FIRE AND ICE Analysis: Lower Healthcare System Costs with Medtronic Cryoballoon
October 13 2016 - 8:30AM
Late Breaking
Clinical Trial Demonstrates Favorable Health Economics and Positive
Clinical Outcomes for AF Patients
DUBLIN AND SEOUL, REPUBLIC OF
KOREA - Oct. 13, 2016 - Medtronic plc (NYSE:MDT) today unveiled
new health economic analysis data from the FIRE AND ICE trial that
favor cryoballoon catheter ablation over radiofrequency (RF)
ablation related to trial period cost savings as a result of fewer
cardiovascular (CV) rehospitalizations and repeat ablations. The
data were presented at a late-breaking clinical trial session at
the Asia Pacific Heart Rhythm Society's Scientific Sessions in
Seoul, Republic of Korea.
The new analyses show that the Arctic
Front® Cryoballoon
Catheter Family reduces payer costs across multiple healthcare
systems, compared to the ThermoCool® line of RF
ablation catheters. Investigators also examined the association
between baseline patient demographics and CV rehospitalizations to
determine if the primary and secondary trial results were
consistent across patient subgroups.
"The cryoballoon technology demonstrates cost
savings across multiple health systems, driven by a reduction in
post-procedure rehospitalizations and reinterventions due to their
underlying disease state," said Prof. Karl-Heinz Kuck, M.D.,
director of cardiology at Asklepios Klinik St. Georg, Hamburg,
Germany, and principal investigator of the trial. "These analyses
highlight the real-world patient outcomes and health system
benefits of the cryoballoon."
The primary results from the FIRE AND ICE trial
were published in The New England Journal of
Medicine and showed comparable safety and effectiveness of
cryoballoon ablation and RF catheter ablation1.
Secondary analyses, which demonstrated significantly fewer repeat
ablations and lower cardiovascular hospitalization rates with
cryoablation, were published in the European Heart
Journal2.
Health Economic Supplementary
Analysis
Total rehospitalization and reintervention events observed during
the trial (average follow up of 1.5 years) were assigned payer
costs based on the healthcare systems and currencies from Germany
(Euro), the United Kingdom (British Pound) and the United States
(USD), respectively. This analysis revealed the cryoablation group
used fewer post-procedure healthcare resources and experienced
fewer repeat ablations and reinterventions compared to the RF group
(205 healthcare utilization events vs. 268), demonstrating
favorable health economics across three major healthcare
systems:
- €244,607 total trial savings under the German
system (p=0.012)
- £139,603 total trial savings under the United
Kingdom system (p=0.013)
- $355,005 total trial savings under the United
States system (p=0.016)
"We are committed to leading the global shift to
value-based healthcare, which means we want to be measured by the
impact we have both on patient outcomes as well as the economic
value we create for the healthcare system," said Colleen Fowler,
vice president and general manager of the AF Solutions business,
part of the Cardiac and Vascular Group at Medtronic. "Today's
findings further underscore the ability of the cryoballoon to make
a difference in care across patients, physicians and healthcare
systems."
"Predictors of Outcomes": Patient
Demographic-Based Clinical Outcomes
Investigators also evaluated baseline patient characteristics and
their association with CV rehospitalizations - one of the trial's
predefined secondary endpoints - to determine whether certain
subgroups may respond more favorably to treatment with the
cryoballoon or RF ablation. Patients with a CHA2DS2-VASC (stroke
risk) score of 0-1, and/or patients with prior direct current
cardioversion were associated with a significantly lower risk of CV
rehospitalization with cryoablation vs. RF ablation.
About FIRE AND ICE
FIRE AND ICE is the largest multicenter,
prospective, randomized study to compare cryoballoon ablation and
point-by-point RF ablation for the treatment of paroxysmal AF. This
landmark, head-to-head, non-inferiority study, published in
The New England Journal of Medicine, enrolled 769 patients. The trial met its
primary efficacy endpoint of showing noninferiority for cryoballoon
compared to RF catheter ablation in reducing arrhythmia recurrence
and the need for antiarrhythmic drug therapy and/or repeat
ablation, but with shorter and more consistent procedure times when
using the cryoballoon. It also met its primary safety endpoint of
time to first all-cause death, all-cause stroke/TIA, or
treatment-related serious adverse events.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services of
the highest quality that deliver clinical and economic value to
healthcare consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
Third party trademarks used in
this release are trademarks of their respective owners.
1 Kuck KH,
Brugada J, Fürnkranz A, et al. N Engl J Med 2016; 374:2235-2245
June 9, 2016 DOI: 10.1056/NEJMoa1602014
2 Kuck KH,
Fürnkranz A, Chun J, et al. Eur Heart J (2016) ehw285 DOI:
http://dx.doi.org/10.1093/eurheartj/ehw285 First published online:
5 July 2016
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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