November 4, 2014
Ver artículo completoGender‐related clinical and echocardiographic outcomes at 30‐day and 12‐month follow up after MitraClip implantation in the GRASP registry
PICO estructurado
Does patient gender influence the safety and efficacy outcomes of MitraClip implantation in patients with moderate-to-severe or severe mitral regurgitation?
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Población
171 consecutive patients with moderate-to-severe (3+) and severe (4+) mitral regurgitation (106 males and 65 females)
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Intervención
Percutaneous edge-to-edge mitral valve repair (PMVR) using the MitraClip system
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Comparador
Male vs Female gender
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Resultado
Primary safety endpoint: incidence of major adverse events at 30 days; Primary efficacy endpoint: freedom from death, surgery for mitral valve dysfunction, or grade≥3+ MR at 12-month follow upcomposite
MitraClip implantation is safe and efficacious up to 12 months regardless of patient gender, though females showed a trend toward poorer NYHA functional class improvement over time.
Resumen
OBJECTIVES: To assess the influence of patients' gender on the outcomes of percutaneous edge-to-edge mitral valve repair (PMVR) using the MitraClip system. BACKGROUND: Although gender-related differences have been extensively documented in patients who undergo surgery for moderate-to-severe (3+) and severe (4+) mitral regurgitation (MR), studies assessing whether these differences exist after PMVR are lacking. METHODS: Clinical and echocardiographic data through 12-month follow up from 171 consecutive patients whom underwent MitraClip implantation and were dichotomized by the gender (106 males and 65 females) were obtained. The primary safety endpoint was the incidence of major adverse events at 30 days and the primary efficacy endpoint was freedom from death, surgery for mitral valve dysfunction, or grade≥3+ MR at 12-month follow up. RESULTS: The primary safety endpoint was observed in four males (3.8%) and four females (6.2%) (P=0.358). Remarkable reduction in MR postprocedure was revealed in both groups, and these results were mostly sustained. Furthermore, left ventricle reverse remodeling and New York Heart Association (NYHA) functional class improvement were revealed in both groups, but females tended to demonstrate worse results over time (P=0.083). The primary efficacy endpoint obtained by Kaplan-Meier estimates was observed in 76.3 and 70.2%, respectively (log rank P=0.231). CONCLUSIONS: MitraClip implantation in patients with 3+ and 4+ MR is safe and efficacious until mid-term follow up, regardless of patients' gender. Despite improvement in NYHA functional class in both groups, female gender demonstrated a trend toward poorer results. Further validation of our findings is warranted.