Original Title: Dispositivos percutáneos temporales de asistencia circulatoria mecánica para el tratamiento y prevención del shock cardiogénico: análisis de eficacia, efectividad y seguridad

Authors' objectives: a) General objective To assess and compare the efficacy, effectiveness and safety of the MCSDs most commonly used in our healthcare setting in the treatment and prevention of CS. b) Specific objectives • To compare the clinical effects of different MCSDs in the treatment of patients with refractory CS. • To compare the clinical effects of different MCSDs in high-risk percutaneous coronary interventions (PCIs).

Authors' results and conclusions: A systematic search in biomedical databases identified 973 potentially relevant publications. Title and abstract screening yielded 92 potentially eligible studies and these subsequently underwent full-text review. Finally, 31 studies were included in the analysis. The quality/reliability of the available evidence was mainly low or very low. Only the studies comparing IABPs with usual care alone or with Impella® devices in high-risk PCI cases were of high quality and reliability. • Impella® devices a) Efficacy and safety of Impella® devices compared with IABPs in high-risk PCI After 90 days of follow-up, in high-risk PCIs, Impella 2.5® devices are associated with lower rates of major adverse effects (MAEs) such as death, acute myocardial infarction, stroke, transient ischemic attack, repeat revascularisation, need for heart or vascular surgery, acute kidney failure, severe hypertension, cardiopulmonary resuscitation or ventricular tachycardia, aortic insufficiency or angiographic failure of PCI, than IABPs. In patients with three-vessel disease and low ventricular ejection fraction, the rate of irreversible adverse effects (death, stroke, or acute myocardial infarction) is lower with circulatory support using an Impella 2.5® device during PCI than with an IABP. No differences have been shown in in-hospital mortality, in the medium or long-term, between Impella 2.5® devices and IAMPs. Regarding results on safety, the risk of complications is similar with both percutaneous devices. b) Efficacy of early vs late placement of Impella 2.5® devices in high-risk PCIs The use of Impella 2.5® devices before PCI is associated with greater survival to discharge, as well as to 30 and 90 days, than its use after this type of coronary intervention. c) Efficacy and safety of Impella 2.5/CP® devices vs IABPs in CS There are no significant differences in mortality at 1 or 6 months in patients with CS treated with Impella 2.5/CP® devices vs IABPs. d) Efficacy of Impella 2.5/CP® devices vs standard medical care in CS Rates of survival to hospital discharge and 6 months are higher in patients with CS treated with Impella 2.5/CP® devices than those receiving standard medical care. e) Efficacy and safety of Impella® devices vs venoarterial ECMO in CS No significant differences have been found in in-hospital, 30-day or 1-year mortality using Impella® devices or venoarterial ECMO (VA-ECMO) in patients with CS. Further, no significant differences have been found in rates of severe bleeding at the insertion site, device-related complications or episodes of peripheral ischaemia associated with these two types of devices. • Venoarterial ECMO devices a) Efficacy and safety of venoarterial ECMO vs IABP in CS In patients with CS, 30-day survival is significantly greater in patients receiving VA-ECMO than those treated with IABPs. Nonetheless, VA-ECMO is associated with a higher rate of device-associated complications. b) Efficacy and safety of venoarterial ECMO alone vs in combination with Impella® devices in CS There are no differences in in-hospital or 30-day mortality between patients with CS treated with VA-ECMO plus an Impella® device and those treated with VA-ECMO alone. Nonetheless, 1-year mortality is significantly lower with circulatory support based on both devices. There are no significant differences in vascular complications or severe bleeding at the insertion site; however, the combination of VA-ECMO and an Impella® device is associated with a greater risk of severe haemolysis. c) Efficacy and safety of VA-ECMO alone vs in combination with IABPs in CS In patients with CS, in-hospital mortality is significantly lower with the combination of VA-ECMO and an IABP than with VA-ECMO alone. The combination of VA-ECMO and an IABP is not associated with a higher rate of complications compared to VA-ECMO alone. • IABPs a) Efficacy and safety of IABPs vs standard medical care in CS There are no significant differences in 30-day mortality between CS patients treated with an IABP and those receiving standard medical care. b) Efficacy and safety of IABPs vs the combination of IABPs and VA-ECMO Survival is greater in patients treated with VA-ECMO combined with an IABP than those treated with an IABP alone. No significant differences in safety, in terms of complications or adverse effects, have been found between these two strategies.

Authors' methods: A systematic review (SR) of the scientific literature was conducted to identify studies comparing the following MCSDs: Impella® ventricular assist devices, intra-aortic balloon pumps (IABPs) and extracorporeal membrane oxygenation (ECMO) devices.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/eu_def/adjuntos/04_Osteba_Dispositivos_percutaneos_temporales.pdf

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>