Ventricular Assist Devices: Challenges of the One-device Era

Abstract

Heart failure (HF) is linked to to high mortality rates and recurrent hospitalisations despite medical and device-based achievements. The use of left ventricular assist devices (LVADs) has improved survival among patients with advanced HF. Significant progress has been achieved with the new generation of continuous-flow devices, particularly with the fully magnetically levitated HeartMate 3. In June 2021, Medtronic announced the abrupt withdrawal of the HeartWare device from the market. This decision has introduced a new era in which the field of mechanical support for advanced HF patients is dominated by a single device – the HeartMate 3. The direct clinical and economic consequences of this change will necessitate new surgical considerations. Because of the expected need for HeartWare device replacement in small patients, new surgical techniques and device adaptation will be needed. The new single-device era will hopefully encourage scientists and engineers to create innovations in the advanced HF arena. Special considerations should be taken during the COVID-19 pandemic when treating patients with LVADs.

Vascular Function in Continuous Flow LVADs: Implications for Clinical Practice

“…The HM 3 device may still induce mechanical shear stress adequate to disturb VWF homeostasis, as suggested by Netuka et al [ 48 ]. Following the abrupt withdrawal of the HeartWare device in June 2021 due to higher incidences of neurological events reported in several observational studies, HM3 became the only FDA-approved LVAD [ 157 ]. This has necessitated the need for innovations to create more options for advanced heart failure in the era of a single device.…”