Early clinical and haemodynamic matched comparison of balloon-expandable valves
© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ..
OBJECTIVES: The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device.
METHODS: Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index.
RESULTS: A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001).
CONCLUSIONS: The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:108 |
|---|---|
| Enthalten in: |
Heart (British Cardiac Society) - 108(2022), 9 vom: 03. Mai, Seite 725-732 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Delgado-Arana, Jose R [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Aortic valve stenosis |
|---|
| Anmerkungen: |
Date Completed 12.04.2022 Date Revised 17.05.2022 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1136/heartjnl-2021-319349 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM328302228 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM328302228 | ||
| 003 | DE-627 | ||
| 005 | 20231225202648.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/heartjnl-2021-319349 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1094.xml |
| 035 | |a (DE-627)NLM328302228 | ||
| 035 | |a (NLM)34285104 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Delgado-Arana, Jose R |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Early clinical and haemodynamic matched comparison of balloon-expandable valves |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 12.04.2022 | ||
| 500 | |a Date Revised 17.05.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a OBJECTIVES: The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device | ||
| 520 | |a METHODS: Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index | ||
| 520 | |a RESULTS: A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001) | ||
| 520 | |a CONCLUSIONS: The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a aortic valve stenosis | |
| 650 | 4 | |a transcatheter aortic valve replacement | |
| 700 | 1 | |a Gordillo-Monge, María X |e verfasserin |4 aut | |
| 700 | 1 | |a Halim, Jonathan |e verfasserin |4 aut | |
| 700 | 1 | |a De Marco, Federico |e verfasserin |4 aut | |
| 700 | 1 | |a Trani, Carlo |e verfasserin |4 aut | |
| 700 | 1 | |a Martin, Pedro |e verfasserin |4 aut | |
| 700 | 1 | |a Infusino, Fabio |e verfasserin |4 aut | |
| 700 | 1 | |a Ancona, Marco |e verfasserin |4 aut | |
| 700 | 1 | |a den Heijer, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Bedogni, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Nombela Franco, Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Moreno, Raul |e verfasserin |4 aut | |
| 700 | 1 | |a Sargella, Gennaro |e verfasserin |4 aut | |
| 700 | 1 | |a Montorfano, Matteo |e verfasserin |4 aut | |
| 700 | 1 | |a Aristizabal-Duque, Cristhian |e verfasserin |4 aut | |
| 700 | 1 | |a Romero-Delgado, Teresa |e verfasserin |4 aut | |
| 700 | 1 | |a Santos, Sandra |e verfasserin |4 aut | |
| 700 | 1 | |a Barrero, Alejandro |e verfasserin |4 aut | |
| 700 | 1 | |a Gomez Salvador, Itziar |e verfasserin |4 aut | |
| 700 | 1 | |a IJsselmuiden, Sander |e verfasserin |4 aut | |
| 700 | 1 | |a Redondo Diéguez, Alfredo |e verfasserin |4 aut | |
| 700 | 1 | |a San Román Calvar, José Alberto |e verfasserin |4 aut | |
| 700 | 1 | |a Amat-Santos, Ignacio J |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Heart (British Cardiac Society) |d 1996 |g 108(2022), 9 vom: 03. Mai, Seite 725-732 |w (DE-627)NLM085989274 |x 1468-201X |7 nnns |
| 773 | 1 | 8 | |g volume:108 |g year:2022 |g number:9 |g day:03 |g month:05 |g pages:725-732 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1136/heartjnl-2021-319349 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 108 |j 2022 |e 9 |b 03 |c 05 |h 725-732 | ||