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Catheter Cardiovasc Interv. 2015 Sep;86(3):528-35. doi: 10.1002/ccd.25999. Epub 2015 May 11.

Midterm clinical outcome following Edwards SAPIEN or Medtronic Corevalve transcatheter aortic valve implantation (TAVI): Results of the Belgian TAVI registry.

Author information

1
Faculty of Medicine and Health Sciences, Department of Translational Pathophysiological Research, Cardiovascular Diseases, University of Antwerp, Universiteitsplein 1, Wilrijk, Belgium.
2
Department of Cardiology and Cardiac Surgery, Antwerp University Hospital, Edegem, Belgium.
3
Department of Cardiology and Cardiac Surgery, University Hospital Leuven, Leuven, Belgium.
4
Department of Cardiology, Centre Hospitalier Universitaire De Liege, Liege, Belgium.
5
Department of Cardiology, Cliniques Saint-Luc, University of Louvain, Brussels, Belgium.
6
Department of Cardiology, OLV Ziekenhuis, Aalst, Belgium.
7
Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.

Abstract

OBJECTIVE:

To assess midterm (3 years) clinical outcomes of transcatheter aortic valve implantation (TAVI) in Belgium using the Edwards SAPIEN valve or the Medtronic CoreValve transcatheter heart valve (THV).

BACKGROUND:

Medium and long term follow-up data of both THVs are still relatively scarce, although of great clinical relevance for a relatively new but rapidly expanding treatment modality. Therefore, reporting mid- and long term clinical outcome data, coming from large "real world" national registries, remains contributive.

METHODS:

Between December 2007 and March 2012, 861 "real world" patients who were not candidates for surgical aortic valve replacement as decided by the local heart teams, underwent TAVI at 23 sites. Eleven sites exclusively used SAPIEN THV (n = 460), while 12 exclusively used CoreValve THV (n = 401). Differences in clinical outcomes by valve system were assessed, according to access route and baseline EuroSCORE risk profile (<10%: low, 10-20%: intermediate and >20%: high risk).

RESULTS:

Overall cumulative survival at 3 years was 51% for SAPIEN vs. 60% for CoreValve (P = 0.021). In transfemorally treated patients, SAPIEN and CoreValve had similar survival at 3 years for each of the baseline EuroSCORE cohorts (low risk: 72% vs. 76%, P = 0.45; intermediate risk: 62% vs. 59%, P = 0.94; high risk: 48% vs. 53%, P = 0.65).

CONCLUSION:

Cumulative midterm 3 year survival after transfemoral TAVI in "real world" patients refused for surgery with similar baseline EuroSCORE risk profile is not different between SAPIEN or CoreValve.

KEYWORDS:

aortic stenosis; registry; transcatheter aortic valve implantation (TAVI); valvular heart disease

PMID:
25963917
DOI:
10.1002/ccd.25999
[Indexed for MEDLINE]
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