Download The NewYork-Presbyterian/Columbia Valve Center

College of Physicians
and Surgeons
In affiliation with
NewYork-Presbyterian Hospital
October, 2011
EMILE BACHA, MD
Calvin F. Barber Professor of Sugery
Chief, Division of Cardiothoracic Surgery
NewYork-Presbyterian Hospital
Department of Surgery
Division of Cardiothoracic Surgery
Morgan Stanley
Children’s Hospital of New York
3959 Broadway, CHN-274
New York, NY 10032
212.305.2688 Tel
212.305.4408 Fax
[email protected]
Earlier this year, I was privileged to take the helm from Dr. Craig Smith, guiding a team of gifted surgeons who
are national leaders in virtually every sub-discipline of cardiac and thoracic surgery. We continue to offer patients the
most advanced procedures available and also work closely with cardiologists, pulmonologists and other specialists to
provide the highest level of integrated, multidisciplinary care.
I am delighted to take this opportunity to report on the latest advances made by the Section of Cardiac Surgery at
NewYork-Presbyterian Hospital/Columbia University Medical Center and to announce that Dr. Michael Argenziano has
been named Section Chief of Cardiac Surgery.
NewYork-Presbyterian/Columbia has a track record of innovations and exceptional outcomes across the board.
We are known for our “firsts” in many areas such as:
• Heart failure, mechanical support devices, and transplantation
• Aortic diseases
• Mitral and aortic valve repair
• Hybrid and endovascular therapies
• Minimally invasive and robotic cardiac surgery
• Surgery for atrial fibrillation
• Adult congenital heart disease
• Coronary artery bypass, including off-pump techniques
The newly opened state-of-the-art facilities at the NewYork-Presbyterian Hospital Vivian and Seymour Milstein
Family Heart Center have also allowed us to expand our capabilities on many fronts.
The NewYork-Presbyterian/Columbia Valve Center
This fall, we are partnering with Columbia’s Center for Interventional Vascular Therapy (CIVT) to launch the
first multidisciplinary program for valve patients, providing surgical, interventional and hybrid options for a variety
of valve conditions. Our cross-disciplinary model is as revolutionary as our new technology in terms of advancing
patient care.
Aortic Valve Disease: The initial PARTNER trial (Placement of AoRTic TraNscathetER Valve), led by Dr. Craig
Smith is now completed. As you know, approximately 300,000 patients in the United States have aortic stenosis
and, about one-third of these patients are considered too sick or too old to undergo surgical replacement.
The PARTNER trial compared transcatheter aortic valve replacement (TAVR) with medical treatment, including
balloon valvuloplasty, in patients deemed too high risk for conventional surgical valve replacement. At the oneyear mark, patients who received the implant showed a 20 percent improvement in survival. They also experienced
fewer hospitalizations and had significant improvement in symptoms as well as quality of life. A second trial
showed that in patients at high risk for conventional surgery TAVR was equivalent to surgery in terms of survival,
with less recovery time. Dr. Mathew Williams will oversee Phase II of this study, focusing on moderate-risk patients.
Mitral Valve Disease: Our surgeons and cardiologists are among the most experienced in the world in minimally
invasive and percutaneous mitral valve repair. In fact, the patent creating this field was written by our surgeons.
As one of the largest enrolling centers in EVEREST II (The Endovascular Valve Edge-to-Edge Repair Study),
Columbia’s physician-scientists have been investigating a non-invasive, percutaneous approach using the
Evalve clip for mitral valve repair. During a weekly multidisciplinary mitral valve clinic, patients are evaluated
for candidacy by a team of surgeons, cardiologists and echocardiographers. In this way, patients are treated
according to their individual diagnosis and valve pathology and receive highly individualized care.
Hybrid Procedures: Columbia is one of a few medical centers in the country performing hybrid procedures, and
we are fortunate to have on staff one of the only practitioners in the U.S. trained in both cardiac surgery and
percutaneous approaches. Dr. Mathew Williams has a dual appointment in interventional cardiology and CT
surgery. While valve and coronary disease can now be approached by minimally invasive surgery with stenting,
multivessel disease can be addressed with a hybrid procedure that begins with stenting in the interventional cardiology lab and is followed by a minimally invasive bypass. At our new hybrid procedures facility, we have begun
training the next generation of surgeons in these innovative techniques.
Adult Congenital Heart Disease: Due to markedly improved outcomes in pediatric cardiac repairs, more than a
million adults in the U.S. are expected to be living with repaired heart defects in the next few years. These patients,
whose conditions can sometimes be quite complex, can benefit specifically from multidisciplinary expertise,
hybrid therapies, and valve repairs. Newly diagnosed atrial septal defects can be treated with minimally invasive
and/or transcatheter therapies.
Heart Failure, Mechanical Support Devices and Transplantation
NewYork-Presbyterian Hospital/Columbia remains one of the two largest heart transplant centers in the world,
performing between 85 and 100 transplants annually.
In March 2009, the Centers for Medicare and Medicaid Services (CMS) Joint Commission approved NewYorkPresbyterian Hospital/Columbia as a VAD destination therapy site. Columbia is now one of the largest centers for
mechanical circulatory assist devices, implanting 60-80 LVADs a year as well as 50 short-term devices such as the
CentriMag® ventricular assist device and the ECMO bridge-to-transplant device.
Earlier this year, Drs. Yoshifuma Naka and Hiroo Takayama successfully implanted the first total artificial heart,
the SynCardia device. SynCardia provides the body with immediate, safe blood flow of up to 9.5 L/min through both
ventricles, and has the shortest waiting-time-to-transplant rate of any device.
Innovations in Aortic Surgery
Dr. Allan Stewart, Director of Aortic Surgery, has developed one of the largest aortic practices in North America.
Patients are seeking his expertise in aortic valve-sparing root replacements and other surgeries for aortic disease. His
multidisciplinary team tailors a treatment plan to each patient’s needs. That plan may involve surveillance, minimally invasive surgery, traditional surgery or endovascular repair. We are also known for our expert treatment of aortic
aneurysms, and for our novel valve sparing procedures.
Among Dr. Stewart’s innovations is the Columbia BioRoot, a stentless pericardial valve sewn into a Valsalva™
graft that replicates the proper anatomy of the aortic root. This provides a new option for patients requiring aortic
root replacement. To date, with well over 400 aortic valve procedures, our mortality and stroke rate is zero.
Minimally Invasive Cardiac Surgery and Atrial Fibrillation Ablation
Since 2000, we have performed over 1400 minimally invasive cardiovascular operations. These comprise a wide
range of procedures, including mitral valve repair and replacement, aortic valve surgery, coronary artery bypass, atrial septal defect repair, cardiac resynchronization, cardiac tumor resection and atrial fibrillation ablation. Minimally
invasive cardiac operations may be performed by a variety of approaches including mini-thoracotomy, partial sternotomy or purely endoscopic procedures. While each of these is suited to a specific operation, all share the common
feature of avoiding a full sternotomy incision.
Since 1999, under the leadership of Dr. Michael Argenziano, we have performed over 900 operations for atrial fibrillation using a variety of novel approaches and technologies. We currently favor an off-pump, beating heart minithoracotomy approach for early paroxysmal atrial fibrillation, and a minimally invasive full bi-atrial Maze procedure
for more advanced cases. In most patients, these operations are performed without the invasiveness of a sternotomy.
A Multidisciplinary Approach to Hypertrophic Cardiomyopathy (HCM)
A new multidisciplinary program for Hypertrophic Cardiomyopathy is led by Drs. Mathew Maurer, (cardiologist), Yoshifumi Naka and Hiroo Takayama (cardiac surgeons), Susheel Kodali (interventional cardiologist), Jonathan
Lu (electrophysiologist), and Wendy Chung (geneticist).
While HCM is prevalent, few centers in the U.S. have the depth and breadth of cardiac expertise to evaluate and
treat these patients along the full spectrum of their condition. Our team provides a comprehensive service for HCM
patients including medical management, pacemaker/defibrillator implantation, alcohol septal ablation, modified and
extended surgical septal myomectomy, genetic testing, and family-based care. End-stage disease may be treated by
ventricular assist device implantation or heart transplantation.
To refer a patient to our bi-monthly HCM clinic, please call 212-305-6380.
Research Studies
The Division of Cardiothoracic Surgery has a long history of success in basic and translational research and, is
currently involved in many investigational protocols focusing on important problems in cardiovascular disease management, patient selection, procedures and drug and device development.
In recognition of our track record in clinical research, in 2007 our group was selected to be a member of the
Cardiothoracic Surgical Trials Network (CTSN). This is a consortium of ten clinical centers renowned for their leadership in cardiothoracic surgery and its members have been selected from hundreds of applicants by the National
Heart, Lung, and Blood Institute of the NIH. Funded by the NIH via the U01 grant mechanism ($35 million over five
years), the CTSN develops and conducts investigations of novel surgical techniques, technologies and pharmaceuticals to combat cardiovascular disease. Dr. Michael Argenziano, Section Chief of Cardiac Surgery and director of
our clinical research organization, serves as the Network PI for the Columbia site. The CTSN is currently enrolling
patients into the following multicenter trials:
• Mitral valve repair vs. replacement in patients with severe ischemic mitral regurgitation
• Mitral valve repair in patients with moderate ischemic mitral regurgitation
• Atrial fibrillation ablation in patients undergoing surgery for mitral regurgitation
• Stem cell therapy in patients receiving LVAD for end-stage heart failure
• Incidence and ramifications of infections in patients undergoing cardiac surgery.
For more information about these trials, contact Dr. Argenziano at 212-305-5888
Ventricular Assist Device (VAD)/Extracorporeal Membrane Oxygenation (ECMO) Trials
Columbia is a leading center for clinical trials of devices for use in bridge-to-transplant and as destination therapy.
Our HeartMate® II bridge-to-transplant (BTT) treatment trial has resulted in FDA approval for BTT use of the
device. HeartMate II® is now commercially available as destination therapy.
We are now investigating HeartWare® VAS, a new device with a magnetically levitated implantable centrifugal
blood pump, as a destination therapy. Its small size allows implantation without creation of a pocket. The
ENDURANCE trial is a prospective, randomized, unblinded, multi-center, non-inferiority evaluation of the
HeartWare® VAS versus HeartMate® II.
In addition, we are participating in a multicenter trial for the Freedom® driver, a small and mobile controller
for patients who have received the Syncardia Total Artificial Heart. This trial will also confirm that patients and lay
caregivers can be trained to manage the Freedom Driver System safely outside the hospital.
Other ongoing studies include:
• Syncardia Post Market Surveillance to demonstrate that the results of the original pivotal clinical investigation
of the Syncardia Total Artificial Heart are generalizable to new clinical sites
• The first U.S. feasibility study of the CARDIOHELP ECMO system, a compact and portable device that
allows us to transport extremely sick patients. This trial is an outgrowth of use of ECMO for the treatment of
cardiogenic shock
• The CentriMag VAS Pivotal Trial to evaluate the safety and effectiveness of the Levitronix® CentriMag®
VAS to support patients with cardiac dysfunction and failure-to-wean from cardiopulmonary bypass.
This ECMO device was developed to treat patients who can't be moved from the operating room without
mechanical circulatory support
• A Cohort Study of Patients with Ventricular Assist Device and their Family Caregivers to Assess Symptoms
• A trial to evaluate the safety and effectiveness of the Duraheart® Left Ventricular Assist System for bridgeto-transplant
• The BIPACS trial is testing the benefits of temporary biventricular pacing for left ventricular dysfunction over
the first day after cardiac surgery. Similar studies are being developed and tested for right ventricular dysfunction as well as cardiac dysfunction in congenital heart disease.
We are also participating in two important trials that may alter the management of patients with end-stage heart
failure. We will soon be enrolling patients to test the hypothesis that VAD therapy improves both survival and quality of life in advanced heart failure patients who are not inotrope-dependent or exercise-intolerant and who have no
signs of malnourishment, end-organ damage, and immobility. To that end, we will be testing HeartWare® VAS in the
REVIVE-IT trial (Randomized Evaluation of VAD InterVEntion before Inotropic Therapy) and HeartMate® II in
ROADMAP trial (Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical
Management in Ambulatory Heart Failure Patients).
For more information about our VAD studies, please contact Dr. Yoshifumi Naka at 212-305-0828 or
Kathy Idrissi MSN, at 212-305-6003.
In addition to our many clinical innovations, Dr. Mehmet Oz continues to spend part of his time advocating for
preventive approaches to general health in a variety of popular media outlets. His multiple Emmy Award winning
daily television show has continued to grow in prominence and boasts the largest viewership of any daytime
syndicated program. Tickets for your staff or families are available at www.doctoroz.com.
To learn more about any of the above initiatives, or to schedule grand rounds or an evening of clinical discussion,
please contact us at 1-800-543-2782 or email us at [email protected]. For details about our clinical programs and research protocols, please visit www.columbiaheart.org.
In summary, I couldn’t be more proud of the cardiac team at NYP/Columbia. We feel we have assembled the
finest multidisciplinary group of physicians and look forward to partnering with you in the care of your patients.
Sincerely,
Emile Bacha, MD
Calvin F. Barber Professor of Surgery
Chief, Division of Cardiothoracic Surgery
NewYork-Presbyterian Hospital