Cardio-psycho-metabolic outcomes of bariatric surgery: design and baseline of the WAS trial.

Obesity is a rapidly emerging health problem and an established risk factor for cardiovascular diseases. Bariatric surgery profoundly reduces body weight and mitigates sequelae of obesity. The open, randomized controlled Würzburg Adipositas Studie (WAS) trial compares the effects of Roux-en-Y gastric bypass (RYGB) vs psychotherapy-supported lifestyle modification in morbidly obese patients. The co-primary endpoint addresses 1-year changes in cardiovascular function (peak VO2 during cardiopulmonary exercise testing) and the quality of life (QoL) (Short-Form-36 physical functioning scale). Prior to randomization, all included patients underwent a multimodal anti-obesity treatment for 6-12 months. Thereafter, the patients were randomized and followed through month 12 to collect the primary endpoints. Afterwards, patients in the lifestyle group could opt for surgery, and final visit was scheduled for all patients 24 months after randomization. Sample size calculation suggested to enroll 90 patients in order to arrive at minimally 22 patients per group evaluable for the primary endpoint. Secondary objectives were to quantify changes in body weight, left ventricular hypertrophy, systolic and diastolic function (by echocardiography and cardiac MRI), functional brain MRI, psychometric scales, and endothelial and metabolic function. WAS enrolled 93 patients (72 women, median age 38 years, BMI 47.5 kg/m2) exhibiting a relevantly compromised exercise capacity (median peakVO2 18.3 mL/min/kg) and the QoL (median physical functioning scale 50). WAS is the first randomized controlled trial focusing on the effects of RYGB on cardiovascular function beyond hypertension. In addition, it will provide a wealth of high-quality data on the cerebral, psychiatric, hepatic, and metabolic function in obese patients after RYGB.

Percutaneous mechanical thrombectomy in acute and subacute lower-extremity ischemia: impact of adjunctive, solely nonthrombolytic endovascular procedures.

PURPOSE: We aimed to evaluate the role of adjunctive, solely nonthrombolytic endovascular therapy in treatment of acute lower-extremity ischemia by rotational percutaneous mechanical thrombectomy. METHODS: A retrospective, single-center evaluation of 165 patients (167 limbs) that underwent rotational percutaneous mechanical thrombectomy between 2009 and 2016 was performed. RESULTS: Rotational percutaneous mechanical thrombectomy was used as a single therapy in 9.0% (15 limbs), followed by percutaneous aspiration thrombectomy in 6.0% (10 limbs), percutaneous transluminal angioplasty in 19.8% (33 limbs) and stenting in 25.7% (43 limbs). Rotational percutaneous mechanical thrombectomy was followed by any combination of these three interventions in 39.5%. Clinical and technical success was documented in 92.2%, complications in 10.3% (n=17). No significant difference in clinical and technical success was observed using rotational percutaneous mechanical thrombectomy alone or with additional endovascular therapy. On a long-term basis, the re-ischemia-free survival was nearly twice as high as in previous studies that reported more cases treated by rotational percutaneous mechanical thrombectomy alone. CONCLUSION: To assure a long-lasting primary patency after percutaneous mechanical thrombectomy, concomitant treatment of underlying lesions with adjunctive, nonthrombolytic endovascular methods should be considered.

Evaluation of superficial femoral artery-lesions after percutaneous transluminal angioplasty: color-coded summation images vs. monochromatic digital subtraction angiography.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) is increasingly requested in the therapy of peripheral arterial occlusive disease. The evaluation of the technical result after balloon angioplasty with regard to bailout stenting is highly dependent on the operators´ subjective assessment and mainly based on the monochromatic digital subtraction angiography (DSA) images. The aim of this study was to compare color-coded single image as a novel diagnostic tool with monochromatic DSA for the analysis of flow limitation and need for stent implantation after PTA of superficial femoral artery (SFA) stenoses. METHODS: During a period of 18 months, 213 SFA lesions were treated by PTA with a standard balloon in 170 patients, resulting in a total of 193 endovascular procedures. The median age of the patients was 77 years (range, 35-96 years). Median length of the treated lesions was 10.5 cm (range, 1.0-50 cm). Three interventional radiologists retrospectively evaluated the results of balloon angioplasty with monochromatic as well as post-processed color-coded DSA images for flow limitations to decide if subsequent stent implantation was necessary. Consensus reading of two experienced interventional radiologists 2 months after the initial review served as reference standard to perform a receiver operating characteristics (ROC) analysis. RESULTS: ROC analysis for readers A, B and C showed area under the curve (AUC) values of 0.797, 0.865 and 0.804 for color-coded DSA and AUC values of 0.792, 0.843 and 0.872 for monochromatic DSA: a significant advantage of color-coded over conventional monochromatic DSA was not found for readers A and B (p > 0.05). Results of reader C were significantly better in the assessment of monochromatic images (p = 0.023). Diagnostic confidence using color-coded images was slightly higher than in monochromatic images (κ = 0.486 vs. κ = 0.459). CONCLUSIONS: In this study, color coded DSA did not reveal to be superior to conventional monochromatic DSA when evaluating results of PTA and when deciding whether stent implantation is necessary or not. This technology, however, requires further experiences with special regard to homogeneously trained radiologists and to the time requirement.