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Background: Mitral regurgitation (MR) is common in patients with heart failure and constitutes an independent risk factor for adverse prognosis besides NYHA-class. The predictive value of dyspnea reduction after transcatheter mitral valve repair (TMVr) on outcome has not been investigated up to now., Methods and Results: We enrolled 627 consecutive patients (47.0% female, 57.4% functional MR; median follow-up 486 days[IQR 157/961]; survival status available in 96.8%; symptoms assessed in n = 556 at baseline / n = 406 at 1 month) treated with isolated percutaneous mitral valve edge-to-edge repair in our center from 06/2010-03/2018 (exclusion of combined forms of TMVr) in a monocentric retrospective analysis. Survival was 97.6% at discharge, 73.9% after 1, 54.5% after 3, 37.6% after 5 and 21.7% after 7-years. Before TMVr, NYHA-classes III/IV were found in 89.0%. Of these, 74.7% reported symptomatic relief (reduction in NYHA-class) one month after procedure (NYHA class recorded in 406 patients at 30 days). NYHA-classes III/IV were documented in 37.2% (p < 0.001) at 30 days and in 36.6% (p < 0.001) at 1 year without significant changes between the follow-ups. Dyspnea reduction was accompanied by significantly improved long-term survival (1 year, 89.1 vs 71.2%, p = 0.001, 2 years: 75.5 vs 58.7%, p = 0.039) and was identified as an independent predictor for lower mortality (1-year HR for increased mortality by missing symptomatic improvement 2.94 [95%CI 1.53-5.65], p = 0.001; long-term HR 1.95 [95%CI 1.29-2.94], p = 0.001) independently in both etiologies of MR., Conclusion: TMVr by edge-to-edge therapy enables early and sustainable symptomatic improvement in nearly 75% of the symptomatic patients. The simple assessment of postinterventional changes in NYHA-class might serve as an independent predictor for mid- and long-term prognosis in both FMR and DMR., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objectives: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear., Background: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis., Methods: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed., Results: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm 2 vs. 0.6 ± 0.3 cm 2 ; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30)., Conclusions: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Introduction: Transcatheter edge-to-edge mitral valve repair using the MitraClip has been widely performed in surgical high-risk patients with reduced left ventricular systolic function and severe functional mitral regurgitation (FMR). Ischaemic heart disease is the leading aetiology of heart disease worldwide. We aimed to assess the clinical implications of ischaemic aetiology in patients with severe FMR who underwent MitraClip implantation., Methods and Results: From two high-volume centres in Germany, we retrospectively compared the clinical outcomes and clinical predictors of all-cause mortality after MitraClip implantation in patients with ischaemic (I-FMR) and non-ischaemic FMR (NI-FMR). In the overall FMR cohort (n = 575), there were 336 (58%) patients with I-FMR and 239 (42%) with NI-FMR. There was no significant difference in survival between the two groups (log-rank p = 0.78). In a multivariable Cox regression analysis of all-cause mortality, different predictors were observed for either group. In I-FMR patients, decreasing tricuspid annular systolic excursion [adjusted hazard ratio (HR adj ) 1.06, 95% confidence interval (95% CI) 1.01-1.14 /1 mm, p = 0.028] and increasing logistic EuroSCORE (HR adj 1.02, 95% CI 1.00-1.03, p = 0.037) were independent predictors, whereas in NI-FMR patients, NT-pro BNP (HR adj 1.05, 95% CI 1.02-1.08, p = 0.001) and age (HR adj 1.06, 95% CI 1.01-1.11, p = 0.013) were independently predictive of mortality., Conclusions: Despite the similar survival between ischaemic and non-ischaemic FMR, different predictors of all-cause mortality were demonstrated. Further clinical studies are mandated to focus on each FMR subgroup with stratification by ischaemic origin.

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.

The objective of this study was to assess the results of catheter-based and surgical reinterventions in primary mitral regurgitation after failed MitraClip therapy. We report on 21 consecutive symptomatic patients with primary mitral regurgitation (median age 78 years) who underwent either repeat MitraClip therapy (n = 7) or mitral valve surgery (n = 14) after failure of the index procedure with 1-2 MitraClip implantations. At the time of reinterventions, 193 (interquartile range [IQR]: 32-622) days after the index procedure, patients had recurrent or persistent grade 3 mitral regurgitation. Early mortality at 30 days was 4.8%. Cardiac-related survival at 2 years was 85.4% (4 cardiac and 4 noncardiac deaths). Three of 7 patients with percutaneous reintervention were converted to surgery at 34, 52, and 56 days because repeat MitraClip therapy was ineffective because of pre-existing clip detachment or leaflet tear. Final therapy was biological mitral valve replacement in 14 of 21 patients (66.7%); 4 were treated with percutaneous repeat MitraClip repair (19%), and in 3 patients, surgical repairs were performed (14.3%). At follow-up with a median of 708 days, New York Heart Association class had improved significantly to class 2 (IQR: 1.0-2.5) (P = 0.0004), and the left ventricular end-diastolic diameter had decreased from 56 (IQR: 52-59) mm to 51 (48-58) mm (P = 0.0378), respectively. Recurrence of significant mitral regurgitation was absent in all but 1 patient with unsuccessful repeat MitraClip therapy who was deemed inoperable. Our data show that both repeat MitraClip and also mitral valve surgery are feasible and safe alternatives in patients without an excessively increased perioperative risk. We conclude that whenever leaflet insertion is not compromised, repeat catheter-based repair is a reasonable redo concept; in the remaining cases, surgery should be offered to the patient., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Aims: The study sought to assess outcomes of transcatheter mitral valve-in-valve implantation (TMVIV) for degenerated bioprostheses and transcatheter mitral valve-in-ring implantation (TMVIR) for failed annuloplasty rings according to access route and the Mitral Valve Academic Research Consortium (MVARC) criteria., Methods and Results: Twenty-four patients (72±13 years; eight men [33%]) underwent TMVIV (n=14) or TMVIR (n=10) for mitral regurgitation (MR; n=17) or stenosis (n=7) using balloon-expandable bioprostheses. Transapical (TA) access was chosen in 13, and transseptal (TS) access in 11 patients. MVARC technical success, device success and procedural success were 95.8%, 41.7% and 33.3%, respectively, with no differences between access routes. Cardiac output (CO) increased significantly by 1.1±0.8 l/min in TS patients, but not in TA patients (ΔCO=0.0±0.5 l/min; p=0.0051). Overall three-year survival was estimated at 57.6% (95% confidence interval: 33.9-81.3; TA 35.5% [5.2-65.9]; TS 90.9% [73.9-100]). Survival up to four years according to vascular access showed a clear benefit in patients treated transseptally (p=0.045)., Conclusions: Regardless of the access route, TMVIV/TMVIR was associated with high technical success yet impaired device success. In the long term, TA access had a significant adverse impact on survival.

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: Hypertrophic obstructive cardiomyopathy (HOCM) with left ventricular outflow tract obstruction frequently involves a systolic anterior motion (SAM) of the anterior mitral leaflet. We hypothesised that SAM could be a new target for MitraClip therapy., Methods and Results: Three patients with HOCM were chosen for MitraClip therapy, due to significant SAM with subsequent mitral regurgitation. Invasive haemodynamic studies (right heart catheterisation, simultaneous transaortic pressure recording, and administration of nitroglycerine) were performed before and after MitraClip implantation, and a six-week follow-up was undertaken. MitraClip implantation was successfully performed with significant reduction of mitral regurgitation and SAM in all patients. Basal peak gradients (before clip: 65±25.5 mmHg; after clip: 7.7±5.0 mmHg) as well as provoked pressure gradients (before clip: 145.3±8.1 mmHg; after clip: 23.2±7.6 mmHg) were significantly reduced after MitraClip implantation. Right heart catheterisation data did not reveal major changes. At six-week follow-up, all patients presented in a persistently improved clinical state (NYHA Class I-II) with insignificant residual MR and continuously reduced LVOT gradients., Conclusions: This is the first catheter-based study targeting primarily a SAM in HOCM to reduce LVOT obstruction. The results prove the concept that SAM is more than an epiphenomenon in HOCM. Thus, SAM-induced obstruction might be a valuable target for the MitraClip.

Objectives: The goal of this study was to assess procedural details and outcomes of repeat MitraClip therapy., Background: MitraClip implantation is a safe and efficacious percutaneous approach to treat significant mitral regurgitation (MR)., Methods: Of 410 inoperable or high surgical risk patients treated with the MitraClip at our institution, 17 (4.1%) patients, as well as 4 patients initially treated at external institutions, underwent repeat MitraClip procedures. Mean age of the 21 patients (14 men [67%]) was 77 years; 15 patients (71%) had functional MR., Results: Repeat procedures performed at a median of 6.3 months (range 0.7 to 34 months) after the index intervention were successful (discharge MR grade ≤2+) in 13 patients (62%), with a pronounced difference in success rate observed between the 13 patients with adequate leaflet insertion at the time of the repeat intervention and the 8 patients in whom loss of leaflet insertion (LLI) (leaflet tear/perforation or partial clip detachment) was present (11 of 13 [85%] vs. 2 of 8 [25%], respectively). The 21 patients were followed for a median of 8.5 (interquartile range: 2.3 to 18.6) months; 13 patients (62%), 8 with adequate leaflet insertion and 5 with LLI, died during follow-up., Conclusions: Repeat MitraClip intervention for significant recurrent MR appears to be a viable therapeutic approach in patients in whom leaflet insertion into the MitraClip is not compromised. LLI is strongly associated with repeat procedural failure., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: To report the first described case of a mitral valve infective endocarditis (IE) post MitraClip®., Methods and Results: An 88-year-old patient at high surgical risk (log. EuroSCORE 30.4%) underwent a MitraClip procedure for severe eccentric organic mitral regurgitation (MR) due to prolapse with a flail leaflet of the P2 segment (flail gap 6 mm). After one month, the patient was readmitted to our department for fever and recurrence of shortness of breath. An echocardiogram demonstrated severe MR recurrence due to ulceration in the region of the posterior leaflet despite good insertion of both clips, and a large vegetation of 1513 mm within the clip region. Blood cultures were positive for staphylococcus aureus. The patient was treated by cardiac surgery with mitral valve replacement due to IE despite a very high logistic EuroSCORE of 56.8%. Histological and bacteriological analysis of the clip devices confirmed active IE. After cardiac surgery, transthoracic echocardiography showed no mitral regurgitation and a mean gradient across the mitral valve bioprosthesis of about 5 mmHg. The patient was discharged to a rehabilitation department 15 days after cardiac surgery., Conclusions: Surgical treatment as bail-out therapy for MR recurrence secondary to IE after MitraClip can be successfully carried out despite a high surgical risk.

The details are reported of a novel treatment strategy using two-clip delivery systems (2CDS) simultaneously, after double trans-septal puncture, for the treatment of severe functional mitral regurgitation. In five individual patients with complex mitral regurgitation, both CDSs were used successfully to titrate for an optimal result. The learning curve and limitations of this particular approach are described.

Aims: Transcatheter mitral valve-in-valve implantation (TMViVI) for the treatment of failing mitral xenografts or recurrent mitral regurgitation after surgical ring implantation is an emerging therapy for patients in need of repeated mitral valve surgery. Despite the fact that these procedures have been shown to be feasible and effective, haemodynamic data after TMViVI are still limited in the literature., Methods and Results: Twelve patients (logES: 39.2±23.5%) were treated either by transapical (n=7) or transseptal (n=5) TMViVI, as a valve-in-valve (ViV, n=8) or valve-in-ring (ViR, n=4) implantation. Left atrial pressures (LAP), transmitral gradients and right heart haemodynamics (Swan-Ganz catheterisation) were studied before and after TMViVI. Procedural success was 100%, mitral regurgitation after TMViVI was mild in one, trace in five and absent in six patients. Thirty-day mortality was 0%. Left atrial pressures decreased significantly after valve implantation (before LAPmean/v-wave: 24.3/44.1 mmHg; after LAP/v-wave 15.9/22.1 mmHg; p<0.001) and cardiac output increased significantly. Transmitral gradients corresponded to mitral surface areas between 1.7 and 3.5 cm2, and were thus very acceptable in terms of the high surgical risk population., Conclusions: In conclusion, TMViVI with the balloon-expandable SAPIEN XT valve for ViV or ViR implantation is feasible with promising acute transmitral haemodynamic data. Nevertheless, sustained long-term performance remains to be demonstrated in the future.

The presence of mitral regurgitation (MR) in patients with heart failure represents an independent predictor of mortality. Until now, the standard therapy for severe MR has been cardiac surgery in order to perform mitral valve replacement or mitral valve repair. With the introduction of the MitraClip® system (Abbott Vascular - Structural Heart, Menlo Park, CA, USA) in 2008, there is now an alternative percutaneous treatment option available for high-risk patients. We report on an 84-year-old male patient who was admitted to the emergency room with increasing shortness of breath due to severe functional MR, at stage NYHA III. In the following days the patient developed cardiogenic shock due to failure of the diuretic medication. The case first described here demonstrates an alternative transseptal route of access via a direct atrial puncture of the RA in a patient with absent inferior vena cava. This approach was successfully used to perform a MitraClip® procedure in this patient with functional MR and cardiogenic shock. It was possible to treat mitral regurgitation and the consecutive cardiogenic shock by implanting two MitraClips®.

Valve-in-valve implantation for degenerated surgical bioprosthetic valves is becoming an increasingly accepted approach in selected high-risk patients. In the past, valve-in-valve implantations have been mainly performed in aortic position and only rarely in mitral position. We describe the case of an 81-year-old female patient with severe mitral regurgitation of a degenerated Carpentier-Edwards biological prosthesis treated by transfemoral and transseptal implantation of a SAPIEN-XT valve., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The number of MitraClip® implantations increased significantly in recent years. Data regarding the impact of weight class on survival are sparse. Hypothesis: We hypothesized that weight class influences survival of patients treated with MitraClip® implantation. Methods: We investigated in‐hospital, 1‐year, 3‐year, and long‐term survival of patients successfully treated with isolated MitraClip® implantation for mitral valve regurgitation (MR) (June 2010–March 2018). Patients were categorized by weight classes, and the impact of weight classes on survival was analyzed. Results: Of 617 patients (aged 79.2 years; 47.3% females) treated with MitraClip® implantation (June 2010–March 2018), 12 patients were underweight (2.2%), 220 normal weight (40.1%), 237 overweight (43.2%), and 64 obesity class I (11.7%), 12 class II (2.2%), and 4 class III (0.7%). Preprocedural Logistic EuroScore (21.1 points [IQR 14.0–37.1]; 26.0 [18.5–38.5]; 26.0 [18.4–39.9]; 24.8 [16.8–33.8]; 33.0 [25.9–49.2]; 31.6 [13.1–47.6]; p =.291) was comparable between groups. Weight class had no impact on in‐hospital death (0.0%; 4.1%; 1.5%; 0.0%; 7.7%; 0.0%; p =.189), 1‐year survival (75.0%; 72.0%; 76.9%; 75.0%; 75.0%; 33.3%; p =.542), and 3‐year survival (40.0%; 36.8%; 38.2%; 48.6%; 20.0%; 33.3%; p =.661). Compared to normal weight, underweight (hazard ratio [HR]: 1.35 [95% confidence interval [CI]: 0.65–2.79], p =.419), obesity‐class I (HR: 0.93 [95% CI: 0.65–1.34], p =.705), class II (HR: 0.39 [95% CI: 0.12–1.24], p =.112), and class III (HR: 1.28 [95% CI: 0.32–5.21], p =.726) did not affect long‐term survival. In contrast, overweight was associated with better survival (HR: 1.32 [95% CI: 1.04–1.68], p =.023). Conclusion: Overweight affected the long‐term survival of patients undergoing MitraClip® implantation beneficially compared to normal weight. [ABSTRACT FROM AUTHOR]

We report on catheter-based treatment of left ventricular outflow tract (LVOT) obstruction targeting primarily a systolic anterior motion of the anterior mitral leaflet in hypertrophic obstructive cardiomyopathy (HOCM). A patient was successfully treated with the MitraClip two years after septal myectomy in conjunction with mitral valve repair. The results prove the concept, that systolic anterior motion (SAM) is clearly involved in gradient formation and is more than an epiphenomenon in HOCM. Thus, SAM-induced subaortic obstruction might be a target for MitraClip implantation. [ABSTRACT FROM AUTHOR]

Many candidates with ischaemic functional mitral regurgitation (FMR) have previously undergone coronary artery bypass grafting (CABG), in which transcatheter mitral valve repair can be reasonable for ameliorating the deteriorated hemodynamic and heart failure symptoms. We sought to elucidate the outcomes of MitraClip (MC) implantation in patients with symptomatic ischaemic FMR after CABG. We investigated clinical characteristics, outcomes and predictive impact of previous CABG on mortality in ischaemic FMR patients who underwent MC implantation from two high-volume centres in Germany. We enrolled 159 patients who previously underwent CABG. Compared with a reference group that did not previously undergo CABG (n = 182), the cohort consisted of more elderly patients (75.0, standard deviation [SD] 7.7 versus 72.9, SD 9.6 years, p = 0.028), more men (84% vs. 69%, p < 0.001), and reduced tricuspid annular plane systolic excursion (14.0, SD 4.0, vs. 16.6, SD 4.6 mm, p < 0.0001). The CABG group showed similar outcomes regarding procedural success (91% vs. 94%, p = 0.24) and 30-day mortality (5.0% vs. 6.0%, p = 0.68), but worse survival after MC implantation (log-rank p = 0.019, hazard ratio 1.56 [95% confidence interval (CI) 1.08–2.26]). After propensity score matching (n = 224), the hazard ratio was 1.18 [95%CI 0.76–1.84] without statistical significance (p = 0.46). Transcatheter mitral valve repair using the MC is a viable treatment option for patients with symptomatic ischaemic FMR after CABG. Although the baseline characteristics seemed to point to sick patients, CABG itself had only a modest impact on survival. • Ischaemic functional mitral regurgitation is the most often in MitraClip candidates. • 47% in ischaemic functional mitral regurgitation had previous coronary bypass. • Short-term result of MitraClip was similar regardless of previous coronary bypass. • Previous coronary bypass had a modest adverse impact on survival after MitraClip. • MitraClip is a viable treatment for patients with previous coronary bypass. [ABSTRACT FROM AUTHOR]