Treating Refractory Cardiogenic Shock With the TandemHeart and Impella Devices: A Single Center Experience

Abstract

BackgroundPatients with cardiogenic shock (CS) are routinely treated with intra-aortic balloon pumps (IABPs). The utility of 2 new percutaneous left ventricular assist devices (PLVADs), the Impella and TandemHeart, is unknown. The objective of this study was to describe the use of PLVADs for patients with CS at our institution.MethodsAll cases involving PLVADs in patients with CS between between January 1, 2008 and June 30, 2010 at a private, tertiary referral hospital were reviewed retrospectively.ResultsAll 76 cases were identified (50 IABP only, 7 Impella, 19 TandemHeart). Most Impella (5/7) and TandemHeart (10/19) patients were initially treated with an IABP before "upgrading" for increased hemodynamic support. All 76 devices (100%) were initiated successfully. Percutaneous revascularization was attempted in 63 patients with angiographic success in 57 (90%). The incidences of major complications were similar between groups, except bleeding occurred less frequently with the IABP. Mean ejection fraction on presentation was 30.4±16.5% and increased by a mean of 6.6±11.4% (P < 0.001). With the institutional approach of treating patients with CS initially with vasopressors and IABPs, then upgrading to an Impella or TandemHeart device for patients refractory to IABP therapy, the overall mortality rate was 40%.ConclusionThe Impella and TandemHeart devices can be initiated successfully in patients with CS, are associated with high rates of angiographic success during high risk percutaneous interventions and may benefit the myocardium during myocardial infarction. Randomized trials are warranted investigating use of the Impella and TandemHeart devices in patients with CS and in patients refractory to conventional IABP therapy.

The effectiveness and safety of the Impella ventricular assist device for high‐risk percutaneous coronary interventions: A systematic review

“…In the controlled observational studies, the 30‐day rates of all‐cause mortality were higher in the Impella arm than in the IABP arm in 2 of the 3 studies that reported this endpoint (Table ) . However, neither reached statistical significance due to their modest sample sizes.…”

“…These outcomes were also examined in one controlled observational study (Table ). Schwartz et al reported lower 30‐day rates of MACE and MI for Impella patients than in IABP patients. However, with a sample size of only 18 patients (13 patients and 5 IABP), no definitive conclusions can be drawn from these data.…”

“…The 20 studies consisted of 4 RCTs [5,6,26,27] and 16 observational studies [7,8,[12][13][14][15][16][17][18][19][20][21][22][23][24][25], including a total of 1,287 patients ( Table 1). All studies were published between 2006 and 2016, and the durations of follow-up ranged from 1 to 42 months.…”

“…Several studies have examined the effectiveness and safety of the Impella device . However, many of these studies were small and produced inconclusive results.…”

Percutaneous cardiac assist devices compared with surgical hemodynamic support alternatives

“…Extracorporeal membrane oxygenation (ECMO) provides more extensive circulatory support but it is associated with high rates of peri‐procedural adverse events . Left ventricular assist devices (LVADs) also have their place in the treatment of cardiac disease; however, they require invasive surgical procedures for their implantation, take longer to deploy, are associated with high complication rates, and often damage the heart muscle . No study has yet demonstrated that LVAD therapy is cost‐effective based on conventional definitions of willingness‐to‐pay criteria .…”