The ever‐changing field of mechanical circulatory support: new challenges at the advent of the ‘single device era’

Abstract

In the past few decades, the treatment options for patients with advanced heart failure (HF) have changed dramatically. 1 Since the introduction of (long-term) mechanical circulatory support (MCS), the prognosis and quality of life of these patients have improved significantly. Technological improvements have changed the landscape of left ventricular assist devices (LVADs): the first-generation pulsatile pumps were large devices that were implanted in the abdomen and the second-generation pumps (axial-flow pumps) were smaller devices implanted within the thorax, more suitable for long-term support. In the most recent decade the third-generation centrifugal continuous-flow LVADs have dominated the field of durable MCS: the HeartWare VAD (HVAD, Medtronic, Minneapolis, MN, USA) with hydro-magnetic (hybrid) levitation and the HeartMate 3 (HM3, Abbott Labs, Chicago, IL, USA) with full magnetic levitation. In large studies, these devices have demonstrated superior survival free from disabling stroke or reoperation to replace a malfunctioning device, compared with second-generation pumps. [2][3][4] Both HVAD and HM3 have been approved for long-term support in advanced HF patients as a bridge to transplantation option and for those patients ineligible to transplantation as 'destination therapy'. However, in the past few years, the amount of de novo HM3 implants have outnumbered the HVAD implants. 5 Recently, two observational studies from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and the European Registry for Patients on Mechanical Circulatory Support (EUROMACS) have described worse outcomes for HVAD vs. HM3 implanted patients. 6,7 In addition, in 2020 Medtronic issued a Safety Notice regarding the HVAD related to a delayed or even failure to restart the LVAD after controller exchange. These factors may have led to the decision of Medtronic to stop the global production and distribution of the HVAD on 3 June 2021. 8 In this viewpoint, we would like to shed light on the outcome data that preceded this decision and address the consequences and challenges it poses to our patients and their health care providers.

Systemic thrombolysis in the management of pump thrombosis in patients with left ventricular assist devices

“…The current findings are of particular relevance given the recent withdrawal of the HeartWare LVAD system of the market by Medtronic ( 13 ). A substantial number of the 4000 living patients have their HeartWare LVAD as DT , and exchange to a HeartMate 3 may be challenging in this vulnerable patient population ( 12 ).…”

Ventricular Assist Devices: Challenges of the One-device Era

“…From the unmatched cohorts of the INTERMACS and EUROMACS, it was apparent that the HVAD was implanted more frequently in small patients, women and in patients with lower INTERMACS profiles (those who were sicker). [9][10][11] Whether this was related to device factors will not be determined as a head-to-head comparison between HM3 and HVAD will not be performed.…”