Late-breaking data at ACC.22 with over 1 million patients
demonstrates a major gap in guideline adherence resulting in higher
mortality for patients with infected CIEDs
April 4, 2022
- Largest ever real-world analysis of Cardiac Implantable
Electronic Device (CIED) infection treatment presented at the
American College of Cardiology’s 71st Annual Scientific Session [1]
demonstrates that approximately 4 in 5 patients are not treated
according to HRS/EHRA Class I guidelines [2,3] for CIED
infection
- In the absence of guideline-driven care, the risk of death
after a CIED infection is 32.4% [1]
- This real-world CIED Infection Medicare Study analyzed the 100%
Medicare fee-for-service population over 14 years and included more
than 1 million CIED patients. It represents a nationwide analysis
of CIED infection care
- The findings demonstrate that adherence to guidelines with
timely lead extraction is associated with higher rates of
survival
- Philips supports physicians through a broad portfolio of Lead
Management solutions designed for safety and predictability,
including both laser and mechanical lead extraction
devices
Amsterdam, the Netherlands Royal Philips (NYSE:
PHG, AEX: PHIA), a global leader in health technology, today
announced late-breaking results of a large-scale, real-world
analysis of U.S. Centers for Medicare & Medicaid Services (CMS)
data on the rates of guideline adherence and associated mortality
in patients with CIED infection [1]. Results were presented at the
American College of Cardiology’s 71st Annual Scientific Session by
Sean Pokorney, M.D., Assistant Professor of Medicine at Duke
University School of Medicine (U.S.) and member of the Duke
Clinical Research Institute. The data demonstrated that
approximately 4 in 5 patients are not treated according to HRS/EHRA
Class I consensus recommendations and guidelines for CIED infection
(full system extraction)[2,3]. Moreover, complete hardware removal
(extraction) within 6 days was associated with a 42.9% lower risk
of death compared with patients who did not undergo
extraction[1].
The study examined 1,065,549 patients in Medicare in the USA who
received a CIED between January 1, 2006 and December 31, 2019.
Patients included in the CIED infection group were those that had
an implant greater than 12 months old, had a primary diagnosis for
infection of a device implant, and had documented antibiotic
therapy. The study was an independent analysis conducted by Duke
University and supported by a research grant from Philips. Philips
had no role in the design or conduct of the analysis.
“This study highlights the life-threatening nature of device
infections and the significant opportunities to improve care in
these complex patients. The findings also emphasize the importance
of timely diagnosis and complete treatment. Making things better
for patients tomorrow will require working with clinicians across
various specialties to advance education to help diagnose CIED
infections and deliver timely care,” said Jonathan P. Piccini, MD.,
M.H.S., the lead investigator of the study, the Director of Cardiac
Electrophysiology section at the Duke Heart Center. “The
opportunity to ensure all patients have access to
guideline-recommended care is not only imperative, but life-saving
for patients across the world.”
“The need for greater awareness and education for physicians,
patients, and caregivers is clearly shown by the results of this
study, so when early signs of infection present, action that is
consistent with guidelines is taken quickly.” said Trudie Lobban
MBE, Founder of Arrhythmia Alliance, a global non-profit patient
advocacy group.
CIEDs are life-saving devices and improve quality of life for
many patients. Each year one million CIEDs are implanted worldwide
[4] (which include pacemakers, implantable
cardioverter-defibrillators and cardiac resynchronization devices).
However, one in 20 of these patients will develop a CIED infection
[5] within three years. Patients diagnosed with CIED infections are
often treated with antibiotics, which is not an effective treatment
option alone – 50-100% of patients treated with only antibiotics
will experience an infection relapse [6,7]. Often medical
professionals lack awareness and experience in CIED infection
management resulting in patients being misdiagnosed or receiving
suboptimal treatments which can lead to negative health outcomes.
Current clinical practice guidelines recommend extraction for all
patients with a definite CIED infection, including complete device
and lead removal. It is estimated that globally more than 16,000
CIED patient lives are at risk each year due to improper treatment.
CIED extraction is proven safe and effective, especially with
earlier diagnosis, which can reduce mortality rates and long-term
costs [8,9].
“This CIED Infection Medicare Study clearly demonstrates that
increasing adherence to Class I guideline care can potentially save
lives,” said Chris Landon, Senior Vice President and General
Manager Image Guided Therapy Devices at Philips. “At Philips, we
are committed to supporting evidence-based medical approaches and
innovating solutions to help physicians improve outcomes and
decrease mortality for CIED infection.”Philips lead
management solutions Lead extraction, when indicated, is a
highly successful, potentially life-saving procedure, with a
clinical success rate of 97.7% and a procedural safety rate of
99.72% [10]. When lead extraction is indicated, Philips supports
physicians with Lead Management solutions through a broad portfolio
of tools designed for safety and predictability, including both
laser and mechanical lead extraction devices. Philips is dedicated
to helping physicians manage every lead safely, predictably, and
responsibly by providing expert tools, training, and ongoing
support.To read more on how Philips supports improving guideline
adherence, click here.
[1] Pokorney SD. Low Rates Of Guideline Directed Care Associated
With Higher Mortality In Patients With Infections Of Pacemakers And
Implantable Cardioverter Defibrillators. American College of
Cardiology (ACC) Late Breaking Clinical Trials. Washington, DC, USA
April 2022 [presentation]. [2] Kusumoto et al. 2017 HRS Expert
Consensus Statement on Cardiovascular Implantable Electronic Device
Lead Management and Extraction. Heart Rhythm, 2017.[3]
Blomström-Lundqvist, C., et al. (2020, Jun 1). European Heart
Rhythm Association (EHRA) international consensus document on how
to prevent, diagnose, and treat cardiac implantable electronic
device infections-endorsed by HRS, APHRS, LAHRS, ISCVID, ESCMID in
collaboration with EACTS. Eur Heart J, 41(21), 2012-2032.
https://doi.org/10.1093/eurheartj/ehaa010.[4] Greenspon A.J. J Am
Coll Cardiol 58:1001–1006.; Kremers MS, Heart Rhythm 2013;
10:e59.[5] Cantillon D. JACC EP. 2017. [6] del Rio A, Anguera I,
Miro JM, et al. Surgical treatment of pacemaker and defibrillator
lead endocarditis: the impact of electrode lead extraction on
outcome. Chest 2003;124:1451–9.[7] Chua, J.D., et al. (2000).
Diagnosis and management of infections involving implantable
electrophysiologic cardiac devices. Annals of Internal Medicine,
133(8): 604-608.[8] Le, K. Y., et al. (2011, Nov). Impact of
timing of device removal on mortality in patients with
cardiovascular implantable electronic device infections. Heart
Rhythm, 8(11), 1678-1685. 21. [9] Greenspon, A. J., et al. (2018,
May). Treatment patterns, costs, and mortality among Medicare
beneficiaries with CIED infection. Pacing Clin Electrophysiol,
41(5), 495-503.[10] Wazni, O. et. al. Lead Extraction in the
Contemporary Setting: The LExICon Study: A Multicenter
Observational RetrospectiveStudy of Consecutive Laser Lead
Extractions, J Am Coll Cardiol, 55:579-586.
For further information, please contact:
Joost Maltha Philips Global Press Office Tel:
+31 6 10 55
8116 E-mail: joost.maltha@philips.com
Fabienne van der FeerPhilips Image Guided TherapyTel: + 31 622
698 001E-mail: fabienne.van.der.feer@philips.com
About Royal Philips Royal Philips (NYSE: PHG,
AEX: PHIA) is a leading health technology company focused on
improving people's health and well-being, and enabling better
outcomes across the health continuum – from healthy living and
prevention, to diagnosis, treatment and home care. Philips
leverages advanced technology and deep clinical and consumer
insights to deliver integrated solutions. Headquartered in the
Netherlands, the company is a leader in diagnostic imaging,
image-guided therapy, patient monitoring and health informatics, as
well as in consumer health and home care. Philips generated 2021
sales of EUR 17.2 billion and employs approximately 78,000
employees with sales and services in more than 100 countries. News
about Philips can be found at www.philips.com/newscenter.
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