Journal of vascular surgery
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Randomized Controlled Trial Multicenter Study
Rationale and design of the MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease (MOBILE) trial investigating autologous bone marrow cell therapy for critical limb ischemia.
Critical limb ischemia (CLI) continues to place a significant encumbrance on patients and the health care system as it progresses to limb loss and long-term disability. Traditional methods of revascularization offer a significant benefit; however, for one-third of CLI patients, these surgical options are not technically possible or patency is severely limited by disease burden (deemed "poor-option" for revascularization). In a previous phase I trial, we demonstrated intramuscular injection of concentrated bone marrow aspirate (cBMA) via MarrowStim (Zimmer Biomet, Warsaw, Ind) harvest is safe and may decrease major amputation in patients with CLI unfit for surgical revascularization. Therefore, we describe and rationalize the MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease (MOBILE) trial, a study geared to provide the pivotal proof of efficacy of cBMA in CLI. ⋯ If successful, MOBILE could add definitive, high-quality evidence in support of cBMA for the treatment of poor-option CLI patients and provide an additional modality for patients who face amputation secondary to advanced limb ischemia.
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Comparative Study
Perioperative outcome of endovascular repair for complex abdominal aortic aneurysms.
As endovascular aneurysm repair (EVAR) continues to advance, eligibility of patients with anatomically complex abdominal aortic aneurysms (AAAs) for EVAR is increasing. However, whether complex EVAR is associated with favorable outcome over conventional open repair and how outcomes compare with infrarenal EVAR remains unclear. This study examined perioperative outcomes of patients undergoing complex EVAR, focusing on differences with complex open repair and standard infrarenal EVAR. ⋯ In this study assessing the perioperative outcomes of patients undergoing repair for anatomically complex AAAs, complex EVAR had fewer complications than complex open repair but carried a higher risk of adverse outcomes than infrarenal EVAR. Further research is warranted to determine whether the benefits of EVAR compared with open repair for complex AAA treatment are maintained during long-term follow-up.
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Carotid endarterectomy (CEA) reduces stroke risk in selected patients. However, CEA risk profile may be different in older patients. We compared characteristics and outcomes of octogenarians and nonagenarians with those of younger patients. ⋯ CEA was performed with low rates of perioperative neurologic events and mortality. Multivariate testing showed that the higher rate of neurologic complications in octogenarians and nonagenarians appeared partially related to symptomatic status and urgent surgery; but after adjusting for these factors, age ≥80 years still predicted a slightly higher rate. Periprocedural CEA outcomes appear similar in comparing older and younger patients, although longer term survival is lower for older patients, and older patients are at greater risk of discharge to other than home. CEA was associated with slightly higher risk of neurologic complications in older patients but may be considered appropriate for selected octogenarians and nonagenarians.
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Concern over perioperative and long-term durability of lower extremity revascularizations among active smokers is a frequent deterrent for vascular surgeons to perform elective lower extremity revascularization. In this study, we examined perioperative outcomes of lower extremity endovascular (LEE) revascularization and open lower extremity bypass (LEB) in active smokers with intermittent claudication (IC) and critical limb ischemia (CLI). ⋯ In active smokers, LEB for IC and CLI requires fewer reinterventions but is associated with a higher rate of postoperative wound complications compared with LEE revascularization. However, the risk for limb amputation is higher in actively smoking patients when treated by LEE compared with LEB for CLI. Importantly, cardiovascular complications are significantly higher in actively smoking patients with IC undergoing LEB compared with LEE. This additional cardiovascular risk should be carefully weighed when proposing LEB for actively smoking patients with nonlimb-threatening IC.
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Comparative Study
The incidence and fate of endoleaks vary between ruptured and elective endovascular abdominal aortic aneurysm repair.
The number of ruptured abdominal aortic aneurysm (r-AAA) patients who are treated by endovascular means is increasing as ruptured endovascular aneurysm repair (r-EVAR) enters the mainstream. However, even today, data on the incidence and behavior of endoleaks after r-EVAR are scarce. This study analyzed whether endoleaks behave differently after EVAR for rupture vs elective AAA repair. ⋯ Compared with e-EVAR, patients who undergo r-EVAR experience a similar incidence of type I endoleaks and a significantly lower incidence of type II endoleaks. The endoleaks in both e-EVAR and r-EVAR patients can frequently be managed by endovascular means. However, r-EVAR patients with type I and type II endoleaks are at a significantly higher risk for stent graft explantation.