- Treatment with the TactiCath™ Contact Force Ablation Catheter,
Sensor Enabled™ resulted in patients with persistent atrial
fibrillation experiencing an improved quality of life
- The catheter is part of Abbott's suite of electrophysiology
solutions designed to improve procedures to address cardiac
arrythmias
ABBOTT
PARK, Ill., April 29,
2022 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced results from the PERSIST-END study, which showed that
nearly nine out of 10 patients (89%) treated for persistent atrial
fibrillation (AFib) with the company's TactiCath™ Contact Force
Ablation Catheter, Sensor Enabled™ (TactiCath SE) remained
symptom-free for up to 15 months following the procedure. The data,
which is being presented at the annual meeting of the Heart Rhythm
Society April 29 – May 1, also showed that due to the more effective
therapy, patients reported significant quality-of-life improvements
and more than 50% reduction in the use of health care
resources.
Millions of Americans are affected by abnormal heart rhythms,
known as arrhythmias, caused by breakdowns in the electrical
pathways of the heart. Left untreated, these breakdowns can lead to
erratic heartbeats or cause the heart to beat too fast or too slow,
which can dramatically impact a person's health. AFib, the most
common arrhythmia, is a condition in which the heart's chambers are
out of sync, causing them to beat in a rapid and chaotic
fashion. Persistent AFib is a type of arrhythmia that lasts
anywhere from one week to a year. If left untreated, AFib may
eventually lead to heart failure or stroke.
"Like many arrhythmias, persistent AFib can be difficult to
treat and to date we have had relatively few approaches approved
specifically to treat this condition," said Douglas Gibson, M.D., site principal
investigator and director of cardiac electrophysiology at
Scripps Clinic and the Prebys Cardiovascular Institute in
San Diego, Calif. "The results of
the PERSIST-END study show that Abbott's TactiCath SE can help
physicians ensure the majority of our persistent AFib patients will
remain symptom-free following their therapy and will go on to
experience dramatic improvements in their quality of life."
AFib is categorized into three types: paroxysmal, persistent or
long-standing persistent. Paroxysmal is defined as an abnormal
heart rhythm that lasts for less than a week, persistent lasts
between one week to a year, and long-standing persistent lasts
longer than a year. Approximately half of patients with AFib have a
long-standing persistent heart rhythm issue while the remaining 50%
are equally divided between paroxysmal and
persistent.1 TactiCath SE was previously approved
for paroxysmal AFib and the data from the PERSIST-END study
supported approval of the additional indication in persistent AFib
in 2021.
TactiCath SE is used as part of a cardiac ablation procedure, a
minimally invasive method that allows doctors to treat the
condition at the source by selectively disrupting the area of the
heart generating abnormal heart beats. The catheter provides
doctors essential and immediate feedback when the tip of the
ablation catheter connects with the tissue within the heart, which
can help improve accuracy and consistency of the procedure. It is
used in conjunction with Abbott's EnSite™ X EP System, the Advisor™
HD Grid Mapping catheter, and EnSite Omnipolar Technology (OT).
"Ablation therapy is an increasingly important option for people
living with cardiac arrhythmias because it allows physicians to
treat the cause of the arrhythmia at its source. However, it can be
a challenging procedure because the right amount of pressure needs
to be applied to the heart wall to be effective, but not so much as
to cause other problems," said Christopher
Piorkowski, M.D., chief medical officer of Abbott's
electrophysiology business. "We developed TactiCath SE to provide
clear information on whether the device is making contact with the
heart wall and whether the pressure is enough to achieve the
therapeutic goals. The outcomes are clear – the system delivers
safe and effective results."
About PERSIST-END
PERSIST-END was a prospective,
multi-center, single-arm clinical trial that included 224 patients
from 21 investigational sites in the U.S. and Australia conducted from 2018 to 2021.
Patients were evaluated for 15 months following the cardiac
ablation procedure for safety, efficacy, and quality of life
measures.
The primary safety endpoint for the trial was defined as the
rate of primary device and/or procedure-related serious adverse
events (SAEs) occurring within seven days of any ablation
procedure. Primary efficacy was defined as freedom from documented
AFib, atrial flutter or tachycardia >30 seconds or longer, new
or increased dose of Class I/III antiarrhythmic drug (AAD), repeat
ablation, and cardioversion through 15 months of follow-up.
The trial met all of its primary safety, effectiveness and
quality of life endpoints. The rate of serious adverse events was
3.1%, which is consistent with other studies in the persistent AFib
population. In addition, the overall primary effectiveness endpoint
found that 61.6% of patients remained free from arrhythmia
recurrence, any new or increased Class I/III AAD, repeat ablation
or cardioversion.
The study further found that participants reported that their
Atrial Fibrillation Effect on the QualiTy-of-life (AFEQT) score
increased by more than 27 points after three months and more than
32 points after 15 months – a clinically important difference
resulting in an average 91.9 quality of life score on a 100-point
scale 15 months after the procedure. Similarly, the patients'
average annual overall cardiovascular-related health care
utilization decreased by 53% in the 15 months following ablation
compared to pre-ablation utilization.
About Cardiac Ablation
When physicians use ablation to
treat cardiac arrhythmias, long flexible tools — called catheters —
are inserted into the heart to study the arrhythmia and to deliver
radio frequency energy. Heat generated from the radio frequency
energy disrupts the cells that are creating the abnormal heart
rhythm. As a result, this tissue is no longer capable of conducting
or sustaining the arrhythmia.
For U.S. important safety information on the TactiCath Contact
Force Ablation Catheter, Sensor Enabled, visit:
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/ablation-technology/tacticath-se-ablation-catheter/indications-safety-warnings.html.
About Abbott
Abbott is a global healthcare leader that
helps people live more fully at all stages of life. Our portfolio
of life-changing technologies spans the spectrum of healthcare,
with leading businesses and products in diagnostics, medical
devices, nutritionals and branded generic medicines. Our 113,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
1 Zoni-Berisso M, Lercari F, Carazza T, Domenicucci
S. Epidemiology of atrial fibrillation: European
perspective. Clin Epidemiol. 2014;6:213-220. Published
2014 Jun 16. doi:10.2147/CLEP.S47385
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SOURCE Abbott