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Gender in the ACCESS-EU registry: a prospective, multicentre, non-randomised post-market approval study of MitraClip® therapy in Europe - Zurich Open Repository and Archive


Gafoor, Sameer; Sievert, Horst; Maisano, Francesco; Baldus, Stephan; Schaefer, Ulrich; Hausleiter, Joerg; Butter, Christian; Ussia, Gian Paolo; Geist, Volker; Widder, Julian D; Moccetti, Tiziano; Schillinger, Wolfgang; Franzen, Olaf (2016). Gender in the ACCESS-EU registry: a prospective, multicentre, non-randomised post-market approval study of MitraClip® therapy in Europe. EuroIntervention, 12(2):257-264.

Abstract

AIMS Gender has been an important factor in outcomes after mitral valve surgery; however, its effect on percutaneous mitral valve repair is not well known. We aimed to report the effect of gender on outcomes in a large European prospective, multicentre, non-randomised post-approval study of percutaneous mitral valve repair. METHODS AND RESULTS Two hundred and five female and 362 male patients with significant mitral regurgitation underwent percutaneous repair at 14 European sites from October 2008 to April 2011. Women and men had similar baseline risk scores, but women had a higher rate of degenerative disease (32% vs. 18%). Women were more likely to have one clip implanted (72% vs. 54%), but had a similar length of stay in the intensive care unit (2.6±4.1 days) and overall length of stay (8.0±6.9 days) compared to men. They were also less likely to be discharged home: more women than men went to skilled nursing facilities (25% vs. 15%) and fewer women went home compared to men (71.9% vs. 83.9%). Thirty-day and 12-month safety results were similar between genders, as was 12-month efficacy (echocardiographic and clinical). Multivariate analysis showed no effect of gender on 12-month survival. CONCLUSIONS In a real-world, post-approval experience in Europe, female patients who underwent percutaneous mitral valve repair experienced safety and efficacy results similar to those of males. However, the discharge rates to skilled nursing facilities rather than home may indicate a need for better optimisation of the female patient's physical and social comorbidities prior to intervention and during the hospitalisation period.

Abstract

AIMS Gender has been an important factor in outcomes after mitral valve surgery; however, its effect on percutaneous mitral valve repair is not well known. We aimed to report the effect of gender on outcomes in a large European prospective, multicentre, non-randomised post-approval study of percutaneous mitral valve repair. METHODS AND RESULTS Two hundred and five female and 362 male patients with significant mitral regurgitation underwent percutaneous repair at 14 European sites from October 2008 to April 2011. Women and men had similar baseline risk scores, but women had a higher rate of degenerative disease (32% vs. 18%). Women were more likely to have one clip implanted (72% vs. 54%), but had a similar length of stay in the intensive care unit (2.6±4.1 days) and overall length of stay (8.0±6.9 days) compared to men. They were also less likely to be discharged home: more women than men went to skilled nursing facilities (25% vs. 15%) and fewer women went home compared to men (71.9% vs. 83.9%). Thirty-day and 12-month safety results were similar between genders, as was 12-month efficacy (echocardiographic and clinical). Multivariate analysis showed no effect of gender on 12-month survival. CONCLUSIONS In a real-world, post-approval experience in Europe, female patients who underwent percutaneous mitral valve repair experienced safety and efficacy results similar to those of males. However, the discharge rates to skilled nursing facilities rather than home may indicate a need for better optimisation of the female patient's physical and social comorbidities prior to intervention and during the hospitalisation period.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Cardiocentro Ticino
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:12 June 2016
Deposited On:08 Dec 2016 08:24
Last Modified:31 Jan 2017 08:31
Publisher:Europa Digital and Publishing
ISSN:1774-024X
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.4244/EIJV12I2A40
PubMed ID:27290685

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