1. health and fitness
2. disease

CardioSourceNews
saturday
6 1 s t
A n n u a l
S c i e n t i f i c
S e s s i o n
•
c h i c a g o
•
m a r c h
2 4
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ACC.12 to showcase the best
in cardiovascular innovation
W
hile ACC.12 might be the 61st Scientific
Session and Expo presented by the College, it is anything but an aging event
mired in its ways. This year’s conference is
breaking new ground by adjusting its format
so attendees can experience more science
and its clinical applications, and new sessions
have been developed to spark interest among
cardiovascular professionals.
“We have tried to make sure we have a
well-rounded approach for the variety of
patients with cardiovascular diseases,” said
ACC President David R. Holmes Jr., MD. “We
are making sure that the scientific interchange
worldwide is brisk, broad, timely and relevant.”
The first change longtime attendees will
notice is that morning sessions will highlight
new science, while afternoon sessions will focus on actual application of the science. Each
evening of the meeting, special Clinical Focus
sessions will offer even more education.
“We are attempting to forge stronger collaborations with many of the professional
organizations with which we work,” said Patrick T. O’Gara, MD, co-chair of the ACC.12
Program Committee. “We have joint sessions
with the Heart Rhythm Society, the Heart
Failure Society of America, the American Society of Echocardiography and the American
What’s new
with ACC-i2
with TCT?
A
CC.12 includes an ACC-i2 with TCT
Learning Pathway program with
five focused tracks: coronary heart
disease, endovascular, imaging, structural heart disease and special topics.
The program reflects the realities of the
cardiovascular professional life and the
transformations physicians are experiencing in medicine. It also ensures attendees
know the latest approaches to complex
coronary disease, both the mechanical and
pharmacological advances to left main
disease, chronic total occlusions and acute
coronary syndromes.
In the endovascular track, experts will
share endovascular therapies for peripheral arterial and venous disease — both
See ACC-i2, page 16
2 7
2 0 1 2
Inside
3 International presentations
3 Lifelong Learning
3 Health IT updates
4 CCS sessions at ACC.12
5 NCDR data presented at sessions
5 Cardiac Care Team programming
6 Get a dose of quality at ACC.12
8 ACC Central offerings
9 Education abounds at ACC Expo
12 LBCT schedule
Today’s schedule
ACC Meet the Experts
8 to 9 a.m.
See program for locations of sessions
ACC/i2 Opening Session
8 to 10 a.m.
Joint Main Tent, Hall B, North building
The ACC Scientific Session returns to a favorite location, Chicago, from today through Tuesday, but it arrives with new approaches to the conference format.
Heart Association, our partner in guidelines
development, as well as other groups. We
feel these are some of the major professional
organizations that many of our members also
belong to, and we want to provide opportunities for joint programming.”
New sessions will open and close ACC.12.
The new Legends of Cardiovascular Medicine series will showcase five physicians who
have made a huge difference in modern-day
treatment of cardiovascular disease. The
legends will be honored for their work, and
then lecture on the future of cardiology, said
Rick A. Nishimura, MD, Program Committee co-chair.
“A bookend to Legends is ‘Innovators in
Cardiology,’ which will wrap up the meeting
See ACC.12 WITH TCT, page 18
Legends of cardiology
Esteemed cardiology
professionals share
expertise during new series
A
new lecture series featuring legendary
cardiovascular leaders will debut as
part of ACC.12. The Legends of Cardiovascular Medicine series will provide attendees with a first-hand glimpse into the unique
professional history and accomplishments
of men and women who have helped shape
cardiovascular care into what it is today.
“This series celebrates these physicians’ unique accomplishments,” said ACC
President David R. Holmes Jr., MD. “It
gives them an opportunity to highlight
some of their accomplishments and to share
their vision of the future of cardiovascular
medicine and science. We are lucky and
honored to have the opportunity to listen to
them speak.”
The series of five lectures will kick off
at the ACC.12 Opening Session and Late-
Breaking Clinical
Trials at 8 a.m. today in North building Hall B, when
Eugene Braunwald,
MD, will give the
Simon Dack lecture,
“The Treatment of
Acute Myocardial
Infarction — Into
Eugene Braunwald, MD
the Second Century.” Braunwald is
best known for his
work in the areas of
congestive heart failure, coronary artery
disease and valvular
heart disease. His
research is credited
for opening the door
to modern-day heart Magdi H. Yacoub, MB
attack treatments.
Also today, Magdi H. Yacoub, MB,
will give the 43rd Annual Bishop Lecture
See LEGENDS, page 19
Poster sessions
9:30 to 10:30 a.m.
Hall A, South building
Expo Coffee Break
9:30 to 11:30 a.m.
Hall A, South building
Expo hall open
9:30 a.m. to 4:30 p.m.
Halls A, South building
Poster sessions
11 a.m. to Noon
Hall A, South building
ACC Meet the Experts
12:15 to 1:45 p.m.
See program for locations of sessions
i2 Meet the Experts
12:15 to 1:45 p.m.
See program for locations of sessions
ACC Meet the Experts
2 to 3:30 p.m.
See program for locations of sessions
i2 Live and Taped Cases
2 to 5 p.m.
See program for locations of sessions
Legends in Cardiovascular Medicine/
Bishop Lecture
2 to 5 p.m.
Room N426
ACC Meet the Experts
4:30 to 6 p.m.
See program for locations of sessions
FIT Forum Jeopardy
4:30 to 6 p.m.
Room N227b
Clinical Focus Sessions
6:30 to 9 p.m.
Fairmont Hotel
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CardioSourceNews
American College of Cardiology
3
Several ACC.12 activities cater
to international audience
A
CC.12 offers an exceptional range of educational and networking activities tailored
for an international audience because of
the substantial following of the ACC Annual
Scientific Session by leading cardiologists
from around the world.
“From an unprecedented 18 Joint International Lunch Symposia to the Legends of
Cardiovascular Symposia series featuring
global luminaries, ACC.12 will offer more
educational content for international attendees than ever before,” said Huon Gray, MD,
chair of the ACC Assembly of International
Governors.
A popular international event returned for
ACC.12 once again — the Fourth Annual
International Cardiovascular Conference:
Focus on the Middle East, which this year
addressed congestive heart failure and cardiometabolic disease. The Friday conference,
explored advances in diagnosis, treatment
and management of cardiovascular disease,
with an emphasis on how these are applied
in the context of physician practice in the
Middle East.
“This symposium was the most robust and
exciting program to date,” said conference
chair, Ari Kugelmass, MD. “It continues to
be a marquee international offering of the
ACC that truly unites physicians throughout
the region and the world.”
Internationally prominent cardiology
leaders will gather at Noon Monday for the
18 International Lunch Symposia. Jointly
sponsored by ACC and national cardiology societies from around the globe, these
popular events will cover a wide range of
topics, from coronary total occlusions to
risk stratification for sudden cardiac death.
“ACC International Lunch Symposia bring
together leading experts from around the
world to discuss selected topics of great clinical importance from their different national
perspectives, offering collaborative learning
strategies for success in cardiovascular care,”
said James McClurken, MD, chair of the
Joint International Lunch Symposia. “The
design of many of these sessions includes
initial case presentations as a focal point
for launch of the topic review by esteemed
experts.”
For the second year, the highest-ranking
abstract writer from each country with a
lunch symposium will be awarded a certificate by the co-chairs of each session to start
the program.
Among the five Legends of Cardiovascular Medicine lectures, the Maseri-Florio
International Lecture, from 2 to 3 p.m.
Monday in Room N231, always features
outstanding investigators in cardiology
who possess a global perspective. Antonio
Colombo, MD, of Milan, Italy, will present
this year’s lecture, which honors his service
as an international leader in interventional
cardiology for pioneering the concept of
adequate stent deployment during coronary
interventions.
At the 61st Annual Convocation, from 6:30
to 8:30 p.m., Monday in Hall B1, Antonio
Chagas, MD, from Sao Paulo, Brazil, will
receive the International Service Award.
This award honors an individual who has
demonstrated a commitment to medically
developing countries and, through benevolent
actions, has enhanced cardiovascular care
One of the most popular segments of the Scientific Session are International Lunch Symposia, which will
be presented at Noon Monday.
and education in these countries.
Twin sessions Monday afternoon pair an
ACC international chapter with an ACC
U.S. state chapter in presenting on major
cardiovascular topics. This year, the Italian
Federation of Cardiology and the Pennsylvania Chapter will present an update on treatment for atrial fibrillation, while the British
Cardiovascular Society and the California
Chapter will cover imaging issues from new
frontiers in echocardiography to the future of
cardiac magnetic resonance.
An array of additional sessions will feature a global focus on cardiovascular care.
Joint sessions of the European Society of
Cardiology and the ACC include “Management of Heart Disease in Pregnancy,” from
8 to 9:30 a.m., Monday in Room W426, and
“Pros and Cons of New Approaches for
Antiplatelet and Anticoagulant Therapy,”
from 8 to 9:30 a.m. Tuesday in Room W426.
The world’s premier Greek cardiologists
will explore the “Mediterranean Diet and
Its Protective Effect on Cardiovascular
Lifelong learning
MOC Study Sessions offer key cardiology reviews
T
he ACC Foundation Study Sessions for
Maintenance of Certification (MOC) are
designed to make the 10-year, time-limited board certificate in cardiovascular disease,
interventional cardiology or electrophysiology
more manageable for cardiologists.
The dedicated workshops, which started
Friday and continue through Monday, will
enable participants to earn MOC points in
medical knowledge required before sitting for
the secure board examination of the American Board of Internal Medicine (ABIM).
“At ACC.12, we offer expert facultymoderated group Study Sessions where we
go over these modules and discuss individual
multiple-choice questions with an eye toward
the concept being tested here,” said Study
Sessions Chair Steve R. Ommen, MD. “We
use the multiple-choice question as a framework to teach and focus on the knowledge
opportunity rather than merely revealing the
correct answer to each question.”
Participants will have their choice of 12
review sessions — two in interventional
cardiology, two in electrophysiology and
eight in general cardiology (half based on
ABIM home-study modules and half based
on new ACC general-cardiology modules).
For ACC.12, the Study Sessions will present
the 2012 module and the 2011 module.
“In the Study Sessions, we hear the experts
approach a basic problem addressed by a test
question,” Ommen said. “They discuss the
nuances in the way the stem of the question
is worded, what is indicated there, what literature speaks to the correct answer and why
other answers might be wrong.”
The questions discussed during Study
Sessions will not appear on the secure ABIM
examination but have been subjected to a
rigorous review process that adheres to the
ABIM’s formal test-writing methodologies.
In contrast to independent study, these sessions offer a group study experience, with the
benefit of encouraging participants to reflect
where their knowledge base may be incorrect
regarding a specific question, Ommen said.
The experts then present information to help
fill that knowledge gap.
After the Study Session, participants may
submit their answers at nearby computer
work stations; each 25-question module is
worth 10 MOC points. All ABIM workshop
participants must be enrolled in the ABIM
MOC program to attend. ABIM staff will be
available to assist with on-site enrollment and
to answer MOC questions. Registrants who
sign up for the new ACC general cardiology
modules may access them online through
their CardioSource accounts.
“These study sessions tend to be highly
popular because it is a powerful learning
device,” Ommen said. “They are successful
because participants carve out time for their
academic development. They are not trying
to shoehorn these sessions in at the end of a
busy day of practice. They are taking advantage of the opportunity to learn from people
who have had a chance to consider the question and provide instruction about the issues
presented in the individual questions.”
In addition to the MOC Study Session,
ACC.12 offers interactive pediatric cardiology sessions based on a group of home-study
modules approved by the American Board
of Pediatrics (ABP). Participants in these
sessions will review the latest in pediatric
cardiology with the experts and their peers,
as well as challenge their medical knowledge
with test questions and receive instant feedback via an audience response system. The
pediatric cardiology study session offers up
to 10 ABP MOC points. The credit approval
period for this module is Jan. 1 to Dec. 31.
Participants must be an ABP diplomate and
enrolled in the ABP MOC process at the time
of the session.
Disease” from 3:45 to 5:15 p.m. Monday in
Room S405. A session by the China Chapter, from 8 to 9:30 a.m. Monday in Room
N229, will focus on prevention.
Members of ACC international chapters
may socialize and make new connections
with fellows from across the U.S. and several
other countries at the ACC New Fellows and
All Chapter Reception from 8 to 9:15 p.m.
in Hall B. Additionally, the International
Lounge is open for all attendees practicing
outside the U.S., offering the opportunity
to network with colleagues, learn about
the multitude of international ACC initiatives and partnerships, and find information
regarding international membership in the
ACC. For the first time ever, all international
ACC chapters will be provided with a special
booth area — the International Chapter
Pavilion — to network with colleagues from
their countries and other international attendees. As always, ACC Central will be the
hub for all things ACC, including an array of
international offerings.
Health IT sessions
help members
stay ‘meaningful’
F
rom 2011-2015, physicians who
demonstrate “meaningful use” of
electronic health record (EHR)
technology and performance during the
reporting period of each payment year
will be eligible for positive payment
incentives.
To help raise awareness of the EHR
Meaningful Use incentive program,
the ACC and the Healthcare Information and Management Systems Society
(HIMSS) will present two special
Spotlight Sessions on Sunday. They
will explain the requirements and what
the proposed Meaningful Use Stage 2
regulations mean for providers.
The first session, “Making the
Electronic Health Record Meaningful
and Useful — A Washington Perspective,” from 12:30 to 1:45 p.m. in Room
N227, features Farzad Mostashari, MD,
ScM, deputy national coordinator for
programs and policy within the Office
of the National Coordinator (ONC) for
See HIT, page 13
4
Saturday
March 24, 2012
CCS at ACC.12: Emphasizing the lifelong care continuum
T
his year’s Congenital Cardiology Solutions (CCS) Learning Pathway at ACC.12
reflects the increasing emphasis on
congenital heart disease as a lifelong disease,
requiring collaborative specialized care.
Nineteen sessions will address the challenging
clinical issues and emphasize quality of care,
use of databases in developing patient care
pathways and recent advances in cardiac care.
“The goal of CCS.12 is to strike a balance
between pediatric and adult CHD (ACHD)
while maintaining an active educational
ACHD program for specialist and general
cardiologists,” said Arwa Saidi, MB, BCh,
the topic coordinator of the CCS working
group and a member of the ACC’s Adult
Congenital and Pediatric Cardiology (ACPC)
Section. “We hope that we have been able to
develop a meeting that appeals to all attendees and have included the results of excellent
research.”
The CCS program begins early today with
the symposium “Complex Issues Facing
ACHD Patients: Obstructive Lesions.” This
will be followed by “Quality, Safety and
Resources Enhancing Pediatric Cardiovascular Care” and “Updates on Care in the CHD
Patient.” These three symposia represent the
stepping stones in a four-day program that
includes the symposium “Women with CHD:
Fertility, Pregnancy and Menopause: Not All
Palpitations Are Cardiac.” A Great Debates
program features debates on the treatment
of newborns with supraventricular tachycardia (SVT), pulmonary valve replacement
in Tetralogy of Fallot (TOF) and the use of
stimulants in patients with CHD.
From 6 to 8 p.m. today, attendees can
network within the adult congenital/pediatric cardiology community by attending the
ACPC Section meeting, which is open to all
CHD professionals.
On Sunday Jane Somerville, MD, will
present the Legends of Cardiovascular
Medicine 2012 Dan G. McNamara lecture
ACC is Your
CardioSource
You can trust the ACC to provide information that helps
you be the best cardiovascular professional you can be.
And ACC Central is the place that brings it all to you.
Visit ACC Central, Booth 10027, to find out about:
• Lifelong Learning: Learn how to take an individualized
approach to cardiovascular education. Improve your
performance. Impact your patients.
• Advancing Quality: Get the latest data collection and
quality improvement tools and resources to help you
demonstrate excellence in your hospital or practice.
• Member Center: Learn how ACC membership can help
you advance your career & apply on site! Current members
can find out how to get more involved, discover the newest
membership benefits, pay dues and more.
• AdvocacyandPracticeSupport:Learn more about the
ACC’s efforts to set a new standard for health care delivery
and get the tools you need to ensure patient access to the
right care at the right time.
at 2 p.m. in Room N228. Somerville will
discuss her 50 years working with cardiac
surgeons, her personal experiences, history of CHD treatment, and thoughts on the
future of CHD care. In addition, four ACC-i2
with TCT sessions on Sunday and Monday
address CHD. Attendees can learn more in
the symposia “Pre-operative Assessment of
Patients on Single Ventricle Pathway” and
“Post-operative Glenns and Fontans: Navigating Turbulent Waters” on Sunday. Monday
will feature “Pulmonary Artery Stenosis:
Current Therapy and Future Directions Live
Case” and “Pulmonary Vein Stenosis: What
Are Realistic Expectations?”
Also on Monday, Meet the Experts sessions will provide advice on “Acquired
Heart Disease in Childhood Epidemiology:
Current and Future Management” and “The
Golden Moment: When Is the Right Time to
Intervene in Congenital Heart Disease?” In
addition, the “Challenging Imaging Issues in
CHD” symposium will look at topics ranging
from “When 3D Can Make a Difference” to
“Quantification of Collateral Flow: When
and How.”
On Tuesday, plan to attend the symposium,
“Coming of Age: The HLHS Turns 21.” Presentations include: “What We Have Learned
about HLH Physiology;” “How Imaging the
HLH Patient Has Changed;” and “Failing
Fontan: Is the HLH Patient Any Different?”
Pediatric cardiologists can also earn up
to 10 American Board of Pediatrics (ABP)
Maintenance of Certification (MOC) credits
with ABP MOC sessions. ACC.12 also offers
more ABIM MOC sessions with modules in
general cardiology, interventional cardiology
and — new this year — electrophysiology.
“An additional and important value in
attending ACC.12 is also the networking
opportunity it provides,” said Lisa Bergersen,
MD, topic co-coordinator of the CCS working group and a member of the ACC’s ACPC
Section. “Everywhere at ACC.12, attendees
will be able to share ideas with colleagues on
the clinical dilemmas you face every day.”
CardioSource News at ACC.12
• MobileApplications:Get your free CardioSource Mobile
Applications designed to put the latest science directly
at your fingertips. Also, learn about other applications
available for those on the go.
Fast. Informative. Convenient.
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at Booth 10027
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March 24, 2012
CardioSource News at ACC.12, the official
publication of ACC’s 61st Annual Scientific
Session, is published by the American
College of Cardiology Foundation.
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CardioSourceNews
American College of Cardiology
5
NCDR data Cardiac Care Team sessions abound at ACC.12
showcased T
at ACC.12
O
ver the course of the last several years,
research from ACC’s National Cardiovascular Data Registry (NCDR®)
has proven itself to be data source for
groundbreaking cardiovascular research.
During ACC.12, a number of abstracts,
including oral and poster presentations,
will showcase the breadth and versatility
of NCDR data. Highlights include:
he past year brought dramatic changes
in the clinical practice landscape, and
these changes are only expected to
continue. These profound changes, while
forcing many cardiovascular professionals
to re-evaluate business as usual, also provide opportunities to improve the way care
is provided to patients.
The ACC.12 program’s broad spectrum
looks to showcase the importance of the
cardiovascular care team and the increased
growth of cardiovascular care options. This
year offers cardiac care associate (CCA)
members state-of-the-art formats and technologies in 16 different topic areas or learn-
ing pathways with programming including
prevention, heart failure, diagnostic testing,
and quality of care and outcomes. Also, the
Lifelong Learning pathway includes the
daylong CCA Team-Based symposium on
Sunday, which focuses on case-based learning of cardiovascular conditions.
CCA members are able to meet accreditation or continuing education credit needs
while at ACC.12. For nurses, the ACCF,
which is accredited by the American Nurses
Credentialing Center’s Commission on
Accreditation, designates the ACC.12 live
educational activity for a maximum of 43.25
continuing education hours. For clini-
cal pharmacists, the University of Florida
College of Pharmacy, which is accredited
by the Accreditation Council for Pharmacy
Education, will be handling the continuing
education credits.
The meeting also has been designated as a
Knowledge-Based Program that will provide
a maximum of 32.5 contact hours of continuing education credit for those who meet the
requirements. For physician assistants, the
ACCF is accredited by the Accreditation
Council for Continuing Medical Education
to provide continuing medical education for
physicians, which applies to physician assistants as well.
Today
• Hemorrhagic and Ischemic Outcomes
Following Bivalirudin vs. Unfractionated Heparin During Carotid Artery
Stenting: Analysis from the NCDR,
9:30 a.m. to Noon in South building
Hall A, Poster #2535-562
• IMPACT Registry™ (IMproving Pediatric and Adult Congenital Treatment):
First Data Report, 11:45 a.m. to Noon in
Room S105a, Oral Presentation #901-8
Sunday
• Temporal Trends in Quality of Care
Among ICD Recipients: Insights from
the NCDR ICD Registry™, 11 to 11:15
a.m. in Room N426, Oral Presentation
#919-4
Monday
• Clinical Trial Participation After Acute
Coronary Syndrome and Associated
Outcomes: Insight from the ACTION
Registry®-GWTG™, 9:30 to 10:30
a.m. in South building Hall A, Poster
#1250-22
• Improving Practice-Based Learning for
Fellows in Training With Cardiology’s
First Ambulatory Quality Improvement Registry: Observations from the
PINNACLE Registry®, 9:30 to 10:30
a.m. in South building, Hall A, Poster
#1254-205
in hypertension innovation
100 Million
Lives Are
at Risk
For the complete Guide to NCDR
abstracts at ACC.12, visit CardioSource.
org/NCDRabstractsatACC.12 or stop by
ACC Central during Expo hours.
SYMPLICITY HTN-3 Trial:
Evaluating Renal Denervation for
Resistant Hypertension
Dinner Symposium Details:
Date:
Sunday, March 25, 2012
Time:
6:30 p.m.–9:00 p.m.
Place:
InterContinental Chicago
Grand Ballroom, 7th Floor
505 North Michigan Avenue
Physician Panel:
Program Highlights:
Resistant hypertension is associated with an increased risk of stroke,
heart attack, heart failure and kidney disease—along with higher
incidences of diabetes and obesity.*
Fortunately, innovative investigational therapies are being researched
in response to this serious and growing health concern. Along with
traditional drug therapy, catheter-based renal denervation (RDN) is
being studied to determine its potential to help the 100 million patients
worldwide† with resistant hypertension.
We are seeking to enroll patients in this study. Visit Medtronic at Booth
#6038 for information on patient eligibility for the SYMPLICITY HTN-3
trial designed to evaluate RDN for resistant hypertension.
r 3FTJTUBOUIZQFSUFOTJPOBOEUIFTZNQBUIFUJD
nervous system
r *OUSPEVDUJPOUPSFOBMEFOFSWBUJPO
r 4:.1-*$*5:)5/BOE4:.1-*$*5:)5/
clinical background
r 4:.1-*$*5:)5/USJBMEFTJHOBOE
current status
Seating is limited! Register now at:
www.RDNsatellitesymposia.com
Transportation will be provided from McCormick
Place® to the InterContinental Chicago.
This event is not part of the official ACC .12 and/or
the ACC-i2 with TCT.
Fun Run/Walk Monday
The second annual CardioSmart 5K Fun
Run/Walk will take place at 6 a.m. Monday
at Arvey Field, near the Field Museum. Register at the CardioSmart Run/ Walk kiosk
on level 2.5 of the McCormick Place Grand
Concourse.
for an exclusive Medtronicsponsored dinner symposium
on resistant hypertension and
the SYMPLICITY HTN-3 trial
Henry Krum—
SYMPLICITY HTN-1 Lead Author
Murray Esler—
SYMPLICITY HTN-2 Lead Author
Suzanne Oparil—
SYMPLICITY HTN-3 Steering Committee
David Kandzari—
SYMPLICITY HTN-3 Steering Committee
Tuesday
• Survival after PCI or CABG in Older Patients With Stable Multivessel Coronary
Disease: Results from the ACCF-STS
Database Collaboration on the Comparative Effectiveness of Revascularization
Strategies (ASCERT Study), 8 to 9:30
a.m. in the ACC.12 Main Tent, North
building, Hall B, Oral Presentation #3087, ACC Special Session: Joint ACC/
JAMA Late Breaking Clinical Trials
Join us at ACC.12
*Persell SD. Prevalence of resistant hypertension in the United States, 2003-2008. Hypertension. 2011;57(6):1076-1080.
†World Heart Federation. Hypertension and cardiovascular disease. 2011. http://www.world-heart-federation.org/
cardiovascular-health/cardiovascular-disease-risk-factors/hypertension/. Accessed October 28, 2011.
Caution: Investigational device. Limited by federal (or United States) law to investigational use. Not for sale in the USA.
For distribution in the USA only. ©2012 Medtronic, Inc. All rights reserved. Printed in USA. UC201205002EN 2/12
6
Saturday
March 24, 2012
Get your daily dose of quality in several ACC.12 sessions
plasty just 64 minutes after arrival at hospital.
Quality improvement initiatives such as the
ACC’s Hospital to Home (H2H), Imaging in
FOCUS Initiative and Door to Balloon Alliance can take credit for helping to facilitate
these successes. The ACC’s suite of NCDR®
registries also continues to play a key role in
benchmarking and improvement.
ACC.12 will provide several opportunities
for cardiovascular professionals to learn more
about incorporating quality improvement into
their day-to-day activities, as well as look
ahead to what high-quality cardiovascular care
might look like in the future.
“The development of innovative new
programs and payment models that reward
physicians who deliver high-quality and efficient care has been a College priority over the
last several years in light of health care reform
and the need to curb out-of-control health
care costs,” said ACC CEO Jack Lewin, MD.
“ACC.12 provides a high-profile opportunity
to highlight our recent successes and share
best practices and lessons learned.”
Don’t Miss These Quality-Related Sessions
at ACC.12.
Today
• “Patient-Centered Care: The New Imperative,” 8 to 9:30 a.m. in Room N226
• “Getting Access to Data: Successful Examples from the NCDR,” 12:15 to 1:45 p.m.
in Room S501a
• “The Challenges in Daily Practice,” 12:15 to
1:45 p.m. in Room N230
• “Measuring and Optimizing Quality in
Your Outpatient Practice: The PINNACLE
Registry,” 4:30 to 6 p.m. in Room S501a
Sunday
• “Tools to Improve the Care Transition: The
Hospital to Home (H2H) Experience,” 8 to
9:30 a.m. in Room S501a
• “U.S. Health System Reform: What’s Missing?” 10:45 a.m. to 2:15 p.m. in Room S100c
Monday
• “Where Will Cardiology Be in 2015?” 8 to
9:30 a.m. in Room N427
• “The Future of Cardiovascular Disease:
Where Are We Going (and Where Do We
Want to Go)?” 10:30 a.m. to Noon in Room
N426
• “Bringing Guidelines to the Bedside: Making Guidelines More Accessible to Clinicians,” 2 to 3:30 p.m.; in N427
• “Transforming Health Care Delivery
Through CV Registries,” 3:45 to 5:15 p.m. in
Room N427
• “Improving Outcomes and Reducing Heart
Failure Readmissions,” 3:45 to 5:15 p.m. in
Room S406b
Stay Connected
at ACC.12!
Check your Program Update for additional
sessions in the Imaging, Quality of Care
and Outcomes Assessment, and Practice
Performance, Improvement and Administration learning pathways. In addition, special
15-minute educational sessions will also
take place today and Sunday in ACC Central
(Booth #10027).
Exhibit focuses
on care for CAD,
heart failure
I
For more information, go to
www.accscientificsession.org/StayConnectedACC12
©2012 American College of Cardiology. A12203
O
ver the last several decades there have
been real advances in cardiovascular science and medicine, the result of cardiologists, nurses and other care providers focusing
on what’s best for their patients, asking new
questions and exploring fresh, innovative ways
to attack the nation’s leading killer.
The 60 percent decline in the death rate
from cardiovascular disease that has occurred
since the 1950s is one of the most significant
achievements in recent decades. Other more
recent advances in the past decade include
a 30 percent decline in heart failure-related
hospital readmissions and findings that heart
attack patients are receiving lifesaving angio-
nformation about the standard of care
for coronary artery disease and heart
failure caused by valvular disease is
explored at the ACC.12 Expo Heart of
Innovation Learning Destination.
The exhibit is divided into four areas —
Minimally Invasive Procedures, Personalized Medicine, Physician-Patient Engagement and TechnoBiology. Each area has a
dedicated gallery. The exhibit also features
a Thought Leader Theater with presentations from experts in each area.
The Minimally Invasive Procedures
area explores surgical approaches at the
forefront of cardiovascular disease treatment. The gallery features a hybrid suite
operating room and state-of-the-art equipment, including a CorPath 200 System
robot. The theater presentations will
address the potential and the challenges
of robotic surgery.
The Personalized Medicine area
highlights equipment, techniques and research used to learn more about the roles
See EXHIBIT, page 16
8
Saturday
March 24, 2012
ACC Central brings Heart House programs to ACC.12
A
tunities to learn more about ACC mobile
resources for iPads, iPhones and other
mobile devices. Visitors can also weigh in
on the upcoming redesign of ACC’s patient
resource, CardioSmart.org. Also, find out
how to download Cardiology magazine,
JACC journals and ACCEL on iPad.
CC Central (Booth #10027) serves as
the one-stop-shop for information and
ACC resources pertaining to critical
quality, advocacy, education and membership
information. ACC staff members are available
throughout the meeting during Expo hours to
answer questions and connect cardiovascular
professionals with products, programs and
member opportunities that best fit their needs.
Key topic areas of the booth include:
The ACC Central Theater
The ACC Central Theater is at the heart
of the booth. Don’t miss presentations
throughout open Expo hours today and
Sunday on topics such as health IT,
the PINNACLE Registry and Network,
social media, Imaging in FOCUS and appropriate use.
Advancing quality
ACC’s quality improvement programs, registries and initiatives are designed to help the
cardiovascular care team improve quality and
demonstrate clinical excellence regardless
of practice setting. Visitors to ACC Central can help the NCDR® celebrate its 15th
anniversary and learn more about how to
begin tracking data to close quality gaps and
remain transparent. Information on each of
the NCDR’s hospital and practice-based registries, including the newest STS/ACC TVT
Registry®, will also be available. In addition,
visitors to the booth can find out how quality
improvement initiatives such as PINNACLE,
Imaging in FOCUS and Hospital to Home
can help ensure high-quality, appropriate and
cost-effective care.
Lifelong learning
ACC’s educational and lifelong learning
products and live courses offer individualized education for all members of the
cardiac care team throughout their careers. During ACC.12, attendees can save
New app puts
ACC.12 at your
fingertips
T
he ACC.12 eMeeting Planner app,
which is available for the iPad, iPhone
and Android, is focused on helping
attendees best use of all the educational
content and offerings at the meeting.
New this year, the app allows users to
easily search and browse sessions and
exhibits, and create easy-to-use daily
schedules. Animated maps are also
designed to help with navigation of the
convention center, plus local Chicago
tourism information. In addition, access
the ACC.12 Twitter feed and download
eBooks of the Final Program, Programat-a-Glance, JACC Abstract Supplement
or CardioSourceNews from ACC.12
directly from the app.
“This app falls right in line with the
overarching theme of innovation at
ACC.12,” said ACC President David
R. Holmes Jr., MD. “Attendees will be
able to access all of the critical ACC.12
information and tools they need with
the touch of a finger. Thank you to the
creative and dedicated ACC staff for
making this fantastic tool a reality.”
Search ACC.12 in your app store or
browse to http://ativ.me/acc to download
the app.
ACC Central (Booth #10027) is open to serve the needs of members and attendees during Expo hours.
15 percent on selected products and live
courses, as well as order a copy of the new
ACCSAP8. In addition, attendees can order
iScience, the ACC.12 Meeting on Demand,
and save more than $1,000.
Advocacy and practice support
ACC Advocacy serves as the voice of the
cardiovascular community both nationally and abroad when it comes to shaping
health care policy. Visitors to ACC Central
can learn more about how to get involved
in ACC legislative efforts, as well as get
up-to-date information on choosing the right
electronic health record and participating in
incentive programs, such as e-prescribing
and the physician quality reporting system.
Member services
Learn why cardiovascular professionals
from around the globe join the ACC at the
member and resource centers of the booth.
ACC staff is on hand to answer membership questions, including how to join the
College, pay dues and get more involved
through member sections. Also, stop by
ACC Central for a sneak peek of the new
ACC Apparel line.
Mobile applications and CardioSource.org
The Mobile Applications and CardioSource.
org section of ACC Central offers oppor-
Today’s ACC Central
Theater Schedule
10:45 to 11:15 a.m.: “Getting Your Bonus:
Navigating E-Prescribing, Meaningful Use
and PQRS”
11:30 a.m. to Noon: “H2H: Best Practices
for Reducing Readmissions”
12:15 to 12:45 p.m.: “CardioSmart: Empowering the Clinician-Patient Relationship”
1 to 1:30 p.m.: “What Do You Know About
ICD-10-CM?”
1:45 to 2:15 p.m.: “Tweeting, Liking and
Everything in Between: How to Connect
with the College Online”
2:30 to 3:45 p.m.: “Health IT Gadgets and
Gizmos”
FIT programming tailored for the future of cardiology
J
ustin Bachmann, MD, 2011-2012 Fellows in Training (FIT) Committee chair,
sat down with CardioSourceNews to
share his thoughts about the FIT programming at ACC.12 and ACC-i2 with TCT.
What can FITs expect to learn
at ACC.12?
The ACC’s Annual Scientific Session is a
great way to meet and network with other
fellows, in addition to learning about the
latest science and receiving career advice
from the best and brightest in the field. The
FIT Committee has worked hard to select
special programming and activities tailored
specifically for FITs. The FIT Forums are
designed to teach attendees how to build
a successful career from finding the right
job to launching a career in cardiovascular
research, getting published, passing the
boards, and negotiating contracts, all of
which are important to the profession but
are not necessarily taught in medical school.
What are some of the special sessions
designed for FITs?
The forums begin with a half-day session
today starting with “Finding the Right Job,”
which will cover the landscape of the job
market and discusses both traditional and
non-traditional job opportunities. Lunch
will be provided during this session. The
next forum session, “Launching a Successful Career,” focuses on the keys to successfully launching a career in cardiovascular
research, including
obtaining funding,
finding the right
mentors and using
social media to
conduct and promote
research. The “Mix
‘n’ Mingle” forum
session is a unique
“fellows only” opJustin Bachmann, MD
portunity to interact
with some of the most prominent leaders
in the field of cardiology over light refreshments in a non-formal setting. The final
session of the day is the always-popular
“FIT Forum Jeopardy,” where fellows can
test their knowledge against one another.
The Forum Jeopardy takes place from 3:30 4:30 p.m. in Bistro ACC of the Expo Hall.
On Sunday, there is a special forum
session on writing and evaluating medical
journals, led by with Anthony N. DeMaria,
MD, editor-in-chief of the Journal of the
American College of Cardiology (JACC),
Jagat Narula, MD, editor-in-chief of JACC:
Cardiovascular Imaging, and Spencer B.
King, MD, editor-in-chief of JACC: Cardiovascular Interventions. The forum session
on Monday, “Guidance for the First Steps
of Your Cardiology Career” will teach
fellows where to start their cardiovascular
journey. Lunch will also be provided in
these sessions.
For those interested in interventional cardiology, there are several ACC-i2 with TCT
Fellows Bootcamps: Coronary I, Coronary
II, Case Review and Structural Heart. There
is also an Adult Congenital and Pediatric
Cardiology (ACPC) Career and Mentoring
Session from 12:30 to 1:45 p.m. Sunday in
Room N231. It will focus on practical steps
to launching a career in pediatric/congenital
cardiology including career tracks, promotions and more. Also check out the focused
learning pathways for FITs available on the
FIT webpage, CardioSource.org/FIT. There
really is something for everyone.
Where is the FIT Lounge and what
activities will be held there?
The FIT Lounge is located in Room N139.
This is an informal meeting area for FITs
to network between sessions or take a break
from the action and recharge with light
refreshments. The Lounge also features
complimentary internet access.
How will this year be different from
previous ACC Scientific Sessions
for FITs?
For the first time, this year there is a FIT
Blog on CardioSource.org featuring special
ACC.12 coverage by FITs and for FITs. The
“FITs on the GO” will be reporting live
from ACC.12 with video interviews and
commentary featuring the latest science. To
view the FIT Blog visit CardioSource.org/
FIT. In addition, a blog on dukecardiologyfellows.org will feature video interviews
with key newsmakers at ACC.12.
CardioSourceNews
American College of Cardiology
9
The ACC.12 Expo features vendor presentations and many learning opportunities. It is open from 9:30 a.m.
to 4:30 p.m. today and Sunday, and from 9:30 a.m. to 2 p.m. Monday.
Satellite Symposia
at ACC.12
With many learning opportunities,
Expo offers something for everyone
T
he ACC.12 Expo carries the learning opportunities from education sessions into
the exhibit hall as it features Learning
Destinations, specialty pavilions and more
than 300 exhibitors showcasing the latest technologies, devices, health information technology and pharmaceuticals.
This year, the Expo schedule offers more
than six hours completely unopposed by
education sessions, so attendees don’t have to
miss any sessions to visit companies and see
the products and services that interest you.
The Expo Hall is open in Hall A of the South
Building from 9:30 a.m. to 4:30 p.m. today and
Sunday, and from 9:30 a.m. to 2 p.m. Monday.
To maximize time visiting exhibits, vendors are organized into specialty areas, including the CardioSmart Pavilion, the Health
IT Pavilion, the Interventional Pavilion,
the Public Service Area and the Publishers
Showcase.
The Learning Destinations include established features such as the Industry-Expert
Theater, Hands-On Learning Labs, poster
presentations and the Heart Songs Learning Lab as well as the Heart of Innovation
Learning Destination (see story on page 6).
Special presentations in the Learning
Destinations include “CardioSmart: Hot Topics for Better Patient Outcomes” from 11:15
a.m. to 12:15 p.m. today in the CV Theater.
Michelle May, MD, author of Eat What You
Love, Love What You Eat: How to Break
Your Eat-Repent-Repeat Cycle, will discuss
unconventional strategies that promote hearthealthy lifestyles.
On Sunday and Monday, see several
presentations on the future of cardiovascular care in the CV Innovations Educational
Forum in the CV Theater. Sponsored by the
ACC, in partnership with Elsevier Business
Intelligence and the International Society for
Cardiovascular Translational Research, the
forum features cutting-edge cardiovascular
research and product development.
Industry-Expert Theater
The Industry-Expert Theater offers one-hour
promotional presentations from industry
leaders on a series of topics, such as treating a patient at risk for sudden cardiac death
after percutaneous or surgical revascularization, the role of platelet reactivity testing for
high-risk PCI patients and considerations for
radionuclide myocardial perfusion imaging
in patients with asthma/COPD.
Vendors presenting in the theater include
Accumetrics; Astellas Pharma US; Boehringer Ingelheim Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Medtronic, Inc.;
Toshiba Medical Systems; and ZOLL.
Interactive Learning Labs
The Interactive Learning Labs combine a
presentation by a clinical or technical expert
on a specific topic with a hands-on tutorial
that leads participants through procedures
with a particular device, piece of equipment or
workstation.
The Actelion Pharmaceuticals US, Inc. lab
is in Booth #23027; the Philips Healthcare
lab is in Booth #22035; the Terumo Medical
Corporation/The Medicines Company lab
is in Booth #22027. Topics include pulmonary arterial hypertension associated with
adult congenital heart disease; advances in
echocardiography, temperature modulation, minimally invasive interventions, sleep
therapy, cardiac CT and cardiology informatics; and transradial access and procedural
anticoagulation therapies.
Posters
Poster presentations are grouped by topic and
are on display from 9:30 a.m. to 4:30 p.m.
today, Sunday and Monday. Poster presentations by authors will take place from 9:30 to
10:30 a.m. and from 11 a.m. to Noon today,
Sunday and Monday, and all presentations
have moderators.
Heart Songs Learning Lab
The Heart Songs Learning Lab is a unique way
to learn cardiac auscultation. To improve auditory recognition skill in cardiac auscultation,
attendees will have the opportunity to view
an introduction to understand the educational
rationale for the program and take a pre-test to
establish a base line for learning skills.
Following the test, attendees can listen
to audio heart sounds while viewing poster
boards that contain didactic information on
each sound. After viewing the poster boards,
attendees can take a test on a computer to see
if the session improved their skills.
Each session takes about 30 minutes to
complete. Sessions are self-paced and can
start at any time.
Clinical Challenges in the Secondary Prevention of CAD*
Saturday, March 24, 2012
6:30 – 8:45 p.m.
Chicago Marriott Downtown
Hemodynamic Catheterization – HFpEF and Beyond*
Sunday, March 25, 2012
6:30 – 9:30 p.m.
Chicago Marriott Downtown
*These events are not part of the official ACC Annual Scientific Session &
Expo and/or ACC-i2 with TCT, as planned by their Program Committees.
March 24 – 27, 2012
McCormick Place
Chicago, IL
V isit us
Bootht
a
19001
For more information on Mayo Clinic educational offerings,
visit www.mayo.edu/cme/cardiovascular-diseases
For referral resources visit www.mayoclinic.org/heart-care
Find Mayo Clinic Cardiovascular CME online at:
12 Saturday
March 24, 2012
Late-Breaking Clinical Trials Schedule
S
tay at the forefront of cardiology by being
the first to see the latest scientific breakthroughs at five featured Late-Breaking
Clinical Trial (LBCT) sessions. Be sure not
to miss the collaborative LBCT sessions with
the New England Journal of Medicine and the
Journal of the American Medical Association.
All sessions will take place in the ACC.12
Main Tent, Hall B of the North building.
SATURDAY
8 to 10 a.m., Session 300
ACC.12 Opening Session and
Late-Breaking Clinical Trials
• Effect of Transendocardial Autologous
Bone Marrow Mononuclear Cell Delivery
on Functional Capacity, Left Ventricular Function and Perfusion in Chronic
Ischemic Heart Failure: The FOCUS
Randomized Trial
• Evaluation of a Novel Antiplatelet Agent
for Secondary Prevention in Patients
with Atherosclerotic Disease: Results of
the Thrombin Receptor Antagonist in
Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P): TIMI
50 Trial
SUNDAY
8 to 9:30 a.m., Session 304
Late-Breaking Clinical Trials II
• Outcomes of Non-Primary PCI at Hospitals With and Without On-site Cardiac
Surgery: CPORT-E Trial. Final Medical
Outcomes
• INFUSE-AMI: A 2x2 Factorial, Multicenter, Prospective, Randomized Evaluation of Intracoronary Abciximab and
Aspiration Thrombectomy in Patients
Undergoing Primary PCI for Anterior
STEMI
• Randomized Comparison of Adding
Cilostazol Versus Doubling the Dose of
Clopidogrel after Receiving Percutaneous Coronary Intervention: The HOSTASSURE Randomized Trial
• A Multifaceted Intervention to Narrow
the Evidence-Based Gap in the Treatment
of Acute Coronary Syndromes: Main
Results from the BRIDGE-ACS Cluster
Randomized Trial
MONDAY
8 to 9:30 a.m., Session 305
Joint American College of Cardiology/
New England Journal of Medicine
Late-Breaking Clinical Trials
• CORONARY: The Coronary Artery
Bypass Grafting Surgery Off or On Pump
Revascularization Study
• ACRIN PA 4005: Multicenter Random-
Indications
The Resolute Integrity Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal
diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to
de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of 2.25 mm to
4.20 mm.
Contraindications
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known hypersensitivity or allergies to aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticagrelor, ticlopidine,
drugs such as zotarolimus, tacrolimus, sirolimus, everolimus or similar drugs or any other analogue or derivative
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angioplasty balloon or proper placement of the stent or stent delivery system
Warnings
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stent implantation procedures, which include subacute and late vessel thrombosis, vascular complications
BOEPSCMFFEJOHFWFOUTt5IJTQSPEVDUTIPVMEOPUCFVTFEJOQBUJFOUTXIPBSFOPUMJLFMZUPDPNQMZXJUIUIF
recommended antiplatelet therapy.
Precautions
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placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can
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risks and benefits of the stent implantation should be assessed for patients with a history of severe reaction to
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have an increased risk of adverse events, including stent thrombosis, stent embolization, myocardial infarction
.*
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The safety and effectiveness of the Resolute Integrity stent have not yet been established in the following
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ized Controlled Study of a Rapid “Rule
Out” Strategy Using CT Coronary
Angiogram Versus Traditional Care for
Low-Risk ED Patients With Potential
Acute Coronary Syndromes
• Oral Rivaroxaban Alone for Symptomatic
Pulmonary Embolism: The EINSTEIN
PE Study
• Late (≥ 2 year) Clinical and Echocardiographic Outcomes After Transcatheter
vs. Surgical Aortic Valve Replacement:
Results from the High-Risk Cohort of the
PARTNER Trial
10:30 a.m. to Noon, Session 306
Late-Breaking Clinical Trials IV
• Comparison of Bariatric Surgical Procedures and Advanced Medical Therapy
for the Treatment of Type 2 Diabetes in
Patients with Moderate Obesity: 1-year
STAMPEDE Trial Results
• A Mendelian Randomized Controlled
Trial of Long Term Reduction in LowDensity Lipoprotein Cholesterol Beginning Early in Life
• A Randomized, Double-blind, Placebocontrolled Trial of the Safety and Efficacy
of a Monoclonal Antibody to Proprotein
Convertase Subtilisin/Kexin Type 9
Serine Protease, REGN727/SAR236553,
in Patients with Primary Hypercholester-
olemia (NCT: 01288443)
• Pacemaker Therapy in Patients with
Neurally-mediated Syncope and Documented Asystole
TUESDAY
8 to 9:30 a.m., Session 308
Joint American College of Cardiology/
Journal of the American Medical
Association Late-Breaking Clinical Trials
• Survival after PCI or CABG in Older
Patients with Stable Multivessel Coronary
Disease: Results from the ACCF-STS
Database Collaboration on the Comparative Effectiveness of Revascularization
Strategies
• Multicenter Randomized Comparative
Effectiveness Trial of Cardiac CT vs Alternative Triage Strategies in Acute Chest
Pain Patients in the Emergency Department: Results from the ROMICAT II Trial
• Results of the IMMEDIATE (Immediate
Myocardial Metabolic Enhancement During Initial Assessment and Treatment in
Emergency Care) Trial: A Double-Blind
Randomized Controlled Trial of Intravenous Glucose, Insulin, and Potassium
(GIK) for Acute Coronary Syndromes in
Emergency Medical Services
• Moderate Pulmonary Embolism Treated
with Thrombolysis (MOPETT Study)
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The safety and effectiveness of the Resolute Integrity stent have not been established in the cerebral, carotid or
peripheral vasculature.
Potential Adverse Events
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*OGFDUJPOPSGFWFSt.*t1FSJDBSEJUJTt1FSJQIFSBMJTDIFNJBQFSJQIFSBMOFSWFJOKVSZt3FOBMGBJMVSFt3FTUFOPTJTPGUIF
TUFOUFEBSUFSZt4IPDLQVMNPOBSZFEFNBt4UBCMFPSVOTUBCMFBOHJOBt4UFOUEFGPSNBUJPODPMMBQTFPSGSBDUVSFt
4UFOUNJHSBUJPOPSFNCPMJ[BUJPO
t4UFOUNJTQMBDFNFOUt4USPLFUSBOTJFOUJTDIFNJDBUUBDLt5ISPNCPTJTBDVUF
TVCBDVUFPSMBUF
Adverse Events Related to Zotarolimus
1BUJFOUTFYQPTVSFUP[PUBSPMJNVTJTEJSFDUMZSFMBUFEUPUIFUPUBMBNPVOUPGTUFOUMFOHUIJNQMBOUFE5IFBDUVBMTJEF
FòFDUTDPNQMJDBUJPOTUIBUNBZCFBTTPDJBUFEXJUIUIFVTFPG[PUBSPMJNVTBSFOPUGVMMZLOPXO5IFBEWFSTFFWFOUT
UIBUIBWFCFFOBTTPDJBUFEXJUIUIFJOUSBWFOPVTJOKFDUJPOPG[PUBSPMJNVTJOIVNBOTJODMVEFCVUBSFOPUMJNJUFE
UPt"OFNJBt%JBSSIFBt%SZTLJOt)FBEBDIFt)FNBUVSJBt*OGFDUJPOt*OKFDUJPOTJUFSFBDUJPOt1BJOBCEPNJOBM
BSUISBMHJBJOKFDUJPOTJUF
t3BTI
1MFBTFSFGFSFODFBQQSPQSJBUFQSPEVDUInstructions for Use for more information regarding indications, warnings,
precautions and potential adverse events.
CAUTION:'FEFSBM64"
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'PSEJTUSJCVUJPOJOUIF64"POMZª.FEUSPOJD*OD"MMSJHIUTSFTFSWFE1SJOUFEJO64"6$&/
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at the toll-free numbers or websites listed below:
www.medtronic.com
www.medtronicstents.com
Medtronic, Inc.
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4BOUB3PTB$"
64"
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LifeLine Customer Support
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CardioSourceNews
American College of Cardiology
13
Pathway developed for cardiovascular administrators
A
CC.12 will feature a new Practice Performance, Improvement and Administration
pathway to help practice administrators and other cardiovascular professionals
navigate the myriad changes in the practice
landscape.
The pathway presents daily educational
programming featuring practical advice from
experts, as well as case studies showcasing
best practices on topics such as health information technology, hospital integration, cardiovascular service line management, medical
liability and health care reform impacts.
“Attendees will find programming that
addresses the challenges that cardiovascular
professionals face in clinical practice
today, as well as programming that provides
them with the tools to adapt to the changing
health care environment and deliver
quality care to their patients,” said Jerome
Hines, MD, co-chair of the Practice Performance, Improvement and Administration
Track.
Attendees will learn what’s new in physician compensation models, explore the ins
and outs of data collection for quality reporting and participate in sessions on coding and
reimbursement, said Co-Chair Jerry Kennett,
MD. In addition, the ACC/MedAxiom/
ACCA series on physician-hospital integration will deliver critical tips for success in negotiating contracts, defining physician value,
avoiding pitfalls and making it all work.
Don’t miss the following practice management sessions:
Today
• “How to Code and Get Reimbursed,”
8 to 9:30 a.m. in Room N231
• “The Challenges in Daily Practice,” 12:15
to 1:45 p.m. in Room N230
• “Information Technology, Medicine
and the Future,” 4:30 to 6 p.m. in Room
N230
Sunday
• “U.S. Health System Reform: What’s Missing?” 10:45 a.m. to 12:15 p.m. in Room
S100c
• “Meaningful Use: A Washington Perspective,” 12:30-1:45 p.m. in Room N227b
• “EHR Lessons from the Trenches,” 2 to
3:30 p.m. in Room N227b
• “Future Compensation Under Health Care
Reform,” 4:30 to 6 p.m. in Room N227b
Monday
• “ACC/MedAxiom/ACCA: Cardiovascular
Service Lines,” 8 to 9:30 a.m. in Room
S105a
• “Where Will Cardiology Be in 2015?”
8 to 9:30 a.m. in Room N427
• “Issues That Have Caused Medical Professional Liability Claims,” 2 to 3:30 p.m.; in
Room S504a
• “Impact on Health Care Policy on the Academic Cardiovascular Mission,” 2 to 5:30
p.m. in Room S402
at 62
s
u
t
60
Visi oth #
Bo
C
C
A
HIT, from page 3
Health Information Technology (IT) at
the U.S. Department of Health and Human Services. Mostashari will discuss
ONC’s role in the Million Hearts initiative and the latest in meaningful use,
particularly the proposed new criteria
for the second stage of meaningful use
implementation. The presentation will
be followed by a reactionary panel discussion of ACC Informatics Committee
members.
“Farzad is a dynamic speaker and we
are pleased to welcome him back this
year to our Annual Scientific Sessions,”
said ACC CEO Jack Lewin, MD. “Our
goal is to have the majority of eligible
members achieve meaningful use by the
end of 2012, so these health IT sessions
are designed to offer different perspectives and help clarify any questions or
concerns that remain. This is a huge
opportunity!”
The second session, “EHR Implementation … Lessons from the Trenches,”
will be presented from 2 to 3:30 p.m.
in Room N227B. It will feature several
EHR implementation case studies and
provide practical advice on implementing health IT in private practice and in
larger hospital systems. The session will
end with an informal Q&A session.
In addition to the two Spotlight Sessions, ACC staff and members of the
College’s Informatics Committee will
present a special “Health IT Gadgets
and Gizmos Show and Tell” from 2:30
to 3:45 p.m. today in the ACC Central
Theater (Booth #10027). The presentation will demonstrate digital programs
available from mobile apps to EHRs. Attendees with additional questions about
EHRs or health IT can sign up for an
individual appointment to “Ask the HIT
Men” at ACC Central.
More information is also available at
the ONC Booth #19076. To learn
more details, visit CardioSource.org/
HealthIT.
Peripheral
Arterial Disease
AV Access
Thrombosis
ST-Elevation
Myocardial Infarction
AngioJet® Thrombectomy Systems
Indications/Contraindications: AngioJet and AngioJet Ultra peripheral indications include:
breaking up and removing thrombus from infra-inguinal peripheral arteries, upper and
lower extremity peripheral arteries, upper extremity peripheral veins, ileofemoral and lower
extremity veins, A-V access conduits, and for use with the AngioJet Ultra Power Pulse Kit for
[OLJVU[YVSHUKZLSLJ[P]LPUM\ZPVUVMWO`ZPJPHUZWLJPÄLKÅ\PKZPUJS\KPUN[OYVTIVS`[PJHNLU[Z
into the peripheral vascular system. Coronary indications include: removing thrombus in the
treatment of patients with symptomatic coronary artery or saphenous vein graft lesions prior
to balloon angioplasty or stent placement. Do not use in patients: who are contraindicated
for intracoronary or endovascular procedures, who cannot tolerate contrast media, and in
whom the lesion cannot be accessed with the wire guide.
Warnings and Precautions: The system has not been evaluated for treatment of pulmonary
embolism or for use in the carotid or cerebral vasculature. Some AngioJet devices have
not been evaluated for use in coronary vasculature. Operation of the catheter may cause
embolization of some thrombus and/or thrombotic particulate debris. Cardiac arrhythmias
may occur and cardiac rhythm should be monitored during catheter use and appropriate
management employed, if needed. Systemic heparinization is advisable to avoid
pericatheterization thrombus and acute rethrombosis. Operation of the system causes
[YHUZPLU[ OLTVS`ZPZ 3HYNL [OYVTI\Z I\YKLUZ TH` YLZ\S[ PU ZPNUPÄJHU[ OLTVNSVIPULTPH
which should be monitored. Consider hydration, as appropriate. Before coronary AngioJet
treatment, verify the presence of thrombus because routine use of AngioJet in every STEMI
patient, without proper selection for thrombus, has been associated with increased mortality
1.800.633.7231 Tel USA
1.763.783.8463 Fax USA
www.interventional.bayer.com
Deep Vein
Thrombosis
Angiographic Fluid
Management
risk. Do not use the system in the coronary vasculature without placing a temporary pacing
JH[OL[LY[VZ\WWVY[[OLWH[PLU[[OYV\NOOLTVK`UHTPJHSS`ZPNUPÄJHU[HYYO`[OTPHZ^OPJOTH`
occur.
Potential Adverse Events: Potential adverse events (in alphabetical order) which
may be associated with use of the system are similar to those associated with other
interventional procedures and include but are not limited to the following: abrupt closure
of treated vessel, acute myocardial infarction, acute renal failure, arrhythmias (including
VF and VT), bleeding from access site, death, dissection, embolization (proximal or distal),
emergent CABG, hematoma, hemolysis, hemorrhage requiring transfusion, hypotension/
hypertension, infection at access site, myocardial ischemia, pain, pancreatitis, perforation,
pseudoaneurysm, reactions to contrast medium, stroke/CVA, thrombosis/occlusion, total
occlusion of treated vessel, vascular aneurysm, vascular spasm, vessel wall or valve damage.
JETSTREAM® Atherectomy Systems
The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature
and to break apart and remove thrombus from upper and lower extremity peripheral
arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature. Refer to
WYVK\J[ SHILSPUN MVY KL]PJLZWLJPÄJ PUKPJH[PVUZ JVU[YHPUKPJH[PVUZ ^HYUPUNZWYLJH\[PVUZ
HUK HK]LYZL L]LU[Z 9_ VUS` :LL WYVK\J[ 0UMVYTH[PVU MVY <ZL MVY ZWLJPÄJ HUK JVTWSL[L
prescribing information. Unless otherwise indicated, all trademarks are owned by MEDRAD,
Inc. or licensed for its use. ©2012 MEDRAD, INC. All Rights Reserved. 2632-001 2/2012
Interventional Solutions
ExpEriEncE
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A12261 ©2012 American College of Cardiology
• SouthBuilding,GrandConcourseLobby,
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• ACCCentral,Booth#10027,inthe
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ACC-i2 WITH TCT, from page 1
the advances and the controversies. Other
symposia include “Renal Interventions for
Hypertension and Renal Function Preservation” and “Peripheral Arterial Disease:
Critical Limb Ischemia.” Attendees can also
learn more about “Platelet Inhibition: What
You Need to Know;” “Vascular Access Outcomes Following PCI for ACS: What You
Need to Know;” and state-of-the-art sessions
for left main coronary intervention, STEMI
and N-STEMI.
ACC-i2 with TCT will provide insight
into the uses of high-tech imaging tools with
sessions such as the “Intravascular Imaging:
Restenosis, Thrombosis and Stent” symposium or the “Imaging Transcatheter Mitral
Valve Procedures” symposium. Attendees
also can discover emerging techniques for
dealing with structural heart disease. For
example, the transcatheter aortic valve
replacement (TAVR) will be featured in
several sessions, including the “TAVR —
Procedural Aspects and Best Practices”
symposium today and a Spotlight Session on
TAVR on Monday. The “Clinically Oriented
Anatomy for the Structural Heart Interventionalist” symposiums, offered as remote
demonstrations by Mark Reisman, MD, are
also expected to be of interest to those taking part in the structural heart track.
“The meeting will reflect ACC President
David Holmes’ passion for science, education and making ACC.12 the very best it can
possibly be,” said E. Murat Tuzcu, MD, chair
of ACC-i2 with TCT. “The ACC-i2 with
TCT curriculum will be accelerated in order
to make sure the attendees visualize both
meetings as the same. It’s very important
to have more integration with the interventional meeting as well as other collaborative partnerships with select cardiovascular
subspecialties.”
Collaboration has become the guiding
word for achieving the best and most appropriate health care for patients. Several
collaborative programming efforts are
planned, such as the Special Sessions for the
whole Cardiac Care Team, which begin with
the “Cardiac Care Team Session 1: Keynote
Address” on Sunday. The sessions continue
through Tuesday with the “Structural Heart
Disease — Mitral Valve” symposium. Two
other Special Sessions focus on multidisciplinary management of the failing heart
Visit
ACC Central
Booth #10027
Limited quantities are available!
©2012 American College of Cardiology A12288
Complimentary
Abstracts on
CD-ROM
Special thanks to:
A12288_ACC12_Abstracts_CD_CSN_Ad.indd 1
2/17/12 1:33 PM
Don’t miss these ACC-i2
with TCT sessions today:
• “Am I Placing Inappropriate ICDs and
Stents? Recent Registry Surprises”
from 8 to 9:30 a.m. in Room S501a
• “TAVR: Procedural Aspects and Best
Practices” from 12:15 to 1:45 p.m. in
Room S102b
• “State-of-the-Art in STEMI Care” from
2 to 3:30 p.m. in Room S404
with team-based evaluation and therapy of
advanced heart disease, parts I and II.
ACC-i2 with TCT also involves partnerships with specialty societies from around
the globe. For example, the “Advances
and Controversies in Carotid, Aortic and
Peripheral Arterial Disease” symposium,
which takes place today, is a collaborative
effort with the Society of Vascular Surgery.
On Monday, ACC-i2 with TCT shares the
podium with several international societies
for the International Luncheon Symposia.
Attendees will have access to the most important, cutting-edge cardiovascular research
during the Late-Breaking Clinical Trials,
which begin today. In addition, three live and
taped case sessions from world-class medical
centers will highlight the best of the best and
provide unique learning opportunities.
“ACC-i2 with TCT is a great place for
one-stop shopping since attendees will be
able to participate in any topic in cardiovascular medicine, not only in certain specialties, but across the board,” said Tuzcu. “This
year will also have more participation from
the audience and more availability through
social media and mobile devices. Overall,
delivering the in-depth technical education
and science that interventionalists demand
and need is the program’s driving force, and
ACC-i2 with TCT delivers.”
EXHIBIT, from page 6
of genes and biomarkers in treating heart
disease. Researchers will review these
advances in the Thought Leader Theater,
where presentations will focus on topics
such as the basics of genetic testing and
the direction of genetic research, how
personalized medicine is practiced today
and how biomarkers can guide heart
failure management.
The Physician-Patient Engagement
area will examine how physicians are
using their patients’ access to technology
to improve physician-patient engagement
and patient outcomes. Access to the Internet may be used to help patients better
understand their conditions by watching
videos online or reading blogs by patients
who have had similar procedures. By
presenting follow-up information at discharge using new technology, patients are
more likely to take their medications and
follow other instructions.
The TechnoBiology area showcases
strides made in stem cell research in the
last decade, and its future direction. Theater presentations will address the future
of stem cells, advances in tissue regeneration, stem cell delivery approaches and the
potential for using allogeneic stem cells.
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18 Saturday
March 24, 2012
ACC.12 with TCT, from page 1
Tuesday,” O’Gara said. “Four visionaries are
going to talk about where we are and where
we are going in cardiovascular medicine and
science from the perspectives of basic research, translational research, population research and clinical care. We think it is going
to be enormously beneficial for the cardiovascular audience to listen to some thought
leaders about where they see us headed.”
Despite the many changes at ACC.12,
the meeting’s centerpiece continues to be
the Late-Breaking Clinical Trials (LBCTs),
which highlight the latest scientific research.
The first LBCT is incorporated into today’s
Opening Showcase Session, which will kick
off the meeting at 8 a.m. The other LBCT
sessions will be presented each morning in
Help shape
the future of
CardioSmart
T
he goal of ACC’s CardioSmart initiative is to partner to prevent, treat and
manage cardiovascular disease by offering people everyday strategies for heart
health. To that end, several CardioSmartsponsored events and activities during
ACC.12 will provide a sneak peek at
product offerings and provide educational
sessions on how to incorporate patientcentered care into everyday practice.
“We want attendees to realize CardioSmart is more than a website and more
than a point-of-care tool,” said CardioSmart Editor JoAnne Foody, MD. “The
new CardioSmart is a network of resources focused on helping patients become
better health care consumers. We not only
want members to learn about us, but we
also want input from them on what they
would like to see from CardioSmart.”
Among the activities planned is a
CardioSmart Pavilion on the Expo floor
to showcase CardioSmart partners and
their tools. In addition, ACC.12 attendees
can help shape the future of CardioSmart
— and get a chance to win an iPad — by
taking part in CardioSmart.org usability
testing from 9:30 a.m. to 4:30 p.m. today
and Sunday at Booth #14052. These
30-minute sessions (which can be scheduled at ACC Central) will help CardioSmart staff develop a new CardioSmart.
org site that best meets the needs of clinicians and their patients. Also, Foody and
the CardioSmart team will provide sneak
previews of the proposed Web designs
and features during two ACC Central
Theater presentations ofrom 12:15 to
12:45 p.m. today and Sunday.
Don’t miss a special session, “PatientCentered Care: The New Imperative,”
from 8 to 9:30 a.m. today in Room
N226 on. Also today, Michelle May,
MD, author of Eat What You Love, Love
What You Eat: How to Break Your EatRepent-Repeat Cycle, will deconstruct
the Mindful Eating Cycle and explore the
bio-psycho-social drivers of each decision
point in the CV Theater located on the
Expo floor (#22097).
Hall B of the North Building. Two of the sessions are collaborative efforts with the New
England Journal of Medicine and the Journal of the American Medical Association.
“The late-breaking clinical trials look particularly strong this year. There are a number
of trials that we think will change practices
in terms of their results,” Holmes said of the
18 abstracts that will be presented.
Education at ACC.12 goes beyond groundbreaking science, with dozens of sessions
each day presented in a variety of formats,
such as symposia, special sessions, Meet the
Experts discussions, International Lunch
Symposia, poster presentations, oral presentations, and Live and Taped Cases.
Sessions are also divided into 16 learning
pathways, including Congenital Cardiology
Solutions, Heart Failure, Imaging, Preven-
ACC.12 Opening Showcase
and Late-Breaking Clinical
Trials
Featuring ACC President David R. Holmes
Jr., MD, and Cardiovascular Legend Eugene
Braunwald, MD
Today, 8-10 a.m.
Main Tent, Hall B of the North Building
tion and Vascular Disease. The ACC has also
partnered with TCT to present the ACC-i2
with TCT pathway, which is focused on interventional science and education.
The education sessions are vital for professionals to earn maintenance of certification
credits, an increased point of emphasis at
ACC.12. In addition, there is also a focus on
Brief Summary of Prescribing Information for XARELTO® (rivaroxaban)
XARELTO® (rivaroxaban) tablets, for oral use
See package insert for full Prescribing Information
WARNINGS: (A) DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR
ATRIAL FIBRILLATION INCREASES RISK OF STROKE,
(B) SPINAL/EPIDURAL HEMATOMA
A. DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR ATRIAL
FIBRILLATION
Discontinuing XARELTO places patients at an increased risk of thrombotic events.
An increased rate of stroke was observed following XARELTO discontinuation in
clinical trials in atrial fibrillation patients. If anticoagulation with XARELTO must
be discontinued for a reason other than pathological bleeding, consider
administering another anticoagulant [see Dosage and Administration (2.1) in full
Prescribing Information, Warnings and Precautions, and Clinical Studies (14.1) in
full Prescribing Information].
B. SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas have occurred in patients treated with XARELTO
who are receiving neuraxial anesthesia or undergoing spinal puncture. These
hematomas may result in long-term or permanent paralysis. Consider these risks
when scheduling patients for spinal procedures. Factors that can increase the
risk of developing epidural or spinal hematomas in these patients include:
t use of indwelling epidural catheters
t concomitant use of other drugs that affect hemostasis, such as non-steroidal
anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
t a history of traumatic or repeated epidural or spinal punctures
t a history of spinal deformity or spinal surgery
[see Warnings and Precautions and Adverse Reactions].
Monitor patients frequently for signs and symptoms of neurological impairment. If
neurological compromise is noted, urgent treatment is necessary [see Warnings
and Precautions].
Consider the benefits and risks before neuraxial intervention in patients
anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and
Precautions].
INDICATIONS AND USAGE
Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation:
XARELTO (rivaroxaban) is indicated to reduce the risk of stroke and systemic
embolism in patients with nonvalvular atrial fibrillation.
There are limited data on the relative effectiveness of XARELTO and warfarin in
reducing the risk of stroke and systemic embolism when warfarin therapy is wellcontrolled [see Clinical Studies (14.1) in full Prescribing Information].
CONTRAINDICATIONS
XARELTO is contraindicated in patients with:
t BDUJWFQBUIPMPHJDBMCMFFEJOH[see Warnings and Precautions]
t TFWFSFIZQFSTFOTJUJWJUZSFBDUJPOUP9"3&-50[see Warnings and Precautions]
WARNINGS AND PRECAUTIONS
Increased Risk of Stroke after Discontinuation in Nonvalvular Atrial Fibrillation:
Discontinuing XARELTO in the absence of adequate alternative anticoagulation
increases the risk of thrombotic events. An increased rate of stroke was observed
during the transition from XARELTO to warfarin in clinical trials in atrial fibrillation
patients. If XARELTO must be discontinued for a reason other than pathological
bleeding, consider administering another anticoagulant [see Dosage and
Administration (2.1) and Clinical Studies (14.1) in full Prescribing Information].
Risk of Bleeding: XARELTO increases the risk of bleeding and can cause serious or
fatal bleeding. In deciding whether to prescribe XARELTO to patients at increased risk
of bleeding, the risk of thrombotic events should be weighed against the risk of
bleeding.
Promptly evaluate any signs or symptoms of blood loss. Discontinue XARELTO in
patients with active pathological hemorrhage.
A specific antidote for rivaroxaban is not available. Because of high plasma protein
binding, rivaroxaban is not expected to be dialyzable [see Clinical Pharmacology (12.3)
in full Prescribing Information]. Protamine sulfate and vitamin K are not expected to
affect the anticoagulant activity of rivaroxaban. There is no experience with
antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving
rivaroxaban. There is neither scientific rationale for benefit nor experience with
systemic hemostatics (desmopressin and aprotinin) in individuals receiving
rivaroxaban. Use of procoagulant reversal agents such as prothrombin complex
concentrate (PCC), activated prothrombin complex concentrate (APCC), or recombinant
factor VIIa (rFVIIa) may be considered, but has not been evaluated in clinical trials.
Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These
include aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic
therapy, and non-steroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions].
Concomitant use of drugs that are combined P-gp and CYP3A4 inhibitors (e.g.
ketoconazole and ritonavir) increases rivaroxaban exposure and may increase
bleeding risk [see Drug Interactions].
Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural
anesthesia) or spinal puncture is employed, patients treated with anticoagulant
agents for prevention of thromboembolic complications are at risk of developing an
epidural or spinal hematoma which can result in long-term or permanent paralysis
[see Boxed Warning].
An epidural catheter should not be removed earlier than 18 hours after the last
administration of XARELTO. The next XARELTO dose is not to be administered earlier
than 6 hours after the removal of the catheter. If traumatic puncture occurs, the
administration of XARELTO is to be delayed for 24 hours.
Risk of Pregnancy Related Hemorrhage: XARELTO should be used with caution in
pregnant women and only if the potential benefit justifies the potential risk to the
mother and fetus. XARELTO dosing in pregnancy has not been studied. The
anticoagulant effect of XARELTO cannot be monitored with standard laboratory testing
the global impact of cardiovascular disease,
as well as the next generation of cardiovascular professionals. “We have specifically
targeted young people coming through cardiology,” Nishimura said.
The education also will continue in the
exhibit hall at the ACC.12 Expo, which will
feature hundreds of vendor booths, plus the
ACC.12 Learning Destinations, including Interactive Learning Labs, the Industry-Expert
Theater and the CV Innovations Educational
Forum. (See related story on page 9.)
“The strength of the overall meeting is that
it brings incredible focus on science and education, and how we then transmit and translate science,” Holmes said. “Perhaps the most
far-reaching part of this program is rolling out
technology that will allow the application of
just-in-time science for patient care.”
XARELTO® (rivaroxaban) tablets
nor readily reversed. Promptly evaluate any signs or symptoms suggesting blood loss
(e.g., a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress).
Severe Hypersensitivity Reactions: There were postmarketing cases of anaphylaxis in
patients treated with XARELTO to reduce the risk of DVT. Patients who have a history
of a severe hypersensitivity reaction to XARELTO should not receive XARELTO [see
Adverse Reactions].
ADVERSE REACTIONS
Clinical Trials Experience: Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of another drug and may not reflect the
rates observed in clinical practice.
During clinical development for the approved indications, 11598 patients were
exposed to XARELTO. These included 7111 patients who received XARELTO 15 mg or
20 mg orally once daily for a mean of 19 months (5558 for 12 months and 2512 for
24 months) to reduce the risk of stroke and systemic embolism in nonvalvular atrial
fibrillation (ROCKET AF) and 4487 patients who received XARELTO 10 mg orally once
daily for prophylaxis of DVT following hip or knee replacement surgery (RECORD 1-3).
Hemorrhage: The most common adverse reactions with XARELTO were bleeding
complications [see Warnings and Precautions].
Nonvalvular Atrial Fibrillation: In the ROCKET AF trial, the most frequent adverse
reactions associated with permanent drug discontinuation were bleeding events, with
incidence rates of 4.3% for XARELTO vs. 3.1% for warfarin. The incidence of
discontinuations for non-bleeding adverse events was similar in both treatment groups.
Table 1 shows the number of patients experiencing various types of bleeding events in
the ROCKET AF study.
Table 1: Bleeding Events in ROCKET AF*
Parameter
XARELTO Event Rate Warfarin Event Rate
N = 7111 (per 100
N = 7125
(per 100
n (%)
Pt-yrs)
n (%)
Pt-yrs)
395 (5.6)
3.6
386 (5.4)
3.5
Major bleeding†
91 (1.3)
0.8
133 (1.9)
1.2
Bleeding into a critical organ‡
Fatal bleeding
27 (0.4)
0.2
55 (0.8)
0.5
Bleeding resulting in transfusion of 183 (2.6)
1.7
149 (2.1)
1.3
• 2 units of whole blood or packed
red blood cells
Gastrointestinal bleeding
221 (3.1)
2.0
140 (2.0)
1.2
* For all sub-types of major bleeding, single events may be represented in more
than one row, and individual patients may have more than one event.
† Defined as clinically overt bleeding associated with a decrease in hemoglobin of
• 2 g/dL, transfusion of • 2 units of packed red blood cells or whole blood,
bleeding at a critical site, or with a fatal outcome. Hemorrhagic strokes are
counted as both bleeding and efficacy events. Major bleeding rates excluding
strokes are 3.3 per 100 Pt-yrs for XARELTO vs. 2.9 per 100 Pt-yrs for warfarin.
‡ The majority of the events were intracranial, and also included intraspinal,
intraocular, pericardial, intraarticular, intramuscular with compartment
syndrome, or retroperitoneal.
Postmarketing Experience: The following adverse reactions have been identified
during post-approval use of rivaroxaban. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: agranulocytosis
Gastrointestinal disorders: retroperitoneal hemorrhage
Hepatobiliary disorders: jaundice, cholestasis, cytolytic hepatitis
Immune system disorders: hypersensitivity, anaphylactic reaction, anaphylactic shock
Nervous system disorders: cerebral hemorrhage, subdural hematoma, epidural
hematoma, hemiparesis
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome
DRUG INTERACTIONS
Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding
cassette G2 (ABCG2) transporters. Inhibitors and inducers of these CYP450 enzymes
or transporters (e.g., P-gp) may result in changes in rivaroxaban exposure.
Drugs that Inhibit Cytochrome P450 3A4 Enzymes and Drug Transport Systems: In drug
interaction studies evaluating the concomitant use with drugs that are combined
P-gp and CYP3A4 inhibitors, increases in rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation) were observed.
Significant increases in rivaroxaban exposure may increase bleeding risk.
t Ketoconazole (combined P-gp and strong CYP3A4 inhibitor): Steady-state
rivaroxaban AUC and Cmax increased by 160% and 70%, respectively. Similar
increases in pharmacodynamic effects were also observed.
t Ritonavir (combined P-gp and strong CYP3A4 inhibitor): Single-dose rivaroxaban
AUC and Cmax increased by 150% and 60%, respectively. Similar increases in
pharmacodynamic effects were also observed.
t Clarithromycin (combined P-gp and strong CYP3A4 inhibitor): Single-dose
rivaroxaban AUC and Cmax increased by 50% and 40%, respectively. The smaller
increases in exposure observed for clarithromycin compared to ketoconazole or
ritonavir may be due to the relative difference in P-gp inhibition.
t Erythromycin (combined P-gp and moderate CYP3A4 inhibitor): Both the single-dose
rivaroxaban AUC and Cmax increased by 30%.
t Fluconazole (moderate CYP3A4 inhibitor): Single-dose rivaroxaban AUC and Cmax
increased by 40% and 30%, respectively.
Avoid concomitant administration of XARELTO with combined P-gp and strong CYP3A4
inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/
CardioSourceNews
American College of Cardiology
LEGENDS, from page 1
from 2 to 3 p.m. in Room N426. Yacoub
has established the largest heart and lung
transplantation program in the world, and
developed novel operations for a number of
complex congenital heart anomalies. In addition, he oversees research related to tissue
engineering, myocardial regeneration,
stem cell biology,
end stage heart failure and transplant
immunology.
The lecture series
will continue with
the Dan G. McNamara Lecture given
by Jane Somerville,
Jane Somerville, MD
MD, from 2 to 3:30 p.m. Sunday in Room
N228. Her lecture, “50 Years with Cardiac
Surgeons,” will chronicle her medical
professional life, including her passion for
cardiac surgery, and specifically congenital
heart disease. Somerville also will discuss
relevant advances made from the 1960s
through the 21st century and the need for
advancements in adult congenital heart
disease.
Valentin Fuster, MD, PhD, will present the James T. Dove Lecture from 4:30
to 5:30 p.m. Sunday in Room N427. His
lecture, “Transition from Cardiovascular
Disease to Health (2012-2020): The Challenge of Identifying Subclinical Disease,”
will cover the three main trends in today’s
cardiovascular field: The move from treating disease to promoting health; the inte-
gration of the heart
and the brain in
health and disease;
and the emergence
of new technology,
specifically imaging,
genetics and tissue
regeneration.
“These are all areas where advanceValentin Fuster, MD, PhD
ments are really happening, and I’ve been lucky to be involved
in all three of the transitions,” Fuster said.
“I’ll discuss my own experiences and how
these three transitions will take place over
the next decade with subclinical disease as
a main focus.”
The final lecture will be the 11th
Annual Maseri-Florio International
XARELTO® (rivaroxaban) tablets
XARELTO® (rivaroxaban) tablets
ritonavir, and conivaptan), which cause significant increases in rivaroxaban exposure
that may increase bleeding risk.
Drugs that Induce Cytochrome P450 3A4 Enzymes and Drug Transport Systems: In a
drug interaction study, co-administration of XARELTO (20 mg single dose with food)
with a drug that is a combined P-gp and strong CYP3A4 inducer (rifampicin titrated
up to 600 mg once daily) led to an approximate decrease of 50% and 22% in AUC
and Cmax, respectively. Similar decreases in pharmacodynamic effects were also
observed. These decreases in exposure to rivaroxaban may decrease efficacy.
Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong
CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort).
Anticoagulants: In a drug interaction study, single doses of enoxaparin (40 mg
subcutaneous) and XARELTO (10 mg) given concomitantly resulted in an additive
effect on anti-factor Xa activity. Enoxaparin did not affect the pharmacokinetics of
rivaroxaban. In another study, single doses of warfarin (15 mg) and XARELTO (5 mg)
resulted in an additive effect on factor Xa inhibition and PT. Warfarin did not affect the
pharmacokinetics of rivaroxaban.
NSAIDs/Aspirin: In ROCKET AF, concomitant aspirin use (almost exclusively at a dose
of 100 mg or less) during the double-blind phase was identified as an independent risk
factor for major bleeding. NSAIDs are known to increase bleeding, and bleeding risk
may be increased when NSAIDs are used concomitantly with XARELTO. In a singledose drug interaction study there were no pharmacokinetic or pharmacodynamic
interactions observed after concomitant administration of naproxen or aspirin
(acetylsalicylic acid) with XARELTO.
Promptly evaluate any signs or symptoms of blood loss if patients are treated
concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs [see
Warnings and Precautions].
Clopidogrel: In two drug interaction studies where clopidogrel (300 mg loading dose
followed by 75 mg daily maintenance dose) and XARELTO (15 mg single dose) were
co-administered in healthy subjects, an increase in bleeding time to 45 minutes was
observed in approximately 45% and 30% of subjects in these studies, respectively. The
change in bleeding time was approximately twice the maximum increase seen with
either drug alone. There was no change in the pharmacokinetics of either drug.
Promptly evaluate any signs or symptoms of blood loss if patients are treated
concomitantly with clopidogrel [see Warnings and Precautions].
Drug-Disease Interactions with Drugs that Inhibit Cytochrome P450 3A4 Enzymes and
Drug Transport Systems: Based on simulated pharmacokinetic data, patients with
renal impairment receiving full dose XARELTO in combination with drugs classified as
combined P-gp and weak or moderate CYP3A4 inhibitors (e.g., amiodarone, diltiazem,
verapamil, quinidine, ranolazine, dronedarone, felodipine, erythromycin, and
azithromycin) may have significant increases in exposure compared with patients with
normal renal function and no inhibitor use, since both pathways of rivaroxaban
elimination are affected.
While increases in rivaroxaban exposure can be expected under such conditions,
results from an analysis in the ROCKET AF trial, which allowed concomitant use with
combined P-gp and weak or moderate CYP3A4 inhibitors (e.g., amiodarone, diltiazem,
verapamil, chloramphenicol, cimetidine, and erythromycin), did not show an increase
in bleeding in patients with CrCl 30 to <50 mL/min [Hazard Ratio (95% CI): 1.05 (0.77,
1.42)]. XARELTO should be used in patients with CrCl 15 to 50 mL/min who are
receiving concomitant combined P-gp and weak or moderate CYP3A4 inhibitors only if
the potential benefit justifies the potential risk [see Use in Specific Populations].
USE IN SPECIFIC POPULATIONS
Pregnancy: Pregnancy Category C: There are no adequate or well-controlled studies
of XARELTO in pregnant women, and dosing for pregnant women has not been
established. Use XARELTO with caution in pregnant patients because of the potential
for pregnancy related hemorrhage and/or emergent delivery with an anticoagulant
that is not readily reversible. The anticoagulant effect of XARELTO cannot be reliably
monitored with standard laboratory testing. Animal reproduction studies showed no
increased risk of structural malformations, but increased post-implantation pregnancy
loss occurred in rabbits. XARELTO should be used during pregnancy only if the
potential benefit justifies the potential risk to mother and fetus [see Warnings and
Precautions].
Rivaroxaban crosses the placenta in animals. Animal reproduction studies have shown
pronounced maternal hemorrhagic complications in rats and an increased incidence
of post-implantation pregnancy loss in rabbits. Rivaroxaban increased fetal toxicity
(increased resorptions, decreased number of live fetuses, and decreased fetal body
weight) when pregnant rabbits were given oral doses of •10 mg/kg rivaroxaban
during the period of organogenesis. This dose corresponds to about 4 times the human
exposure of unbound drug, based on AUC comparisons at the highest recommended
human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were
given oral doses of 120 mg/kg. This dose corresponds to about 14 times the human
exposure of unbound drug.
Labor and Delivery: Safety and effectiveness of XARELTO during labor and delivery
have not been studied in clinical trials. However, in animal studies maternal bleeding
and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6
times maximum human exposure of the unbound drug at the human dose of 20 mg/day).
Nursing Mothers: It is not known if rivaroxaban is excreted in human milk.
Rivaroxaban and/or its metabolites were excreted into the milk of rats. Because many
drugs are excreted in human milk and because of the potential for serious adverse
reactions in nursing infants from rivaroxaban, a decision should be made whether to
discontinue nursing or discontinue XARELTO, taking into account the importance of
the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use: Of the total number of patients in the RECORD 1-3 clinical studies
evaluating XARELTO, about 54% were 65 years and over, while about 15% were
>75 years. In ROCKET AF, approximately 77% were 65 years and over and about 38%
were >75 years. In clinical trials the efficacy of XARELTO in the elderly (65 years or
older) was similar to that seen in patients younger than 65 years. Both thrombotic and
bleeding event rates were higher in these older patients, but the risk-benefit profile
was favorable in all age groups [see Clinical Pharmacology (12.3) and Clinical Studies
(14) in full Prescribing Information].
Females of Reproductive Potential: Females of reproductive potential requiring
anticoagulation should discuss pregnancy planning with their physician.
Renal Impairment: The safety and pharmacokinetics of single-dose XARELTO (10 mg)
were evaluated in a study in healthy subjects [CrCl •80 mL/min (n=8)] and in subjects
with varying degrees of renal impairment (see Table 2). Compared to healthy subjects
with normal creatinine clearance, rivaroxaban exposure increased in subjects with
renal impairment. Increases in pharmacodynamic effects were also observed.
Table 2: Percent Increase of Rivaroxaban PK and PD Parameters from Normal in
Subjects with Renal Insufficiency from a Dedicated Renal Impairment
Study
Renal Impairment Class
[CrCl (mL/min)]
Parameter
Mild
Moderate
Severe
[50 to 79]
[30 to 49]
[15 to 29]
N=8
N=8
N=8
Exposure
AUC
44
52
64
28
12
26
(% increase relative to normal)
Cmax
FXa Inhibition
AUC
50
86
100
9
10
12
(% increase relative to normal)
Emax
PT Prolongation
AUC
33
116
144
4
17
20
(% increase relative to normal)
Emax
PT = Prothrombin time; FXa = Coagulation factor Xa; AUC = Area under the
concentration or effect curve; Cmax = maximum concentration; Emax = maximum
effect; and CrCl = creatinine clearance
Patients with renal impairment taking P-gp and weak to moderate CYP3A4 inhibitors
may have significant increases in exposure which may increase bleeding risk [see
Drug Interactions].
Nonvalvular Atrial Fibrillation: In the ROCKET AF trial, patients with CrCl 30 to
50 mL/min were administered XARELTO 15 mg once daily resulting in serum
concentrations of rivaroxaban and clinical outcomes similar to those in patients with
better renal function administered XARELTO 20 mg once daily. Patients with CrCl 15 to
30 mL/min were not studied, but administration of XARELTO 15 mg once daily is also
expected to result in serum concentrations of rivaroxaban similar to those in patients
with normal renal function [see Dosage and Administration (2.1) in full Prescribing
Information].
Hepatic Impairment: The safety and pharmacokinetics of single-dose XARELTO
(10 mg) were evaluated in a study in healthy subjects (n=16) and subjects with varying
degrees of hepatic impairment (see Table 3). No patients with severe hepatic
impairment (Child-Pugh C) were studied. Compared to healthy subjects with normal
liver function, significant increases in rivaroxaban exposure were observed in
subjects with moderate hepatic impairment (Child-Pugh B). Increases in pharmacodynamic effects were also observed.
Table 3: Percent Increase of Rivaroxaban PK and PD Parameters from Normal
in Subjects with Hepatic Insufficiency from a Dedicated Hepatic
Impairment Study
Hepatic Impairment Class
(Child-Pugh Class)
Parameter
Mild
Moderate
(Child-Pugh A) (Child-Pugh B)
N=8
N=8
Exposure
AUC
15
127
0
27
(% increase relative to normal)
Cmax
FXa Inhibition
AUC
8
159
0
24
(% increase relative to normal)
Emax
PT Prolongation
AUC
6
114
2
41
(% increase relative to normal)
Emax
PT = Prothrombin time; FXa = Coagulation factor Xa; AUC = Area under the
concentration or effect curve; Cmax = maximum concentration; Emax = maximum
effect
Avoid the use of XARELTO in patients with moderate (Child-Pugh B) and severe (ChildPugh C) hepatic impairment or with any hepatic disease associated with coagulopathy
[see Dosage and Administration (2.3) in full Prescribing Information and Warnings and
Precautions].
OVERDOSAGE
Overdose of XARELTO may lead to hemorrhage. A specific antidote for rivaroxaban is
not available. Rivaroxaban systemic exposure is not further increased at single doses
>50 mg due to limited absorption. Discontinue XARELTO and initiate appropriate
therapy if bleeding complications associated with overdosage occur. The use of
activated charcoal to reduce absorption in case of XARELTO overdose may be
considered. Due to the high plasma protein binding, rivaroxaban is not expected to be
dialyzable [see Warnings and Precautions and Clinical Pharmacology (12.3) in full
Prescribing Information].
Active Ingredient Made in Germany
Finished Product
Manufactured for:
Licensed from:
Manufactured by:
Janssen Pharmaceuticals, Inc.
Bayer HealthCare AG
Janssen Ortho, LLC Titusville, NJ 08560
51368 Leverkusen, Germany
Gurabo, PR 00778
© Janssen Pharmaceuticals, Inc. 2011
Revised: December 2011
10185202
02X12012BBA
19
Lecture presented
by famed interventionalist Antonio
Colombo, MD, from
2 to 3 p.m. Monday
in Room N231.
His lecture is “Personal Insights Leading to Scientific
Developments.”
Antonio Colombo, MD
“The legends
are selected on the basis of outstanding
contributions to the field of cardiovascular
medicine, recognized by all cardiologists as
true leaders and innovators,” said ACC.12
Co-Chair Rick Nishimura, MD. “This is
truly a unique opportunity to bring these
tremendously revered people all in one
place.”
Explore the benefits of a new treatment option
Visit Booth #10007
Please see the Brief Summary of the full Prescribing Information,
including Boxed WARNINGS, on adjacent pages.
© Janssen Pharmaceuticals, Inc. 2012
March 2012
02X11182R1
XARELTO® is licensed from Bayer HealthCare AG, 51368 Leverkusen, Germany.
Janssen Pharmaceuticals, Inc.