Improves upon AMI cardiogenic shock historical
survival of 50%
Abiomed (NASDAQ:ABMD) announces that new data from the
National Cardiogenic Shock Initiative Study (NCSI) on 171
consecutive AMI cardiogenic shock (AMICS) patients from 35 sites
demonstrates 72% survival with 98% native heart recovery at
discharge. The patients were treated with the NCSI protocol, which
includes placing the Impella heart pump before revascularization.
The study demonstrates the protocol-based approach to increasing
survival rates in cardiogenic shock is reproducible in academic and
community hospitals across the United States. Results were
presented at the 2019 Society for Cardiovascular Angiography &
Interventions (SCAI) Scientific Sessions and simultaneously
published in Catheterization and Cardiovascular Interventions
(CCI).
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National Cardiogenic Shock Initiative
(NCSI) with Impella best practices demonstrates 72% survival with
98% native heart recovery at discharge. This improves upon AMI
cardiogenic shock historical survival of 50%. (Graphic: Abiomed,
Inc.)
The investigators of the physician-led NCSI represent the
largest working group studying the effects of mechanical
circulatory support in AMICS patients. Their goals are to increase
cardiogenic shock survival, which has stagnated for the last 20
years at around 50% and provide unloading therapy to achieve native
heart recovery1. The NCSI protocol includes best practices of
placing Impella pre-PCI, identifying shock early and minimizing the
use of inotropes. These best practices were identified
retrospectively through Abiomed’s Impella Quality (IQ) Database and
the U.S. Impella Registry, now called the cVAD Study, and were
tested and validated prospectively in the original Detroit CSI
study, which demonstrated improved survival and native heart
recovery.
The NCSI used patient selection criteria that mimicked prior
cardiogenic shock studies2,3. Patients included in the study were
treated between July 2016 and February 2019.
Patient Characteristics
Demographics
All (n=171)
Average age 63 years Gender – male 77%
AMI cardiogenic shock present on admission 68% On
inotropes or vasopressors prior to or during index procedure
83% Witnessed out-of-hospital cardiac arrest
20% In-hospital cardiac arrest 29% CPR at the time of
Impella insertion 10%
“By adopting the NCSI protocol, physicians around the country
have standardized the treatment of cardiogenic shock and are
improving patient outcomes by using best practices which include
early placement of the Impella heart pump,” said William O’Neill,
MD, medical director of the Center for Structural Heart Disease at
Henry Ford Hospital. “Similar to door-to-balloon time, the adoption
of these best practices is an evolution in clinical practice that
will benefit our sickest patients. Tracking, collecting and
applying real-world evidence will allow physicians to continue to
increase survival and heart recovery for these patients.”
“This new clinical data validates, as prior publications have
demonstrated, the importance of best practice protocols to improve
survival and native heart recovery for patients with cardiogenic
shock,” said Michael R. Minogue, Chairman, President and Chief
Executive Officer of Abiomed. “Abiomed is committed to
investing in innovation, clinical research with prior and future
FDA studies, and analyzing real-world evidence through our Impella
Quality (IQ) Database and cVAD Study. We will continue to partner
with physicians and hospital teams to create the field of heart
recovery.”
Since FDA PMA approval, Abiomed has collected data on
nearly 100% of U.S. Impella patients in the observational IQ
Database. This clinical data, combined with
the FDA post-approval studies embedded in Abiomed’s
prospective cVAD Study, helped identify and validate best practices
for Impella use associated with improved survival and native heart
recovery. These best practices, including use of Impella pre-PCI,
reduction of inotropes, early identification of shock, and
hemodynamic monitoring with pulmonary artery catheters, have now
been validated in multiple publications:
- Journal of Interventional Cardiology,
2014: Placement of Impella pre-PCI is associated with more complete
revascularization and improved survival to discharge in the setting
of AMI cardiogenic shock (65% with Impella placed pre-PCI vs. 41%
post-PCI, p=0.023).
- American Journal of Cardiology, 2017:
Initiation of Impella before PCI and prior to initiation of
inotropes or vasopressors is independently associated with improved
survival. Survival to discharge was 68%, 46%, 35%, 35%, and 26% for
patients requiring 0, 1, 2, 3, and ≥4 inotropes before mechanical
circulatory support, respectively (p <0.001), in an analysis of
281 AMI cardiogenic shock patients.
- Journal of Interventional Cardiology,
2017: Demonstrates a 48% survival at 30 days when Impella is
implanted pre-PCI, compared to a 13% survival when Impella is
implanted post-PCI for left main in cardiogenic shock
(p=0.004).
- American Heart Journal, 2018: Analysis
of 15,259 U.S. patients in the IQ Database demonstrated an
improvement in survival to explant from 52% to 59% when Impella was
placed pre-PCI (p=0.001).
- National Cardiogenic Shock Initiative
Study Late Breaking Clinical Science, TCT 2018: Data from the
first 104 patients utilizing best practices in the National
Cardiogenic Shock Initiative (NCSI) Study found 77% survival to
discharge with 99% native heart recovery.
- Circulation, 2018: Analysis reinforces
best practices of reduced use of inotropes and placement of Impella
pre-PCI leads to improved survival rates. Survival benefit of
Impella pre-PCI revealed trend vs “matched” IABP-Shock: 57.3% vs.
46.7% (p=0.18). Significant survival to discharge benefit with
Impella in patients who did not receive inotropes (56.6% vs. 29.4%
p<0.01). A subset of patients from this paper was presented
at American College of Cardiology (ACC) 2019 Scientific
Sessions when Andreas Schäfer, MD, presented an abstract that
showed improved survival to discharge when Impella is placed
pre-PCI of 71% vs. 49% post-PCI (p= 0.0021).
- Journal of the American College of
Cardiology, 2018: Rab, et al., summarizes data from IQ Database,
cVAD Study and NCSI and concluded that best practices are
associated with improved survival in AMI cardiogenic shock.
- Journal of the American College of
Cardiology, 2019: After Inova Heart and Vascular
Institute instituted a best practice protocol that includes
early use of percutaneous mechanical circulatory support, AMI
cardiogenic shock survival at 30 days rose from 44% to 82%
(p=0.0001).
1. Impella has exclusive FDA approval as a therapy for
cardiogenic shock to allow for native heart recovery.2.
Intra-aortic Balloon Support for Myocardial Infarction with
Cardiogenic Shock; Thiele, H, et al., New England Journal of
Medicine. 2012 Oct 4; DOI: 10.1056/NEJMoa12084103. PCI Strategies
in Patients with Acute Myocardial Infarction and Cardiogenic Shock:
Results of the Culprit-Shock Trial; Thiele, H. et al., New England
Journal of Medicine. 2017 Dec 21; DOI: 10.1056/NEJMoa1710261
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. FDA PMA
approved to treat certain advanced heart failure patients
undergoing elective and urgent percutaneous coronary interventions
(PCI) such as stenting or balloon angioplasty, to re-open blocked
coronary arteries. The Impella 2.5, Impella CP, Impella CP with
SmartAssist™, Impella 5.0® and Impella LD® are U.S. FDA approved
heart pumps used to treat heart attack or cardiomyopathy patients
in cardiogenic shock, and have the unique ability to enable native
heart recovery, allowing patients to return home with their own
heart. The Impella RP® is U.S. FDA approved to treat right heart
failure or decompensation following left ventricular assist device
implantation, myocardial infarction, heart transplant, or
open-heart surgery.
In Europe, the Impella 2.5, Impella CP and Impella CP with
SmartAssist are CE marked for treatment of high-risk PCI and AMI
cardiogenic shock patients for up to 5 days. Impella 5.0 and
Impella LD are CE marked to treat heart attack or cardiomyopathy
patients in cardiogenic shock for up to 10 days. The Impella 5.5™
heart pump is CE marked to treat heart attack or cardiomyopathy
patients in cardiogenic shock for up to 30 days. The Impella RP is
CE marked to treat right heart failure or decompensation following
left ventricular assist device implantation, myocardial infarction,
heart transplant, open-heart surgery, or refractory ventricular
arrhythmia.
To learn more about the Impella platform of heart pumps,
including their approved indications and important safety and risk
information associated with the use of the devices, please visit
www.impella.com.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading
provider of medical devices that provide circulatory support. Our
products are designed to enable the heart to rest by improving
blood flow and/or performing the pumping of the heart. For
additional information, please visit www.abiomed.com.
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella
CP, Impella RP, and Impella Connect are registered trademarks of
Abiomed, Inc., and are registered in the U.S. and certain foreign
countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and
SmartAssist are pending trademarks of Abiomed, Inc.
FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including
statements regarding development of Abiomed's existing and new
products, the company's progress toward commercial growth, and
future opportunities and expected regulatory approvals. The
company's actual results may differ materially from those
anticipated in these forward-looking statements based upon a number
of factors, including uncertainties associated with development,
testing and related regulatory approvals, including the potential
for future losses, complex manufacturing, high quality
requirements, dependence on limited sources of supply, competition,
technological change, government regulation, litigation matters,
future capital needs and uncertainty of additional financing, and
other risks and challenges detailed in the company's filings with
the Securities and Exchange Commission, including the most recently
filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
Readers are cautioned not to place undue reliance on any
forward-looking statements, which speak only as of the date of this
release. The company undertakes no obligation to publicly release
the results of any revisions to these forward-looking statements
that may be made to reflect events or circumstances that occur
after the date of this release or to reflect the occurrence of
unanticipated events.
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version on businesswire.com: https://www.businesswire.com/news/home/20190521005741/en/
Tom LangfordDirector, Communications and Public
Relations978-882-8408tlangford@abiomed.com
Ingrid Goldberg WardDirector, Investor
Relations978-646-1590igoldberg@abiomed.com
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