Durable ventricular assist device in Spain (2007-2020). First report of the REGALAD registry.

INTRODUCTION AND OBJECTIVES: This report presents the clinical characteristics, outcomes and complications of all consecutive patients implanted with a long-term mechanical circulatory support device in Spain between 2007 and 2020. METHODS: Analysis of the Spanish Registry of durable ventricular assist devices (REGALAD) including data form Spanish centers with a mechanical circulatory support program. RESULTS: During the study period, 263 ventricular assist devices were implanted in 22 hospitals. The implanted device was an isolated continuous-flow left ventricular assist device in 182 patients (69%), a pulsatile-flow device (58 isolated left ventricular and 21 biventricular) in 79 (30%), and a total artificial heart in 2 patients (1%). The strategy of the implant was as bridge to heart transplant in 78 patients (30%), bridge to candidacy in 110 (42%), bridge to recovery in 3 (1%) and destination therapy in 72 patients (27%). Overall survival at 6, 12 and 24 months was 79%, 74% and 69%, respectively, and was better in continuous-flow left ventricular assist devices (84%, 80%, and 75%). The main adverse events related to this therapy were infections (37% of patients), bleeding (35%), neurological (29%), and device malfunction (17%). CONCLUSIONS: Durable ventricular assist devices have emerged in Spain in the last few years as a useful therapy for patients with advanced heart failure. As in other international registries, the current trend is to use continuous-flow intracorporeal left ventricular devices, which are associated with better results. Adverse events continue to be frequent and severe.

Usefulness of Impella support in different clinical settings in cardiogenic shock.

BACKGROUND: The Impella pump has emerged as a promising tool in patients with cardiogenic shock (CS). Despite its attractive properties, there are scarce data on the specific clinical setting and the potential role of Impella devices in CS patients from routine clinical practice. METHODS: This is an observational, retrospective, single center, cohort study. All consecutive patients with diagnosis of CS and undergoing support with Impella 2.5®, Impella CP® or Impella 5.0® from April 2015 to December 2020 were included. Baseline characteristics, management and outcomes were assessed according to CS severity, age and cause of CS. Main outcome measured was in-hospital mortality. RESULTS: A total of 50 patients were included (median age: 59.3 ± 10 years). The most common cause of CS was acute coronary syndrome (ACS) (68%), followed by decompensation of previous cardiomyopathy (22%). A total of 13 patients (26%) had profound CS. Most patients (54%) improved pulmonary congestion at 48 h after Impella support. A total of 19 patients (38%) presented significant bleeding. In-hospital mortality was 42%. Among patients with profound CS (n = 13), five patients were previously supported with venoarterial extracorporeal membrane oxygenation. A total of eight patients (61.5%) died during the admission, and no patient achieved ventricular recovery. Older patients (≥ 67 years, n = 10) had more comorbidities and the highest mortality (70%). Among patients with ACS (n = 34), 35.3% of patients had profound CS; and in most cases (52.9%), Impella support was performed as a bridge to recovery. In contrast, only one patient from the decompensated cardiomyopathy group (n = 11) presented with profound CS. In 90.9% of these cases, Impella support was used as a bridge to cardiac transplantation. There were no cases of death. CONCLUSIONS: In this cohort of real-life CS patients, Impella devices were used in different settings, with different clinical profiles and management. Despite a significant rate of complications, mortality was acceptable and lower than those observed in other series.