Introduction and objectives: Advances made in transcatheter aortic valve implantation (TAVI) valvular technology have resulted in better outcomes and fewer complications compared with older ...generations. We studied the rate and determinants of paravalvular leak (PVL) using Evolut PRO vs SAPIEN 3 valves as well as other perioperative and in-hospital outcomes.
Methods: A total of 110 consecutive patients with severe aortic stenosis scheduled for transfemoral TAVI were randomly selected to receive the SAPIEN 3 (N = 59) or the Evolut PRO valve (N = 51). Annular dimensions were determined by transesophageal echocardiography guided balloon sizing. The following postoperative and in-hospital endpoints were assessed: PVL, conduction defects, valve embolization, need for a second valve, annular rupture, stroke, vascular complications, acute kidney injury, and in-hospital mortality. We also studied the possible anatomical determinants of PVL.
Results: There were no relevant baseline differences between the 2 groups regarding clinical and echocardiographic characteristics. In-hospital complications were comparable between both valves apart from a significantly higher rate of immediate postoperative PVL and at discharge (≥ grade II) between the Evolut PRO and the SAPIEN 3 valves (19.6% vs 6.8%) and (5.9% vs 1.7%), respectively. Of the anatomical variables described, the left ventricular outflow tract/ascending aorta angle, aortic angulation, and calcification had a significant impact on PVL in the Evolut PRO valves. The left ventricular outflow tract/ascending aorta angle revealed a negative correlation with implantation depth in the Evolut PRO valves but not in the SAPIEN 3 ones.
Conclusions: Both valves demonstrated favorable comparable outcomes except for a significantly higher rate of PVL in patients implanted with Evolut PRO valves.
Introducción y objetivos: Los avances en la tecnología de implante percutáneo de válvula aórtica (TAVI) han dado lugar a mejores resultados y menos complicaciones en comparación con las generaciones anteriores. Se estudió la incidencia y los determinantes de las fugas periprotésicas (FPP) con las válvulas Evolut PRO y SAPIEN 3, así como otros resultados periprocedimiento y hospitalarios.
Métodos: Se seleccionó aleatoriamente a 110 pacientes consecutivos con estenosis aórtica grave programados para TAVI transfemoral para recibir una válvula SAPIEN 3 (n = 59) o una Evolut PRO (n = 51). Las dimensiones anulares se determinaron mediante el dimensionamiento del balón guiado por ecocardiografía transesofágica. Tras el procedimiento y durante la hospitalización se evaluaron los siguientes objetivos: FPV, defectos de conducción, embolización de la válvula, necesidad de una segunda válvula, rotura anular, accidente vascular cerebral, complicaciones vasculares, daño renal agudo y mortalidad intrahospitalaria. También se estudiaron los posibles determinantes anatómicos de la FPV.
Resultados: No hubo diferencias basales relevantes entre los 2 grupos en cuanto a las características clínicas y ecocardiográficas. Las complicaciones intrahospitalarias fueron comparables entre ambos tipos de válvulas, excepto una incidencia significativamente mayor de FPV (de grado II o superior) inmediata tras el procedimiento y al alta con las válvulas Evolut PRO en comparación con las SAPIEN 3 (19,6 frente a 6,8% y 5,9 frente a 1,7%, respectivamente). De las variables anatómicas, el ángulo entre el tracto de salida del ventrículo izquierdo y la aorta ascendente, la angulación aórtica y la calcificación tuvieron un impacto significativo en la FPV en las válvulas Evolut PRO. El ángulo entre el tracto de salida del ventrículo izquierdo y la aorta ascendente tuvo una correlación negativa con la profundidad de implantación en las válvulas Evolut PRO, pero no en las válvulas SAPIEN 3.
Conclusiones: Ambas válvulas demostraron resultados favorables comparables, excepto por una incidencia significativamente mayor de FPV en los pacientes con válvulas Evolut PRO.
ABSTRACT Introduction and objectives: Advances made in transcatheter aortic valve implantation (TAVI) valvular technology have resulted in better outcomes and fewer complications compared with older ...generations. We studied the rate and determinants of paravalvular leak (PVL) using Evolut PRO vs SAPIEN 3 valves as well as other perioperative and in-hospital outcomes. Methods: A total of 110 consecutive patients with severe aortic stenosis scheduled for transfemoral TAVI were randomly selected to receive the SAPIEN 3 (N = 59) or the Evolut PRO valve (N = 51). Annular dimensions were determined++ by transesophageal echocardiography guided balloon sizing. The following postoperative and in-hospital endpoints were assessed: PVL, conduction defects, valve embolization, need for a second valve, annular rupture, stroke, vascular complications, acute kidney injury, and in-hospital mortality. We also studied the possible anatomical determinants of PVL. Results: There were no relevant baseline differences between the 2 groups regarding clinical and echocardiographic characteristics. In-hospital complications were comparable between both valves apart from a significantly higher rate of immediate postoperative PVL and at discharge (≥ grade II) between the Evolut PRO and the SAPIEN 3 valves (19.6% vs 6.8%) and (5.9% vs 1.7%), respectively. Of the anatomical variables described, the left ventricular outflow tract/ascending aorta angle, aortic angulation, and calcification had a significant impact on PVL in the Evolut PRO valves. The left ventricular outflow tract/ascending aorta angle revealed a negative correlation with implantation depth in the Evolut PRO valves but not in the SAPIEN 3 ones. Conclusions: Both valves demonstrated favorable comparable outcomes except for a significantly higher rate of PVL in patients implanted with Evolut PRO valves.
Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR ...may play a key strategy in treating patients in whom THVs fail.
The authors sought to examine outcomes following redo-TAVR.
The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.
Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke 1.4%, 7 valve malposition 3.3%, 2 coronary obstruction 0.9%, 20 new permanent pacemaker 9.6%, no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.
Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.
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Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The ...choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.
The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).
Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.
For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm
vs. 1.37 ± 0.5 cm
; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).
In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
Background
Although there is a trend toward direct transcatheter aortic valve implantation (TAVI), still balloon predilatation is necessary in some cases, especially in patients with severe ...calcification. However, predilatation including rapid ventricular pacing may have adverse outcomes, especially in patients with reduced ejection factor (EF).
Objective
To evaluate the impact of predilatation on in-hospital outcomes in patients with reduced versus preserved EF underwent TAVI.
Methods
This was a prospective observational study including 110 patients (72 patients with preserved EF (≥50%) and 38 patients with reduced EF (<50%)) who underwent TAVI. The two groups were compared regarding in-hospital outcomes.
Results
Predilatation was done routinely in all 110 patients. The mean age was significantly higher in patients with preserved EF (82.76 ± 5.74 vs. 80.13 ± 6.51 years; p = 0.03). The majority (51.4%) of patients with preserved EF were females but the majority (73.7%) of those with reduced EF were males (P < 0.001). Predilatation showed no statistical difference regarding in-hospital mortality (2.6% vs. 1.4%; p = 0.29), hemodynamic instability (5.3% vs. 0.0%; p = 0.11), stroke (0% vs. 1.4%; p = 0.67), conduction defects (13.2% vs. 19.4%; p = 0.29), permanent pacemaker implantation (7.9% vs. 5.5%; p = 0.45), paravalvular leakage (5.3% vs. 2.8%; p = 0.42), vascular complications (7.9% vs. 11.1%; p = 0.43), and acute kidney injury (7.9% vs. 7%; p = 0.4) in patients with reduced versus preserved EF, respectively.
Conclusion
When balloon predilatation is inevitable during TAVI it is safe in patients with reduced as well as preserved EF with no added risk of hemodynamic instability or other outcomes.
DLC coatings, with properties like high wear resistance, corrosion protection and low friction coefficient under unlubricated conditions, are becoming more and more popular in different fields every ...year, and offer a wide application spectrum in many industrial areas. A new approach is the deposition of thick DLC films with thickness up to 55μm. With this level of thickness, it is possible to create interesting tribological systems with high mechanical load carrying capacity even on softer steels, which are used in general engineering. However, under lubricated conditions, DLC films can show very different behavior compared to dry conditions. In this work three different DLC coatings were investigated. A “Hard” and a “Soft” coating, as well as a Multilayer DLC film. As substrate material, samples of steel grade 4140 were used. In order to determine the influence of the surface condition, each coating was deposited on a rough (sandblasted) and a polished substrate. The friction coefficient (COF) was determined by a pin-on-disc tribometer with a 100Cr6 (AISI 52100) ball counterpart and a sliding distance of 2000m. In addition, the wear track and the surface defects were investigated by confocal microscopy. The used lubricants were water and engine oil.
The experiments showed that under same tribological parameters all lubricated DLC coatings on polished samples suffered under strong fatigue wear on the surface. By using thick coatings, it could be realised that this is not caused by an adhesion problem, because the resulting defects do not reach the steel interface. Fatigue wear was found for lubrication with oil as well as for lubrication with water. In contrast DLC coated rough surfaces showed no fatigue wear, also under lubricated condition. By using rough DLC coatings the wear of the counterpart is obviously remarkable increased. If the tribological experiments were done under excessive use of oil (not on a thin oil film), no fatigue wear on the surface could be found as well. On smooth surfaces the adhesion forces caused by the thin oil or water film seem to be responsible for the observed fatigue wear defects. It is also shown that with a special topography of the DLC coating fatigue wear under slightly lubricated condition can be eliminated and simultaneously the wear of the counterpart can be kept very low.
•Fatigue wear on lubricated DLC coatings is found during pin-on-disc tribology tests•The use of thick DLC coatings showed, that former results regarding coating damage were misinterpreted as adhesion problems•A way for surface modification is proposed to prevent fatigue wear in lubricated sliding contacts
In many cases the lifetime of technical structures and components is depending on the behaviour of cracks. Due to the complex geometry and loading situation in real-world structures cracks are often ...subjected to a superposition of normal, in-plane and out-of-plane loading. In this paper a new criterion for 3D crack growth under multiaxial loading, that means superposition of the fracture modes Mode I, II and III, is described. The criterion allows the prediction of three-dimensional crack surfaces advancing from arbitrary 3D crack fronts with the help of the two deflection angles φ0 and ψ0. The underlying theory for the development of this new criterion is described in detail.
Buried bumper syndrome (BBS) is a rare adverse event of PEG tubes. This study compared the newly developed Flamingo device (Fujifilm Medwork GmbH, Höchstadt, Germany) with conventional endoscopic ...techniques for BBS treatment.
This prospective, randomized controlled trial compared the Flamingo set (study group) with other endoscopic techniques (control group) for BBS treatment in 6 German hospitals. The primary endpoint was procedure time. Further outcome parameters were technical success, adverse event rate, and number and cost of devices used in each group.
Thirty-six patients (18 in each group; mean age, 73 years; 12 women) were included in this study between March 2018 and December 2022. Median time since placement of the feeding tube was 30 months. The bumper was located in the gastric corpus in 27 patients, and the internal bumper was completely overgrown in 31 patients. The duration of the removal procedure was 17 minutes (range, 3-72) in the study group compared with 38 minutes (range, 12-111) in the control group (P = .046). The primary technical success rate was 77.8% in the study group and 55.6% in the control group (P = .157), whereas the overall technical success rate was 100% compared with 83.3% (P = .070). Adverse events occurred in 4 patients (11.1%).
Endoscopic removal of the buried bumper using the Flamingo device was significantly faster than that with other endoscopic techniques and showed a higher technical success rate. This device may become the endoscopic treatment of choice for BBS. (Clinical trial registration number: NCT03186066.).
Aim:
Self-monitoring of blood glucose (BG) by means of handheld BG systems is a cornerstone in diabetes therapy. The aim of this article is to describe a procedure with proven traceability for ...calibration and evaluation of BG systems to guarantee reliable BG measurements.
Methods:
Isotope dilution gas chromatography mass spectrometry (ID/GC/MS) is a method that fulfills all requirements to be used in a higher-order reference measurement procedure. However, this method is not applicable for routine measurements because of the time-consuming sample preparation. A hexokinase method with perchloric acid (PCA) sample pretreatment is used in a measurement procedure for such purposes. This method is directly linked to the ID/GC/MS method by calibration with a glucose solution that has an ID/GC/MS-determined target value. BG systems are calibrated with whole blood samples. The glucose levels in such samples are analyzed by this ID/GC/MS-linked hexokinase method to establish traceability to higher-order reference material.
Results:
For method comparison, the glucose concentrations in 577 whole blood samples were measured using the PCA-hexokinase method and the ID/GC/MS method; this resulted in a mean deviation of 0.1%. The mean deviation between BG levels measured in >500 valid whole blood samples with BG systems and the ID/GC/MS was 1.1%.
Conclusions:
BG systems allow a reliable glucose measurement if a true reference measurement procedure, with a noninterrupted traceability chain using ID/GC/MS linked hexokinase method for calibration of BG systems, is implemented. Systems should be calibrated by means of a traceable and defined measurement procedure to avoid bias.
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