Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries: primary safety and effectiveness results of the re-route trial.

AIM: Aim of the study was to provide additional clinical data regarding the safety and technical success of the OffRoad Re-Entry Catheter System (Boston Scientific, Natick, MA, USA) for subintimal recanalization of chronic total occlusions (CTO) in the femoropopliteal arteries. METHODS: A total of 92 patients (mean age 70.3±10.6 years; 70% male) were enrolled in this prospective, single-arm, post-market study conducted at 12 European centers. Patients were required to have claudication or critical limb ischemia and a CTO lesion in a native femoropopliteal artery. The primary safety endpoint was the composite rate of device-related major adverse events (MAEs; i.e., death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation of the treated lower limb) at 30 days. Effectiveness was based on device technical success, defined as placement of a guidewire in the true lumen distal to a CTO. RESULTS: Ninety patients were evaluable for the primary safety endpoint. The 30-day device-related MAE rate was 3.3% (3/90), with an upper confidence bound of 6.5%, which was lower than the prespecified performance goal of 15%. All 3 events were clinically significant peripheral emboli. Technical success was 84.8% (78/92) with a lower confidence bound of 78.6%, which exceeded the prespecified performance goal of 76%. A decrease of ≥1 Rutherford category was observed in 75% (65/87) of patients at the 30 day visit. CONCLUSION: The Re-ROUTE trial results demonstrate acceptable performance of the OffRoad system in terms of safety and technical success for the recanalization of femoropopliteal CTOs.

Successful revascularization of chronic total occlusion of lower extremity arteries: a wire only and bail out use of re-entry device approach.

AIM: The management of progressive peripheral artery disease experienced a vast change in paradigms over the last decades for the benefit of minimal invasive therapy as a first-line strategy. With the constant development of new devices, materials and dedicated access strategies, more complex lesions can be managed but the limitations to successfully treat chronic total occlusions are still the challenge to re-enter the true lumen. The aim of this retrospective study was to investigate, if a "wire only" strategy leads to an acceptable success rate in a mixed cohort of CTO lesions and to what extend re-entry devices are used. METHODS: We retrospectively analyzed patients treated at the Vascular Center Berlin between 2011 and 2013 with chronic total occlusion out of a prospective conducted database (Endovascular MILestones - EMIL) for demographics, risk factors, co-morbidities, technical success rates, lesion characteristics and use of guidewires as well as re-entry systems. A total of 128 patients with 146 lesions, which represent a subgroup of all the cases performed in our center, following a predefined treatment algorithm for chronic total occlusions (CTOs), have been analyzed. RESULTS: We achieved a technical success in 133 (91.1%) of all cases following a "wire only" strategy. Out of 13 (8.9%) CTOs with technical failure in 7 (53.9%) CTOs a re-entry device (Off-Road®) with a 100% technical success has been used. In 91.1% of chronic total occlusion lesions the use of 2 wires only (88.7%) led to a successful recanalization. A "wire only" strategy followed by the use of a re-entry device as a bail out strategy, led to a total of 140 (96%) lesions to be successfully recanalized. CONCLUSION: In more than 90% of all cases with chronic total occlusion of peripheral lower extremity arteries, endovascular intervention has been successful following a "wire only" strategy. When deciding to use a re-entry device, in case of a failure of a proper wire re-entry at the reconstitution point, a technical success rate of 100% was achieved. Therefore following a strict wire algorithm and considering the use of a re-entry system as a bail out strategy will lead to a successful minimal invasive management of chronic total occlusion in nearly 100% of the cases with TASC II A - D lesions.

[Effect of a synthetic GnRF vaccine (Improvac®) on daily weight gain and carcass quality of boars. A field trial in Bavaria]. / Einfluss einer GnRH-Vakzine (Improvac®) auf Gewichtszunahmen und Schlachtkörperqualität von Ebern. Ein Feldversuch in Bayern.

OBJECTIVE: The effects of vaccination against gonadotropin releasing factor (GnRF) with Improvac® (Pfizer Animal Health) were compared with surgical castration in fattening pigs. MATERIAL AND METHODS: A total of 205 pigs were surgically castrated (group K) and 191 were vaccinated twice (group V) using the boar taint vaccine (Improvac®; 2ml s.c.). The first dose was administered atthe age of 12 weeks when the animals were moved into the fattening unit and the second dose in week 18, 4-6 weeks before the planned slaughter date. Live weights were recorded in weeks 1, 4, 12, 18, and 22. In weeks 18 and 20, length and width of the testicles of 171 animals of group V were measured. After slaughtering cold carcass weight, back fat depth, muscle thickness, percent lean meat, and fat and muscle areas of the carcasses were determined. A piece of the neck muscle from each pig was used to conduct a cooking and melting sensory test. RESULTS: While no significant weight difference was evident in week 22 (K=89.4kg; V=88.6kg), cold carcass weight, and back fat and muscle thickness were lower for vaccinates. Vaccinates had higher average daily weight gains (ADW) after the second injection from week 18 up to the cut-off weighing in week 22 (V=1121g; K=1007g; p<0.001) in contrast to average daily weight gains between weeks 12 and 18 (K=740g; V=668g; p<0.001). After the second injection, testicle size of vaccinated pigs decreased significantly. All animals were negative for boar taint by both cooking and melting tests. CONCLUSION: Boars vaccinated against boar taint had lower ADW before the second vaccination, but compensated the weight difference after complete vaccination. The significant reduction in the testicle size after the second injection indicates a vaccination success. After vaccination no boar taint was detected in carcasses. CLINICAL RELEVANCE: Vaccination as well as surgical castration reliably prevents the incidence of boar taint. The late rise in daily gain can be beneficial if management is aligned.

[Arterial occlusive disease. Catheter-directed thrombolytic therapy]. / Arterielle Verschlusskrankheit. Kathetergeführte thrombolytische Therapie.

Local catheter-directed thrombolysis of extremity artery or bypass thromboembolic occlusions is a promising therapeutic option with comparatively low complication rates, if the severity of the ischemia does not require urgent surgical revascularization. This therapeutic decision has to be made by a vascular team taking individual circumstances and contraindications into consideration. Apart from an adequate dosage, a strict intrathrombotic administration of the fibrinolytic agent and careful clinical monitoring including surveillance of the coagulation system is necessary and intensive care unit resources should be used. If necessary the thrombolysis therapy can be combined with mechanical thrombaspiration and balloon dilatation or surgical correction of an underlying lesion.

Therapeutic arteriogenesis in peripheral arterial disease: combining intervention and passive training.

The prevalence of peripheral arterial disease (PAD) is on the rise in an aging population, significantly affecting quality of life, morbidity and mortality. Besides medical treatment and surgical or interventional revascularization, supervised exercise programs are a primary treatment modality for PAD. Training may significantly increase pain-free walking time (+ 180 %) while avoiding the associated complications of (repeated) invasive revascularization. Training effects rely on an improvement of risk factor management, muscle function, economy of movement, hemorheology, vascular growth and collateral vessel growth. Exercise training upregulates pulsatile fluid shear stress on the vascular endothelium, prompting an improvement of endothelial function (eNOS, NO) and an outgrowth of preexistent collaterals (arteriogenesis) to functional conductance arteries outside the ischemic area at risk. However, the necessary intense minimum training intervals compromise patient compliance, and the impaired functional status of many PAD patients limits active exercise training. Strategies are necessary to a) increase training compliance, b) make the benefits of exercise training available to patients unable to exercise actively and c) therapeutically enhance the adaptive growth of biological bypasses (arteriogenesis). A modified form of “passive exercise training” derived from enhanced external counterpulsation (low-pressure ECP) which was originally developed for the therapy of heart failure, may prove to be an option for this group of patients. Therefore, this review article suggests a tailored combination therapy, consisting of a facilitating revascularization procedure to restore arterial inflow, succeeded by supervised exercise training, which has yielded promising therapeutic results in clinical trials. Further studies, using appropriate imaging methods and controls, are under way to (a) establish the efficacy of low-pressure EECP in PAD patients and (b) to directly correlate training-induced improvements of collateral flow to the functional improvements seen with exercise training.

Rational diagnostic and treatment of diseases of the cerebrocervical circulation.

This is an update of current diagnostic and therapeutic strategies for treatment of cerebrovascular, predominantly atherosclerotic diseases.

[Are the TASC recommendations for diagnosis and treatment of PAOD still relevant?]. / Sind TASC-Kriterien in der Diagnostik und Therapie der pAVK noch relevant?

With regards to the rapid progress of interventional therapy in the treatment of PAOD the revision of the published guidelines (TASC Recommendations 2000) is more than necessary. The current options in therapy are modified constantly. Therefore, published recommendations might be not up-to-date. In consideration of the number of interventions and operations which are performed throughout Europe a trend towards less invasive treatment becomes apparent. Guidelines and recommendations from the Charing Cross and the ACC/AHA (ACC/AHA Guidelines for the Management of Patients With Peripheral Arterial Disease 2005) are reflecting this development. Regardless of the complexity of the planned procedure interventional treatment is almost always first choice therapy. A yearly revision of the actual guidelines would be useful, leading to an up-to-date modality. Although in the diagnostic pathway MRI and CTA gain more importance, the gold standard in diagnosis of PAOD remains the standardised measurement of the walking capacity, ankle-brachial index (ABI) and duplex ultrasound.

[Hemobahn-endoprosthesis: long-term experience (< or = 4 years follow-up) with percutaneous application in stenoses and occlusions of the superficial femoral artery]. / Hemobahn-Endoprothese: 4-Jahres-Erfahrungen mit der perkutanen Anwendung bei Stenosen und Verschlüssen der Arteria femoralis superficialis.

We tested the value of hemobahn-endoprosthesis in a prospective, nonrandomized, clinical trial in PAD-patients with femoral artery occlusive disease. During 4 years we placed in 52 patients (55 extremities) a total of 78 hemobahn-endoprostheses for treatment of stenoses (15%) or occlusions (85%) of femoral artery. The average length of the treated lesions was 11.6 cm, the mean length of the hemobahn-endoprosthesis was 15.9 cm, the average device diameter 6.1 mm. In 45% of the patients we used cross-over and in 55% ipsilateral antegrade technique. Fontaine's clinical stages were II b (89%), III (2%) and IV (9%); there were 15 diabetics. The average period of follow-up was 33 months (1-52 months). The primary/secondary patency rates after the first year (n = 50) were 64% vs. 78%, after 2 years (n = 46) 61% vs. 76%, after 3 years (n = 32) 53% vs. 66% and after 4 years (n = 14) 29% vs. 50%. After the first experiences in 1998 with 10 stent-occlusions in 14 treated extremities, indications were checked and thereafter hemobahn was only used in "ideal indications" as segments with a length of > or = 1 cm proximal and distal without any obstruction, no lesions in the popliteal artery, at least one open lower leg vessel and no severe calcifications. The primary/secondary patency rates were significantly better after exclusion of nonideal patients treated during the first year: Thus, primary/secondary patency rates were 76 % vs. 90% after first year (n = 32), 74 % vs. 89% after second year (n = 38) and 71% vs. 83% after third year (n = 24); after 4 years of 8 treated arteries 4 were primary and 7 were secondary open. Hemobahn-endoprostheses are suitable for treatment of long femoral artery occlusions. The medium patency rate in "ideal indications" is higher than that obtained by angioplasty with or without uncovered stents.