Advances in Valvular Heart Disease - DSpace Home

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Advances in Valvular Heart Disease - DSpace Home
Pulse
SPRING 2013
Advances in Valvular Heart Disease
Inside
Novel Imaging Techniques for Valvular Heart Disease
Percutaneous Heart Valve Replacement
The Role of Nursing in Aortic Valve Replacement
Transcatheter Pulmonary Valve Replacement
ValvesofHeart.org
Entering the Record Book
Clinical Trials in Interventional Cardiology
Pulse
SPRING 2013
Advances in Valvular Heart Disease
3
Message from the Director
feature stories
4
Novel Ultrasound Imaging Techniques for Assessment of Valvular Heart Disease
7
Percutaneous Heart Valve Replacement
this issue
10
The Integral Role of Nursing in Transcatheter Aortic Valve Replacement
11
2013 Live Symposium of Complex Coronary and Vascular Cases
12
Transcatheter Pulmonary Valve Replacement in Congenital Heart Disease
14
ValvesofHeart.org: A Unique, Online Resource for Surgeons, Cardiologists, Anatomists,
Physiologists, and Historians
16
Entering the Record Book for International Cardiovascular Disease Detection
18
Clinical Trials in Interventional Cardiology
20
New Faces
Introducing: Usman Baber, MD, MS, Jeffrey Bander, MD, Ira Blaufarb, MD, FACC, Johanna
Paola Contreras, MD, MS, Nicholas DuBois, MD, Icilma V. Fergus, MD, Ramon Gendy, DPM,
Harvey S. Hecht, MD, FACC, Kenneth John Herwig II, MD, Donna Ingram, MD, FACC, Jacob
S. Koruth, MD, Jason Kovacic, MD, PhD, Marc A. Miller, MD, David Anmoo Rim, MD, Janice
Scobie, MD, MS, Partho P. Sengupta, MBBS, MD, DM, FASE, Rony Y. Shimony, MD, FACC,
Michael Alan Sicat, MD, FACC, Daniel E. Soffer, MD, FACC, FSCAI, Jason Song, MD, FACC,
and Nenad Trubelja, MD, FACC
22
The Cardiovascular Research Institute to Expand in Mount Sinai’s New Research Building
24
CME Calendar of Events
Editor
Jonathan L. Halperin, MD
www.mountsinai.org/pulse
Front cover image: Assessment of kinetic energy of two-dimensional flow
across a mitral valve leaflet. (See article on page 7.)
Message from the Director
The effective surgical
management of patients
with valvular heart disease
through commissurotomy
and valve replacement
was one of the earliest
success stories in
modern cardiovascular
therapeutics. As cardiac
surgery approaches
its second century,
physicians and surgeons
at Mount Sinai Heart
are playing leading roles
in developing the next
generation of treatment
strategies. Among the
next steps in the journey
of valvular heart disease
are the advancement of
alternatives to valve replacement and delivering safer, more durable
interventions to address both stenotic and regurgitant lesions.
Mount Sinai Heart has assembled an internationally renowned
valvular surgery team under the direction of David H. Adams, MD,
Professor and Chair of the Department of Cardiothoracic Surgery
and Director of the Mitral Valve Repair Reference Center, which
offers patients the highest likelihood of repair available anywhere in
the world. In patients with purely structural mitral incompetence,
the success rate in avoiding valve replacement at Mount Sinai Heart
approaches 100 percent. Expertise in complex mitral valve repair
extends as well to patients with advanced cardiomyopathy associated
with annular dilatation. When appropriate, mitral valve repair can
be performed using minimally invasive approaches and coupled
with procedures to correct atrial fibrillation or reduce the risk of
thromboembolism.
perform more than 15,000 echocardiograms annually. In addition,
CT and MRI developments have transformed our understanding of
the mechanisms by which valvular heart disease leads to changes
in myocardial and aortic structure and function, so that the therapy
of valvular stenosis and regurgitation is holistic with respect to
cardiovascular mechanics.
In the arena of valve replacement, our physicians are pioneering
an array of catheter-based methods that provide life-saving
alternatives in situations where until recently patients had li#le
hope. The number of patients undergoing transcatheter aortic valve
replacement has increased exponentially, from 9 procedures in the
first six months of 2011 to 39 procedures in the first six months of
2012 and more than 100 by year’s end, as success at Mount Sinai
Heart has made the intervention routine. Working collaboratively,
interventional cardiologists, under the leadership of Samin K.
Sharma, MD, Director of Interventional Cardiology, and colleagues in
the field of cardiothoracic surgery evaluate candidates for this novel
technology so therapy can be personalized to each patient, child, or
adult (see page 10).
In all aspects of cardiovascular disease management, from
prevention to intervention and on to recovery and rehabilitation,
our sights extend far beyond New York City, as demonstrated by the
extraordinary international efforts of Jagat Narula, MD, Director of
the Cardiovascular Imaging Program and Associate Dean for Global
Health (see page 19).
The remarkable accomplishments of the faculty and staff at Mount
Sinai Heart are changing the future for people with valvular heart
disease, who today can enjoy length and quality of life comparable
to patients with normal hearts. I am proud to share some of their
achievements with you.
Valentin Fuster, MD, PhD
Director of Mount Sinai Heart
Because optimum treatment begins with accurate diagnosis, we
have made a comprehensive commitment to advanced noninvasive
cardiac imaging. The latest generation of three-dimensional
echocardiography can reveal subtle aspects of abnormal valve
function and blood flow pa#erns, which, in turn, inform the
approach to surgical repair, enhances success, and nearly eliminates
the need for re-operation. The Echocardiography Laboratories
3
Novel Ultrasound Imaging Techniques for
Assessment of Valvular Heart Disease
BY PARTHO P. SENGUPTA, MD, AND JAGAT NARULA, MD, PHD
The age distribution of populations in Western countries will change
radically over the next several decades, with an approximately
twofold increase in people older than age 65 by the year 2050. A
sharp increase in the prevalence of degenerative valvular heart
disease is also expected, and the number of patients requiring
heart valve intervention worldwide is expected to triple during
this period, from 290,000 in 2003 to more than 850,000 by 2050.1
Echocardiography remains a cost-effective tool for initial assessment
and serial follow-up of patients with valve disease. Comprehensive
evaluation of patients with valve disease, however, requires not only
quantitative analysis of the severity of the hemodynamic lesion,
but also an understanding of the relationship between dynamic
valve geometry, altered blood flow, and the adaptive or maladaptive
changes in cardiac muscle function. Fast and powerful integrated
cardiac imaging so$ware has emerged over the past decade that
gathers, stores, and manipulates large volumes of data.2 Following is
a brief summary of emerging trends in technology for noninvasive
assessment of valve geometry and function.
CARDIAC VALVE DYNAMICS
The three-dimensional geometry of the lines of leaflet a#achments
and material properties of the leaflets determine the instantaneous
stresses exerted on a cardiac valve by flowing blood. With the advent
of real-time three-dimensional echocardiography and novel tracking
algorithms, dynamic changes in moving structures such as valve
leaflets can be assessed throughout the cardiac cycle (Figure 1).
Understanding these instantaneous changes in leaflet geometry is
related to the mechanism of valve dysfunction and is pertinent to
the selection of an optimum valve repair strategy and the design of
devices to assure favorable surgical outcomes. The potential utility
of this approach has been specifically validated for assessment of the
mitral valve.
The mitral apparatus comprises the annulus, anterior and posterior
leaflets, and corresponding papillary muscles. The mitral annulus
has a saddle-shaped hinge near the junction of the fibrous and
muscular parts of the valve that reduces leaflet stress. Repair
techniques therefore have increasingly emphasized restoring this
geometry to assure optimum valve motion during opening and
closure. So$ware that geometrically reconstructs the mitral valve
using datasets acquired from three-dimensional echocardiography
has substantially improved understanding of the effects of different
surgical techniques on valvular geometry. For instance, geometric
reconstruction has demonstrated that full annuloplasty rings
distort the saddle-shaped geometry of the mitral valve, while partial
annuloplasty bands maintain the normal annular configuration.
EFFECT OF VALVE DISEASE ON MYOCARDIAL
FUNCTION
Because of adaptive remodeling of the le$ ventricle, patients with
valve disease may remain asymptomatic or minimally symptomatic
for prolonged periods, even when the hemodynamic defect is severe.3
Uncovering ventricular dysfunction is crucial to management
decisions in asymptomatic patients, but the le$ ventricular ejection
fraction is not a sensitive marker of global le$ ventricular systolic
function in the presence of hypertrophy or volume overload; these
patients may have myocardial dysfunction even while the ejection
fraction is preserved. Speckle tracking echocardiography is a
relatively new technique that can be used in conjunction with twodimensional or three-dimensional echocardiography to resolve the
multidirectional components of le$ ventricular motion and disclose
subclinical ventricular dysfunction (Figure 2). The tracking system
is based on grayscale B-mode imaging and automatic measurement
of the distance between ultrasound speckles during the cardiac
Figure 1. Dynamic mitral valve
geometry during a cardiac cycle
as assessed by three-dimensional
transesophageal echocardiography.
(A) Three-dimensional model of the mitral
valve constructed by tracing the annulus,
leaflets, and points of coaptation. (B) Mitral
valve geometry at mitral valve closure
(pre-ejection). (C) Mitral valve geometry
at end-systole. Blue and red dots show
the annular margins of the anterior and
posterior mitral leaflets, respectively.
4
cycle.4 Myocardial function analysis derived from speckle tracking
has been validated with tagged magnetic resonance imaging. Speckle
tracking is highly reproducible with minimal intra- or interobserver
variability. Application of speckle tracking echocardiography has also
been extended to the study of regional and global function of other
cardiac chambers, including the right ventricle and le$ atrium.
Speckle tracking echocardiography is undergoing standardization
and is expected to improve the yield of routine echocardiography in
valvular heart disease by defining the pa#ern of adaptive remodeling
and detecting subclinical myocardial dysfunction.5 For example,
aortic stenosis (AS) results in progressive le$ ventricular (LV)
hypertrophy due to increased a$erload. The LV ejection fraction,
however, remains preserved during the asymptomatic phase of
the disease. Speckle tracking–derived cardiac long-axis function is
reduced in patients with severe AS and improves following aortic
valve replacement.6 Similarly, aortic regurgitation (AR) involves
a significant increase in LV volume and preload. Compensation
through remodeling and ventricular dilation masks the onset of
clinical LV dysfunction. Cardiac long-axis function is reduced in
patients with AR, and modest improvement is seen a$er aortic
valve replacement. Reduced speckle tracking echo-derived long-axis
function declines in patients with severe mitral stenosis and mitral
regurgitation before changes in circumferential or radial strain
rates develop.4,7
BLOOD FLOW AND HEMODYNAMICS
Blood flow through the le$ ventricle is characterized by a strong,
compact jet that enters the chamber through the mitral orifice during
diastole in two distinct pulses: the early filling wave (E-wave), during
ventricular relaxation, followed by the A-wave produced by atrial
contraction. During systole, pressure rises in the chamber and the
mitral valve closes, while the aortic valve opens and blood is ejected
into the systemic circulation. The geometry and movement of the
valvular leaflets have important influences on intraventricular
flow. Blood passing through the valves creates vortices similar
to those generated by water crossing a narrow channel. An early
observation linking natural vortex formation with the function of
the cardiovascular system is found in a notebook of Leonardo da
Vinci.8 In a well-designed investigation, da Vinci modeled the aortic
valve and sinuses of Valsalva from casts of oxen hearts. Observing
the vortices formed in the sinuses, he predicted the mechanism of
closure. As blood was forced through the valve, vortices in the sinuses
edged back into the cusps of the valve, and when flow ceased at
end-systole, these forced the cusps to coapt, forming a perfect seal to
prevent reflux.
Modern day investigations have confirmed several of da Vinci’s
observations. Flow vortices in the aortic sinuses have been implicated
in valve closure and coronary perfusion. Regarding the mitral valve,
Figure 2. Assessment of left
ventricular volume and mechanical
function using three-dimensional
speckle-tracking echocardiography
in a patient with mitral regurgitation.
(A) Endocardial boundaries tracked
from volumetric datasets. (B) Regional
segmental function is assessed by
regional time-volume curves and wall
mechanics. (C) and (D) Myocardial
regional contractility is assessed by
computing regional strain. Shades of
green represent a parametric display of
regional strain.
5
Figure 3. Assessment of kinetic
energy of two-dimensional flow
across a mitral valve leaflet.
(A) Normal flow across the mitral valve
results in asymmetrical vortex ring
formation with clockwise rotation that
redirects flow toward the ventricular
outflow tract. Echo-contrast particles have
been tracked to compute two-dimensional
flow. Kinetic energy is derived from bubble
velocity measurements. Regions of
higher energy are shown in red. (B) Flow
across a mitral bioprosthesis inclined
toward the interventricular septum (inset).
Abnormal orientation of the prosthesis
reverses flow in the ventricle, generating
a counterclockwise vortex. Abnormal
vortex formation is associated with energy
dissipation that may adversely affect
ventricular remodeling.
blood rotates as it flows into the relaxed ventricle, resulting in
large anterior and small posterior vortices. The geometry of the le$
ventricle and the dynamic interaction between these flow pa#erns
and the mitral valve leaflets creates a predominantly anteriorly
directed vortex with clockwise rotation that helps conserve energy
from diastole to systole.5 Changes in the mitral valve due to disease
or surgery directly affect this intraventricular flow pa#ern, and
preliminary data suggest that in patients with prosthetic valves,
myocardial energy dissipates more rapidly than in healthy subjects,
depending on valve type and orientation as well as LV geometry
(Figure 3). Changes in flow therefore influence LV performance, and
careful assessment of flow pa#erns may help guide valve surgery to
reduce energy dissipation and favor optimum LV remodeling.
In summary, novel imaging techniques have the potential to
identify patients with valvular heart disease at higher risk of
clinical deterioration and to improve the efficiency and reliability of
surveillance. As this technology improves, less expensive, simpler
protocols for assessment using a single modality will be integrated
into the routine care of patients with common valvular lesions.
ABOUT THE AUTHORS
REFERENCES
1 Yacoub MH, Takkenberg JJ. Will heart valve tissue engineering change the world? Nat
Clin Pract Cardiovasc Med 2005;2:60–1.
2 Sengupta PP, Marwick TH, Narula J. Adding dimensions to unimodal cardiac images.
JACC Cardiovasc Imaging 2011;4:816–8.
PARTHO SENGUPTA, MD
is Associate Professor of Medicine and
Cardiology at the Icahn School of Medicine at
Mount Sinai and widely acclaimed in clinical
echocardiography and ultrasound research.
3 Sengupta SP, Sengupta PP, Narula J. Echocardiographic investigations of myocardial
function in mitral stenosis: making sense of the echolalia. Cardiology 2011;119:142–4.
4 Geyer H, Caracciolo G, Abe H, et al. Assessment of myocardial mechanics using
speckle tracking echocardiography: fundamentals and clinical applications. J Am Soc
Echocardiogr 2010;23:351–69.
5 Sengupta PP, Korinek J, Belohlavek M, et al. Left ventricular structure and function:
basic science for cardiac imaging. J Am Coll Cardiol 2006;48:1988–2001.
6 Dal-Bianco JP, Khandheria BK, Mookadam F, Gentile F, Sengupta PP. Management of
asymptomatic severe aortic stenosis. J Am Coll Cardiol 2008;52:1279–92.
7 Sengupta PP, Mohan JC, Mehta V, et al. Effects of percutaneous mitral
commissurotomy on longitudinal left ventricular dynamics in mitral stenosis:
quantitative assessment by tissue velocity imaging. J Am Soc Echocardiogr
2004;17:824–8.
8 Narula J, Vannnan MA, DeMaria AN. Of that waltz in my heart. J Am Coll Cardiol
2007;49:917–20.
6
JAGAT NARULA, MD, PHD
is Phillip J. and Harriet L. Goodhart
Professor of Medicine in Cardiology and
Associate Dean for Global Health at the
Icahn School of Medicine at Mount Sinai and
Director of Cardiovascular Imaging at Mount
Sinai Heart. Dr. Narula is also Editor-in-Chief
of the Journal of the American College of
Cardiology – Cardiovascular Imaging.
Percutaneous Heart Valve Replacement
BY SAMIN K. SHARMA, MD, JASON C. KOVACIC, MD, ANNAPOORNA S. KINI, MD,
AND DAVID H. ADAMS, MD
Calcific aortic valve stenosis (AS) affects an estimated 300,000
people worldwide and is associated with considerable morbidity
and mortality. The prevalence is increasing as the population ages,
afflicting 2 to 3 percent of North Americans older than age 65.1
Until recently, the main treatment for AS was surgical aortic valve
replacement (SAVR, AVR). Although highly effective, such surgery
requires prolonged general anesthesia and cardiopulmonary bypass
and typically involves a hospital stay of 4 to 5 days followed by
several months for full recovery. Because AS o$en affects older,
frail people with comorbidities, many patients with severe AS are
poor candidates for surgery; nearly one-third of those who would
benefit from the operation do not undergo AVR. As an alternative,
balloon aortic valvuloplasty has been employed as a palliative
measure in managing symptomatic patients, but the duration of
symptom relief a$er balloon aortic valvuloplasty seldom exceeds 12
to 18 months.2
or transaortic approach. In occasional situations, the procedure
involves a transapical le$ ventricular approach. Rather than
replacing the diseased valve with a new one as with SAVR, TAVR
uses an implantable bioprosthetic valve that is mounted inside a
collapsible metallic frame. In its collapsed state, the valve and the
supporting frame have a diameter of just 6 mm, which facilitates
catheter-based delivery. The framed valve is positioned directly
within the orifice of the diseased valve and expanded. As the frame
dilates the opening, the new valve inside opens and functions
immediately (Figure 1). In contrast to conventional surgery,
TAVR can be performed under light general anesthesia without
cardiopulmonary bypass, making recovery faster and easier.
Many patients who are too frail or ill for SAVR can be successfully
managed with TAVR.
EVOLVING TREATMENT OPTIONS
In the pivotal PARTNER (Placement of Aortic Transcatheter Valve)
Trial (Cohort B) of patients with severe AS deemed surgically
inoperable due to high risk clinical features, TAVR using the
Edwards SAPIEN valve (Figure 2) was associated with a 20 percent
reduction in all-cause mortality during the first year, from 50 percent
in the medically treated control arm to 30 percent in the group
undergoing TAVR (Figure 3). The composite endpoint of death or
repeated hospitalization was reduced by 30 percent.3 The U.S. Food
and Drug Administration (FDA) has approved the Edwards SAPIEN
valve (Figure 2) for use outside the context of a clinical trial.
The development of percutaneous aortic valve replacement has
opened a new era in treatment for AS. Interventional cardiologists
and cardiothoracic surgeons at Mount Sinai Heart are leading
the investigation of transcatheter aortic valve replacement or
implantation (TAVR, TAVI) by making Mount Sinai Heart a
principal site for evaluation of the Medtronic CoreValve®. Unlike
SAVR, TAVR involves deployment of a prosthetic valve via a
transfemoral catheter, or less commonly a subclavian arterial
EARLY RESULTS WITH TAVR
Figure 1. The Medtronic CoreValve®
prosthesis in situ following successful
percutaneous deployment.
Ascending aorta
Nitinol frame
CoreValve®
Bioprosthetic valve
Aortic sinuses and
coronary ostia
Aortic valve annulus
Le$ ventricle
7
Figure 2. The FDA-approved Edwards SAPIEN
aortic valve prosthesis.
THE NEXT STAGE
In some ways comparable to the Edwards SAPIEN valve, the Medtronic
CoreValve (Table 1) is deployed through a smaller sheath (18 vs 24
French). Given these obvious advantages, physicians at Mount Sinai
Heart have been eager to adopt the TAVR procedure and have taken a
leadership role in the development of the TAVI technology. Initially, the
TAVR procedure was performed exclusively as part of the Medtronic
CoreValve U.S. Pivotal Trial, which plans to enroll 1,600 patients across
multiple sites. High-risk patients, defined according to inclusion and
exclusion criteria (Figure 4), are subcategorized to include those too
frail or unwell to undergo SAVR.
Mount Sinai investigators are also engaged in developing methods
to treat other valve diseases using minimally invasive, catheterbased techniques. Therapies for percutaneous reduction of mitral
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A PARADIGM SHIFT IN CARDIAC CARE
The introduction of catheter-based approaches to the management
of patients with structural heart disease like severe AS is changing
the way patients are managed throughout the technologically
developed world. As this trend continues, patients will no longer
be routinely referred to an interventional cardiologist or cardiac
surgeon based upon a specific cardiac diagnosis, but instead will
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regurgitation (MR) have shown promise in early clinical trials.4 While
it seems likely that surgical valve repair will remain the optimum
strategy for most patients with severe MR, novel procedures may
become the preferred approach to avoid open-chest surgery in selected
high-risk patients with this disorder. With our close associations
between cardiac surgeons and interventional cardiologists and other
key services, Mount Sinai Heart is at the forefront of this revolution.
Figure 3. All-cause mortality rates following
TAVR using the Edwards SAPIEN device
compared with medical management without
valve replacement among inoperable patients in
the PARTNER Trial (Cohort B). Event rates were
calculated using the Kaplan–Meier method and
compared by the log-rank test. Reproduced with
permission from Leon et al.3
Table 1. Comparison of the Edwards
SAPIEN and Medtronic CoreValve
percutaneous aortic valve prostheses.
Figure 4. Enrollment flowchart for the
Medtronic CoreValve U.S. Pivotal Trial.
Edward Sapien Valve
Medtronic CoreValve
First in man
June 2002
April 2004
Approval in Europe
September 2007
May 2007
Expansion
Balloon-expandable
Self-expandable
Frame
Stainless steel
Nitinol
Valve material
Bovine
Porcine
Sheath size
21-24 Fr
18 Fr
Aortic annulus
≥ 18mm ≤ 25mm
≥ 20mm ≤ 27mm
Area
1.7cm2
1.7cm2
Access site
Transfemoral, Transapical
Transfemoral, Subclavian, Transaortic
Repositioning
No
Yes
Enrollment Flowchart – MCS TAVI vs. SAVR
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be evaluated by both types of specialists, working together, to
select the optimum approach for each patient. Mount Sinai Heart
was founded on this principle, and pioneered the concept in the
FREEDOM (Future REvascularization Evaluation in Patients with
Diabetes Mellitus: Optimal management of Multivessel Disease)
Trial, which is revolutionizing the way patients with diabetes
mellitus and advanced coronary artery disease are managed. The
collaboration of skilled surgeons and interventional cardiologists
with access to advanced diagnostic imaging data and cu#ing-edge
technologies like TAVR assures the best clinical outcomes based on
individualized application of the latest modalities. Coupled with
the experience that comes from high interventional volumes for
both vascular and valvular disorders, the collaborative approach
continues a long tradition at Mount Sinai of assuring the highest
quality cardiovascular care.
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ABOUT THE AUTHORS
SAMIN K. SHARMA, MD
is Director of Clinical and Interventional
Cardiology, Professor of Medicine, and
President, Mount Sinai Heart Network.
JASON C. KOVACIC, MD
is Assistant Professor of Cardiology the at the
Icahn School of Medicine at Mount Sinai.
ANNAPOORNA S. KINI, MD
REFERENCES
1 Rajamannan NM, Bonow RO, Rahimtoola SH. Calcific aortic stenosis: an update. Nat
Clin Pract Cardiovasc Med 2007;4:254–62.
2 Agarwal A, Kini AS, Attanti S, et al. Results of repeat balloon valvuloplasty for treatment
of aortic stenosis in patients aged 59 to 104 years. Am J Cardiol 2005;95:43–7.
3 Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic
stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–607.
4 Feldman T, Foster E, Glower DG, et al. Percutaneous repair or surgery for mitral
regurgitation. N Engl J Med 2011;364:1395–406.
is Professor of Medicine at the Icahn School
of Medicine at Mount Sinai, and Director of
The Cardiac Catheterization Laboratory at
Mount Sinai Heart.
DAVID H. ADAMS, MD
is Marie-Josee and Henry R. Kravis
Professor and Chair of the Department of
Cardiothoracic Surgery at the Icahn School of
Medicine at Mount Sinai.
9
The Integral Role of Nursing in
Transcatheter Aortic Valve Replacement
BY MELISSA MATTIMORE, ACNP-BC
Aortic stenosis (AS) is a common clinical condition associated
with a poor prognosis once symptoms develop. For patients with
severe AS, surgical aortic valve replacement (SAVR) is the standard
treatment. Transcatheter aortic valve replacement or implantation
(TAVR) has emerged as a promising new option for older, sicker
patients, in whom the risk of open-heart surgery is prohibitively
high. Mount Sinai Heart has been involved in the CoreValve U.S.
Pivotal Trial since December 2010, performing the first TAVR
procedure with the Medtronic CoreValve® system in the United
States (see page 7). Proper use of TAVR requires an interdisciplinary
approach that includes both registered clinical nurses (RNs) and
nurse practitioners (NPs) who have well-defined responsibilities to
ensure that patients receive appropriate comprehensive care before,
during, and a$er the procedure.
In clinical practice, at least 30 percent of older patients with severe
symptomatic AS do not undergo surgical replacement of the aortic
valve due to their high surgical risk. In the first two years a$er
symptoms appear, the mortality rate in these patients is about 50
percent despite medical management. Treating this group of patients
with a safe, effective, minimally invasive catheter-based approach
is a promising alternative and may set the stage for a paradigm
shi$ in the way patients with AS are managed in the future. An
upcoming trial will evaluate the use of this technique for aortic-valve
replacement in patients with moderate surgical risk. The use of this
therapy in patients at lower surgical risk remains to be seen.
THE ROLE OF THE NURSE PRACTITIONERS
Before the trial began, NPs in Mount Sinai Heart’s Cardiac
Catheterization Laboratory received comprehensive education
about the evaluation and management of patients with aortic valve
disease. They also gained specific knowledge about the trial protocol,
including the objectives of the investigation, trial organization,
target patient population, inclusion and exclusion criteria, screening
procedures, design, patient education and informed consent process,
structure and function of the percutaneous valve deployment device,
randomization method, pre- and post-procedural patient care,
follow-up procedures and requirements, primary and secondary
trial endpoints, device accountability, concomitant therapy, and
data and safety monitoring plans. NPs play a primary role during
the screening evaluation of potential candidates using a systematic
approach that ensures continuity and enhances rapport with patients
and family members. During the pre-procedural phase, NPs also
work closely with the research coordinator, referring physicians,
house staff, clinical nurses, and interventional cardiologists.
Once a patient has been identified as a candidate for the CoreValve
Trial, the patient and family meet with the NP and research
coordinator to learn about the study, diagnostic testing, implantation
procedure, and follow-up. Working in direct communication with
the patient’s cardiologist, a thorough history, physical examination,
and review of prior diagnostic tests and procedures are conducted.
Once consent is obtained, diagnostic testing is carried out to assess
the patient’s eligibility for inclusion, including routine blood tests,
10
transthoracic echocardiography, catheterization of the right side
and le$ side of the heart, CT angiography of the chest, subclavian
arteries, abdomen and pelvis, carotid ultrasound examination, and
assessment of pulmonary function. Abnormal findings may warrant
additional imaging or consultation. When the diagnostic screening
process has been completed, the clinical data are reviewed by the
screening commi#ee.
Once a patient is approved for enrollment, informed consent is
obtained and a date for the procedure is set. The patient is admi#ed
to The Mount Sinai Hospital at least two days prior to the procedure
At least 30 percent of older
patients with severe symptomatic
AS do not undergo surgical
replacement of the aortic valve
due to their high surgical risk.
for comprehensive neurological assessment, which includes
administration of the National Institutes of Health standardized
stroke scale within 24 hours of the procedure. Patients with
pacemakers or implanted defibrillators undergo evaluation by a
cardiac electrophysiologist and interrogation of the device. During this
advanced phase of evaluation, the Catheterization Laboratory (Cath
Lab) NP is in frequent communication with RNs and NPs on the cardiac
telemetry unit to ensure that all protocol requirements and patient
needs are addressed.
On the day of the procedure, the nurse practitioner and research
coordinator maintain contact with the nurses on the cardiac
telemetry unit and the Cath Lab charge nurse to facilitate smooth
and efficient patient flow, and to coordinate with the receiving unit
(cardiothoracic surgical ICU or CCU) to prepare for the patient’s
arrival once the TAVR procedure has been completed.
The NP and research coordinator see the patients daily to assess
their progress and discuss any issues with the critical care team
managing the patients. The NP also reviews the status of patients
when they return for follow-up assessments as specified by the
research protocol.
ROLE OF THE CATHETERIZATION
LABORATORY NURSES
During every TAVR procedure, two cardiac catheterization RNs, a
cardiac operating room (OR) RN, and two cardiovascular technicians
(CVTs) assist the interventional cardiologists. A scrub nurse
prepares the device and loads the valve onto the delivery system for
implantation, assuring easy positioning and release. A circulating
nurse monitors the patient’s vital signs, hemodynamics, and clinical
condition throughout the procedure, performs and reports arterial
blood gas analyses and measures the activated clo#ing time, and
communicates with the cardiologists and anesthesiologist to ensure
that necessary instruments, medications, and blood products are
available. The cardiac OR nurse prepares the patient for the unlikely
event that emergency SAVR becomes necessary as a result of clinical
deterioration or implant complication. Cardiovascular technologists
prepare the table for the procedure, including preparation of
the sheaths, catheters, and wires that will be used during TAVR.
Throughout the procedure, one CVT is responsible for providing
necessary equipment while the other CVT monitors and records
hemodynamic data.
Upon completion of the procedure, the cardiac catheterization RNs
ensure a smooth transition to the receiving unit, including providing
a verbal report of the patient’s history, course, and condition. The
RNs in the receiving unit have advanced critical care experience
and knowledge of the protocols specific to the monitoring of TAVR
patients, including hourly assessment of neurological status, access
sites, and progressive mobilization. Patients arrive in the ICU
intubated, sedated, and mechanically ventilated, with an arterial
monitoring line, Swan-Ganz catheter, and temporary transvenous
pacemaker, requiring one-to-one nursing care. The nurses initiate
and facilitate early extubation and progressive care so that the
patient can transition to the step-down unit at the appropriate time.
Depending on individual needs and condition, patients are later
discharged to their homes or to a rehabilitation facility.
Collaboration is imperative to assure the success of all new medical
technologies. Mount Sinai Heart takes an interdisciplinary approach
to the care of patients enrolled in the CoreValve U.S. Pivotal Trial to
support positive outcomes and meet the challenge of an increasing
volume of cases. For cardiovascular nurses, it has been extraordinarily
rewarding to be a part of this historic advance in cardiology.
REFERENCES
1 Krishnaswamy A, Tuzcu EM, Kapadia S. Update on transcatheter aortic valve
implantation. Curr Cardiol Reports 2010;12:393–403.
2 CoreValve U.S. Pivotal Trial; Medtronic CoreValve U.S. Pivotal Trial Protocol Training.
2011. High Risk Version 4.0 & Extreme Risk Version 5.0.
3 Lindeke L, Block D. Interdisciplinary collaboration in the 21st century. Minnesota Med
2001;8:42–5.
ABOUT THE AUTHOR
MELISSA MATTIMORE, ACNP-BC
is a Nurse Practitioner at Mount Sinai Heart.
2013 Live Symposium of Complex
Coronary and Vascular Cases
June 11–14, 2013
Course Directors:
Samin K. Sharma, MD, Director of Clinical and Interventional
Cardiology, President of Mount Sinai Heart Network, Dean of
International Clinical Affiliations
Annapoorna S. Kini, MD, Director of Cardiac Cath Lab and
Director of Interventional Cardiology Fellowship Program
Emphasizing the intricate details of the procedural techniques, Mount
Sinai Heart’s 16th Annual Live Symposium of Complex Coronary and
Cardiovascular Cases will again focus on a course to present a multi-device
approach to revascularization of patients with complex coronary and
cardiovascular disease. This year will be a new 4-day format including a Nurse
Tech Symposium, Endovascular Symposium, Coronary Symposium and
Structural Heart Disease Symposium.
The symposium, to be held June 11–14, will include live cases with panel
discussions highlighting complex high-risk coronary cases, unprotected left
main, chronic total occlusion, distal protection devices, alcohol septal ablation,
aortic and mitral valvuloplasty, percutaneous valve replacement, peripheral,
endovascular and carotid stenting, PFO/ASD closure.
Directed by Samin K. Sharma, MD, and Annapoorna S. Kini, MD, this continuing
medical education program is expected to bring over 600 physicians,
nurses, and technicians to New York City to learn the latest techniques in
interventional cardiology. In addition to Mount Sinai faculty, guest faculty
will include 23 renowned interventional cardiologists from across the United
States, as well as from India, England, Germany, and Japan.
For more information about this symposium, please visit
www.cccsymposium.org.
11
Transcatheter Pulmonary Valve
Replacement in Congenital Heart Disease
BY BARRY A. LOVE, MD
Surgically placed conduits from the right ventricle to the pulmonary
artery are used to palliate several forms of congenital heart disease
(Table 1). Regardless of the type, over time these conduits become
dysfunctional with stenosis, regurgitation, or both. Bioprosthetic
valves, when placed in the pulmonary position, suffer the same
fate, leading to stenosis and/or regurgitation. Mechanical valves are
not used in this position because of the unacceptably high rate of
thrombosis.
Patients with right ventricle–to–pulmonary artery conduits or
bioprosthetic pulmonary valves are subject to a lifetime need for
replacement, especially young patients.
Conduit stenosis imposes pressure-load on the right ventricle,
resulting in hypertrophy, systolic and diastolic dysfunction, and
eventually right ventricular failure.1 While pulmonary regurgitation
had traditionally been considered relatively benign, recent studies
have shown that this condition leads to right ventricular dilation,
systolic and diastolic dysfunction, and ultimately, irreversible right
ventricular damage.2 Determining the optimum time for subsequent
intervention requires balancing the risk of the procedure against the
risk of developing right ventricular failure.
In the past, surgery was the only option for conduit revision and it
carries a risk of complications that increases with each subsequent
revision. Prolonging the life of the conduit, which reduces the need
for repeated surgery, would have clear advantages for this patient
population. (Table 1)
Table 1. Commonly performed congenital heart operation requiring right ventricle–
to–pulmonary artery conduits or prosthetic pulmonary valves
1
Tetralogy of Fallot with pulmonary atresia
2
Tetralogy of Fallot s/p repair and s/p pulmonary valve replacement
3
Truncus arteriosus
4
Aortic stenosis s/p Ross procedure
5
Pulmonary stenosis s/p valvotomy
6
TGA with VSD and pulmonary stenosis s/p Rastelli procedure
7
Other
s/p=status post; TGA=transposition of the great arteries;
VSD=ventricular septal defect
HISTORY
In 2000, Philipp Bonhoeffer, MD, at Necker Hospital in Paris,
reported the first-in-human replacement of a pulmonary valve using
a catheter-based system,3 leading to the development of the Melody®
Transcatheter Pulmonary Valve. This device is fashioned from a
bovine internal jugular valve mounted on a platinum-iridium stent
(Figure). Unlike humans, cows have a valve in the internal jugular
vein that prevents reflux of blood into the head, which may have an
12
evolutionary advantage because of the amount of time cows spend
with their head below heart level. The bovine jugular vein is well
suited for use as a conduit because the deep leaflet coaptation allows
function over a wide range of diameters and geometries.
The delivery system is an adaptation of the conventional balloon-inballoon catheter used to implant large diameter stents in patients
with congenital heart disease. The major modification was the
addition of a tapered distal sha$ (the “carrot”) and a retractable
sheath to protect the valve as it is advanced into position (Figure).
The outer diameter of the delivery system is relatively large (22
French), but most patients older than eight years can tolerate this
via a femoral venous approach, and manual compression a$er
the procedure is usually sufficient to achieve hemostasis. In small
patients or those with difficult anatomy, a jugular approach or hybrid
delivery through the right ventricular free wall has been used. The
maximum internal diameter of the expanded valve is 22 mm (24 mm
outer diameter), beyond which adequate leaflet coaptation is not
maintained. Hence, the Melody valve is not suitable for most patients
with large outflow tract diameters, as typically occurs a$er repair
of Tetralogy of Fallot with a transannular patch. For patients with
Tetralogy of Fallot who have undergone previous surgical pulmonary
valve replacement, however, the Melody valve replacement offers an
excellent alternative to reoperation when valve dysfunction develops.
For patients with large outflow tracts who have not undergone
previous valve surgery, a catheter-delivered scaffold is under
development to allow for transcatheter valve deployment.
REGULATORY APPROVAL
The valve and delivery system were recently granted Humanitarian
Device Exemption (HDE) approval by the U.S. Food and Drug
Administration (FDA). The Melody valve is the first transcatheter
valve to receive FDA approval. Further adaptation of Bonhoeffer’s
work has led to development of transcatheter aortic valves for use in
acquired heart disease, which are on the cusp of FDA approval. This
is a reversal of the usual approval course where devices for acquired
heart disease typically win FDA approval long before similar devices
to treat congenital or pediatric heart disease.
The FDA-labeled indications for the Melody valve include moderate
or severe regurgitation and/or stenosis of the right ventricular
outflow tract (RVOT) conduit associated with a systolic gradient of
at least 35 mm Hg. The type of approval (HDE) does allow for use of
the device beyond the labeled indications with the approval of the
institutional review board. The valve has been successfully used in
the tricuspid, mitral, and aortic positions. The manufacturer reports,
however, that bench testing of the Melody valve in the mitral and
aortic positions predicts shorter valve longevity.
RISKS
Major complications of transcatheter pulmonary valve placement
occur infrequently.4 There is approximately a 1 percent risk of
A
B
C
Figure. (A) Pulmonary artery angiogram in the lateral projection showing
stenosis at the level of the pulmonary xenograft valve (arrows). Severe
regurgitation is seen with contrast refluxing into the right ventricle (RV). (B)
After stenting across the stenotic area, the Melody valve is positioned with
D
E
the delivery system. The platinum-iridium stent is more radio-opaque than
the stainless steel stent already in position. (C) Balloon expansion of the
Melody valve. (D) Melody valve and Ensemble delivery system. (E) Pulmonary
angiogram after Melody valve placement showing a competent valve.
CASE EXAMPLE
A 20-year-old woman with a history of pulmonary stenosis as an infant
had undergone surgical valvotomy at age three months. She did well, but
had progressive pulmonary insufficiency and right ventricle dilation.
At age 19 years, she underwent surgical pulmonary valve replacement
with a xenogra$ valve, but this device rapidly became dysfunctional
with stenosis and regurgitation. The patient, who had been minimally
symptomatic prior to the procedure, became dyspneic climbing one
flight of stairs. She was referred to Mount Sinai for evaluation and
treatment. Echocardiography confirmed moderate conduit stenosis
with a maximum gradient of 70 mm Hg and moderate prosthetic
valve regurgitation.
conduit rupture if stenotic conduits are expanded too aggressively,
but this can usually be managed percutaneously because, a$er
deployment, the Melody valve functions as a covered stent. Coronary
artery compression can occur if the conduit courses adjacent to a
coronary artery. This situation arises more o$en in patients who
have undergone the Ross procedure. Following initial reports of this
complication, experienced physicians know to carefully assess the
course of the coronary arteries before expanding a stent in the RVOT.
In rare circumstances, the Melody valve cannot be deployed because
of the risk of coronary artery impingement.
Long-term follow-up has shown reasonable valve function over time
and freedom from catheter-based or surgical re-intervention of 95
percent at one year and 76 percent at four years.5 One of the major
reasons for Melody valve failure is stent fracture where the stent
loses integrity due to one or more fatigue fractures from recurrent
compression. Decreasing the compressive forces on the stent should
decrease this risk. For this reason, most implanters will place one or
more high-strength stainless steel, balloon-expandable stents in the
conduit prior to the implantation of the Melody valve. This provides
additional support and will hopefully reduce the incidence of stent
fracture. If, however, the valve should become dysfunctional over
time, a second Melody valve can be implanted inside the first.
CONCLUSIONS
Transcatheter pulmonary valve replacement has become the
procedure of choice for children and adults with right ventricle–to–
pulmonary artery conduits that have developed significant stenosis
or regurgitation. The founding work of the congenital cardiology
community in developing this technology has opened the door for
transcatheter aortic valve replacement in adults with acquired
aortic stenosis.
The patient was brought to the catheterization laboratory where
hemodynamics showed a 45 mmHg peak gradient across the prosthetic
pulmonary valve with severe pulmonic insufficiency (A). A Palmaz 3110
stent was first expanded to 22 mm in the outflow tract to provide a more
rigid scaffold for the valve, and then the Melody valve (D) was delivered
on a 22-mm delivery system and expanded within the Palmaz stent
(B and C). A$er valve placement, the stenosis and regurgitation were
completely eliminated (E). The patient was discharged the following day
and returned to school the next week.
REFERENCES
1 Hayes CJ, Gersony WM, Driscoll DJ, et al. Second natural history study of congenital
heart defects. Results of treatment of patients with pulmonary valvar stenosis.
Circulation 1993;87:128–37.
2 Meyer RA, Korfhagen JC, Covitz W, Kaplan S. Long-term follow-up study after closure
of secundum atrial septal defect in children: an echocardiographic study. Am J Cardiol
1982;50:143–8.
3 Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Percutaneous replacement of pulmonary
valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction.
Lancet 2000;356:1403–5.
4 McElhinny DB, Hellenbrand WE, Zahn EM, et al. Short- and medium-term outcomes
after transcatheter pulmonary valve placement in the expanded multicenter U.S.
Melody valve trial. Circulation 2010;122:507–16.
5 Lurz P, Coats L, Khambadkone S, et al. Percutaneous pulmonary valve implantation:
impact of evolving technology and learning curve on clinical outcome. Circulation
2008;117:1964–72.
ABOUT THE AUTHOR
BARRY A. LOVE, MD
is Assistant Professor of Pediatrics at the Icahn
School of Medicine at Mount Sinai and Director
of the Congenital Cardiac Catheterization
Laboratory at Mount Sinai Heart.
13
Valvesof Heart.org: A Unique, Online
Resource for Surgeons, Cardiologists,
Anatomists, Physiologists, and Historians
BY FARZAN FILSOUFI, MD
Valvesof Heart.org is a unique open-access website rooted in the
understanding that history should inform current practice and
the future direction of any field, including cardiac subspecialties.
Launched in 2011 as a collaboration between physicians at Mount
Sinai Heart and the Pierre and Marie Curie University in Paris,
France, ValvesofHeart.org is designed to provide readers — surgeons,
cardiologists, anatomists, physiologists, and historians — with a
comprehensive view of valvular heart disease with dual emphases on
historical and contemporary approaches.
The first edition, ValvesofHeart.org, primarily focuses on the mitral
valve and is divided into two sections, titled Historic Review and
Current Status. The Current Status section features five subsections.
Fundamentals describes our understanding of mitral valve disease
based on pathophysiological triad and functional classification
approaches of valve analysis as developed by Alain Carpentier, MD,
PhD, Chairman Emeritus, Department of Cardiovascular Surgery,
Broussais Hospital, and Professor Emeritus at the Pierre and Marie
Curie University, both in Paris, France. Two extensive webpages are
devoted to transesophageal echocardiography and surgical valve
analysis, including more than 50 videos.
Disease-Specific Approach analyzes the state-of-the-art knowledge of
predominant etiologies of mitral valve disease. For each etiology, the
website includes the clinical presentation, pathology, diagnosis with a
particular emphasis on echocardiography, and modern treatment with
a specific focus on surgical indications and management.
Case Studies, organized around specific diseases, provide in-depth
descriptions of unique pathologic cases with extensive imaging studies.
Reconstructive Valve Video Surgery, which features a functional
approach, includes numerous video clips. Techniques of valve
reconstruction in each functional group based on their pathological
features and the “one lesion, one technique” principle are described
with extensive imaging studies and operative views.
Prosthetic Heart Valves describes in detail mechanical and
bioprosthetic valves, including long-term outcomes of valve
replacement in the aortic and mitral positions. Valve-related
complications and long-term survival are reported for the most
commonly used prosthetic valves. This subsection also includes
extensively analyzed clinical studies published during the last decade,
with a minimum follow-up of five years.
Diagnostic Tools describes in depth the development of
sphygmography, X-ray, electrocardiogram, cardiac catheterization,
and, more recently, echocardiography. For each technology,
developmental background is given and analyzed, along with
applications in the diagnosis of the diseases of the mitral valve. This
section covers primarily an era extending from the middle of the
nineteenth century to the 1970s.
Disease-Specific Approach focuses on the development of knowledge
pertaining to the specific etiologies of valvular heart disease.
The authors reviewed in a chronologic manner the progress that
was made in understanding the most common causes of mitral
valve disease, including rheumatic fever, infective endocarditis,
degenerative disease, and ischemic cardiomyopathy.
Mitral Valve Surgery is devoted to the birth of cardiac surgery in the
twentieth century. The authors have reviewed the pioneering works
of giants who performed the first cases of mitral valve surgery. They
subsequently analyzed the development of cardiac valve prostheses
and the original works of Dr. Carpentier and Albert Starr, MD,
Special Advisor to the Dean of Medicine at Oregon Health and
Science University.
Featured authors and their work(s) were selected based on major
medical bibliography references. For each historic author, the entire
title of the first-edition work is included, along with any available
portrait, the frontispiece and the title page, and appropriate museumquality illustrations. Original excerpts from many rare books are also
displayed, and texts that were originally published in Latin include
English or French translations.
The editorial board of the website is composed of internationally
recognized physicians in the field of cardiovascular medicine,
including Drs. Carpentier and Starr, both recipients of the Lasker
Award. Multiple collaborative projects are in progress with
physicians from the United States, India, England, France, Australia,
and the Netherlands.
Since ValvesofHeart.org launched, it has a#racted more than 20,000
unique visitors, with a total number of visits exceeding 60,000.
The website is linked to major scientific societies and will soon be
connected to CardioSource and theheart.org.
ABOUT THE AUTHOR
The robust Historic Review is organized into four subsections.
Chronologic Approach traces the development of knowledge of the
structure and function of the heart, circulatory system, and diseases
of the heart, with emphasis on the mitral valve. It begins with an
overview of 16th century descriptive anatomy, outlines 17th century
experimental physiology with the discovery of blood circulation, and
showcases the work of major European contributors until the end of
the 19th century.
14
FARZAN FILSOUFI, MD
is Professor of Cardiothoracic Surgery at the
Icahn School of Medicine at Mount Sinai.
Entering the Record Book for International
Cardiovascular Disease Detection
BY CHERYL DE JONG-LAMBERT
In January, a team of cardiologists led by Jagat Narula, MD, Director
of the Noninvasive Imaging Program at Mount Sinai Heart, and Partho
Sengupta, MD, Director of Cardiac Ultrasound Research, made history by
organizing the most extensive free community program for the detection
and prevention of cardiovascular disease ever launched. Held in Sirsa,
India, a remote, impoverished community 175 miles northeast of New
Delhi, the program vastly exceeded goals for hypertension, diabetes,
and lipid screening, and for the number of carotid ultrasound and
echocardiographic examinations performed. Staff from Guinness
World Records closely followed the program and confirmed four
record-breaking events on January 25, 2012.
The preventive cardiology program included risk stratification
of more than 6,000 people, including laboratory testing for
blood sugar and cholesterol and carotid ultrasound examination,
and was a part of Dr. Narula’s HAPPY (Heart A#ack Prevention
Program for You) program. The heart ultrasound program was
led by Dr. Sengupta with the support from the American Society
of Echocardiography. Dr. Narula, who is also Associate Dean for
Global Health at the Icahn School of Medicine at Mount Sinai
and Editor-in-Chief of the Journal of the American College of
Cardiology (Imaging), also collaborated with Leonard Hofstra, MD,
PhD, a professor at Free University, Amsterdam, Netherlands.
The program was also supported by Rajababoo Panwar, MD, ViceChancellor of the Rajasthan University of Health Sciences, Jaipur, and
Ravi Kasliwal, MD, of the Medanta Hospitals, New Delhi. The camp
was carried out at the Shah Satnam Ji Research and Development
Foundation, a leading community-welfare organization in Sirsa, under
the guidance of a social reformer and spiritual guru Gurmeet Ram
Rahim Singh Ji Insan.
INTERNATIONAL PROGRAM WITH LOCAL ROOTS
The hallmark of HAPPY, which operates in the Netherlands, United
States, United Kingdom, and India, is its orientation to local
geographic and ethnic characteristics. As such, the trend-se#ing
outreach activities in Sirsa were encouraged by a highly respected
spiritual mentor and social reformer who motivated physicians and
HAPPY set additional world
records by performing cardiac
risk profiling for diabetes and
dyslipidemia among 4,684 patients
in less than 24 hours.
other health care providers to join this unique endeavor. The HAPPY
program, known as True HAPPY for the people of Sirsa (the truth
seekers), has screened 14,000 patients over three years to assess
coronary risk factors.
On two consecutive days in 2012, a team of 30 physicians,
cardiovascular sonographers, and engineers performed 1,026
echocardiograms over 48 hours, the largest number of ultrasoundDoppler examinations ever completed in such a se#ing and
Saint Gurmeet Ram Rahim Singh Ji
Insan inaugurated the Heart Health
Fair on January 24, 2012 where
1026 ultrasound examinations of the
heart were undertaken. This was the
largest number of echocardiograms
performed in a camp se#ing as
confirmed by the Guinness Book of
World Records.
15
True HAPPY camp screened 4500 asymptomatic subjects for their risk factors for development of
heart disease. More than 4500 subjects were examined; blood sugar, blood cholesterol, and carotid
ultrasound examinations were performed in another record-breaking effort.
time period. The event established a new paradigm by digitally
transmi#ing images from the remote rural campsite to 75 physicians
who interpreted the studies at remote locations worldwide,
including Mount Sinai Heart, other major U.S. and Canadian
hospitals, and medical centers in Georgia, Bulgaria, Greece, and
Saudi Arabia. The initiative was sponsored by the American Society
of Echocardiography, and GE Healthcare contributed handheld
ultrasound devices and portable echocardiographic equipment.
SETTING A CLINICAL RECORD
HAPPY set additional world records by performing cardiac risk
profiling for diabetes and dyslipidemia among 4,684 patients in less
than 24 hours. Carotid intima-medial wall thickness was measured in
more than 500 high-risk individuals using state-of-the-art technology
supported by the Panasonic Corporation.
HAPPY was strategically scheduled to coincide with the week of
festivities surrounding Gurmeet Ram Rahim Singh Ji Insan’s birthday
in January, when over 15 million people from India and around
16
the world assembled to practice meditation under the guidance of
the spiritual leader. Dr. Narula plans to return to Sirsa in January
2013 to support another major humanitarian effort on behalf of the
American Society of Echocardiography and Mount Sinai Heart.
“Working together with local religious leaders, renowned experts
in cardiology at local academic centers, and partners in the
cardiovascular device industry, dedicated physicians and professional
organizations are having an unprecedented impact on the global
burden of cardiovascular disease through earlier detection of patients
at risk,” explains Dr. Narula.
ABOUT THE AUTHOR
CHERYL DE JONG-LAMBERT
is Editorial Director of the Mount Sinai
Heart Pulse.
Clinical Trials in Interventional Cardiology
BY ROXANA MEHRAN, MD
Clinical research is the cornerstone of medical therapy. Physicians
rely on the results of well-designed and meticulously executed
clinical trials to inform guidelines and practice, guide clinical
decision-making, and determine which patients may benefit most
from treatment. Unfortunately, over the past decade, the practice of
clinical research in the United States has been declining. Increasingly
difficult regulatory pathways, lack of institutional support for clinical
investigators, and shrinking funding from industry and government
have conspired to lower trial enrollment. As a result, in 2009, onethird of the Phase 3 trials sponsored by the 20 largest pharmaceutical
companies were conducted entirely outside of the U.S.1 To reverse
this unfavorable trend, high-volume clinical centers must commit
themselves to creating and engaging in top-quality clinical research.
To champion this goal, during the past year, Mount Sinai Heart
expanded the Office of Interventional Cardiovascular Research and
Clinical Trials to include large-scale, pivotal trials using innovative
treatment strategies as well as those which explore new applications
for drugs and devices already approved for other indications.
HIGH VOLUME, EXCELLENT OUTCOMES
Mount Sinai’s Cardiac Catheterization Laboratories, for example, have
the highest patient volume in the nation, with approximately 10,000
diagnostic angiograms and 8,000 coronary and peripheral arterial
interventions performed annually. Among all 54 catheterization labs
in New York State, Mount Sinai’s lab has been awarded the highest
two-star rating in both overall and non-emergency categories for
the last 15 years. The institution’s wealth of resources includes a
wide base of referring physicians who partner with Mount Sinai’s
dedicated research staff. In the past year, physicians and staff have
recruited participants in eight clinical trials, initiated another four,
and laid the groundwork for an additional six key trials before
the end of 2012. These trials, described below, evaluate treatment
strategies for coronary and peripheral atherosclerotic disease,
valvular heart disease, prevention of contrast-induced nephropathy,
and control of refractory hypertension.
Mount Sinai is currently participating in the Tryton Side Branch
Stent System™ trial for lesions at coronary bifurcations. The Tryton
device is a new stent specifically designed for placement in a side
branch of an artery obstructed by atherosclerotic disease, allowing
for balloon angioplasty and deployment of a drug-eluting stent in
the main vessel. Dr. Annapoorna S. Kini, MD, Associate Director of
Mount Sinai’s Cath Lab and Principal Investigator (PI) for the Tryton
study, enrolled the first patient in September 2011, and Mount Sinai
Heart is among the leading sites for enrollment in this trial.
Dr. Kini is also site PI of the EXPERT-CTO trial (Evaluation of the
XIENCE Coronary Stent, Performance, and Technique in Chronic
Total Occlusion), which aims to determine the best strategy for
revascularization in patients with chronic occlusive coronary
disease. Subjects are randomized to receive one of the designated
commercially available drug-eluting stents. The first U.S. patient was
enrolled at Mount Sinai in September 2011.
EXCEL
On the horizon is the EXCEL (Evaluation of Xience Prime versus
Coronary Artery Bypass Surgery for Effectiveness of Le$ Main
Revascularization) collaboration between cardiothoracic surgeons
and interventional cardiologists who plan to randomize 2,500
patients with le$ main coronary artery disease to therapy with either
drug-eluting stents or coronary bypass gra$ surgery. Farzan Filsoufi,
MD, Professor of Cardiothoracic Surgery, and Samin K. Sharma,
MD, Director of Clinical Cardiology and President of the Mount Sinai
Heart Network, are leading this initiative at Mount Sinai Heart.
The key to the success of many of today’s interventional procedures
is the accurate visual representation of vessels and lesions. Among
the available imaging modalities are angiography, ultrasound,
flow reserve, and infrared spectroscopy. The information gleaned
from these images guides treatment and may predict outcomes.
Under the direction of Dr. Kini and Pedro R. Moreno, MD,
Professor of Cardiology, a pioneer in the study of inflammation
and atherosclerosis, Mount Sinai researchers are studying the
role of near-infrared (NIR) fluorescent spectroscopy in the COLOR
Physicians at Mount Sinai Heart
enrolled the first patient in
Tryton study, and Mount Sinai
is among the leading enrollment
sites in the trial.
Registry (Chemometric Observation of LCP of Interest in Native
Coronary Arteries) and YELLOW Trial (Reduction in YEllow Plaque
by Aggressive Lipid LOWering Therapy). NIR spectroscopy quantifies
the lipid content of the plaque core, based on the premise that
plaque composition is a determinant of thrombotic occlusion and
acute coronary syndromes. Using the NIR score, patients can be
randomized to one of two lipid-lowering medication regimens and the
fat content of the lesion is monitored by both angiography and NIR
spectroscopy. An extension of this research, the CANARY (Coronary
Assessment by Near-infrared of Atherosclerotic Rupture-prone
Yellow) trial investigates the lesions with high lipid scores that are
prone to rupture to determine whether distal protection devices may
reduce periprocedural myocardial infarction in patients undergoing
percutaneous intervention.
UTOPIA
Another trial involving imaging is UTOPIA (Comparing Intravascular
Ultrasound-Guided Atherectomy To Angiography Guided
17
Atherectomy in Peripheral Vascular Interventions for TASC’s A, B,
C Lesions), directed by Prakash Krishnan, MD, Assistant Professor
of Cardiology and of Radiology, in which intravascular ultrasound
(IVUS) is used in patients with peripheral arterial disease. Consenting
patients are randomized to undergo either atherectomy guided by
angiographic assessment or IVUS. Mount Sinai Heart is the first
site in New York State and leading site in the U.S. in enrollment
for the international LEVANT-2 Trial (Continuation Registry of
the Moxy Drug Coated Balloon for Treatment of Femoropopliteal
Arteries), directed by Dr. Krishnan; George Dangas, MD, Director of
Cardiovascular Innovation; and Jose Wiley, MD, Assistant Professor
of Cardiology and of Radiology, to compare outcomes with a drugcoated balloon device versus conventional angioplasty in patients
with lower extremity arterial obstructive disease above the knee.
COREVALVE U.S. PIVOTAL TRIAL
Investigators at Mount Sinai Heart have made substantial
contributions to the CoreValve U.S. Pivotal Trial exploring the role
of transcatheter aortic valve replacement devices in patients with
severe aortic stenosis. This study promises to shi$ the paradigm of
patient management for this common type of valvular heart disease
by evaluating the safety and efficacy of the CoreValve device in
patients randomized to either transcatheter aortic valve implantation
with the CoreValve or surgical aortic valve replacement. As in the
EXCEL trial, the study requires close collaboration between cardiac
surgeons, interventional cardiologists, and other members of the
clinical staff. Along with David H. Adams, MD, Professor and Chair
of Cardiothoracic Surgery and national PI of the trial, Dr. Sharma
enrolled the first patient in the U.S. at Mount Sinai in 2010. Since
that time, additional subjects have been enrolled with the goal of
improving survival and quality of life over 12 months.
In addition, Michael C. Kim, MD, Director of the Coronary Care Unit
and of Medical Education in Mount Sinai’s Cath Lab, is investigating
strategies to preserve kidney function in patients undergoing
procedures involving administration of radiographic contrast
agents. Although many approaches have been tried in the past, the
only method proven effective is hydration, thus leading clinicians
to question which and how much fluid to use. In the double-blind,
multicenter BOSS Trial (Sodium Bicarbonate to Reduce the Incidence
of Contrast-Induced Nephropathy (CIN) in Patients with Chronic
Kidney Disease), patients undergoing catheter-based angiography
are randomized to intravenous saline or bicarbonate infusions to
assess the influence on renal function and patient outcomes. Dr. Kim
is the PI of a trial that is studying the optimum volume of fluid for
kidney protection, using the RenalGuard™ system to replace fluids by
matching urinary output.
Finally, SYMPLICITY-HTN3 is a multicenter trial evaluating renal
artery denervation with the Symplicity® Catheter System™, an
investigational approach to treatment of uncontrolled hypertension.
Dr. Dangas is collaborating with Lawrence R. Krakoff, MD, Professor
of Cardiology, and Jeffrey W. Olin, DO, Professor of Cardiology,
to assess this potentially life-changing strategy for the large
18
number of patients whose blood pressure is difficult to control
with available medication due to either inadequate efficacy or
compliance. Referrals from cardiologists, nephrologists, internists,
and general practitioners are essential for successful recruitment,
and physicians are encouraged to refer patients with uncontrolled
hypertension for consideration.
Mount Sinai Heart was the first
site in New York State to enroll
patients in the international
LEVANT-2 trial and leads the U.S.
in enrollment.
The Office of Interventional Cardiovascular Research and Clinical
Trials at Mount Sinai Heart works closely with referring physicians
to identify appropriate candidates for these and other ongoing
trials. If you have questions or are interested in learning more about
interventional cardiovascular research at Mount Sinai, please contact
Dr. Mehran or Theresa Franklin-Bond by phone at 212-659-9647 or
email at theresa.franklin-bond@mountsinai.org.
REFERENCES
1 Glickman SW, McHutchison JG, et al. Ethical and scientific implications of the
globalization of clinical research. N Engl J Med 2009;360:816–23.
2 Mehran R. Understanding and Reversing the Decline in US Clinical Research
participation, Scope of the Problem and Root Causes: CRF Perspective. 2010.
Presented at Transcatheter Cardiovascular Therapeutics (TCT) September 21–25, in
Washington, DC.
ABOUT THE AUTHOR
ROXANA MEHRAN, MD
is Professor of Medicine in Cardiology and
Director of Interventional Cardiovascular
Research and Clinical Trials at The Zena and
Michael A. Wiener Cardiovascular Institute of
the Icahn School of Medicine at Mount Sinai.
New Faces
The Zena and Michael A. Weiner Cardiovascular Institute is pleased to announce
the following newly appointed members of the cardiology full-time faculty.
Usman Baber, MD, MS, Assistant Professor of Medicine,
Cardiac Catheterization Laboratories
Dr. Baber is a graduate of University of Texas Southwestern Medical Center. He completed residency training at
Parkland Memorial Hospital in Dallas and fellowship training in cardiology and interventional cardiology at Mount Sinai.
He holds a master’s degree in biostatics from Columbia University. His main interests include coronary interventions,
outcomes in high-risk populations, and cardiorenal pathophysiology.
Jeffrey Bander, MD, Assistant Professor of Medicine,
Cardiac Catheterization Laboratories
Dr. Bander is a graduate of the Harvard Medical School. He completed residency training at the Columbia-Presbyterian
Hospital and fellowship training in cardiology and interventional cardiology at Mount Sinai. His interests include
complex coronary and peripheral interventions and coagulation abnormalities in patients with aortic valve disease.
Ira Blaufarb, MD, FACC
Dr. Blaufarb joined the CVI full-time faculty in August 2012 in the role of Associate Professor. Dr. Blaufarb received his
Bachelor of Science from Union College and his Doctor of Medicine from Jefferson Medical College. He completed
his residency at The Mount Sinai Hospital in New York and a fellowship in cardiology at the Albert Einstein College
of Medicine. He also recently completed an Executive MBA Program at NYU. Dr. Blaufarb is board certified in
Cardiovascular Disease and Nuclear Cardiology with a particular interest in women’s cardiac health.
Johanna Paola Contreras, MD, MS,
Assistant Professor of Medicine, Cardiology
Dr. Contreras is a graduate of the Harvard Medical School. She completed residency training in medicine and
fellowship training in cardiology at the Brigham & Women’s Hospital and in advanced heart failure and transplantation
at the Tufts University Medical Center. She holds a master’s degree in clinical translational science. Her interests
include novel community-based medical and device-based therapy for patients at all stages of heart failure and the
elimination of health care disparities.
Nicholas DuBois, MD
Dr. DuBois joined the CVI full-time faculty in August 2012 in the role of Associate Professor. Dr. DuBois graduated
magna cum laude from Harvard College before receiving his Doctor of Medicine from Cornell University Medical
Center in 1999. He completed his residency at Montefiore Hospital and his fellowship in cardiology at the Cleveland
Clinic Foundation. Dr. DuBois is board certified in Internal Medicine, Cardiovascular Disease, and Nuclear Cardiology
with a particular interest in managing hypertension and coronary artery disease.
Icilma V. Fergus, MD,
Assistant Professor of Clinical Medicine and Director,
Cardiovascular Disparities
A graduate of the State University of New York Downstate School of Medicine, Dr. Fergus completed residency training at
the Albert Einstein Medical Center and fellowship training in cardiology at Weill-Cornell Medical Center. She has served as
Chief of the Division of Cardiology at the Harlem Hospital, and as a member of the Board of Directors of the New York City
Affiliate of the American Heart Association and the Association of Black Cardiologists. Her interests include hypertension,
diastolic dysfunction, and heart disease in women and urban populations, particularly underserved communities.
Ramon Gendy, DPM
Dr. Ramon Gendy joined the CVI full-time faculty in August 2012 in the role of Instructor of the Practice of Orthopedics.
Dr. Gendy graduated from New York College of Podiatric Medicine (NYCPM) in 2007. After graduation, he joined North
General Hospital in New York to do his residency in Podiatric Medicine. He has also volunteered to travel to Honduras
and El Salvador as part of “The Baja Project for Crippled Children,” a medical mission team of podiatrists that operates
on children with foot deformities. Dr. Gendy joined a private podiatric practice in White Plains, New York until 2012
and ran his own private practice in Clifton, New Jersey from February 2011 until he joined our team at Mount Sinai in
August 2012. Dr. Gendy is board certified by the American Board of Wound Management with an interest in wound
management and limb salvage.
19
Harvey S. Hecht, MD, FACC, Professor of Medicine and Associate Director of
Cardiovascular Imaging
Dr. Hecht is a graduate of the Albert Einstein College of Medicine, where he completed residency training in internal
medicine prior to completing fellowship training in cardiology at the Beth Israel Hospital in Boston. He is a nationally
and internationally recognized expert in cardiac imaging and preventive cardiology. He established CT centers in
New Jersey and at the Lenox Hill Hospital, where he pioneered the development of coronary computed tomographic
angiography. He was the first president of the Society of Atherosclerosis Imaging, was a founding member of the
Society of Cardiovascular Computed Tomography, and he currently sits on its Board of Directors.
Kenneth John Herwig II, MD, Assistant Professor of Clinical Medicine,
Cardiac Catheterization Laboratories
Dr. Herwig is a graduate of Pennsylvania State University. He completed residency training at North Shore University
Hospital, and Cornell University Medical College, and fellowship training in cardiology at the Columbia-Presbyterian
Medical Center. His experience of more than 20 years in clinical medicine and cardiology has made him an integral
part of the offsite physician network.
Donna Ingram, MD, FACC
Dr. Ingram joined the CVI full-time faculty in August 2012 in the role of Associate Professor. Dr. Ingram received
a Bachelor of Science from Hobart-William Smith College in 1983. She then completed a Master of Science in
neurophysiology at the University of Texas (Houston). She received her Doctor of Medicine from New York Medical
College and went on to Mount Sinai Hospital for her residency in Internal Medicine. She completed her Cardiology
Fellowship at New York Hospital-Cornell University Medical Center in 1996. She is board certified in Cardiovascular
Disease with a particular interest in preventative cardiology.
Jacob S. Koruth, MD, Assistant Professor of Medicine,
Cardiac Electrophysiology Laboratories
Dr. Koruth is a graduate of Christian Medical College in India. He completed residency training at St. Vincent Hospital
and fellowship training in cardiology and electrophysiology at Creighton University, Massachusetts General Hospital,
and The Mount Sinai Hospital. His interests include ablation of atrial fibrillation and ventricular tachycardia and the use
of renal artery sympathetic denervation as an investigational treatment for hypertension.
Jason Kovacic, MD, PhD, Assistant Professor of Medicine,
Cardiac Catheterization Laboratories
Dr. Kovacic is a graduate of the University of Melbourne Medical School and earned a doctoral degree in cardiovascular
medicine at the Victor Chang Cardiac Research Institute. He completed residency and fellowship training in cardiology
at St. Vincent’s Hospital in Sydney, Australia, and fellowship training in interventional cardiology at Mount Sinai. Working
at National Institutes of Health, he discovered new pathways leading to arterial obstructive disease, and his ongoing
research program is exploring new therapeutic applications of stem cells for cardiovascular disease.
Marc A. Miller, MD, Assistant Professor of Medicine,
Cardiac Catheterization Laboratories
A graduate of Mount Sinai School of Medicine*, Dr. Miller completed residency and fellowship training in medicine,
cardiology, and cardiac electrophysiology at Mount Sinai. He is the principal investigator of an ongoing study
evaluating a step-wise algorithm for catheter ablation of post-myocardial infarction ventricular tachycardia
(STRATUM-VT) and recently completed a prospective study assessing the effects of percutaneous left ventricular
assist device support during ablation of ventricular tachycardia (PERMIT-1). His interests include atrial fibrillation,
ablation of ventricular tachycardia, the prevention of sudden cardiac death, and renal artery sympathetic denervation
for treatment of refractory hypertension.
* Now called the Icahn School of Medicine at Mount Sinai
David Anmoo Rim, MD, Assistant Professor of Clinical Medicine,
Cardiac Catheterization Laboratories
Dr. Rim is a graduate of the College of Medicine at Seoul National University in Korea. He completed residency
training in psychiatry at the Veterans Administration – New York Harbor Health System and Englewood Hospital and
fellowship training in cardiovascular medicine at the Jewish Hospital and Medical Center and Beth Israel Medical Center.
A practitioner for over 30 years, Dr. Rim has been recruited to join the offsite physician network and strengthen ties with
Korean communities in New York City.
20
Janice Scobie, MD, MS, Instructor in Health Evidence and Policy, Mount Sinai
Dr. Scobie is a graduate of University of Pennsylvania School of Medicine. She completed residency training at the
University of Pennsylvania and fellowship training in cardiology at Mount Sinai, and she holds a master’s degree in
health policy research. Her interests include cardiovascular disease prevention and health disparities, factors that
impact adherence to preventive therapy, community-based participatory research, and reduction of disparities in
access to health care.
Partho P. Sengupta, MBBS, MD, DM, FASE, Associate Professor of Medicine and
Director of Cardiac Ultrasound Research
Dr. Sengupta is a graduate of the All-India Institute of Medical Sciences in New Delhi. He completed residency and
fellowship training at Mayo Clinic and served as Director of Noninvasive Cardiology and Cardiac Imaging at the
University of California at Irvine. Widely recognized as an outstanding clinical investigator and educator, he is Associate
Editor of the Journal of American College of Cardiology – Imaging, a member of the Board of Directors of the American
Society of Echocardiography (ASE), and Chair of the 2013 ASE World Summit on Echocardiography.
Rony Y. Shimony, MD, FACC, Assistant Professor of Medicine,
Cardiac Catheterization Laboratories and Director,
Mount Sinai Heart and Vascular Center
Dr. Shimony is a graduate of Buffalo University and completed residency and fellowship training in cardiology at the Lenox
Hill Hospital. He is a leading clinical cardiologist with more than 25 years of experience in patient care and education and
has received numerous awards, including a special congressional recognition for outstanding service to the community.
His interests span all aspects of cardiology, including electrophysiology and arrhythmia device management.
Michael Alan Sicat, MD, FACC, Assistant Professor of Medicine, Cardiac
Catheterization Laboratories
Dr. Sicat is a graduate of the University of the East Ramon Magsaysay Memorial Medical Center in the Philippines. He
completed residency training in at Staten Island University Hospital and fellowship training in cardiology at the Saint
Vincent Catholic Medical Centers of New York. He serves as Faculty Cardiologist for Mount Sinai Heart in Staten Island.
Daniel E. Soffer, MD, FACC, FSCAI, Co-Director,
Carotid Endovascular Services, Cardiac Catheterization Laboratories
Dr. Soffer is a graduate of Ben Gurion University in Israel. He completed residency and fellowship training in cardiology at
Lenox Hill Hospital and training in interventional cardiology at the William Beaumont Hospital in Michigan. He was a twotime recipient of the Swiss Foundation Scholarship in the early 1990s and was named one of America’s top physicians by
Consumers’ Research Council of America. His interests include high-risk coronary interventions, carotid stenting, and limb
salvage procedures.
Jason Song, MD, FACC, Assistant Professor of Medicine,
Cardiac Catheterization Laboratories
Dr. Song is a graduate of Tufts University School of Medicine. He completed residency and fellowship training in
cardiology at Montefiore Medical Center. His interests include noninvasive cardiology, preventive cardiology, heart
failure, aortic disease, and peripheral vascular disease. Fluent in Korean, Dr. Song is part of the Mount Sinai outreach
program in Queens and other boroughs.
Nenad Trubelja, MD, FACC, Assistant Professor of Medicine and Director, NonInvasive Cardiovascular Imaging, Mount Sinai Heart and Vascular Center
Dr. Trubelja is a graduate of University of Zagreb School of Medicine in Croatia. He completed residency training at
New York University Medical Center and fellowship training in critical care medicine and cardiology at the MemorialSloan Kettering Cancer Center and Lenox Hill Hospital. His interests include general clinical cardiology, critical care,
echocardiography, and nuclear cardiology.
21
The Cardiovascular Research Institute
Expanding in the New Leon and Norma
Hess Center for Science and Medicine
BY ROGER J. HAJJAR, MD
In October, The Mount Sinai Medical Center completed construction of
the Leon and Norma Hess Center for Science and Medicine, a state-ofthe-art research and clinical facility that will increase the institution’s
research capacity by 30 percent. Since breaking ground in 2009, the
Hess Center has been one of the largest building projects in New York
City and one of the few research facilities to open anywhere in the
United States this year.
The Wiener Family Cardiovascular Research Center, part of Mount
Sinai Heart, is among the entities that will move to the Hess Center,
expanding from 10,000 to 25,000 square feet. This growth will allow
the Center to increase to 100 cardiovascular scientists, up from the
current 60 investigators, with the goal of identifying three new drugs
that will enter clinical trials over the next five years.
EXPANDING CARDIOVASCULAR RESEARCH
Two areas targeted for high-level recruitment include vascular
biology, with the goal of closely integrating clinical and basicscience efforts in vascular diseases, and regenerative medicine, with
a focus on cardiac stem cell biology that has a strong potential for
clinical translation.
The sleek, 10-story building, located on Madison Avenue between
101st and 102nd streets, will also house the Institute for Genomics and
Multiscale Biology, the Translational and Molecular Imaging Institute,
the Tisch Cancer Institute, and the Friedman Brain Institute. Clinical
facilities including the Derald H. Ru#enberg Treatment Center of The
Tisch Cancer Institute, Mount Sinai Primary Care Associates, and the
Mount Sinai Diabetes Center will also be located in the Hess Center
and in the adjoining 52-story Residential Tower.
Designed by Skidmore, Owings & Merrill, architects of the Willis
Tower in Chicago (o$en called the Sears Tower) and One World Trade
Center (formerly named the Freedom Tower) the six laboratory
floors are connected by a grand circular stairway that symbolizes
and enhances interdisciplinary collaboration and translation, as each
floor flows into a common area. Within each laboratory, scientists
have played key roles in designing space to accelerate scientific
advancement and optimize translation of basic research findings into
new cures for human disease.
During the last five years, the Cardiovascular Research Center has
recruited nine principal investigators who have developed pioneering
programs in a range of fields, such as first-in-man gene therapy trials
in heart failure, now in Phase 3. Under the direction of Jean-Sebastien
Hulot, MD, PhD, the cardiovascular pharmacogenomics program
recently uncovered a genetic profile that renders patients resistant
to treatment with clot-dissolving drugs following coronary stent
placement. By combining clinical and genetic risk factors, Dr. Hulot
and his team are now developing genomic-medicine approaches that
span multiple areas of cardiology.
22
The new, state-of-the-art Leon and Norma Hess Center for Science
and Medicine features a grand spiral staircase that is lined with wipe
boards and designed to facilitate translation. The 10-story building
increases Mount Sinai’s research capacity by 30 percent.
UNIQUE GRANT FOR GENE THERAPY RESEARCH
The National Institutes of Health (NIH) recently awarded the Research
Center a $10 million grant to develop cardiac gene therapy as a
treatment for heart failure, the only grant of its kind in the nation.
With an eye toward recruiting, developing and retaining top talent, the
Cardiovascular Research Center has established a rigorous training
program for junior investigators that resulted in 8 five-year mentored
career awards from the NIH.
ABOUT THE AUTHOR
ROGER J. HAJJAR, MD
is Director of the Wiener Family
Cardiovascular Research Center and is
an Arthur & Janet C. Ross Professor of
Medicine of the Icahn School of Medicine at
Mount Sinai
23
CME Calendar of Events
Continuing medical education is a priority at the Cardiovascular Institute, and these sessions provide an opportunity
for faculty and fellows to interact with visiting cardiologists. The institute sponsors nearly 50 lectures, conferences,
and academic rounds every month, and we invite you to share in these special educational events as o$en as you can.
For information about conference locations or an updated schedule, please contact Mayra Viruet at (212) 241-7784
(mayra.viruet@mountsinai.org).
Program Highlights: Cardiology Conferences
VISITING PROFESSORS
January 7, 2013
Eric Peterson, MD
Duke University
February 11, 2013
Mark Taubman, MD
University of Rochester
March 18, 2013
Kim Eagle, MD
University of Michigan
April 22, 2013
Rick Nishimura, MD
Mayo Clinic
May 20, 2013
David Pinsky, MD
University of Michigan
June 17, 2013
Mark Josephson, MD
Beth Israel
Daily/Weekly Conferences
MONDAYS
TUESDAYS
WEDNESDAYS
THURSDAYS
FRIDAYS
@ 7:45 am
Grand Rounds
@ 12 Noon
Electrocardiography
Conference
Alternate Wednesdays
@ 8 am
Advanced Core Curriculum
@ 7:15 am
Coronary Anatomy Lecture
3rd Tuesday @ 7:45 am
EPS Conference
1st Wednesday @ 12 Noon
Fellows Journal Review
@ 7:45 am
Fellows Rounds with
Valentin Fuster, MD, PhD
Alternating Fridays
@ 7:45 am
Journal Club
4th Tuesday @ 7:45 am
Cardiology M&M
Conference
3rd Wednesday @ 12 Noon
Cardiovascular Pathology
Conference
@ 12 Noon
Clinical Cardiology
Conference (Dr. J. Meller)
Monthly @ 12 Noon
Visiting Professor
Monthly @ 5 pm
Visiting Professor/
Controversies in Cardiology
4th Wednesday @ 12 Noon
Hemodynamics Rounds
Other Daily/Weekly Conferences
CATH LAB
Every 1st Monday @ 7:15 am
(3rd Monday if 1st Monday
is a holiday)
Cath Lab QA Meeting
Every 2nd Monday @ 6:30 am
(4th Monday if 2nd Monday is a
holiday)
Cath Lab Research Meeting
Every 4th Monday @ 7:15 am
Endovascular Case Discussion
Every 1st, 2nd & 5th Tuesday
@ 7:45 am
Cath Lab Morning Report
Every 1st Tuesday @ 7:15 am
Interventional Board Review
Every 2nd Tuesday @ 7:15 am
Interventional Journal Club
Every 3rd Tuesday @ 8 am
Interventional Live Webcast
Every 4th & 5th Tuesday @ 7:15 am
Interventional Case Presentation
Every 4th Tuesday @ 7:45 am
Cardiology M&M Conference
24
Every 1st Wednesday @ 7:15 am
Endovascular Lecture Series
Every 1st, 3rd, 4th & 5th Thursday
@ 7:15 am
Coronary Anatomy Rounds
Every 2nd Thursday @ 7:15 am
Cardiac Hemodynamic Rounds
Every 1st & 3rd Friday @ 6:30 am
Interventional Publications Meeting
Every 2nd Friday @ 7:15 am
High-Risk CT & PCI
Conference
ANESTHESIOLOGY
GRAND ROUNDS
Wednesday @ 6:45 am
Clinical Case Conference
CARDIOTHORACIC SURGERY
2nd Wednesday @ 8 am
Quality Assurance
Conference
1st, 4th & 5th Wednesday @ 8 am
Clinical Conference
PEDIATRIC CARDIOLOGY
Mondays and Fridays @ 8:30 am
Multidisciplinary Meeting
1st Monday @ 4 pm
ICU Didactics
2nd Monday @ 4 pm
MRI
@ 3 pm Cardiothoracic Conf Div Bus
Meeting
3rd Wednesday
@ 8 am Pathology
@ 3 pm Cardiothoracic Conf/M&M
@ 5 pm Echo Didactics
3rd Monday @ 4 pm
ICU/Core Curriculum Lecture
4th Wednesday
@ 8 am Journal Club
@ 3 pm Cardiothoracic Conf
@ 5 pm Echo Didactics
1st Tuesday @ 8:30 am
Echo Lab Business Meeting
Thursdays @ 8 am
Pediatric Grand Rounds
2nd Tuesday @ 8:30 am
Echo Didactics/Protocols
3rd Tuesday @ 8:30 am
Echo Didactics/Protocols
4th Tuesday @ 8:30 am
Echo Didactics/Q & A
1st Wednesday
@ 8 am Core Lecture
@ 3 pm Cardiothoracic Conf
@ 5 pm Echo Didactics
2nd Wednesday
@ 8 am Cath/EP
VASCULAR SURGERY
Monday @ 7 am
Core Curriculum
Monday @ 7:30 am
Case Presentations
4th Mondays @ 7 am
Journal Club
Mount Sinai Heart
Telephone Numbers (area code 212)
Director, Mount Sinai Heart
Valentin Fuster, MD, PhD
Director, Clinical &
Interventional Cardiology
241-7911
Electrophysiology
Vivek K. Reddy, MD
241-7114
Samin K. Sharma, MD, FACC 241-4021
Hypertension
Lawrence R. Krakoff, MD
410-1540
Cardiac Anesthesiology
David L. Reich, MD
241-7467
Heart Failure &
Transplantation
Sean P. Pinney, MD
Anelechi Anyanwu, MD
212-7300
659-6811
Cardiac Health Program
John Corrente
241-8597
Lipid Management
Donald A. Smith, MD, MPH
241-7651
Cardiothoracic Surgery
David H. Adams, MD
659-6800
Medical Education
Martin E. Goldman, MD
241-3078
Cardiac Nursing
Linda Paxton, MBA, BSN
241-7673
Metabolic Disorders
Robert S. Rosenson, MD
659-8731
Cardiology Administration
241-4030
Nuclear Cardiology &
Stress Testing
Milena J. Henzlova, MD
241-1718
Cardiology Appointments
427-1540
Pediatric Cardiology
Ira A. Parness, MD
241-8662
Cardiomyopathy Program
Jill Kalman, MD
241-0511
Pulmonary Hypertension
Ajith, Nair, MD
241-7300
Cardiovascular MRI &
CT Imaging
Javier Sanz Salvo, MD
241-3000
Telemetry Unit
Joseph Sweeny, MD
241-7016
Catherization Laboratories
Annapoorna S. Kini, MD
241-0935
Transfer a Patient
Clinical Trials Unit
Michael J. Domanski, MD
659-9181
Vascular Laboratory
Jeffrey W. Olin, DO
241-6773
Consultation Service
David A. Vorchheimer, MD
241-4258
Vascular Medicine
Jeffrey W. Olin, DO
241-9454
Coronary Care Unit
Umesh K. Gidwani, MD
241-7222
Vascular Surgery
Peter L. Faries, MD
241-0756
1-885-MS HEART
Vein Program
Windsor Ting, MD
241-5315
Women’s CARE
Mary Ann McLaughlin, MD
241-3340
CVI Central Scheduling
(Non-invasive testing and CT & MRI
Cardiovascular Imaging)
Development
Karen Colimore
731-7437
Echocardiography
Farooq A. Chaudhry, MD
241-7784
1-800 TO SINAI
25
Pulse
Mount Sinai Heart
The Mount Sinai Medical Center
One Gustave L. Levy Place, Box 1030
New York, NY 10029
For more on the new Leon and Norma Hess Center for Science and Medicine, see page 22.
© 2013 The Mount Sinai Medical Center | Marketing & Communications | !.mountsinai.org