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Competing Interests: Funding Support and Author Disclosures Dr von Stein has received speaker honoraria and travel expenses by Edwards Lifesciences. Dr Iliadis has received travel support by Abbott and Edwards Lifesciences and consultant honoraria by Abbott and Edwards Lifesciences. Dr Baldus has received honorarium for consultation by Abbott and Edwards Lifesciences. Dr Pfister has received speaker fees by Edwards Lifesciences and Abbott.

Background: A novel echocardiography-based definition of atrial functional tricuspid regurgitation (A-FTR) has shown superior outcomes in patients undergoing conservative treatment or tricuspid valve transcatheter edge-to-edge repair. Its prognostic significance for transcatheter tricuspid valve annuloplasty (TTVA) outcomes is unknown., Objectives: This study sought to investigate prognostic, clinical, and technical implications of A-FTR phenotype in patients undergoing TTVA., Methods: This multicenter study investigated clinical and echocardiographic outcomes up to 1 year in 165 consecutive patients who underwent TTVA for A-FTR (characterized by the absence of tricuspid valve tenting, midventricular right ventricular [RV] dilatation, and impaired left ventricular ejection fraction) and nonatrial functional tricuspid regurgitation (NA-FTR)., Results: A total of 62 A-FTR and 103 NA-FTR patients were identified, with the latter exhibiting more pronounced RV remodeling. Compared to baseline, the tricuspid regurgitation (TR) grade at discharge was significantly reduced (P < 0.001 for both subtypes), and TR ≤II was achieved more frequently in A-FTR (85.2% vs 60.8%; P = 0.001). Baseline TR grade and A-FTR phenotype were independently associated with TR ≤II at discharge and 30 days. In multivariate analyses, A-FTR phenotype was a strong predictor (OR: 5.8; 95% CI: 2.1-16.1; P < 0.001) of TR ≤II at 30 days. At 1 year, functional class had significantly improved compared to baseline (both P < 0.001). One-year mortality was lower in A-FTR (6.5% vs 23.8%; P = 0.011) without significant differences in heart failure hospitalizations (13.3% vs 22.7%; P = 0.188)., Conclusions: Direct TTVA effectively reduces TR in both A-FTR, which is a strong and independent predictor of achieving TR ≤II, and NA-FTR. Even though NA-FTR showed more RV remodeling at baseline, both phenotypes experienced similar symptomatic improvement, emphasizing the benefit of TTVA even in advanced disease stages. Additionally, phenotyping was of prognostic relevance in patients undergoing TTVA., Competing Interests: Funding Support and Author Disclosures Dr J. von Stein has received lecture fees from Edwards Lifesciences. Dr Iliadis has received travel support from Abbott and Edwards Lifesciences; and has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Kalbacher has received personal fees from Edwards Lifesciences, Abbott, and Pi-Cardio Ltd; and has received research grants and honoraria for consultation from Edwards Lifesciences. Dr Rudolph has received research grants and honoraria for consultation from Edwards Lifesciences. Dr Baldus has received honoraria for consultation from Abbott and Edwards Lifesciences. Dr Pfister has received speaker fees from Edwards Lifesciences and Abbott. Dr Körber has received travel support from JenaValve; and has received lecture fees from Edwards Lifesciences and Abbott. All other 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.)

Objectives: The association of pulmonary hypertension (PH) with the outcome after mitral transcatheter edge-to-edge repair (M-TEER) focusing on the new ESC/ERS guidelines definition for PH., Background: PH is frequently found in patients with mitral regurgitation and is associated with lower survival rates. Recent studies were based on echocardiographic parameters, but results based on invasive haemodynamics differentiating distinct types of PH using the new definition for PH are missing., Methods: 449 consecutive M-TEER-treated patients from December 2009 to February 2015 were included in this retrospective analysis. All patients were stratified by the distinct types of PH (no PH, precapillary PH, isolated postcapillary PH, combined post-PH and precapillary PH) according to the definitions of the ESC/ERS guidelines for the diagnosis of PH from 2015 (meanPA cut-off <25 mm Hg, pulmonary capillary wedge pressure (PCWP) cut-off ≤15 mm Hg, diastolic pulmonary gradient cut-off ≥7 mm Hg or pulmonary vascular resistance (PVR) >3 WU) and 2022 (meanPA cut-off ≤20 mm Hg, PCWP cut-off ≤15 mm Hg, PVR cut-off ≥3 WU)., Results: Patients with any type of PH (2015: meanPA cut-off 25 mm Hg; 2022: meanPA cut-off >20 mm Hg) showed a higher risk of death after M-TEER compared with patients with no PH (2015: HR 1.61 (95% CI 1.25 to 2.07); p<0.001 and 2022: HR 2.09 (95% CI 1.54 to 2.83); p<0.001). Based on the new PH definition, each PH subgroup showed a lower survival after M-TEER compared with patients with no PH. Echocardiographic estimated systolic PAP showed a correlation with invasively measured mean pulmonary artery pressure (mPAP) (r=0.29, p<0.001) and systolic pulmonary arterial pressure (r=0.34,p<0.001). Cox-regression analysis showed higher invasive diastolic, systolic and mean pulmonary pressures were associated with higher all-cause mortality (p<0.001). In addition, invasive measured higher right atrial pressure, lower pulmonary arterial compliance, higher PVR and higher wedge pressure were identified as predictors of all-cause mortality after M-TEER., Conclusions: The new PH definition discriminates PH groups and mortality better than the old definition. The lower threshold of mPAP of 20mmHg improved prognostication in this cohort of patients., Competing Interests: Competing interests: TU, BF, K-HK and SR declare the full disclosure of any relationship with industry. IE received lecture honoraria and research grants by Abbott and lecture honoraria by Edwards. HA received travel support by Abbott. T. Schmidt, S. Willems, CF received lecture honoraria and travel support from Abbott Vascular and Edwards Lifesciences. RP received lecture honoraria from Abbott Vascular and Edwards and is a consultant for Edwards. SB received lecture honoraria and research grants from Edwards and Abbott., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry., Methods: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year., Results: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07)., Conclusions: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aims: While invasively determined congestion holds mechanistic and prognostic significance in acute heart failure (HF), its role in patients with tricuspid regurgitation (TR)-related right- heart failure (HF) undergoing transcatheter tricuspid valve intervention (TTVI) is less well established. A comprehensive understanding of congestion patterns might aid in procedural planning, risk stratification, and the identification of patients who may benefit from adjunctive therapies before undergoing TTVI. The aim of this study was to investigate the role of congestion patterns in patients with severe TR and its implications for TTVI., Methods and Results: Within a multicentre, international TTVI registry, 813 patients underwent right heart catheterization (RHC) prior to TTVI and were followed up to 24 months. The median age was 80 (interquartile range 76-83) years and 54% were women. Both mean right atrial pressure (RAP) and pulmonary capillary wedge pressure (PCWP) were associated with 2-year mortality on Cox regression analyses with Youden index-derived cut-offs of 17 mmHg and 19 mmHg, respectively (p < 0.01 for all). However, RAP emerged as an independent predictor of outcomes following multivariable adjustments. Pre-interventionally, 42% of patients were classified as euvolaemic (RAP <17 mmHg, PCWP <19 mmHg), 23% as having left-sided congestion (RAP <17 mmHg, PCWP ≥19 mmHg), 8% as right-sided congestion (RAP ≥17 mmHg, PCWP <19 mmHg), and 27% as bilateral congestion (RAP ≥17 mmHg, PCWP ≥19 mmHg). Patients with right-sided or bilateral congestion had the lowest procedural success rates and shortest survival times. Congestion patterns allowed for discerning specific patient's physiology and specifying prognostic implications of right ventricular to pulmonary artery coupling surrogates., Conclusion: In this large cohort of invasively characterized patients undergoing TTVI, congestion patterns involving right-sided congestion were associated with low procedural success and higher mortality rates after TTVI. Whether pre-interventional reduction of right-sided congestion can improve outcomes after TTVI should be established in dedicated studies., (© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy., Objectives: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry., Methods: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee., Results: Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline)., Conclusions: At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy., Competing Interests: Funding Support and Author Disclosures Dr Smith is on the CLASP IID Trial leadership team and has received institutional grant and travel support for device evaluation from Edwards Lifesciences; has received institutional grants from Artivion; and honoraria for speaking from Artivion and Medtronic. Dr Lim is a consultant for Opus, Nyra, Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, V Wave, and WL Gore. Dr Gillam is a consultant for Philips, Bracco, and Edwards Lifesciences; and directs an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic for which she receives no direct compensation. Dr Zahr is a consultant and has received research grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant and has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Goldman consults in minimally invasive mitral valve observation for Edwards Lifesciences. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller is a consultant and proctor for Edwards Lifesciences. Dr Dhoble is a consultant and proctor for Edwards Lifesciences and Abbott. Dr Smalling has received clinical trial grant support from Edwards Lifesciences, Medtronic, and Abbott; and serves as a consultant for Abbott. Dr Latib is a consultant and serves on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Kodali is a consultant for Admedus, Dura Biotech, TriCares, Phillips, and TriFlo; has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and serves on a scientific advisory board and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Lurz has received institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr O’Neill is a consultant for Abiomed, BSCI, and Abbott; and was previously a consultant for Edwards Lifesciences. Dr Laham is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr Kar is a consultant for Abbott, Medtronic, Boston Scientific, WL Gore, Laminar, Intershunt, and V wave; has received institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; is the co-national principal investigator for the REPAIR MR Trial and EXPAND registry and co-national principal investigator for the PINNACLE FLX Trial and CHAMPION Trial; serves on the steering committee for the Triluminate Trial; and is an executive committee member for the RELIEVE HF Trial. Dr Schofer has received travel support from Edwards Lifesciences and Abbott/St. Jude Medical; has received speaker honoraria from Edwards Lifesciences and Boston Scientific; and is a consultant for Edwards Lifesciences and Abbott. Dr Inglessis-Azuaje is a proctor for Edwards Lifesciences and Medtronic; and serves as a lecturer for Edwards Lifesciences and Boston Scientific. Dr Baldus has received research funding from Abbott; and has received lecturing fees from Edwards Lifesciences, Abbott, and Medtronic. Dr Szerlip is a proctor for Edwards Lifesciences and Abbott; is a speaker for Edwards Lifesciences and Boston Scientific; serves as a national principal investigator for an early feasibility study for Edwards Lifesciences; serves on the advisory board for Abbott; and is part of a steering committee for Medtronic. Dr Kliger is a consultant for and has received speaker honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Webb is a consultant and national principal investigator for Edwards Lifesciences–sponsored clinical studies; and has received speaking honoraria, travel support, or grant support from Edwards Lifesciences. Dr von Bardeleben is a principal investigator for Phase 3, post-market clinical trials and investigator-initiated trials (Reshape II HF, TENDER, EuroSMR and other registries) for Abbott, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Neochord, Philips and Siemens. Dr Ruf has received speaker, consulting, and proctoring fees from Abbott Laboratories and Edwards Lifesciences. Dr Guerrero has received grant support, and consulting and proctoring fees from Edwards Lifesciences. Dr McCabe is a consultant and has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and holds equity in Excision Medical. Dr Davidson is a consultant and has received research grant support from Edwards Lifesciences. Dr Shah has received grant support, consulting, and proctoring fees from Edwards Lifesciences. Dr Yadav is a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and is a speaker for Abbott. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott for which he receives no direct compensation. Dr Hausleiter is a consultant, and receives speaker honoraria and institutional research support from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: Although mitral valve transcatheter edge-to-edge repair (M-TEER) achieves symptomatic benefit for a broad spectrum of patients with relevant secondary mitral regurgitation, conflicting data exist on its prognostic impact., Objectives: Adapted enrollment criteria approaching those used in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and MITRA-FR (Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation) trials were retrospectively applied to a European real-world registry to evaluate the influence of the respective criteria on outcomes., Methods: A total of 1,022 patients included in the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry and treated with M-TEER (November 2008 to September 2019) were stratified into COAPT-eligible (n = 353 [34.5%]) and COAPT-ineligible (n = 669 [65.5%]) as well as MITRA-FR-eligible (n = 408 [48.3%]) and MITRA-FR-ineligible (n = 437 [51.7%]) groups., Results: Although the stratification of patients according to adapted MITRA-FR criteria led to comparable outcomes regarding all-cause mortality (P = 0.19), the application of adapted COAPT enrollment criteria demonstrated lower mortality rates in COAPT-eligible compared with COAPT-ineligible patients (P < 0.001). Multivariable Cox regression analysis identified New York Heart Association functional class IV (hazard ratio [HR]: 2.29; 95% confidence interval [CI]: 1.53-3.42; P < 0.001), logarithmic N-terminal pro-brain natriuretic peptide (HR: 1.47; 95% CI: 1.24-1.75; P < 0.001), and right ventricular-to-pulmonary arterial coupling (HR: 0.10; 95% CI: 0.02-0.57; P = 0.009) as independent predictors of outcome. Yet improvement of functional outcome was demonstrated in a subset of patients irrespective of COAPT eligibility status., Conclusions: In this real-world cohort of patients with secondary mitral regurgitation undergoing M-TEER, the retrospective application of adapted COAPT enrollment criteria successfully identified a specific phenotype demonstrating lower mortality rates. On the contrary, stratification according to adapted MITRA-FR criteria resulted in comparable outcomes., Competing Interests: Funding Support and Author Disclosures Dr Orban has received speaker honoraria from Abbott Medical. Dr Kalbacher has received speaker honoraria from Abbott Medical and Edwards Lifesciences; has received travel expenses from Abbott Medical and Edwards Lifesciences; and has received proctor fees from Edwards Lifesciences. Dr Hausleiter has received speaker honoraria from Abbott Medical. Dr Pfister has received speaker honoraria and travel expenses from Abbott Medical. Dr Baldus has received speaker honoraria from Abbott Medical and Edwards Lifesciences; and has received research grants from Abbott Medical. Dr Lubos has received speaker honoraria, travel expenses, and research grants from Abbott Medical. Dr Lurz has received speaker honoraria from Abbott Medical; and has received consultant fees from Abbott Medical and Edwards Lifesciences. Dr Karam has received consultant fees from Abbott Medical. Dr Iliadis has received consultant fees from Abbott Medical and Edwards Lifesciences; and has received travel expenses from Abbott Medical. Dr Petrescu has received consultant fees and research grants from Abbott Medical. Dr Metra has received consultant fees from Abbott Medical; and has received speaker honoraria from Edwards Lifesciences. Dr Windecker has received research grants from Abbott Medical and Edwards Lifesciences. Dr Ludwig has received travel expenses from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Reliable risk scores in patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) are lacking. Heart failure is common in these patients, and risk scores derived from heart failure populations might help stratify TMVR patients., Methods: Consecutive patients from three Heart Centers undergoing TMVR were enrolled to investigate the association of the "Get with the Guidelines Heart Failure Risk Score" (comprising the variables systolic blood pressure, urea nitrogen, blood sodium, age, heart rate, race, history of chronic obstructive lung disease) with all-cause mortality., Results: Among 815 patients with available data 177 patients died during a median follow-up time of 365 days. Estimated 1-year mortality by quartiles of the score (0-37; 38-42, 43-46 and more than 46 points) was 6%, 10%, 23% and 30%, respectively (p < 0.001), with good concordance between observed and predicted mortality rates (goodness of fit test p = 0.46). Every increase of one score point was associated with a 9% increase in the hazard of mortality (95% CI 1.06-1.11%, p < 0.001). The score was associated with long-term mortality independently of left ventricular ejection fraction, NYHA class and NTproBNP, and was equally predictive in primary and secondary mitral regurgitation., Conclusion: The "Get with the Guidelines Heart Failure Risk Score" showed a strong association with mortality in patients undergoing TMVR with additive information beyond traditional risk factors. Given the routinely available variables included in this score, application is easy and broadly possible., (© 2021. The Author(s).)

Background: Hepatorenal dysfunction is a strong prognostic predictor in patients with heart failure. However, the prognostic impact of the hepatorenal dysfunction in patients undergoing transcatheter mitral valve repair (TMVR) has not been well studied., Methods: In consecutive patients who underwent edge-to-edge TMVR at three German centers, the model for end-stage liver disease excluding international normalized ratio (MELD-XI) score was calculated as 5.11 × ln [serum total bilirubin (mg/dl)] + 11.76 × ln [serum creatinine (mg/dl)] + 9.44. Patients were stratified into high (> 11) or low (≤ 11) MELD-XI score of which an incidence of the composite outcome, consisting of all-cause mortality and heart failure hospitalization, within 2 years after TMVR was assessed., Results: Of the 881 patients, the mean MELD-XI score was 11.0 ± 5.9, and 415 patients (47.1%) had high MELD-XI score. The MELD-XI score was correlated with male, effective regurgitant orifice area, and tricuspid regurgitation severity and inversely related to left ventricular ejection fraction. Patients with high MELD-XI score had a higher incidence of the composite outcome than those with low MELD-XI score (47.7% vs. 29.8%; p < 0.0001), and in multivariable analysis, the high MELD-XI score was an independent predictor of the composite outcome [adjusted hazard ratio (HR) 1.34; 95% confidence interval (CI) 1.02-1.77; p = 0.04). Additionally, the MELD-XI score as a continuous variable was also an independent predictor (adjusted HR 1.02; 95% CI 1.00-1.05; p = 0.048)., Conclusions: The MELD-XI score was associated with clinical outcomes within 2 years after TMVR and can be a useful risk-stratification tool in patients undergoing TMVR., (© 2021. The Author(s).)

Background Optimizing risk stratification in patients undergoing transcatheter mitral valve repair is an ongoing challenge. The Mitral Regurgitation International Database (MIDA) score represents a user-friendly mortality risk stratification tool that is validated on a large-scale registry of patients with degenerative mitral regurgitation (MR). We here assessed the potential benefit of the MIDA risk score for patients with functional or degenerative MR undergoing transcatheter mitral valve repair. Methods and Results In total, 680 patients undergoing MitraClip implantation were stratified according to MIDA score tertiles into a low (0-7), intermediate (8-9), and a high (10-12) MIDA score group. MR was assessed in follow-up echocardiograms in 416 patients at 323±169 days after transcatheter mitral valve repair. During 2-year follow-up, 8.2% (15/182) of patients with low, 21.3% (64/300) with intermediate, and 26.3% (52/198) with high MIDA score died (log-rank test P <0.001). Hazard of all-cause mortality increased by 13% (95% CI, 3%-25%) with every additional point of the MIDA score. Subanalysis of 431 patients with functional MR showed similar results. Furthermore, rates of a combined end point of mortality and hospitalization for heart failure were higher with increasing MIDA score (30% [54/182], 38% [113/300] and 48% [94/198], respectively, log-rank test P =0.001). Frequency of residual MR ≥II at follow-up increased with increasing MIDA score group (33%, 44%, and 59%, respectively, P <0.001). Conclusions The MIDA mortality risk score maintains its predictive utility in patients undergoing transcatheter mitral valve repair, regardless of MR cause. Moreover, it was predictive of worse event-free survival regarding a combined end point of mortality and hospitalization for heart failure, and was associated with postprocedural residual MR ≥II and MR recurrence.

Background: Frailty is a common characteristic of patients undergoing transcatheter mitral valve repair (TMVR). It is unclear whether the physical vulnerability of frail patients translates into increased procedural health care utilization., Methods and Results: Frailty was assessed using the Fried criteria in 229 patients undergoing TMVR using the MitraClip system at our institution and associations with total costs and costs by cost centers within the hospital incurred during periprocedural hospitalization were examined. Frail patients (n = 107, 47%) compared to non-frail patients showed significantly higher total costs [median/interquartile range, excluding implant costs: 7,337 € (5,911-9,814) vs 6,238 € (5,584-7,499), p = 0.001], with a difference in means of 2,317 €. Frailty was the only clinical baseline characteristic with significant association with total costs. Higher total costs in frail patients were attributable primarily to longer stay on intermediate/intensive care unit (3.8 ± 5.7 days in frail vs 2.1 ± 1.7 days in non-frail, p = 0.003), but also to costs of clinical chemistry and physiotherapy. The prolonged stay on intermediate/intensive care unit in frail patients was attributable to postprocedural complications such as bleeding, kidney injury, infections and cardiovascular instability., Conclusion: Frailty is associated with a mean 32% increase of hospital costs in patients undergoing TMVR, which is primarily the result of a prolonged recovery and increased vulnerability to complications. These findings are valuable for a hospital's total cost calculation and resource allocation planning. Since frailty is regarded a potentially reversible health state, preventive interventions may help reduce costs in frail patients.

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.)

Objectives: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population., Methods and Results: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates., Conclusion: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy., (© 2019 Wiley Periodicals, Inc.)

Background: Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options., Objectives: The authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study., Methods: Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events., Results: Mean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm 2 vs. 0.4 cm 2 ; p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01)., Conclusions: Six-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System [TRI-REPAIR]; NCT02981953)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Percutaneous treatment of atrioventricular (AV) valve disease has long been restricted to therapy of mitral stenosis, and was only lately expanded to mitral regurgitation. 15 years ago the MitraClip edge to edge repair was first applied to human pathology. In Europe, German centers were the first to widely adopt this technique in patients with mitral regurgitation and high or inappropriate risk for surgery. Given the exponential rise in implantation procedures, expertise of the operators and investigator initiated investigations substantially contributed to improvements in procedural processes and patient selection. Meanwhile, additional techniques to repair the mitral and tricuspid valve were introduced to German interventionalists, both reconstructive techniques as well as first experiences with transcatheter implantation of mitral valve bioprostheses. Of note, specialized Heart Valve referral Centers catalyzed the adoption of these techniques. This review summarizes the contributions of German Heart Centers to recent developments in percutaneous therapy of AV valve disease.

Objectives: The aim of this study was to describe the impact of frailty in patients undergoing percutaneous mitral valve repair (PMVR)., Background: Frailty is common in elderly patients and those with comorbidities and is associated with adverse prognosis., Methods: Frailty according to the Fried criteria was assessed in consecutive patients admitted for PMVR. Associations of frailty with 6-week (device success, changes in 6-min walking distance and Minnesota Living With Heart Failure Questionnaire and Short Form 36 physical and mental component scores, and improvement ≥1 New York Heart Association functional class) and long-term outcomes during a median follow-up period of 429 days were examined., Results: Of 213 patients admitted for PMVR (median age 78 years; age range 50 to 95 years; 57.3% men), 45.5% were classified as frail. Compared with nonfrail patients, frail patients had a similar device success rate (81.4% vs. 84.5%; p = 0.56) and improvement in 6-min walking distance, New York Heart Association functional class, and Short Form-36 scores but a more pronounced improvement in Minnesota Living With Heart Failure Questionnaire score (mean change -15.9 vs. -11.2 points; p = 0.002). Mortality at 6 weeks was significantly higher in frail (8.3%) compared with nonfrail (1.7%) patients (p = 0.03). Hazards of death (hazard ratio: 3.06; 95% confidence interval: 1.54 to 6.07; p = 0.001) and death or heart failure decompensation (hazard ratio: 2.03; 95% confidence interval: 1.22 to 3.39; p = 0.007) were significantly increased in frail patients during long-term follow-up, which did not change relevantly after adjustment for European System for Cardiac Operative Risk Evaluation score and N-terminal pro-brain natriuretic peptide level., Conclusions: PMVR can be performed with equal efficacy and is associated with at least similar short-term functional improvement in frail patients. These results support the continued use of PMVR in frail elderly patients with the goal of palliation of heart failure symptoms and improvement in quality of life., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The use of the MitraClip system has gained widespread acceptance for the treatment of patients with mitral regurgitation (MR) who are not suitable for the conventional surgery. This study sought to investigate the early and 1-year outcome after MitraClip therapy of patients with MR and cardiac comorbidities., Methods and Results: Outcomes through 12-month follow-up of patients (n = 528) who underwent MitraClip implantation were obtained from the German transcatheter mitral valve interventions (TRAMI) registry. The majority of these patients (n = 409, 77.5 %) also suffered from coronary artery disease (CAD). Patients with a dilated cardiomyopathy (DCM, n = 65, 12.3 %) or concomitant valvular aortic disease (AV, n = 54, 10.2 %) were less frequent. Although the prevalent pathogenesis was functional MR, patients with DCM had significantly more frequent a functional MR (96.9 %) compared to patients with CAD (74.9 %) or AV (62.5 %, p < 0.001). Technical success was achieved in 97.5 % of patients. Procedural echocardiograms demonstrated in the vast majority of patients a reduction from severe MR III to mild MR I with no difference between the groups (p = 0.83). The peri-procedural complication rate was very low. At 30-day and 12-month follow-up, the majority of patients were in NYHA functional class II or lower. The rate of death, stroke, and myocardial infarction (MACCE) was comparable in the three patient groups during 12-month follow-up (DCM 26.9 %, CAD 30.3 % and AV 27.5 %, p = 0.85)., Conclusions: The MitraClip implantation is feasible and safe even in high-risk patients with MR and cardiac comorbidities.

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.)

Aims: Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial., Methods and Results: The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+., Conclusions: This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Due to the demographic change, chronic valvular heart disease becomes increasingly important - especially age-related primary diseases of the aortic and mitral valve as well as secondary diseases of the mitral and tricuspid valve caused by other age-related cardiac disorders. Medical treatment is limited to symptom relief by use of diuretics. Specific drugs or drugs with a prognostic benefit are not available. Thus, valve repair or replacement are the key options for treatment of relevant valvular heart disease. While open heart surgery was the only approach for a long time, interventional, catheter-based therapies have evolved in the last decade. This article describes up-to-date recommendations on indications for surgery for the most prevalent valvular heart diseases in adults - aortic stenosis, and aortic, mitral and tricuspid regurgitation)., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: We aimed at identifying predictors of renal impairment and its impact on long-term outcome after transcatheter aortic valve implantation (TAVI)., Background: Renal impairment is common in mostly elderly, multimorbid patients undergoing TAVI. The risk of periprocedural renal function impairment and its association with outcome is incompletely understood., Methods: In 458 consecutive patients (mean age, 80.6 ± 7.0 years, 52.2% women) who underwent routine TAVI procedures, we assessed estimated glomerular filtration rate (eGFR) at baseline, during 72-hr postprocedure and at discharge. Over a median follow-up of 0.96 years, we observed 142 deaths., Results: In multivariable-adjusted models, predictors of renal function deterioration within 72 hr were baseline eGFR (β = 0.83, 95% confidence interval [CI] = 0.76/0.91; P < 0.0001), body mass index (β = -1.20, 95% CI = 1.77/-0.62; P < 0.0001), and major access site complications (β = -14.82, 95% CI = -26.52/-3.11; P = 0.013) including bleeding (β = -11.97, 95% CI = -21.05/-2.89; P = 0.0099). Strongest renal function predictor of 1-year mortality in risk factor adjusted analyses was the change of eGFR within 72 hr (odds ratio, 0.97; 95% CI = 0.96/0.98; P < 0.0001). The addition of information on the change of eGFR increased the C-statistic of the logistic EuroSCORE (P = 0.021)., Conclusions: In our routine TAVI sample, baseline eGFR, body mass index, and major access site complications mainly owing to bleeding were correlates of acute kidney injury after TAVI. Acute renal impairment was a risk factor for mortality and adverse cardiovascular events which provided risk information beyond the EuroSCORE., (© 2014 Wiley Periodicals, Inc.)

Aims: This analysis from the German Mitral Valve Registry investigates the impact of the learning curve with the MitraClip(®) technique on procedural success and complications., Methods and Results: Consecutive patients treated since 2009 in centers that performed more than 50 transcatheter mitral repairs were included. Results of the first half of the patients were compared to those of the second. Altogether 496 patients from 10 centers were included. Patients treated later had less common severe heart failure symptoms (patients with NYHA IV: 22.1 vs. 14.5 %, p < 0.05). The EuroSCORE I (22.0 vs. 23.0 %, p = ns) and Society of Thoracic Surgeons (STS) score (7.5 vs. 9.5 %, p = ns) did not differ between both groups. Procedural success was 95.6 % (238/249) in the first cases and 94.7 % (232/245, p = ns) subsequently. Also procedural time (104.3 vs. 119 min, p = ns) and complications did not decrease over time., Conclusion: A learning curve using the MitraClip(®) device does not appear to significantly affect acute MR reduction, hospital and 30-day mortality. Most likely, the proctor system leads to already high initial procedure success and relatively short procedure time.

Objective: To evaluate in-hospital and short-term outcomes of percutaneous mitral valve repair according to patients' logistic EuroSCORE (logEuroSCORE) in a multicenter registry, Background: The logEuroSCORE is an established tool to predict the risk of mortality during cardiac surgery. In high-risk patients percutaneous mitral valve repair with the MitraClip system represents a less-invasive alternative, Methods: Data from 1002 patients, who underwent percutaneous mitral valve repair with the MitraClip system, were analyzed in the German Transcatheter Mitral Valve Interventions (TRAMI) Registry. A logEuroSCORE (mortality risk in %) ≥ 20 was considered high risk, Results: Of all patients, 557 (55.6%) had a logEuroSCORE ≥ 20. Implantation of the MitraClip was successful in 95.5 % (942/986) patients. Moderate residual mitral valve regurgitation was more often detected in patients with a logEuroSCORE ≥ 20 (23.8% vs. 17.1%, respectively, P < 0.05). In patients with a logEuroSCORE ≥ 20 the procedural complication rate was 8.9% (vs. 6.4, n.s.) and the in-hospital MACCE rate 4.9% (vs. 1.4% P < 0.01). The in-hospital mortality rate in patients with a logEuroSCORE ≥ 20 and logEuroSCORE < 20 was 4.3 and 1.1%, respectively (P ≤ 0.01) CONCLUSION: Percutaneous mitral valve repair with the MitraClip system is feasible in patients with a logEuroSCORE ≥ 20 with similar procedural results compared to patients with lower predicted risk. Although mortality was four times higher than in patients with logEuroSCORE < 20, mortality in high risk patients was lower than predicted. In those with a logEuroSCORE ≥ 20, moderate residual mitral valve regurgitation was more frequent., (© 2014 Wiley Periodicals, Inc.)

Objectives: The aim of the study was to assess predictors of acute procedural failure in surgical high-risk patients undergoing MitraClip (Abbott Vascular, Abbott Park, Illinois) therapy., Background: MitraClip implantation is a novel percutaneous option to treat significant mitral regurgitation (MR)., Methods: In 300 patients (75 ± 9 years of age, 190 [63%] men), of whom 32 (10.7%) had been unsuccessfully treated (discharge MR grade of >2+), baseline clinical and echocardiographic variables were evaluated by exact logistic regression and classification tree analyses to assess their impact on acute procedural failure. Acute procedural failure was differentiated into aborted procedure (no MitraClip implanted; n = 11) and "clip failure" (inadequate MR reduction despite MitraClip implantation; n = 21)., Results: Multivariate logistic regression identified effective regurgitant orifice area (EROA), mitral valve orifice area (MVOA), and mean transmitral pressure gradient (TMPG) as independent predictors of overall acute procedural failure. Classification tree analysis revealed that an EROA >70.8 mm(2) (n = 28) was associated with a high rate (25%) of clip failures, whereas the combination of an MVOA ≤3.0 cm(2) and a TMPG ≥4 mm Hg (n = 16) was associated with a high rate (37.5%) of aborted procedures. Failure rates of ≤10% were observed in all patients with an EROA ≤70.8 mm(2) and either an MVOA >3.0 cm(2) (n = 217) or an MVOA ≤3.0 cm(2) in concert with a TMPG ≤3 mm Hg (n = 39). Multinomial logistic regression identified an EROA >70.8 mm(2) and a TMPG ≥4 mm Hg as independently predictive of clip failure, but an MVOA ≤3.0 cm(2) and a TMPG ≥4 mm Hg as independently predictive of procedure abortion., Conclusions: In surgical high-risk patients undergoing MitraClip therapy, a TMPG ≥4 mm Hg, an EROA ≥70.8 mm(2), and an MVOA ≤3.0 cm(2) carry an increased risk of procedural failure., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Closure of patent foramen ovale following presumed paradoxical embolic stroke remains controversial. The answer to the question as to whether cardiovascular risk factors (CVRF) impact on the recurrence of stroke in patients who have undergone PFO closure remains elusive so far. We aimed to investigate the potential impact of CVRF on the long-term rate of stroke/TIA recurrence in patients treated with an occluder following presumed paradoxical embolic stroke., Methods and Results: 443 patients (mean age: 50.0±12.6 yrs, female: 206 [46.5%]) undergoing percutaneous PFO closure after presumed paradoxical embolic stroke were followed for a median time of 43.0 [interquartile range: 20.0-86.0] months. During the follow-up period a total of 22 (5.0%) strokes/TIAs and 17 (3.8%) deaths were observed. Cox regression analysis identified hypertension, age and the Essen stroke risk score as predictors of recurrent stroke/TIA., Conclusions: This study shows that, in patients with a prior presumed paradoxical embolic stroke, the risk for recurrent stroke/TIA after PFO closure is firmly linked to the presence of CVRF.

Background: Optimal transcatheter aortic valve (TAVI) results require accurate valve positioning, including anatomically correct orientation and secure fixation within the aortic annulus, thereby potentially decreasing paravalvular regurgitation. The new Engager (Medtronic 3F Therapeutics, Santa Ana, CA) transapical valve system captures the native leaflets for sealing and allows for tactile feedback during valve placement. We report initial safety and performance outcomes of the Engager system through 6 months in patients with severe aortic valve stenosis at high risk for surgical aortic valve replacement., Methods: An interim analysis was performed on the first 61 enrolled September 2011 through May 2012. Inclusion criteria comprised severe aortic stenosis, New York Heart Association functional class of II or greater, logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 20% or greater, or contraindication to surgical aortic valve replacement. The primary endpoint was all-cause mortality at 30 days. Patients were evaluated 24 to 48 hours post-procedure, at hospital discharge, 30 days and 6 months. Follow-up is planned annually through five years., Results: Baseline characteristics for the 61 patients were mean age 81.9 ± 4.4 years, 62.3% female, 88.5% New York Heart Association class III/IV, 52.5% coronary artery disease, and 54.2% extracardiac arteriopathy. For all of the attempted implantations (n = 60), the Engager prosthesis was positioned in the correct anatomic position without conversions to surgery, second valve implantation, device malposition, aortic annular rupture, or coronary obstruction. All-cause mortality was 9.9% at 30 days and 16.9% at 6 months. The baseline mean aortic valve gradient was 43.7 ± 16.7 mm Hg and 11.5 ± 5.0 mm Hg at 30 days, and showed similar reduction at 6 months (13.9 ± 6.2 mm Hg). There was no paravalvular regurgitation greater than mild through 6 months., Conclusions: Early postoperative results support implantation success and valve safety. Analysis for 6 month outcomes shows stable hemodynamic performance and clinical outcome. (Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System-the Engager European Pivotal Trial; NCT01348438)., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background and Aim of the Study: Female gender has recently been suggested to predict a beneficial outcome and lower mortality following transcatheter aortic valve implantation (TAVI). The study aim was to address gender differences in outcome following TAVI and potentially to replicate these findings., Methods: The present single-center prospective registry of 326 patients with severe aortic stenosis treated by TAVI between 2008 and 2011 consisted of 181 women and 145 men., Results: The procedural risk was not significantly different between men and women at baseline. For all-cause mortality no difference was observed at 30 days and at 12 months after TAVI., Conclusion: While several baseline characteristics between men and women treated by TAVI were shown to be different among the study population, no difference was observed in survival between both genders.

Objectives: We report the results of a large single-center study evaluating predictors and outcomes after transcatheter aortic valve implantation (TAVI) with different devices and access routes according to the Valve Academic Research Consortium (VARC)., Background: The widespread adoption of TAVI warrants a systematic analysis of outcomes. Only few comprehensive data exist comparing different approaches as selected by a heart team., Methods: TAVI was performed in 326 consecutive patients (mean age 80.6 ± 7.1 years, 55.5% female) at high risk for surgery with balloon-expandable and self-expanding devices through transfemoral or transapical access. Data were analyzed according to VARC endpoints; predictors of mortality were identified., Results: All-cause mortality was 10.1% (30 days) and 29.9% (1 year) overall and comparable with regard to valve or access choice (P = 0.295) despite different risk profiles at baseline. Device success and 30-day safety endpoints were achieved in 87.1 and 21.2%. Myocardial infarction [hazard ratio (HR) 6.52], stage-2 and -3 acute kidney injury (HR 2.52 and 6.80) and major access site complications (HR 1.96) were independent predictors of 1-year all-cause mortality. Device success had a protective effect (HR 0.58). Baseline predictors included body mass index <20 kg/m(2) (HR 3.20), NYHA class IV (HR 1.87), left ventricular ejection-fraction <30% (HR 2.30), higher STS-PROM scores (HR 1.05 per percent), and age (group 75-85 years, HR 0.47)., Conclusions: Comparable results were achieved with different devices and access routes in a heart team approach. Baseline and perioperative predictors of all-cause mortality were identified, contributing to the refinement of patient and device selection criteria for TAVI., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: In inoperable or high-surgical-risk patients, transcatheter aortic valve replacement (TAVR) and repair of the mitral valve using the MitraClip have emerged as novel treatment strategies. We sought to assess the feasibility and effectiveness of bivalvular transcatheter therapy in patients with coexisting aortic stenosis and mitral regurgitation., Methods: Out of 285 patients treated with TAVR and 226 patients who underwent MitraClip therapy at our institution, 11 patients (78 ± 6years, 9 men [82%]) received both therapies. TAVR preceded MitraClip therapy in 10 patients, with 3 patients undergoing both interventions in a single session., Results: TAVR via transapical (n = 6) or transfemoral (n = 5) access utilized the Sapien/Sapien XT and CoreValve prostheses in 7 and 4 patients, respectively. All TAVR procedures were successful, with significant increases in effective aortic orifice area and decreases in mean transvalvular pressure gradient. MitraClip therapy succeeded in reducing MR severity to <2+ in 10 patients. Periprocedurally, 1 patient sustained a stroke. At a median of 208 days, 2 patients were in NYHA functional class II, with only 1 patient improved from before TAVR, and 6 patients were in class III (improvement in 1). Four patients had died at a median of 60 days after MitraClip therapy., Conclusion: Bivalvular transcatheter treatment of patients with coexisting aortic stenosis and MR is technically feasible, even in a single session. Given the low prevalence of midterm functional improvement, factors predictive of clinical benefit from catheter-based double-valve intervention remain to be determined., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objectives: This study sought to report on the feasibility and early results of transcatheter aortic valve implantation employing a second-generation device in a series of patients with pure aortic regurgitation., Background: Efficacy and safety of transcatheter aortic valve implantation in patients with calcific aortic stenosis and high surgical risk has been demonstrated. However, experience with implantation for severe noncalcified aortic regurgitation has been limited due to increased risk for valve dislocation or annular rupture., Methods: Five patients (mean age: 66.6 ± 7 years) underwent transapical implantation of a JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for moderate to severe, noncalcified aortic regurgitation. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] range 3.1% to 38.9%). Procedural and acute clinical outcomes were analyzed., Results: Implantation was successful in all cases without relevant remaining aortic regurgitation or signs of stenosis in any of the patients. No major device- or procedure-related adverse events occurred and all 5 patients were alive with improved exercise tolerance at 3-month follow-up., Conclusions: Noncalcified aortic regurgitation continues to be a challenging pathology for transcatheter aortic valve implantation due to the risk for insufficient anchoring of the valve stent within the aortic annulus. This report provides first evidence that the JenaValve prosthesis may be a reasonable option in these specific patients due to its unique stent design, clipping the native aortic valve leaflets, and offering promising early results., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The influence of age on baseline demographics and outcomes of patients selected for MitraClip has not been previously investigated., Methods and Results: Baseline demographics and acute outcomes in 1,064 patients from the German TRAMI registry were stratified by age (525 patients ≥76 years and 539 patients <76 years). In elderly patients, logistic EuroSCORE was higher (25[15-40]% vs. 18[10-31]%, p<0.0001) and the proportion of women was greater (47.2% vs. 29.3%, p<0.0001). Elderly patients were more likely to have preserved left ventricular ejection fraction >50% (40.1% vs. 21.8%, p<0.0001) and degenerative mitral regurgitation (DMR, 35.3% vs. 25.6%, p<0.01). Age was the most frequent reason for non-surgical treatment in the elderly (69.4% vs. 36.1%, p<0.0001). The intrahospital MACCE (death, myocardial infarction, stroke) was low in both groups (3.5% vs. 3.4%, p=0.93) and the proportion of non-severe mitral regurgitation at discharge was similar (95.8% vs. 96.4%, p=0.73). A logistic regression model did not reveal any significant impact of age on acute efficacy and safety of MitraClip therapy. In both groups, the majority of patients were discharged home (81.8% vs. 86.2%, p=0.06)., Conclusions: Elderly and younger patients have similar benefits from MitraClip therapy. Age was the most frequent cause for denying surgery in elderly patients.

Aims: A substantial percentage of patients with mitral regurgitation (MR) in need of mitral valve repair are currently considered not suitable for conventional surgery. In Germany, the largest cohort of patients studied to date has been treated using a percutaneous, catheter-based approach. We report the acute outcomes of patients enrolled in the investigator-initiated German transcatheter mitral valve interventions (TRAMI) registry., Methods and Results: Between January 2009 and August 2011, 486 patients [median age 75 (interquartile range 70-80) years; 200 women (41%)] were enrolled in the registry (309 retrospectively and 177 prospectively), with 481 patients (99%) having undergone percutaneous edge-to-edge therapy for MR using the MitraClip. At baseline, 93% of patients were in New York Heart Association (NYHA) functional class III or IV and 71% of patients had a left ventricular ejection fraction (LVEF) ≤50%. Two-thirds of patients presented with functional MR. Procedural success was achieved in 94% of patients, with grade III present in 93% of patients at baseline yet only 6% post-intervention. Retrospective patients were followed for a median of 183 days, prospective patients for a median of 44 days. The periprocedural complication rate was low, with only minor bleedings as the most significant event. In-hospital and post-discharge mortality was 2.5% and 12.5%, respectively., Conclusions: Data from the German TRAMI registry suggest that MitraClip therapy is a viable treatment option in daily clinical routine for high surgical risk patients with significant MR.

Objectives: This study reports the results of a series of transapical mitral valve-in-valve implantations and aims to offer guidance on technical aspects of the procedure., Background: Mitral valve reoperations due to failing bioprostheses are associated with high morbidity and mortality. Transcatheter techniques may evolve as complementary approaches to surgery in these high-risk patients., Methods: Six patients (age 75 ± 15 years) received transapical implantation of a balloon-expandable pericardial heart valve into a degenerated bioprosthesis (range 27 to 31 mm) in mitral position at our institution. All patients were considered high risk for surgical valve replacement (logistic EuroSCORE: 33 ± 15%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed., Results: Implantation was successful in all patients with reduction of mean transvalvular gradients from 11.3 ± 5.2 mm Hg to 5.5 ± 3.6 mm Hg (p = 0.016) and median regurgitation from grade 3.0 (interquartile range [IQR]: 2.7 to 3.1) to 0 (IQR: 0 to 1.0, p = 0.033) with trace paravalvular regurgitation remaining in 2 patients. Apical bleeding occurred in 2 patients requiring rethoracotomy in 1 and resuscitation in a second patient, the latter of whom died on postoperative day 6. In the remaining patients, median New York Heart Association functional class improved from 3.0 (IQR: 3.0 to 3.5) to 2.0 (IQR: 1.5 to 2.0, p = 0.048) over a median follow-up of 70 (IQR: 25.5 to 358) days., Conclusions: With acceptable results in a high-risk population, transapical mitral valve-in-valve implantation can be considered as a complementary approach to reoperative mitral valve surgery in select patients., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Transcatheter valve-in-valve implantation is evolving as an alternative to reoperative valve replacement in high-risk patients with degenerated bioprostheses. Nevertheless, hemodynamic performance is limited by the previously implanted xenograft. We report our experience with patient-prosthesis mismatch (PPM) after valve-in-valve implantation in the aortic position., Methods: Eleven patients (aged 79.3 ± 6.1 years) received transapical implantation of a balloon-expandable pericardial heart valve into a degenerated bioprosthesis (size, 23.9 ± 1.6 mm; range, 21-27 mm) in the aortic position. All patients were considered high risk for surgical valve replacement (logistic European System for Cardiac Operative Risk Evaluation, 31.8% ± 24.1%). Severe PPM was defined as an indexed effective orifice area less than 0.65 cm(2)/m(2), determined by discharge echocardiography., Results: Severe PPM was evident in 5 patients (group 1) and absent in 6 patients (group 2). Mean transvalvular gradients decreased from 29.2 ± 15.4 mm Hg before implantation to 21.2 ± 9.7 mm Hg at discharge (group 1) and from 28.2 ± 9.0 mm Hg before implantation to 15.2 ± 6.5 mm Hg at discharge (group 2). Indexed effective orifice area increased from 0.5 ± 0.1 cm(2)/m(2) to 0.6 ± 0.1 cm(2)/m(2) and from 0.6 ± 0.3 cm(2)/m(2) to 0.8 ± 0.3 cm(2)/m(2). Aortic regurgitation decreased from grade 2.0 ± 1.1 to 0.4 ± 0.5 overall. No differences in New York Heart Association class improvement or survival during follow-up were observed. One patient required reoperation for symptomatic PPM 426 days after implantation., Conclusions: Valve-in-valve implantation can be performed in high-risk surgical patients to avoid reoperation. However, PPM frequently occurs, making adequate patient selection crucial. Small bioprostheses (<23 mm) should be avoided. Implantation into 23-mm xenografts can be recommended only for patients with a body surface area less than 1.8 m(2). Larger prostheses seem to carry a lower risk for PPM. Although no delay in clinical improvement was seen at short-term, 1 PPM-related surgical intervention raises concern regarding long-term performance., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: Transcatheter aortic valve implantation (TAVI) has recently been advocated to decrease perioperative risk in high-risk patients. In this propensity-score analysis we compared outcomes after TAVI to those after surgical aortic valve replacement (AVR)., Methods: From June 2009 through June 2010, 82 consecutive patients underwent TAVI via a transapical (n = 60) or transfemoral (n = 22) approach using the Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, Calif). Mean patient age was 81.9 ± 5.2 years, 64.6% were women. Logistic EuroSCORE was 23.6% ± 1.4% and Society of Thoracic Surgeons score was 8.7% ± 1.3%. A group of 82 patients after surgical AVR was retrieved from our database, yielding a control group that was matched to the cases with respect to baseline demographics and typical risk factors., Results: Overall mortality did not differ significantly between TAVI and AVR groups at 30 days (7.3% vs 8.6%), 90 days (13.6% vs 11.1%), or 180 days (17.8% vs 16.9%; P = .889). Conversion to surgery was necessary in 2 (2.4%) TAVI cases. Perioperative stroke occurred in 2 (2.4%) cases per group. Pacemakers were implanted for new-onset heart block in 3.7% and 2.4% in the TAVI and AVR groups, respectively (P = 1.0). TAVI resulted in shorter operative times (P < .001), shorter ventilation times (P < .001), and shorter length of stay in the intensive care unit (P = .008). Duration of hospital stay, however, was not significantly different (P = .11)., Conclusions: In our experience, mortality rates are similar after both types of procedure. Patients receiving TAVI benefit from faster postoperative recovery. Until more clinical data become available, the optimal procedure has to be determined for each patient according to individual risk factors., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: We investigated our experience with combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) as an alternative strategy in high-risk patients., Background: Combined surgical aortic valve replacement and coronary artery bypass grafting are the gold standard treatment for patients with aortic stenosis and concomitant coronary artery disease. However, a substantial share of patients is unfit for surgery due to contraindications., Methods: Twenty-eight patients (15 female) underwent combined TAVI and PCI after being refused for surgery. In 21 patients (group 1) a staged approach of PCI prior to subsequent TAVI was chosen. Seven patients (group 2) were treated in a single-stage procedure., Results: Mean patient age was 80.1 ± 6.9 years, pre-procedural risk assessment revealed a mean logEuroSCORE of 26.8 ± 13.4%. Left ventricular ejection fraction was 45.6 ± 11.1%. Baseline mean/peak transvalvular gradients were 40.2 ± 16.8 and 65.6 ± 26.6 mmHg, respectively, and decreased to mean/peak values of 9.3 ± 4.2/15.2 ± 8.4 mmHg (p < 0.0001), effective orifice area increased from 0.73 ± 0.25 to 1.74 ± 0.47 cm(2) (p < 0.0001). In group 2, fluoroscopy time and amount of contrast agent were significantly higher compared to group 1 (18.1 ± 9.2 vs. 9.5 ± 7.0 min; p = 0.03/292.3 ± 117.5 vs. 171.9 ± 68.4 ml; p = 0.006). In group 1, patients received PCI 14.3 ± 9.6 days prior to TAVI. In group 2, PCI was performed immediately before TAVI. A mean of 1.6 ± 1.0 stents was placed per patient. No periprocedural myocardial infarction or stroke occurred in any patient. Thirty-day mortality was 7.1% (2/28)., Conclusion: Our strategy of staged or single-stage TAVI and PCI proved feasible and safe in this high-risk patient population. Whether there is advantage of one approach over the other remains to be elucidated.

A 62-year-old woman presented with shortness of breath and NYHA III. Severe heart failure was due to reduced systolic function. The woman reported of lung edema at two times. Computed tomography scan and magnetic resonance imaging showed a congenitally corrected transposition of the great arteries (CC-TGA). Echocardiographic findings revealed a high grade tricuspid regurgitation. For treatment of the tricuspid regurgitation, we used a percutaneous approach. The Evalve MitraClip(®) system has demonstrated feasibility and safety in the treatment of mitral regurgitation. Three months after successful tricuspid valve clipping, the patient is fine and NYHA score is reduced to grade I., (© 2011 Copyright the Authors. Congenital Heart Disease © 2011 Wiley Periodicals, Inc.)

Objectives: We report our experience with transcatheter valve-in-valve implantations in patients with degenerated bioprostheses in aortic and mitral position., Background: Xenograft degeneration is a potential problem after biological valve replacement. Reoperation remains the gold standard with very good short- and long-term results. In selected patients not suitable for surgery however, interventional techniques for valve implantation and repair may be valuable alternative treatment options with regard to the good results of transcatheter valve implantation for native aortic valve stenosis., Methods: Five patients presented with significant xenograft degeneration 15.4 ± 5.2 years after aortic (n = 4) and mitral (n = 1) valve replacement. Mean patient age was 82.0 ± 6.5 years and predicted operative mortality was 55.8% ± 18.9% (logistic EuroSCORE). Transcatheter valve-in-valve implantation was performed successfully through a transapical access in all patients. A 23-mm Edwards Sapien valve was deployed into the degenerated valve prosthesis., Results: Mean transvalvular gradients were reduced from 31.2 ± 17.4 to 19.0 ± 12.4 mm Hg in aortic and from 9 to 3 mm Hg in mitral position without significant regurgitation in any of these patients. Two patients died within 30 days due to low cardiac output and acute hemorrhage, respectively, one of whom presented with a EuroSCORE of 88.9%., Conclusions: With growing need for reoperative valve replacement in elderly patients with disproportional operative risks, transcatheter valve-in-valve implantation in aortic and mitral position offers an alternative treatment option. Although valve function after transcatheter implantation was good in all patients, two high risk patients died in the postoperative period due to their significant comorbidities, underscoring the bail-out character of this procedure., (© 2010 Wiley-Liss, Inc.)

Background: Air embolism in patients undergoing percutaneous interventions requiring access to the left atrium (LA) represents a potentially fatal complication. Here we tested if a decline in LA pressures following sedation represents an important mechanistic link underlying air intrusion into the LA., Methods and Results: Left atrial pressures were measured in 26 consecutive patients (49 +/- 14 years; 27% male), who underwent percutaneous atrial septal occlusion for persistent foramen ovale or secundum atrial septal defects. Patients either received sedation by propofol allowing for guidance by transesophageal echocardiography (n = 13) or underwent occluder implantation without sedation and under fluoroscopic control only (n = 13). Whereas mean expiratory LA pressures remained unchanged in either group, sedation provoked a marked decline in the mean inspiratory LA pressure as compared to non-sedated patients (Delta p 6.9 +/- 8.6 mm Hg vs. 0.1 +/- 1.2 mm Hg in nonsedated patients, P < 0.001). Ex vivo experiments evaluating the air-tightness of different sheaths in response to negative pressures revealed air aspiration at -13.4 +/- 1.2 mm Hg of suction in all cases, once a guide wire was inserted., Conclusions: Negative LA pressures in conjunction with air-leaking sheaths are identified as potentially important factors for air intrusion into the LA with the patient's sedation being a primary risk factor to lower LA pressure levels. The results advocate close monitoring of LA pressures during intervention, prevention of airway collapse and protection of LA sheaths from communication with the atmosphere, during procedures under sedation., ((c) 2008 Wiley-Liss, Inc.)

Aims Right ventricular to pulmonary artery (RV-PA) coupling has been established as a prognostic marker in patients with severe tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve interventions (TTVI). RV-PA coupling assesses right ventricular systolic function related to pulmonary artery pressure levels, which are ideally measured by right heart catheterization. This study aimed to improve the RV-PA coupling concept by relating tricuspid annular plane systolic excursion (TAPSE) to mean pulmonary artery pressure (mPAP) levels. Moreover, instead of right heart catheterization, this study sought to employ an extreme gradient boosting (XGB) algorithm to predict mPAP levels based on standard echocardiographic parameters. Methods and results This multicentre study included 737 patients undergoing TTVI for severe TR; among them, 55 patients from one institution served for external validation. Complete echocardiography and right heart catheterization data were available from all patients. The XGB algorithm trained on 10 echocardiographic parameters could reliably predict mPAP levels as evaluated on right heart catheterization data from external validation (Pearson correlation coefficient R : 0.68; P value: 1.3 × 10−8). Moreover, predicted mPAP (mPAPpredicted) levels were superior to echocardiographic systolic pulmonary artery pressure (sPAPechocardiography) levels in predicting 2-year mortality after TTVI [area under the curve (AUC): 0.607 vs. 0.520; P value: 1.9 × 10−6]. Furthermore, TAPSE/mPAPpredicted was superior to TAPSE/sPAPechocardiography in predicting 2-year mortality after TTVI (AUC: 0.633 vs. 0.586; P value: 0.008). Finally, patients with preserved RV-PA coupling (defined as TAPSE/mPAPpredicted > 0.617 mm/mmHg) showed significantly higher 2-year survival rates after TTVI than patients with reduced RV-PA coupling (81.5% vs. 58.8%, P < 0.001). Moreover, independent association between TAPSE/mPAPpredicted levels and 2-year mortality after TTVI was confirmed by multivariate regression analysis (P value: 6.3 × 10−4). Conclusion Artificial intelligence–enabled RV-PA coupling assessment can refine risk stratification prior to TTVI without necessitating invasive right heart catheterization. A comparison with conservatively treated patients is mandatory to quantify the benefit of TTVI in accordance with RV-PA coupling. [ABSTRACT FROM AUTHOR]