EVAR Results in Higher Patient-Level Safety Benefit than Surgery for AAA

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Endovascular aneurysm repair (EVAR) is safer than open repair of abdominal aortic aneurysm (AAA) as measured by numerous patient safety indicators including mortality, according to a report published online July 9, 2014, ahead of print in JAMA Surgery.

Methods
Investigators led by John Rose, MD, MPH, of the University of California, San Diego (San Diego, CA), looked at data for 43,385 EVAR procedures and 27,561 open repairs extracted from the Nationwide Inpatient Sample from 2003 to 2010. Patient safety indicators were defined and calculated according to Agency for Healthcare Research and Quality specifications.

Strong Evidence of EVAR Advantage

There were 4,383 documented patient safety indicators and 3,717 deaths during the study period. Compared with open surgery, the risk of death and any patient safety indicator was reduced (table 1).

Table 1. Death, Patient Safety Indicators

 

EVAR
(n= 43,385)

 

Open Repair
(n = 27,561)

 

P Value 

Death

1.8%

10.6%

< .001

Any Patient Safety Indicator

3.0%

11.2%

< .001

Patients undergoing EVAR were less likely than those undergoing open surgery to experience:

  • Failure to rescue
  • Iatrogenic pneumothorax
  • Central venous catheter-related sepsis
  • Postoperative hemorrhage
  • Postoperative physiological or metabolic derangement
  • Postoperative respiratory failure
  • Postoperative pulmonary embolism or deep vein thrombosis
  • Postoperative sepsis
  • Accidental puncture or laceration 

No differences between groups were seen for decubitus ulcer, postoperative hip fracture, postoperative wound dehiscence, or transfusion reaction.

The proportion of AAA repairs that were EVAR increased steadily from 41.1% in 2003 to 75.3% in 2010. Multivariable analysis showed a reduction across time in the likelihood of any patient safety indicator occurring after EVAR compared with open repair (OR 0.58; 95% CI 0.51-0.65), as well as a decline in 2010 compared with 2003 in the risk-adjusted odds of any patient safety indicator (OR 0.63; 95% CI 0.45-0.87).

Interestingly, the risk-adjusted odds of death after EVAR decreased in 2004, 2007, 2008, and 2010, while odds of death after open repair did not change significantly during any of the years studied. According to the study authors, the factors making EVAR safer in some years than others are unclear.

“Variation in performance with EVAR may correlate with changes in practice patterns such as adaptations of EVAR devices (ie, percutaneous techniques) or expansion of indications to new patient cohorts (ie, emergency cases),” they note. “The adoption of laparoscopic partial nephrectomy, laparoscopic radical nephrectomy, and laparoscopic colectomies represents the greatest reduction in [patient safety indicators] after passing a critical ‘tipping point,’” which corresponds to a transition as early adopters master the procedure, they add.

Patient-Centered Outcomes Matter

In an invited commentary accompanying the study, Paul N. Suding, MD, of Lafayette, CO, and Lamont D. Paxton, MD, of Oakland, CA, both in private practice, say the study does not answer whether EVAR is beneficial in the long term because patient safety indicators evaluate patients for a 30-day period only.

“Moreover, the mortality for open repair… was higher than one would anticipate for this approach and likely indicates that, during the period of the study, open repair remained the preferred technique for emergency operations and for patients who had unfavorable anatomy for endovascular aneurysm repair,” they write.

Gary M. Ansel, MD, of Riverside Methodist Hospital (Columbus, OH), told TCTMD in a telephone interview that patient safety indicators provide valuable information that clinicians and patients can use when discussing treatment options.

“How newer technology and procedures affect the general, real-world population is sometimes not known so this is reassuring,” Dr. Ansel said. “Having outcome data like these gives us information that isn’t typically looked at in clinical trials. Some of these [patient safety indicators] may not be of importance academically, but for the patient they are a really big deal. From a common sense standpoint anything that prolongs your hospital stay, puts you on a ventilator, or brings you back in for wound care is going to be important to the patient who is undergoing that procedure.”

He added that the discussion is particularly relevant when describing EVAR to patients as a less invasive procedure compared with surgery.

“It’s important to have data like these to show the patient that it really does reduce your complications in a meaningful way,” Dr. Ansel said. “We’re at a point [with EVAR] where it’s not so much about whether the device works, it’s more the adaptability in the general population.”

 


Sources:
1. Rose J, Evans C, Barleben A. Comparative safety of endovascular aortic aneurysm repair over open repair using patient safety indicators during adoption. JAMA Surg. 2014;Epub ahead of print.

2. Suding PN, Paxton LD. How to use patient safety indicators to monitor vascular surgery technologies [editorial]. JAMA Surg. 2014;Epub ahead of print.

Disclosures:

  • Drs. Rose, Suding, and Paxton report no relevant conflicts of interest.
  • Dr. Ansel reports serving on the advisory boards of Cordis/Johnson & Johnson, Medtronic, Trivascular, and WL Gore.

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