Showing papers on "MitraClip published in 2016"

One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry

Abstract: Aims The transcatheter mitral valve interventions (TRAMI) registry was established in order to assess safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I 20.0%) between August 2010 and July 2013. We present the 1-year outcome in this MitraClip cohort—which is the largest published to date. Methods and results Seven forty-nine patients (90.5%) were available for 1-year follow-up and included in the following analyses. Mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes were recorded. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection. The 1-year mortality was 20.3%. At 1 year, 63.3% of TRAMI patients pertained to NYHA functional classes I or II (compared with 11.0% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. Importantly, a significant proportion of patients regained the complete independence in self-care after MitraClip implantation (independence in 74.0 vs. 58.6% at baseline, P = 0.005). Predictors of 1-year mortality were NYHA class IV (hazard ratio, HR 1.62, P = 0.02), anaemia (HR 2.44, P = 0.02), previous aortic valve intervention (HR 2.12, P = 0.002), serum creatinine ≥1.5 mg/dL (HR 1.77, P = 0.002), peripheral artery disease (HR 2.12, P = 0.0003), left ventricular ejection fraction <30% (HR 1.58, P = 0.01), severe tricuspid regurgitation (HR 1.84, P = 0.003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual post-procedural severe mitral regurgitation) (HR 4.36, P < 0.0001). Conclusions Treatment of significant MR with MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. In the TRAMI cohort, the failure of procedural success exhibited the highest hazard ratio concerning the prediction of 1-year mortality.

Transcatheter treatment of severe tricuspid regurgitation with the MitraClip system

Abstract: Aim The aim of this study was to show technical principles and feasibility of transcatheter tricuspid valve repair by use of the MitraClip system. Methods and results Three consecutive patients were treated successfully for severe symptomatic Tricuspid regurgitation. Three-dimensional transoesophageal echocardiography confirmed reduction of measured effective regurgitant orifice in all patients [effective regurgitant orifice area-baseline/post-procedure (cm2): 0.7/0.3; 1.5/0.8; 0.4/0.1], which was accompanied by an increase in left ventricular stroke volumes [baseline/post-procedure (mL): 42.8/45.4; 38/45; 35.2/45], decrease of measured levels of N terminal pro brain natriuretic peptide (pg/mL: baseline/post-procedure: 548/440; 2526/1702; 1754/623), and significant relief of clinical symptoms for chronic right heart failure in all patients. Conclusions Transcatheter tricuspid valve repair by use of interventional edge-to-edge repair with the MitraClip system was feasible, and safe in three consecutive patients. Reduction of tricuspid insufficiency associates with relief of clinical symptoms for right heart failure. This strategy seems a promising treatment option for patients at prohibitive surgical risk.

Mitral Regurgitation After Transcatheter Aortic Valve Replacement: Prognosis, Imaging Predictors, and Potential Management

Abstract: Objectives This study sought to analyze the clinical impact of the degree and improvement of mitral regurgitation in TAVR recipients, validate the main imaging determinants of this improvement, and assess the potential candidates for double valve repair with percutaneous techniques. Background Many patients with severe aortic stenosis present with concomitant mitral regurgitation (MR). Cardiac imaging plays a key role in identifying prognostic factors of MR persistence after transcatheter aortic valve replacement (TAVR) and for planning its treatment. Methods A total of 1,110 patients with severe aortic stenosis from 6 centers who underwent TAVR were included. In-hospital to 6-month follow-up clinical outcomes according to the degree of baseline MR were evaluated. Off-line analysis of echocardiographic and multidetector computed tomography images was performed to determine predictors of improvement, clinical outcomes, and potential percutaneous alternatives to treat persistent MR. Results Compared with patients without significant pre-TAVR MR, 177 patients (16%) presented with significant pre-TAVR MR, experiencing a 3-fold increase in 6-month mortality (35.0% vs. 10.2%; p 35.5 mm (odds ratio: 9.0; 95% confidence interval: 3.2 to 25.3; p Conclusions Significant MR is not uncommon in TAVR recipients and associates with greater mortality. In more than one-half of patients, the degree of MR improves after TAVR, which can be predicted by characterizing the mitral apparatus with multidetector computed tomography. According to standardized imaging criteria, at least 1 in 10 patients whose MR persists after TAVR could benefit from percutaneous mitral procedures, and even more could be treated with MitraClip after dedicated pre-imaging evaluation.

Comparison of Percutaneous Mitral Valve Repair Versus Conservative Treatment in Severe Functional Mitral Regurgitation.

Abstract: Percutaneous mitral valve repair (PMVR) using the MitraClip System is feasible and entails clinical improvement even in patients with high surgical risk and severe functional mitral regurgitation (MR). The aim of this study was to assess survival rates and clinical outcome of patients with severe, functional MR treated with optimal medical therapy (OMT) compared with those who received MitraClip device. Sixty patients treated with OMT were compared with a propensity-matched cohort of 60 patients who underwent PMVR. Baseline demographics and echocardiographic variables were similar between the 2 groups. The mean age of patients was 75 years, and 67% were men. The median logistic EuroSCORE and EuroSCORE II were 17% and 6%, respectively, because of the presence of several co-morbidities. The mechanism of MR was functional in all cases with an ischemic etiology in 52% of patients. Median left ventricle ejection fraction was 34%. All the patients were symptomatic for dyspnea with 63% and 12% in the New York Heart Association class III and IV, respectively. In PMVR group, the procedure was associated with safety and very low incidence of procedural complications with no occurrence of procedural and inhospital mortality. After a median follow-up of 515 days (248 to 828 days), patients treated with PMVR demonstrated overall survival, survival freedom from cardiac death and survival free of readmission due to cardiac disease curves higher than patients treated conservatively (log-rank test p = 0.007, p = 0.002, and p = 0.04, respectively). In conclusion, PMVR offers a valid option for selected patients with high surgical risk and severe, functional MR and entails better survival outcomes compared with OMT.

3D Printed Modeling for Patient-Specific Mitral Valve Intervention: Repair With a Clip and a Plug

Abstract: A 62-year-old man with peripheral vascular disease, chronic kidney disease (glomerular filtration rate <30 ml/min), previous coronary artery bypass grafting, and recent treatment for bacterial endocarditis was referred for refractory decompensated congestive heart failure (New York Heart

Impact of percutaneous mitral valve repair using the MitraClip system on tricuspid regurgitation

Abstract: AIMS: Tricuspid regurgitation (TR) severity and right ventricular (RV) dysfunction have been identified as significant predictors of outcome after mitral valve surgery. The aim of the present study was to investigate the impact of percutaneous mitral valve repair (PMVR) with the MitraClip system on functional TR severity and RV function. METHODS AND RESULTS: Among 119 consecutive patients with severe mitral regurgitation who underwent PMVR, 67 had complete baseline and follow-up transthoracic echocardiography after 3-12 months (6.8±2.9 months). TR severity was graded as mild, moderate, and severe. RV systolic function was assessed by fractional area change (FAC) and tricuspid annular plane systolic excursion (TAPSE). Clinical endpoints at follow-up included mortality, reoperation of the mitral valve, hospitalisation for congestive heart failure and New York Heart Association (NYHA) functional class. After PMVR, a significant decrease in TR severity (by at least one grade) was observed in 22 (33%) patients, while an increase occurred in only seven (10%) patients (p=0.02). Overall, systolic RV function (FAC and TAPSE), RV dimensions, and tricuspid annular diameter did not change significantly. Baseline SPAP was significantly higher (57±15 vs. 43±14 mmHg, p=0.002) and SPAP reduction significantly larger (-14±13 versus 1±15 mmHg, p=0.012) in patients who improved their TR. Multivariate logistic regression analysis identified the change in SPAP as the only significant predictor of changes in TR (odds ratio [OR] [for every change in SPAP by 10 mmHg] 1.90, 95% CI: 1.02±3.54; p=0.044). Patients with mild/moderate TR at follow-up after PMVR had lower event rates compared to those with severe TR (35% vs. 78%, respectively, p=0.025). CONCLUSIONS: PMVR using the MitraClip device improves functional TR severity in approximately one third of patients, particularly in those who experience a significant SPAP reduction after the procedure.

Cerebral Protection During MitraClip Implantation: Initial Experience at 2 Centers.

Abstract: Objectives This study sought to assess the feasibility and safety of using a filter-based cerebral protection system (CPS) during MitraClip implantation and to report on the histopathologic analysis of the captured debris. Background Stroke is one of the serious adverse events associated with MitraClip therapy. Methods Between July 2014 and March 2015, 14 surgical high-risk patients (age 75 ± 7 years; 7 men; median logistic EuroSCORE 21%) underwent MitraClip implantation employing cerebral protection with a dual embolic filter system. All patients had severe mitral regurgitation of predominantly functional origin. Results All procedures were successfully completed for both CPS deployment/retrieval and MitraClip implantation. A total of 28 filters (2 from each patient) were analyzed. Microscopically, debris was identified in all 14 patients. The most common tissue types were acute thrombus and small fragments of foreign material, which were found in 12 patients (85.7%) each. Organizing thrombus was present in 4 patients (28.6%), valve tissue and/or superficial atrial wall tissue in 9 patients (64.3%), and fragments of myocardium in 2 patients (14.3%). No transient ischemic attacks, strokes, or deaths occurred peri-procedurally or during a median follow-up interval of 8.4 months. Conclusions In this small study of patients undergoing MitraClip treatment with cerebral protection, embolic debris potentially conducive to cerebrovascular events was found in all patients. Debris was composed most often of acute thrombus, foreign material likely originating from the hydrophilic device coating, and valve/atrial wall tissue. Further studies are warranted to assess the impact of cerebral protection on the incidence of cerebrovascular events after MitraClip therapy.

Impact of Preprocedural Left Ventricular Ejection Fraction on 1-Year Outcomes After MitraClip Implantation (from the ACCESS-EU Phase I, a Prospective, Multicenter, Nonrandomized Postapproval Study of the MitraClip Therapy in Europe)

Abstract: This report describes the 12-month outcomes of the a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe (ACCESS-EU postapproval study of MitraClip therapy) with respect to preprocedural left ventricular ejection fraction (LVEF). Transcatheter deployment of the MitraClip device may be considered for patients who are not suitable for conventional surgery. A total of 567 patients with significant mitral regurgitation (MR) underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were subdivided by preprocedural LVEF (A: 10% to 20%, B: >20% to 30%, C: >30% to 40%, D: >40%). Procedural safety and efficacy and treatment outcomes including MR grade, New York Heart Association (NYHA) functional class, 6-minute walk test, and the Minnesota Living with Heart Failure Questionnaire were analyzed at baseline, 30 days, and 12 months. Baseline mean logistic EuroSCORE was 25 ± 19; 87% of patients were in NYHA classes III or IV (A: 96%, B: 83%, C: 90%, D: 86%). There was no incidence of death or stroke intraprocedurally. Eleven patients died within 30 days with no differences among subgroups. Kaplan–Meier survival at 12 months was 81.8% (A: 71%, B: 79%, C: 87%, D: 86%). There was a significant improvement in MR severity at 30 days and 12 months (p

Percutaneous Direct Annuloplasty With Cardioband to Treat Recurrent Mitral Regurgitation After MitraClip Implantation.

Abstract: A 74-year-old man was referred for worsening symptoms of left-sided heart failure (New York Heart Association functional class III) 1 year after undergoing an edge-to-edge repair with 2 MitraClips (Abbott Vascular, Santa Clara, California) for functional mitral regurgitation (FMR) at another

MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experience†.

Abstract: OBJECTIVES To compare the surgical and percutaneous edge-to-edge (EE) repair in patients with severe left ventricular (LV) dysfunction and secondary mitral regurgitation (MR). METHODS We reviewed the prospectively collected data of the first 120 consecutive patients (age: 65 ± 9.8 years, EF: 28 ± 8.2%) treated with surgical (65 patients) or percutaneous (55 patients) EE repair for severe secondary MR in our institution. Age (P = 0.005) and logistic European System for Cardiac Operative Risk Evaluation (P < 0.0001) were significantly higher in the MitraClip group. LVEF (P = 0.37), end-diastolic (P = 0.83) and end-systolic (P = 0.68) volumes and systolic pulmonary artery pressure (SPAP) (P = 0.58) were similar. The follow-up was 100% complete [median: 4 years; interquartile range (IQR): 2.2-7.2]. RESULTS The length of hospital stay was 10 days (IQR: 8-13) for surgery and 5 days (IQR: 3.9-7.8) for MitraClip (P < 0.0001). Hospital mortality (3 vs 0%, P = 0.49) and freedom from cardiac death at 4 years (80.8 ± 4.9% vs 79.1 ± 5.9%, P = 0.9) were not significantly different in the surgical and MitraClip group, respectively. Residual MR ≥ 2+ at hospital discharge was 7.6% for surgery and 29% for MitraClip (P = 0.002). At 4 years, freedom from MR ≥ 2+ (74.9 ± 5.6% vs 51.4 ± 7.4%, P = 0.01) and freedom from MR ≥ 3+ (92.8 ± 3.4% vs 68.1 ± 7%, P = 0.002) were both significantly higher in the surgical group. Multivariate analysis identified the use of MitraClip as an independent predictor of recurrence of MR ≥ 2+ [Hazard ratio (HR): 2.1, 95% confidence interval (CI): 1.1-3.9, P = 0.02] as well as of MR ≥ 3 (HR: 6.1, 95% CI: 1.5-24.3, P = 0.01). In the surgical group, no predictors of cardiac mortality were identified. In the MitraClip group, left ventricular end-diastolic diameter (HR: 1.1, 95% CI: 1-1.2, P = 0.005) and SPAP (HR: 1, 95% CI: 1-1.1, P = 0.005) were independent predictors of cardiac death at the follow-up. CONCLUSIONS MitraClip therapy is a safe therapeutic option in selected high-risk patients with secondary MR and relevant comorbidities. The surgical EE provides higher efficacy both postoperatively and at the mid-term follow-up.

Predictors for short-term outcomes of patients undergoing transcatheter mitral valve interventions: analysis of 778 prospective patients from the German TRAMI registry focusing on baseline renal function

Abstract: AIMS Factors predicting outcomes after MitraClip implantation are not well defined. We aimed to report the influence of baseline renal function on short-term outcomes of patients enrolled in the investigator-initiated German transcatheter mitral valve interventions (TRAMI) registry. METHODS AND RESULTS Twenty participating German centres prospectively included 778 patients (mean age 76.0 years [71-81], 38.8% female gender) at high surgical risk (mean logistic EuroSCORE 20% [12-32%]) undergoing TMVR with the MitraClip for the treatment of symptomatic functional (70%) or degenerative (30%) mitral valve regurgitation (FMR, DMR). The patients were stratified according to renal function before clip implantation. The prevalence of moderate to severe renal impairment (glomerular filtration rate [GFR] 60 ml/min]; 49.6%, moderate renal impairment [GFR 30-60 ml/min]; 13.1%, severe renal impairment [GFR <30 ml/min]). TMVR was successfully completed in 98.2% of cases; acute procedural failure, in-hospital and 30-day mortality rates were 1.8%, 2.3% and 4.4%, respectively. Acute procedural failure and mortality rates (in-hospital, 30-day) were significantly higher in patients with severe renal impairment (5.9%, 7.8%, 14.1%), as compared to patients with moderately (1%, 1.3%, 3.0%) or mildly impaired to normal (1.4%, 1.7%, 2.9%) renal function (p<0.0001). Following Cox regression analysis, the prevalence of severe renal impairment at the time of TMVR was the only predictor for increased 30-day mortality rates (hazard ratio 3.42, 95% confidence interval 1.88-6.2; p<0.0001). CONCLUSIONS Renal function at the time of interventional mitral valve repair with the MitraClip system is a strong predictor for procedural outcomes. Patients with severe renal impairment have a more than threefold increased risk for acute procedural failure, in-hospital death and 30-day mortality.

Prognostic Significance of Right Ventricular Dysfunction in Patients With Functional Mitral Regurgitation Undergoing MitraClip.

Abstract: Functional mitral regurgitation (MR) is common in patients with heart failure and left ventricular (LV) dysfunction. MitraClip (MC) is a novel therapeutic option for patients with high-risk MR. Similar to LV dysfunction, right ventricular dysfunction (RVD) is an important predictor of patients with heart failure. We aimed to clarify the effect of RVD on outcomes of functional MR and LV dysfunction after MC implantation. We examined 117 patients with severe functional MR and reduced LV ejection fraction (≤40%) treated with MC. RVD was defined as tricuspid annular plane systolic excursion

Intraprocedural assessment of mitral regurgitation during the mitraclip procedure: Impact of continuous left atrial pressure monitoring.

Abstract: Introduction Intraprocedural assessment of mitral regurgitation (MR) is a challenging issue during the MitraClip procedure, which might influence not only the position but also the number of MitraClips implanted. Though transesophageal echocardiography (TEE) is the predominant tool used during the MitraClip procedure, MR assessment might be facilitated by a multimodality approach including continuous and simultaneous determination of left atrial and left ventricular (LV) pressure. Methods 86 consecutive patients (76.5 ± 8 years) who qualified for the MitraClip procedure were included into the study. In all patients, the multimodal assessment of MR (TEE, LV angiogram, TEE bubble evaluation, left atrial (LA) pressure => MitraScore) was performed after introducing the MitraClip guide catheter. In the first 42 patients (group A, no CAP), left atrial (LA) pressure (peak pressure of V-wave) was determined only before and after MitraClip implantation, whereas, in the subsequent 44 patients (group B, with CAP), continuous left atrial pressure monitoring (CAP) was performed. Results Patients with CAP (group B) had similar total procedural durations and no increase in the complication rate. MitraScore decreased from 10.5 to 3.5 in group A compared to 10.7 to *2.8 in group B (*P = 0.021 vs. group B). Whether the significant improvement of intraprocedural MR in group B translated into superior MR reduction in the conscious patient, was analyzed by transthoracic echocardiography (TTE) in a blinded fashion. Again MR reduction was significantly greater (P = 0.03) in group B (MR grade 2.8 to 0.9) as compared to group A (MR grade 2.8 to 1.3) and 2D vena contracta decreased from 0.54 ± 0.15 cm to 0.17 ± 0.10 in group B compared to group A (0.56 ± 0.19 cm to *0.23 ± 0.12; *P = 0.01 vs. group B). Conclusions Multimodality assessment of intraprocedural MR supported by continuous left atrial pressure monitoring was associated with superior intraprocedural results translating into improved MR reduction also at the end of the hospital stay. © 2016 Wiley Periodicals, Inc.

Optimal results immediately after MitraClip therapy or surgical edge-to-edge repair for functional mitral regurgitation: are they really stable at 4 years?

Abstract: OBJECTIVES Recurrent mitral regurgitation (MR) is common after surgical and percutaneous (MitraClip) treatment of functional MR (FMR). However, the Everest II trial suggested that, in patients with secondary MR and initially successful MitraClip therapy, the results were sustained at 4 years and were comparable with surgery in terms of late efficacy. The aim of this study was to assess whether both those findings were confirmed by our own experience. METHODS We reviewed 143 patients who had an initial optimal result (residual MR ≤ 1+ at discharge) after MitraClip therapy (85 patients) or surgical edge-to-edge (EE) repair (58 patients) for severe secondary MR (mean ejection fraction 28 ± 8.5%). Patients with MR ≥ 2+ at hospital discharge were excluded. The two groups were comparable. Only age and logistic EuroSCORE were higher in the MitraClip group. RESULTS Follow-up was 100% complete (median 3.2 years; interquartile range 1.8;6.1). Freedom from cardiac death at 4 years (81 ± 5.2 vs 84 ± 4.6%, P = 0.5) was similar in the surgical and MitraClip group. The initial optimal MitraClip results did not remain stable. At 1 year, 32.5% of the patients had developed MR ≥ 2+ (P = 0.0001 compared with discharge). Afterwards, patients with an echocardiographic follow-up at 2 years (60 patients), 3 years (40 patients) and 4 years (21 patients) showed a significant increase in the severity of MR compared with the corresponding 1 year grade (all P < 0.01). Freedom from MR ≥ 3+ at 4 years was 75 ± 7.6% in the MitraClip group and 94 ± 3.3% in the surgical one (P = 0.04). Freedom from MR ≥ 2+ at 4 years was 37 ± 7.2 vs 82 ± 5.2%, respectively (P = 0.0001). Cox regression analysis identified the use of MitraClip as a predictor of recurrence of MR ≥ 2+ [hazard ratio (HR) 5.2, 95% confidence interval (CI) 2.5-10.8, P = 0.0001] as well as of MR ≥ 3 (HR 3.5, 95% CI 0.9-13.1, P = 0.05). CONCLUSIONS In patients with FMR and optimal mitral competence after MitraClip implantation, the recurrence of significant MR at 4 years is not uncommon. This study does not confirm previous observations reported in the Everest II randomized controlled trial indicating that, if the MitraClip therapy was initially successful, the results were sustained at 4 years. When compared with the surgical EE combined with annuloplasty, MitraClip therapy provides lower efficacy at 4 years.

Deep sedation versus general anesthesia in percutaneous edge-to-edge mitral valve reconstruction using the MitraClip system

Abstract: Percutaneous edge-to-edge mitral valve reconstruction (PMVR) has emerged as a treatment option in patients with severe mitral regurgitation not considered suitable candidates for surgery. The majority of PMVR procedures are performed under general anesthesia (GA), although deep sedation (DS) appears to be an attractive alternative. We thus sought to assess the impact on intensive care unit (ICU) length of stay, efficacy, and safety of DS in comparison to GA in patients undergoing PMVR using the MitraClip® system. Sixty consecutive patients underwent PMVR procedures at two centers. The first 30 patients were treated by GA followed by 30 patients undergoing DS under different settings. The primary clinical endpoint was ICU length of stay. The primary efficacy endpoint included procedural success and procedural duration. The safety endpoint was defined as a composite of death, stroke, cardiogenic shock, moderate and severe bleeding as well as pneumonia. The ICU length of stay was significantly shorter in the DS group in comparison to GA patients (p = 0.001). The hospital length of stay did not differ following DS in comparison to GA (p = 0.96). Procedural success was high in both groups (100 versus 96.7 %, p = 0.34) at similar procedural duration time (p = 0.60). No difference between GA and DS was observed with respect to the occurrence of the combined safety endpoint (p = 0.47). In comparison to GA, DS reduces the ICU length of stay in PMVR without negative effects on safety and efficacy. Prospective randomized trials are needed to confirm these findings.

Transcatheter mitral valve repair with the MitraClip(®) can be performed without general anesthesia and without conscious sedation.

Abstract: General anesthesia is known to be associated with an increased risk for complications, especially in elderly and multi-morbid patients, the primary target population of the MitraClip® technique. The aim is to assess whether general anesthesia and even conscious sedation can be avoided during the MitraClip® procedure. A total of 91 consecutive patients who underwent MitraClip® implantation [median 77 years, (IQR 72–83), 40 % female] were retrospectively analyzed. The first 26 patients were treated in general anesthesia. Afterwards, local anesthesia was chosen as primary anesthetic approach. Altogether, 28 (31 %) patients received general anesthesia, local anesthesia was performed in 35 (38 %) patients with sedation and in 28 (31 %) patients without sedation. The respective patient groups were similar regarding their baseline characteristics. Procedural success (successful implantation of at least one clip and post-procedure MR grade ≤2) was achieved in 89 % with no difference between the groups (93 % in general anesthesia, 89 % in local anesthesia with sedation, 86 % in local anesthesia without sedation, p = ns). No difference regarding hospital complications was noted. Local anesthesia with and without sedation was associated with less necessity for ICU/IMC stay (100 % in general anesthesia, 14 % in local anesthesia with sedation, 14 % in local anesthesia without sedation; p < 0.0001). One-year estimated survival was not significantly different among the groups (63, 82 and 75 %; p = ns). Transcatheter mitral valve repair with the MitraClip® can be performed without general anesthesia and even without conscious sedation with similar procedural success and complication rates.

Impact of chronic kidney disease on outcomes after percutaneous mitral valve repair with the MitraClip system: insights from the GRASP registry.

Abstract: AIMS Our aim was to evaluate the impact of baseline chronic kidney disease (CKD) on clinical outcomes after percutaneous edge-to-edge mitral valve repair (PMVR). METHODS AND RESULTS Two hundred and fourteen consecutive patients dichotomised by the presence of baseline CKD (n=113) or no-CKD (n=101) had their clinical outcomes compared up to 12-month follow-up. The primary safety endpoint was the incidence of major adverse events and the primary efficacy endpoint was freedom from death, surgery for MV dysfunction, or grade ≥3+ MR. The primary safety endpoint was demonstrated in 12.4% vs. 2.0% in CKD and no-CKD patients, respectively (p=0.003). The primary efficacy endpoint at 12 months was significantly lower in CKD patients (65.8% vs. 84.2%, respectively, log-rank p=0.005). While MR reduction and NYHA functional class improvement were mostly sustained and equivalent up to 12 months in no-CKD patients, they were impaired in CKD patients. Baseline CKD was an independent predictor of the primary efficacy endpoint (adjusted HR 2.48, 95% CI: 1.29 to 4.79, p=0.006) and calcified leaflet predicted grade ≥3+ MR at 12 months (adjusted HR 6.56, 95% CI: 2.71 to 15.88, p<0.001). CONCLUSIONS CKD patients had worse clinical outcomes compared with no-CKD patients post PMVR. CKD was an independent predictor of the primary efficacy endpoint, whereas calcified leaflet was an independent predictor of grade ≥3+ MR at 12 months.

Long‐term survival and preprocedural predictors of mortality in high surgical risk patients undergoing percutaneous mitral valve repair

Abstract: Objectives To evaluate long-term survival in high surgical risk patients undergoing percutaneous mitral valve repair (MVR) using the MitraClip® system and to identify preprocedural predictors of long-term mortality. Background Data for long-term survival and preprocedural predictors of mortality after percutaneous MVR in high surgical risk patients are sporadic. Methods From January 2009 to April 2013, 136 consecutive high surgical risk patients, with symptomatic moderate-to-severe or severe mitral regurgitation (MR), underwent percutaneous MVR using the MitraClip system. Cardiac and overall survival was determined at one and 2 years postprocedure. Univariate and multivariate analysis was performed to identify preprocedural predictors of long-term mortality. Results One year postprocedure, cardiac and overall survival was 86.7% and 84.6%, respectively and at 2 years cardiac and overall survival was 77.7% and 74.8%, respectively. In univariate analysis advanced age, lower body mass index, impaired renal function, elevated levels of log-N-terminal-pro-brain-natriuretic-peptide (log-NTproBNP), poor performance in functional tests (New York Heart Association (NYHA) class) and high logistic Euroscore (LES) and Society of Thoracic Surgeons (STS) score were identified as preprocedural predictors of long-term cardiac mortality. In multivariate analysis preoperative NYHA class III and IV, elevated levels of log-NTproBNP and advanced age predicted long-term cardiac mortality. Conclusions Percutaneous MVR using the MitraClip system has favorable long-term survival rates in high surgical risk patients. Preprocedural NYHA functional class III and IV, elevated log-NTproBNP levels and advanced age predict higher long-term cardiac mortality and should be considered during patient selection. © 2015 Wiley Periodicals, Inc.

Transcatheter Repair of Primary Tricuspid Valve Regurgitation Using the MitraClip System

Abstract: We report the case of a 71-year-old male patient with a history of heart transplantation 26 years previously. He presented with severe right-sided heart failure due primarily to high-grade tricuspid regurgitation (TR) caused by flail of the septal leaflet due to chordal rupture ([Figures 1A to 1C][

The Learning Curve for Transcatheter Mitral Valve Repair With MitraClip

Abstract: Objectives This study sought to assess the learning curve for TMVR for treatment of primary mitral regurgitation (MR). Background Data are lacking regarding the technical experience required to achieve optimal clinical outcomes with transcatheter mitral valve repair (TMVR) using the edge-to-edge MitraClip technique. Methods We examined the sequential experience of the first 75 patients (age 80 ± 9 years; 77% male) who underwent TMVR at our institution. A sequence number of each patient was assigned as a continuous variable and in tertiles for analysis. Results TMVR with MitraClip was successful in 97% with an average procedural time of 106 ± 39 minutes. The 30-day rate of major adverse cardiovascular events was 7%. With increased case experience, there were decreases in procedural time, fluoroscopy time, length of hospital stay, and major adverse cardiovascular events. Procedural success, residual mitral regurgitation and NYHA functional classification at 30-day follow-up remained unchanged throughout the experience. Conclusions The learning curve for TMVR with MitraClip for treatment of primary MR is characterized by a sequential reduction in procedure time, fluoroscopy time, procedural complications, and hospital length of stay at a tertiary academic medical center. Thirty-day procedural results are favorable and similar during the initial learning period.