Supplement

Impella 5.5 as an Ideal Bridge to Left Ventricular Assist Device

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Support:The development of this supplement was funded by Abiomed.

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Implantation of a left ventricular assist device (LVAD) after extracorporeal membrane oxygenation (ECMO) can compromise the survival of heart failure patients.1,2 Dr Reichenspurner’s research hypothesis is that axillary implantation of an Impella 5.0 or Impella 5.5 transvalvular pump after extracorporeal life support (ECLS), such as ECMO, and before LVAD implantation could serve as a bridge-to-decision treatment, enhancing survival by enabling patient mobility, decreasing complications and facilitating evaluation of right ventricular (RV) function to assist ECLS weaning. The Impella 5.0 is a 21 Fr microaxial pump providing up to 5 l per minute of antegrade blood flow from the left ventricle (LV) to the aorta for up to 10 days. The device is placed using a 9 Fr catheter with axillary access, enabling patient mobility. Additional features of the Impella 5.5 include fibre optical pressure sensing, a modified motor size for improved deliverability, increased pump output to 5.5 l/min, increased ease of positioning and extended usage for up to 30 days.3

Dr Reichenspurner demonstrated the viability of Impella bridging with a multicentre feasibility study of LVAD after ECMO and Impella 5.0 implantation.4 Nine patients with Interagency Registry for Mechanically Assisted Circulatory Support 1 heart failure received venoarterial-ECMO on day 0, Impella 5.0 implantation on day 8, ECMO removal on day 9, continued Impella bridge support to day 17 and LVAD implantation on day 17. The study was a success, with no in-hospital mortality and only one death approximately 7 months after treatment. A recent study of 19 heart failure patients who received Impella 5.5 as a bridge to LVAD after implantation with short-term device support, such as ECMO, also experienced a 90% survival rate with few complications nearly 6 months after treatment.5

Other recent studies have demonstrated that using Impella 5.0 as a bridge to LVAD decreases bleeding and thromboembolic complications, while providing neurological recovery time. Sixteen heart failure patients who received axillary Impella 5.0 treatment after percutaneous femoral ECMO treatment experienced fewer thromboembolic complications, no access site bleeding requiring revision and reduced administration of blood products compared with those receiving ECMO alone.6 Impella 5.0, used as a bridge to decision in patients on ECLS with unclear neurological outcomes, resulted in significant improvement in quantitative measures of cerebral performance after 30 days.7

Dr Reichenspurner concluded that Impella 5.0 is an established and successful therapy for LV failure. Impella 5.0 support allows mobilisation and optimisation of patients before LVAD implantation, and enables evaluation of RV function after weaning from ECLS. Results after LVAD implantation are excellent in patients bridged with Impella 5.0. Impella 5.5 is a further improvement, with initial success demonstrated in bridging patients to LVAD.

References

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  2. Tsyganenkoo D, Gromann TW, Schoenrath F, et al. Predictors of mid-term outcomes in patients undergoing implantation of a ventricular assist device directly after extracorporeal life support. Eur J Cardiothorac Surg 2019;55:773–9.
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  3. Bernhardt AM, Hakmi S, Sinning C, et al. First-in-man implantations of a newly developed transaortic axial flow ventricular assist device (Impella 5.5). J Heart Lung Transplant 2019;38:S342.
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  4. Bertoldi LF, Pappalardo F, Lubos E, et al. Bridging INTERMACS 1 patients from VA-ECMO to LVAD via Impella 5.0: de-escalate and ambulate. J Crit Care 2020;57:259–63.
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  7. Bernhardt AM, Zipfel S, Reiter B, et al. Impella 5.0 therapy as a bridge-to-decision option for patients on extracorporeal life support with unclear neurological outcomes. Eur J Cardiothorac Surg 2019;56:1031–6.
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