Complications More Common After Fenestrated vs Standard EVAR

Fenestrated endovascular abdominal aortic aneurysm repair (FEVAR) is associated with higher rates of transfusion and postoperative complications compared with standard EVAR, according to a study published online December 8, 2014, ahead of print in the Journal of Vascular Surgery. The risk of death, however, was comparable between the 2 approaches.Complications More Common After Fenestrated vs Standard EVAR

But, write Christopher J. Abularrage, MD, of the Johns Hopkins Hospital (Baltimore, MD), and colleagues, “although mortality was similar, trends toward increased cardiac and renal complications [with FEVAR] may suggest the need for judicious dissemination of this new technology.”

The researchers looked at data from the American College of Surgeons National Surgical Quality Improvement Program database on adult patients undergoing FEVAR for juxtarenal AAA (n = 458) or EVAR for infrarenal AAA (n = 19,060) from 2005 to 2012. The Zenith Fenestrated AAA Endovascular Graft (Cook Medical), approved in 2011, was used in some FEVAR cases, as were other devices. 

On average, FEVAR patients were slightly older, less likely to have a preoperative history of bleeding, and more likely to be in American Society of Anesthesiologists (ASA) class 4/5 (life-threatening or moribund condition), although rates of comorbidities were generally similar between the 2 groups.

FEVAR procedures took longer on average than EVAR (median operative time 156 vs 137 minutes; P < .001). Additionally, FEVAR patients were more likely to have thrombocytopenia (21.2% vs 15.6%) and to require brachial exposure (5.0% vs 0.5%; P < .001 for both), and to have longer average postoperative length of stay (3.3 vs 2.8 days; P = .03). 

In the 30 days following the procedures, the rates of overall complications, postoperative transfusions of at least 4 units of packed red blood cells, and superficial surgical site infections were elevated in FEVAR patients. Other complications, including cardiac problems and the need for dialysis, and mortality were numerically—but not significantly—higher after FEVAR (table 1).

Table 1. 30-Day Postoperative Outcomes

 

FEVAR

(n = 458)

EVAR

(n = 19,060)

P Value

Any Complication

23.6%

14.3%

< .001

Postoperative Transfusion

15.3%

6.1%

< .001

Superficial Surgical Site Infection

3.1%

1.6%

.01

Any Cardiac Complication

2.2%

1.3%

.09

Dialysis

1.5%

0.8%

.08

Mortality

2.4%

1.5%

.12

 

On multivariate analysis, FEVAR was an independent predictor of the need for postoperative transfusion both when operative time fell below the 75th percentile (adjusted OR 1.72; 95% CI 1.09-2.72) and when it was above that threshold (adjusted OR 5.33; 95% CI 3.55-8.00). 

The findings were similar when analyses were restricted to nonemergency cases only.

Concern about Widespread FEVAR Use 

Just as EVAR has become preferred over open surgical repair of infrarenal AAA, FEVAR—which is a more complex procedure requiring larger sheath sizes and more catheter and wire exchanges than EVAR—has emerged as a less invasive option for repairing juxtarenal AAA and has been associated with lower reported risks of perioperative mortality and postoperative complications like renal impairment, new-onset hemodialysis, and cardiac problems compared with open surgery.

“As such, there is great enthusiasm that FEVAR for [juxtarenal] AAA will result in the same endovascular revolution that EVAR did for [infrarenal] AAA,” Dr. Abularrage and colleagues write. “There is concern, however, that the widespread adoption of this new technology in the community may not result in the same outcomes as it did in specialized centers.” 

The results of this study argue for careful use of the technology, “with close monitoring of adjudicated outcomes,” they continue. “FEVAR is not proven as safe as EVAR, and long-term follow-up is needed. Furthermore, strict adherence to the instructions for use for FEVAR will likely be critical to long-term success.”

Dr. Abularrage and colleagues acknowledge some shortcomings of the analysis, including the retrospective design, the ability to look only at perioperative outcomes, and the inability to identify which patients underwent FEVAR as part of a clinical or IDE trial, or the manufacturer of the devices used. 

“Despite these limitations,” they write, “this is one of the largest studies of FEVAR to date, and the findings found on univariate analysis are a stark reminder that adjudicated outcomes for procedures performed in the community are critical to understanding the effect of technology on the care of patients.”

 


Source:
Glebova NO, Selvarajah S, Orion KC, et al. Fenestrated endovascular repair of abdominal aortic aneurysms is associated with increased morbidity but comparable mortality with infrarenal endovascular aneurysm repair. J Vasc Surg. 2014;Epub ahead of print.

 

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Disclosures
  • Dr. Abularrage reports no relevant conflicts of interest.

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