Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-To-Edge Repair: Observations From the bRIGHT TriClip Study.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR) has experienced fast adoption following commercial approval. Defining the appropriate target population for TEER therapy is important to guide patient selection. The aim of this study was to characterize tricuspid valve anatomy and coaptation gap in subjects receiving TEER for the treatment of TR in a contemporary postmarket setting. METHODS: The bRIGHT study is a prospective, multicenter, single-arm, postmarket study evaluating the safety and effectiveness of the TriClip device. Procedural outcomes included implant success, acute procedural success, TR severity, major adverse events, single-leaflet device attachment, and embolization through 30 postprocedure days. Tricuspid valve characteristics, including morphology, annulus size, and leaflet mobility, were assessed via two-dimensional transesophageal echocardiography from the screening visit by an independent echo core lab to characterize subject variability. Coaptation gap measurements were taken in both the transgastric short-axis (TG SAX) and RV inflow/outflow views. RESULTS: The independent echo core lab performed a detailed assessment of the tricuspid valve on 135 consecutive subjects with available TG SAX views from 24 sites. Tricuspid valve morphologies included 2 to 5 leaflets, with a non-trileaflet valve in 28% of subjects and ≥4 leaflets in 21% of subjects. The etiology of TR was functional in 91% (96/105), mixed in 7% (7/105), and lead induced in 2% (2/105) of subjects. Leaflet mobility was mildly restricted in 69% (78/113) and moderately restricted in 7% (8/113) of subjects. Annulus diameter averaged 4.7 ± 0.7 cm with a range of 2.5 to 6.2 cm. From the TG SAX view, the coaptation gap measured 8.1 ± 3.1 and 5.2 ± 2.3 mm in the central and mid regions of the anterior-septal coaptation line and 6.6 ± 3.2 and 3.8 ± 2.1 mm in the central and mid regions of the septal-posterior coaptation line, respectively. From the right ventricular inflow/outflow view, the coaptation gap measured 4.7 ± 2.4, 5.2 ± 2.4, and 4.6 ± 3.0 mm in the anterior, mid, and posterior regions of the tricuspid valve, respectively. Thirty-day TR reduction (by number of grades) was similar among subjects with coaptation gaps of <7 mm, 7 to 10 mm, and >10 mm. CONCLUSION: A broad range of anatomies was observed in this postmarket population. Characterization of the tricuspid valve and coaptation gap will help to better understand and better define the target patient population for tricuspid TEER therapy.

Terahertz Spectroscopic Molecular Sensor for Rapid and Highly Specific Quantitative Analytical Gas Sensing.

Quantitative analytical gas sampling is of great importance in a range of environmental, safety, and scientific applications. In this article, we present the design, operation, and performance of a recently developed tabletop terahertz (THz) spectroscopic molecular sensor capable of rapid (minutes) and sensitive detection of polar gaseous analytes with near "absolute" specificity. A novel double-coil absorption cell design and an array of room-temperature sorbent-based preconcentration modules facilitate quantitative THz detection of light polar volatile compounds, which often challenge the capabilities of established gas sensing techniques. Acetone, ethanol, methanol, acetaldehyde, formaldehyde, and isoprene are detected at low parts-per-billion to high parts-per-trillion levels. This work evaluates performance-limiting factors for THz spectroscopy-based chemical identification: (1) spectral signal to noise and (2) preconcentrator efficiency.

Safety of transesophageal echocardiography during transcatheter edge-to-edge tricuspid valve repair: A single-center experience.

Objectives: We aimed to determine transesophageal echocardiography (TEE) related complications during Transcatheter edge-to-edge tricuspid valve repair (TTVR). Background: Transesophageal echocardiography is essential to guide structural heart disease (SHD) interventions. TTVR has become an evolving procedure for high-risk patients not suitable for surgery. Whether this complex procedure is associated with TEE related complications is not known so far. Methods: We retrospectively analyzed 64 consecutive patients undergoing TTVR between 2019 and 2021 with the TriClip system (Abbott, Chicago, IL, USA) at our center. All procedures were performed under general anesthesia (GA). TEE related complications were classified as major and minor complications. Results: Transesophageal echocardiography related complications were observed in two patients (3.1%) with one major complication (1.6%) and one minor complication (1.6%). In one patient perforation of the esophageal mucosa requiring red blood cell transfusion was observed, the other patient had hematemesis due to minor esophageal and gastric lesions without the need for blood transfusion. Both patients recovered during hospital stay with no persistent symptoms at discharge. Conclusions: Transesophageal echocardiography related complications during TTVR are clinically relevant occurring in 3.1% of the patients. Further investigations are needed to identify potential risk factors and patients at high risk to develop a TEE related complication in the course of TTVR.

Outcomes of culture-negative vs. culture-positive infective endocarditis: the ESC-EORP EURO-ENDO registry.

AIM: Fatality of infective endocarditis (IE) is high worldwide, and its diagnosis remains a challenge. The objective of the present study was to compare the clinical characteristics and outcomes of patients with culture-positive (CPIE) vs. culture-negative IE (CNIE). METHODS AND RESULTS: This was an ancillary analysis of the ESC-EORP EURO-ENDO registry. Overall, 3113 patients who were diagnosed with IE during the study period were included in the present study. Of these, 2590 (83.2%) had CPIE, whereas 523 (16.8%) had CNIE. As many as 1488 (48.1%) patients underwent cardiac surgery during the index hospitalization, 1259 (48.8%) with CPIE and 229 (44.5%) with CNIE. The CNIE was a predictor of 1-year mortality [hazard ratio (HR) 1.28, 95% confidence interval (CI) 1.04-1.56], whereas surgery was significantly associated with survival (HR 0.49, 95% CI 0.41-0.58). The 1-year mortality was significantly higher in CNIE than CPIE patients in the medical subgroup, but it was not significantly different in CNIE vs. CPIE patients who underwent surgery. CONCLUSION: The present analysis of the EURO-ENDO registry confirms a higher long-term mortality in patients with CNIE compared with patients with CPIE. This difference was present in patients receiving medical therapy alone and not in those who underwent surgery, with surgery being associated with reduced mortality. Additional efforts are required both to improve the aetiological diagnosis of IE and identify CNIE cases early before progressive disease potentially contraindicates surgery.

The predictive value of intraprocedural mitral gradient for outcomes after MitraClip and its peri-interventional dynamics.

BACKGROUND: The current data on the impact of the increased mitral gradient (MG) on outcomes are ambiguous, and intraprocedural assessment of MG can be challenging. Therefore, we aimed to evaluate (a) peri-interventional dynamics of MG, (b) the impact of intraprocedural MG on clinical outcomes, and (c) predictors for unfavorable MG values after MitraClip. METHODS: We prospectively included patients who underwent MitraClip. All patients underwent echocardiography at baseline, intraprocedurally, at discharge, and after 6 months. 12-month survival was documented. RESULTS: One hundred and seventy five patients (age 81.2 ± 8.2 years, 61.2% male) with severe mitral regurgitation (MR) were included. We divided our cohort into two groups according to intraprocedural MG with a threshold of 4.5 mm Hg, determined by a multivariate analysis of predictors for 12-month mortality (<4.5 mm Hg: Group 1, ≥4.5 mm Hg: Group 2). Intraprocedural MG ≥4.5 mm Hg was found to be the strongest independent predictor for 12-month mortality (HR: 2.33, P = .03, OR: 1.70, P = .05), and >3.9 mm Hg was associated with adverse functional outcomes (OR: 1.96, P = .04). The baseline leaflet-to-annulus index >1.1 was found to be the strongest independent predictor (OR: 9.74, P = .001) for unfavorable intraprocedural MG, followed by the number of implanted clips (P = .01), MG at baseline (P = .02), and central clip implantation (P = .05). CONCLUSION: An intraprocedural MG <3.9 mm Hg appears to be the best strategy for 1-year survival and favorable functional outcomes after edge-to-edge MV repair with MitraClip independently from MR etiology. Peri-interventional echocardiographic and procedural parameters are useful for the adequate assessment of intraprocedural MG.

Single-center five-year outcomes after interventional edge-to-edge repair of the mitral valve.

BACKGROUND: The MitraClip procedure was established as a therapeutic alternative to mitral valve surgery for symptomatic patients with severe mitral regurgitation (MR) at prohibitive surgical risk. In this study, the aim was to evaluate 5-year outcomes after MitraClip. METHODS: Consecutive patients undergoing the MitraClip system were prospectively included. All patients underwent clinical follow-up and transthoracic echocardiography. RESULTS: Two hundred sixty-five patients (age: 81.4 ± 8.1 years, 46.7% female, logistic EuroSCORE: 19.7 ± 16.7%) with symptomatic MR (60.5% secondary MR [sMR]). Although high procedural success of 91.3% was found, patients with primary MR (pMR) had a higher rate of procedural failure (sMR: 3.1%, pMR: 8.6%; p = 0.04). Five years after the MitraClip procedure, the majority of patients presented with reduced symptoms and improved functional capacity (functional NYHA class: p = 0.0001; 6 minutes walking test: p = 0.04). Sustained MR reduction (≤ grade 2) was found in 74% of patients, and right ventricular (RV) function was significantly increased (p = 0.03). Systolic pulmonary artery pressure (sPAP) was significantly reduced during follow-up only in sMR patients (p = 0.05, p = 0.3). Despite a pronounced clinical and echocardiographical amelioration and low interventional failure, 5-year mortality was significantly higher in patients with sMR (p = 0.05). The baseline level of creatinine (HR: 0.695), sPAP (HR: 0.96) and mean mitral valve gradient (MVG) (HR: 0.82) were found to be independent predictors for poor functional outcome and mortality. CONCLUSIONS: Transcatheter mitral valve repair with the MitraClip system showed low complication rates and sustained MR reduction with improved RV function and sPAP 5 years after the procedure was found in all patients, predominantly in patients with sMR. Despite pronounced functional amelioration with low procedure failure, sMR patients had higher 5-year mortality and worse outcomes. Baseline creatinine, MVG, and sPAP were found to be independent predictors of poor functional outcomes and 5-year mortality.

Clinical outcomes and thrombus resolution in patients with solid left atrial appendage thrombi: results of a single-center real-world registry.

BACKGROUND: Data on thrombus resolution and clinical outcome data after a therapy of LAA thrombus with novel oral anticoagulants (NOACs) are scarce. METHODS: In this single-center study, we retrospectively analyzed 78 patients diagnosed with a solid LAA thrombus by transesophageal echocardiography (TEE). We assessed baseline clinical and echocardiographic characteristics, the anticoagulatory regimens and outcomes of patients with (responders) and without (non-responders) thrombus resolution. RESULTS: Mean age was 76.1 ± 8.3 years, patients were male in 57.7% and presented with a high risk for thromboembolism (CHA2DS2-VASc: 4.3 ± 1.1). At thrombus diagnosis, 44.9% patients were treated with a NOAC, while 41.0% were under therapy with a VKA. Complete thrombus resolution was achieved after a mean of 116 ± 79 days in a total of 51.3% of patients, 35.9% showed a reduction of thrombus size, whereas 12.8% showed no changes in thrombus dimensions. There was no statistically significant difference in the rate of LAA thrombus resolution between VKA and NOACs (41.2 vs. 57.1%, p = 0.18). However, in cases in which only the therapy with a NOAC led to complete thrombus resolution, the time needed was significantly shorter than with VKA (81 ± 38 vs. 129 ± 46 days, p = 0.03). Regarding safety outcomes, no differences in bleeding or thromboembolism were observed between patients with and without thrombus resolution. CONCLUSIONS: In this registry, approximately 85% of LAA thrombi were diagnosed in patients with ongoing OAC. Thrombus resolution was observed in nearly 50% of cases. Although there was no difference in the rate of LAA thrombus resolution between VKA and NOACs, the resolution time was shorter in patients prescribed a NOAC.

Comparison of different imaging modalities for the quantification of tricuspid valve geometry and regurgitation: a retrospective, single-center study.

BACKGROUND AND AIMS: Tricuspid regurgitation (TR) is a frequent valvular heart disease with relevant adverse impact on patients' prognosis. Adequate TR imaging and evaluation is challenging. In this study, we aimed to compare different imaging modalities (echocardiography and multi-slice computed tomography) for the assessment of tricuspid valve (TV) function and geometry. METHODS: We retrospectively investigated patients that presented to University Hospital Bonn, Germany, between September 2018 and March 2019, who underwent comprehensive echocardiography and multi-slice computed tomography (MSCT) to evaluate TR. MSCT was considered the reference approach for dimensional assessment of TV anatomy and echocardiography (transthoracic echocardiography + transesophageal echocardiography) for functional assessment of TV. We used Spearman's Rank order correlation, Bland-Altman analysis, and intra-class correlation to compare the different imaging modalities. RESULTS: Forty patients (Mean Age ± SD: 77.5 ± 7.1 years; 35% female) with high grade TR (effective regurgitant orifice area, EROA: 0.49 ± 0.3 cm2, RegVol: 49.5 ± 13.4 mL) were included. There was a statistically significant but moderate correlation between 2D-TEE and MSCT for anteroposterior (AP) (r = 0.68, 95% confidence interval [CI]: 0.44-0.93, P = .05; intraclass correlation [ICC]: 0.77, P = .03) and septolateral (SL) diameters (r = 0.71, 95% CI: 0.33-0.93, P = .03; ICC = 0.76, P = .05). MSCT and 3D-TEE showed a strong correlation for determination of TV annulus area (r = 0.94, 95% CI: 0.57-0.98, P = .002; ICC = 0.95, P = .4), perimeter (r = 0.9, 95% CI: 0.6-0.98, P = .002; ICC = 0.97, P = .3) and diameters (AP-Diameter: r = 0.73, 95% CI: 0.06-0.94, P = .03; ICC = 0.83, P = .09; SL-Diameter: r = 0.86, 95% CI: 0.47-0.97, P = .02; ICC = 0.95, P = .1). Only 3D-TEE allowed for direct measurement of planimetric EROA, which exhibited a significant difference from calculated EROA (0.49 ± 0.4 cm2, 0.67 ± 0.17 cm2, P = .05; r = 0.93, 95% CI: 0.5 to 0.99, P = .006). According to Bland-Altman analysis, we found a relevant agreement between MSCT and 3D-TEE only for TV area (bias: -1.95, 95% limits of agreement -3.6 to -0.1). CONCLUSION: Only 3D-TEE allowed for sufficient simultaneous functional and dimensional assessment of TR in our cohort.

TAVR outcome after reclassification of aortic valve stenosis by using a hybrid continuity equation that combines computed tomography and echocardiography data.

BACKGROUND: In the continuity equation, assumption of a round-shaped left ventricular outflow tract (LVOT) leads to underestimation of the true aortic valve area in two-dimensional echocardiography. The current study evaluated whether inclusion of the LVOT area, as measured by computed tomography (CT), reclassifies the degree of aortic stenosis (AS) and assessed the impact on patient outcome after transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Four hundred and twenty-two patients with indexed aortic valve area index (AVAi) of <0.6 cm2 /m2 , assessed by using the classical continuity equation (mean age: 81.5 ± 6.1 years, 51% female, mean left ventricular ejection fraction: 53.2 ± 13.6%), underwent TAVR and were included. After inclusion of the CT measured LVOT area into the continuity equation, the hybrid AVAi led to a reclassification of 30% (n = 128) of patients from severe to moderate AS. Multivariate predictors for reclassification were male sex, lower mean aortic gradient, and lower annulus/LVOT ratio (all p < .01). Reclassified patients had significantly higher sST2 at baseline and higher NT-proBNP values at baseline and 6 months follow-up compared to non-reclassified patients. Acute kidney injury was experienced more frequently after TAVR by reclassified patients, but no significant mortality difference occurred during 2 years of follow-up. CONCLUSION: The hybrid AVAi reclassifies a significant portion of low-gradient severe AS patients into moderate AS. Reclassified patients showed increased fibrosis and heart failure markers at baseline compared to non-reclassified patients. But reclassification had no significant impact on mortality up to 2 years after TAVR. Routine assessment of hybrid AVAi seems not to improve further risk stratification of TAVR patients.

Right ventricular assessment in patients undergoing transcatheter or surgical aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative treatment option to surgical aortic valve replacement (SAVR) in selected high-risk patients. In this study, we aimed to evaluate the prognostic value of right ventricular (RV) functional imaging to predict clinical response to TAVR and SAVR. METHODS: One hundred and ten patients with symptomatic severe aortic valve stenosis (AVS) undergoing successful TAVR and 32 controls undergoing SAVR were prospectively enrolled. Six months follow up (FU) included two-dimensional (2D) transthoracic echocardiography (TTE) with RV deformation imaging. RESULTS: Baseline TTE showed no significant differences between groups (TAVR and SAVR) in conventional left ventricular (LV) and RV functional parameters (LV ejection fraction [LV-EF]: p = .21; tricuspidal annular plane systolic excursion [TAPSE]: 1.8 ± 0.5 cm, 1.9 ± 0.4 cm, p = .21), and RV strain (right ventricular-global longitudinal strain [RV-GLS] -11.6 ± 5.2%, -11.5 ± 6.5%, p = .70). At FU LV function was unchanged in both groups (p > .05); RV function was significantly improved after TAVR (RV-GLS: -11.6 ± 5.2%, -13.4 ± 6.1%, p = .005; TAPSE: 1.8 ± 0.5 cm, 1.9 ± 0.3 cm, p = .05), and worsened after SAVR (RV-GLS: -11.5 ± 6.5%, -8.9 ± 5.2%, p = .04; TAPSE: 1.9 ± 0.4 cm, 1.5 ± 0.3 cm, p < .001). Functional New York Heart Association (NYHA) class remained unchanged in patients after SAVR (p = .21), and improved after TAVR (p < .001). Baseline RV function was linked with clinical response to TAVR (TAPSE, p < .0001; RV-GLS, p = .04), and the development of RV-GLS was associated with functional worsening after SAVR (p = .05). CONCLUSION: Baseline RV function and changes of right heart mechanics are closely associated with functional improvements after AVR. SAVR, but not TAVR, seems to have detrimental effects on RV-function.

Left atrial global function in chronic heart failure patients with functional mitral regurgitation after MitraClip.

BACKGROUND: Left atrial (LA) volumes and function are believed to improve following interventional reduction of mitral regurgitation (MR) with MitraClip. However, exact LA alterations after MitraClip in patients with functional MR and functional mitral regurgitation (FMR) are unknown. OBJECTIVES: We aimed to evaluate the effect of MitraClip on LA volumes and global function in patients with FMR and its importance for patients' prognosis. METHODS: All patients underwent three-dimensionally transthoracic echocardiography with an offline evaluation of LA geometry and strain analysis at baseline and follow-up (FU). FU examinations were planned for 6 and 12 months after MitraClip. RESULTS: We prospectively included 50 consecutive surgical high-risk (logistic EuroSCORE: 17.2 ± 13.9%) patients (77 ± 9 years, 22% female) with symptomatic moderate-to-severe to severe functional MR without atrial fibrillation. Echocardiographic evaluation showed that the E/E' ratio was significantly higher at FU (15.6 ± 7.3, 24.1 ± 13.2, p = .05) without relevant changes in systolic left ventricle (LV) function (p = .5). LA volumes (end-diastolic volume [LA-EDV] and end-systolic volume [LA-ESV]) (LA-EDV: 83.1 ± 39.5 ml, 115.1 ± 55.3 ml, p = .012; LA-ESV: 58.4 ± 33.4 ml, 80.1 ± 43.9 ml, p = .031), muscular mass (105.1 ± 49.3 g, 145.4 ± 70.6 g, p = .013), as well as LA stroke volume (24.6 ± 12.5 ml, 34.9 ± 19.1 ml, p = .016) significantly increased after the procedure. LA ejection fraction (LA-EF: 31.7 ± 12.8%, 31.1 ± 12.3%, p = .8) and atrial global strain (aGS: -10.8 ± 5.4%, -9.7 ± 4.45%, p = .4) showed no significant changes at FU. Despite no relevant changes during FU, the baseline aGS was found to be the strongest predictor for mortality and adverse interventional outcome. CONCLUSION: MitraClip increases atrial stroke volume, atrial volumes, and muscular mass in patients with FMR. We found that the baseline aGS the strongest predictor for mortality, rehospitalization, and higher residual MR at FU.

Left Ventricular Longitudinal Contractility Predicts Acute-on-Chronic Liver Failure Development and Mortality After Transjugular Intrahepatic Portosystemic Shunt.

Acute deterioration of liver cirrhosis (e.g., infections, acute-on-chronic liver failure [ACLF]) requires an increase in cardiac contractility. The insufficiency to respond to these situations could be deleterious. Left ventricular global longitudinal strain (LV-GLS) has been shown to reflect left cardiac contractility in cirrhosis better than other parameters and might bear prognostic value. Therefore, this retrospective study investigated the role of LV-GLS in the outcome after transjugular intrahepatic portosystemic shunt (TIPS) and the development of ACLF. We included 114 patients (48 female patients) from the Noninvasive Evaluation Program for TIPS and Their Follow-Up Network (NEPTUN) cohort. This number provided sufficient quality and structured follow-up with the possibility of calculating major scores (Child, Model for End-Stage Liver Disease [MELD], Chronic Liver Failure Consortium acute decompensation [CLIF-C AD] scores) and recording of the events (development of decompensation episode and ACLF). We analyzed the association of LV-GLS with overall mortality and development of ACLF in patients with TIPS. LV-GLS was independently associated with overall mortality (hazard ratio [HR], 1.123; 95% confidence interval [CI],1.010-1.250) together with aspartate aminotransferase (HR, 1.009; 95% CI, 1.004-1.014) and CLIF-C AD score (HR, 1.080; 95% CI, 1.018-1.137). Area under the receiver operating characteristic curve (AUROC) analysis for LV-GLS for overall survival showed higher area under the curve (AUC) than MELD and CLIF-C AD scores (AUC, 0.688 versus 0.646 and 0.573, respectively). The best AUROC-determined LV-GLS cutoff was -16.6% to identify patients with a significantly worse outcome after TIPS at 3 months, 6 months, and overall. LV-GLS was independently associated with development of ACLF (HR, 1.613; 95% CI, 1.025-2.540) together with a MELD score above 15 (HR, 2.222; 95% CI, 1.400-3.528). Conclusion: LV-GLS is useful for identifying patients at risk of developing ACLF and a worse outcome after TIPS. Although validation is required, this tool might help to stratify risk in patients receiving TIPS.

6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation.

BACKGROUND: Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. OBJECTIVES: The authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study. METHODS: Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events. RESULTS: Mean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm2 vs. 0.4 cm2; p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01). CONCLUSIONS: Six-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System [TRI-REPAIR]; NCT02981953).

Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes.

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.

Contrast-free, echocardiography-guided left atrial appendage occlusion (LAAo): a propensity-matched comparison with conventional LAAo using the AMPLATZER™ Amulet™ device.

AIMS: Percutaneous left atrial appendage occlusion (LAAo) is commonly performed under fluoroscopy including the use of contrast dye. In this study, we aimed to assess feasibility and safety of contrast-free, 3D-echo-based LAAo with the use of the AMPLATZER™ Amulet™ device. METHODS AND RESULTS: We analyzed 20 patients (74 ± 10 years, 65% males) at an increased thromboembolic and bleeding risk (CHA2DS2VASC 4.0 ± 1.3; HAS-BLED 3.5 ± 0.9) with chronic renal failure (GFR 41 ± 21 ml/min) undergoing LAAo without the use of contrast dye at our center and compared the results with a propensity-matched cohort (1:1 matching) of conventionally treated patients receiving contrast agent. Contrast-free LAAo was associated with less radiation exposure (13.1 ± 19.2 vs. 32.9 ± 21.2 Gy*cm2, p < 0.01) and fluoroscopy time (5.0 ± 3.4 vs. 11.6 ± 4.9 min, p < 0.01). Procedural success rates were excellent in both groups (100%) without severe periprocedural complications (i.e. procedural death, stroke/systemic embolism, myocardial infarction, cardiac tamponade or major bleeding). CONCLUSIONS: Echocardiographically guided LAAo without the use of contrast dye appears safe and feasible. This approach appears to be associated with reduced radiation exposure and may represent an alternative to traditional LAAo, especially in patients in whom the avoidance of contrast dye is warranted.

Carotid strain measurement in patients with pseudoxanthoma elasticum - Hint for a different pathomechanism?

Pseudoxanthoma Elasticum (PXE), caused by autosomal-recessive mutations in the ATP-binding cassette transporter (ABCC6) gene, is known for high prevalence of atherosclerosis. A novel method investigating elastic properties of arteries in atherosclerotic patients is vascular strain analysis. We compared 44 PXE patients with peripheral artery disease (PXE+PAD group) with 50 control patients, each 25 without (control group) and with PAD (PAD group). All participants underwent an angiological examination including ankle-brachial index (ABI) and were examined with speckle-tracking based vascular strain analysis of common carotid arteries, measuring radial displacement (r.Dis), radial velocity (r.Vel), radial strain (r.Str), circumferential strain (c.Str), radial strainrate (r.SR) and circumferential strainrate (c.SR). We found significant lower ABI in patients with PXE compared to all other groups (each p < 0.01). The vascular strain analysis resulted in significantly decreased values in the PAD group compared to PXE with PAD (each p ≤ 0.01) and controls without PAD (each p ≤ 0.05), whereas no significant difference could be found between PXE+PAD and controls without PAD. We found significant negative correlations between low strain values and a higher prevalence of PAD in non-PXE patients (r.Str r = -0.34; c.Str r = -0.35; r.SR: r = -0.51; c.SR: r = -0.53). In conclusion, PXE patients had similar values for arterial stiffness compared to controls without PAD in vascular strain analysis. In this group, arterial stiffness parameters were significantly higher compared to non-PXE PAD patients. It is worth to discuss whether PAD-like manifestations in PXE are a different kind of disease and might need another strategy in diagnostics and therapy.

Impairment of vascular strain in patients with obstructive sleep apnea.

BACKGROUND: Obstructive sleep apnea (OSA) is an independent risk factor for the development of cardiovascular diseases. Aim of this present study was to evaluate and extend recent research on the influence of obstructive sleep apnea on vascular strain. METHODS: A total number of 98 patients were integrated in the study. Patients were grouped according to the Apnea-Hypopnea-Index (AHI) in patients with mild-to-moderate OSA (5/h ≤ AHI < 30/h), severe OSA (AHI ≥ 30/h) and controls (AHI < 5/h). Groups were matched in age, body-mass-index and cardiovascular risks. Vascular strain of common carotid arteries was assessed by ultrasound speckle-tracking. A minor group of 30 patients and controls further underwent assessment of vascular strain of brachial and femoral arteries. Additionally, all patients underwent blood testing to reveal potential influences of inflammatory markers on arterial stiffness. In additional analysis we examined the effect of statin therapy on vascular strain. RESULTS: Patients with OSA showed significantly reduced values of vascular strain of common carotid arteries. Radial and circumferential strains were significantly lower in both patients with mild-to-moderate (p = .05) and patients with severe OSA (p = .001) compared to control. Vascular strain parameters of brachial and femoral arteries showed no consistent results. There were no significant correlations of inflammatory markers with vascular strain parameters. No significant differences in vascular strain were detected between statin and non-statin groups. CONCLUSION: Patients with OSA show significantly reduced vascular strain assessed by ultrasound-based speckle-tracking. Vascular stiffness increases with the severity of the disease. Target vessels to assess vascular strain in patients with OSA are common carotid arteries, whereas other sites of the arterial tree are not reliable. No significant impact of current statin therapy on vascular strain was found. Further studies are needed to evaluate potential benefit of statins in secondary prevention of atherosclerosis in OSA.