Impella 5.5 use in women: A multicenter study

Area of Science:

• Cardiology
• Medical Devices
• Clinical Outcomes

Background:

• The Impella 5.5 is a left ventricular assist device used for hemodynamic support.
• Sex-based differences in outcomes with mechanical circulatory support devices are not well understood.

Purpose of the Study:

• To compare the safety and efficacy of the Impella 5.5 device between male and female patients.
• To identify any sex-specific differences in complications and mortality.

Main Methods:

• Retrospective review of adult patients who received an Impella 5.5 implant between June 2020 and May 2024.
• Comparison of demographics, baseline characteristics, complications, and outcomes between sexes.
• Multivariable logistic regression analysis to predict in-hospital mortality.

Main Results:

• Of 254 patients, 16% were female. Females had lower baseline hemoglobin but similar cardiac risk factors and body size compared to males.
• Rates of pre- and post-implant complications, duration of support, and successful bridging to durable therapies were similar between sexes.
• In-hospital and 1-year mortality rates were comparable, with female sex not being a predictor of mortality.

Conclusions:

• The Impella 5.5 demonstrates comparable safety, biocompatibility, and efficacy in female patients.
• These findings support increased consideration for Impella 5.5 utilization in female populations.
• No increased complications or reduced device performance were observed in women.