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Catheter Cardiovasc Interv. 2019 Feb 24. doi: 10.1002/ccd.28144. [Epub ahead of print]

One-year clinical outcome with a novel self-expanding transcatheter heart valve.

Author information

1
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
2
Institut für Anästhesiologie, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
3
Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.
4
Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
5
Department of Internal Medicine I, Cardiology, St. Johannes-Hospital, Dortmund, Germany.

Abstract

OBJECTIVES:

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:

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:

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:

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:

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".

KEYWORDS:

ACURATE neo; VARC-2; aortic valve stenosis; outcome; transfemoral transcatheter aortic valve replacement

PMID:
30801906
DOI:
10.1002/ccd.28144

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