[The IBD-Control questionnaire: German translation and validation of the standardized questionnaire for Patient Reported Outcome Measurement in inflammatory bowel disease]. / Der IBD-Control-Fragebogen: Deutsche Übertragung und Validierung des standardisierten Fragebogens zur Messung des Outcomes aus Patientensicht bei chronisch entzündlichen Darmerkrankungen.

BACKGROUND: Subjectively perceived results of treatment will be in the center of defining treatment success on the way to value-based and patient-centered health care. Patient-reported outcome measures (PROMs) serve as an instrument to measure treatment success. In inflammatory bowel disease (IBD), measuring treatment success from a patient's point of view is performed with the validated IBD-Control questionnaire. Because the IBD-Control questionnaire has not been published in German yet, the translation and validation of the IBD-Control in the German-speaking part of Switzerland was necessary before use. METHODS: We have translated the English original version of the IBD-Control questionnaire into German in a state-of-the-art procedure of "forward-backward translation" and validated the translated IBD-Control questionnaire with 154 patients with Crohn's disease or with ulcerative colitis. RESULTS: Professional health care and translation experts have contributed to the translation of the IBD-Control into German. The IBD-Control-D is an accepted questionnaire. Spearmans Rho showed high consistency between the IBD-Control-8-Subscore and the IBD-Control-VAS-Score (r=0.632). The disease activity in the past 6 months highly correlated with the IBD-8 subscore (r=0.640) as well as with the IBD-Control-VAS-Score (r=0.622). The IBD-Control-8-Subscore highly correlated with the Harvey Bradshaw Index (r=-0.620) and the partial Mayo Score (r=-0.679), as well as the IBD-Control-VAS-Score with the Harvey Bradshaw Index (r=-0.484) and the Mayo Score (r=-0.435), showing sufficient construct validity. The result is the German version of the IBD-Control, the IBD-Control-D, published here. CONCLUSION: The original English version is a valid instrument, and its use has proven to be a suitable instrument in German-speaking areas to make the subjective feeling of illness and treatment outcome measurable.

5-year results of a newly implemented mechanical circulatory support program for terminal heart failure patients in a Swiss non-cardiac transplant university hospital.

BACKGROUND: In Switzerland, long-term circulatory support programs have been limited to heart transplant centers. In 2014, to improve the management of patients with end-stage heart failure not eligible for transplantation, we implemented a left ventricular assist device (LVAD) program for destination therapy at the University Hospital of Basel. METHODS: We described the program set-up with practical aspects. Patients aged 65 and above with therapy refractory end-stage heart failure without major contraindication for LVAD implantation were included. Younger patients with bridge-to-candidacy profile were also considered. Using the Kaplan-Meier estimate, we retrospectively analyzed the overall survival and freedom from major adverse events after LVAD implantation. We compared our results to internationally reported data. RESULTS: Between October 2014 and September 2019, 16 patients received an LVAD in our center. The mean age at implantation was 67.1 years. The mean EuroSCORE II was 24.4% and the median INTERMACS level was 4. Thirteen patients received an LVAD as destination therapy and three patients as bridge-to-candidacy. The overall survival was 87.5 and 70% at 1 and 2 years, respectively. Freedom from stroke was 81.3% at 1 and 2 years. Freedom from device infection was 67.7 and 58.7% at 1 and 2 years, respectively. Freedom from gastrointestinal bleeding was 75 and 56.3% at 1 and 2 years, respectively. Freedom from readmission was 50 and 31.3% and at 6 months and 1 year, respectively. CONCLUSIONS: The Basel experience demonstrated the possible implementation of an LVAD program for destination therapy or bridge-to-candidacy in a non-transplant comprehensive heart-failure center with midterm survival results and freedom from major adverse events comparable to international registries. Patient selection remains crucial. TRIAL REGISTRATION: This study was registered on the ClinicalTrials.gov database ( NCT04263012 ).

Prosthetic valve endocarditis caused by Pseudomonas aeruginosa with variable antibacterial resistance profiles: a diagnostic challenge.

BACKGROUND: Infective endocarditis (IE) caused by gram-negative bacilli is rare. However, the incidence of this severe infection is rising because of the increasing number of persons at risk, such as patients with immunosuppression or with cardiac implantable devices and prosthetic valves. The diagnosis of IE is often difficult, particularly when microorganisms such as Pseudomonas aeruginosa, which rarely cause this infection, are involved. One of the mainstays for the diagnosis of IE are persistently positive blood cultures with the same bacteria, while polymicrobial bacteremia usually points to another cause, e.g. an abscess. The antimicrobial resistance profile of some P. aeruginosa strains may change, falsely suggesting an infection with several strains, thus further increasing the diagnostic difficulties. CASE PRESENTATION: A 66-year old male patient who had a transcatheter aortic valve implantation (TAVI) one year previously developed fever seven days after an elective inguinal hernia repair. During the following four weeks, P. aeruginosa with different antibiotic resistance profiles was repeatedly isolated from blood cultures. Repeated trans-esophageal echocardiograms (TEE) were negative and an infection by different P. aeruginosa strains was suspected. Extensive diagnostic workup for an infectious focus was performed with no results. Finally, an oscillating mass on the aortic valve was detected by TEE five weeks after the initial positive blood cultures. P. aeruginosa endocarditis was confirmed by culture of the surgically removed valve. Whole genome sequencing of the last two P. aeruginosa isolates (valve and blood culture) revealed identical strains, with genome mutations for AmpR, AmpD and OprD. CONCLUSIONS: The diagnosis of prosthetic valve endocarditis is particularly difficult for several reasons. The modified Duke criteria have a lower sensitivity for patients with prosthetic valve endocarditis and the infection may be caused by "unusual" pathogens such as P. aeruginosa. Patients with repeatedly positive blood cultures should make clinicians suspicious for endocarditis even if imaging studies are negative and if isolated pathogens are "unusual". Repeatedly positive blood cultures for P. aeruginosa should be considered as "persistent bacteremia" (suspicious for IE) even in the presence of different antibiotic susceptibility patterns, since P. aeruginosa might rapidly activate or deactivate resistance mechanisms depending on antibiotic exposition.

Association of Communication Interventions to Discuss Code Status With Patient Decisions for Do-Not-Resuscitate Orders: A Systematic Review and Meta-analysis.

Importance: Whether specific communication interventions to discuss code status alter patient decisions regarding do-not-resuscitate code status and knowledge about cardiopulmonary resuscitation (CPR) remains unclear. Objective: To conduct a systematic review and meta-analysis regarding the association of communication interventions with patient decisions and knowledge about CPR. Data Sources: PubMed, Embase, PsycINFO, and CINAHL were systematically searched from the inception of each database to November 19, 2018. Study Selection: Randomized clinical trials focusing on interventions to facilitate code status discussions. Two independent reviewers performed the data extraction and assessed risk of bias using the Cochrane Risk of Bias Tool. Data were pooled using a fixed-effects model, and risk ratios (RRs) with corresponding 95% CIs are reported. Data Extraction and Synthesis: The study was performed according to the PRISMA guidelines. Main Outcomes and Measures: The primary outcome was patient preference for CPR, and the key secondary outcome was patient knowledge regarding life-sustaining treatment. Results: Fifteen randomized clinical trials (2405 patients) were included in the qualitative synthesis, 11 trials (1463 patients) were included for the quantitative synthesis of the primary end point, and 5 trials (652 patients) were included for the secondary end point. Communication interventions were significantly associated with a lower preference for CPR (390 of 727 [53.6%] vs 284 of 736 [38.6%]; RR, 0.70; 95% CI, 0.63-0.78). In a preplanned subgroup analysis, studies using resuscitation videos as decision aids compared with other interventions showed a stronger decrease in preference for life-sustaining treatment (RR, 0.56; 95% CI, 0.48-0.64 vs 1.03; 95% CI, 0.87-1.22; between-group heterogeneity P < .001). Also, a significant association was found between communication interventions and better patient knowledge (standardized mean difference, 0.55; 95% CI, 0.39-0.71). Conclusions and Relevance: Communication interventions are associated with patient decisions regarding do-not-resuscitate code status and better patient knowledge and may thus improve code status discussions.

Modified frozen elephant trunk for acute type A aortic dissection: a comparative study with standard repair technique.

Objectives: We hypothesized that antegrade open stent graft implantation in the descending aorta during acute type A aortic dissection surgery is safe and improves patient outcome compared with the standard repair technique. Methods: Hundred and forty-one consecutive patients underwent surgery for acute type A aortic dissection at our institution from 2010 to 2016. Of those, 104 patients underwent ascending aorta and hemiarch repair under hypothermic circulatory arrest with antegrade cerebral perfusion (standard group). Since 2013, 37 patients have undergone the standard procedure combined with antegrade stent implantation in the descending aorta (stented group). A matched analysis using the logistic EuroSCORE (37 patients per group) was done. All data were collected prospectively. Results: The mean logistic EuroSCORE was 29 in both groups, P = 1. Cardiopulmonary bypass time was 150 ± 57 (standard) vs 157 ± 48 (stented) min, P = 0.6; aortic clamping 99 ± 47 (standard) vs 100 ± 36 (stented) min, P = 1. Stented patients had longer circulatory arrest times with antegrade cerebral perfusion, 23 ± 7 vs 15 ± 7 min, P < 0.001. Stroke occurred in 24.3% (standard) vs 8.1% (stented), P = 0.1; paraplegia developed in 2.7% (standard) vs 0% (stented), P = 1. Abdominal intervention due to suspected visceral ischaemia was needed in 18.9% (standard) vs 5.4% (stented), P = 0.2. 30-day mortality was 13.5% (standard) vs 0% (stented), P = 0.05. Survival at 6-month was 100% and 86.5% in patients with implanted stents and standard repair, respectively, P = 0.02. Conclusions: Antegrade, open stent graft implantation into the descending aorta during acute type A aortic dissection repair is safe and is associated with improved outcomes at 6 months postoperatively compared to the standard repair technique.

A new cable-tie-based sternal closure device: infectious considerations.

OBJECTIVES: To determine the difference in sternal infection and other infectious events between conventional wire and cable-tie-based closure techniques post-sternotomy in a collective of patients after cardiac surgery. METHODS: The sternal ZipFix™ (ZF) system consists of a biocompatible poly-ether-ether-ketone (PEEK) cable-tie that surrounds the sternum through the intercostal space and provides a large implant-to-bone contact. Between 1 February 2011 and 31 January 2012, 680 cardiac operations were performed via sternotomy at our institution. After the exclusion of operations for active endocarditis and early mortality within 7 days, 95 patients were exclusively closed with ZF and could be compared with 498 who were closed with conventional wires (CWs) during the same period. A multivariable logistic regression analysis, including body mass index, renal impairment and emergency as suspected confounders and inverse propensity weights was performed on the infection rate. RESULTS: Total infection rate was 6.1%, with a total of 36 diagnosed sternal infections (5 in ZF and 31 in CW). Comparing ZF with CW with regard to sternal infection, there is no statistically significant difference related to the device (odds ratio: 0.067, confidence interval: 0.04-9.16, P=0.72). The propensity modelling provided excellent overlap and the mean propensity was almost the same in both groups. Thus, we have observed no difference in receiving either ZF or CW. No sternal instability was observed with the ZF device, unlike 4/31 patients in the CW group. The overall operation time is reduced by 11 min in the ZF group with identical perfusion and clamping times. CONCLUSIONS: Our study underlines a neutral effect of the sternal ZipFix™ system in patients regarding sternal infection. Postoperative complications are similar in both sternal closure methods. The cable-tie-based system is fast, easy to use, reliable and safe.

Hypothermic circulatory arrest using antegrade cerebral perfusion is safe for elective aortic arch surgery.

BACKGROUND: We hypothesized that hypothermic circulatory arrest (HCA) can be performed with a low operative risk and does not add to the morbidity in elective procedures. METHODS: A total of 178 patients with a mean (± SD) age of 62 (± 10) years underwent HCA for elective aortic surgery from April 2008 to September 2011. Pre- and postoperative clinical data were collected prospectively. RESULTS: Hemiarch replacement was performed in 97% patients. Mean logistic Euroscore I was 17% (± 15). HCA was performed at 26°C bilateral tympanic temperature. Mean HCA duration was 17 (±) min. Mean cross-clamp time was 106 (± 39) min. Overall 30-day mortality was 2% and stroke occurred in 4% of patients. Overall 6-month survival was 96%. Cox regression analysis for 6-month survival revealed four variables with significant influence: the logistic Euroscore I (p = 0.008), age (p = 0.04), cross-clamp time (p = 0.008), and reoperation for bleeding complications (p = 0.04). CONCLUSIONS: HCA with open distal anastomosis for elective aortic repair can be performed with low operative mortality, even in the elderly, and seems not to add to the morbidity of the procedure.

Effects of the novel polymer gel LeGoo on human internal thoracic arteries.

PURPOSE: Established hemostatic devices can injure vessel wall integrity. LeGoo (Pluromed, Woburn, MA), a novel poloxamer gel with reverse thermosensitive properties, is a new device for temporary occlusion of blood vessels. The present study investigated the effects of LeGoo on vascular function and morphology. DESCRIPTION: The distal end of the human internal thoracic artery was used to assess vascular function of LeGoo-applied segments in organ bath experiments and by scanning electron microscopy. EVALUATION: After LeGoo application, both maximal contractile responses to noradrenaline and endothelium-dependent relaxant responses to acetylcholine were significantly reduced. Scanning electron microscopy showed areas of injured endothelium with exposure of subendothelial structures being in line with the functional changes. CONCLUSIONS: Data suggested that application of LeGoo induced significant endothelial injury and deterioration of the smooth muscle in human internal thoracic arteries.

Management of acute respiratory distress syndrome using pumpless extracorporeal lung assist.

PURPOSE: To describe the use of a pumpless extracorporeal lung assist device in the treatment of severe acute respiratory distress syndrome (ARDS). CLINICAL FEATURES: A 15-yr-old girl developed severe post-traumatic ARDS. After all conventional treatment strategies failed, we inserted a pumpless extracorporeal lung assist device. This device consists of an arterial cannula inserted into the femoral artery, and a membrane oxygenator with a venous cannula that returns the oxygenated blood back to the patient's femoral vein. Since the driving force is the patient's blood pressure, a roller pump with its negative side effects is not needed. The device allowed removal of excessive PaCO(2) and, by applying minimal ventilation, minimization of further ventilator-induced lung injury. The pumpless extracorporeal lung assist device remained in situ for ten days without any adverse side effect. During this time, the lung recovered such that mechanical ventilation could be reinstalled cautiously. The device was then removed and, after a prolonged period of intensive care, the patient recovered without any sequelae. CONCLUSION: In this case of a severely damaged lung, an arteriovenous pumpless extracorporeal lung assist was a helpful device to remove elevated CO(2) and reduce mechanical stress by applying minimal ventilation. This device is simple to operate and has the potential of being used routinely in the treatment of severe ARDS.

Improved endothelial function after a modified harvesting technique of the internal thoracic artery.

OBJECTIVE: One of the most important factors in bypass surgery is the preservation of endothelial function in the arterial graft. It was of interest, therefore, whether a slightly modified preparation procedure during surgery could contribute to improved endothelial function of the graft. We compared the functional activity of internal thoracic arteries (ITA) prepared according to the traditional harvesting method with occlusion by a clip, dissection at the distal end and storage of the artery in papaverine until its implantation (CA) with the functional activity of arteries which were also prepared and wrapped in papaverine, but were left perfused and dissected immediately before their anastomoses (PA). METHODS: Samples of ITA were obtained from a total number of 28 patients, undergoing bypass surgery, and randomly distributed into two groups. The arteries were cut into rings and suspended in organ baths, containing Krebs-Henseleit solution, for isometric tension recording. Cumulative concentration response curves were determined for the contractile agents endothelin-1 (ET-1), 5-hydroxytryptamine (5-HT), noradrenaline (NA) and potassium chloride (KCl) and the relaxant compounds acetylcholine (ACH) and sodium nitroprusside (SNP) during active tone induced by 30 mM KCl. RESULTS: ET-1 and 5-HT stimulated rings from both groups within the same concentration ranges but elicited significantly (P<0.05) higher contractile responses in CA compared to PA. By contrast, concentration response curves for KCl and NA where nearly superimposable. On the other hand, maximal endothelium-dependent relaxant responses to ACH proved to be significantly stronger in PA (0.84+/-0.20 g) as compared to CA (0.31+/-0.05 g, P<0.05) while endothelium independent relaxant responses to SNP where similar in both groups. CONCLUSION: These data suggest that leaving the ITA perfused during harvesting might improve considerably the endothelial function of the graft.

Late Aspergillus fumigatus endomyocarditis with brain abscess as a lethal complication after heart transplantation.

We report the case of a 65-year-old male patient who died from lethal Aspergillus fumigatus endomyocarditis and multiple cerebral septic emboli 6 months after cardiac transplantation. This complication developed 4 weeks after diagnosis of bilateral pulmonary aspergillosis, which was immediately treated by surgical removal and intravenous amphotericin B. Preceding colonization with Aspergillus spp was not identified. Primary cytomegalovirus infection (donor+/recipient-) and toxoplasmosis reactivation (donor+/recipient+) occurring at 1 and 2 months post-transplantation were successfully treated.