A New Paradigm in Mechanical Circulatory Support: 100-Patient Experience

Chung, Joshua; Emerson, Dominic; Ramzy, Danny; Akhmerov, Akbarshakh; Megna, D.; Esmailian, F.; Kobashigawa, J.A.; Cole, R.; Moriguchi, J.; Trento, Alfredo

doi:10.1016/j.athoracsur.2019.08.041

Cited by 44 publications

(54 citation statements)

References 18 publications

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“…However, there is some evidence that increased support with the Impella 5.0 improves cardiogenic shock survival, particularly as a bridge to transplantation or durable LVAD. [13][14][15] The Impella 5.5 ® with SmartAssist ® hemodynamic monitoring was approved in September 2019, by the Food and Drug Administration (FDA) for treatment of cardiogenic shock, whether following acute myocardial infarction or cardiac surgery, or in the setting of cardiomyopathy or myocarditis not responsive to medical management. We report the early outcomes of the first 200 US patients implanted with the Impella 5.5.…”

Section: Introductionmentioning

confidence: 99%

Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device

Ramzy

Anderson

Batsides

et al. 2021

Innovations�(Phila)

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Objective To report the initial clinical experience with the Impella 5.5® with SmartAssist®, a temporary left ventricular assist device that provides up to 6.2 L/min forward flow, with recent FDA approval for up to 14 days. Methods From October 2019 to March 2020, 200 patients at 42 US centers received the Impella 5.5 and entered into the IQ registry, a manufacturer-maintained quality database that captures limited baseline/procedural characteristics and outcomes through device explant. Post hoc subgroup analyses were conducted to assess the role of baseline and procedural characteristics on survival, defined as successful device weaning or bridge to durable therapy. Results Median patient age was 62 years (range, 13 to 83 years); 83.4% were male. The device was most commonly used for cardiomyopathy (45.0%), acute myocardial infarction complicated by cardiogenic shock (AMICS; 29.0%), and post cardiotomy cardiogenic shock (PCCS; 16.5%). Median duration of support was 10.0 days (range, 0.001 to 64.4 days). Through device explant, overall survival was 74.0%, with survival of 80.0%, 67.2%, 57.6%, and 94.7% in cardiomyopathy, AMICS, PCCS, and others (comprising high-risk revascularization, coronary artery bypass graft, electrophysiology/ablation, and myocarditis), respectively. Patients requiring extracorporeal membrane oxygenation and Impella support (35 patients, 17.5%) had significantly lower survival (51.4% vs 78.8%, P = 0.002). Conclusions In the first 200 US patients treated with the Impella 5.5, we observed overall survival to explant of 74%. Survival outcomes were improved compared to historic rates observed with cardiogenic shock, particularly PCCS. Prospective studies assessing comparative performance of this device to conventional strategies are warranted in future.

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Section: Introductionmentioning

confidence: 99%

Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device

Ramzy

Anderson

Batsides

et al. 2021

Innovations�(Phila)

Self Cite

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“…We have experienced hemolysis with Impella, particularly at greater flow settings, which may have been needed with significant AR. In a recent report by Chung and colleagues, 3 significant hemolysis occurred in 13% to 26% of patients supported with axillary Impella support for decompensated heart failure. Lastly, we hoped to eliminate the potential vascular complications while simultaneously providing support that enables ambulation with this technique.…”

Section: Discussionmentioning

confidence: 95%

Temporary extracorporeal left ventricular support with transapical ProtekDuo cannula

et al. 2021

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“…Transaxillary implantation of Impella 5.0, either performed surgically of percutaneously, is gaining increasing acceptance as an effective method to unload the left ventricle. [1][2][3][4][5] A relevant advantage of this access is the possibility of a full mobilization of patients, being this particularly favourable in patients needing prolonged support awaiting heart transplantation. 1 In some published series transaxillary implantation of Impella 5.0 was performed thorough the right axillary artery.…”

Section: Discussionmentioning

confidence: 99%

“…[1][2][3][4][5] A relevant advantage of this access is the possibility of a full mobilization of patients, being this particularly favourable in patients needing prolonged support awaiting heart transplantation. 1 In some published series transaxillary implantation of Impella 5.0 was performed thorough the right axillary artery. 2,3 Complications have been observed during support with Impella, such as vascular injury at the site of insertion (pseudoaneurysm, hematoma, thrombosis, limb ischemia), rupture of mitral chords, injury to the aortic valve leaflets, hemolysis and thrombocytopenia.…”

Section: Discussionmentioning

confidence: 99%

“…The reported incidence of stroke in patients supported by a transaxillary Impella 5.0 is 10%. 1,2 The risk of thrombosis of the innominate artery during support by means of right transaxillary Impella is still unknown. In our case the very long duration of the support with Impella and the hypercoagulable state associated to sepsis may have promoted the formation of intra-arterial thrombus.…”

Section: Discussionmentioning

confidence: 99%

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Thrombosis of the innominate artery during prolonged cardiac support by right transaxillary Impella 5.0 device

et al. 2021

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We describe an unexpected complication in a 46-years-old man affected by ischemic cardiomyopathy who received a prolonged mechanical cardiac support by means of right transaxillary Impella 5.0. The postoperative course was complicated by recurrent septicemia from multi-durg resistant Acinetobacter baumanii. He underwent implantation of venoarterial extracorporeal membrane oxygenation because of refractory cardiac arrest, followed by Impella removal that has been complicated by embolic stroke. The likely source of the embolus was a large thrombus inside the innominate artery. After a long-standing right transaxillary device implantation, particularly in patients with intercurrent septic episodes, a CT angiographic scan should be planned to exclude arterial thrombosis before removal of the transarterial device.

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A New Paradigm in Mechanical Circulatory Support: 100-Patient Experience

Cited by 44 publications

References 18 publications

Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device

Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device

Temporary extracorporeal left ventricular support with transapical ProtekDuo cannula

Thrombosis of the innominate artery during prolonged cardiac support by right transaxillary Impella 5.0 device

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