Transcatheter Aortic Valve Replacement for Aortic Stenosis

Interventional cardiologists and cardiac surgeons at Penn Medicine are performing transcatheter aortic valve replacement (TAVR) surgery for patients with aortic stenosis who are not candidates for open-heart surgery.

As original investigators in the PARTNER trial [1] 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 etiologies include congenital disease, rheumatic fever and stenosis arising 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 2021 - The SMART Trial

In April 2021, the first patient in the Small Annuli Randomized to Evolut™ or Sapien (SMART) post-market trial [NCT04722250] was treated at Penn Medicine. A randomized, head-to-head study comparing two TAVR systems in patients with severe symptomatic aortic stenosis (AS), the SMART trial compares valve safety and performance of the self-expanding Evolut™ PRO and PRO+TAVR Systems (Medtronic) with the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (Edwards Lifesciences).

The study will enroll approximately 700 patients at more than 90 international sites, and is being led by Howard C. Herrmann, MD, Health System Director for Interventional Cardiology.

The SMART trial evaluates valve performance in patients with with small aortic annuli and symptomatic severe native aortic stenosis. Given this focus, the majority of study participants are expected to be women, a currently underrepresented patient population in TAVR literature.

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

Published on: April 19, 2021

References

1. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ, for the PARTNER Trial Investigators. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients. N Engl J Med. 2011;364:2187-2198.

 

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