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June 19, 2014

Safety of EVAR Compares Favorably to Surgery in Low-Risk Patients

June 20, 2014—A comparative study of the safety of endovascular aneurysm repair (EVAR) and open surgical repair of abdominal aortic aneurysms (AAAs) in low-risk male patients was published by Jeffrey J. Siracuse, MD, et al online ahead of print in the Journal of Vascular Surgery (JVS).

The investigators found that even among those male patients at low risk for surgery on the basis of comorbidities, EVAR is associated with reduced perioperative mortality and major complications. Whereas clinical decisions must account for safety and long-term effectiveness, the short-term benefit of EVAR is evident even among male patients at the lowest risk for surgical repair, concluded the investigators in JVS.

The background of the study is that the prevalence of significant comorbidities among patients with AAAs has contributed to widespread enthusiasm for EVAR. However, the advantages of EVAR in patients at low risk for surgical repair remain unclear. The objective of this study was to assess perioperative outcomes of EVAR and surgery in low-risk patients, noted the investigators.

As summarized in JVS, patients undergoing EVAR and surgical repair for infrarenal AAAs were identified in the 2007 to 2010 National Surgical Quality Improvement Program data sets. AAA-specific risk stratification by the Medicare aneurysm scoring system was used to create matched low-risk (score < 3) cohorts. Perioperative morbidity and mortality were assessed by crude comparisons of matched groups and regression models.

Of 11,753 elective patients undergoing EVAR, there were 4,339 (37%) who were deemed low risk (score < 3). A matched cohort of 1,576 low-risk patients was developed from a total of 3,804 (41%) undergoing surgery. The low-risk cohorts included only male patients and those < 75 years old without significant cardiac, pulmonary, or vascular comorbidities. Mean age in both low-risk groups was 67 ± 6 years (P = NS).

EVAR patients had higher rates of obesity (40% vs 33%; P < .001), diabetes (16% vs 13%; P = .005), history of cardiac intervention (24% vs 19%; P < .001), cardiac surgery (23% vs 20%; P = .02), steroid use (4% vs 2%; P = .002), and bleeding disorders/anticoagulation (9% vs 6%; P = .001) compared with surgical repair patients. There were no other differences between the matched cohorts.

The investigators found that EVAR was associated with reduced 30-day mortality (0.5% vs 1.5%; P < .01) and reduced rates of major complications, including the following: sepsis (0.7% vs 3.2%; P < .01), unplanned intubation (1% vs 5.4%; P < .001), pneumonia (0.8% vs 6.1%; P < .001), acute renal failure (0.4% vs 2.7%; P < .001), and early reoperation (3.7% vs 6%; P < .001). Furthermore, EVAR was associated with reduced perioperative morbidity across organ systems, including venous thromboembolism (0.1% vs 0.3%; P = .001), transfusion requirement of more than four units (2% vs 13%; P < .001), cardiac arrest (0.2% vs 0.8%; P = .001), neurologic deficits (0.2% vs 0.5%; P = .032), and urinary tract infections (1.2% vs 2%; P = .02), reported the investigators in JVS.

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June 20, 2014

FDA Provides Draft Guidance for Industry to Correct Misinformation on Internet/Social Media Platforms

June 20, 2014

FDA Provides Draft Guidance for Industry to Correct Misinformation on Internet/Social Media Platforms


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