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.

Device-related complications after Impella mechanical circulatory support implantation: An IMP-IT observational multicentre registry substudy / Ancona, M. B.; Montorfano, M.; Masiero, G.; Burzotta, F.; Briguori, C.; Pagnesi, M.; Pazzanese, V.; Trani, C.; Piva, T.; De Marco, F.; Di Biasi, M.; Pagnotta, P.; Casu, G.; Garbo, R.; Preti, G.; Nicolini, E.; Sclafani, R.; Colonna, G.; Mojoli, M.; Siviglia, M.; Denurra, C.; Caprioglio, F.; Scandroglio, A. M.; Tarantini, G.; Chieffo, A.. - In: EUROPEAN HEART JOURNAL. ACUTE CARDIOVASCULAR CARE. - ISSN 2048-8726. - 10:9(2021), pp. 999-1006. [10.1093/ehjacc/zuab051]

Device-related complications after Impella mechanical circulatory support implantation: An IMP-IT observational multicentre registry substudy

Casu G.;
2021-01-01

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.
2021
Device-related complications after Impella mechanical circulatory support implantation: An IMP-IT observational multicentre registry substudy / Ancona, M. B.; Montorfano, M.; Masiero, G.; Burzotta, F.; Briguori, C.; Pagnesi, M.; Pazzanese, V.; Trani, C.; Piva, T.; De Marco, F.; Di Biasi, M.; Pagnotta, P.; Casu, G.; Garbo, R.; Preti, G.; Nicolini, E.; Sclafani, R.; Colonna, G.; Mojoli, M.; Siviglia, M.; Denurra, C.; Caprioglio, F.; Scandroglio, A. M.; Tarantini, G.; Chieffo, A.. - In: EUROPEAN HEART JOURNAL. ACUTE CARDIOVASCULAR CARE. - ISSN 2048-8726. - 10:9(2021), pp. 999-1006. [10.1093/ehjacc/zuab051]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11388/323794
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