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Objectives The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. Background The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformite Europeene mark in 2014, but only limited clinical data are available so far. Methods This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. Results Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. Conclusions Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

BackgroundA logistic European System for Cardiac Operative Risk Evaluation (logEuroSCORE) ≥20% is frequently recognised as a finite criteria for transcatheter aortic valve implantation (TAVI) reimbursement, despite guideline modifications to reflect the appropriacy of TAVI in selected lower-risk patients. The aim was to evaluate the clinical value of this threshold cut-off in TAVI patients and to identify factors associated with mortality in those below this threshold.MethodsWe analysed data from a single-centre, German, observational, TAVI-patient registry, gathered between 2008 and 2016. Patients were stratified by logEuroSCORE (≥ or Results1679 patients (logEuroSCORE ConclusionsAt our institution, patients with a logEuroSCORE

The fabrication of bit-patterned media (BPM) is crucial for new types of hard disk drives. The development of methods for the production of BPM is progressing rapidly. Conventional lithography reaches the limit regarding lateral resolution, and new routes are needed. In this study, we mainly focus on the dependence of the size and shape of magnetic nanodots on the Ar+-ion etching duration, using silica dots as masks. Two-dimensional (2D) arrays of magnetic nanostructures are created using silica-filled diblock-copolymer micelles as templates. After the self-assembly of the micelles into 2D hexagonal arrays, the polymer shell is removed, and the SiO2 cores are utilized to transform the morphology into a (Co/Pt)2-multilayer via ion etching under normal incidence. The number of preparation steps is kept as low as possible to simplify the formation of the nanostructure arrays. High-resolution in situ grazing-incidence small-angle X-ray scattering (GISAXS) investigations are performed during the Ar+-ion etching to monitor and control the fabrication process. The in situ investigation provides information on how the etching conditions can be improved for further ex situ experiments. The GISAXS patterns are compared with simulations. We observe that the dots change in shape from cylindrical to conical during the etching process. The magnetic behavior is studied by utilizing the magneto-optic Kerr effect. The Co/Pt dots exhibit different magnetic behaviors depending on their size, interparticle distance, and etching time. They show ferromagnetism with an easy axis of magnetization perpendicular to the film. A systematic dependence of the coercivity on the dot size is observed.

Aims Initial studies of catheter-based renal arterial sympathetic denervation to lower blood pressure in resistant hypertensive patients renewed interest in the sympathetic nervous system's role in the pathogenesis of hypertension. However, the SYMPLICITY HTN-3 study failed to meet its prespecified blood pressure lowering efficacy endpoint. To date, only a limited number of studies have described the microanatomy of renal nerves, of which, only two involve humans. Methods and Results Renal arteries were harvested from 15 cadavers from the Klinikum Osnabruck and Schuchtermann Klinik, Bad Rothenfelde. Each artery was divided longitudinally in equal thirds (proximal, middle, and distal), with each section then divided into equal superior, inferior, anterior, and posterior quadrants, which were then stained. Segments containing no renal nerves were given a score value = 0, 1–2 nerves with diameter 4 nerves or nerve diameter ≥600 µm a score = 3. A total of 22 renal arteries (9 right-sided, 13 left-sided) were suitable for examination. Overall, 691 sections of 5 mm thickness were prepared. Right renal arteries had significantly higher mean innervation grade (1.56 ± 0.85) compared to left renal arteries (1.09 ± 0.87) (P

The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions.The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far.This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure.Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cmTransfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

The "transfemoral (TF) first" approach to access route selection in transcatheter aortic valve implantation (TAVI) is popular; however, the risk of major vascular complications is substantial. The "best for TF" approach identifies only the patients with ideal anatomy for TF-TAVI, potentially minimizing complications.To characterize the outcomes of patients undergoing TAVI at a large-volume site that employs this approach.Patients who underwent TAVI at the Bad Rothenfelde Heart Centre between 2008 and 2016 were consecutively enrolled. Findings were compared to those from large, multicenter registries.Of the 1,644 patients enrolled, 1,140 underwent TA- and 504 TF-TAVI. Comorbidities were more frequent in TA patients, who also had higher risk scores (EuroSCORE: 25.5% vs. 21.2%; STS score: 11.0% vs. 7.5%;At this high-volume center, the use of a "best for TF" approach to TAVI resulted in low mortality and complication rates.Przezcewnikowe wszczepienie zastawki aortalnej (TAVI) w przypadku ciężkiej stenozy aortalnej jest powszechnie akceptowaną metodą leczenia odpowiednio wyselekcjonowanych pacjentów.Celem badania jednoośrodkowego było retrospektywne porównanie wczesnych i odległych wyników terapii pacjentów leczonych z dostępu przezudowego i przezkoniuszkowego.Do badania zakwalifikowano 1644 chorych (892 kobiety, 752 mężczyzn, średnia wieku: 81 ±5,8 roku) poddanych przezcewnikowemu wszczepieniu zastawki aortalnej w Heart Center w Bad Rothenfelde w latach 2008–2016.Z dostępu przezkoniuszkowego leczono 1140 pacjentów, a z dostępu przezudowego 504 (EuroSCORE: 25,5% vs 21,2%; STS score: 11,0% vs 7,5%;Zgodna ze wskazaniami kwalifikacja pacjentów i właściwy wybór drogi dostępu do przezcewnikowego wszczepienia zastawki aortalnej prowadzi do optymalizacji wyników leczenia.

Transcatheter transfemoral mitral valve repair using the MitraClip system (Abbott Vascular, USA) is used in high-risk or inoperable patients with severe mitral regurgitation. We report the first-in-human simultaneous transfemoral clipping of the mitral and tricuspid valve completed by occlusion of an atrial septal defect (ASD). The procedure was performed in an 84-year-old patient in October 2015. After effective reduction of mitral and tricuspid regurgitations using the MitraClip system a PFO Occluder (St. Jude Medical, USA) was implanted. Transfemoral simultaneous mitral and tricuspid valve repair using the MitraClip system with ASD occlusion seems to be an effective therapy for high-risk or inoperable patients.Przezcewnikowa implantacja zapinki MitraClip (Abbott Vascular, USA) jest stosowana w leczeniu pacjentów wysokiego ryzyka z ciężką niedomykalnością zastawki mitralnej. Autorzy przedstawiają pierwszą na świecie jednoczesną implantację zapinki MitraClip na zastawce mitralnej i trójdzielnej, włącznie z zamknięciem jatrogennego ASD (PFO Occluder), wykonaną przez żyłę udową u 84-letniej pacjentki w październiku 2015 r.

Initial studies of catheter-based renal arterial sympathetic denervation to lower blood pressure in resistant hypertensive patients renewed interest in the sympathetic nervous system's role in the pathogenesis of hypertension. However, the SYMPLICITY HTN-3 study failed to meet its prespecified blood pressure lowering efficacy endpoint. To date, only a limited number of studies have described the microanatomy of renal nerves, of which, only two involve humans.Renal arteries were harvested from 15 cadavers from the Klinikum Osnabruck and Schuchtermann Klinik, Bad Rothenfelde. Each artery was divided longitudinally in equal thirds (proximal, middle, and distal), with each section then divided into equal superior, inferior, anterior, and posterior quadrants, which were then stained. Segments containing no renal nerves were given a score value = 0, 1-2 nerves with diameter300 µm a score = 1; 3-4 nerves or nerve diameter 300-599 µm a score = 2, and4 nerves or nerve diameter ≥600 µm a score = 3. A total of 22 renal arteries (9 right-sided, 13 left-sided) were suitable for examination. Overall, 691 sections of 5 mm thickness were prepared. Right renal arteries had significantly higher mean innervation grade (1.56 ± 0.85) compared to left renal arteries (1.09 ± 0.87) (P 0.001). Medial (1.30 ± 0.59) and distal (1.39 ± 0.62) innervation was higher than the proximal (1.17 ± 0.55) segments (p 0.001). When divided in quadrants, the anterior (1.52 ± 0.96) and superior (1.71 ± 0.89) segments were more innervated compared to posterior (0.96 ± 0.72) and inferior (0.90 ± 0.68) segments (P 0.001).That the right renal artery has significantly higher innervation scores than the left. The anterior and superior quadrants of the renal arteries scored higher in innervation than the posterior and inferior quadrants did. The distal third of the renal arteries are more innervated than the more proximal segments. These findings warrant further evaluation of the spatial innervation patterns of the renal artery in order to understand how it may enhance catheter-based renal arterial denervation procedural strategy and outcomes.The SYMPLICITY HTN-3 study dealt a blow to the idea of the catheter-based renal arterial sympathetic denervation. We investigated the location and patterns of periarterial renal nerves in cadaveric human renal arteries. To quantify the density of the renal nerves we created a novel innervation score. On average the right renal arteries were significantly more densely innervated than the left renal arteries, the anterior and superior segments were significantly more innervated compared to the posterior and inferior segments, absolute innervation scores in the proximal third of the left or right renal arteries were always lower when compared to distal segments. These findings may enhance catheter-based renal arterial denervation procedural strategy and outcomes.

We describe a case of Takotsubo cardiomyopathy in a 75-year-old woman after an elective extraction of 10 teeth of the lower jaw using bilateral mandibular anesthesia. The patient complained of shortness of breath and chest pain after 24h. Coronary angiography showed smooth normal coronary arteries with thrombolysis in myocardial infarction III flow. Left ventriculography demonstrated apical ballooning. Three months later, the patient is symptom-free, with normal left ventricular function. We assume that the complex and robust procedures in dentistry together with a systemic absorption of epinephrine are sufficient triggers for the development of Takotsubo cardiomyopathy. In our case, we advocate an external catecholamine exposure rather than an internal catecholamine excess. We need more vigilance when assessing such patients. Learning objective: We describe a stress-induced cardiomyopathy with late symptom development despite an uncomplicated tooth extraction. There was only one case of Takotsubo cardiomyopathy with acute symptoms described in the literature, although after complicated tooth extraction. It could be interesting for physicians that the complex and robust procedures in dentistry together with a systemic absorption of epinephrine are sufficient triggers for the development of Takotsubo cardiomyopathy.>

Background— Cinaciguat (BAY 58–2667) is the first of a new class of soluble guanylate cyclase activators in clinical development for acute decompensated heart failure. We aimed to assess the hemodynamic effects, safety, and tolerability of intravenous cinaciguat in patients with acute decompensated heart failure (pulmonary capillary wedge pressure ≥18 mm Hg). Methods and Results— After initial dose finding (part A; n=27), cinaciguat was evaluated in the nonrandomized, uncontrolled proof-of-concept part of the study (part B; n=33) using a starting dose of 100 μg/h, which could be titrated depending on hemodynamic response. Patients were categorized as responders if their pulmonary capillary wedge pressure decreased by ≥4 mm Hg compared with baseline. Final doses of cinaciguat after 6 hours of infusion in part B were 50 μg/h (n=2), 200 μg/h (n=12), and 400 μg/h (n=16). Compared with baseline, a 6-hour infusion of cinaciguat led to significant reductions in pulmonary capillary wedge pressure (−7.9 mm Hg), mean right atrial pressure (−2.9 mm Hg), mean pulmonary artery pressure (−6.5 mm Hg), pulmonary vascular resistance (−43.4 dynes · s · cm −5 ), and systemic vascular resistance (−597 dynes · s · cm −5 ), while increasing heart rate by 4.4 bpm and cardiac output by 1.68 L/min. The responder rate was 53% after 2 hours, 83% after 4 hours, and 90% after 6 hours. Cinaciguat was well tolerated, with 13 of 60 patients reporting 14 drug-related treatment-emergent adverse events of mild to moderate intensity, most commonly hypotension. Conclusions— Cinaciguat has potent preload- and afterload-reducing effects, increasing cardiac output. Further investigation of cinaciguat for acute decompensated heart failure is warranted.

Transapical transcatheter aortic valve implantation (TA-TAVI) is the method of choice in patients with severe stenosis of the aortic valve, high operative risk, and an adverse peripheral vasculature. The procedure is generally guided by peripheral arterial access angiography. We report on a 71-year-old patient in whom, because of the absence of an alternative peripheral arterial access route, TA-TAVI was supported by the apical insertion of the angiography catheter. This approach was effective and safe, and proper valve deployment was feasible without unexpected procedural complications.

Objectives Postimplantation right ventricular dysfunction is associated with increased morbidity and mortality in ventricular assist device (VAD) recipients. This study aimed to determine the preoperative risk factors for severe right heart failure needing biventricular mechanical circulatory support in children with end-stage heart failure. Methods We reviewed data from 84 children supported with long-term VADs at the German Heart Institute Berlin between January 1999 and October 2010. Right ventricular assist device (RVAD) support was needed for 24 (29%) patients, and the other 60 (71%) were implanted with left ventricular assist devices (LVADs). Results The median age at implantation was 7 years (12 days-18 years), and the median support time was 41 days (1-432 days). Of the 84 patients, the overall survival to transplantation or recovery of ventricular function was 69%. Compared with children implanted with LVAD, patients receiving biventricular support had significantly higher postoperative mortality (P = 0.04). The multivariate logistic regression indicated that decreased milrinone use was the only preoperative factor independently associated with increased requirement for biventricular support (odds ratio: 0.1, 95% confidence interval: 0.04-0.64, P = 0.01). Children treated with milrinone preoperatively showed improved survival after implantation (P = 0.04). Conclusions Paediatric patients needing biventricular support had significantly higher postoperative mortality. Preoperative milrinone use might decrease the risk of severe right ventricular failure requiring additional RVAD insertion and improve postimplantation survival in children with advanced heart failure.

Objective: Although the ventricular assist device (VAD) has been a well-established therapy for larger adolescents and adult patients with advanced heart failure, current experience with the use of VAD for mechanical circulatory support in infants and young children with small body surface area is still limited. Methods: Between January 1999 and December 2009, 56 small children with body surface area < 1.2 m 2 were implanted with Berlin Heart EXCOR pediatric VAD in Germany Heart Institute Berlin. The etiology of end-stage myocardial failure included noncongenital (75%) and congenital heart disease (25%); the median age at implant was 1 year (12 days to 14 years), and the median support time was 55 days (1—432 days). Results: Of the 56 pediatric patients, 24 were bridged to heart transplantation, 12 were explanted following myocardial recovery, two continued to receive support, and the other 18 died on support. The accurate rate of survival on VAD support was 81.1% 5.8% and 51.4% 9.3% at 30 days and 1 year after EXCOR implantation. Patients receiving biventricular support had a trend towards higher postimplantation mortality as compared with children implanted with left ventricular assist device (LVAD) (P = 0.09). Lower post-implantation survival was also observed in patients with congenital cardiac disease compared with children with a non-congenital etiology (P < 0.001). Conclusions: Berlin Heart EXCOR pediatric VAD could provide satisfactory and safe circulatory support for small children with end-stage heart disease.

Sternal contact of aortic aneurysms in redo operations may require specific techniques to safely control bleeding during sternotomy and surgical dissection. This is the first report on the preoperative use of an inflatable balloon to prevent massive hemorrhage by inserting the balloon--a procedure performed in the cardiac catheterization laboratory--before rethoracotomy. A false ascending aortic aneurysm was successfully sealed by transaortic wire-guided balloon placement from the iliac artery. Gentle traction on the inflated balloon catheter, which was placed inside the false aneurysm, effectively sealed the entrance to the aneurysm. A straightforward median redo sternotomy procedure was subsequently performed without blood loss from the unavoidably opened aneurysm. My colleagues and I propose this technique for aneurysms of mycotic or anastomotic origin, which have an anatomically distinct entry channel.

Objectives This study aimed to determine the pre-implantation predictors for in-hospital mortality in children with ventricular assist device (VAD) support. Background Candidate selection is of critical importance for improved outcomes in patients supported with VAD. However, risk factors for post-VAD survival in children are still not clearly understood. Methods From June 1996 to December 2009, 92 children underwent implantation of a long-term VAD at Germany Heart Institute Berlin. Data on all these patients were retrospectively analyzed, and pre-operative risk factors for in-hospital survival after VAD implantation were identified by multivariate logistic regression. Results Of the 92 subjects, the median age at implantation was 7 years (range 12 days to 18 years), and the median support time was 35 days (range 1 to 591 days). The overall survival rate to transplantation or recovery of ventricular function was 63%. Independent predictors of in-hospital mortality in children included congenital etiology (odds ratio [OR]: 11.2; 95% confidence interval [CI]: 2.6 to 47.5), norepinephrine requirement (OR: 6.9; 95% CI: 1.4 to 31), C-reactive protein level >6.3 mg/dl (OR: 4.9; 95% CI: 1.1 to 22.1), and central venous pressure >17 mm Hg (OR: 4.6; 95% CI: 1.1 to 20). Conclusions Congenital etiology, pre-operative norepinephrine requirement, higher serum C-reactive protein, and central venous pressure were associated with increased in-hospital mortality in children with VAD support. Optimal candidate selection and timing of VAD insertion may be of great importance for improved outcomes in children with advanced heart failure.