Search

The prevalence of left ventricular (LV) thrombus formation following percutaneous mitral valve edge-to-edge repair (TMVR) with the MitraClip system is unclear. Decreased total stroke volume and perfusion of the LV apex after mitral valve repair may facilitate thrombus formation especially in the context of reduced LV function. LV thrombus may cause disabling stroke or other thromboembolic events in this elderly and multimorbid patient cohort. Analyses of the prevalence of and risk factors for left ventricular thrombus formation in patients treated with the MitraClip system due to severe mitral valve regurgitation. All discharge and follow-up transthoracic echocardiographic examinations up to 6 months of 453 consecutive patients treated with the MitraClip system were screened for the presence of LV thrombus. Prevalence of LV thrombus formation was 1.1% (5/453). Importantly, LV thrombi were exclusively found in patients with severely depressed left ventricular systolic function (LV-EF < 30%), comprising a prevalence of 4.4% in this subgroup (5/113). Importantly, two of these patients were under active DOAC therapy with Rivaroxaban and Apixaban, respectively. Apart from LV-EF, we did not identify other factors that might have facilitated LV thrombus formation. LV thrombus formation following percutaneous mitral valve repair occurred exclusively in patients with severely depressed LV-EF. As two patients developed LV thrombus despite of DOAC therapy, anticoagulation with a Vitamin K antagonist should be considered in patients with an indication for oral anticoagulation following TMVR., (© 2022. The Author(s).)

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

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

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

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

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

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

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

Aims: This study sought to determine the incidence and identify predictors of acute kidney injury (AKI) following percutaneous edge-to-edge mitral valve repair (PMVR) and compare the risk of AKI between PMVR and surgical mitral valve repair (SMVR)., Methods and Results: We performed a single-centre analysis of 378 patients receiving treatment for mitral regurgitation (196 consecutive patients undergoing PMVR and 182 patients undergoing SMVR). The incidence of AKI (any stage according to KDIGO) following PMVR was 17.9%. Intervention duration (OR 1.01, 95% CI: 1.00-1.02) and peripheral vascular disease (OR 7.69, 95% CI: 3.25-18.17) predicted AKI after PMVR. Patients suffering from AKI after PMVR demonstrated poorer survival (median followup 428 days). SMVR patients were significantly younger, had fewer comorbidities and better renal function at baseline. Nevertheless, AKI occurred numerically more often after SMVR than PMVR (25.8% vs. 17.9%, p=0.060), and a multivariable regression model adjusting for differences between both groups confirmed a significantly lower risk for AKI following PMVR (OR 0.22, 95% CI: 0.11-0.44, p<0.001)., Conclusions: These data show a significant incidence of AKI after PMVR that must be taken into account in periprocedural care. Nevertheless, our data suggest that SMVR carries an even higher risk of AKI, which should be considered when a decision has to be made between the two therapies.

Background: Estimating the quantitative effect of transcatheter mitral valve repair on functional parameters and quality of life is important for individual treatment decision-making., Methods: 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., Results: 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., Conclusion: 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., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We evaluated end-tidal CO2 (etCO2), which has been proposed to assess acute hemodynamic changes, to guide percutaneous edge-to-edge mitral valve repair (PMVR) with the MitraClip system., Methods: Thirty-nine patients (aged 78 ± 14 years) undergoing PMVR for moderate-to-severe mitral regurgitation (MR) of primary and secondary etiology were included. General anesthesia was maintained with sevoflurane and constant ventilation parameters to ensure stable etCO2 tension. MR grade was determined semiquantitatively by transesophageal echocardiography by 2 experienced operators blinded to etCO2 measurements. etCO2 levels were measured 3, 5, 10, and 15 min after final MitraClip placement., Results: Overall, etCO2 increased from 32.2 ± 1.7 before to 35.4 ± 3.0, 34.6 ± 2.6, and 34.2 ± 2.4 mm Hg 3, 5, and 10 min after implantation. A significant correlation was noted between the echocardiographic reduction in MR grade and the increase in etCO2. ANOVA for repeated measures confirmed a significant increase in etCO2 after clip implantation (corrected F = 20.0; p < 0.001) and revealed a significantly greater increase in etCO2 in patients with MR reduction ≥2 grades as compared to lesser MR reductions (F = 6.47; p = 0.015). Blood pressure changes did not correlate with the degree of MR reduction., Conclusions: We observed a close correlation between the reduction in MR grade during PMVR and etCO2, which might evolve as a useful parameter to complement treatment guidance during PMVR., (© 2017 S. Karger AG, Basel.)

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

Aims: Factors predicting outcomes after MitraClip implantation are not well defined. We aimed to report the influence of baseline renal function on short-term outcomes of patients enrolled in the investigator-initiated German transcatheter mitral valve interventions (TRAMI) registry., Methods and Results: Twenty participating German centres prospectively included 778 patients (mean age 76.0 years [71-81], 38.8% female gender) at high surgical risk (mean logistic EuroSCORE 20% [12-32%]) undergoing TMVR with the MitraClip for the treatment of symptomatic functional (70%) or degenerative (30%) mitral valve regurgitation (FMR, DMR). The patients were stratified according to renal function before clip implantation. The prevalence of moderate to severe renal impairment (glomerular filtration rate [GFR] <60 ml/min) was 62.7% (37.3%, normal renal function [GFR >60 ml/min]; 49.6%, moderate renal impairment [GFR 30-60 ml/min]; 13.1%, severe renal impairment [GFR <30 ml/min]). TMVR was successfully completed in 98.2% of cases; acute procedural failure, in-hospital and 30-day mortality rates were 1.8%, 2.3% and 4.4%, respectively. Acute procedural failure and mortality rates (in-hospital, 30-day) were significantly higher in patients with severe renal impairment (5.9%, 7.8%, 14.1%), as compared to patients with moderately (1%, 1.3%, 3.0%) or mildly impaired to normal (1.4%, 1.7%, 2.9%) renal function (p<0.0001). Following Cox regression analysis, the prevalence of severe renal impairment at the time of TMVR was the only predictor for increased 30-day mortality rates (hazard ratio 3.42, 95% confidence interval 1.88-6.2; p<0.0001)., Conclusions: Renal function at the time of interventional mitral valve repair with the MitraClip system is a strong predictor for procedural outcomes. Patients with severe renal impairment have a more than threefold increased risk for acute procedural failure, in-hospital death and 30-day mortality.

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

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

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

Objectives: Transcatheter-based treatment of valvular heart disease has increasingly been implemented for the treatment of high-risk patients. The impact of these new treatment modalities on surgical valve programmes is unclear at present. We sought to evaluate the impact of an interventional mitral valve programme on surgical mitral valve activity and to assess the risk profiles of the respective patient populations., Methods: Between 2007 and 2011, 1112 patients underwent mitral valve surgery for isolated or combined procedures. An interventional mitral valve programme was initiated in 2008, with 270 patients treated from 2008 to 2011. Data were prospectively entered into a database and retrospectively analysed., Results: From 2007 to 2011, surgical mitral valve activity increased by 29.9% compared with a 9.8% increase nationwide (P = 0.09). Compared with the year before the introduction of a MitraClip programme, mean logistic EuroSCORE I of surgical patients was similar in 2011 (2007: 9.4 ± 10.4 vs 2011: 9.5 ± 10.5; P = 0.92), while overall 30-day mortality decreased from 7.2 to 4.4% (P = 0.22). The risk profile of surgical patients decreased significantly regarding several parameters. For isolated mitral valve repair, 30-day mortality was 1.5% (6 of 406) in all patients during the study period. Mean logistic EuroSCORE I of transcatheter patients was significantly higher when compared with that of surgical patients (28.8 ± 18.8 vs 9.5 ± 10.5%; P < 0.01)., Conclusions: Since the implementation of an interventional mitral valve programme, surgical mitral valve activity has increased over the following years. The risk profile of surgical patients decreased regarding several important parameters, although the overall logistic EuroSCORE I remained unchanged. An integrated approach to mitral valve disease with complementary surgical and non-surgical treatment options may possibly help in relieving the undertreatment of patients with severe mitral regurgitation.

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

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

Objective: Surgical mitral valve repair carries an elevated perioperative risk in the presence of severely reduced ventricular function and relevant comorbidities. We sought to assess the feasibility of catheter-based mitral valve repair using a clip-based percutaneous edge-to-edge repair system in selected patients at high surgical risk with mitral regurgitation grade 3 or worse., Methods: Between 2002 and January 2011, 202 consecutive patients without prior mitral valve surgery (age 75 ± 9 years; 63% were male) with symptomatic functional (65%), degenerative (27%), or mixed (8%) mitral regurgitation were treated with a percutaneous clip system for approximation of the anterior and posterior mitral leaflets. Risk for mitral valve surgery was considered high in terms of a mean logistic European System for Cardiac Operative Risk Evaluation of 44% (range, 21%-54%). Preprocedural left ventricular ejection fraction was 35% or less in 36% of patients. An interdisciplinary heart team of cardiologists and cardiac surgeons discussed all patients., Results: Percutaneous clip implantation was successful in 186 patients (92%). Patients were treated with 1 clip (n = 125; 62%), 2 clips (n = 64; 32%), or 3 or more clips (n = 7; 3%). Reduction in mitral regurgitation from pre- to postprocedure was significant (P < .0001) and remained stable within the first 12 months in the majority of patients. Thirty-day mortality was 3.5% (7/202 patients). Hospital stay was 12 ± 10 days, and median intensive care unit stay was 1 day (range, 0-45 days). Eleven patients required surgical valve repair/replacement at a median of 38 days (0-468 days) after percutaneous clip implantation., Conclusions: Clip-based percutaneous mitral valve repair is a safe, low-risk, and effective therapeutic option in symptomatic patients with a high risk for surgery and does not exclude later surgical repair., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Conventional or minimally invasive surgical mitral valve repair (MVR) is the gold-standard treatment for severe mitral regurgitation (MR) of any etiology. Given its good safety profile, trans-catheter MVR with the MitraClip™ device is used increasingly for high-risk or inoperable patients. We report our experience with failed MitraClip™ therapy and its impact on subsequent surgical strategies, such as the feasibility of MVR in high-risk patients., Methods: During a follow-up of 344 ± 227 days from the first 215 consecutive patients treated with the MitraClip™ device, six patients required surgical re-intervention due to failed repair (n = 3) or recurrent severe MR (n = 3) at 35.8 ± 47.7 (range 0-117) days after trans-catheter MVR. Feasibility of secondary surgical MVR was assessed with regard to prior clip therapy., Results: In three patients, secondary surgical MVR was successfully performed following the surgical strategy deemed optimal before trans-catheter treatment. Injury of the mitral leaflets caused by prior clip treatment was present in three other patients and influenced the surgical strategy toward more complex surgical techniques in one case and MV replacement in two others. One patient died 6 days after MV replacement. All other patients are alive with adequate valve function at the latest follow-up of 12.4 ± 7.4 months (range 4-22)., Conclusions: Secondary surgical MVR was feasible in some patients after prior clip treatment, but led to valve replacement in others. At present, patient selection criteria for trans-catheter MVR should not be expanded toward more healthy patients, as primary trans-catheter MVR may complicate secondary surgery in certain cases and may even preclude reconstructive valve surgery., (Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

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

Aims: We sought to assess the feasibility of catheter-based mitral valve repair using the MitraClip system in high-surgical-risk patients with mitral regurgitation (MR) > or =grade 3+., Methods and Results: MitraClip therapy was performed in 51 consecutive patients [73 +/- 10 years; 34 (67%) men] with symptomatic functional [n = 35 (69%)] or organic MR [n = 16 (31%)]. Mean logistic EuroSCORE was 29 +/- 22%; Society of Thoracic Surgeons score was 15 +/- 11. Left ventricular (LV) ejection fraction was 36 +/- 17%. In 35 patients (69%), adverse mitral valve morphology and/or severe LV dysfunction were present. MitraClip implantation was successful in 49 patients (96%). Most patients [n = 34/49 (69%)] were treated with a single clip, whereas 14 patients (29%) received two clips and one patient received three clips. Mean device and fluoroscopy times were 105 +/- 65 min and 44 +/- 28 min, respectively. Procedure-related reduction in MR severity was one grade in 16 patients (31%), two grades in 24 patients (47%), and three grades in 9 patients (18%). Forty-four of the 49 successfully treated patients (90%) showed clinical improvement at discharge [NYHA functional class > or =III in 48 patients (98%) before and 16 patients (33%) after the procedure (P < 0.0001)]. There were no procedure-related major adverse events and no in-hospital mortality., Conclusion: Mitral valve repair using the MitraClip system was shown to be feasible in patients at high surgical risk primarily determined by an adverse mitral valve morphology and/or severe LV dysfunction.

Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year. This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335) [Display omitted] [ABSTRACT FROM AUTHOR]

Objective: A sizeable proportion of patients with secondary mitral regurgitation (SMR) do not receive guideline-directed medical therapy (GDMT) for heart failure (HF). We investigated the association between the use of GDMT and mortality in patients with SMR who underwent transcatheter edge-to-edge repair (TEER).Methods: We retrospectively analysed patients with SMR and a left ventricular ejection fraction of <50% who underwent TEER at three centres. According to current HF guidelines, GDMT was defined as triple therapy consisting of beta-blockers, renin-angiotensin system (RAS) inhibitors and mineralocorticoid receptor antagonists (MRAs). Patients were divided into two groups: GDMT and non-GDMT groups. We calculated the propensity scores and carried out inverse probability of treatment weighting (IPTW) analyses to compare 2-year mortality between the two groups.Results: Of 463 patients, 228 (49.2%) were treated with GDMT upon discharge. IPTW-adjusted Kaplan-Meier curve showed patients with GDMT had a lower incidence of mortality than those without GDMT (19.8% vs 31.1%, p=0.011). In IPTW-adjusted Cox proportional hazards analysis, GDMT was associated with a reduced risk of 2-year mortality (HR: 0.58; 95% CI: 0.35 to 0.95; p=0.030), which was consistent among clinical subgroups. Moreover, patients with GDMT had a higher rate of left ventricular reverse remodelling at 1 year after TEER than those without GDMT.Conclusion: GDMT, defined as triple therapy consisting of beta-blockers, RAS inhibitors and MRAs, was associated with a reduced risk of 2-year mortality after TEER for SMR. Optimisation of medical therapy is crucial to improve clinical outcomes in patients undergoing TEER for SMR. [ABSTRACT FROM AUTHOR]

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

BACKGROUND: Treatment options for secondary tricuspid regurgitation (TR) remain limited. Early real-world data of a new percutaneous direct annuloplasty system for tricuspid repair were examined. METHODS: The first 60 patients treated with the Cardioband tricuspid valve repair system at 4 centers were included in this retrospective study. The primary efficacy end point was technical success with reduction of TR ≥2 grades at discharge. Combined primary safety end point was major adverse events (death, myocardial infarction, cardiothoracic surgery, and stroke) at 30 days. RESULTS: Median patient age was 76 years (73-82), median EuroScore II was 3.9% (2.2-8.1), heart failure with preserved ejection fraction was present in 78%, and 81.7% were in the New York Heart Association class III/IV. Massive or torrential TR was found in 51.7%, and severe TR in 48.3%. The primary efficacy end point was achieved in 45%, while 60.3% of patients had less-than-severe TR at discharge. Vena contracta was reduced by 47% from 12.9±4.8 to 7.0±3.4 mm (P<0.001). Overall, the majority of patients (81.7%) improved at least by 1 New York Heart Association class. At follow-up 81.3% of patients presented in the New York Heart Association class I or II. The primary safety end point occurred in 4 patients with 2 in-hospital deaths, both not device related. Right coronary artery complications (vessel perforation or stent implantation) occurred in 9 patients (15%). Procedural time decreased from 298 to 185 minutes (P<0.001) with efficacy remaining stable (P=0.817) when comparing procedure numbers 11 or more to the earliest 5 procedures per center. CONCLUSIONS: This first real-world experience suggests that transcatheter treatment of advanced secondary TR using direct annuloplasty is feasible and reasonably safe early in the learning curve, with significant symptomatic benefit. Further studies are warranted to provide data on long-term outcome and patient prognosis. [ABSTRACT FROM AUTHOR]

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

Background: Left atrial (LA) dimension is a marker of disease severity and outcome in primary and secondary mitral regurgitation. In transcatheter mitral valve repair, LA enlargement might additionally impact on device handling and technical success through an altered anatomy and atrial annular dilatation.Methods and Results: Data from the multicentre German TRAnscatheter Mitral valve Interventions registry (TRAMI) were used to analyse the association of baseline LA diameter by tertiles with efficacy, safety and long-term clinical outcome in patients undergoing edge-to-edge repair with MitraClip. In 520 of 843 patients prospectively enrolled in TRAMI, baseline LA diameter were reported [median (interquartile range) LA diameter in tertiles: 44 (40-46) mm, 51 (48-53) mm and 60 (55-66) mm]. Larger LA diameters were significantly associated with secondary aetiology of mitral regurgitation, lower ejection fraction, larger left ventricle, male sex and atrial fibrillation (all P < 0.05). Technical success was not different across tertiles (96%, 95.4% and 98.4%, respectively; P = 0.43) as were major in-hospital cardiovascular and cerebral adverse events (mortality, myocardial infarction or stroke: 1.8%, 1.2% and 4.4%, respectively; P = 0.11 across tertiles). However, 4-year mortality significantly increased with larger LA diameter (32.9%, 46.4% and 51.7%, respectively; P < 0.01), as did hospitalization in survivors (60%, 67.6% and 78.9%, respectively; P < 0.05). The association between LA diameter and outcome remained significant after multivariable adjustment including baseline left ventricular end-diastolic diameter.Conclusion: Left atrial enlargement is a strong and independent predictor of adverse long-term outcome after transcatheter mitral valve repair. Further study is warranted to examine whether timely intervention may have the potential to modify outcome. [ABSTRACT FROM AUTHOR]

Aims As periprocedural risk is low, MitraClip implantation is often performed in critically ill, not fully recompensated patients, who are in NYHA functional class IV at the time of the procedure, to accelerate convalescence. We herein sought to evaluate the procedural and 30-day outcome of this patient group. Methods and results A total of 803 patients undergoing MitraClip implantation were included in the German Mitral Valve Registry, and 30-day outcomes were prospectively assessed. Patients were separated based on NYHA functional class [( NYHA IV ( n = 143), III ( n = 572), and I/ II ( n = 88)]. No difference was noted in co-morbities and echocardiographic parameters of LV function between groups. However, parameters of severity of mitral regurgitation ( MR) were higher in NYHA IV patients. High procedural success rates and low residual MR grades at discharge were observed throughout all groups. In-hospital major adverse cardiac events were similar between groups. Importantly, 30-day mortality (8.0% vs. 3.2% vs. 4.8%; P < 0.05) was significantly higher in NYHA IV patients, whereas rehospitalization did not differ between groups. At 30 days, 47.6% of NYHA IV patients were still in NYHA class III or IV compared with 32.5% and 14.8% in the other groups ( P < 0.05), although NYHA functional class decreased in 69% of patients. Quality of life, which was very poor at baseline, showed an overall improvement in NYHA IV patients after 30 days, with, for example, a reduction of bed-ridden patients from 19.6% to 3.3%. Conclusion MitraClip therapy is feasible and safe even in critically ill, not fully recompensated patients and leads to symptomatic improvement in over two-thirds of these patients; however, it is associated with an elevated 30-day mortality. [ABSTRACT FROM AUTHOR]

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

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<0.001). An increase in 1 SD of the MPI score (0.14 points, possible range of MPI score 0-1) was associated with a hazard ratio of 2.13 (95% CI, 1.58-2.73; 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. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this article is to report early and mid-term outcomes of the ACCESS-EU study (ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe), a European prospective, multicenter, nonrandomized post-approval study of MitraClip therapy (Abbott Vascular, Inc., Santa Clara, California). Background: MitraClip has been increasingly performed in Europe after approval; the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes. Methods: A total of 567 patients with significant mitral valve regurgitation (MR) underwent MitraClip therapy at 14 European sites. Mean logistic European System for Cardiac Operative Risk Evaluation at baseline was 23.0 ± 18.3; 84.9% patients were in New York Heart Association functional class III or IV, and 52.7% of patients had an ejection fraction ≤40%. Results: The MitraClip implant rate was 99.6%. A total of 19 patients (3.4%) died within 30 days after the MitraClip procedure. The Kaplan-Meier survival at 1 year was 81.8%. Intensive care unit and hospital length of stay was 2.5 ± 6.5 days and 7.7 ± 8.2 days, respectively. Single leaflet device attachment was reported in 27 patients (4.8%). There were no MitraClip device embolizations. Thirty-six subjects (6.3%) required mitral valve surgery within 12 months after the MitraClip implant procedure. There was improvement in the severity of MR at 12 months, compared with baseline (p < 0.0001), with 78.9% of patients free from MR, severity of >2+ at 12 months. At 12 months, 71.4% of patients had New York Heart Association functional class II or class I. Six-min-walk-test improved 59.5 ± 112.4 m, and Minnesota-living-with-heart-failure score improved 13.5 ± 20.5 points. Conclusions: In the real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are high-risk, elderly patients, mainly affected by functional MR. In this patient population, the MitraClip procedure is effective with low rates of hospital mortality and adverse events. [ABSTRACT FROM AUTHOR]

The generalizability of the COAPT trial results on the benefit of TMVR in patients with secondary mitral regurgitation is unclear. 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. 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. 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. • Trials of TMVR in patients with secondary mitral regurgitation are controversial. • The COAPT trial showed a substantial benefit in a highly selected study population. • COAPT-like patients represent approximately half of TMVR patients in a real-world cohort. • Non COAPT-like patients had a substantially worse long-term clinical outcome. • Functional benefit was similar in COAPT-like and non COAPT-like patients. [ABSTRACT FROM AUTHOR]

Abstract Background MitraClip therapy is increasingly used in patients deemed inoperable to treat severe mitral regurgitation (MR), but long-tern data is scarce. Aims The multicentre, industry-independent German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises the largest prospectively enrolled cohort of patients treated by MitraClip therapy. The current analysis is focusing on long-term mortality rates, cardiac rehospitalization and reintervention. Methods and results Long-term follow-up (median time 1037 days) in the TRAMI registry was available for 722 patients treated at 20 German centres. Improvements in New York Heart Association (NYHA) functional class (I/II long-term: 65% vs. 1-year follow-up: 63.3%) and self-rated health-status (EuroQuol visual analogue scale [EQ VAS] long-term: 60 [50–70] vs. 1-year follow-up: 60 [50; 70]) were pertained over time. Estimated mortality rates by Kaplan-Meier method were 19.7% for 1-year, 31.9% for 2-year and 53.1% for 4-year follow-up without differences found for MR aetiology. Multivariable Cox-regression analysis identified previous aortic valve implantation (hazard ratio [HR] = 2.21; p < 0.0001), NYHA class IV (HR = 1.78; p < 0.001), prior cardiac decompensation (HR = 1.63; p < 0.001), creatinine > 1.5 mg/dl (HR = 1.63; p < 0.0001) and left ventricular ejection fraction < 30% (HR = 1.60; p < 0.001) as most predictive for long-term mortality. Conclusions Long-term outcome in the TRAMI registry confirmed lasting clinical improvements and low intervention rates. Long-term mortality was strongly influenced by cardiac and non-cardiac co-morbidities and was found comparable for both MR aetiologies. Highlights • Long-term outcome was analyzed in the German Transcatheter Mitral Valve Interventions (TRAMI) registry comprising 799 patients treated at 20 centers in Germany. • This study demonstrated relevant clinical improvements and low reintervention rates, yet mortality rates exceeding 50% at 4-year follow-up. • To further understand the prognostic potential of MitraClip therapy, reliable evidence of the ongoing RCTs in FMR patients is urgently needed. [ABSTRACT FROM AUTHOR]