Sliding behaviour and surface quality after static air polishing of conventional and modern bracket materials : In vitro analysis.

OBJECTIVES: As part of orthodontic treatment, air polishing is routinely used for professional tooth cleaning. Thus, we investigated the effects of static powder polishing on sliding behaviour and surface quality of three different bracket materials (polymer, ceramic, metal), including a 3D-printed bracket. METHODS: Two bracket types of each material group were polished with an air-polishing device using sodium bicarbonate. Exposure times were set at 10, 20, and 60 s; the application distance was 5 mm. The force loss due to sliding resistance was tested with an orthodontic measurement and simulation system (OMSS) using a 0.016 inchâ€¯× 0.022 inch stainless steel archwire. Untreated brackets served as control. Polishing effects and slot precision were evaluated using an optical digital and scanning electron microscope. RESULTS: Sliding behaviour and slot precision differed significantly between and within the groups. Prior to polishing, polymer brackets showed the least force loss, ceramic brackets the highest. With progressive polishing time, the resistance increased significantly with titanium brackets (26 to 37%) and decreased significantly with steel brackets (36 to 25%). Polymer brackets showed the smallest changes in force loss with respect to polishing duration. Slot precision showed the largest differences between material groups and was primarily manufacturer-dependent with hardly any changes due to the polishing time. CONCLUSION: Powder polishing can positively or negatively affect the sliding properties of the bracket-archwire complex but is more dependent on the bracket-archwire material combination (i.e., manufacture-dependent slot precision). For titanium brackets, resistance only increased after 60 s of polishing. For ceramic brackets, effective reduction was observed after 10 s of polishing. Polymer brackets, including the 3D-printed brackets, showed better sliding properties than ceramic or metal brackets even after polishing for 60 s. Removal of plaque and dental calculus should lead to a noticeable improvement of the sliding properties and outweighs structural defects that may develop.

Ghost Ileostomy: Safe and Cost-effective Alternative to Ileostomy After Rectal Resection for Deep Infiltrating Endometriosis.

BACKGROUND/AIM: Endometriosis infiltrating the rectum often requires resection with a protecting stoma. A ghost ileostomy (GI) is an alternative to prevent the psychological burden for the young women affected. The present study evaluated the safety and cost-effectiveness of the ghost ileostomy (GI) procedure in a group of patients after rectal resection for deep infiltrating endometriosis. PATIENTS AND METHODS: The prospective controlled interventional trial was conducted in 54 consecutive patients with deep infiltrating endometriosis of the rectum. GI was considered after ultra-low resection with primary anastomosis, previous colorectal anastomosis, or pelvic redo surgery. Loop ileostomy (LI) was performed after simultaneous colpotomy with suture, only. Operating time, morbidity according to the Clavien-Dindo classification (CDC), duration of hospital stay, and patient satisfaction were obtained. Individual costs were estimated for the endometriosis procedure with or without a GI or LI, including stoma supply and closure expenses. RESULTS: Of the 54 patients, 27 received GI (50%), whereas 4 underwent LI (7%). The remaining 23 patients received no outlet (NO). The complication rate did not differ among the GI, LI, and NO groups. Two cases were re-operated and required a diverting stoma, one in the GI and the NO group each. The additional healthcare expenses for each patient receiving a LI averaged 6,000 €. The patients were very satisfied with the option of a GI. CONCLUSION: GI is a cost-effective and safe alternative to LI after rectal resection for deep infiltrating endometriosis in cases where it is required. The individual costs per patient were reduced substantially, with a cumulative savings of 160,000 € in healthcare expenditure. Additionally, the method clearly lowers the psychological burden on the young women concerned.

Bisphenol A-Related Effects on Bone Morphology and Biomechanical Properties in an Animal Model.

Bisphenol A (BPA), which is contained in numerous plastic products, is known to act as an endocrine-disruptive, toxic, and carcinogenic chemical. This experimental series sought to determine the influence of BPA exposure on the femoral bone architecture and biomechanical properties of male and female Wistar rats. BPA was applied subcutaneously by using osmotic pumps. After 12 weeks, the bones were analyzed by micro-computed tomography (micro-CT) and a three-point bending test. Comparing the female low- and high-dose groups, a significantly greater marrow area (p = 0.047) was identified in the group exposed to a higher BPA concentration. In addition, the trabecular number tended to be higher in the female high-dose group when compared to the low-dose group (p > 0.05). The area moment of inertia also tended to be higher in the male high-dose group when compared to the male low-dose group (p > 0.05). Considering our results, BPA-related effects on the bone morphology in female Wistar rats are osteoanabolic after high-dose exposure, while, in male rats, a tendency toward negative effects on the bone morphology in terms of a reduced cross-sectional cortical area and total area could be demonstrated.

Comparative in vitro analysis of the sliding resistance of a modern 3D-printed polymer bracket in combination with different archwire types.

OBJECTIVES: To analyse the sliding resistance of a modern 3D-printed polymer bracket combined with different archwire types and to compare the results with conventionally used polymeric, ceramic and metal brackets. It was of further interest which bracket-archwire combination could be best qualified for clinical use. MATERIALS AND METHODS: The sliding behaviour was tested using an orthodontic measurement and simulation system (OMSS) for the use of two bracket types of the polymer, ceramic and metal group in combination with a 0.016 inch × 0.022 inch and 0.017 inch × 0.025 inch archwire of nickel-titanium (NiTi), titanium-molybdenum alloy (TMA) and stainless steel. Six bracket types were combined with six different archwire types and compared to each other. RESULTS: The sliding resistance showed significant differences between various the bracket-archwire complexes. The combination of 3D-printed polymer brackets with both steel archwire cross-sections showed the least values of sliding resistance (average 23-29%), while the combination of ceramic brackets with TMA archwires presented the highest (average 47%). CONCLUSIONS: The present study could show that modern 3D-printed bracket materials can have similar or even better mechanical properties than conventional ones regarding sliding resistance. Although the combination of bracket and archwire material is decisive for low sliding resistance values, the selection of the bracket material seems to have a greater influence than the selection of the archwire material or its cross section. CLINICAL RELEVANCE: It might be possible in future to combine aesthetic and biomechanical requirements for aesthetic brackets by using 3D-printing technology.

Impact of demographic and perioperative risk factors on complication rates in skin-sparing/nipple-sparing mastectomy with implant-based reconstruction using titanized polypropylene mesh (TiLOOP® Bra).

BACKGROUND: Skin/nipple-sparing mastectomies (SSM/NSSM) have been reported to have acceptable complication rates and good aesthetic outcomes with high patient satisfaction. However, in this relatively young and rapidly expanding field of reconstructive plastic surgery, differences in perioperative management are noted between breast centers. Prospective studies of complication rates using a titanized polypropylene mesh (TiLOOP® Bra) are currently lacking. METHODS: A prospective subgroup analysis was performed based on the data set of the prospective, single-arm, multicenter observational study (PRO-BRA). Early complication rates after skin/nipple-sparing mastectomy with implant-based immediate or secondary reconstruction using a titanized polypropylene mesh (TiLOOP® Bra) subpectorally were investigated in relation to demographic factors, as well as intra-and postoperative management. The subgroup consists of 258 patients. Complications were categorised into necrosis, infection, postoperative bleeding or hematoma, seroma, wound healing delays and R1-situations. RESULTS: Early complication rates of SSM/NSSM using titanium-based meshes are comparable to complication-rates using ADM's. Logistic regression shows significantly higher risk for wound healing delays, necrosis and seroma with increasing BMI, abladat- and implant-weight (OR 1,17 -1,66, p-value < 0,001). Smokers have significantly higher necrosis rates (20.7%) compared to non-smokers (5.5%) (p-value = 0.002). Discharge with drainage results in a trend toward higher rates of wound healing complications. CONCLUSION: The use of TiLOOP® Bra meshes was shown to have acceptable complication rates. Complication rates depend on certain demographic and intraoperative risk factors and should be considered in indications and information of patients.

Transcatheter Aortic Valve Implantation in Patients Who Cannot Undergo Transfemoral Access.

INTRODUCTION: Though transfemoral (TF) access has emerged as a gold standard access for patients with aortic stenosis who undergo transcatheter aortic valve implantation (TAVI), there has been no study that has characterized patients who cannot undergo TF access in detail. We aim to evaluate the contraindications for TF access, their incidence, classify them, and provide the outcomes of patients who failed to be TF candidates. METHODS: From 925 patients who underwent TAVI between February 2014 and May 2020 at our heart center, 130 patients failed to be TF candidates and underwent transapical-transcatheter aortic valve implantation (TA-TAVI). In this study, we included all those patients who failed to be TF candidates and underwent TA-TAVI using the third-generation balloon expandable valve (Edwards SAPIEN 3 valve [S3]) (116 patients; STS score 6.07 ± 4.4; age 79.4 ± 7). RESULTS: The incidence of patients unsuitable for TF access at our heart center was 14%. We classified this TAVI population into absolute contraindication for TF access n = 84 (72.5%) and increased interventional risk for TF access n = 32 (27.5%). After TA-TAVI of this specific population using S3, the in-hospital mortality and stroke were 1.7 and 1.7%, respectively. The vascular injury rate was 1.7%. We registered no paravalvular leakage ≥2. The pacemaker rate was 7.4%. The mean transvalvular pressure gradient was 8.7 mm Hg. CONCLUSION: The incidence of patients who cannot undergo TF access or who are at high interventional risk is considerably high. TA-TAVI, supported with sufficient interventional experience and appropriate valve system, represents an excellent alternative for patients with distinct vasculopathy.

Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial.

BACKGROUND: Intrathoracic anastomotic leaks represent a major complication after Ivor Lewis esophagectomy. There are two promising endoscopic treatment strategies in the case of leaks: the placement of self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT). Up to date, there is no prospective data concerning the optimal endoscopic treatment strategy. This is a protocol description for the ESOLEAK trial, which is a first small phase 2 randomized trial evaluating the quality of life after treatment of anastomotic leaks by either SEMS placement or EVT. METHODS: This phase 2 randomized trial will be conducted at two German tertiary medical centers and include a total of 40 patients within 2 years. Adult patients with histologically confirmed esophageal cancer, who have undergone Ivor Lewis esophagectomy and show an esophagogastric anastomotic leak on endoscopy or present with typical clinical signs linked to an anastomotic leak, will be included in our study taking into consideration the exclusion criteria. After endoscopic verification of the anastomotic leak, patients will be randomized in a 1:1 ratio into two treatment groups. The intervention group will receive EVT whereas the control group will be treated with SEMS. The primary endpoint of this study is the subjective quality of life assessed by the patient using a systematic and validated questionnaire (EORTC QLQ C30, EORTC QLQ-OES18 questionnaire). Important secondary endpoints are healing rate, period of hospitalization, treatment-related complications, and overall mortality. DISCUSSION: The latest meta-analysis comparing implantation of SEMS with EVT in the treatment of esophageal anastomotic leaks suggested a higher success rate for EVT. The ESOLEAK trial is the first study comparing both treatments in a prospective manner. The aim of the trial is to find suitable endpoints for the treatment of anastomotic leaks as well as to enable an adequate sample size calculation and evaluate the feasibility of future interventional trials. Due to the exploratory design of this pilot study, the sample size is too small to answer the question, whether EVT or SEMS implantation represents the superior treatment strategy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03962244 . Registered on May 23, 2019. DRKS-ID DRKS00007941.

Impact of diverse aortic pathologies on outcomes after transapical transcatheter aortic valve replacement.

OBJECTIVES: Some patients who undergo transcatheter aortic valve replacement (TAVR) have a concomitant diverse aortic pathologies (AP). They are usually considered high-risk candidates for the procedure and require further assessment to determine the best vascular approach. The impact of these AP on TAVR is not well known as the information is scarce. We aimed to evaluate midterm clinical impact of different AP after transapical (TA)-TAVR. METHODS: Twenty patients with atherosclerotic/occluding aortic diseases (A/OAD) (porcelain aorta, Leriche Syndrome, penetrating aortic ulcer, and aortic thrombus), 24 patients with aortic morphologic diseases (AMD) (thoracic/abdominal aortic aneurysms, aortic kinking, aortic type B dissection, aortic elongation/tortuosity, and previous aortic intervention), and 11 patients with combined aortic diseases (CAD) underwent TA-TAVR treatment between January 2011 and November 2019 at our center. We conducted up to 5-years clinical follow-up. RESULTS: All patients were classified in the heart team as a high interventional risk. The 30-day mortality and stroke were 5% and 10% in the A/OAD, 8.3% and 0% in the AMD, and 0% and 0% in the CAD, respectively. The median time of freedom from a composite of death and cardio-cerebral adverse events was 22.1 months [95% confidence interval [CI]: 9.9-34.3] in A/OAD versus 34.3 months [95% CI: 15.6-53] in AMD versus 17 months [95% CI: 0-39.4] in CAD; p = .525. We registered neither procedural aortic injury nor aortic syndrome at follow-up. The moderate/severe paravalvular leakage rates were 5%, 0% and 0% in the A/OAD, AMD and CAD, respectively. CONCLUSION: Independent of underlying AP, the TA-TAVR is a safe method and shows very promising early and midterm outcomes in patients with various AP.

Transapical transcatheter aortic valve implantation in patients with aortic diseases.

OBJECTIVES: Patients scheduled for transcatheter aortic valve implantation (TAVI) treatment frequently present with concomitant aortic diseases, in which case they are usually considered to be at high interventional risk and, in particular, unable to undergo the transfemoral TAVI approach. Since the establishment of the 'transfemoral first' strategy for TAVI, there has been an evidence gap with regard to the outcomes of such patients. We aimed to evaluate the mid-term outcomes after transapical TAVI in patients with diverse aortic diseases. METHODS: Fifty-five consecutive elderly patients (78.4 years; standard deviation: 8.6 years) at intermediate surgical risk with severe aortic stenosis and aortic diseases (porcelain aorta 36%, ascending aneurysm 15%, descending aneurysm 26%, type-B dissection 4%, aortic thrombus 7%, Leriche syndrome 4%, aortic kinking 11%, aortic ulcer 2%, previous aortic operation 20%, aortic elongation/tortuosity 4%) underwent transapical TAVI treatment between January 2011 and November 2019 at our institution. We used the second-and third-generation self- and balloon-expanding valves. The follow-up time was 92.6 patient-years. RESULTS: The Society of Thoracic Surgery-Predicted Risk of Mortality score was 7% (standard deviation: 4%). The 30-day mortality and all-stroke rates were 6% and 4%, respectively. The median survival time was 24.9 months (95% confidence interval 17.6-32.3). The median time of freedom from a composite of death and cardio-cerebral adverse events was 24.3 months (95% confidence interval 11.9-36.8). The rate of moderate/severe paravalvular leakage was 2%. The pacemaker rate was 10%. No early or late aortic syndrome occurred. CONCLUSIONS: Transapical TAVI is a safe method and shows very promising early and mid-term outcomes, without early/late aortic syndrome, in patients with aortic diseases for whom transfemoral TAVI as the first-line transcatheter method might be contraindicated or not feasible.

Transcatheter aortic valve replacement using the SAPIEN 3 valve versus surgical aortic valve replacement using the rapid deployment INTUITY valve: Midterm outcomes.

OBJECTIVES: Little data have been published on the midterm effect of transapical/transfemoral-transcatheter aortic valve replacement (TA-/TF-TAVR) using the Edwards SAPIEN 3 valve (S3). We aimed to compare the outcomes after TA-/TF-TAVR utilizing the S3 (TA-/TF-S3) valve with those after surgical aortic valve replacement utilizing the rapid deployment Edwards INTUITY valve (RD-SAVR). METHODS: Between March 2012 and April 2018, 122 patients with aortic stenosis underwent TA-S3, 77 patients underwent TF-S3 and 182 patients underwent RD-SAVR through partial sternotomy at our institution. We conducted clinical and echocardiographic midterm follow-ups. The primary outcomes of the study were the incidence of new pacemakers permanent pacemaker implantation (PPI), the occurrence of paravalvular leakage (PVL) and the hemodynamic performance of the valves. RESULTS: All study groups were at intermediate surgical risk. The 30-day all-cause mortality and stroke rates in the TA-S3, TF-S3, and RD-SAVR groups were 4.1% and 1.6%, 3.9% and 2.6%, and 3.8% and 2.2%, respectively. The RD-SAVR group had significantly smaller PVL and PPI rates than did the TA-/TF-S3 group (p < .0001). At the discharge, the one-year postprocedure mean gradients were 9 ± 5.1/10 ± 4.5 mmHg, 11 ± 4.1/12 ± 3.8 mmHg, and 10.1 ± 4.3/10.4 ± 2.6 mmHg in the TA-S3, TF-S3, and RD-SAVR groups, respectively. Midterm valve thrombosis, Re-TAVR/SVAR were low and similar among the study groups, whereas endocarditis was higher in the TAVR group. CONCLUSION: RD-SAVR was superior to TA-/TF-S3 in the PVL and PPI rates. We observed similar early outcomes and valve hemodynamics. The endocarditis was higher in the TAVR group.

Subaxial Cervical Spine Injury in the Elderly and Treatment-Related Mortality - Anterior or Posterior Approach. / Subaxiale Halswirbelsäulenverletzungen des alten Menschen und therapiebedingte Mortalität ­ sind ventrale oder dorsale Operationsverfahren besser?

BACKGROUND: Subaxial cervical spine injury especially in the elderly can be associated to severe complications and disability. Until today there is no consensus concerning the best operative treatment. A potential superiority of anterior or posterior fixation is the subject of controversial discussions. OBJECTIVES: The aim of this study was to compare the outcome of anterior and posterior fixation after subaxial cervical spine trauma in the elderly focussing on the postoperative mortality. MATERIAL AND METHODS: A retrospective cohort analysis was performed to analyse the data of 43 patients. Especially mortality data were collected. RESULTS: A total of 43 patients was identified. Anterior fixation was performed in 21 patients, posterior fixation was performed in 22 patients. There were no significant differences between these groups. Although statistical significance was not reached, a slightly higher mortality was found among patients undergoing anterior fixation (52,4 vs. 31,8%). Furthermore the male sex, a higher age, translation injuries, long duration of operation and hospitalisation as well as postoperative complications were slightly associated to a higher mortality. CONCLUSIONS: Subaxial cervical spine trauma is associated to a high mortality in the elderly. Although neither anterior nor posterior fixation could show a significant superiority, every surgical decision making should be performed individually for each patient balancing the advantages and disadvantages of each method.

Evaluation of effectiveness and stability of aligner treatments using the Peer Assessment Rating Index.

AIMS: The aims of this study were to measure treatment effects of aligner treatments in adult patients directly after treatment and the stability of these effects after a short-term retention period using the Peer Assessment Rating (PAR) Index. METHODS: This double-center trial consecutively screened 98 adult patients of whom 33 patients were treated according to predefined inclusion and exclusion criteria. The study sample was shown to be representative for adult orthodontic reality with regard to gender, age, and distribution of malocclusion type. Malocclusion severity was rated by using the PAR Index measured at baseline (T0), after finishing orthodontic treatment with Invisalign® (T1; Align Technology Inc., Santa Clara, CA, USA) and after a mean retention period of 10 months (T2). Furthermore, to better understand the observed treatment modality, specific treatment characteristics were recorded and analyzed. RESULTS: The average PAR score at T0 was 22.18 (standard deviation [SD] ± 8.68). Posttreatment PAR score was 4.64 (SD ± 4.23) at T1 and was stable after a retention period of 10.07 months at T2 (SD ± 126.80 days; PAR 4.36, SD ± 3.93). All of the study cases showed a significant reduction of the total PAR score between T0 and T1 (p < 0.001), but no further difference between T1 and T2 (PAR 4.64 vs. 4.36). Cases were either classified 'improved' (n = 23) or 'greatly improved' (n = 10); no case was classified into the third PAR Index category 'worse or no different'. On average, 72 aligners (SD ± 22) with 12 attachments per treatment (SD ± 4) were used to align teeth. Six patients needed a case refinement with a mean of 23 (SD ± 8) further aligners. The maximum number of needed ClinCheck® (Align Technology Inc., Santa Clara, CA, USA) treatment plan revisions was 18 (mean 7, SD ± 4). CONCLUSION: The detected improvement rate indicated a good standard of orthodontic treatment using aligners. Treatment effects were stable throughout a short-term retention period using a specific retention protocol. Effectiveness and stability were equally achieved in mild, moderate, and rather severe cases within this consecutive sample. A critical focus should be placed on accurate treatment planning in order to make tooth movements predictable, realistic, and stable.

Transapical-transcatheter aortic valve implantation using the Edwards SAPIEN 3 valve.

BACKGROUND: Scarcely any data has been published on the mid-term effect of transapical-transcatheter aortic valve implantation (TA-TAVI) using the Edwards SAPIEN 3 valve (S3; Edwards Lifesciences Corp., Irvine, CA, USA). We present mid-term clinical and echocardiographic outcomes after TA-TAVI utilizing S3. METHODS: Between 02/2014-06/2017, 122 elderly patients with severe aortic stenosis underwent TA-TAVI utilizing S3 at our institution. We conducted clinical and echocardiographic follow-up. The mean follow-up was 15 months. All end-point-related outcomes were adjudicated according to Valve Academic Research Consortium-2 definitions. RESULTS: The STS-score of the entire cohort was 6.26±4.6. More than one-third of the patients exhibited severe peripheral artery disease. The 30-d all-cause mortality, all-stroke rate, and myocardial infarction of the entire cohort were 4.1%, 1.6%, and 0.8% respectively. Median survival time of the entire cohort was 35 months. The cumulative mid-term myocardial infarction and stroke rate was 2.6% and 3.5%, respectively. The postoperative moderate/severe paravalvular leakage occurred in 1.6% of cases. At discharge, one-year and two-year postprocedure peak/mean gradients were 16.6±8.3/ 9±5.1 mmHg, 18±6.9/ 10±4.5 mmHg, and 22.2±5.4/ 12.8±4.6 mmHg, respectively. The rate of new pacemaker cases was 14.1%. Acute kidney injury network 2/3 appears, as an independent predictor of mortality. CONCLUSIONS: We observed very promising early and mid-term clinical outcomes with a high degree of device success and good hemodynamic performance after TA-TAVI using the S3 in the intermediate risk patient profile.

Oversized versus Non-oversized Prosthesis: Midterm Outcomes after Transcatheter Aortic Valve Replacement Using SAPIEN 3 Valve.

BACKGROUND: A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards Lifesciences Corp., Irvine, California, United States) to ensure device success. We aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve after transapical-transcatheter aortic valve replacement (TA-TAVR). METHODS: Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution, 42 received OS prosthesis. We used computed tomography (CT) derived effective diameter to assess oversizing. We defined oversizing if the labeled diameter of the selected valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated by the annulus area. We conducted a midterm follow-up and compared the OS cohort with the non-OS (nOS) cohort. RESULTS: The study groups showed similar risk score and age (STS [Society of Thoracic Surgery] score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus 2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively. Midterm freedom from death and from cardiocerebral events was similar in both groups. Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected as an independent predictor of mortality. CONCLUSION: Oversizing reduces the risk of device failure and intraprocedural postdilation but increases the risk of PPI. Early and midterm morbidity and mortality after OS and nOS with S3 are comparable.

Real-world data confirm the effectiveness of caplacizumab in acquired thrombotic thrombocytopenic purpura.

Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare but life-threatening condition. In 2018, the nanobody caplacizumab was approved for the treatment of adults experiencing an acute episode of aTTP, in conjunction with plasma exchange (PEX) and immunosuppression for a minimum of 30 days after stopping daily PEX. We performed a retrospective, observational analysis on the use of caplacizumab in 60 patients from 29 medical centers in Germany during acute disease management. Caplacizumab led to a rapid normalization of the platelet count (median, 3 days; mean 3.78 days). One patient died after late treatment initiation due to aTTP-associated complications. In 2 patients with initial disease presentation and in 4 additional patients with laboratory signs of an exacerbation or relapse after the initial therapy, PEX-free treatment regimens could be established with overall favorable outcome. Caplacizumab is efficacious in the treatment of aTTP independent of timing and ancillary treatment modalities. Based on this real-world experience and published literature, we propose to administer caplacizumab immediately to all patients with an acute episode of aTTP. Treatment decisions regarding the use of PEX should be based on the severity of the clinical presentation and known risk factors. PEX might be dispensable in some patients.

ADAMTS13 and VWF activities guide individualized caplacizumab treatment in patients with aTTP.

Introduction of the nanobody caplacizumab was shown to be effective in the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in the acute setting. The official recommendations include plasma exchange (PEX), immunosuppression, and the use of caplacizumab for a minimum of 30 days after stopping daily PEX. This study was a retrospective, observational analysis of the use of caplacizumab in 60 patients from 29 medical centers in Germany. Immunosuppressive treatment led to a rapid normalization of ADAMTS13 activities (calculated median, 21 days). In 35 of 60 patients, ADAMTS13 activities started to normalize before day 30 after PEX; in 11 of 60 patients, the treatment was extended beyond day 30; and in 5 patients, it was extended even beyond day 58 due to persistent autoimmune activity. In 34 of 60 instances, caplacizumab was stopped before day 30 with a favorable outcome whenever ADAMTS13 activities were >10%. In contrast, 11 of 34 patients with ADAMTS13 activities <10% at the time of stopping caplacizumab treatment developed a nonfavorable outcome (disease exacerbation or relapse). In some cases, prolongation of the treatment interval to every other day was feasible and resulted in a sustained reduction of von Willebrand factor activity. ADAMTS13 activity measurements are central for a rapid diagnosis in the acute setting but also to tailor disease management. An ADAMTS13 activity-guided approach seems safe for identifying the individual time point when to stop caplacizumab to prevent overtreatment and undertreatment; this approach will result in significant cost savings without jeopardizing the well-being of patients. In addition, von Willebrand factor activity may serve as a biomarker for drug monitoring.

Social media and orthodontics: A mixed-methods analysis of orthodontic-related posts on Twitter and Instagram.

INTRODUCTION: In modern health care, social media has become an important tool for both patients and professionals. On platforms like Twitter and Instagram, patients can express their experiences, attitudes, and emotions regarding their orthodontic treatment or the available treatment options. This study aimed to investigate orthodontic-related social media use by analyzing the contents of posts made by patients and/or peers and exploring potential differences of users' attitudes on Twitter and Instagram. METHODS: During a 30-day period, we collected 361 orthodontic-related posts-153 from Twitter and 208 from Instagram-using the same search strategy on both platforms. A mixed-methods approach was applied. First, all posts were structured according to a qualitative content analysis. Subsequently, quantitative analysis was performed to detect potential differences between posts on Twitter and Instagram. RESULTS: The following main themes were identified: "Getting braces" and "Getting braces removed," "Limitations due to braces," "Seeking information," and "Comedy." In addition to this classification, all posts were categorized as positive, negative, or neutral. Pictures and emoticons were frequently used to express experiences, attitudes, and emotions regarding orthodontic appliances. There were significant differences between posts on Twitter and those on Instagram; that is, the latter contained more posts that were categorized as positive. CONCLUSIONS: To date, only a few studies addressed the role of social media for orthodontic patients. This study provided insights into the experiences, attitudes, and emotions of patients and their peers regarding orthodontics and helped to reveal the potential impact of social media use on the field of orthodontics. Attention must be paid to the functional differences between Twitter and Instagram because these might lead patients to express themselves in specific ways.

Peculiarities of health literacy in people with mental disorders: A cross-sectional study.

BACKGROUND: Health literacy (HL) is considered a key concept to positively address relevant decisions concerning physical and mental health. According to an integrated model of a European Consortium, the process to access, understand, appraise and apply health information is at the centre of practising HL. AIM: In this study, we examine HL in a population with an early onset of a mental disorder (MD). METHODS: Results are based on a cross-sectional survey among people with MD (n = 310) who sought help at an early detection centre for MD in Cologne, Dresden or Munich. Help-seekers filled out the European Health Literacy Survey questionnaire (HLS-EU-Q) on perception-based HL, socio-demographic data and general health status. Psychopathology was assessed separately by trained specialists. Data are compared with a representative sample of the German population. RESULTS: Overall, HL was lower in a sample with MD compared with the general population. Disease-specific limitations were present in accessing, appraising and applying health information, whereas understanding was perceived fairly easy. Statistical analysis of limited HL revealed correlations with the diagnosis of affective disorders and anxiety disorders, an increase of depressive symptoms as well as the presence of more than one MD. In line with these findings, low levels of HL were associated with a worse general health status. CONCLUSION: In a population with MD, accessing, appraising and applying health information seemed to be particularly challenging. Therefore, educational programmes that mainly focus on increasing knowledge might not be sufficient for improving the HL in people with MD. Further research should concentrate on context-specific HL to foster behavioural change and improve overall health.

Mid-Term Outcomes after Transapical and Transfemoral Transcatheter Aortic Valve Implantation for Aortic Stenosis and Porcelain Aorta with a Systematic Review of Transfemoral versus Transapical Approach.

BACKGROUND: We have aimed to analyze early and mid-term outcomes of patients undergoing transapical/transfemoral transcatheter aortic valve implantation (TA-/TF-TAVI) for aortic stenosis and porcelain aorta (PAo) in our institution. Additionally, we postulated that the TA approach may be associated with a more favorable neurological outcome than the TF approach; hence, a systematic literature review was conducted. METHODS: Between 2011 and 2017, 15 patients with PAo underwent TA-TAVI and 4 patients with PAo TF-TAVI at our institution. The assessment of PAo was done either intraoperatively after aborted sternotomy or via computed tomography for elective TAVI. We conducted mid-term follow-up. Furthermore, a systematic review was performed to compare the mortality and neurological outcomes of TF and TA-TAVI approaches. RESULTS: TA/TF-TAVIs were performed with 100% device success, without paravalvular leakage ≥ 2 and without procedural death. The 30-day mortality/stroke rates were 6.6%/0% in TA-TAVI and 0%/25% in TF-TAVI, respectively. The 6-month, 1-year, and 2-year survival rates were in TA/TF-TAVI 93%/75%, 82%/66.6%, and 50%/0%, respectively.The pooled results derived from the literature review were as follows: The prevalence of PAo in the TAVI population is 9.74%; the mean logistic EuroSCORE is 41.9% in TA-TAVI versus 16.2% in TF-TAVI; the mean 30-day mortality is 5.9% in TA-TAVI versus 6.3% in TF-TAVI, and the mean stroke is 0.8% in TA-TAVI versus 9% in TF-TAVI. CONCLUSION: TA-TAVI shows promising early and mid-term outcomes in patients with PAo. TF-TAVI performed in patients with PAo is likely to be associated with higher rates of stroke than TA-TAVI.

Cognitive behavioural therapy for the treatment of late life depression: study protocol of a multicentre, randomized, observer-blinded, controlled trial (CBTlate).

BACKGROUND: Late-life depression (LLD) is one of the most prevalent mental disorders in old age. It is associated with various adverse outcomes and frequent use of health care services thereby remaining a serious public health concern. Compared with depression in early adulthood, most treatment options of LLD are less effective. Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects. Although cognitive behavioural therapy (CBT) is highly established and effective in depression in young and mid-life there is only a limited number of small studies on CBT in LLD. An LLD-specific CBT has not yet been compared to an active, but unspecific supportive psychological intervention in a multicentre trial. METHODS: Here we present the design of the CBTlate trial, which is a multicentre, randomized, observer-blinded, active-controlled, parallel group trial. CBTlate aims at including 248 patients with LLD of both genders at 7 sites in Germany. The purpose of the study is to test the hypothesis that a 15-session individually-delivered CBT specific for LLD is of superior efficacy in reducing symptoms of depression in comparison with a supportive unspecific intervention (SUI) of the same quantity. The intervention includes 8 weeks of individual treatment sessions twice per week and a follow-up period of 6 months after randomization. The primary end point is the severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS). Secondary endpoints include depressive symptoms at week 5 and at follow-up (6 months after randomization). Additional secondary endpoints include the change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up. Add-on protocols include MRI and the collection of blood samples. DISCUSSION: This study is the first multicentre trial of a specific CBT intervention for LLD compared to an unspecific supportive psychological intervention administered in a specialist setting. It has important implications for developing and implementing efficient psychotherapeutic strategies for LLD and may be a significant step to broaden treatment options for people suffering from LLD. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03735576, registered on 24 October 2018); DRKS (DRKS00013769, registered on 28 June 2018).