Journal of vascular surgery
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Randomized Controlled Trial
Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.
The surgical site infection (SSI) rate in vascular surgery after groin incision for lower extremity revascularization can lead to significant morbidity and mortality. This trial was designed to study the effect of negative pressure wound therapy (NPWT) on SSI in closed groin wounds after lower extremity revascularization in patients at high risk for SSI. ⋯ This study demonstrated a nonsignificant lower rate of groin SSI in high-risk revascularization patients with NPWT compared with standard dressing. Owing to a lower than expected infection rate, the study was underpowered to detect a difference at the prespecified level. The NPWT group did show significantly shorter mean hospital duration of stay compared with the standard dressing group.
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Randomized Controlled Trial Multicenter Study Comparative Study
Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms.
Randomized trials have shown an initial survival benefit of endovascular over conventional open abdominal aortic aneurysm repair but no long-term difference up to 6 years after repair. Longer follow-up may be required to demonstrate the cumulative negative impact on survival of higher reintervention rates associated with endovascular repair. ⋯ During 12 years of follow-up, there was no survival difference between patients who underwent open or endovascular abdominal aortic aneurysm repair, despite a continuously increasing number of reinterventions in the endovascular repair group. Endograft durability and the need for continued endograft surveillance remain key issues.
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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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Randomized Controlled Trial Comparative Study
A randomized controlled trial and cost-effectiveness analysis of early cannulation arteriovenous grafts versus tunneled central venous catheters in patients requiring urgent vascular access for hemodialysis.
Early cannulation arteriovenous grafts (ecAVGs) are proposed as an alternative to tunneled central venous catheters (TCVCs) in patients requiring immediate vascular access for hemodialysis (HD). We compared bacteremia rates in patients treated with ecAVG and TCVC. ⋯ Compared with TCVC+/-AVF, a strategy of ecAVG+/-AVF reduced the rate of culture-proven bacteremia and mortality in patients requiring urgent vascular access for HD. The strategy also proved to be cost-neutral.
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Randomized Controlled Trial
The effect of supervised exercise therapy for intermittent claudication on lower limb lean mass.
Supervised exercise is currently recommended for the first-line treatment of intermittent claudication based on improvement in walking capacity. However, the promotion of skeletal muscle atrophy by repetitive ischemia-reperfusion caused by treadmill-based programs remains a concern. Because preservation of skeletal muscle mass (SMM) and lean mass (LM) is integral to functional capacity and longevity, this study measured the effect of standard treadmill-based supervised exercise on SMM and regional lower limb LM in patients with intermittent claudication. ⋯ Twelve weeks of standard treadmill-training for intermittent calf claudication did not result in loss of calf LM; however, a significant decrease in bilateral thigh LM was observed, even in patients with unilateral symptoms. Further research on optimum exercise modalities and end points are required to determine the pathophysiology and effects of these changes on function and survival.