Incidence of delayed angiographic femoral artery complications using the EXOSEAL vascular closure device

Background and purpose

Femoral artery injuries are known complications of percutaneous vascular closure devices (VCDs). We studied the incidence of delayed femoral artery angiographic irregularities after neurointerventional procedures in which the EXOSEAL extravascular closure device was used for femoral arterial puncture closure.

Methods

Adult patients who underwent femoral arterial puncture closures with an EXOSEAL VCD and had a follow-up femoral artery angiogram from June 2012 through August 2013 were reviewed. A blinded radiologist compared pre-deployment and follow-up femoral arteriograms for the presence of femoral artery stenosis, dissection, pseudoaneurysm, or development of an arteriovenous fistula. Hospital records were reviewed for major or minor complications of the groin site or femoral artery.

Results

The EXOSEAL VCD achieved hemostasis, without evidence of a groin hematoma or requiring subsequent prolonged manual compression, in 400 of 441 closures following transfemoral arterial access, representing a device success rate of 90.7%. A total of 98 patients underwent 102 repeat angiograms following closure with the EXOSEAL VCD. The average time to the repeat angiogram was 73.5 days (range 0–488, median 28). Follow-up femoral arteriography demonstrated an irregularity in seven cases, all of which were vessel stenoses of <50%. There were no dissections, pseudoaneurysms, infections, or ischemic events in the study population.

Conclusions

Angiographic irregularities were seen in 6.86% of cases after closure with the EXOSEAL VCD. There were no clinically significant vascular complications. Thus, femoral artery closure with EXOSEAL carries a low risk of clinically significant delayed angiographic findings.     

Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of Video-Assisted Thoracic Surgery Lobectomy Procedures: A Retrospective,Observational Study

Introduction

Video-assisted thoracic surgery (VATS) lung resections are complex procedures with a critical role played by endoscopic staplers in the transection of vessels, bronchi, and lung tissue. This retrospective, observational study compared hospital resource use, costs, and complications of VATS lobectomy procedures for whom powered versus manual endoscopic surgical staplers were used.

Methods

Patients?≥?18 years of age undergoing elective VATS lobectomy during an inpatient admission from January 1, 2012 to September 30, 2016 were identified from the Premier Healthcare Database (first admission?=?index admission). Use of either powered or manual endoscopic staplers during the index admission was identified from hospital administrative records. Multivariable regression analyses adjusting for patient, hospital, and provider characteristics and hospital-level clustering were carried out to compare the following outcomes between the powered and manual stapler groups: hospital length of stay (LOS), operating room time (ORT), hospital costs, complications (bleeding and/or transfusions, air leak complications, pneumonia, and infection), discharge status, and 30-, 60-, and 90-day all-cause readmissions.

Results

The powered and manual stapler groups comprised 659 patients (mean age 66.1 years; 53.6% female) and 3100 patients (mean age 66.7 years; 54.8% female), respectively. In the multivariable analyses, the powered stapler group had shorter LOS (4.9 vs. 5.9 days, P?<?0.001), lower total hospital costs ($23,841 vs. $26,052, P?=?0.009), and lower rates of combined hemostasis complications (bleeding and/or transfusions; 8.5% vs. 16.0%, P?<?0.001) and transfusions (5.4% vs. 10.9%, P?=?0.002), compared with the manual stapler group. Other outcomes did not differ significantly between the study groups. Similar trends were observed in subanalyses comparing devices across predominant manufacturers in each group, and in subanalyses of patients with comorbid chronic obstructive pulmonary disease.

Conclusion

In this analysis of VATS lobectomy procedures, powered staplers were associated with significant benefits with respect to selected types of hospital resource use, costs, and clinical outcomes when compared with manual staplers.

Funding

Johnson & Johnson.

     

Use of glucose solution for the alleviation of gemcitabine-induced vascular pain: a double-blind randomized crossover study

Purpose

Gemcitabine is widely used for chemotherapy in many types of cancers. However, vascular pain frequently occurs during its infusion, which can be serious enough to cause treatment discontinuation. This study was conducted to determine whether dissolution with 5 % glucose solution would relieve vascular pain compared with the approved use of saline as the diluent.

Methods

Patients with cancer who were treated with weekly gemcitabine were eligible. Vascular pain was assessed during two consecutive administrations in a double-blind, randomized crossover study. One group was scheduled to receive gemcitabine dissolved in saline followed by gemcitabine in 5 % glucose solution. In the other group, 5 % glucose solution was followed by saline. The primary endpoint was frequency of vascular pain for the total infusions of each solvent and the secondary endpoints were intensity, as assessed on a visual analogue scale and duration of vascular pain.

Results

Eighty-seven patients were randomly assigned to each treatment schedule. Frequency of vascular pain was significantly lower with 5 % glucose solution compared with saline (40 versus 63 %; p?<?0.001). The intensity of vascular pain was also reduced with 5 % glucose solution compared with saline (mean, 1.3 versus 2.7 points; p?<?0.001). There was no significant statistical difference in duration of vascular pain between the 5 % glucose solution and saline solution groups (mean, 21 versus 18 min; p?=?0.420).

Conclusions

The use of 5 % glucose solution to dissolve gemcitabine significantly reduced the frequency and the intensity of vascular pain compared with the use of saline.     

Intraosseous vascular access in adults using the EZ-IO in an emergency department

Background

Intraosseous (IO) access is an alternative to conventional intravenous access.

Aims

We evaluate the use of the EZ-IO? as an alternative vascular access for patients in the emergency department.

Methods

A non-randomized, prospective, observational study was performed in adults using the EZ-IO? powered drill device.

Results

Twenty-four patients were recruited. There were 35 intraosseous insertions, including 24 tibial and 11 humeral insertions. All EZ-IO? insertions were achieved within 20 s and were successful at the first attempt except for one. Of the intraosseous insertions, 88.6% were reported to be easier than intravenous cannulation. We found flow rates to be significantly faster using a pressure bag. The seniority of operators did not affect the success of insertion. Complications included a glove being caught in the drill device and extravasation of fluid although they were easily preventable.

Conclusion

The use of the EZ-IO? provides a fast, easy and reliable alternative mode of venous access, especially in the resuscitation of patients with no venous vascular access in the emergency department. Flow rates may be improved by the use of pressure bags.     

International evidence-based recommendations on ultrasound-guided vascular access

Purpose

To provide clinicians with an evidence-based overview of all topics related to ultrasound vascular access.

Methods

An international evidence-based consensus provided definitions and recommendations. Medical literature on ultrasound vascular access was reviewed from January 1985 to October 2010. The GRADE and the GRADE-RAND methods were utilised to develop recommendations.

Results

The recommendations following the conference suggest the advantage of 2D vascular screening prior to cannulation and that real-time ultrasound needle guidance with an in-plane/long-axis technique optimises the probability of needle placement. Ultrasound guidance can be used not only for central venous cannulation but also in peripheral and arterial cannulation. Ultrasound can be used in order to check for immediate and life-threatening complications as well as the catheter’s tip position. Educational courses and training are required to achieve competence and minimal skills when cannulation is performed with ultrasound guidance. A recommendation to create an ultrasound curriculum on vascular access is proposed. This technique allows the reduction of infectious and mechanical complications.

Conclusions

These definitions and recommendations based on a critical evidence review and expert consensus are proposed to assist clinicians in ultrasound-guided vascular access and as a reference for future clinical research.     

Emergency department cancer unit and management of oncologic emergencies: experience in Asan Medical Center

Purpose

With the increasing incidence of cancer patients, our institute set up an emergency department (ED) unit for cancer (cancer emergency room, CER). We intended to clarify the operating characteristics and administrative benefits of the CER.

Methods

The CER was opened in May 2009. Retrospective review of all patients managed in the CER from January 2010 to December 2010 was performed, and data of the patients during January 2008 to December 2008 were collected to compare the care before and after the introduction of the CER.

Results

A total of 5,502 cancer patients visited the CER during 2010; 88.8?% had solid tumor and 11.2?% had hematologic malignancies. Diagnosis was grouped into four categories: disease progression (55.5?%), infection (22.8?%), treatment-related complications (14.7?%), and noncancer-related problems (7?%). Common treatments included antibiotic administration (28.9?%), pain control (22.9?%), and drainage procedures (16.2?%). Of the 5,502 patients, 52.7?% were discharged, 0.2?% died during the stay, home service was supplied to 0.6?% for palliative care, and 4.5?% were transferred to other hospitals including hospice care center. When compared with the year 2008, inpatient unit admission decreased, cost of care in both ED and inpatient unit was reduced (all P values <0.05). However, length of stay in ED and inpatient unit was not different.

Conclusion

ED unit for cancer has a valuable role in managing patients with cancers, not only progression of disease but also various toxicities related to its treatments.     

TEG® and RapidTEG® are unreliable for detecting warfarin-coagulopathy: a prospective cohort study

Background

Thromboelastography^® (TEG) utilizes kaolin, an intrinsic pathway activator, to assess clotting function. Recent published studies suggest that TEG results are commonly normal in patients receiving warfarin, despite an increased International Normalized Ratio (INR). Because RapidTEG? includes tissue factor, an extrinsic pathway activator, as well as kaolin, we hypothesized that RapidTEG would be more sensitive in detecting a warfarin-effect.

Methods

Included in this prospective study were 22 consecutive patients undergoing elective cardioversion and receiving warfarin. Prior to cardioversion, blood was collected to assess INR, Prothrombin Time, TEG, and RapidTEG.

Results

INR Results: 2.8?±?0.5 (1.6 to 4.2). Prothrombin Time Results: 19.1?±?2.2 (13.9. to 24.3). TEG Results (Reference Range): R-Time: 8.3?±?2.7 (2–8); K-Time: 2.1?±?1.4 (1–3); Angle: 62.5?±?10.3 (55–78); MA: 63.2?±?10.3 (51–69); G: 9.4?±?3.5 (4.6-10.9); R-Time within normal range: 10 (45.5%) with INR 2.9?±?0.3; Correlation coefficients for INR and each of the 5 TEG variables were insignificant (P?>?0.05). RapidTEG Results (Reference Range): ACT: 132?±?58 (86–118); K-Time: 1.2?±?0.5 (1–2); Angle: 75.4?±?5.2 (64–80); MA: 63.4?±?5.1 (52–71); G: 8.9?±?2.0 (5.0-11.6); ACT within normal range: 9 (40.9%) with INR 2.7?±?0.5; Correlation coefficients for INR and each of the 5 RapidTEG variables were insignificant (P?>?0.05).

Conclusions

TEG, using kaolin activation, and RapidTEG, with kaolin and tissue factor activation, were normal in a substantial percent of warfarin patients, despite an increased INR. The false-negative rate for detecting warfarin coagulopathy with either test is unacceptable. The lack of correlation between INR and all TEG and RapidTEG components further indicates that these methodologies are insensitive to warfarin effects. Findings suggest that intrinsic pathway activation may mitigate detection of an extrinsic pathway coagulopathy.     

Cerebrovascular segmentation and planning of depth electrode insertion for epilepsy surgery

Purpose

Depth electrodes are inserted in the brain to locate the epileptogenic zone without craniotomy, but there is risk of surgical hemorrhage. Preoperative planning is required to mitigate this risk. A preoperative imaging, segmentation and three dimensional (3D) visualization procedure was developed to provide neurosurgeons with cortical and vascular anatomy information for surgical planning and neuronavigation.

Methods

Cerebral vascular imaging was performed with phase-contrast magnetic resonance angiography (PC-MRA). Fuzzy c-means was performed to extract brain parenchyma from the PC-MRA images. A multi-scale vessel enhancement filter and thresholding process were combined to segment the vasculature and suppress background noise in the PC-MRA images. Finally, 3D visualization of the vasculature and cortical structures was implemented using volume rendering.

Results

Quantitative and qualitative validation of the vascular segmentation method were done. Using manual vascular segmentation as the gold standard, our method produced a satisfactory result: sensitivity was as high as 90 % at a specificity level of 95 %. Moreover, comparing the 3D visualizations of the vasculature and cortical structure for 4 patients with their respective intraoperative craniotomy photographs showed high levels of similarity.

Conclusion

A new automated segmentation and visualization procedure provides sufficient and accurate cortical and vascular anatomy information compared to intraoperative photographs. This method has potential to assist neurosurgeons with planning and neuronavigation for depth electrode insertion with avoidance of cerebral hemorrhage.     

Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis

Purpose

To evaluate the diagnostic accuracy of ultrasonography of optic nerve sheath diameter (ONSD) for assessment of intracranial hypertension.

Methods

Systematic review without language restriction based on electronic databases, with manual review of literature and conference proceedings until July 2010. Studies were eligible if they compared ultrasonography of ONSD with intracranial pressure (ICP) monitoring. Data were extracted independently by three authors. Random-effects meta-analysis and meta-regression were performed.

Results

Six studies including 231 patients were reviewed. No significant heterogeneity was detected for sensitivity, specificity, positive and negative likelihood ratios or diagnostic odds ratio. For detection of raised intracranial pressure, pooled sensitivity was 0.90 [95% confidence interval (CI) 0.80?C0.95; p for heterogeneity, p _het?=?0.09], pooled specificity was 0.85 (95% CI 0.73?C0.93, p _het?=?0.13), and the pooled diagnostic odds ratio was 51 (95% CI 22?C121). The area under the summary receiver-operating characteristic (SROC) curve was 0.94 (95% CI 0.91?C0.96).

Conclusions

Ultrasonography of ONSD shows a good level of diagnostic accuracy for detecting intracranial hypertension. In clinical decision-making, this technique may help physicians decide to transfer patients to specialized centers or to place an invasive device when specific recommendations for this placement do not exist.     

Management of acute coronary syndrome in emergency departments: a cross sectional multicenter study (Tunisia)

Background

We aimed to describe diagnosed acute coronary syndrome (ACS) and its care management and outcomes in emergency departments (EDs) and to determine related cardiovascular risk factors (CVRFs).

Methods

We conducted a cross sectional multicenter study that included 1173 adults admitted to EDs for acute chest pain (ACP) in 2015 at 14 sites in Tunisia. Data included patients’ baseline characteristics, diagnosis, treatment and output.

Results

ACS represented 49.7% of non-traumatic chest pain [95% CI: 46.7–52.6]; 74.2% of ACS cases were unstable angina/non-ST-segment-elevation myocardial infarction (UA/NSTEMI). Males represented 67.4% of patients with ACS (p?<?0.001). The median age was 60?years (IQR 52–70). Emergency medical service transportation was used in 11.9% of cases. The median duration between chest pain onset and ED arrival was two hours (Inter quartile ranges (IQR) 2–4?h). The age-standardized prevalence rate was 69.9/100,000 PY; the rate was 96.24 in men and 43.7 in women. In the multivariable analysis, CVRFs related to ST segment elevation myocardial infarction were age correlated to sex and active smoking. CVRFs related to UA/NSTEMI were age correlated to sex, familial and personal vascular history and type 2 diabetes. We reported 27 cases of major adverse cardiovascular events (20.0%) in patients with STEMI and 36 in patients with UA/NSTEMI (9.1%).

Conclusion

Half of the patients consulting EDs with ACP had ACS. Emergency medical service transportation calls were rare. Management delays were acceptable. The risk of developing an UA/NSTEMI was equal to the number of CVRFs +?1. To improve patient outcomes, it is necessary to increase adherence to international management guidelines.

     

AV interval optimization using pressure volume loops in dual chamber pacemaker patients with maintained systolic left ventricular function

Background

Atrioventricular (AV) interval optimization is often deemed too time-consuming in dual-chamber pacemaker patients with maintained LV function. Thus the majority of patients are left at their default AV interval.

Objective

To quantify the magnitude of hemodynamic improvement following AV interval optimization in chronically paced dual chamber pacemaker patients.

Patients and methods

A pressure volume catheter was placed in the left ventricle of 19 patients with chronic dual chamber pacing and an ejection fraction >45?% undergoing elective coronary angiography. AV interval was varied in 10?ms steps from 80 to 300?ms, and pressure volume loops were recorded during breath hold.

Results

The average optimal AV interval was 152?±?39?ms compared to 155?±?8?ms for the average default AV interval (range 100–240?ms). The average improvement in stroke work following AV interval optimization was 935?±?760?mmHg/ml (range 0–2,908; p?p?=?0.01).

Conclusion

The overall hemodynamic effect of AV interval optimization in patients with maintained LV function is in the same range as for patients undergoing cardiac resynchronization therapy for several parameters. The positive effect of AV interval optimization also applies to patients who have been chronically paced for years.     

Cardiac troponin T concentrations above the 99th percentile value as measured by a new high-sensitivity assay predict long-term prognosis in patients with acute coronary syndromes undergoing routine early invasive strategy

Objective

A recently developed immunoassay for high-sensitivity measurement of cardiac troponin T (hsTnT) allows measurement at the 99th percentile for a normal population with an assay imprecision <10%. It is unclear whether such a low cutpoint (14?ng/L) is helpful for long-term risk stratification of patients with an acute coronary syndrome (ACS) undergoing routine early invasive strategy.

Patients and main outcome measures

Consecutive patients with ACS admitted to a chest pain unit were studied. The usefulness of hsTnT for early diagnosis of myocardial infarction (MI) and prediction of all-cause death or death/MI over a median of 271?days following presentation was compared against the fourth generation cTnT at the 99th percentile cutpoint.

Results

Of 1,384 patients with ACS enrolled, 47.8% had non-ST-segment elevation MI (NSTEMI), 26.4% unstable angina, 21.8% STEMI and 4% had non-ACS. Adjusted risk for all-cause death [adjusted HR 8.26 (95%CI: 1.13?C66.33), p?=?0.038] and death/MI [adjusted HR 2.71 (95% CI: 1.15?C6.38), p?=?0.023] were significantly higher with hsTnT above the 99th percentile. In particular, among patients with a standard fourth generation cTnT result below the 99th percentile cutoff (0.01?ng/mL), hsTnT improved risk assessment. Mortality risk associated with an elevated hsTnT was present across the spectrum of ACS, as well as in conditions with hsTnT elevations not related to ACS.

Conclusion

hsTnT at the 99th percentile cutoff is useful for the diagnostic evaluation of patients with ACS, and provides strong and independent predictive power for adverse long-term outcomes even after early invasive strategy.     

Gender-specific predictors of early mortality after coronary artery bypass graft surgery

Background

Female gender is a risk factor for early mortality after coronary artery bypass graft surgery (CABG). Yet, the causes for this excess mortality in women have not been fully explained.

Objectives

To analyse gender differences in early mortality (30?days post surgery) after CABG and to identify variables explaining the association between female gender and excess mortality, taking into account preoperative clinical and psychosocial, surgical and postoperative risk factors.

Methods

A total of 1,559 consecutive patients admitted to the German Heart Institute Berlin (2005–2008) for CABG were included in this prospective study. A comprehensive set of prespecified preoperative, surgical and postoperative risk factors were examined for their ability to explain the gender difference in early mortality.

Results

Early mortality after CABG was higher in women than in men (6.9 vs. 2.4?%, HR 2.91, 95?% CI 1.70–4.96, P?P?P?P?=?0.01), respiratory insufficiency (9.4 vs. 5.3?%, P?=?0.006) and resuscitation (5.2 vs. 1.8?%, P?=?0.001). The combination of these factors explained 71?% of the gender difference in early mortality; age and physical functioning alone accounted for 61?%. Adjusting for these variables, HR for female gender was 1.36 (95?% CI 0.77–2.41, P?=?0.29).

Conclusions

Age, physical function and postoperative complications are key mediators of the overmortality of women after aortocoronary bypass surgery. Self-assessed physical functioning should be more seriously considered in preoperative risk assessment particularly in women.     

Efficacy and safety of a high loading dose of clopidogrel administered prehospitally to improve primary percutaneous coronary intervention in acute myocardial infarction: the randomized CIPAMI trial

Objectives

To compare a loading dose of 600?mg clopidogrel given in the prehospital phase versus clopidogrel administered only after the diagnostic angiogram in patients with STEMI scheduled for primary PCI.

Background

The optimal time and dose for the initiation of clopidogrel therapy in patients with STEMI scheduled for primary PCI has not been studied in prospective randomized trials.

Methods

The primary efficacy endpoint was the TIMI 2/3 patency of the infarct-related artery in the diagnostic angiography immediately prior to PCI.

Results

We randomized 337 patients to prehospital (n?=?166) loading dose versus standard therapy (n?=?171). The time interval between initiation of clopidogrel therapy and diagnostic angiography was 47?min. TIMI 2/3 patency before PCI was not different between the groups (49.3 vs. 45.1%, P?=?0.5). We observed a trend towards a reduction of the combined endpoint death, re-infarction, and urgent target vessel revascularization in the prehospital-treated patients (3.0 vs. 7.0%, P?=?0.09), this difference was significant if patients were classified as treated (4/161 vs. 13/174; 2.5 vs. 7.5%, P?P?=?0.8).

Conclusions

Early inhibition of the platelet ADP-receptor with a high loading dose of 600?mg clopidogrel given in the prehospital phase in patients with STEMI scheduled for primary PCI is safe, did not increase pre-PCI patency of the infarct vessel, but was associated with a trend towards a reduction in clinical events.     

Safety and efficacy of different stent types for the endovascular therapy of extracranial vertebral artery disease

Objectives

This study aims to determine safety and efficacy of different stent types for extracranial vertebral artery stenting (EVAS) at a single-center institution.

Background

Although endovascular revascularization techniques are well established for a variety of arterial vessel territories, its role within the vertebrobasilar system is less well defined.

Methods

We retrospectively analyzed all EVAS procedures performed at our institution between 1997 and 2012.

Results

A total of 35 EVAS procedures were attempted in 35 patients with symptomatic occlusive extracranial vertebral artery (EVA) disease. Carotid self-expanding bare-metal stents (BMS-SE; n = 18), coronary balloon-expandable bare-metal stents (BMS-BE; n = 7) or drug-eluting stents (DES-BE; n = 16) were used according to physician’s choice. The overall technical and clinical success rate was 100 and 94 %, respectively. Periprocedural complications included one death 14 days after intervention due to complications of initial stroke and 3 (9 %) patients with access site complications. Follow-up after a median of 18 ± 21 months yielded an overall in-stent restenosis rate of 23 % and a recurring clinical symptoms rate of 20 % whereas both endpoints were closely associated as 83 % of patients with recurring symptoms showed significant restenosis. Concerning the stent type, BMS-SE were associated with a significant higher in-stent restenosis rate compared to balloon-expandable stents (p = 0.012), and although not statistically significant, there was a clear trend towards a lower in-stent restenosis rate in drug-eluting compared to bare-metal stents (p = 0.068).

Conclusions

In patients with symptomatic extracranial vertebral artery disease, stenting is a safe and effective treatment option whereas balloon-expandable stents, and particularly drug-eluting stents, are superior to self-expanding stents.     

Transcatheter aortic valve implantation in patients with and without concomitant coronary artery disease: comparison of characteristics and early outcome in the German multicenter TAVI registry

Objective

To examine the prevalence and impact of concomitant coronary artery disease (CAD) on short-term outcome after transcatheter aortic valve implantation (TAVI).

Background

The prevalence of CAD in patients undergoing surgical aortic valve replacement is estimated at 30–50?% and its presence increases procedural risk. The prevalence and impact of CAD on outcome after TAVI are not well defined.

Methods

We analyzed 1,382 patients enrolled in the German TAVI registry; the majority (81?%) received the Medtronic CoreValve. The presence of coronary lesions with ≥50?% stenosis on pre-TAVI angiography defined the existence of concomitant CAD.

Results

859 patients (62.2?%) had concomitant CAD, of which 534 (62.3?%) had multi-vessel and 83 (9.7?%) left main disease. Patients with CAD were younger (81.5?±?6.1 vs. 82.1?±?6.3?years, p?<?0.05), more commonly males (49.4 vs. 30.0?%, p?<?0.0001) and diabetics (36.9 vs. 31.2?%, p?<?0.05), and had a worse Canadian Cardiovascular Society angina class at baseline compared to patients with no CAD. During TAVI patients with CAD more often required additional coronary intervention and had longer procedures, but procedural success rates were similar (97.1 vs. 97.7?%). Crude in-hospital mortality was higher in patients with CAD (10.0 vs. 5.5?%, OR 1.90, 95?% CI 1.23–2.93), but this was not significant after adjustment for confounders (adjusted OR 1.41, 95?% CI 0.85–2.33). Both groups had significant improvement in 30-day symptoms and quality of life.

Conclusion

The prevalence of CAD in contemporary TAVI patients is high. Its presence characterizes a high-risk population and is associated with increased crude short-term mortality, largely explained by co-morbidities, but does not limit functional improvement after TAVI.     

Comparison of 3,000 and 5,000 IU aXa/day certoparin in the prevention of deep-vein thrombosis after total hip replacement

Background

The aim was to investigate, whether 5,000 IUaXa/day certoparin lowers the incidence of deep vein thrombosis (DVT) in patients undergoing elective hip replacement surgery vs. 3,000 IUaXa/day. Double-blind, multicenter, randomised trial in 500 patients. Primary endpoint: incidence of symptomatic or asymptomatic DVT (bilateral ascending venography).

Results

Mean age was 71?±?10?years with a higher prevalence of previous DVT (8vs.4%) and pulmonary embolism (PE) (4vs.1%) in the high dose group. Mean duration of surgery was 82?±?32 and 85?±?36 min. DVT was detected in 28 (11.1%) of the low dose and 35 (14.1%) of the high dose group (p?=?n.s.). Combined distal-proximal DVT was observed in 5 (2%) and 4 (1.6%) patients respectively. No difference in bleeding events was found.

Conclusion

This trial confirms prior data showing that the conventional dosage of 3,000?IU aXa is effective and safe for the prevention of venous thromboembolic events after hip replacement surgery.     

The role of endovascular expertise in carotid artery stenting: results from the ALKK-CAS-Registry in 5,535 patients

Purpose

Several scientific committees have proposed an accentuation of operator minimal requirements before accreditation for carotid artery stenting is granted. The current study aims to identify potential effects from increasing site experience on periprocedural safety and outcome of carotid artery stenting (CAS).

Methods

Between 1996 and December 2009, 5,535 procedures have been entered into the prospective, controlled ALKK-CAS-Registry. The total cohort was divided in four subgroups according to the consecutive patient order at each participating center: patients 1–49 (n?=?1,485), 50–99 (n?=?1,118), 100–199 (n?=?1,521) and ≥200 (n?=?1,411).

Results

The median age of all patients was 71?years; 52.8?% had a symptomatic carotid stenosis. A decline in the rates of in-hospital major stroke (2.1, 1.9, 1.6, 0.9, p for trend 0.014) and of ipsilateral strokes (3.1, 2.4, 2.5, 1.6?%, p for trend 0.019) was substantiated with increasing site experience. This significant trend was preserved in the combined rate of major stroke and death (4.0, 3.2, 3.4, 2.4?%, p for trend 0.034). Apart from CAS experience, improvements in CAS technique, a decreasing number of symptomatic patients and an increasing number of procedures under embolic protection (each p for trend <0.05) might have contributed to these results.

Conclusions

The results show a gradual reduction of in-hospital stroke rates with increasing center experience. Extensive supervision of CAS learners and further promotion of proctorship programs seem to be essential.     

Cardiogoniometry as a diagnostic tool in patients with acute coronary syndromes: results of the CGM@ACS trial

Background

Cardiogoniometry (CGM) is a novel electrocardiac method utilising computer-assisted three-dimensional information on cardiac potentials.

Objective

To investigate the potential of CGM in discriminating non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and relevant coronary stenosis upon hospital admission by prospectively comparing its sensitivity, specificity and accuracy against those of a single troponin test and a 12-lead ECG performed on admission

Design

A multicenter prospective observational trial.

Setting

Eight interventional cardiac centres in Germany.

Patients

A cohort of 216 patients (mean age 67?years, 34.7?% female) who presented with acute chest pain or dyspnoea without ST-segment elevation and were scheduled for coronary angiography within 72?h of admission.

Intervention

Pre-angiography screening by CGM, troponin test, 12-lead ECG

Main outcome measures

ECG, troponin and CGM on admission compared with final diagnosis of NSTE-ACS or relevant diameter stenosis ≥70?% verified by an independent review board and an angiographic core laboratory.

Results

NSTE-ACS was finally confirmed in 162 cases, whereas the remaining 54 cases without proof of NSTE-ACS served as controls. Diagnostic sensitivity for NSTE-ACS was 28, 50 and 69?% and specificity 78, 96 and 54?% for first ECG, serial troponin and first CGM, respectively. Accuracy was 40, 62 and 65?%. The sensitivity of the tests to detect relevant coronary stenosis (n?=?126) was 32, 53 and 74?%, respectively. The sensitivity of CGM to detect NSTE-ACS (65?%) or relevant stenosis (71?%) was high even in patients with normal troponin and ECG.

Conclusions

CGM can detect NSTE-ACS at first medical contact. CGM in conjunction with traditional markers, 12-lead ECG and troponin may effectively aid early decision making in patients presenting with acute chest pain.     

Kosteneffizienzvergleich von Physiotherapie, manueller Therapie und hausärztlicher Therapie in der Behandlung von Nackenschmerzen

Objective

To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neckpain.

Design

Economic evaluation alongside a randomized controlled trial.

Setting

Primary care.

Participants

A total of183 patients with neck pain for at least two weeks recruited by 42 general practitioners and randomly allocated to manual therapy (n=60, spinal mobilization), physiotherapy (n=59, mainly exercise), or general practitioner care (n=64, counseling, education, and drugs).

Main outcome measures

Clinical outcomes were perceived: recovery, intensity of pain, functional disability, and quality of life. Direct and indirect costs were measured by means of cost diaries that were kept by patients for one year. Differences in mean costs between groups, cost effectiveness, and cost utility ratios were evaluated by applying non-parametric bootstrapping techniques.

Results

The manual therapy group showed a faster improvement than the physiotherapy group and the general practitioner care group up to 26 weeks, but differences were negligible by follow-up at 52 weeks. The total costs of manual therapy (447 EUR) were around one third of the costs of physiotherapy (1297 EUR) and general practitioner care (1379 EUR). These differences were significant: p<0.01 for manual therapy vs. physiotherapy and manual therapy vs. general practitioner care, and p=0.55 for general practitioner care vs. physiotherapy. The cost effectiveness ratios and the cost utility ratios showed that manual therapy was less costly and more effective than physiotherapy or general practitioner care.

Conclusions

Manual therapy (spinal mobilization) is more effective and less costly for treating neck pain than physiotherapy or care by a general practitioner.