Comparison of device‐specific adverse event profiles between Impella platforms

Abstract

Background: The Impella (Abiomed) ventricular support system is a family of temporary mechanical circulatory support (MCS) devices used to treat patients with cardiogenic shock, acute cardiogenic decompensation, and for high-risk percutaneous or surgical revascularization. These devices include the percutaneously implanted 2.5/cardiac power (CP) and the surgically implanted 5.0/left direct (LD). Despite the beneficial effects and increased usage of these devices, data to assess adverse outcomes and guide clinician decision-making between the Impella CP and 5.0/LD are limited. Methods: This is a retrospective analysis of 91 consecutive patients who required at least 24 h of Impella support, from January 1, 2015 to December 31, 2019. Groups were stratified based on either initial Impella CP or 5.0/LD placement. Clinical outcomes and in-hospital complications were compared. Results: Impella CP was implanted in 66 patients (mean age: 61 ± 15 years, male 71.2%) and Impella 5.0/LD was implanted in 25 patients (mean age: 62 ± 9 years, male 84.0%). There was greater stability of device position (p = .033), less incidence of hemolysis (p < .001), and less frequent need for additional MCS (p = .001) in patients implanted with the Impella 5.0/LD compared with Impella CP in this study cohort. Patients with Impella 5.0/LD were more likely to survive from Impella and survive to discharge. Conclusions: This study suggests that for patients who require temporary MCS for more than 24 h, the Impella 5.0/LD may have a more favorable device-specific adverse profile compared with the Impella CP.

A case series analysis on the clinical experience of Impella 5.5® at a large tertiary care centre

“… 2 In previous versions of pVAD, design revisions, generally with larger French sizes and higher output, had favourable complication profiles compared with prior versions. 12 Overall, in our cohort, the complication rate was reasonably low, with access site haematomas and kidney injury being the most common adverse events. Vascular complications at the axillary insertion site occurred in three patients, requiring device removal in one patient due to an expanding axillary haematoma.…”

La gestione infermieristica e la prevenzione delle complicanze nel paziente portatore di dispositivo di assistenza ventricolare Impella

“…10 Gli esiti secondari alla condizione di emolisi risultano essere controproducenti per il paziente. 37 La gestione dei pazienti post-impianto con il dispositivo Impella presso la terapia intensiva è fondamentale per consentire il massimo potenziale del dispositivo e garantire risultati accettabili. 21 L'attuazione di un programma educativo Impella fornisce agli infermieri numerosi benefici e garantisce al paziente assistenza competente da parte dell'Infermiere.…”

“…4,10 Gli esiti secondari alla condizione di emolisi possono essere: incidenza di ictus ischemico o emorragico, incidenza di ulteriore Supporto Circolatorio Meccanico (MCS) con necessità di upgrade a Impella 5.0/LD o all'ossigenazione Extracorporea a Membrana (ECMO). 37 Rimozione L'utilizzo prolungato del dispositivo Impella è strettamente correlato all'insorgenza di complicanze; quindi, i test di svezzamento precoce risultano utili per ridurne l'insorgenza. 21 Analizzando l'articolo di Pietrasik et al 31 si deduce che il monitoraggio regolare dei parametri emodinamici durante la MCS prolungata è fondamentale per valutare l'efficacia del supporto emodinamico e per selezionare il momento ottimale dello svezzamento.…”

Handling high-risk patients in the catheterization laboratory

“…These complications include arrhythmias, bleeding, cardiac tamponade, haemolysis, perforation, valve injury, renal failure, or changing of the device position. 5 , 6 Thus, prior to any procedure each patient case should be discussed and coronary artery disease treatment strategy outlined among team members. Once a treatment plan has been derived and approved, any necessary baseline blood laboratory tests should be performed before procedure initiation.…”