TAVR Achieves Positive Short-term Outcomes in Bicuspid Valves

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Transcatheter aortic valve replacement (TAVR) is feasible in patients with bicuspid aortic valves, achieving short-term clinical and hemodynamic improvements despite the condition being contraindicated for such procedures. Results from a small patient series were published online June 8, 2012, in the American Journal of Cardiology.

Dominique Himbert, MD, of Bichat-Claude Bernard Hospital (Paris, France), and colleagues reviewed the outcomes of 15 patients with bicuspid valve stenosis who received TAVR using the CoreValve system (Medtronic, Minneapolis, MN) from January 2009 to January 2012 at their institution. Average age of patients was 80 years, with a mean Society of Thoracic Surgeons score of 8% and a logistic EuroSCORE of 17%. The patients were all in New York Heart Association (NYHA) functional classes III and IV.

Procedures were performed by transfemoral access in 14 cases and by subclavian access in 1.  The 29-mm CoreValve device was used in 13 patients and the 26-mm device in 2. Procedural success was achieved in 14 patients, with no intraprocedural deaths. One patient developed acute respiratory distress a few hours after implantation, because the prosthesis was implanted too low. The patient did not survive despite emergency surgical valve replacement.

No Adverse Events Apart from 1 In-Hospital Death

Immediate hemodynamic performance of the prosthesis was satisfactory in 13 patients, with paraprosthetic or central aortic regurgitation grade ≤ 1+ and transprosthetic gradient < 20 mm Hg. Median hospital stay from procedure to discharge was 9 days and the 30-day Valve Academic Research Consortium combined safety endpoint was achieved in 14 patients (93%). Aside from the 1 in-hospital death, there were no other major adverse events. Permanent pacemakers were required in 6 patients.

At discharge, mean postimplantation prosthetic gradient was 11 ± 4 mm Hg, and ≤ 1+ paraprosthetic leaks were observed in all but 2 patients. The mean prosthetic ellipticity index was 0.7 ± 0.2 at the level of the native annulus and 0.8 ± 0.2 at the level of the prosthetic leaflets. After a mean follow-up period of 8 ± 7 months, 1 patient had died from aortic dissection; there were no additional adverse events. All but 2 patients who survived to discharge were in NYHA class I or II.

“Our results suggest that TAVI using the [CoreValve system] and a transarterial approach is feasible and may be associated with good immediate and midterm clinical and hemodynamic results in selected high-risk patients with [aortic stenosis] and [bicuspid aortic valve],” the researchers conclude.

They caution, though, that the current patient series does now allow for evaluation of long-term prosthesis durability in this setting.

For the most part, the authors note, patients with bicuspid aortic valves have been excluded from TAVR trials and there is very little clinical experience with such cases. Bicuspid valve has been considered a contraindication to TAVR for a number of reasons:

  • Aortic annular diameters too large or not suitable for current transcatheter valves
  • Asymmetric distribution of calcification precluding full expansion of the prosthesis and increasing risk of paravalvular aortic regurgitation and annular rupture
  • Associated lesions of the ascending aorta

The CoreValve system was chosen due to the patients’ large annular diameters (≥ 25 mm in 11 cases) and the assumed theoretical advantage of the supra-annular position of the device’s leaflets.

“In clinical practice, because of anatomic limitations and technical challenges, the use of TAVI should remain limited in patients with bicuspid aortic valves and proposed on a case-by-case basis . . . if mandatory clinical indication is established and in the absence of an alternative treatment,” the authors note.

Study Details

At baseline, calcium score using multislice CT was 4,553 ± 1,872 arbitrary units. Aortic valve area was 0.8 ± 0.3 cm2, while the gradient was 60 ± 19 mm Hg.


Himbert D, Pontnau F, Messika-Zeitoun D, et al. Feasibility and outcomes of transcatheter aortic valve in high-risk patients with stenotic bicuspid aortic valves. Am J Cardiol. 2012;Epub ahead of print.



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