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Curriculum topic: Valvular heart diseases
Transcutaneous aortic valve implantation (TAVI) has evolved into standard therapy for elderly patients with aortic valve stenosis who require surgical valve replacement. The rapid development from an experimental procedure 10 years ago to a routine intervention has only been possible because complication rates have declined considerably. This effect can be in part attributed to improvements in the valve prostheses and their delivery systems and, of course, to the tapering out of the learning curve due to increasing experience. Nonetheless, the procedure still bears specific risks for complications that may critically influence the outcome. Despite awareness of these risks the in-hospital mortality is still 5–8% as recently shown by the large scale German Aortic valve RegistrY (GARY).1
The Valve Academic Research Consortium (VARC) has provided a standardised approach on how to characterise the specific complications. This standardised endpoint definition was updated in 2012 in the VARC-2 consensus document.2 The composite endpoints—device success, early safety at 30 days, clinical efficacy after 30 days, and time-related valve safety—are detailed in box 1.
Composite endpoints according to Valve Academic Research Consortium-2 (VARC-2)2
Device success
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Absence of procedural mortality AND
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Correct positioning of a single prosthetic heart valve into proper anatomical location AND
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Intended performance of the prosthetic heart valve (no prosthesis–patient mismatch and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s) AND
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No moderate or severe prosthetic valve regurgitation
Early safety (at 30 days)
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All cause mortality
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All strokes (disabling and non-disabling)
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Life threatening bleeding
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Acute kidney injury (stage 2 or 3, including renal replacement therapy)
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Coronary artery obstruction requiring intervention
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Major vascular complication
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Valve related dysfunction requiring repeat procedure (balloon valvuloplasty, transcatheter aortic valve implantation (TAVI), or surgical aortic valve replacement)
Clinical efficacy (after 30 days)
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All cause mortality
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All strokes (disabling and non-disabling)
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Hospitalisations for valve-related symptoms or worsening congestive …
Footnotes
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Contributors HM, W-KK, and JK wrote the manuscript. TW and CH provided intellectual input and revised the manuscript.
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Competing interests In compliance with EBAC/EACCME guidelines, all authors participating in Education in Heart have disclosed potential conflicts of interest that might cause a bias in the article. The authors have no competing interests.
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Provenance and peer review Commissioned; externally peer reviewed.