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

The purpose of this paper was to evaluate the impact of proportionality of secondary mitral regurgitation (SMR) in a large real-world registry of transcatheter edge-to-edge mitral valve repair (TMVr) BACKGROUND: Differences in the outcomes of recent randomized trials of TMVr for SMR may be explained by the proportionality of SMR severity to left ventricular (LV) volume.The ratio of pre-procedural effective regurgitant orifice area (EROA) to LV end-diastolic volume (LVEDV) was retrospectively assessed in patients undergoing TMVr for severe SMR between 2008 and 2019 from the EuroSMR registry. A recently proposed SMR proportionality scheme was adapted to stratify patients according to EROA/LVEDV ratio in 3 groups: MR-dominant (MD), MR-LV-co-dominant (MLCD), and LV-dominant (LD). All-cause mortality was assessed as a primary outcome, secondary heart failure (HF) outcomes included hospitalization for HF (HHF), New York Heart Association (NYHA) functional class, N-terminal pro-B-type natriuretic peptide (NT-proBNP), 6-min-walk distance, quality of life and MR grade.A total of 1,016 patients with an EROA/LVEDV ratio were followed for 22 months after TMVr. MR was reduced to grade ≤2+ in 92%, 96%, and 94% of patients (for MD, MLCD, and LD, respectively; p = 0.18). After adjustment for covariates including age, sex, diabetes, kidney function, body surface area, LV ejection fraction, and procedural MR reduction (grade ≤2+), adjusted rates of 2-year mortality in MD patients did not differ from those for MLCD patients (17% vs. 18%, respectively), whereas it was higher in LD patients (23%; p = 0.02 for comparison vs. MD+MLCD). The adjusted first HHF rate differed between groups (44% in MD, 56% in MLCD, 29% in LD; p = 0.01) as did the adjusted time for first death or HHF rate (66% in MD, 82% in MLCD, 68% in LD; p = 0.02). Improvement of NYHA functional class was seen in all groups (p 0.001). Values for 6-min-walk distances, quality of life and NT-proBNP improved in most patients.MD and MLCD patients had a comparable, adjusted 2-year mortality rate after TMVr which was slightly better than that of LD patients. Patients treated with TMVr had symptomatic improvement regardless of EROA/LVEDV ratio.

Background The generalizability of the COAPT trial results on the benefit of TMVR in patients with secondary mitral regurgitation is unclear. Methods Functional and long-term clinical outcome were examined in 122 consecutive patients with secondary mitral regurgitation and reduced ejection fraction undergoing TMVR. “COAPT-like” patients were defined according to principal COAPT inclusion/exclusion criteria if all of the following was fulfilled: symptomatic mitral regurgitation grade 3+ or more according to American guidelines; left ventricular ejection fraction ≥ 20%, left ventricular end-systolic dimension ≤ 70 mm, estimated pulmonary artery systolic pressure ≤ 70 mmHg, mitral valve orifice area ≥ 4 cm2, no prior mitral valve procedure, no right sided congestive heart failure, no COPD requiring home oxygen therapy and NYHA class less than IVb. Results 51% of 122 patients (mean age 74 ± 10 years, 76% male) showed COAPT-like characteristics. COAPT-like patients showed a significantly lower hazard for the composite endpoint of mortality and heart failure hospitalization (HR 0.51, 95%CI 0.30–0.89, p = .017) during a mean follow-up of 16 ± 6 months, with an estimated 1-year event rate of 20% vs 43%, respectively. The improvement in functional outcomes 6 min walking distance (76 ± 136 m vs. 31 ± 90 m), Minnesota Living with Heart Failure Questionnaire (−6 ± 19 vs. −10 ± 23) and Short Form 36 physical component score (3.8 ± 10 vs. 5.5 ± 11) was similar in COAPT-like and the other patients. Conclusion In this first real world cohort half of the patients undergoing TMVR showed COAPT-like characteristics and these patients showed a substantially better clinical outcome. The mid-term functional benefit was similar in COAPT-like and other patients.

Background Transcatheter Mitral Valve Repair (TMVR) with MitraClip is an important treatment option for patients with severe mitral regurgitation. The lack of appropriate, validated and specific means to risk stratify TMVR patients complicates the evaluation of prognostic benefits of TMVR in clinical trials and practice. Purpose We aimed to develop an optimized risk stratification model for TMVR patients using machine learning (ML). Methods We included a total of 1009 TMVR patients from three large university hospitals, of which one (n=317) served as an external validation cohort. The primary endpoint was all-cause 1-year mortality, which was known in 95% of patients. Model performance was assessed using receiver operating characteristics. In the derivation cohort, different ML algorithms, including random forest, logistic regression, support vectors machines, k nearest neighbors, multilayer perceptron, and extreme gradient boosting (XGBoost) were tested using 5-fold cross-validation in the derivation cohort. The final model (Transcatheter MITral Valve Repair MortALIty PredicTion SYstem; MITRALITY) was tested in the validation cohort with respect to existing clinical scores. Results XGBoost was selected as the final algorithm for the MITRALITY Score, using only six baseline clinical features for prediction (in order of predictive importance): blood urea nitrogen, hemoglobin, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), mean arterial pressure, body mass index, and creatinine. In the external validation cohort, the MITRALITY Score's area under the curve (AUC) was 0.783, outperforming existing scores which yielded AUCs of 0.721 and 0.657 at best. 1-year mortality in the MITRALITY Score quartiles across the total cohort was 0.8%, 1.3%, 10.5%, and 54.6%, respectively. Odds of mortality in MITRALITY Score quartile 4 as compared to quartile 1 were 143.02 [34.75; 588.57]. Survival analyses showed that the differences in outcomes between the MITRALITY Score quartiles remained even over a timeframe of 3 years post intervention (log rank: p Conclusion The MITRALITY Score is a novel, internally and externally validated ML-based tool for risk stratification of patients prior to TMVR. These findings may potentially allow for more precise design of future clinical trials, may enable novel treatment strategies tailored to populations of specific risk and thereby serve future daily clinical practice. Funding Acknowledgement Type of funding sources: None. Summary Figure

Background: Given their advanced age and high comorbidity, individual risk assessment is crucial in patients undergoing transcatheter mitral and tricuspid valve repair. Therefore, we evaluated the use of a comprehensive geriatric assessment score, the multidimensional prognostic index (MPI), for risk stratification in these patients. Methods: We conducted a prospective, observational single-center study, including 226 patients undergoing percutaneous repair for mitral or tricuspid regurgitation. The MPI was calculated preprocedural and covers 8 domains (activities of daily living, instrumental activities of daily living, mental status, nutrition, risk of pressure ulcers, comorbidity, medication, and marital/cohabitation status). We sought to identify an association of MPI score with procedural outcomes and 6-month mortality. Results: A total of 53.1% of patients were stratified as low risk according to MPI (MPI-1 group), 44.2% as medium risk (MPI-2 group), and 2.7% as high risk (MPI-3 group). Procedural efficacy and safety were similar between groups. The estimated survival rate at 6 months was 97±2% in MPI-1 group, 79±4% in MPI-2 group (hazard ratio, 6.90 [95% CI, 2.36–12.2]; P ≤0.001) and 50±20% in MPI-3 group (hazard ratio, 20.3 [95% CI, 4.51–91.3]; P P ≤0.001) for death after 6 months. The risk association of the MPI with mortality remained significant in multivariate analysis including risk factors, such as peripheral artery disease and NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels. Conclusions: A comprehensive geriatric assessment with the MPI score provides additional information on mortality risk beyond established cardiovascular risk factors.

Percutaneous mitral valve repair (PMVR) has emerged as standard treatment in selected patients with clinically relevant mitral regurgitation and elevated surgical risk. Until now, valid risk stratification tools in patients undergoing PMVR have been missing [(1)][1]. The CHA2DS2-VASc score was

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

Purpose The aim of this study was to investigate the clinical impact and post-procedural development of tricuspid regurgitation (TR) in patients undergoing the MitraClip procedure for severe mitral regurgitation. Methods In this present multicentre study, we included 940 patients undergoing MitraClip implantation for symptomatic mitral regurgitation from August 2010 to September 2018. Patients were categorized according to concomitant TR (none or mild vs moderate vs severe) and the prognostic impact of TR on 1-year mortality was evaluated. Moreover, in 377 patients, we assessed 3-months echocardiographic controls to further analyse the post-procedural development of TR. Results At baseline, concomitant TR was graded none/mild in 393 (42%), moderate in 316 (34%), and severe in 231 (25%) patients. During 1-year follow-up, 141 of 940 (15%) patients died. According to mild/none, moderate and severe TR, mortality rates were 13%, 12%, and 23%, respectively, revealing a higher prevalence of death in patients with severe TR (p=0.001). Kaplan-Meier analysis and log-rank test confirmed inferior survival rates for patients with severe TR (p=0.001), while there were no significant difference in survival rates between patients with none/mild vs moderate TR (p=0.561). Regarding 1-year mortality, multivariate cox regression analysis, revealed an odds ratio of 1.739 (1.024–2.953; p=0.041), associated with severe TR. After 3-months follow-up, echocardiography in 377 patients showed following TR grade distributions: 44% none/mild, 37% moderate and 19% severe TR. In 100 patients (27%), TR improved by one or more grades, while 64 patients (17%) showed a TR worsening. In patients with severe TR at baseline, 42 of 91 (46%) patients showed a reduction in TR of one or more grades. Patients with severe TR at baseline, who showed a TR improvement during 3-months follow-up, had lower rates of 1-year mortality (p=0.025). For these patients, in regression analysis, right atrial area was revealed as only predictor of TR improvement after MitraClip procedure [odds ratio 0.958 (0.918–0.999); p=0.046]. Conclusion One-fourth of patients undergoing MitraClip procedure for mitral regurgitation had concomitant severe tricuspid regurgitation which was predictive for worse prognosis. Post-procedural TR improvement of one or more grades was frequent in these patients and was associated with higher survival-rates. Funding Acknowledgement Type of funding source: None

Background Recent studies indicate that careful patient selection is key for the percutaneous edge-to-edge repair via MitraClip procedure. The MIDA Score represents a useful tool for patient selection and is validated in patients with degenerative mitral regurgitation (MR). Aim We here assessed the potential benefit of the MIDA Score for patients with functional or degenerative MR undergoing edge-to-edge mitral valve repair via the MitraClip procedure. Methods In the present study, we retrospectively included 520 patients from three Heart Centers undergoing MitraClip implantation for MR. All parameters of the MIDA Score were available in these patients, consisting of the 7 variables age, symptoms, atrial fibrillation, left atrial diameter, right ventricular systolic pressure, left-ventricular end-systolic diameter, left ventricular ejection fraction. According to the median MIDA-Score of 9 points, patients were stratified in to a high and a low MIDA Score group and association with all-cause mortality was evaluated. Moreover, MR was assessed in echocardiographic controls in 370 patients at discharge, 279 patients at 3-months and 222 patients at 12 months after MitraClip implantation. Results During 2-years follow-up after MitraClip implantation, 69 of 291 (24%) patients with a high MIDA Score and 25 of 229 (11%) patients with a low MIDA Score died. Kaplan-Meier analysis and log rank test showed inferior rates of death in patients with a low score (p Conclusion The MIDA Mortality Risk Score remained its predictive ability in patients with degenerative or function MR undergoing transcatheter edge-to-edge mitral valve repair. Moreover, a high MIDA score was associated with a higher frequency of post-procedural residual moderate/severe MR, indicating a lower effectiveness of this procedure in these patients. Funding Acknowledgement Type of funding source: None

Background Reliable risk scores in patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) are lacking. Heart failure is common in these patients, and risk scores derived from heart failure populations might help stratify TMVR patients. Methods Consecutive patients from three Heart Centers undergoing TMVR were enrolled to investigate the association of the “Get with the Guidelines Heart Failure Risk Score” (comprising the variables systolic blood pressure, urea nitrogen, blood sodium, age, heart rate, race, history of COPD) with all-cause mortality. Results Among 815 patients with available data 177 patients died during a mean follow-up time of 419 days. Estimated one-year mortality by quartiles of the score (0–37; 38–42, 43–47 and more than 47 points) was 6%, 10%, 23% and 30%, respectively (p Conclusion The “Get with the Guidelines Heart Failure Risk Score” showed a strong association with mortality in patients undergoing TMVR with additive information beyond traditional risk factors. Given the routinely available variables included in this score, application is easy and broadly possible. Funding Acknowledgement Type of funding source: None

Background Reliable risk scores in patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) are lacking. Heart failure is common in these patients, and risk scores derived from heart failure populations might help stratify TMVR patients. Methods Consecutive patients from three Heart Centers undergoing TMVR were enrolled to investigate the association of the “Get with the Guidelines Heart Failure Risk Score” (comprising the variables systolic blood pressure, urea nitrogen, blood sodium, age, heart rate, race, history of chronic obstructive lung disease) with all-cause mortality. Results Among 815 patients with available data 177 patients died during a median follow-up time of 365 days. Estimated 1-year mortality by quartiles of the score (0–37; 38–42, 43–46 and more than 46 points) was 6%, 10%, 23% and 30%, respectively (p p = 0.46). Every increase of one score point was associated with a 9% increase in the hazard of mortality (95% CI 1.06–1.11%, p Conclusion The “Get with the Guidelines Heart Failure Risk Score” showed a strong association with mortality in patients undergoing TMVR with additive information beyond traditional risk factors. Given the routinely available variables included in this score, application is easy and broadly possible. Graphic abstract

Background The recently published Cardiovascular Outcomes Assessment of the mitraclip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) randomized trial has shown a huge benefit in the survival of patients with systolic heart failure and functional mitral regurgitation treated with MitraClip. However, patients in COAPT were highly selected and the clinical course in real-world patients with and without fulfilment of the trial inclusion criteria is unclear. Methods Our study examined the clinical outcome in consecutive patients from our Heart Centre with reduced left-ventricular ejection fraction (EF20%, left ventricular end-systolic dimension 4 cm2, no prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure). The composite endpoint of all-cause mortality or heart failure hospitalization and the endpoint of heart failure hospitalization were analysed. Results Among 123 patients who underwent mitraclip implantation 60.2% fulfilled the inclusion criteria of COAPT. Overall, 54 patients (46.6%) died or were hospitalized for heart failure during a median follow-up time of 19 months. The composite endpoint was significantly less frequent (p=0.01) in patients fulfilling the COAPT selection criteria than in those not fulfilling the criteria, with an estimated 1-year event rate of 24.6% vs 49.1%. Patients with COAPT inclusion criteria had a 49% lower hazard of the composite endpoint (95% CI 12–70%, p=0.015). Heart failure hospitalization was significantly less frequent (p=0.039) in patients fulfilling COAPT selection criteria than in those who did not, with an estimated 1-year event rate of 19% vs. 36.8%. Patients with COAPT inclusion criteria had a 50% lower hazard for heart failure hospitalization (95% CI 1–75%, p=0.046). Of note, the 1-year all-cause mortality in our patients fulfilling COAPT inclusion criteria was lower compared to the renowned COAPT trial (10% vs. 19%). Conclusion In this single center study the outcome of patients with functional mitral regurgitation undergoing mitraclip therapy was significantly worse in patients not fulfilling COAPT inclusion criteria, indicating that these criteria might help identify futility. The remarkable difference in outcome between real-world patients and COAPT trial patients warrants further study to elucidate underlying causes, which might affect the transferability of the COAPT results.

Estimating the quantitative effect of transcatheter mitral valve repair on functional parameters and quality of life is important for individual treatment decision-making. We combined data from a prospective monocentric cohort study (N = 215) with data from a systematic literature review (PubMed search term “mitraclip”, till 30.04.2016) on patients undergoing MitraClip with at least mortality after discharge reported as an outcome. Effects on functional parameters were reported as range of mean change. 36 observational studies and 1 randomized controlled trial were identified. Due to substantial heterogeneity of effect estimates (I 2-heterogeneity >75%) and inadequate quality of studies with a lack of comparison group in 97.4% and lack of an independent assessment of outcomes in 86.8%, no pooled estimates were calculated. All studies reported improvements of mean New York Heart Association (NYHA) class (0.5–1.9 classes), Short-Form (SF)-12/36 scores (4.4–9.2 for physical component score, 2.6–8.9 for mental component score), 6-min walk distance [(6MWD) 2–336 m] and Minnesota Living with Heart failure questionnaire (MLWHFQ) score (−7 to −18 points), with improvements regarded as clinically relevant in 20 of 29 studies for NYHA class, in all of 7 studies for SF12/36, in 9 of 15 studies for 6MWD and in all of 8 studies for MLWHFQ. MitraClip therapy provides improvements in physical capacity, physical and mental functioning and disease-specific quality of life in the majority of patients. However, more comparative and high-quality studies are required for understanding the heterogeneity of results, which is crucial for optimal patient selection.

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