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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.

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.

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.

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.

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.