One-year clinical outcome with a novel self-expanding transcatheter heart valve.
Aged
Aged, 80 and over
Aortic Valve
/ diagnostic imaging
Aortic Valve Stenosis
/ diagnostic imaging
Female
Heart Valve Prosthesis
Hemodynamics
Humans
Male
Prospective Studies
Prosthesis Design
Risk Factors
Severity of Illness Index
Time Factors
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
ACURATE neo
VARC-2
aortic valve stenosis
outcome
transfemoral transcatheter aortic valve replacement
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
15 Nov 2019
15 Nov 2019
Historique:
received:
26
10
2018
revised:
08
01
2019
accepted:
28
01
2019
pubmed:
26
2
2019
medline:
26
8
2020
entrez:
26
2
2019
Statut:
ppublish
Résumé
To evaluate 1-year outcome using the ACURATE neo (Symetis S.A., a Boston Scientific Company, Ecublens, Switzerland) according to the updated Valve Academic Research Consortium (VARC-2) with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety". Initial reports on the clinical performance of patients treated with the ACURATE neo are promising; however, information regarding one-year outcome is scarce, especially with regard to the composite endpoints proposed by the VARC-2. One hundred and fifty one consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with the ACURATE neo for severe aortic valve stenosis were enrolled. Data were prospectively collected and event rates during follow-up were calculated as the Kaplan-Meier estimates. Mean age was 81.1 ± 5.9 years and 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2-20.5]. Device success was achieved in 88.1% (133/151) and procedure related mortality was 0.7% (1/151). At one-year, all-cause mortality was 3.3% (5/151), while permanent pacemaker implantation occurred in 12.7% (19/151) of patients. The "clinical efficacy after 30 days" was observed in 24.8% (37/151), where the main contributor was symptom worsening in 14.8% (22/151) of cases. "Time-related valve safety" occurred in 22.0% (33/151) with structural valve deterioration as main contributor in 10.7% (16/151) of cases. Using the ACURATE neo, we found a favorable safety profile with low all-cause mortality at 1 year. The reported VARC-2 defined composite endpoints at 1 year reveal low rates of "clinical efficacy after 30 days" and "time-related valve safety".
Sections du résumé
OBJECTIVES
OBJECTIVE
To evaluate 1-year outcome using the ACURATE neo (Symetis S.A., a Boston Scientific Company, Ecublens, Switzerland) according to the updated Valve Academic Research Consortium (VARC-2) with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety".
BACKGROUND
BACKGROUND
Initial reports on the clinical performance of patients treated with the ACURATE neo are promising; however, information regarding one-year outcome is scarce, especially with regard to the composite endpoints proposed by the VARC-2.
METHODS
METHODS
One hundred and fifty one consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with the ACURATE neo for severe aortic valve stenosis were enrolled. Data were prospectively collected and event rates during follow-up were calculated as the Kaplan-Meier estimates.
RESULTS
RESULTS
Mean age was 81.1 ± 5.9 years and 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2-20.5]. Device success was achieved in 88.1% (133/151) and procedure related mortality was 0.7% (1/151). At one-year, all-cause mortality was 3.3% (5/151), while permanent pacemaker implantation occurred in 12.7% (19/151) of patients. The "clinical efficacy after 30 days" was observed in 24.8% (37/151), where the main contributor was symptom worsening in 14.8% (22/151) of cases. "Time-related valve safety" occurred in 22.0% (33/151) with structural valve deterioration as main contributor in 10.7% (16/151) of cases.
CONCLUSIONS
CONCLUSIONS
Using the ACURATE neo, we found a favorable safety profile with low all-cause mortality at 1 year. The reported VARC-2 defined composite endpoints at 1 year reveal low rates of "clinical efficacy after 30 days" and "time-related valve safety".
Identifiants
pubmed: 30801906
doi: 10.1002/ccd.28144
pmc: PMC6899934
doi:
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
783-792Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.
Références
JAMA. 2015 Mar 10;313(10):1019-28
pubmed: 25756438
J Am Coll Cardiol. 2016 Dec 20;68(24):2670-2689
pubmed: 27978952
J Am Coll Cardiol. 2012 Oct 9;60(15):1438-54
pubmed: 23036636
EuroIntervention. 2017 May 15;13(1):53-59
pubmed: 28169214
Circulation. 2014 Mar 18;129(11):1233-43
pubmed: 24370552
JACC Cardiovasc Imaging. 2015 Mar;8(3):340-60
pubmed: 25772838
J Am Coll Cardiol. 2012 Mar 27;59(13):1134-41
pubmed: 22440213
Eur Heart J. 2016 Jul 21;37(28):2252-62
pubmed: 27190101
Am J Cardiol. 2018 May 15;121(10):1231-1238
pubmed: 29703437
N Engl J Med. 2016 Apr 28;374(17):1609-20
pubmed: 27040324
Lancet. 2016 May 28;387(10034):2218-25
pubmed: 27053442
JACC Cardiovasc Interv. 2016 Dec 26;9(24):2541-2554
pubmed: 28007203
JACC Cardiovasc Interv. 2018 Mar 26;11(6):567-578
pubmed: 29566803
Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60
pubmed: 23026738
EuroIntervention. 2017 Oct 13;13(9):e1040-e1046
pubmed: 28804056
EuroIntervention. 2017 Dec 20;13(11):1273-1280
pubmed: 28870877
EuroIntervention. 2018 Feb 02;13(15):e1764-e1770
pubmed: 29131801
JACC Cardiovasc Interv. 2017 Oct 23;10(20):2078-2087
pubmed: 29050625
PLoS One. 2017 Sep 14;12(9):e0180815
pubmed: 28910289
Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417
pubmed: 28874031
EuroIntervention. 2017 Dec 20;13(11):1255-1257
pubmed: 29260715
Rev Esp Cardiol (Engl Ed). 2019 Feb;72(2):145-153
pubmed: 29551701
J Cardiovasc Comput Tomogr. 2012 Nov-Dec;6(6):366-80
pubmed: 23217460
Circulation. 2017 Mar 21;135(12):1123-1132
pubmed: 28104716
Eur Heart J. 2017 Sep 21;38(36):2717-2726
pubmed: 28605423
EuroIntervention. 2013 Sep 10;9 Suppl:S107-10
pubmed: 24025946
Circulation. 2016 Jul 12;134(2):130-40
pubmed: 27400898
JACC Cardiovasc Interv. 2016 Feb 8;9(3):244-254
pubmed: 26847116
EuroIntervention. 2016 Jun 20;12(3):375-80
pubmed: 27320429
Catheter Cardiovasc Interv. 2019 Nov 15;94(6):783-792
pubmed: 30801906
JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9
pubmed: 25616819
JACC Cardiovasc Interv. 2018 Jul 23;11(14):1368-1374
pubmed: 30025731
Clin Res Cardiol. 2017 Dec;106(12):995-1004
pubmed: 28795259
N Engl J Med. 2011 Jun 9;364(23):2187-98
pubmed: 21639811
J Am Coll Cardiol. 2014 Jul 15;64(2):129-40
pubmed: 25011716