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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]

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

Copyright of Der Kardiologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Intraprocedural transesophageal echocardiography (TEE) guidance plays an essential role in transcatheter repair therapy of the tricuspid valve (TV). So far, several different imaging concepts are in use. We propose an imaging protocol that fully addresses the morphological complexity of the TV and further offers efficacious workarounds for the frequently occurring restrictions of TV imaging in edge‐to‐edge repair of the TV. As a tertiary referral center with a large experience of more than 250 cases of transcatheter edge‐to‐edge repair (TEER) of the TV performed at the Heart Valve Center in Mainz/Germany, we have constantly adapted our peri‐interventional echocardiographic approach to accomplish both. As a key measure for success, we intensely rely on the transgastric acoustic windows that not only deliver high‐resolution information on the morphology of the TV and all relevant procedural steps but also help to avoid the frequent shadowing artifacts experienced in transesophageal imaging. [ABSTRACT FROM AUTHOR]

Purpose of Review: To provide a detailed overview of complications associated with MitraClip therapy and its development over time with the aim to alert physicians for early recognition of complications and to offer treatment strategies for each complication, if possible. Recent Findings: The MitraClip system (MC) is the leading transcatheter technique to treat mitral regurgitation (MR) and has been established as a safe procedure with very low adverse event rates compared to mitral surgery at intermediate to high risk or in secondary MR. Lately, the fourth MC generation has been launched with novel technical features to facilitate device handling, decrease complication rates, and allow the treatment of even complex lesions. Summary: Although the complication rate is low, adverse events are associated with increased morbidity and mortality. The most common complications are bleeding, acute kidney failure, procedure-induced mitral stenosis, and an iatrogenic atrial septal defect with unknown clinical impact. [ABSTRACT FROM AUTHOR]

Transcatheter tricuspid valve therapies are an emerging field in structural heart interventions due to the rising number of patients with severe tricuspid regurgitation and the high risk for surgical treatment. Computed tomography (CT) allows exact measurements of the annular plane, evaluation of adjacent structures, assessment of the access route, and can also be used to identify optimal fluoroscopic projection planes to enhance periprocedural imaging. This review provides an overview of current transcatheter tricuspid valve repair and replacement therapies and to what extent CT can support these interventions. [ABSTRACT FROM AUTHOR]

Background: Concomitant tricuspid regurgitation (TR) is a common finding in mitral regurgitation (MR). Transcatheter repair (TMVR) is a favorable treatment option in patients at elevated surgical risk. To date, evidence on long-term prognosis and the prognostic impact of TR after TMVR is limited. Methods: Long-term survival data of patients undergoing isolated edge-to-edge repair from June 2010 to March 2018 (combinations with other forms of TMVR or tricuspid valve therapy excluded) were analyzed in a retrospective monocentric study. TR severity was categorized and the impact of TR on survival was analysed. Results: Overall, 606 patients [46.5% female, 56.4% functional MR (FMR)] were enrolled in this study. TR at baseline was categorized severe/medium/mild/no or trace in 23.2/34.3/36.3/6.3% of the cases. At 30-day follow-up, improvement of at least one TR-grade was documented in 34.9%. Severe TR at baseline was identified as predictor of 1-year survival [65.2% vs. 77.0%, p = 0.030; HR for death 1.68 (95% CI 1.12–2.54), p = 0.013] and in FMR-patients also regarding long-term prognosis [adjusted HR for long-term mortality 1.57 (95% CI 1.00–2.45), p = 0.049]. Missing post-interventional reduction of TR severity was predictive for poor prognosis, especially in the FMR-subgroup [1-year survival: 92.9% vs. 78.3%, p = 0.025; HR for death at 1-year follow-up 3.31 (95% CI 1.15–9.58), p = 0.027]. While BNP levels decreased in both subgroups, TR reduction was associated with improved symptomatic benefit (NYHA-class-reduction 78.6 vs. 65.9%, p = 0.021). Conclusion: In this large study, both, severe TR at baseline as well as missing secondary reduction were predictive for impaired long-term prognosis, especially in patients with FMR etiology. TR reduction was associated with increased symptomatic benefit. [ABSTRACT FROM AUTHOR]

Aims: Several approaches for transcatheter mitral valve repair for functional mitral valve regurgitation are established. Interventional direct annuloplasty is a novel trans‐venous, trans‐septal approach. While feasibility was proven recently, knowledge on its influence on cardiac dimensions, pressures, biomarkers, and clinical outcomes is sparse. Methods and results: Patients consecutively treated with direct annuloplasty‐only procedures between December 2015 and April 2018 were included in this monocentric analysis. Echocardiographic measurements, biomarker levels, clinical status [New York Heart Association (NYHA) class and 6 min walk test] were assessed at baseline, at discharge, and at a 30 day follow‐up. Overall, 18 patients (in mean 77.0 ± 7.4 years, 44.4% women) with initially all high‐grade mitral valve regurgitation (MR) were included in this study. Procedural success rate was high (94.4%) without severe complications. Direct annuloplasty resulted in MR‐reduction (post‐procedural‐MR mild or no/trace: 72.2%) and the proportion of patients with severe dyspnoea (NYHA III/IV) was reduced (88.9% vs. 50%, P = 0.008). Clinical results were associated with a relevant diminution of left atrial volumes (−16.5%, P < 0.001) and cardiac pressures [left atrial pressure (−32.3%, P = 0.019) and systolic pulmonary arterial pressure (PAP, −15.8%, P = 0.025)]. Patients with lower baseline levels of PAP (P = 0.022) as well as elevated highly sensitive troponin (P = 0.034) were more likely to archive clinical benefit (improvement in NYHA class ≥1 grade) after 1 month, which could not be correlated with the grade of MR‐reduction. Conclusions: Transcatheter mitral valve repair by direct annuloplasty results in a relevant reduction of intracardiac pressures, left atrial volumes, dyspnoea, and MR. Lower PAP and higher troponin values at baseline could be associated to dyspnoea reduction. [ABSTRACT FROM AUTHOR]

Objectives: Several interventional approaches have been established for the treatment of severe mitral regurgitation (MR) in patients at elevated risk for surgery. Direct annuloplasty is a relatively novel option in transcatheter mitral valve repair dedicated to reverse pathology in specific subsets of MR. With regard to echocardiographic guidance, this procedure presents with higher efforts in comparison with edge‐to‐edge therapy to enable safe and exact positioning of the device's anchors; evidence on optimal peri‐interventional imaging is sparse. We tested a specific 3D‐echo‐guidance protocol implementing single‐beat multiplanar reconstruction (MPR) and evaluated its feasibility. Methods: Overall, 16 patients consecutively treated with transcatheter direct annuloplasty for severe MR (87.5% functional/6.3% degenerative/6.3% mixed pathology) were entered in this monocentric analysis. Of these, two patients received a combined procedure including edge‐to‐edge repair. For all implantations, a 3D‐echo‐guidance protocol inheriting MPR was employed. Results: Periprocedural device time decreased continuously (overall mean 140 ± 55.1 minutes, 213 ± 38 minutes in the first 4 vs 108 ± 33 minutes in the last 4 procedures, P =.018) using the MPR‐based echo protocol, going along with reduced fluoroscopy times and doses. Technical success rate was high (93.8%) without any serious cardiac‐related adverse events. MR could be relevantly improved. Conclusion: Echocardiographic guidance of transcatheter direct annuloplasty using a real time MPR‐based protocol is feasible and safe. Optimized imaging might enable reduced implantation times and potentially increases safety. [ABSTRACT FROM AUTHOR]

Copyright of Der Kardiologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Aims: Mitral annuloplasty using the Carillon Mitral Contour System (CMCS) reduces secondary mitral regurgitation (SMR) and leads to reverse left ventricular remodelling. The aim of this study was to evaluate the effect of the CMCS on the mitral valve annulus (MA) and left atrial volume (LAV). Methods and results: We retrospectively evaluated the data of all patients treated with the CMCS at our centre. Using transthoracic echocardiography, MA diameters were assessed by measuring the anterolateral to posteromedial extend (ALPM) and the anterior to posterior (AP) dimensions, respectively. Also, LAV and left ventricular end‐diastolic volume (LVEDV) were assessed. Patients were examined at three time points: baseline, at 20–60 days (30dFUP), and at 9–15 months (1yFUP), using paired analysis. From July 2014 until March 2019, 75 cases of severe SMR were treated using CMCS. Cases in which other devices were used in combination (COMBO therapy, n = 35) or in which the device could not be implanted (implant failure, n = 3) were excluded, leaving 37 patients in the present analysis. Analysis at 30dFUP showed a significant reduction of 16% in the mean ALPM diameter (7.27 ± 5.40 mm) and 15% in the AP diameter (6.57 ± 5.33 mm). Analysis of LAV also showed a significant reduction of 21% (36.61 ± 82.67 mL), with no significant change in LVEDV. At 1yFUP, the reduction of both the mean ALPM diameter of 14% (6.24 ± 5.70 mm) and the mean AP diameter of 12% (5.46 ± 4.99 mm) remained significant and stable. The reduction in LAV was also maintained at 23% (37.03 ± 56.91 mL). LAV index was significantly reduced by 17% at 30dFUP (15.44 ± 40.98 mL/m2) and by 13% at 1yFUP (11.56 ± 31.87 mL/m2), respectively. LVEDV index showed no significant change at 30dFUP and a non‐significant 10% reduction at 1yFUP (17.75 ± 58.79 mL/m2). Conclusions: The CMCS successfully treats symptomatic SMR with a stable reduction of not only the AP diameter of the MA, but the current study also demonstrates an additional reduction of the ALPM dimension at both 30dFUP and 1yFUP. We have also shown for the first time that LAV and LAV index are significantly reduced at both 30dFUP and 1yFUP and a non‐significant positive remodelling of the LVEDV. This positive left atrial remodelling has not been looked for and demonstrated in earlier randomized studies of CMCS. [ABSTRACT FROM AUTHOR]

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 (HRadj) 1.06, 95% confidence interval (95% CI) 1.01-1.14 /1 mm, p = 0.028] and increasing logistic EuroSCORE (HRadj 1.02, 95% CI 1.00-1.03, p = 0.037) were independent predictors, whereas in NI-FMR patients, NT-pro BNP (HRadj 1.05, 95% CI 1.02-1.08, p = 0.001) and age (HRadj 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. [ABSTRACT FROM AUTHOR]

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. View large Download slide View large Download slide [ABSTRACT FROM AUTHOR]

Objective: Histological analyses of debris captured by a cerebral protection system (CPS) during transcatheter valve-in-valve (VIV) procedures have not been reported.Methods: Fifteen consecutive patients with stenotic aortic (n=13) or mitral (n=2) surgical or transcatheter bioprostheses were treated with implantation of a transcatheter heart valve (THV) in the presence of a dual-filter CPS. Mean patient age was 75 years; mean logistic EuroSCORE was 31%. Filters were collected and histological assessment of debris was performed. Patients were followed clinically until discharge.Results: Debris captured by either or both filters was detected in all patients. Acute thrombus was the most common type of debris, found in all patients, followed in frequency by arterial wall tissue (n=12 patients (80%)), calcification (n=11 (73%)) and valve tissue (n=9 (60%)). Less frequently found were organised thrombus (n=5 (30%)), foreign material (n=4 (27%)) and myocardium (n=2 (13%)). A median of 123 debris particles per patient was detected, with a trend towards a greater median number of particles collected in proximal filters (78 vs 39, p=0.065). The average maximum particle diameter was 88 (range 56-175) µm, with a median of 20 particles ≥150 µm. No stroke or transient ischaemic attack (TIA) had occurred by the time of discharge (mean 8 days).Conclusions: Transcatheter VIV procedures were associated with the release of particulate debris into the cerebral circulation in all patients. The type of debris suggests that debris originates predominantly from arterial and valvular passage of the THV. [ABSTRACT FROM AUTHOR]

Aims Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. Methods and results The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤ 2+. Conclusions This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR. [ABSTRACT FROM AUTHOR]

Transfemoral aortic valve replacement (TAVR) has become a standard therapeutic option for patients with symptomatic severe aortic stenosis. Special anatomies can pose distinct challenges for vascular access and later closure of the access site, for example, in preoperated patients. Here, we elucidate a case of transfemoral TAVR with vascular access by direct puncture of an aorto‐bifemoral bypass graft and illustrate the feasibility of vascular closure by an anchored collagen‐plug vascular closure device (Teleflex MANTA®). [ABSTRACT FROM AUTHOR]

The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014–2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p < 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications. [ABSTRACT FROM AUTHOR]

The article discusses research which focused on the administration of neochord anterior leaflet treatment to reduce neo left ventricular outflow tract (LVOT) obstruction risk following transcatheter mitral valve replacement. Topics explored include the therapeutic use of transapical repair with neochord implantation for mitral valve disease, the medical condition of the patient involved in the study, and the valve performance and outcomes recorded following treatment.