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

Innovations : Technology and Techniques in Cardiothoracic and Vascular Surgery
Danny RamzyEdward Soltese

Abstract

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. 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. 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 myocard...Continue Reading

References

Jul 21, 2004·Journal of the American College of Cardiology·Rupert FinckeUNKNOWN SHOCK Investigators
Nov 5, 2008·Annals of Internal Medicine·Raban V JegerUNKNOWN AMIS Plus Registry Investigators
Aug 28, 2012·The New England Journal of Medicine·Holger ThieleUNKNOWN IABP-SHOCK II Trial Investigators
Nov 5, 2016·Journal of the American College of Cardiology·Dagmar M OuweneelJosé P S Henriques
Jan 4, 2017·The American Journal of Cardiology·Mir B BasirWilliam W O'Neill
Sep 20, 2017·Circulation·Sean van DiepenUNKNOWN American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality
Mar 1, 2018·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Sandeep M PatelHiram G Bezerra
Mar 9, 2018·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Dirk W DonkerMichael Broomé
Apr 5, 2019·Circulation. Cardiovascular Interventions·Lukas HunzikerUNKNOWN AMIS Plus Registry Investigators are listed in alphabetic order with the names of the local principal investigators
Sep 30, 2019·The Annals of Thoracic Surgery·Joshua S ChungAlfredo Trento
Feb 1, 2020·The Thoracic and Cardiovascular Surgeon·Markus K Heinemann
Jun 17, 2020·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Danny RamzyMark Anderson

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Citations

Sep 26, 2021·Journal of Cardiac Surgery·Kyle A SimonsenRamachandra C Reddy

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Methods Mentioned

BETA
coronary artery bypass

Software Mentioned

Excel
QuickCalcs
GraphPad
SmartAssist
Impella

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