Extracorporeal Life Support in Infarct-Related Cardiogenic Shock.

BACKGROUND: Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality. METHODS: In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy. RESULTS: A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25). CONCLUSIONS: In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).

Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation.

BACKGROUND: Myocardial infarction is a frequent cause of out-of-hospital cardiac arrest. However, the benefits of early coronary angiography and revascularization in resuscitated patients without electrocardiographic evidence of ST-segment elevation are unclear. METHODS: In this multicenter trial, we randomly assigned 554 patients with successfully resuscitated out-of-hospital cardiac arrest of possible coronary origin to undergo either immediate coronary angiography (immediate-angiography group) or initial intensive care assessment with delayed or selective angiography (delayed-angiography group). All the patients had no evidence of ST-segment elevation on postresuscitation electrocardiography. The primary end point was death from any cause at 30 days. Secondary end points included a composite of death from any cause or severe neurologic deficit at 30 days. RESULTS: A total of 530 of 554 patients (95.7%) were included in the primary analysis. At 30 days, 143 of 265 patients (54.0%) in the immediate-angiography group and 122 of 265 patients (46.0%) in the delayed-angiography group had died (hazard ratio, 1.28; 95% confidence interval [CI], 1.00 to 1.63; P = 0.06). The composite of death or severe neurologic deficit occurred more frequently in the immediate-angiography group (in 164 of 255 patients [64.3%]) than in the delayed-angiography group (in 138 of 248 patients [55.6%]), for a relative risk of 1.16 (95% CI, 1.00 to 1.34). Values for peak troponin release and for the incidence of moderate or severe bleeding, stroke, and renal-replacement therapy were similar in the two groups. CONCLUSIONS: Among patients with resuscitated out-of-hospital cardiac arrest without ST-segment elevation, a strategy of performing immediate angiography provided no benefit over a delayed or selective strategy with respect to the 30-day risk of death from any cause. (Funded by the German Center for Cardiovascular Research; TOMAHAWK ClinicalTrials.gov number, NCT02750462.).

Clinical performance and risk factors of all-ceramic screw-retained implant crowns in the posterior region based on a retrospective investigation.

OBJECTIVES: Clinical data on all-ceramic screw-retained implant crowns (SICs) luted on titanium base abutments (TBAs) over more than 3 years are sparse. This study aimed to evaluate the clinical performance and potential risk factors for these restorations. MATERIALS AND METHODS: Analysis took place based on the medical patient-records of three dental offices. Implant survival and prosthetic complications over time were evaluated. The study included SICs in premolar and molar regions made from monolithic lithium disilicate ceramic (M_LiDi) or veneered zirconia (V_ZiO) luted on a TBA documented over an observation time of at least 3 years. Survival and complication rates were calculated and compared by a log-rank test. Cox-Regressions were used to check potential predictors for the survival (p < .05). RESULTS: Six hundred and one crowns out of 371 patients met the inclusion criteria and follow-up period was between 3.0 and 12.9 (mean: 6.4 (SD: 2.1)) years. Over time, six implants had to be removed and 16 restorations had to be refabricated. The estimated survival rates over 10 years were 93.5% for M_LiDi and 95.9% for V_ZiO and did not differ significantly among each other (p = .80). However, V_ZiO showed significantly higher complication rates (p = .003). Material selection, sex, age, and implant diameter did not affect the survival of investigated SICs but crown height influences significantly the survival rate (hazard ratio, HR = 1.26 (95%CI: 1.08, 1.49); p = .043). CONCLUSIONS: Screw-retained SICs luted on TBAs that were fabricated from monolithic lithium disilicate ceramic or veneered zirconia showed reliable and similar survival rates. Increasing crown heights reduced survival over the years.

Clinical performance of monolithic lithium disilicate hybrid abutment crowns over at least 3.5 years.

PURPOSE: Hybrid abutment crowns (HACs) made from monolithic ceramics represent an efficient option for single restorations on implants. However, long-term data are scarce. The purpose of this clinical trial was to evaluate the survival and complication rates of CAD-CAM fabricated HACs over a time period of at least 3.5 years. MATERIALS AND METHODS: Twenty-five patients with a total of 40 HACs made of monolithic lithium disilicate ceramic bonded to a titanium base CAD-CAM abutment were retrospectively evaluated. All implants and screw-retained restorations were placed and manufactured in the same department of a university hospital. Only crowns that had been in service for more than 3.5 years were included in the study. HACs were evaluated regarding technical and biological complications. Functional Implant Prosthodontic Scores (FIPS) were obtained. RESULTS: The mean observation time was 5.9 ± 1.4 years. Implant survival was 100%, and HAC survival was 97.5%. Over the observation period, one crown fracture was observed, necessitating refabricating of the restoration. Three minor biological complications were found. The overall mean FIPS score was 8.69 ± 1.12 points. CONCLUSIONS: Within the limitations of this study, monolithic screw-retained HACs milled from lithium disilicate ceramics and bonded to titanium bases appeared to be a reliable treatment option over more than 3.5 years due to their low biological and technical complication rates.

The agony of choice: Impact of the host animal species on the enzyme-linked immunosorbent assay performance for host cell protein quantification.

Host cell proteins (HCPs) are inevitable process-related impurities in biotherapeutics commonly monitored by enzyme-linked immunosorbent assays (ELISAs). Of particular importance for their reliable detection are the anti-HCP polyclonal antibodies (pAbs), supposed to detect a broad range of HCPs. The present study focuses on the identification of suitable host animal species for the development of high-performance CHO-HCP ELISAs, assuming the generation of pAbs with adequate coverage and specificity. Hence, antibodies derived from immunization of sheep, goats, donkeys, rabbits, and chickens were compared concerning their amount of HCP-specific antibodies, coverage, and performance in a sandwich ELISA. Immunization of sheep, goats, donkeys, and rabbits met all test criteria, whereas the antibodies from chickens cannot be recommended based on the results of this study. Additionally, a mixture of antibodies from the five host species was prepared to assess if coverage and ELISA performance can be improved by a multispecies approach. Comparable results were obtained for the single- and multispecies ELISAs in different in-process samples, indicating no substantial improvement for the latter in ELISA performance while raising ethical and financial concerns.

Biomechanical behavior of implants with different diameters in relation to simulated bone loss- an in vitro study.

OBJECTIVES: Bone resorption around implants could influence the resistance of the implant abutment complex (IAC). The present in vitro study aimed to assess the stability to static fatigue of implants presenting different levels of bone losses and diameters. MATERIALS AND METHODS: Ninety implants with an internal conical connection with 3 different implant diameters (3.3 mm (I33), 3.8 mm (I38), and 4.3 mm (I43)) and 3 simulated bone loss settings (1.5 mm (I_15), 3.0 mm (I_30), and 4.5 mm (I_45) (n = 10)) were embedded and standard abutments were mounted. All specimens were artificially aged (1,200,000 cycles, 50 N, simultaneous thermocycling) and underwent subsequently load-to-fracture test. For statistical analysis, Kolmogorov-Smirnov test, Kruskal-Wallis test, and Mann-Whitney U test (p < 0.05) were applied. RESULTS: All test specimens withstood the artificial aging without damage. The mean failure values were 382.1 (± 59.2) N (I3315), 347.0 (± 35.7) N (I3330), 315.9 N (± 30.9) (I3345), 531.4 (± 36.2) N (I3815), 514.5 (± 40.8) N (I3830), 477.9 (± 26.3) N (I3845), 710.1 (± 38.2) N (I4315), 697.9 (± 65.2) N (I4330), and 662.2 N (± 45.9) (I4345). The stability of the IACs decreased in all groups when bone loss inclined. Merely, the failure load values did not significantly differ among subgroups of I43. CONCLUSIONS: Larger implant diameters and minor circular bone loss around the implant lead to a higher stability of the IAC. The smaller the implant diameter was, the more the stability was affected by the circumferential bone level. CLINICAL RELEVANCE: Preserving crestal bone level is important to ensure biomechanical sustainability at implant systems with a conical interface. It seems sensible to take the effect of eventual bone loss around implants into account during implant planning processes and restorative considerations.

Forced surgical extrusion using an axial tooth extraction system as a practicable technique for preserving severely destroyed teeth? - Clinical outcomes up to 4.8 years.

OBJECTIVE: Several extrusion techniques have been described to restore teeth with insufficient coronal tooth structure and to avoid their extraction. Still, there is little evidence for a treatment concept combining surgical extrusion using an atraumatic axial extraction system. MATERIALS AND METHODS: A total of nine patients, each with an iso- or subgingival fractured tooth, were retrospectively examined. Treatment of the damaged tooth comprised an atraumatic forced surgical extrusion performed with an axial tooth extraction system and a more coronal positioning within the socket. The teeth were initially splinted and subsequently restored. The follow-up period was up to 57.1 months and averaged 36.5 (SD: ±13.5) months. RESULTS: All nine teeth were still in situ, without signs of inflammation. During the period of the provisional restoration, six prosthetic complications occurred, which were resolved with little effort, whereas, success rate for the definitive restoration was 100%. No biological complications were observed concerning the root apex or soft tissue. The radiographically measured mean extrusion distance was 3.4 (SD: ±1.0) mm, so that a sufficient prosthetic ferrule could be reestablished. CONCLUSIONS: Surgical extrusions using an axial tooth extraction system demonstrate low biological and prosthetic complications rates over observation time. CLINICAL SIGNIFICANCE: The presented extrusion approach preserves soft and hard tissue and is an efficient treatment option for severely destroyed teeth. Saving hopeless teeth by this relatively predictable and feasible procedure has hardly any disadvantages for patients, and in case of failure, an implant or fixed partial denture are still an option.

Predictable esthetics in hybrid and resin-based CAD/CAM restorative materials: Translucency as a function of material thickness.

AIM: The CAM of esthetically pleasing monolithic dental restorations presents with specific challenges. One vital parameter to consider is the translucency of the materials. Previous studies have proven a correlation between translucency and material thickness for various all-ceramic materials. The aim of the present study was to assess and define the relationship between thickness and translucency in modern resin-based restorative materials. MATERIALS AND METHODS: Specimens fabricated from two resin nano-ceramics (Cerasmart, Lava Ultimate), a polymer-infiltrated ceramic network (Vita Enamic), and a polymethyl methacrylate (Telio CAD) were examined, representing these different material classes. For each material, 12 specimens (n = 12) were fabricated in five thicknesses (0.4, 0.7, 1.0, 1.3, and 1.6 mm; N = 240). The translucency was measured with a spectrophotometer. The total light transmittance for each specimen was calculated applying specialized software. Regression curves were fitted to the results and their coefficient of determination (R2) fit was determined. RESULTS: Logarithmic regression curves showed the best R2 approximation (Cerasmart: R2 = 0.994; Vita Enamic: R2 = 0.978; Lava Ultimate: R2 = 0.997; Telio CAD: R2 = 0.997) to the light transmission values. CONCLUSIONS: The results of the present study indicate that the translucency of resin-based materials can be calculated using a mathematic approach to estimate their optical behavior. Cerasmart, Lava Ultimate, Vita Enamic, and Telio CAD exhibit a logarithmic relationship between material thickness and translucency. By determining material-specific coefficients for this logarithmic function, the resulting translucency can be computed for any given material thickness.

Towards a Precise NMR Quantification of Acute Phase Inflammation Proteins from Human Serum.

Nuclear Magnetic Resonance (NMR) spectra of human serum and plasma show, besides metabolites and lipoproteins, two characteristic signals termed GlycA and B arising from the acetyl groups of glycoprotein glycans from acute phase proteins, which constitute good markers for inflammatory processes. Here, we report a comprehensive assignment of glycoprotein glycan NMR signals observed in human serum, showing that GlycA and GlycB signals originate from Neu5Ac and GlcNAc moieties from N-glycans, respectively. Diffusion-edited NMR experiments demonstrate that signal components can be associated with specific acute phase proteins. Conventionally determined concentrations of acute phase glycoproteins correlate well with distinct features in NMR spectra (R2 up to 0.9422, p-value <0.001), allowing the simultaneous quantification of several acute phase inflammation proteins. Overall, a proteo-metabolomics NMR signature of significant diagnostic potential is obtained within 10-20 min acquisition time. This is exemplified in serum samples from COVID-19 and cardiogenic shock patients showing significant changes in several acute phase proteins compared to healthy controls.

Mineralocorticoid receptor-antagonism prevents COVID-19-dependent glycocalyx damage.

Proinflammatory cytokines target vascular endothelial cells during COVID-19 infections. In particular, the endothelial glycocalyx (eGC), a proteoglycan-rich layer on top of endothelial cells, was identified as a vulnerable, vasoprotective structure during infections. Thus, eGC damage can be seen as a hallmark in the development of endothelial dysfunction and inflammatory processes. Using sera derived from patients suffering from COVID-19, we could demonstrate that the eGC became progressively worse in relation to disease severity (mild vs severe course) and in correlation to IL-6 levels. This could be prevented by administering low doses of spironolactone, a well-known and highly specific aldosterone receptor antagonist. Our results confirm that SARS-CoV-2 infections cause eGC damage and endothelial dysfunction and we outline the underlying mechanisms and suggest potential therapeutic options.

Application of 3D-printed colored 3D-models for the fabrication of full ceramic restorations: A technical report.

OBJECTIVE: This paper presents a novel digital workflow that expedites and facilitates the manufacturing of high-end full-ceramic restorations based on "Print and Press"-Technology combined with 3D-printed colored 3D-models. CLINICAL CONSIDERATIONS: Despite ongoing innovations and developments in the digital workflow, the precision, and the final esthetic outcome is still limited compared with conventional press ceramics. The proposed method combines the advantages of digital scan- and design technologies with the proven conventional press-technology to accomplish high-end full-ceramic restorations. The restoration is digitally designed, the data set is 3D-printed in resin that can be burned out, subsequently conventionally embedded and pressed. Final esthetic finishing of the partial restorations is done on a 3D-printed physical colored 3D-model. CONCLUSION: The report describes synergetic effects of digital and analog procedures. 3D-printed colored 3D-models can positively support the manufacturing of full ceramic restorations regarding their optical integration. Therefore, the use of 3D-printed colored 3D-models signifies a new innovative technique with many promising application areas. CLINICAL SIGNIFICANCE: The combination of excellent clinical long-term data for pressed ceramic restorations and proven digital processes, like intraoral scanning, design, and additive manufacturing, in the dental field promise an individual workflow for predictability and excellent esthetics.

Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality. METHODS: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score-matched cohort. RESULTS: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63-0.98]; P=0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site-related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%). CONCLUSIONS: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.

Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial.

BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.

Best practices on critical reagent characterization, qualification, and life cycle management for HCP immunoassays.

The performance of immunoassays for the detection and quantification of host-cell proteins (HCPs) in biopharmaceuticals depends on the quality of the critical assay reagents. Not only their preparation, but also a stringent life-cycle management, including reagent qualification, requalification, and replacement, plays a crucial role in ensuring consistent and reliable results. To provide a cross-industry perspective on HCP reagent management, we conducted a survey on common practices among several pharmaceutical and biotech companies. Based on its outcome, as well as informed by a corresponding roundtable session ("Managing critical reagents over time") at the BioPharmaceutical Emerging Best Practices Association HCP conference in 2019, this study presents specific recommendations and proven concepts to support immunoassay reagent management for monitoring HCPs.

Questioning coverage values determined by 2D western blots: A critical study on the characterization of anti-HCP ELISA reagents.

Host cell proteins (HCPs) constitute a major class of process-related impurities, whose substantial clearance must be demonstrated by suitable analytical methods to warrant product quality and reduce potential safety risks for patients. In this regard, enzyme linked immunosorbent assays (ELISAs), which primarily rely on the quality of the HCP reference standard (immunogen) and HCP-specific polyclonal antibodies, are considered the gold standard for HCP monitoring. For the qualification of the employed antibodies, two-dimensional (2D) western blots (2D-WBs) are the preferred technique to determine the coverage, though a number of practical constraints are well recognized. By using several orthogonal approaches, such as affinity-based mass spectrometry and indirect ELISA, the present study revealed potential detection gaps (i.e., noncovered HCPs) of conventional 2D-WBs, which can be primarily attributed to two different root causes: (i) low amounts of proteins or antibodies being unable to overcome the detection limit and (ii) western blot artifacts due to the loss of conformational epitopes through protein denaturation hindering HCP-antibody recognition. In contrast, the lack of specific antibodies against certain (particularly, low molecular weight) HCPs, as proposed in previous studies, seems to play only a minor role. Together, these findings imply that CHO-HCP ELISA antibodies are better than qualification studies by 2D-WBs indicate.

The risk of worsening of myasthenia by cardiovascular medication as reflected by reporting frequency.

BACKGROUND AND PURPOSE: Some groups of cardiovascular drugs (beta-blocking drugs, Ca antagonists, antiarrhythmics) are listed as potentially worsening myasthenia. An empirical basis for alternative recommendations for antihypertensive and antiarrhythmic therapy in myasthenia patients has not yet been provided. METHODS: From the World Health Organization pharmacovigilance database, we retrieved total and myasthenia-related counts of adverse drug reactions for various groups of drugs used in cardiovascular disease and drugs with related mechanism of action used in other indications. We calculated the reporting odds ratio as a measure of a disproportional fraction of myasthenia-related events among all events. A 95% confidence interval of reporting odds ratio (ROR) >1 was taken as an indication for a higher risk. Because our approach involves a considerable number of tests, this situation is referred to as a signal that requires additional confirmation. RESULTS: A signal for an increased risk was noted for tizanidine, for alpha-blocking drugs, for beta-blocking drugs, and for Ca antagonists. ROR indicated a lower-than-average risk for salbutamol, angiotensin receptor antagonists, oral anticoagulants, thrombocytic function inhibitors, and heparins. CONCLUSIONS: Angiotensin receptor antagonists, angiotensin-converting enzyme inhibitors, and diuretics seem to be safe in antihypertensive therapy. Surprisingly, and yet requiring confirmation by case reports, alpha receptor-blocking drugs seem to carry a risk of myasthenia worsening. Amiodarone seems to be a safe alternative in antiarrhythmic therapy in patients with myasthenia.

A Comprehensive Assessment of All-Oleate Polysorbate 80: Free Fatty Acid Particle Formation, Interfacial Protection and Oxidative Degradation.

PURPOSE: Enzymatic polysorbate (PS) degradation and resulting free fatty acid (FFA) particles are detrimental to biopharmaceutical drug product (DP) stability. Different types and grades of polysorbate have varying propensity to form FFA particles. This work evaluates the homogenous all-oleate (AO) PS80 alongside heterogeneous PS20 and PS80 grades in terms its propensity to form FFA particles and other important attributes like interfacial protection and oxidation susceptibility. METHODS: FFA particle formation rates were compared by degrading PS using non-immobilized hydrolases and fast degrading DP formulations. Interfacial protection of monoclonal antibodies (mAbs) was assessed by agitation studies in saline using non-degraded and degraded PS. Several antioxidants were assessed for their ability to mitigate AO PS80 oxidation and subsequent mAb oxidation by a 40°C placebo stability study and a 2, 2'-Azobis (2-amidinopropane) dihydrochloride stress model, respectively. RESULTS: Visible and subvisible particles were significantly delayed in AO PS80 formulations compared with heterogeneous PS20 and PS80 formulations. Non-degraded AO PS80 was less protective of mAbs against the air-water interface compared with heterogeneous PS20. Interfacial protection by AO PS80 improved upon degradation owing to high surface activity of FFAs. Diethylenetriaminepentaacetic acid (DTPA) completely mitigated AO PS80 oxidation unlike L-methionine and N-Acetyl-DL-Tryptophan. However, DTPA did not mitigate radical mediated mAb oxidation. CONCLUSION: AO PS80 is a promising alternative to reduce FFA particle formation compared with other PS types and grades. However, limitations observed here---such as lower protection against interfacial stresses and higher propensity for oxidation---need to be considered in assessing the risk/benefit ratio in using AO PS80.

Time and costs related to computer-assisted versus non-computer-assisted implant planning and surgery. A systematic review.

AIM: To study the time and costs involved with computer-assisted versus non-computer-assisted implant planning and placement. MATERIAL AND METHODS: Based on the PICO question, "In patients receiving dental implants, is computer-assisted implant planning and surgery (CAIPS) compared to non-computer-assisted implant planning and surgery (non-CAIPS) beneficial in terms of treatment related costs and time involved?", a search path was created to perform an electronic search in the databases PubMed, PubMed Central, EMBASE, and Cochrane. The publication period of eligible publications extended from 01.01.2005 to 04.05.2020. Four independent reviewers reviewed the literature to identify studies that met the eligibility inclusion criteria. A further manual search of articles was performed, and gray literature was excluded. Corresponding authors of potentially eligible manuscripts were contacted for further information. RESULTS: Of the 1354 retrieved titles after the search were screened. Thirty-one articles have been identified to read the full text, resulting in four articles to be analyzed for the present review all of which were RCTs. In total, 182 partially and completely edentulous patients were treated with 416 implants following either non-computer-assisted or computer-assisted implant planning and surgery to determine the duration of the single working steps and the financial aspects of the different procedures. CONCLUSIONS: When evaluating the time and costs involved with the diagnostic and planning procedures in computer-assisted implant planning and surgery workflow protocols, one can summarize that these are higher than in the non-computer-assisted workflow protocols. The time involved with the procedures appears to be the driving factor when it comes to economic considerations. On the basis of the conclusions, also the time for the prosthetic restoration should be taken into account.

Extracorporeal life support system during cardiovascular procedures: Insights from the German Lifebridge registry.

The frequency of mechanical circulatory support (MCS) device application has increased in recent years. Besides implantation in the emergency setting, such as circulatory arrest, MCS is also increasingly used electively to ensure hemodynamic stability in high-risk patients, for example, during percutaneous coronary interventions (PCI), valve interventions or off-pump coronary bypass surgery. Lifebridge (Zoll Medical GmbH, Germany) is a compact percutaneous MCS device widely used in daily clinical routine. The present study aimed to investigate the indications, feasibility, and outcomes after use of Lifebridge in cardiac interventions, evaluating a large-scale multicenter database. A total of 60 tertiary cardiovascular centers were questioned regarding application and short-term outcomes after the use of the Lifebridge system (n = 160 patients). Out of these 60 centers, eight consented to participate in the study (n = 39 patients), where detailed data were collected using standardized questionnaires. Demographic and clinical characteristics of the patient population, procedural as well as follow-up data were recorded and analyzed. In 60 interrogated centers, Lifebridge was used in 74% of emergency cases and 26% in the setting of planned interventions. The subcohort interrogated in detail displayed the same distribution of application scenarios, while the main cardiovascular procedure was high-risk PCI (82%). All patients were successfully weaned from the device and 92% (n = 36) of the patients studied in detail survived after 30 days. As assessed 30 days after insertion of the device, bleeding requiring red blood cell (RBC) transfusion constituted the main complication, occurring in 49% of cases. In our analysis of clinical data, the use of Lifebridge in cardiac intervention was shown to be feasible. Further prospective studies are warranted to identify patients who benefit from hemodynamic MCS support despite the increased rate of RBC transfusion due to challenges in access sites during cardiovascular procedures.

Immediate unselected coronary angiography versus delayed triage in survivors of out-of-hospital cardiac arrest without ST-segment elevation: Design and rationale of the TOMAHAWK trial.

Patients experiencing out-of-hospital cardiac arrest (OHCA) without ST-segment elevation are a heterogenic group with a variety of underlying causes. Up to one-third of patients display a significant coronary lesion compatible with myocardial infarction as OHCA trigger. There are no randomized data on patient selection and timing of invasive coronary angiography after admission. METHODS AND RESULTS: The TOMAHAWK trial randomly assigns 558 patients with return of spontaneous circulation after OHCA with no obvious extracardiac origin of cardiac arrest and no ST-segment elevation/left bundle-branch block on postresuscitation electrocardiogram to either immediate coronary angiography or initial intensive care assessment with delayed/selective angiography in a 1:1 ratio. The primary end point is 30-day all-cause mortality. Secondary analyses will be performed with respect to initial rhythm, electrocardiographic patterns, myocardial infarction as underlying cause, neurological outcome, as well as clinical and laboratory markers. Clinical follow-up will be performed at 6 and 12 months. Safety end points include bleeding and stroke. CONCLUSION: The TOMAHAWK trial will address the unresolved issue of timing and general indication of angiography after OHCA without ST-segment elevation.