Impella 5.5 use in women: A multicenter study

Background

We sought to compare the outcomes of Impella 5.5 use between sexes.

Methods

All adult patients who underwent Impella 5.5 implantation at the University of Pennsylvania and Columbia University between June 2020 and May 2024 were retrospectively reviewed. Demographics, baseline status, complications, and outcomes were compared between sexes. Laboratory values were examined with a linear mixed model, and a parsimonious multivariable logistic regression was developed to assess factors predictive of in-hospital mortality.

Results

Of 254 patients, 41 (16%) were female and 213 (84%) were male. Before implant, females had lower hemoglobin levels (9.6 vs 11.2 g/dl, p < 0.05), but similar cardiac risk factors (all p > 0.05). The smaller size of females did not preclude device implantation (height: 1.7 vs 1.8 m; weight: 74.8 vs 88.0 kg, all p < 0.05), and only 1 out of 41 (2.4%) females required direct aortic placement due to prohibitive anatomy. Preimplant mechanical circulatory support, duration of support, and postimplant rates of stroke, infection, and bleeding were similar (all p > 0.05). In addition, laboratory biocompatability markers did not differ between sexes, nor did rates of successful bridging to durable therapies (all p > 0.05). Finally, in-hospital and 1-year mortality were similar (all p > 0.05), and female sex was not identified as a risk factor for in-hospital mortality (odds ratio 0.91, p > 0.05).

Conclusions

Females do not experience increased complications from the Impella 5.5, nor reduced device biocompatibility. Our data support greater consideration of device use in females.