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

Background: MitraClip therapy is increasingly used in patients deemed inoperable to treat severe mitral regurgitation (MR), but long-tern data is scarce., Aims: The multicentre, industry-independent German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises the largest prospectively enrolled cohort of patients treated by MitraClip therapy. The current analysis is focusing on long-term mortality rates, cardiac rehospitalization and reintervention., Methods and Results: Long-term follow-up (median time 1037 days) in the TRAMI registry was available for 722 patients treated at 20 German centres. Improvements in New York Heart Association (NYHA) functional class (I/II long-term: 65% vs. 1-year follow-up: 63.3%) and self-rated health-status (EuroQuol visual analogue scale [EQ VAS] long-term: 60 [50-70] vs. 1-year follow-up: 60 [50; 70]) were pertained over time. Estimated mortality rates by Kaplan-Meier method were 19.7% for 1-year, 31.9% for 2-year and 53.1% for 4-year follow-up without differences found for MR aetiology. Multivariable Cox-regression analysis identified previous aortic valve implantation (hazard ratio [HR] = 2.21; p < 0.0001), NYHA class IV (HR = 1.78; p < 0.001), prior cardiac decompensation (HR = 1.63; p < 0.001), creatinine > 1.5 mg/dl (HR = 1.63; p < 0.0001) and left ventricular ejection fraction < 30% (HR = 1.60; p < 0.001) as most predictive for long-term mortality., Conclusions: Long-term outcome in the TRAMI registry confirmed lasting clinical improvements and low intervention rates. Long-term mortality was strongly influenced by cardiac and non-cardiac co-morbidities and was found comparable for both MR aetiologies., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objectives: This study sought to determine the feasibility, safety, and exploratory efficacy of the Embrella Embolic Deflector (EED) system (Edwards Lifesciences, Irvine, California) in patients undergoing transcatheter aortic valve replacement (TAVR)., Background: Few data exist on the value of using embolic protection devices during TAVR., Methods: This pilot study included 52 patients who underwent transfemoral TAVR. The EED system was used in 41 patients, whereas 11 patients underwent TAVR without embolic protection (control group). Cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and within 7 days and 30 days after TAVR., Results: The EED system was successfully deployed at the level of the aortic arch in all patients with no complications. The deployment of the EED system was associated with high-intensity transient signals (HITS) as evaluated by transcranial Doppler (median: 48 [interquartile range: 17 to 198] HITS), and a higher total number of HITS was observed in the EED group (p < 0.001 vs. control group). DW-MRI performed within 7 days after TAVR showed the presence of new ischemic lesions in all patients in both groups, with a median number of 7 (interquartile range: 3 to 13) lesions per patient. The use of the EED system was associated with a lower lesion volume compared with the control group (p = 0.003). All new cerebral lesions had disappeared on the DW-MRI performed at 30 days after TAVR. Two strokes unrelated to the EED system occurred 2 and 29 days after TAVR., Conclusions: This study showed the feasibility and safety of using the EED system in TAVR procedures. The EED system did not prevent the occurrence of cerebral microemboli during TAVR or new transient ischemic lesions as evaluated by DW-MRI, but it was associated with a reduction in lesion volume. Further studies are warranted to determine the efficacy of using the EED system during TAVR procedures., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The risk of clinically apparent, periprocedural stroke after thoracic endovascular aortic repair (TEVAR) due to dislodgement and embolization of aortic debris from intravascular manipulation of guidewires, catheters, and large-bore delivery systems ranges between 2% and 6% and has been associated with increased postoperative mortality. The rate of clinically silent cerebral ischemia is yet unknown, but may be even higher., Methods: Nineteen patients (13 male, 6 female) who underwent TEVAR were included into this descriptive study. Periprocedural apparent and silent cerebral ischemia was assessed by daily clinical neurologic assessment and serial cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and 5 days (median, interquartile range: 3.5) after the procedure., Results: The TEVAR was successful in all patients without immediate clinically apparent neurologic deficits. Postinterventional cerebral DW-MRI detected a total of 29 new foci of restricted diffusion in 12 of 19 TEVAR patients (63%). Lesions were usually multiple (1 to 6 lesions per patient) and ranged in size between 15 mm3 and 300 mm3; 16 lesions were found in the left hemisphere, 13 lesions in the right hemisphere. Overstenting of the left subclavian artery was performed in 8 cases, but was not associated with lateralization of lesions. There were no additional apparent neurologic events during the in-hospital period., Conclusions: Thoracic endovascular aortic repair resulted in a high incidence of new foci of restricted diffusion on cerebral DW-MRI in a pattern suggestive of periprocedural embolization. Although multiple lesions per patients were found, these lesions were not associated with apparent neurologic deficits during the in-hospital period. Further developments in TEVAR should be directed toward reducing the risk of periprocedural cerebral embolization., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate whether supra-aortic angiography during preparatory balloon aortic valvuloplasty (BAV) improves valve sizing., Background: Current recommendations for valve size selection are based on annular measurements by transesophageal echocardiography and computed tomography, but paravalvular aortic regurgitation (PAR) is a frequent problem., Methods: Data of 270 consecutive patients with either conventional sizing (group 1, n = 167) or balloon aortic valvuloplasty-based sizing (group 2, n = 103) were compared. PAR was graded angiographically and quantitatively using several hemodynamic indices., Results: PAR was observed in 113 patients of group 1 and 41 patients of group 2 (67.7% vs. 39.8%, p < 0.001). More than mild PAR was found in 24 (14.4%) patients of group 1 and 8 (7.8%) patients of group 2. According to pre-interventional imaging, 40 (39%) patients had a borderline annulus size, raising uncertainty regarding valve size selection. Balloon sizing resulted in selection of the bigger prosthesis in 30 (29%) and the smaller prosthesis in the remaining patients, and only 1 of these 40 patients had more than mild PAR. As predicted by the hemodynamic indices of PAR, mortality at 30 days and 1 year was less in group 2 than in group 1 (5.8% vs. 9%, p = 0.2 and 10.6% vs. 20%, p = 0.01)., Conclusions: Preparatory balloon aortic valvuloplasty during transcatheter aortic valve implantation improves valve size selection, reduces the associated PAR, and increases survival in borderline cases., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to identify risk factors for thrombus formation on the Amplatzer Cardiac Plug (ACP) (St. Jude Medical, St. Paul, Minnesota) after left atrial appendage occlusion., Background: Left atrial appendage occlusion with the ACP aims to reduce the risk of embolic stroke and bleeding complications associated with vitamin K antagonists in patients with atrial fibrillation., Methods: We performed transesophageal echocardiography before discharge and after 3, 6, and 12 months in 34 patients with atrial fibrillation undergoing ACP implantation and receiving dual antiplatelet therapy. Clinical, echocardiographic, and hemostaseological parameters were retrospectively analyzed to identify risk factors for thrombus formation., Results: Three patients had thrombi before discharge, 3 more at the 3-month follow-up. No differences were found in left atrial volume, left atrial appendage velocity, spontaneous echo contrast, transmitral gradient, or mitral regurgitation between patients without or with thrombi. CHADS2 (Congestion, Hypertension, Age, Diabetes, and Stroke) score (2.0 ± 1.1 vs. 4.3 ± 1.0), CHA2DS2-VASc (CHADS2 plus Vascular Disease and Sex Category) score (5.2 ± 1.3 vs. 6.8 ± 0.8), and pre-interventional platelet count (215.9 ± 63.9/nl vs. 282.5 ± 84.4/nl) were higher and ejection fraction (50.6 ± 11.4% vs. 39.7 ± 10.6%) lower in those with thrombi. Factor 2, factor 5, or methylenetetrahydrofolate reductase mutations and genetic variants associated with reduced clopidogrel activity were not more frequent in patients with thrombi., Conclusions: Transesophageal echocardiography identified 17.6% of patients with thrombus formation on the ACP despite dual antiplatelet therapy. CHADS2 and CHA2DS2-VASc scores, platelet count, and ejection fraction are risk factors for such thrombus formation., (Published by Elsevier Inc.)

Objectives: To evaluate feasibility, safety, efficacy as well as acute and short-term outcome of hemodynamically supported percutaneous coronary intervention (PCI) by a percutaneous, catheter-based left ventricular assist device (LVAD) (Impella LP 2.5, Abiomed Europe GmbH, Aachen, Germany) in a high-risk patient population with acute coronary syndrome., Background: Although hemodynamic support by intraaortic balloon pump favorably affects myocardial oxygen supply and demand, it has modest effects on cardiac output, providing passive support only. In contrast, the Impella LP 2.5 microaxial pump, which is placed within the left ventricular outflow tract and actively ejects blood into the ascending aorta, might offer additional hemodynamic support and thereby procedural safety during PCI., Methods: Thirty-eight consecutive high-risk patients (mean age, 69.7 ± 10.3 years, logistic EuroSCORE, 22.4 ± 14.9%) with unstable angina pectoris or non-ST-segment elevation myocardial infarction and severe three-vessel-disease were included in the study. Clinical and laboratory examinations were performed at baseline as well as at 6, 24 and 48 h after the procedure and 30 days after discharge., Results: Device insertion and explantation was feasible in all patients without vascular complications and continuous hemodynamic stability was obtained during PCI. PCI was uneventfully performed in all but one patient for technical reasons. One non procedure-related death occurred 7 days after the intervention, accounting for a total 30-day mortality of 2.86%. Other major cardiac or cerebrovascular events did not occur., Conclusions: LVAD support using a percutaneous microaxial flow pump is a promising and safe approach for high-risk PCI providing good short-term results., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Intramural hematoma (IMH) of the aorta and penetrating aortic ulcer (PAU) are important variant forms of classic double-barrel aortic dissection in patients presenting with acute aortic syndrome. Recent insights provided by modern high-resolution imaging are currently challenging previous pathophysiologic concepts underlying IMH and PAU, suggesting a close relationship of both entities. Thoracic endovascular aortic repair (TEVAR) offers a less invasive approach to the treatment of affected patients with very encouraging early to midterm results. This review discusses current indication for TEVAR in IMH and PAU patients in the view of an improved understanding of these diseases.