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Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?

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Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better? / Puls, Miriam; Huenlich, Mark; Boekstegers, Peter; Lubos, Edith; von Bardeleben, Ralph S; May, Andreas E; Nickenig, Georg; Baldus, Stefan; Sievert, Horst; Ouarrak, Taoufik; Senges, Jochen; Schillinger, Wolfgang.

in: CATHETER CARDIO INTE, Jahrgang 96, Nr. 3, 01.09.2020, S. E360-E368.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Puls, M, Huenlich, M, Boekstegers, P, Lubos, E, von Bardeleben, RS, May, AE, Nickenig, G, Baldus, S, Sievert, H, Ouarrak, T, Senges, J & Schillinger, W 2020, 'Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?', CATHETER CARDIO INTE, Jg. 96, Nr. 3, S. E360-E368. https://doi.org/10.1002/ccd.28613

APA

Puls, M., Huenlich, M., Boekstegers, P., Lubos, E., von Bardeleben, R. S., May, A. E., Nickenig, G., Baldus, S., Sievert, H., Ouarrak, T., Senges, J., & Schillinger, W. (2020). Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better? CATHETER CARDIO INTE, 96(3), E360-E368. https://doi.org/10.1002/ccd.28613

Vancouver

Puls M, Huenlich M, Boekstegers P, Lubos E, von Bardeleben RS, May AE et al. Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better? CATHETER CARDIO INTE. 2020 Sep 1;96(3):E360-E368. https://doi.org/10.1002/ccd.28613

Bibtex

@article{ee07294c9081491dad469b60a9824910,
title = "Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?",
abstract = "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.",
keywords = "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",
author = "Miriam Puls and Mark Huenlich and Peter Boekstegers and Edith Lubos and {von Bardeleben}, {Ralph S} and May, {Andreas E} and Georg Nickenig and Stefan Baldus and Horst Sievert and Taoufik Ouarrak and Jochen Senges and Wolfgang Schillinger",
note = "{\textcopyright} 2019 Wiley Periodicals, Inc.",
year = "2020",
month = sep,
day = "1",
doi = "10.1002/ccd.28613",
language = "English",
volume = "96",
pages = "E360--E368",
journal = "CATHETER CARDIO INTE",
issn = "1522-1946",
publisher = "Wiley-Liss Inc.",
number = "3",

}

RIS

TY - JOUR

T1 - Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?

AU - Puls, Miriam

AU - Huenlich, Mark

AU - Boekstegers, Peter

AU - Lubos, Edith

AU - von Bardeleben, Ralph S

AU - May, Andreas E

AU - Nickenig, Georg

AU - Baldus, Stefan

AU - Sievert, Horst

AU - Ouarrak, Taoufik

AU - Senges, Jochen

AU - Schillinger, Wolfgang

N1 - © 2019 Wiley Periodicals, Inc.

PY - 2020/9/1

Y1 - 2020/9/1

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Female

KW - Germany

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Hemodynamics

KW - Humans

KW - Male

KW - Mitral Valve/diagnostic imaging

KW - Mitral Valve Annuloplasty/adverse effects

KW - Mitral Valve Insufficiency/diagnostic imaging

KW - Postoperative Complications/mortality

KW - Prospective Studies

KW - Prosthesis Design

KW - Recovery of Function

KW - Registries

KW - Risk Assessment

KW - Risk Factors

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1002/ccd.28613

DO - 10.1002/ccd.28613

M3 - SCORING: Journal article

C2 - 31789488

VL - 96

SP - E360-E368

JO - CATHETER CARDIO INTE

JF - CATHETER CARDIO INTE

SN - 1522-1946

IS - 3

ER -