Transcatheter edge-to-edge mitral valve repair (TMVR) is the main interventional approach for patients with moderate to severe symptomatic secondary mitral valve regurgitation (MR) and high surgical risk.1 The use of both fluoroscopic and transesophageal echocardiographic images is key to success, as the visualization of the beating heart's anatomic structures is essential. Echocardiographic-fluoroscopic fusion imaging (FI) offers a real-time overlay of merged echocardiographic and fluoroscopic images (Figure 1).

Real-time fusion imaging has emerged as a sophisticated tool to guide structural heart disease (SHD) interventions. The overlay of 2 different imaging modalities allows the interventionalist to visualize echocardiographic images within a fluoroscopic image that offers intuitive perception of the

Both pre-existing atrial fibrillation (AF) and mitral valve pressure gradients (MVPG) created by MitraClip implantation have demonstrated predictive power for unfavorable outcomes. Therefore, we aimed to assess the impact of MVPG following MitraClip on outcomes in patients with and without AF. A total of 200 patients who underwent MitraClip implantation in our institution were enrolled. Echocardiography was obtained before and after the procedure. The primary endpoint of the study was all-cause mortality 1-year after MitraClip implantation. Secondary end points were clinical improvements in NYHA functional class and reduction in MR severity after MitraClip implantation. Two hundred patients (74 +/- 10 years, left ventricular ejection fraction 41% +/- 14%, logistic Euro-SCORE I 21 +/- 15) were enrolled into the final analysis. One hundred twelve patients (56%) had pre-existing AF. One-year all-cause mortality was 17% without any differences between patients with or without pre-existing AF. Comparing postprocedural MVPG of surviving and deceased patients, deceased patients with pre-existing AF exhibited significantly elevated postprocedural MVPG compared with surviving patients without AF (4.8 +/- 2.1 mm Hg vs 3.6 +/- 1.8 mm Hg; p = 0.010). ROC analysis and Kaplan-Meier survival curves identified significantly reduced survival in AF patients with postprocedural MVPG above 4.0 mm Hg (p = 0.011). After MitraClip, a MVPG above 4.0 mm Hg in patients with pre-existing AF was a significant outcome predictor in univariate and multivariate analysis. In conclusion, we identified a high-risk cohort characterized by postprocedural MVPG above 4.0 mm Hg and pre-existing AF predicting poor long-term outcome. (C) 2018 Elsevier Inc. All rights reserved.

Background Transcatheter mitral valve repair (TMVR) has been shown to have acute effects on mitral valve geometry in patients with functional mitral regurgitation (FMR). This study investigates the impact of MitraClip ® therapy-induced annular remodeling on clinical outcome and mitral regurgitation in heart failure patients. Methods TMVR was performed successfully in 45 patients with FMR. In this study, mitral valve datasets were obtained before and directly after MitraClip ® implantation using three-dimensional (3D) transesophageal echocardiography, and were analyzed offline retrospectively using dedicated 3D reconstruction software. Patients underwent clinical and echocardiographic evaluation at baseline and after 6 months. At follow-up, the patients were allocated into two groups according to their improvement in New York Heart Association (NYHA) functional class: a Low Responder group with ΔNYHA <1.5 ( n = 25); and a High Responder group with ΔNYHA ≥1.5 ( n = 20). Results At 6-month follow-up, data analysis revealed that while mitral regurgitation was reduced significantly in both groups, only the High Responder group had experienced significant downsizing of the 3D circumference (137 ± 14 mm to 126 ± 13 mm; p < 0.01) and the anterior-to-posterior diameter (33 ± 5 mm to 29 ± 4 mm; p < 0.01) of the mitral annulus during the intervention. Furthermore, only the High Responder group with reverse annular remodeling as shown had substantial advances in quality of life (Minnesota living with heart failure questionnaire: 55 ± 10 to 34 ± 14 points; p < 0.01) and functional status (6-min walk distance: 290 ± 104 m to 462 ± 111 m; p = 0.07). Conclusion Our study demonstrates that instantaneous left ventricular annular remodeling during MitraClip ® implantation is associated with improved clinical outcome of heart failure patients with functional mitral regurgitation. Trial registration The study was approved by the local ethics committee (Study Number 4497R, Registration ID: 2013121585). Trial registration: NCT02033811 Retrospectively registered January 9, 2014.

ObjectivesTo investigate in a series of 232 patients whether the MitraClip® procedure can be performed safely using deep sedation (DS) without general anesthesia (GA).BackgroundTranscatheter mitral valve repair using the MitraClip® system is a safe and effective therapy for severe mitral regurgitation (MR) in patients who are at high operative risk or are unsuitable for surgery. For these patients, avoidance of GA might be beneficial.MethodsBetween 2011 and 2015, we performed 232 MitraClip® procedures for the treatment of severe MR. Of those, 76 procedures were performed using GA, while the remaining 156 procedures were performed using DS.ResultsAge, logistic EuroScore, severity of MR, left and right ventricular function, and renal function did not differ between the groups. The primary combined safety endpoint, which was defined as the occurrence of major adverse cardiac and cerebrovascular events, conversion to surgery, major vascular complications or pneumonia, did not differ between MitraClip® procedures performed using GA and MitraClip® procedures performed using DS. Intraprocedural conversion to GA was required in 2% of the patients in the DS group. There were no differences in procedural success or clinical outcome between the groups at the 3‐month follow‐up. Preparation time in the catheterization laboratory and intensive care unit (ICU) stay were shorter in the DS group compared to the GA group.ConclusionThe MitraClip® implantation performed using DS is as safe and effective as MitraClip® implantation performed using GA. © 2017 Wiley Periodicals, Inc.

Visual guidance through echocardiography and fluoroscopy is crucial for a successful transseptal puncture (TSP) in a prespecified region of the fossa ovalis. The novel EchoNavigator system Release II (EchoNav II, Philips Healthcare, Andover, Massachusetts, USA) enables the real-time fusion of fluoroscopic and echocardiographic images. We evaluated this new imaging method in respect to safety and efficacy of TSP during MitraClip implantation and left atrial appendage closure.

Background Preprocedural manual multi-slice-CT-segmentation tools (MSCT-ST) define the gold standard for planning transcatheter aortic valve replacement (TAVR). They are able to predict the perpendicular line of the aortic annulus (PPL) and to indicate the corresponding C-arm angulation (CAA). Fully automated planning-tools and their clinical relevance have not been systematically evaluated in a real world setting so far. Methods and Results The study population consists of an all-comers cohort of 160 consecutive TAVR patients with a drop out of 35 patients for technical and anatomical reasons. 125 TAVR patients underwent preprocedural analysis by manual (M-MSCT) and fully automated MSCT-ST (A-MSCT). Method-comparison was performed for 105 patients (Cohort A). In Cohort A, CAA was defined for each patient, and accordance within 10° between M-MSCT and A-MSCT was considered adequate for concept-proof (95% in LAO/RAO; 94% in CRAN/CAUD). Intraprocedural CAA was defined by repetitive angiograms without utilizing the preprocedural measurements. In Cohort B, intraprocedural CAA was established with the use of A-MSCT (20 patients). Using preprocedural A-MSCT to indicate the corresponding CAA, the levels of contrast medium (ml) and radiation exposure (cine runs) were reduced in Cohort B compared to Cohort A significantly (23.3±10.3 vs. 35.3 ±21.1 ml, p = 0.02; 1.6±0.7 vs. 2.4±1.4 cine runs; p = 0.02) and trends towards more safety in valve-positioning could be demonstrated. Conclusions A-MSCT-analysis provides precise preprocedural information on CAA for optimal visualization of the aortic annulus compared to the M-MSCT gold standard. Intraprocedural application of this information during TAVR significantly reduces the levels of contrast and radiation exposure. Trial Registration ClinicalTrials.gov NCT01805739

BACKGROUND:Mitral regurgitation causes left atrial (LA) and left ventricular (LV) dysfunction, dilatation, and remodeling. Following percutaneous mitral valve repair (PMVR) using the MitraClip® approach, reverse cardiac remodeling is desirable. To date, the influence of PMVR on LA and segmental LV function and remodeling has not been investigated in detail.METHODS:Twenty-six patients who received the MitraClip device were enrolled in an open-label, single-center observational study. Patients underwent clinical assessment, conventional echocardiography and global and segmental longitudinal strain analysis of the left atrium and left ventricle by speckle tracking echocardiography at baseline and at a three-month follow up.RESULTS:PMVR improved both LV systolic function (from 40.5 ± 2.5% to 45.0 ± 2.5%, p = 0.04) and LV global longitudinal strain (from -8.9 ± 0.7% to -10.7 ± 0.9%, p = 0.004). Segmental analysis revealed improved myocardial deformation mainly in the basal (basalseptal -8.9 ± 0.8% to -12.9 ± 0.8%, p = 0.0002; basallateral -7.9 ± 1.1% to -13.9 ± 1.4%, p = 0.0005) and midventricular segments (mid-septal -12.7 ± 0.9% to -14.5 ± 1.1%, p = 0.02; mid-lateral -7.5 ± 0.8% to -10.8 ± 1.2%, p = 0.006). In patients with pre-procedural preserved LA function with sinus rhythm the impact of PMVR revealed an improvement in LA global conduit function (from 10.6 ± 1.2% to 13.9 ± 1.6%, p = 0.003) and global contractile function (from -2.1 ± 0.47% to -3.5 ± 0.5%, p = 0.03). The reversed remodeling was not associated with altered levels of the cardiac biomarkers matrix metalloproteinase 2 (MMP-2) and MMP-9, tissue-inhibitors of MMPs (TIMP-2 and ST-2).CONCLUSIONS:PMVR improves global segmental LV and LA function and leads to a reverse remodeling.

AIM:To investigate the accuracy of a rotational C-arm CT-based 3D heart model to predict an optimal C-arm configuration during transcatheter aortic valve replacement (TAVR).METHODS:Rotational C-arm CT (RCT) under rapid ventricular pacing was performed in 57 consecutive patients with severe aortic stenosis as part of the pre-procedural cardiac catheterization. With prototype software each RCT data set was segmented using a 3D heart model. From that the line of perpendicularity curve was obtained that generates a perpendicular view of the aortic annulus according to the right-cusp rule. To evaluate the accuracy of a model-based overlay we compared model- and expert-derived aortic root diameters.RESULTS:For all 57 patients in the RCT cohort diameter measurements were obtained from two independent operators and were compared to the model-based measurements. The inter-observer variability was measured to be in the range of 0°-12.96° of angular C-arm displacement for two independent operators. The model-to-operator agreement was 0°-13.82°. The model-based and expert measurements of aortic root diameters evaluated at the aortic annulus (r = 0.79, P < 0.01), the aortic sinus (r = 0.93, P < 0.01) and the sino-tubular junction (r = 0.92, P < 0.01) correlated on a high level and the Bland-Altman analysis showed good agreement. The interobserver measurements did not show a significant bias.CONCLUSION:Automatic segmentation of the aortic root using an anatomical model can accurately predict an optimal C-arm configuration, potentially simplifying current clinical workflows before and during TAVR.

Percutaneous catheter-based techniques for the treatment of structural heart disease are becoming more complex, and current imaging techniques have limitations: while fluoroscopy gives poor visualisation of cardiac anatomical structures, echocardiography is limited in its ability to detect the position of catheters and devices. The EchoNavigator® (Philips) live image guidance tool is a novel system that integrates real-time echocardiography with fluoroscopic X-ray imaging, optimising the guidance and positioning of devices. Use of the EchoNavigator system facilitates improved understanding of anatomical structures while showing enhanced visualisation of catheter and device movements. Early clinical experience suggests that the technology is feasible and safe, and provides enhanced understanding of the relationship between soft tissue anatomy and catheter devices in structural heart disease. The use of the EchoNavigator system can improve the confidence of interventional cardiologists in the targeting and positioning of devices in percutaneous interventions in structural heart disease, and has the potential to reduce procedural time, reduce the dosage of contrast and radiation and increase safety in the performance of procedural steps.

The procedural success of interventions in structural heart disease depends on adequate peri-interventional imaging using a combination of fluoroscopy, MSCT-data with 3D-reconstruction and echocardiography. The major advantage of peri-interventional imaging consists in the optimized view of the cardiac structures and the monitoring of the entire procedure with an excellent spatial resolution. Because soft-tissue informations cannot be provided by fluoroscopy alone, hybrid fusion imaging has the potential to increase safety, accuracy and procedural effectiveness in interventional cardiology.

Background: Common complications during MitraClip procedure are bleeding and ischemic events. The right strategy of platelet inhibition is unknown and challenging, as there are substantial interindividual response variabilities to antiplatelet drugs and additionally, many MitraClip patients are on permanent oral anticoagulation because of atrial fibrillation. We aimed to investigate the incidence of (i) high- and low on-treatment platelet reactivity (HTPR, LTPR) to antiplatelet medication and (ii) clinical complications in MitraClip patients.Methods: In an observational single-center cohort study we investigated 73 patients who underwent MitraClip implantation. Clopidogrel effects were measured using the vasodilator-stimulated protein phosphorylation (VASP) assay, aspirin effects by light-transmission aggregometry (LTA). Clinical complications were investigated during six-month follow-up.Results: HTPR to clopidogrel was observed in 44 patients, LTPR to clopidogrel in 6 patients. 16 patients had HTPR to aspirin. Major complications occurred in 12 patients, overall bleeding complications in 27 patients, overall ischemic events in two patients. The incidence of HTPR/LTPR did not differ between patients with- vs. without clinical complications. Bleeding complications were not more frequent in patients with additional oral anticoagulation.Conclusions: In this study, the incidence of HTPR to clopidogrel was very high (60% of patients). Despite these insufficient clopidogrel antiplatelet effects, ischemic events were rare and bleeding complications more frequent Additionally, many patients undergoing MitraClip procedure were on permanent oral anticoagulation because of atrial fibrillation. The optimal antithrombotic regiment should be investigated in large scale clinical trials under consideration of the high incidence of HTPR to clopidogrel medication in MitraClip patients. (C) 2015 Elsevier Inc. All rights reserved.

BACKGROUND AND OBJECTIVE:Endothelial dysfunction is predictive for cardiovascular events and may be caused by decreased bioavailability of nitric oxide (NO). NO is scavenged by cell-free hemoglobin with reduction of bioavailable NO up to 70% subsequently deteriorating vascular function. While patients with mitral regurgitation (MR) suffer from an impaired prognosis, mechanisms relating to coexistent vascular dysfunctions have not been described yet. Therapy of MR using a percutaneous mitral valve repair (PMVR) approach has been shown to lead to significant clinical benefits. We here sought to investigate the role of endothelial function in MR and the potential impact of PMVR.METHODS AND RESULTS:Twenty-seven patients with moderate-to-severe MR treated with the MitraClip® device were enrolled in an open-label single-center observational study. Patients underwent clinical assessment, conventional echocardiography, and determination of endothelial function by measuring flow-mediated dilation (FMD) of the brachial artery using high-resolution ultrasound at baseline and at 3-month follow-up. Patients with MR demonstrated decompartmentalized hemoglobin and reduced endothelial function (cell-free plasma hemoglobin in heme 28.9±3.8 μM, FMD 3.9±0.9%). Three months post-procedure, PMVR improved ejection fraction (from 41±3% to 46±3%, p = 0.03) and NYHA functional class (from 3.0±0.1 to 1.9±1.7, p<0.001). PMVR was associated with a decrease in cell free plasma hemoglobin (22.3±2.4 μM, p = 0.02) and improved endothelial functions (FMD 4.8±1.0%, p<0.0001).CONCLUSION:We demonstrate here that plasma from patients with MR contains significant amounts of cell-free hemoglobin, which is accompanied by endothelial dysfunction. PMVR therapy is associated with an improved hemoglobin decompartmentalization and vascular function.

Der intraprozedurale Erfolg von Interventionen hängt von einer sinnvollen Kombination aus Fluoroskopie, 3D-rekonstruierten MSCT-Datensätzen sowie dem Einsatz 2D- und 3D-gestützter Echokardiografie ab. Vorteile bestehen hier in dem zusätzlichen Informationsgehalt der bildgebenden Modalitäten hinsichtlich Präzision der anatomischen und geometrischen Erfassung komplexer Herzstrukturen. Da diese Informationen nicht alleine durch die Fluoroskopie bereitgestellt werden können, hat der Einsatz der hybriden Fusionsbildgebung in der interventionellen Kardiologie das Potenzial, die prozedurale Sicherheit sowie die Effektivität hinsichtlich Device-Platzierung zu steigern. Diese Innovation ermöglicht zudem eine Limitation von Strahlendosis sowie eingesetzter Kontrastmittelmenge.

Patent foramen ovale (PFO) and atrial septal defect (ASD) are frequent congenital heart defects in adults. While the indication for surgical or interventional closure of an ASD is sufficiently evaluated, the necessity of closing a PFO remains a topic of academic discussions. In this article we present epidemiological data, show the actual anatomic classification, highlight relevant aspects of periinterventional imaging and review the latest trials. Moreover, we present the actual evidence relating to antiplatelet medication following device closure.

Background Patients with anemia show a negative outcome in percutaneous coronary intervention, transcatheter aortic valve replacement and cardiac surgery. The impact of anemia on periprocedural major adverse cardiac and cerebrovascular events (MACCE) and mortality in patients undergoing treatment of severe mitral regurgitation (MR) with percutaneous mitral valve repair using the MitraClip® system is not known. Objective To assess whether percutaneous mitral valve repair with the MitraClip® system is safe and effective in patients with anemia. Methods and results 80 patients with severe and moderate-to-severe MR were included in this open-label observational single-center study. Anemia was prevalent in 51.3% of patients (n = 41). MitraClip® devices were successfully implanted in 97.6% (n = 40) of patients with anemia and in 97.4% (n = 38) of patients without anemia (p = 0.971). Periprocedural MACCE occurred in 4.9% (n = 2) of patients with anemia and 5.1% (n = 2) of patients without anemia (p = 0.959). Thirty-day mortality was 2.4% (n = 1) in patients with anemia and 5.1% (n = 2) in patients without anemia (p = 0.611). Follow up of up to 12 months showed a significant improvement of NYHA class and quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire in both groups. One-year survival was 80.5% in patients with anemia and 84.6% in patients without anemia (p = 0.634). Conclusion Mitral valve repair with the MitraClip® system can be performed safely and efficiently in patients with anemia. Anemia does not affect clinical outcome and quality of life in patients undergoing mitral valve repair.

Background Endothelial dysfunction is a key factor in the development of atherosclerosis. Commonly, endothelial function is determined in the brachial artery, whereas patients with peripheral artery disease ( PAD ) present with lower limb atherosclerosis. We hypothesized that in PAD, a segmental or local association exists between endothelial dysfunction and atherosclerotic structural changes. Methods and Results We used ultrasound to study endothelial function as flow‐mediated vasodilation, intima media thickness, and local stiffness of the superficial femoral artery ( SFA ) and brachial artery ( BA ). PAD patients with symptomatic SFA or below‐the‐knee disease were compared with age‐matched patients without PAD and young healthy controls. PAD patients with SFA or below‐the‐knee disease exhibited endothelial dysfunction of the proximal SFA (flow‐mediated vasodilation: 3.9±0.6%, 3.7±0.6%) compared with healthy controls (7.4±1.0%) and patients without PAD (5.4±0.6%). Brachial artery flow‐mediated vasodilation values were not different in PAD patients with SFA or below‐the‐knee disease compared with patients without PAD , but they were significantly lower than those of healthy controls. Endothelial dysfunction correlated with increased intima media thickness or plaque thickness at the site of flow‐mediated vasodilation measurement across vascular sites. In PAD patients with SFA disease, SFA flow‐mediated vasodilation was further impaired within and distal to stenosis (prestenosis 3.9±0.6%, intrastenosis 2.3±0.7%, poststenosis 2.5±0.6%) and recovered within 24 hours after SFA balloon angioplasty to prestenotic values but not to the brachial artery or SFA values in patients without PAD or controls. Conclusion A close association exists between local endothelial function and atherosclerotic structural remodeling, suggesting that in PAD , local and segmental factors—in addition to systemic factors—influence local endothelial function. Our data point toward a pathophysiological role for lower extremity endothelial dysfunction in PAD .

Mitralklappenerkrankungen, und hier vor allem schwere Mitralinsuffizienzen, nehmen in unserer Bevölkerung immer mehr zu. Betroffen sind häufig ältere Patienten mit zahlreichen Komorbiditäten, die aufgrund eines zu hohen perioperativen Risikos inoperabel sind. Da die Ergebnisse einer konservativen Therapie bei diesen Patienten oft unbefriedigend sind, konnten in den letzten Jahren interventionelle Techniken entwickelt werden, die auch bei diesen Patienten eine direkte Behandlung des Vitiums erlauben. Innovative Entwicklungen in der bildgebenden Diagnostik haben zu einem verbesserten diagnostischen und therapeutischen Management von Patienten mit Mitralklappenvitien geführt. Dies wirkt sich auf die Auswahl von Patienten für ein chirurgisches oder ein interventionelles Vorgehen gravierend aus. Dieser Review beschreibt die diagnostischen Möglichkeiten der Echokardiographie, anhand derer die Struktur und die Funktion der Mitralklappe für die Planung und die Durchführung eines chirurgischen oder eines interventionellen Vorgehens exakt beurteilt werden können.

Aims To investigate whether percutaneous left atrial appendage (LAA) closure guided by automated real-time integration of 2D-/3D-transesophageal echocardiography (TEE) and fluoroscopy imaging results in decreased radiation exposure. Methods and Results In this open-label single-center study LAA closure (AmplatzerTM Cardiac Plug) was performed in 34 consecutive patients (8 women; 73.1±8.5 years) with (n = 17, EN+) or without (n = 17, EN-) integrated echocardiography/fluoroscopy imaging guidance (EchoNavigator® [EN]; Philips Healthcare). There were no significant differences in baseline characteristics between both groups. Successful LAA closure was documented in all patients. Radiation dose was reduced in the EN+ group about 52% (EN+: 48.5±30.7 vs. EN-: 93.9±64.4 Gy/cm2; p = 0.01). Corresponding to the radiation dose fluoroscopy time was reduced (EN+: 16.7±7 vs. EN-: 24.0±11.4 min; p = 0.035). These advantages were not at the cost of increased procedure time (89.6±28.8 vs. 90.1±30.2 min; p = 0.96) or periprocedural complications. Contrast media amount was comparable between both groups (172.3±92.7 vs. 197.5±127.8 ml; p = 0.53). During short-term follow-up of at least 3 months (mean: 8.1±5.9 months) no device-related events occurred. Conclusions Automated real-time integration of echocardiography and fluoroscopy can be incorporated into procedural work-flow of percutaneous left atrial appendage closure without prolonging procedure time. This approach results in a relevant reduction of radiation exposure. Trial Registration ClinicalTrials.gov NCT01262508

Mitral valve disease, especially severe mitral valve insufficiency, is an increasing issue in our population. Older patients with multiple comorbidities in particular are often denied surgery due to an increased perioperative risk. Because conservative medical treatment of mitral valve disease is often unsatisfactory, interventional techniques to treat mitral valve disease have emerged in recent years as serious alternatives to surgical treatment. Innovative developments in cardiovascular imaging have opened up new ways of looking at the mitral valve for improved diagnostic and therapeutic management of patients with mitral valve disease. These advantages of imaging are important for correct patient selection with either surgical or interventional strategies. This review describes the diagnostic capabilities of echocardiographic techniques for a precise diagnosis of the mitral valve structure and function for planning and performing interventional or surgical procedures.