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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.)

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.)

Background: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established., Objectives: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study., Methods: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year., Results: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline)., Conclusions: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life., Competing Interests: Funding Support and Author Disclosures This work was supported by Edwards Lifesciences. Prof Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Schmitz has received speaker fees and proctor honorarium from Edwards Lifesciences and Abbott. Dr Geisler has received personal fees (lecture honoraria) and institutional research grants from Edwards Lifesciences. Dr Hausleiter is a consultant and receives speaker fees and institutional research support from Edwards Lifesciences. Prof Eitel has received research grants from Abbott Vascular and speaker fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Lubos has received grants from Abbott and personal fees from Abbott, Abiomed, AstraZeneca, Bayer, Edwards Lifesciences, New Valve Technology, and Novartis. Dr von Bardeleben is a principal investigator for Abbott, DZHK, Edwards Lifesciences, JensCare, Medtronic, NeoChord, and the University of Göttingen IIT; and serves as an advisor, proctor, or speaker for Abbott, Edwards Lifesciences, JenaValve, JensCare, Medtronic, NeoChord, Philips, and Siemens. Dr Berti has received honoraria from and is a consultant for Proctor & Gamble, Abbott, and Boston Scientific. Dr De Marco has received honoraria and consultation fees from Edwards Lifesciences. Dr Linke has received grants from Novartis and Edwards Lifesciences; personal fees from Abbott, Abiomed, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, Sanofi Genzyme, and Pfizer; and other fees from Picardia, Filterlex, and Transverse Medical outside the submitted work. Dr Hengstenberg has received institutional research grants from Edwards Lifesciences, Boston Scientific, Abbott, and Medtronic; and serves as a proctor for Edwards Lifesciences and Boston Scientific. Dr Baldus has received a research grant from Abbott; and lecture fees from Abbott and Edwards Lifesciences. Dr Spargias has received honoraria or consultation fees from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Denti is a consultant for InnovHeart, Approxima, Picardia, and HRV; and receives speaker fees from Edwards Lifesciences and Abbott. Prof Nickenig has received research funding from the Deutsche Forschungsgemeinschaft, the German Federal Ministry of Education and Research, the EU, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical; and has received honoraria for lectures or advisory boards from Abbott, AGA Medical, AstraZeneca, Bayer, Berlin, Cardiovalve, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical. Prof Möllmann has receives speaker/proctor fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Prof Rottbauer is a consultant for and receives speaker honoraria from Edwards Lifesciences. Dr Praz received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, Medira, and Siemens Healthineers. Dr Butter has received lecture fees from Edwards Lifesciences and Abbott; and educational grants from Boston Scientific. Dr Van Mieghem has received research grants from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi-Sankyo, AstraZeneca, and Teleflex; and scientific advisory fees from Anteris, JenaValve, Abbott Vascular, Boston Scientific, Medtronic, Amgen, Daiichi-Sankyo, Siemens, Pie Medical, and Teleflex. Dr Sherif is a consultant for and receives speaker honoraria from Edwards Lifesciences. Dr Swaans is a proctor/lecturer for Abbott Vascular, Boston Scientific, Bioventrix, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, Medtronic, and Philips Healthcare. Dr Witkowski is an advisory board member and has received honoraria from Abbott and Edwards Lifesciences. Dr Buch participates in the Abbott structural heart advisory group; and has received honoraria from Abbott. Prof Seidler has received honoraria for lectures, advisory boards, or travel grants from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Corvia, Cytokinetics, Edwards Lifesciences, Medtronic, Myocardia, Novartis, Pfizer, and Teleflex. Dr Eißmann has received honoraria or consultation fees from Edwards Lifesciences and Abbott Vascular. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott for which he receives no direct compensation. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and a speaker for Abbott. Dr Rassaf has received research funding from the Deutsche Forschungsgemeinschaft and Abbott; and receives honoraria for lectures or advisory boards from AstraZeneca, Bayer, Berlin Chemie, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Novartis, and Pfizer. Dr Luedike received research grants and honoraria for consulting and lectures from Edwards Lifesciences, Novartis, and Pfizer. 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.)

Background: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort., Objectives: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry., Methods: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year., Results: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year., Conclusions: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335)., Competing Interests: Funding Support and Author Disclosures The TENDER study was carried out without financial support from industry. It was initiated as an academic investigator trial by LMU University Hospital and Universitätsmedizin Mainz. Dr Baldus has received research grants and honoraria from Abbott and Edwards Lifesciences. Dr Rudolph has received speaker honoraria from Abbott. Dr Andreas has received proctoring, consulting, and speaker fees from Edwards Lifesciences, Abbott, Medtronic, Boston, Zoll, and AbbVie; and institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Duncan has received consulting fees and honoraria from Abbott, Edwards Lifesciences, Medtronic, NeoChord. Dr Nombela serves as a physician proctor for and has received advisory fees from Abbott Cardiovascular, Edwards Lifesciences, and Products + Features. Dr Ruge serves as a physician proctor for and has received advisory fees from Abbott Medical. Dr Conradi serves as an advisory board member for Abbott, Medtronic, and JenaValve; and is a consultant for Edwards Lifesciences, Boston Scientific, MicroPort, Pi-Cardia. Dr Dumonteil has received consulting and proctoring fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Barth has received speaker and advisory fees from Abbott Cardiovascular and Edwards Lifesciences. Dr Adamo has received speaker honoraria from Abbott, Medtronic, and Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, New Valve Technology, Terumo, and Venus; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, MTEX Cardio, Venus, and Squadra; has received royalty income from and holds intellectual property rights with Edwards Lifesciences; is a shareholder (including share options) in CardioGard, Cardiovalve, Magenta, SwissVortex, Transseptal Solutions, 4Tech, and Perifect. Dr Lurz has received honoraria from ReCor Medical and Innoventric; and has received institutional grants from Edwards Lifesciences and ReCor. Dr Hausleiter has received speaker fees, research support, and advisory fees from Edwards Lifesciences. Dr von Bardeleben has received speaker or advisory fees from Abbott Cardiovascular, Edwards Lifesciences, Medtronic, NeoChord, Philips, and Siemens; and has conducted unpaid trial activity for Abbott Cardiovascular, Edwards Lifesciences, Jenscare Scientific, Medtronic, and NeoChord. 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.)

Background: History of cancer is common in patients undergoing transcatheter mitral valve repair (TMVR)., Objectives: Aim was to examine the impact of cancer history on outcomes after TMVR., Methods: In patients of a monocentric prospective registry of TMVR history of cancer was retrospectively assessed from records. Associations with 6-week functional outcomes and clinical outcomes during a median follow-up period of 594 days were examined., Results: Of 661 patients (mean age 79 years; age-range 37-101 years; 56.1% men), 21.6% had a history of cancer with active disease in 4.1%. Compared with non-cancer patients, cancer patients had a similar procedural success rate (reduction of mitral regurgitation to grade 2 or lower 91.6% vs. 88%; p = 0.517) and similar relevant improvement in 6-min walking distance, NYHA class, Minnesota Living with Heart Failure Questionnaire score and Short Form 36 scores. 1-year survival (83% vs. 82%; p = 0.813) and 1-year survival free of heart failure decompensation (75% vs. 76%; p = 0.871) were comparable between cancer and non-cancer patients. Patients with an active cancer disease showed significantly higher mortality compared with patients having a history of cancer (hazard ratio 2.05 [95% CI 1.11-3.82; p = 0.023]) but similar mortality at landmark analysis of 1 year., Conclusion: TMVR can be performed with equal efficacy in patients with and without cancer and symptomatic mitral regurgitation. Cancer patients show comparable clinical outcome and short-term functional improvement as non-cancer patients. However, longterm mortality was increased in patients with active cancer underlining the importance of patient selection within the heart-team evaluation., (© 2023. The Author(s).)

Background: Transcatheter repair emerges as a treatment option in patients with tricuspid regurgitation (TR) and high surgical risk., Aims: This study aimed to compare leaflet-based and annuloplasty-based transcatheter repair in patients with TR., Methods: In a retrospective analysis consecutive patients undergoing either transcatheter edge-to-edge repair (TEER) or direct annuloplasty (AP) for relevant TR at 2 centers were compared with respect to baseline characteristics, procedural efficacy and safety (death, myocardial infarction, procedure or device-related cardiothoracic surgery, or stroke at 30 days)., Results: 161 patients (57% female, median age 79 [75-82] years) with comparable clinical baseline characteristics in the TEER (n = 87) and AP (n = 74) group were examined. Baseline TR grade was significantly less severe in the TEER compared to the AP group (torrential 9.2 vs. 31.1%, p = 0.001). Technical success and improvement of TR grades were not significantly different across groups. In analysis matched for baseline TR severity, reduction of TR grade to less than moderate was significantly more common in the AP group (47.8 vs. 26.1%, p = 0.031). Major or more severe bleeding occurred in 9.2% of TEER and 20.3% of AP patients (p = 0.049) without any fatal bleedings. Major adverse events (MAE) were similar across groups with four patients (4.7%) in the TEER group and five patients (6.9%) in the AP group (p = 0.733) and 6-month survival did not differ significantly., Conclusions: Differences observed between patients treated with TEER and AP provide first evidence for tailoring distinct transcatheter treatment techniques to individual patient characteristics., (© 2023. The Author(s).)

Background: We previously reported procedural and 30-day outcomes of a German early multicenter experience with the PASCAL system for severe mitral regurgitation (MR). This study reports 1-year outcomes of mitral valve transcatheter edge-to-edge repair with the PASCAL system according to MR etiology in a large all-comer cohort., Methods and Results: Clinical and echocardiographic outcomes up to 1-year were investigated according to MR etiology (degenerative [DMR], functional [FMR], or mixed [MMR]) in the first 282 patients with symptomatic MR 3+/4+ treated with the PASCAL implant at 9 centers in 2019. A total of 282 patients were included (33% DMR, 50% FMR, 17% MMR). At discharge, MR reduction to ≤1+/2+ was achieved in 58%/87% of DMR, in 75%/97% of FMR, and in 78%/98% of patients with MMR ( P =0.004). MR reduction to ≤1+/2+ was sustained at 30 days (50%/83% DMR, 67%/97% FMR, 74%/100% MMR) and at 1 year (53%/78% DMR, 75%/97% FMR, 67%/91% MMR) with significant differences between etiologies. DMR patients with residual MR 3+/4+ at 1-year had at least complex valve morphology in 91.7%. Valve-related reintervention was performed in 7.4% DMR, 0.7% FMR, and 0.0% MMR ( P =0.010). At 1-year, New York Heart Association Functional Class was significantly improved irrespective of MR etiology ( P <0.001)., Conclusions: In this large all-comer cohort, mitral valve transcatheter edge-to-edge repair with the PASCAL system was associated with an acute and sustained MR reduction at 1-year in all causes. However, in patients with DMR, MR reduction was less pronounced, reflecting the high incidence of complex or very complex anatomies being referred for mitral valve transcatheter edge-to-edge repair.

Background: Coronary artery disease (CAD) is frequently diagnosed in patients with aortic valve stenosis. Treatment options include surgical and interventional approaches. We therefore analyzed short-term outcomes of patients undergoing either coronary artery bypass grafting with simultaneous aortic valve replacement (CABG + AVR) or staged percutaneous coronary intervention and transcatheter aortic valve implantation (PCI + TAVI)., Methods: From all patients treated since 2017, we retrospectively identified 237 patients undergoing TAVI within 6 months after PCI and 241 patients undergoing combined CABG + AVR surgery. Propensity score matching was performed, resulting in 101 matched pairs., Results: Patients in the CABG + AVR group were younger compared with patients in the PCI + TAVI group (71.9 ± 4.9 vs 81.4 ± 3.6 years; p  < 0.001). The overall mortality at 30 days before matching was higher after CABG + AVR than after PCI + TAVI (7.8 vs 2.1%; p  = 0.012). The paired cohort was balanced for both groups regarding demographic variables and the risk profile (age: 77.2 ± 3.7 vs78.5 ± 2.7 years; p  = 0.141) and EuroSCORE II (6.2 vs 7.6%; p  = 0.297). At 30 days, mortality was 4.9% in the CABG + AVR group and 1.0% in the PCI + TAVI group ( p  = 0.099). Rethoracotomy was necessary in 7.9% in the CABG + AVR, while conversion to open heart surgery was necessary in 2% in the PCI + TAVI group. The need for new pacemaker was lower after CABG + AVR than after PCI + TAVI (4.1 vs 6.9%; p  = 0.010). No paravalvular leak (PVL) was noted in the CABG + AVR group, while the incidence of moderate-to-severe PVL after PCI + TAVI was 4.9% ( p  = 0.027)., Conclusion: A staged interventional approach comprises a short-term survival advantage compared with combined surgery for management of CAD and aortic stenosis. However, PCI + TAVI show a significantly higher risk of atrioventricular block and PVL. Further long-term trials are warranted., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Transcatheter mitral valve implantation (TMVI) with self-expanding (SAV) or balloon-expandable (BAV) valves are rising as promising treatment options for high-risk patients with symptomatic mitral valve (MVD) disease unsuitable for alternative treatment options., Aims: The aim of this study was to examine the clinical, procedural and outcome parameters of patients undergoing SAV or BAV for MVD., Methods: In this observational and single-center case series, fifteen consecutive patients treated with the Tendyne Mitral Valve System (SAV) and thirty-one patients treated with SAPIEN prosthesis (BAV) were included., Results: The patients (aged 78 years [interquartile range (IQR): 65.5 to 83.1 years], 41% women, EuroSCORE II 10.3% [IQR: 5.5 to 17.0%] were similar regarding baseline characteristics, despite a higher rate of prior heart valve surgery and prevalence of MV stenosis in the SAV-group. At discharge, the SAV-group had a mean transvalvular gradient of 4.2 mmHg, whereas the BAV-group had a mean transvalvular gradient of 6.2 mmHg. None or trace paravalvular leakage (PVL) was assessed in 85% in SAV-group and 80% in the BAV-group. 320 day all-cause and cardiac mortality rates were comparable in both groups (SAV: 26.7% vs BAV: 20%, p = 0.60). Four deaths occurred early in the SAV-group until 32 days of follow-up., Conclusions: In high-risk patients with MVD, TMVI presents a promising treatment option with encouraging mid-term outcomes and good valve durability. TMVI either with BAV or SAV may be developed to an established treatment option., (© 2022. The Author(s).)

Background: Transcatheter aortic valve replacement (TAVR) has become an established alternative to surgical aortic valve replacement (AVR) for higher risk patients. Periprocedural TAVR complications decreased with a growing expertise of implanters. Yet, TAVR can be accompanied by life-threatening adverse events such as intraprocedural cardiopulmonary resuscitation (CPR). This study retrospectively analyzed predictors and outcomes in a cohort of patients from a high-volume center undergoing periprocedural CPR during TAVR., Methods: A total of 729 patients undergoing TAVR, including 59 with intraprocedural CPR, were analyzed with respect to peri- and postprocedural outcomes., Results: Patients undergoing CPR showed a significantly lower left ventricular ejection fraction (LVEF) and lower baseline transvalvular mean and peak pressure gradients. The systolic blood pressure measured directly preoperatively was significantly lower in the CPR cohort. CPR patients were in a higher need for intraprocedural defibrillation, heart-lung circulatory support, and conversion to open heart surgery. Further, they showed a higher incidence of atrioventricular block grade III , valve malpositioning, and pericardial tamponade. The in-hospital mortality was significantly higher after intraprocedural CPR, accompanied by a higher incidence of disabling stroke, new pacemaker implantation, more red blood cell transfusion, and longer stay in intensive care unit., Conclusion: Impaired preoperative LVEF and instable hemodynamics before valve deployment are independent risk factors for CPR and are associated with compromised outcomes. Heart rhythm disturbances, malpositioning of the prosthesis, and pericardial tamponade are main causes of the high mortality of 17% reported in the CPR group. Nevertheless, mechanical circulatory support and conversion to open heart surgery reduce mortality rates of CPR patients., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to assess short-term outcomes of patients with failed aortic valve bioprosthesis undergoing valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) or redo surgical aortic valve replacement (rSAVR)., Methods: Between 2009 and 2019, 90 patients who underwent ViV-TAVR ( n  = 73) or rSAVR ( n  = 17) due to failed aortic valve bioprosthesis fulfilled the inclusion criteria. Groups were compared regarding clinical end points, including in-hospital all-cause mortality. Patients with endocarditis and in a need of combined cardiac surgery were excluded from the study., Results: ViV-TAVR patients were older (78.0 ± 7.4 vs. 62.1 ± 16.2 years, p  = 0.012) and showed a higher prevalence of baseline comorbidities such as atrial fibrillation, diabetes mellitus, hyperlipidemia, and arterial hypertension. In-hospital all-cause mortality was higher for rSAVR than in the ViV-TAVR group (17.6 vs. 0%, p  < 0.001), whereas intensive care unit stay was more often complicated by blood transfusions for rSAVR patients without differences in cerebrovascular events. The paravalvular leak was detected in 52.1% ViV-TAVR patients compared with 0% among rSAVR patients ( p  < 0.001)., Conclusion: ViV-TAVR can be a safe and feasible alternative treatment option in patients with degenerated aortic valve bioprosthesis. The choice of treatment should include the patient's individual characteristics considering ViV-TAVR as a standard of care., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background: Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary., Objectives: The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy., Methods: Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee., Results: The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm 2 , and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001)., Conclusions: The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833)., Competing Interests: Funding Support and Author Disclosures The PASCAL IID registry is funded by Edwards Lifesciences. Dr Hausleiter is a consultant and receives speaker honoraria and institutional research support from Edwards Lifesciences. Dr Lim is a consultant for Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. 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 for and receives research grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant for and receives research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Goldman has provided 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 receives 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; receives institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and serves on the scientific advisory for and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Lurz receives institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr O’Neill is a consultant for Abiomed, BSCI, and Abbott; and was previously a consultant (expired) 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; receives 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; is the 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 receives travel support from Edwards Lifesciences and Abbott/St Jude Medical; has received speaking honoraria from Edwards Lifesciences and Boston Scientific; and is a consultant for Edwards Lifesciences and Abbott. Dr Inglessis-Azuaje is a proctor and serves as a lecturer for Edwards Lifesciences; is a consultant and proctor for Medtronic; and is a lecturer for Boston Scientific. Dr Baldus receives research funding from Abbott; and has received lecturing fees from Edwards Lifesciences, Abbott and Medtronic. 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 Smith is on the CLASP IID trial leadership team and receives institutional grant and travel support for device evaluation from Edwards Lifesciences; receives institutional grants from Artivion; and received honoraria for speaking from Artivion and Medtronic. Dr Rodés-Cabau receives institutional research grants and speaker fees from Edwards Lifesciences. Dr Whisenant is a consultant for Edwards Lifesciences and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Secondary mitral regurgitation (SMR) is a progressive disease with characteristic pathophysiological changes that may influence prognosis. Although the staging of SMR patients suffering from heart failure with reduced ejection fraction (HFrEF) according to extramitral cardiac involvement has prognostic value in medically treated patients, such data are so far lacking for edge-to-edge mitral valve repair (M-TEER)., Objectives: This study sought to classify M-TEER patients into disease stages based on the phenotype of extramitral cardiac involvement and to assess its impact on symptomatic and survival outcomes., Methods: Based on echocardiographic and clinical assessment, patients were assigned to 1 of the following HFrEF-SMR groups: left ventricular involvement (Stage 1), left atrial involvement (Stage 2), right ventricular volume/pressure overload (Stage 3), or biventricular failure (Stage 4). A Cox regression model was implemented to investigate the impact of HFrEF-SMR stages on 2-year all-cause mortality. The symptomatic outcome was assessed with New York Heart Association functional class at follow-up., Results: Among a total of 849 eligible patients who underwent M-TEER for relevant SMR from 2008 until 2019, 9.5% (n = 81) presented with left ventricular involvement, 46% (n = 393) with left atrial involvement, 15% (n = 129) with right ventricular pressure/volume overload, and 29% (n = 246) with biventricular failure. An increase in HFrEF-SMR stage was associated with increased 2-year all-cause mortality after M-TEER (HR: 1.39; CI: 1.23-1.58; P < 0.01). Furthermore, higher HFrEF-SMR stages were associated with significantly less symptomatic improvement at follow-up., Conclusions: The classification of M-TEER patients into HFrEF-SMR stages according to extramitral cardiac involvement provides prognostic value in terms of postinterventional survival and symptomatic improvement., Competing Interests: Funding Support and Author Disclosures Dr Orban has received speaker fees from Abbott Vascular and Tomtec Imaging Systems. Dr Karam has received consultant fees from Edwards Lifesciences and Medtronic; and has received proctor fees from Abbott. Dr von Bardeleben has received institutional grants and has served as a speaker for Abbott Vascular and Edwards Lifesciences; and has performed trials unpaid for Abbott Vascular, Edwards Lifesciences, Lifetec, Medtronic, and NeoChord. Dr Iliadis has received travel support from Abbott; and has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Pfister has received consultancy and speaker fee from Edwards Lifesciences; and has received speaker fee by Abbott Vascular. The Department of Cardiology of the Leiden University Medical Centre received unrestricted research grants from Abbott Vascular, Bayer, Biotronik, Bioventrix, Boston Scientific, Edwards Lifesciences, GE Healthcare, and Medtronic. Dr Higuchi has received lecture fees from Medtronic Japan, Daiichi Sankyo, and Ono Pharmaceutical Company. Dr Petronio has received consulting fees and honoraria for lectures from Abbott and Medtronic; has received consulting fees from Boston; and has received honoraria fees from Daiichi Sankyo. Dr Melica has served as a proctor for Abbott Vascular. Dr Braun has received speaker honoraria from Abbott Vascular. Dr Windecker reports research and educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson and Johnson, Medicure, Medtronic, Merck Sharp and Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave. Dr Windecker serves as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers. Dr Windecker is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Praz has received travel expenses from Abbott Vascular, Polares Medical, and Edwards Lifesiences. Dr Kalbacher has received proctor and lecture fees from Edwards Lifesciences; and has received lecture fees from Abbott Vascular. Dr Lurz has received grants from Abbott Medical and Edwards Lifesciences. Dr Bax has received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Hausleiter has received research support and speaker honoraria from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Body surface area (BSA) has been reported to be the stronger predictor for prognosis than body mass index in heart failure (HF) patients. The sex-specific association of BSA with mortality has been unclear., Methods: EuroSMR, a European multicenter registry, included patients who underwent edge-to-edge repair (TEER) for secondary mitral regurgitation (SMR). The outcome was two-year all-cause mortality., Results: The present cohort included 1594 HF patients (age, 74 ± 10 years; male, 66%). Association of calculated BSA with two-year all-cause mortality was evaluated. Patients were classified into three BSA groups: the lowest 10% (S), the highest 10% (L), and intermediate between S and L (M). Mean BSA was 1.87 ± 0.21 m 2 (male, 1.94 ± 0.18 m 2 ; female, 1.73 ± 0.18 m 2 ). The association of BSA with the endpoint in females showed a U-shaped curve, indicating worse prognosis for both S and L. The association in males followed a linear regression, demonstrating better prognosis for L. Hazard ratio (HR) of L to S in males was 0.43 (95% confidence interval [CI], 0.25-0.74; p = 0.002), whereas HR of L to M in females was 1.76 (95% CI, 1.11-2.78; p = 0.016) (p for interaction = 0.003)., Conclusions: Sex-specific association patterns demonstrate the complex influence of anthropomorphic factors in HF patients scheduled for TEER. Further investigation beyond simple evaluation of weight and height is needed for better comprehension of the obesity paradox and better prediction of the results of transcatheter therapy in HF patients., Competing Interests: Conflicts of interest Dr. Higuchi has received lecture fees from Medtronic Japan, Daiichi Sankyo, and Ono Pharmaceutical Company. Dr. Orban has received speaker fees from Abbott Vascular and Tomtec Imaging Systems. Dr. Adamo has received payment from Abbott and Medtronic. Dr. Melica has received consulting fee and honoraria for lectures from Abbott and honoraria for lectures from Edwards. Dr. Karam has received consultant fees from Abbott Vascular. Dr. Praz has received travel expenses from Abbott Vascular, Polares Medical and Edwards. LifesciencesDr. Kalbacher has received lecture fees and travel expenses by Abbott and proctor and lecture fees as well as travel expenses by Edwards Lifesciences. Dr. Schofer has received personal fees from Boston Scientific and travel compensation from Abbott Vascular and Edwards Lifesciences. Dr. Ludwig has received travel compensation from Abbott Vascular. Dr. Braun has received speaker honoraria from Abbott Vascular. Dr. Windecker has received grants from Abbott, Amgen, Astra Zeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi-Aventis, Sinomed, Terumo, and V-wave. Dr. Pfister has received consulting fees from Edwards Lifesciences, honoraria for lectures and financial support for attending symposia by Abbott Vascular, and honoraria for lectures from Edwards Lifesciences. Dr. von Bardeleben has received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr. Lurz has received grants from Abbott Vascular, Edwards Lifesciences, and ReCor Medical. Dr. Petronio has received consulting fees and honoraria for lectures from Abbott and Medtronic, consulting fee from Boston, and honoraria fee from Daiichi Sankyo. Dr. Hausleiter has received research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: In addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking., Objectives: The aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems., Methods: Procedural and 30-day outcomes were investigated in a propensity score-matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE)., Results: Technical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562)., Conclusions: In this first large propensity score-matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome., Competing Interests: Funding Support and Author Disclosures Dr Iliadis has received travel support from Abbott; and has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Hausleiter has received research grants and speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr Möllmann has received speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Rudolph has received research grants and consulting honoraria from Edwards Lifesciences. Dr von Bardeleben has received consulting and lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Edwards Lifesciences, NeoChord, and Medtronic. Dr Nef has received speaker and consulting honoraria from Abbott Vascular and Edwards Lifesciences. Dr Luedike has received consulting and lecture honoraria from Edwards Lifesciences. Drs Pfister and Baldus have received consulting honoraria from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery., Methods: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated., Results: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001)., Conclusion: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report., (© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Among patients with severe functional mitral regurgitation (FMR), atrial functional mitral regurgitation (aFMR) represents an underrecognized entity. Data regarding outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) in aFMR remain scarce., Objectives: The objective of this study was to analyze the outcome of aFMR patients undergoing M-TEER., Methods: Using patients from the international EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry undergoing M-TEER for FMR, the authors analyzed baseline characteristics and 2-year outcomes in aFMR in comparison to non-aFMR and ventricular FMR. Additionally, the impact of right ventricular dysfunction (RVD) (defined as right ventricular to pulmonary artery uncoupling) on outcome after M-TEER was assessed., Results: Among 1,608 FMR patients treated by M-TEER, 126 (7.8%) were categorized as aFMR. All 126 aFMR patients had preserved left ventricular function without regional wall motion abnormalities, left arterial dilatation and Carpentier leaflet motion type I. Procedural success (defined as mitral regurgitation ≤2+ at discharge) was 87.2% (P < 0.001) and New York Heart Association (NYHA) functional class significantly improved during follow-up (NYHA functional class III/IV: 86.5% at baseline to 36.6% at follow-up; P < 0.001). The estimated 2-year survival rate in aFMR patients was 70.4%. Two-year survival did not differ significantly between aFMR, non-aFMR, and ventricular FMR. Besides NYHA functional class IV, RVD was identified as a strong independent predictor for 2-year survival (HR: 2.82 [95% CI: 1.24-6.45]; P = 0.014)., Conclusions: aFMR is a frequent cause of FMR and can be effectively treated with M-TEER to improve symptoms at follow-up. Advanced heart failure symptoms and RVD were identified as important risk factors for survival in aFMR patients., Competing Interests: Funding Support and Author Disclosures Dr Stolz has received travel expenses from Edwards LifeSciences. Dr Orban has received speaker honoraria from Abbott Vascular and Abbot Medical; and has received speaker fees from TOMTEC Imaging Systems. Dr Karam has received speaker honoraria from Abbott Vascular; and has received consultant fees from Abbott Medical. Dr Praz has received travel expenses from Abbott Medical and Edwards LifeSciences. Dr Kalbacher has received speaker honoraria and travel expenses from Abbott Medical; and has received speaker honoraria, travel expenses, and proctor fees from Edwards LifeSciences. Dr Lubos has received speaker honoraria and research grants from Abbott Medical. Dr Braun has received speaker honoraria from Abbott Vascular. Dr Melica has received proctor fees from Abbott Medical. Dr Näbauer has received speaker honoraria from Abbott Vascular. Dr Higuchi has received lecture fees from Medtronic Japan, Daiichi Sankyo, and Ono Pharmaceutical Company. Dr Pfister has received speaker honoraria and travel expenses from Abbott Medical. Dr Iliadis has received consultant fees and travel expenses from Abbott Medical; and has received consultant fees from Edwards LifeSciences. Dr Baldus has received speaker honoraria from Abbott Medical and Edwards LifeSciences; and has received research grants from Abbott Medical. Dr Schofer has received travel expenses from Abbott Medical and Edwards LifeSciences. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi-Aventis, Sinomed, and Terumo, V-Wave; serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; and is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Lurz has received speaker honoraria and consultant fees from Abbott Medical. Dr Metra has received consultant fees from Abbott Medical; and has received speaker honoraria from Edwards LifeSciences. Dr Hausleiter has received speaker honoraria from and serves as consultant for Abbott Vascular and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: A sizeable proportion of patients with secondary mitral regurgitation (SMR) do not receive guideline-directed medical therapy (GDMT) for heart failure (HF). We investigated the association between the use of GDMT and mortality in patients with SMR who underwent transcatheter edge-to-edge repair (TEER)., Methods: We retrospectively analysed patients with SMR and a left ventricular ejection fraction of <50% who underwent TEER at three centres. According to current HF guidelines, GDMT was defined as triple therapy consisting of beta-blockers, renin-angiotensin system (RAS) inhibitors and mineralocorticoid receptor antagonists (MRAs). Patients were divided into two groups: GDMT and non-GDMT groups. We calculated the propensity scores and carried out inverse probability of treatment weighting (IPTW) analyses to compare 2-year mortality between the two groups., Results: Of 463 patients, 228 (49.2%) were treated with GDMT upon discharge. IPTW-adjusted Kaplan-Meier curve showed patients with GDMT had a lower incidence of mortality than those without GDMT (19.8% vs 31.1%, p=0.011). In IPTW-adjusted Cox proportional hazards analysis, GDMT was associated with a reduced risk of 2-year mortality (HR: 0.58; 95% CI: 0.35 to 0.95; p=0.030), which was consistent among clinical subgroups. Moreover, patients with GDMT had a higher rate of left ventricular reverse remodelling at 1 year after TEER than those without GDMT., Conclusion: GDMT, defined as triple therapy consisting of beta-blockers, RAS inhibitors and MRAs, was associated with a reduced risk of 2-year mortality after TEER for SMR. Optimisation of medical therapy is crucial to improve clinical outcomes in patients undergoing TEER for SMR., Competing Interests: Competing interests: RP has received speaker and consultant honoraria from Abbott and Edwards Lifesciences, outside the submitted work. GN has received research funding from the Deutsche Forschungsgemeinschaft, the German Federal Ministry of Education and Research, the European Union, Abbott, Edwards Lifesciences, Medtronic and St Jude Medical; and has honoraria for lectures or advisory boards from Abbott, Edwards Lifesciences, Medtronic and St Jude Medical. SB has received lecture honoraria from Edwards Lifesciences, Bayer Vital, CVRx, MSD Sharp&Dome, JenaValve Technology and Abbott; and research grants from IcoVifor, Symetis SA, Pfizer, JenaValve Technology, Valtech, OptumInsight, Biotronik and Abbott, outside the submitted work. CI has received travel support from Abbott and speaker and consultant honoraria from Abbott and Edwards Lifesciences, outside the submitted work. TT has been financially supported in part by a fellowship from the Japanese College of Cardiology. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess temporal trends of patient baseline characteristics, risk profile and outcome of transcatheter aortic valve implantation (TAVI) between 2013 and 2020., Background: Guideline recommendations and increasing confidence in TAVI therapy may have changed the selection of TAVI patients., Methods: Baseline risk profile and VARC-2 outcome of 15,344 patients undergoing TAVI at 5 high volume centers in Germany over the time period 2013-2020 was analyzed., Results: Over the 8 years, annual TAVI volumes more than doubled from 1071 in 2013 to 2996 in 2020. The baseline surgical risk estimated by the Society of Thoracic Surgeons (STS) score declined from 7.2 ± 6.2% to 4.6 ± 3.7% (P < 0.001) as a consequence of lower comorbidity burden, whereas mean age remained unchanged (2013 81.0 ± 6.1; 2020 80.8 ± 6.4; P = 0.976) with patients ≥ 80 years accounting for about two-third of the treated cohort. Periprocedural complications including bleeding (2013 24.5%; 2020 12.1%; P < 0.001), vascular complications (2013 20.7%; 2020 11.7%; P < 0.001) and new permanent pacemaker implantation (2013 20.1%; 2020 13.8%, P < 0.001) decreased significantly. Similarly, the 30-day mortality decreased from 5.4% to 2.1% (P < 0.001), but remained high in high-risk patients (STS > 8% 2013 7.5%; 2020 6.9%; P = 0.778)., Conclusion: From 2013 to 2020, mortality and burden of complications following TAVI procedure significantly decreased in a large multicenter registry from Germany. Proportion of elderly patients remained stable, while the surgical risk profile decreased., (© 2021. The Author(s).)

Objective: Periinterventional stroke is one of the most feared potential complication, among patients treated with transcatheter aortic valve implantation (TAVI). The purpose of this review was to investigate the incidence of cerebrovascular events and the influence of postinterventional neurologic check-up in patients undergoing TAVI., Methods: A systematic review and meta-analysis were conducted according to the PRISMA guideline. Three separate electronic searches of the public domains Medline and Clinicaltrials.gov were performed to identify the 30-day incidence of stroke within randomized controlled trials (RCTs) and registries for patients undergoing a TAVI procedure. A meta-analysis was conducted to evaluate the 30-day incidence of stroke within RCTs. Furthermore, we pooled the RCTs in which a scheduled neurological check-up was conducted or not to investigate the effect of this intervention., Results: Twenty-three studies including 399,491 TAVI patients were included, 6370 from RCTs, 833 from cerebral-embolic protection device RCTs and 392,288 were adopted from registries. The mean 30-day incidence of stroke among all reviewed studies was 2.33%. In RCTs evaluating TAVI the pooled stroke incidence was 3.86%, among RCTs focused CEP the incidence was 6.36% and in registries the incidence was 2.29%. Ten RCTs conducted scheduled neurological check-ups, the incidence in these was 4.03% and among the remaining RCTs it was 2.47%. In the meta-analysis, the pooled 30-day stroke incidence was 3.61% (95% CI 2.57-4.79%)., Conclusion: This systematic review demonstrates that the stroke incidences following TAVI differ strongly according to the study design and neurological follow-up. Intense neurological testing increases the incidence of a stroke after TAVI., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Aims: To investigate the role of left atrial volume index (LAVi) in patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge-to-edge mitral valve repair (TEER)., Methods and Results: Outcomes were evaluated in SMR patients of a European multicentre registry according to baseline LAVi. Main analysis was performed for all-cause mortality; residual mitral regurgitation (MR) and New York Heart Association (NYHA) class improvement were analysed for patients available. A total of 1074 patients were included with a median LAVi (interquartile range) of 58 ml/m 2 (46-73). Postprocedural reduction of MR grade to ≤2+ was similar across LAVi quintiles, ranging 91%-96% (p = 0.26). Symptomatic benefit (≥1 NYHA class improvement) also did not differ by LAVi quintiles (61%-68% of patients) (p = 0.66). The risk of mortality increased by 23%-42% in the four upper quintiles compared to the bottom quintile (LAVi <42 ml/m 2 ). The hazard ratio (HR) of mortality was 1.35 (95% confidence interval [CI] 1.02-1.78, p = 0.035) associated with a LAVi >42 ml/m 2 , which was attenuated after multivariable adjustment (HR 1.18, 95% CI 0.83-1.67, p = 0.36). A significant interaction was found for MR severity and pulmonary hypertension, with an increased risk of death associated with enlarged LAVi in patients with inframedian effective regurgitant orifice area (HR 1.99, 95% CI 1.06-3.74, p = 0.032) and in patients with systolic pulmonary pressure ≤50 mmHg (HR 1.67, 95% CI 1.02-2.75, p = 0.042) in multivariable analysis., Conclusion: Procedural success and symptomatic benefit were high throughout the whole range of LAVi. The prognostic impact of left atrial enlargement was relevant in patients with less severe SMR and without pulmonary hypertension, reinforcing the need to identify patients in the early course of backward congestion to achieve good long-term outcome after TEER., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objectives: The aim of this study was to analyse the outcome of patients between 50 and 69 years of age undergoing biological or mechanical aortic valve replacement., Methods: Data were collected from the German Aortic Valve Registry. Data were analysed regarding baseline characteristics and outcome parameters such as 5-year survival, stroke and reintervention., Results: In total., 3046 patients undergoing isolated surgical aortic valve replacement between 2011 and 2012 were investigated and a propensity score matching was performed. Within this period, 2239 patients received a biological prostheses, while 807 patients received a mechanical prosthesis. Mean age in the biological group was 63.07 (±5.11) and 57.34 (±4.67) in the mechanical group (standardized mean difference 1.172). In the overall cohort, there were more female patients in the biological group (32.7% vs 28.4%) and log EuroSCORE I was higher (5.41% vs 4.26%). After propensity matching (610 pairs), there was no difference in the mortality at 5-year follow-up (12.1% biological vs 9.2% mechanical P = 0.05) nor for reoperation/reintervention (2.5% biological vs 2.0% mechanical, P = 0.546). Patients undergoing mechanical aortic valve replacement suffered from a higher stroke rate 3.3% vs 1.5% (P = 0.04) at 5-year follow-up., Conclusions: Aortic valve replacement with biological or mechanical prostheses showed similar 5-year outcomes for survival and reoperation in a propensity-matched cohort, but significantly increased stroke rate after mechanical aortic valve replacement. This could influence the choice of a mechanical valve in younger patients., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: In patients with severe mitral regurgitation (MR) who are scheduled for transcatheter mitral valve repair (TMVR), risk stratification is predominantly based on surgical risk scores., Aims: We sought to characterise and define stages of right heart remodelling in patients undergoing TMVR and evaluate the impact of this staging classification on survival., Methods: According to echocardiographic parameters, 929 patients undergoing MitraClip treatment were classified into three stages: severe MR without right heart damage (stage 0), with moderate-to-severe tricuspid regurgitation (TR) (stage 1), with right ventricular dysfunction defined as a reduced fractional area change <35% and a tricuspid annular plane systolic excursion <17 mm, or with increased right atrial area >25 cm 2 and/or indexed right ventricular volume >30 ml/m 2 (stage 2). We compared clinical outcomes and performed a multivariate analysis to evaluate the predictive value of the extent of cardiac damage., Results: Rates of one-year all-cause mortality increased with more advanced stages of right heart remodelling (stage 0: 8% vs stage 1: 9.7% vs stage 2: 18.1%; p<0.001). In the multivariate analysis, advanced cardiac damage was an independent predictor of one-year all-cause mortality (stage 2: p=0.007)., Conclusions: A simple staging classification objectively characterises the extent of right heart remodelling caused by MR and allows risk prediction in patients undergoing a MitraClip procedure.

Background: In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) and heart failure with severely reduced ejection fraction, prediction of postprocedural left ventricular ejection fraction (LVEF) improvement is challenging. Decision-making and timing for implantable cardioverter defibrillator (ICD) treatment are difficult and benefit is still unclear in this patient population., Objective: Aims of the study were to analyse long-term overall mortality in TAVI-patients with a preprocedural LVEF ≤ 35% regarding LVEF improvement and effect of ICD therapy., Methods and Results: Retrospective analysis of a high-risk TAVI-population suffering from severe AS and heart failure with a LVEF ≤ 35%. Out of 1485 TAVI-patients treated at this center between January 2013 and April 2018, 120 patients revealed a preprocedural LVEF ≤ 35% and had sufficient follow-up. 36.7% (44/120) of the patients suffered from persistent reduced LVEF without a postprocedural increase above 35% within 1 year after TAVI or before death, respectively. Overall mortality was neither significantly reduced by LVEF recovery above 35% (p = 0.31) nor by additional ICD treatment in patients with persistent LVEF ≤ 35% (p = 0.33)., Conclusion: In high-risk TAVI-patients suffering from heart failure with LVEF ≤ 35%, LVEF improvement to more than 35% did not reduce overall mortality. Patients with postprocedural persistent LVEF reduction did not seem to benefit from ICD treatment. Effects of LVEF improvement and ICD treatment on mortality are masked by the competing risk of death from relevant comorbidities., (© 2021. The Author(s).)

Aims: Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI., Methods and Results: From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0-83.0, EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (n = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT., Conclusion: This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort., Method and Results: All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p = 0.41)., Conclusion: In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Recurrent mitral regurgitation (MR) following MitraClip has not been thoroughly investigated. We aimed to examine the predictive factors, morphology, and long-term outcome of recurrent MR after MitraClip., Methods: We assessed data from the Heart Failure Network Rhineland registry from August 2010 to October 2018. Competing risk analyses were performed using the Fine and Gray model to assess the risk of recurrent MR., Results: Among 685 MitraClip patients with a reduction in MR to ≤2+, 61 patients developed recurrent MR within the first 12 months. Flail leaflet (hazard ratio, 3.68; P =0.002) and residual MR (MR grade 2+ versus ≤1+: hazard ratio, 2.56; P =0.03) were the predictors of recurrent MR in primary MR patients, while left atrial volume (per 10 mL increase: hazard ratio, 1.11; P <0.001) and residual MR (hazard ratio, 2.45; P =0.01) were independently associated with recurrent MR in secondary MR patients. In primary MR patients, loss of leaflet insertion or leaflet tear were the predominant morphologies with recurrent MR. In secondary MR patients, more than half of the patients with recurrent MR did not show any disorder of the clip or leaflets. Patients with recurrent MR were more likely to experience unplanned heart failure hospitalization or heart failure symptom with New York Heart Association scale III/IV (54.1% versus 37.8%; P =0.018) and undergo a repeat mitral valve intervention (9.8% versus 2.2%; P =0.005) during the follow-up. In the landmark survival analysis, patients with recurrent MR tended to have lower long-term survival (58.7% versus 83.9%; P =0.08) than patients without recurrent MR., Conclusions: Flail leaflet and residual MR were the predictors of recurrent MR in primary MR patients, while a larger left atrial volume and residual MR were associated with recurrent MR in secondary MR patients, which may be associated with long-term clinical outcomes of patients after MitraClip.

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.)

Objectives: The aim of this study was to examine predictors and impact of postoperative delirium (POD) on outcome after percutaneous repair of mitral and tricuspid valves., Background: POD is common in elderly patients and contributes to increased health care costs and worse outcome. Predictors of POD in percutaneous mitral or tricuspid valve procedures are unclear., Methods: In a prospective single-center study, patients were screened for POD using the Confusion Assessment Method on the first and second postprocedural days, and up until 7 days in patients with clinical suspicion of delirium. Associations of POD with baseline characteristics, periprocedural outcome and mid-term mortality were examined., Results: One hundred and seventy-seven patients were included (median age 78 years [72-82], 41.8% female) and median (IQR) follow-up was 489 (293-704) days. Patients developing POD (n = 16, 9%) did not differ in baseline and procedural characteristics but more often received postinterventional blood transfusions (37.5% vs. 9.9%, p value = 0.007) and suffered from infections (43.8% vs. 9.9%, p value = 0.001). Patients with POD showed worse survival (HR: 2.71 [1.27-5.78]; p = 0.01), with an estimated 1-year survival of 46 ± 13% compared to 80 ± 3% in patients without POD (log-rank p value 0.007). In multivariate Cox regression, POD remained a significant predictor of mid-term mortality (HR 4.75 [1.97-11.5]; p = 0.001)., Conclusion: After percutaneous mitral or tricuspid valve repair, POD was independently associated with worse mid-term survival. Procedure- rather than patient-associated characteristics such as blood transfusions and infections emerged as important risk factors for development of POD. Considering the substantial prognostic impact of POD, further studies on its prevention are warranted to improve patient outcome., (© 2021. The Author(s).)

Aims: This multicentre study investigated the association of periprocedural changes in the levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) with clinical outcomes after transcatheter edge-to-edge mitral valve repair (TMVR)., Methods and Results: Patients were retrospectively analysed who underwent TMVR with the MitraClip system (Abbott Vascular, Santa Clara, CA, USA) and had available sequential NT-proBNP testing at baseline and 2 months after TMVR. Periprocedural changes in NT-proBNP following TMVR were assessed as the percent change in NT-proBNP between baseline and the 2 month follow-up, and the significant reduction in NT-proBNP was defined as a decrease of >30% in the follow-up NT-proBNP compared with the pre-procedural NT-proBNP level. Primary outcome was defined as a composite outcome consisting of all-cause mortality and hospitalization due to heart failure from 2 months to 2 years after TMVR. Additionally, we identified the cut-off value of pre-procedural NT-proBNP to predict the composite outcome using a receiver operating characteristic analysis (cut-off: 2485 pg/mL). Of 485 patients undergoing TMVR (age: 76.2 ± 9.2 years, female: 42.1%, secondary mitral regurgitation: 67.2%), 150 patients (30.9%) had the significant reduction in NT-proBNP (>30%) following the procedure. Patients with the NT-proBNP reduction had a lower incidence of the composite outcome, compared with those without the reduction in NT-proBNP (31.4% vs. 40.2%; log-rank P = 0.03). The significant reduction in NT-proBNP was also associated with a lower risk of the composite outcome [adjusted hazard ratio (HR): 0.67; 95% confidence interval (CI): 0.45-0.97; P = 0.04], independently of pre-procedural NT-proBNP levels and other clinical parameters. The percent change in NT-proBNP was associated with a linear trend of the incidence of the composite outcome (adjusted HR per 10% decrease: 0.96; 95% CI: 0.94-0.98; P < 0.001). A stratified analysis revealed that the prognostic impact of the significant reduction in NT-proBNP was consistent among clinical subgroups, including aetiology of mitral regurgitation (P for interaction = 0.99). Higher pre-procedural NT-proBNP level (>2485 pg/mL) was associated with the increased risk of the composite outcome (adjusted HR: 1.50; 95% CI: 1.03-2.17; P = 0.03); however, patients with a higher pre-procedural NT-proBNP who achieved the significant reduction in NT-proBNP had a similar risk of the composite outcome to those with a lower pre-procedural NT-proBNP., Conclusions: Changes in sequential NT-proBNP measurements were associated with clinical outcomes within 2 years after TMVR. The assessment of NT-proBNP dynamics may be valuable to assess the residual risk for patients undergoing TMVR and could assist with post-procedural management after TMVR., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Mitral valve repair may lead to alterations of tricuspid regurgitation (TR)., Aims: We aimed to investigate alterations, predictors and prognostic relevance of TR evolution in a large-scale multicentre population of patients undergoing transcatheter mitral valve repair (TMVR) via the MitraClip., Methods: In total, we included 531 TMVR patients with at least one available follow-up echocardiography. TR improvement was defined as a TR ≥II at baseline, which showed a decline of at least one TR categorisation., Results: Distribution of preprocedural TR severity was TR 0/I 41% (220/531), TR II 39% (209/531) and TR ≥III 19% (102/531), respectively. Follow-up echocardiography was at 308±187 days. TR severity improved to TR 0/I 49% (259/531), TR II 35% (183/531) and TR III 17% (89/531), p=0.003. Out of 311 patients with TR ≥II at baseline, 41% (127/311) showed TR improvement. Atrial fibrillation (AF), residual mitral regurgitation ≥II (rMR) and tricuspid annular diameter (TAD) remained variables which prevented TR improvement (odds ratio 0.49 [0.29-0.84], 0.47 [0.27-0.81] and 0.97 [0.93-0.997], respectively). TR improvement was associated with better event-free survival regarding post-procedural heart failure hospitalisation (HHF) (hazard ratio 0.6 [0.38-0.94]). The main changes of TR severity occurred within 3 months post TMVR (p=0.006), while there were only minor TR changes between 3 and 12 months of follow-up (p=0.813)., Conclusions: TR improvement was frequent after TMVR. Predictors preventing TR improvement were AF, post-procedural rMR, and TAD. Furthermore, TR improvement was an early phenomenon occurring primarily within the first three months post TMVR and served as a suitable marker of reduced HHF.

Background: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality., Aims: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study., Methods: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team., Results: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001)., Conclusions: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.

Objectives: The aim of this study was to develop a machine learning (ML)-based risk stratification tool for 1-year mortality in transcatheter mitral valve repair (TMVR) patients incorporating metabolic and hemodynamic parameters., Background: The lack of appropriate, well-validated, and specific means to risk-stratify patients with mitral regurgitation complicates the evaluation of prognostic benefits of TMVR in clinical trials and practice., Methods: A total of 1,009 TMVR patients from 3 university hospitals within the Heart Failure Network Rhineland were included; 1 hospital (n = 317) served as external validation. The primary endpoint was all-cause 1-year mortality. Model performance was assessed using receiver-operating characteristic curve analysis. In the derivation cohort, different ML algorithms were tested using 5-fold cross-validation. The final model, called MITRALITY (transcatheter mitral valve repair mortality prediction system) was tested in the validation cohort with respect to existing clinical scores., Results: Extreme gradient boosting was selected for the MITRALITY score, using only 6 baseline clinical features for prediction (in order of predictive importance): urea, hemoglobin, N-terminal pro-brain natriuretic peptide, mean arterial pressure, body mass index, and creatinine. In the external validation cohort, the MITRALITY score's area under the curve was 0.783 (95% CI: 0.716-0.849), while existing scores yielded areas under the curve of 0.721 (95% CI: 0.63-0.811) and 0.657 (95% CI: 0.536-0.778) at best., Conclusions: The MITRALITY score is a novel, internally and externally validated ML-based tool for risk stratification of patients prior to TMVR, potentially serving future clinical trials and daily clinical practice., Competing Interests: Funding Support and Author Disclosures The 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.)

Aims: The number of transcatheter mitral valve repair (TMVr) procedures has increased substantially during the last years. A better understanding of the relationship between hospital volume of transcatheter transvenous mitral valve repairs using MitraClip® and patient outcomes may provide information for future policy decisions to improve patient management., Methods and Results: We analysed patient characteristics and in-hospital outcomes for all TMVr procedures using MitraClip® performed in Germany from 2011 to 2017. Hospitals were stratified according to centre volumes and patients were compared for baseline characteristics and adverse in-hospital events. Overall, 24 709 inpatients were treated during the observational period. Patients treated in centres with a volume of ≤10 procedures annually developed more often pulmonary embolism (odds ratio 2.22, 95% confidence interval 1.19-4.13; P = 0.012) compared to those treated in centres with a volume of >10 procedures annually, whereas no association of centre volume (≤10 or >10) was found with in-hospital mortality (P = 0.728). Although patients treated in centres with an annual volume >25 TMVr procedures had higher numbers of comorbidities compared to those treated in centres with an annual volume of ≤25 TMVr procedures, in-hospital mortality did not differ (3.6% vs. 3.5%, P = 0.485). Similarly, when centre volumes were stratified for ≤50 vs. >50 procedural volumes, no association with in-hospital mortality was recorded (P = 0.792). A lower rate of mitral valve surgery after MitraClip® was observed over time, particularly in high-volume centres., Conclusion: Annual numbers of MitraClip® implantations increased from 2011 to 2017 in Germany, whereas in-hospital mortality remained stable. Although patients treated in high-volume centres had a more unfavourable risk profile, in-hospital mortality was comparable to that of low-volume centres., (© 2021 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background:  Rapid deployment aortic valve replacement (RDAVR) and transcatheter aortic valve implantation (TAVI) have emerged as increasingly used alternatives to conventional aortic valve replacement to treat patients at higher surgical risk. Therefore, in this single-center study, we retrospectively compared clinical outcomes and hemodynamic performance of two self-expanding biological prostheses, the sutureless and rapid deployment valve (RDV) Perceval-S (PER) and the transcatheter heart valve (THV) ACURATE neo /TF (NEO) in a 1:1 propensity-score-matching (PSM) patient cohort., Methods:  A total of 332 consecutive patients with symptomatic aortic valve stenosis underwent either singular RDAVR with PER (119) or TAVI with NEO (213) at our institutions between 2012 and 2017. To compare the unequal patient groups, a 1:1 PSM for preoperative data and comorbidities was conducted. Afterward, 59 patient pairs were compared with regard to relevant hemodynamic parameter, relevant paravalvular leak (PVL), permanent postoperative pacemaker (PPM) implantation rate, and clinical postoperative outcomes., Results:  Postoperative clinical short-term outcomes presented with slightly higher rates for 30-day all-cause mortality (PER = 5.1% vs. NEO = 1.7%, p  = 0.619) and major adverse cardiocerebral event in PER due to cerebrovascular events (transient ischemic attack [TIA]-PER = 3.4% vs. TIA-NEO = 1.7%, p  = 0.496 and Stroke-PER = 1.7% vs. Stroke-NEO = 0.0%, p  = 1). Moreover, we show comparable PPM rates (PER = 10.2% vs. NEO = 8.5%, p  = 0.752). However, higher numbers of PVL (mild-PER = 0.0% vs. NEO = 55.9%, p  = 0.001; moderate or higher-PER = 0.0% vs. NEO = 6.8%, p  = 0.119) after TAVI with NEO were observed., Conclusion:  Both self-expanding bioprostheses, the RDV-PER and THV-NEO provide a feasible option in elderly and patients with elevated perioperative risk. However, the discussed PER collective showed more postoperative short-term complications with regard to 30-day all-cause mortality and cerebrovascular events, whereas the NEO showed higher rates of PVL., Competing Interests: None declared., (Thieme. All rights reserved.)

Objectives and Background: Percutaneous edge-to-edge mitral valve (MV) repair (PMVR) is broadly applied in high-risk patients with relevant mitral regurgitation (MR). We investigated the incidence of cleft-like indentations (CLI) and their impact on PMVR., Methods and Results: In a retrospective single center analysis including 263 patients undergoing PMVR with the MitraClip®-system between 11/2012 and 7/2016, MV anatomy was assessed by 3-dimensional transesophageal echocardiography. CLI were present in 37/263 patients (14.1%). Of these, 62.2% had 1 CLI, 27% had 2 CLI, and 10.8% had 3 CLI, mostly concerning segment P2 or P2/3 of the MV. Baseline characteristics were similarly distributed. Interestingly, most patients with CLI suffered from secondary MR (n = 29, 78%). The number of deployed MitraClips was higher in patients with CLI (2 [1.25-2] vs. 2 [1, 2], p = .035), whereas procedural as well as clinical success was similar: MR grade (1.2 vs. 1.5, p = .061), vena contracta width (4.2 vs. 4.5 mm, p = .293), dPmean (4.2 vs. 4.0 mmHg, p = .618) at discharge and NYHA class at 30 days did not differ between groups. Periprocedural complications were rare and equally distributed between groups. At 30 days, MR reduction persisted in patients with CLI (95.8% of these selected patients had a MR grade ≤ 2)., Conclusions: CLI of the MV are common in patients undergoing PMVR, also when presenting mainly with secondary MR. While the number of clips needed to address MR is slightly higher in patients with CLI, procedural success rates appear not to be affected. PMVR seems to be a safe treatment option for patients with CLI., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objectives: The authors sought to assess sex-based differences in characteristics and outcomes of patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) for secondary mitral regurgitation (SMR)., Background: Subgroup analysis from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial indicated potential sex-related differences in outcomes after TMVR. The impact of sex on results after TMVR in a real-world setting is unknown., Methods: The authors assessed clinical outcomes and echocardiographic parameters in women and men undergoing TMVR for SMR between 2008 and 2018 who were included in the large, international, multicenter real-world EuroSMR registry (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation)., Results: A total of 1,233 patients, including 445 women (36%) and 788 men (64%), were analyzed. Although women were significantly older and had fewer comorbidities than men, TMVR was equally effective in women and men (mitral regurgitation [MR] grade ≤2+ at discharge: 93.2% vs. 94.6% for women vs. men; p = 0.35). All-cause mortality at 1 year (17.9% vs. 18.9%, adjusted hazard ratio: 0.806; p = 0.46) and at 2-year follow-up (26.5% vs. 26.4%, adjusted hazard ratio: 0.757; p = 0.26) were similar in women versus men after multivariate regression analysis. Durability of MR reduction, improvement in symptoms, quality of life, and functional capacity did also not differ during follow-up., Conclusions: Results from the EuroSMR registry confirmed effective and similar MR reduction with TMVR in women and men. There were no sex-related differences in clinical outcomes up to 2 years of follow-up., Competing Interests: Funding Support and Author Disclosures This work was supported by Klinikum der Universität München. Dr. Orban has received speaker honoraria from Abbott Vascular. Dr. Karam has received consultant fees from Abbott Vascular. Dr. Kalbacher has received travel expenses and lecture fees from Abbott Vascular. Dr. Pfister has received financial support for attending symposia by Abbott Vascular. Dr. Lurz has been a consultant to Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr. Windecker has received research and educational grants to his institution from Abbott, Amgen, Bayer, Bristol Myers Squibb, Biotronik, Boston Scientific, CSL Behring, Medtronic, Edwards Lifesciences, Polares, and Sinomed. Prof. Hausleiter has received speaker honoraria from and has served as consultant for Abbott Vascular and 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.)

Aims: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study., Methods and Results: Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively., Conclusions: These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.

Objectives: The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system., Background: The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture., Methods: Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE)., Results: Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%)., Conclusions: Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status., Competing Interests: Author Disclosures Drs. Pfister and Baldus have received honoraria for consulting from Edwards Lifesciences. Dr. Luedike has received honoraria for consulting and lectures from Edwards Lifesciences. Dr. Rudolph has received research grants and honoraria for consulting from Edwards Lifesciences. Dr. Hausleiter has received research grants and speaking honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr. Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr. Nef has received speaking and consulting honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Möllmann has received speaking honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr. von Bardeleben has received consulting and lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Cardiac Dimensions, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Patients undergoing percutaneous mitral valve repair (PMVR) show a substantial heterogeneity of prognostic and symptomatic benefit. Iron deficiency and anaemia are associated with worse outcomes in heart failure patients. We investigated the impact of these comorbidities on functional and clinical outcome after PMVR., Methods and Results: Iron deficiency and anaemia were prospectively assessed in 130 patients undergoing PMVR with MitraClip. Associations with functional outcomes at 6 weeks [6 min walking distance (6MWD), Short-Form-36 physical component score, and Minnesota Living with Heart Failure Questionnaire score, New York Heart Association class] and long-term clinical outcome were examined. Iron deficiency and anaemia were frequent with 52% and 50%, respectively. Patients with anaemia showed significant worse baseline functional measures, whereas patients with iron deficiency showed only a trend for lower baseline 6MWD. The benefit in functional outcomes after PMVR was notable and did not differ significantly by iron deficiency or anaemia status (range of median changes in 6MWD 35 to 45 m, physical component score 5.6 to 7.2, Minnesota Living with Heart Failure Questionnaire -8.0 to -10.5; improvement of ≥1 New York Heart Association class 69% to 80%). Anaemia was associated with higher risk for the combined endpoint of mortality and heart failure hospitalization (hazard ratio: 2.51; 95% confidence interval: 1.24-5.1; P = 0.01), whereas iron deficiency showed a trend towards more heart failure hospitalizations (hazard ratio: 2.94; 95% confidence interval: 0.94-9.03; P = 0.09)., Conclusions: The prevalence of iron deficiency and anaemia is high in patients undergoing MitraClip. Clinical baseline status and long-term outcome were worse particularly in patients with anaemia. However, the functional benefit of PMVR was equal in patients with and without iron deficiency and anaemia., (© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)