosn, M Cleary
1Johnson and Johnson Interventional Systems, Rancho Cordova, CA 95670.
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|July 1, 1993
Summary
The improved Sternotomy Hemopump offers enhanced hemodynamic support for cardiogenic shock patients. This second-generation ventricular assist device (VAD) shows high reliability and reduced complications, paving the way for new clinical trials.
Area of Science:
- Biomedical Engineering
- Cardiovascular Devices
- Medical Technology
Background:
- The first-generation Hemopump, an intra-arterial axial flow blood pump, demonstrated clinical efficacy in cardiogenic shock but faced limitations.
- Issues included device non-insertion, drive cable fractures, and manufacturing scalability challenges, hindering its widespread adoption.
Purpose of the Study:
- To introduce and evaluate the second-generation Sternotomy Hemopump, designed for improved reliability and manufacturing.
- To assess the hemodynamic performance, biocompatibility, and durability of the redesigned device.
Main Methods:
- The Sternotomy Hemopump features design modifications for ascending aorta insertion, including a shorter inflow cannula and a more robust drive cable.
- Performance was evaluated using pulsatile mock loop testing, in vivo experiments (up to 2 weeks), and in vitro endurance testing.
Main Results:
- The device achieved a flow of 5.7 L/min at 100 mmHg in mock loop tests.
- In vivo studies showed low plasma free hemoglobin (mean 8.7 mg/dl), minimal valve injury, and acceptable renal infarction rates.
- In vitro endurance testing demonstrated 99.9% reliability over 7 days with 95% confidence.
Conclusions:
- The Sternotomy Hemopump represents a significant advancement over the first-generation device, addressing previous limitations.
- Its improved design, performance, and reliability support its evaluation in upcoming clinical trials, including its use in aorto-coronary artery bypass surgery.