TY - JOUR
T1 - Early Outcomes of the First 200 US Patients Treated with Impella 5.5
T2 - A Novel Temporary Left Ventricular Assist Device
AU - Ramzy, Danny
AU - Anderson, Mark
AU - Batsides, George
AU - Ono, Masahiro
AU - Silvestry, Scott
AU - D’Alessandro, David A.
AU - Funamoto, Masaki
AU - Zias, Elias A.
AU - Lemaire, Anthony
AU - Soltese, Edward
N1 - Funding Information:
Dana Bentley, MWC, assisted with the writing of this report and is an employee of Abiomed, the device manufacturer. Abiomed provided medical writing and statistical support for this manuscript. The author(s) received no financial support for the research, authorship, and/or publication of this article.
Publisher Copyright:
© The Author(s) 2021.
PY - 2021/7
Y1 - 2021/7
N2 - 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.
AB - 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.
KW - cardiogenic shock
KW - heart failure
KW - Impella
KW - left ventricular assist device
KW - mechanical circulatory support
UR - http://www.scopus.com/inward/record.url?scp=85107591294&partnerID=8YFLogxK
U2 - 10.1177/15569845211013329
DO - 10.1177/15569845211013329
M3 - Article
C2 - 34101514
AN - SCOPUS:85107591294
SN - 1556-9845
VL - 16
SP - 365
EP - 372
JO - Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
JF - Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
IS - 4
ER -