JAMA surgery
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Randomized Controlled Trial Multicenter Study
Cost-effectiveness of cervical total disc replacement vs fusion for the treatment of 2-level symptomatic degenerative disc disease.
Cervical total disc replacement (CTDR) was developed to treat cervical spondylosis, while preserving motion. While anterior cervical discectomy and fusion (ACDF) has been the standard of care for 2-level disease, a randomized clinical trial (RCT) suggested similar outcomes. Cost-effectiveness of this intervention has never been elucidated. ⋯ The incremental cost-effectiveness ratio of CTDR compared with traditional ACDF is lower than the commonly accepted threshold of $50,000 per QALY. This remains true with varying input parameters in a robust sensitivity analysis, reaffirming the stability of the model and the sustainability of this intervention.
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Randomized Controlled Trial Comparative Study Observational Study
Surgeon's 30-day outcomes supporting the carotid revascularization endarterectomy versus stenting trial.
While the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) has been widely accepted as a landmark trial establishing an equivalent risk of major adverse events following carotid endarterectomy (CEA) or carotid artery stenting (CAS), the applicability of these findings to single centers has been questioned owing to the rigid selection criteria for investigators in the study. Although refuted by the findings of a subsequent study, a substudy of CREST established a higher periprocedural stroke rate for CAS when the surgeon was a vascular surgeon. ⋯ Similar to CREST, the 30-day risk of composite major adverse events was equivalent for the 2 treatment modalities. We attribute our comparable incidence of perioperative stroke with CAS and CEA to improved patient selection. We excluded most patients older than 80 years and those with complex anatomy from consideration for CAS. Our results confirm those of CREST and demonstrate that both CEA and CAS can be performed safely by a vascular surgeon in properly selected patients.
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Randomized Controlled Trial
Perioperative mortality following repair of abdominal aortic aneurysms: application of a randomized clinical trial to real-world practice using a validated nationwide data set.
Because of the restrictions applied to the conduct of randomized clinical trials, the risks reported in their comparison of open and endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) may not be applicable to real-world vascular surgical practice. The magnitude of this deviation is indeterminate. ⋯ Perioperative mortality reported by the OVER trial is significantly lower than outcomes from practices outside the restriction of randomized clinical trials. We attribute this difference to the fact that the OVER trial excluded high-risk patients deemed unfit for open repair. This finding supports the need for individualized assessment of risk and treatment selection for patients with infrarenal AAA. There has been no change in perioperative mortality after EVAR in recent years despite improvements in techniques, devices, and proficiency.
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Randomized Controlled Trial Multicenter Study Comparative Study
Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial.
In vitro and animal model data suggest that intraoperative preservation solutions may influence endothelial function and vein graft failure (VGF) after coronary artery bypass graft (CABG) surgery. Clinical studies to validate these findings are lacking. ⋯ Patients undergoing CABG whose vein grafts were preserved in a buffered saline solution had lower VGF rates and trends toward better long-term clinical outcomes compared with patients whose grafts were preserved in saline- or blood-based solutions.
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Randomized Controlled Trial
Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial.
Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus. ⋯ In obese patients with type 2 diabetes, RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management, with emergent differences over 1 year. Both treatments improve general quality-of-life measures, but RYGB provides greater improvement in the effect of weight on quality of life. These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed.