Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve

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...

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Main Authors: Yusuke Watanabe, Shinichi Shirai, Norio Tada, Toru Naganuma, Futoshi Yamanaka, Hiroshi Ueno, Minoru Tabata, Masanori Yamamoto, Kentaro Hayashida, Shigeaki Kato, Yusuke Enta, Masaki Miyasaka, Masataka Taguri, Masaki Hata, Masahiro Yamawaki
Format: Article
Language:English
Published: BMJ Publishing Group 2021-02-01
Series:Open Heart
Online Access:https://openheart.bmj.com/content/8/1/e001531.full
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author Yusuke Watanabe
Shinichi Shirai
Norio Tada
Toru Naganuma
Futoshi Yamanaka
Hiroshi Ueno
Minoru Tabata
Masanori Yamamoto
Kentaro Hayashida
Shigeaki Kato
Yusuke Enta
Masaki Miyasaka
Masataka Taguri
Masaki Hata
Masahiro Yamawaki
author_facet Yusuke Watanabe
Shinichi Shirai
Norio Tada
Toru Naganuma
Futoshi Yamanaka
Hiroshi Ueno
Minoru Tabata
Masanori Yamamoto
Kentaro Hayashida
Shigeaki Kato
Yusuke Enta
Masaki Miyasaka
Masataka Taguri
Masaki Hata
Masahiro Yamawaki
author_sort Yusuke Watanabe
collection DOAJ
description 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 cm2/m2 or severe if <0.65 cm2/m2 at the indexed effective orifice area by postprocedural echocardiography.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.
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spelling doaj-art-ecb15146687b495fab10ff15a76a6e8b2024-11-11T13:30:08ZengBMJ Publishing GroupOpen Heart2053-36242021-02-018110.1136/openhrt-2020-001531Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valveYusuke Watanabe0Shinichi Shirai1Norio Tada2Toru Naganuma3Futoshi Yamanaka4Hiroshi Ueno5Minoru Tabata6Masanori Yamamoto7Kentaro Hayashida8Shigeaki Kato9Yusuke Enta10Masaki Miyasaka11Masataka Taguri12Masaki Hata13Masahiro Yamawaki14Department of Infection Prevention and Control, Tokyo Medical University Hospital, Shinjuku, Tokyo, JapanDepartment of Cardiology, Kokura Memorial Hospital, Kitakyushu, JapanDepartment of Cardiology, Sendai Kosei Hospital, Sendai, JapanDepartment of Cardiology, New Tokyo Hospital, Matsudo, JapanDepartment of Cardiology, Shonan Kamakura General Hospital, Kamakura, JapanSecond Department of Internal Medicine, Toyama University Hospital, Toyama, JapanDepartment of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Centre, Chiba, JapanDepartment of Cardiology, Toyohashi Heart Center, Toyohashi, JapanDepartment of Cardiology, Keio University School of Medicine, Tokyo, JapanCardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, JapanCardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, JapanCardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, Japan6 Department of Data Science, School of Data Science, Yokohama City University, Yokohama, JapanCardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, JapanDepartment of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, JapanBackground 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 cm2/m2 or severe if <0.65 cm2/m2 at the indexed effective orifice area by postprocedural echocardiography.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.https://openheart.bmj.com/content/8/1/e001531.full
spellingShingle Yusuke Watanabe
Shinichi Shirai
Norio Tada
Toru Naganuma
Futoshi Yamanaka
Hiroshi Ueno
Minoru Tabata
Masanori Yamamoto
Kentaro Hayashida
Shigeaki Kato
Yusuke Enta
Masaki Miyasaka
Masataka Taguri
Masaki Hata
Masahiro Yamawaki
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
title Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve
title_full Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve
title_fullStr Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve
title_full_unstemmed Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve
title_short Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve
title_sort incidence and predictors of prosthesis patient mismatch after tavi using sapien 3 in asian differences between the newer and older balloon expandable valve
url https://openheart.bmj.com/content/8/1/e001531.full
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