A groundbreaking study, SAVE-PCI, has revealed that a novel percutaneous ventricular assist device (pVAD) from China, the NyokAssist, matches the safety of an intra-aortic balloon pump (IABP) in high-risk PCI procedures. The study, presented at TCT 2025, showcases the device's impressive performance with minimal adverse outcomes within 30 days. The NyokAssist's unique design, featuring an external motor, reduces costs and prevents heat-related blood damage, addressing a significant concern with traditional pVADs. This breakthrough device has already been granted breakthrough device status by the US Food and Drug Administration in 2023.
The study, conducted across 11 centers in China, enrolled 236 hemodynamically stable patients undergoing nonemergency, high-risk PCI. The patients were randomized to receive support from either the pVAD or IABP. The results were remarkable, with similar rates of MACCE and individual components of mortality, repeat revascularization, TIA, stroke, and MI between the two groups. Major adverse events were rare, and there were no vascular complications.
The study's strengths include a complete lack of vascular complications and a balanced baseline between the two groups, except for a higher proportion of males in the pVAD arm. The study's findings have sparked interest in the field, with researchers and medical professionals eager to explore the potential of pVADs in high-risk PCI. The debate over the best form of hemodynamic support is set to be informed by the PROTECT IV and CHIP-BCIS3 trials, which will provide clarity on the differences between Impella and IABP.
The future of hemodynamic support in high-risk PCI hinges on the outcomes of the PROTECT IV trial. Experts predict that the average Canadian interventionalist will likely opt for more cost-effective solutions, such as balloon pumps, in most cases. The development of more devices by various manufacturers is expected to drive competition and reduce costs, making these life-saving technologies more accessible to patients and payers alike.
