Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

Capodanno, Davide; Petronio, Anna Sonia; Prendergast, Patrick J.; Eltchaninoff, Hélène; Vahanian, Alec; Modine, Thomas; Lancellotti, Patrizio; Søndergaard, Lars; Ludman, Peter; Tamburino, Corrado; Piazza, Nicolò; Hancock, Jane; Mehilli, Julinda; Byrne, Robert A.; Baumbach, Andreas; Kappetein, Arie Pieter; Windecker, Stephan; Bax, Jeroen J.; Haude, Michael

doi:10.1093/ejcts/ezx244

Cited by 175 publications

(95 citation statements)

References 28 publications

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“…Increases in transvalvular gradients could be a signal of early valve deterioration, as well as result of subclinical valve thickening or thrombosis . Recently, a new definition of valve dysfunction was proposed by Capodanno et al, which is based on assessment of transvalvular gradients and PVL alone. In contrast to the VARC‐2 criteria, this definition bears the advantage of simplifying assessment of valve dysfunction on one hand, but on the other it may result in lower rates of valve degeneration.…”

Section: Discussionmentioning

confidence: 99%

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

Pellegrini

Rheude

Trenkwalder

et al. 2019

Cathet Cardio Intervent

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ObjectivesTo 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”.BackgroundInitial 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.MethodsOne 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.ResultsMean 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.ConclusionsUsing 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”.

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Section: Discussionmentioning

confidence: 99%

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

Pellegrini

Rheude

Trenkwalder

et al. 2019

Cathet Cardio Intervent

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“…An increase in transprosthetic velocity and gradients with concomitant increase in valve EOA and DVI is actually related to an increase in flow during follow-up and should not be mistaken for a HVD. Stage 3 consists in SVD with severe HVD characterised by: (1) an increase in mean transprosthetic gradient ≥20 mm Hg since SAVR or TAVI with concomitant marked decrease in valve EOA and DVI and/or (2) new onset or worsening of transprosthetic regurgitation by at least two grades with final grade of severe regurgitation.Classification terminology proposed by: *Dvir et al 12 and †Capodanno et al 11

‡The most important criteria to define hemodynamic HVD is a significant increase in mean transprosthetic gradient with concomitant decrease in valve effective orifice area and Doppler velocity index; and/or a new onset or a worsening of transprosthetic valve regurgitation.

§This criteria is corroborative but should not be used in isolation to define HVD.

AVR, aortic valve replacement; HVD, hemodynamic valve deterioration; LV, left ventricle; MDCT, multidetector CT; SVD, structural valve deterioration; TEE, transesophageal echocardiography; TTE, transthoracic echocardiography.

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Section: Definition Of Bioprosthetic Valve Deteriorationmentioning

confidence: 99%

Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation

Salaün

Clavel

Rodés‐Cabau

et al. 2018

Heart

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The main limitation of bioprosthetic valves is their limited durability, which exposes the patient to the risk of aortic valve reintervention. Transcatheter aortic valve implantation (TAVI) is considered a reasonable alternative to surgical aortic valve replacement (SAVR) in patients with intermediate or high surgical risk. TAVI is now rapidly expanding towards the lower risk populations. Although the results of midterm durability of the transcatheter bioprostheses are encouraging, their long-term durability remains largely unknown. The objective of this review article is to present the definition, mechanisms, incidence, outcome and management of structural valve deterioration of aortic bioprostheses with specific emphasis on TAVI. The structural valve deterioration can be categorised into three stages: stage 1: morphological abnormalities (fibrocalcific remodelling and tear) of bioprosthesis valve leaflets without hemodynamic valve deterioration; stage 2: morphological abnormalities and moderate hemodynamic deterioration (increase in gradient and/or new onset of transvalvular regurgitation); and stage 3: morphological abnormalities and severe hemodynamic deterioration. Several specifics inherent to the TAVI including valve oversizing, manipulation, delivery, positioning and deployment may cause injuries to the valve leaflets and increase leaflet mechanical stress, which may limit the long-term durability of transcatheter bioprostheses. The selection of the type of aortic valve replacement and bioprosthesis should thus take into account the ratio between the demonstrated durability of the bioprostheses versus the life expectancy of the patient. Pending the publication of robust data on long-term durability of transcatheter bioprostheses, it appears reasonable to select SAVR with a bioprosthesis model that has well-established long-term durability in patients with low surgical risk and long life expectancy.

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“…In such cases, the scenario for SVD is characterised as ‘isolated haemodynamic dysfunction’ of the prosthesis 44. Finally, the term ‘bioprosthesis valve failure’ includes severe SVD and its clinical consequences (symptomatic patients); hence SVD now is the preferred main outcome of interest in studies assessing the long-term performance of TAVI and SAVR 4…”

Section: Inconsistent Definitions Of Svd Among Tavi Studiesmentioning

confidence: 99%