Novel percutaneous VAD for high risk-PCI feasible, safe in small study
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Key takeaways:
- Use of a novel low-profile, high continuous flow percutaneous ventricular assist device was feasible in six high-risk patients undergoing PCI.
- No device-related adverse events were reported.
Use of a novel miniaturized, expandable percutaneous ventricular assist device was shown to be feasible and potentially safe in a small study of six high-risk patients undergoing PCI, a speaker reported.
The first-in-human data of a novel percutaneous VAD system (Supira Medical) for high-risk PCI were presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
Image: Adobe Stock
“The predicate device here in the U.S is a transaortic axial flow pump, and certainly Impella [Abiomed] has garnered a lot of attention. They have several platforms out there, both surgically and percutaneously, that can be implemented,” Gagan Singh, MD, MS, director of clinical cardiovascular research at University of California, Davis, said during a press conference. “Acute MI cardiogenic shock is associated with 50% mortality. Some of that may or may not be related to the lack of [mechanical circulatory support] use, but nonetheless, it is an issue ... with each of these devices, the price you have to pay is vascular complications and homolysis, which is a significant health care economic issue. For every Impella device, balloon pump or [extracorporeal membrane oxygenation] support device you put in, there is at least a one and a half or two times increase in the cost of care for that patient if they suffer a vascular complication.
“That’s not necessarily the device’s fault, it’s the profile. ... We can take anything and decrease the profile of it, but there’s a price you have to pay for that. The smaller you go, the less support you get ... especially as it comes to homolysis,” Singh said. “That’s where this Supira device comes in. It’s a single percutaneous assist device ... and we think that it’s a device that can be used for both high-risk PCI and cardiogenic shock.”
For this nonrandomized, single-arm, single-center, prospective trial, Singh and colleagues evaluated the feasibility and safety of a low-profile (10F), high continuous flow device for temporary CV hemodynamic support in six high risk-patients undergoing PCI (mean age, 58 years; 83% men; mean BMI, 30 kg/m2).
Singh stated that the novel pump can expand up to 22F and “gives you the same amount of support that some of these higher caliber devices can do that are surgically implanted, but it can be miniaturized all the way down to 10F, which is an enormous engineering feat in and of itself.”
The primary endpoints included a procedural success endpoint, defined as delivery of the catheter, hemodynamic support and catheter removal, and a safety endpoint, defined as freedom from device-related major adverse events (vascular complications, aortic valve injury, mitral valve injury and systemic embolization).
Baseline comorbidities included prior MI (66%), diabetes (50%), tobacco use (50%) and pulmonary hypertension (50%). Overall, 66% of participants had multivessel disease, according to a press release.
Singh reported 100% procedural success and no periprocedural device-related adverse events. There were no early indicators of clinically significant hemolysis, according to the release.
The device support time ranged from 42 to 96 minutes.
“When you think about the problems with current percutaneous devices that are in different buckets, you can’t address one bucket without affecting everything else. What this device has been able to link is that the profile has been reduced by maintaining flow and lack of homolysis,” Singh said during the press conference. “Unlike other devices, which just have an aortic sensor, this one has a left ventricular [microelectromechanical system] sensor. You get direct left ventricular pressure and aortic pressure, which allows for ease of use, ease of weaning and monitoring.”
Collapse
Singh G, et al. Late-Breaking Presentation IV. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 18-20, 2023; Phoenix.
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