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\begin{document}

\title{Title: Using NIS database,~ Impella use was associated with highest~
whereas Intraaortic balloon pump with lowest mortality~ in patients with
cardiogenic shock}



\author[1]{Mohammad Reza Movahed}%
\affil[1]{Affiliation not available}%


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  \date{June 15, 2024}


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\textbf{Subtitle:} A word of caution in the use of Impella in patients
with cardiogenic shock

Author: Mohammad Reza Movahed, MD, PhD \textsuperscript{1,2,3}

University of Arizona Tucson\textsuperscript{1} University of Arizona
Phoenix\textsuperscript{2}

Correspondent:

M Reza Movahed, MD, PhD, FACP, FACC, FSCAI, FCCP

Clinical Professor of Medicine, University of Arizona, Tucson

Clinical Professor of Medicine, University of Arizona, Phoenix

1501 No Campbell Aven

Tucson, AZ 85724

Tel: 949 400 0091

Email: rmova@aol.com

Conflict of interest: None

Keywords: Acute coronary syndrome; cardiogenic shock; shock; cardiac
assist device; IABP; cardiac support; congestive heart failure; device
use; myocardial infarction; Impella

With great interest, I read the manuscript entitled ``Comparative
Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device
(MCS) ~vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support
in Patients With Cardiogenic Shock'' in JAMA Cardiology. (1) They found
that the adjusted 30-day mortality risk post-PCI was 41.3\% in the IABP
cohort which was 11.4\% lower than with the use of MCS and was similar
to no device et al (difference IABP vs no device 3.1\%). Their findings
were consistent even though they adjusted for every possible confounding
factor. ~ ~They also avoided acceptance that mortality was much lower in
the IABP cohort in comparison to MCS and was similar to any device use
despite the fact that most patients treated with IABP are much sicker
and if IABP had no positive effect on mortality, higher mortality
suggesting a positive effect of IABP on mortality in their patients with
cardiogenic shock.~ We published a preprint paper (2) pending peer
review publication by analyzing over 844,020 patients with all types of
cardiogenic shocks using the largest available Nationwide Inpatient
Sample (NIS) database. 101,870 were treated with IABP and 39,645 with an
Impella. Consistent with their results, we found much higher inpatient
mortality rates with Impella use despite adjusting for over 47
confounding factors. Regardless of the severity or any underlying
condition, Impella increased mortality in patients with acute myocardial
infarction-induced cardiogenic shock (AMICS) by approximately 30\%
whereas IABP reduced mortality by over 30\% ~regardless of severity or
hospital type. The benefit of IABP was also consistent regardless of
comorbidities and also was highly significant in comparison to no device
in all subgroup cohorts. Two meta-analyses of Impella trials showed
worse outcomes using Impella in patients with AMICS. (3,4) Finally,
using the NIS database, patients with AMICS showed significantly higher
mortality. (5) ~Until large randomized trials are conducted,
cardiologists need to exert utmost caution in the judiciary use of
Impella and utilize it only in selected patients until more safety data
are available.

.

\textbf{References:}

\begin{enumerate}
\tightlist
\item
  Almarzooq ZI, Song Y, Dahabreh IJ, Kochar A, Ferro EG, Secemsky EA,
  Major JM, Farb A, Wu C, Zuckerman B, Yeh RW. Comparative Effectiveness
  of Percutaneous Microaxial Left Ventricular Assist Device vs
  Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in
  Patients With Cardiogenic Shock. JAMA Cardiol. 2023 Aug
  1;8(8):744-754.
\item
  Movahed MR, Talle A, Hashemzadeh M. In Patients with Cardiogenic,
  Shock Intra-Aortic Balloon Pump is Associated with the Lowest Whereas
  Impella with the Highest Mortality Regardless of Severity or Hospital
  Types Using the Large Nationwide Inpatient Sample (NIS).
  https://ssrn.com/abstract=4517178 or
  http://dx.doi.org/10.2139/ssrn.4517178
\item
  Panuccio G, Neri G, Macr\selectlanguage{ngerman}ì LM, Salerno N, De Rosa S, Torella D. Use of
  Impella device in cardiogenic shock and its clinical outcomes: A
  systematic review and meta-analysis. Int J Cardiol Heart Vasc. 2022
  Mar 25;40:101007
\item
  Moustafa A, Khan MS, Saad M, Siddiqui S, Eltahawy E. Impella Support
  Versus Intra-Aortic Balloon Pump in Acute Myocardial Infarction
  Complicated by Cardiogenic Shock: A Meta-Analysis. Cardiovasc Revasc
  Med. 2022 Jan;34:25-31.
\item
  Jin C, Yandrapalli S, Yang Y, Liu B, Aronow WS, Naidu SS. A Comparison
  of In-Hospital Outcomes Between the Use of Impella and IABP in Acute
  Myocardial Infarction Cardiogenic Shock Undergoing Percutaneous
  Coronary Intervention. J Invasive Cardiol. 2022 Feb;34(2):E98-E103
\end{enumerate}

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