30 research outputs found
Valvulotomy of the great saphenous vein in ex situ non-reversed and in situ setting: a multicenter post-market study to assess the safety and efficacy of the AndraValvulotome™”
Purpose
To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft.
Methods
This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy.
Results
Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46–91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20–70 cm) with a median diameter of 5.0 mm (range 3–6 mm) and 4.0 mm (range 2–6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection).
Conclusion
The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD
Guidelines on proceeding with transition of pediatric patients with hematological malignancy to adult setting
BackgroundPatients cured from hematological malignancies should be subject to long-life routine medical supervision. Patients who did not complete their therapy during childhood require further therapy when reaching adulthood (18 years).ObjectiveDetermination of guidelines and suggestions on proceeding with pediatric patients with hematological malignancies undergoing transition to adult hematology centers, with respect to Polish conditions of national medical health-care system.MethodsPanel of experts in the field of pediatric and adult hematology analyzed current situation in Polish pediatric and adult hematology centers and reviewed the literature on transition process of minor patients from pediatric to adult setting.ResultsFactors determining problems of patient transition and models of care of patient in pediatric and adult hematology settings were analyzed. Existing models of transition in Poland as well as experience from international models were presented: model of direct transition, model of adolescence medicine, sequential model and consultation model. Suggestions of changes facilitating process of patient transition, and guidelines on proceeding with patients with respect to diagnosis of malignancy and phase of oncological therapy were presented, involving cooperation of pediatric and adult centers, specialists in pediatric hematology and adult hematology, as well as the payer and scientific societies.ConclusionsProcess of transition of patients requires coordination and cooperation, preferably at the level of medical institutions. This should ensure optimal medical care to patients cured from malignancy and facilitate long-term medical supervision and gathering data on treatment efficacy and side effects