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One‐year clinical outcome with a novel self‐expanding transcatheter heart valve
Author(s) -
Pellegrini Costanza,
Rheude Tobias,
Trenkwalder Teresa,
Mayr N. Patrick,
Michel Jonathan,
Kastrati Adnan,
Schunkert Heribert,
Kasel Albert M.,
Joner Michael,
Hengstenberg Christian,
Husser Oliver
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28144
Subject(s) - medicine , valve replacement , stenosis , aortic valve stenosis , surgery , retrospective cohort study , aortic valve , cardiology
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”.