Clinicians

MSCHONY Outcomes Surpass All in NY State

by Columbia Surgery on January 11, 2012

Morgan Stanley Children's Hospital of New York

The Department of Surgery is pleased to announce that Morgan Stanley Children’s Hospital of New York (MSCHONY) has been recognized by the New York State Department of Health (NYS-DOH) in its most recent report on pediatric congenital cardiac surgery for having the lowest risk-adjusted mortality rate (RAMR) in the state. MSCHONY’s pediatric cardiac surgery program was the only hospital in the New York State to have a RAMR significantly below the state average, and the only center to receive recognition for its exceptional outcomes for the past twelve years.

Congenital heart defects encompass a wide range of abnormalities present at birth. According to the National Heart Lung and Blood Institute, these are the most prevalent forms of birth defects, affecting approximately 35,000 newborns annually, or 8 in 1,000 infants. Approximately .2 to .3 percent of cases require corrective surgery.

The “Pediatric Congenital Cardiac Surgery in New York State, 2006-2009” report uses statistical methodologies to standardize data on all pediatric congenital cardiac surgeries statewide, and then compares the mortality rates of each hospital to the statewide risk-adjusted average. This enables outcomes at all ten hospitals in the state approved to perform pediatric cardiac surgery to be compared, while accounting for differences in outcomes based upon various risk factors and other demographic determinants that may influence patient outcomes. In particular, this adjusts for differences in outcomes for hospitals that perform a higher volume of high-risk procedures.

The statewide mortality rate from 2006-2009 was 3.35 percent for all pediatric congenital cardiac surgery patients. At MSCHONY, the risk-adjusted mortality rate was the lowest in the state, at 1.95 percent. The report also indicates that MSCHONY performed 1,624 pediatric congenital cardiac surgeries between 2006 and 2009, or more than twice the number of procedures performed by the second highest volume surgical center.

In this three year period, 31.5 percent of all pediatric congenital cardiac surgeries in New York State were performed at MSCHONY. While experience alone is not a determinant of successful outcomes, MSCHONY has consistently demonstrated superior outcomes along while demonstrating expertise and extensive experience with a wide range of procedures, including high-risk surgeries.

For more information about pediatric congenital cardiac surgery, please visit New York-Presbyterian Morgan Stanley Children’s Hospital of New York (MSCHONY).

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Drs. Brodie and Bacchetta publish review article on ECMO in NEJM

Matthew Bacchetta, MD, MBA, MA

Matthew Bacchetta, MD, MBA, MA

NewYork-Presbyterian Hospital/Columbia University Medical Center has officially launched the Center for Acute Respiratory Failure, which offers expertise in using lung bypass technology to help adult patients whose lungs are rapidly shutting down. Already one of the largest centers in the world for respiratory as well as cardiac failure in adults, NewYork-Presbyterian/Columbia is expanding further due to its new ECMO program.

Launch of the center coincides with publication of an article Extracorporeal Membrane Oxygenation for ARDS in Adults in the November 17, 2011 issue of New England Journal of Medicine by the center’s co-directors, Daniel Brodie, MD, and Matthew Bacchetta, MD. This important article explains how extracorporeal membrane oxygenation (ECMO) can take over the function of the lungs in adults with acute respiratory distress syndrome (ARDS) to give severely damaged lungs time to rest and heal.

In addition to improving ECMO techniques in order to reduce side effects, Drs. Brodie and Bacchetta have also devised a mini-ECMO unit that can be used to transport critically ill patients to the Center. These advances represent a dramatic improvement in the treatment of patients with ARDS, which can be associated with high mortality rates.

Daniel Brodie, MD

While ECMO is used at other centers, very few hospitals in the world treat as many adult patients with ECMO. NewYork-Presbyterian/Columbia treats about 70 a year, and that number is growing. More unusual in the U.S. is the team’s ability to travel to area hospitals, place patients on their adapted ECMO unit, and transport them to the Center. This allows the team to bring patients into NYP/Columbia who would otherwise be too sick to be transported by ambulance, so that they can receive ECMO and other advanced respiratory care. According to Dr. Brodie, “Evidence is accumulating that referring patients with severe respiratory failure to a center capable of performing ECMO is beneficial for these patients.”

This innovative application of ECMO to patients with ARDS has been highly successful: every adult ECMO patient treated here has recovered and is now thriving. Click here to read their stories.

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Kenneth P. Olive, PhD

Kenneth P. Olive, PhD

NewYork-Presbyterian Hospital/Columbia University Medical Center is participating in an important trial of a new drug known as IPI-926 that could improve survival outcomes in patients with metastatic pancreatic cancer. Kenneth P. Olive, PhD, Assistant Professor of Medicine and Pathology and member of the Pancreas Center, led the original basic science study that provided the scientific foundation for the clinical use of this drug.

According to Dr. Olive, pancreatic tumors build protective walls around themselves that prevent chemotherapy from getting into the tumor. IPI-926 works by inhibiting a tumor’s ability to build and maintain that wall. With this wall weakened, already existing therapies could prove much more effective, doing more damage to the cancer and less to the patient. If it turns out that other cancers behave in a similar manner, IPI-926 could potentially improve the outcomes of tens of thousands of cancer patients around the world — which explains the excitement that the latest developments in IPI-926 research generated when presented at the American Society of Clinical Oncology (ASCO) in early June.

An early trial designed primarily to test the toxicity of IPI-926 in combination with gemcitabine (the national standard-of-care treatment for pancreatic cancer) found a very positive early outcome. In this Phase I-b trial, 31% of patients with metastatic pancreatic cancer had partial responses after treatment with IPI-926 + gemcitabine, which compares favorably with the historical rate of 5% in patients treated with gemcitabine alone. Even more notably, the regimen was extremely well-tolerated with very little additional toxicity over gemcitabine alone.

With these early promising results, Infinity Pharmaceuticals, the company behind the IPI-926 research, is now conducting a larger Phase II trial across 29 institutions to further evaluate the drug’s efficacy. M. Wasif Saif, MD, MBBS, and Dr. Olive are directing the NYP/Columbia arm of this 118-patient, randomized, double-blind trial.

It’s still too early to say what the results of this important study will be, but Dr. Olive believes that the level of hope in the pancreatic cancer research field is higher than it has been in many years. Pancreatic cancer outcomes have scarcely improved in the past 40 years — but that may soon change, he says. “This is an extremely dynamic and exciting time in pancreatic cancer research. There is so much happening right now, and this is one example. There are many other investigative drugs working their way through research pipeline and into the clinical trial process. My level of hope and enthusiasm for a breakthrough in pancreatic cancer is tremendously elevated. We are starting to make inroads against this devastating disease, which has not been true for decades.”

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As reported in the New York Times June 5, 2011, the drug exemestane (Aromasin) was found to significantly reduce the occurrence of breast cancer in post-menopausal women at high risk of developing breast cancer. Not only was the risk of breast cancer reduced by 65% in the study, but the drug was found safe and more tolerable than other drugs in its class.

The ensuing media attention has generated a flurry of questions among patients with breast cancer, many of whom are asking whether they can take exemestane instead of tamoxifen, with the hope of avoiding the side effects associated with the latter medication.

To clear up some common misconceptions and put this study in perspective, Sheldon Feldman, MD, Chief of the Breast Surgery Section at NewYork-Presbyterian/Columbia, talked with the Columbia Surgery blog.

Q: What did this study find?

Dr. Feldman: The study included about 4500 postmenopausal women at moderately high risk of developing breast cancer. Half the participants took exemestane and half took a placebo for three years. At that point, 11 of the women taking exemestane had developed breast cancer, and 32 taking the placebo had developed breast cancer. That translates to a 65% reduction in risk associated with this medication.

The drug also reduced the incidence of precancerous lesions including ductal carcinoma in situ, lobular carcinoma in situ, atypical ductal hyperplasia, and atypical lobular hyperplasia.

Q: What kind of drug is exemestane?

Dr. Feldman: Exemestane is an aromatase inhibitor, which are agents that suppress estrogen production and inhibit the development of breast cancer after menopause.

After menopause, a woman’s body makes very little estrogen. The little that is made is produced by the adrenal glands, which make testosterone, and then the aromatase enzyme converts the testosterone into estrogen. Aromatase inhibitors block this conversion, thereby shutting of the main source of estrogen production in postmenopausal women.

Before menopause, the body is flooded with estrogen because the ovaries are still working. So if aromatase inhibitors like exemestane are given to premenopausal women, the drug won’t stop the estrogen production from the ovaries.

Q: What does this study suggest for women interested in preventing breast cancer?

Dr. Feldman: This is the question that needs to be carefully looked at, because there are some common misconceptions arising in the wake of this study.

First, women need to understand that exemestane is only effective after menopause. If women take it before menopause, they will not receive the estrogen-suppressing benefit.

Second, this study investigated using exemestane for preventing breast cancer from occurring in the first place — not treating it after it has been diagnosed. Exemestane has previously been shown to be effective to treat women with breast cancer, and like tamoxifen, exemestane is commonly used for treatment. The importance of this study is that it provides clear evidence about its value in preventing breast cancer as well.

Third, the patients in the exemestane study were at higher risk of developing breast cancer than the general population, based on a risk assessment model called Gail, but the study did not include women who have BRCA1 or BRCA2 gene mutations, who are at the highest risk.

Q: Is exemestane effective in preventing all forms of breast cancer?

Dr. Feldman: In short, no. There are many different types of breast cancer. This study found exemestane was only effective in preventing estrogen receptor or progesterone receptor positive breast cancers, which are easier to treat and less dangerous than other types of breast cancer. The drug had no significant effect in preventing other types of breast cancer.

Clearly it is an important thing to prevent any type of breast cancer, but in the long term no survival benefit has been demonstrated with the use of exemestane.

If we could find ways to prevent the more aggressive forms of breast cancer with the worst prognosis, such as HER2 or triple-negative breast cancer, then we would be better able to improve survival rates associated with breast cancer. The ‘home run’ in breast cancer research will be to develop an agent to prevent estrogen receptive negative breast cancer and to be able to offer that prevention to younger women with many years of potential future risk.

Q: How does exemestane compare to tamoxifen and raloxifene?

Dr. Feldman: Historically, tamoxifen was found to be effective in preventing breast cancer because women who took it for treatment of cancer in one breast were found to have a significantly reduced risk of developing cancer in the opposite breast. We know that taking tamoxifen before menopause, earlier in life, has a long-term protective effect, and that tamoxifen and raloxifene are effective in preventing breast cancer in both pre- and post-menopausal women. Exemestane, on the other hand, is effective only after menopause. It can’t be used to protect women during the important years before menopause, but only in their later years.

The research so far indicates that exemestane appears to be safer than tamoxifen and raloxifene, which are associated with a higher risk of endometrial cancer and blood clots, as well as effects such as fatigue and depression. Because of these risks and effects, many women are reluctant to take tamoxifen and raloxifene. Although bone loss has been a concern with other aromatase inhibitors, exemestane did not produce any measurable changes in bone health. Its main side effects included aches, hot flashes, joint pain, and fatigue – but overall these effects were less problematic than those associated with tamoxifen. So overall, exemestane’s safety profile appears to be very reassuring.

Q: How do you counsel women about preventing breast cancer?

Dr. Feldman: Reducing risk for breast cancer may involve many options. Lifestyle choices, especially diet and weight management, are extremely important. I counsel women to maintain a healthy weight, because fat cells have estrogen receptors in them, and more fat cells promote breast cancer. Good nutrition and good quality food are both very important.

When we are considering methods of prevention, medications have to be nontoxic and have acceptable side effects, or women will not take them. If there were a completely nontoxic pill to prevent breast cancer, people would take it – but there isn’t, so the better option is to exercise and eat well.

Beyond lifestyle measures, we can offer many options, both medical and surgical. Exemestane is one more tool we now have available, which may be a good choice for post-menopausal women at high risk based on their family history. Women at very high risk, such as those with BRCA1 or BRCA2 gene mutations, may choose surgical prevention; at the Breast Surgery Section we have great surgical techniques including excellent reconstructive methods, and the rate of risk-reducing mastectomies has been increasing.

In short, anyone concerned about risk of breast cancer should come to NYP/Columbia for an evaluation and to learn about the options for prevention.

Full text of the study on exemestane is available at the New England Journal of Medicine: Exemestane for Breast-Cancer Prevention in Postmenopausal Women.

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A special program at NYP/Columbia Department of Surgery Residency Program allows surgery residents to gain valuable surgical experience in underserved countries. The program has come a long way from its earliest ventures; it is now a major, well-funded effort regularly sending residents all around the world including Korea, Brazil, Ethiopia, Kenya, India, and many other countries.

Mark Hardy, MD

Mark Hardy, MD

It began in 2007, when Mark Hardy, MD, FACS was the Residency Program Director and Vice Chair for Education of the Department of Surgery. Dr. Hardy felt strongly that the residents should have more experience with open operations than they were likely to get at NYP/Columbia, where the vast majority of surgeries are performed laparoscopically. He appealed to the hospital for salary and insurance support, which was arranged by Dr. Richard Liebowitz, the Designated Institutional Official for GME. The Chair of Department of Surgery, Craig Smith, MD, agreed to provide financial support for residents’ travel and living expenses. Before long, Dr. Hardy was sending or taking with him residents to complete six- to eight-week surgical rotations in foreign hospitals that were generally not equipped with the kind of advanced laboratory or radiologic support available at home. “The residents were forced to arrive at a diagnosis without the aid of technology—using their hands and brains,” as Dr. Hardy put it.

The hospital’s arrangement with participating countries is “a two-way education street with benefit to both parties,” Dr. Hardy explains. NYP/Columbia residents and faculty teach foreign residents and staff to perform some of the newest surgical and monitoring techniques developed back home. In return, residents are not only given the invaluable opportunity to perform many open surgeries supervised by local surgeons, but they are also exposed to surgical diseases with which they have little familiarity, such as huge substernal goiters, tissue destructive infections, typhoid bowel perforations, and unusual traumas such as crocodile bites.

The latest developments in the project have included visits by foreign faculty from the underserved countries as observers to NYP/Columbia, so they may directly observe modern surgical approaches and import them to their home countries when appropriate. The recently established Hallym-Columbia International Surgical Education Fund by Dr. Dai-Won Yoon, MD, PhD, Chairman of the Board of Trustees of Ilsong Educational Foundation of Korea, will support the exchange of NYP/Columbia and Korean Hallym University surgical faculty with the local senior surgeons in the underserved nations. In addition, the American Board of Surgery and the RRC (Resident Review Committee) have decided to selectively approve some of the resident foreign country rotations and even accredit appropriately supervised cases performed by both PG4s and PG5s at foreign institutions which meet strictly defined conditions.

“I am very pleased by these developments and the progress that has been made in the field of global surgical training,” says Dr. Hardy. “Although there is still much to be accomplished, as the foreign surgical resident and faculty rotation program continues to expand, the Department of Surgery is swiftly becoming a truly global enterprise with many goodwill ambassadors who both learn and teach, as well as provide necessary surgical care to those who need it most.”

Mark Hardy, MD, FACS, is Auchincloss Professor of Surgery at the Columbia University College of Physicians and Surgeons, and Director Emeritus and Founder of Renal and Islet Transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center.

Related Link:
International Program Lets Columbia Surgical Residents Experience Global Surgical Care

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Date: Friday, November 18, 2011
Time: 12:00 pm – 5:15 pm
Location: Columbia University Medical Center, Alumni Auditorium, Black Building, 650 West 168th Street, New York, NY 10032
Directors: Sheldon M. Feldman, MD, FACS and Dawn L. Hershman, MD, MS
Register: Nina Scatton, Program Coordinator at 201.346.7009,
njs2144@columbia.edu
, online, or by mail.

Breast Cancer Management 2012

Breast Cancer Management 2012

This November, the NewYork-Presbyterian/Columbia University Department of Surgery Clinical Breast Cancer Program is reaching out to a broad range of clinicians to attend the Breast Cancer Management 2012 CME.

The afternoon of lectures and case studies is an invaluable opportunity to learn about the latest progress in breast cancer management and is open to all clinicians who take part in the care of breast cancer patients. Presentations will highlight key components of the multidisciplinary treatment of patients with breast cancer, updating attendees on the implications of active clinical trials throughout the medical community.

Physicians at the forefront of breast cancer research will present on cutting edge developments in prevention, diagnosis and treatment, spanning the disciplines of surgery, medical oncology, radiation, radiology, pathology and psychology. Speakers will highlight emerging technology that’s paving the way for increasingly personalized treatment through recent progress in tumor biology and genetics.

Following each of the day’s three sessions, a breast cancer tumor board of faculty experts will lead an interactive discussion with attendees in response to questions raised by the session’s content. The discussion panel will confront current clinical controversies over therapeutic interventions, while offering multidisciplinary perspectives on topics ranging from screening patients in high-risk groups to the treatment of those with late stage breast cancer.

This program has been designed for primary care physicians, obstetricians, gynecologists, internists, medical oncologists, radiation oncologists, gynecological oncologists, surgical oncologists, radiologists, pathologists, nurses, and any other clinicians involved in the management and treatment of patients with breast cancer. If you would like to claim CME credits, there is a $35 registration fee. If you do NOT plan to claim CME credits, there is no fee to attend the program.

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Mitral Valve Repair Device, MitraClip, Temporarily Recalled

by Columbia Surgery on August 11, 2011

As of May 2011, performance of MitraClip, a minimally invasive procedure to correct mitral regurgitation, has been voluntarily suspended due to a problem with its catheter delivery system.

Since 2008, about 3000 patients with severe mitral valve regurgitation (leaky mitral valve) have been treated with MitraClip rather than open surgery. In this minimally invasive procedure a small clip is delivered via catheter to the heart, where it is carefully placed over the center of the mitral valve. This non-surgical option has been an important alternative for patients who may be unable to withstand open surgery. MitraClip has been advanced and investigated at NewYork-Presbyterian/Columbia since the first EVEREST trial in 2004, and is currently available throughout the U.S. as part of the EVEREST II trial.

Mitral Rgurgitation

Mitral Regurgitation: During systole, contraction of the left ventricle causes abnormal backflow (arrow) into the left atrium.
1. Mitral Valve 2. Left Ventricle 3. Left Atrium 4. Aorta

This year, three patients at other institutions experienced complications after the catheter delivery system malfunctioned and subsequent procedures were needed to correct the problem. No patients at NewYork-Presbyterian/Columbia experienced that complication. According to Susheel K. Kodali, MD, Assistant Professor of Clinical Medicine, Center for Interventional Vascular Therapy, Columbia University College of Physicians and Surgeons, “The problem involved the delivery system and not the clip itself. Patients who have already received the MitraClip need not worry about this recall, since their procedures were successful.”

Dr. Kodali expects MitraClip procedures will resume once the catheter delivery system is redesigned.

Learn more about MitraClip and the EVEREST study here:
Heart surgery without the surgeon: Researchers test Evalve for non-invasive mitral valve repair“.

* Photo Credit: bit.ly/qUTUsE

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Two recent studies suggest that women in their forties may have something to gain from mammography breast cancer screening, and that lack of screening in that age-group may disproportionately affect minority women. The U.S. Preventatives Task Force (USPTF) does not currently recommend mammography breast cancer screening for women under the age of 50, based on findings that potential benefits of earlier screening are outweighed by the harms from false-positive results and unnecessary biopsies.

One study supporting earlier screening looked back at data on cases of breast cancer from over a 10-year period to compare women who were diagnosed by mammography to those diagnosed by other means. The study, released by the University of Missouri-Columbia, found that women age 40-49 who were diagnosed with breast cancer by mammography had smaller tumors, less spreading to lymph nodes, and a better overall survival rate.

Another study, from Loma Linda University in California, suggests that recommendations for breast cancer screening might overlook disparities in cancer incidence among different ethnicities. The study found that minorities, particularly Hispanic and Asian women, were overrepresented in younger women who were diagnosed with breast cancer.

“For some Asian women and other minorities, the peak incidence (of breast cancer) is a decade earlier,” said Sheldon Feldman, MD, Chief of the Breast Surgery Section at NewYork-Presbyterian Hospital/Columbia University Medical Center. According to Dr. Feldman, recommendations for the general population may not be the best advice for all women. Commenting in an article “Mammogram rules may harm younger women, minorities” on msnbc.com in May, 2001, Dr. Feldman noted that if certain populations should take a different approach to breast cancer screening, then regardless of whether USPTF guidelines represent the best advice for a majority of people, those exceptions should be noted: “Whether or not you agree with the general recommendations for average groups, then certainly for minorities and certain subgroups, those recommendations need to be altered.”

Recommendations for breast cancer screening?

Read more about screening and treatments for breast cancer at breastmd.org.

Related Link:
U.S. Preventive Services Task Force: Screening for Breast Cancer

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On Thursday, October 20, The Pancreas Center of NewYork-Presbyterian Hospital/Columbia University Medical Center will be holding the 2011 Gigi Shaw Arledge Conference on Pancreatic Diseases. This all-day event is targeted for clinicians and scientists, covering pancreatic cancer research from basic, translational, clinical and epidemiological perspectives and will feature distinguished guest lecturers and leaders in the field of pancreatic diseases.

The conference is being held due to the generous support of the Gigi Arledge Foundation. Giselle (Gigi) Arledge, the late wife of Columbia Trustee and benefactor Roone Arledge, passed away from pancreatic cancer in 2010. According to foundation President Catherine Shaw, ” Now is the time to move pancreatic cancer research forward. Dr. Chabot, Dr. Wang and the team at The Pancreas Center are leaders in this battle. With their focus on research, treatment and prevention, they are helping develop society’s knowledge of pancreatic cancer. In my mother’s honor, I have donated a research and endowment fund that will support the Center’s scientific research”.

Gigi Shaw Arledge and Catherine Shaw

Gigi Shaw Arledge and Catherine Shaw

For more information about Gigi Arledge and the foundation’s mission please read, In Her Own Words: Catherine Shaw, President of the Gigi Arledge Foundation.

Event details can be found at the 2011 Gigi Shaw Arledge Conference on Pancreatic Disease Event Page or by contacting Stephanie Scheeler at 201-346-7003 or sas2258@columbia.edu.

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Attention: Health care providers who treat older adults with cardiovascular disease

Greater New York Geriatric Cardiology Consortium

Greater New York Geriatric Cardiology Consortium

You are invited to attend the Greater New York Geriatric Cardiology Consortium’s kick-off event Friday, September 9, 2011 at the Vivian and Seymour Milstein Heart Center, NewYork-Presbyterian/Columbia, New York.

As described in a recent Journal of the American College of Cardiology white paper, it is time for a new paradigm in cardiac care of older adults. According to Mathew Maurer, MD, “There are significant disparities between the needs of older adults and the current status of cardiac care today.” To address this challenge, noted experts throughout the New York area have formed the Greater New York Geriatric Cardiology Consortium (GNYGCC).

Newly established in 2011 with NIH funding, GNYGCC includes members from Columbia University Medical Center, Albert Einstein College of Medicine/Montefiore Medical Center, Mount Sinai Medical Center, New York University, Rockefeller University, Weill Cornell Medical Center, and Yale School of Medicine. Their goal is to improve the care of older adults with cardiovascular disease by organizing professional medical education activities and performing innovative, multi-center and multi-disciplinary investigator-initiated clinical research.

After Innovations in Geriatric Cardiology in September, the consortium will set out to identify the current state of affairs among aging patients with cardiovascular disease through its ongoing seminar series, beginning in October, 2011. Thirteen topics will be covered in this series, which is modeled after the Essentials of Cardiac Care in Older Adults (ECCOA) curriculum.

The kick-off event on September 9 will include plenary sessions by nationally noted experts. Sessions will be followed by members’ presentations of current research, cocktails, and hors d’oeuvres.

Participants who attend the seminar series during the following year will receive a Certificate of Attendance from Columbia University.

Innovations in Geriatric Cardiology is free and open to all health care practitioners, but space is limited. To register for this event, please contact info@gnygcc.org.

For more information about the seminar series, please visit Innovations in Geriatric Cardiology: Greater New York Geriatric Cardiology Consortium Kick-off Event or call Stephen Helmke at 212-932-4537

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