Incidence and predictors of prosthesis-patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve.
Aortic Valve
/ diagnostic imaging
Aortic Valve Insufficiency
/ diagnosis
Aortic Valve Stenosis
/ diagnosis
Bioprosthesis
/ adverse effects
Echocardiography
Follow-Up Studies
Heart Valve Prosthesis
/ adverse effects
Humans
Incidence
Japan
/ epidemiology
Prospective Studies
Prosthesis Design
Registries
Survival Rate
/ trends
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
aortic valve stenosis
cardiac catheterization
heart valve prosthesis implantation
Journal
Open heart
ISSN: 2053-3624
Titre abrégé: Open Heart
Pays: England
ID NLM: 101631219
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
28
11
2020
revised:
01
02
2021
accepted:
05
03
2021
entrez:
19
3
2021
pubmed:
20
3
2021
medline:
24
9
2021
Statut:
ppublish
Résumé
The balloon-expandable SAPIEN 3 (S3) is superior to the older-generation balloon-expandable SAPIEN XT (XT) in a lower incidence of paravalvular aortic regurgitation, lower complication rates and better survival in transcatheter aortic valve implantation (TAVI). However, prosthesis-patient mismatch (PPM) more frequently occurs in S3 than XT. Further, little information is available on PPM after TAVI using S3 in Asians. This study aims to determine the incidence and predictors of PPM in S3 by focusing on the difference between S3 and XT using data from a Japanese multicentre registry. From the Optimised transCathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) registry, 2134 patients undergoing TAVI using S3 or XT were included. PPM was defined as moderate if ≧0.65 but ≦0.85 cm The incidence of moderate and severe PPM in S3 was 13.3% and 1.3%, respectively. The 20 mm transcatheter heart valve (THV) was more frequently used in S3 than XT (7.4% vs 2.4%, p<0.0001). PPM was more frequently observed in S3 than XT (14.7% vs 8.8%, p<0.0001). Multivariate logistic regression analysis revealed S3 predicted PPM (OR 1.92 (95% CI 1.35 to 2.74), p=0.0003). The mutual predictors for PPM between S3 and XT were younger age, larger body surface area, smaller aortic valve area, no balloon postdilatation and the use of 20 mm and 23 mm THV. When comparing 23 mm, 26 mm and 29 mm S3, the ORs of 20 mm S3 were 5.67 (95% CI 2.88 to 11.12), 19.24 (95% CI 8.13 to 46.86) and 51.03 (95% CI 12.28 to 280.77), respectively. The incidence of PPM after TAVI using S3 was 14.6% overall in this Asian population. PPM was more frequently observed in S3 than XT. A considerable number of patients were treated by the 20 mm S3 in an Asian cohort. The 20 mm THV was identified as a strong predictor for PPM.
Sections du résumé
BACKGROUND
The balloon-expandable SAPIEN 3 (S3) is superior to the older-generation balloon-expandable SAPIEN XT (XT) in a lower incidence of paravalvular aortic regurgitation, lower complication rates and better survival in transcatheter aortic valve implantation (TAVI). However, prosthesis-patient mismatch (PPM) more frequently occurs in S3 than XT. Further, little information is available on PPM after TAVI using S3 in Asians. This study aims to determine the incidence and predictors of PPM in S3 by focusing on the difference between S3 and XT using data from a Japanese multicentre registry.
METHODS
From the Optimised transCathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) registry, 2134 patients undergoing TAVI using S3 or XT were included. PPM was defined as moderate if ≧0.65 but ≦0.85 cm
RESULTS
The incidence of moderate and severe PPM in S3 was 13.3% and 1.3%, respectively. The 20 mm transcatheter heart valve (THV) was more frequently used in S3 than XT (7.4% vs 2.4%, p<0.0001). PPM was more frequently observed in S3 than XT (14.7% vs 8.8%, p<0.0001). Multivariate logistic regression analysis revealed S3 predicted PPM (OR 1.92 (95% CI 1.35 to 2.74), p=0.0003). The mutual predictors for PPM between S3 and XT were younger age, larger body surface area, smaller aortic valve area, no balloon postdilatation and the use of 20 mm and 23 mm THV. When comparing 23 mm, 26 mm and 29 mm S3, the ORs of 20 mm S3 were 5.67 (95% CI 2.88 to 11.12), 19.24 (95% CI 8.13 to 46.86) and 51.03 (95% CI 12.28 to 280.77), respectively.
CONCLUSIONS
The incidence of PPM after TAVI using S3 was 14.6% overall in this Asian population. PPM was more frequently observed in S3 than XT. A considerable number of patients were treated by the 20 mm S3 in an Asian cohort. The 20 mm THV was identified as a strong predictor for PPM.
Identifiants
pubmed: 33737333
pii: openhrt-2020-001531
doi: 10.1136/openhrt-2020-001531
pmc: PMC7978259
pii:
doi:
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: NT, MY, TN, SS, KM, MT, HU and YW are clinical proctors for Edwards Lifesciences and Medtronic. KT and KH are clinical proctors of Edwards Lifesciences.
Références
N Engl J Med. 2016 Apr 28;374(17):1609-20
pubmed: 27040324
JACC Cardiovasc Interv. 2017 Aug 14;10(15):1578-1587
pubmed: 28734891
J Am Coll Cardiol. 2017 Mar 14;69(10):1215-1230
pubmed: 27956264
Eur Heart J Cardiovasc Imaging. 2016 Sep;17(9):1054-62
pubmed: 27002141
Circulation. 2020 Jan 28;141(4):260-268
pubmed: 31736332
JACC Cardiovasc Interv. 2015 Mar;8(3):462-471
pubmed: 25790764
Circ Cardiovasc Interv. 2017 Sep;10(9):
pubmed: 28916601
Circ J. 2019 Feb 25;83(3):672-680
pubmed: 30700661
Catheter Cardiovasc Interv. 2019 Apr 1;93(5):971-979
pubmed: 30467966
EuroIntervention. 2020 Feb 20;15(14):1240-1247
pubmed: 31763985
Ann Thorac Surg. 2018 Jul;106(1):14-22
pubmed: 29630873
JACC Cardiovasc Interv. 2018 Sep 10;11(17):1710-1718
pubmed: 30121276
Eur Heart J. 2016 Jul 21;37(28):2252-62
pubmed: 27190101
Am J Cardiol. 2015 Nov 15;116(10):1566-73
pubmed: 26428022
J Cardiol. 2015 Feb;65(2):112-6
pubmed: 24927855
JACC Cardiovasc Interv. 2019 Nov 11;12(21):2173-2182
pubmed: 31564593
J Am Coll Cardiol. 2014 Sep 30;64(13):1323-34
pubmed: 25257633
N Engl J Med. 2019 May 2;380(18):1695-1705
pubmed: 30883058
JACC Cardiovasc Interv. 2018 Apr 23;11(8):771-780
pubmed: 29673509
J Am Coll Cardiol. 2012 Oct 9;60(15):1438-54
pubmed: 23036636
JACC Cardiovasc Interv. 2019 May 27;12(10):936-948
pubmed: 31122351
Eur Heart J Cardiovasc Imaging. 2018 Feb 1;19(2):225-233
pubmed: 28329317
J Card Surg. 2020 Feb;35(2):360-366
pubmed: 31794109
Circulation. 2016 Jul 12;134(2):130-40
pubmed: 27400898
J Am Coll Cardiol. 2018 Dec 4;72(22):2701-2711
pubmed: 30257798
Lancet. 2019 Nov 2;394(10209):1619-1628
pubmed: 31570258
J Am Heart Assoc. 2020 Jan 21;9(2):e014609
pubmed: 31914879