TVA Medical – Everlinq Endoavf System as a viable alternative to surgical AVF procedures
February 1, 2017
TVA Medical Inc., of Austin, Texas, reported several clinical updates involving its Everlinq Endoavf System, an endovascular technique to create hemodialysis access without open surgery, with other potential clinical applications. The Everlinq Endoavf System has European CE mark and Health Canada Medical Device License for end-stage renal disease (ESRD) patients who need hemodialysis, and commercialization has begun at select centers in Europe. It is not commercially available in the U.S. and is currently under review by the U.S. FDA. Scientific data from the Everlinq Endoavf System were presented at the 2017 Leipzig Interventional Course in Germany. One-year data presented from the single-arm, prospective, multicenter Novel Endovascular Access Trial (NEAT) study in patients with ESRD showed high fistula maturation (91 percent); high patency (84 percent); low thrombosis (10.5 percent); and low interventions (0.46 per patient year). At two centers in Germany reporting real-world experience with the Everlinq Endoavf System, physicians achieved 100 percent procedural success; dialysis initiation in 86 percent of patients within 56 days; and a low rate of interventions. In addition, data were reported from a preclinical feasibility study using the Everlinq Endoavf System for peripheral artery disease (PAD). The cadaver study demonstrated the feasibility of creating an endovascular in situ vein bypass – in place of a surgical distal autologous vein bypass – for below-the-knee revascularization, without stents, couplers or other foreign material. Results were also presented from a study evaluating the Everlinq 4 Endoavf System, which is designed to enable other access sites like the wrist, using a 4 French (vs. 6 French) catheter system. The prospective, single arm, single center trial showed 97 percent procedural success and fistula maturation in 81 percent of patients within 30 days.
Anti-clotting drugs may be unnecessary for most surgery patients
As many as three out of four surgery patients could be receiving anti-clotting medications that they do not need, according to a study led by investigators at the University of Utah School of Medicine. The research, published online in Annals of Surgery, challenges standard of care guidelines specifying that all general surgery patients receive anticoagulants. The treatment is meant to prevent formation of blood clots in the veins. In the worst cases, clots could break free and block blood flow to vital organs such as the lungs, causing sudden death. However, the new findings suggest that the preventative measure may be unnecessary for most patients, and could even be harmful to a small proportion. The investigators reviewed 14,776 records from 13 research studies to determine which surgical patients were most likely, and least likely, to benefit from anticoagulants. Within the studies were a broad range of surgical patients, ranging from individuals with few to multiple clotting risk factors such as obesity, advanced age, and personal or family history of blood clots. They were segregated into one of five categories indicating overall clot risk. Assessment was based on a tool called the Caprini score that gauges the impact of each patient’s collection of risk factors. Risk stratification revealed a large patient-to-patient variation in clot risk. Patients who were not given anticoagulants, and who were gauged to be at highest risk, were 14-fold more likely to develop clots than those in the low risk category (10.7 percent vs. 0.7 percent). These findings were independent of the type of surgery required by patients. The high risk patients, when given anticoagulants, had significantly decreased risk for developing clots. However, that same benefit did not carry over to the rest of the patients, who comprised 75 percent of the study population. Statistical analyses showed that the anticoagulant medications did not make a significant difference in clotting rates of mid or low risk patients. “A ‘one-size-fitsall approach’ doesn’t always make sense,” said the study’s lead author Christopher Pannucci. “A healthy 35-year-old is very different from someone who is 85 and has a history of clots. Our research indicates that there could be a substantial number of people who are being over-treated.” Eliminating overtreatment could cut down on unnecessary costs, and results from this study suggest it could also prevent medical complications in some patients. The data were gathered based on observational data, and prospective studies will need to be done to prove whether anticoagulants work better for some patient populations as compared to others.