Subscribe to RSS
DOI: 10.1055/s-0041-1732316
Low Incidence of Prosthesis-Patient Mismatch Following Extremely Small Transcatheter Aortic Valve Replacement with 20-mm Sapien 3
![](https://www.thieme-connect.de/media/ija/202202/lookinside/thumbnails/10-1055-s-0041-1732316_210048-1.jpg)
Abstract
Transcatheter aortic valve replacement has been developed as an emerging technique to treat patients with aortic valve disease. However, safety and outcome data on extremely small transcatheter heart valves (THV) is limited. We aimed to assess hemodynamic profiles and clinical outcome of very small balloon expandable THVs with 20-mm Sapien 3 (SP3).
We examined data for all patients who received third-generation SP3 THV at a single hospital. Complications and clinical outcomes were defined based on the VARC-2 criteria. Postoperative prosthesis-patient mismatch (PPM) was defined as indexed effective orifice area (EOA) < 0.85 cm2/m2. We compared clinical characteristics and outcome between patients with 20-mm (n = 21), 23-mm (n = 67), and 26- or 29-mm (n = 113) sized valves.
The 20-mm group included significantly higher number of Asian and female populations with lower body surface area. The baseline CT annular area in the 20-mm group was 316.5 ± 24.9 mm2. There was no significant difference between groups in procedural mortality or early safety at 30 days. The higher procedural complication was observed in 20-mm group due to significant differences in minor vascular and bleeding complications. Despite higher post-THV gradients and smaller indexed EOA in 20-mm group, no PPM was observed in 20-mm group. The mortality at 30 days and 1 year in 20-mm group was 4.8% and 16.7%, respectively.
The patients who received very small THVs with 20-mm SP3 did not result in PPM and experienced favorable early safety and midterm outcome in our cohort.
Keywords
transcatheter aortic valve replacement - prosthesis-patient mismatch - small aortic annulus - aortic stenosis - outcomePublication History
Received: 02 April 2021
Accepted: 15 June 2021
Article published online:
25 August 2021
© 2021. International College of Angiology. This article is published by Thieme.
Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA
-
References
- 1 Mack MJ, Leon MB, Thourani VH. et al; PARTNER 3 Investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019; 380 (18) 1695-1705
- 2 Popma JJ, Deeb GM, Yakubov SJ. et al; Evolut Low Risk Trial Investigators. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019; 380 (18) 1706-1715
- 3 Head SJ, Mokhles MM, Osnabrugge RL. et al. The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient-years. Eur Heart J 2012; 33 (12) 1518-1529
- 4 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 (13) 1323-1334
- 5 Thyregod HG, Steinbrüchel DA, Ihlemann N. et al. No clinical effect of prosthesis-patient mismatch after transcatheter versus surgical aortic valve replacement in intermediate- and low-risk patients with severe aortic valve stenosis at mid-term follow-up: an analysis from the NOTION trial. Eur J Cardiothorac Surg 2016; 50 (04) 721-728
- 6 Deeb GM, Chetcuti SJ, Yakubov SJ. et al. Impact of annular size on outcomes after surgical or transcatheter aortic valve replacement. Ann Thorac Surg 2018; 105 (04) 1129-1136
- 7 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
- 8 Salna M, Khalique OK, Chiuzan C. et al. Impact of small prosthesis size on transcatheter or surgical aortic valve replacement outcomes. Catheter Cardiovasc Interv 2018; 91 (04) 765-773
- 9 Meguro K, Kakizaki R, Hashimoto T. et al. Early safety and efficacy of Sapien 3 20 mm transcatheter heart valve implantation in small Japanese body size. Heart Surg Forum 2018; 21 (05) E341-E344
- 10 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 Am Coll Cardiol 2012; 60 (15) 1438-1454
- 11 Hahn RT, Leipsic J, Douglas PS. et al. Comprehensive echocardiographic assessment of normal transcatheter valve function. JACC Cardiovasc Imaging 2019; 12 (01) 25-34
- 12 Yoon SH, Ohno Y, Araki M. et al. Comparison of aortic root anatomy and calcification distribution between Asian and Caucasian patients who underwent transcatheter aortic valve implantation. Am J Cardiol 2015; 116 (10) 1566-1573
- 13 Yoon SH, Ahn JM, Hayashida K. et al; Asian TAVR Investigators. Clinical outcomes following transcatheter aortic valve replacement in Asian population. JACC Cardiovasc Interv 2016; 9 (09) 926-933
- 14 Overtchouk P, Guedeney P, Rouanet S. et al. Long-term mortality and early valve dysfunction according to anticoagulation use: the FRANCE TAVI Registry. J Am Coll Cardiol 2019; 73 (01) 13-21
- 15 Watanabe Y, Hayashida K, Lefèvre T. et al. Transcatheter aortic valve implantation in patients of small body size. Catheter Cardiovasc Interv 2014; 84 (02) 272-280
- 16 Mooney J, Sellers SL, Blanke P. et al. CT-defined prosthesis-patient mismatch downgrades frequency and severity, and demonstrates no association with adverse outcomes after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2017; 10 (15) 1578-1587
- 17 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 (22) 2701-2711
- 18 Abdelghani M, Allali A, Kaur J. et al. Impact of prosthesis-iteration evolution and sizing practice on the incidence of prosthesis-patient mismatch after transcatheter aortic valve replacement. Catheter Cardiovasc Interv 2019; 93 (05) 971-979
- 19 Miyasaka M, Tada N, Taguri M. et al; OCEAN-TAVI Investigators. Incidence, predictors, and clinical impact of prosthesis-patient mismatch following transcatheter aortic valve replacement in Asian patients: the OCEAN-TAVI Registry. JACC Cardiovasc Interv 2018; 11 (08) 771-780
- 20 Miyasaka M, Tada N, Taguri M. et al; OCEAN-TAVI investigators. Incidence and predictors of prosthesis-patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve. Open Heart 2021; 8 (01) e001531
- 21 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; 97 (06) E875-E886