ClinicalImpact of sex on short term in-hospital outcomes with transcatheter edge-to-edge mitral valve repair☆,☆☆
Introduction
Mitral valve regurgitation (MR) is a common valvular condition, present in adults affecting > 2 million people in the United States [1], [2], [3]. Patients with mild-moderate MR are followed with close surveillance while severe MR often requires repair or replacement [4]. Traditionally, surgical valve repair or replacement has been the standard of care. More recently, percutaneous valve repair with MitraClip® has become an alternative treatment option. To date, surgery has been shown to have more favorable outcomes as compared to a percutaneous approach [5]. An increasing number of patients however are not surgical candidates. The Euro Heart Survey showed that half of the patients eligible for surgery by the ACC guidelines did not have surgery due to high risk for peri-operative complications [6]. The mortality risk with surgery in high risk patients can be as high as 25% [7], [8]. Those patients who are at high-risk for surgery may benefit from treatment with a percutaneous approach.
Surgical literature suggested sex disparities in patients undergoing surgery for mitral valve disease [9]. Women are less likely to be referred for surgery than men and present later in the disease process [9], [10]. At the time of surgery, females have more advanced disease and often present with greater comorbidities than their male counterparts [11]. Females have worse short and long-term post-operative survival compared with males [12]. MitraClip (Abbott Vascular, Santa Clara, CA) has emerged as a novel treatment option for MR. MitraClip is the only percutaneous technology currently approved by the US Food and Drug Administration for mitral valve repair.
There is limited data assessing for sex disparities with in-hospital outcomes, length of stay and cost in patients undergoing treatment with MitraClip in the United States. To date, these studies have had small patient populations and most studies were conducted in Europe [13], [14], [15], [16]. We sought to compare outcomes by sex in patients undergoing MitraClip from a large, US database.
Section snippets
Data source
Data were obtained from the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample (NIS) database from January 2012–December 2014 [17]. HCUP is a family of databases containing longitudinal hospital care data that has been sponsored by AHRQ since 1988. NIS includes hospital inpatient stays from a national sample of > 1000 hospitals representing 8 million stays on an annual basis. The database represents a stratified 20% sample
Results
A total of 521 (weighted 2605) patients underwent TMVR between 2012 through 2014. The overall number of MitraClip procedures increased from 2012 to 2014 [Fig. 2]. In our study, 302 (weighted 1510) patients were male and 219 (weighted 1095) patients were female. The mean age was 73 years and was similar with both cohorts [Table 1]. The population was predominantly white (74.9%). The majority of admissions were elective (72.4%) and the most common primary payment method was Medicare or Medicaid
Discussion
In our study, we assessed if disparities in sex existed in patients undergoing transcatheter edge-to-edge mitral valve repair in the United States. Our results suggest that males and females have similar in-hospital outcomes with MitraClip in a large “real-world” patient population. This is consistent with previous data on sex specific outcomes that suggested that male and females benefit equally from mitral valve repair with MitraClip [13], [15]. However, these prior studies comparing sex for
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2020, American Journal of CardiologyCitation Excerpt :Results from the Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry, a nonrandomized prospective single-center study on 171 patients also showed similar 30-day safety outcomes,8 and a 3-center retrospective analysis on 173 patients showed similar 12-month mortality.9 Doshi et al conducted an analysis utilizing the NIS years 2012 to 2014, including 521 patients, and found no significant differences between women and men in in-hospital mortality, in-hospital complications, or length of stay.15 Importantly, this current analysis is larger and more contemporary, as it reflects real world practice for TMVR after FDA approval in 2013.
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