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Int J Cardiol. 2019 Dec 1;296:32-37. doi: 10.1016/j.ijcard.2019.06.013. Epub 2019 Jun 12.

Outcomes of transcatheter aortic valve replacement without predilation of the aortic valve: Insights from 1544 patients included in the SOURCE 3 registry.

Author information

1
Groupe CardioVasculaire Interventionnel (GCVI), Clinique Pasteur, Toulouse, France. Electronic address: ndumonteil@clinique-pasteur.com.
2
Aarhus University Hospital, Skejby, Denmark.
3
Asklepios Clinic, Hamburg, Germany.
4
University Hospital La Timone, Marseille, France.
5
Department of Internal Medicine II - Cardiology, University Hospital of Ulm, Ulm, Germany.
6
Herzzentrum Brandenburg, Bernau, Germany.
7
Edwards Lifesciences, Prague, Czech Republic.
8
University Hospital, Angers, France.
9
University Hospital, Münster, Germany.
10
Padova Hospital, Italy.
11
King's College Hospital London, United Kingdom.
12
Private Hospital Jacques Cartier, Massy, France.

Abstract

AIMS:

To investigate the impact of transcatheter aortic valve replacement (TAVR) without preliminary balloon aortic valvuloplasty (pre-BAV) on periprocedural outcomes in a large, real-world registry.

METHODS AND RESULTS:

The SOURCE 3 registry was an observational, multi-center, single-arm study of patients with severe, symptomatic aortic stenosis at high surgical risk treated with the SAPIEN 3 transcatheter heart valve (THV). Procedural and 30-day outcomes were compared between two groups of 772 patients each (retrospectively matched) with or without pre-BAV. All baseline clinical, echocardiographic, and anatomical valve characteristics were comparable between groups except for Society of Thoracic Surgeons (STS) score, which was lower in the direct TAVR group (6.0 ± 5.9 vs 7.8 ± 8.3; p = 0.003). In the direct TAVR group, there were less post-dilatations (8.1% vs. 13.1%, p = 0.002), shorter procedural time (70.9 ± 39.8 min vs 73.0 ± 32.2 min, p = 0.033) and fluoroscopy time (13.4 ± 7.0 min vs 14.9 ± 7.4 min, p < 0.001). Other procedural outcomes and echocardiographic variables at 30 days did not differ significantly between the two groups: safety endpoint (10.4% with pre-BAV vs 13.5% with direct TAVR, p = 0.059), mortality (2.1% vs 2.3%, p = 0.730), disabling strokes (0.4% vs 0.5%, p = 0.704), and moderate to severe paravalvular leak (PVL) (3.2% vs 2.2%, p = 0.40). Unexpectedly, new permanent pacemaker implantation and life-threatening bleeds were less frequently observed with pre-BAV group than with direct TAVR (10.4% vs 13.9%, p = 0.032 and 3.5% vs 6.5%, p = 0.007, respectively).

CONCLUSION:

In this large TAVR dataset, direct implantation of the SAPIEN 3 THV without pre-BAV was feasible and safe and resulted in shorter procedures, without impact on 30-day prosthesis function and PVL.

PMID:
31256993
DOI:
10.1016/j.ijcard.2019.06.013
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