Blood transfusion and venous thromboembolism trends and risk factors in primary and aseptic revision total hip and knee arthroplasties: A nationwide investigation of 736,061 cases.

BACKGROUND: Over the last years, new transfusion guidelines and pharmaceuticals have been introduced in primary and revision total hip and knee arthroplasty (P-THA, P-TKA, R-THA, R-TKA). In the US, a substantial decrease in transfusions has been observed in recent years. Little data exists on the subject in Europe. In this context we aimed to analyze: (1) Is there also a significant decrease in blood transfusion for these procedures in Germany? (2) Which patient and hospital related factors are associated with the risk of blood transfusion? (3) Is there a trend in complications, especially venous thromboembolism and stroke events that can be linked to tranexamic acid use? HYPOTHESIS: There is a significant trend in decreasing blood transfusions in hip and knee arthroplasty. METHODS: Using nationwide healthcare insurance data for inpatient hospital treatment, 736,061 cases treated between January 2011 and December 2017 were included (318,997 P-THAs, 43,780 R-THAs, 338,641 P-TKAs, 34,643 R-TKAs). Multivariable logistic regression was used to model the odds of transfusion as a function of the year of surgery. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were calculated. RESULTS: In each cohort the odds of transfusion decreased over time (2017 vs. 2011 (reference): P-THA: OR 0.42 (95%CI: 0.39-0.45), P-TKA: OR 0.41 (95%CI: 0.37-0.46), R-THA: OR 0.52 (95%CI: 0.47-0.58), R-TKA: OR 0.53 (95%CI: 0.46-0.61). Patient-related risk factors for blood transfusion included older age, female gender, lower Body Mass Index, comorbidities such as renal failure, cardiac arrhythmia, congestive heart failure, valvular disease, coagulopathy, depression, and antithrombotic medication prior to surgery. Venous thromboembolism or stroke events did not increase over the study period. DISCUSSION: The incidence of blood transfusions in primary and revision TKA and THA decreased over the study period. This may be due to new transfusion guidelines and the introduction of novel pharmaceuticals such as tranexamic acid. A further improved patient blood management and a focus on vulnerable patient groups might lead to a further future reduction of transfusions, especially in R-THA. LEVEL OF EVIDENCE: III; comparative observational study.

Low Hospital Volume Increases Re-Revision Rate Following Aseptic Revision Total Knee Arthroplasty: An Analysis of 23,644 Cases.

BACKGROUND: Along with rising numbers of primary total knee arthroplasty (TKA), the number of revision total knee arthroplasties (R-TKAs) has been increasing. R-TKA is a complex procedure requiring special instruments, implants, and surgical skills. Therefore it is likely that hospitals with more R-TKAs have more experience with this type of surgery and therefore fewer complications. The purpose of this study is to evaluate the relationship between hospital volume and re-revision rate following R-TKA. METHODS: Using nationwide healthcare insurance data for inpatient hospital treatment, 23,644 aseptic R-TKAs in 21,573 patients treated between January 2013 and December 2017 were analyzed. Outcomes were 90-day mortality, 1-year re-revision rate, and in-house adverse events. The effect of hospital volumes on outcomes were analyzed by means of multivariate logistic regression. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were calculated. RESULTS: Hospital volume had a significant effect on 1-year re-revision rate (≤12 R-TKA/a: OR 1.44, CI 1.20-1.72; 13-24 R-TKA/a: OR 1.43, CI 1.20-1.71; 25-52 R-TKA/a: OR 1.13, CI 0.94-1.35; ≥53 R-TKA/a: reference). Ninety-day mortality and major in-house adverse events decreased with increasing volume per year, but after risk adjustment this was not statistically significant. CONCLUSION: We found evidence of higher risk for re-revision surgery in hospitals with fewer than 25 R-TKA per year. It might contribute to improved patient care if complex elective procedures like R-TKA which require experience and a specific logistic background were performed in specialized centers.

Obesity Increases the Risk of Postoperative Complications and Revision Rates Following Primary Total Hip Arthroplasty: An Analysis of 131,576 Total Hip Arthroplasty Cases.

BACKGROUND: The aim of our study is to evaluate the association of body mass index (BMI) and the risk of postoperative complications, mortality, and revision rates following primary total hip arthroplasty given other potentially confounding patient characteristics in a large cohort study. METHODS: Using nationwide billing data for inpatient hospital treatment of the biggest German healthcare insurance, 131,576 total hip arthroplasties in 124,368 patients between January 2012 and December 2014 were included. Outcomes were 90-day mortality, 1-year revision procedures (with and without removal or exchange of implants), 90-day surgical complications, 90-day femoral fractures, and overall complications. The effect of BMI on outcome was analyzed using multivariable logistic regression. Risk-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: BMI had a significant effect on overall complications (30-34 in kg/m2: OR 1.1, CI 1.0-1.2, P = .014; 35-39: OR 1.5, CI 1.3-1.6, P < .001; ≥40: OR 2.1, CI 1.9-2.3, P < .001; <30: reference). The OR for 1-year revision procedures (30-34: OR 1.2, CI 1.1-1.4, P = .001; 35-39: OR 1.6, CI 1.4-1.8, P < .001; ≥40: OR 2.4, CI 2.1-2.7, P < .001; <30: reference) and 90-day surgical complications increased with every BMI category. For mortality and periprosthetic fractures there was a higher risk only for patients with BMI ≥40. CONCLUSION: BMI increases the risk of revision rates in a liner trend. Therefore, the authors believe that patients with a BMI >40 kg/m2 should be sent to obesity medicine physicians in order to decrease the body weight prior elective surgery.

Simulation of three surgical techniques combined with two different bone-borne forces for surgically assisted rapid palatal expansion of the maxillofacial complex: a finite element analysis.

Surgically assisted rapid palatal expansion (SARPE) is a common treatment to correct transverse maxillary deficiencies. Finite element analysis was simulated for six designs of SARPE based on a computed tomography scan of a human skull: median osteotomy with palatal (type A) or alveolar ridge (type B) bone-borne force, additional lateral osteotomy with palatal (type C) or alveolar ridge (type D) bone-borne force, and additional pterygomaxillary separation with palatal (type E) or alveolar ridge (type F) bone-borne force. The transverse expansion was about 1.0mm. The distribution of von Mises stress and the displacement were evaluated. The largest stress distribution was after types A and B, followed by types C and D, and finally types E and F. Displacement increased simultaneously. Palatal bone-borne forces (types A, C, and E) led to higher stress distributions in the midface and maxilla, but to a more parallel expansion compared with alveolar ridge-borne forces (types B, D, and F). The largest bony displacements at the midpalatal suture were anterior in all models. Increased weakening of the bony pillar of the facial skeleton and the use of palatal bone-borne forces leads to a decrease in stress distribution in the midface and to a more parallel transverse expansion of the maxilla.

Maxillary advancement versus mandibular setback in class III dentofacial deformity: are there any differences in aesthetic outcomes?

A retrospective evaluation of maxillary advancement and mandibular setback in class III patients was performed and their aesthetic outcomes compared. Patients with a sella-nasion-A-point angle (SNA) of 80-84° were selected. Pre- and postoperative lateral cephalograms were obtained for 34 class III patients; these were divided into two groups according to the surgical procedure performed: mandibular setback group (n=17) and maxillary advancement group (n=17). The pre- and postoperative cervical length, lip-chin-throat angle, lower/upper lip thickness, distance from the lower/upper lip to the aesthetic line, soft tissue angle, facial contour angle, and nasolabial angle of the two groups were compared. Significant differences were observed for cervical length (P=0.0003) and sex (P=0.003) when comparing maxillary advancement with mandibular setback. Although the preoperative cervical length was similar in the two groups, it increased significantly after maxillary advancement and decreased after mandibular setback. In this study, the differences in aesthetic outcomes depending on the surgical procedure performed were considered. Some aesthetically important parameters proved to be superior after maxillary advancement when compared to mandibular setback, even with the maxilla in the normal position.

Haemorrhagic shock in mice--intracellular signalling and immunomodulation of peritoneal macrophages' LPS response.

Haemorrhagic shock leads to decreased proinflammatory cytokine response which is associated with an increased susceptibility to bacterial infections. In the present study, the effect of GM-CSF on lipopolysaccharide (LPS)-induced TNF-alpha release and MAPkinase activation was analysed on the background of a possible immunostimulating activity of this substance. Male BALB/c mice were bled to a mean arterial blood pressure of 50 mmHg for 45 min followed by resuscitation. Peritoneal macrophages were isolated 20 h after haemorrhage and incubated with 10 ng/ml GM-CSF for 6h before LPS stimulation. TNF-alpha synthesis was studied in the culture supernatants using ELISA. Phosphorylation of ERK, p38MAPK and IkappaBalpha was detected by Western blotting. LPS-induced TNF-alpha production of peritoneal macrophages was significantly decreased 20 h after haemorrhage in comparison to the corresponding cells of sham-operated mice. In parallel the phosphorylation of IkappaBalpha was less in LPS-stimulated peritoneal macrophages from haemorrhagic mice. LPS-induced phosphorylation of ERK1/2 was also decreased in peritoneal macrophages isolated after haemorrhagic shock. In contrast, p38MAPK was phosphorylated more intensely after LPS-stimulation in macrophages collected from shocked mice. GM-CSF incubation elevated LPS-induced TNF-alpha response of macrophages from both sham-operated and shocked mice which was accompanied by an elevated IkappaB and ERK phosphorylation. In general, GM-CSF treatment in vitro enhanced peritoneal macrophages LPS-response both in terms of TNF-alpha synthesis and IkappaB and MAPK signalling, but the levels always stayed lower than those of GM-CSF-treated cells from sham-operated animals. In conclusion, GM-CSF preincubation could partly reactivate the depressed functions of peritoneal macrophages and may therefore exert immunostimulating properties after shock or trauma.

Efficacy and safety of a novel moldable, resorbable, and degradable sealant of bone surfaces for hemostasis after bone graft harvesting from the iliac crest.

STUDY DESIGN: A prospective, controlled, open, randomized multicenter study. OBJECTIVE: The study's objective was to demonstrate equivalence of a novel, moldable, resorbable, and degradable synthetic polymer (Bone Seal) compared with a collagen fleece (Lyostypt) in efficacy and safety for topical hemostasis after iliac crest bone graft harvesting. SUMMARY OF BACKGROUND DATA: Harvesting cortico-cancellous bone from the iliac crest is a well established procedure in orthopedic and particularly in spine surgery. It is associated with significant morbidity at the donor site where hematoma formation may cause impaired wound healing and infections in up to 10% of cases. METHODS: A total of 112 patients were included in the safety analysis. Safety was determined by a compound wound healing score and the incidence of adverse clinical effects. One hundred and eight patients were studied for equivalence in efficacy using a compound bleeding score. The handling properties and the application to the bone surface of either device were measured with two additional compound scores. RESULTS: The mean bleeding scores in the final analysis was 4.5 +/- 1.3 for the Bone Seal group and 4.2 +/- 1.3 for the collagen fleece group. Bone Seal was better applicable to the bleeding bone surfaces than the collagen fleece, even though its handling was more complicated. Wound healing and the incidences of adverse clinical events were comparable in either study group. CONCLUSIONS: Bone Seal is an effective and safe hemostatic material for sealing bleeding bone surfaces after iliac crest bone graft harvesting. By virtue of its hemostatic efficacy, Bone Seal is preventive for wound healing disorders.

Effects of antimicrobial agents on spontaneous and endotoxin-induced cytokine release of human peripheral blood mononuclear cells.

Because the immunomodulatory effects of antibiotics could possibly influence the degree of the systemic and local response to infection, knowledge of their intrinsic influence on the host's inflammatory response appears to be essential. Therefore, this study investigated the effects of frequently used antimicrobial agents (beta-lactams, quinolones gentamicin, vancomycin and metronidazole) on the in-vitro tumor necrosis factor (TNF)-alpha and interleukin (IL)-6 production of isolated human peripheral blood mononuclear cells (PBMNC), cultured with or without endotoxin, in comparison with those effects obtained in a whole-blood assay system. In the presence of ciprofloxacin, ofloxacin, gentamicin, vancomycin, and metronidazole, a significant inhibition of the endotoxin-stimulated TNF-alpha production of human peripheral blood mononuclear cells (PBMNC) was found at therapeutic levels. Only ofloxacin showed a significant inhibitory influence on the endotoxin-induced IL-6 production of PBMNC. In the whole-blood assay, significant effects were not detectable. None of the antibiotics showed cytotoxicity. It is concluded that, at present, the direct immunological effects of antibiotics should be interpreted carefully with regard to the experimental conditions, and regardless of the therapeutic implications. To assess the potential direct immunomodulatory effect of antimicrobial agents, different cell culture procedures should be used.

[The comparative effectiveness of different infusion and blood warming methods]. / Experimentelle Untersuchung zur Effektivität verschiedener Infusions- und Blutwärme-verfahren.

UNLABELLED: Heat loses during surgery occur mainly to the environment and due to infusions and irrigations. Infusions given at room temperature account for a great deal of the total heat deficit during major operations, e.g., the infusion of 53 ml/kg 20 degrees C fluid leads to a loss of 1 degree C in mean body temperature. Hence, heating i.v. fluids will add to the effect of other measures aimed at reducing heat loss to the environment. We investigated the efficacy of different warming methods for i.v. fluids in an experimental model by measuring the temperature at the end of the delivery line. METHODS: The following in-line warmers were studied: Hotline HL-90 and System H-250/heat exchanger D-50 (Level 1 Technologies, Marshfield, USA), Astotherm IFT 260 (Stihler Elektronic GmbH, Stuttgart, Germany), RSLB 30 H Gamida (Productions Hospitalieres Francaises, Eaubonne, France), Bair Hugger 241/Modell 500 Prototype (Augustine Medical, Eden Prairie, USA). They were compared with pre-warming infusions (39 degrees C) only using the Clinitherm S (Labor Technik Barkey GmbH, Bielefeld, Germany) and pre-warming with "active insulation" of the delivery line using the Autotherm/Autoline system (Labor Technik Barkey GmbH, Bielefeld, Germany). We investigated the influence of four variables on the efficacy of warming: (1) flow rate (50-15,000 ml/h); (2) ambient temperature (20 degrees C and 25 degrees C); (3) infusion bag temperature (6 degrees C, 20 degrees C, and 39 degrees C); and (4) length of infusion system downstream from the heat exchanger. Fluid temperatures were measured using thermistors of 1 mm diameter (Modell YSI 520, Yellow Springs Instruments Co., Yellow Springs, USA) incorporated into 3-way stopcocks. Temperatures were recorded using Hellige temperature monitors (Hellige GmbH, Freiburg im Breisgau, Germany) and the signals were collected at 10 Hz through an AD converter and averaged over 1 min. Flows were calculated by timed collection into calibrated cylinders; 10 to 12 different flow rates were taken to define one temperature/ flow plot. Effective warming was defined as a temperature > 33 degrees C at the end of the infusion line. RESULTS: At high flow rates (> 2,500 ml/h) using 20 degrees C fluids at 20 degrees C ambient temperature, the H-250/D-50 system gave the highest temperatures throughout the range and showed effective warming from 1,300 ml/h on over the entire range tested (35 degrees C at 17,000 ml/h) compared to the RSLB 30 H Gamida system (3,000-18,000 ml/h) (Fig. 2). This difference in performance was almost abolished with fluids at 6 degrees C (Fig. 4). Similar efficacy could be reached by using prewarmed infusions that gave effective warming at > 2,000 ml/h and reached 39 degrees C at 13,000 ml/h. Prewarmed infusions could be used effectively down to > 80 ml/h applying "active insulation" (Autotherm/Autoline) to the whole infusion system. The Hotline HL-90 (50-4, 700 ml/h) appeared to be the most effective in-line warmer in the low (< 250 ml/h) and middle (250-2,500 ml/h) flow range, followed by the Astotherm IFT 260 (400-4,000 ml/h), but only if used with a length of 40 cm down-stream from the heat exchanger (Fig. 1). Increasing this distance to 145 cm markedly reduced its efficacy below the range of 2,000 ml/min (1,200- 3,000 ml/h) (Fig. 5). The Bair Hugger 241 Prototype showed a narrow effective range (700-1,300 ml/h) that could be extended beyond 1,300 ml/h by the use of prewarmed infusions (Figs. 1 and 3). The performance for 6 degrees C solutions and ambient temperatures of 25 degrees C are given in Fig. 4 and Table 1. CONCLUSIONS: The importance of infusion warming increases with the amount of fluid given.(ABSTRACT TRUNCATED)

[Implantation of a phrenic stimulator in central respiratory paralysis]. / Implantation eines Phrenicus-Stimulators bei zentraler Atemlähmung.

Neoplastic or traumatic lesions of the brain stem or the upper spinal cord frequently cause respiratory insufficiency necessitating permanent mechanical ventilation. If the integrity of the diaphragm and its nerves is not affected, adequate ventilation can be achieved by electric stimulation of the phrenic nerves. Diaphragm pacing systems mean the patients can be independent of ventilator treatment. This is a psychological advantage for the patient, giving him or her the option of living in less specialized medical care units and perhaps even at home. CASE REPORT. We report the case of a 47-year-old man with a brain stem tumour, which was resected in large pieces. During the postoperative period an increasingly severe respiratory insufficiency developed, which finally made continuous mechanical ventilation necessary. After the viability of the phrenic nerves and contractility of the diaphragm had been shown by direct stimulation of the nerves to be still intact, it was decided that a diaphragm pacer system should be implanted. A "Diaphragm Pacer System S232 G" (Avery Laboratories, Glen Cove, N.Y., USA: external transmitter, antenna, implanted electrode and receiver) was implanted. Using a supraclavicular approach, phrenic nerve electrodes were placed around each nerve and connected with subcutaneous implants of radio signal receivers. Six days after implantation phrenic nerves were stimulated for a first short period. External antenna loops were taped to the skin over the implanted receiver sites (Fig. 3). The impulses produced by the transmitter were delivered via these antenna loops and led to contraction of the diaphragm, providing almost normal respiration. The duration of stimulation was increased stepwise from 1 h a day to full-time stimulation. Three weeks after implantation of the diaphragm pacer system the patient could be totally weaned from mechanical ventilation. After a further 2 weeks it was possible to discharge him from the intensive care unit, and he was then transferred to a rehabilitation centre.

Oxygen cost of breathing for assisted spontaneous breathing modes: investigation into three states of pulmonary function.

OBJECTIVE: We investigated the effects of continuous positive airway pressure (CPAP) and pressure support ventilation (PSV) on the oxygen cost of breathing (VO2resp) for different states of pulmonary function. Additionally VO2resp was measured during spontaneous breathing. DESIGN: This was done in a controlled and prospective study. Ventilatory modes were applied randomly. SETTING: Measurements were performed in a quiet room on volunteers (VOL) and inpatients treated for chronic obstructive pulmonary disease (COPD). Post-operative patients after aortocoronary bypass surgery (ACB) were studied on the cardio-thoracic intensive care unit just before and after extubation. PATIENTS: Healthy volunteers (n = 14), postoperative patients after aorto-coronary bypass surgery (n = 15) and patients with COPD (n = 9, xFEV1 47.7%) were the objects of study. INTERVENTIONS: Demand flow CPAP (5 mbar) and PSV (7 mbar, PEEP 5 mbar), using the Hamilton Veolar ventilator, were investigated in comparison to spontaneous breathing. MEASUREMENTS AND RESULTS: VO2 was measured by a Datex Deltatrac metabolic monitor. VO2resp was calculated by subtraction of total oxygen uptake (VO2tot) in controlled mode ventilation (CMV) from that in the respective spontaneous breathing mode. For VOL and COPD patients who were not intubated, a CPAP facemask connected to a short 7.5 mm tube was used as connection to the ventilator. Breathing spontaneously under a canopy system VOL showed a VO2resp of 4.5 +/- 4.0% compared to 9.2 +/- 3.5% for ACB and 15.4 +/- 7.7% for COPD. CPAP changed the VO2resp to 7.8 +/- 3.9%, 12.0 +/- 4.0% and 9.1 +/- 3.6% respectively. PSV reduced the VO2resp to 7.9 +/- 3.8% in ACB and 7.7 +/- 5.5% in COPD. CONCLUSIONS: This investigation confirms findings that postoperative patients have a mild increase in VO2resp. COPD exhibit the highest increase in VO2resp. Tracheal tubes, masks and CPAP on a demand flow apparatus increases VO2resp in volunteers and postoperative patients after cardiac surgery. The same amount of CPAP in contrary reduces VO2resp in patients with COPD. Pressure support ventilation can offset the additional VO2resp induced by CPAP but at the same level does not further reduce VO2resp in COPD patients.

[Echocardiographic functional parameters of the left ventricle as a prognostic indicator in coronary heart disease]. / Echokardiographische Funktionsparameter des linken Ventrikels als Prognoseindikator bei der koronaren Herzkrankheit.

The value of two-dimensional cross-sectional echocardiography for the estimation of the left ventricular function had been investigated in 241 consecutive patients with suspected coronary artery disease (CAD). The day before left heart catheterization the left ventricular volumes (EDV, ESV) as well as the global left ventricular ejection fraction (EF) were calculated from the RAO-equivalent in the 2D-echo and in addition the classification of the EF was visually performed from different cross-sections. The coronary angiography showed in 208/241 patients hemodynamically effective stenoses (lumen restriction greater than 50%). For 192/208 patients there were diagnostically usable 2D-echograms as well as clinical data over an observation period of 3 years and 7 months. The 2D-echo correspond quite well to the levocardiography for the calculation of the EDV with r = 0.75, with r = 0.85 for the ESV, and with r = 0.80 for the EF. The mere visual evaluation of the EF out of the 2D-echo agreed well in 84% of the cases to the quantitative determination. During the observation period 18/192 patients died; 17/18 of these patients of cardial causes. Out of the patients with normal EF in the 2D-echo only 3.5% died, with slightly reduced EF 10% died. With highly reduced EF mortality was with 40% significantly increased (p less than 0.001). Thus in patients with CAD unfavourable long-time prognosis may be quickly recognized by their markedly reduced left ventricular function in the 2D-echocardiogram, which shows favourable correspondence to invasive data.

[Spontaneous remission of lung metastases in renal cell carcinoma]. / Spontane Remission von Lungenmetastasen bei Nierenzellkarzinom.

Pulmonary metastases were first noted in a 47-year-old man, 15 months after a radical right nephrectomy and local radiotherapy. They progressed over the subsequent ten months despite progestagen administration. But they regressed slowly after the progestagen had been discontinued so that eight months later they were no longer demonstrable radiologically. The remission has so far persisted for 3 1/2 years.

Topographical analysis of proliferation ([3H]thymidine labelling index and mitotic index) as compared with tumour growth and tumour weight in xenotransplanted melanoma. Changes due to local and systemic application of azelaic acid.

Xenotransplanted human melanoma was investigated by measuring the increase in tumour volume and in final tumour weight (macroscopical parameters) and histomorphological parameters of cell proliferation: Mitotic index (MI) and autoradiographic [3H]thymidine labelling index (LI). A total of 87 tumours, derived from a human melanoma metastasis and a primary nodular melanoma respectively, were analysed by these methods in two series. Topical treatment of the tumours with azelaic acid cream resulted in a statistically significant reduction in the increase in tumour volume and, in the first series, in a clear decrease in final tumour weight and in the MI, as compared with controls. The LI was decreased only in the superficial region of the tumours, i.e. at the site of treatment. Subtumoral injection of azelaic acid (disodium salt solution) was the second route of local therapy. It was followed by a significant reduction in the increase in tumour volume, of final tumour weight (first series) and in the MI. The average LI was clearly smaller than in the controls, especially at the tumour base, which was the site of injection (local effect). Systemic (intravenous) injection of azelaic acid (same concentration of the disodium salt solution) had no negative effect on the increase in tumour volume or final tumour weight, but was followed by a clear reduction of the MI. The average LI of this group was significantly smaller than in the controls as well. This effect was most impressive in the perivascular regions of large and small vessels, which fact can be interpreted as a sort of local effect via the blood stream after systemic application of azelaic acid.(ABSTRACT TRUNCATED AT 250 WORDS)