Journal of Vascular Surgery
Volume 49, Issue 1 , Pages 42-46, January 2009

The outcome of thoracic endovascular aortic repair (TEVAR) in patients with renal insufficiency

Presented at the Twenty-First Annual Meeting of the Eastern Vascular Society, Baltimore, Md, Sep 30-Oct 4, 2007.

Hospital of the University of Pennsylvania, Philadelphia, Pa

Received 22 April 2008; accepted 23 July 2008. published online 25 November 2008.

Article Outline

Objective

We sought to determine the effects of renal insufficiency on thoracic endovascular aortic repair (TEVAR) outcome and to identify predictors for adverse events.

Methods

Eighty-four patients with renal insufficiency (creatinine ≥1.5 mg/dL) were analyzed from a prospective TEVAR database from April 1, 1999, to January 1, 2008. Patients were subdivided into groups by creatinine level (mg/dL): group 1 (1.5-2.0), group 2 (2.0-3.0), group 3 (>3.0), and group 4 (preoperative dialysis-dependent). Demographics, aneurysm/aortic lesion characteristics, perioperative morbidity, mortality, and follow-up data were compared with 246 control patients (<1.5 mg/dL).

Results

Comorbidities were similar between the renal insufficiency and control groups, except for age (74 ± 8 vs 69 ± 6 years, P < .0002), male gender (73% vs 58%, P < .02), and presence of peripheral vascular disease (56% vs 38%, P < .005). Mean follow-up was 9 months. The renal insufficiency and control groups had similar aortic pathologies, including fusiform (51% vs 57%) and saccular aneurysms (27% vs 37%). Overall mean serum creatinine and creatinine clearance did not worsen during follow-up. Perioperatively, 18 patients (21%) patients required dialysis. Nine patients (11%) presented a newly acquired need for dialysis. Degree of preoperative renal impairment correlated with increasing dialysis requirement: group 1, 5% (3 of 55); group 2, 25% (3 of 12); group 3, 38% (3 of 8); and group 4, 100% (9 of 9). Three patients did not recover baseline renal function. Contrast type (isosmolar vs hyposmolar) and amount (96 ± 8 mL vs 100 ± 8 mL, P = .33) was similar between the dialysis and no-dialysis groups. Renal insufficiency patients had a statistically significant higher rate of major adverse events (25% vs 6.9%, P < .00003), 30-day mortality (11% vs 4.4%, P < .05), and myocardial infarction (6.0% vs 1.0%, P < .013) than controls. One or more major adverse events occurred in 25%, including stroke (6.0%), myocardial infarction (6.0%), and spinal cord ischemia (4.8%). Predictors for adverse events included emergency repair (odds ratio, 3.1; 95% confidence interval, 1.1-8.4; P = 0.037) and baseline creatinine >2.0 (odds ratio, 5.9; 95% confidence interval, 2.1-16.8; P = .001). Age, gender, adjunctive access, type of aortic pathology, and number of device components did not adversely affect outcome.

Conclusion

Patients with preoperative renal insufficiency maintain renal function after TEVAR. However, this patient population may be susceptible to increased adverse events, with emergency repair and baseline creatinine >2.0 mg/dL serving as strong predictors.

 

The multicenter Gore TAG (W. L. Gore and Associates, Flagstaff, Ariz) pivotal trial led to United States Food and Drug Administration approval for endovascular repair of descending thoracic aortic aneurysms in March 2005 in the United States, although pivotal trials were conducted as early as 1998 in Europe.1, 2 Since then, thoracic endovascular aortic repair (TEVAR) has had more widespread applicability and is increasingly being used for other aortic pathologies such as complicated type B dissection,3, 4, 5 traumatic transection,6, 7, 8 and aneurysmal disease extending into the arch or visceral segment requiring debranching procedures.9, 10, 11

Long regarded as the less morbid approach to treating thoracic aortic pathologies, the recent article summarizing the phase II, 5-year results of the TAG study rather definitively showed a reduction in aneurysm-related death without a compromise in overall survival.12 Given these findings as well as continued advances in device design and delivery, TEVAR is positioned to become the preferred modality of treatment of diverse aortic pathologies in patients with suitable anatomy. With this increase in applicability is a need for risk stratification to help predict adverse events and potentially improve outcome.

Patients with renal insufficiency are recognized as a subset of patients prone to perioperative events13, 14 and have been noted to have a higher cardiovascular morbidity and mortality15 attributable to the systemic effects of atherosclerosis as well as elevated circulating levels of angiotensin II.16 We sought to determine whether preoperative renal insufficiency affected outcome in patients undergoing TEVAR and attempted to identify risk factors for adverse outcome in this subset of patients. In addition, we studied the effect of TEVAR on renal function in this population.

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Methods 

A prospective database of TEVAR patients entered from April 1, 1999, to January 1, 2008, was retrospectively reviewed. Patients undergoing hybrid procedures were excluded. Patients were divided into two main groups: patients with renal insufficiency were defined by a serum creatinine level of ≥1.5 mg/dL, and the control group, by creatinine of <1.5 mg/dL. The patients with renal insufficiency were further subdivided into four groups by serum creatinine level: group 1, 1.5 to 2.0; group 2, 2.0 to 3.0; group 3, >3.0 mg/dL, and group 4, dialysis-dependent preoperatively. Inclusion criteria consisted of a fusiform aneurysm diameter >5.0 cm in size, a saccular aneurysm of any size, a ruptured aneurysm of any size, type B dissection with malperfusion, and traumatic transection. All protocols and procedures were approved by the FDA and the Institutional Review Board with written informed consent.

Demographic information, aortic lesion/pathology, and perioperative morbidity/mortality were analyzed and compared between patients with and without renal insufficiency. Major adverse events were defined as death, stroke, spinal cord ischemia (SCI), or myocardial infarction (MI). The effect of TEVAR on renal function was assessed by recording serum creatinine levels in the preoperative, perioperative (stable creatinine before discharge), and follow-up periods (range, 1-24 months). Creatinine clearance was estimated using the Cockcroft-Gault equation, which helps to account for differences due to age, gender, and weight:

The development of the need for hemodialysis was recorded. The amount and type of contrast used for the procedure was also analyzed.

Data analysis 

Comparison of continuous variables between groups was made using the t test. Comparison of categoric variables between groups was made using the Fisher exact test (two-tailed). Analysis of variance (ANOVA) was used to compare continuous variables among three or more groups. Logistic regression analysis was used to help determine predictors for major adverse events in the renal insufficiency population. The Pearson correlation coefficient was used to determine a relationship between two groups. A two-tailed P < .05 was considered to be statistically significant.

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Results 

Patients and demographics 

From April 1, 1999, to January 1, 2008, 390 patients underwent TEVAR at our institution. Hybrid procedures were excluded from analysis. The 330 patients with complete records were subdivided into 84 patients with renal insufficiency and 246 without renal insufficiency. Mean follow-up was 9 months (range, 1-24 months). Patients in the renal insufficiency cohort were significantly older (74 ± 8 vs 69 ± 6 years, P < .0002), more likely to be men (73% vs 58%, P < .02), and more likely to carry a diagnosis of peripheral vascular disease (56% vs 38%, P < .005) compared with the control group. The two groups were otherwise similar with respect to comorbidities (Table I). Fusiform aneurysms were the most common aortic lesion in both groups (51% and 57%), with saccular aneurysms the next most common (27% and 37%). Because only complicated type B aortic dissections were treated, all patients in this group had a creatinine >1.5 mg/dL. Both groups had a similar percentage of emergency cases (39% vs 33%, P = .43). The use of adjunctive access between groups was not statistically significant (Table II).

Table I. Patient demographics and comorbidities
VariableCr > 1.5 mg/dLCr < 1.5 mg/dL (control)P
Patients, No.84246
Age, mean ± SD, y74±869±6.0002a
Male, %7358.02a
Hypertension, %9289.68
COPD/tobacco use, %6757.13
Hypercholesterolemia, %6155.38
CAD, %5748.17
Prior AAA repair, %2722.37
PVD, %5638.005a
Diabetes mellitus, %3123.19

AAA, Abdominal aortic aneurysm; COPD, chronic obstructive pulmonary disease; Cr, creatinine; PVD, peripheral vascular disease; SD, standard deviation.

aDenotes statistically significant difference.

Table II. Anatomic and clinical features
FeatureCr ≥1.5 mg/dLCr <1.5 mg/dLP
Fusiform aneurysm, %5157.42
Saccular aneurysm, %2737.11
Dissection/transection, %22…N/A
Emergency case, %3933.43
Adjunctive access, %2118.52

Cr, creatinine; N/A, not applicable.

Renal function over time 

Serum creatinine did not worsen perioperatively or at follow-up in any of the groups (P = .46; Fig 1). In fact, the group 3 patients exhibited an overall improvement in renal function (P < .02). Six of eight patients in group 3 had type B dissections presenting with malperfusion, thus accounting for the increase in renal function. These results were further substantiated by calculating the creatinine clearance (Fig 2). Again, renal function was preserved in all groups, both perioperatively as well as at late follow-up, with improvement of renal function noted in group 3 patients.

  • View full-size image.
  • Fig 1. 

    Serum creatinine levels over time by patient groups. Control, Serum creatinine < 1.5 mg/dL; Group 1, 1.5 to 2.0; Group 2, 2.0 to 3.0; Group 3, >3.0 mg/dL; Group 4, dialysis-dependent preoperatively. Results are presented with the standard deviation.

  • View full-size image.
  • Fig 2. 

    Creatinine clearance over time by patient groups. Control, Serum creatinine < 1.5 mg/dL; Group 1, 1.5 to 2.0; Group 2, 2.0 to 3.0; Group 3, >3.0 mg/dL; Group 4, dialysis-dependent preoperatively. Results are presented with the standard deviation.

Perioperative dialysis was required in 18 of 84 patients (21%), and nine had a newly acquired need for dialysis. The degree of preoperative renal impairment correlated with increasing dialysis requirement (r = 0.92, P < .03; Table III). Nevertheless, only three patients (2 from group 2, 1 from group 3) did not recover baseline renal function. One patient from group 2 had had a prior nephrectomy for renal cell carcinoma and underwent a renal stent placement during the index procedure due to flap encroachment on the renal artery ostia. The other patient from group 2 had renal artery stenosis as well as congestive heart failure. The patient from group 3 had a complicated postoperative course marked by myocardial infarction and development of postoperative ileus and worsening abdominal examination prompting an exploratory laparotomy, which proved to be negative. Interestingly, contrast type (isosmolar vs hyposmolar) and contrast amount (96 ± 8 mL vs 100 ± 8 mL) did not differ between the groups with and without dialysis (P = .33).

Table III. Progression to perioperative dialysis by group
GroupPatients on dialysis, No. (%)
Control0/246(0)
Group 13/55(5)
Group 23/12(25)
Group 33/8(38)
Group 49/9(100)

Control, Serum creatinine < 1.5 mg/dL; Group 1, 1.5-2.0; Group 2, 2.0-3.0; Group 3, >3.0 mg/dL; Group 4, dialysis-dependent preoperatively.

Perioperative morbidity and mortality 

Patients with renal insufficiency had a statistically significant higher rate of major adverse events (25% vs 6.9%, P < .00003), 30-day mortality (11% vs 4.4%, P < .05), and rate of MI (6.0% vs 1.0%, P < .013). At least one adverse event occurred in 25% of patients, including stroke, 6.0% (n = 5), MI, 6.0% (n = 5), and SCI, 4.8% (n = 4). Four of five stroke patients underwent zone II coverage. Three of four patients with SCI had undergone prior abdominal aortic aneurysm (AAA) repair, although three patients had recovered by discharge (Table IV).

Table IV. Morbidity and mortality in control vs renal insufficiency groups
VariableCr ≥ 1.5 mg/dLCr < 1.5 mg/dL (control)P
Major adverse event rate, %256.9.00003a
30-day mortality, %114.4.05a
Stroke, %63.2.33
Myocardial infarction, %6.01.013a
Spinal cord ischemia, %4.82.4.28

Cr, Creatinine.

aStatistical significance.

Logistic regression analysis was used to determine predictors for adverse events in the renal insufficiency population. Both emergency case (odds ratio, 95% confidence interval, 1.1-8.4, P = .037) and baseline creatinine >2.0 mg/dL (odds ratio, 5.9; 95% confidence interval, 2.1-16.8, P < .0001) were strong predictors. Age, gender, type of aortic pathology, need for adjunctive access, and number of device components did not adversely affect outcome.

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Discussion 

Thoracic aortic endografting is becoming the approach of choice for the treatment of descending thoracic aortic aneurysms. As experience with other aortic lesions and pathologies progresses, the applicability of TEVAR will continue to grow and evolve. Because it is substantially less morbid, it has led to the inclusion of sicker patients not normally considered surgical candidates. Risk stratification is thus an important element of preoperative planning.

Renal insufficiency has been associated with worse outcome after surgical procedures. Perioperative mortality13, 17 and myocardial infarction18 has been shown to be higher in patients with renal insufficiency after carotid endarterectomy. This has been attributed to the systemic effects of atherosclerosis. Patients with atherosclerotic renal artery disease have a greater degree of left ventricular hypertrophy, left ventricular diastolic dysfunction, and higher circulating levels of angiotensin II, causing hypertension and an impaired endothelium-dependent vasodilatory response.19

The effect of renal dysfunction after coronary artery bypass grafting (CABG) has also been well studied and reported. A review using the Society of Thoracic Surgeons National Adult Cardiac database showed that the preoperative glomerular filtration rate was a powerful predictor for perioperative mortality and morbidity, including stroke, sternal wound infection, and increased hospital stay.20 Worsening degree of renal impairment has also been shown to adversely affect survival, with an estimated 5-year survival rate of 45% in patients with bilateral renal artery stenosis, dropping to 18% in patients who are dialysis-dependent.16

This study was undertaken to evaluate the effects of preoperative renal insufficiency on outcome after TEVAR. We found that patients with renal insufficiency defined by serum creatinine level of >1.5 mg/dL had a statistically significant higher rate of 30-day mortality and MI than the control group, findings that parallel those described after carotid endarterectomy and CABG. In addition, major adverse events defined as the aggregate rate of stroke, SCI, MI, and 30-day mortality was higher in patients with renal insufficiency.

A prior study from this institution noted the relationship between proximal landing zone, severity of atheroma in the arch, and the risk of perioperative stroke.21 Four of the five patients in this study with stroke underwent zone II coverage. Unfortunately, preoperative information regarding the arch was only available in two of these patients, demonstrating mobile atheroma. To our knowledge, no studies have correlated the presence of mobile atheroma in the arch with renal insufficiency; this would be the subject of future study.

Four patients in this study presented with SCI, three of whom had had prior AAA repair, a known risk factor for paraplegia after TEVAR.22 Supplanting our results, recent data from the European Collaborators on Stent-Graft Techniques for AAA and Thoracic Aortic Aneurysm and Dissection Repair (EUROSTAR) registry showed that paraplegia was independently correlated with renal failure as well as open AAA repair.23

Predictors for adverse events in this study included emergency repair and baseline creatinine level >2.0 mg/dL. As a manifestation of end-organ dysfunction from widespread effects of atherosclerosis, the relationship between creatinine elevation and adverse events is not unexpected. The emergency nature of >30% of the patients in this study speaks to the acuity of aortic pathology seen at our institution. Because many of these patients had some degree of hemodynamic instability (ie, tachycardia), the increase in myocardial events is not surprising. The hemodynamic instability or threat of impending rupture in these patients also precluded the use of spinal cord protective measures, including lumbar drainage and left carotid–subclavian bypass.

We were also interested in assessing the effect TEVAR had on renal function in this patient population. Concerns regarding the effects of nephrotoxic agents and potential embolic events due to stent graft proximity to the renal artery orifices led to a series of studies documenting the effects of EVAR on renal function. Alsac et al24 reported a 10% decline in creatinine clearance after EVAR 1 year postoperatively, with no difference noted between suprarenal or infrarenal fixation. Greenberg et al25 similarly showed a decrement in renal function 12 months postoperatively, although this effect was transient. Parmer et al26 evaluated the effect of EVAR on patients with chronic renal insufficiency, and although the differences were not statistically significant, there was a similar decrease in renal function over time.6

TEVAR, however, differs from EVAR in many respects, which may explain why renal function was preserved in this study. The more proximal nature of landing zones makes stroke and SCI of greater concern than renal artery embolization. Because of the lack of balloon-catheter manipulation in the vicinity of the renal artery orifices, the embolic risk should be markedly diminished. In addition, the amount of contrast required for TEVAR is likely less than that for EVAR, particularly with the use of modular bifurcated prostheses for repair of AAA. Indeed, the overall average volume required in our series was 99 mL, in contrast to the 134 mL for EVAR previously reported by our institution.26 In addition, the inclusion of dissection pathology in this study perhaps decreased the number of potential atheroembolic events that might have been observed with thrombus-laden degenerative aneurysms. Indeed, renal function not only did not deteriorate in complicated dissection patients but, rather, improved over time.

Renal protective measures used by our institution included pretreatment with acetylcysteine after 2000 and pretreatment with acetylcysteine and sodium bicarbonate solution after 2004. A 600-mg oral dose of acetylcysteine was administered twice daily the day before and the day of the procedure. The sodium bicarbonate solution (dextrose 5% with 154 mEq of sodium bicarbonate/L) was either administered at 3 mL/kg/h 1 hour before the procedure, followed by 1 mL/kg/h 6 hours after the procedure, or alternatively for those patients with a history of congestive heart failure, was administered at a maintenance rate for a minimum of 12 hours preoperatively and for 6 hours postoperatively. Isosmolar, noniodinated contrast was used intraoperatively in patients with creatinine levels >1.5 mg/dL after 2003. The advantages of limiting nephrotoxic contrast agents preoperatively with the use of magnetic resonance angiography initially seemed attractive,27 but the recognition of nephrogenic systemic fibrosis occurring after gadolinium exposure has limited its usefulness in the renal insufficiency population. Contrast-enhanced computed tomography imaging is thus preferred preoperatively because it provides the most accurate anatomic information without the risk of nephrogenic systemic fibrosis, and, in our experience, has not caused a decrement in renal function. Postoperatively, the use of noncontrast computed tomography as well as plain radiographs allow for measurement of aneurysm sac diameter as well as detection of any stent fractures or migration.

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Conclusions 

Patients with preoperative renal insufficiency preserve renal function after TEVAR with rare progression to dialysis-dependence long-term. However, this patient population may be susceptible to increased adverse events, with emergency repair and baseline creatinine levels >2.0 mg/dL serving as strong predictors.

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Author contributions 


Conception and design: EW

Analysis and interpretation: GW, BJ, EW

Data collection: GW, WS

Writing the article: GW, EW

Critical revision of the article: GW, RF, AP, WS, EW

Final approval of the article: EW, RF

Statistical analysis: GW, EW

Obtained funding: Not applicable

Overall responsibility: GW

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References 

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 Competition of interest: none.

 CME article

PII: S0741-5214(08)01240-8

doi:10.1016/j.jvs.2008.07.070

Journal of Vascular Surgery
Volume 49, Issue 1 , Pages 42-46, January 2009

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