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

Kennel, Peter J.; Lumish, Heidi; Kaku, Yuji; Fried, Justin; Kirtane, Ajay J.; Karmpaliotis, Dimitri; Takayama, Hiroo; Naka, Yoshifumi; Sayer, Gabriel; Uriel, Nir; Takeda, Koji; Masoumi, Amirali

doi:10.1002/ehf2.13512

Cited by 19 publications

(18 citation statements)

References 15 publications

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“…6 Additionally, Kennel et al described a case series of 14 IMP5.5 patients managed with a UFH strategy and found three patients (21%) and one patient (7%) experienced bleeding and ischemic stroke events, respectively. 3 While data is limited evaluating the bleeding rates with the IMP5.5 device, our findings suggest a comparable rate of major bleeding and ischemic events with earlier models of IMP support using a UFH-based strategy.…”

Section: Discussionsupporting

confidence: 52%

“…Our center commonly utilizes the Impella® 5.5 (IMP5.5) which is a surgically implanted pump, indicated for the treatment of ongoing CS due to acute myocardial infarction, post‐cardiac surgery, cardiomyopathy, or as a de‐escalation strategy from ECMO. In a report of initial clinical outcomes for IMP5.5 more than 75% of patients with CS were bridged to another advanced therapy or recovery, including de‐escalation from VA‐ECMO 3 …”

Section: Introductionmentioning

confidence: 99%

“…In a report of initial clinical outcomes for IMP5.5 more than 75% of patients with CS were bridged to another advanced therapy or recovery, including de-escalation from VA-ECMO. 3 The recommended anticoagulation strategy for IMP5.5 is systemic unfractionated heparin (UFH) with a UFHbased dextrose purge solution to prevent device thrombosis. 4 Yet various clinical scenarios require avoiding systemic heparin exposure, such the development of heparin-induced thrombocytopenia (HIT).…”

Section: Introductionmentioning

confidence: 99%

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Outcomes of systemic bivalirudin and sodium bicarbonate purge solution for Impella 5.5

et al. 2022

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Background: Impella 5.5 (Abiomed; Danvers, MA) (IMP5) is a commonly used, surgically implanted, tMCS device that requires systemic anticoagulation and purge solution to avoid pump failure. To avoid heparin-induced thrombocytopenia (HIT) from unfractionated heparin (UFH) use, our program has explored the utility of bivalirudin (BIV) for systemic anticoagulation and sodium bicarbonatedextrose purge solution (SBPS) in IMP5.5. Methods: This single center, retrospective study included 34 patients supported on IMP5.5 with BIV based AC and SBPS between December 1st 2020 to December 1st 2021.The efficacy and safety end points were incidence of development of HIT, Tissue Plasminogen Activator (tPA) use for suspected pump thrombosis, stroke, and device failure as well as clinically significant bleeding. Results:The median duration of IMP5.5 support was 9.8 days (IQR: 6-15). Most patients were bridged to HTX (58%) followed by recovery (27%) and LVAD implantation (15%). Patients were therapeutic on bivalirudin for 64% of their IMP5.5 support. One patient (2.9%) suffered from ischemic stroke and 26.5% (9) patients developed clinically significant bleeding. tPA was administered to 7(21%) patients. One patient in the entire cohort developed HIT. Conclusions:Our experience supports the use of systemic BIV and SBPS as a method to avoid heparin exposure in a patient population predisposed to the development of HIT.

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Section: Discussionsupporting

confidence: 52%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Outcomes of systemic bivalirudin and sodium bicarbonate purge solution for Impella 5.5

et al. 2022

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“…From 4173 articles, we reviewed 206 full-text articles. In total, we included 71 studies (63 observational, 8 PSM/RCTs) detailing 4280 adult patients that reported on the use of microaxial LVADs in CS ( Figure 1 ) [ 16 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 …”

Section: Resultsmentioning

confidence: 99%

Microaxial Left Ventricular Assist Device in Cardiogenic Shock: A Systematic Review and Meta-Analysis

Tan

Low²,

Ng³

et al. 2022

Life

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Microaxial left ventricular assist devices (LVAD) are increasingly used to support patients with cardiogenic shock; however, outcome results are limited to single-center studies, registry data and select reviews. We conducted a systematic review and meta-analysis, searching three databases for relevant studies reporting on microaxial LVAD use in adults with cardiogenic shock. We conducted a random-effects meta-analysis (DerSimonian and Laird) based on short-term mortality (primary outcome), long-term mortality and device complications (secondary outcomes). We assessed the risk of bias and certainty of evidence using the Joanna Briggs Institute and the GRADE approaches, respectively. A total of 63 observational studies (3896 patients), 6 propensity-score matched (PSM) studies and 2 randomized controlled trials (RCTs) were included (384 patients). The pooled short-term mortality from observational studies was 46.5% (95%-CI: 42.7–50.3%); this was 48.9% (95%-CI: 43.8–54.1%) amongst PSM studies and RCTs. The pooled mortality at 90 days, 6 months and 1 year was 41.8%, 51.1% and 54.3%, respectively. Hemolysis and access-site bleeding were the most common complications, each with a pooled incidence of around 20%. The reported mortality rate of microaxial LVADs was not significantly lower than extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pumps (IABP). Current evidence does not suggest any mortality benefit when compared to ECMO or IABP.

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“…5 support from 2010 to 2018 compared to 253 patients listed from 2018 to 2021, with Impellasupported patients being significantly more likely to undergo transplantation after 2018. While a few studies have documented promising early outcomes with the recently approved Impella 5.5,[27][28][29][30] differences in the utilization and outcomes between the Impella 5.0 and 5 5. have not yet been analyzed.…”

mentioning

confidence: 99%

Waitlist and transplant outcomes for patients bridged to heart transplantation with Impella 5.0 and 5.5 devices

Hill

Kwon

Shorbaji

et al. 2022

Journal of Cardiac Surgery

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Background: Impella devices are increasingly utilized as a bridge to heart transplantation (BTT) and are now prioritized as Status 2 under the current heart allocation policy. This study evaluated waitlist and post-transplant outcomes of patients supported with Impella 5.0/5.5 devices. Methods:The United Network of Organ Sharing registry was used to identify adults waitlisted or transplanted with Impella 5.0 or 5.5 devices from 2010 to 2021.Separate analyses were performed for waitlist and transplantation outcomes for patients supported by Impella 5.0/5.5 devices. Competing outcomes for the waitlist analysis included rates of transplantation, recovery, and death or clinical deterioration. Among patients undergoing transplantation, the primary outcome was 1-year survival. Secondary outcomes included rates of rejection, new postoperative dialysis, stroke, and pacemaker implantation after transplantation.Results: There were 344 patients waitlisted and 394 patients transplanted with an Impella 5.0 (n = 212 and 251) or 5.5 (n = 132 and 143) device. Competing risk regression demonstrated similar likelihood of transplant (subhazard ratio [SHR], 1.33 (0.98-1.81, p = 0.067)) and similar likelihood of death or clinical deterioration (SHR, 0.67 [0.27-1.69, p = 0.400]) for Impella 5.5 patients. In the transplanted cohort, unadjusted 1-year post-transplant survival was comparable at 91.3% versus 94.6% (log-rank p = 0.661) for patients supported by Impella 5.0 or 5.5 device, respectively, a finding that persisted after risk-adjustment (HR 1.22, p = 0.699). Post-transplant complication rates were also comparable between 5.0 and 5.5 patients.Conclusions: Impella devices can be used as a BTT with excellent survival and minimal post-transplant morbidity. Outcomes were comparable for Impella 5.0 and 5.5 devices.

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

Cited by 19 publications

References 15 publications

Outcomes of systemic bivalirudin and sodium bicarbonate purge solution for Impella 5.5

Outcomes of systemic bivalirudin and sodium bicarbonate purge solution for Impella 5.5

Microaxial Left Ventricular Assist Device in Cardiogenic Shock: A Systematic Review and Meta-Analysis

Waitlist and transplant outcomes for patients bridged to heart transplantation with Impella 5.0 and 5.5 devices

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