To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. Materials and Methods: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Followup evaluations were conducted at 30 days and 6 months. Results: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory-adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. Conclusion: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.
Background: The aim of this study was the analysis of the influence of prognostic factors on short-and long-term outcomes of gastric cancer resection. Patients and Methods: A database of 709 patients who had gastric cancer resection between 2007 and 2015 was compiled. Results: Total gastrectomy (TG) and subtotal proximal gastrectomy (SPG) significantly increased the risk of overall complications (p=0.0015 and 0.0173, respectively) and surgical complications (p=0.0141 and 0.0035, respectively). Moreover the resection of an additional organ was an independent prognostic factor of overall complications (p<0.0001), systemic complications (p=0.0503), surgical complications (p<0.0001) and relaparotomy (p=0.0259). T stage (p<0.0001), N stage (p<0.0001), M stage (p<0.0001) and radical resection (p<0.0001) significantly affected 5year survival rates. Conclusion: Early diagnosis and radical resection was crucial in 5-year survival rates. However, the type of gastrectomy and the resection of an additional organ were the most important factors in short-term outcomes of treatment for such patients.Gastric cancer is the second most common cancer of the gastrointestinal tract in the world. In 2020, the incidence of new cases of gastric cancer was estimated at 1,089,103, with a mortality rate of 768,793 people globally. Unlike East Asia, gastric cancer is a relatively rare neoplasm in North America and some highly developed countries in Western Europe. However, even there it is one of the most common causes of death from malignant neoplasms (1). In Poland, the number of deaths from gastric cancer reaches 5000 per year. In 2018, 3155 men and 1745 women died from this in our country (2).Currently, the majority of publications concern aspects of multimodal therapy with pre-and perioperative chemotherapy, even in the presence of oligometastasis. Nevertheless, surgical resection is still the most effective treatment for such patients, and the principles of surgery of gastric cancer are usually well established (3)(4)(5).Although data from a large number of articles reveals the impact of prognostic factors on the prognosis of patients with gastric cancer resection, survival is significantly improved by the effectiveness of surgical treatment measured by short-term outcomes. Most reports involving prognostic factors for patients after gastric cancer resection focus on the 5-year survival rate. There are no in detail articles on the influence of prognostic factors on short-term outcomes of treatment such as overall complications, systemic complications, surgical complications, relaparotomy and perioperative mortality (6-30). There are many prognostic factors that could affect the short-term outcomes of gastric cancer resection including gender, age, location, histologic type, tumour staging, type of gastrectomy, number of retrieved lymph nodes or resection of an additional organ.In this study we carried out univariate and multivariate analysis of prognostic factors which, in addition to long-term outcomes (5-year survival), also affecte...
In many countries around the world (including the United States, Canada, and Spain), research is being conducted into the impact of air pollution on the formation of various types of cancer. For a long time it was thought that the inhalation of pollutants could lead to lung diseases. Now the effects of air pollutants on tumors in the airways, kidneys, bladder, breast, and colon have been investigated and are better understood. It is now known that particulates in air pollution can cross the blood–brain barrier and also reach the placenta. The aim of this study was to find a possible relationship between the emission of pollutants into the atmosphere and the formation of specific types of tumors in the Polish population. Two databases available on the Internet were used in the analysis: the bank of measurement data on air quality in Poland (the repository of Environmental Protection Inspection) and cancer statistics. The pollution measurement data for the years 2000–2016 were taken from the Chief Inspectorate for Environmental Protection website, a database with results from 264 stations located in Poland for 13 types of gases and atmospheric pollutants. Statistical data on cancer C00–D09 (according to the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10)) in the Polish population in the years 1999–2015 were retrieved from onkologia.org.pl. A novel code was constructed, allowing the downloading of statistics from the databases, examination of their correlation, and selection of the best model of regression through machine learning. The results of the analyses indicate a high correlation of air pollution with the incidence of selected types of cancer. Particularly noteworthy is the observed effect of NOx on the incidence of small and large intestine cancers in the Masovia and West Pomerania provinces. The other gases and pollutants with the most significant impact on the incidence of gastrointestinal cancer have also been identified. Based on statistical analysis, we found a correlation between air pollution and tumor incidence in individual provinces, as well as an influence of the emission of nitrogen oxides on the cancer incidence rate.
Esophageus or gaster resection in patients with malignant disease is still a treatment of choice. It is obvious that each surgical procedure in these patients carries some possibility of complications. Esophageo-gastric or esophageo-jejuno anastomosis has a 4-27% frequency of fistula occurrence. All these result in 65% mortality in cases of poorer prognosis. The aim of this paper is not to present all types of complications but to objectively analyse the usefulness of the covered stent placement in the treatment of anastomotic fistulas. We present six patients who were treated for postoperative fistula of esophageo-gastric anastomosis (1 case) or esophageo-jejuno anastomosis (5 cases). All patients were treated with stapler suture for digestive tract reconstruction after malignancy removal during the primary surgical procedure. Signs and symptoms of suture leak between 5-8 days post-surgery were observed. Conservative therapy was not effective. Thus a new method of treatment was employed - covered stent placement. The procedure was performed under X-ray control. In all treated patients there was change for the better and quick reduction of secretion from the fistulas was observed. All patients were discharged from the department after several days and all had survived at 30 days follow-up. Covered esophageal stent placement seems to be a safe and promising method of treatment for patients with anastomotic fistula which significantly reduces mortality and improves quality of live. Our experiences confirms that of other investigators.
CAS is safe and successful procedure with low early and long-term adverse events. Special attention should be put on patients with bilateral and left ICA stenoses. If possible, longer stents should be applied.
The novel Polish self-expandable nitinol carotid stent with hybrid cell technology shows optimal biocompatibility and a vascular healing profile, and therefore may be introduced for first-in-man application.
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