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.
ABSTRACT
The thirteenth annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 27,314 patients receiving continuous flow durable left ventricular assist devices (LVAD) over the last decade (2012-2021). In 2021, 2,464 primary LVADs were implanted, representing a 23.5% reduction in the annual volume compared to peak implantation in 2019 and an ongoing trend from the prior year. This decline is likely a reflection of the untoward effects of the COVID-19 pandemic and the change in the US heart transplant allocation system in 2018. The last several years have been characterized by a shift in device indication and type with 81.1% of patients now implanted as destination therapy and 92.7% receiving an LVAD with full magnetic levitation in 2021. However, despite an older, more ill population being increasingly supported pre-implant with temporary circulatory devices in the recent (2017-2021) vs prior (2012-2016) eras, the 1- and 5-year survival continues to improve at 83.0% and 51.9%, respectively. The adverse events profile has also improved, with significant reduction in stroke, gastrointestinal bleeding, and hospital readmissions. Finally, we examined the impact of the change in heart transplant allocation system in 2018 on LVAD candidacy, implant strategy, and outcomes. In the competing outcomes analysis, the proportion of transplant eligible patients receiving a transplant has declined from 56.5% to 46.0% at 3 years, while the proportion remaining alive with ongoing support has improved from 24.1% to 38.1% at 3 years, underscoring the durability of the currently available technology.