Percutaneous Edge-to-Edge Mitral Valve Repair With the MitraClip System Following Surgical Annuloplasty Ring Dehiscence (original) (raw)
Related papers
Heart, 2013
Background Percutaneous mitral valve repair (MVR) using the MitraClip system has become a valid alternative for patients with severe mitral regurgitation (MR) and high operative risk. Objective To identify clinical and periprocedural factors that may have an impact on clinical outcome. Design Multi-centre longitudinal cohort study. Setting Tertiary referral centres. Patients Here we report on the first 100 consecutive patients treated with percutaneous MVR in Switzerland between March 2009 and April 2011. All of them had moderate-severe (3+) or severe (4+) MR, and 62% had functional MR. 82% of the patients were in New York Heart Association (NYHA) class III/IV, mean left ventricular ejection fraction was 48% and the median European System for Cardiac Operative Risk Evaluation was 16.9%. Interventions MitraClip implantation performed under echocardiographic and fluoroscopic guidance in general anaesthesia. Main outcome measures Clinical, echocardiographic and procedural data were prospectively collected. Results Acute procedural success (APS, defined as successful clip implantation with residual MR grade ≤2+) was achieved in 85% of patients. Overall survival at 6 and 12 months was 89.9% (95% CI 81.8 to 94.6) and 84.6% (95% CI 74.7 to 91.0), respectively. Univariate Cox regression analysis identified APS (p=0.0069) and discharge MR grade (p=0.03) as significant predictors of survival. Conclusions In our consecutive cohort of patients, APS was achieved in 85%. APS and residual discharge MR grade are important predictors of mid-term survival after percutaneous MVR.
Journal of the American College of Cardiology, 2017
Background: Severe degenerative mitral valve regurgitation (DMR) carries an adverse prognosis, yet afflicted patients may not undergo treatment despite availability of contemporary therapy. We sought to examine the relationship between surgical risk, therapeutic penetrance, and survival for patients with MR. Methods: 169 patients (mean age 75.8 yrs; 48.5% men) with symptomatic DMR (grade 3 or 4) were referred to our institution for consideration of surgery. Risk was calculated using the Society of Thoracic Surgeons (STS) score, and clinical outcomes were examined through a median follow-up period of 9 months. Results: Of the 169 patients, surgical risk was low (STS <3%), intermediate (3 to 8%), or high (>8%) in 60 (34.9%), 66 (38.4%), and 46 (27.6%) patients, respectively. Overall, 57.0% were treated with Mitraclip or cardiac surgery. Therapeutic penetrance was not related to surgical risk (low 65% vs. intermediate 53.0% vs. high 52.2%; p=0.30). Low-risk, treated patients predominantly received surgery (94.9%), while MitraClip was utilized in 62.9% of intermediate-risk patients and 100% of those at high-risk. Patients who received any mitral valve intervention tended to show a higher survival than untreated patients (Figure). Conclusions: For patients with symptomatic DMR, the employment of a multidisciplinary approach achieves therapeutic penetrance in the majority of patients across the spectrum of surgical risk, and may be associated with improved long-term survival.
Journal of the American College of Cardiology, 2014
Mitral regurgitation (MR) is the most common valve disease in the United States. However, a significant number of patients are denied surgery due to increased age, poor ventricular function, or associated comorbidities, putting them at high risk for adverse events. Moreover, the benefit of surgery for MR is unclear in patients with functional (secondary) MR. Recently, percutaneous repair of the mitral valve with a particular device (MitraClip, Abbott, Menlo Park, California) has emerged as a novel therapeutic option for patients with secondary MR or those deemed to be high risk for surgery. We review data from its initial concept through clinical trials and current data available from several registries. We focused on lessons learned regarding adequate patient selection, along with current and future perspectives on the use of device therapy for the treatment of MR.
The Journal of Thoracic and Cardiovascular Surgery, 2012
Objective: The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. Methods: Of 279 patients enrolled, 80 surgical patients underwent 82 MVoperations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. Results: The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P ¼ .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37patients (P <.001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P ¼ .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. Conclusions: These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.
Journal of the American College of Cardiology, 2014
BACKGROUND Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-risk DMR patients have not been previously reported. OBJECTIVES This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive surgical risk undergoing TMVR. METHODS A prohibitive-risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies. RESULTS A total of 141 high-risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive surgical risk (STS score: 13.2 AE 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 AE 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR #1þ or MR 2þ. At 1 year, the majority of surviving patients (82.9%) remained MR #2þ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 AE 40.1 ml to 108.5 AE 37.9 ml; p < 0.0001 [n ¼ 69 survivors with paired data]). SF-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced. CONCLUSIONS TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year.
Kardiologia Polska, 2014
BACKGROUND Mitral regurgitation (MR) is the second most frequent indication for valve surgery. There are few studies addressing mitral valve (MV) surgery in the context of etiology of MR. AIMS We aimed to compare postoperative outcomes in the context of the etiological mechanism of MR in patients after MV surgery. METHODS The study group included 337 consecutive patients with severe MR. Preoperative comorbidities, postoperative clinical course, and predictors of in-hospital mortality were assessed. RESULTS Primary etiology of MR was observed in 72% of patients, and of secondary, in 28% (P <0.001). Among the primary MR group, the most common etiological factor was fibroelastic deficiency (79%), followed by Barlow disease (16%) and rheumatic disease (5%) (P <0.001). Secondary MR was seen in ischemic heart disease (67%) and dilated cardiomyopathy (33%) (P <0.001). The incidence of death and complications following surgery did not differ between the groups. Univariate analysis revealed that higher risk of death was associated with older age, severe heart failure symptoms, impaired left ventricular ejection fraction, previous percutaneous coronary interventions, cardiopulmonary bypass time, low cardiac output syndrome, and wound infections (P = 0.004, P <0.001, P = 0.005, P = 0.009, P = 0.002, P = 0.006, and P = 0.03, respectively). Also MV replacement with concomitant other valve surgery increased the risk of mortality (P = 0.049). CONCLUSIONS This study indicates that the clinical outcomes and in-hospital mortality in patients with severe MR correlate with the type of procedure and concomitant perioperative comorbidities rather than the etiological mechanism of MR itself.
Selecting patients for percutaneous mitral valve therapy
Interventional Cardiology, 2011
Selecting patients for percutaneous mitral valve therapy review Patients with severe symptomatic mitral regurgitation benefit from correction of mitral regurgitation. Surgical mitral valve repair or replacement is the current standard of care for these patients. However, high risk of surgery in many of these patients, lack of universal expertise for mitral valve repair and moderate long-term success in correcting functional mitral regurgitation are some of the current challenges. Over the last decade we have witnessed important advances in the development of transcatheter techniques for mitral valve repair to overcome some of these challenges and compliment surgical treatment options. Percutaneous edge-to-edge repair has completed a commendable randomized clinical trial and several other devices have meaningful human experience. The role of these treatment options is evolving at a rapid pace. The use of these options will mostly be driven by the need (high-risk surgical patients and functional mitral regurgitation), anatomical feasibility and, to some extent, by local expertise and opinions. This article focuses on available clinical data and appropriate anatomical features for percutaneous therapies with comparable surgical data, with a view to aid patient selection for this evolving field. KEYWORDS: annuloplasty n MitraClip™ n mitral regurgitation n mitral valve repair