Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device

Abstract

Objective To report the initial clinical experience with the Impella 5.5® with SmartAssist®, a temporary left ventricular assist device that provides up to 6.2 L/min forward flow, with recent FDA approval for up to 14 days. Methods From October 2019 to March 2020, 200 patients at 42 US centers received the Impella 5.5 and entered into the IQ registry, a manufacturer-maintained quality database that captures limited baseline/procedural characteristics and outcomes through device explant. Post hoc subgroup analyses were conducted to assess the role of baseline and procedural characteristics on survival, defined as successful device weaning or bridge to durable therapy. Results Median patient age was 62 years (range, 13 to 83 years); 83.4% were male. The device was most commonly used for cardiomyopathy (45.0%), acute myocardial infarction complicated by cardiogenic shock (AMICS; 29.0%), and post cardiotomy cardiogenic shock (PCCS; 16.5%). Median duration of support was 10.0 days (range, 0.001 to 64.4 days). Through device explant, overall survival was 74.0%, with survival of 80.0%, 67.2%, 57.6%, and 94.7% in cardiomyopathy, AMICS, PCCS, and others (comprising high-risk revascularization, coronary artery bypass graft, electrophysiology/ablation, and myocarditis), respectively. Patients requiring extracorporeal membrane oxygenation and Impella support (35 patients, 17.5%) had significantly lower survival (51.4% vs 78.8%, P = 0.002). Conclusions In the first 200 US patients treated with the Impella 5.5, we observed overall survival to explant of 74%. Survival outcomes were improved compared to historic rates observed with cardiogenic shock, particularly PCCS. Prospective studies assessing comparative performance of this device to conventional strategies are warranted in future.

High flow from Impella 5.5 with partial veno‐arterial extracorporeal membrane oxygenation support: Case series

“…The Impella 5.5, which was recently introduced, has a shorter shaft without a pigtail and can provide a higher flow compared to prior Impella devices. To date, there is no consensus regarding optimal flow balance when Impella 5.5 is used in the setting of EC‐PELLA 2,3,5 . Possible concerns of high ECMO flow during EC‐PELLA support are high afterload from VA‐ECMO, less antegrade flow through the heart, and complications related to high VA‐ECMO flow (e.g., bleeding, hyperperfusion, etc).…”

Destination left ventricular assist devices in island states: asking too much or the inevitable solution

“…Additionally, with the current withdrawal of the Heartware (Medtronic, Minneapolis, Minn) from the market, different approaches are being implemented to ensure patient safety for the future LVAD systems. Newer technologies such as the Impella 5.5 (Abiomed, Danvers, Massachusetts, USA) assist device are gaining ground in the USA as a transitioning and bridging approach [19]. Although to date FDA approves a limited 2-week implant duration using this technology, its use has shown success in patients for up to 2 months; this option opens doors to the possibility of less invasive horizons to heart failure patients even in remote regions especially for island states [19].…”

“…Newer technologies such as the Impella 5.5 (Abiomed, Danvers, Massachusetts, USA) assist device are gaining ground in the USA as a transitioning and bridging approach [19]. Although to date FDA approves a limited 2-week implant duration using this technology, its use has shown success in patients for up to 2 months; this option opens doors to the possibility of less invasive horizons to heart failure patients even in remote regions especially for island states [19]. Finally, although any LVAD training requires specific implantation and perioperative training at experienced mainland centers, some islands have their own cardiac surgery training programs.…”

Use of a novel bicarbonate‐based Impella 5.5 purge solution in a coagulopathic patient

“…It can be used as a bridge to recovery, to an intracorporeal device, or to transplantation. 2 To prevent blood from entering the device motor, a dextrose-based purge solution provides a countercurrent pressure gradient (Figure 1). To prevent the buildup of biomaterial within the purge gaps, the purge solution is formulated with heparin (25-50 units/ml) in a dextrose solution of varying concentrations (5%-20%).…”

“…The Impella 5.5 temporary axial flow VAD has been established as an effective tool for the management of cardiogenic shock. It can be used as a bridge to recovery, to an intracorporeal device, or to transplantation 2 . To prevent blood from entering the device motor, a dextrose‐based purge solution provides a countercurrent pressure gradient (Figure 1).…”