Device-Related Adverse Events and Flow Capacity of Percutaneous Ventricular Assist Devices.

Abstract

Complication management is crucial in patients receiving mechanical circulatory devices. However, there are limited data on the association between the risks of complications and device type in patients with percutaneous ventricular assist devices (PVAD). The Japanese registry for PVAD (J-PVAD) is a nationwide ongoing registry that enrolls consecutive patients with cardiogenic shock treated with PVAD. We analyzed 5717 patients in the J-PVAD from February 1, 2020, to December 31, 2022, to compare the incident risks of device-related problems and all-cause mortality within 30 days after PVAD introduction based on flow capacities of first-line PVAD (low: Impella 2.5/CP, n=5375; high: Impella 5.0/5.5, n=342). The overall incidence of major device-related problems, including hemolysis, major bleeding, kidney injury, sepsis, and pump stop were 13%, 21%, 7%, 3%, and 1%, respectively. The all-cause mortality rate was 34%. The incident risks of hemolysis (hazard ratio [HR] 0.38, 95% confidence interval [CI] 0.24-0.58), kidney injury (HR 0.32, 95%CI 0.18-0.57), and pump stop (HR 0.38, 95%CI 0.16-0.91) were lower in patients with high-flow PVAD compared with those with low-flow PVAD. The risks of major bleeding or sepsis did not differ significantly between groups. The risk of all-cause mortality was lower in patients with high-flow PVAD compared with those with low-flow PVAD (HR 0.79, 95%CI 0.65-0.96). Compared with those with low-flow PVAD, patients with high-flow PVAD had lower incident risks of device-related problems, including hemolysis, kidney injury, and pump stop, as well as lower risk of all-cause mortality.