Designation as ‘Unfit for Open Repair’ Predicts Worse EVAR Outcomes

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Surgeon classification of a patient as unfit for open repair of an abdominal aortic aneurysm (AAA) predicts higher rates of postoperative complications and reduced long-term survival following endovascular aneurysm repair (EVAR), according to a study published online August 20, 2013, ahead of print in Circulation: Cardiovascular Quality and Outcomes.

Randall R. De Martino, MD, of Dartmouth-Hitchcock Medical Center (Lebanon, NH), and colleagues analyzed 1,653 patients who underwent elective EVAR for AAA < 6.5 cm at 21 centers in the Vascular Study Group of New England registry between 2003 and 2011. Of this cohort, 309 patients (19%) were deemed unfit for open repair by the operating surgeon.

What Makes a Patient Unfit for Surgery

Using a multivariable model, the researchers identified multiple characteristics associated with designation of patients as unfit for open repair, including notably severe COPD:

  • Age ≥ 80 years (OR 2.7; 95% CI 1.6-4.3; P < 0.001)
  • Female sex (OR 1.7; 95% CI 1.2-2.4; P = 0.003)
  • Stable angina (OR 2.8; 95% CI 1.8-4.2; P < 0.001)
  • Ejection fraction < 30% (OR 4.9; 95% CI 2.1-11.0; P < 0.001)
  • Prior MI (OR 1.6; 95% CI 1.1-2.4; P = 0.007)
  • Aneurysm size > 5.5 cm (OR 1.9; 95% CI 1.5-2.5; P < 0.001)
  • Untreated COPD (2.5; 95% CI 1.8-3.6; P < 0.001)
  • COPD treated with medications (OR 3.7; 95% CI 2.7-5.1; P < 0.001)
  • COPD on at-home oxygen (OR 16.4; 95% CI 9.2-29.3; P < 0.001)

More Complications, Lower Survival

Overall, designation as unfit for open repair tripled the frequency of major postoperative complications, driven largely by higher rates of cardiovascular and pulmonary complications. No difference was seen in early mortality (table 1).

Table 1. Postoperative Outcomes After EVAR

 

Unfit for
Open Repair
(n = 309)

Fit for
Open Repair
(n = 1,344)

P Value

Any Major Complicationa

12.5%

3.7%

<0.001

Cardiac Complicationsb

7.8%

3.1%

<0.001

Pulmonary Complicationsc

3.6%

1.6%

0.029

Mortality

0.7%

0.3%

0.313

a Death or cardiac or pulmonary complication.
b MI, congestive heart failure, or dysrhythmia.
c Pneumonia or need for reintubation.

Unfit surgical patients also had longer ICU stays, were less likely to be extubated in the operating room, and had higher rates of bowel ischemia and renal dysfunction.

Patients designated as unfit for surgery showed lower long-term survival compared with their ‘fit’ counterparts (93% vs. 96% at 1 year; 73% vs. 89% at 3 years, and 61% vs. 80% at 5 years; log rank P < 0.001). After adjustment for baseline characteristics, an unfit designation predicted a higher likelihood of worse 5-year survival (HR 1.6; 95% CI 1.2-2.2).

Reassuring Physicians

In a telephone interview with TCTMD, Dr. De Martino said that the results of his study echoed those of the randomized EVAR-2 trial in that “patients with a large comorbidity burden who may not be eligible for open repair [were found to] have substantially reduced life expectancy even if their aneurysm is fixed with an endovascular approach.”

Noting that the current data come from a quality-improvement registry, Dr. De Martino commented that although the physicians’ assessments of patient fitness for surgery were subjective, “[They] capture things that may not be identified in a normal registry. This study gives validity to what we call the ‘eyeball test.’”

This validation may be reassuring to physicians since currently the grounds for selecting patients who will benefit from EVAR consist of balancing the risk of rupture against the risk of undergoing a procedure and the patient’s anticipated life expectancy, Dr. De Martino said, adding that these criteria can sometimes be vague and have to be applied on a patient-by-patient basis.

Study Limitations

In a telephone interview with TCTMD, Frank A. Lederle, MD, of the Veterans Affairs Medical Center (Minneapolis, MN), pointed out that the mean aneurysm diameter among unfit patients was 5.6 cm, meaning that more than half of this group underwent EVAR despite having aneurysms smaller than 5.5 cm. “Randomized trials show that even in the healthiest patients there is no benefit to repairing aneurysms [this size],” he reported.

Noting that a quarter of patients in the unfit group were older than age 82, Dr. Lederle added that it is “remarkable that someone who is in an unfit condition would have elective repair of an aneurysm at that age.”


Source:
De Martino RR, Brooke BS, Robinson W, et al. Designation as “unfit for open repair” is associated with poor outcomes after endovascular aortic aneurysm repair. Circ Cardiovasc Qual Outcomes. 2013;Epub ahead of print.

 

 

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Disclosures
  • Drs. De Martino and Lederle report no relevant conflicts of interest.

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