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.

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.

Catheter Ablation for Atrial Fibrillation with Heart Failure.

BACKGROUND: Mortality and morbidity are higher among patients with atrial fibrillation and heart failure than among those with heart failure alone. Catheter ablation for atrial fibrillation has been proposed as a means of improving outcomes among patients with heart failure who are otherwise receiving appropriate treatment. METHODS: We randomly assigned patients with symptomatic paroxysmal or persistent atrial fibrillation who did not have a response to antiarrhythmic drugs, had unacceptable side effects, or were unwilling to take these drugs to undergo either catheter ablation (179 patients) or medical therapy (rate or rhythm control) (184 patients) for atrial fibrillation in addition to guidelines-based therapy for heart failure. All the patients had New York Heart Association class II, III, or IV heart failure, a left ventricular ejection fraction of 35% or less, and an implanted defibrillator. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. RESULTS: After a median follow-up of 37.8 months, the primary composite end point occurred in significantly fewer patients in the ablation group than in the medical-therapy group (51 patients [28.5%] vs. 82 patients [44.6%]; hazard ratio, 0.62; 95% confidence interval [CI], 0.43 to 0.87; P=0.007). Significantly fewer patients in the ablation group died from any cause (24 [13.4%] vs. 46 [25.0%]; hazard ratio, 0.53; 95% CI, 0.32 to 0.86; P=0.01), were hospitalized for worsening heart failure (37 [20.7%] vs. 66 [35.9%]; hazard ratio, 0.56; 95% CI, 0.37 to 0.83; P=0.004), or died from cardiovascular causes (20 [11.2%] vs. 41 [22.3%]; hazard ratio, 0.49; 95% CI, 0.29 to 0.84; P=0.009). CONCLUSIONS: Catheter ablation for atrial fibrillation in patients with heart failure was associated with a significantly lower rate of a composite end point of death from any cause or hospitalization for worsening heart failure than was medical therapy. (Funded by Biotronik; CASTLE-AF ClinicalTrials.gov number, NCT00643188 .).

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.

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.

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.

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.

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.

Controlling intestinal colonization of high-risk haematology patients with ESBL-producing Enterobacteriaceae: a randomized, placebo-controlled, multicentre, Phase II trial (CLEAR).

OBJECTIVES: We assessed the efficacy and safety of an oral antimicrobial regimen for short- and long-term intestinal eradication of ESBL-producing Escherichia coli and Klebsiella pneumoniae (ESBL-EC/KP) in immunocompromised patients. METHODS: We performed a randomized (2:1), double-blind multicentre Phase II study in four haematology-oncology departments. Patients colonized with ESBL-EC/KP received a 7 day antimicrobial regimen of oral colistin (2 × 106 IU 4×/day), gentamicin (80 mg 4×/day) and fosfomycin (three administrations of 3 g every 72 h), or placebo. Faecal, throat and urine specimens were collected on day 0, 6 ± 2, 11 ± 2, 28 ± 4 and 42 ± 4 after treatment initiation, and the quantitative burden of ESBL-EC/KP, resistance genes and changes in intestinal microbiota were analysed. Clinicaltrials.gov: NCT01931592. RESULTS: As the manufacture of colistin powder was suspended worldwide, the study was terminated prematurely. Overall, 29 (18 verum/11 placebo) out of 47 patients were enrolled. The short-term intestinal eradication was marginal at day 6 (verum group 15/18, 83.3% versus placebo 2/11, 18.2%; relative risk 4.58, 95% CI 1.29-16.33; Fisher's exact test P = 0.001) and not evident at later timepoints. Quantitative analysis showed a significant decrease of intestinal ESBL-EC/KP burden on day 6. Sustained intestinal eradication (day 28 + 42) was not achieved (verum, 38.9% versus placebo, 27.3%; P = 0.299). In the verum group, mcr-1 genes were detected in two faecal samples collected after treatment. Microbiome analysis showed a significant decrease in alpha diversity and a shift in beta diversity. CONCLUSIONS: In this prematurely terminated study of a 7 day oral antimicrobial eradication regimen, short-term ESBL-EC/KP suppression was marginal, while an altered intestinal microbiota composition was clearly apparent.

Outcome of Self-Expanding Metal Stents in the Treatment of Anastomotic Leaks After Ivor Lewis Esophagectomy.

BACKGROUND: Esophageal anastomotic leakages after Ivor Lewis esophagectomy are severe and life-threatening complications. We analyzed the outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy. METHODS: Seventy patients with esophageal anastomotic leakage after Ivor Lewis esophagectomy for esophageal cancer who had received SEMS treatment between January 2006 and December 2015 at our clinic were identified in this retrospective study. The patients were analyzed according to demographic characteristics, risk factors, leakage characteristics, stent characteristics, stent-related complications, sealing success rate and mortality. RESULTS: Over a 10-year period, 70 patients received SEMS as treatment for postoperative anastomotic leakage after esophagectomy. Technical success of esophageal stenting in anastomotic leakage was achieved in 50 out of 70 cases (71.4%). Sealing success rate was 70% (n = 49) with a median treatment of 28 days (range 7-87). In 20 patients (28.6%), stent-related complications, such as stenosis, dislocation, leakage persistence, perforation or esophagotracheal fistula occurred after the SEMS treatment. Sixty-one patients (87.1%) survived SEMS treatment of esophagogastric anastomotic leakage. Mean follow-up for all patients was 38 months (IQR 10-76), and no significant difference was found in a comparison of the long-term survival rate between patients with successful and unsuccessful SEMS treatment. CONCLUSIONS: The management of esophageal anastomotic leaks after Ivor Lewis esophagectomy with SEMS is effective, safe and technically feasible. Aggressive non-surgical management should be considered when developing a treatment plan for stenting.

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).

Impact of ab-interno trabeculectomy on Bruch's membrane opening-based morphometry of the optic nerve head for glaucoma progression analysis.

PURPOSE: To analyze the longitudinal change in Bruch's membrane opening minimal rim width (BMO-MRW) and circumpapillary retinal nerve fiber layer (RNFL) thickness using spectral domain optical coherence tomography (SD-OCT) after glaucoma surgery via ab-interno trabeculectomy in adult glaucoma patients. METHODS: Retrospective audit of 65 eyes of 65 participants undergoing ab-interno trabeculectomy using electroablation of the trabecular meshwork. In 53 eyes, surgery was combined with phacoemulsification and posterior chamber lens implantation. Pre- and postoperative SD-OCT examinations of the optic nerve head (ONH), intraocular pressure (IOP), and visual field data were analyzed. Longitudinal change in morphometric SD-OCT parameters of the ONH was compared and correlated to change in IOP and visual field function. RESULTS: BMO-MRW increased significantly between baseline (BL) and follow-up (FU) within the first 6 months after surgery (BL = 167.85 ± 90 µm; FU = 175.59 ± 89 µm; p = 0.034). This increase correlated with postoperative lowering of IOP (rho = - 0.41; p = 0.016). Nine months after surgery (range, 7-12 months), there was no significant change in BMO-MRW (BL = 196.79 ± 79; FU = 196.47 ± 85 µm; p = 0.95), while in later follow-up, a decrease of BMO-MRW was found (BL = 175.18 ± 78; FU = 168.65 ± 72; p = 0.05). RNFL thickness was unchanged in early (p > 0.16) and significantly decreased in later follow-up (p = 0.009). Mean deviation (MD) of visual field function did not show a significant change before and after surgery. CONCLUSION: Electroablative ab-interno trabeculectomy leads to a significant transient mild increase in BMO-MRW. This increase was shown to correlate with IOP lowering. Significant loss of BMO-MRW in later follow-up may reflect insufficient IOP reduction by surgery. The parameters RNFL thickness and MD seem less impacted directly by surgery.

An Analysis of 2.3 Million Participations in the Continuing Medical Education Program of a General Medical Journal: Suitability, User Characteristics, and Evaluation by Readers.

BACKGROUND: Physicians frequently use continuing medical education (CME) in journals. However, little is known of the evaluation of journal CME by readers and also user and participation characteristics. Deutsches Ärzteblatt, the journal of the German Medical Association, is distributed to every physician in Germany and regularly offers its readers CME articles. Therefore, it provides a unique opportunity to analyze a journal CME program directed at an entire population of physicians. OBJECTIVE: The aim is to show key sociodemographic characteristics of participants, frequency and temporal distributions of participations, and to analyze whether the articles are suitable for a general medical audience, how physicians rate the CME articles, how successful they were in answering simple multiple-choice questions, and to detect distinct clusters of participants. METHODS: Using obligatory online evaluation forms and multiple-choice questions, we analyzed all participations of the entire 142 CME articles published between September 2004 and February 2014. We compared demographic characteristics of participants with official figures on those characteristics as provided by the German Medical Association. RESULTS: A total of 128,398 physicians and therapists (male: 54.64%, 70,155/128,393; median age class 40 to 49 years) participated 2,339,802 times (mean 16,478, SD 6436 participations/article). Depending on the year, between 12.33% (44,064/357,252) and 16.15% (50,259/311,230) of all physicians in the country participated at least once. The CME program was disproportionally popular with physicians in private practice, and many participations took place in the early mornings and evenings (4544.53%, 1,041,931/2,339,802) as well as over the weekend (28.70%, 671,563/2,339,802). Participation by specialty (ranked in descending order) was internal medicine (18.25%, 23,434/128,392), general medicine (16.38%, 21,033/128,392), anesthesiology (10.00%, 12,840/128,392), and surgery (7.06%, 9059/128,392). Participants rated the CME articles as intelligible to a wider medical audience and filling clinically relevant knowledge gaps; 78.57% (1,838,358/2,339,781) of the sample gave the CME articles very good or good marks. Cluster analysis revealed three groups, one comprised of only women, with two-thirds working in private practice. CONCLUSIONS: The CME article series of Deutsches Ärzteblatt is used on a regular basis by a considerable proportion of all physicians in Germany; its multidisciplinary articles are suitable to a broad spectrum of medical specialties. The program seems to be particularly attractive for physicians in private practice and those who want to participate from their homes and on weekends. Although many physicians emphasize that the articles address gaps in knowledge, it remains to be investigated how this impacts professional performance and patient outcomes.

Does the Tokyo guidelines predict the extent of gallbladder inflammation in patients with acute cholecystitis? A single center retrospective analysis.

BACKGROUND: The Tokyo guidelines provide criteria for the diagnosis and classification of acute cholecystitis in three severity grades. However, no data exists on the predictive value of these guidelines. The aim of this study was to analyze the accuracy of the Tokyo guidelines as a predicting parameter for the severity of acute cholecystitis in patients undergoing laparoscopic cholecystectomy. METHODS: A retrospective analysis of the charts of patients undergoing laparoscopic cholecystectomy for acute cholecystitis in a primary care hospital within a five-year period was performed. The preoperative severity grades were compared with the histological extent of inflammation. RESULTS: One hundred thirty-eight patients; 79 with severity grade I, 33 with grade II and 26 with grade III were analyzed. The incidence of uncomplicated cholecystitis decreased with increasing severity grade, while the incidence of complicated cholecystitis increased with increasing severity. However, complicated cholecystitis was evident in an unexpectedly high number of cases with severity grade I. There was a significant correlation (χ (2)(1) = 10. 43, p = 0.01) between the preoperative severity grade and the extent of gallbladder inflammation on histopathology. Conversion to open surgery (14 vs. 5, p = 0.002) and complications (17 vs. 7, p = 0.001) were significantly higher in patients with preoperative severity grade II/III compared to patients with severity grade I. CONCLUSION: Worsening clinical severity correlated significantly with worseing pathology, findings from blood test and clinical outcomes; rates of conversion and morbidity. However, the Tokyo guidelines may have a tendency to underestimate the extent of inflammation in male patients with severity grade I and over estimate the difficulty of dissection in severity grade II.

Primary cholecystectomy is feasible in elderly patients with acute cholecystitis.

BACKGROUND: While early cholecystectomy is generally accepted as the standard procedure for young and fit patients with acute cholecystitis, controversy exits on the management of elderly and severely sick patients. We postulated that primary cholecystectomy is feasible in this subgroup. The aim of this study was to compare the outcomes of young and fit patients to those of elderly patients undergoing surgery for acute cholecystitis. METHODS: The outcomes of elderly patients (≥70 years) undergoing surgery for acute cholecystitis in a primary care center in Germany were retrospectively compared to those of younger patients (<70 years). RESULTS: 152 patients, 74 aged ≥ 70 years (study group) and 78 < 70 years (control) were included for analysis. The study group was significantly older at the time of surgery (78 vs. 68 years, p = 0.02). Severe cholecystitis was seen in a significant number of cases in the study group, p = 0.01. Equally, the mean WBC (19.5 vs. 17, p = 0.02), CRP (26 vs. 22, p = 0.04) and APACHE II score (17 vs. 8, p = 0.01) were significantly higher in the study group. There was no significant difference in the duration of anesthesia (123 vs. 133 min, p = 0.70) and surgery (72 vs. 81 min, p = 0.90) amongst both groups. There was no significant difference in rate of complication amongst both groups (24 vs. 14%, p = 0.11). Two cases of mortality were recorded (1.3%) in the study group. CONCLUSION: The age of the patient cannot be the sole factor in deciding whether or not a patient with acute cholecystitis is fit for surgery.

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.

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.

Clinically defined chemotherapy-associated bowel syndrome predicts severe complications and death in cancer patients.

BACKGROUND: Neutropenic patients are at risk of abdominal complications and yet the incidence and impact of these complications on patients' morbidity and mortality have not been sufficiently evaluated. We aimed to assess a clinical rule for early detection of abdominal complications leading to death or transfer to intensive care in patients with chemotherapy-associated neutropenia. DESIGN AND METHODS: This observational multicenter study was carried out in seven German hematology-oncology departments. For inclusion, neutropenia of at least 5 consecutive days was required. Risk factors for "transfer to intensive care" and "death" were assessed by backward-stepwise binary logistic regression analyses. Chemotherapy-associated bowel syndrome was defined as a combination of fever (T ≥37.8 °C) and abdominal pain and/or lack of bowel movement for 72 hours or more. Five hundred and twenty-one neutropenic episodes were documented in 359 patients. RESULTS: The incidence of chemotherapy-associated bowel syndrome was 126/359 (35%) in first episodes of neutropenia. Transfer to intensive care occurred in 41/359 (11%) and death occurred in 17/359 (5%) first episodes. Chemotherapy-associated bowel syndrome and duration of neutropenia were identified as risk factors for transfer to intensive care (P<0.001; OR 4.753; 95% CI 2.297-9.833, and P=0.003; OR 1.061/d; 95% CI 1.021-1.103). Chemotherapy-associated bowel syndrome and mitoxantrone administration were identified as risk factors for death (P=0.005; OR 4.611; 95% CI 1.573-13.515 and P=0.026; OR 3.628; 95% CI 1.169-11.256). CONCLUSIONS: The occurrence of chemotherapy-associated bowel syndrome has a significant impact on patients' outcome. In future interventional clinical trials, this definition might be used as a selection criterion for early treatment of patients at risk of severe complications.