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

Yuki Ikeda; Shunsuke Ishii; Shohei Nakahara; Saeko Iikura; Teppei Fujita; Yuichiro Iida; Takeru Nabeta; Nobuhiro Sato; Junya Ako

doi:10.1093/ehjacc/zuae132

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

Eur Heart J Acute Cardiovasc Care. 2024 Nov 19:zuae132. doi: 10.1093/ehjacc/zuae132. Online ahead of print.

Authors

Yuki Ikeda¹, Shunsuke Ishii¹, Shohei Nakahara¹, Saeko Iikura¹, Teppei Fujita¹, Yuichiro Iida¹, Takeru Nabeta¹, Nobuhiro Sato¹, Junya Ako¹

Affiliation

¹ Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.

PMID: 39560117
DOI: 10.1093/ehjacc/zuae132

Abstract

Background: 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).

Methods: 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).

Results: 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).

Conclusions: 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.

Keywords: Complication; Impella; Prognosis; Propensity Score Matching; Shock.

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