None listed
Conditions
Brief summary
We propose treating hypertensive moderate heart failure by directly treating aortic stiffness (increasing aortic distensibility; increasing expansion and contraction). Our passive recoil extra aortic balloon counterpulsation device, the BioQ Cardiac Assist device (BioQ CA), reduces aortic stiffness leading to a reduction in afterload, achieving reduced pulse and mean aortic pressures in pilot animal testing by 27% and 10% respectively, and improved left coronary artery (LCA) blood flow by 39%. The device is minimally invasive, non-blood contacting, failure mode safe, and requires no pump, leads, or ECG timing, and is a cost effective approach. Additionally, the device offers the ability to adjust its performance post implantation (for future chronic studies) by changing balloon pressure via a subcutaneous inflation port. Device proof-of-principle has been established where the BioQ CA device has shown to operate as a counterpulsation device by decreasing heart load, reducing pulse and mean pressures, and improving left coronary artery blood flow. These changes are within the range of improvement achieved with pump powered Intra-Aortic Balloon Pump (IABP) and extra-aortic balloon (EAB) systems, and the blood pressure reduction achieved with renal denervation and barostim modulation, demonstrating our passive recoil counterpulsation device is competitive on performance yet with the advantages of being a simple self-powered, stand alone device, offering superior cost savings compared to other technology approaches. More recently the device was implanted in two patients in India prior to scheduled coronary artery bypass grafting (CABG). Devices were attached around the ascending aorta for approx. 30 minutes with increases in left coronary artery (LCA) blood flow of 30% to 100% measured, cardiac output improvements of up to 18%, and heart rate decreased by 8%. Patients recovered normally and were released from hospital with no adverse events. This data is very competitive and justifies further acute studies before considering a chronic human study. In this pilot study, we propose to test up to 40 patients with the device for 30 minutes on consenting patients who are scheduled for CABG. Testing will be done during vessel harvesting to minimise procedure time. We aim to measure LCA blood flow, arterial blood pressures, and cardiac output.
Interventions
The BIOQ CA is a passive recoil extra aortic balloon that is strapped to the ascending aorta using a vessel cuff that wraps around the vessel. The device is then inflated up to the blood pressure of the patient and active for 30 minutes of testing. The BioQ CA device dampens the pressure pulse when the heart ejects blood charging the device, and discharges pushing back on the vessel when the heart is filling. This is achieved by the compression and expansion of the balloon and the air contained
The BIOQ CA is a passive recoil extra aortic balloon that is strapped to the ascending aorta using a vessel cuff that wraps around the vessel. The device is then inflated up to the blood pressure of the patient and active for 30 minutes of testing. The BioQ CA device dampens the pressure pulse when the heart ejects blood charging the device, and discharges pushing back on the vessel when the heart is filling. This is achieved by the compression and expansion of the balloon and the air contained within it. The device is implanted by the treating cardiac surgeon prior to performing the scheduled procedure while the patient in under general anaesthesia. Patients will be grouped into 2 groups as follows: Group 1 will consist of up to 20 patients with hypertensive HF with low ejection fraction (30% - 45% EF). Group 2 will consist of up to 20 patients with hypertensive HF with preserved ejection fraction (>50% EF).
Sponsors
BIOQ DEVICES PTY LTD
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria will include • Adults of 18 years or over • Patient has read and signed the informed consent prior to study related procedures • Willing and able to comply with all required follow-up evaluations and assessments • Patients scheduled for Coronary Artery Bypass Grafting (CABG) will be assessed for: 1) hypertension and ejection fraction (EF) cut-offs defined below, 2) Presence of heart failure ( Class I to IV), 3) coronary artery disease, 4) aortic stiffness, 5) stroke risk, 6) valve dysfunction, 7) aortic calcification and atherosclerosis 8) ischemia/non-ischemia classification. o Group 1 will consist of up to 20 patients with hypertensive heart failure PLUS low ejection fraction (30% - 45% EF). o Group 2 will consist of up to 20 patients with hypertensive heart failure PLUS preserved ejection fraction (>50% EF).
Exclusion criteria
Exclusion criteria will include: • history of previous stroke, • significant mitral and or aortic valve disease/dysfunction, • ascending aortic disease calcification or atherosclerosis or aneurysm. • intraoperative echo or epi-aortic ultrasound will be used during the surgical procedures to exclude or confirm presence of severe aortic disease before applying the device as a final precautionary measure prior to placement. Patients will be excluded at this point if they are confirmed in the exclusion criteria.
Outcome results
None listed