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Background Tricuspid regurgitation (TR) frequently develops in patients with long‐standing pulmonary hypertension, and both pathologies are associated with increased morbidity and mortality. This study aimed to improve prognostic assessment in patients with severe TR undergoing transcatheter tricuspid valve intervention (TTVI) by relating the extent of TR to pulmonary artery pressures. Methods and Results In this multicenter study, we included 533 patients undergoing TTVI for moderate‐to‐severe or severe TR. The proportionality framework was based on the ratio of tricuspid valve effective regurgitant orifice area to mean pulmonary artery pressure. An optimal threshold for tricuspid valve effective regurgitant orifice area/mean pulmonary artery pressure ratio was derived on 353 patients with regard to 2‐year all‐cause mortality and externally validated on 180 patients. Patients with a tricuspid valve effective regurgitant orifice area/mean pulmonary artery pressure ratio ≤1.25 mm 2 /mm Hg (defining proportionate TR) featured significantly lower 2‐year survival rates after TTVI than patients with disproportionate TR (56.6% versus 69.6%; P =0.005). In contrast with patients with disproportionate TR (n=398), patients with proportionate TR (n=135) showed more pronounced mPAP levels (37.9±9.06 mm Hg versus 27.9±8.17 mm Hg; P −16 ) and more severely impaired right ventricular function (tricuspid annular plane systolic excursion: 16.0±4.11 versus 17.0±4.64 mm; P =0.012). Moreover, tricuspid valve effective regurgitant orifice area was smaller in patients with proportionate TR when compared with disproportionate TR (0.350±0.105 cm 2 versus 0.770±0.432 cm 2 ; P −16 ). Importantly, proportionate TR remained a significant predictor for 2‐year mortality after adjusting for demographic and clinical variables (hazard ratio, 1.7; P =0.006). Conclusions The proposed proportionality framework promises to improve future risk stratification and clinical decision‐making by identifying patients who benefit the most from TTVI (disproportionate TR). As a next step, randomized controlled studies with a conservative treatment arm are needed to quantify the net benefit of TTVI in patients with proportionate TR.

BackgroundThe deployment process of the largest self-expandable device (STHV-34) during transcatheter aortic valve implantation (TAVI) might be challenging due to stabilization issues. Whether the use of different TAVI-guidewires impact the procedural success and outcome is not well-known. Therefore, we sought to evaluate the impact of non-Lunderquist (NLu) vs. the Lunderquist (Lu) guidewires during TAVI using the STHV-34 on the procedural and 30-day outcomes.MethodsThe primary study endpoint was defined as the final implantation depth (ID) depending on the selected guidewire strategy. Key secondary endpoints included VARC-3-defined complications.ResultsThe study cohort included 398 patients of four tertiary care institutions, of whom 79.6% (317/398) had undergone TAVI using NLu and 20.4% (81/398) using Lu guidewires. Baseline characteristics did not substantially differ between NLu and Lu patients. The average ID was higher in the Lu cohort (NLu vs. Lu: −5.2 [−7.0–(−3.5)] vs. −4.5 [−6.0–(−3.0)]; p = 0.022*). The optimal ID was reached in 45.0% of patients according to former and only in 20.1% according to nowadays best practice recommendations. There was no impact of the guidewire use on the 30-day outcomes, including conduction disturbances and pacemaker need (NLu vs. Lu: 15.1 vs. 18.5%; p = 0.706).ConclusionThe use of the LunderquistTM guidewire was associated with a higher ID during TAVI with the STHV-34 without measurable benefits in the 30-day course concerning conduction disturbances and associated pacemaker need. Whether using different guidewires might impact the outcome in challenging anatomies should be further investigated in randomized studies under standardized conditions.

INTRODUCTION Guideline-directed medical therapy (GDMT), based on the combination of beta blockers (BB), renin-angiotensin system inhibitors (RAS-I), and mineralocorticoid-receptor antagonists (MRA), is known to have a major impact on the outcome of the patients with heart failure with reduced ejection fraction (HFrEF). Although GDMT is recommended prior to M-TEER, not all patients tolerate it. We studied the association of GDMT prescription with survival in HFrEF patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). METHODS AND RESULTS EuroSMR, a European multicenter registry, included SMR patients with left ventricular ejection fraction of less than fifty percent. The outcome was 2-year all-cause mortality. Of 1344 patients, BB, RAS-I, and MRA were prescribed in 1169 (87%), 1012 (75%), and 765 (57%) patients at the time of M-TEER, respectively. Triple GDMT prescription was associated with a lower 2-year all-cause mortality compared to non-triple GDMT (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.60-0.91). The association persisted in patients with glomerular filtration rate of

AIMS Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. METHODS AND RESULTS From 05/2014 to 03/2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalisation after 1 year. Among 746 patients included (78.5 years [IQR 72.0-83.0], EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with ten different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (N = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. CONCLUSION This registry included the largest number of patients treated with TMVI to date. TMVI with ten dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes. This article is protected by copyright. All rights reserved.

BACKGROUND Midterm data comparing clinical outcomes after successful implantation of self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. We aimed to compare 2-year outcomes after successful transcatheter aortic valve implantation (TAVI) with the Edwards balloon-expandable or the Medtronic self-expanding THV. METHODS Two-year outcomes were analyzed according to the implanted THV in the GALILEO trial. Major adverse cardiac and cerebrovascular events (MACCE) was a composite of all-cause death or thromboembolic events including stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism. RESULTS Among 1644 patients recruited in 136 centers across 16 countries between 2015 and 2018, 499 received a self-expanding and 757 patients received a balloon-expandable THV. Patients treated with a self-expanding THV were more likely to be female, and had higher surgical risk, lower hemoglobin levels, and more frequent valve-in-valve procedures than those with a balloon-expandable THV. After multivariable adjustment, there were no significant differences in major clinical outcomes between self-expanding versus balloon-expandable THV: MACCE (17.0% vs. 13.4%, adjusted-hazard ratios [HR] 1.18, 95% confidence intervals [CI]: 0.82-1.69); all-cause death (11.4% vs. 9.3%, adjusted-HR 1.26; 95% CI: 0.78-2.05); cardiovascular death (8.5% vs. 4.0%, adjusted-HR 1.53; 95% CI: 0.82-2.86), any stroke (5.1% vs. 3.7%, adjusted-HR 0.86; 95% CI: 0.43-1.73); major or life-threatening bleeding (5.9% vs. 6.8%, adjusted-HR 0.93; 95% CI: 0.53-1.63). CLINICAL TRIAL REGISTRATION https://www. CLINICALTRIALS gov. NCT02556203. CONCLUSIONS Two-year follow-up data from the GALILEO trial indicate that successful TAVI either with self-expanding or balloon-expandable THVs according to physician discretion did not show difference in rates of MACCE.

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

Supplemental material, sj-docx-1-tak-10.1177_17539447221131203 for Cardiopulmonary function during exercise in heart failure with reduced ejection fraction following baroreflex activation therapy by Pia I. Nottebohm, Daniel Dumitrescu, Stefanie Hamacher, Christopher Hohmann, Navid Madershahian, Stephan Baldus, Hannes Reuter and Marcel Halbach in Therapeutic Advances in Cardiovascular Disease

BACKGROUND Among patients with severe functional mitral regurgitation (FMR), atrial functional MR (aFMR) represents an underrecognized entity. Data regarding outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) in aFMR remain scarce. OBJECTIVES The objective was to analyze the outcome of aFMR patients undergoing M-TEER. METHODS Using patients from the international EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry undergoing M-TEER for FMR, we analyzed baseline characteristics and 2-year outcomes in aFMR in comparison to non-aFMR and ventricular FMR. Additionally, the impact of right ventricular dysfunction (RVD, defined as right ventricular to pulmonary artery uncoupling) on outcome after M-TEER was assessed. RESULTS Among 1,608 FMR patients treated by M-TEER, 126 (7.8%) were categorized as aFMR. All 126 aFMR patients had preserved left ventricular function without regional wall motion abnormalities, left arterial dilatation and Carpentier leaflet motion type I. Procedural success (defined as mitral regurgitation ≤2+ at discharge) was 87.2% (P < 0.001) and New York Heart Association (NYHA) functional class significantly improved during follow-up (NYHA class III/IV: 86.5% at baseline to 36.6% at follow-up; P < 0.001). The estimated 2-year survival rate in aFMR patients was 70.4%. Two-year survival did not differ significantly between aFMR, non-aFMR and ventricular FMR. Besides NYHA class IV, RVD was identified as strong independent predictor for 2-year survival (HR: 2.82 [95% CI: 1.24-6.45]; P = 0.014). CONCLUSIONS aFMR is a frequent cause of FMR and can be effectively treated with M-TEER to improve symptoms at follow-up. Advanced heart failure symptoms and RVD were identified as important risk factors for survival in aFMR patients.

Supplemental material, sj-docx-1-tak-10.1177_17539447221131203 for Cardiopulmonary function during exercise in heart failure with reduced ejection fraction following baroreflex activation therapy by Pia I. Nottebohm, Daniel Dumitrescu, Stefanie Hamacher, Christopher Hohmann, Navid Madershahian, Stephan Baldus, Hannes Reuter and Marcel Halbach in Therapeutic Advances in Cardiovascular Disease

Additional file 3. Definition of Safety Endpoints (ICD-10-GM and OPS Codes).

Background: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. Methods: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. Results: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio‚ 0.88 [95% CI, 0.66–1.18]; P =0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio‚ 0.97 [95% CI, 0.76–1.24]; P =0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or or P values for interaction >0.10). Conclusions: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

Additional file 2. Definition of Effectiveness Endpoints (ICD-10-GM Codes).

Additional file 1. Definition of Baseline Characteristics.

Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study.

BACKGROUND: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. AIMS: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. METHODS: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. RESULTS: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p

BACKGROUND: Mitral valve repair may lead to alterations of tricuspid regurgitation (TR). AIMS: We aimed to investigate alterations, predictors and prognostic relevance of TR evolution in a large-scale multicentre population of patients undergoing transcatheter mitral valve repair (TMVR) via the MitraClip. METHODS: In total, we included 531 TMVR patients with at least one available follow-up echocardiography. TR improvement was defined as a TR ≥II at baseline, which showed a decline of at least one TR categorisation. RESULTS: Distribution of preprocedural TR severity was TR 0/I 41% (220/531), TR II 39% (209/531) and TR ≥III 19% (102/531), respectively. Follow-up echocardiography was at 308±187 days. TR severity improved to TR 0/I 49% (259/531), TR II 35% (183/531) and TR III 17% (89/531), p=0.003. Out of 311 patients with TR ≥II at baseline, 41% (127/311) showed TR improvement. Atrial fibrillation (AF), residual mitral regurgitation ≥II (rMR) and tricuspid annular diameter (TAD) remained variables which prevented TR improvement (odds ratio 0.49 [0.29-0.84], 0.47 [0.27-0.81] and 0.97 [0.93-0.997], respectively). TR improvement was associated with better event-free survival regarding post-procedural heart failure hospitalisation (HHF) (hazard ratio 0.6 [0.38-0.94]). The main changes of TR severity occurred within 3 months post TMVR (p=0.006), while there were only minor TR changes between 3 and 12 months of follow-up (p=0.813). CONCLUSIONS: TR improvement was frequent after TMVR. Predictors preventing TR improvement were AF, post-procedural rMR, and TAD. Furthermore, TR improvement was an early phenomenon occurring primarily within the first three months post TMVR and served as a suitable marker of reduced HHF.

Background Optimizing risk stratification in patients undergoing transcatheter mitral valve repair is an ongoing challenge. The Mitral Regurgitation International Database (MIDA) score represents a user‐friendly mortality risk stratification tool that is validated on a large‐scale registry of patients with degenerative mitral regurgitation (MR). We here assessed the potential benefit of the MIDA risk score for patients with functional or degenerative MR undergoing transcatheter mitral valve repair. Methods and Results In total, 680 patients undergoing MitraClip implantation were stratified according to MIDA score tertiles into a low (0–7), intermediate (8–9), and a high (10–12) MIDA score group. MR was assessed in follow‐up echocardiograms in 416 patients at 323±169 days after transcatheter mitral valve repair. During 2‐year follow‐up, 8.2% (15/182) of patients with low, 21.3% (64/300) with intermediate, and 26.3% (52/198) with high MIDA score died (log‐rank test P

\(\textbf {Background:}\) The aim of the present study was to analyze incidence, risk factors, and association with long-term outcome of postoperative delirium (POD) after transcatheter aortic valve replacement (TAVR). \(\textbf {Methods:}\) Six hundred and sixty one consecutive patients undergoing TAVR were prospectively enrolled from January 2016 to December 2017. POD was assessed regularly during ICU-stay using the CAM-ICU test. \(\textbf {Results:}\) The incidence of POD was 10.0% (\(\it n\) = 66). Patients developing POD were predominantly male (65%), had higher EuroSCORE II (5.4% vs. 3.9%; \(\it P\) = 0.041) and were more often considered frail (70% vs. 26%; \(\it P\) < 0.001). POD was associated with more peri-procedural complications including vascular complications (19.7 vs. 9.4; \(\it P\) = 0.017), bleeding (12.1 vs. 5.4%; \(\it P\) = 0.0495); stroke (4.5 vs. 0.7%; \(\it P\) = 0.025), respiratory failure requiring ventilation (16.7% vs. 1.8%; \(\it P\) < 0.001), and pneumonia (34.8% vs. 7.1%; \(\it P\) < 0.001). Consequently, patients with POD had significantly longer ICU- (7.9 vs. 3.2 days \(\it P\) < 0.001) and hospital-stay (14.9 vs. 9.0 days; \(\it P\) < 0.001), and higher in-hospital mortality (6.1 vs. 2.1%; \(\it P\) = 0.017). Logistic regression analysis identified male sex (odds ratio (OR) 2.2 [95% confidence interval (CI) 1.2–4.0); \(\it P\) = 0.012], atrial fibrillation [OR 3.0 (CI 1.6–5.6); \(\it P\) < 0.001], frailty [OR 4.3 (CI 2.4–7.9); \(\it P\) < 0.001], pneumonia [OR 4.4 (CI 2.3–8.7); \(\it P\) < 0.001], stroke [OR 7.0 (CI 1.2–41.6); \(\it P\) = 0.031], vascular complication [OR 2.9 (CI 1.3–6.3); \(\it P\) = 0.007], and general anesthesia [OR 2.0 (CI 1.0–3.7); \(\it P\) = 0.039] as independent predictors of POD. On Cox proportional hazard analysis POD emerged as a significant predictor of 2-year mortality [HR 1.89 (CI 1.06–3.36); \(\it P\) = 0.030]. \(\textbf {Conclusion:}\) POD is a frequent finding after TAVR and is significantly associated with reduced 2-year survival. Predictors of delirium include not only peri-procedural parameters like stroke, pneumonia, vascular complications and general anesthesia but also baseline characteristics as male sex, atrial fibrillation and frailty.

Additional file 3. Supplemental methods

Additional file 4: Supplemental Table 1. Gene array data for most common cardiac integrins and integrin binding proteins. Supplemental Table 2. Integrins and integrin binding proteins expression changes. Supplemental Table 3. Gene array data for most common cardiac gap junction proteins. Supplemental Table 4. Gap junction protein expression changes.

Background Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. Methods We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns. Results After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P=0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P=0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53). Conclusions In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.) Supported by Bayer in collaboration with Janssen Pharmaceuticals. Dr. Dangas reports iving lecture lees from Bayer, receiving grant support, paid to his institution, and lecture fees from Daiichi Sankyo, and previously holding equity in Medtronic; Dr. Mollmann, receiving lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer; Dr. Makkar, receiving grant support, consulting fees, and travel support from Abbott Vascular, grant support, lecture fees, and travel support from Edwards Lifesciences, and grant support and consulting fees from Medtronic and Boston Scientific; Dr. FIerrmann, receiving grant support, paid to his institution, from Abbott Vascular and Boston Scientific and grant support, paid to his institution, and consulting fees from Edwards Lifesciences and Medtronic; Dr. Giusrino, receiving consulting fees from Bristol-Myers Squibb/Pfizer; Dr. De Backer, receiving lecture fees from Boston Scientific; Dr. Guimaraes, being employed by Cardialysis; Dr. Mack, serving as a trial coprimary investigator for Edwards Lifesciences and Abbott Vascular and serving as a study chair for Medtronic; Dr. Schafer, receiving grant support from the Medicines Company; Dr. Thomitzek, being employed by and holding stock in Bayer; Dr. Valgimigli, receiving lecture fees from AstraZeneca, Als'imedical CID, Vifor Pharma, and Medscape, grant support and lecture fees from 'Ceram, consulting fees and lecture fees from Abbott Vascular, Bayer, and Bristol-Myers Squibb, and consulting fees from Daiichi Sankyo, Opsens, CoreFIDW, Idorsia Pharmaceuticals, and iVascular; Dr. Vranekx, receiving fees for serving on a speakers bureau from Daiichi Sankyo, lecture tees from AstraZeneca, and fees for serving on a steering committee and travel support from CSL Behring; Dr. Welsh, receiving grant support and honoraria from AstraZeneca, Bayer, and Boehringer Ingelheim; Dr. Wildgoose, being employed by and holding stock in Janssen Pharmaceuticals; Dr. Volkl, being employed by Janssen Pharmaceuticals; Dr. van Amsterdam, being employed by Cardialysis; Dr. Zazula, being employed by Bayer; Dr. Mehran, receiving advisory board fees and consulting fees from Sanofi-Aventis and Janssen, receiving lecture fees from Bayer, receiving grant support, paid to her institution, and lecture fees from Daiichi Sankyo, and previously holding equity in Medtronic; and Dr. Windecker, receiving grant support, paid to his institution, advisory board fees, and travel support from Amgen and grant support, paid ro his institution, from Abbott Vascular, Bayer, Bristol-Myers Squibb, CSL Behring, Boston Scientific, Bic rronik, Medtronic, Edwards Lifesciences, Polares Medical, and Sinomed. No other potential conflict of interest relevant to this article was reported. Windecker, S (reprint author), Windecker, S (reprint author) stephan.windecker@insel.ch

\(\bf Objective\) Residual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves. \(\bf Methods\) 642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge. \(\bf Results\) PVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p

Background: Little is known about the role of cyclooxygenase (COX)-2 in gastroesophageal reflux disease (GERD) and the development of Barrett's metaplasia. The objectives of this study were to further analyze COX-2 mRNA expression in patients with GERD compared to Barrett's esophagus (BE) and Barrett's cancer (BC). Methods: Tissue samples from 110 patients with GERD (n = 43), BE (n = 20), and BC (n = 47) were obtained in routine upper GI endoscopy. Expression levels of COX-2 were measured by quantitative real-time reverse trancriptase polymerase chain reaction (RT-PCR). Also, 24-h pH monitoring was performed in all patients of the GERD study group and the DeMeester composite score was used to match COX-2 mRNA expression with the severity of acid exposure in the lower esophagus. Results: COX-2 mRNA is progressively upregulated within the metaplasia-dysplasia-adenocarcinoma (MDA) sequence (p = 0.001). COX-2 levels of the squamous epithelium in the distal esophagus from patients with GERD and a pathologic mean DeMeester score (>14.72) were significantly higher than in patients with normal DeMeester scores (p = 0.01). Conclusion: In summary our findings suggest that alterations in COX-2 mRNA expression occur independently of endoscopic or histologic signs of GERD in the acid-exposed squamous epithelium of the distal esophagus. However, this early COX-2 increase in GERD is further upregulated within the MDA sequence for yet unknown reasons

Objectives This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment. Background Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device. Methods Thirty-one patients (71.8 ± 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 ± 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 ± 11%) were prospectively enrolled. Results Procedural success rate, defined as delivery of the entire device, was 100%. There were no periprocedural deaths (0%), and mortality rate at 1 month or prior to hospital discharge and at 7 months was 5% and 9.7% respectively. Cinching of the implanted Cardioband reduced the annular septolateral dimension by >30% from 3.7 ± 0.5 cm at baseline to 2.5 ± 0.4 cm after 1 month and to 2.4 ± 0.4 cm after 6 months, respectively (p < 0.001). Percentage of patients with FMR ≥3 was reduced from 77.4% to 10.7% 1 month after the procedure (p < 0.001) and 13.6% (p < 0.001) at 7 months. Percentage of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2% after 7 months (p < 0.001); exercise capacity as assessed by 6-min walking test increased from 250 ± 107 m to 332 ± 118 m (p < 0.001) and quality of life (Minnesota Living With Heart Failure Questionnaire) was also significantly improved (p < 0.001). Conclusions In this feasibility trial in symptomatic patients with FMR, transcatheter mitral annuloplasty with the Cardioband was effective in reducing MR and was associated with improvement in heart failure symptoms and demonstrated a favorable safety profile. (Cardioband With Transfemoral Delivery System; NCT01841554)

Additional file 2: Table S1. Enriched Gains and Losses (percentage of altered samples, range and involved Genes). A: Enriched Gains in LNM vs. PT. B: Enriched Losses in LNM vs. PT. C: Enriched Gains in OM vs. PT. D: Enriched Losses in PT vs. OM. E: Enriched Losses in LNM vs. OM. F: Enriched Gains in OM vs. LNM. G: Enriched Losses in OM vs. LNM. Table S2. Involved pathways, genes and respective protein class in enriched alterations. A: Altered pathways in enriched Gains (LNM vs PT). B: Altered pathways in enriched Losses (LNM vs PT).

Increased systemic levels of myeloperoxidase (MPO) are associated with the risk of coronary artery disease (CAD). To identify the genetic factors that are associated with circulating MPO levels, we carried out a genome-wide association study (GWAS) and a gene-centric analysis in subjects of European ancestry and African Americans (AAs). A locus on chromosome 1q31.1 containing the complement factor H (CFH) gene was strongly associated with serum MPO levels in 9305 subjects of European ancestry (lead SNP rs800292; P = 4.89 × 10−41) and in 1690 AA subjects (rs505102; P = 1.05 × 10−8). Gene-centric analyses in 8335 subjects of European ancestry additionally identified two rare MPO coding sequence variants that were associated with serum MPO levels (rs28730837, P = 5.21 × 10−12; rs35897051, P = 3.32 × 10−8). A GWAS for plasma MPO levels in 9260 European ancestry subjects identified a chromosome 17q22 region near MPO that was significantly associated (lead SNP rs6503905; P = 2.94 × 10−12), but the CFH locus did not exhibit evidence of association with plasma MPO levels. Functional analyses revealed that rs800292 was associated with levels of complement proteins in serum. Variants at chromosome 17q22 also had pleiotropic cis effects on gene expression. In a case–control analysis of ∼80 000 subjects from CARDIoGRAM, none of the identified single-nucleotide polymorphisms (SNPs) were associated with CAD. These results suggest that distinct genetic factors regulate serum and plasma MPO levels, which may have relevance for various acute and chronic inflammatory disorders. The clinical implications for CAD and a better understanding of the functional basis for the association of CFH and MPO variants with circulating MPO levels require further study.

Einleitung: Das Vorgehen beim papillären Mikrokarzinom (PMC) der Schilddrüse ist kontrovers. In der eigenen Klinik werden seit 2003 auch bei gutartiger Struma fast ausschließlich Thyreoidektomien oder Hemithyreoidektomien durchgeführt. Wir untersuchten, ob dies auch das weitere [for full text, please go to the a.m. URL], 129. Kongress der Deutschen Gesellschaft für Chirurgie

Inflammatory processes and foam cell formation are key determinants in the initiation and progression of atherosclerosis. Electrophilic nitro-fatty acids, byproducts of nitric oxide- and nitrite-dependent redox reactions of unsaturated fatty acids, exhibit antiinflammatory signaling actions in inflammatory and vascular cell model systems. The in vivo action of nitro-fatty acids in chronic inflammatory processes such as atherosclerosis remains to be elucidated.Herein, we demonstrate that subcutaneously administered 9- and 10-nitro-octadecenoic acid (nitro-oleic acid) potently reduced atherosclerotic lesion formation in apolipoprotein E-deficient mice. Nitro-fatty acids did not modulate serum lipoprotein profiles. Immunostaining and gene expression analyses revealed that nitro-oleic acid attenuated lesion formation by suppressing tissue oxidant generation, inhibiting adhesion molecule expression, and decreasing vessel wall infiltration of inflammatory cells. In addition, nitro-oleic acid reduced foam cell formation by attenuating oxidized low-density lipoprotein-induced phosphorylation of signal transducer and activator of transcription-1, a transcription factor linked to foam cell formation in atherosclerotic plaques. Atherosclerotic lesions of nitro-oleic acid-treated animals also showed an increased content of collagen and alpha-smooth muscle actin, suggesting conferral of higher plaque stability.These results reveal the antiatherogenic actions of electrophilic nitro-fatty acids in a murine model of atherosclerosis.

ObjectivesThe aim of the study was to assess predictors of acute procedural failure in surgical high-risk patients undergoing MitraClip (Abbott Vascular, Abbott Park, Illinois) therapy.BackgroundMitraClip implantation is a novel percutaneous option to treat significant mitral regurgitation (MR).MethodsIn 300 patients (75 ± 9 years of age, 190 [63%] men), of whom 32 (10.7%) had been unsuccessfully treated (discharge MR grade of >2+), baseline clinical and echocardiographic variables were evaluated by exact logistic regression and classification tree analyses to assess their impact on acute procedural failure. Acute procedural failure was differentiated into aborted procedure (no MitraClip implanted; n = 11) and “clip failure” (inadequate MR reduction despite MitraClip implantation; n = 21).ResultsMultivariate logistic regression identified effective regurgitant orifice area (EROA), mitral valve orifice area (MVOA), and mean transmitral pressure gradient (TMPG) as independent predictors of overall acute procedural failure. Classification tree analysis revealed that an EROA >70.8 mm2 (n = 28) was associated with a high rate (25%) of clip failures, whereas the combination of an MVOA ≤3.0 cm2 and a TMPG ≥4 mm Hg (n = 16) was associated with a high rate (37.5%) of aborted procedures. Failure rates of ≤10% were observed in all patients with an EROA ≤70.8 mm2 and either an MVOA >3.0 cm2 (n = 217) or an MVOA ≤3.0 cm2 in concert with a TMPG ≤3 mm Hg (n = 39). Multinomial logistic regression identified an EROA >70.8 mm2 and a TMPG ≥4 mm Hg as independently predictive of clip failure, but an MVOA ≤3.0 cm2 and a TMPG ≥4 mm Hg as independently predictive of procedure abortion.ConclusionsIn surgical high-risk patients undergoing MitraClip therapy, a TMPG ≥4 mm Hg, an EROA ≥70.8 mm2, and an MVOA ≤3.0 cm2 carry an increased risk of procedural failure.

Aims: The CardiobandTM (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 guidelinerecommended 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.

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.

Das übergeordnete Ziel der Arbeiten war, Methoden im Mausmodell zu entwickeln und zu evaluieren, mit denen das Verhalten intramyokardial transplantierter Zellen, deren Wirkmechanismus und deren Effekt auf das linksventrikuläre Remodeling in-vivo gemessen werden kann. Das Schicksal der transplantierten Zellen und die Wirkmechanismen – zelluläre Inflammation und Angiogenese – wurden dabei vor allem mittels Positronen-Emissions-Tomographie (PET) untersucht. Für die Etablierung der Bildgebung des LV Remodeling spielte die kardiale Magnetresonanztomographie (MRT) die tragende Rolle.