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


Journal

Open heart
ISSN: 2053-3624
Titre abrégé: Open Heart
Pays: England
ID NLM: 101631219

Informations de publication

Date de publication:
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.

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Auteurs

Masaki Miyasaka (M)

Cardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, Japan masaki108@gmail.com.

Norio Tada (N)

Cardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, Japan.

Masataka Taguri (M)

Cardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, Japan.
Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.

Shigeaki Kato (S)

Cardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, Japan.
Center for Regional Cooperation Iwaki, Meisei University, Iwaki, Fukushima, Japan.

Yusuke Enta (Y)

Cardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, Japan.

Masaki Hata (M)

Cardiovascular Center, Sendai Kosei Hospital, Sendai, Miyagi, Japan.

Yusuke Watanabe (Y)

Department of Internal Medicine, Teikyo University Hospital, Itabashi-ku, Tokyo, Japan.

Toru Naganuma (T)

Interventional Cardiology Unit, New Tokyo Hospital, Matsudo, Chiba, Japan.

Masahiro Yamawaki (M)

Department of Cardiovascular Medicine, Saiseikai Yokohamashi Tobu Hospital, Yokohama, Japan.

Futoshi Yamanaka (F)

Department of Cardiovascular Medicine, Shonankamakura General Hospital, Kamakura, Kanagawa, Japan.

Shinichi Shirai (S)

Cardiology, Kokura Mem Hosp, Kitakyushu, Fukuoka, Japan.

Hiroshi Ueno (H)

Cardiovascular Medicine, University of Toyama University Hospital, Toyama, Toyama, Japan.

Kazuki Mizutani (K)

Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan.

Minoru Tabata (M)

Department of Cardiovascular Surgery, Tokyo Bay Urayasu Ichikawa Medical Center, Chiba, Japan.

Kensuke Takagi (K)

Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Gifu, Japan.

Masanori Yamamoto (M)

Interventional Cardiology, Toyohashi Heart Center, Toyohashi, Aichi, Japan.

Kentaro Hayashida (K)

Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.

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