Thorac Cardiovasc Surg 2019; 67(S 01): S1-S100
DOI: 10.1055/s-0039-1678992
Short Presentations
Monday, February 18, 2019
DGTHG: Auf den Punkt gebracht - Kathetergestützte Herzklappenverfahren
Georg Thieme Verlag KG Stuttgart · New York

One-Year Outcomes following Transapical Delivery of a Novel, Low-Profile Self-expandable Transcatheter Valve: Results from the ACURATE Neo TA Study

L. Conradi
1   Universitäres Herzzentrum Hamburg, Hamburg, Germany
,
M. Hilker
2   University Medical Center Regensburg, Regensburg, Germany
,
J. Kempfert
3   Deutsches Herzzentrum Berlin, Berlin, Germany
,
J. Börgermann
4   Herzzentrum Duisburg, Duisburg, Germany
,
H. Treede
5   Mitteldeutsches Herzzentrum, Halle, Germany
,
D. Holzhey
6   Herzzentrum Leipzig, Leipzig, Germany
,
H. Schröfel
7   Heart Center Freiburg University, Freiburg, Germany
,
K. W. Kim
8   Kerckhoff-Heart Center Bad Nauheim, Bad Nauheim, Germany
,
U. Schäfer
1   Universitäres Herzzentrum Hamburg, Hamburg, Germany
,
D. Wünsch
9   Boston Scientific, Clinical Sciences, Marlborough, United States
,
T. Walther
10   Universitätsklinikum Frankfurt, Frankfurt am Main, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
28 January 2019 (online)

   All articles of this category

Objectives: This analysis evaluates 1-year outcomes with the self-expanding ACURATE neo (Boston Scientific, Marlborough, Massachusetts, United States) transcatheter heart valve (THV) following transapical transcatheter aortic valve implantation (TA) using a novel, low-profile TA delivery system.

Methods: This prospective, multicenter, single-arm study enrolled patients with severe aortic stenosis at seven centers in Germany. All patients were assessed by the Heart Team to be at high surgical risk (defined as STS Score ≥8% or having other comorbid conditions) and ineligible for transfemoral access. The primary safety endpoint was all-cause mortality at 6 months and the primary performance endpoint was procedural success in the absence of MACCE at 30 days. Procedural success was defined as successful implantation of a single THV in the correct location with aortic regurgitation ≤2+, mean aortic gradient < 20 mm Hg, aortic valve area ≥1cm2, no valve reintervention ≤24 hours postprocedure, and no intraprocedural mortality.

Results: A total of 60 patients (age: 79.8 ± 4.7 years, 52% (31/60) female, logEuroSCORE II 6.1 ± 5.0%, STS score 4.3 ± 2.9%) were enrolled. Baseline transvalvular gradient was 40.2 ± 16.4 mm Hg and aortic valve area was 0.7 ± 0.2 cm2. Device and procedural success rates were 100 and 98.3%, respectively (one patient died intraprocedurally due to apical rupture). Procedural success in the absence of MACCE at 30 days was 90.0% (54/60). 30-day mortality was 8.3% (5/60). Outcomes at 6 months and 1 year are shown in the following table.

Conclusions: The 1-year data of the ACURATE neo TA study confirm good hemodynamic performance of this THV. Clinical outcomes likely reflect the overall poor health status of patients eligible for this TA TAVI trial with only 5% of deaths (3/60) classified as definitely procedure related. This TAVI system remains the only platform for antegrade TA TAVI using a self-expandable THV.

6 months

12 months

Note: 6- and 12-month outcomes.

All-cause mortality, % (n/N)

15 (9/60)

20 (12/60)

Major stroke, % (n/N)

3.3 (2/60)

3.3 (2/60)

Valve reintervention, % (n/N)

0 (0/60)

0 (0/60)

Major vascular complication, % (n/N)

3.3 (2/60)

3.3 (2/60)

NYHA functional class I/II, % (n/N)

88 (44/49)

95.7 (45/47)

New permanent pacemaker, % (n/N)

21.2 (11/52)

23.1 (12/52)

Mean aortic gradient, mm Hg (n)

6.3 ± 2.3 (50)

6.3 ± 3.2 (48)

Aortic valve area, cm2 (n)

1.8 ± 0.5 (50)

2.2 ± 2.2 (48)

moderate or greater paravalvular leak, % (n/N)≥≥≥≥

4.4 (2/45)

5.0 (2/40)