Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy
Marco Ancona, Matteo Montorfano, Giulia Masiero, Francesco Burzotta, Carlo Briguori, Matteo Pagnesi, Vittorio Pazzanese, Carlo Trani, Tommaso Piva, Federico De Marco, Maurizio Di Biasi, Paolo Pagnotta, Gavino Casu, Roberto Garbo, Gerlando Preti, Elisa Nicolini, Rocco Sclafani, Giuseppe Colonna, Marco Mojoli, Massimo Siviglia, Cristiana Denurra, Francesco Caprioglio, Anna Mara Scandroglio, Giuseppe Tarantini, Alaide Chieffo
Abstract
AIMS: To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy. METHODS AND RESULTS: A total of 406 patients have been included in this registry: 56.4% in the setting of CS, while 43.6% patients in the setting of HR-PCI. DRCs were defined as a composite endpoint of access-site bleeding, limb ischaemia, vascular complication requiring treatment, haemolysis, aortic injury, and left ventricular perforation. DRC incidence in the overall population was 25.6%, with significantly higher rate in the CS (37.1%) than in the HR-PCI (10.7%) group. The most frequent complication was haemolysis (11.8%), which occurred almost exclusively in CS population. Access-site bleeding was observed in 9.6% of the overall population, with no significant difference between the two groups. Limb ischaemia was observed in 8.3% of the overall population, with significantly higher rate in the CS group. CS and right ventricular dysfunction appear as the strongest independent predictors of DRC. One-year mortality in patients with DRC appears higher than in patients with no DRC. However, DRC was not confirmed as an independent predictor of 1-year mortality at multivariate analysis. CONCLUSION: In the IMP-IT registry, the rate of DRC was 25.6%, with CS being the strongest independent predictor. DRC was not found as an independent predictor of 1-year mortality.