Author + information
- Jeffrey J. Popma1,
- Michael J. Reardon2,
- Stanley Chetcuti3,
- David H. Adams4,
- Susheel Kodali5,
- Paul Sorajja6,
- James B. Hermiller Jr.7 and
- Wilson Y. Szeto8
- 1Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
- 2Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, United States
- 3University of Michigan Health Center, Ann Arbor, Michigan, United States
- 4Mount Sinai Medical Center, New York, New York, United States
- 5New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States
- 6Minneapolis Heart Institute, Minneapolis, Minnesota, United States
- 7St. Vincent Hospital/The Heart Center of Indiana, Indianapolis, Indiana, United States
- 8University of Pennsylvania, Philadelphia, Pennsylvania, United States
Bicuspid aortic valve (BAV) disease is less common than tricuspid aortic valve disease in patients with symptomatic severe aortic stenosis, but may occur more often in younger patients and those with ascending aortopathy. Outcomes after transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis in patients with BAV disease are not fully known.
We reviewed the baseline demographics and clinical outcomes in 15,850 patients enrolled in the STS TVT Registry from January 2014 to September 2016 at 322 US institutions. 486 (3.1%) were categorized with BAV disease. Thirty-day clinical and echocardiographic data are included.
Clinical demographics and 30-day procedural outcomes are shown (Table). Patients with BAV disease had a mean age of 72.5±11.7 years, 54.9% were male, and the mean STS PROM score was 6.4±5.1%. The procedural time was 133.1±66.4 minutes, and 3.7% had a valve-in-valve procedure. Patients with BAV disease treated with Evolut R TAVR had less frequent use of >1 valve (3.7% vs 9.2%), higher device success rates (94.2% vs 90.8%), and lower 30-day mortality rates, moderate-severe aortic regurgitation (AR), and permanent pacemaker placement (PPM) rates than patients treated with the CoreValve system. A limitation of the study was that 46.5% of patients received the 31-mm CoreValve valve, whereas data are not yet available with the Evolut R 34-mm XL valve.
|Variable*||CoreValve N=295||Evolut R N=191|
|Male sex, %||62.4||43.5|
|>1 Valve used, %||9.2||3.7|
|Device success, %||90.8||94.2|
|30-Day mortality, %||6.2||2.2|
|30-Day any stroke, %||2.1||2.6|
|30-Day moderate-severe AR, %||24.3||7.7|
|30-Day mean gradient, mmHg||9.0±4.4||9.4±5.4|
|30-Day new PPM, %||25.8||12.6|
*All % are KM rates except for AR.
Treatment of BAV disease with a self-expanding bioprosthesis was evaluated retrospectively and showed an acceptable safety and effectiveness profile. The retrievable and repositionable Evolut R system provided better procedural outcome in patients with BAV disease than the early generation CoreValve system, resulting in less frequent use of multiple valves, higher device success rates, and lower rates of 30-day moderate-severe AR and need for a PPM.
STRUCTURAL: Valvular Disease: Aortic