Journal of vascular surgery
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Physician-modified endovascular devices are becoming commonplace in a modern climate where innovation outpaces regulated technological advancement. Off-label use of medical devices occurs on a daily basis throughout many institutions across the United States and when performed by physicians, is both legal and unregulated. The purpose of this invited commentary is to review the regulatory, compliance, and legal issues regarding the practice of medical device modification.
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Comparative Study
The impact of endograft type on inflammatory response after endovascular treatment of abdominal aortic aneurysm.
To evaluate the impact of endograft type on the inflammatory response after elective endovascular repair of abdominal aortic aneurysms. ⋯ Endograft type appears to influence the inflammatory response after endovascular aortic repair. The postimplantation syndrome was apparent during the first 24 hours and decreased afterward. Anaconda and Zenith endografts induced a more intense inflammatory response. A "milder" inflammatory activation was observed in patients with an Excluder endograft. The postimplantation syndrome was not associated with perioperative adverse clinical events showing a benign course. The possible long-term sequelae of postimplantation syndrome require further investigation.
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This single-center, prospective study aimed to investigate the technical success and outcome of intentional coverage of the left subclavian artery (LSA) in patients undergoing thoracic endovascular aortic repair (TEVAR) for traumatic rupture of the aortic isthmus at a tertiary care medical center. ⋯ Coverage of the LSA during TEVAR for traumatic aortic injuries appears to be a feasible, safe method for extending the endograft landing zone without increasing the risk of paraplegia, stroke, or left arm ischemia. Left vertebral artery diameter can be used to identify patients at risk for postoperative left arm ischemia.
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Clinical pathways aimed at reducing hospital length of stay following vascular surgery have been broadly implemented to reduce costs. However, early hospital discharge may adversely affect the risk of readmission or mortality. To address this question, we examined the relationship between early discharge and 30-day outcomes among patients undergoing a high-risk vascular surgery procedure, thoracic aortic aneurysm (TAA) repair. ⋯ Discharging patients home early following uncomplicated TEVAR or open TAA repair is associated with reduced hospital costs without adversely impacting 30-day readmission or mortality rates. These data support the safety and cost-effectiveness of programs aimed at early hospital discharge in selected vascular surgery patients.
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Comparative Study
Outcomes comparison of HeRO and lower extremity arteriovenous grafts in patients with long-standing renal failure.
The Hemodialysis Reliable Outflow (HeRO) graft is becoming a recognized alternative to lower extremity arteriovenous grafts (LEAVGs) as an option for patients who have exhausted traditional upper extremity access; however, which should be applied preferentially is unclear. ⋯ In access challenged patients, LEAVG and HeRO offer similar rates of secondary patency, infection, and all-cause mortality. The LEAVG required fewer interventions to maintain patency, and the HeRO maintains the benefit of utilizing the upper extremity site of venous drainage. In our practice, we prefer the HeRO to LEAVG, especially in patients with peripheral arterial disease and in the obese population, because it preserves lower extremity access options.