44 results on '"Koell B"'
Search Results
2. Impact of anaemia and iron deficiency on long-term outcomes following transcatheter edge-to-edge repair in degenerative vs. secondary mitral regurgitation: results from a large single-center study
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Khurrami, S, primary, Koell, B, additional, Ludwig, S, additional, Pauschinger, C, additional, Weimann, J, additional, Reichenspurner, H, additional, Conradi, L, additional, Schaefer, A, additional, Blankenberg, S, additional, Lubos, E, additional, Schofer, N, additional, and Kalbacher, D, additional
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- 2023
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3. NYHA class IV in patients with degenerative mitral regurgitation undergoing transcatheter edge-to-edge repair: Results of the worldwide, multicenter PRIME-MR registry
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Koell, B, primary, Ludwig, S, additional, Weimann, J, additional, Scotti, A, additional, Weber, M, additional, Iliadis, C, additional, Xhepa, E, additional, Dreyfus, J, additional, Paradis, J M, additional, Praz, F, additional, Modine, T, additional, Hausleiter, J, additional, Donal, E, additional, Coisne, A, additional, and Kalbacher, D, additional
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- 2023
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4. The impact of unstable results following transcatheter mitral edge-to-edge repair on long-term outcomes
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Pauschinger, C, primary, Koell, B, additional, Weimann, J, additional, Schirmer, J, additional, Reichenspurner, H, additional, Ludwig, S, additional, Conradi, L, additional, Schaefer, A, additional, Blankenberg, S, additional, Schofer, N, additional, and Kalbacher, D, additional
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- 2023
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5. Left and right ventricular hemodynamic response after transcatheter mitral valve replacement
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Strotmann, L, primary, Schrage, B N, additional, Koell, B, additional, Weimann, J, additional, Rommel, K P, additional, Waldschmidt, L, additional, Seiffert, M, additional, Schaefer, A, additional, Kirchhof, P, additional, Reichenspurner, H, additional, Blankenberg, S, additional, Schofer, N, additional, Kalbacher, D, additional, Conradi, L, additional, and Ludwig, S, additional
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- 2023
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6. C-Reactive Protein to Albumin Ratio offers superior risk prediction in patients undergoing mitral valve edge-to-edge repair: a comparison to established surgical risk scores
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Koell, B, primary, Ludwig, S, additional, Weimann, J, additional, Waldschmidt, L, additional, Schirmer, J, additional, Reichenspurner, H, additional, Blankenberg, S, additional, Conradi, L, additional, Schofer, N, additional, and Kalbacher, D, additional
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- 2022
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7. The impact of residual mitral regurgitation on outcomes in patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair
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Waldschmidt, L, primary, Koell, B, additional, Ludwig, S, additional, Weimann, J, additional, Schirmer, J, additional, Reichenspurner, H, additional, Blankenberg, S, additional, Conradi, L, additional, Schofer, N, additional, and Kalbacher, D, additional
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- 2022
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8. Outcomes of patients with severe mitral regurgitation treated with transcatheter mitral valve implantation or medical therapy
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Ludwig, S, primary, Sedighian, S, additional, Weimann, J, additional, Koell, B, additional, Waldschmidt, L, additional, Schaefer, A, additional, Seiffert, M, additional, Westermann, D, additional, Reichenspurner, H, additional, Blankenberg, S, additional, Schofer, N, additional, Lubos, E, additional, Conradi, L, additional, and Kalbacher, D, additional
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- 2022
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9. Long-Term survival and functional status in patients with elevated mitral valve pressure gradient after transcatheter mitral valve repair
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Koell, B, primary, Ludwig, S, additional, Weimann, J, additional, Waldschmidt, L, additional, Schofer, N, additional, Seiffert, M, additional, Schirmer, J, additional, Westermann, D, additional, Reichenspurner, H, additional, Blankenberg, S, additional, Lubos, E, additional, Conradi, L, additional, and Kalbacher, D, additional
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- 2021
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10. Acute hemodynamic changes and long term prognostic impact of pulmonary hypertension in patients undergoing percutaneous mitral valve edge to edge repair
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Koell, B, primary, Ludwig, S, additional, Bhadra, O, additional, Gossling, A, additional, Schofer, N, additional, Schirmer, J, additional, Conradi, L, additional, Reichenspurner, H, additional, Blankenberg, S, additional, Lubos, E, additional, and Kalbacher, D, additional
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- 2020
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11. Impact of tricuspid regurgitation and its postprocedural reduction on long term outcome in patients undergoing percutaneous mitral valve edge to edge repair
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Koell, B, primary, Ludwig, S, additional, Bhadra, O, additional, Schofer, N, additional, Schirmer, J, additional, Conradi, L, additional, Reichenspurner, H, additional, Blankenberg, S, additional, Lubos, E, additional, and Kalbacher, D, additional
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- 2020
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12. Early results of a real-world series with two transapical transcatheter mitral valve replacement devices
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Ludwig, S., primary, Kalbacher, D., additional, Schofer, N., additional, Schäfer, A., additional, Koell, B., additional, Seiffert, M., additional, Schirmer, J., additional, Schäfer, U., additional, Westermann, D., additional, Reichenspurner, H., additional, Blankenberg, S., additional, Lubos, E., additional, and Conradi, L., additional
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- 2020
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13. P3858High H2FPEF score is an independent predictor of adverse outcome in patients with severe aortic stenosis and preserved ejection fraction undergoing TAVR
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Ludwig, S, primary, Voigtlaender, L, additional, Ruebsamen, N, additional, Kalbacher, D, additional, Koell, B, additional, Linder, M, additional, Waldschmidt, L, additional, Schirmer, J, additional, Seiffert, M, additional, Conradi, L, additional, Schaefer, U, additional, Reichenspurner, H, additional, Blankenberg, S, additional, Westermann, D, additional, and Schofer, N, additional
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- 2019
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14. Diastolic pressure gradient predicts outcome in patients with heart failure and preserved ejection fraction
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Zotter-Tufaro, C, primary, Duca, F, additional, Aschauer, S, additional, Kammerlander, A, additional, Koell, B, additional, Dalos, D, additional, Mascherbauer, J, additional, and Bonderman, D, additional
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- 2015
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15. ChemInform Abstract: Synthesis and X‐Ray Analysis of New Spirophosphoranes
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KOELL, B. +, primary, TOTSCHNIG, K., additional, VOEGEL, J. +, additional, PERINGER, P., additional, MUELLER, E. P. +, additional, FISCHER, M., additional, and PETTER, W., additional
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- 1990
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16. Atrial Secondary Tricuspid Regurgitation: Insights Into the EuroTR Registry.
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Stolz L, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Rück A, Doldi PM, Novotny J, Zdanyte M, Adamo M, Vincent F, Schlegel P, von Bardeleben RS, Stocker TJ, Weckbach LT, Wild MG, Besler C, Brunner S, Toggweiler S, Grapsa J, Patterson T, Thiele H, Kister T, Tarantini G, Masiero G, De Carlo M, Sticchi A, Konstandin MH, Van Belle E, Metra M, Geisler T, Estévez-Loureiro R, Luedike P, Karam N, Maisano F, Lauten P, Praz F, Kessler M, Kalbacher D, Rudolph V, Iliadis C, Lurz P, and Hausleiter J
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- Humans, Male, Female, Aged, Europe, Prevalence, Time Factors, Risk Factors, Aged, 80 and over, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Recovery of Function, Heart Atria physiopathology, Heart Atria diagnostic imaging, Heart Atria surgery, Progression-Free Survival, Treatment Outcome, Risk Assessment, Retrospective Studies, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency epidemiology, Tricuspid Valve Insufficiency mortality, Registries, Tricuspid Valve physiopathology, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Severity of Illness Index, Cardiac Catheterization adverse effects
- Abstract
Background: Atrial secondary tricuspid regurgitation (A-STR) has been proposed as an important etiologic subentity of secondary tricuspid regurgitation (STR). Patients with A-STR are frequently treated using transcatheter tricuspid valve edge-to-edge repair (T-TEER)., Objectives: The aims of this study were to evaluate prevalence and outcomes following T-TEER for severe A-STR and to compare the results to patients with nonatrial STR., Methods: The study included patients from the EuroTR (European Registry of Transcatheter Repair for Tricuspid Regurgitation) registry who underwent T-TEER for STR from 2016 until 2022. A-STR was defined as a ratio of end-systolic right atrial area to right ventricular area ≥1.5 in the presence of preserved right ventricular function (tricuspid annular plane systolic excursion >17 mm). The primary study endpoint was 2-year survival free from heart failure hospitalization. Secondary endpoints were 2-year survival, tricuspid regurgitation (TR) reduction at discharge and 1-year follow-up as well as changes in NYHA functional class., Results: This study included 641 patients (50% women) with a mean age of 79 ± 7 years. The overall prevalence of A-STR was 31% (n = 196). A-STR was associated with a higher prevalence of atrial fibrillation, less frequent comorbidities, better biventricular function, less leaflet tenting, and larger atria. Although TR severity was comparable at baseline, patients with A-STR had more effective procedural TR reduction (TR ≤2+ in 86.9% vs 80.4% of those with nonatrial STR; P = 0.005). Although NYHA functional class improved in both STR subetiologies, the symptomatic burden was lower in patients with A-STR at the latest available follow-up (NYHA functional class ≥III in 46% of patients with nonatrial STR vs 38% in those with A-STR; P = 0.033). Beyond that, A-STR was associated with higher 2-year survival rates free from heart failure hospitalization (66.3% [Q1-Q3: 58.2%-75.5%] vs 47.5% [Q1-Q3: 41.7%-54.7%] in patients with nonatrial STR; P < 0.001). Median survival follow-up was 379 days [Q1-Q3: 155-697 days]., Conclusions: A-STR is a common phenotype of STR and is associated with effective TR reduction and symptomatic reduction after T-TEER., Competing Interests: Funding Support and Author Disclosures Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Kresoja has received travel expenses from Edwards Lifesciences. Dr von Stein has received lecture honoraria from Edwards Lifesciences. Dr Rottbauer has received speaker honoraria Edwards Lifesciences and Abbott. Der Denti has served as a consultant for InnovHeart, Pi-Cardia, HVR, and Approxima; and has received speaker honoraria from Abbott and Edwards Lifesciences. Dr Rassaf has received speaker honoraria and consulting fees from AstraZeneca, Bayer, Pfizer, and Daiichi-Sankyo. Dr Barreiro-Perez has received speaker fees from Abbott Vascular, Edwards Lifesciences, and Venus Medtech. Dr Adamo has received consulting fees in the past 3 years from Abbott Structural Heart and Edwards Lifesciences. Dr von Bardeleben has received institutional grants from and served as a speaker for Abbott Vascular and Edwards Lifesciences. Dr Toggweiler has received personal honoraria from Medtronic, Boston Scientific, Biosensors, Abbott Vascular, Medira, Shockwave Medical, Teleflex, atHeart Medical, Cardiac Dimensions, Polares Medical, Amarin, Sanofi, AstraZeneca, ReCor Medical, and Daiichi-Sankyo; has received institutional research grants from Edwards Lifesciences, Boston Scientific, Fumedica, Novartis, and Boehringer Ingelheim; and holds equity in Hi-D Imaging. Dr Metra has received consulting fees in the past 3 years from Abbott Structural Heart, AstraZeneca, Bayer, Boehringer Ingelheim, Edwards Lifesciences, and Roche Diagnostics. Dr Geisler has received speaker honoraria and research grants from AstraZeneca, Bayer, Bristol Myers Squibb/Pfizer, Ferrer/Chiesi, Medtronic, and Edwards Lifesciences (all unrelated to this study). Dr Estévez-Loureiro has received speaker fees from Abbott Vascular, Edwards Lifesciences, Boston Scientific, and Venus Medtech. Dr Lüdike has received speaker honoraria and consulting fees from AstraZeneca, Bayer, Pfizer, and Edwards Lifesciences; and has received research honoraria from Edwards Lifesciences. Dr Maisano received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, Terumo, and Venus Medtech; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex, Venus, Squadra, and Valgen; has received royalty income from and holds intellectual property rights with Edwards Lifesciences; and is a shareholder (including share options) in Magenta, Transseptal Solutions, and 4Tech. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, Medira, and Siemens Healthineers. Dr Kessler has received speaker honoraria from Edwards Lifesciences and Abbott. Dr Kalbacher has received personal fees from Abbott Medical, Edwards Lifesciences, Pi-Cardia, and Medtronic. Dr Rudolph has received research grants from Abbott Medical, Boston Scientific, and Edwards Lifesciences. Dr Iliadis has received consultant fees and travel expenses from Abbott Medical and Edwards Lifesciences. Dr Lurz has received institutional grants from Edwards Lifesciences; and has received honoraria from Innoventrics. Dr Hausleiter has received research grant support and speaker honoraria from Edwards Lifesciences. Dr Sticchi has served on an advisory board for Edwards Lifesciences. Dr Tarantini has received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Karam has received consultant fees from Edwards Lifesciences, Boston Scientific, and Medtronic; and has received proctor fees from 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.)
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- 2024
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17. The prognostic value of the Dandel's index in patients undergoing tricuspid transcatheter edge-to-edge repair.
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Kassar M, Brugger N, Stolz L, Gerçek M, Fortmeier V, Kresoja KP, von Stein J, Koell B, Rottbauer W, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Rück A, Zdanyte M, Adamo M, Vincent F, Schlegel P, von Bardeleben RS, Wild MG, Toggweiler S, Konstandin MH, Van Belle E, Metra M, Geisler T, Estévez-Loureiro R, Luedike P, Karam N, Maisano F, Lauten P, Kessler M, Kalbacher D, Iliadis C, Lurz P, Windecker S, Hausleiter J, Rudolph V, and Praz F
- Abstract
Aims: Conventional parameters of right ventricular (RV) function are load-dependent and therefore do not accurately reflect contractility in patients with relevant tricuspid regurgitation (TR). RV adaptability to load has been characterized using the Dandel's index in patients with heart failure, but its prognostic value in patients undergoing tricuspid transcatheter edge-to-edge repair (T-TEER) has not been investigated so far., Methods and Results: From the EuroTR registry (2019 to 2022), patients with complete datasets and a minimum of 2-years of follow-up were included. RV functional parameters (i.e. tricuspid annular plane systolic excursion [TAPSE], fractional area change [FAC], TAPSE/systolic pulmonary arterial pressure [sPAP]), as well as a echocardiographic RV load adaptation index (Dandel's index) were assessed and their predictive value in terms of all-cause mortality evaluated using logistic multivariate logistic regression. The majority of the 364 patients had secondary TR (96%) and were severely symptomatic (New York Heart Association class ≥III; 92%). At 2-year follow-up, 36% of patients had died. Functional RV parameters (TAPSE: hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.62-0.84; FAC: HR 0.73, 95% CI 0.59-0.91), coupling index (TAPSE/sPAP: HR 0.8, 95% CI 0.65-0.99) and Dandel's index (HR 0.67, 95% CI 0.53-0.85) were all associated with mortality at 2 years in univariable analyses. In a multivariate logistic regression model, the Dandel's index maintained its predictive value (p < 0.001), along with TAPSE and absence of signs of right heart failure, with an optimal threshold of 20.5 determined by the receiver-operating characteristic analysis. This threshold also successfully predicted cardiac hospital readmission. A multivariate analysis was conducted to identify parameters linked to RV function and predicting clinical outcomes., Conclusion: Assessment of the RV capacity to adjust for changes in loading conditions predicted mortality in patients with severe symptomatic TR undergoing T-TEER. The use of a multiparametric approach including the Dandel's index to assess RV function had an incremental value for the stratification of patients into subgroups with different prognosis., (© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
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- 2024
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18. Long-Term Outcomes After Edge-to-Edge Repair of Secondary Mitral Regurgitation: 5-Year Results From the EuroSMR Registry.
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Stocker TJ, Stolz L, Karam N, Kalbacher D, Koell B, Trenkwalder T, Xhepa E, Adamo M, Spieker M, Horn P, Butter C, Weckbach LT, Novotny J, Melica B, Giannini C, von Bardeleben RS, Pfister R, Praz F, Lurz P, Rudolph V, Metra M, and Hausleiter J
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- Humans, Aged, Male, Female, Time Factors, Treatment Outcome, Risk Factors, Aged, 80 and over, Europe, Risk Assessment, Middle Aged, Functional Status, Ventricular Function, Left, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency mortality, Mitral Valve Insufficiency diagnostic imaging, Registries, Mitral Valve surgery, Mitral Valve physiopathology, Mitral Valve diagnostic imaging, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Recovery of Function, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality
- Abstract
Background: Mitral valve transcatheter edge-to-edge repair (M-TEER) reduces secondary mitral regurgitation (MR) in heart failure and impacts survival in selected patients as demonstrated in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. However, long-term outcome data after M-TEER under real-world conditions are lacking., Objectives: This study sought to assess long-term efficacy and survival after M-TEER in a large real-world registry., Methods: We analyzed patients with significant secondary MR undergoing M-TEER from the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry. Long-term MR reduction, functional outcomes, survival rate, and predictors for all-cause mortality were assessed., Results: In this study, 1,628 patients undergoing M-TEER (mean age 73.8 years, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 6.9%, 86.6% NYHA functional class ≥III) with available long-term data were included. Five-year survival was 35.0%. Long-term MR reduction (MR grade ≤2+: baseline 4.1%, discharge 92.2%, 5-year follow-up 85.5%; P < 0.001) and functional improvement (NYHA ≤II: baseline 13.4%, 5-year follow-up 60.1%; P < 0.001) was observed. The degree of residual MR was associated with 5-year survival (residual MR grade ≤1+: 38.6%; 2+: 30.5%; ≥3+: 22.6%; P < 0.001). Independent predictors for 5-year all-cause mortality post-M-TEER included age, renal function, residual MR, NYHA functional class, left ventricular ejection-fraction, and COAPT trial eligibility (P < 0.01 for all)., Conclusions: This extensive multicenter registry underscores the long-term efficacy of M-TEER in real-world clinical practice and identifies predictors for long-term survival. These findings contribute valuable insights for optimizing patient selection in routine clinical interventions., Competing Interests: Funding Support and Author Disclosures Dr Stocker has served as consultant for Occlutech International and received speaker honoraria from Edwards Lifesciences. Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Weckbach has received speaker honoraria from AstraZeneca and Bayer. Dr Koell has received personal fees from Edwards Lifesciences. Dr Kalbacher has received personal fees from Abbott Medical, Edwards Lifesciences, Medtronic, and Pi-Cardia Ltd. Dr Hausleiter has received speaker honoraria from and served as a consultant for Edwards Lifesciences. 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.)
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- 2024
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19. Impact of Pulmonary Hypertension on Outcomes After Transcatheter Tricuspid Valve Edge-to-Edge Repair.
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Stolz L, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Rück A, Doldi PM, Novotny J, Zdanyte M, Adamo M, Vincent F, Schlegel P, von Bardeleben RS, Stocker TJ, Weckbach LT, Wild MG, Besler C, Brunner S, Toggweiler S, Grapsa J, Patterson T, Thiele H, Kister T, Tarantini G, Masiero G, De Carlo M, Sticchi A, Konstandin MH, Van Belle E, Metra M, Geisler T, Estévez-Loureiro R, Luedike P, Karam N, Maisano F, Lauten P, Praz F, Kessler M, Kalbacher D, Rudolph V, Iliadis C, Lurz P, and Hausleiter J
- Abstract
Background: Data regarding the association of pulmonary hypertension (PH) and outcomes in patients undergoing transcatheter tricuspid valve edge-to-edge repair (T-TEER) are scarce., Objectives: The aims of this study were 1) to investigate the impact of PH on outcomes after T-TEER; and 2) to shed further light on the role of pre- and postcapillary PH in patients undergoing T-TEER for relevant tricuspid regurgitation (TR)., Methods: The study included patients from the EuroTR (European Registry of Transcatheter Repair for Tricuspid Regurgitation; NCT06307262) registry who underwent T-TEER for relevant TR from 2016 until 2023 with available invasive evaluation of systolic pulmonary artery pressure (sPAP) using right heart catheterization. Study endpoints were procedural TR reduction, improvement in NYHA function class, and a combined endpoint of death or heart failure hospitalization (HFH) at 2 years., Results: Among a total of 1,230 patients (mean age 78.6 ± 7.0 years, 51.4% women), increasing sPAP was independently associated with increasing rates of 2-year death or HFH (HR: 1.027; 95% CI: 1.003-1.052; P = 0.030; median survival follow-up 343 days [Q1-Q3: 114-645 days]). No significant survival differences were observed for patients with pre- vs postcapillary PH. Sensitivity analysis revealed an sPAP value of 46 mm Hg as the optimized threshold for the prediction of death or HFH. Being observed in 526 patients (42.8%), elevated sPAP (>46 mm Hg) was associated with more severe heart failure symptoms at baseline and follow-up. Importantly, NYHA functional class significantly improved and TR severity was significantly reduced irrespective of PH., Conclusions: PH is an important outcome predictor in patients undergoing T-TEER for relevant TR. In contrast to previous studies, no significant differences were observed for patients with pre- and postcapillary PH in terms of survival free from HFH., Competing Interests: Funding Support and Author Disclosures Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Kresoja has received travel expenses from Edwards Lifesciences. Dr von Stein has received lecture honoraria from Edwards Lifesciences. Dr Rottbauer has received speaker honoraria from Edwards Lifesciences and Abbott. Dr Denti has served as a consultant for InnovHeart, Picardia, HVR, and Approxima; and has received speaker honoraria from Abbott and Edwards Lifesciences. Dr Rassaf has received speaker honoraria and consulting fees from AstraZeneca, Bayer, Pfizer, and Daiichi-Sankyo. Dr Barreiro-Perez has received speaker fees from Abbott Vascular, Edwards Lifesciences, and Venus Medtech. Dr Adamo has received consulting fees in the past 3 years from Abbott Structural Heart and Edwards Lifesciences. Dr von Bardeleben has received institutional grants from and has served as a speaker for Abbott Vascular and Edwards Lifesciences. Dr Toggweiler has received personal honoraria from Medtronic, Boston Scientific, Biosensors, Abbott Vascular, Medira, Shockwave Medical, Teleflex, atHeart Medical, Cardiac Dimensions, Polares Medical, Amarin, Sanofi, AstraZeneca, ReCor Medical, and Daiichi-Sankyo; has received institutional research grants from Edwards Lifesciences, Boston Scientific, Fumedica, Novartis, and Boehringer Ingelheim; and holds equity in Hi-D Imaging. Dr Metra has received consulting fees in the past 3 years from Abbott Structural Heart, AstraZeneca, Bayer, Boehringer Ingelheim, Edwards Lifesciences, and Roche Diagnostics. Dr Geisler has received speaker honoraria and research grants from AstraZeneca, Bayer, Bristol Myers Squibb/Pfizer, Ferrer/Chiesi, Medtronic, and Edwards Lifesciences (all unrelated to this study). Dr Estévez-Loureiro has received speaker fees from Abbott Vascular, Edwards Lifesciences, Boston Scientific, and Venus Medtech. Dr Lüdike has received speaker honoraria and consulting fees from AstraZeneca, Bayer, Pfizer, and Edwards Lifesciences; and has received research honoraria from Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, Terumo, and Venus Medtech; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex, Venus Medtech, Squadra, and Valgen; has received royalty income from and holds intellectual property rights with Edwards Lifesciences; and is a shareholder (including share options) in Magenta, Transseptal Solutions, and 4Tech. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, Medira, and Siemens Healthineers. Dr Kessler has received speaker honoraria from Edwards Lifesciences and Abbott. Dr Kalbacher has received personal fees from Abbott Medical, Edwards Lifesciences, Pi-Cardia, and Medtronic. Dr Rudolph has received research grants from Abbott Medical, Boston Scientific, and Edwards Lifesciences. Dr Iliadis has received consultant fees and travel expenses from Abbott Medical and Edwards Lifesciences. Dr Lurz has received institutional grants from Edwards Lifesciences and honoraria from Innoventrics. Dr Hausleiter has received research grant support and speaker honoraria from Edwards Lifesciences. Dr Sticchi has served on an advisory board for Edwards Lifesciences. Dr Tarantini has received speaker fees for Abbott Vascular and Edwards Lifesciences. Dr Karam has received consultant fees from Edwards Lifesciences, Boston Scientific, and Medtronic; and has received proctor fees from 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.)
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- 2024
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20. Residual tricuspid regurgitation after tricuspid transcatheter edge-to-edge repair: Insights into the EuroTR registry.
- Author
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Stolz L, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Rück A, Doldi PM, Novotny J, Zdanyte M, Adamo M, Vincent F, Schlegel P, von Bardeleben RS, Stocker TJ, Weckbach LT, Wild MG, Brunner S, Toggweiler S, Grapsa J, Patterson T, Thiele H, Kister T, Konstandin MH, Van Belle E, Metra M, Geisler T, Estévez-Loureiro R, Luedike P, Karam N, Maisano F, Lauten P, Praz F, Kessler M, Kalbacher D, Rudolph V, Iliadis C, Lurz P, and Hausleiter J
- Subjects
- Humans, Female, Male, Aged, Tricuspid Valve surgery, Europe epidemiology, Prognosis, Treatment Outcome, Aged, 80 and over, Follow-Up Studies, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation adverse effects, Survival Rate trends, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency epidemiology, Registries, Cardiac Catheterization methods
- Abstract
Aims: Data on the prognostic impact of residual tricuspid regurgitation (TR) after tricuspid transcatheter edge-to-edge repair (T-TEER) are scarce. The aim of this analysis was to evaluate 2-year survival and symptomatic outcomes of patients in relation to residual TR after T-TEER., Methods and Results: Using the large European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR registry) we investigated the impact of residual TR on 2-year all-cause mortality and New York Heart Association (NYHA) functional class at follow-up. The study further identified predictors for residual TR ≥3+ using a logistic regression model. The study included a total of 1286 T-TEER patients (mean age 78.0 ± 8.9 years, 53.6% female). TR was successfully reduced to ≤1+ in 42.4%, 2+ in 40.0% and 3+ in 14.9% of patients at discharge, while 2.8% remained with TR ≥4+ after the procedure. Residual TR ≥3+ was an independent multivariable predictor of 2-year all-cause mortality (hazard ratio 2.06, 95% confidence interval 1.30-3.26, p = 0.002). The prevalence of residual TR ≥3+ was four times higher in patients with higher baseline TR (vena contracta >11.1 mm) and more severe tricuspid valve tenting (tenting area >1.92 cm
2 ). Of note, no survival difference was observed in patients with residual TR ≤1+ versus 2+ (76.2% vs. 73.1%, p = 0.461). The rate of NYHA functional class ≥III at follow-up was significantly higher in patients with residual TR ≥3+ (52.4% vs. 40.5%, p < 0.001). Of note, the degree of TR reduction significantly correlated with the extent of symptomatic improvement (p = 0.012)., Conclusions: T-TEER effectively reduced TR severity in the majority of patients. While residual TR ≥3+ was associated with worse outcomes, no differences were observed for residual TR 1+ versus 2+. Symptomatic improvement correlated with the degree of TR reduction., (© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)- Published
- 2024
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21. Impact of Intraprocedural Mitral Regurgitation and Gradient Following Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation.
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Ludwig S, Koell B, Weimann J, Donal E, Patel D, Stolz L, Tanaka T, Scotti A, Trenkwalder T, Rudolph F, Samim D, von Stein P, Giannini C, Dreyfus J, Paradis JM, Adamo M, Karam N, Bohbot Y, Bernard A, Melica B, Quagliana A, Lavie Badie Y, Kessler M, Chehab O, Redwood S, Lubos E, Søndergaard L, Metra M, Primerano C, Iliadis C, Praz F, Gerçek M, Xhepa E, Nickenig G, Latib A, Schofer N, Makkar R, Granada JF, Modine T, Hausleiter J, Kalbacher D, and Coisne A
- Subjects
- Humans, Male, Female, Aged, Treatment Outcome, Risk Factors, Time Factors, Aged, 80 and over, Heart Failure physiopathology, Heart Failure mortality, Heart Failure therapy, Heart Failure diagnostic imaging, Heart Failure etiology, Risk Assessment, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency mortality, Registries, Mitral Valve surgery, Mitral Valve physiopathology, Mitral Valve diagnostic imaging, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization mortality, Recovery of Function, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Hemodynamics
- Abstract
Background: The impact of intraprocedural results following transcatheter edge-to-edge repair (TEER) in primary mitral regurgitation (MR) is controversial., Objectives: This study sought to investigate the prognostic impact of intraprocedural residual mitral regurgitation (rMR) and mean mitral valve gradient (MPG) in patients with primary MR undergoing TEER., Methods: The PRIME-MR (Outcomes of Patients Treated With Mitral Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation) registry included consecutive patients with primary MR undergoing TEER from 2008 to 2022 at 27 international sites. Clinical outcomes were assessed according to intraprocedural rMR and mean MPG. Patients were categorized according to rMR (optimal result: ≤1+, suboptimal result: ≥2+) and MPG (low gradient: ≤5 mm Hg, high gradient: > 5 mm Hg). The prognostic impact of rMR and MPG was evaluated in a Cox regression analysis. The primary endpoint was 2-year all-cause mortality or heart failure hospitalization., Results: Intraprocedural rMR and mean MPG were available in 1,509 patients (median age = 82 years [Q1-Q3: 76.0-86.0 years], 55.1% male). Kaplan-Meier analysis according to rMR severity showed significant differences for the primary endpoint between rMR ≤1+ (29.1%), 2+ (41.7%), and ≥3+ (58.0%; P < 0.001), whereas there was no difference between patients with a low (32.4%) and high gradient (42.1%; P = 0.12). An optimal result/low gradient was achieved in most patients (n = 1,039). The worst outcomes were observed in patients with a suboptimal result/high gradient. After adjustment, rMR ≥2+ was independently linked to the primary endpoint (HR: 1.87; 95% CI: 1.32-2.65; P < 0.001), whereas MPG >5 mm Hg was not (HR: 0.78; 95% CI: 0.47-1.31; P = 0.35)., Conclusions: Intraprocedural rMR but not MPG independently predicted clinical outcomes following TEER for primary MR. When performing TEER in primary MR, optimal MR reduction seems to outweigh the impact of high transvalvular gradients., Competing Interests: Funding Support and Author Disclosures Dr Ludwig has received travel compensation from Edwards Lifesciences; has received speaker honoraria from Abbott; has received advisory fees from Bayer; and is a consultant for New Valve Technology. Dr Koell has received personal fees from Edwards Lifesciences. Dr Donal has received research facilities from GE Healthcare and Abbott. Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Scotti has served as a consultant for Edwards Lifesciences and NeoChord Inc. Dr Melica has served as a proctor for Abbott. Dr Samim has received funding for an online course from Edwards Lifesciences. Dr Dreyfus has received consulting or speaker fees from Abbott. Dr Karam has received consultant fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Kessler has received speaker honoraria for Edwards Lifesciences and Abbott. Dr Lavie Badie has served as a consultant and proctor for Abbott; and has served as a proctor for Abbott. Dr Metra has received consulting honoraria of minimal amounts from Abbott Structural, AstraZeneca, Bayer, Boehringer Ingelheim, Edwards Lifesciences Roche diagnostics Novo Nordisk, in the last 3 years. Dr Iliadis has received personal fees from Abbott and Edwards Lifesciences. Dr Gerçek has received funding from the Ruhr University Bochum (Advanced Clinician Scientist); and has served as a consultant for Edwards Lifesciences. Dr Latib has served on the Advisory Board for Medtronic, Abbott Vascular, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc, V-dyne, and Philips. Dr Kalbacher has received personal fees from Abbott Medical, Edwards Lifesciences, Medtronic, and Pi-Cardia Ltd. Dr Coisne has served as a consultant for Abbott, Edwards Lifesciences, and GE Healthcare; and has received speaker fees from Abbott, AstraZeneca, GE Healthcare, Merck Sharp & Dohme, and Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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22. Right Coronary Artery Injury in Transcatheter Annuloplasty for Secondary Tricuspid Regurgitation: A Real-World Multicenter Study.
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Althoff J, Gietzen T, Hasse C, Rudolph V, Gerçek M, Friedrichs KP, Kalbacher D, Koell B, Pfister R, and Koerber MI
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- Aged, Aged, 80 and over, Female, Humans, Male, Coronary Vessels diagnostic imaging, Coronary Vessels injuries, Coronary Vessels surgery, Heart Injuries etiology, Heart Injuries diagnostic imaging, Heart Injuries therapy, Heart Injuries surgery, Heart Valve Prosthesis, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Vascular System Injuries diagnostic imaging, Vascular System Injuries etiology, Vascular System Injuries surgery, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Cardiac Valve Annuloplasty, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Tricuspid Valve surgery, Tricuspid Valve diagnostic imaging, Tricuspid Valve physiopathology, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency etiology
- Published
- 2024
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23. Guideline-Directed Medical Therapy and Survival After TEER for Secondary Mitral Regurgitation With Right Ventricular Impairment.
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Mazzola M, Giannini C, Adamo M, Stolz L, Praz F, Butter C, Pfister R, Iliadis C, Melica B, Sampaio F, Kalbacher D, Koell B, Spieker M, Metra M, Stephan von Bardeleben R, Karam N, Kresoja KP, Lurz P, Petronio AS, Hausleiter J, and De Carlo M
- Subjects
- Humans, Female, Male, Aged, Treatment Outcome, Time Factors, Risk Factors, Europe, Aged, 80 and over, Risk Assessment, Echocardiography, Transesophageal, Mitral Valve physiopathology, Mitral Valve diagnostic imaging, Mitral Valve surgery, Middle Aged, Recovery of Function, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency mortality, Registries, Ventricular Dysfunction, Right physiopathology, Ventricular Dysfunction, Right mortality, Ventricular Dysfunction, Right etiology, Ventricular Dysfunction, Right diagnostic imaging, Ventricular Dysfunction, Right therapy, Ventricular Function, Right, Practice Guidelines as Topic, Guideline Adherence, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Cardiovascular Agents therapeutic use, Cardiovascular Agents adverse effects
- Abstract
Background: Right ventricular impairment is common among patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation (SMR). Adherence to guideline-directed medical therapy (GDMT) for heart failure is poor in these patients., Objectives: The aim of this study was to evaluate the impact of GDMT on long-term survival in this patient cohort., Methods: Within the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) international registry, we selected patients with SMR and right ventricular impairment (tricuspid annular plane systolic excursion ≤17 mm and/or echocardiographic right ventricular-to-pulmonary artery coupling <0.40 mm/mm Hg). Titrated guideline-directed medical therapy (GDMT
tit ) was defined as a coprescription of 3 drug classes with at least one-half of the target dose at the latest follow-up. The primary outcome was all-cause mortality at 6 years., Results: Among 1,213 patients with SMR and right ventricular impairment, 852 had complete data on medical therapy. The 123 patients who were on GDMTtit showed a significantly higher long-term survival vs the 729 patients not on GDMTtit (61.8% vs 36.0%; P < 0.00001). Propensity score-matched analysis confirmed a significant association between GDMTtit and higher survival (61.0% vs 43.1%; P = 0.018). GDMTtit was an independent predictor of all-cause mortality (HR: 0.61; 95% CI: 0.39-0.93; P = 0.02 for patients on GDMTtit vs those not on GDMTtit ). Its association with better outcomes was confirmed among all subgroups analyzed., Conclusions: In patients with right ventricular impairment undergoing transcatheter edge-to-edge repair for SMR, titration of GDMT to at least one-half of the target dose is associated with a 40% lower risk of all-cause death up to 6 years and should be pursued independent of comorbidities., Competing Interests: Funding Support and Author Disclosures Dr Pfister is a consultant for Edwards Lifesciences; and has received speaker honoraria from Edwards Lifesciences and Abbott Vascular. Dr Iliadis is a consultant for Abbott and Edwards Lifesciences. Dr Kalbacher has received personal fees from Abbott, Edwards Lifesciences, and Pi-Cardia Ltd. Dr Metra has received consulting/speaker fees from Amgen, Livanova, Vifor Pharma, AstraZeneca, Bayer, Boehringer Ingelheim, Edwards Lifesciences, and Roche Diagnostics. 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.)- Published
- 2024
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24. Left and Right Ventricular Hemodynamic Response After Transcatheter Mitral Valve Replacement.
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Ludwig S, Strotmann LS, Schrage BN, Koell B, Coisne A, Scotti A, Rommel KP, Weimann J, Schwarzl M, Seiffert M, Reichenspurner H, Blankenberg S, Schäfer A, Burkhoff D, Schofer N, Granada J, Conradi L, and Kalbacher D
- Abstract
Background: Transcatheter mitral valve replacement (TMVR) represents a novel treatment option for patients with mitral regurgitation (MR), but little is known about the hemodynamic impact of MR elimination following TMVR. We sought to investigate the hemodynamic impact of TMVR on left ventricular (LV) and right ventricular (RV) function using noninvasive pressure-volume loops., Methods: All consecutive patients undergoing TMVR with dedicated devices between May 2016 and August 2022 were enrolled. The end-diastolic and end-systolic pressure-volume relationships were estimated from 26 patients using single-beat echocardiographic measurements at baseline and after TMVR at discharge. RV function was assessed by RV-pulmonary artery (PA) coupling and RV fractional area change. One-year follow-up was available for 19 patients. The prognostic impact of calculated end-diastolic volume at an end-diastolic pressure of 20 mmHg (VPed20) reduction was assessed by Cox regression., Results: A total of 26 patients (77.0 years [interquartile range 73.9-80.1], N = 17 [65.4%] male) with successful TMVR were included (secondary MR [N = 21, 80.8%]; median LV ejection fraction was 37.0% [interquartile range 30.7-50.7]). At discharge, a decrease in VPed20 ( p < 0.001) indicating leftward shift of end-diastolic pressure-volume relationship, and an increase of the end-systolic elastance slope ( p = 0.007) were observed after TMVR. No changes were observed for RV-PA coupling ( p = 0.19) and RV fractional area change ( p = 0.22). At 1-year follow-up, LV contractility (end-systolic elastance) and RV-PA coupling remained stable. Vped20 reduction at discharge was significantly associated with 1-year all-cause mortality or heart failure hospitalization (hazard ratio 0.16, 95% CI 0.04-0.71, p = 0.016)., Conclusions: Noninvasive assessment of pressure-volume loops demonstrated early LV reverse remodeling and improved LV contractility, while RV performance was preserved. These results indicate the potential prognostic impact of complete MR elimination after TMVR., Competing Interests: S. Ludwig has received travel compensation from Edwards Lifesciences, speaker honoraria from Abbott, and advisory fees from Bayer, and is a consultant to New Valve Technology (NVT). D. Kalbacher has received personal fees from Abbott Medical, Edwards Lifesciences, Medtronic Inc, and Pi-Cardio Ltd. A. Schaefer received speaker honoraria from Abbott. The other authors had no conflicts to declare., (© 2024 The Author(s).)
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- 2024
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25. Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair.
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Stolz L, Doldi PM, Kresoja KP, Bombace S, Koell B, Kassar M, Kirchner J, Weckbach LT, Ludwig S, Stocker TJ, Glaser H, Schöber AR, Massberg S, Näbauer M, Rudolph V, Kalbacher D, Praz F, Lurz P, and Hausleiter J
- Subjects
- Humans, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Quality of Life, Treatment Outcome, Eligibility Determination, Cardiac Catheterization adverse effects, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Heart Failure therapy, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency
- Abstract
Background: According to the TRILUMINATE (Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) trial, transcatheter tricuspid edge-to-edge repair (T-TEER) improves quality of life beyond medical treatment, while no effects on heart failure hospitalization (HFH) and survival were observed at 1 year. However, the generalizability of the TRILUMINATE trial to real-world conditions remains a subject of discussion., Objectives: The aim of this study was to apply the clinical TRILUMINATE inclusion and exclusion criteria to a real-world T-TEER patient group and evaluate symptomatic and survival outcome in TRILUMINATE-eligible and TRILUMINATE-ineligible patients., Methods: Clinical TRILUMINATE inclusion and exclusion criteria were applied to a cohort of patients who underwent T-TEER at 5 European centers from 2016 to 2022. Study patients were compared regarding baseline characteristics, survival, HFH, and symptomatic outcomes as measured by NYHA functional class, a quality-of-life questionnaire and 6-minute walk distance., Results: Of 962 patients, 54.8% were classified as TRILUMINATE eligible, presenting with superior left ventricular function and fewer comorbidities compared with the ineligible population. Tricuspid regurgitation reduction, improvement in NYHA functional class, quality of life, and exercise capacity were comparable in both groups. However, the 1-year survival and HFH rates significantly differed (tricuspid regurgitation ≤2+ at discharge, 82% vs 85%; survival, 85% vs 75%; HFH, 14% vs 22% for eligible vs ineligible patients)., Conclusions: The observed differences in survival and HFH outcomes suggest a limited generalizability of TRILUMINATE to real-world conditions and indicate the need for additional studies evaluating the outcomes after T-TEER in less selected patient populations., Competing Interests: Funding Support and Author Disclosures Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, Medira, and Siemens Healthineers. Dr Kalbacher has received personal fees from Abbott Medical, Edwards Lifesciences, and Pi-Cardia. Dr Ludwig has received travel compensation from Edwards Lifesciences; has received advisory fees from Bayer; and has received speaker honoraria from Abbott. Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Rudolph serves on the advisory boards of Edwards Lifesciences and Abbott Vascular; and has received research grants from Edwards Lifesciences and Abbott Vascular. Dr Kresoja has received travel expenses from Edwards Lifesciences. Dr Lurz has received institutional grants from Edwards Lifesciences; and has received honoraria from Innoventric. Dr Hausleiter has received research grant 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 © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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26. Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Guideline-Directed Medical Therapy Uptitration.
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Adamo M, Tomasoni D, Stolz L, Stocker TJ, Pancaldi E, Koell B, Karam N, Besler C, Giannini C, Sampaio F, Praz F, Ruf T, Pechmajou L, Neuss M, Iliadis C, Baldus S, Butter C, Kalbacher D, Lurz P, Melica B, Petronio AS, von Bardeleben RS, Windecker S, Butler J, Fonarow GC, Hausleiter J, and Metra M
- Subjects
- Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Retrospective Studies, Treatment Outcome, Stroke Volume, Heart Failure, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency complications
- Abstract
Background: Guideline-directed medical therapy (GDMT) optimization is mandatory before transcatheter edge-to-edge mitral valve repair (M-TEER) in patients with secondary mitral regurgitation (SMR) and heart failure (HF) with reduced ejection fraction (HFrEF). However, the effect of M-TEER on GDMT is unknown., Objectives: The authors sought to evaluate frequency, prognostic implications and predictors of GDMT uptitration after M-TEER in patients with SMR and HFrEF., Methods: This is a retrospective analysis of prospectively collected data from the EuroSMR Registry. The primary events were all-cause death and the composite of all-cause death or HF hospitalization., Results: Among the 1,641 EuroSMR patients, 810 had full datasets regarding GDMT and were included in this study. GDMT uptitration occurred in 307 patients (38%) after M-TEER. Proportion of patients receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists was 78%, 89%, and 62% before M-TEER and 84%, 91%, and 66% 6 months after M-TEER (all P < 0.001). Patients with GDMT uptitration had a lower risk of all-cause death (adjusted HR: 0.62; 95% CI: 0.41-0.93; P = 0.020) and of all-cause death or HF hospitalization (adjusted HR: 0.54; 95% CI: 0.38-0.76; P < 0.001) compared with those without. Degree of MR reduction between baseline and 6-month follow-up was an independent predictor of GDMT uptitration after M-TEER (adjusted OR: 1.71; 95% CI: 1.08-2.71; P = 0.022)., Conclusions: GDMT uptitration after M-TEER occurred in a considerable proportion of patients with SMR and HFrEF and is independently associated with lower rates for mortality and HF hospitalizations. A greater decrease in MR was associated with increased likelihood for GDMT uptitration., Competing Interests: Funding Support and Author Disclosures Dr Adamo has received speaker fees from Abbott Vascular and Medtronic. Dr Baldus has received lecture fees and research support from Abbott and Edwards Lifesciences. Dr Kalbacher has received speaker honoraria from Abbott; and has received travel expenses and proctor fees from Edwards Lifesciences. Dr Lurz has received institutional research grants from Edwards Lifesciences and Abbott Vascular. Dr Petronio has been a consultant for Abbott Vascular, Boston Scientific, and Medtronic. Dr von Bardeleben has served on trial steering committees (unpaid) for Abbott, Edwards Lifesciences, Medtronic, and Neochord; and has served on advisory boards for and received speaker fees from Abbott, Edwards Lifesciences, Medtronic, Neochord, Philips, and Siemens. Dr Windecker has received institutional research, travel, or educational grants 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 & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as advisory board member and/or 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 with payments to his institution; and has been an unpaid member of the steering/executive committee groups of several investigator-initiated trials that receive funding by industry. Dr Hausleiter has received speaker honoraria from Abbott Vascular. Prof Metra has received consulting honoraria for participation in steering committees or advisory boards or for speeches from Abbott Vascular, Amgen, AstraZeneca, Bayer, Edwards Lifesciences, Fresenius, Novartis, and Servier. 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.)
- Published
- 2023
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27. Leaflet Morphology and its Implications for Direct Transcatheter Annuloplasty of Tricuspid Regurgitation.
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Körber MI, Roder F, Gerçek M, Koell B, Kalbacher D, Iliadis C, Brüwer M, Friedrichs KP, Rudolph V, Baldus S, and Pfister R
- Subjects
- Humans, Aged, 80 and over, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Mitral Valve surgery, Echocardiography adverse effects, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency etiology
- Abstract
Background: Leaflet morphology has been associated with treatment success in edge-to-edge repair of tricuspid regurgitation (TR), but the impact on annuloplasty is unclear., Objectives: The authors sought to examine the association of leaflet morphology with efficacy and safety of direct annuloplasty in TR., Methods: The authors analyzed patients who underwent catheter-based direct annuloplasty with the Cardioband at 3 centers. Leaflet morphology was assessed according to number and location of leaflets by echocardiography. Patients with simple morphology (2 or 3 leaflets) were compared with complex morphology (>3 leaflets)., Results: The study included 120 patients (median age 80 years) with ≥severe TR. A total of 48.3% of patients had a 3-leaflet morphology, 5% a 2-leaflet morphology, and 46.7% had >3 tricuspid leaflets. Baseline characteristics did not differ relevantly between groups except for a higher incidence of torrential TR grade (50 vs 26.6%) in complex morphologies. Postprocedural improvement of 1 (90.6% vs 92.9%) and 2 (71.9% vs 67.9%) TR grades was not significantly different between groups, but patients with complex morphology had more often residual TR ≥3 at discharge (48.2 vs 26.6%; P = 0.014). This difference did not remain significant (P = 0.112) after adjusting for baseline TR severity, coaptation gap, and nonanterior jet localization. Safety endpoints including complications of the right coronary artery, and technical success did not show significant differences., Conclusions: Efficacy and safety of transcatheter direct annuloplasty using Cardioband are not affected by leaflet morphology. Assessment of leaflet morphology should be part of procedural planning in patients with TR and might help to individually tailor repair techniques to patient anatomy., Competing Interests: Funding Support and Author Disclosures Dr Körber has received travel support and consultant honoraria from Edwards Lifesciences. Dr Kalbacher has received lecture fees from Abbott Medical and Edwards Lifesciences; has and has received proctor fees from Edwards Lifesciences and Picardia Ltd. Dr Iliadis has received travel support from Abbott; and has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Friedrichs has received lecture fees from Abbott; and proctor and has received speaker fees from Edwards Lifesciences. Dr Rudolph has received research grants from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Baldus has received research support from Abbott and AstraZeneca; and has received lecture fees from Abbott, Edwards Lifesciences, and AstraZeneca. 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.)
- Published
- 2023
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28. Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation.
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Scotti A, Coisne A, Taramasso M, Granada JF, Ludwig S, Rodés-Cabau J, Lurz P, Hausleiter J, Fam N, Kodali SK, Rosiene J, Feinberg A, Pozzoli A, Alessandrini H, Biasco L, Brochet E, Denti P, Estévez-Loureiro R, Frerker C, Ho EC, Monivas V, Nickenig G, Praz F, Puri R, Sievert H, Tang GHL, Andreas M, Von Bardeleben RS, Rommel KP, Muntané-Carol G, Gavazzoni M, Braun D, Koell B, Kalbacher D, Connelly KA, Juliard JM, Harr C, Pedrazzini G, Russo G, Philippon F, Schofer J, Thiele H, Unterhuber M, Himbert D, Alcázar MU, Wild MG, Windecker S, Jorde U, Maisano F, Leon MB, Hahn RT, and Latib A
- Subjects
- Male, Humans, Female, Tricuspid Valve surgery, Treatment Outcome, Registries, Tricuspid Valve Insufficiency, Heart Valve Prosthesis Implantation methods, Heart Failure complications
- Abstract
Aims: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone., Methods and Results: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03)., Conclusion: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men., Competing Interests: Conflict of Interest: A.S. has served as a consultant and received consulting fees from NeoChord Inc. A.C. has served as a consultant for Abbott and received speaker fees from Abbott and GE Healthcare. M.T. has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. S.L. has received travel compensation from Edwards Lifesciences. J.R.C. has received institutional research grants from Edwards Lifesciences. P.L. has received speaker fees from Abbott. J.H. has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. S.K.K. has served on the scientific advisory board for Microinterventional Devices, Dura Biotech, Thubrikar Aortic Valve, and Supira; has served as a consultant for Meril Lifesciences, Admedus, Medtronic, and Boston Scientific; has served on the steering committee for Edwards Lifesciences and Abbott Vascular; has received honoraria from Meril Lifesciences, Admedus, Abbott Vascular, and Dura Biotech; and owns equity in Dura Biotech, Thubrikar Aortic Valve, Supira, and MID. H.A. has received consulting fees from Abbott and Edwards LifeSciences. E.B. has received speaker fees from Abbott Vascular. P.D. has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and has received honoraria from Abbott and Edwards Lifesciences. R.E.L. has received speaker fees from Abbott, Boston, and Edwards Lifesciences. E.C.H. has served as a consultant and received consulting fees from NeoChord Inc. F.P. has received travel expenses from Edwards Lifesciences, Abbott Vascular, and Polares Medical. H.S. has received study honoraria, travel expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. G.H.L.T. has served as a consultant, physician advisory board member, and faculty trainer for Abbott Structural Heart; has served as a consultant for Medtronic and NeoChord; and has served as a physician advisory board member for JenaValve. M.A. has served as a proctor/consultant for and has received speaking fees from Abbott, Edwards LifeSciences, Boston, Zoll, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. M.G. has served as a consultant for Abbott Vascular. D.B. has received speaker honoraria and travel support from Abbott Vascular. D.K. has received lecture fees from Abbott and Edwards Lifesciences. K.A.C. has received honoraria from Abbott. J.S. has served as a consultant for Edwards Lifesciences. S.W. reports research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, 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 & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, V-Wave. S.W. serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, 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. He 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. F.M. has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; has reported being a cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (FMR surgical annuloplasty); and has reported being a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. M.B.L. has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. R.T.H. has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; has been the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3mensio. A.L. has served on the advisory board for Medtronic, Abbott Vascular Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc, V-dyne, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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29. Staging Heart Failure Patients With Secondary Mitral Regurgitation Undergoing Transcatheter Edge-to-Edge Repair.
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Stolz L, Doldi PM, Orban M, Karam N, Puscas T, Wild MG, Popescu A, von Bardeleben RS, Iliadis C, Baldus S, Adamo M, Thiele H, Besler C, Unterhuber M, Ruf T, Pfister R, Higuchi S, Koell B, Giannini C, Petronio A, Kassar M, Weckbach LT, Butter C, Stocker TJ, Neuss M, Melica B, Braun D, Windecker S, Massberg S, Praz F, Näbauer M, Kalbacher D, Lurz P, Metra M, Bax JJ, and Hausleiter J
- Subjects
- Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Stroke Volume, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Heart Failure diagnostic imaging, Heart Failure therapy, Heart Failure etiology, Heart Valve Prosthesis Implantation adverse effects, Atrial Fibrillation
- Abstract
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.)
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- 2023
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30. Guideline-directed medical therapy in patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation.
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Higuchi S, Orban M, Adamo M, Giannini C, Melica B, Karam N, Praz F, Kalbacher D, Koell B, Stolz L, Braun D, Näbauer M, Wild M, Doldi P, Neuss M, Butter C, Kassar M, Ruf T, Petrescu A, Ludwig S, Pfister R, Iliadis C, Unterhuber M, Sampaio F, Ferreira D, Thiele H, Baldus S, von Bardeleben RS, Massberg S, Windecker S, Lurz P, Petronio AS, Lindenfeld J, Abraham WT, Metra M, and Hausleiter J
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- Humans, Stroke Volume, Ventricular Function, Left, Heart Failure drug therapy
- Abstract
Aims: Guideline-directed medical therapy (GDMT), based on the combination of beta-blockers (BB), renin-angiotensin system inhibitors (RASI), and mineralocorticoid receptor antagonists (MRA), is known to have a major impact on the outcome of patients with heart failure with reduced ejection fraction (HFrEF). Although GDMT is recommended prior to mitral valve transcatheter edge-to-edge repair (M-TEER), not all patients tolerate it. We studied the association of GDMT prescription with survival in HFrEF patients undergoing M-TEER for secondary mitral regurgitation (SMR)., Methods and Results: EuroSMR, a European multicentre registry, included SMR patients with left ventricular ejection fraction <50%. The outcome was 2-year all-cause mortality. Of 1344 patients, BB, RASI, and MRA were prescribed in 1169 (87%), 1012 (75%), and 765 (57%) patients at the time of M-TEER, respectively. Triple GDMT prescription was associated with a lower 2-year all-cause mortality compared to non-triple GDMT (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.60-0.91). The association persisted in patients with glomerular filtration rate <30 ml/min, ischaemic aetiology, or right ventricular dysfunction. Further, a positive impact of triple GDMT prescription on survival was observed in patients with residual mitral regurgitation of ≥2+ (HR 0.62; 95% CI 0.44-0.86), but not in patients with residual mitral regurgitation of ≤1+ (HR 0.83; 95% CI 0.64-1.08)., Conclusion: Triple GDMT prescription is associated with higher 2-year survival after M-TEER in HFrEF patients with SMR. This association was consistent also in patients with major comorbidities or non-optimal results after M-TEER., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
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- 2022
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31. Reply: Could Left Atrial Function Modify Outcomes After Transcatheter Edge-to-Edge Repair of the Mitral Valve?
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Koell B, Ludwig S, Weimann J, and Kalbacher D
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- Atrial Function, Left, Cardiac Catheterization adverse effects, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery
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- 2022
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32. Left atrial volume index and outcome after transcatheter edge-to-edge valve repair for secondary mitral regurgitation.
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Iliadis C, Kalbacher D, Lurz P, Petrescu AM, Orban M, Puscas T, Lupi L, Stazzoni L, Pires-Morais G, Koell B, Besler C, Ruf TF, Stolz L, Tence N, Adamo M, Giannini C, Guerreiro C, Hellmich M, Baldus S, Schofer N, Thiele H, von Bardeleben RS, Hausleiter J, Karam N, Metra M, Petronio AS, Melica B, and Pfister R
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- Heart Atria diagnostic imaging, Humans, Mitral Valve surgery, Treatment Outcome, Heart Failure, Heart Valve Prosthesis Implantation methods, Hypertension, Pulmonary etiology, Mitral Valve Insufficiency surgery
- Abstract
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/m2 ). 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/m2 , 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.)- Published
- 2022
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33. Management of patients with mitral regurgitation ineligible for standard therapy undergoing TMVI screening.
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Ludwig S, Sedighian R, Weimann J, Koell B, Waldschmidt L, Schäfer A, Seiffert M, Westermann D, Reichenspurner H, Blankenberg S, Schofer N, Lubos E, Conradi L, and Kalbacher D
- Subjects
- Cardiac Catheterization, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery
- Abstract
Background: Transcatheter mitral valve implantation (TMVI) represents a novel treatment alternative for patients with severe mitral regurgitation (MR) considered ineligible for standard therapies. Data on the management of patients after TMVI screening are scarce., Aims: We aimed to investigate outcomes of patients with severe MR undergoing TMVI evaluation treated with either TMVI, bailout-transcatheter edge-to-edge repair (bailout-TEER) or medical therapy (MT)., Methods: Between May 2016 and February 2021, 121 patients with MR considered ineligible for standard therapy were screened for TMVI. Outcomes were assessed for the subgroups of patients treated with TMVI, bailout-TEER and MT. The primary composite endpoint was all-cause death or heart failure hospitalisation after one year., Results: The subgroups of TMVI (N=38), bailout-TEER (N=28) and MT (N=44) differed significantly with regard to MR aetiology (secondary MR: TMVI 68.4%, bailout-TEER 39.3%, MT 38.6%, p=0.014) and left ventricular ejection fraction (TMVI 37.0% [31.4-51.2], bailout-TEER 48.0% [35.3-58.3], MT 54.5% [40.8-60.0], p<0.001). At discharge and after one year, MR was reduced to ≤mild residual MR in all patients undergoing TMVI, while ≥moderate residual MR was present in 25.9% and 20.0% of patients, respectively, after bailout-TEER, and in 100.0% of patients on MT at one year. The primary endpoint occurred in 72.2% of patients remaining on MT, in 51.6% of patients undergoing TMVI and in 40.2% of those receiving bailout-TEER., Conclusions: In MR patients considered ineligible for standard therapy, TMVI provided acceptable clinical outcomes and MR elimination in the majority of patients. In screen-failed patients, bailout-TEER represented a reasonable alternative while MT was associated with poor outcomes.
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- 2022
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34. Long-Term Outcomes of Patients With Elevated Mitral Valve Pressure Gradient After Mitral Valve Edge-to-Edge Repair.
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Koell B, Ludwig S, Weimann J, Waldschmidt L, Hildebrandt A, Schofer N, Schirmer J, Westermann D, Reichenspurner H, Blankenberg S, Conradi L, Lubos E, and Kalbacher D
- Subjects
- Echocardiography, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency etiology, Mitral Valve Insufficiency surgery
- Abstract
Objectives: The aim of this study was to investigate the adverse impact of elevated postprocedural mitral valve pressure gradient (MPG) on outcome in a real-world population of patients with severe mitral regurgitation (MR) who underwent transcatheter mitral valve edge-to-edge repair (TEER)., Background: TEER has become a routine treatment alternative for patients with severe MR at high surgical risk. The consequences of elevated MPG after TEER have been subject to controversial debates., Methods: All consecutive patients undergoing TEER for either severe degenerative MR (DMR) or functional MR (FMR) at a high-volume center between September 2008 and January 2020 were prospectively included and followed periodically. Postprocedural MPG by discharge transthoracic echocardiography was considered elevated at ≥5 mm Hg. The primary combined endpoint was death or heart failure rehospitalization after 5 years., Results: A total of 713 patients undergoing TEER (DMR, n = 265; FMR, n = 445) were included. Elevated postprocedural MPG was present in 37.0% of those with DMR (n = 98) and 22.0% of those with FMR (n = 98). In contrast to patients with FMR, 6-minute walk distance did not improve in patients with DMR with elevated MPG. Kaplan-Meier analyses did not demonstrate significant differences for the primary endpoint in patients with DMR (low vs elevated MPG, 67.3% vs 74.4%; P = 0.06) and those with FMR (78.6% vs 74.8%; P = 0.54). After adjustment, elevated MPG was an independent predictor of the primary endpoint in patients with DMR (HR: 1.59; 95% CI: 1.03-2.45; P = 0.034) but not in those with FMR (HR: 0.87; 95% CI: 0.63-1.22; P = 0.43)., Conclusions: Elevated postprocedural MPG is an independent predictor of adverse clinical and functional outcomes in patients with DMR but not in those with FMR., Competing Interests: Funding Support and Author Disclosures Dr Ludwig has received travel expenses from Edwards Lifesciences. Dr Schofer has received nonfinancial support from Abbott and Edwards Lifesciences. Dr Blankenberg has received grants and personal fees from Abbott. Dr Conradi has received personal fees from Edwards Lifesciences; and is a proctor and consultant for Abbott. Dr Lubos has received speaker honoraria, travel expenses, and research grants from Abbott. Dr Kalbacher has received speaker honoraria from Abbott; and has received travel expenses and proctor fees 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.)
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- 2022
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35. Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair.
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Koell B, Orban M, Weimann J, Kassar M, Karam N, Neuss M, Petrescu A, Iliadis C, Unterhuber M, Adamo M, Giannini C, Melica B, Ludwig S, Massberg S, Praz F, Pfister R, Thiele H, Stephan von Bardeleben R, Baldus S, Butter C, Lurz P, Windecker S, Metra M, Petronio AS, Hausleiter J, Lubos E, and Kalbacher D
- Subjects
- Aged, Europe epidemiology, Female, Follow-Up Studies, Humans, Male, Mitral Valve Insufficiency mortality, Mitral Valve Insufficiency physiopathology, Prognosis, Retrospective Studies, Survival Rate trends, Adaptation, Physiological, Cardiac Catheterization methods, Heart Valve Prosthesis Implantation methods, Mitral Valve surgery, Mitral Valve Insufficiency surgery, Outcome Assessment, Health Care methods, Registries
- Abstract
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.)
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- 2021
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36. Current devices and interventions in mitral regurgitation.
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Koell B, Kalbacher D, and Lubos E
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- Aged, Aortic Valve, Cardiac Catheterization, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Heart Valve Prosthesis Implantation, Mitral Valve Annuloplasty, Mitral Valve Insufficiency surgery
- Abstract
Mitral regurgitation (MR) is the most common valvular disease. With a rising incidence in older age, the prevalence of relevant comorbidities inevitably increases. Considering the constantly aging population with high surgical risk, transcatheter therapy of MR is gaining increasing importance. Interventional therapy of either primary or secondary MR represents an alternative to pure drug or surgical therapy. With mitral valve transcatheter edge-to-edge repair, a well-established treatment has evolved in the past two decades. In addition, direct or indirect annuloplasty and ultimately transcatheter mitral valve implantation further expand the armamentarium. The current broad spectrum of interventional therapy options allows for patient-oriented therapy individually targeting different MR pathologies. This review discusses the current landscape of transcatheter therapies for relevant MR., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2021
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37. Characteristics and Outcomes of Patients Ineligible for Transcatheter Mitral Valve Replacement (TMVR): Implications for Future Device Innovation.
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Ludwig S, Koell B, Sedighian R, Weimann J, Schofer N, Schäfer A, Voigtländer L, Waldschmidt L, Schirmer J, Seiffert M, Pecha S, Westermann D, Reichenspurner H, Blankenberg S, Lubos E, Conradi L, and Kalbacher D
- Subjects
- Cardiac Catheterization, Female, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnosis, Mitral Valve Insufficiency surgery
- Abstract
Objectives: Due to high rates of transcatheter mitral valve replacement (TMVR) screening failure, a substantial proportion of patients with severe mitral regurgitation (MR) remains on optimal medical treatment (OMT) only. Data on outcomes of these patients ineligible for mitral interventions are scarce. This study aimed to assess characteristics and outcomes of severe MR patients treated medically following TMVR screening failure., Methods: From 2016-2020, a total of 111 patients with severe MR underwent screening for TMVR. Screening failure occurred in 66 cases. Among these, 30 patients were treated with OMT only. Characteristics of these patients were analyzed, Kaplan-Meier estimates calculated, and univariate regression analysis performed. Median follow-up time was 2.26 years (95% confidence interval, 1.24-3.25)., Results: Anatomical reasons for screening failure in the study cohort (n = 30) were left ventricular (LV) restraints, risk of LV outflow tract obstruction, mitral annulus calcification, and sizing issues. Median ejection fraction was 56.0% (interquartile range, 38.8%-60.0%). Concomitant tricuspid regurgitation and severe pulmonary hypertension were present in 36.7% and 46.2%, respectively. Intercommissural diameters ranged from 22.5-52.0 mm. Mortality was 23.6% after 6 months and 35.7% after 1 year. Factors associated with mortality were female sex, MR severity, ischemic MR, high N-terminal pro-brain natriuretic peptide levels, and small annulus diameters., Conclusions: Despite growing experience with TMVR, the subset of MR patients anatomically eligible for TMVR is small and many patients are treated medically. Mortality in these patients remains high, underlining an unmet need for adequate therapeutic alternatives. TMVR devices adapting to broader annular size ranges with smaller ventricular profiles might fill this gap.
- Published
- 2021
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38. Prognostic value of the H 2 FPEF score in patients undergoing transcatheter aortic valve implantation.
- Author
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Ludwig S, Pellegrini C, Gossling A, Rheude T, Voigtländer L, Bhadra OD, Linder M, Kalbacher D, Koell B, Waldschmidt L, Schirmer J, Seiffert M, Reichenspurner H, Blankenberg S, Westermann D, Conradi L, Joner M, and Schofer N
- Subjects
- Humans, Prognosis, Stroke Volume, Ventricular Function, Left, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis surgery, Heart Failure epidemiology, Transcatheter Aortic Valve Replacement
- Abstract
Aims: The aim of this study was to assess the prognostic value of the H
2 FPEF score in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) and preserved left ventricular ejection fraction (EF)., Methods and Results: In this multicentre study, a total of 832 patients from two German high-volume centres, who received TAVI for severe AS and preserved EF (≥50%), were identified for calculation of the H2 FPEF score. Patients were dichotomized according to low (0-5 points; n = 570) and high (6-9 points; n = 262) H2 FPEF scores. Kaplan-Meier and Cox regression analyses were applied to assess the prognostic impact of the H2 FPEF score. We observed a decrease in stroke volume index (-2.04 mL/m2 /point) and mean transvalvular gradients (-1.14 mmHg/point) with increasing H2 FPEF score translating into a higher prevalence of paradoxical low-flow, low-gradient AS among patients with high H2 FPEF score. One year after TAVI, the rates of all-cause (low vs. high H2 FPEF score: 8.0% vs. 19.4%, P < 0.0001) and cardiovascular (CV) mortality (1.9% vs. 9.0%, P < 0.0001) as well as the rate of CV mortality or rehospitalization for congestive heart failure (6.4% vs. 23.2%, P < 0.0001) were higher in patients with high H2 FPEF score compared with those with low H2 FPEF score. After multivariable analysis, a high H2 FPEF score remained independently predictive of all-cause mortality [hazard ratio 1.59 (1.28-2.35), P = 0.018] and CV mortality or rehospitalization for congestive heart failure [hazard ratio 2.92 (1.65-5.15), P < 0.001]. Among the H2 FPEF score variables, atrial fibrillation, pulmonary hypertension, and elevated left ventricular filling pressure were the strongest outcome predictors., Conclusions: The H2 FPEF score serves as an independent predictor of adverse CV and heart failure outcome among TAVI patients with preserved EF. A high H2 FPEF score is associated with the presence of paradoxical low-flow, low-gradient AS, the HFpEF in patients with AS. By identifying patients in advanced stages of HFpEF, the H2 FPEF score might be useful as a risk prediction tool in patients with preserved EF scheduled for TAVI., (© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)- Published
- 2021
- Full Text
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39. Screening for transcatheter mitral valve replacement: a decision tree algorithm.
- Author
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Ludwig S, Ruebsamen N, Deuschl F, Schofer N, Kalbacher D, Schaefer A, Koell B, Westermann D, Reichenspurner H, Blankenberg S, Schäfer U, Conradi L, and Lubos E
- Subjects
- Algorithms, Decision Trees, Humans, Mitral Valve, Treatment Outcome, Cardiac Catheterization methods, Heart Valve Prosthesis Implantation methods, Mitral Valve Insufficiency surgery
- Abstract
Aims: The high frequency of screening failure for anatomical reasons in patients with severe mitral valve regurgitation (MR) is a limiting factor in the screening process for transcatheter mitral valve replacement (TMVR). However, data on optimal patient selection are scarce. The present study aimed to develop a screening algorithm based on TMVR screening data., Methods and Results: A total of 195 screenings for six different TMVR devices were performed in 94 high-risk patients with severe MR. We compared baseline echocardiographic and multislice computed tomography (MSCT) parameters between the subgroups of patients accepted (N=33) and rejected for TMVR (N=61). Reasons for screening failure were assessed, and a decision tree algorithm was statistically derived. Reasons for screening failure were small LV dimensions (30.6%), small (7.5%) or large (22.5%) annular size, potential risk of LVOT obstruction (22.0%) or mitral annulus calcification (15.6%). A four-step decision tree algorithm to assess TMVR eligibility was developed resulting in an AUC of 0.80 (95% CI: 0.71, 0.89, p<0.0001)., Conclusions: This study presents the first screening algorithm to assess anatomical eligibility for TMVR in patients with severe MR, based on simple MSCT criteria. Given the high rate of TMVR screening failure, this algorithm may facilitate the identification of potential TMVR candidates.
- Published
- 2020
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40. Establishment of an enhanced recovery after surgery protocol in minimally invasive heart valve surgery.
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Kubitz JC, Schulte-Uentrop L, Zoellner C, Lemke M, Messner-Schmitt A, Kalbacher D, Sill B, Reichenspurner H, Koell B, and Girdauskas E
- Subjects
- Adult, Atrial Fibrillation diagnosis, Atrial Fibrillation etiology, Female, Humans, Intensive Care Units, Length of Stay, Male, Middle Aged, Minimally Invasive Surgical Procedures adverse effects, Pain etiology, Postoperative Complications, Retrospective Studies, Treatment Adherence and Compliance, Treatment Outcome, Aortic Valve surgery, Enhanced Recovery After Surgery, Mitral Valve surgery
- Abstract
Protocols for "Enhanced recovery after surgery (ERAS)" are on the rise in different surgical disciplines and represent one of the most important recent advancements in perioperative medical care. In cardiac surgery, only few ERAS protocols have been described in the past. At University Heart Center Hamburg, Germany, we invented an ERAS protocol for patients undergoing minimally invasive cardiac valve surgery. In this retrospective single center study, we aimed to describe the implementation of our ERAS program and to evaluate the results of the first 50 consecutive patients. Our ERAS protocol was developed according to a modified Kern cycle by an expert group, literature search, protocol creation and pilot implementation in the clinical practice. Data of the first 50 consecutive patients undergoing minimally invasive cardiac valve surgery were analysed retrospectively. The key features of our multidisciplinary ERAS protocol are physiotherapeutic prehabilitation, minimally invasive valve surgery techniques, modified cardiopulmonary bypass management, fast-track anaesthesia with on- table extubation and early mobilisation. A total of 50 consecutive patients (mean age of 51.9±11.9 years, mean STS score of 0.6±0.3) underwent minimally-invasive mitral or aortic valve surgery. The adherence to the ERAS protocol was high and neither protocol related complications nor in-hospital mortality occurred. 12% of the patients developed postoperative atrial fibrillation, postoperative delirium emerged in two patients and reintubation was required in one patient. Intensive care unit stay was 14.0±7.4 hours and total hospital stay 6.2±2.9 days. Our ERAS protocol is feasible and safe in minimally-invasive cardiac surgery setting and has a clear potential to improve patients outcome., Competing Interests: The authors have declared that no competing interests exist.
- Published
- 2020
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41. Fluid status and outcome in patients with heart failure and preserved ejection fraction.
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Koell B, Zotter-Tufaro C, Duca F, Kammerlander AA, Aschauer S, Dalos D, Antlanger M, Hecking M, Säemann M, Mascherbauer J, and Bonderman D
- Subjects
- Aged, Aged, 80 and over, Dielectric Spectroscopy, Disease-Free Survival, Female, Heart Failure complications, Heart Failure mortality, Hospitalization, Humans, Male, Middle Aged, Prospective Studies, Ventricular Function, Left, Heart Failure physiopathology, Stroke Volume physiology, Water-Electrolyte Balance physiology
- Abstract
Background: Most heart failure with preserved ejection fraction (HFpEF) patients, at some point, present to an emergency department with typical symptoms of volume overload. Clinically, most respond well to standard diuretic therapy, sometimes at the cost of renal function. The study sought to define the prognostic significance of fluid status versus renal function in patients with HFpEF., Methods: One hundred sixty-two consecutive patients with HFpEF were enrolled in our prospective registry. Twelve patients with clinically overt decompensation were excluded. Fluid status at baseline was determined by bioelectrical impedance spectroscopy. The primary outcome measure was a combined end point consisting of hospitalization for heart failure and/or death for cardiac reason., Results: Mean age was 74.4±8.4years. Ninety-one (61%) patients were hypo- or normovolemic (relative fluid overload [Rel. FO] -0.7±5.7%) while 59 (39%) patients presented with fluid overload (Rel. FO 11.5±2.7%). During a median follow-up of 24.3months (interquartile range: 19.8-33.2), 34% of patients reached the combined end point. Multivariate Cox hazard analysis identified fluid overload (hazard ratio: 3.09; 95% confidence interval: 1.68-5.68; p<0.001) as an independent predictor of adverse outcome. Patients with fluid overload and normal renal function showed a worse event-free survival compared to the subgroup with normohydration and impaired renal function (log-rank: p=0.042)., Conclusion: HFpEF patients with measurable fluid overload face a dismal prognosis as compared to euvolemic patients. Our data, while preliminary, suggest that patients with fluid overload may face a better outcome under continued fluid removal irrespective of changes in eGFR., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2017
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42. Diastolic Pressure Gradient Predicts Outcome in Patients With Heart Failure and Preserved Ejection Fraction.
- Author
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Zotter-Tufaro C, Duca F, Kammerlander AA, Koell B, Aschauer S, Dalos D, Mascherbauer J, and Bonderman D
- Subjects
- Aged, Aged, 80 and over, Cohort Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Registries, Treatment Outcome, Blood Pressure physiology, Heart Failure diagnosis, Heart Failure physiopathology, Hypertension, Pulmonary diagnosis, Hypertension, Pulmonary physiopathology, Stroke Volume physiology
- Published
- 2015
- Full Text
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43. Outcome in Heart Failure with Preserved Ejection Fraction: The Role of Myocardial Structure and Right Ventricular Performance.
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Goliasch G, Zotter-Tufaro C, Aschauer S, Duca F, Koell B, Kammerlander AA, Ristl R, Lang IM, Maurer G, Mascherbauer J, and Bonderman D
- Subjects
- Aged, Female, Humans, Male, Prospective Studies, Risk Factors, Heart Failure physiopathology, Heart Ventricles physiopathology, Myocardium pathology, Stroke Volume
- Abstract
Background: Heart failure with preserved ejection fraction (HFpEF) is recognized as a major cause of cardiovascular morbidity and mortality. Thus, a profound understanding of the pathophysiologic changes in HFpEF is needed to identify risk factors and potential treatment targets in this specific patient population. Therefore, we aimed to comprehensively assess the impact of left- and right-ventricular function and hemodynamics on long-term mortality and morbidity in order to improve risk prediction in patients with HFpEF., Methods and Results: We prospectively included 142 consecutive patients with HFpEF into our observational, non-interventional registry. Echocardiography, cardiac magnetic resonance imaging and invasive hemodynamic assessments including myocardial biopsy were performed at baseline. We detected significant correlations between left ventricular extracellular matrix and left ventricular end-diastolic diameter (r = -0.64;p = 0.03) and stroke volume (r = -0.53;p = 0.04). Hospitalization for heart failure and/or cardiac death was observed over a median follow up of 10 months. The strongest risk factors were reduced right ventricular function (adj. HR 6.62;95%CI 3.12- 14.02;p<0.001), systolic pulmonary arterial pressure (adj. HR per 1-SD 1.55;95%CI 1.15- 2.09;p = 0.004) and the pulmonary artery wedge pressure (adj. HR per 1-SD 1.51;95%CI 1.09-2.08; p = 0.012). The area under the ROC curve for right ventricular function was 0.63, for systolic pulmonary arterial pressure 0.75, and for pulmonary artery wedge pressure 0.68., Conclusion: The current study emphasizes the importance of right ventricular function and pulmonary pressures on outcome in patients with HFpEF providing pathophysiological insights into the hemodynamic changes in HFpEF.
- Published
- 2015
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44. Prognostic Significance and Determinants of the 6-Min Walk Test in Patients With Heart Failure and Preserved Ejection Fraction.
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Zotter-Tufaro C, Mascherbauer J, Duca F, Koell B, Aschauer S, Kammerlander AA, Panzenboeck A, Sadushi-Kolici R, Bangert C, Laimer D, Ristl R, Lang IM, and Bonderman D
- Subjects
- Aged, Cardiac Catheterization, Female, Heart Failure pathology, Heart Failure physiopathology, Heart Ventricles pathology, Humans, Male, Prognosis, Prospective Studies, Ventricular Dysfunction, Left physiopathology, Walking physiology, Exercise Test, Heart Failure diagnosis, Stroke Volume physiology
- Abstract
Objectives: This study sought to define the prognostic significance and clinical determinants of the 6-min walk distance (6-MWD) in affected patients., Background: Symptoms of exertional fatigue and dyspnea, as well as a reduced exercise tolerance, are cardinal features of pulmonary hypertension associated with heart failure and preserved ejection fraction (PH-HFpEF). Mechanisms limiting exercise capacity in this specific entity remain incompletely understood., Methods: Consecutive patients with PH-HFpEF, as confirmed by right heart catheter, were enrolled in our prospective registry. Hospitalization for HF and/or death for cardiac reasons were defined as primary outcome. Multiple regression models were constructed to establish determinants of the 6-MWD. For quantification of left ventricular (LV) extracellular matrix (ECM), myocardial biopsies were taken from 18 patients., Results: Between December 2010 and July 2013, 142 PH-HFpEF patients were included in the study. After a mean follow-up of 14.0 ± 10.0 months, 43 patients (30.3%) reached the combined endpoint. The 6-MWD was found to be an independent predictor of outcome and was influenced by a variety of clinical, echocardiographic, hemodynamic, laboratory, and pulmonary parameters. There was a significant inverse correlation between the 6-MWD and the extent of ECM in the LV myocardium., Conclusions: Impaired exercise capacity in PH-HFpEF patients is explained by cardiac and noncardiac factors. The 6-MWD predicts outcome and may be a useful endpoint in clinical trials., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2015
- Full Text
- View/download PDF
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