The effectiveness and safety of the Impella ventricular assist device for high‐risk percutaneous coronary interventions: A systematic review

Ichou, Jamal Ait; Larivée, Natasha; Eisenberg, Mark J.; Suissa, Karine; Filion, Kristian B.

doi:10.1002/ccd.27316

Cited by 21 publications

(19 citation statements)

References 34 publications

(148 reference statements)

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“…In our cohort protected by ECLS, the rate of renal failure, 12%, was slightly higher than in Flaherty's study, but still lower than the described unprotected rate. The main complication in our study cohort was bleeding requiring RBC transfusion, occurring in 49% of cases, which is considerably more frequent than in other prospective and retrospective cohorts described elsewhere 26 . Although anemia has been shown to be associated with adverse outcome in patients with acute coronary syndrome or patients undergoing PCI, numerous studies have demonstrated that RBC transfusion is independently associated with increased mortality and increased rate of major adverse cardiac events (MACE) in these patients 27‐32 .…”

Section: Discussionmentioning

confidence: 66%

Extracorporeal life support system during cardiovascular procedures: Insights from the German Lifebridge registry

et al. 2020

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Section: Discussionmentioning

confidence: 66%

Extracorporeal life support system during cardiovascular procedures: Insights from the German Lifebridge registry

et al. 2020

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“…It is rapidly deployed and improves heart function in patients with acute CS but also for patients with chronic heart failure. They have proven to be safe, and effective at improving hemodynamic parameters when the heart is acutely decompensated [4]. The devices can be inserted with multiple approaches but also with different types of operators.…”

Section: Introductionmentioning

confidence: 99%

The role of the axillary Impella 5.0 device on patients with acute cardiogenic shock

Tarabichi

Ikegami

Russo

et al. 2020

J Cardiothorac Surg

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Background: Acute cardiogenic shock is associated with high mortality rates. The Impella device is a microaxial left ventricular assist device that can be inserted through the axillary artery. The purpose of our study is to determine the role of the Axillary Impella devices on patients with acute cardiogenic shock. Methods: A retrospective chart review was conducted to identify patients who underwent Axillary Impella device placement for acute cardiogenic shock from January 1st, 2014 to September 30th, 2018 at a single institution. Inpatient records were examined to determine duration of device, length of stay (LOS), postoperative complications, and 30-day in-hospital mortality. Results: A total of 40 patients, who were primarily men (N = 29) with a mean age of 61.2 ± 10.7 years old, underwent Axillary Impella placement for cardiogenic shock. The primary reasons for implant were (1) required upgraded support from an Impella CP or intra-aortic balloon pump (iabp) to Impella 5.0, (2) to treat left ventricular (LV) distention for patients on extracorporeal mechanical oxygenation (ECMO), and (3) to provide longer term support and allow for mobilization of the patients in whom a device was already indwelling. Twenty-three of the patients had previous devices already in place including a Femoral Impella CP device or an iabp and 9 patients were on ECMO support. The duration of the device was 21.05 ± 17 days with the LOS of 40.8 ± 28 days for those patients. Seventeen of the patients went on to additional surgery including (1) Heartmate 3 device placement (N = 6), (2) other cardiac procedures such as surgical revascularization (N = 9), and orthotopic heart transplantation (N = 2). A total of 21 patients of the 40 (52%) died during their hospitalization with 7 patients (17%) having complications related to the Impella device. These complications included right arm ischemia or neuropathy (N = 3) and Impella malfunction requiring device replacement (N = 4). The majority of these devices were placed in the right axillary artery (N = 38) versus the left axillary artery (N = 2). Conclusions: A total of 58% (N = 23) of the study patients had previous mechanical support and 23% (N = 9) were on ECMO demonstrating the severity of disease and accounting for the high mortality. The Axillary Impella device allows for a minimally invasively placed device that is durable with a mean duration of 3 weeks. The Axillary artery Impella 5.0 provides upgraded full cardiac support while allowing for mobilization of the patient. In addition, it treats LV distention in patients on ECMO while avoiding sternotomy. Finally, the Axillary Impella provides time for decision making for explant, additional therapy with either long-term devices or orthotopic heart transplant.

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“…A recently published systematic review reported the outcomes of controlled and uncontrolled studies of high-risk PCI with Impella 2.5-support, the majority being 30-day MACCE. [ 10 ] MACCE in the controlled studies ranged between 15% and 35% during a 30-day follow-up whereas uncontrolled studies demonstrated considerably lower 30-day MACCE between 5% and 20%. [ 12 – 14 , 25 – 27 ] Compared to intraaortic balloon pump, protected PCI with the Impella showed a trend toward lower MACCE after 90 days while there was no difference after 30 days.…”

Section: Discussionmentioning

confidence: 99%

“…[ 6 – 8 ] In this subset of patients, the temporary implantation of a peripheral ventricular assist device may improve short- and long-term outcomes. [ 9 , 10 ]…”

Section: Introductionmentioning

confidence: 99%

Unprotected versus protected high-risk percutaneous coronary intervention with the Impella 2.5 in patients with multivessel disease and severely reduced left ventricular function

et al. 2018

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Selecting a revascularization strategy in patients with multivessel disease (MVD) and severely reduced left ventricular ejection fraction (LVEF) remains a challenge. PCI with Impella 2.5 may facilitate high-risk PCI, however long-term results comparing unprotected versus protected PCI are currently unknown. We sought to evaluate the outcome of patients undergoing protected compared to unprotected percutaneous coronary intervention (PCI) in the setting of MVD and severely reduced LVEF.We included patients with MVD and severely reduced LVEF (≤35%) in this retrospective, single-centre study. Patients that underwent unprotected PCI before the start of a dedicated protected PCI program with Impella 2.5 were compared to patients that were treated with protected PCI after the start of the program. The primary endpoint was defined as major adverse cardiac and cerebrovascular events (MACCE) during a 1-year follow-up. The secondary endpoints consisted of in-hospital MACCE and adverse events.A total of 61 patients (mean age 70.7 ± 10.9 years, 83.6% male) were included in our study, of which 28 (45.9%) underwent protected PCI. The primary endpoint was reached by 26.7% and did not differ between groups (P = .90). In-hospital MACCE (P = 1.00) and in-hospital adverse events (P = .12) also demonstrated no significant differences. Multivariate logistic regression identified procedural success defined as complete revascularization and absence of in-hospital major clinical complications as protective parameter for MACCE (OR 0.17, 95% CI 0.04–0.70, P = .02).Patients with MVD and severely depressed LVEF undergoing protected PCI with Impella 2.5 demonstrate similar in-hospital and one-year outcomes compared to unprotected PCI.

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The effectiveness and safety of the Impella ventricular assist device for high‐risk percutaneous coronary interventions: A systematic review

Cited by 21 publications

References 34 publications

Extracorporeal life support system during cardiovascular procedures: Insights from the German Lifebridge registry

Extracorporeal life support system during cardiovascular procedures: Insights from the German Lifebridge registry

The role of the axillary Impella 5.0 device on patients with acute cardiogenic shock

Unprotected versus protected high-risk percutaneous coronary intervention with the Impella 2.5 in patients with multivessel disease and severely reduced left ventricular function

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