[Reimbursement in psychiatry and psychosomatics: proof of concept for a system based on daily costs]. / Vergütungssystem für Psychiatrie und Psychosomatik: Studie zur Machbarkeit eines tageskostenbasierten Entgeltsystems.

BACKGROUND: In Germany a new reimbursement system for psychiatry and psychosomatics is under development. Based on total costs of each case from selected hospitals and day clinics, in 2013 the Institute for the Hospital Remuneration System (InEK) proposed to reimburse the hospital costs daily with step-wise decreasing remuneration, mainly depending on the ICD-10 diagnosis, duration of stay and some complicating factors (PEPP grouper). It is controversial whether this degressive system will result in an inadequate remuneration of patients with longer duration of severe symptoms, such as suicidality in depression or autoaggressive behavior in borderline personality disorder and will eventually lead to advantages for acutely ill patients with short duration of stay compared to chronically ill patients. OBJECTIVES: This study formulated and tested an alternative remuneration system (proof of concept) mainly based on an analysis of daily cost data instead of the total costs of each case. MATERIAL AND METHODS: The study is based on 147,749 treatment days from 4,633 cases of patients with psychotic disorders (PEPP-PA03) in 6 hospitals. As possible cost separating factors the study analyzed days with and without intensive psychiatric care, 1 to 1 care, psychological diagnostics, magnetic resonance imaging (MRI), acute crisis intervention, age at admission, the first days of treatment and day of discharge. RESULTS AND DISCUSSION: Nearly all factors tested were shown to be statistically significant in separating daily hospital costs. Based on these findings an alternative calculation algorithm (TEPPconcret), which grouped the cases with respect to age, intensive care, 1 to 1 care, treatment days 1-4 and day of discharge, was formulated and tested. For psychotic disorders TEPPconcret with a basic rate complemented by daily add-on payments depending on the effort involved, is a serious alternative to the PEPP system and awaits further evaluation.

Innovative technologies for SFA occlusions: drug coated balloons in SFA lesions.

The concept of using a balloon catheter to directly deliver an antiproliferative drug at the site of injury has become one of the most interesting technological developments in endovascular therapy. There have been important advances in knowledge concerning balloon-based drug delivery technologies during the last years, and different methods have been developed by different companies to coat the balloon with the antiproliferative agent. Currently there is a rapidly increasing clinical study program using drug coated balloons (DCB) in different locations and indications. There are four already finished randomized studies in patients with superficial femoral artery lesions investigating the efficacy of paclitaxel release by DCB, and all demonstrated significantly improved patency rates compared to balloon angioplasty with non coated balloons. DCB offer several advantages compared to drug eluting stents, since any stentless technology for improvement of longterm patency is preferable to overcome the drawbacks of stenting. This technology has demonstrated the capacity to have a significant impact on the practice of percutaneous cardiovascular interventions in the future.

Evidence of carotid atherosclerosis in orthopantomograms and the risk for future cardiovascular events.

BACKGROUND: Evidence of carotid atherosclerosis can be detected in 3 to 5% of orthopantomogram (OPG) investigations. The clinical impact of these findings is unknown. We investigated the association of OPG findings of carotid atherosclerosis with the occurrence of future cardiovascular adverse events. PATIENTS AND METHODS: We randomly selected 411 of 1268 participants with pre-existent cardiovascular disease from the prospective Inflammation in Carotid Arteries Risk for Arthrosclerosis Study (ICARAS) and assessed their OPGs for the presence of calcified atherosclerotic lesions or indirect signs of atherosclerosis, such as surgical clips or intravascular stents. The degree of carotid stenosis was measured by duplex ultrasound investigations. Patients were then followed for median 39 months (interquartile range 33 to 44 months) for the occurrence of major adverse cardiovascular events (MACE) including myocardial infarction, coronary revascularisation, stroke and death. RESULTS: We found no statistically significant association between the presence of carotid atherosclerosis detected on OPGs and the presence of a significant carotid stenosis (left carotid artery kappa=0.08; right carotid artery kappa=0.12), or the degree of carotid stenosis (P=0.20). Furthermore, the presence of OPG signs of carotid atherosclerosis was not statistically significant associated with future MACE (adjusted hazard ratio 0.92, 95% confidence interval 0.59 to 1.42; P=0.70). CONCLUSIONS: Evidence of carotid plaque revealed by OPGs in patients with previously known cardiovascular disease is no useful prognostic marker for MACE. Detection of carotid atherosclerosis by OPGs in these patients therefore has no clinical consequence.

New stents for SFA.

Endovascular stent implantation was introduced to femoropopliteal procedures almost two decades ago. Initial results with balloon-expandable stainless steel stents and self expanding Elgiloy stents, however, were disappointing. In particular, recurrence rates after long-segment femoropopliteal stenting were rather high, in the range of 60% to 80% at 1 year. After years of stagnation, recent developments in femoropopliteal stent technology have been promising. Self-expanding nitinol stents have been evaluated in several prospective studies. Initial problems with stent fractures seem to be resolved using second-generation devices. The second generation of Nitinol stents have an enhanced flexibility particularly also in axial direction due to a reduction of cell interconnections and a more spiral orientation of the interconnections. However, until now there is no proof of any impact of the stent design on restenosis rate. Otherwise, stenting has been shown to be beneficial compared to balloon angioplasty especially in longer femoropopliteal lesions. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The main unresolved problem with femoropopliteal stenting is the treatment of instent restenosis. Future concepts to further improve long-term patency after femoropopliteal stenting are therefore under investigation, including drug-eluting stents (DES), biodegradable stents, and coated stent-grafts. Stent grafts appear to be a viable option for the treatment of complex superficial femoral artery lesions, with comparable outcomes to prosthetic above-knee femoropopliteal bypass surgery. Concerning DES, we have to wait for the results of the ongoing studies.

Renal artery stenosis predicts adverse cardiovascular and renal outcome in patients with peripheral artery disease.

BACKGROUND: Patients with symptomatic peripheral artery disease (PAD) are considered cardiovascular high-risk patients. Our aim was to investigate whether incidental renal artery stenosis (RAS) increases the risk for adverse cardiovascular and renal outcomes in these patients. MATERIALS AND METHODS: We prospectively enrolled 487 consecutive patients admitted for revascularization of symptomatic PAD and performed a renal overview angiogram categorizing RAS as absent (0-29%), moderate (30-59%) and severe (>or= 60%) respectively. Clinical follow-up was for median 15 months (IQR 12-22) for the occurrence of major adverse events [MAE: composite of death, myocardial infarction (MI), stroke, percutaneous coronary intervention, coronary bypass surgery, amputation and kidney failure]. Glomerular filtration rates (GFR) were obtained at 12 months to quantify the course of renal function. RESULTS: A severe RAS was found in 76 patients (15.6%). Overall MAE occurred in 121 patients (24.8%), the composite endpoint of MI, stroke, amputation and death occurred in 101 patients (20.7%). Patients with a severe RAS had a 1.87-fold increased adjusted risk for MAE (95% CI 1.12-3.12, P = 0.017), a 2.51-fold increased adjusted risk for occurrence of the composite endpoint of MI, stroke, amputation and death (95% CI 1.45-4.34, P = 0.001) and a 2.93-fold increased risk for death (95% CI 1.41-6.08, P = 0.004), compared to those of patients without RAS respectively. We observed a significant association between the decrease of GFR over the 12-month follow-up period and the severity of RAS by multivariable analysis (P = 0.044). CONCLUSION: Severe RAS in patients with symptomatic PAD is an independent predictor of major adverse cardiovascular events, adverse renal outcome and mortality.

Matching carotid anatomy with carotid stents.

Carotid artery stenting (CAS) has emerged as a promising minimal invasive treatment alternative to carotid arterectomy for patients with symptomatic and asymptomatic carotid artery stenosis. Complication rates of CAS continuously decreased during recent years. Operator experience and technical improvements equally contributed to the improved safety of the procedure. Today, devices specifically designed to fit the requirements of carotid interventions are available and allow a lesion-tailored interventional strategy. The choice of stents seems to play an important role in achieving optimal outcomes with the endovascular technique. Basically, three major types of stents are currently available: open cell nitinol stents, closed cell nitinol stents, and closed cell Elgiloy stents. The concept of cell design has implications on plaque coverage, but also on mechanical properties of the devices and conformation to carotid anatomy. The present review discusses the concept of lesion-tailored stenting to optimize early and late outcomes after CAS.

In vitro detection of C4d-fixing HLA alloantibodies: associations with capillary C4d deposition in kidney allografts.

Capillary C4d deposition is a valuable marker of antibody-mediated rejection (AMR). In this analysis, flow cytometric detection of alloantibody-triggered C4d deposition to HLA antigen-coated microparticles ([C4d]FlowPRA) was evaluated for its value as a marker for C4d deposition in renal allografts. For comparative analysis, 105 first renal biopsies performed for graft dysfunction and an equal number of concurrent sera were subjected to immunohistochemistry and [C4d] plus standard [IgG]FlowPRA, respectively. C4d deposition/fixation was detected in 17 biopsies and, applying [C4d]FlowPRA HLA class I and II screening, also in a small number of corresponding sera (N = 20). IgG reactivity detected by standard [IgG]FlowPRA was more frequent (49% of sera). Comparing [C4d]FlowPRA screening with capillary C4d staining, we found a high level of specificity (0.92 [95% confidence interval: 0.86-0.98]), which far exceeded that calculated for [IgG]FlowPRA (0.60 [0.50-0.70]). [IgG]FlowPRA screening, however, turned out to be superior in terms of sensitivity (0.94 [0.83-1.05] vs. 0.76 [0.56-0.97] calculated for C4d-fixing panel reactivity). Remarkably, posttransplant single antigen testing for identification of complement-fixing donor-specific alloreactivities failed to improve the predictive value of FlowPRA-based serology. In conclusion, our results suggest that detection of complement-fixing HLA panel reactivity could provide a specific tool for monitoring of C4d-positive AMR.

Non-randomized, prospective, multi-centre evaluation of the ABSOLUTE .035 peripheral self-expanding stent system for occluded or stenotic superficial femoral or proximal popliteal arteries (ASSESS Trial): acute and 30-day results.

AIM: The aim of the paper was to investigate the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of superficial femoral or proximal popliteal arteries. Due to a lack of large controlled trials proving its long-term durability femoropopliteal artery stenting is still a matter of debate. In this paper we report the study design, the acute and short-term results of a prospective European registry on the treatment of TASC B and C femoropopliteal lesions with the use of the ABSOLUTE stent. METHODS: This prospective, non-randomized, multi-centre study enrolled 122 patients with symptomatic peripheral occlusive disease at 14 sites in Europe. Patients were included with obstructed femoropopliteal arteries. Key inclusion criteria were de novo lesions > or = 4.0 mm and < or = 7.0 mm in diameter, and > or = 40 mm and < or = 200 mm in length. Single target vessel treatment had to be performed with a maximum of three stents. RESULTS: Mean target lesion length was 108 +/- 44 mm (range 22.2 to 200 mm) and mean reference vessel diameter 4.6 +/- 0.8 mm by quantitative angiography; 71% of the lesions analyzable by quantitative angiography (QA) had total occlusions. A total of 227 stents were implanted, 224 of which were deployed successfully (98.7%). Mean percentage of diameter stenosis was reduced from 90.9 +/- 15.5 % (range 41.3 to 100) to 19.0 +/- 8.4% (range 2.3 to 41.5). Device and procedural success were 83.6% each whereas technical success reached 100%. Sixteen lesions had a > or = 30% residual stenosis post-procedure, 6 of them (37.5%) rated as being calcified. Eleven patients experienced major complications (9.1%) and 6 patients experienced minor complications (5%) within 30 days. Duplex ultrasound based 1-month restenosis rate was 9.3%. Target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were 0.8% and 1.7%, respectively and amputation rate was 0.8%. Mean ankle-brachial index (ABI) at rest and after exercise increased significantly from baseline to 30 days follow-up by 0.63 +/- 0.20 to 0.94 +/- 0.17 and from 0.44 +/- 0.23 to 0.85 +/- 0.21, respectively (P<0.001 each). CONCLUSION: The treatment of TASC B and C femoro-popliteal lesions with use of the ABSOLUTE stent is safe and feasible. Short-term follow-up documents persistent improvement of hemodynamics. The 6- and 12-month data have to be awaited for further conclusions:

Endovascular stent implantation for treatment of peripheral artery disease.

Endovascular stent implantation is a rapidly emerging technology for treatment of arterial obstructions in the entire circulation. During recent years, several randomized studies evaluated the effects of stenting in lower limb arteries. We herein provide an overview on data of trials in the iliac and femoropopliteal vessel area discussing the benefits and limitations of endovascular stents. In the iliac arteries, midterm and long-term data from one randomized trial including analysis on patency, clinical outcomes, cost-effectiveness and quality of life indicate that balloon angioplasty with selective stenting remains the therapy of choice for endovascular revascularization. In the femoropopliteal arteries, balloon-expanding stents were not superior to balloon angioplasty for treatment of short lesions, and self-expanding nitinol stents also failed to show a beneficial effect in short lesions below 5 cm. However, including longer lesions, one randomized trial indicated a beneficial effect of nitinol stents in lesions with a median length around 10-12 cm. Further studies and longer follow-up intervals are needed to confirm these data. Meanwhile, balloon angioplasty with optional stenting also remains the recommended endovascular approach for the femoropopliteal segment.

Influence and interaction of diabetes and lipoprotein (a) serum levels on mortality of patients with peripheral artery disease.

BACKGROUND: Diabetes mellitus is a risk factor for early complications and mortality in patients with peripheral artery disease. Lipoprotein (a) [Lp(a)] is also suggested to be a marker of increased cardiovascular risk. We investigated the association and interaction between diabetes mellitus, lipoprotein(a) and mortality in high risk patients with peripheral artery disease (PAD). METHODS: We studied 700 consecutive patients [median age 73 years, interquartile range (IQR) 62-80, 393 male (56%)] with PAD from a registry database. Atherothrombotic risk factors (diabetes, smoking, hyperlipidaemia, arterial hypertension) and Lp(a) serum levels were recorded. We used stratified multivariate Cox proportional hazard analyses to assess the mortality risk at a given patient's age with respect to the presence of diabetes and Lp(a) serum levels (in tertiles). RESULTS: Patients with Lp(a) levels above 36 mg dL(-1) (highest tertile) and insulin-dependent type II diabetes had a 3.01-fold increased adjusted risk for death (95% confidence interval 1.28-6.64, P = 0.011) compared to patients without diabetes or patients with non-insulin-dependent type II diabetes. In patients with Lp(a) serum levels below 36 mg dL(-1) (lower and middle tertile), diabetes mellitus was not associated with an increased risk for death. CONCLUSION: Insulin-dependent type II diabetes mellitus seems to be associated with an increased risk for mortality in PAD patients with Lp(a) serum levels above 36 mg dL(-1). PAD patients with non-insulin-dependent type II diabetes, and patients with diabetes and Lp(a) levels below 36 mg dL(-1) showed survival rates comparable to PAD patients without diabetes.

Adequacy of automated peritoneal dialysis with and without manual daytime exchange: A randomized controlled trial.

Until now, it remains unclear whether the addition of manual daytime exchanges or increasing the nightly dialysate flow is the best strategy to optimize automated peritoneal dialysis (APD) treatment. In this open-label randomized controlled crossover trial, 18 patients with high-average (HA) or low-average (LA) peritoneal transport rates sequentially underwent two different APD regimens for 7 days each, with an intermittent washout period of 7 days. 'Manual exchange' treatment was a conventional APD with low nightly dialysate flow and one manual daytime exchange. 'High-flow' treatment was defined by cycler therapy with high dialysate flow but without manual daytime exchange. Creatinine clearances (8.56+/-1.22 vs 7.87+/-1.04 l/treatment, P = 0.011) and urea nitrogen clearances (12.83+/-1.98 vs 11.68+/-1.06 l/treatment, P = 0.014) were significantly increased during 'high-flow' treatment compared to 'manual exchange' treatment. Sodium removal was significantly lower and glucose absorption was higher with the 'high-flow' regimen. Phosphate clearances, beta2-microglobulin clearances, ultrafiltration, and peritoneal protein loss were not different between the two treatment modalities. Subgroup analysis dependent on peritoneal transport types showed that the effect on clearances was most marked and significant in HA transporters, whereas sodium removal was lowest in LA transporters. We conclude that small solute clearances can be significantly improved and middle molecule clearances maintained in APD patients by increasing the nightly dialysate flow instead of adding a manual daytime exchange. However, the possible benefit of better clearances with higher nightly treatment volumes has to be weighed against increased costs and the possible negative impact of impaired sodium removal, especially in LA transporters.

Safety and efficacy of endoscopic balloon dilation for treatment of Crohn's disease strictures.

BACKGROUND AND STUDY AIMS: Strictures are a substantial cause of morbidity in patients with Crohn's disease. Endoscopic balloon dilation is a therapeutic option in limited strictures to avoid intestinal surgery, although there have been few reports regarding the long-term outcome. PATIENTS AND METHODS: Balloon dilation was scheduled for 46 patients (26 women, 20 men; median age 34) with Crohn's-associated symptomatic and radiographically confirmed intestinal stenosis. The study plan envisaged up to four consecutive treatments within the first 2 months until relief of symptoms, and thereafter dilations depending on clinical requirements. RESULTS: Dilation was not possible in seven of the 46 patients (15 %), due to technical problems (n = 2), internal fistulas (n = 3), or absence of a stenosis (n = 2). Thirty-nine patients received at least one treatment. The site of obstruction was the ileocolonic anastomosis in 23 of the 39 patients (59 %) and surgically untreated areas in 16 patients (41 %). After the initial dilation series (median 1, interquartile range 1-2), strictures were traversed in 37 of the 39 patients (95 %). During a median follow-up period of 21 months (range 3-98 months), 24 of the 39 patients (62 %) underwent a repeat intervention, including 12 (31 %) with repeat dilation, 11 (28 %) with surgical resection, and one patient who received an intestinal stent. The cumulative percentages of patients without a repeat intervention or surgery at 6, 12, 24, and 36 months were 68 %, 48 %, 36 %, and 31 %, and 97 %, 91 %, 84 % and 75 %, respectively. Two perforations and one case of severe bleeding were seen in the 73 dilation procedures (4 %) performed. CONCLUSIONS: Endoscopic balloon dilation is a safe and effective method that allows surgery to be avoided in approximately 75 % of patients with Crohn's-associated short intestinal strictures. However, recurrent symptoms frequently make it necessary to repeat the procedure.

Pivotal role of complement-fixing HLA alloantibodies in presensitized kidney allograft recipients.

Recipient presensitization represents a major risk factor for kidney allograft loss. Complement fixation may be a critical attribute of deleterious alloantibodies. We investigated clinical impact of complement-fixing HLA presensitization employing [C4d]FlowPRA, a novel assay permitting selective detection of HLA panel reactive antibody (PRA)-triggered C4 complement split product deposition. A cohort of 338 kidney transplants was evaluated for presensitization applying [C4d]FlowPRA together with [IgG]FlowPRA and complement-dependent cytotoxicity (CDC)-PRA. Analysis of HLA class I alloreactivities revealed a high incidence of C4d-positive graft dysfunction in [IgG]FlowPRA(+)/[C4d]FlowPRA(+) and [IgG]FlowPRA(+)/[C4d]FlowPRA(-) recipients (23% and 22% vs. 3% in [IgG]FlowPRA(-) patients). Only patients with complement-fixing HLA class I immunization had inferior graft survival [75% (3 years) vs. 91% and 89%, respectively (p=0.036)]. Despite frequent finding of capillary C4d deposition (28%), complement-fixing HLA class II immunization was not associated with inferior survival rates. This may have been due to reduction of clinical effects by intense immunosuppression in presensitized patients. Evaluating CDC, 29% of CDC-PRA(+)/[C4d]FlowPRA(+) recipients had C4d-positive graft dysfunction. For these patients 3-year graft survival was worst, followed by CDC-PRA(+)/[C4d]FlowPRA(-) and CDC-PRA(-) patients (76% vs. 81% vs. 90%, p=0.014). Results highlight a strong impact of complement-fixing HLA presensitization. Discerning complement-activating abilities of HLA alloantibodies, [C4d]FlowPRA may help identify recipients at particularly high risk for graft rejection and loss.

The role of multi-slice spiral CT angiography in patient management after endovascular therapy.

OBJECTIVES: To bring out the role of multi-slice spiral CT angiography (MS-CTA) in patient management after endovascular therapy of subclavian artery stenosis. METHODS: Twenty-one consecutive patients with clinically suspected restenosis after endovascular treatment of subclavian artery stenosis or occlusion were included in the study. Eleven patients had been treated with percutaneous transluminal angioplasty (PTA) alone and 10 with PTA and stenting. The mean follow-up period after PTA or stenting was 57 (+/-27 SD) months. CTA was performed using a bolus-triggered high-resolution protocol with biphasic intravenous contrast medium injection. Axial images and curved planar reformations (CPRs) were rated by three readers with regard to patency of supra-aortic vessels. Imaging findings were correlated with a standardized clinical assessment. RESULTS: All examinations were of diagnostic quality. Of 21 referred patients, 7 had significant reobstruction of the treated subclavian artery. Six of the 7 patients with significant restenosis on CTA were treated conservatively (antiplatelet agents), despite 2 of them being symptomatic on the standardized clinical assessment, which showed a sensitivity and specificity of 86% in predicting stenosis. One patient was treated with PTA and stent deployment because of strong subjective suffering. CONCLUSION: MS-CTA is useful for exclusion or quantification of clinically suspected restenosis in carefully selected patients after endovascular therapy where ultrasound is inconclusive and/or contrast-enhanced magnetic resonance angiography is contraindicated.

Haem oxygenase-1 genotype and cardiovascular adverse events in patients with peripheral artery disease.

BACKGROUND: A functional GT dinucleotide length polymorphism in the haem oxygenase-1 (HO-1) gene promoter is thought to be involved in the pathogenesis of cardiovascular disease. Short (< 25) (GT)n repeats are suggested to facilitate enhanced HO-1 up-regulation in response to injury and confer potent anti-inflammatory and antioxidative effects. MATERIALS AND METHODS: We investigated the association between the HO-1 GT-polymorphism and cardiovascular outcome in 472 patients with advanced peripheral artery disease. Cardiovascular risk profile and DNA samples for determination of the HO-1 genotype (carrier vs. noncarrier of a short (GT)n repeat allele) were obtained at baseline, and patients were followed for median 21 months for the occurrence of coronary events (myocardial infarction, percutaneous coronary interventions and coronary artery bypass graft), cerebrovascular events (stroke or carotid revascularization) and all-cause mortality. RESULTS: Coronary events occurred in 48 patients (9%), cerebrovascular events in 40 patients (9%) and 59 patients (13%) died. In total, 173 major adverse cardiovascular events (MACE) occurred in 133 patients (28%). Carriers of the short (GT)n repeat allele had a 0.46-fold reduced adjusted hazard ratio for coronary events (P = 0.016) as compared to noncarriers. No significant difference was found for cerebrovascular events, mortality and overall MACE. CONCLUSION: Apparently, the HO-1 genotype exerts potentially protective effects against coronary adverse events in patients with peripheral artery disease. Homozygous and heterozygous carriers of < 25 (GT)n repeats had lower rates of myocardial infarction, percutaneous coronary interventions and coronary bypass operations compared to patients with longer (GT)n repeats.

The role of Chlamydia pneumoniae in human aortic disease-a hypothesis revisited.

BACKGROUND: The role of Chlamydia pneumoniae in the pathogenesis of aortic aneurysm is controversial. We investigated the presence of C. pneumoniae in tissue samples excised from patients and controls. METHODS: Aortic wall specimens were obtained from 17 patients with acute Stanford type A aortic dissection, 25 patients with thoracic aortic aneurysms (TAA) and 23 patients with abdominal aortic aneurysms (AAA). Eighty-three tissue samples of 73 control patients free of aortic disease were obtained either at surgery or autopsy. The presence of Chlamydia subspecies DNA (sequences specific for all known Chlamydiaceae) and DNA of C. pneumoniae, C. trachomatis and C. psittaci were assessed by a validated highly sensitive and specific real time polymerase chain reaction (PCR) analysis. Atherosclerotic risk factors were assessed in all patients. RESULTS: We failed to detect C. pneumoniae and C. psittaci-DNA in any of the 148 vessel specimens. C. trachomatis-DNA was detected in 1/65 patients and in none of 83 controls (P=0.43). Chlamydia subspecies DNA was found in samples of eight cases and in one control (P=0.01), however, no significant differences were found between the subgroups aortic dissection (P=0.09), TAA (P=0.99) and AAA (P=0.15) and respective controls. CONCLUSIONS: C. pneumoniae does not play a clinically relevant role in acute and chronic aortic disease. The impact of other organisms of the family Chlamydiaceae needs further evaluation.

Effects of intravenous prostaglandin E1 on arterial compliance: a randomized controlled trial.

BACKGROUND: Prostanoids are in widespread use for the treatment of critical limb ischemia and are suggested to improve arterial compliance. However, dose- and time-dependency of these drug effects are indeterminate. We investigated the influence of intravenous application of prostanoids on arterial compliance parameters in patients with critical limb ischemia due to peripheral artery disease (PAD). PATIENTS AND METHODS: We included 82 consecutive patients with PAD Fontaine stage III and IV in a patient-blinded, randomized controlled trial. Patients were randomly assigned to either single dose intravenous treatment with 40 microg (n = 29) or 60 microg (n = 27) of Alprostadil (PGE1) in 250 ml 0.9% saline over 2 hours, or 250 ml 0.9% saline solution as a placebo group (n = 26). Large and small artery compliance was measured by peripheral pulse contour analysis at baseline, at one hour during intravenous infusion of Alprostadil, immediately after and 24 hours after the end of the infusion. For study purposes the patients received Alprostadil only once during the observation period of 2 days. RESULTS: Large artery compliance, blood pressure, heart rate and cardiac output were unaffected by PGE1 administration irrespectively of drug-dosage or time interval. Small artery compliance increased at 1 hour during intravenous application of Alprostadil (40 microg Alprostadil p = 0.001; 60 microg Alprostadil p < 0.0001) compared to placebo and increased median +47% (IQR +5% to +100%) after administration of 40 microg Alprostadil and median +32% (IQR -11% to +88%) after 60 microg Alprostadil (p = 0.5). Immediately after the end of Alprostadil infusion small artery compliance decreased to baseline levels. CONCLUSIONS: Prostaglandin E1 causes a significant improvement of small artery compliance during the time of intravenous application. However, this effect rapidly diminishes after the end of administration and no dose-dependency between 40 microg and 60 microg Alprostadil is observed.

Vasospasm of the scrotum--a manifestation of Raynaud's phenomenon?

Raynaud's phenomenon (RP) is characterized by local artery vasoconstriction in response to cold exposure or emotional stress. RP appears as attacks of blanching or cyanosis of digits, or both, followed by a hyperaemic phase. Usually the digits of the hands or less commonly of the feet are affected. Other sites such as nose, ears could also be affected. We report a patient who has been suffering for long time of cold induced sensitivity associated with well demarcated pallor of the scrotum.

Low level laser therapy for treatment of primary and secondary Raynaud's phenomenon.

BACKGROUND: We recently performed a pilot study which suggested that clinical and thermographic improvements occurred in patients with primary and secondary Raynaud's phenomenon (RP) following treatment with low level laser irradiation (LLLI). In view of these findings, we have proceeded with a double blind, placebo-controlled study. METHODS: Forty seven patients suffering from primary or secondary RP were randomly assigned in a double-blind manner to receive either 10 sessions of distant LLLI (16 f, 8 m, median age 45 years) or placebo irradiation (21 f, 2 m, median age 46 years) during winter months. The attack frequency of RP was measured by a diary count; its severity was assessed by means of visual analogue scale. Response to cold challenge test before and after LLL or placebo treatment was assessed by infrared thermography. RESULT: Overall a significant reduction of the frequency as well as the severity of RP in patients with either LLLI (frequency p < 0.0001, severity p < 0.0001) or placebo treatment (frequency p < 0.0001, severity p = 0.02) was found, but patients in the LLLI group exhibited a statistically more significant improvement of the frequency at 6 weeks p = 0.007 and 3 months p = 0.02 and the severity p = 0.02, p = 0.04 of RP. Thermographic response to cold challenge improved only in patients treated with LLL but not in those treated with placebo. CONCLUSION: LLLI significantly lowers the frequency and severity of Raynaud's attacks in patients with primary and secondary RP. Since this therapeutic modality is a safe, and non-invasive treatment, it might be considered as an alternative to existing therapeutic regimes.