Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?
Aged
Aged, 80 and over
Female
Germany
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
/ adverse effects
Hemodynamics
Humans
Male
Mitral Valve
/ diagnostic imaging
Mitral Valve Annuloplasty
/ adverse effects
Mitral Valve Insufficiency
/ diagnostic imaging
Postoperative Complications
/ mortality
Prospective Studies
Prosthesis Design
Recovery of Function
Registries
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
MitraClip
TRAMI registry
cerebral-embolic risk
mitral regurgitation
percutaneous edge-to-edge mitral valve repair
single and dual clip implantation
stroke
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 09 2020
01 09 2020
Historique:
received:
02
08
2018
revised:
31
07
2019
accepted:
12
11
2019
pubmed:
4
12
2019
medline:
7
4
2021
entrez:
3
12
2019
Statut:
ppublish
Résumé
To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry. The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse. In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year. Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02). TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating.
Sections du résumé
OBJECTIVES
To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry.
BACKGROUND
The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse.
METHODS
In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year.
RESULTS
Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02).
CONCLUSIONS
TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating.
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
E360-E368Informations de copyright
© 2019 Wiley Periodicals, Inc.
Références
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