At the Penn Aorta Center, interventional cardiologists and cardiac surgeons are performing transcatheter aortic valve replacement (TAVR) surgery for patients with aortic stenosis who are not candidates for open-heart surgery.
Figure 1: During transcatheter aortic valve replacement surgery, an artificial valve mounted on a stent is deployed directly over the diseased native aortic valve.
As original investigators in the PARTNER trial [N Engl J Med. 2011] that led to Food and Drug Administration approval for the first transcatheter aortic heart valve for aortic stenosis, cardiovascular specialists at Penn Medicine are among the most experienced in the country at transcatheter aortic valve replacement. Today, Penn Medicine performs more than 500 TAVR procedures each year.
In adults, aortic stenosis is primarily a condition caused by age-related calcium deposition at the valve, and degenerative calcific aortic stenosis is the primary indication for aortic valve replacement in symptomatic patients. Other, less common causes include congenital diseases, rheumatic fever, and stenosis resulting from radiotherapy and other treatments.
Open-heart valve replacement surgery is the gold standard treatment for otherwise healthy patients with aortic stenosis. Because the physical demands of the procedure and other comorbidities may be prohibitive, however, many older patients are not candidates for open surgery.
TAVR employs a biological valve crimped onto a stent and folded inside a large bore catheter. The catheter is introduced at the groin and threaded up the aorta. Upon reaching the aortic valve, a balloon is inflated to deploy the stented valve directly over the calcified native valve, typically eliminating the need for surgical removal.
In the PARTNER trial, the transcatheter valve proved to be significantly superior to medical treatment in inoperable patients with severe symptomatic aortic stenosis. Penn researchers are now involved in the second phase of the trial, which is investigating a new and better valve design coupled with a smaller diameter delivery system that permits less invasive access at the groin.
Update 2024 - The SMART Trial
The first patient in the Small Annuli Randomized to Evolut™ or Sapien (SMART) post-market trial [NCT04722250] was treated at Penn Medicine in 2021. A randomized, head-to-head study comparing two TAVR systems in patients with severe symptomatic aortic stenosis, the SMART trial compared valve safety and performance of the Medtronic self-expanding Evolut™ PRO and PRO+TAVR Systems (SEV) with the Edwards Lifesciences balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (BEV).
Led by Howard C. Herrmann, MD, Health System Director for Interventional Cardiology, the SMART trial enrolled approximately 700 patients at more than 90 international sites. Given the trial’s focus on patients with small aortic annuli and symptomatic severe native aortic stenosis, the majority of study participants (N=621) were women, an underrepresented patient population in TAVR literature.
Results, published in 2024, found that among women with severe symptomatic aortic stenosis and small aortic annuli undergoing transcatheter aortic valve replacement, the use of SEVs as compared to BEVs, resulted in similar clinical outcomes and a markedly reduced incidence of bioprosthetic valve dysfunction through 12 months, including a lower risk of prosthesis-patient mismatch and better 12-month quality of life.
Case study
Mr. L, an 88-year-old man, was referred to Penn Interventional Cardiology by his community cardiologist after a decade of progressive heart failure (LVEF 30%) when an echocardiogram demonstrated a heavily calcified aortic valve. Mr. L had no signs of concomitant organ dysfunction and was in otherwise relatively good health. Because he was frail, however, he was felt to be inoperable.
At Penn, a physical examination revealed signs (a low-intensity carotid pulse and a pronounced heart murmur), indicative of aortic stenosis. After an angiogram demonstrated the patency of his iliac and coronary arteries and lung and kidney function were determined to be good, Mr. L was judged a good candidate for transcatheter aortic valve replacement surgery. After a consultation, he agreed to have the procedure.
The surgery proceeded without complications. Following anesthesia, the right femoral artery was dilated and a sheath introduced and advanced to the thoracic aorta. A guide wire was then threaded to the heart and the artificial valve advanced to the aortic valve. Mr. L’s heart was then paced to halt ejection, and the artificial valve was inflated over the damaged native aortic valve. Mr. L remained in the hospital for five days, after which he went home to recuperate.
At his six-month follow-up evaluation, echocardiography showed near-normal left ventricular function, and Mr. L reported notably improved quality of life.
Access
Penn Heart and Vascular Center
Perelman Center for Advanced Medicine
East Pavilion, 2nd Floor
3400 Civic Center Boulevard
Philadelphia, PA 19104
Penn Presbyterian Medical Center
Heart Institute Building, Suite 2A
51 N 39th Street
Philadelphia, PA 19104
Penn Aorta Center
About the Penn TAVR Program
Penn cardiologists and cardiac surgeons have been performing TAVR since 2007 at Penn Medicine and now complete more than 500 procedures per year, making Penn one of the top five TAVR programs in the country. Beginning with the groundbreaking PARTNER trial, TAVR clinical research at Penn has sought to improve the use of TAVR and extend its indications. These and other clinical trials of innovative nonsurgical treatments and techniques, often unavailable elsewhere, may be accessed through the Penn Heart Valve Disease Program.
Penn Faculty Team
Cardiac Surgery
Pavan Atluri, MD
Director, Minimally Invasive and Robotic Cardiac Surgery Program
Director, Cardiac Transplantation
Professor of Surgery at the Hospital of the University of Pennsylvania
Interventional Cardiology
Howard C. Herrmann, MD
System Director, Interventional Cardiology
Section Chief, Interventional Cardiology, Hospital of the University of Pennsylvania
John Winthrop Bryfogle Professor of Cardiovascular Diseases
Professor of Medicine in Surgery
Paul N. Fiorilli, MD
Co-Director, Transcatheter Valve Program
Program Director, Interventional Cardiology Fellowship Training Program
Assistant Professor of Clinical Medicine (Cardiovascular Medicine)
Cardiology
Robert Fenning, MD
Associate Professor of Clinical Medicine (Cardiovascular Medicine)
Jay S. Giri, MD, MPH
Director, Cardiovascular Catheterization Laboratories, Hospital of the University of Pennsylvania
Associate Professor of Medicine (Cardiovascular Medicine) at the Hospital of the University of Pennsylvania
Taisei Kobayashi, MD, LCDR, USNR
Director, Cath Lab, Corporal Michael J. Crescenz Veterans Affairs Medical Center
Assistant Professor of Clinical Medicine (Cardiovascular Medicine)
Robert H. Li, MD
Co-Director, Transcatheter Aortic Valve Replacement Program, Penn Presbyterian Medical Center
Associate Professor of Clinical Medicine (Cardiovascular Medicine)
Penn Aorta Center Faculty (Cardiac Surgery)
Chase Brown, MD
Surgical Director, Coronary Revascularization, Penn Presbyterian Medical
Center Assistant Professor of Surgery at the Hospital of the University of Pennsylvania
Kendall Lawrence, MD
Assistant Professor of Surgery at the Hospital of the University of Pennsylvania