Korean Circ J.  2021 Mar;51(3):222-231. 10.4070/kcj.2020.0409.

Comparison of Transcatheter Aortic Valve Replacement between SelfExpanding versus Balloon-Expandable Valves in Patients with Small Aortic Annulus

• Lee YJ
• Lee SJ
• Hong SJ
• Shim CY
• Ahn CM
• Kim JS
• Kim BK
• Hong GR
• Ko YG
• Choi D
• Jang Y
• Hong MK

• KMID: 2513519
• DOI: http://doi.org/10.4070/kcj.2020.0409

Abstract

Background and Objectives
Transcatheter aortic valve replacement (TAVR) has been reported as a good alternative for surgical aortic valve replacement in patients with small aortic annulus. Head-to-head comparisons of different transcatheter aortic valves in these patients are insufficient. We compared the outcomes after TAVR between two different types of recent transcatheter aortic valves (self-expanding vs. balloon-expandable) in patients with small aortic annulus.
Methods
A total of 70 patients with severe aortic stenosis and small annulus (mean diameter ≤23 mm or minimal diameter ≤21 mm on computed tomography) underwent TAVR with either a self-expanding valve with supra-annular location (n=45) or a balloon-expandable valve with intra-annular location (n=25). The echocardiographic hemodynamic parameters after TAVR and 1-year follow-up were compared.
Results
Between the self-expanding and balloon-expandable valve-treated patients, the clinical outcomes including permanent pacemaker implantation (11.1% vs. 8.0%), acute kidney injury stage 2 or 3 (4.4% vs. 4.0%), and major vascular complication (4.4% vs. 0.0%) were similar without all-cause mortality, stroke, and life-threatening bleeding during 30-day follow-up. Compared with the balloon-expandable valve-treated patients, the self-expanding valve-treated patients presented larger effective orifice area (EOA) (1.46±0.28 vs. 1.75±0.42 cm² , p=0.002) and indexed EOA (0.95±0.21 vs. 1.18±0.28 cm² /m² , p=0.001), whereas mean aortic valve gradient (11.7±2.9 vs. 8.9±5.2 mmHg, P=0.005) and incidence of ≥moderate prosthesis-patient mismatch (36.0% vs. 8.9%, p=0.009) were lower. These hemodynamic differences were maintained at 1-year follow-up.
Conclusions
TAVR with self-expanding valves was associated with superior hemodynamic outcomes compared with balloon-expandable valves in patients with small aortic annulus.

Keyword

Transcatheter aortic valve replacement; Aortic valve stenosis

Figure

• 

  Figure 1 Echocardiographic outcomes at baseline, discharge, and 1-year follow-up.Effective orifice area (A), indexed effective orifice area (B), and mean aortic valve pressure gradient (C).EOA = effective orifice area; iEOA = indexed effective orifice area.

• 

  Figure 2 Incidence of prosthesis-patient mismatch and paravalvular leak at discharge and 1-year follow-up.Prosthesis-patient mismatch (A) and paravalvular leak (B). There was no severe paravalvular leak during 1-year follow-up.

Reference

1. Kalavrouziotis D, Rodés-Cabau J, Bagur R, et al. Transcatheter aortic valve implantation in patients with severe aortic stenosis and small aortic annulus. J Am Coll Cardiol. 2011; 58:1016–1024. PMID: 21867836.

2. Pibarot P, Weissman NJ, Stewart WJ, et al. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis. J Am Coll Cardiol. 2014; 64:1323–1334. PMID: 25257633.

3. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017; 135:e1159–95. PMID: 28298458.

4. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017; 38:2739–2791. PMID: 28886619.

5. Mauri V, Kim WK, Abumayyaleh M, et al. Short-term outcome and hemodynamic performance of next-generation self-expanding versus balloon-expandable transcatheter aortic valves in patients with small aortic annulus: a multicenter propensity-matched comparison. Circ Cardiovasc Interv. 2017; 10:e005013. PMID: 28951395.

6. Rogers T, Steinvil A, Gai J, et al. Choice of balloon-expandable versus self-expanding transcatheter aortic valve impacts hemodynamics differently according to aortic annular size. Am J Cardiol. 2017; 119:900–904. PMID: 28109558.

7. Watanabe Y, Hayashida K, Lefèvre T, et al. Transcatheter aortic valve implantation in patients of small body size. Catheter Cardiovasc Interv. 2014; 84:272–280. PMID: 23613222.

8. Yashima F, Yamamoto M, Tanaka M, et al. Transcatheter aortic valve implantation in patients with an extremely small native aortic annulus: the OCEAN-TAVI registry. Int J Cardiol. 2017; 240:126–131. PMID: 28606674.

9. Freitas-Ferraz AB, Tirado-Conte G, Dagenais F, et al. Aortic stenosis and small aortic annulus. Circulation. 2019; 139:2685–2702. PMID: 31157994.

10. Binder RK, Rodés-Cabau J, Wood DA, et al. Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve. JACC Cardiovasc Interv. 2013; 6:293–300. PMID: 23517842.

11. Manoharan G, Walton AS, Brecker SJ, et al. Treatment of symptomatic severe aortic stenosis with a novel resheathable supra-annular self-expanding transcatheter aortic valve system. JACC Cardiovasc Interv. 2015; 8:1359–1367. PMID: 26315740.

12. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013; 145:6–23. PMID: 23084102.

13. DuBois D, DuBois EF. A formula to estimate the approximate surface area it height and weight be known. Arch Intern Med (Chic). 1916; 17:863–871.

14. Rodés-Cabau J, Pibarot P, Suri RM, et al. Impact of aortic annulus size on valve hemodynamics and clinical outcomes after transcatheter and surgical aortic valve replacement: insights from the PARTNER Trial. Circ Cardiovasc Interv. 2014; 7:701–711. PMID: 25270901.

15. Hase H, Yoshijima N, Yanagisawa R, et al. Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: the OCEAN-TAVI registry. Catheter Cardiovasc Interv. 2020; [Epub ahead of print].

16. Herrmann HC, Daneshvar SA, Fonarow GC, et al. Prosthesis-patient mismatch in patients undergoing transcatheter aortic valve replacement: From the STS/ACC TVT registry. J Am Coll Cardiol. 2018; 72:2701–2711. PMID: 30257798.

17. Regazzoli D, Chiarito M, Cannata F, et al. Transcatheter self-expandable valve implantation for aortic stenosis in small aortic annuli: the TAVI-SMALL registry. JACC Cardiovasc Interv. 2020; 13:196–206. PMID: 31883714.

18. Hahn RT, Leipsic J, Douglas PS, et al. Comprehensive echocardiographic assessment of normal transcatheter valve function. JACC Cardiovasc Imaging. 2019; 12:25–34. PMID: 29909110.