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Early Feasibility Study of a Novel Mechanical Circulatory Support Device for High-Risk PCI

Croce, Kevin J. ; Kirtane, Ajay J. ; Götberg, Matthias LU ; Kandzari, David E. ; Bergmark, Brian ; Tamez, Hector ; McEntagart, Margaret ; Klein, Andrew J.P. ; Cavalcante, Rafael and Yeh, Robert (2026) In Circulation: Cardiovascular Interventions 19(7). p.016457-016457
Abstract

Mechanical circulatory support (MCS) devices provide hemodynamic stability during high-risk percutaneous coronary interventions (HR-PCI), potentially reducing the incidence of adverse events and permitting more complete revascularization.1,2 According to clinical guidelines in the United States, MCS is recommended during PCI for selected high-risk patients undergoing coronary artery revascularization (class IIb, level of evidence B).3 Current MCS devices have limitations related to device migration, hemolysis, and access site vascular and bleeding complications. The CHIP-BCIS3 trial (N=300) found that routine Impella CP use during complex high-risk PCI in patients with severe left ventricular dysfunction did not improve composite... (More)

Mechanical circulatory support (MCS) devices provide hemodynamic stability during high-risk percutaneous coronary interventions (HR-PCI), potentially reducing the incidence of adverse events and permitting more complete revascularization.1,2 According to clinical guidelines in the United States, MCS is recommended during PCI for selected high-risk patients undergoing coronary artery revascularization (class IIb, level of evidence B).3 Current MCS devices have limitations related to device migration, hemolysis, and access site vascular and bleeding complications. The CHIP-BCIS3 trial (N=300) found that routine Impella CP use during complex high-risk PCI in patients with severe left ventricular dysfunction did not improve composite outcomes over 22 months (win ratio, 0.85 [95% CI, 0.63–1.15]; P=0.30) compared with standard care, and showed a trend toward higher mortality and periprocedural injury, highlighting the need for optimized MCS-supported PCI options.4

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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
catheter, feasibility studies, heart, hemodynamics, percutaneous coronary intervention
in
Circulation: Cardiovascular Interventions
volume
19
issue
7
pages
016457 - 016457
publisher
American Heart Association
external identifiers
  • scopus:105041161860
  • pmid:42063404
ISSN
1941-7640
DOI
10.1161/CIRCINTERVENTIONS.125.016457
language
English
LU publication?
yes
id
120c5eae-f058-4081-b788-c2e59a206f55
date added to LUP
2026-09-02 15:23:24
date last changed
2026-09-16 16:10:13
@article{120c5eae-f058-4081-b788-c2e59a206f55,
  abstract     = {{<p>Mechanical circulatory support (MCS) devices provide hemodynamic stability during high-risk percutaneous coronary interventions (HR-PCI), potentially reducing the incidence of adverse events and permitting more complete revascularization.1,2 According to clinical guidelines in the United States, MCS is recommended during PCI for selected high-risk patients undergoing coronary artery revascularization (class IIb, level of evidence B).3 Current MCS devices have limitations related to device migration, hemolysis, and access site vascular and bleeding complications. The CHIP-BCIS3 trial (N=300) found that routine Impella CP use during complex high-risk PCI in patients with severe left ventricular dysfunction did not improve composite outcomes over 22 months (win ratio, 0.85 [95% CI, 0.63–1.15]; P=0.30) compared with standard care, and showed a trend toward higher mortality and periprocedural injury, highlighting the need for optimized MCS-supported PCI options.4</p>}},
  author       = {{Croce, Kevin J. and Kirtane, Ajay J. and Götberg, Matthias and Kandzari, David E. and Bergmark, Brian and Tamez, Hector and McEntagart, Margaret and Klein, Andrew J.P. and Cavalcante, Rafael and Yeh, Robert}},
  issn         = {{1941-7640}},
  keywords     = {{catheter; feasibility studies; heart; hemodynamics; percutaneous coronary intervention}},
  language     = {{eng}},
  number       = {{7}},
  pages        = {{016457--016457}},
  publisher    = {{American Heart Association}},
  series       = {{Circulation: Cardiovascular Interventions}},
  title        = {{Early Feasibility Study of a Novel Mechanical Circulatory Support Device for High-Risk PCI}},
  url          = {{http://dx.doi.org/10.1161/CIRCINTERVENTIONS.125.016457}},
  doi          = {{10.1161/CIRCINTERVENTIONS.125.016457}},
  volume       = {{19}},
  year         = {{2026}},
}