Anatomical Characteristics Associated With Hypoattenuated Leaflet Thickening in Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement.

Aortic Valve / diagnostic imaging Aortic Valve Stenosis / diagnostic imaging Heart Valve Prosthesis Humans Prospective Studies Prosthesis Design Transcatheter Aortic Valve Replacement / adverse effects Treatment Outcome

Hypoattenuated leaflet thickening Low risk Structural valve degeneration Transcatheter aortic valve replacement

Journal

Cardiovascular revascularization medicine : including molecular interventions

ISSN: 1878-0938

Titre abrégé: Cardiovasc Revasc Med

Pays: United States

ID NLM: 101238551

Informations de publication

Date de publication:
06 2021

Historique:

received: 22 09 2020

accepted: 22 09 2020

pubmed: 2 11 2020

medline: 26 10 2021

entrez: 1 11 2020

Statut: ppublish

Résumé

This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration. The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis. In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT. This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events.

Sections du résumé

BACKGROUND/PURPOSE

METHODS/MATERIALS

The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis.

RESULTS

In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT.

CONCLUSIONS

This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events.

Identifiants

DOI: 10.1016/j.carrev.2020.09.034 PMID: 33129688

pubmed: 33129688

pii: S1553-8389(20)30586-8

doi: 10.1016/j.carrev.2020.09.034

pii:

doi:

Banques de données

ClinicalTrials.gov

['NCT02628899']

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

1-6

Informations de copyright

Déclaration de conflit d'intérêts

Declaration of competing interest All other authors have no conflicts of interest to disclose.