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Background: Reducing mitral regurgitation (MR) during mitral transcatheter edge-to-edge repair (M-TEER) may come at the cost of increased mitral valve gradient (MVG). The combined impact of residual MR and MVG on clinical outcomes after M-TEER is unknown., Objectives: This study sought to evaluate the impact of postprocedure MR and MVG on clinical outcomes after M-TEER., Methods: EXPANDed is a pooled, patient-level cohort of the EXPAND (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) and EXPAND G4 studies, which were designed to evaluate real-world safety and effectiveness of the third- and fourth-generation MitraClip TEER Systems. Subjects were categorized by echocardiographic core laboratory (ECL) assessments into 4 groups according to 30-day MR grade and mean MVG: 1) MR ≤1+/MVG <5 mm Hg; 2) MR ≤1+/MVG ≥5 mm Hg; 3) MR ≥2+/MVG <5 mm Hg; and 4) MR ≥2+/MVG ≥5 mm Hg., Results: A total of 1,723 subjects had evaluable echocardiograms at 30 days: 72% had MR ≤1+/MVG <5 mm Hg, 18% had MR ≤1+/MVG ≥5 mm Hg, 7% had MR ≥2+/MVG <5 mm Hg, and 3% had MR ≥2+/MVG ≥5 mm Hg. MR≤1+ was sustained through 1 year in 93% of patients who achieved 30-day MR≤1+. MVG decreased from 30 days to 1 year in subjects with MVG ≥5 mm Hg (6.7 ± 4.0 to 5.5 ± 2.5 mm Hg MR ≤1+/MVG ≥5 mm Hg and 6.5 ± 1.5 to 5.5 ± 1.7 mm Hg MR ≥2+/MVG ≥5 mm Hg). One-year rates of all-cause mortality and heart failure hospitalization were lower for subjects who achieved MR ≤1+ at 30 days, regardless of MVG., Conclusions: Reduction of MR to mild or less after M-TEER with the latest-generation MitraClip systems was associated with clinical benefit regardless of MVG., Competing Interests: Funding Support and Author Disclosures The EXPAND (NCT03502811) and EXPAND G4 (NCT04177394) studies were funded and sponsored by Abbott. Dr Singh has received consulting fees and honoraria from Abbott. Dr Price has received consulting fees and honoraria from Abbott, Boston Scientific, InnovHeart, Medtronic, Philips Medical, W.L. Gore & Associates, and Shockwave Medical. Dr Shuvy has served as a clinical proctor for Abbott. Dr Rogers has received consulting fees from Abbott, Biosense Webster, and Boston Scientific. Dr Bedogni is a consultant and proctor for Abbott, Medtronic, BSCI, and Meril. Dr Asch's work as an academic core laboratory director is performed through institutional research grants (MedStar Health) with Abbott, Boston Scientific, Medtronic Edwards Lifesciences, Neovasc, Ancora Heart, LivaNova, MVRx, InnovHeart, Polares Medical, and Aria CV. Dr Dong and Peterman are employees of Abbott. Dr Rodriguez has received grants and support for research from Abbott, Edwards Lifesciences, Boston Scientific, AtriCure, and CardioMech; and received honoraria or consulting fees from Abbott, Edwards Lifesciences, Philips, Teleflex, and CardioMech. Dr Kar is a consultant to Abbott, Boston Scientific, Medtronic, Peija Medical, and V-Wave, and has received research grants from Abbott, Boston Scientific, Medtronic, V-Wave, HighLife, Pi-Cardia, Laminar, and Cardiomech. Dr von Bardeleben has performed non-paid trial activities for Abbott, Edwards Lifesciences, Medtronic, and the University of Göttingen (IIT); and served on the advisory board or Speakers Bureau for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, and NeoChord. Dr Maisano has received grants and/or institutional research support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received honoraria and consulting fees (personal and institutional) from Abbott, Medtronic, Edwards Lifesciences, Xeltis, and CardioValve; has received royalty income and intellectual property rights from Edwards Lifesciences, and is a shareholder (including stock options) of CardioGard, Magenta, SwissVortex, Transseptal Solutions, Occlufit, 4Tech, and Perifect. All other authors authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The COAPT Trial was the first ever to demonstrate a survival benefit in treating functional mitral regurgitation (FMR). That was achieved through transcatheter mitral repair in selected patients. The exact proportion of patients fulfilling COAPT selection criteria in the real-world is unknown., Aims: To assess the applicability of COAPT criteria in real world and its impact on patients' survival., Methods: We assessed the clinical data and follow-up results of all consecutive patients admitted for FMR at our Department between January 2016 and May 2021 according to COAPT eligibility. COAPT eligibility was retrospectively assessed by a cardiac surgeon and a cardiologist., Results: Among 394 patients, 56 (14%) were COAPT eligible. The most frequent reasons for exclusion were MR ≤ 2 (22%), LVEF < 20% or >50% (19%), and non-optimized GDMT (21.3%). Among Non-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% confidence interval [CI: 0.864, 0.96] vs. 71.8% [CI: 0.509, 0.926], respectively, p = 0.027)., Conclusions: Only a minority (14%) of real-world patients with FMR referred to a tertiary hospital fulfilled the COAPT selection criteria. Among Non-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% [0.864, 0.96] vs. 71.8% [0.509, 0.926], respectively, p = 0.027)., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Following the introduction in the latest European and American guidelines, transcatheter edge-to-edge repair has become a valid alternative to surgery for ineligible patients. Among the available technologies, MitraClip (Abbott) was the first to be introduced for the percutaneous treatment of mitral regurgitation with the edge-to-edge technique. Although its safety and effectiveness has been widely demonstrated, the optimal procedural results are highly dependent from operators' experience. In this manuscript, we provide a full guide of advanced steering maneuvers of MitraClip in different scenarios of transseptal puncture., (© 2024 Wiley Periodicals LLC.)

The mitral valve (MV) plays an important role in the pathophysiology of hypertrophic obstructive cardiomyopathy (HOCM). Dynamic left ventricular outflow tract (LVOT) obstruction, caused by systolic anterior motion (SAM), is a common occurrence in most patients with hypertrophic cardiomyopathy and is directly associated with the MV apparatus. First line therapy for HOCM patients is pharmacological, and surgical intervention is often indicated for patients who do not respond to medical therapy. Emerging research on mitral disease in HOCM, specifically mitral regurgitation (MR), demonstrates that these patients frequently do not respond to standard therapeutic options, and can benefit from MV interventions. In this review, we describe the involvement of the MV in the pathogenesis of HOCM, discuss medical therapy, and explore available mitral procedures. Surgical myectomy, often combined with various modifications to the MV apparatus, is frequently necessary to achieve a durable resolution of LVOT obstruction and SAM-related MR. Alcohol septal ablation, an alternative to surgical myectomy, will be briefly mentioned. We also emphasize the role of transcatheter edge-to-edge repair (TEER) as a promising and novel therapeutic option for HOCM patients. Over time, TEER has established itself as an effective and safe procedure, demonstrating success across a spectrum of anatomical variations. The leaflet modification and movement restriction achieved through TEER help reduce SAM and, consequently, have the potential to alleviate LVOT obstruction and SAM-related MR. Furthermore, we propose a treatment algorithm for cases where TEER is a potential course of action for patients who are at high risk for other interventions., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Transcatheter mitral edge-to-edge repair (TEER) is an established procedure for managing mitral regurgitation (MR) in high-risk patients. It is effective in treating both primary and secondary MR, as reported in the surgical and interventional literature. Over time, TEER has gained popularity and achieved procedural success in various anatomies. The less invasive nature of TEER, along with its high safety profile and immediate haemodynamic improvement suggest potential benefits in high-risk populations who are not normally included in major trials. These patients, often deemed unsuitable for surgical intervention, are typically managed conservatively, despite accumulating evidence suggesting the potential of clinical improvement by reducing MR through TEER. Examples include post-myocardial infarction MR, patients with hypertrophic obstructive cardiomyopathy and patients experiencing recurrent MR after surgical intervention. This review discusses the utilisation of TEER beyond recognised indications, examining outcomes and limitations in diverse patient populations. Further studies are warranted to evaluate the benefits of TEER in clinical scenarios beyond the current indications.

Background: COAPT-trial entry criteria are useful to identify patients with better outcomes after transcatheter edge-to-edge repair (TEER). However, up to one-half of real-world patients with secondary mitral regurgitation (SMR) undergoing TEER do not meet these highly selective criteria and no study has formally investigated them. The aim of this study was to evaluate the predictors of good outcome after TEER in COAPT-ineligible patients., Methods: All consecutive patients with SMR and heart failure (HF) treated with MitraClip at 3 European centres were retrospectively screened. The presence of at least 1 COAPT exclusion criterion was used to define a COAPT-ineligible profile, allowing the inclusion in the study population. Freedom from all-cause death or HF hospitalisation was evaluated at 2-year follow-up (primary end point)., Results: A total of 305 patients (47%) had a COAPT-ineligible profile. An overall 58% rate of all-cause death or HF hospitalisation was detected at 2 years. Patients with a single COAPT exclusion criterion experienced fewer adverse events than those with multiple criteria (55% vs 69%). At multivariable Cox regression analysis, New York Heart Association functional class II, younger age (< 75 years), lower serum creatinine (< 2 mg/dL), lower left ventricular end-diastolic volume (< 240 mL), and the absence of hemodynamic instability, atrial fibrillation, and chronic obstructive pulmonary disease were independently associated with good outcome., Conclusions: In this real-world series of patients with SMR undergoing TEER, a COAPT-ineligible profile was common. The presence of only 1 COAPT exclusion criterion or the absence of hemodynamic instability were associated with the most favourable outcomes., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Optimal transseptal puncture (TSP) position on the interatrial septum as well as proper catheter direction and maneuverability in the left atrium (LA) are key elements for successful mitral valve (MV) interventions. TSP is usually performed from the right femoral vein being more comfortable for the operator and easier to reach the fossa ovalis. In the cases reported, TSP was performed from left femoral vein (LFV) to improve delivery system maneuverability and trajectory inside the LA in the context of MV repair with MitraClip. According to this early experience, LFV approach might be considered as first choice or as an alternative solution in patients in whom a higher position of the delivery system relative to the mitral annulus is needed., (© 2021 Wiley Periodicals LLC.)

The field of transcatheter mitral valve repair (TMVr) for mitral regurgitation (MR) is rapidly evolving. Besides the well-established transcatheter mitral edge-to-edge repair approach, there is also growing evidence for therapeutic strategies targeting the mitral annulus and mitral valve chordae. A patient-tailored approach, careful patient selection and an experienced interventional team is crucial in order to optimise procedural and clinical outcomes. With further data from ongoing clinical trials to be expected, consensus in the Heart Team is needed to address these complexities and determine the most appropriate TMVr therapy, either single or combined, for patients with severe MR., Competing Interests: Competing interests: ODB received institutional research grants and consulting fees from Abbott and Boston Scientific. MT is a consultant for Abbott Vascular, Boston Scientific and 4tech; received personal fees from Edwards Lifesciences, Mitraltech, CoreMedic and Swissvortex; and is a shareholder of 4Tech. FM obtained grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, Terumo, Consulting fees, Honoraria personal and institutional from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Occlufit; has Royalty Income/IP Rights Edwards Lifesciences; and is shareholder (including share options) of Cardiogard, Magenta, SwissVortex, Transseptal solutions, Occlufit, 4Tech, Perifect. LS received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic and Edwards Lifesciences. All other coauthors have no conflict of interest to disclose concerning this manuscript., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR., Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate., Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR ( P <0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients ( P =0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P <0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P =0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P =0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P =0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P <0.001) were both independently associated with repeat mitral valve replacement., Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Background: Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition., Methods: We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34)., Results: Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement., Conclusions: MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF., (Copyright © 2020 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

The segmentation of the mitral valve annulus and leaflets specifies a crucial first step to establish a machine learning pipeline that can support physicians in performing multiple tasks, e.g. diagnosis of mitral valve diseases, surgical planning, and intraoperative procedures. Current methods for mitral valve segmentation on 2D echocardiography videos require extensive interaction with annotators and perform poorly on low-quality and noisy videos. We propose an automated and unsupervised method for the mitral valve segmentation based on a low dimensional embedding of the echocardiography videos using neural network collaborative filtering. The method is evaluated in a collection of echocardiography videos of patients with a variety of mitral valve diseases, and additionally on an independent test cohort. It outperforms state-of-the-art unsupervised and supervised methods on low-quality videos or in the case of sparse annotation., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Transcatheter edge-to-edge mitral valve repair is a viable alternative to surgery in patients with severe mitral regurgitation and high surgical risk. Yet the specific group of patients who would optimally benefit from this therapy remains to be determined. Selection of patients for transcatheter strategy is currently based on surgical prognostic scores and technical feasibility. Meanwhile, various clinical, anatomic, and procedural factors have been recently recognized as predictors of adverse outcomes following transcatheter edge-to-edge mitral valve repair, including device failure, recurrent mitral regurgitation, and mortality. Integration of these prognostic factors in the decision-making process of the heart team might improve patient management and outcomes. Herein, the authors review the different factors related to symptomatic status, comorbidity, serum biomarkers, echocardiographic findings, and procedural technique that have been identified as independent predictors of adverse outcome following transcatheter edge-to-edge mitral valve repair and discuss their potential application in everyday clinical practice., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The Swiss national registry on percutaneous mitral valve interventions (MitraSwiss) was established in 2011 to monitor safety/efficacy of percutaneous mitral valve repair (PMVR) with the MitraClip device. The aim of this analysis was to report the outcome after PMVR in a real-world, all-comers population and its predictors after inclusion of more than 1,200 patients, stratifying the results according to mitral regurgitation (MR) aetiology. Here we report the in-hospital, short and midterm outcomes of all patients prospectively enrolled., Methods and Results: Since 2011, MitraSwiss has enrolled 1,212 patients with moderate and severe MR of functional (FMR) or degenerative (DMR) aetiology treated with PMVR in 10 centres. Pre-specified endpoints included clinical, echocardiographic and functional parameters with follow-up planned up to five years. Outcomes are compared according to MR aetiology. Acute procedural success was achieved in 91.5% of cases, with no differences between FMR and DMR and sustained good midterm results. NYHA class and pulmonary pressure improved significantly in both cohorts. Cumulative probability of death at five years was 54% (95% CI: 45-63) in FMR and 45% (95% CI: 37-54) in DMR (HR 1.15, p=0.009). Age, anaemia, impaired renal function and reduced left ventricular ejection fraction resulted in being independent predictors of death at five years., Conclusions: In a large contemporary cohort of non-surgical patients with severe MR, the safety and effectiveness of PMVR have been confirmed. At midterm follow-up, mortality and MACE were lower in DMR patients, though MR aetiology was not directly and independently associated with outcome.

Objectives: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear., Background: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis., Methods: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed., Results: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm 2 vs. 0.6 ± 0.3 cm 2 ; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30)., Conclusions: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Objectives: The aim of this study was to retrospectively compare the characteristics, procedural courses, and outcomes of patients presenting with concomitant mitral regurgitation (MR) and tricuspid regurgitation (TR) in the TriValve (Transcatheter Tricuspid Valve Therapies) and TRAMI (Transcatheter Mitral Valve Interventions) registries., Background: Transcatheter mitral edge-to-edge valve repair (TMVR) has been shown to be successful in patients with severe MR. Lately, edge-to-edge repair has also emerged as a possible treatment for severe TR in patients at high risk for cardiac surgery. In patients with both severe MR and TR, the yield of concomitant transcatheter mitral and tricuspid valve repair (TMTVR) for patients at high surgical risk is unknown., Methods: The characteristics, procedural data, and 1-year outcomes of all patients in the international multicenter TriValve registry and the German multicenter TRAMI registry, who presented with both severe MR and TR, were retrospectively compared. Patients in TRAMI (n = 106) underwent isolated TMVR, while those in TriValve (n = 122) additionally underwent concurrent TMTVR in compassionate and/or off-label use., Results: All 228 patients (mean age 77 ± 8 years, 44.3% women) presented with significant dyspnea at baseline (New York Heart Association functional class III or IV in 93.9%), without any differences in the rates of pulmonary hypertension and chronic pulmonary disease. The proportion of patients with left ventricular ejection fraction <30% was higher in the TMVR group (34.9% vs. 18.0%; p < 0.001), while patients in the TMTVR group had lower glomerular filtration rates. At discharge, MR was comparably reduced in both groups. At 1 year, overall all-cause mortality was 34.0% in the TMVR group and 16.4% in the TMTVR group (p = 0.035, Cox regression). On multivariate analysis, TMTVR was associated with a 2-fold lower mortality rate (hazard ratio: 0.52; p = 0.02). The rate of patients in New York Heart Association functional class ≤II at 1 year did not differ (69.4% vs. 67.0%; p = 0.54)., Conclusions: Concurrent TMTVR was associated with a higher 1-year survival rate compared with isolated TMVR in patients with both MR and TR. Further randomized trials are needed to confirm these results., (Copyright © 2020. Published by Elsevier Inc.)

Transcatheter atrial septal defect (ASD) device closure has gained increasing popularity over the past decades due to shorter hospital stay and the absence of skin scars. However, concern about the seriousness of device-related complications is accumulating. We report a case of device fracture in a young asymptomatic woman almost 4 years after percutaneous secundum ASD closure, resulting in mitral valve perforation. Subsequently, elective surgical removal of the device and mitral valve reconstruction was performed. This case demonstrates that complications from transcatheter ASD closure may even occur late after implantation., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]., Methods and Results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]., Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

Aims: The Cardioband™ (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of consecutive patients who underwent the Cardioband procedure between 2013 and 2016., Methods and Results: Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guideline-recommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year [but worsened by at least one grade in 11 patients (22%)]. Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (-19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01)., Conclusion: In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.

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.)

Objectives: The aim of this study was to evaluate the predictors of left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR)., Background: LVOT obstruction is a major concern with TMVR, but limited data exist regarding its predictors and impact on outcomes., Methods: Patients with pre-procedural multidetector row computed tomography (MDCT) undergoing TMVR for failed mitral bioprosthetic valves (valve-in-valve), annuloplasty rings (valve-in-ring), and mitral annular calcification (valve-in-MAC) were included in this study. Echocardiographic and procedural characteristics were recorded, and comprehensive assessment with MDCT was performed to identify the predictors of LVOT obstruction (defined as an increment of mean LVOT gradient ≥10 mm Hg from baseline). The new LVOT (neo-LVOT) area left after TMVR was estimated by embedding a virtual valve into the mitral annulus on MDCT, simulating the procedure., Results: Among 194 patients with pre-procedural MDCT undergoing TMVR (valve-in-valve, 107 patients; valve-in-ring, 50 patients; valve-in-MAC, 37 patients), LVOT obstruction was observed in 26 patients (13.4%), with a higher rate after valve-in-MAC than valve-in-ring and valve-in-valve (54.1% vs. 8.0% vs. 1.9%; p < 0.001). Patients with LVOT obstruction had significantly higher procedural mortality compared with those without LVOT obstruction (34.6% vs. 2.4%; p < 0.001). Receiver-operating characteristic curve analysis showed that an estimated neo-LVOT area ≤1.7 cm 2 predicted LVOT obstruction with sensitivity of 96.2% and specificity of 92.3%., Conclusions: LVOT obstruction after TMVR was associated with higher procedural mortality. A small estimated neo-LVOT area was significantly associated with LVOT obstruction after TMVR and may help identify patients at high risk for LVOT obstruction., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Moving transcatheter valve intervention towards atrioventricular (AV) valves implies increasing complexity. Some of the knowledge that has been generated during the development of mitral devices can be applied to the tricuspid valve (TV). A deep understanding of the peculiar anatomy of the TV and of the right heart chambers, with differences and similarities between the two AV valves, is fundamental to overcoming the specific challenges related to transcatheter TV therapies. The aim of this report is to explore similarities and differences between the mitral and tricuspid valve apparatus, and their interventional implications.

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.)

Mitral regurgitation (MR) is the one of the most frequent valvular heart diseases in the developed world, often requiring surgical correction. Degenerative MR is the most common type of non-ischemic, organic MR in the western world. Since no medical treatment has been shown to be effective in preventing the consequences of volume overload in asymptomatic degenerative MR, risk stratification is essential. Currently, this is achieved using clinical and precisely quantified echocardiographic parameters, with newer technologies like cardiac magnetic resonance gaining increasing prominence. While surgical mitral repair, often performed using minimally invasive/robotic techniques, is the current gold-standard for definitive therapeutic management, there is rapid emergence of percutaneous techniques for mitral valve repair/replacement in cases of degenerative MR. This state-of-the-art-review will discuss the latest knowledge in the natural history, imaging, surgical and percutaneous therapies in patients with degenerative MR., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Severe mitral regurgitation (MR) confers an adverse prognosis, frequently with debilitating symptoms of heart failure. While open surgical correction has been the standard of care for decades, novel catheter-based technologies have emerged that are highly effective in the treatment of MR. These percutaneous technologies, which include methods for both repair as well as valve replacement, have the potential to address unmet clinical needs in patients with MR, and serve as a viable alternative to surgery., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair., Objectives: This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR])., Methods: From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria., Results: A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005)., Conclusions: The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

We aimed to investigate the safety and medium-term durability of an adjustable mitral annuloplasty ring in patients undergoing surgery for mitral valve regurgitation. Forty-five patients requiring mitral valve repair were enrolled into this prospective, multicentre study between May 2012 and May 2013 in six hospitals in Europe and Israel. Study endpoints evaluated the performance and safety of the device assessed using inter-individual comparisons. Implantation was performed through a sternotomy in ten patients and mini-thoracotomy in 35 patients. The ring was adjusted after declamping and weaning from cardio-pulmonary bypass under echocardiographic guidance if the coaptation surface was not optimal, or in cases of residual mitral regurgitation. Follow-up was performed up to 2 years post-procedure. Mean age was 61 ± 12 years. Ring adjustment was performed in 71% of patients to optimise the results of mitral valve repair. Following the procedure, 11/45 patients (24%) who had had mild residual mitral regurgitation had no mitral regurgitation following ring adjustment. Two patients with severe mitral regurgitation post-procedure had mild regurgitation following ring adjustment. Coaptation length increased significantly after adjustment. One patient died before hospital discharge due to complications unrelated to the adjustable ring. One patient had to undergo re-operation at 39 days post-procedure due to endocarditis. At 2 years of follow-up, 78% of patients had no residual mitral regurgitation and 22% had mild residual mitral regurgitation. Adjustable mitral annuloplasty ring implantation was safe in all patients. Mitral valve repair with the adjustable ring was durable in all patients who reached 2 years follow-up., Clinical Trial Registration: NCT01617720.

Introduction: Mitral regurgitation (MR) is one of the major valvular disease. Although surgical mitral valve (MV) repair is the standard of care for patients with severe MR, an unmet need exists in the management of patients with severe symptomatic MR and high surgical risk. Transcatheter MV therapies are alternative treatment option in such patients with moderate to severe and symptomatic MR. Areas covered: Literatures to direct the reader to important further reading were searched with relevant websites; www.ncbi.nlm.nih.gov/pubmed using search word 'transcatheter mitral intervention'. Expert commentary: A variety of transcatheter techniques have emerged for the percutaneous treatment of MR. We should carefully select one or combination procedure for each patient as an ideal tailor-made transcatheter MV therapy in order to improve the outcomes.

Aims: Transcatheter mitral valve replacement (TMVR) provides definitive valve replacement through a minimally invasive procedure. In the setting of TMVR, it remains unclear how relevant the differences between different mitral annular (MA) diameters are. We sought to define a simplified and reproducible method to describe the MA size., Methods and Results: Using cardiac computed tomography angiography (CTA) studies of 47 patients, 3D MA perimeter (P3D) was annotated. The aorto-mitral continuity was excluded from MA contour either by manual annotation (yielding a saddle-shape model) or by simple truncation at the medial and lateral trigones (yielding a D-shape model). The method of the least squares was used to generate the projected MA area (Aproj) and perimeter (Pproj). Intercommissural (IC) and septolateral (SL) diameters, Dmean = (IC diameter + SL diameter)/2, area-derived diameter (DArea = 2 x √(A/π)) and perimeter-derived diameter (DPerimeter = P/π) were measured. MA eccentricity, height, and calcification (MAC) were assessed. Thirty studies were re-read by the same and by another observer to test intra- and inter-observer reproducibility. Patients (age, 75 ± 12 years, 66% males) had a wide range of mitral regurgitation severity (none-trace in 8%, mild in 55%, moderate-severe in 37%), MA size (area: 5-16 cm2), eccentricity (-8-52%), and height (3-11 mm). MAC was seen in 11 cases, in whom MAC arc occupied 26 ± 20% of the MA circumference. DArea (36.0 ± 4.0 mm) and DPerimeter (37.1 ± 3.8 mm) correlated strongly (R2 = 0.97) and were not significantly different (P = 0.15). The IC (39.3 ± 4.6 mm) and the SL (31.4 ± 4.5 mm) diameters were significantly different from DArea (P < 0.001) while Dmean (35.4 ± 4.0 mm) was not (P = 0.5). The correlation of DArea was stronger with Dmean (R2 = 0.96) than with IC and SL diameters (R2 = 0.69 and 0.76, respectively). The average difference between DArea and Dmean was +0.6 mm and the 95% limits of agreement were 2.1 and -0.9 mm. Similar results were found when the D-shape model was applied. All MA diameters showed good reproducibility with high intraclass correlation coefficient (0.93-0.98), small average bias (0.37-1.1 mm), and low coefficient of variation (3-7%) for intra- and inter-observer comparisons. Reproducibility of DArea was lower in patients with MAC., Conclusion: MA sizing by CTA is readily feasible and reproducible. Dmean is a simple index that can be used to infer the effective MA size., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Objectives: Transapical valve implantation is traditionally performed through a left antero-lateral mini-thoracotomy. A self-expandable apical closure device has recently been developed for full-percutaneous transapical valve implantation. We performed haemodynamics stress-tests on an animal model to evaluate the sealing properties., Methods: Under general anaesthesia 5 pigs (mean weight: 67 ± 6 Kg) received full heparinization (100 IU/Kg; activated clotting time >250 s and, through inferior mini-sternotomies, 21-Fr introducer sheaths for transapical aortic valve implantation (outer diameter: 25-Fr) were placed over-the-wire in the apexes. Delivery-catheters carrying folded occluders (SAFEX TM final design) were inserted in the introducer sheaths and plugs were then deployed under fluoroscopic guidance. Phase 1: after protamine injection, apical bleeding was monitored for 1 h with standard haemodynamics condition. Phase 2: we induced systemic hypertension with adrenaline infusion to test the sealing properties under stress. Animals were sacrificed after Phase 2 and hearts were removed and inspected., Results: Five plugs were successfully introduced and deployed in 5 pig hearts. Plugs provided good apical sealing in each animal and a mean of 7 ± 4 ml of blood lost per animal was collected during Phase 1: haemodynamics remained stable and no plug dislodgement was detected (mean blood pressure: 52 ± 9 mmHg). During Phase 2, mean systolic and diastolic peak levels reached 268 ± 24 mmHg and 175 ± 17 mmHg, respectively, without plug dislodgment or bleeding. Post-mortem inspection showed good plug deployment and fixation without myocardial damage., Conclusions: The new apical occluder seals large-sized apical access sites in animal models also during induced systemic hypertension. This pilot study is a further step towards full-percutaneous transapical valve procedures in the clinical setting., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Introduction: Functional mitral regurgitation is a debilitating condition, related to worsening of functional capacity and heart failure symptomatology. Cardioband (Valtech Cardio, Or Yehuda, Israel) is a novel technology designed for transcatheter repair of the mitral valve in the treatment of functional MR. Areas covered: A brief summary to direct the reader to important further reading, relevant websites; www.valtechcardio.com . An article about this device, relevant websites; www.ncbi.nlm.nih.gov/pubmed using search word 'Cardioband'. Expert commentary: This device has been designed to be completely implantable percutaneously in a closed beating heart fashion. The adjustability features under the beating heart and guided by echocardiography allow to provide a tailored therapy to each particular mitral valve and regurgitation condition.

Aims: The aim of the study was to report preclinical safety and feasibility of a new transcatheter direct mitral annuloplasty intervention in an acute animal model., Methods and Results: Twenty healthy pigs underwent Cardioband (Valtech Cardio, Or Yehuda, Israel) transcatheter implantation under intracardiac echocardiographic and fluoroscopic guidance. Through a neo inferior vena cava approach, transseptal access was arranged. The device was delivered into the left atrium using a multi-steerable catheter and fixed to the mitral annulus with multiple helix anchors. Following device cinching, reduction of annular size was evaluated. In all animals the device could be successfully implanted and displayed 100% function, with the average procedure duration and fluoroscopy times being 78±23 minutes and 27±9 minutes, respectively. In total, 246 anchors (average 12.3 per device) were delivered and optimal anchor placement was achieved in 95.1%, while inadequate anchor position (4%) and injury of the coronary sinus or atrium (0.8%) occurred in the rest. Following maximal cinching, diastolic transmitral flow velocity and coaptation lengths were markedly increased (p<0.001), whereas septolateral and intercommissural distances were significantly decreased (p<0.001), when compared to pre-contraction baseline, demonstrating efficient annular reduction by the device., Conclusions: Transcatheter direct annuloplasty with a surgical-like adjustable device is feasible in the porcine animal model. The humanised porcine model has been instrumental in demonstrating feasibility and in establishing the procedural steps.

Objectives: This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment., Background: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device., Methods: Thirty-one patients (71.8 ± 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 ± 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 ± 11%) were prospectively enrolled., Results: Procedural success rate, defined as delivery of the entire device, was 100%. There were no periprocedural deaths (0%), and mortality rate at 1 month or prior to hospital discharge and at 7 months was 5% and 9.7% respectively. Cinching of the implanted Cardioband reduced the annular septolateral dimension by >30% from 3.7 ± 0.5 cm at baseline to 2.5 ± 0.4 cm after 1 month and to 2.4 ± 0.4 cm after 6 months, respectively (p < 0.001). Percentage of patients with FMR ≥3 was reduced from 77.4% to 10.7% 1 month after the procedure (p < 0.001) and 13.6% (p < 0.001) at 7 months. Percentage of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2% after 7 months (p < 0.001); exercise capacity as assessed by 6-min walking test increased from 250 ± 107 m to 332 ± 118 m (p < 0.001) and quality of life (Minnesota Living With Heart Failure Questionnaire) was also significantly improved (p < 0.001)., Conclusions: In this feasibility trial in symptomatic patients with FMR, transcatheter mitral annuloplasty with the Cardioband was effective in reducing MR and was associated with improvement in heart failure symptoms and demonstrated a favorable safety profile. (Cardioband With Transfemoral Delivery System; NCT01841554)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

As transcatheter mitral replacement technologies have recently been applied in early clinical trials, the question as to whether valve implantation would have the potential to become the leading percutaneous mitral valve therapy has been raised. The aim of this report is to give an overview of the different peculiarities of percutaneous replacement and repair techniques, and to predict whether the two approaches will have a complementary rather than a competitive clinical role in the near future.

Aims: Gender has been an important factor in outcomes after mitral valve surgery; however, its effect on percutaneous mitral valve repair is not well known. We aimed to report the effect of gender on outcomes in a large European prospective, multicentre, non-randomised post-approval study of percutaneous mitral valve repair., Methods and Results: Two hundred and five female and 362 male patients with significant mitral regurgitation underwent percutaneous repair at 14 European sites from October 2008 to April 2011. Women and men had similar baseline risk scores, but women had a higher rate of degenerative disease (32% vs. 18%). Women were more likely to have one clip implanted (72% vs. 54%), but had a similar length of stay in the intensive care unit (2.6±4.1 days) and overall length of stay (8.0±6.9 days) compared to men. They were also less likely to be discharged home: more women than men went to skilled nursing facilities (25% vs. 15%) and fewer women went home compared to men (71.9% vs. 83.9%). Thirty-day and 12-month safety results were similar between genders, as was 12-month efficacy (echocardiographic and clinical). Multivariate analysis showed no effect of gender on 12-month survival., Conclusions: In a real-world, post-approval experience in Europe, female patients who underwent percutaneous mitral valve repair experienced safety and efficacy results similar to those of males. However, the discharge rates to skilled nursing facilities rather than home may indicate a need for better optimisation of the female patient's physical and social comorbidities prior to intervention and during the hospitalisation period.

Aims: We present here the first-in-man case report of a patient with a significant residual "intra-clip" jet treated by the implantation of an AMPLATZER Vascular Plug II., Methods and Results: A 64-year-old gentleman came to our attention for mitral regurgitation (MR) recurrence four years after transcatheter mitral repair with MitraClip. After the implantation of two further MitraClips, residual intra-clip MR was present, without room for a further clip. An AMPLATZER Vascular Plug II was successfully deployed between the two clips. Final echocardiography showed residual mild MR, without any sign of mitral stenosis., Conclusions: This case demonstrates the feasibility of the implantation of an AMPLATZER Vascular Plug between two MitraClips to treat significant residual "intra-clip" MR, when the implantation of an adjunctive clip is not feasible. This approach may represent an effective therapeutic solution in case of a significant residual intra-clip jet.