Mount Sinai Medical Center 2023 Annual Research Report by mountsinaimedicalcenter

2023 ANNUAL

RESEARCH REPORT

TABLE OF CONTENTS 06 09 11 17

Mount Sinai Medical Center Overview 7 — Awards and Accolades

Message From Leadership

Decades of Medical Progress 70 Years of Pioneering Research and Breakthroughs

Training Future Generations of Physicians Mount Sinai’s Dedication to Education and Teaching

Research Overview 19 - Mount Sinai's Office of Research Administration and Institutional Review Board 21 - Academic-Affiliated Research 23 - Mount Sinai Comprehensive Cancer Center 35 - The Columbia University Division of Cardiology and Cardiac Surgery at Mount Sinai Medical Center 43 - Wien Center for Alzheimer’s Disease and Memory Disorders 51 - Exploring Basic Science Research at Mount Sinai Medical Center 55 - Mount Sinai's Additional Research Highlights 69 - The Philanthropic Pillars Behind Mount Sinai's Mission

Mission: To provide high quality health care to our diverse community enhanced through teaching, research, charity care and financial responsibility.

Max Orovitz, Dan Ruskin, Philip Chasin, and Isadore Hecht stand before a billboard announcing a fundraising campaign to build Mount Sinai Hospital.

1949 Founded in 1949, Mount Sinai Medical Center is the largest private, independent, not-for-profit teaching hospital in Florida. As a medical center whose mission is to provide high-quality health care to our diverse community, enhanced through teaching, research, charity care, and financial responsibility, Mount Sinai is committed to providing expert, compassionate care to all. Mount Sinai delivers an unmatched level of clinical expertise, supported by robust research and teaching opportunities. We are dedicated to recruiting and training top physicians and surgeons from around the country, who work together across multiple disciplines to deliver a patient-centric approach to care. Mount Sinai’s ongoing partnerships with New York’s prestigious Columbia University have allowed us to provide our community access to the only Ivy League-affiliated cardiovascular, urology, orthopedics, and oncology programs in South Florida. These programs combine the strengths of two leaders, enhancing our outstanding level of service and providing greater access to state-of-the-art technology, research, and treatment options. Among a select few original statutory teaching hospitals in the state, Mount Sinai is the hospital of choice for those who seek the level of expertise and care that only a teaching hospital can offer.

Awards and Accolades

The only hospital in South Florida to be named one of Healthgrades’ top 5% of hospitals in the nation for four years in a row, 2023, 2022, 2021, and 2020.

Named one of America’s 100 Best Hospitals in Critical Care, Pulmonary Care, and Gastrointestinal Care, and received a Gastrointestinal Surgery Excellence Award by Healthgrades for 2023.

Named one of America’s Best Physical Rehabilitation Centers by Newsweek; ranked No. 5 in Florida and No. 1 in South Florida in 2022.

The only Ivy League-affiliated cardiology, urology, orthopedics, and oncology programs in South Florida, backed by Columbia University.

Cardiology

The most cardiac surgery procedures performed in South Florida over the past 10 years.

The most cardiac valve procedures performed in South Florida over the past 10 years.

Cardiology

One of only two stroke centers in Miami-Dade County to be designated as a Comprehensive Stroke Center with The Joint Commission. This designation assures patients that the center follows national standards and guidelines that can significantly improve the outcomes of the most complex stroke cases.

South Florida’s LARGEST private, nonprofit teaching hospital.

Largest Teaching Hospital

The first breast center in South Florida to receive accreditation from the National Accreditation Program for Breast Centers.

To learn more about our story, please scan the QR code.

For over 70 years, Mount Sinai Medical Center has been dedicated to serving the community by delivering the highest quality medical care to all. Today, that same mission remains at the heart of everything we do. Our culture of caring and compassion resonates through our Mount Sinai family of physicians, employees, donors, and board members. They each play a meaningful role in upholding our tenets of inclusiveness and decreasing health care disparities, while helping to shape the future of care for our patients. For over seven decades, we have been providing South Florida with access to high-quality care, enhanced through research and teaching. Our annual report aims to celebrate our rich history of clinical exploration and innovation, while highlighting many of the breakthrough clinical trials and studies in progress today. Guided by our mission, Mount Sinai has a long history of investing in research and innovation. Early in our history, Mount Sinai Medical Center built the Harry Pearlman Biomedical Research Institute with laboratory space dedicated to basic and translational research. Our research footprint continued to grow throughout the years, with the addition of five research programs under a newly created Medical Research Foundation, which included our early commitment to cardiology care and research. Each decade welcomed new medical breakthroughs and procedures in cancer treatment, geriatric medicine, surgical techniques, radiology, open-heart surgery, and more. Our research efforts combined with our robust teaching programs ensured the next generation of clinicians had the resources to expand our groundbreaking work for decades to come. Each person helped, each life saved, and each family positively impacted are a testament to our highly skilled and award-winning team. We continue to build toward the future, ensuring access to high-quality care for our community. While our patients see the results of this every day through care we provide, our commitment to research and innovation continues to fuel the clinical care and discoveries that will improve the health and well-being of generations to come. Throughout the years and as the health care landscape changes, Mount Sinai has remained committed to practicing great medicine, enhanced through teaching and research opportunities. We invite you to explore Mount Sinai Medical Center’s programs and research endeavors over the past year. Thank you for your interest in our medical center. Sincerely,

Alon Z. Weizer, MD, MS Senior Vice President and Chief Medical Officer

Gino R. Santorio President and Chief Executive Officer 9

Alon Z. Weizer, MD, MS Senior Vice President and Chief Medical Officer

Gino R. Santorio

President and Chief Executive Officer

Decades of Medical Progress: 70 Years of Pioneering Research and Breakthroughs

From its inception, one of the fundamental pillars of Mount Sinai’s mission was, and remains, high-quality care, enhanced through research. This early emphasis on research enabled the medical center to celebrate significant medical breakthroughs, decade after decade.

1950s In the early 1950s, Mount Sinai opened the first state-of-the-art laboratory and launched five new research programs under a newly created Medical Research Foundation. Mount Sinai also became the first hospital in Florida to introduce a subspecialty in cardiology and perform open-heart valve surgery.

1950s That same decade, the hospital recruited a cardiopulmonary physiologist with impressive experience, Philip Samet, MD. Dr. Samet led the opening of a cardiopulmonary laboratory to assist in clinical diagnosis and research. Soon after, Mount Sinai gained recognition as a leader in openheart surgery — a practice that was still in its infancy.

1960s By the end of the 1960s, the institution had 425 physicians and 39 specialties, including notable departments such as radiation oncology, thoracic and cardiovascular surgery, cardiopulmonary medicine, and pathology and laboratory services. It was during this time that the National Heart Institute chose Mount Sinai as one of the few selected hospitals in the United States, for research in various drugs for the treatment of heart disease.

1970s In the early 1970s, the medical center was among six hospitals in the world to have a medical cyclotron (to destroy cancerous tumors via radiation damage), as well as a dedicated radiology building with a positron emission tomography (PET) instrument. Also, Mount Sinai was the first in the region to have a wholebody scanner with magnetic resonance imaging (MRI).

1970s Physicians in the hospital’s nuclear medicine division conducted a six-week study of 150 patients with a new ultrasound device that possessed the ability to detect cancerous lumps in the breast without using potentially dangerous radiation. Mount Sinai became one of the first American hospitals to employ this process, known as automated ultrasonography of the breast for the early detection of breast disease.

1980s In the 1980s, the world was gaining awareness of acquired immune deficiency syndrome (AIDS). Mount Sinai’s researchers took part in early studies to measure the amount of virus in a patient’s blood.

1980s This decade saw the launch of the Wien Center for Alzheimer’s Disease and Memory Disorders, which played a pivotal role in nationwide memory disorder research, including innovative memory testing, functional ability assessment, and advanced brain imaging using MRI and PET to study aging and Alzheimer’s disease. Additionally, it pioneered new memory disorder treatments.

1980s The 1980s embraced even more research and innovation, including the opening of Miami-Dade’s only leukocyte-typing laboratory and receiving a prestigious grant from the National Cancer Institute to carry out novel clinical research and provide new treatments to cancer patients and healthy individuals at risk for cancer.

1987 In 1987, the Mount Sinai Community Clinical Oncology Program (CCOP) launched for community-based research. The next year, it was one of only two hospitals chosen nationwide for an immunotherapy cancer study with the National Cancer Institute, becoming a key clinical research hub in South Florida.

1990s The 1990s brought more innovation and a continued dedication to research. In 1995, the hospital was awarded a $10 million federal grant to test dualchamber pacemakers. The study, led by Gervasio Lamas, MD, revolutionized cardiac pacemakers.

1990s In the 1990s and early 2000s, the Wien Center contributed to significant research on Alzheimer’s disease, including the discovery of the APOE e4 gene allele as a prominent genetic cause, as well as the identification of other genetic and environmental risk factors for sporadic Alzheimer’s disease through its involvement in the NIH-funded MIRAGE Study.

2000s In the 2000s, Mount Sinai was one of the only centers in the country that conducted clinical trials using immunotherapy to treat melanoma. And, in partnership with Cornell University, a lung screening study established that low-intensity CT scanning would identify patients with early lung cancer — especially smokers. This study changed the standard of care for treating lung cancer and led to various national studies.

2003 In 2003, the Wien Center initiated the annual Mild Cognitive Impairment (MCI) Symposium series, which has grown into an international symposium for the presentation and discussion of issues relating to the earliest stages of Alzheimer’s disease. The Public Education Forum was developed as a companion to the MCI Symposium as a vehicle to disseminate the findings presented in the MCI Symposium, which completed its 21st annual iteration in 2023.

2005 In 2005, Mount Sinai’s CCOP earned the prestigious American Society of Clinical Oncology Award for enhancing clinical trial participation and diversity, specifically by including minorities in Phase 3 trials, ensuring equitable access to cutting-edge cancer therapies. Notably, the medical center achieved a remarkable 31% Hispanic and 15% Black patient enrollment, surpassing national averages.

2005 In 2005, Mount Sinai’s Wien Center for for Alzheimer's Disease and Memory Disorders joined the NIH-funded Alzheimer’s Disease Neuroimaging Initiative (ADNI), an international study. Through ADNI, the Wien Center advanced diagnostic approaches for early stage Alzheimer’s using MRI and PET, published in top journals.

2013 Mount Sinai’s CCOP ran a Breast Cancer Prevention Trial (BCPT), which demonstrated that we could prevent breast cancer in high-risk patients with tamoxifen. The second prevention trial, the Study of Tamoxifen and Raloxifene (STAR), entered more than 19,000 women to compare the effects of these two drugs in reducing the incidence of breast cancer.

2013 The CCOP was the largest continually funded program in oncology studies in South Florida through 2013. Research on cancer prevention was the primary focus of its research.

2013 In 2013, Dr. Gervasio Lamas served as the principal investigator and Chair of the Trials to Access Chelation Therapy (TACT). After the initial 10-year TACT study, Dr. Lamas found extraordinary results, particularly relating to diabetic patients with cardiovascular disease.

2015 In 2015, the Wien Center received an NIH grant with the University of Florida to fund an Alzheimer’s Disease Research Center to examine early stage Alzheimer’s detection and to study the disease across diverse ethnic groups. This grant was renewed in 2020, expanding to include the University of Miami, FIU, and FAU.

2016 In 2016, TACT 2 received a $37 million grant from the NIH, offering an exciting look at the future of chelation therapy. A review was published by the Journal of the American College of Cardiology, identifying the effect of chelation on lead and cadmium and the likely mechanism of chelation benefit.

2023 In 2023, Dr. Gervasio Lamas co-authored a statement published by the American Heart Association, which identified that chronic exposure to low levels of lead, cadmium, and arsenic through commonly used household items, air, water, soil, and food is associated with an increased risk of cardiovascular disease.

In the 1990s, Dr. S. Howard Wittels, Chief of Anesthesiology, monitors a patient during surgery.

Training Future Generations of Physicians: Mount Sinai’s Dedication to Education and Teaching

As one of Florida’s original statutory teaching hospitals, educating the next generation of physicians remains one of the vital pillars of Mount Sinai’s mission. The medical center became a teaching hospital in 1953 when it established its first medical residency program. It was also the only not-forprofit hospital in the region to receive approval from the American Medical Association for the training of residents.

In the early 1970s, Mount Sinai entered into an agreement with Miami-Dade Community College, providing classrooms and clinical facilities for instruction. Among the first of its kind, the arrangement served the community by providing students with the finest medical education available. Its training centered on medical laboratory technology, respiratory therapy, medical records technology, and nursing. The decade also welcomed more education-focused initiatives, including a classroom-style auditorium for the study of radiology, a medical library, a pulmonary research program, and the first operation room observation gallery in the Southeast.

Today, we are dedicated to ensuring our community has talented, well-trained doctors now and in the future. Through a variety of residency and fellowship programs, The Andrew Witkoff Center for Graduate Medical Education at Mount Sinai brings together the best and brightest minds in medicine, creating a challenging environment where emerging doctors are trained by faculty who are experts in their field. Each year, our institution trains approximately 216 residents and fellows, in addition to over 350 medical students. Our robust and sought-after programs have enabled the medical center to create a successful conduit that addresses the ongoing physician shortage South Florida is experiencing. The Andrew Witkoff Center for Graduate Medical Education at Mount Sinai’s teaching curriculum and programs support continuous learning for our robust medical staff, residents, fellows, and students. This continuous learning feeds medical advances, a higher quality of care, and better results for patients. As a teaching hospital, our community has access to well-educated and enthusiastic residents and fellows, who are handpicked by the medical center to be part of our program. This year alone, over 6,000 students applied to fill 75 available residency positions. Patients have the added benefit of being seen by physician attendings who stay abreast of the latest in diagnosis and treatment options via regular conferences, symposiums, and their own groundbreaking research. All applicable residency and fellowship programs at Mount Sinai are accredited by the Accreditation Council for Graduate Medical Education (ACGME) or the Council on Podiatric Medical Education (CPME). This means residents, fellows, faculty, and patients are benefiting from the highest level of teaching and education. 18

Upholding Research Ethics: Mount Sinai’s Office of Research Administration and Institutional Review Board

Research Overview

The Office of Research Administration is responsible for overseeing the development, implementation, and monitoring of policies and procedures related to award administration activities, human subject-related research, and the Institutional Review Board. The department also reviews award budgets to assure financial compliance, manages the accreditation process of various bodies, and ensures compliance with sponsor and federal regulations. The Office of Research Administration includes Juan R. Sabater, MD, AVP, Research Administration; Yvonne Ortiz, Manager, Research Administration; and Ana Reyes Mendoza, Senior Accounting Clerk. The Institutional Review Board (IRB) is responsible for the review and approval of all human subject research conducted at Mount Sinai Medical Center. Made up of varying backgrounds and expertise, its members are charged with fostering a collaborative relationship with Mount Sinai Medical Center’s research community to ensure that research involving human subjects is conducted in accordance with federal regulations and ethical principles of respect for persons, beneficence, and justice. All faculty members and trainees complete education to ensure that they are knowledgeable of the ethical and regulatory aspects of research. These principles require the balancing of risks to subjects against the scientific knowledge to be gained and the potential benefits to subjects and society. The IRB includes Tony Adams, MD, Chair; Ignacio Zabaleta, MD, Vice Chair; and Yvonne Ortiz, Manager. 20

Academic-Affiliated Research Mount Sinai Medical Center is the only Ivy League-affiliated hospital in South Florida with Columbia University faculty clinically caring for patients in the specialties of oncology, cardiac and vascular medicine, orthopedic surgery, and urology. Several of our faculty collaborate closely with investigators at Columbia in New York.

Cardiovascular Medicine TACT2 is a National Institutes of Health-sponsored randomized controlled trial led by Gervasio Lamas, MD, Professor of Medicine at Columbia University Irving Medical Center and Chair of Medicine/Chief of Cardiology, Division of Cardiology, Mount Sinai Medical Center. The study is evaluating the use of removing toxic metals using Na2EDTA infusions to study the impact on cardiovascular disease in patients with diabetes and prior myocardial infarction. This study has a metals and biorepository core lab at Columbia University in the Department of Environmental Health Sciences.

Orthopedic Surgery Ettore Vulcano, MD, Chief of the Division of Orthopedic Surgery at Mount Sinai Medical Center and Associate Professor of Orthopedic Surgery at Columbia University, has multiple research collaborations with colleagues at Columbia University that are focused on minimally invasive procedures for orthopedic foot and ankle surgery.

Oncology/Cancer Mount Sinai Medical Center is a National Cancer Institute affiliate of the Columbia University Minority and Underserved Community Oncology Research Program (MU-NCORP), allowing the South Florida community access to cancer clinical trials at Columbia University Irving Medical Center and New York-Presbyterian Hospital. Our oncology team regularly participates in collaborative tumor boards with Columbia University, providing our patients access to a nationally recognized multidisciplinary review of care.

Academic Collaboration in Alzheimer’s Disease: The Alzheimer’s Disease Research Network. The ADRC is a collaboration between Mount Sinai, University of Florida, University of Miami, and other academic research organization in Florida to advance care for Alzheimer’s disease.

MOUNT SINAI MEDICAL CENTER ADRC Focus: Hispanics and early cognitive impairment

UNIVERSITY OF MIAMI ADRC Focus: Phenotyping African-Americans (AA) and Hispanics

UNIVERSITY OF FLORIDA ADRC Focus: Lewy body diseases and early cognitive impairment For more information on the Wein Center and ADRC, please see page 43.

Mount Sinai Comprehensive Cancer Center: Program Overview and Research Highlights

Mount Sinai’s Comprehensive Cancer Center, affiliated with Columbia University, is a nationally recognized, award-winning cancer treatment program that embraces a collaborative, multidisciplinary approach to diagnosing and treating nearly every type of cancer in adults. The only Ivy League-affiliated cancer program in South Florida, our team includes experts in medical oncology, radiation therapy, and surgery. Focused on the needs of each individual patient, our caring team develops a comprehensive treatment plan for each patient that addresses all aspects of their care and recovery. In addition to targeted treatment to eliminate patients’ cancer, our team provides robust support services for both patients and their families. This includes nutritional counseling, pain management care, and mental health care through our psycho-oncology services, access to support groups, a genetics program, and much more. We are committed to providing an environment that caters to patients’ physical and emotional healing, while working tirelessly to deliver the best possible medical outcomes. From prevention and screening, to treatment with the latest cutting-edge technology, to research and clinical trials, South Floridians look to Mount Sinai Medical Center as a trusted resource for high-quality, advanced cancer care. Hope, strength, and support are at the heart of everything we do. So, when patients and their families choose Mount Sinai, they get a network of compassionate, expert cancer care professionals who are committed to fighting together for their cure. 24

Delivering True Clinical Excellence to Our Community

Rendering of the Irma and Norman Braman Comprehensive Cancer Center, scheduled to open in 2025.

In 2025, Mount Sinai Medical Center will unveil the Irma and Norman Braman Comprehensive Cancer Center on our main campus in Miami Beach. The new building will add to the medical center’s already robust ability to provide expert, patient-centric care, in affiliation with Columbia University’s Herbert Irving Comprehensive Cancer Center in New York. As an NCI-designated facility, the partnership with Columbia provides South Florida patients access to enhanced clinical trials and research. Patient care plans are reviewed and informed by a joint tumor board made up of select clinicians and medical experts from both organizations. Their goal is to determine the best treatment protocol for each individual. As many Mount Sinai oncologists are assistant professors at Columbia, this impactful partnership serves to reinforce the long-standing cooperation between the two organizations with the mutual goal of providing a better quality of life for patients and, ultimately, a cure for cancer. The Braman Comprehensive Cancer Center is embracing the future of oncology care with the implementation of a robust Cancer Genetics Program, as well as leveraging advanced genomics and other molecular tools, to fully leverage precision medicine and to provide the most effective treatment for each patient. At over 200,000 square feet, the light-filled, ultramodern Braman Comprehensive Cancer Center will create much-needed, patient-centric access to personalized treatment.

Steven N. Hochwald, MD, MBA, FACS Director of Mount Sinai Comprehensive Cancer Center Chief of Surgical Oncology Associate Director of the Mount Sinai-Columbia University affiliation at Mount Sinai Medical Center A leading pancreatic and gastrointestinal surgical oncologist, and an avid clinician and researcher, Dr. Hochwald has focused on technical advances in minimally invasive upper gastrointestinal surgeries and on developing new targets and agents for the treatment of pancreatic, esophageal, gastric, and other gastroesophageal malignancies. He has performed more than 1,000 minimally invasive resections of the esophagus, stomach, and pancreas, using both laparoscopic and robotic approaches. He has extensively taught minimally invasive upper gastrointestinal surgery to surgical residents, surgical oncology fellows, and faculty members from around the United States and abroad. Dr. Hochwald’s scientific passion is identifying novel molecular targets for treatment in difficult-to-treat cancers such as esophageal, gastric, and pancreatic cancer. His own research has identified that squamous cell carcinomas of the esophagus are particularly dependent on glucose for survival and that targeting glucose-dependent pathways may prove to be efficacious in these malignancies.

Dr. Hochwald’s Vision for the Braman Comprehensive Cancer Center

Learn more about Dr. Hochwald

“Traditional therapies for patients with cancer have focused on imprecise regimens that often cause toxicity and are not very effective. Cancer comes in many different types and subtypes. We are building a team of experts that will provide more precise and personalized care for cancer patients being treated at our center. We will do this by leveraging current research advances and artificial intelligence solutions to develop novel individualized and powerful treatments while preserving quality of life.”

Mike Cusnir, MD Chief, Division of Hematology and Oncology Co-Director, Gastrointestinal Malignancies Assistant Professor at the Columbia University Division of Hematology/Oncology at Mount Sinai Medical Center Dr. Cusnir holds board certifications in internal medicine, hematology, and oncology. Since joining Mount Sinai Medical Center in 2003, Dr. Cusnir has been active in clinical trials and published multiple articles. He is Co-Director of Gastrointestinal Malignancies and has a special interest in gastrointestinal, genitourinary, and head and neck malignancies. Dr. Cusnir also is passionate about educating future medical generations. He holds academic titles from the University of Miami and Nova Southeastern University, and he has been named Attending of the Year by residents and interns for multiple years.

Learn more about Dr. Cusnir

Learn more about Dr. Ben-David

Kfir Ben-David, MD Roni Jacobson Endowed Chairman of Surgery Program Director, General Surgery Residency An expert in gastrointestinal surgery, Dr. Ben-David specializes in the minimally invasive and robotic surgical treatment of various conditions such as esophageal, gastric, and pancreatic cancer; gastroesophageal reflux; achalasia; and paraesophageal and complex hiatal hernias. He also oversees the weight loss surgical program at Mount Sinai Medical Center. Board-certified in general surgery by the American Board of Surgery, Dr. BenDavid has performed more than 500 minimally invasive esophagectomies — the most ever performed in Florida.

Jacqueline Barrientos, MD, MS Chief, Hematologic Malignancies Director, Oncology Research Assistant Professor at the Columbia University Division of Hematology/Oncology at Mount Sinai Medical Center Dr. Barrientos served as principal investigator on several clinical trials that led to the approval of novel therapies that changed the treatment paradigm of CLL and lymphoma. She has co-authored several landmark publications in prestigious medical journals. She has been honored with several awards, including the American Society of Hematology - Harold Amos Medical Faculty Development Program (AMFDP) Award. She is a passionate researcher and clinician who takes a patient-centered approach to her care every day.

Learn more about Dr. Barrientos

Brian Slomovitz, MD

Director of Gynecologic Oncology Co-Chair of the Cancer Research Committee at Mount Sinai Medical Center A specialist in clinical trial development, robotic surgery, sentinel lymph node evaluation, and immunotherapy, Dr. Brian Slomovitz is Director of Gynecologic Oncology and Co-Chair of the Cancer Research Committee at Mount Sinai Medical Center. He is also a Professor of Obstetrics and Gynecology at Florida International University. Dr. Slomovitz is a member of the board of directors at the Gynecological Oncology Group (GOG) Foundation and the Uterine Cancer Lead for GOG Partners. He is also the national or global principal investigator on several GOG Partners, NCI, and Alliance Foundation clinical trials. He has authored more than 100 peer-reviewed articles and lectured extensively.

Learn more about Dr. Slomovitz

Research Highlights Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. Mirza MR, Chase DM, Slomovitz BM, dePont Christensen R, Novák Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Hanker LC, Stuckey A, Boere I, Gold MA, Auranen A, Pothuri B, Cibula D, McCourt C, Raspagliesi F, Shahin MS, Gill SE, Monk BJ, Buscema J, Herzog TJ, Copeland LJ, Tian M, He Z, Stevens S, Zografos E, Coleman RL, Powell MA; RUBY Investigators. N Engl J Med. 2023 Mar 27. DOI: 10.1056/NEJMoa2216334. Online ahead of print. PMID: 36972026.

This was an international Phase 3 randomized controlled trial comparing dostarlimab, a checkpoint inhibitor, versus placebo and standard chemotherapy in patients with Stage 3 of 4 endometrial cancer or recurrence after treatment. The study demonstrated significant improvement in disease-specific and overall survival in patients receiving dostarlimab and conventional chemotherapy versus placebo and conventional chemotherapy. Patients who had tumors with high mismatch repair and microsatellite instability benefited even more from the dostarlimab and chemotherapy than those without these alterations. Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial. Liau LM, Ashkan K, Brem S, Campian JL, Trusheim JE, Iwamoto FM, Tran DD, Ansstas G, Cobbs CS, Heth JA, Salacz ME, D’Andre S, Aiken RD, Moshel YA, Nam JY, Pillainayagam CP, Wagner SA, Walter KA, Chaudhary R, Goldlust SA, Lee IY, Bota DA, Elinzano H, Grewal J, Lillehei K, Mikkelsen T, Walbert T, Abram S, Brenner AJ, Ewend MG, Khagi S, Lovick DS, Portnow J, Kim L, Loudon WG, Martinez NL, Thompson RC, Avigan DE, Fink KL, Geoffroy FJ, Giglio P, Gligich O, Krex D, Lindhorst SM, Lutzky J, Meisel HJ, Nadji-Ohl M, Sanchin L, Sloan A, Taylor LP, Wu JK, Dunbar EM, Etame AB, Kesari S, Mathieu D, Piccioni DE, Baskin DS, Lacroix M, May SA, New PZ, Pluard TJ, Toms SA, Tse V, Peak S, Villano JL, Battiste JD, Mulholland PJ, Pearlman ML, Petrecca K, Schulder M, Prins RM, Boynton AL, Bosch ML. JAMA Oncol. 2023 Jan 1;9(1):112-121. DOI: 10.1001/jamaoncol.2022.5370.PMID: 36394838 Free PMC Article. Clinical Trial. In this large international randomized controlled trial, the authors compared treatment with a dendritic cell vaccine plus standard of care versus standard of care alone in patients with newly diagnosed glioblastoma, a rare and deadly brain cancer. Given the poor prognosis of this cancer, the addition of the vaccine extended overall survival by six months, compared to standard of care treatment, which was both statistically and clinically significant.

Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. Chesney J, Lewis KD, Kluger H, Hamid O, Whitman E, Thomas S, Wermke M, Cusnir M, Domingo-Musibay E, Phan GQ, Kirkwood JM, Hassel JC, Orloff M, Larkin J, Weber J, Furness AJS, Khushalani NI, Medina T, Egger ME, Graf Finckenstein F, Jagasia M, Hari P, Sulur G, Shi W, Wu X, Sarnaik A. J Immunother Cancer. 2022 Dec;10(12):e005755. DOI: 10.1136/jitc-2022-005755. PMID: 36600653 Free PMC Article. Clinical Trial. Patients with recurrent melanoma refractory to immunotherapy have few options. In this Phase 2 trial, the study group explored the use of lifileucel based on experience of treating 66 patients with measurable responses. Lifileucel is an autologous tumor-infiltrating lymphocyte (TIL) cell therapy based on the patient’s own tumor. Of the 153 patients in the study, eight patients had a complete response and 40 patients had a partial response to therapy. Based on the safety profile of the therapy, the authors concluded that this supported the potential benefit of lifileucel in this heavily treated patient population with limited treatment options. Health-related quality of life and treatment satisfaction in Chronic Lymphocytic Leukemia (CLL) patients on ibrutinib compared to other CLL treatments in a real-world US cross sectional study. Deering KL, Sundaram M, Harshaw Q, Trudeau J, Barrientos JC. PLoS One. 2022 Oct 6;17(10):e0270291. DOI: 10.1371/journal.pone.0270291. eCollection 2022. PMID: 36201482 Free PMC Article. CLL is a common blood disorder. In the early stages of the disease, many patients often do not require treatment but only close surveillance. As a result, treatment often impacts the quality of life of patients who otherwise feel normal. This study compared health-related quality of life (HRQOL) in patients who either have not been treated or not treated with ibrutinib versus those patients on ibrutinib using validated survey instruments. The authors found that ibrutinib treatment had better HRQOL and treatment satisfaction when compared to patients receiving other therapies, irrespective of line of therapy. Long-term outcomes for ibrutinib-rituximab and chemoimmunotherapy in CLL: updated results of the E1912 trial. Shanafelt TD, Wang XV, Hanson CA, Paietta EM, O’Brien S, Barrientos J, Jelinek DF, Braggio E, Leis JF, Zhang CC, Coutre SE, Barr PM, Cashen AF, Mato AR, Singh AK, Mullane MP, Little RF, Erba H, Stone RM, Litzow M, Tallman M, Kay NE. Blood. 2022 Jul 14;140(2):112-120. DOI: 10.1182/blood.2021014960. PMID: 35427411 Free PMC Article. Clinical Trial. The authors present the long-term follow-up of the randomized trial comparing the long-term efficacy of ibrutinib-rituximab (IR) therapy to fludarabine, cyclophosphamide, and rituximab (FCR) and describe the tolerability of continuous ibrutinib. Among the 354 patients randomized to IR, 214 (60.5%) currently remain on ibrutinib. Sustained improvement in overall survival (OS) was observed for patients in the IR arm (HR, 0.47; P = .018). In conclusion, IR therapy offers superior progression-free survival (PFS) relative to FCR in patients with IGHV-mutated or unmutated CLL, as well as superior OS. Continuous ibrutinib therapy is tolerated beyond five years in the majority of CLL patients.

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The Columbia University Division of Cardiology and Cardiac Surgery at Mount Sinai Medical Center: Program Overview and Research Highlights

Dr. Steve Xydas, Chief of the Columbia University Division of Cardiac Surgery

Mount Sinai Medical Center is home to the Mount Sinai Heart Institute, Florida’s premier cardiovascular program. Backed by Columbia University, our program offers patients access to the only Ivy League-affiliated cardiovascular program in South Florida. We use a multidisciplinary approach to patient care, bringing together cardiac experts from multiple subspecialties, such as surgery, electrophysiology, clinical and interventional cardiology, rehabilitation medicine, and vascular surgery. In addition, the Mount Sinai Heart Institute offers patients access to the latest innovations in cardiac care, including breakthrough research and participation in clinical trials.

Mount Sinai Is the Region’s Leader in Cardiovascular Care Mount Sinai performed the most cardiac surgery procedures in South Florida over the past 10 years**

Mount Sinai performed the most cardiac valve procedures in South Florida over the past 10 years**

Mount Sinai is the only hospital in South Florida offering robotic, minimally invasive heart surgery

Mount Sinai performed the region’s first open-heart surgery in 1964 and since then continues to perform an average of 940 heart procedures each year

Mount Sinai’s cardiovascular team includes physicians who are experts at performing a high volume of diagnostic cardiac catheterizations, as well as catheter-based procedures to treat heart disease

Mount Sinai’s Stroke and Chest Pain Center has earned the designation as a Comprehensive Stroke Center, making it one of two hospitals in Miami-Dade County and one of just 16 in the state of Florida to receive the designation **AHCA YEAR-END 2013 ⎯ 3RD QTR 2022 ⎯ SOUTH FLORIDA

Learn more about Dr. Lamas

Gervasio A. Lamas, MD Chairman of Medicine Chief, Columbia University Division of Cardiology at Mount Sinai Medical Center Co-Director, Mount Sinai Heart Institute Professor of Medicine at Columbia University Irving Medical Center (CUIMC) Dr. Lamas is a fellow of the American College of Cardiology, the American Heart Association, and the European Society of Cardiology. He has served as the chair or member of multiple data and safety monitoring boards and participated on multiple national committees, including serving as Chairman of the Clinical Trials Review Committee of the National Heart, Lung, and Blood Institute. During his career, he has enrolled thousands of patients in many U.S. and international trials in order to advance the science of cardiovascular care and prevent death and disability from heart disease. Dr. Lamas has acted as a manuscript reviewer and has published over 440 articles and abstracts in prestigious, high-impact journals, including the New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, and others.

Steve Xydas, MD Chief of the Columbia University Division of Cardiac Surgery at Mount Sinai Medical Center Co-Director, Mount Sinai Heart Institute Co-Director, Aortic Center Dr. Xydas is board-certified in cardiac and general surgery and is an expert in minimally invasive, open, endovascular, and transcatheter approaches to a full spectrum of serious cardiac diseases, including valve disease, coronary disease, and aortic aneurysms. He has extensive experience in valve-sparing aortic root repairs and innovative treatments for thoracic aneurysms. Dr. Xydas has extensive research and commercial experience with transcatheter aortic valve replacement using the SAPIEN and CoreValve devices. He is a co-investigator on clinical trials, including the CoreValve Pivotal, CoreValve SURTAVI, and SAPIEN 3 (Partner 3) TAVR trials, as well as the International Aortic Arch Surgery Study Group. He has participated in many international operative surgical symposia and has lectured on national and international levels.

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Learn more about Dr. Beohar

Nirat Beohar, MD Vice Chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center Medical Director, Structural Heart Disease Program Director, Cardiac Catheterization Laboratory Director, Interventional Cardiology Fellowship Program Professor of Medicine at CUIMC Dr. Nirat Beohar has devoted his career to the use and development of catheter-based therapies for the treatment of heart disease. Dr. Beohar has a broad repertoire of catheter-based therapies. He has extensive expertise in implanting catheter-delivered heart aortic valves. He is expert at treating complex coronary conditions such as left main and multivessel disease, as well as chronic total occlusions. He has expertise with devices to close atrial septal defects, patent foramen ovales (PFOs), and other intracardiac shunts. For patients in cardiogenic shock, he implants left ventricular assist devices such as the TandemHeart and Impella. He also is skilled in transseptal catheterization, a highly specialized technique used to access the left side of the heart to treat structural heart disease. Additionally, he has had experience with percutaneous therapies for peripheral vascular disease.

Christos George Mihos, DO Director, Echocardiography Laboratory, Columbia University Division of Cardiology, Mount Sinai Medical Center Professor of Medicine at CUIMC Dr. Christos G. Mihos is a renowned noninvasive cardiologist and echocardiographer with extensive experience in clinical cardiovascular research. His academic focus spans valvular heart disease, cardiomyopathy (inherited and acquired), and strain echocardiography for cardiac mechanics in health and disease. Dr. Mihos led the creation of the GE HealthCare “Vivid Learning Academy on Strain Imaging in Echocardiography,” working closely with global cardiovascular imaging experts to promote strain echocardiography’s adoption in clinical practice. He’s also an esteemed editorial board member and guest editor for the Journal of Thoracic Disease and Reviews in Cardiovascular Medicine. He’s a frequent presenter at national and international conferences, and his research has been in prestigious journals including the Journal of the American College of Cardiology. In addition to his research contributions, Dr. Mihos serves as a mentor to medical students, residents, and fellows.

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Research Highlights Coronary Orbital Atherectomy in Patients With Severe Aortic Stenosis. Donatelle M, Agasthi P, Parise H, Igyarto Z, Martinsen BJ, Leon MB, Beohar N. J Invasive Cardiol. 2022 Oct;34(10):E696-E700. PMID: 36200995. This study evaluated the use of coronary orbital atherectomy (OA) in patients with severe aortic stenosis. OA is used to clear large amounts of calcifications blocking a coronary artery prior to being able to place a stent to help support the blood supply to the heart. Because of the lack of information in scientific literature, the authors studied over 600 patients at Mount Sinai and found the procedure of placing a coronary stent was safe in this patient population with 100% success, with few complications. The trial to assess chelation therapy 2 (TACT2): Rationale and design. Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Kim H, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Santella RM, Escolar E, Aude YW, Fonseca V, Elliott T, Lewis EF, Farkouh ME, Nathan DM, Mon AC, Gosnell L, Newman JD, Mark DB; TACT2 Investigators. Am Heart J. 2022 Oct;252:1-11. DOI: 10.1016/j.ahj.2022.05.013. Epub 2022 May 19. PMID: 35598636 Clinical Trial.

TACT2 is an NIH-sponsored, randomized, 2x2 factorial, double-masked, placebocontrolled, multicenter clinical trial testing 40 weekly infusions of a multicomponent edetate disodium (disodium ethylenediaminetetraacetic acid, or Na2EDTA)-based chelation solution and twice-daily oral, high-dose multivitamin and mineral supplements in patients with diabetes and a prior myocardial infarction (MI). The primary endpoint is time to first occurrence of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. Impact of baseline renal dysfunction on cardiac outcomes and end-stage renal disease in heart failure patients with mitral regurgitation: the COAPT trial. Beohar N, Ailawadi G, Kotinkaduwa LN, Redfors B, Simonato M, Zhang Z, Morgan LG, Escolar E, Kar S, Lim DS, Mishell JM, Whisenant BK, Abraham WT, Lindenfeld J, Mack MJ, Stone GW. Eur Heart J. 2022 May 1;43(17):1639-1648. DOI: 10.1093/eurheartj/ehac026. PMID: 35134897 Clinical Trial. The COAPT trial randomized 614 patients with heart failure and severe mitral regurgitation to MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone. The study was designed to understand the impact of treatment on progression of renal failure in this patient population. MitraClip versus GDMT alone improved outcomes regardless of baseline renal dysfunction and reduced new-onset, end-stage renal disease and the need for new renal replacement therapy (dialysis).

Right ventricular hypertrophy in apical hypertrophic cardiomyopathy. Mihos CG, Escolar E, Fernandez R. Echocardiography. 2023 May 7. DOI: 10.1111/echo.15588. Online ahead of print. PMID: 37149842. Right ventricular hypertrophy (RVH+) in hypertrophic cardiomyopathy occurs in one-third of patients; however, outcomes in apical hypertrophic cardiomyopathy (ApHCM) have not been described. The authors studied a large cohort of patients to understand the outcomes of patients with right ventricular hypertrophy and apical cardiomyopathy. When compared with patients without right ventricular hypertrophy, patients with RVH+ had worse overall heart function on echocardiography and at three-year follow-up had a greater incidence of heart failure hospitalization.

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The Wien Center for Alzheimer’s Disease and Memory Disorders: Program Overview and Research Highlights

Dr. Rajan Duara meets with a patient in his office at the Wein Center.

The Wien Center for Alzheimer’s Disease and Memory Disorders at Mount Sinai Medical Center offers hope through screening programs; early diagnosis; delaying progression by treating memory, cognitive problems, and behavioral disturbances at an early stage; supporting and providing education to the caregivers and the public; and in conducting cutting-edge research. The Wien Center’s multidisciplinary approach incorporates neurology, psychiatry, geriatrics, diagnostic imaging, counseling, social support, and referral to appropriate community resources to develop successful and effective treatment options for Alzheimer’s disease and other forms of dementia and memory disorders. Since its inception in 1986, the Wien Center for Alzheimer’s Disease and Memory Disorders has been the leading memory disorder clinic in the state of Florida. The center has created a full-service model program for providing the diverse and comprehensive clinical services required for patients with Alzheimer’s disease and related disorders, as well as research in neuropsychological diagnosis, genetics, biomarkers, brain imaging (with MRI, FDG PET, and amyloid PET), and epidemiology. As a result, the Wien Center has provided the clinical and research basis for creating the first two NIH-funded Alzheimer’s Disease Research Centers (ADRCs) in the state of Florida, namely the Florida ADRC (2005-2010) and the 1Florida Alzheimer’s Disease Research Center (2015 to 2020, and its renewal from 2020 to 2025).

The 1Florida ADRC is a collaboration between Mount Sinai Medical Center, the University of Miami, the University of Florida, Florida Atlantic University (FAU), and Florida International University (FIU). Mount Sinai has been the primary site for clinical research in Alzheimer’s since 2015. The main goals of the 1Florida ADRC are to study the earliest diagnostic changes in Alzheimer’s disease and determine factors quantifiable in MRI and PET scans and in biomarkers in the blood that will determine future progression rates in a diverse population. A major goal is also to train young investigators, with an emphasis on conducting research into the relationship between clinical, cognitive, brain imaging, genetic, and blood-based biomarker tests. This is to learn more about brain health and the full spectrum of Alzheimer’s disease (AD) from its earliest stages onward. 44

In addition to the active, ongoing collaboration with several institutions within the 1Florida ADRC, the Wien Center is a participant in NIH-funded grants with University of Miami; University of California, San Diego (USCD); and Florida Atlantic University (FAU). In collaboration with investigators at FAU, Mount Sinai has received funding from NIH to better understand the role of bilingualism in preventing or delaying the decline in memory and thinking in older adults with disorders such as Alzheimer’s disease. In association with UCSD, NIH has funded Mount Sinai to study how subjective perceptions about memory and thinking ability in older Hispanic adults are related to actual performance on memory and thinking tests over time, and to biomarkers in blood. In 2023, in response to the first full approval of a disease-modifying drug for Alzheimer’s disease (namely lecanemab, or “Leqembi”), the Wien Center is joining a study in the ALZ-NET Registry. The study aims to determine the efficacy and safety of the drug in Alzheimer’s disease patients who are more representative of the general population, than those who participated in the clinical trials that were used by the FDA to approve the drug. The Wien Center has also been a major site for several national and international clinical trials in the field of Alzheimer’s, including the Alzheimer’s Disease Neuroimaging Initiative (ADNI) from 2005 to the present time. The Wien Center has a 30-year history of research on diverse populations (especially Hispanics), and it has greatly contributed to developing neuropsychological tests for early diagnosis of cognitive impairment in ethnically and linguistically diverse populations. The Wien Center was also one of the earliest centers to incorporate the use of brain imaging for identifying the presence and severity of neurodegenerative vascular disease of the brain and the methodology for staging the transition from normal cognitive aging to dementia.

The Wien Center has also collaborated with the School of Engineering at Florida International University from 2014 onward, to enable MRI scans and PET scans, utilizing tracers to study the earliest structural changes and amyloid protein deposition in the brain quantitatively, and to differentiate the diagnostic features in different ethnic groups. This has been a major factor in advancing the science at the 1Florida ADRC and enabling its renewal in 2020. The center is the lead institution for the Florida Brain Bank, which provides a resource for patients and their families to enable brain donation and obtain an expert neuropathological diagnosis of the cause of dementia. The Brain Bank also provides a rich source of brain tissue for researchers in Florida, throughout the United States, and around the globe, to gain a better understanding of Alzheimer’s and other memory disorders. The center’s leadership in the field of memory disorders has also helped Mount Sinai Medical Center earn recognition from U.S. News & World Report as one of America’s Best Hospitals. What’s more, the center also has earned a number of prestigious grants from the National Institutes of Health (NIH) and various foundations to conduct cutting-edge research on Alzheimer’s disease, and in establishing one of only 31 Alzheimer’s Disease Research Centers in the nation.

Advancing Knowledge: Bridging the Gap Between Alzheimer’s Research and the Public MCI Symposium The MCI Symposium series was initiated in 2003 by the Wien Center for Alzheimer’s Disease and Memory Disorders at Mount Sinai Medical Center, Miami Beach, under the direction of Ranjan Duara, MD. The purpose of the first and subsequent symposia have been to provide a CME-accredited forum for professionals, where new information is provided and in-depth discussions can take place about the earliest stages of Alzheimer’s disease and other conditions that result in cognitive impairment in the elderly. The symposia have featured national and international experts in the fields of neurology, neuropsychology, psychiatry, geriatrics, epidemiology, genetics, imaging, and neuropathology. The topics discussed at these symposia have included the biology, early detection, prevention, and treatment of conditions that result in cognitive impairment in the elderly.

The Alzheimer’s Public Educational Forum The forum was initiated in 2010 after it was graciously underwritten by Marilyn and Myers Girsh. It is intended for at-risk family members, caregivers, the public at large, and professionals. It was an in-person event from 2010 to 2020, and it has been a virtual event after the COVID pandemic from 2021 to 2023. Over 500 persons registered for the virtual event on April 2, 2023, which had a focus on “Recent Developments in the Treatment of Alzheimer’s Disease.” Since its inception, the event has been organized and moderated by Dr. Duara. The faculty in 2023 consisted of national experts from Yale, Mayo Clinic Rochester, UCSD, UPENN, and the University of Miami.

Ranjan Duara, MD

Medical Director of the Wien Center for Alzheimer’s Disease and Memory Disorders Dr. Ranjan Duara is a neurologist and a fellow of the American Academy of Neurology. He has been the Medical Director of the Wien Center for Alzheimer’s Disease and Memory Disorders from 1990 onward and has served as Associate Director of the Clinical Core of the 1Florida ADRC, a research collaboration between four university medical centers and Mount Sinai Medical Center in Florida. Dr. Duara is a Courtesy Professor of Neurology at the University of Florida College of Medicine, Gainesville, and the Herbert Wertheim College of Medicine, Florida International University, Miami. He also serves as the principal investigator of the State of Florida Dementia Brain Bank Program. Dr. Duara’s research has focused primarily on early diagnosis of Alzheimer’s disease and other dementias, neuroimaging, genetic epidemiology, and the methodology for staging the transition from normal cognitive aging to dementia. He has contributed to more than 300 articles in peer-reviewed scientific journals and has been an investigator in observational studies on aging, as well as clinical trials of novel agents for the treatment of Alzheimer’s disease.

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Research Highlights Associations Between Country where Education is Obtained and Cognitive Functioning Among South American and Caribbean Older Adults Living in the U.S. Rodriguez MJ, Burke S, Padron D, Duarte A, Rosselli M, Grieg-Custo M, Grudzien A, Loewenstein DA, Duara R. J Cross Cult Gerontol. 2022 Sep;37(3):257-274. DOI: 10.1007/s10823-022-09456-0. Epub 2022 Oct 17.PMID: 36251109. The increasing prevalence of Alzheimer’s disease (AD) among Hispanics calls for a need for examining factors that affect cognitive functioning and risk of AD among Hispanic older adults. This is the first study to examine the country where education was obtained among individuals from countries located in different regions with different cultures that may influence their education and cognitive development throughout life. Findings contribute to the cross-cultural neuropsychological literature in understanding factors that are unique to Hispanic older adults at risk for developing AD. Imaging features of small vessel disease in cerebral amyloid angiopathy among patients with Alzheimer’s disease. Nagaraja N, DeKosky S, Duara R, Kong L, Wang WE, Vaillancourt D, Albayram M. Neuroimage Clin. 2023 May 17;38:103437. DOI: 10.1016/j.nicl.2023.103437. Online ahead of print. PMID: 37245492 Free PMC Article. Cerebral small vessel disease biomarkers, including white matter hyperintensities (WMH), lacunes, and enlarged perivascular spaces (ePVS) are under investigation to identify those specific to cerebral amyloid angiopathy (CAA). In subjects with Alzheimer’s disease (AD), we assessed characteristic features and amounts of WMH, lacunes, and ePVS in four CAA categories (no, mild, moderate, and severe CAA) and correlated these with the Clinical Dementia Rating Sum of Boxes (CDR-SB) score, APOE genotype, and neuropathological changes at autopsy. The study consisted of 232 patients, of which 222 patients had FLAIR data available and 105 patients had T2-MRI. Among patients with AD, occipital predominant WMH is more likely to be found in patients with severe CAA than in those without CAA. The high-grade ePVS in centrum semiovale were common in all AD patients regardless of CAA severity.

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Exploring Basic Science Research: At Mount Sinai Medical Center

While all scientific research conducted at Mount Sinai Medical Center ultimately aims to improve health, our basic science research programs focus on understanding the mechanisms behind the functioning of the human body in health and illness. By utilizing experimental designs that can be specifically tested and revised in the laboratory setting, these discoveries of the biologic processes can then be applied or translated into direct application to patient care. Led by a nationally recognized physicianscientist, Mount Sinai Medical Center has a long history of supporting a diversity of basic science research that has ultimately had an impact on understanding conditions such as asthma, cystic fibrosis, and cardiovascular diseases.

Juan Sabater, MD AVP, Research Administration Director of the Aerosol Research Laboratory Core faculty member in the Pulmonary and Critical Care Medicine Fellowship Program Dr. Juan Sabater has been a member of Mount Sinai Medical Center for over 27 years. Dr. Sabater’s research laboratory is recognized worldwide for its expertise in developing and using “translational models” to study the pathophysiology of asthma, chronic obstructive pulmonary disease, and cystic fibrosis (CF). The models’ usefulness is, in part, related to the similarity to the human airways, specifically its responses to inflammatory mediators, which affect pulmonary function and mucociliary clearance. The similarity in airway responses and mechanistic pathways involved have made these models highly useful in preclinical testing of compounds that may subsequently be used in the treatment of these diseases. Dr. Sabater’s work has been extensively published in major peer-reviewed journals, has helped secure several patents, supported numerous NIH studies, and moved novel drug interventions into human clinical trials.

Research Highlights E-cigarette aerosols of propylene glycol impair BK channel activity and parameters of mucociliary function. Kim MD, Chung S, Baumlin N, Sun L, Silswal N, Dennis JS, Yoshida M, Sabater J, Horrigan FT, Salathe M. Am J Physiol Lung Cell Mol Physiol. 2023 Apr 1;324(4):L468-L479. DOI: 10.1152/ajplung.00157.2022. Epub 2023 Feb 21. PMID: 36809074. This study evaluated the impact of propylene glycol, which is used in e-cigarettes as a carrier. In the study, the authors showed that the propylene glycol caused increased mucous production and decreased function of the bronchial cells to clear secretions. A Nonrandomized Trial of the Effects of Passive Simulated Jogging on Short-Term Heart Rate Variability in Type 2 Diabetic Subjects. Adams JA, Lopez JR, Banderas V, Sackner MA. J Diabetes Res. 2023 Apr 11;2023:4454396. DOI: 10.1155/2023/4454396. eCollection 2023. PMID: 37082380 Free PMC Article. Clinical Trial. Diabetes has become a global pandemic and impacts many body functions, including heart rate variability. Heart rate is influenced by the autonomic nervous system, and the peripheral neuropathy that occurs in diabetes can cause this system to function less well. The study evaluated the use of a passive jogging system in 10 patients with diabetes and found that using this device over a period of time decreased heart rate variability. The advantage of this device is that it is low-impact, and even patients with functional disability can use it.

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Mount Sinai’s Additional Research Highlights

Research is an integral part of all departments and divisions at Mount Sinai Medical Center. Medical staff and residents seek to improve care by asking questions and developing innovative care both in their own field and with collaboration across medical specialties. The medical center’s Department of Pathology, led by Robert Poppiti, MD, promotes a culture of investigation and collaboration in research across most of the departments in our medical center. Our Columbia University Division of Orthopedic Surgery at Mount Sinai Medical Center answers important questions related to orthopedic surgery and clinical care, publishing in nationally recognized peerreviewed journals.

The Columbia University Division of Urology at Mount Sinai has published extensively, reporting on both innovative approaches to clinical care, patterns of care for urologic diseases, and as a site for an innovative clinical trial to treat a rare urologic cancer. Our Emergency Medicine Department has an active clinical research program, answering important questions that influence how emergency care is delivered. The Division of Gastroenterology at Mount Sinai performs research to improve the quality of GI care. These specialties along with our many other clinical departments and divisions integrate research and innovation into their clinical care. Included are both a listing of key publications as well as a bibliography of the extensive research efforts of all our faculty members.

Colombia University, New York-Presbyterian Hospital

Research Highlights Emergency Medicine Ultrasound-Guided Trigger Point Injections for the Treatment of Neck and Back Pain in the Emergency Department: A Randomized Trial. Farrow RA 2nd, Newberry M, Zitek T, Farrow J, Mechanic OJ, Rosselli M. J Ultrasound Med. 2023 May;42(5):1023-1032. DOI: 10.1002/jum.16113. Epub 2022 Oct 10. PMID: 36214230 Clinical Trial. This randomized trial compared the use of trigger point injections versus standard of care (nonsteroidal anti-inflammatory medications and muscle relaxants) in patients presenting to the emergency room with neck and back pain. While there was no significant difference in pain scores at the time of discharge from the emergency room, patients receiving trigger point injections experienced better pain relief at first assessment and required less rescue medication than those patients receiving standard of care.

Anesthesiology COVID-19-Induced Changes in Photoplethysmography. Peck J, Wishon MJ, Wittels H, Hasty F, Hendricks S, Lee SJ, Wittels SH. Mil Med. 2023 Feb 28:usad025. DOI: 10.1093/milmed/usad025. Online ahead of print. PMID: 36852874. Photoplethysmography (PPG) is the science behind many commonly used medical devices such as the pulse oximeter. PPG changes have been described in existing in vitro studies following artificially induced clot activation. COVID-19 causes increased clot formation. The authors evaluated PPG recordings and D-dimer levels for patients hospitalized with COVID19 and compared them with the PPG tracings from non-COVID controls in the intensive care unit. PPG recordings were obtained using a Tiger Tech COVID Plus monitor, which received FDA emergency use authorization in March 2020 for monitoring the biometrics of patients with COVID-19. The results demonstrated significant differences in the prevalence rate of PPG dropout among patients with COVID-19 versus non-COVID controls. While PPG may be nonspecific, it may be a useful noninvasive tool to detect microvascular clotting in patients in the ICU setting.

Internal Medicine Prognosis in Hispanic patient population with pulmonary arterial hypertension: An application of common risk stratification models. Fadah K, Cruz Rodriguez JB, Alkhateeb H, Mukherjee D, Garcia H, Schuller D, Mohammad KO, Sahay S, Nickel NP. Pulm Circ. 2023 Apr 1;13(2):e12209. DOI: 10.1002/pul2.12209. eCollection 2023 Apr. PMID: 37020706 Free PMC Article. This study aimed to fill a knowledge gap in the outcomes and risk stratification of Hispanic pulmonary artery hypertension (PAH) patients, the largest minority group in the United States. This study found that the Hispanic PAH cohort’s baseline demographics, functional class, hemodynamics, and PAH-targeted therapies are comparable to non-Hispanic PAH cohorts. We found a higher proportion of patients with PAH-CHD (congestive heart disease) than in other Caucasian-predominant cohorts. Similar to other PAH cohorts, mortality among Hispanic PAH patients remains high. Current risk stratification tools are applicable to the Hispanic population. Pulmonary Granulomas and Mycobacterial Infection: Concordance between the Results of Special Stains Performed on Lung Tissue Sections and Tissue Cultures. Bahmad HF, Azimi R, Kilinc E, Tuda C, Vincentelli C. Diseases. 2022 Nov 1;10(4):96. DOI: 10.3390/diseases10040096. PMID: 36412590 Free PMC Article. The most common cause of infectious pulmonary granulomas worldwide is Mycobacterium tuberculosis. The diagnosis is based on clinical presentation, histopathologic findings, detection of acid-fast bacilli (AFB) in tissue or sputum using special stains, and/or isolation of mycobacteria in cultures or via PCRbased methods. Different studies have shown that high levels of discrepancy exist between these diagnostic approaches in lung tissue specimens. The authors studied and compared different approaches to detecting Mycobacterium tuberculosis. The authors measured the concordance between the results of the histopathological examination (special stains) and bacteriological tissue cultures. While there was good concordance between different stains, there was not concordance between stains and tissue cultures. This study highlights the need for more advanced diagnostic methods such as PCR to confirm mycobacterial infections and improve patient management. Importantly, species-level identification of mycobacteria is necessary to guide treatment.

Obstetrics and Gynecology Reduction of Cesarean Delivery Rates in South Florida: The MSMC Experience. Kostolias, Alessandra MD; Husnain, Zia MD; James, Jane MSN; Lauture, Adolphia MD; Mayrink, Maximiliano DO; Perez, Jorge MD. Obstetrics & Gynecology. 141(5S):p 59S, May 2023. DOI: 10.1097/01.AOG.0000930512.24906.d7. At the time of initial evaluation, Florida had one of the highest rates of caesarean section (Csection) delivery in the United States. Mount Sinai Medical Center joined the PROVIDE initiative in 2017 to reduce C-section rates in Florida. The authors report that they were able to reduce the C-section rate at Mount Sinai from approximately 38% at the beginning of the study to 27.7% in 2019 (compared to Florida rate of 29.7% in 2019). The authors shared innovative tools and best practices that allow them to continue to improve on the quality of care provided to women in South Florida.

Orthopedic Surgery Accuracy of Intraoperative Mechanical Axis Alignment to Long-Leg Radiographs following Robotic-Arm-Assisted Unicompartmental Knee Arthroplasty. Roche MW, Vakharia RM, Law TY, Sabeh KG. J Knee Surg. 2023 Jun;36(7):752-758. DOI: 10.1055/s-0042-1742647. Epub 2022 Feb 3. PMID: 35114720. Improper alignment and implant positioning following unicompartmental knee arthroplasty (UKA) has been shown to lead to postoperative pain and increase the incidence of revision procedures. The use of robotic-arm assistance for UKA (RAUKA) has become an area of interest to help overcome these challenges. The purpose of this study was to compare intraoperative imaging to postoperative images to see how well they correlated in assessing alignment of the knee replacement since this can change when the patient starts to bear weight on the joint after surgery. RAUKA demonstrates excellent consistency when comparing postoperative weight bearing long-leg X-rays to final intraoperative image-based non-weight-bearing alignment. Common Orthopaedic Injuries in CrossFit Athletes. Shim SS, Confino JE, Vance DD. J Am Acad Orthop Surg. 2023 Jun 1;31(11):557-564. DOI: 10.5435/JAAOS-D-22-01219. PMID: 37155727. CrossFit is a high-intensity exercise program that has gained popularity over the past few decades. CrossFit combines movements from Olympic weight lifting, gymnastics, powerlifting, and high-intensity interval training. The most common CrossFit injuries occur in the shoulder (25% of all injuries), spine (14%), and knee (13%). Male athletes are markedly more likely to experience injuries than female athletes, and injuries occur markedly less when there is supervised coaching of the athletes. The most common causes of injury in CrossFit include improper form and exacerbation of a prior injury. This article summarizes the injuries and makes recommendations on treatment.

Dr. Karim Sabeh poses for a picture as part of a local media opportunity, after conducting the first robotic knee replacement in Florida.

Orthopedic Surgery The Statistical Fragility of Platelet-Rich Plasma as Treatment for Plantar Fasciitis: A Systematic Review and Simulated Fragility Analysis. Gupta A, Ortiz-Babilonia C, Xu AL, Rogers D, Vulcano E, Aiyer AA. Foot Ankle Orthop. 2022 Dec 24;7(4):24730114221144049. DOI: 10.1177/24730114221144049. eCollection 2022 Oct. PMID: 36582654 Free PMC Article. Not all randomized controlled trials that demonstrate a statistical benefit are reproducible. In settings where there are multiple trials with conflicting results, systematic reviews, and metaanalysis of the data can make sense of the results. The authors evaluated trials using platelet-rich plasma as a treatment of plantar fasciitis. Of 432 studies screened, eight studies (52 outcome events) were included in this analysis. The authors’ findings suggest that RCTs evaluating PRP for AT therapy lack statistical robustness, because changing only a small number of events may alter outcome significance.

Urology Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma. Labbate C, Woldu S, Murray K, Rose K, Sexton W, Tachibana I, Kaimakliotis H, Jacob J, Dickstein R, Linehan J, Nieder A, Bjurlin M, Humphreys M, Ghodoussipor S, Quek M, O’Donnell M, Eisner B, Feldman A, Lotan Y, Matin SF. J Urol. 2023 May;209(5):872-881. DOI: 10.1097/JU.0000000000003185. Epub 2023 Jan 19. PMID: 36657029. Early experience with UGN-101 for the treatment of upper tract urothelial cancer — A multicenter evaluation of practice patterns and outcomes. Woldu SL, Labbate C, Murray KS, Rose K, Sexton W, Tachibana I, Kaimakliotis H, Jacob J, Dickstein R, Linehan J, Nieder A, Bjurlin MA, Humphreys M, Ghodoussipour S, Quek ML, O’Donnell M, Eisner BH, Feldman AS, Matin SF, Lotan Y. Urol Oncol. 2023 Mar;41(3):147.e15-147.e21. DOI: 10.1016/j.urolonc.2022.10.029. Epub 2022 Nov 22. Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report. Matin SF, Pierorazio PM, Kleinmann N, Gore JL, Shabsigh A, Hu B, Chamie K, Godoy G, Hubosky SG, Rivera M, O’Donnell M, Quek M, Raman JD, Knoedler JJ, Scherr D, Weight C, Weizer A, Woods M, Kaimakliotis H, Smith AB, Linehan J, Coleman J, Humphreys MR, Pak R, Lifshitz D, Verni M, Klein I, Konorty M, Strauss-Ayali D, Hakim G, Seltzer E, Schoenberg M, Lerner SP. J Urol. 2022 Apr;207(4):779-788. DOI: 10.1097/JU.0000000000002350. Epub 2021 Dec 17. PMID: 34915741 Clinical Trial. Upper tract urothelial cancer is a rare cancer involving the lining of the ureter and internal portion of the kidney in contact with the urine. Historically, surgery to remove the kidney and ureter has been the primary treatment option putting patients at risk for worsening kidney disease. Because of the location of the cancer, it has been difficult to treat this cancer with local chemotherapy. UGN101 is a novel reverse thermal gel carrying a chemotherapy called mitomycin. When cold, the gel is a liquid that can be instilled into the upper urinary tract. It then solidifies at body temperature, allowing the slow release of chemotherapy to the cancer locally. The original trial demonstrated a strong complete response to treatment for low-grade cancer with the ability to save kidneys. These subsequent studies demonstrate the safety and durability of response to treatment as well as the real-world effectiveness of this therapy. 61

The State of Robotic Partial Nephrectomy: Operative, Functional, and Oncological Outcomes From A Robust Multi-Institution Collaborative. Razdan S, Okhawere KE, Ucpinar B, Saini I, Deluxe A, Abaza R, Eun DD, Bhandari A, Hemal AK, Porter J, Stifelman MD, Crivellaro S, Pierorazio PM, Badani KK. Urology. 2023 Mar;173:92-97. DOI: 10.1016/j.urology. 2022.12.021. Epub 2022 Dec 30. PMID: 36592701. The current study evaluated outcomes for patients undergoing robotic-assisted partial nephrectomy, which is used to remove cancers from the kidney while preserving as much kidney function as possible. In this cohort of > 2,500 patients, the authors showed that the risk of intraoperative, postoperative, and 30-day complications were low with good long-term cancer control as well as kidney function preservation. Healthier patients with less-complex cancers tended to have better outcomes. Use of phosphodiesterase-5 inhibitors and the incidence of melanoma. Wayne G, Demus T, Jivanji D, Atri E, Herzog B, Wong V, Garcia M, Cedeno J, Nagoda E, Polackwich A. Cancer Epidemiol. 2022 Sep 19;81:102251. DOI: 10.1016/j.canep.2022.102251. Online ahead of print. PMID: 36137424. There have been reports of use of PDE-5 inhibitors increasing the risk of melanoma. PDE-5 inhibitors are typically prescribed for male erectile dysfunction, and they were introduced in 1998. To assess the risk, the authors used the SEER registry, which is a large cancer registry that captures information on incidence and outcomes of patients with cancer. They evaluated trends in diagnosis before and after the introduction of PDE-5 inhibitors and found that the incidence of melanoma did not increase (decreased by 2%), suggesting that PDE-5 inhibitors do not increase the risk on an epidemiologic level.

Dr. Alan M. Nieder performs a procedure using Blue Light Cystoscopy, a unique technology used to detect and diagnose tumors in the bladder.

Surgery Phosphohistidine signaling promotes FAK-RB1 interaction and growth factor-independent proliferation of esophageal squamous cell carcinoma. Zhang J, Gelman IH, Qu J, Hochwald SN. Oncogene. 2023 Feb;42(6):449-460. DOI: 10.1038/s41388-022-02568-4. Epub 2022 Dec 13. PMID: 36513743. Squamous cell carcinoma of the esophagus tends to have limited response to treatments that target the tyrosine kinase pathway, which is a common target in many cancers. The authors explored a potentially novel pathway to attack esophageal squamous cell carcinoma in a cell model. Results of this study could lead to the development of novel therapies against esophageal squamous cell carcinoma. Routine Radiologic Assessment for Anastomotic Leak Is Not Necessary in Asymptomatic Patients After Esophagectomy for Esophageal Cancer. Kang H, Ben-David K, Sarosi GA, Thomas RM. J Gastrointest Surg. 2022 Feb;26(2):279-285. DOI: 10.1007/s11605-021-052193. Epub 2022 Jan 17. PMID: 35037179. This study examined a cohort of patients who had undergone an esophagectomy (removal of the esophagus) for cancer with an anastomosis (connection) made in the cervical region (neck). Historically, it has been common practice to evaluate the connection with an X-ray after surgery to look for a leak. The authors showed that this routine testing was not helpful, as it had a low sensitivity of identifying a leak. Also, most leaks presented, on average, nine days after surgery with symptoms and were diagnosed at that time. This study is useful to improve the efficiency of care and utilization of resources.

Pathology Improving documentation of blood product administration using a standardized electronic health record-based system: a single-institution experience. Bahmad HF, Oh KS, Delgado R, Azimi R, Olivares E, Poppiti R, Howard L, Alghamdi S. Am J Clin Pathol. 2023 May 15:aqad049. DOI: 10.1093/ajcp/aqad049. Online ahead of print. PMID: 37186872. The authors conducted a process improvement study. They implemented changes in the electronic medical record to improve the reporting of completion of blood product administration, which is important for patient safety and clinical documentation. The authors were able to improve documentation with their changes from 35% to 76% over one year. Potential diagnostic utility of PRAME and p16 immunohistochemistry in melanocytic nevi and malignant melanoma. Bahmad HF, Oh KS, Alexis J. J Cutan Pathol. 2023 Apr 27. DOI: 10.1111/cup.14438. Online ahead of print. PMID: 37114299. This study examined whether PRAME and p16 staining could distinguish between malignant melanoma versus melanocytic nevi (not cancer). They showed that these two markers were useful in distinguishing between these two entities. 63

Establishment and characterization of prostate organoids from treatment-naïve patients with prostate cancer. Cheaito K, Bahmad HF, Hadadeh O, Msheik H, Monzer A, Ballout F, Dagher C, Telvizian T, Saheb N, Tawil A, El-Sabban M, El-Hajj A, Mukherji D, Al-Sayegh M, Abou-Kheir W. Oncol Lett. 2022 Jan;23(1):6. DOI: 10.3892/ol.2021.13124. Epub 2021 Nov 5. PMID: 34820005 Free PMC Article. Organoids are organized cell cultures derived from an individual patient’s cancer. These are useful because treatments can be tested against the organoids to see which one will work the best and which treatments will not be effective, saving the patient from therapies that may be ineffective yet cause toxicity. It can be difficult to generate organoids from certain cancers. The authors report on their experience demonstrating the ability to create accurate prostate cancer organoids and test them to assess response to therapy.

Pioneering Progress: Mount Sinai’s Advanced Research Institute (ARI) Unveils a Vision for Medical Innovation and Collaboration

The Advanced Research Institute Aligned with our mission, Mount Sinai is launching its first-ever integrated research and innovation center, designed to revolutionize medicine through innovation, collaboration, and clinical and translational research within our health care institution. The Advanced Research Institute (ARI) at Mount Sinai Medical Center will systematize our research efforts and growth throughout our health care institution. As a teaching hospital, ARI will provide insights into real-world data and clinical studies that lead to scientific breakthroughs and transform patient care.

Our Vision ARI will provide leadership and infrastructure to support a robust, innovative, and worldclass, patient-centered research platform for clinical and translational research. It will create an infrastructure to support investigator-initiated research that answers questions and identifies potential solutions to improve the lives of patients by investigating innovative ideas, diagnostics, and therapies. ARI will also work to support investigators with hypothesis generation and preliminary data that gives them greater success in competing for federal, state, and foundation grant funding. Our focus is to build out and develop the key infrastructural resources, technology, physical space, and experienced research administration/personnel to launch and maintain the center. This overview includes, but is not limited to, the following:

ARI will systematize our research efforts and growth throughout our health care institution. Whether it’s identifying a new protocol for a unique cancer treatment or studying specific disease states in our diverse patient population, ARI will help experienced investigators and new researchers design, conduct, and manage research studies to create clinical and translational outcomes and best practices. It will provide much-needed scientific, administrative, and regulatory support for clinical and translational research throughout our health care institution.

Fostering a Legacy of Giving: The Philanthropic Pillars Behind Mount Sinai’s Mission

Mount Sinai Medical Center has been fortunate to receive philanthropic support from individuals and corporations that believe in the vision of the hospital’s original founders, who sought to bring a hospital to Miami Beach where doctors could practice and patients could receive care without discrimination. Today, that support comes primarily from a collection of outstanding groups formed under the umbrella of the Mount Sinai Medical Center Foundation. Through their generosity, leadership, and a commitment to our mission, Mount Sinai is poised to continue to serve our community for generations to come. Robust philanthropic support of our research endeavors allows us to translate learning from every patient into innovation and discovery that improves the lives of patients both at Mount Sinai and beyond. Should you be interested in learning more about our philanthropic opportunities within research or other areas of the medical center, please contact the Mount Sinai Medical Center Foundation.

In 1981, members of the Young Presidents Club broke ground for the new child care center.

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