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Percutaneous therapy has emerged as an option for treatment of mitral regurgitation for selected, predominantly high-risk patients. Most of the percutaneous approaches are modifications of existing surgical approaches. Catheter-based devices mimic these surgical approaches with less procedural risk, due to their less-invasive nature. Percutaneous annuloplasty can be achieved indirectly via the coronary sinus or directly from retrograde left ventricular access. Catheter-based leaflet repair with the MitraClip (Abbott Laboratories, Abbott Park, Illinois) is accomplished with an implantable clip to mimic the surgical edge-to-edge leaflet repair technique. A large experience with MitraClip has been reported, and several other percutaneous approaches have been successfully used in smaller numbers of patients to demonstrate proof of concept, whereas others have failed and are no longer under development. There is increasing experience in both trials and practice to begin to define the clinical utility of percutaneous leaflet repair, and annuloplasty approaches are undergoing significant development. Transcatheter mitral valve replacement is still in early development. [ABSTRACT FROM AUTHOR]

Percutaneous therapy for the treatment of mitral regurgitation has emerged rapidly over the past few years. Most of the percutaneous approaches are modifications of existing surgical approaches to mitral annuloplasty or leaflet repair. Catheter-based devices mimic these surgical approaches with less procedural morbidity and mortality as a consequence of their less invasive nature. Percutaneous annuloplasty can be achieved indirectly via the coronary sinus or directly from retrograde left ventricular access. Catheter-based leaflet repair is accomplished using an implantable clip to mimic the surgical edge-to-edge technique. Several of these percutaneous approaches have been successfully used in patients to demonstrate proof of concept, while others have already stopped further development. There is increasing experience in both trials and practice to begin to define the clinical utility of percutanenous leaflet repair, and annuloplasty approaches are undergoing significant development. [ABSTRACT FROM AUTHOR]

Surgical valve repair for mitral regurgitation (MR) has been used for decades. Percutaneous approaches to mitral valve repair have been undergoing evaluation in trials over the last few years, and could offer less-invasive alternatives to surgery for the treatment of MR. Patient selection for surgical repair has been defined not only by the pathophysiology of MR, but also by the likelihood of successful repair for degenerative compared with functional MR. Patients with degenerative MR have excellent acute and long-term results following surgical repair; the acute risks of surgery in patients with heart failure are high in comparison, and late recurrent MR has been problematic after surgical repair for ischemic MR. Patient selection for percutaneous approaches to MR will be influenced by both the underlying valve pathology and the expected outcomes in various patient subsets, and also by the characteristics of the various percutaneous devices. This Review examines the established selection criteria for surgical repair and discusses the potential impact of new percutaneous approaches. [ABSTRACT FROM AUTHOR]

Background: Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration-approved devices.Objectives: The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation.Methods: Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. In 1,867 patients, data were linked to patient-specific Centers for Medicare and Medicaid Services administrative claims for analyses.Results: The median age was 82 years (55.8% men), with a median Society of Thoracic Surgery predicted risk of mortality of 6.1% (interquartile range: 3.7% to 9.9%) and 9.2% (interquartile range: 6.0% to 14.1%) for mitral repair and replacement, respectively. Overall, in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with Centers for Medicare and Medicaid Services linkage data, the mortality at 30 days and at 1 year was 5.2% and 25.8%, respectively, and repeat hospitalization for heart failure at 1 year occurred in 20.2%. Variables associated with mortality or rehospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation.Conclusions: Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety. Our findings may help determine which patients have favorable long-term outcomes with this therapy. [ABSTRACT FROM AUTHOR]

Mitral regurgitation, depending on severity and symptoms, may require treatment. Current options include the repair and replacement of the mitral valve. There is a trend of favoring transcatheter approaches, particularly in high-risk patients with comorbidities. In addition, emerging mitral valve prosthetics are in development and may provide additional options for these patients. [ABSTRACT FROM AUTHOR]

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 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 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 ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ 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 ± 40.1 ml to 108.5 ± 37.9 ml; p < 0.0001 [n = 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. (Real World Expanded Multi-center Study of the MitraClip System [REALISM]; NCT01931956) [ABSTRACT FROM AUTHOR]

Aims To evaluate the haemodynamic effect of acute procedural success (APS) after MitraClip therapy in patients with haemodynamic decompensation. Methods and results Of 107 patients, 79 achieved APS after MitraClip implantation. The increase in cardiac index (CI) was primarily detected in patients with a low baseline CI (2.0 ± 0.5 to 2.5 ± 5 L/min/m2, P < 0.001). There was a decrease in left ventricular end-diastolic pressure (LVEDP) (20 ± 5 to 13 ± 5 mmHg, P = 0.002) and mean pulmonary capillary wedge pressure (PCWPm) (20 ± 4 to 16 ± 5 mmHg, P = 0.001) in patients with values >15 mmHg at baseline, and a decrease in mean pulmonary artery systolic (PAPm) (36 ± 4 to 29 ± 7 mmHg P = 0.003) in those with values >30 mmHg before the MitraClip procedure. Patients with decompensation compared with patients with compensation experienced significant reduction in LVEDP (–8.3 ± 11.9 mmHg vs. –0.2 ± 4.5 mmHg, P = 0.009), a reduction in PCWPm (–3.5 ± 5.6 mmHg vs. 1.9 ± 4.7 mmHg, P < 0.001), and a reduction in PAPm (–8 ± 9 mmHg vs. 3 ± 6 mmHg, P < 0.001). Conclusion The favourable haemodynamic effects of MitraClip therapy on CI were primarily detected in patients with low CI before the procedure, and improvements in left-sided filling pressure and PAP were primarily seen in those with elevated values at baseline. [ABSTRACT FROM AUTHOR]

Patients in cardiogenic shock due to severe failure of a mitral bioprosthesis have extremely high risk for repeat standard cardiac surgery. This patient population may benefit the most form the least invasive intervention. We report a successful transseptal mitral valve-in-valve implant performed in a patient in cardiogenic shock due to a flail mitral bioprosthesis requiring bridging intravenous inotropic and intra-aortic balloon pump support. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation. Background: Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at 1 year overall. We report the 4-year outcomes from the EVEREST II trial. Methods: Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the MitraClip (Abbott, Menlo Park, California) device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients prospectively consented to 5 years of follow-up. Results: At 4 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the intention-to-treat population was 39.8% versus 53.4% in the percutaneous repair group and surgical groups, respectively (p = 0.070). Rates of death were 17.4% versus 17.8% (p = 0.914), and 3+ or 4+ MR was present in 21.7% versus 24.7% (p = 0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% versus 2.2% (p < 0.001) at 1 year and 24.8% versus 5.5% (p < 0.001) at 4 years. Conclusions: Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at 4 years. (Endovascular Valve Edge-to-Edge Repair Study [EVEREST II]; NCT00209274) [Copyright &y& Elsevier]

Aims Functional mitral regurgitation (FMR) contributes to morbidity and mortality in heart failure (HF) patients. The aim of this study was to determine whether percutaneous mitral annuloplasty could safely and effectively reduce FMR and yield durable long-term clinical benefit. Methods and results The impact of mitral annuloplasty (Carillon Mitral Contour System) was evaluated in HF patients with at least moderate FMR. Patients in whom the device was placed then acutely recaptured for clinical reasons served as a comparator group. Quantitative measures of FMR, left ventricular (LV) dimensions, New York Heart Association (NYHA) class, 6 min walk distance (6MWD), and quality of life were assessed in both groups up to 12 months. Safety and key functional data were assessed in the implanted cohort up to 24 months. Thirty-six patients received a permanent implant; 17 had the device recaptured. The 30-day major adverse event rate was 1.9%. In contrast to the comparison group, the implanted cohort demonstrated significant reductions in FMR as represented by regurgitant volume [baseline 34.5 ±11.5 mL to 17.4 ±12.4 mL at 12 months (P < 0.001)]. There was a corresponding reduction in LV diastolic volume [baseline 208.5 ±62.0 mL to 178.9 ±48.0 mL at 12 months (P =0.015)] and systolic volume [baseline 151.8 ±57.1 mL to 120.7 ±43.2 mL at 12 months (P =0.015)], compared with progressive LV dilation in the comparator. The 6MWD markedly improved for the implanted patients by 102.5 ±164 m at 12 months (P =0.014) and 131.9 ±80 m at 24 months (P < 0.001). Conclusion Percutaneous reduction of FMR using a coronary sinus approach is associated with reverse LV remodelling. Significant clinical improvements persisted up to 24 months. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population. Background: The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair. Methods: The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses. Results: Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF. Conclusions: Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF. [Copyright &y& Elsevier]

Objectives: The objective of this study was to evaluate the acute hemodynamic consequences of mitral valve (MV) repair with the MitraClip device (Abbott Vascular, Menlo Park, California). Background: Whether surgical correction of mitral regurgitation (MR) results in a low cardiac output (CO) state because of an acute increase in afterload remains controversial. The acute hemodynamic consequences of MR reduction with the MitraClip device have not been studied. Methods: We evaluated 107 patients with cardiac catheterization before and immediately following percutaneous MV repair with the MitraClip device. In addition, pre- and post-procedural hemodynamic parameters were studied by transthoracic echocardiography. Results: MitraClip treatment was attempted in 107 patients, and in 96 (90%) patients, a MitraClip was deployed. Successful MitraClip treatment resulted in: 1) an increase in CO from 5.0 ± 2.0 l/min to 5.7 ± 1.9 l/min (p = 0.003); 2) an increase in forward stroke volume (FSV) from 57 ± 17 ml to 65 ± 18 ml (p < 0.001); and 3) a decrease in systemic vascular resistance from 1,226 ± 481 dyn·s/cm5 to 1,004 ± 442 dyn·s/cm5 (p < 0.001). In addition, there was left ventricular (LV) unloading manifested by a decrease in LV end-diastolic pressure from 11.4 ± 9.0 mm Hg to 8.8 ± 5.8 mm Hg (p = 0.016) and a decrease in LV end-diastolic volume from 172 ± 37 ml to 158 ± 38 ml (p < 0.001). None of the patients developed acute post-procedural low CO state. Conclusions: Successful MV repair with the MitraClip system results in an immediate and significant improvement in FSV, CO, and LV loading conditions. There was no evidence of a low CO state following MitraClip treatment for MR. These favorable hemodynamic effects with the MitraClip appear to reduce the risk of developing a low CO state, a complication occasionally observed after surgical MV repair for severe MR. (A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge Repair Study [EVEREST I]; NCT00209339 and EVEREST II; NCT00209274) [Copyright &y& Elsevier]

Mitral regurgitation (MR) poses a significant clinical burden in the adult population, which is expected to increase even more with the ever prolonging life expectancies in developed countries. New technology has brought MR, once exclusively the arena of cardiac surgeons, to the attention of interventional cardiologists. A variety of device-oriented transcatheter strategies have evolved in recent years. A comprehensive understanding of mitral valvular anatomy is crucial for the selection of patients, the implementation of devices, and further refinements of these transcatheter techniques if they are eventually to produce procedural and clinical success. The aim of this review is to elucidate the morphology of the mitral valvular complex, integrating key anatomical features into the developing transcatheter options for the treatment of MR. [ABSTRACT FROM AUTHOR]

Introduction: Independent clinical event committees are the gold standard for event validation in clinical studies. However, little is known about the comparative performance of administrative claims data versus physician adjudication for event ascertainment in structural heart disease studies. Methods: Patients at high surgical risk undergoing transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation and enrolled in the EVEREST II High Risk Registry and the REALISM Continued-Access Registry from 2007-2013 were linked to Medicare claims. Physician adjudicated outcomes (mortality, heart failure hospitalization, renal failure, and bleeding / transfusion) were compared against the same outcomes defined with prespecified sets of ICD9-CM diagnosis or procedure codes. Concordance was evaluated with agreement statistics and comparisons of cumulative incidence. Results: Among 706 patients in the trial registries, 418 were successfully linked to Medicare data and had 1-year follow-up. The mean age was 79.7, 60% were male, 63.6% had functional MR, and 83.8% had at least NYHA class III symptoms. Concordance, as measured by sensitivity, specificity, positive and negative predictive values and kappa statistics for agreement between physician adjudication and claims data are presented in Figure 1A and was best for mortality and worst for renal failure. Time to event was most concordant for mortality and least concordant for bleeding (Figure 1B-E). Conclusions: Among patients eligible for Fee-For-Service Medicare and undergoing MitraClip, ascertainment of mortality and heart failure hospitalization was highly concordant between physician adjudication and administrative claims, with claims overestimating the rate of bleeding and renal failure. Further work is necessary to determine the role of administrative claims in event ascertainment in studies of structural heart disease. [ABSTRACT FROM AUTHOR]