Objectives: To investigate how the changes of left ventricle ejection fraction (LVEF) between admission and discharge affected the long-term outcome in patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Background: An acute impairment of LVEF after surgical repair of mitral regurgitation, known as afterload mismatch, has been associated with increased all-cause mortality. Afterload mismatch after percutaneous edge-to-edge mitral valve repair has been postulated to be a transient phenomenon. Methods: This study is based on a single-center, retrospective, observational registry of patients who underwent percutaneous edge-to-edge mitral valve repair with the MitraClip (Abbot Vascular) system for the treatment of symptomatic, moderate-to-severe mitral regurgitation. We included data on 399 patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Expert echocardiographers assessed LVEF before the procedure and at discharge. The patients were divided into three groups according to the difference of periprocedural LVEF measurements: unchanged (n = 318), improved (n = 40), and decreased (n = 41) LVEF. Results: The median follow-up time was 2.0 years. When adjusted for gender, NYHA class and estimated glomerular filtration rate, decreased postprocedural LVEF was associated with an increased risk of death (adjusted HR 2.05, 95% CI 1.26–3.34) and increased postprocedural LVEF with a reduced risk of death (adjusted HR 0.47, 95% CI 0.24–0.91) compared to unchanged LVEF. Conclusion: Among patients who underwent percutaneous edge-to-edge mitral valve repair, decreased postprocedural LVEF was associated with increased mortality, while improved LVEF was associated with lower mortality compared to unchanged LVEF.
Introduction
The Watchman‐FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex‐ball" during deployment, and flattened surface. We report our real‐world experience with the Watchman‐FLX device in two centers with consolidated LAAC expertise.
Methods
We enrolled 200 consecutive Watchman‐FLX patients (2019–2021) in a nonrandomized double‐center registry; procedural data and follow‐up for midterm clinical outcomes were collected. A control group of 100 patients treated with first‐generation Watchman (2.5) was included.
Results
According to mean CHAD2DS2‐VASc (5 ± 1.40) and HAS‐BLED (3.8 ± 1.01) scores, the population included in this study was at high risk: 29% had a previous stroke and 56.5% a bleeding event. Main LAAC indications were symptomatic hemorrhage (39.5%), need for triple antithrombotic therapy (39%), gastrointestinal bleeding (32%), and oral anticoagulation intolerance (18%). Transesophageal echocardiography guidance was followed in 93% of cases (48% in general anesthesia and 45% under conscious sedation). Repositioning an FLX device was required in 20% of cases and no complication occurred. In 96% of patients, the first selected device was delivered, while in 4% a device size change was required after the first choice (7% with Watchman 2.5). Peridevice leaks (<5 mm) were found postimplant in two cases (1%). Overall, the procedural success rate was 99.5%. One patient's procedure was unsuccessful (0.5%), due to left atrial appendage (LAA) anatomy; differently, the mean failure rate with Watchman 2.5 was 2%. No device embolization was reported. Complications (8.5%) were mainly related to the access site (3%); major bleedings (1%), and in‐hospital death (0.5%) rarely occurred. After a follow‐up of 272 ± 173 days, 2.3% of cases experienced a non‐device‐related stroke and 0.6% fatal bleeding.
Conclusion
Our registry showed a high procedural success rate of the Watchman‐FLX in a high‐risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow‐up period.
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