Mount Sinai first in US to implant aortic valve prosthesis to treat severe aortic stenosis

December 21, 2010

David H. Adams, MD, Marie-Josée and Henry R. Kravis Professor and Chairman of the Department of Cardiothoracic Surgery, Samin K. Sharma, MD, the Zena and Michael A. Weiner Professor and Director of the Cardiac Catheterization Laboratory, and Annapoorna S. Kini, MD, Associate Professor and Associate Director of the Cardiac Catheterization Laboratory at The Mount Sinai Medical Center, have performed the first implantation of the Medtronic CoreValve® Transcatheter Aortic Valve Prosthesis in the United States. The CoreValve System is a new device that treats severe aortic stenosis, which affects about 300,000 people worldwide. Designed to replace a diseased aortic heart valve percutaneously via a catheter, CoreValve potentially provides a safe and less invasive alternative to open heart surgery.

The normal aortic valve opens and closes each time the heart beats to allow blood to leave the pumping chamber of the heart. In many patients of advanced aged, the leaflets of the valve become calcified, leading to a narrowing or stenosis of the valve and symptoms which include shortness of breath on activity. Severe aortic stenosis mostly affects patients older than 70 years of age, and the standard-of-care is open heart surgery to replace the diseased valve. It is estimated over one-third of patients with severe aortic stenosis are ineligible for conventional surgery, and many more are at high risk by undergoing it. Left untreated, about half of patients with symptomatic severe aortic stenosis will die within one year.

"There is an enormous unmet need in this patient population for a safe and effective treatment," said Dr. Adams, who is also the National Co-Principal Investigator for the Medtronic CoreValve U.S. FDA Pivotal Trial, along with Dr. Jeff Popma, of the Beth Israel Deaconess Medical Center and Harvard Medical School. "CoreValve provides an exciting new option for these patients without the invasiveness of open heart surgery. We hope this FDA trial will help establish this treatment as an effective option for selected patients with severe aortic stenosis."

"In the past, high risk patients suffering from the most severe forms of aortic stenosis were often treated by balloon aortic valvuloplasty, which is effective for approximately six months. CoreValve at Mount Sinai gives us another tool to continue to treat the sickest of patients and provide long-lasting relief," said Dr. Sharma.

Aortic stenosis is a heart condition that occurs when the aortic valve narrows, preventing it from properly opening and closing, and diminishing blood flow between the heart and the rest of the body. The reduced blood flow increases pressure within the heart, causing the heart to weaken and function poorly. When aortic stenosis becomes severe and symptoms develop, it is life-threatening.

The first recipient of the Transcatheter CoreValve in U.S. is a 88-year-old male with recurrent heart failure due to severe aortic stenosis, whose symptoms recurred despite undergoing balloon aortic valvuloplasty three months earlier. His aorta was highly calcified, precluding traditional surgical aortic valve replacement. CoreValve implantation was deemed the only option for him to prolong his life span, and he underwent the procedure on December 17.

The Medtronic CoreValve System is a new technology designed to replace a diseased aortic heart valve without open heart surgery and without surgical removal of the diseased valve. In the Medtronic CoreValve U.S. Clinical Trial, the replacement valve is delivered primarily through a small opening in the femoral artery, threaded through arteries and across the aorta, and deployed in the native aortic valve. Once in place, the CoreValve is designed to take over the native valve's function and ensure that oxygen-rich blood flows into the aorta and circulates throughout the body.

"As the first center in the United States to implant this device Mount Sinai is once again demonstrating our commitment to providing innovative, treatments for our patients," said Wayne Keathley, President & Chief Operating Officer, The Mount Sinai Hospital. "Dr. Adams is a leader in this field and his work with our world-class interventional cardiology team led by Dr. Samin Sharma clearly demonstrates the strength and breadth of clinical talent at Mount Sinai."
-end-
Dr. Adams is a world-renowned leader in the field of heart valve surgery and mitral valve reconstruction. Last year, patients from more than 35 different states came to New York to be under the care of Dr. Adams and his team. He is the co-inventor of two mitral valve annuloplasty repair rings with Edwards Lifesciences, and the inventor of a new tricuspid annuloplasty ring with Medtronic; Mount Sinai School of Medicine and Dr. Adams receive royalties for these inventions. .

Dr. Sharma is a world renowned interventional cardiologist, and, according to New York State Department of Health reports, has the highest angioplasty success rate (lowest mortality less than 0.2 percent) for an interventional cardiologist in the state since 1994.

Dr. Adams and Dr. Sharma lead a multidisciplinary team of physicians and clinical support personnel that will coordinate the Medtronic CoreValve trial at Mount Sinai.

About Mount Sinai Heart

Mount Sinai Heart is a national leader in cardiac care, encompassing clinicians, scientists, nurses and associated caregivers under the leadership of visionary director Valentin Fuster, MD, PhD. In a short time since its inception in April 2006, Mount Sinai Heart has gained its own reputation as one of the world's leading centers for cardiovascular medicine and advanced diagnosis, particularly in the fields of imaging, treatment, and therapeutic technologies. Mount Sinai Heart was ranked 13th in the nation in 2010 by U.S. News & World Report.

About The Mount Sinai Medical Center

The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Mount Sinai School of Medicine. Established in 1968, Mount Sinai School of Medicine is one of few medical schools embedded in a hospital in the United States. It has more than 3,400 faculty in 32 departments and 15 institutes, and ranks among the top 20 medical schools both in National Institute of Health funding and by U.S. News & World Report. The school received the 2009 Spencer Foreman Award for Outstanding Community Service from the Association of American Medical Colleges.

The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation's oldest, largest and most-respected voluntary hospitals. In 2009, U.S. News & World Report ranked The Mount Sinai Hospital among the nation's top 20 hospitals based on reputation, patient safety, and other patient-care factors. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 530,000 outpatient visits took place.

For more information, visit www.mountsinai.org. Follow us on Twitter @mountsinainyc.

The Mount Sinai Hospital / Mount Sinai School of Medicine

Related Aortic Stenosis Articles from Brightsurf:

Aortic valve replacement during COVID-19 pandemic
The outcomes associated with deferred compared with expedited aortic valve replacement in patients with severe aortic stenosis during the COVID-19 pandemic are evaluated in this observational study.

Patients deferred for transcatheter aortic valve replacement because of COVID-19
This single-center study of 77 patients describes the outcomes of patients with symptomatic severe aortic stenosis during the COVID-19 pandemic.

External ultrasound therapy of calcific aortic stenosis -- First-in-man
Cardiawave (France) has developed a Non-Invasive Ultrasound Therapy (NIUT) for the treatment of cardio-valvular diseases such as aortic stenosis.

Cutting-edge imaging may provide insight into the functional significance of a stenosis
A novel study aims to evaluate whether optical coherence tomography (OCT) parameters may predict fractional flow reserve (FFR) values and assess if OCT parameters may predict clinical outcome in patients with negative FFR.

Management and outcomes of aortic dissection in pregnancy with Marfan Syndrome
In Marfan Syndrome (MFS), aortic dilatation is one of the main cardiovascular manifestations which deteriorate due to the physiological changes during pregnancy.

Researchers uncover new cause of abdominal aortic aneurysm
Researchers have discovered that a family of lipids (fats) contribute to the development of a serious aortic disease, by driving clotting in the blood vessel wall.

Early valve replacement versus watchful waiting in patients with severe aortic stenosis
Patients with severe aortic stenosis who have no symptoms may benefit more from an aggressive strategy of early valve replacement than from a conservative watch-and-wait approach, according to new research published today online in The Annals of Thoracic Surgery.

Registry helps move aortic dissection care forward
Diagnosis, treatments and outcomes for acute aortic dissection have evolved.

In study, TAVR is superior to surgery for low-risk patients with aortic valve stenosis
A large clinical trial has found that a minimally invasive procedure to replace a narrowed heart valve performed better than surgery in patients who were good candidates for surgery.

Women more likely to have poorer outcomes following aortic surgery
New research says women fare worse than men following aortic heart surgery.

Read More: Aortic Stenosis News and Aortic Stenosis Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.