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. 2015 May;61(5):1151-9.
doi: 10.1016/j.jvs.2014.12.053. Epub 2015 Feb 3.

Adherence to Endovascular Aortic Aneurysm Repair Device Instructions for Use Guidelines Has No Impact on Outcomes

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Free PMC article

Adherence to Endovascular Aortic Aneurysm Repair Device Instructions for Use Guidelines Has No Impact on Outcomes

Joy Walker et al. J Vasc Surg. .
Free PMC article

Abstract

Objective: Prior reports have suggested unfavorable outcomes after endovascular aortic aneurysm repair (EVAR) performed outside of the recommended instructions for use (IFU) guidelines. We report our long-term EVAR experience in a large multicenter registry with regard to adherence to IFU guidelines.

Methods: Between 2000 and 2010, 489 of 1736 patients who underwent EVAR had preoperative anatomic measurements obtained from the M2S, Inc, imaging database (West Lebanon, NH). We examined outcomes in these patients with regard to whether they had met the device-specific IFU criteria. Primary outcomes were all-cause mortality and aneurysm-related mortality. Secondary outcomes were endoleak status, adverse events, reintervention, and aneurysm sac size change.

Results: The median follow-up for the 489 patients was 3.1 years (interquartile range, 1.6-5.0 years); 58.1% (n = 284) had EVAR performed within IFU guidelines (IFU-adherent group), and 41.9% (n = 205) had EVAR performed outside of IFU guidelines (IFU-nonadherent group). Preoperative anatomic data showed that 62.4% of the IFU-nonadherent group had short neck length, 10.2% had greater angulation than recommended, 7.3% did not meet neck diameter criteria, and 20% had multiple anatomic issues. A small portion (n = 49; 10%) of the 489 patients were lost to follow-up because of leaving membership enrollment (n = 28), moving outside the region (n = 10), or discontinuing image surveillance (n = 11). There was no significant difference in any of the primary or secondary outcomes between the IFU-adherent and IFU-nonadherent groups. Aneurysm sac size change at any time point during follow-up also did not differ significantly between the two groups. A Cox proportional hazard model showed that IFU nonadherence was not predictive of all-cause mortality (hazard ratio, 1.0; P = .91). Similarly, IFU nonadherence was not identified as a risk factor for aneurysm-related mortality or adverse events in stepwise Cox proportional hazards models.

Conclusions: In our cohort of EVAR patients with detailed preoperative anatomic information and long-term follow-up, overall mortality and aneurysm-related mortality were unaffected by IFU adherence. In addition, rates of endoleak and reintervention after initial EVAR were similar, suggesting that lack of IFU-based anatomic suitability was not a driver of outcomes.

Conflict of interest statement

Author conflict of interest: none.

Figures

Fig. 1
Fig. 1
Effect of instructions for use (IFU) guidelines on all-cause mortality. Kaplan-Meier survival curves for 489 endovascular aortic aneurysm repair (EVAR) patients with M2S anatomic data at the initial EVAR procedure stratified by IFU guideline status (P = .82, log-rank test). All standard errors were <10%.
Fig. 2
Fig. 2
Effect of instructions for use (IFU) guidelines on aneurysm-related mortality (ARM). Kaplan-Meier survival curves for 489 endovascular aortic aneurysm repair (EVAR) patients with M2S anatomic data at the initial EVAR procedure stratified by IFU guideline status (P = .17, log-rank test). All standard errors were <10%.
Fig. 3
Fig. 3
Abdominal aortic aneurysm (AAA) sac size change in 489 endovascular aortic aneurysm repair (EVAR) patients with M2S anatomic data at the initial EVAR procedure: overall and stratified by instructions for use (IFU) guideline status. All standard errors were <10%.

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