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Closing Rem a rk s
In This
I S S U E
• C A S E S T U D Y
Intracardiac Echocardiography
Considerations During
Implantation of the
GORE ® HELEX Septal Occluderr
• F E A T U R E D T O P I C
New, More User-Friendly Medical
Website Launches:
goremedical.com
P E R F O R M A N C E b y d e s i g n
• I N T H E N E W S
Gore REDUCE Clinical Study
Steering Committee Responds
to CLOSURE I Data
• U P C O M I N G E V E N T S
C A S E S T U D Y
Intracardiac Echocardiography
Considerations During Implantation
of the GORE ® HELEX Septal Occluder
Mark H. Hoyer, MD
Professor of Clinical Pediatrics, Section of Pediatric Cardiology,
Director of Cardiac Catheterization and Interventional Cardiology,
Riley Hospital for Children, Indiana University School of Medicine
In the previous issue of Closing Remarks, a detailed discussion of atrial
septal anatomy was presented, followed by imaging techniques necessary
to fully assess atrial septal defect (ASD) size and rims. Transthoracic and
transesophageal echocardiography were the highlighted imaging modalities.
In this issue, a recent ASD closure procedure is shared to illustrate the use of
intracardiac echocardiography (ICE) for initial anatomic evaluation and for
guiding closure of the defect with a GORE ® HELEX Septal Occluder.
Continued on inside cover...
Winter 2010 • Issue XII

Intracardiac Echocardiography Considerations During
Implantation of the GORE ® HELEX Septal Occluder
Continued from cover...
An eight-year-old girl presented for
transcatheter ASD closure at a weight
of 24.6 kg. A prior transthoracic
echo showed a defect diameter
of approximately 10 mm, and the
posterosuperior (SVC), anterosuperior
(aortic), anteroinferior (tricuspid
valve), posteroinferior (IVC), and
posterosuperior (pulmonary
vein) rims were all adequate.
Using general anesthesia and
heparin anticoagulation, cardiac
catheterization revealed normal right
heart pressures and a Q p
/ Q s
of 1.3.
ICE imaging was performed using an
8F ACUNAV Intracardiac Echo Catheter
through a contralateral venous sheath.
As part of the usual imaging protocol,
a complete ICE evaluation was
completed as follows:
Note: Any control knob adjustments
of the ICE catheter are best made by
moving the locking ring clockwise
to the locked position first and then
moving the A / P or L / R control knob
as needed, thereby maintaining their
position.
1. “Home” view (Figure 1): the ICE
catheter arrow indicator at the control
end corresponds to the transducer
orientation at the catheter tip, and
Right Atrial Disk
Left Atrial Disk
Figure 2 Implanted GORE ® HELEX Septal Occluder
in hypothetical heart model.
this should be oriented toward patient
left and slightly anterior; the tricuspid
valve is seen with the right atrium
above and the right ventricle below;
superior is screen right, and inferior is
screen left; occasionally adjusting the
control knob slightly to the Anterior
(A) location is necessary.
2. Using both hands (right hand
at control knob area, left hand on
catheter near introducer sheath entry),
the catheter is rotated clockwise (when
looking from patient’s feet to head) or
away from operator; during this slow
rotation, one may see a prominent
Eustachian valve or Chiari network,
but typically the coronary sinus starts
“rounding” out, and subsequently
the LV and RV outflow tracts are
seen; variations in cardiac anatomy
and position often require gentle
adjustment of the L / R control knob to
optimize the image.
3. With further clockwise rotation,
the mitral valve, left atrial appendage,
and a fully round cross-section of the
coronary sinus are visible (Figures 2
and 3); the atrial septum is well seen;
as clockwise rotation continues,
the left-sided pulmonary veins are
typically seen as an upside down
“Y” connection, with the left superior
vein to screen right and the left
inferior vein to screen left; color flow
is red / orange as the direction of flow
is toward the transducer, which is
situated in the right atrium (Figure 4).
4. As one continues a clockwise
rotation around the back of the heart,
the descending aorta is seen next in
a horizontal orientation.
5. Just to patient right of the
descending aorta are the right-sided
pulmonary veins, again found by
clockwise rotation beyond the
descending aorta. Without any
control knob adjustment, these most
commonly appear as a foreshortened
upside down “Y” connection;
significantly enhanced imaging of the
right-sided veins can be achieved by
locking the L / R control knob toward
Figure 1. Home view.
Figure 3. View of the left atrial appendage
and mitral valve. The atrial is also well seen.
Figure 4. Left superior and inferior pulmonary
veins.

Figure 5. Right middle and lower pulmonary
veins.
“L” (toward operator). This corresponds
to left when looking up from patient’s
feet to head, but counterintuitively is
patient right; then rotate the entire
ICE catheter slightly clockwise or
counterclockwise to obtain images of
the elongated right-sided pulmonary
veins; this usually shows the right
middle (screen right) and right lower
(screen left) pulmonary veins joining
(Figure 5); to image the right upper
pulmonary vein, one then minimally
advances the entire ICE catheter inward
(superiorly) while gently rotating
clockwise even more, and the vein
comes into view farther right on the
screen (more superior).
6. After carefully assessing the
underlying anatomy, attention is
then turned to the atrial septum; the
Figure 7. Balloon sizing with measurement
marked by crosshairs.
coronary sinus and posteroinferior
rim has already been seen during the
initial clockwise sweep, but can be
viewed again.
7. From “Home” view, the control
knob is locked in a posterior position
and the entire catheter is rotated
clockwise, revealing the atrial
septum and ASD; this is ideal for the
anterosuperior (aortic) rim, opposite
of which is the posteroinferior or
posterosuperior rim (Figure 6).
8. From this view, adjusting the
locked control knob toward “R”
(clockwise toward patient left), the
ASD is often more optimally imaged,
and minor adjustments of this knob
clockwise or counterclockwise may
be necessary; with more pronounced
clockwise rotation (away from
Figure 9. ICE appearance before freeing
Eustachian valve.
operator), a bicaval view is often
seen, allowing measurements of the
caval rims.
9. Therefore, with ICE, measurements
of the five important rims (superior,
anterosuperior, anteroinferior,
posteroinferior, and posterosuperior)
can usually be obtained; however, it
may be necessary to visualize these
rims during control knob “sweeps,”
with the desired images being
somewhat in between.
In our case illustration, the baseline
measurement of the defect was 9.5 mm,
while the rim measurements
were as follows: superior 13 mm,
anterosuperior 7 mm, anteroinferior > 20
mm, posteroinferior 10 mm, and
posterosuperior 10.9 mm.
Figure 6. ASD with anterosuperior and
posterior rims.
Figure 8. Eustachian valve is caught within
the GORE ® HELEX Device discs.
Figure 10. ICE appearance after Eustachian
valve freed from device.

Figure 11. RA angiogram provides considerable
information about device position and
freedom from surrounding structures.
Using a balloon sizing catheter over
an extra stiff exchange wire and color
stop-flow technique, the defect was
sized at 13.5-14 mm (Figure 7).
A 30 mm GORE ® HELEX Septal Occluder
(device : defect diameter ratio = 2.2)
was implanted by standard techniques,
and follow-up ICE imaging showed the
inferior portion of the right atrial disc
to be slightly separated from the atrial
septum. It actually appeared caught on
the Eustachian valve (Figure 8), so a
5F multipurpose catheter was used to
gently push on the right atrial side of
the disc, freeing up the disc from the
Eustachian valve. Consequently, the
device had a flatter profile (Figures 9
and 10, before and after).
A right atrial angiogram was performed
by hand through the long delivery
sheath, showing the contrast
enveloping the right atrial disc, as well
as reflux of contrast into the SVC and
coronary sinus (Figure 11).
This provided reassurance that the
device does not impede important flow
within the heart.
Intracardiac echocardiography provides
detailed images of the heart, especially
the atrial septum. The ability to
clearly see the posteroinferior rims
of an ASD provides an advantage
over transesophageal echo, which
often results in suboptimal near-field
imaging. In addition, the use of ICE
precludes the need for endotracheal
intubation in older patients or adults,
thereby simplifying the procedure.
Please refer to GORE ® HELEX Septal Occluder
Instructions for Use at goremedical.com for
a complete description of all indications,
contraindications, warnings, precautions and
adverse events.

F E A T U R E D T O P I C
New, More User-Friendly Medical Website Launches:
goremedical.com
Gore Sales Associate, Alvaro De La
Mora, knew just what to do when one
of his customers — an interventional
cardiologist — requested product
animation for use at an upcoming
seminar.
“I referred him to goremedical.com,”
Alvaro says. “I knew he’d be able to
quickly and easily get what he needed,
and now he can share that animation
with fellow physicians.”
Those physicians can also use the
website to learn more about Gore medical
technologies. The recently redesigned
site makes it easy to find such content
as newsletters, brochures, instructional
videos and frequently asked questions,
among additional resources.
Meeting Diverse Needs
The impact of goremedical.com is
far reaching. And after undergoing a
redesign, the site is being touted as more
attractive, brand reflective and userfriendly.
It contains much of the same
content as the previous goremedical.
com, but in a new format.
“We wanted to make it easy for website
visitors to access what they’re looking
for,” says Medical Products Division
marketing associate and project
co-champion Matt Markiewicz. “Our old
site generated fairly positive feedback,
but it had so much information that it
was starting to become cluttered. The
new site is more polished. We worked to
minimize the number of clicks it takes
for visitors to get to the information
they need.”
Matt says the project team analyzed
the latest web design research to create
a site that would satisfy visitors. “We
wanted to know — when people look at a
website, what do they look at first? How
do they read the information? We took all
of this into account to make the site more
visually appealing.”
The content is accessible through four
categories of links — products, conditions,
specialties and resources — increasing
the likelihood that visitors will find what
they need. “A doctor might be more likely
to click on a product name, whereas a
patient might be more likely to click on a
condition name,” Matt says. “Because the
website has so many different types of
visitors, we provided them with different
ways to access information.”
Once visitors find what they’re looking
for, the website’s search engine provides
links to related terms, making it simple
for visitors to find more information
relevant to their profession, diagnosis
or procedure.
Continued on next page...

New, More User-Friendly Medical Website Launches:
goremedical.com
Continued from previous page...
Yielding Positive Feedback
“When information is hard to find, your
biggest concern is that people will leave
the site frustrated,” Matt says. “Our
metrics indicate that with the new site,
people are having more success finding
what they need.”
Customers have also provided positive
feedback. Alvaro, for example, recounts
an interaction with another doctor who
recently used the site: “He came to me
and thanked our company for offering
such a user-friendly, well thought-out
site. He had a patient in his office
who wanted more information about
one of our products, and by visiting
goremedical.com, he quickly found
what he needed.”
In this age of information technology,
Alvaro says a growing number of
doctors and patients turn to the Internet
to learn more about the medical
devices they’re using or receiving.
“Goremedical.com allows them to get
their questions answered,” he says.
“And it really lays the information out
for them in a nice, user-friendly format.”
Creating a Consistent Brand Voice
The new site does more than answer
doctor and patient questions. It also
leverages the power of the Gore brand.
The site shares a similar look and feel
with gore.com, including a banner that
incorporates brand color and imagery.
The banner also features animation and
an area that highlights new products,
events and other important information.
And, like gore.com, the site features a
navigation bar above the banner and
four columns of links below.
And the consistent branding reminds
visitors that Gore’s diverse medical
products come from the same company—
one with a long history of innovation and
integrity. “We want them to know that
these products are made by Gore and
backed by Gore,” Matt says. “We have
set the bar really high in the medical
community. It’s important that whether
you’re looking for a hernia patch or an
endovascular graft that you know the
product is from Gore, and you can trust it
because it comes from Gore.”
View the new site design at:
goremedical.com and
goremedical.com/HELEX

I N T H E N E W S
Gore REDUCE Clinical Study Steering Committee Clarify the Current Status
of CLOSURE I Data
The Gore REDUCE Clinical Study Principal
Investigators have prepared the following
statement on behalf of the Gore REDUCE
Clinical Study Steering Committee in
response to the recent CLOSURE I results:
The Gore REDUCE Clinical Study is a
prospective, randomized, multi-center,
multi-national trial designed to
demonstrate safety and effectiveness
of the GORE ® HELEX Septal Occluder for
PFO closure in patients with history of
cryptogenic stroke or imaging-confirmed
Transient Ischemic Attack (TIA). The
unique study, which includes up to fifty
investigational sites in the US and Europe,
is on track. More information visit,
clinical.goremedical.com/REDUCE.
“On November 15, 2010 at the American
Heart Association (AHA) annual meeting
in Chicago, Anthony Furlan, MD presented
the results of CLOSURE I, a prospective,
multi-center, randomized controlled trial
of PFO closure with the STARFLEX ® Device
(NMT Medical, Inc) versus best medical
therapy for the prevention of recurrent
stroke and/or transient ischemic attack
(TIA) in patients with cryptogenic stroke /
TIA and PFO. The results of the study,
as presented, showed no statistically
significant difference between device
closure and best medical therapy. In a
discussant presentation, Pierre Amarenco,
MD concluded that PFO closure is not
needed for the majority of patients
with stroke and PFO and should not be
performed in routine practice. However,
he noted that many patients with stroke
and PFO have alternative (non-PFO)
causes for their strokes, and argued
that this may have diluted a true causal
effect of PFO in the CLOSURE I study.
Dr. Amarenco left open the possibility that
PFO closure may still be considered in
patients with truly cryptogenic stroke.
This presentation and the recommendations
discussed would appear to refute
the innovative device approach to the
prevention of recurrent cryptogenic stroke
in patients with PFO. However, there are
several key issues that we believe should
limit the impact of the CLOSURE I results
on the ongoing Gore REDUCE Clinical
Study. These issues are mostly related to
device and patient selection:
• CLOSURE I included patients with
clinically-defined (not imaging-confirmed)
TIAs. Recent studies have shown that
MRI-negative TIAs are associated with an
extremely low risk of subsequent stroke.
Inclusion of such patients likely resulted
in an underestimation of stroke event
rates in both arms of the trial as compared
to a population with strokes confirmed
by imaging.
• The majority of the stroke endpoint
events during follow-up appeared to
have a determinable origin, suggesting
that these patients likely had alternative
explanations for their index stroke. Stroke
due to atherosclerosis or small vessel
disease would not be affected by PFO
closure, and therefore would bias the
results toward underestimating a potential
treatment effect for PFO closure (i.e., bias
towards the null).
• Nearly half of the stroke endpoint
events in the PFO closure arm appeared
to be directly related to the device itself,
and about a quarter of these occurred
in the first 30 days after implantation.
Alternative devices (like the GORE ® HELEX
Septal Occluder) may offer substantial
advantages and fewer complications,
thereby increasing the differences
between device and medical therapy.
• Although device-related complications
were considered insignificant, the
incidence of new atrial fibrillation (5.7%)
and device thrombus (four cases and two
cases lead to a subsequent stroke) appear
to be associated with recurrent events
and more frequent when compared to the
GORE ® HELEX Septal Occluder reports.
• Medical therapy differed between
PFO closure and control arm, thereby
introducing a confounding effect on the
study endpoints.
We, the Gore REDUCE Clinical Study
Principal Investigators, conclude that
improved patient selection focused on
truly cryptogenic strokes (rather than
other causes of stroke or TIA) and use of
a device with a low complication rate is
needed to determine whether PFO closure
is superior to best medical therapy.
The Gore REDUCE Clinical Study addresses
the CLOSURE I limitations by design:
• All TIAs must be confirmed by
neuroimaging studies, which will prevent
the inclusion of spurious neurological
events that are not vascular in origin.
• Eligibility criteria are more stringent
and better exclude patients with
non-cryptogenic strokes, such as the
exclusion of lacunar strokes and exclusion
of patients with a substantial burden of
vascular risk factors.
• Both test and control arms for the study
have the same medical therapy and sites
are directed to apply a uniform medical
therapy regimen for both test and control
subjects.
• The clinical literature for the GORE ®
HELEX Septal Occluder supports a low rate
of device related atrial fibrillation and a
nearly non-existent incidence of device
thrombus formation.
With additional PFO trials still underway,
much remains to be determined regarding
the best course of therapy for cryptogenic
stroke patients with PFO. Taking into
consideration the Gore REDUCE Clinical
Study design and the noted shortcomings
of the CLOSURE I study, the Gore REDUCE
Clinical Study Steering Committee has
concluded that the best course of action is
to continue the study without significant
changes. Additionally, in June, the FDA
also recommended that the Gore REDUCE
Clinical Study continue as original planned.
At this point in time there is no compelling
reason to alter the current clinical study.
It remains imperative, as it has since
the beginning of the trial, that we recruit
patients with truly cryptogenic stroke (and
PFO) to get a definitive answer to these
essential questions.”
Thank you for your continued commitment
to this important study.
Scott Kasner, MD
US Neurology Principal Investigator
John Rhodes, MD
US Cardiology Principal Investigator
Lar Søndergaard, MD
Nordic Region Cardiology Principal Investigator
Lars Thomassen, MD, PhD
Nordic Region Neurology Principal Investigator

U P C O M I N G E V E N T S
Please Join Us...
February 9 – 11 Los Angeles International Stroke Conference
Booth #126
2011 Scheduled GORE MEDICAL MASTERY SERIES Courses Sponsored by Gore
February 24 – 25 Durham Atrial Septal Defect Closure Course
with an Animal Lab
March 3 – 4 Chicago Atrial Septal Defect Closure Course
with an Animal Lab
March 24 – 25 Philadelphia Atrial Septal Defect Closure Course
with an Animal Lab
May * Detroit Atrial Septal Defect Closure Course
with an Animal Lab and the assistance
of a proctor
* Date to be announced. Please check with your local Gore Sales Associate for further information.
Gore’s commitment to excellence continues with the GORE MEDICAL MASTERY SERIES.
The Atrial Septal Defect Closure courses provide Interventional Cardiologists with the
opportunity to develop their knowledge of implant techniques. Contact your local Gore
Sales Associate for further information regarding these various course opportunities.
If you have a topic that you would like us to consider in a future issue of Closing Remarks,
please contact your local Gore Sales Associate or e-mail ClosingRemarks@wlgore.com
W. L. Gore & Associates, Inc.
Flagstaff, AZ 86004
+65.67332882 (Asia Pacific) 800.437.8181 (United States)
00800.6334.4673 (Europe) 928.779.2771 (United States)
goremedical.com
INDICATIONS FOR USE IN THE US: The GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter
closure of ostium secundum atrial septal defects (ASDs). INDICATIONS FOR USE UNDER CE MARK: The GORE HELEX Septal Occluder is a permanently
implanted prosthesis indicated for the percutaneous, transcatheter closure of atrial septal defects (ASDs), such as ostium secundum and patent foramen
ovale. Refer to Instructions for Use at goremedical.com for a complete description of all contraindications, warnings, precautions and adverse events.
Products listed may not be available in all markets.
ACUNAV is a trademark of BioSense Webster ®
STARFLEX ® is a trademark of NMT Medical, Inc.
GORE ® , HELEX, PERFORMANCE BY DESIGN, and designs are trademarks of W. L. Gore & Associates.
© 2010 W. L. Gore & Associates, Inc. AP4553-EN1 NOVEMBER 2010