Search

Background: With the advent of novel recanalization techniques and emerging devices, percutaneous coronary intervention (PCI) has become a promising leading treatment option for patients with chronic total occlusions (CTO). The present study aims to evaluate the acute outcomes of PCI in previously failed re-attempted vs. first-attempted CTO-lesions. Methods: Between 2012 and 2019, 619 patients were included and treated with PCI of at least one CTO. 253 patients were re-attempted lesions, while 366 were initially attempted lesions. Results: Re-attempted lesions were more complex, including higher Japanese-CTO (J-CTO) score and the need for a retrograde approach. The procedure time and fluoroscopy time were longer in this group. Nevertheless, overall success rates were comparable between both groups of patients. In-hospital events were rare and without significant differences. Conclusions: Re-attempted CTO lesions are more complex than first-attempt lesions and are associated with longer procedural times. However, they can be safely intervened by experienced operators with a similar success rate.

BACKGROUND: Venous thromboembolism (VTE), encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a leading cause of morbidity and mortality worldwide. METHODS: GARFIELD-VTE is a prospective, non-interventional observational study of real-world treatment practices. We aimed to capture the 36-month clinical outcomes of 10,679 patients with objectively confirmed VTE enrolled between May 2014 and January 2017 from 415 sites in 28 countries. FINDINGS: A total of 6582 (61.6 %) patients had DVT alone, 4097 (38.4 %) had PE ± DVT. At baseline, 98.1 % of patients received anticoagulation (AC) with or without other modalities of therapy. The proportion of patients on AC therapy decreased over time: 87.6 % at 3 months, 73.0 % at 6 months, 54.2 % at 12 months and 42.0 % at 36 months. At 12-months follow-up, the incidences (95 % confidence interval [CI]) of all-cause mortality, recurrent VTE and major bleeding were 6.5 (7.0-8.1), 5.4 (4.9-5.9) and 2.7 (2.4-3.0) per 100 person-years, respectively. At 36-months, these decreased to 4.4 (4.2-4.7), 3.5 (3.2-2.7) and 1.4 (1.3-1.6) per 100 person-years, respectively. Over 36-months, the rate of all-cause mortality and major bleeds were highest in patients treated with parenteral therapy (PAR) versus oral anti-coagulants (OAC) and no OAC, and the rate of recurrent VTE was highest in patients on no OAC versus those on PAR and OAC. The most frequent cause of death after 36-month follow-up was cancer (n = 565, 48.6 %), followed by cardiac (n = 94, 8.1 %), and VTE (n = 38, 3.2 %). Most recurrent VTE events were DVT alone (n = 564, 63.3 %), with the remainder PE, (n = 236, 27.3 %), or PE in combination with DVT (n = 63, 7.3 %). INTERPRETATION: GARFIELD-VTE provides a global perspective of anticoagulation patterns and highlights the accumulation of events within the first 12 months after diagnosis. These findings may help identify treatment gaps for subsequent interventions to improve patient outcomes in this patient population. ispartof: THROMBOSIS RESEARCH vol:222 pages:31-39 ispartof: location:United States status: published

Background: Percutaneous coronary intervention (PCI) of total chronic total occlusion (CTO) still remains a major challenge in interventional cardiology. There is only insignificant knowledge reported in the literature about the influence of body mass index (BMI) on acute outcome, including success rates and complications in CTO-PCI. Methods: Between 2012 and 2017, we included 508 patients. They underwent PCI for at least one CTO. Antegrade and retrograde CTO techniques were applied. The retrograde approach was used only after failed antegrade intervention. BMI was calculated according to the definitions of the World Health Organization. It was subdivided as normal weight (18.5–24.9 kg/m2), overweight (25–29.9 kg/m2), obese (30–34.9 kg/m2), and very obese (≥35 kg/m2). The Shapiro–Wilk test was used to test for normality of distribution. Continuous variables were tested for differences with Kruskal–Wallis or Mann–Whitney U test as appropriate. Categorical variables were tested with Fisher exact test. Results: Out of the 508 patients, 77 (15.2%) had normal weight, 286 (56.3%) were overweight, 106 (20.9%) obese, and 39 (7.7%) very obese. Radiation dose and examination time increased with elevated BMI categories (p

Background: The plasma-derived atherogenic index (AIP) is associated with an increasing risk for cardiovascular diseases. Whether an increased AIP may predict the complexity of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO), according to available research, has never been investigated before. Methods: Three hundred seventeen patients were included prospectively and treated with PCI for at least one CTO between 2012 and 2017. High-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) plasma levels were measured 24 h before PCI. All patients were stratified into tertiles of AIP (defined as 0.11, 0.11–0.21, > 0.21) based on their TG/HDL-C (AIP) levels. Results: Mean AIP of all patients undergoing CTO-PCI was 0.53 ± 0.29. The majority of patients were male (82.6%), and mean age was 61 ± 10.4 years. Increased AIP > 0.21 was associated with longer occlusion length (statistical trend p = 0.082) and stent routes (p = 0.022) and with a higher number of implanted stents (n > 4) (statistical trend p = 0.072). Success rates were similar in all AIP categories (p = 0.461). In-hospital PCI-related complications were rare and not statistically different (p = 0.852). Conclusions: This study demonstrates for the first time that an increased AIP may predict the complexity of CTO-PCI and additionally may help to improve planning and quality of CTO-PCI.

International audience; Exertional lower limb pain is a frequent diagnostic issue in elderly patients. Arterial claudication results from the mismatch between the oxygen requirement of, and oxygen delivery to the exercising muscles. Non-invasive vascular investigations (ultrasound imaging, plethysmography or segmental pressure) are used in routine at rest or following exercise, but none can be used during walking or to directly monitor cutaneous oxygen delivery to the limb. Here, we review the methods, tips and traps of the transcutaneous oxygen pressure measurement technique and potential applications.Transcutaneous oxygen pressure measurement is largely used in vascular medicine for patients with critical limb ischemia. It can also detect regional blood flow impairment at the proximal and distal limb simultaneously and bilaterally during exercise. Exercise-oximetry can also analyze systemic oxygen pressure changes on a reference area on the chest, to screen for occult pulmonary disease. As a surface technique, it does not directly measure muscle oxygen content but provides a reliable estimation of regional blood flow impairment.With the use of a recently reported index that is independent of the unknown transcutaneous gradient for oxygen, exercise-oximetry provides some accurate information compared to classical non-invasive vascular investigations to argue for a vascular or non-vascular origin of exertional lower limb pain during exercise. Although a time consuming technique, it is a simple test and it is progressively spreading among referral vascular centers as a useful non-invasive diagnostic tool for patients suspected of arterial claudication.

ZusammenfassungDie Dosierungen der direkten oralen Antikoagulanzien für die langfristige Erhaltungstherapie nach akuter tiefer Venenthrombose und Lungenembolie erfordern im Alltag häufig eine individuelle Entscheidung, da für die Präparate Apixaban und Rivaroxaban jeweils 2 Dosen zur Verfügung stehen, für die es keine festgelegten separaten Indikationsspektren gibt. Daher hat die Arbeitsgemeinschaft der niedergelassenen Gefäßchirurgen und Gefäßmediziner Deutschlands e. V. dieses Positionspapier entwickelt. Patienten mit einem klar identifizierbaren und passageren Triggerfaktor für die venöse Thromboembolie (z. B. Trauma, Operation, akute internistische Erkrankung, orale Kontrazeption, Schwangerschaft) oder einer isolierten Unterschenkelvenenthrombose haben ein geringes Rezidivrisiko und werden i. d. R. nicht dauerhaft antikoaguliert. Besteht eine hohes Rezidivrisiko bei fortbestehendem Triggerfaktor (z. B. fortbestehende aktive Tumorerkrankung, zweifelsfrei nachgewiesenes Antiphospholipidsyndrom sowie ein Gerinnungsinhibitormangel von Protein C, Protein S oder Antithrombin bei positiver Familienanamnese bez. venöser Thromboembolien [VTE], Erstereignis einer Lungenembolie, mehrfachen Rezidiven einer VTE) ist eine verlängerte Erhaltungstherapie indiziert, sofern nicht ein sehr hohes Blutungsrisiko dagegen spricht. Bei allen Patienten mit einer abgelaufenen VTE, bei denen man grundsätzlich die Antikoagulationsphase beenden würde, kann eine verlängerte Prophylaxe fortgeführt werden, da auch diese Patienten ein höheres Rezidivrisiko haben als ein Mensch, der noch nie eine VTE gehabt hat.

Background: Failure of delivering a stent or a balloon across the target lesion during percutaneous coronary intervention (PCI) of chronic total occlusion (CTO), especially in arteries with calcified tortuous anatomy, is often due to insufficient backup support from the guiding catheter. The purpose of this study was to assess the feasibility of the GuideLiner (GL) catheter use. Methods: We examined 18 patients and used the GL catheter to overcome poor support and excessive friction in standardized antegrade and retrograde CTO procedures. The GL is a coaxial, monorail guiding catheter extension delivered through a standard guiding catheter and is available in different sizes. Results: Almost all lesions were classified as severely calcified (94.4 ± 0.24%). The Japanese CTO score reflecting lesion complexity was 3.56 ± 0.78. All procedures were performed femorally; the retrograde approach was used in 27.8 ± 0.46% of cases. The overall success rate was 88.9 ± 0.32%; there were no relevant complications. Conclusions: The GL catheter is an adjunctive interventional device which enhances and amplifies CTO-PCI. Its use is indicated in cases in which back-up force needs to be strengthened to pass a CTO despite advanced calcification. It can be recommended as an important additional tool in advanced interventional cardiology such as antegrade and retrograde CTO-PCI if other techniques like anchor balloon or anchor wire are not possible. Keywords: Chronic total occlusion, GuideLiner catheter, Percutaneous coronary intervention, Severe calcification

ZusammenfassungDer Nutzen von medizinischen Thromboseprophylaxestrümpfen (AES) als physikalisches Mittel zur Prävention von venösen Thrombosen der unteren Extremität wird im Zeitalter der evidenzbasierten Medizin infrage gestellt. Die aktuellen S3-Leitlinien schreiben sogar, dass ihre Nichtanwendung in den allermeisten Fällen explizit im Empfehlungskorridor dieser Leitlinie liegt. Die niedermolekularen Heparine (NMH) und die direkten oralen Antikoagulanzien (DOAK) haben über Studien zur Thromboseprophylaxe bei elektivem Knie- und Hüftgelenkersatz ihre Zulassung erhalten, allerdings ist zur Anwendung von AES in diesen Zulassungsstudien nichts bekannt. Nun wurden erstmals die Ergebnisse der zusätzlichen Wirkung der AES in den Zulassungsstudien von Edoxaban publiziert. Danach betrug die Inzidenz von venösen Thromboembolien 6,0%, wenn AES getragen wurden, und 13,0%, wenn keine AES getragen wurden. Da in den Zulassungsstudien von NMH und den DOAKs nicht die Anwendung von AES kontrolliert wurde, kann nicht gesagt werden, wie groß der Effekt der AES auf das Gesamtergebnis ist, und die Studienergebnisse gelten nur vor dem Hintergrund der allgemeinen Anwendung von AES.

Background Parenteral anticoagulants and vitamin K antagonists (VKAs) have constituted the cornerstone of venous thromboembolism (VTE) treatment. Meanwhile, direct oral anticoagulants (DOACs) provide physicians with an alternative. The Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE observes real-world treatment practices. Objectives Describe initial anticoagulation (AC) treatment patterns in VTE patients who received parenteral AC, VKAs, and/or DOACs within ±30 days of diagnosis. Methods VTE patients were categorized into parenteral AC only, parenteral AC with transition to VKA, VKA only, parenteral AC with transition to DOAC, and DOAC only. Results A total of 9647 patients were initiated on AC treatment alone. 4781 (49.6%) patients received DOACs ± parenteral ACs; 3187 (33.0%), VKA ± parenteral ACs; and 1679 (17.4%) parenteral ACs alone. Rivaroxaban was the most frequently used DOAC (79.4%). DOACs were more frequently used in North America/Australia (58.1%), Europe (52.2%), and Asia (47.6%) than in Latin America (29.7%) and the Middle East/South Africa (32.5%). In patients with suspected VTE, most received parenteral AC monotherapy (67.7%). Patients with deep vein thrombosis were more likely to receive DOACs alone than those with pulmonary embolism with or without deep vein thrombosis (36.2% vs 25.9%). Active cancer patients received parenteral AC alone (58.9%), with 25.5% receiving DOAC ± parenteral AC and 12.8% parenteral AC and VKA. A total of 46.5% of pregnant patients received parenteral AC monotherapy, 34.0% were treated with VKA ± parenteral AC, and 19.5% received a DOAC (± parenteral AC). Conclusion AC treatment patterns vary by patient population, geographic region and site of VTE. Guidelines for AC therapy are not always adhered to.

In routine clinical work, the dosage of direct oral anticoagulants for long-term maintenance therapy after acute deep vein thrombosis and pulmonary embolism is often made on an individual basis. As two doses are available for the preparations apixaban and rivaroxaban and no separate indication spectra have been specified. The working group of practising vascular physicians and surgeons in Germany has therefore developed this position paper. Patients with a clearly identified and temporary trigger factor for venous thromboembolism (e.g. trauma, operation, acute internal disease, oral contraception or pregnancy or isolated thrombosis of veins in the lower leg have a lower risk of recurrence and are generally not given permanent anticoagulation. If there is a high risk of recurrence with unchanged trigger factor (e.g. active malignancy, unambiguous antiphospholipid syndrome or deficiency of a clotting factor, such as Protein C, Protein S or antithrombin with a positive family history of venous thromboembolism, first occurrence of a pulmonary embolism, multiple recurrence of VTE) prolonged maintenance therapy is indicated, unless this is contraindicated by a very high risk of bleeding. For all patients with former VTE and whose anticoagulation phase has in principle been completed, prolonged prophylaxis can be continued, as these patients too are at increased risk of VTE.Die Dosierungen der direkten oralen Antikoagulanzien für die langfristige Erhaltungstherapie nach akuter tiefer Venenthrombose und Lungenembolie erfordern im Alltag häufig eine individuelle Entscheidung, da für die Präparate Apixaban und Rivaroxaban jeweils 2 Dosen zur Verfügung stehen, für die es keine festgelegten separaten Indikationsspektren gibt. Daher hat die Arbeitsgemeinschaft der niedergelassenen Gefäßchirurgen und Gefäßmediziner Deutschlands e. V. dieses Positionspapier entwickelt. Patienten mit einem klar identifizierbaren und passageren Triggerfaktor für die venöse Thromboembolie (z. B. Trauma, Operation, akute internistische Erkrankung, orale Kontrazeption, Schwangerschaft) oder einer isolierten Unterschenkelvenenthrombose haben ein geringes Rezidivrisiko und werden i. d. R. nicht dauerhaft antikoaguliert. Besteht eine hohes Rezidivrisiko bei fortbestehendem Triggerfaktor (z. B. fortbestehende aktive Tumorerkrankung, zweifelsfrei nachgewiesenes Antiphospholipidsyndrom sowie ein Gerinnungsinhibitormangel von Protein C, Protein S oder Antithrombin bei positiver Familienanamnese bez. venöser Thromboembolien [VTE], Erstereignis einer Lungenembolie, mehrfachen Rezidiven einer VTE) ist eine verlängerte Erhaltungstherapie indiziert, sofern nicht ein sehr hohes Blutungsrisiko dagegen spricht. Bei allen Patienten mit einer abgelaufenen VTE, bei denen man grundsätzlich die Antikoagulationsphase beenden würde, kann eine verlängerte Prophylaxe fortgeführt werden, da auch diese Patienten ein höheres Rezidivrisiko haben als ein Mensch, der noch nie eine VTE gehabt hat.

Background: The aim of the study was to compare trends in frequency of atrial fibrillation (AF) with the prescription rates of oral anticoagulants (OAC) and the incidence of embolic stroke (ES) from 2005 through 2014. Methods: Annual numbers of hospitalized patients with AF and ES were extracted from the Federal Bureau of Statistics. Defined daily doses (DDD) of prescribed OAC among outpatients were extracted from the insurance drug information system. Results: The number of cases hospitalized with the diagnosis AF increased continuously by 78.3% (1.25 Million in 2005 to 2.19 Million in 2014, p < 0.001), likewise frequency of ES increased by 89.0% (from 46,068 to 87,050, p < 0.001) and the number of prescribed DDD of OAC almost doubled by 105.4% (from 271,328 to 557,281, p < 0.001). There is an almost linear correlation between occurrence of AF and ES (R-2 = 0.9683). In contrast association between prescription rate of OAC and incidence of ES is not linear as there was a disproportional increase in OAC prescriptions beginning in the year 2010 that is not accompanied by a reduction of cases hospitalized with ES. Conclusions: Our analysis of drug treatment rates for OAC in outpatients and hospitalization rates for ES revealed a disproportional increase in prescription of OAC beginning in the year 2010 that does not affect the number of cases hospitalized with ES. (c) 2018 Elsevier Inc. All rights reserved.

In this age of evidence-based medicine, the use of medical thrombosis prophylaxis stockings (AES) as a physical strategy for the prevention of lower limb venous thrombosis has been questioned. The current German S3 guidelines even state that their non-application is, in the vast majority of cases, explicitly covered by the recommendations of this guideline. Low molecular weight heparins (NMH) and direct oral anticoagulants (DOAK) have received approval for thrombosis prophylaxis in elective knee and hip joint replacement, but the use of AES is absent from these approval studies. The results of the additional effects of the AES in the approval studies of Edoxaban were published for the first time. According to these results, the incidence of venous thromboembolism was 6.0% when AES were worn and 13.0% when AES were not worn. Since the approval studies of NMH and the DOAKs did not control for the use of AES, the impact of AES on the overall results remains unclear. Therefore the study results are only valid in the context of the general application of AES. Guidelines commissions should take this into account in their recommendations.Der Nutzen von medizinischen Thromboseprophylaxestrümpfen (AES) als physikalisches Mittel zur Prävention von venösen Thrombosen der unteren Extremität wird im Zeitalter der evidenzbasierten Medizin infrage gestellt. Die aktuellen S3-Leitlinien schreiben sogar, dass ihre Nichtanwendung in den allermeisten Fällen explizit im Empfehlungskorridor dieser Leitlinie liegt. Die niedermolekularen Heparine (NMH) und die direkten oralen Antikoagulanzien (DOAK) haben über Studien zur Thromboseprophylaxe bei elektivem Knie- und Hüftgelenkersatz ihre Zulassung erhalten, allerdings ist zur Anwendung von AES in diesen Zulassungsstudien nichts bekannt. Nun wurden erstmals die Ergebnisse der zusätzlichen Wirkung der AES in den Zulassungsstudien von Edoxaban publiziert. Danach betrug die Inzidenz von venösen Thromboembolien 6,0%, wenn AES getragen wurden, und 13,0%, wenn keine AES getragen wurden. Da in den Zulassungsstudien von NMH und den DOAKs nicht die Anwendung von AES kontrolliert wurde, kann nicht gesagt werden, wie groß der Effekt der AES auf das Gesamtergebnis ist, und die Studienergebnisse gelten nur vor dem Hintergrund der allgemeinen Anwendung von AES.

Although chronic wounds have a high socio-economic impact, data on comparative effectiveness of treatments are rare. UrgoStart(®) is a hydroactive dressing containing a nano-oligosaccharide factor (NOSF). This study aimed at evaluating the cost-effectiveness of this NOSF-containing wound dressing in vascular leg ulcers compared with a similar neutral foam dressing (UrgoCell(®) Contact) without NOSF. Cost-effectiveness analysis from the perspective of the German statutory health care system was performed using a decision tree model for a period of 8 weeks. Cost and outcome data were derived from the clinical study 'Challenge' suggesting a response rate (≥40% wound size reduction) of UrgoStart(®) of 65·6% versus 39·4% for the comparator. In the treatment model, effect-adjusted costs of €849·86 were generated after 8 weeks for treatment with UrgoStart(®) versus €1335·51 for the comparator resulting in an effect-adjusted cost advantage of €485·64 for UrgoStart(®) . In linear sensitivity analyses, the outcomes were stable for varying assumptions on prices and response rates. In an 8-week period of treatment for vascular leg ulcers, UrgoStart(®) shows superior cost-effectiveness when compared with the similar neutral foam dressing without any active component (NOSF). As demonstrated within a randomised, double-blind clinical trial, UrgoStart(®) is also more effective in wound area reduction than the neutral foam dressing. Wound healing was not addressed in this clinical trial. Follow-up data of 12 months to allow for reulceration assessment were not generated.

Vascular closure devices (VCD) are well established to facilitate hemostasis after cardiac catheterization procedures. However, impairment of flow due to the reduction of femoral artery diameter remains a major concern. The present study aims to evaluate leg perfusion before and after application of collagen- and suture-based vascular closure devices.A total of 366 patients (age: 64.3 years+/-10.7, male: 71.3%) were randomized to receive femoral access site closure with either a collagen-based closure device (group A) (n=214) or a suture-mediated device (group B) (n=152), immediately following coronary catheterization procedures. In all patients, the ankle-brachial-index (ABI) was measured before and the day after closure device application.In group A, mean ABI at baseline was 1.09+/-0.2, in group B 1.11+/-0.2. In both groups, there was a significant, albeit clinically not relevant, reduction in post-procedural ABI (group A: 1.04+/-0.2, p0.01 vs baseline, group B: 1.06+/-0.2, p0.01 vs baseline). DeltaABI was not different between both VCD groups (p=0.55). In patients with peripheral vascular disease (PVD), neither the Angioseal device (mean ABI at baseline 0.76+/-0.1) nor the Perclose-device (mean ABI at baseline 0.79+/-0.1) induced a remarkable impairment of leg perfusion (Angioseal: 0.77+/-0.1, p=0.9 vs baseline, Perclose: 0.78+/-0.1, p=1.0 vs baseline). Clinically, no aggravation of claudication was observed in the PVD patient group.Both vascular closure devices are not associated with clinically relevant reduction in ABI. There was no difference between the two groups with respect to the level of flow impairment. Both devices may be safely used in patients with reduced ABI.

Wir analysierten in einer prospektiven Studie die Bedeutung von Autoantikorpern bei Patienten mit einer peripheren arteriellen Verschlusskrankheit (pAVK), die nur ein geringes Risikoprofil aufwiesen. Von 698 konsekutiven Patienten mit einer pAVK, die 1998 und 1999 zur interventionellen Therapie eingewiesen wurden, wurden 121 Patienten (61 ± 12 Jahre) nach folgenden Kriterien ausgewahlt: niedriges Risiko fur eine Atherosklerose, rarifizierte distale Arterien ohne Mediasklerose, erhohte Blutsenkungsgeschwindigkeit (BSG) oder C-reaktives Protein (CRP), die nicht durch ein Stadium IV der pAVK erklarbar waren. Folgende Autoantikorper wurden bestimmt: antinukleare Antikorper (ANA), Antikorper gegen extrahierbare Kernantigene, doppelstrangige DNA (ds-DNA), antineutrophiles Zytoplasma (c- und p-ANCA), Phospholipide [phosphatidylserine (APSA) und β2-Glykoprotein], glatte (SMA) und quergestreifte Muskulatur (StrMA). 38 pAVK-Patienten (35%) wiesen eine erhohte Autoantikorperkonzentration auf. In dieser Gruppe war der Anteil der Patienten mit einer beschleunigten BSG erhoht [p = 0,0043, Odds Ratio = 7.1 (95%-KI: 1,49–33,81)]. Die haufigsten Autoantikorper waren ANA bei 17 Patienten (14%), gefolgt von APSA and β2-Glykoproteinantikorpern. Wahrend eines Nachbeobachtungszeitraums von 24 ± 6 Monaten wurde bei den Patienten mit erhohten Autoantikorperkonzentrationen keine Vaskulitis oder Kollagenose klinisch manifest. Der Nachweis erhohter Autoantikorperkonzentrationen ist bei pAVK-Patienten nicht selten. Eine systematische Autoantikorperbestimmung bei pAVK-Patienten mit geringem Atheroskleroserisiko erhoht nicht den Anteil nachgewiesener oder sich entwickelnder Vaskulitiden bzw. Kollagenosen.

The objective of this study was to assess the initial safety and feasibility of a novel suture-mediated device for closure of femoral access sites immediately after diagnostic or interventional cardiac catheterization. In a prospective study, 150 patients (mean age, 61.5 years; 109 male) underwent femoral access closure with a novel suture closure device (Superstitch, Sutura) immediately after diagnostic (n = 106) or interventional (n = 44) catheterization procedures, independently of the coagulation status. All patients were monitored for 24 hr after the procedure. The closure device was successfully deployed in 92% of patients. Immediate hemostasis was achieved in 77% of patients with no differences between patients undergoing diagnostic catheterization or coronary interventions (79% vs. 73%; P = 0.659). After 2 min of additional light manual compression, hemostasis was achieved in 92% of patients. There was one major complication requiring vascular surgery (0.7%). The novel suture closure device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.

Despite recent advances in interventional cardiology, vascular access complications continue to be a significant problem. Conventional manual compression of the femoral access site is associated with prolonged immobilization and significant patient discomfort. We investigated the performance of a collagen-based closure device applied immediately after catheterization and its complication rate in 1,317 consecutive patients undergoing cardiac catheterization or coronary angioplasty. Patients undergoing coronary angioplasty (n = 644) received more heparin than patients with diagnostic cardiac catheterization (n = 673; 9,675 +/- 1,144 IU vs. 6,419 +/- 2,211 IU; P0.0001). Deployment success rates of the closure device were comparable for patients undergoing diagnostic vs. interventional procedures (95.8% vs. 96.7%; P = 0.46). Complete hemostasis immediately after deployment of the device was achieved in90% of all patients, but was lower in the interventional group (93.7% vs. 90.6%; P = 0.05). Major complications including any vascular surgery, major bleeding requiring transfusion, retroperitoneal hematoma, thrombosis or loss of distal pulses, groin infections, significant groin hematoma, and death were observed in 0.53% of all patients, with no differences between diagnostic or interventional patients (0.62% vs. 0.45%; P = 0.953). Subgroup analysis revealed female gender as a predictor of access site complications. Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications.

The objective of this study was to assess the early safety and efficacy of the novel 6 Fr Angio-Seal device for routine clinical use after diagnostic cardiac catheterization and coronary angioplasty. In a prospective study, we used the 6 Fr Angio-Seal device in 180 consecutive patients (131 male, 49 female, mean age 60.7 years) for closure of femoral arterial puncture sites immediately after diagnostic (n = 108) or interventional (n = 72) coronary procedures independent of the coagulation status. All patients were monitored for 24 hr after the procedure and followed for 30 days. The closure device was successfully deployed in 95.4% after diagnostic catheterization versus 98.6% after coronary angioplasty (P = 0.963). Immediate hemostasis was achieved in 91.5% versus 90.1% of the patients (P = 0.993). Major complications were observed 1.9% versus 2.8% of the patients (P = 0.885). During 30-day follow-up, no late events or complications were reported. The 6 Fr Angio-Seal device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.

Although chronic wounds have a high socio‐economic impact, data on comparative effectiveness of treatments are rare. UrgoStart (®) is a hydroactive dressing containing a nano‐oligosaccharide factor (NOSF). This study aimed at evaluating the cost‐effectiveness of this NOSF‐containing wound dressing in vascular leg ulcers compared with a similar neutral foam dressing (UrgoCell (®) Contact) without NOSF. Cost‐effectiveness analysis from the perspective of the German statutory health care system was performed using a decision tree model for a period of 8 weeks. Cost and outcome data were derived from the clinical study ‘Challenge’ suggesting a response rate (≥40% wound size reduction) of UrgoStart (®) of 65·6% versus 39·4% for the comparator. In the treatment model, effect‐adjusted costs of €849·86 were generated after 8 weeks for treatment with UrgoStart (®) versus €1335·51 for the comparator resulting in an effect‐adjusted cost advantage of €485·64 for UrgoStart (®). In linear sensitivity analyses, the outcomes were stable for varying assumptions on prices and response rates. In an 8‐week period of treatment for vascular leg ulcers, UrgoStart (®) shows superior cost‐effectiveness when compared with the similar neutral foam dressing without any active component (NOSF). As demonstrated within a randomised, double‐blind clinical trial, UrgoStart (®) is also more effective in wound area reduction than the neutral foam dressing. Wound healing was not addressed in this clinical trial. Follow‐up data of 12 months to allow for reulceration assessment were not generated.

We analysed the effect of different body features on contact area, interface pressure and pressure distribution of three different mattresses. Thirty-eight volunteers (age ranged from 17 to 73 years, 23 females) were asked to lie on three different mattresses in a random order: I, standard hospital foam mattresses; II, higher specification foam mattresses (Viscorelax Sure® ); III, constant low pressure devices (CareMedx® , AirSystems). Measurements were performed in supine position and in a 90° left- and right-sided position, respectively, using a full-body mat (pressure mapping device Xsensor X2-Modell). Outcome variables were contact area (CA) in cm(2) , mean interface pressure (IP) in mmHg and pressure distribution (PD) estimated as rate of low pressures between 5 and 33 mmHg on each mattress in percent. Mean CA was lowest in the standard hospital foam mattresses and increased in the higher specification foam mattresses and was highest in the constant low pressure device (supine position: 491 ± 86 cm(2) , 615 ± 95 cm(2) , 685 ± 116 cm(2) ). Mean IP was highest in the standard hospital foam mattresses and lower but similar in the higher specification foam mattresses and the constant low pressure devices (supine position: 22·3 ± 1·5 mmHg, 17·6 ± 1·7 mmHg, 17·6 ± 2·2 mmHg). Models were estimated for CA, IP and PD including the independent variables height, weight and waist-to-hip-ratio (WHR). They show that body morphology seems to play a minor role for CA, IP and PD, but very thin and tall patients and very small and obese people might benefit from different mattresses. Our data show that CA increases with increasing specification of mattresses. Higher specification foam mattresses and constant low pressure devices show similar IP, but constant low pressure devices show a wider pressure distribution. Body morphology should be considered to optimise prevention for single patients.

We assessed the diagnostic performance of whole-body 3D contrast-enhanced MR angiography in comparison with digital subtraction angiography (DSA) of the lower extremities in patients with peripheral arterial occlusive disease. SUBJECTS AND METHODS. Fifty-one patients with clinically documented peripheral arterial occlusive disease referred for DSA of the lower extremity arterial system underwent whole-body MR angiography on a 1.5-T MR scanner. Paramagnetic gadobutrol was administered and five contiguous stations were acquired with 3D T1-weighted gradient-echo sequences in a total scanning time of 72 sec. DSA was available as a reference standard for the peripheral vasculature in all patients. Separate blinded data analyses were performed by two radiologists. Additional vascular disease detected by whole-body MR angiography was subsequently assessed on sonography, dedicated MR angiography, or both.All whole-body MR angiography examinations were feasible and well tolerated. AngioSURF-based whole-body MR angiography had overall sensitivities of 92.3% and 93.1% (both 95% confidence intervals [CIs], 78-100%) with specificities of 89.2% and 87.6% (both CIs, 84-98%) and excellent interobserver agreement (kappa = 0.82) for the detection of high-grade stenoses. Additional vascular disease was detected in 12 patients (23%).Whole-body MR angiography permits a rapid, noninvasive, and accurate evaluation of the lower peripheral arterial system in patients with peripheral arterial occlusive disease, and it may allow identification of additional relevant vascular disease that was previously undetected.

In patients with early manifestation of peripheral arterial occlusive disease (PAOD) and a less classical atherosclerotic risk profile, vasculitis is presumed to be the underlying disease. We performed a prospective study of the importance of determination of autoantibodies used for the diagnosis of vasculitis and collagen diseases in patients with symptomatic PAOD.698 consecutive patients (mean age +/- SD: 68 +/- 10 years) were included who were referred from 1998 to 1999 for interventional treatment of PAOD. In 121 PAOD-patients (61 +/- 12 years) with a less pronounced atherosclerotic risk profile, or rarefied distal arteries without sclerosis of the media, or elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) independent from the stage IV of PAOD, the following autoantibodies were investigated: antinuclear antibodies (ANA), antibodies against extractable nuclear antigens (ENA): SCL 70, RNP, SS-A, SS-B, Jo-1, SM), double-stranded DNA antibodies (ds-DNA), antineutrophil cytoplasmatic antibodies (c- and p-ANCA), antiphospholipid antibodies [phosphatidylserine (APSA) and beta(2)-glycoprotein], smooth (SMA) and striated muscle (StrMA). ANA, SMA and StrMA were estimated by indirect immunofluorescence technique, ENA by Western-blot and the others by enzyme linked immunoassay.38 PAOD-patients (35%) had increased autoantibody concentrations. The rate of different PAOD stages and localization did not differ between the group of patients with increased autoantibody concentrations and the group of patients without. But the group of patients with increased autoantibody concentrations had higher rates of elevated ESR [p-value of 0.0043, odds ratio of 7.1 (95% CI: 1.49-33.81)]. ANA were the most frequent autoantibodies detected in 17 (14%) of the 121 patients followed by APSA and autoantibodies directed against beta(2)-glycoprotein. During follow-up of 24 +/- 6 months no vasculitis or collagen diseases associated with the elevated autoantibody concentrations became clinically manifest in the 38 patients. Two patients died due to coronary heart disease. Four patients had a worsening of their PAOD but no amputation was performed. Out of the 83 patients without elevated concentrations of autoantibodies, eight patients died and three amputations were carried out.All in all, increased autoantibody concentrations in patients suffering from peripheral atherosclerosis are not a rare finding. A systematic determination of autoantibodies, especially in patients with a low atherosclerotic risk profile, does not increase the number of manifest or developing vasculitis of collagen disease.

According to the Chapel Hill Consensus Conference, large peripheral arteries are only affected by giant cell vasculitis and, in rare cases, by polyarteritis nodosa.1,2 Vasculitis becomes apparent through involvement of typical organs (lung, kidney, skin) or raised C reactive protein (CRP) level or erythrocyte sedimentation rate (ESR). Thus, a specific diagnostic effort to exclude vasculitis as an underlying disease in patients with peripheral arterial occlusive disease (PAOD) may be unnecessary. On the other hand, there is increasing evidence that humoral immunity may have a role in the pathogenesis of atherosclerosis.1,2,9 Antinuclear antibodies were reported in 70% of patients with severe coronary heart disease (CHD), compared with in only 17% in the control group.3 Thus, we prospectively studied the …

CONCLUSION: During passage of CO2, the signal loss on MRI images resulted from the temporary replacement of the protons by CO2, which appeared to show an extremely low signal. Therefore CO2 was quite distinctive from other contrast agents that mostly depend on T1 shortening caused by a paramagnetic agent. Since CO2 is a normal component in the blood, the human organism is equipped to clear large quantities of CO2 completely during the first pass through the lungs. The combination of CO2 , resulting in signal loss, and a bloodpool agent, resulting in high signal, is a, new, safe promising method for guidance of a catheter-tip during interventional MRI. Like in fluoroscopy-guided vascular interventions it will enable real time evaluation of flow and inadvertently occurring subtle changes, like small dissections.

Poster Abstract