Stents before CABG tied to higher risk for diabetic patients

Transcription

VOL. 11
C OURTESY
OF
AATS
Stents before CABG
tied to higher risk
for diabetic patients
Human malignant mesothelioma spheroids treated with PaxeNPs demonstrated caspase-3 up-regulation from negligible
within the 24 hours after Pax-Rho-eNP treatment to significantly
increased at 28 and 72 hours, compared with Pax-C/E.
3-D tumor cell model
validates nanotech
Frontline Medical News
M
alignant mesothelioma poses a significant
challenge for clinicians because of its ability to resist
chemotherapy, but the use
of three-dimensional tumor
spheroid models
has shown that local administration
of paclitaxel in a
nanoparticle platform achieved better tumor penetration than
conventional paclitaxel therapy, investigators reported.
The study is in the May issue
of the Journal of Thoracic
and Cardiovascular Surgery.
Dr. Hongyi Lei of
Brigham and Women’s
Hospital, Boston, and his
colleagues used the in vi-
tro mesothelioma spheroid
model because two-dimensional in vitro monolayer
cell culture experiments do
not replicate the superior
efficacy of paclitaxel-loaded
expansile nanoparticles (PaxeNPs), suggesting that PaxeNPs utilize a unique drug
delivery mechanism.
The study observed that spheroids treated with
Pax-eNP showed
increased drug penetration
and a 38-fold higher intraspheroidal drug concentration at 24 hours than that
of paclitaxel dissolved in
Cremophor EL/ethanol ( J.
Thorac. Cardiovasc. Surg.
2014 [doi:10.1016/
j.jtcvs.2015.02.020]).
See Nanotech · page 15
THORACIC SURGERY NEWS
151 Fairchild Ave.,
Suite 2,
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BY RICHARD KIRKNER
Higher 5-year death rates observed.
BY RICHARD KIRKNER
S
ince the debut of
drug-eluting stents,
more high-risk patient
groups, namely diabetic
patients, have undergone
coronary stenting
as opposed to
coronary artery
bypass grafting
(CABG) as an
option to open
blocked arteries. However,
a review study of 7,005
CABG procedures from
1996 to 2007 at Mercy St.
Vincent Medical Center
in Toledo, Ohio, found
that diabetic patients with
triple-vessel disease and a
prior percutaneous coronary
intervention with stenting
(PCI-S) who underwent
CABG had a 39% greater
risk of death within 5 years
of the operation.
The findings, published in
the May issue of the Journal of Thoracic
and Cardiovascular Surgery,
are significant,
according to Dr.
Victor Nauffal and
his colleagues at the American University of Beirut,
because increasing numbers
of patients with coronary
stents are referred for CABG
(J. Thorac. Cardiovasc. Surg.
2015 [doi:10.1016/
See Stents · page 8
•
NO. 5
•
MAY 2015
I N S I D E
News
Mini-Pump
FDA approves mini heart
pump to help maintain
function and circulation
during high-risk PCI. • 2
Cardiopulmonary
Transplantation
High/Low ECMO
Use of ECMO as a bridgeto-transplant showed worse
outcomes at low-volume
centers. • 9
Residents’ Corner
Percutaneous
Predicament
The skills are needed;
training must move with
the times, but where’s the
time? • 11
News from AATS
Fellowships Galore
See the awardees, apply for
new opportunities, and
register for meetings
around the world. • 12
Dr. Michael J. Davidson remembered
BY MITCHEL L. ZOLER
I
t’s extremely unusual for
a cardiologist or cardiac
surgeon to die in the line
of duty, but that tragedy
occurred this January in
Boston when the enraged
son of a patient mortally
shot Dr. Michael J. Davidson
while he was on the job as
director of endovascular cardiac surgery at Brigham and
Women’s Hospital.
Dr. Davidson had been
an active coinvestigator in
the PARTNER study since it
began in 2007 to make the
first direct comparison of
a transcatheter aortic valve
replacement (TAVR) system
against aortic valve replacement with conventional
heart surgery.
Because of Dr. Davidson’s long and active
involvement with the
PARTNER trial, his colleagues decided to dedicate the study’s 5-year
follow-up findings to him,
making the announcement
during the first public release of the 5-year results
in mid-March at the annual
meeting of the American
College of Cardiology.
“On behalf of the PARTNER team, we would like
to dedicate this study – the
See Davidson · page 2
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NEWS
2
MAY 2 0 1 5 • THO R A C IC S UR G ERY NEW S
Slain surgeon honored
Davidson from page 1
5-year outcomes – to Mike Davidson,” said Dr.
Michael J. Mack as he finished his podium presentation of the report.
Preceding Dr. Mack’s talk, the session began
with brief remarks about Dr. Davidson from Dr.
Martin B. Leon, coleader of the PARTNER trial,
and then the airing of a 6-minute video featuring
several of Dr. Davidson’s colleagues recalling his
unique career and accomplishments.
Notable in their comments was the outline they
provided of the unusual training and career path
Dr. Davidson forged for himself, based on his remarkably prescient realization a decade or more
ago that the future of cardiology and cardiac sur-
gery lay in fusing the two into a hybrid discipline.
Dr. Davidson’s colleagues cited the training
he undertook to become both a fully qualified
cardiac surgeon and a skilled interventional cardiologist, turning himself into an embodiment of
the “heart team.” Several in the video called him
“visionary” for recognizing this fusion as an important step toward the future of treating heart
disease.
The poignancy of the moment did not stop
there.
After the video ended and before Dr. Mack delivered the session’s first talk, ACC president Dr.
Patrick T. O’Gara presented a posthumous distinguished-service award from the ACC to Dr. Davidson – with Dr. O’Gara handing the award to the
fallen surgeon’s parents, including his father, Dr.
Robert M. Davidson, a longtime ACC fellow and
former clinical chief of cardiology at Cedars-Sinai
Medical Center in Los Angeles.
Following the award, Dr. Athena Poppas, chair
of the meeting’s program committee and cochair
for the latebreaker session on heart valve replacement, stressed that the entire session was dedicated to honor Dr. Michael J. Davidson.
Perhaps most moving of all were the small
white buttons that Dr. O’Gara, Dr. Davidson’s
parents, and others wore on their lapels during
the session, featuring a blue heart and the initials MJD. It combined for an affecting tribute to
someone who had played a central role in transforming heart valve replacement and then was
murdered for doing this work.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
FDA approves mini heart pump for use during high-risk PCI
BY ELIZABETH MECHCATIE
A
miniature heart pump has been
approved by the Food and Drug
Administration to “help certain patients maintain stable heart function
and circulation during certain highrisk percutaneous coronary intervention (HRPCI) procedures,” the
agency has announced.
The Impella 2.5 System, manufactured by Abiomed, is “intended
for temporary use by patients with
severe symptomatic CAD [coronary
artery disease] and diminished (but
stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass
treatment,” according to the FDA’s
statement.
“Use of the Impella 2.5 System
is intended to prevent episodes of
unstable heart function, including
unstable blood pressure and poor
circulation, in patients who are at
high risk for its occurrence,” Dr.
William Maisel, acting director of
the Office of Device Evaluation in
the FDA’s Center for Devices and
Radiological Health, said in the
statement.
Approval was based on the PROTECT II study and observational
data from the USpella Registry.
“The overall data provided evidence that, for patients with severe
CAD and diminished heart function,
the temporary circulatory support
provided by the Impella 2.5 System
during an HRPCI procedure may
allow a longer and more thorough
procedure by preventing episodes
of hemodynamic instability ... due
to temporary abnormalities in heart
function,” the FDA statement said.
In addition, “fewer later adverse
events,” such as the need for repeat
HRPCI procedures, “may occur in
patients undergoing HRPCI with
the pump compared to patients undergoing HRPCI with an intra-aortic
balloon pump,” according to the
FDA.
The FDA statement also noted
that the system can be used as an alternative to the intra-aortic balloon
pump “without significantly increasing the safety risks of the HRPCI
procedure.”
As a postmarketing requirement,
the manufacturer will conduct a
single-arm study of the device in
high-risk PCI patients, according to
the company’s statement announcing
approval.
The wording of the approved
indication is as follows, according
to Abiomed: “The Impella 2.5 is a
temporary (less than or equal to 6
hours) ventricular support device
indicated for use during high-risk
PCI performed in elective or urgent
hemodynamically stable patients
with severe coronary artery disease
and depressed left ventricular ejection fraction, when a heart team,
including a cardiac surgeon, has
determined high-risk PCI is the appropriate therapeutic option. Use of
the Impella 2.5 in these patients may
prevent hemodynamic instability that
may occur during planned temporary
coronary occlusions and may reduce
peri- and postprocedural adverse
events.”
emechcatie@frontlinemedcom.com
THORACIC SURGERY NEWS
AMERICAN ASSOCIATION
FOR
THORACIC SURGERY
Editor Michael J. Liptay, M.D.
Associate Editor, General Thoracic
Sai Yendamuri, M.D.
Associate Editor, Adult Cardiac Jennifer S. Lawton, M.D.
Associate Editor, Cardiopulmonary Transplant Matthias Loebe, M.D.
Associate Editor, Congenital Heart Robert Jaquiss, M.D.
Resident/Fellow Editors: Elliot Servais, M.D., David Shersher, M.D.
Executive Director Cindy VerColen
Thoracic Surgery News is the official newspaper of the American
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NEWS
THOR AC ICS URGE RYNE W S. COM • M AY 2015
3
Updated IMPROVE-IT results show bigger benefits
BY BRUCE JANCIN
S AN DIE GO – The initial presentation of the
IMPROVE-IT trial at last November’s American
Heart Association Scientific Sessions told only half
the story of the actual clinical impact of lipid-lowering with the combination of ezetimibe and simvastatin as opposed to simvastatin alone. That’s
because the main analysis included only the first
cardiovascular event patients experienced. Many
participants with a nonfatal first event went on to
have a second, third, or even a fourth event. And
while additional events haven’t traditionally been
counted in acute coronary syndrome clinical trials,
they should be, Sabina A. Murphy said at the annual meeting of the American College of Cardiology.
“All events, not just first events, are important to
patients and clinicians. Total events have implications for patient morbidity, clinical management,
need for recurrent hospitalization, and total costs,”
said Ms. Murphy, head of biostatistics at the TIMI
Study Group at Brigham and Women’s Hospital,
Boston.
Analyses that include recurrent events are common in some other medical fields, including oncology and rheumatology, she added.
In last November’s initial findings from IMPROVE-IT (Improved Reduction of Outcomes:
Vytorin Efficacy International Trial), the combination of 10 mg ezetimibe/40 mg simvastatin
(Vytorin) daily resulted in a modest yet statistically
significant 6.4% relative risk reduction in the primary composite endpoint, compared with 40 mg
of simvastatin alone, reported Dr. Christopher P.
Cannon, professor of medicine at Harvard Medical
School, Boston.
Most observers hailed this result as clinically
important, since IMPROVE-IT was the first study
to show that lowering cholesterol with a nonstatin
reduces cardiovascular events, and it showed that
the lower a patient’s LDL cholesterol, the better
the outcomes: The mean LDL with combination
therapy was 54 mg/dL, compared with 70 mg/dL
in controls.
The double-blind study included 18,144 patients
randomized within 10 days of an acute coronary
syndrome. The primary composite outcome comprised cardiovascular death, nonfatal MI, nonfatal
stroke, rehospitalization for unstable angina, and
coronary revascularization. The 6.4% relative
risk reduction was based solely on first events, of
which there were 5,314 during a median 6 years
of follow-up. But there were also 4,231 subsequent
primary endpoint events, including 2,297 second
events, 972 third events, and 456 fourth ones.
While 170 fewer first events occurred with combination therapy than with simvastatin alone, there
were also 251 fewer additional or recurrent cardiovascular events in the ezetimibe/simvastatin group
that were not incorporated in the initial analysis.
Here’s the key point: While the relative risk reduction for first primary endpoint events was 6.4%
with combination therapy, the risk of additional
events was reduced by 12%, resulting in a more
substantial 9% relative risk reduction for total
events.
For the prespecified secondary composite endpoint consisting of death due to coronary heart
disease, nonfatal MI, or urgent coronary revascularization, the initial analysis based solely upon
first events showed an 8.8% relative risk reduction
with ezetimibe/simvastatin.
But the fuller view includes a 21% reduction in
the risk of additional events, resulting in a 15%
relative risk reduction for total events during a median 6 years of follow-up.
In an exploratory analysis examining the harder
endpoints of cardiovascular death, nonfatal MI, or
cerebrovascular accident, the relative risk reduction
for total events was 12% with combination therapy. Ezetimibe/simvastatin was associated with a
13% reduction in all nonfatal MIs occurring during
follow-up and a 23% reduction in nonfatal strokes,
according to Ms. Murphy.
Among every 1,000 IMPROVE-IT participants
on ezetimibe/simvastatin rather than simvastatin
alone for 1 year there were 11 fewer total primary
outcome events, including 5 fewer nonfatal MIs, 2
less nonfatal strokes, and 4 fewer revascularization
procedures.
She reported serving as a consultant to Merck
and receiving research grants from AstraZeneca,
Daiichi Sanko, GlaxoSmithKline, and Merck.
bjancin@frontlinemedcom.com
CoreValve receives first TAVR valve-in-valve indication
BY MITCHEL L. ZOLER
T
he U.S. Food and Drug Administration has expanded its approved
use of the CoreValve transcatheter
aortic-valve replacement (TAVR)
system to include patients who already have undergone aortic valve
replacement and need a second valve
replacement done as a valve-in-valve
placement.
With this action, CoreValve became
the first TAVR system to receive U.S.
approval for valve-in-valve use. The
CoreValve System received FDA
approval for TAVR performed on
native aortic valves in January 2014
in patients at “extreme risk,” and in
June 2014 for those at “high risk,”
for surgical aortic valve replacement.
Valve-in-valve TAVR is only feasible
in patients with a failing bioprosthetic
aortic valve: It is not for patients with
a failing mechanical aortic valve.
“The CoreValve System offers a
less-invasive treatment option for a
significant number of patients with
failed tissue aortic valves whose medical teams determine that the risks
associated with repeat open-heart
surgery are high or extremely high,”
Dr. William H. Maisel, deputy center
director for science and chief scientist in the FDA’s
Center for Devices and Radiological Health,
said in a written
statement.
The CoreValve, which is
designed to sit in
a supra-annular
DR. MAISEL
location 12 mm
above the aortic valve annulus, is well suited for
valve-in-valve replacement because
the only portion of the CoreValve
that actually fills the annular space
and the ring of the existing valve is
the CoreValve’s sealer. This results in
a tight seal that produces less paravalvular leak than when the sealer
sits in a native annulus that is often
deformed with calcium, noted Dr.
Michael J. Reardon, professor of
cardiothoracic surgery at Methodist
Hospital in Houston. Because the
sealer exerts pressure on the old
valve ring in the annulus instead of
on myocardium, placing the Core-
Valve as a valve-in-valve produces
much less conduction disruption and
results in fewer patients who need a
pacemaker after TAVR, he said.
Dr. Reardon anticipates that many
U.S. patients now in their 80s with a
failing bioprosthetic aortic valve will
be interested in nonsurgical TAVR
replacement. These patients often do
not want conventional open-heart
surgery, he said in an interview.
The FDA reviewed clinical data collected from a U.S. clinical trial with
143 patients, an agency representative
said in the statement. In the clinical
trial, the estimated rate of 30-day survival without major stroke was 96%,
and 89% after 6 months.
According to the agency, aortic
valve-in-valve use of the CoreValve
System should be limited to patients
who need replacement of a failed
tissue aortic valve but are at extreme
or high risk of death or serious complications from traditional open-heart
surgery. A decision as to whether the
product and procedure are appropriate for a patient “should involve careful evaluation by the patient’s heart
medical team, including a cardiologist
and a cardiac surgeon.” The FDA said
that the CoreValve System should not
be used in patients who have any infection, have a mechanical aortic heart
valve, cannot tolerate anticoagulant
drugs, or have sensitivity to titanium,
nickel, or contrast media.
Dr. Maisel had no disclosures. Dr.
Reardon has served as an adviser to
Medtronic, the company that markets the CoreValve.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
Note in clarification
With regard to the article “Hybrid revascularization remains
relatively rare” in the April issue
of Thoracic Surgery News (p. 9):
Dr. Vinod H. Thourani wished to
clarify that, as he stated in his presentation, the current work he reported on from Emory University
was performed by Dr. Michael
Halkos, who is the leader of hybrid revascularization at Emory,
and that Dr. Halkos was lead author and researcher in several of
the other studies reported upon.
4
NEWS
Fast-track protocol cuts lung resection complications
BY PATRICE WENDLING
CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays
following cancer-related lung resection without
raising readmissions or emergency visits after discharge, a study showed.
“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of
care,” Dr. Amin Madani, from McGill University in
Montreal, said at the annual meeting of the Central Surgical Association (CSA).
Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is
little evidence to support its use and effectiveness
in lung resection.
Surgeons at McGill established an integrated, multimodal approach to perioperative care
of these patients after creating a written, evidence-based, step-by-step pathway.
Key elements, Dr. Madani explained, are
standardized preoperative patient education;
removal of urine drains on postoperative day 1;
removal of the last chest tube by postop (POD)
day 3, if there is <300 cc of drainage in 24 hours
and no air leak; ambulation goals of more than
75 m thrice-daily by POD 3; introduction of
solid food on POD 1; and a target discharge of
POD 4.
To examine the effectiveness of the pathway, the
authors retrospectively analyzed outcomes in 127
patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was
implemented in September 2012. At baseline, the
two groups were similar with respect to age, sex,
body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function,
and smoking history.
Hospital length of stay was significantly reduced
after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by
patients with an uncomplicated hospital course
who were discharged after a median of 5 days after
the pathway was implemented, according to Dr.
Madani.
It was not the case that patients went home too
early, as readmissions (5% vs. 6%) and ED visits
(3% vs. 5%) were similar between both groups, he
added.
After the pathway was implemented, patients
had earlier Foley catheter removal (POD 2 vs. 1),
IV discontinuation (POD 3 vs. 2), ambulation (POD
2 vs. 1), last chest tube removal (POD 5 vs. 4), and
epidural removal (POD 5 vs. 4).
The enhanced recovery pathway
group had fewer overall complications
than did the traditional care group (37%
vs. 50%; P = .03), a threefold decrease
in urinary tract infections (3% vs. 12%;
P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P
= .38) and surgical site infections (1% vs.
6%; P = .07), he said.
DR. MADANI
Despite significantly earlier removal
of chest tubes after the pathway, there
was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being
removed too early, causing harm to patients,” Dr.
Madani said.
In multivariate regression analysis adjusted for
age, sex, BMI, and ASA score, there was a significant negative association between implementation
of an enhanced recovery pathway and length of
stay (beta, –0.18; P < .01) and complications (odds
ratio, 0.46; P < .01), but not readmissions (OR,
1.59; P = .44).
Early removal of chest tubes and urinary catheter were independent predictors of decreased
length of stay.
Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said that the
development of care pathways to enhance recovery after surgery is gaining a lot of interest in
the surgical community, but he went on to ask
how much it cost to implement.
The overall cost of the surgeon-driven initiative,
involving multiple pathways for various surgical
procedures, is about $120,000 annually, or $100/
patient for the 1,200 patients undergoing surgery
using an ERP program at the McGill University
Health Centre each year, Dr. Madani said. This
cost also includes a full-time nurse practitioner
now serving as the pathway coordinator and
roughly $13,000 for patient education booklets, but
no additional staff.
An audience member questioned whether the
authors have identified factors predicting
which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the
80-year-old, narcotic-naive woman with
diabetes, who simply won’t progress.
“That’s a very good point, and I agree
there are some patients whom you can’t
fast track,” Dr. Madani replied.
“Part of the deal here is that, yes, we
have this protocolized pathway; however,
the surgeon still has the right to change
that if they feel it is important. We didn’t look at
the specifics of which patient [factors] achieved
adherence, but we could at some point in the future.”
CSA President and session moderator Christopher McHenry, from MetroHealth Medical Center
in Cleveland, said he was impressed with the study
and called the findings very believable.
“I think all of these recovery pathways can be
very beneficial,” Dr. McHenry said in an interview.
“It helps us re-look at how we’re managing our
patients and see if there are ways that we can
improve on their postoperative management that
may lead to earlier discharge.”
The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr.
Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
pwendling@frontlinemedcom.com
Digoxin linked to higher mortality in AFib patients
EWPATIES
BY PATRICE WENDLING
SAN DIEGO – Digoxin increases the
risk of death by 27% in patients with
atrial fibrillation, a meta-analysis of
19 studies showed.
Patients with AF and kidney failure
faced a 60% to 70% increase in mortality, compared with their counterparts not taking digoxin, according to
a press release on the study.
A weaker association between digoxin and death was observed in AF
patients who also had heart failure, a
finding the authors suggest warrants
further investigation.
“Until further research can be
done, I would suggest physicians use
caution when prescribing digoxin for
patients with atrial fibrillation, especially given that there are alternative
drugs available that might be safer,”
lead author Dr. Waqas Qureshi said
in a statement.
The results were released in advance
of their March 15 presentation at the
annual meeting of the American College of Cardiology in San Diego.
About 5.6 million Americans have
atrial fibrillation and roughly 1 in 5
are prescribed digoxin for heart rate
control. Current guidelines recommend digoxin as first-line therapy in patients who aren’t physically active and
as a second-line drug for more active
patients.
“Based on consistent results com-
ing out of many studies, our results
suggest digoxin should be downgraded from its position as a front-line
agent for certain patients with atrial
fibrillation,” Dr. Qureshi, a clinical
and research cardiology fellow at
Wake Forest School of Medicine in
Winston-Salem, N.C., recommended.
The authors reviewed 19 studies
including five cohort and randomized
controlled trials involving 501,681
patients. Of these, 458,311 patients
had AF and 111,978 were prescribed
digoxin.
In a random effects model, digoxin
was associated with an increased risk
of mortality, with a pooled hazard
ratio of 1.27 (95% confidence interval
1.19-1.36; P < .001).
Several studies in the meta-analysis
suggest that higher blood levels of
digoxin increase the risk of death. The
mechanism behind the increased mortality is not known, although previous
studies have suggested digoxin increases the risk of thromboembolism.
The meta-analysis accounted for
risk factors and comorbidities reported in the various studies, but it’s possible that some confounding factors
may not have been accounted for, the
authors acknowledge.
“The study points to the need
for a well-structured, targeted trial
to investigate digoxin’s safety,” Dr.
Qureshi stated.
pwendling@frontlinemedcom.com
CONGENITAL HEART DISEASE
5
Linking registries, databases may reduce SSIs
Database (STS-CHSD).
To further facilitate the flow and
interpretation of data, the invesurveillance of cardiac surgical
tigators used a visualization tool
site infections (SSIs) improved
to analyze the STS-CHSD for case
significantly when
ascertainment; to resolve
registry and infection
discrepancies among STScontrol surveillance data
CHSD, infection surveilwere linked with electronic
lance, and billing of SSI
health records, a retrospeccases; and to assess the imtive analysis showed.
pact of the hospital’s qualiOver the course of a
ty improvement protocols.
47-month period starting
These protocols consistin 2011, Vaidehi Nayar of
ed of wound alert reports
the Children’s Hospital
from the EHR, bedside reDR. NAYAR
of Philadelphia and her
views for SSI adjudication,
coinvestigators launched
inpatient and outpatient
a quality improvement initiative at
SSI prevention bundles, prophylactic
their institution that linked adminantibiotic dosing changes, removal of
istrative databases with their clinical
steroids from the bypass circuit, and
registry, allowing caregivers to more
biller education on SSIs.
accurately monitor and assess SSIs
Control charts in the data visuand provide more effective adjudicaalization tool allowed for statistical
tion and treatments thereafter.
monitoring of SSI rate changes, and
The investigators chose to link
SSI case discrepancies across the datheir hospital’s electronic health
tabases were reviewed to ensure that
record (EHR) billing information
differences were the result of variaand reporting from the infection
tions in SSI reporting criteria for each
surveillance database for the Nationdatabase, not inaccurate surveillance
al Healthcare Safety Network with
population ascertainment or inaccudata from the Society of Thoracic
rate SSI identification, according to
Surgeons Congenital Heart Surgery
Ms. Nayar and her colleagues,
BY DEEPAK CHITNIS
PERSPECTIVE
S
AATS
CARDIOVASCULAR
VALVE
SYMPOSIUM
2015
SAVE THE DATE
T
his study demonstrates dramatically different surgical site infection (SSI) rates for the same patient
cohort as detected by three different surveillance methods: hospital
billing (derived from the electronic
health records), a surgical database,
and a tracking system developed
by the Centers for Disease Control
and Prevention.
On the low end, 79 SSIs were
reported by one system, 156 by another, and 433 by the third method
– a more than fivefold discrepancy.
The authors developed a technique
to reconcile the three systems and
then evaluated a variety of interventions designed to reduce the SSI
rate. As a result of this initiative,
the quality of event reporting was
improved (with greater agreement
between reporting methods) and
the rate of SSIs was reduced.
The implications of this report
are sobering and should be of great
“Workflow changes, including
the wound alert report and bedside
reviews, facilitated communication
interest to all surgeons and hospital
administrators for several reasons.
First and fundamentally, the report
suggests that widely used reporting
systems may be inaccurate and
produce conflicting results. Since
the results of these reports are
used to assess and modify clinical
practice, this is very disturbing. Additionally, the results may be used
by payers as a basis for financial
reward (or penalty) and therefore
must be accurate. Finally, exposure
of the use of erroneous information as the source data for billing
may render an institution vulnerable to civil and criminal penalties.
For all of these reasons, the present
report should prompt self-assessment by all institutions, if it has
not already been undertaken.
Dr. Robert Jaquiss is associate medical
editor for congenital heart disease for
Thoracic Surgery News.
among providers and improved adjudication of suspected SSIs,” she said
Continued on following page
COURSE DIRECTORS
David H. Adams
Mount Sinai School of Medicine
New York, New York, USA
Joseph S. Coselli
Baylor College of Medicine
Houston, Texas, USA
Walter J. Gomes
Federal University of São Paulo
São Paulo, Brazil
Pedro J. del Nido
Boston Children’s Hospital
Boston, Massachusetts, USA
Thoralf M. Sundt, III
Massachusetts General Hospital
Boston, Massachusetts, USA
November 20 - 21, 2015
Renaissance Marriott São Paulo
São Paulo, Brazil
www.aats.org/valvebrazil
6
CONGENITAL HEART DISEASE
Continued from previous page
in presenting the J. Maxwell Chamberlain Memorial Paper for Congenital Heart Surgery at the annual
meeting of the Society of Thoracic
Surgeons in San Diego earlier this
year.
In total, 156 SSIs were identified via
THE OFFICIAL
NEWSPAPER
OF THE
the STS-CHSD, 79 via the infection
surveillance database, and 433 via
billing.
There was a significant decrease in
the rolling 12-month SSI rate from
2.48% (21/848 in January 2013) to
0.76% (11/1,442 in January 2014),
based on the STS-CHSD data, although Ms. Nayar pointed out that
Accurate assessment of SSI
data ‘has implications for
public reporting, benchmarking,
assessment of [quality
improvement] impact, and
possible denial of payments.’
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this decline could not definitely be
attributed to reporting improvements or to the specific quality
improvement initiatives that were
implemented.
Ms. Nayar also explained that there
was a “general improvement in reporting, as shown by the stark drop
in billing” and “a general alignment
of all three data sources.”
“Accurate assessment of morbidity data, including [SSIs], has
implications for public reporting,
benchmarking, assessment of [quality improvement] impact, and possible denial of payments,” said Ms.
Nayar.
“In summary, we achieved our
two simultaneous goals of improving SSI reporting – or decreasing the
data errors – and decreasing SSI incidents by improving overall patient
care.”
During discussion, Ms. Nayar elaborated on the study’s generalizability
and potential application to other facets of congenital heart disease treatments, saying that such application is,
in fact, possible.
“Yes, this is very generalizable, but
one key important fact is relevant: As
long as there is a source of truth for
case ascertainment, this methodology can be used in several different
areas,” she explained.
“For example, we are currently working at our institution to
integrate and link the [Pediatric
Cardiac Critical Care Consortium]
database to be able to better monitor any critical care–related morbidity information and ultimately use
similar methodology to assess the
impact of outcomes in the critical
care field.”
Ms. Nayar said that she did not
have any relevant financial conflicts
of interest to disclose.
dchitnis@frontlinemedcom.com
For daily updates
follow
@ThoracicTweets
on
Follow us on Twitter (@ThoracicTweets) and like us on Facebook.
www.thoracicsurgerynews.com
and
Thoracic
Surgery News
on
ACQUIRED CARDIAC DISEASE
7
26% 1-year death,
Restrictive vs. liberal
stroke rate after TAVR transfusion after surgery
BY MARY ANN MOON
O
ne year after transcatheter
aortic valve replacement
in the United States, the
overall mortality was 23.7%,
the stroke rate was 4.1%, and
the composite outcome of
death and stroke was 26.0%,
according to a report published
in JAMA.
Long-term outcomes for
TAVR haven’t been well studied until now, yet the procedure is being performed with
increasing frequency
for aortic stenosis in patients who are too high
risk to undergo conventional surgical aortic
valve replacement, said
Dr. David R. Holmes
Jr. of the Mayo Clinic,
Rochester, Minn., and
his associates.
They assessed 1-year
outcomes by analyzing administrative data from the Centers
for Medicare & Medicaid Services and clinical data from the
Transcatheter Valve Therapies
Registry, an initiative of the
Society of Thoracic Surgeons
and the American College of
Cardiology.
The study involved 12,182
patients who underwent TAVR
at 299 medical centers across
the country during a 19-month
period. The patients’ median
age was 84 years; 95% were
white and 52% were women.
The transfemoral approach
was used in most patients,
but alternative approaches
were used in roughly 44%. As
expected for an elderly, highrisk study population, baseline
functional status was poor and
comorbidities were common.
They included reduced left
ventricular ejection fraction
(26% of patients), prior stroke
(12%), moderate or severe
lung disease (28%), renal failure (16%), peripheral vascular
disease (32%), and atrial fibrillation (42%), Dr. Holmes and
his associates reported (JAMA
2015 March 10 [doi:10.1001/
jama.2015.1474]).
In addition to the mortality
and stroke rates listed above,
the 1-year rate of one rehos-
pitalization was 24.4%, that
of two rehospitalizations was
12.5%, and that of three or
more rehospitalizations was
11.6%. The 1-year readmission
rate specifically for stroke,
heart failure, or repeat aortic
valve intervention was 18.6%.
These are important considerations for elderly, fragile
patients because rehospitalizations indicate “an unacceptable quality-of-life outcome”
and are very costly, the investigators noted.
Several baseline charac‘It may be
possible [from
this data] to
identify patients
who may not
benefit from this
procedure.’
DR. HOLMES
teristics, including male sex,
severe chronic obstructive
pulmonary disease, dialysis-dependent end-stage renal
disease, older age, higher
STS Predicted Risk of Operative Mortality (PROM)
score, a history of atrial
fibrillation/flutter, and use
of an access route (other
than transfemoral), were
found to be independently
associated with higher 1-year
mortality.
Thus, “It may be possible to
identify patients who may not
benefit from this procedure
and who should be counseled
accordingly.”
For example, in this study
there was a small (77 patients)
very high-risk subset of patients – aged 85-94 years, dependent on dialysis, and having
an STS PROM score greater
than 15% – whose 1-year mortality was 53.5%.
The STS and the ACC supported this study, and support
the Transcatheter Valve Therapies Registry.
Dr. Holmes reported having
no relevant financial disclosures; his associates reported
ties to Boston Scientific, Edwards Lifesciences, Janssen, Eli
Lilly, Boehringer Ingelheim,
Bayer, and AstraZeneca.
BY MARY ANN MOON
A
fter cardiac surgery, using a restrictive transfusion threshold
– forgoing transfusion until hemoglobin level drops to 7.5 g/dL – does
not decrease morbidity or costs of care,
compared with using a liberal transfusion threshold of 9 g/dL, according to a
report published online in the New England Journal of Medicine.
Several blood management guidelines
and health policy statements recommend
the restrictive approach in the hope that
it will reduce the increasing demand on
blood services and the high costs of
storing, handling, and administering redcell units, and also because transfusions
following cardiac surgery have been
linked to infection, low cardiac output,
acute kidney injury, and increased mortality.
Clinicians remain uncertain about a
safe threshold for transfusions in this
setting, which is evidenced by the striking variation in transfusion rates among
cardiac centers in the United States
(8%-93%) and the United Kingdom
(25%-75%), said Dr. Gavin J. Murphy
of the British Heart Foundation and
department of cardiovascular sciences,
University of Leicester (England) and his
associates.
They performed the Transfusion Indication Threshold Reduction (TITRe2) study
to test the hypothesis that the restrictive
approach is superior to the liberal approach regarding both postoperative morbidity and health care costs.
Adults undergoing nonemergency
cardiac surgery at 17 specialty centers
in the United Kingdom were randomly
assigned to a restricted (1,000 patients)
or a liberal (1,003 patients) transfusion
threshold.
The median patient age was 70 years,
and 68% were men. Most of the procedures were CABG or valve surgeries.
Contrary to expectations, the primary
outcome – a composite of serious infection or an ischemic event such as stroke,
MI, gut infarction, or acute kidney injury within 3 months – occurred in 35.1%
of patients in the restrictive-threshold
group and 33.0% in the liberal-threshold
group.
Secondary outcomes, including length
of ICU stay and rates of clinically significant pulmonary complications, also were
similar between the two study groups.
Rates of other serious postoperative
complications were similar, at 35.7% and
34.2%, as was general health status as
assessed via the EuroQol Group 5-Dimension Self-Report Questionnaire,
further contradicting the study hypothesis.
Mean health care costs were similar between the two study groups:
the equivalent of $17,762 with restrictive-threshhold transfusions and
$18,059 with liberal-threshold transfusions, Dr. Murphy and his associates
noted (N. Engl. J. Med. 2015 March 12
[doi:10.1056/NEJMoa1403612]).
Unexpectedly, 3-month mortality was
significantly higher with restrictive- than
with liberal-threshold transfusions (4.2%
vs 2.6%).
This association persisted in sensitivity
analyses and “is a cause for concern,” but
it may be due to chance alone, the investigators added.
PERSPECTIVE
F
indings like those of
Murphy et al. provide
a great opportunity for
discussion and debate,
which could lead to development of a consensus
on the best postoperative
care for these patients.
Cardiac surgery departments should review the
TITRe2 trial results and
decide which threshold
they deem to be the most
appropriate for transfusion.
The extreme range in
hospitals’ rates of transfusion in cardiac surgery
– from less than 5% to
more than 90% – is extraordinary. Having clinicians actively debate the
evidence presented in TITRe2, create transparent
interpretations, develop
protocols, and hold themselves accountable for
following those protocols
would represent important steps for improving
patient care.
John Spertus, M.D., is at
the University of Missouri-Kansas City and Saint
Luke’s Mid America Heart
Institute, Kansas City. He
reported receiving grant
support from Lilly, Gilead,
Amorcyte, Genentech, and
Abbott Vascular; receiving
personal fees from United
Healthcare, Novartis, and
Amgen; having an equity
interest in Health Outcomes
Sciences; and owning copyrights to the Seattle Angina
Questionnaire, the Kansas
City Cardiomyopathy Questionnaire, and the Peripheral Artery Questionnaire. Dr.
Spertus made these remarks
in an editorial accompanying Dr. Murphy’s report
(N. Engl. J. Med. 2015
March 12 [doi: 10.1056/
NEJMe1415394]).
8
ACQUIRED CARDIAC DISEASE
Mortality risk after CABG
Stents from page 1
j.jtcvs.2015.01.051). This study investigated whether diabetic patients with
triple-vessel disease and a stent had
poorer outcomes because of endothelial dysfunction and the strain of triple-vessel disease on the heart.
The final study comprised 1,583
diabetic patients with triple-vessel
disease, 202 (12.8%) of whom had
coronary stents. The study defined
triple-vessel disease as blockages of
50% or more in all three native coronary vessels or left main artery plus
right coronary artery disease.
Early mortality rates – death within 30 days of the procedure – were
similar between the two groups:
3.3% overall, 3% in the prior-PCI
group, and 3.3% in the no-PCI
group; therefore, prior PCI was not a
predictor of early mortality. Five-year
cumulative survival was 78.5% in the
no-PCI group, compared with 74.8%
in the PCI group. When adjusting for
a variety of clinical variables before
CABG, stenting was associated with a
39% greater mortality at 5 years.
The investigators found the emergence of drug-eluting stents during
the 10-year study period did not
contribute significantly to outcomes.
The cause of death was known for
81.7% (282 of 345) of the deaths in
the overall cohort, with 5-year cardiac deaths higher in the PCI-S group:
8.4% vs. 7.5% for the no-PCI group.
“Notably, 100% of PCI-S cardiac
mortality was categorized as coronary heart disease related compared
to 89.3% (92/103) of cardiac mortality in the no-PCI group.”
Dr. Nauffal and his colleagues concluded that: “An early team-based
approach including a cardiologist
and cardiac surgeon should be im-
plemented for optimal revascularization strategy selection in diabetics
with triple-vessel disease and for
close medical follow-up of those
higher risk CABG patients with history of intracoronary stents.”
The Johns Hopkins Murex Research
Award supported Dr. Nauffal. The authors had no other disclosures.
PERSPECTIVE
B
ecause diabetes affects vascular physiology and can lead to
multivessel disease, surgical revascularization vs. percutaneous coronary intervention has proved more
successful in diabetic patients, Dr.
Paul Kurlansky said in his invited
commentary. However, “the potential impact of newer generation
drug-eluting stents on improving
these results remains to be seen,”
he wrote ( J. Thorac. Cardiovasc.
Surg. 2015 [doi:10.1016/
j.jtcvs.2015.02.007).
Comparing CABG and PCI in diabetic patients has been challenging
for a variety of reasons, including
the nuances of clinical judgment
and different techniques. “It is in this
gray zone of clinical ambiguity that
many if not most patients actually
reside,” he said, giving credit to Dr.
Nauffal and his colleagues for trying
to address this ambiguity.
The study data,
however, had
many limitations,
Dr. Kurlansky
said. The authors
could not specify
indications for
stent deployment, disease
severity at the
time of stenting
and the choice of procedure among
them. “An equally plausible hypothesis might therefore suggest that the
appropriate need for prior stenting
identified a subset of patients with
more aggressive disease who therefore succumbed at an earlier age,”
he said.
CABG that utilizes the internal
mammary artery has been linked
to enhanced physiologic properties
that promote vasodilatation, inhibit
thrombosis and atherosclerosis, and
support the health of the vascular
endothelium, he noted. In the diabetic patient, these properties may
enhance the ability of CABG to
address not only arterial blockages,
but also the underlying physiology
of atherosclerosis.
“With the rising tide of diabetic
vasculopathy, it will become increasingly important to consider
both clinical utility and underlying
physiology in navigating the uncertain path to optimal patient care,”
Dr. Kurlansky wrote.
Dr. Kurlansky is with the department
of surgery at Columbia University,
New York.
AMERICAN ASSOCIATION
FOR THORACIC SURGERY
We Model Excellence
AATS
FOCUS ON THORACIC
SURGERY:TECHNICAL
CHALLENGES AND
COMPLICATIONS
SAVE
THE DATE
October 23-24, 2015
PROGRAM DIRECTORS
Seaport Hotel and World Trade Center
Boston, MA, USA
G. Alec Patterson
David J. Sugarbaker
www.aats.org
CARDIOPULMONARY TRANSPLANTATION
9
Low-volume centers have poorest results with ECMO
BY DEEPAK CHITNIS
SAN DIEGO – Lung transplantation centers that are considered low
volume tend to have lower rates
of survival than do those of their
medium- and high-volume counterparts when patients are bridged
to transplant using extracorporeal
membrane oxygenation (ECMO),
according to researchers.
“Increasingly, [ECMO] is used as
a bridge to lung transplantation; indeed, the use of ECMO has tripled
over the past 15 years and survival
has increased by the same magnitude,” Dr. Jeremiah A. Hayanga said
at the annual meeting of the Society
of Thoracic Surgeons.
“An entire body of literature has
linked high-volume [centers] to improved outcomes in the context of
complex surgical procedures. Lung
transplantation [LTx] falls within
the same domain, and has been considered subject to the same inverse
volume-outcome paradigm,” said
Dr. Hayanga of Michigan State University, Grand Rapids.
He and his coinvestigators conducted a retrospective analysis of 16,603
LTx recipients in the International
survival rates when ECMO was
Registry for Heart and Lung Transused for bridging.
plantation who underwent ECMO as
One-year survival probability was
their bridging strategy between 2005 roughly 40% in low-volume centers
and 2010.
and roughly 70% in high-volume
Centers were stratified into catego- centers, while 5-year survival probries of low, medium, and high based
ability was well under 25% for reon the volume of LTx procedures
cipients from low-volume centers
they performed over the study interand around 50% for those from
val: Low was defined as fewhigh-volume centers (P
er than 25, medium as 25-50,
= .0006). No significant
and high volume as more
differences existed for
than 50.
non-ECMO patients,
Overall, 85 of the 16,603
regardless of center voltransplant recipients in
ume.
the study population were
“No differences existed
bridged via ECMO: 20
in survival in medium(23.5%) of them in low-voland high-volume cenume centers, 30 (35.3%) in
ters,” said Dr. Hayanga.
DR. HAYANGA
medium-volume centers,
“Transplanting withand 35 (41.2%) in high-volout ECMO as a bridge
ume centers. The researchers used
showed fewer survival differences
Cox proportional hazard modeling
[among centers] for both 1-year
to identify predictors of both 1- and
and 5-year survival. However, when
5-year survival rates, which were
ECMO was used as a bridge, the
found to be significantly lower in
low-volume center [survival rates]
low-volume centers – 13.61% at 5
were dramatically lower at both 1
years post LTx.
year and 5 years.”
Looking at just the high-volume
When Dr. Hayanga and his
and low-volume centers, the recolleagues examined procedural
searchers noted “significant differvolume as a continuous variable,
ences” in both 1-year and 5-year
however, a single inflection point
was determined as the point at
which survival outcomes steadily
improve – 19 procedures. Centers
that performed at least 19 LTx procedures between 2005 and 2010 experienced an uptick in survival rates,
even though centers that saw 19-25
procedures were still considered low
volume, the researchers noted.
“The corresponding C-statistic,
however, is just under 60%,” cautioned Dr. Hayanga.
“The C-statistic is a measure of
the explanatory power of a variable
– in this case, [center] volume – in
accounting for the variability in
outcome, or survival in this case.
To put that number into context, a
C-statistic of 50% means ‘no explanatory power’ whatsoever.”
Dr. Hayanga explained that he and
his coauthors compared transplant
recipient and donor characteristics
using analysis of variance (ANOVA)
and chi-square tests to compare
variables, cumulative survival using
Kaplan-Meier curves, and significance
using log-rank tests.
Dr. Hayanga reported no financial
conflicts of interest.
dchitnis@frontlinemedcom.com
GENERAL THORACIC
10
Biopsy bests HRCT for lung fibrosis, has risks
BY RICHARD M. KIRKNER
S
urgical lung biopsy performs
well and is relatively safe for
evaluating suspected interstitial
lung diseases, but may be especially
helpful in confirming the diagnosis and directing the treatment of
patients with idiopathic
pulmonary fibrosis with
atypical signs and symptoms, researchers have
found.
In patients with immune disorders or severe respiratory dysfunction, or on mechanical
ventilation, clinicians should weigh
the diagnostic benefits of surgical lung biopsy (SLB) against its
potential risks, according to a systematic review and meta-analysis
of 23 studies that were published
In 8 studies, biopsy influenced
a change in treatment plan
42%-90% of the time. Overall,
treatment plans were altered
for 59.5% of patients who
received a specific diagnosis
and in 55.2% of those without
a definitive diagnosis.
between 2000 and 2014, comprising
2,148 patients. Dr. Qian Han of the
Guangzhou Institute of Respiratory
Disease in China led the investigative team.
The findings were published in
the May issue of the Journal of
Thoracic and Cardiovascular Surgery.
The meta-analysis focused on
diagnostic yield of biopsy samples
and postbiopsy mortality within
90 days of surgery ( J. Thorac. Cardiovasc. Surg. 2014 [doi:10.1016/j.
jtcvs.2014.12.057). The mean age of
patients across the studies ranged
from 36 to 62 years. The population
of the meta-analysis included 1,632
(76%) who had undergone video-assisted thoracic surgery (VATS) and
268 (12.5%) who had open-lung biopsy.
Slightly more than one third
(33.5%) of diagnoses involved idiopathic pulmonary fibrosis, followed
by nonspecific interstitial
pneumonia (12%), hypersensitivity pneumonitis
(9.6%), cryptogenic organizing pneumonia (7.5%),
sarcoidosis (6.8%), and
connective tissue disease related to
interstitial lung disease (4%).
The median diagnostic yield across
all studies was 95%, ranging from
42% to 100% depending on the study.
One study showed a diagnostic yield
below 70%.
Eight studies showed that the
biopsy influenced a change in the
treatment plan 42%-90% of the time.
In the entire meta-analysis, treatment
plans were altered for 59.5% of patients who received a specific diagnosis and in 55.2% of those without a
definitive diagnosis.
“These results suggested that an
alteration in treatment may not be
directed by a definitive histological
diagnosis, and nonspecific histological results could also be useful in clinical practice,” Dr. Han said.
Eleven of the studies used CT
guidance to obtain biopsies without
a preference to lobe, but two studies
predisposed to the right lobes had diagnostic yields of 84% and 94%.
One study avoided the lingual or
middle lobe, with a diagnostic yield
of 97%, and another focused on the
lingular lobe only, and demonstrated
a 100% yield.
Two studies showed that biopsy
samples from lingual or middle lobes
had the same diagnostic yield as did
those from other lobes.
With regard to diagnostic performance based on biopsy numbers, one
PERSPECTIVE
T
he role of surgical biopsy in the
high-risk population with interstitial lung disease is well suited for
surgical review because thoracic
surgeons must weigh the
risks, including potential
mortality, and benefits
when discussing options
with patients and families,
Dr. Katie S. Nason noted
in her invited editorial
commentary.
Current guidelines suggest that SLB is no longer
essential for diagnosis
of idiopathic pulmonary fibrosis
and they now consider an HRCT
scan showing unusual interstitial
pneumonia (UIP) sufficient for diagnosis. “However, in the absence
of diagnostic imaging criteria for
UIP, specifically honeycombing,
surgical lung biopsy with inter-
study showed that multiple biopsies
may increase the diagnostic yield.
Twelve studies obtained one to
three samples, and among them eight
studies suggested that one sample
containing both lesion and normal
tissue was sufficient to represent
pathological changes. One study
showed that multiple biopsies may
increase diagnostic yield.
Of the 16 studies that provided
sufficient data on mortality rates,
the pooled 30- and 90-day mortality
rates were 2.2% (95% CI, 1.0-4.0)
and 3.4% (95% CI, 1.8-5.5), respectively. The composite postoperative
mortality rate was 3.6% (95% CI,
2.1-5.5).
In their discussion, Dr. Han and
colleagues addressed the controversy
surrounding the use of lingual vs.
middle lobe biopsy by noting that
high-resolution CT (HRCT) can be
valuable in identifying the appropriate biopsy location.
While multiple studies supported
the effectiveness of only one biopsy
as long as it contained both normal
and abnormal tissue, the researchers
pointed out that future studies evaluating biopsy samples would do well
to evaluate biopsy number combined
with sample size.
HRCT, while highly specific, may
be less sensitive than SLB in the
diagnosis of idiopathic pulmonary
fibrosis, they found. Two studies
that the meta-analysis looked at
compared the diagnostic yield between SLB and HRCT; SLB finally
diagnosed idiopathic pulmonary
pretation by an expert pathologist
is necessary and should be performed to further define patients
with possible UIP,” Dr. Nason
wrote. “Comprehensive application of this
approach will delineate
circumstances in which
a surgical biopsy will be
more informative than
an HRCT scan as well as
when a surgical biopsy is
not necessary.”
She called for a multi-institutional, international
registry to collect and better understand data on the diagnostic
yield and mortality after SLB for
interstitial lung disease.
Dr. Nason is an assistant professor of
cardiothoracic surgery at the University of Pittsburgh.
fibrosis in 75%-91% of suspected
cases and in 19%-74% of cases
when HRCT did not raise suspicion
of the disease.
“These findings suggested that
HRCT, albeit highly specific, is less
sensitive in the diagnosis of IPF,
therefore necessitating the utility
‘These findings suggested
that HRCT, albeit highly
specific, is less sensitive in
the diagnosis of IPF, therefore
necessitating the utility
of SLB in the diagnosis of
these HRCT-omitted cases.’
of SLB in the diagnosis of these
HRCT-omitted cases,” they wrote.
On the safety issue, while studies
that excluded patients on mechanical
ventilation reported lower mortality
rates and two studies identified ventilator dependence as an independent
risk factor for mortality, the investigators reported that the higher mortality rates were probably the result of a
sicker patient population rather than
the SLB procedure itself.
They wrote that to “indiscreetly
refuse” to perform SLB in these patients is “overcautious and inappropriate” given the benefits of SLB in
validating diagnoses and influencing
treatment plans.
Dr. Han and his colleagues reported having no relevant disclosures.
RESIDENTS CORNER
11
Why cardiac surgeons must adopt the appropriate
percutaneous skills to stay relevant
BY RICHARD M. KIRKNER
W
ith the widespread adoption of transcatheter aortic valve replacement and
the public’s embrace of minimally invasive procedures, cardiac surgeons must adapt
quickly to stay relevant in the future,
and that means acquiring skills to perform percutaneous procedures, Dr.
Tom C. Nguyen and Dr. Isaac George
wrote in the Young Surgeon column in
the May issue of the Journal of Thoracic and Cardiovascular Surgery.
Drawing upon their own year in a structural
heart endovascular fellowship, Dr. Nguyen and
In fact, in order to provide the best
comprehensive care for patients, a
collaborative heart team including
cardiologists and surgeons who all
are equally proficient in endovascular
techniques is essential.
Dr. George both called for a new approach to
surgical training that encompasses percutaneous
technology and procedures, “with a caveat that
failure to do so will exclude surgeons from treat-
ing valve disease altogether in the future” ( J.
Thorac. Cardiovasc. Surg. 2015;149:675-77 [doi:
10.1016/j.jtcvs.2014.11.091]).
In making their case, Dr. Nguyen and Dr.
George invoked psychologist
Abraham Maslow’s famous
“law of the instrument,” saying: “I suppose it
is tempting, if the
only tool you have
is a hammer, to
treat everything as
if it were a nail.”
Dr. Nguyen is with the University of Texas and Memorial DR. NGUYEN
Hermann Heart and Vascular
Institute in Houston. Dr. George is with New
York-Presbyterian Hospital and Columbia University in New York.
Cardiac surgeons must break out of that sort
of limiting mindset and learn from the evolution of vascular surgery, which was once just a
domain of general surgery but then evolved into
its own specialty, they said.
Patients with peripheral vascular disease who
were once surgical candidates instead opted for
less-invasive endovascular procedures as interventional radiology techniques advanced.
“This direction may have had devastating consequences for vascular surgeons if it were not
PERSPECTIVE
D
r. Nguyen and Dr. George address an important current topic regarding the need
for cardiothoracic surgeons to quickly adopt
and become experts in nontraditional techniques (percutaneous, minimally invasive interventions). Alluding to the historic failure of
cardiac surgeons to adopt early angiography
(and subsequently lose a valuable share of the
market to interventional
cardiology) and citing vascular surgeons who aggressively avoided this fate (by being
early adopters of endovascular techniques), the authors
propose an alternate schema
moving forward.
As is clear, TAVR is here
to stay. There is a growing
emphasis on percutaneous
and minimally invasive cardiac interventions
that require an elaborate set of nontraditional
skills (access, wires, fluoroscopy, angiography,
endostenting, and percutaneous closure, to
name a few) that take time and experience to
develop. Programs are currently mandated by
the Centers for Medicare & Medicaid Services
to team a cardiologist and a cardiac surgeon
for reimbursement, although this limitation
may eventually be eased. When that happens,
will cardiac surgeons have the market share,
hospital privileges, and experience to be able
to independently handle a TAVR case? If not,
will the cardiac surgeon play second fiddle to
an experienced interventional cardiologist as
valvular disease will become increasingly better
managed without a traditional sternotomy?
This issue is critical to the young cardiothoracic trainee. How do “the cardiac surgeons
of the past … transform into the surgeons of
the future?” Dr. Nguyen and Dr. George propose a three-pronged approach: early clinical
adoption (mainly by attendings, departments,
and institutions); appropriate training; and
innovation to move technology forward. The
discussed training arm is critical and requires
dedicated time. Both authors spent 1 year as
advanced fellows in structural heart disease,
and only after a high-volume, multidisciplinary experience did they become more
facile with catheter-based techniques. I agree
with the authors’ conclusion that advanced
fellowship training in percutaneous and endovascular techniques (which includes intimate
collaboration with cardiology) is critical. This
advanced training needs to be regulated and
restricted to centers of high-volume excellence, where the surgeon is capable of being
the team leader, thus making it a much more
robust learning experience.
Dr. David D. Shersher is one of the resident medical
editors for Thoracic Surgery News.
for their ability and willingness to learn new
skills so that they could also perform catheter-based interventions,” according to Dr. Nguyen and Dr. George.
Catheter-based treatment for heart valve disease
is following a similar path, but that doesn’t mean
cardiac surgeons should vacate this field to cardiologists.
“In fact, in order to provide the best comprehensive care for patients, a collaborative heart
team including cardiologists and surgeons who all
are equally proficient in endovascular techniques
is essential,” they wrote.
Further, if surgeons can work independently of
cardiologists by learning and adopting percutaneous techniques, new technologies will be able to
advance even faster.
“Surgeons have an intimate knowledge of the
heart that is unmatched by any specialty; translation of this knowledge into structural heart valve
technology is logical and needed,” Dr. Nguyen
and Dr. George said.
Also, surgeons well versed in all techniques – endovascular, minimally invasive
surgery, and conventional
surgery – will be equipped to
objectively offer the procedure that’s best suited for the
patient rather than their own
skill set.
Acquiring the necessary
percutaneous skills, however,
poses a high hurdle for cardiDR. GEORGE
ac surgeons.
They must be able to
perform the entire transapical and transaortic
transcatheter aortic valve replacement (TAVR)
procedure and thus seize the currently held lead
for the procedure from the cardiologist, accordResidents continued on page 15
12
NEWS FROM AATS
F. Griffith Pearson Fellowship
Awardees Named
T
he AATS is proud to announce the awardees of
the F. Griffith Pearson
Fellowship, the first “Honoring
Our Mentors” Fellowship. The
program acknowledges the
leadership and dedication of
surgeons in the field.
to defray living expenses during his
four to six weeks of training.
DR. SANCHEZ
The awardees are Pablo Sanchez
and James L. Lubawski, Jr.
The fellowship supports surgeons who have finished their
residencies, allowing them to
advance their clinical techniques
at a North American institution.
Each winner will receive $3,500
DR. LUBAWSKI
Pablo Sanchez, MD
Institution: University of Maryland
Host Institution: Toronto General
Hospital, Toronto Lung Transplant
Program
Fellowship Focus: Build Ex Vivo
Perfusion skills
James L. Lubawski, Jr., MD
Institution: Central DuPage
Hospital (Illinois)
Host Institution: The University of
Texas MD Anderson Cancer Center
Fellowship Focus: Advanced lung
cancer cases
Apply Today for the
Advanced Valve Disease
Educational Fellowship
Sponsor: Medtronic
Fellowship Overview:
Offers surgeons the opportunity
to interactively observe valvular
heart disease specialists and connect with them about treatment,
technical skills and management
of perioperative patients for a
minimum of one month up to
three months
Potential Host Institutions
Cleveland Clinic
Johns Hopkins University
Mount-Sinai Medical Center
New York University
University of Southern California
Deadline: June 15, 2015
More information/application
submission: http://aatsgrahamfoundation.org/awards_valveEDU.cgi
First Edwards Lifesciences
Advanced Treatments of
Valve Disease Fellow
Chosen
V
ictor Dayan has been named the first Edwards Lifesciences Advanced Treatments
of Valve Disease Fellow.
He will receive a $25,000 award to defray travel
and living expenses for a minimum of three
months training at a host institution in valve repair, transcatheter repair or replacement of valves.
DR. DAYAN
Victor Dayan, MD
Institution: Hospital de Clinicas, Centro Cardiovascular
(Montevideo, Uruguay)
Host Institution: Mayo Clinic
Fellowship Focus: Enhancing clinical techniques in valve disease
Applications Now Open for the
Advanced Endobronchial
Ultrasound (EBUS) Training
Fellowship
Sponsor: Olympus America
Fellowship Overview: Permits young
North American thoracic surgeons to
spend between one and six months
studying clinical techniques at an
EBUS-proficient institution.
Host Sites
Toronto General Hospital, Division of
Thoracic Surgery
University of Texas MD Anderson
Cancer Center
Deadline: June 1, 2015
More information/application submission: http://aatsgrahamfoundation.
org/awards_advancedEBUS.cgi
Submit Today for the
James L. Cox Fellowship in
Atrial Fibrillation Surgery
Also Don’t Miss These Important
Fellowship & Training Opportunities
This Spring
Sponsor: AtriCure
Sentara Heart Hospital
(Norfolk, VA)
Swedish Medical Center
(Englewood, CO)
University of Pittsburgh Medical
Center
University of Virginia
Washington University School of
Medicine, Barnes Jewish Hospital
(St. Louis, MO)
Ethicon Fellowship for
Advanced Thoracic Minimally
Invasive Surgery (MIS)
Sponsored by Ethicon Endo-Surgery
Offers North American young CT
surgeons and their surgical teams the
opportunity to enhance their skills in
thoracic minimally invasive surgery by
spending a one- or two-day period at
clinical sites.
Thoracic Surgery Training Fellowship
Sponsored by Ethicon China/Chinese
International Medical Foundation
Offers young Chinese surgeons the opportunity to spend between one month
and one year obtaining advanced thoracic surgery skills at North American
institutions.
Deadline: May 26, 2015
More information/application
submission: http://aatsgrahamfoundation.org/awards_atricure.
cgi
Learn more:
http://aatsgrahamfoundation.org/activities.cgi
Learn more about eligibility and application requirements:
http://aatsgrahamfoundation.org/
activities.cgi
Fellowship Overview: Gives
newly graduated CT surgeons the
opportunity to spend up to three
months improving their atrial
fibrillation techniques at a host institution.
Potential Host Sites
Franciscan St. Francis Hospital
(Indianapolis, IN)
Inova Fairfax Hospital (Fairfax, VA)
Pauley Heart Center at Virginia
Commonwealth University Health
System
NEWS FROM AATS
13
AATS Launches Lung Cancer Screening Calculator Online
T
he American Association for Thoracic Surgery
(AATS) has launched a Lung Cancer Screening
Calculator to help individuals determine whether or not they should seek diagnostic screening. The
tool is especially relevant given that the Centers for
Medicare and Medicaid Services (CMS) announced
on February 5, 2015 that Medicare will now cover
an annual CT lung cancer screening for patients that
meet certain criteria. AATS was very involved in the
process of getting CMS to approve such screenings.
Covered individuals must:
** Be between ages 55 and 77, who are currently
smokers or quit within the last 15 years.
** Have a tobacco smoking history of at least 30
“pack years” (an average of one pack a day for 30
years).
** Receive a written order from a physician or a
qualified non-physician practitioner.
The AATS Writing Group for Lung Cancer Screening and Surveillance under co-chairs Drs. Francine
L. Jacobson and Michael T. Jaklitsch (Brigham and
Women’s Hospital) was instrumental in developing
this diagnostic tool.
The Group has identified other high-risk groups,
including people between 54 and 77 who:
** Are lung cancer survivors.
** Have 20 “pack years” of smoking plus an additional factor that places their lung cancer risk at
five percent over the next five years.
Lung cancer is the third most common cancer and
a leading cause of US cancer deaths.
Individuals can use the calculator online at aats.
org/tools/lung-cancer/ to determine whether or
not they should pursue a CT screening. The page
allows them to print out the results for discussion
with their patients.
Save the Date: Heart Valve Summit –
Medical, Surgical & Interventional Decision-making
October 1-3, 2015
Radisson Blu Aqua Hotel
Chicago, IL
than five million individuals just in
this country. VHD can be congenital
or acquired, and patients may or may
not exhibit symptoms. Although
there are national guidelines regarding
management of VHD, controversies
in care in the areas of advanced technology and medicine demand that
collaborative methods be created for
diagnosis and strategic medical, surgical and interventional management.
Course Directors
David H. Adams
Mount Sinai Medical Center
Steven F. Bolling
University of Michigan
Robert O. Bonow
Northwestern University
Howard C. Herrmann
University of Pennsylvania
Nurse Planner
Michele Mistovich, RN, MS
Northwestern Memorial Hospital
Course Background
Heart disease is the leading cause of
death in the United States. Valvular
heart disease (VHD) affects more
conference will engage participants in
discussions, debates and potential controversies using real-world cases. Its
faculty will include renowned experts,
who are on the cutting edge of clinically relevant VHD data.
Course Objective
The American College for Cardiology (ACC) and AATS once again
will bring together cardiologists and
surgeons for a case-based course addressing the rapid advances in VHD
treatment.
This interdisciplinary course will combine clinical decision-making with
medical, surgical and interventional
options for patient care, taking into
account that constantly changing
management tools can impact the
surgical team. Breakout sessions for
cardiologists, cardiac surgeons, nurses
and physician assistants have been
designed to help specialists manage
their unique challenges from a team
perspective.
Focusing on interactivity and practical decision-making, this unique
Target Audience
The 2015 Heart Valve Summit is
intended for cardiologists, interventional cardiologists, cardiothoracic surgeons, internists, nurses,
physician assistants and all health
care professionals involved in the
evaluation, diagnosis and/or management of VHD patients.
Accreditation
Physicians
This course has been approved for
AMA PRA Category 1 Credits™.
Nurses
The American College of Cardiology
Foundation is accredited as a provider
of continuing nursing education by the
American Nurses Credentialing Center’s Commission on Accreditation.
Registration/housing information:
http://www.aats.org/valve
Save the Date: Focus on Thoracic Surgery –
Technical Challenges and Complications
Mark your calendar for the 2015
Focus on Thoracic Surgery. This
year’s emphasis is on technical challenges and complications.
October 23-24, 2015
Seaport Hotel & World Trade
Center, Boston, MA
Overview
Complications remain one of
the major challenges in treating
patients. The 2015 Focus on Thoracic Surgery will concentrate on
the intraoperative challenges and
management complications facing thoracic surgeons in treating
lung and esophageal cancers. This
year’s course is particularly aimed
at operating surgeons who are
active and seek to learn innovative solutions to clinical problems
during surgery.
This course will display new advanced diagnosis and prompt
management approaches, allowing attendees to understand and
readily translate them into daily
practice.
The two-day conference will have a
faculty of experts in the field who
are leaders in the application of new
technologies in surgical manage-
ment. It will combine informational
sessions, panel discussions and complex case presentations.
Focus on Thoracic Surgery is a must
for surgeons who specialize in the
treatment of lung and esophageal
cancers and want to enhance their
skills so they can overcome challenges and complications in their
surgical practices.
Program Committee Members
Thomas A. D’Amico
Duke University
Shaf Keshavjee
University of Toronto
James D. Luketich
University of Pittsburgh
Bryan F. Meyers
Washington University
Scott J. Swanson
Brigham and Women’s Hospital
Program Directors
G. Alec Patterson
Washington University
David J. Sugarbaker
Baylor College of Medicine
For more information:
http://aats.org/focus/
14
NEWS FROM AATS
Save the Date: First AATS Aortic Symposium in Asia
Don’t miss the AATS Aortic Symposium Workshop Kobe to be held the day before the Japanese
Association for Thoracic Surgery Annual Meeting.
October 16, 2015
Kobe Portopia Hotel, Kobe, Japan
In partnership with:
Japanese Association for Thoracic Surgery
Japanese Society for Cardiovascular Surgery
Japanese Society for Vascular Surgery
This one-day symposium will include expert lec-
For Central & South American Surgeons:
AATS Cardiovascular Valve
Symposium/Brazil
November 20-21, 2015
November 20-21, 2015
Renaissance Marriott São Paolo
São Paolo, Brazil
This symposium is part of the Edwards Lifesciences Foundation Every
Heartbeat Matters initiative aimed at
impacting the global burden of heart
valve disease by 2020 — reaching one
million underserved people through
education, screening and treatment.
Course Directors
David H. Adams
Mount Sinai Medical Center
Joseph S. Coselli
Texas Heart Institute
Pedro J. del Nido
Children’s Hospital, Department of
Cardiac Surgery
Walter Jose Gomes
Escola Paulista de Medicina - Federal
University of São Paulo
It is for physicians whose patients
have limited health care, are over 60,
and are vulnerable to rheumatic heart
disease and/or at risk of heart valve
disease today or in the future.
More information: To come
tures from invited faculty on the pathophysiology, diagnosis and treatment of aortic aneurysms
and dissections, as well as presented abstracts.
www.aats.org/KobeWorkshop
Coming in 2016: The Inaugural AATS
Surgical Patient Safety Course
AATS announces its inaugural AATS
Surgical Patient Safety Course aimed
at advancing patient care -- the mission
of every surgical team.
June 24-25, 2016
Renaissance Boston Waterfront
Hotel
Boston, MA
Course Objective/Content
The course will promote a culture
of safety and help reduce preventable harm by offering surgical team
members with a multidimensional ap-
proach to improved patient care. The
curriculum will combine didactic and
interactive presentations and focused
workshops. It will provide essential
knowledge, skills and attitudes about
patient safety aimed at improving care
now and in the future.
Target Audience
All members of the CT surgical team
including surgeons, perfusionists, nurse
practitioners, and physician assistants.
www.aats.org/patientsafety.
CLASSIFIEDS
Also available at MedJobNetwork.com
Disclaimer THORACIC SURGERY NEWS assumes the statements made in classified advertisements are accurate, but cannot investigate the statements and assumes no responsibility or liability concerning their
content. The Publisher reserves the right to decline, withdraw, or edit advertisements. Every effort will be made to avoid mistakes, but responsibility cannot be accepted for clerical or printer errors.
EVOLVING SCIENCE AND TECHNOLOGY
3-D mesothelioma model
Nanotech from page 1
The researchers said their findings showed that three-dimensional
spheroid models “are valuable tools
for investigating cytotoxic mechanisms and nanoparticle-tumor interactions, particularly given the costs
and limitations of in vivo animal
studies.”
Their findings were first presented
at the 94th Annual Meeting of the
American Association for Thoracic
Surgery last year in Toronto.
Despite advances of nanoparticle-based drug delivery systems,
difficulties in evaluating the effectiveness of these drugs in local
chemotherapy have hindered their
adoption in the clinic. Studies of
the same agent utilizing in vitro vs.
in vivo methods have shown con-
flicting results, they noted.
The observation that Pax-eNP
treatment of intraperitoneal mesothelioma significantly improved
survival in lab animals in vivo, compared with conventional paclitaxel,
led to the use of the three-dimensional spheroid model. Dr. Lei and
colleagues called this revelation
“striking” because Pax-eNP exposure
of the identical mesothelioma tumor
cells plated as a two-dimensional
monolayer in vitro demonstrated
equal or worse results.
PERSPECTIVE
“W
hile this study contributes
greatly to the body of knowledge available regarding potential
treatment strategies for malignant
mesothelioma, one might argue that
the more important impact of this
paper relates to the successful implementation of an unconventional
tumor model,” Dr. Mara B. Antonoff
wrote in her invited commentary (J.
Thorac. Cardiovasc. Surg. 2015 [doi:
10.1016/j.jtcvs.2015.02.015].
Dr. Antonoff acknowledged their
quest for a solution that was more
cost-effective than animal models and
better approximated in vivo biological
actions of the drug. However, she
Residents
noted the three-dimensional models
“are not without limits, either.”
Adoption is
limited because
of the time
and expertise
involved in spheroid formation.
“Nonetheless,
it is clear that
such models are
a huge improvement over our
current in vitro models,” she wrote.
Among the limits of the three-dimensional spheroid model she
pointed out are that it lacks the
continued from page 11
ing to Dr. Nguyen and Dr. George.
“To do this, surgeons will have to change their
mindset regarding their role in the procedure and
be willing to learn the technology.”
The minimum time commitment to learn
these procedures is 6 months; for residents, a
multiple cell types typical in an actual tumor and quantitative assessment of the results can be difficult.
But the spheroid model does
enhance the ability to screen novel
drugs and drug-delivery systems.
“This timely and well-constructed
study provides a foundation upon
which we may build our knowledge
of chemotherapeutic delivery mechanisms, while setting an outstanding
example, and perhaps a new standard, for in vitro methodology.”
Dr. Antonoff is a clinical instructor at
University of Texas M.D. Anderson
Cancer Center in Houston.
dedicated structural heart fellowship can take
up to a year. The 20 interventional procedures
that graduates are now required to perform “is
not nearly enough,” they wrote.
It may require significant changes to the
overall training model to allow proficiency.
Because percutaneous skills also apply to all
future structural heart interventions, such as
15
“This suggested that eNP may be
more effective at penetration and/
or persistence within multicellular
tumors and led to the use of a 3-D
tumor spheroid mode,” according to
the researchers.
“Given the high cost and limitations of in vivo animal studies,
spheroid models may present a clinically relevant platform for screening
novel pharmaceuticals and unique
drug-delivery systems during the
preclinical phase,” the researchers
indicated.
They also investigated spheroid
cytotoxicity in a clinic-like setting
following a 4-hour, high-dose (1,000
ng/mL) paclitaxel exposure via
conventional and eNP vehicles.
They found that Pax-eNP exposure
led to greater tumor cytotoxicity
at 72 hours, and that cytotoxicity
continued seven days later because
Pax-eNPs rapidly enter the tumor
spheroid and remain intracellular,
slowly releasing the drug.
“The prolonged drug release
mechanism that pH-triggered PaxeNP uses appears to be unique,
leading to markedly higher intraspheroidal drug delivery, prolonged
intratumoral drug release and superior antitumor efficacy,” the investigators concluded.
The authors had no disclosures.
percutaneous mitral valve repair and replacement, percutaneous tricuspid valve repair and
replacement, and pulmonary valve replacement,
such skills can help the cardiac surgeon get past
seeing valvular heart disease as just a nail, but
rather something requiring a suite of different
tools to treat.
The authors reported having no disclosures.
PERSPECTIVE
N
guyen and George’s expert review, “Beyond the hammer: The
future of cardiothoracic surgery”
addresses a question that resonates
in the mind of any CT resident
completing their training – how can
I best position myself today for success as a practicing cardiothoracic
surgeon tomorrow? The authors
astutely identify several factors that
predict an increasing emphasis on
percutaneous and minimally invasive techniques in the management
of structural heart disease, drawing parallels between modern-day
cardiac surgeons and the vascular
surgeons who have successfully
integrated endovascular techniques
into their practice and training paradigm. I would extend this discussion
to include general thoracic surgery
wherein endoscopic and broncho-
scopic techniques are rapidly gaining momentum in oncologic staging
and the management of both benign and malignant chest diseases.
The authors commend the Thoracic Surgery Residency Review
Committee and American Board of
Thoracic Surgery for recognizing
the need for endovascular skills;
however, they note that the 20 required cases is far fewer than what
is needed for proficiency. Nevertheless, the article suggests pursuing
additional fellowship training rather
than promoting a significant change
in the current cardiothoracic residency curriculum – a very important message.
The authors clearly recognize
that success in CT surgery requires,
first and foremost, excellent surgical
skills. As noted in the article, “The
first step is to master traditional
surgical techniques…”
The ability to operate will always
be what sets the surgeon apart
and allows us to bring a complete
“toolbox” to the bedside. So while I
read this article with great interest,
I remind myself to resist the temptation as a CT resident to focus too
much on these endovascular and
endoscopic techniques during the
core training. The 2-3 year traditional residency is simply too short;
emphasis must remain on fundamentals of the craft.
Thereafter, as Nguyen and
George suggest, young CT surgeons can pursue additional
training whether in the form of
advanced fellowship programs or
as junior faculty. This may be an argument in favor of the I-6 pathway.
Perhaps the I-6 thoracic residency
provides the time frame and early
integration necessary to successfully train a CT surgeon in all the
aforementioned techniques. This
remains to be seen.
However, as the first wave of I-6
trainees begins to matriculate, we
will soon have our answer. The
bottom line is that advanced endoscopic and endovascular techniques
will undoubtedly be necessary
components in the CT surgeon’s
toolbox and each CT resident
should have a clear plan for how
best to acquire these skills, but only
after first becoming really good
with that hammer.…
Dr. Elliot Servais is one of our resident
medical editors for Thoracic Surgery
News.
indd single with guides.indd 1
4/27/2015 5:18:15 PM

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