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Background: Valve-in-valve (VIV) treatment with transcatheter aortic valve replacement (TAVR) is a viable option for patients with failing aortic bioprosthetic valves. Optimal management of those with concomitant mitral regurgitation (MR) remains undetermined. Therefore, we sought to assess the implications of concomitant MR in patients undergoing VIV-TAVR., Methods and Results: The PARTNER 2 VIV registry enrolled patients with degenerated surgical aortic bioprosthesis at high risk for reoperation. Patients with core-laboratory echocardiographic assessment of MR were analyzed; severe MR was excluded. We compared patients with ≤mild MR versus moderate MR and assessed changes in MR severity and clinical outcomes. A total of 339 patients (89 initial registry, 250 continued access) underwent VIV procedures; mean age 79.0 ± 10.2 years, mean Society of Thoracic Surgeon score 8.9 ± 4.5%. At baseline, 228/339 (67.3%) had ≤mild MR and 111/339 (32.7%) had moderate MR. In paired analysis, there was significant improvement in ≥moderate MR from baseline to 30 days (32.6% vs. 14.5%, p < .0001 [n = 304]), and no significant change between 30 days and 1 year (13.4% vs. 12.1%, p = .56 [n = 224]) or 1 year and 2 years (11.0% vs. 10.4%, p = .81 [n = 182]). There was no difference in death or stroke between ≤mild MR and moderate MR at 30 days (4.0% vs. 7.2%, p = .20), 1 year (15.5% vs. 15.3%, p = .98) or 2 years (26.5% vs. 23.5%, p = .67)., Conclusion: Moderate concomitant MR tends to improve with VIV-TAVR, and was not a predictor of long-term adverse outcomes in this cohort. In selected patients undergoing VIV-TAVR, it may be appropriate to conservatively manage concomitant MR., Clinical Trial Registration: ClinicalTrials.gov NCT# 03225001., (© 2020 Wiley Periodicals, Inc.)

Objectives: Unbiased information regarding the surgical management of patients with mitral regurgitation (MR) at the nationwide level are scarce and mainly US-based. The Programme de Médicalisation des Systèmes d'Information, a mandatory national database, offers the unique opportunity to assess the presentation and outcomes of all consecutive mitral valve (MV) surgeries performed in France in the contemporary era., Methods: We collected all MV surgeries performed for MR in France in 2014-2016. MR aetiology was classified as degenerative (DMR), secondary (SMR) or Other (rheumatic or congenital disease and infective endocarditis)., Results: During the 3-year period, 18 167 MV surgeries were performed in France (55% repair and 45% replacement; 52% isolated). Age was 66±12 years and 59% were male. Aetiology was DMR in 42%, SMR in 16% and other in 42% including 19% with uncertain aetiologies. Overall, in-hospital mortality was 6.5% and increased with age, female gender, Charlson Comorbidity Index, type of surgery (replacement vs repair), associated surgery (combined vs isolated) and MR aetiology (all p<0.01). In-hospital mortality and rate of death/readmission for heart failure (HF) at 1 year were 3.4% and 13%, respectively for DMR (2.4% and 11% for isolated DMR) and 7.8% and 27%, respectively for SMR (5.5% and 23% for isolated SMR). Repair rate was 55% overall, 68% in DMR and 72% for isolated DMR surgery (70% of all DMR). Repair rates decreased with age, Charlson Comorbidity Index and female sex (all p<0.0001)., Conclusion: In this cross-sectional contemporary prospective nationwide database, in-hospital mortality and 1 year rate of death and HF readmission were considerable overall and in all subsets. Repair rates were suboptimal overall especially in the elderly and women subsets. These results underline the need to develop strategies to improve management and outcomes of patients with both DMR and SMR., Competing Interests: Competing interests: DM-Z is a consultant for Edwards Lifesciences, Mardil and Cardiawave and receives research grants from Edwards Lifesciences and Abbott vascular. PC is an Edwards Lifesciences employee. M-ES has received research grants from Edwards Lifesciences. PV is an Edwards Lifesciences employee. TEF is an Edwards Lifesciences employee. BI has received consultant fees from Edwards Lifesciences and speaker’s fees from Boehringer Ingelheim and Novartis. J-FO has received Consultant fees from Landanger, Delacroix-Chevalier and speaker’s fees from Abbott, Medtronic, Sanofi. AV has received speaker’s fees from Edwards Lifesciences., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Mitral regurgitation (MR) in heart failure (HF) notoriously carries a poor prognosis. While there are multiple interventional options for treatment, the optimal intervention remains controversial. Therefore, we aimed to evaluate the efficacy and safety of surgery, medical therapy, and transcatheter intervention in secondary MR., Methods: A systematic database search was performed to identify all randomized controlled trials (RCTs) that evaluate various interventions for secondary MR. We performed a Bayesian network meta-analysis to calculate odd ratios (ORs) and 95% credible intervals (CIs). The primary endpoint was all-cause mortality. Secondary endpoints were moderate-severe MR, HF-hospitalizations, and freedom from severe HF symptoms., Results: We identified 12 RCTs (2316 total patients; age 67.6 ± 11; 63% males, and 74% with ischemic cardiomyopathy). There was a significant reduction of mortality at 24-months with transcatheter leaflet repair compared with medical therapy (OR = 0.57; 95% CI = 0.34-0.96). However, there were no significant differences among the competing treatments in all-cause mortality at the earlier time points of 30-days or 12-months (P > 0.05). Recurrent moderate-severe MR was significantly less with valvular interventions compared with medical therapy (P < 0.05), but there were no differences in the rates of HF-hospitalizations or persistent severe HF symptoms between the competing interventions (P > 0.05)., Conclusions: Among patients with HF and secondary MR, transcatheter leaflet repair was associated with significantly reduced 24-month mortality compared with medical therapy. Valvular interventions were associated with lower rates of recurrent moderate-severe MR, but non-significant improvements in clinical outcomes. Further long-term studies are needed to identify the best route of intervention for secondary MR., Competing Interests: Conflicts of interest MH received a research grant (Abbott). TF discloses the following relationships - Vice President of Edwards Lifesciences, Medical Affairs, Transcatheter Mitral and Tricuspid Therapies. DLB discloses the following relationships - Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co‑leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, PLx Pharma, Takeda. The remaining authors report no relationships that could be construed as a conflict of interest., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS)., Methods: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up., Results: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years., Conclusions: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up., Trial Registration Number: NCT01940120., Competing Interests: Competing interests: SK is a consultant for and has received honoraria/institutional research support from Abbott, Boston Scientific, WL Gore, Mitralign, Edwards. TF is a consultant for and has received honoraria/institutional research support from Abbott, Boston Scientific, Edwards and WL Gore. AQ has received research grant from Abbott. DSL is a consultant for and has received research grants from Abbott. RWS has received grant support from Abbott Vascular. HCH has received institutional research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, St Jude Medical, Medtronic, Cardiokinetx, Gore and Mitraspan; is a consultant for Edwards Lifesciences and Siemens; and has equity ownership in Microinterventional Devices. LM’s institution has received research grants from Abbott Vascular, Boston Scientific, Cordis, Medtronic, Eli Lilly, Daiichi Sankyo, Bristol-Myers Squibb and Sanofi-Aventis. All other authors have reported they have no relationships relevant to the contents of this paper to disclose., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study., Background: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated., Methods: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days., Results: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively., Conclusions: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349)., (Copyright © 2019. Published by Elsevier Inc.)

Background: Clinical event committees are commonly employed for event validation in clinical studies, but little is known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for ascertainment of adverse events in structural heart disease studies., Methods and Results: Medicare claims were linked to 418 patients >65 years of age who underwent transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation from 2007 to 2013 as part of the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) High-Risk Registry or the REALISM (Real World Expanded Multicenter Study of the MitraClip System) Continued-Access Registry. Each registry adjudicated mortality, heart failure hospitalization, renal failure, ventilation, and bleeding/transfusion within 1 year. Concordance of claims-based outcomes with events was assessed in 3 ways: 1-year occurrence, cumulative incidence, and synchrony of first events. For event occurrence, positive predictive value (PPV) of claims versus adjudication was the highest for mortality (PPV=97%) and heart failure hospitalization (PPV=69%) but lower for bleeding (PPV=40%) and renal failure (PPV=19%). Whereas claims-based cumulative incidence for mortality, heart failure hospitalization, and renal failure were consistent with clinician-triggered adjudication, incidence curves for bleeding events and ventilation diverged, with claims identifying a greater number of events. When events were detected by both methods, however, over 75% of event dates matched exactly. Mitral valve reinterventions were identified through claims with perfect sensitivity and specificity relative to physician adjudication., Conclusions: Ascertainment of mortality, heart failure hospitalization, and renal failure was highly concordant between physician adjudication and administrative claims. Further work is necessary to determine the role of administrative claims in event ascertainment in both prospective and retrospective studies of structural heart disease.

Objectives: The aim of this study was to assess the additional utility of measuring left atrial (LA) pressure as a complement to transesophageal echocardiography (TEE) and Doppler imaging., Background: The efficacy of the MitraClip (MC) is assessed intraoperatively by TEE. However, TEE measures are operator dependent and can be influenced by left ventricular (LV) function and changes in LA compliance., Methods: Fifty patients undergoing MC therapy with continuous left-sided heart pressure measurements were analyzed. LA V-wave pressure (LAvP), LA mean pressure (LAmP), LV systolic pressure, and LV end-diastolic pressure were measured continuously. LA pressures were indexed to LV pressures to account for changes in afterload during the procedure., Results: Most patients (70%) had degenerative mitral regurgitation (MR). TEE MR grade decreased from 3+ to 0+. LAvP (p < 0.001), LAmP (p = 0.007), LV end-diastolic pressure (p = 0.001), LAvP index (p < 0.001), and LAmP index (p = 0.001) decreased significantly, and LV systolic pressure(p = 0.009) significantly increased after MC therapy. In multivariate Cox regression analysis, intraprocedural increase of LAmP index, but not post-MC ≥2+ residual MR, was significantly associated with rehospitalization due to heart failure (hazard ratio: 3.377; 95% CI: 3.180 to 3.585; p = 0.007) and with New York Heart Association functional class III to IV (hazard ratio: 1.497; 95% CI: 1.006 to 2.102; p = 0.005) in the follow-up period., Conclusions: This study demonstrates the value of real-time monitoring of LA pressure during MC therapy to predict clinical outcomes. An increase in LAmP was a predictive of worse clinical outcomes at short-term follow-up, independent from echocardiographic findings., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System)., Methods: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated., Results: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients ( P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% ( P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure ( P<0.0001)., Conclusions: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling., Clinical Trial Registration: https://www.clinicaltrials.gov . Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.

Background: Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated SMR with surgery is not well established in this population, and medical management remains the preferred approach in most patients. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial was designed to determine whether transcatheter mitral valve (MV) repair with the MitraClip device is safe and effective in patients with symptomatic HF and clinically significant SMR., Study Design: The COAPT trial is a prospective, randomized, parallel-controlled, open-label multicenter study of the MitraClip device for the treatment of moderate-to-severe (3+) or severe (4+) SMR (as verified by an independent echocardiographic core laboratory) in patients with New York Heart Association class II-IVa HF despite treatment with maximally tolerated guideline-directed medical therapy (GDMT) who have been determined by the site's local heart team as not appropriate for MV surgery. A total of 614 eligible subjects were randomized in a 1:1 ratio to MV repair with the MitraClip plus GDMT versus GDMT alone. The primary effectiveness end point is recurrent HF hospitalizations through 24 months, analyzed when the last subject completes 12-month follow-up, powered to demonstrate superiority of MitraClip therapy. The primary safety end point is a composite of device-related complications at 12 months compared to a performance goal. Follow-up is ongoing, and the principal results are expected in late 2018., Conclusions: HF patients with clinically significant SMR who continue to be symptomatic despite optimal GDMT have limited treatment options and a poor prognosis. The randomized COAPT trial was designed to determine the safety and effectiveness of transcatheter MV repair with the MitraClip in symptomatic HF patients with moderate-to-severe or severe SMR., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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., (Copyright © 2018. Published by Elsevier Inc.)

Background: Survival outcome after MitraClip treatment, compared with surgical or conservative treatment, is not well defined. We examined survival after MitraClip treatment in a large multicenter real-life setting., Methods and Results: We retrospectively formed matched high-risk surgically and conservatively treated control cohorts to compare to a high-risk MitraClip cohort. One thousand thirty-six patients were included in 4 Dutch centers, of which 568 were treated with the MitraClip. The observed survival at 5-year follow-up in our MitraClip cohort was low (39.8%) but was comparable to our conservative cohort (40.5%). Observed 5-year survival for our surgical cohort was 76.3%. However, there were significant differences between the baseline characteristics of the 3 studied cohorts, with the MitraClip cohort having the highest comorbidity burden. After adjusting for baseline differences by using Cox regression, the MitraClip and surgical cohorts showed similar survival ratios (hazard ratio, 0.92; 95% confidence interval, 0.67-1.26; P =0.609), whereas both showed a lower mortality hazard when compared with conservative treatment (hazard ratio, 0.61; 95% confidence interval, 0.49-0.77; P <0.001 and hazard ratio, 0.56; 95% confidence interval, 0.42-0.76; P <0.001, respectively)., Conclusions: This matched analysis suggests a lower mortality hazard for MitraClip intervention in a high-risk population with symptomatic mitral regurgitation when compared with conservative management alone., (© 2018 American Heart Association, Inc.)

Background: Although reverse remodeling of the left atrium (LA) has been shown after MitraClip placement in degenerative mitral regurgitation (MR), changes in LA strain and strain rate have not been evaluated in these patients or compared with surgical mitral valve repair., Methods and Results: We included 87 subjects (mean age 59.7±12.3 years) with degenerative MR enrolled in the randomized EVEREST II trial (Endovascular Valve Edge-to-Edge Repair Study II). Baseline peak positive LA strain (ε) and strain rates along with longitudinal left ventricular strain (LV ε) were compared with 12-month follow-up measures. At 12 months, all 38 mitral valve repair subjects had ≤2+ MR, and 31 of the 49 MitraClip had ≤2+ MR. Baseline LA strain and strain rate values were similar in MitraClip and mitral valve repair groups. Of the strain rate measures, only peak early diastolic strain rate was consistently decreased in all treatment arms. In patients with reduced baseline LA ε, no significant change in LA ε occurred in either the MitraClip or mitral valve repair group despite significant MR and LA volume reduction. However, in patients with normal or high baseline ε, successful MR reduction by either method resulted in return of LA ε to normative values. There was a significant correlation between LA ε, LV ε values, and change in LA ε and LV ε over time., Conclusions: Changes seen in LA ε seem to depend on baseline LA and LV function. Changes in LA ε after MR reduction may reflect a decrease in LA expansion but may also be influenced by the degree of pre-existing LA dysfunction., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00209274., (© 2018 American Heart Association, Inc.)

Objectives: Differences in terms of safety and efficacy of percutaneous edge-to-edge mitral repair between patients with functional and degenerative mitral regurgitation (MR) are not well established. We performed a systematic review and meta-analysis to clarify these differences., Methods: PubMed, EMBASE, Google scholar database and international meeting abstracts were searched for all studies about MitraClip. Studies with <25 patients or where 1-year results were not delineated between MR aetiology were excluded. This study is registered with PROSPERO., Results: A total of nine studies investigating the mid-term outcome of percutaneous edge-to-edge repair in patients with functional versus degenerative MR were included in the meta-analysis (n=2615). At 1 year, there were not significant differences among groups in terms of patients with MR grade≤2 (719/1304 vs 295/504; 58% vs 54%; risk ratio (RR) 1.12; 95% CI: 0.86 to 1.47; p=0.40), while there was a significantly lower rate of mitral valve re-intervention in patients with functional MR compared with those with degenerative MR (77/1770 vs 80/818; 4% vs 10%; RR 0.60; 95% CI: 0.38 to 0.97; p=0.04). One-year mortality rate was 16% (408/2498) and similar among groups (RR 1.26; 95% CI: 0.90 to 1.77; p=0.18). Functional MR group showed significantly higher percentage of patients in New York Heart Association class III/IV (234/1480 vs 49/583; 16% vs 8%; p<0.01) and re-hospitalisation for heart failure (137/605 vs 31/220; 23% vs 14%; p=0.03). No differences were found in terms of single leaflet device attachment (25/969 vs 20/464; 3% vs 4%; p=0.81) and device embolisation (no events reported in both groups) at 1 year., Conclusions: This meta-analysis suggests that percutaneous edge-to-edge repair is likely to be an efficacious and safe option in patients with both functional and degenerative MR. Large, randomised studies are ongoing and awaited to fully assess the clinical impact of the procedure in these two different MR aetiologies., Competing Interests: Competing interests: FM has received consulting fees from Abbott Vascular, Medtronic, ValtechCardio, and St. Jude Medical; is a founder of 4Tech; and has received royalties from Edwards Lifesciences. TF has received consulting fees and research support from Abbott, Boston Scientific, Edwards and WL Gore. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: The MitraClip® system is a percutaneous treatment for mitral regurgitation (MR) that has shown promising results in patients who are inoperable or at high risk for mitral surgery. Data on the efficacy of the system over optimal medical therapy, above all in patients with functional MR, are scarce. The study aim was to assess the effect of MitraClip on the survival of patients with moderate/severe or severe MR compared to medical therapy, using meta-analytical techniques., Methods: Independently, reviewers searched electronically for relevant articles based on predefined criteria and end-points. Only articles with a comparison between MitraClip and conservative therapy were included. Standard meta-analysis techniques were used. The primary outcomes were 30-day and one-year mortalities., Results: Five observational reports were included that enrolled a total of 1,271 patients: 720 patients underwent percutaneous mitral valve repair (PMVR) with the MitraClip device, and 551 were managed conservatively. A total of 49 all-cause mortality events was reported at 30 days: 3.05% (22/720) in the PMVR arm, and 4.90% (27/510) in the conservative group, with no significant differences in all-cause mortality (OR 0.64; 95% CI 0.36-1.14). A total of 269 all-cause mortality events at one year was reported: 15.14% (109/720) in the PMVR arm, and 29.04% (160/551) in the conservative group. A significant difference favoring PMVR with the MitraClip system over medical therapy alone was observed (OR 0.44; 95% CI 0.30-0.64, p <0.0001). Neither significance between study heterogeneity (p = 0.18) nor publication bias was detected (p = 0.3)., Conclusions: PMVR with the MitraClip system may be associated with an improvement in one-year survival compared to stand-alone medical management.

MitraClip is an approved therapy for mitral regurgitation (MR); however, health care resource utilization pre- and post-MitraClip remains understudied., Methods: Patients with functional and degenerative MR at high surgical risk in the EVEREST II High-Risk Registry and REALISM Continued-Access Study were linked to Medicare data. Pre- and post-MitraClip all-cause death, stroke, myocardial infarction, heart failure (HF), and bleeding hospitalizations were identified. Inpatient costs, adjusted to 2010 US dollars, were calculated, and event rate ratios and cost ratios were estimated with multivariable modeling., Results: Among 403 linked patients, the mean age was 80 years, 60% were male, mean baseline left ventricular ejection fraction was 49.6%, 83.3% were New York Heart Association class III/IV, 78.2% were MR grade 3+/4+, and 63.3% had functional MR. All-cause hospitalization decreased from 1,854 to 1,435/1,000 person-years (P<.001). HF hospitalization decreased following MitraClip (749 vs 332/1000 person-years, P<.001), but bleeding increased (199 vs 298/1000 person-years, P<.001). Changes in stroke and myocardial infarction were not statistically significant. Overall mean Medicare costs per patient were similar pre- and post-MitraClip, although there was a significant decrease in mean costs among those that survived a full year after MitraClip ($18,131 [SD $25,130] vs $11,679 [SD $22,486], P=.02)., Conclusions: MitraClip was associated with a reduced rate of all-cause and HF hospitalizations and an increased rate of bleeding hospitalizations. One-year Medicare costs were reduced in those who survived a full year after the MitraClip procedure. Payors and providers seeking to reduce HF hospitalizations and associated Medicare costs may consider MitraClip among appropriate patients likely to survive 1 year., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, but less effective reduction in MR at 1 year., Objectives: This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery., Methods: Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up., Results: At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival., Conclusions: Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: We compared 30-day and 1-year survival among high-risk mitral regurgitation (MR) patients treated with the MitraClip (Abbott Vascular, Abbott Park, IL) with matched non-surgically treated patients from the Duke Echocardiography Laboratory Database (DELD)., Methods and Results: High-risk patients with 3+/4+ MR managed non-surgically between years 2000 and 2010 in the longitudinal DELD were matched to high-risk MitraClip patients. Patient matching was performed using the method of nearest available Mahalanobis distance metric within calipers defined by the propensity score. Kaplan-Meier estimates and stratified Cox proportional hazards models were used to compare survival at 30 days and 1 year. Among 953 high-risk DELD patients available for matching, 30-day and 1-year mortality were 6.5% and 26.2%. Close matches were obtained for 239 of the 351 MitraClip patients. The 30-day mortality in MitraClip patients was lower (4.2%) when compared with matched DELD patients (7.2%). The 1-year relative risk of mortality of the MitraClip compared with non-surgical treatment was 0.64 (95% CI 0.45-0.91; log-rank P = .013). These results in favor of the MitraClip remained significant upon further adjustment for baseline differences between groups (P = .043)., Conclusions: This matched comparison of severe MR patients at high surgical risk supports the safety of the MitraClip relative to medical therapy at 30 days and a survival benefit at 1 year., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Research and development of percutaneous therapy for mitral regurgitation (MR) began over a decade ago with concepts based on coronary sinus annuloplasty which had the potential to mimic established surgical procedures. While at the present time leaflet repair with the MitraClip has become the most frequently used device approach, several devices that accomplish direct annuloplasty have recently made important advances. Still in their early stages, three direct annuloplasty devices have been used in early human clinical experience, and other methods have been tested in preclinical models. As annuloplasty itself has been the mainstay of surgery for functional MR (FMR) for decades, the prospect of transcatheter direct annuloplasty is, by its nature, more attractive and the devices involved more closely mimic surgery. As these procedures and devices are still evolving, their future role needs to be further defined and established.

Percutaneous treatment of mitral regurgitation (MR) is a promising alternative for patients with functional MR (FMR) who are not appropriate for surgery and are not responding to optimal medical therapy and cardiac resynchronization therapy. Unlike degenerative MR, where repair therapy is clearly preferred, the optimal approach for FMR has not been defined. Challenges for novel mitral repair devices are to demonstrate safety and superior efficacy to medical management in higher risk patients. Transcatheter mitral valve replacement is emerging as a feasible therapy, but requires significant additional clinical trials to define its place in treating heart failure related to MR., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Chronic kidney disease (CKD) is strongly related to outcome in cardiovascular diseases. The relationship between treatment of mitral regurgitation (MR) and renal function is not well described. We sought to evaluate renal function before and after mitral valve repair by the MitraClip device., Methods and Results: Patients with moderate-to-severe or severe (3+ or 4+, respectively) MR by core laboratory determination who underwent transcatheter mitral valve repair with the MitraClip device in multicenter, investigational trials were included in this study. Estimated glomerular filtration rate (eGFR) was evaluated before and at hospital discharge, 30 days, 6 months, and 1 year after mitral valve repair. Eight hundred fifty-four patients with baseline mean eGFR 61.5 ± 23.1 mL/min/1.73 m(2) were studied, including 438 (51.3%) with eGFR ≥ 60 mL/min/1.73 m(2) (CKD stage 1 or 2), 371 (42.6%) with eGFR 30 to 59 mL/min/1.73 m(2) (CKD stage 3), and 52 (6.1%) with eGFR < 30 mL/min/1.73 m(2) (CKD stage 4 or 5). Baseline renal dysfunction was more prevalent in older patients with a history of heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, hypertension, and atrial fibrillation. Baseline eGFR was associated with 1-year survival (P < 0.001) after MitraClip repair. At 1-year follow-up, the mean change in eGFR for the overall cohort was -1.0 ± 15.1 mL/min/1.73 m(2); for patients with CKD stage 1 or 2, stage 3, or stage 4 or 5, mean change was -4.1 ± 16.6, +2.6 ± 12.4, and +4.8 ± 9.5 mL/min/1.73 m(2), respectively. Linear mixed effect modeling demonstrated a strong association between MR and eGFR, and a statistically significant improvement in eGFR in patients with CKD stage 4 or 5 associated with MR reduction to ≤ 2+ (P = 0.007)., Conclusions: Renal dysfunction is associated with lower survival in patients with severe MR even after percutaneous mitral valve repair. Reduction in MR severity by the MitraClip device is associated with improvement in renal function at 1 year in patients with baseline renal dysfunction., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifiers: NCT00209274, NCT01931956, NCT01940120., (© 2015 American Heart Association, Inc.)

Background: A 71-year-old woman affected by idiopathic dilated cardiomyopathy with normal coronary arteries and permanent atrial fibrillation was found to have severe mitral regurgitation at transthoracic echocardiography (TTE), due to annular dilatation and restricted motion of the posterior leaflet. Because of poor quality of life, high functional class (NYHA Class III) and the high risk of surgery, the patient agreed to undergo the implantation of a MitraClip device. During the procedure, the transoesophageal echocardiographic (TEE) images were of a poor quality since the view of the mitral valve in the mid-oesophageal and transgastric projections did not accurately show the valve leaflets and the convergence area of the regurgitation at colour Doppler, which is indispensable for the correct positioning of the clip., Investigation: Physical examination, transthoracic echocardiography, transoesophageal echocardiography., Diagnosis: Severe mitral regurgitation suitable for MitraClip implantation., Management: Transthoracic, and not transoesophageal, echocardiography approach during MitraClip procedure.

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)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To describe predictors of the number of MitraClip devices implanted during percutaneous repair of mitral regurgitation (MR), and the long-term reduction in MR., Background: In the EVEREST trials, one or two MitraClip devices were implanted to reduce MR, as needed., Methods: Preprocedural transthoracic echocardiograms (TTE) and transesophageal echocardiograms (TEE) of 233 subjects who received 1 or 2 MitraClip devices in the EVEREST II Randomized Trial and High-Risk Study were analyzed. TEEs were reviewed for etiology of MR and pathoanatomic features of the valve, valve apparatus, and the regurgitant jet. Follow-up MR was assessed by TTE postprocedure and at 12 months., Results: Ninety-seven subjects (42%) had two MitraClip devices implanted. Subjects with quantitatively more severe MR were more likely to receive two devices [mean regurgitant volume (RV) 45.9 ± 21.9 vs. 36.3 ± 18.5 mL, P <0.001]. On multivariate analysis, increased anterior leaflet thickness (OR 1.7 per mm, P = 0.007) and greater baseline RV (OR 1.21 per 10 mL, P = 0.01) were associated with increased odds of implanting two devices. The frequency of 2+ MR or less at discharge was similar regardless of the number of devices implanted. After propensity matching, patients had quantitatively similar MR at twelve-month follow-up, regardless of whether one or two MitraClip devices were implanted (P = 0.6)., Conclusions: Subjects with thicker anterior mitral leaflets and more severe MR were more likely to receive two MitraClip devices. Immediate and long-term reduction in MR was similar regardless of the number of devices implanted at the time of the procedure., (Copyright © 2012 Wiley-Liss, Inc., a Wiley company.)

Aims: With the recent developments in the field of transcatheter aortic valve replacement for aortic stenosis there has been a similar advance in the field of transcatheter mitral valve therapy for mitral regurgitation (MR). Both the anatomy of the mitral apparatus and the spectrum of pathology of MR are more complex than for aortic valve disease, and thus the development of MR therapies has been more complicated and less rapid., Methods and Results: The purpose of this review of recent literature is to provide a synopsis of the present technologies under development for percutaneous therapy for MR. Leaflet repair with MitraClip has accrued the largest human experience among the technologies that are under development, having been used to treat over 6,000 patients. MitraClip is currently being used in patients with functional MR and at high risk for conventional surgery. Coronary sinus, or indirect annuloplasty, has the next largest clinical experience, with several hundred patients treated in trials. Other MR therapy devices, including several direct annuloplasty approaches, mitral valve replacement prostheses, and chordal replacement devices, are still in the earlier phases of development., Conclusions: The early technological advances have not only enhanced our understanding of the complex interplay of different components of the mitral valve apparatus but also promise continued refinement in our present modalities of treatment and improved clinical outcomes for future patients.

Background: Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet., Methods: We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days., Results: At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline., Conclusions: Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).

The percutaneous management of valvular heart disease has recently been receiving a great deal of interest as an area of great potential. Innovative technologies are now being developed to treat mitral regurgitation. Although there are established surgical techniques for treating organic mitral regurgitation, the surgical management of functional mitral regurgitation remains controversial, and such patients have a poor prognosis. Therefore, a percutaneous treatment for functional mitral regurgitation holds great clinical potential. Having a nonsurgical approach available may be attractive to patients with organic mitral valve regurgitation as well. Several approaches and devices have been designed to treat specifically functional mitral regurgitation, and some of these have been applied to humans in early-stage evaluations. The MitraClip device (Abbott Laboratories, Abbott Park, IL) has been used to treat both functional and degenerative mitral valve regurgitation and has been compared to surgery in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) randomized trial. Although the field of percutaneous management of mitral regurgitation is at an early stage, it has been demonstrated that percutaneous approaches can reduce mitral regurgitation, suggesting there is a great deal of potential for clinical benefit to patients with mitral regurgitation.

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., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California)., Background: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets., Methods: Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory., Results: A total of 107 patients were treated. Ten (9%) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of < or =1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9%, 94.0%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability., Conclusions: Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339. EVEREST II; NCT00209274).

Background: Functional mitral regurgitation (FMR), a well-recognized component of left ventricular remodeling, is associated with increased morbidity and mortality in heart failure patients. Percutaneous mitral annuloplasty has the potential to serve as a therapeutic adjunct to standard medical care., Methods and Results: Patients with dilated cardiomyopathy, moderate to severe FMR, an ejection fraction <40%, and a 6-minute walk distance between 150 and 450 m were enrolled in the CARILLON Mitral Annuloplasty Device European Union Study (AMADEUS). Percutaneous mitral annuloplasty was achieved through the coronary sinus with the CARILLON Mitral Contour System. Echocardiographic FMR grade, exercise tolerance, New York Heart Association class, and quality of life were assessed at baseline and 1 and 6 months. Of the 48 patients enrolled in the trial, 30 received the CARILLON device. Eighteen patients did not receive a device because of access issues, insufficient acute FMR reduction, or coronary artery compromise. The major adverse event rate was 13% at 30 days. At 6 months, the degree of FMR reduction among 5 different quantitative echocardiographic measures ranged from 22% to 32%. Six-minute walk distance improved from 307+/-87 m at baseline to 403+/-137 m at 6 months (P<0.001). Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved from 47+/-16 points at baseline to 69+/-15 points at 6 months (P<0.001)., Conclusions: Percutaneous reduction in FMR with a novel coronary sinus-based mitral annuloplasty device is feasible in patients with heart failure, is associated with a low rate of major adverse events, and is associated with improvement in quality of life and exercise tolerance.

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.

Objectives: This study sought to evaluate the clinical results of a percutaneous approach to mitral valve repair for mitral regurgitation (MR)., Background: A surgical technique approximating the middle scallops of the mitral leaflets to create a double orifice with improved leaflet coaptation was introduced in the early 1990s. Recently, a percutaneous method to create the same type of repair was developed. A trans-septal approach was used to deliver a clip device that grasps the mitral leaflet edges to create the double orifice., Methods: General anesthesia, fluoroscopy, and echocardiographic guidance are used. A 24-F guide is positioned in the left atrium. The clip is centered over the mitral orifice, passed into the left ventricle, and pulled back to grasp the mitral leaflets. After verification that MR is reduced, the clip is released., Results: Twenty-seven patients had six-month follow-up. Clips were implanted in 24 patients. There were no procedural complications and four 30-day major adverse events: partial clip detachment in three patients, who underwent elective valve surgery, and one patient with post-procedure stroke that resolved at one month. Three additional patients had surgery for unresolved MR, leaving 18 patients free from surgery. In 13 of 14 patients with reduction of MR to < or =2+ after one month, the reduction was maintained at six months., Conclusions: Percutaneous edge-to-edge mitral valve repair can be performed safely and a reduction in MR can be achieved in a significant proportion of patients to six months. Patients who required subsequent surgery had elective mitral valve repair or intended replacement.

Background--Although reverse remodeling of the left atrium (LA) has been shown after MitraClip placement in degenerative mitral regurgitation (MR), changes in LA strain and strain rate have not been evaluated in these patients or compared with surgical mitral valve repair. Methods and Results--We included 87 subjects (mean age 59.7±12.3 years) with degenerative MR enrolled in the randomized EVEREST II trial (Endovascular Valve Edge-to-Edge Repair Study II). Baseline peak positive LA strain (ε) and strain rates along with longitudinal left ventricular strain (LV ε) were compared with 12-month follow-up measures. At 12 months, all 38 mitral valve repair subjects had ≤2+ MR, and 31 of the 49 MitraClip had ≤2+ MR. Baseline LA strain and strain rate values were similar in MitraClip and mitral valve repair groups. Of the strain rate measures, only peak early diastolic strain rate was consistently decreased in all treatment arms. In patients with reduced baseline LA ε, no significant change in LA ε occurred in either the MitraClip or mitral valve repair group despite significant MR and LA volume reduction. However, in patients with normal or high baseline ε, successful MR reduction by either method resulted in return of LA ε to normative values. There was a significant correlation between LA ε, LV ε values, and change in LA ε and LV ε over time. Conclusions--Changes seen in LA ε seem to depend on baseline LA and LV function. Changes in LA ε after MR reduction may reflect a decrease in LA expansion but may also be influenced by the degree of pre-existing LA dysfunction. Clinical Trial Registration--URL: https://www.clinicaltrials.gov. Unique identifier: NCT00209274. [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]

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: Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system.Methods: In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions.Findings: Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II.Interpretation: This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes.Funding: None. [ABSTRACT FROM AUTHOR]

Background-The effect of preoperative mitral regurgitation (MR) on clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. This study sought to examine the impact of moderate and severe MR on outcomes after TAVR and surgical aortic valve replacement (SAVR). Methods and Results-Data were drawn from the randomized Placement of Aortic Transcatheter Valve (PARTNER) Trial cohort A patients with severe, symptomatic aortic stenosis undergoing either TAVR (n=33 1) or SAVR (n=299). Both TAVR and SAVR patients were dichotomized according to the degree of preoperative MR (moderate/severe versus none/mild). At baseline, moderate or severe MR was reported in 65 TAVR patients (19.6%) and 63 SAVR patients (21.2%). At 30 days, among survivors who had isolated SAVR/TAVR, moderate/severe MR had improved in 25 SAVR patients (69.4%) and 30 TAVR patients (57.7%), was unchanged in 10 SAVR patients (27.8%) and 19 TAVR patients (36.5%), and worsened in 1 SAVR patient (2.8%) and 4 TAVR patients (5.8%; all P=NS). Mortality at 2 years was higher in SAVR patients with moderate or severe MR than in those with mild or less MR (49.8% versus 28.1%; adjusted hazard ratio, 1.73; 95% confidence interval, 1.01-2.96; P=0.04). In contrast, MR severity at baseline did not affect mortality in TAVR patients (37.0% versus 32.7%, moderate/severe versus none/mild; hazard ratio, 1.14; 95% confidence interval, 0.72-1.78; P=0.58; P for interaction=0.05). Conclusions-Both TAVR and SAVR were associated with a significant early improvement in MR in survivors. However, moderate or severe MR at baseline was associated with increased 2-year mortality after SAVR but not after TAVR. TAVR may be a reasonable option in selected patients with combined aortic and mitral valve disease. [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]