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Vascular and Interventional Radiology |
1 Departments of Radiology (D.J.S., A.H.M., J.F.A., K.D.H.)
2 Internal Medicine, Division of Cardiovascular Medicine (C.A.), Box 170, University of Virginia Health Sciences Center, Charlottesville, VA 22908
3 Department of Radiology, St Vincent's Hospital, Toledo, Ohio (J.K.M.).
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Abstract |
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 TOP Abstract IntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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MATERIALS AND METHODS: Diagnostic renal angiography and percutaneous renal interventions were performed by using gadodiamide (total dose, 0.3 mmol/kg) and CO2 as intraarterial contrast agents in 25 procedures in 24 patients with renal insufficiency. Serum creatinine levels were obtained within 24 hours before and at 24 and 48 hours after the procedure. Increases in serum creatinine of more than 44 µmol/L were considered clinically important. Gadodiamide-enhanced angiograms were compared with CO2-enhanced angiograms.
RESULTS: In 23 (92%) of 25 procedures, there was no increase in serum creatinine level at 48 hours. One patient with acute and chronic rejection of a renal transplant and one with evidence of cholesterol embolization had a clinically important increase in serum creatinine level at 48 hours. No marked increase in creatinine level was observed in patients with relatively low baseline levels (n = 19). Gadodiamide-enhanced angiograms appeared to be better than CO2-enhanced angiograms for help in identifying renal artery occlusions, visualizing renal vessels incompletely filled with CO2, and determining the progress of intervention.
CONCLUSION: Gadodiamide appears to be a safe and useful intraarterial contrast agent in patients with renal insufficiency and can be used to supplement or confirm CO2-enhanced angiographic findings.
Index terms: Angiography, contrast media, 961.122 • Carbon dioxide • Gadolinium • Renal arteries, stenosis or obstruction, 961.72
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Introduction |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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Percutaneous treatment of RAS by using balloon angioplasty with or without stent insertion has been advocated (9) to help preserve renal function. Yet, the determination of when the RAS is the cause of renal insufficiency can be difficult. Noninvasive evaluation with the use of radionuclide studies, ultrasonography (US), computed tomographic (CT) angiography, and magnetic resonance (MR) angiography have been advocated, but all of these methods have their shortcomings (10–18). Angiography remains the reference standard for the diagnosis of RAS. However, most clinicians are reluctant to subject patients with renal insufficiency to the potential risks of contrast nephropathy associated with the use of iodinated contrast material. CO2 has been advocated (19,20) as a nonnephrotoxic alternative to iodinated contrast material, but several authors (21,22) have reported overestimation of the degree of stenosis when CO2-enhanced angiography was used. Bowel gas artifact superimposed on the renal artery and its branches can also render CO2-enhanced angiograms nondiagnostic. In addition, some patients are unable to tolerate repeat injections of CO2 into the abdominal aorta due to the accumulation of CO2 in the mesenteric vessels and the subsequent development of abdominal pain. Therefore, an additional nonnephrotoxic angiographic contrast agent would be useful in patients suspected of having a renal vascular cause of renal insufficiency. Although experience with intraarterial gadodiamide is limited in patients with renal insufficiency, gadolinium-based agents have been used safely as intraarterial contrast media for angiographic procedures in selected patients (23–25).
The purpose of our study was to evaluate the use of gadodiamide in conjunction with CO2 as angiographic contrast agents to aid in the diagnosis and percutaneous treatment in 24 consecutive patients who underwent 25 angiographic procedures to evaluate for RAS as the cause of renal insufficiency.
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MATERIALS AND METHODS |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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Arterial access was achieved by using the common femoral artery in all patients. In patients undergoing evaluation of native kidneys, the initial arteriogram was obtained with use of CO2 delivered via a 5-F catheter with extra side holes (Sos Omni; Angiodynamics, Glen Falls, NY) or a 5-F pigtail catheter (Ultra High-Flow; Mallinckrodt, St Louis, Mo). In patients with a renal transplant, the initial arteriogram was obtained with use of CO2 injected via a 4-F catheter (Straight Flush; Angiodynamics) in patients with an ipsilateral access site or via a 5-F Sos Omni catheter (Angiodynamics) with side holes in patients with a contralateral access site. The CO2 gas (30–50 mL) was delivered by using a plastic bag delivery system and hand injections as previously described by Hawkins et al (26).
Radiographic images were obtained by using a 40-cm image intensifier and various high-resolution digital subtraction systems (Siemens Medical Systems, Iselin, NJ). CO2-enhanced angiography was initially performed in the anteroposterior position. Additional CO2-enhanced angiograms were obtained with the side of the patient ipsilateral to the renal artery being studied and elevated on a 45° wedge cushion. The image intensifier was angled in different obliquities to optimize visualization of the origin of the renal arteries. In patients with renal transplants, CO2-enhanced angiography was performed in the anteroposterior position to visualize the lower abdominal aorta and the aortic bifurcation. Additional CO2-enhanced angiograms were obtained with the side of the patient ipsilateral to the renal transplant and elevated on a 45° wedge cushion. The image intensifier was again angled in different obliquities to optimize visualization of the ipsilateral iliac artery, the renal transplant artery, and the arterial anastomosis. CO2-enhanced images were obtained at 85 kVp with a film rate of four frames per second for 3 sec followed by two frames per second.
Once the optimal tube angle for defining the renal artery origin (or, in the case of the patients with a renal transplant, the ipsilateral iliac artery and renal transplant artery) was identified, angiography with gadodiamide (Omniscan; Nycomed, Princeton, NJ) enhancement was performed either by hand injecting 8–10 mL of full-strength gadodiamide (0.5 mol/L) or by power injecting 18–30 mL of gadodiamide intraarterially during 2 seconds. Radiographs were obtained by using high-spatial-resolution digital subtraction angiography. Gadodiamide-enhanced angiograms were obtained at 96 kVp, with a film rate of three frames per second for 3 seconds followed by two frames per second. The images were interpreted by one of four interventional radiologists (D.J.S., A.H.M., J.F.A., K.D.H.).
Renal artery angioplasty and stent insertion were performed as previously described (20,27,28). Selective angiography of the treated artery before and after the intervention was performed with CO2 and 4–8 mL of gadodiamide. The total dose of gadodiamide was limited to 0.3 mmol per kilogram of body weight (range, 0.16–0.30 mmol/kg; total volume range, 20–70 mL). Renal artery pressures and pressure gradients were not measured during this study.
Serum creatinine levels were obtained on the day of the procedure, before the examination, and approximately 24 and 48 hours after the procedure. A change in the serum creatinine level of more than 0.5 mg/dL (44 µmol/L) was considered to be clinically important (29).
To evaluate the reliability of the differences in serum creatinine levels, the mean values were tested by using the Fisher exact test. The creatinine data were reduced to two categories, and a two-by-two contingency table was created. The Fisher exact test was used because of the small numbers of patients. The Fisher exact test was used to compare differences in creatinine level ranges in the gadodiamide group with those in a control group of patients who underwent imaging with iodinated contrast material. Statistical significance was defined at the .05 level.
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RESULTS |
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For the 25 procedures, the mean serum creatinine level before the procedure was 3.1 mg/dL (274 µmol/L); 48 hours after the procedure, it was 3.2 mg/dL (283 µmol/L) (Table 1). Of the 25 procedures, 15 were diagnostic angiography only (mean creatinine level: before angiography, 3.5 mg/dL [309 µmol/L]; 48 hours after angiography, 3.5 mg/dL [309 µmol/L]). None of these patients had a hemodynamically significant stenosis. Ten patients with significant RAS underwent diagnostic arteriography and renal artery intervention (bilateral PTA and stent insertion [n = 5], unilateral PTA and stent insertion [n = 1], unilateral PTA [n = 1], renal transplant artery PTA and stent insertion [n = 1], renal transplant artery PTA [n = 1], iliac artery PTA and stent insertion proximal to renal transplant artery [n = 1]). The mean serum creatinine level before the intervention was 2.7 mg/dL (239 µmol/L); 48 hours after the intervention, it was 2.8 mg/dL (248 µmol/L) (Table 1).
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There were 11 procedures performed in patients with a baseline creatinine level of 1.6–2.5 mg/dL (141–221 µmol/L) (group 1), eight procedures were performed in patients with a baseline creatinine level of 2.6–3.9 mg/dL (230–345 µmol/L) (group 2), and six procedures were performed in patients whose baseline creatinine level was greater than or equal to 4.0 mg/dL (354 µmol/L) (group 3) (Table 3). Clinically important elevations in serum creatinine level of 0.5 mg/dL (44 µmol/L) or greater after the procedure were found in group 3. No patients with a baseline serum creatinine level of 1.6–3.9 mg/dL (141–345 µmol/L) who were undergoing a diagnostic procedure alone or both diagnostic and interventional procedures demonstrated a clinically important elevation in serum creatinine level after the procedure. When the number of patients from groups 1 and 2 with a clinically important increase in serum creatinine level (0 of 19 patients) were compared with the number of patients from group 3 with a clinically important increase (two of six patients), the difference was statistically significant (P = .05).
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DISCUSSION |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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Both surgical and percutaneous methods for renal revascularization have been performed. Surgical techniques include aortorenal bypass with the use of a vein, hypogastric artery, or synthetic graft material; renal endarterectomy; and hepatorenal and splenorenal bypass (32–38). Surgical renal revascularization has resulted in improvement or stabilization of renal function in as many as 75%–80% of selected patients (39,40). These procedures have been performed with relatively low mortality rates (2%–6%) and high technical success rates (>90%) (39,40). However, mortality rates were higher with bilateral reconstruction and as the patient's baseline serum creatinine level increased (41). Hallett et al (41) suggested that surgical revascularization is probably not worthwhile in patients with a baseline serum creatinine level of greater than 4.0 mg/dL (354 µmol/L) because of higher mortality rates and decreased likelihood for improvement in renal function. Others (42) have advocated a more aggressive approach, including surgical revascularization whenever the distal renal artery is identified and appears normal at arteriography, as long as at least 10% of renal function is contributed by the ischemic kidney regardless of baseline renal function or renal size.
Percutaneous renovascular procedures provide a less invasive alternative for the treatment of renal insufficiency due to RAS. In several series (43,44), improvement or stabilization of renal function after renal PTA has been shown. Patients with bilateral RAS responded more favorably, because renal insufficiency associated with unilateral RAS suggests that a substantial component of parenchymal renal disease is present (45). Therefore, one would expect the best results in patients with bilateral RAS with normal-sized kidneys and minimal underlying renal parenchymal disease.
Unfortunately, the selection of patients with renal insufficiency who will respond to renal revascularization can be difficult. US provides a reliable screening method for evaluating renal size and morphology. Unfortunately, US is less reliable for help in detecting significant RAS. Although high sensitivities and specificities have been reported for US in the detection of RAS (46), the diagnosis of RAS by using US appears more elusive than was originally thought (10,12,13).
Radionuclide scanning has been reported (47) to be helpful in the diagnosis of RAS associated with renovascular hypertension, but these studies have not been helpful in patients with renal insufficiency (10). CT angiography necessitates the use of iodinated contrast material and, therefore, is usually avoided in patients with renal insufficiency. MR angiography has recently been proposed as a potential noninvasive screening test for RAS; however, MR angiographic techniques tend to lead to overestimations of stenoses and do not reliably depict the more distal main renal artery and its segmental branches (10,15–18). Gadolinium-enhanced techniques may overcome some limitations associated with MR angiography (48,49), although many facilities currently do not possess the state-of-the-art magnets or the software and imaging systems necessary to perform these newer MR angiographic studies.
Angiography performed with iodinated contrast material, therefore, remains the reference standard for help in the diagnosis of RAS. However, the relationship between contrast material–induced nephropathy and preexisting renal insufficiency is well described (29,50–53). Indeed, the potential for contrast material–induced nephropathy is usually a major concern and often results in the referring physician forgoing angiography. To limit the amount of iodinated contrast material administered to patients with renal insufficiency, intraarterial digital subtraction angiographic techniques have been used (54). Yet, in patients undergoing renal PTA, acute renal insufficiency has been reported (3) to occur in up to 26% of patients.
To determine the frequency of contrast material–induced nephropathy in patients undergoing angiographic work-up for RAS at our institution, we retrospectively reviewed the records of 25 consecutive patients with renal insufficiency (serum creatinine level > 1.5 mg/dL [133 µmol/L]) who were evaluated between April and December 1995 and underwent angiography with iodinated contrast material with or without renal PTA and stent insertion at our institution. The mean serum creatinine levels in this entire group, as well as the breakdown on the basis of the type of procedure and baseline serum creatinine levels are shown in Tables 1–3. When patients with a baseline serum creatinine level of 1.6–3.9 mg/dL (141–345 µmol/L; groups 1 and 2 in Table 3) who underwent CO2-enhanced and gadodiamide-enhanced angiography, with or without intervention, were compared with those who underwent angiography with iodinated contrast material, none (0%) of 19 CO2-enhanced and gadodiamide-enhanced studies were associated with a substantial postprocedural rise in serum creatinine level, whereas five (23%) of 22 iodinated contrast material–enhanced studies were (P = .0507). This difference approaches statistical significance, and a larger series may confirm the significance of this difference.
Recent improvements in CO2-enhanced digital subtraction angiography and delivery have resulted in improved visualization of the renal arteries without the use of iodinated contrast material (20,26). However, there are some drawbacks to CO2-enhanced angiography. Because CO2 is a gas, it does not mix with blood but floats above it. The entire vessel must be filled with CO2 to avoid underestimating the diameter of the vessel. Incomplete filling of vessels with CO2 probably accounts for reports of overestimation of the degree of stenosis at CO2-enhanced angiography (22,55,56). Patient motion, as well as superimposed bowel gas, can degrade the CO2-enhanced images. Although CO2 has been found to be safe in patients with renal insufficiency, trapping of CO2 in the mesenteric vessels can cause transient mesenteric ischemia. Concern about causing mesenteric ischemia may result in early termination of the study (20,56–58). Livedo reticularis, rhabdomyolysis, massive intestinal infarction, and death in a single patient have also been attributed to CO2-enhanced angiography (59).
Because of these potential shortcomings of CO2-enhanced angiography, gadolinium-based contrast agents have been advocated for use in patients with renal insufficiency to reduce the risk of iodinated contrast material–induced nephropathy. Several authors (23–25,60–62) have described the use of gadolinium-based contrast agents in angiographic studies of the abdominal aorta and mesenteric, pelvic, peripheral, and renal arteries.
Gadolinium has an atomic number of 64 and a k-absorption edge of approximately 50 keV. Gadolinium-based contrast agents have been shown to absorb sufficient energy to be visualized with digital subtraction angiography. The optimal kilovolt peak for imaging with gadolinium-based contrast agents appears to be between 77 and 96 kVp (63). Use of the higher kilovolt peak range (up to 96 kVp) should result in optimum image quality while reducing the radiation exposure to the patient. However, the image quality with gadolinium-based agents is consistently inferior when compared with that achieved with iodinated contrast agents. Nevertheless, images of diagnostic quality can be obtained (24,61).
Gadodiamide demonstrates pharmacokinetics that are similar to those of iodinated x-ray contrast agents. There is no reported animal experience with intraarterial delivery of gadolinium-based contrast agents. Two studies with 15 and 12 patients and several case reports (23–25,60–62) have been published in which intraarterial gadolinium-based contrast agents were used for digital subtraction angiography. At the time this article was written, we had used gadolinium-based contrast agents distributed in arteries throughout the body (with the exception of the cerebral vessels and heart) in more than 100 patients, without evidence of vascular thrombosis.
We have encountered no complaints of pain or discomfort when performing renal angiography either with gadopentetate dimeglumine (Magnevist, Berlex Laboratories, Wayne, NJ) or gadodiamide. With peripheral angiography for the selective study of the extremities in outpatients, however, it is clear that gadodiamide with an osmolarity of 789 mOsm per kilogram of water is less painful than gadopentetate dimeglumine with an osmolarity of greater than 1,800 mOsm per kilogram of water. Gadodiamide is nearly completely excreted by means of glomerular filtration via the kidneys and has a half-life of approximately 70 minutes in patients with normal renal function. Even in patients with impaired renal function, glomerular filtration remains the major route of elimination of gadodiamide, although the half-life of clearance can be expected to increase to upwards of 5.8 hours in patients with renal insufficiency (creatinine clearance, 20–60 mL/min [0.33–1.00 mL/sec]) (64).
The total dose of gadolinium administered to each patient in our study was limited to 0.3 mmol/kg or less. Results in animal studies (65) have not shown evidence of nephrotoxicity when single doses of gadodiamide as high as 10 mmol/kg or 1.25 mmol/kg daily for 28 days were used. Gadolinium-based contrast agents, including gadodiamide, have not been associated with nephrotoxicity in patients with renal insufficiency at doses up to and including 0.3 mmol/kg (66–69). Doses in this range and concentration can be challenging to work with. Thoughtful preparation must be used for each gadodiamide injection.
In our study, angiography was performed with the use of gadodiamide and CO2 as the contrast agents. CO2-enhanced angiography provided localization of the renal artery origins and allowed optimization of the obliquity of the image intensifier to best evaluate the origins of the renal arteries. When compared with CO2-enhanced angiograms, gadodiamide-enhanced images provided better delineation of the occluded renal arteries, better visualization of the origin of the renal arteries when underfilling with CO2 occurred (Figs 1, 2), and better definition of the main renal artery and its segmental branches (Figs 3, 4). Gadodiamide also was useful in that it facilitated better visualization of the renal artery anatomy during an intervention (Figs 5, 6). However, CO2-enhanced angiography is helpful in minimizing the amount of gadodiamide necessary to define the renal artery anatomy.
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The 10% mortality rate in the patients who underwent an interventional procedure in this study is most likely due to the small sample size. Since the end of this study, eight additional patients have undergone renal PTA with or without stent insertion by using CO2 and gadodiamide as the only contrast agents and have experienced no serious complication. In addition, a retrospective review of the renal PTA procedures and/or stent insertions performed at our institution between July 1, 1996 and January 1, 1998, reveals that 162 patients have undergone renal PTA and/or stent insertion. The only 30-day mortality that we encountered was in the patient reported in this article (30-day mortality rate, <1%). This mortality rate is in agreement with the 1%–2% mortality rate associated with renal artery PTA reported in the literature (2,4–6,70).
In the 19 patients with a creatinine level of less than 4.0 mg/dL (354 µmol/L) (groups 1 and 2), none had a marked (>0.5 mg/dL [44 µmol/L]) increase in serum creatinine level 48 hours after their procedure. One patient in this group had a marked elevation in serum creatinine level after 48 hours. The one patient in this group had undergone kidney transplantation and had a baseline serum creatinine level of 3.l mg/dL (274 µmol/L); this patient underwent PTA and had a mild increase in serum creatinine level (3.6 mg/dL [318 µmol/L]) 48 hours after the procedure. However, because of a 2-week history of congestive heart failure and angina, the patient underwent cardiac catheterization with iodinated contrast material on the 2nd postprocedural day. Three days after cardiac catheterization, the serum creatinine level increased to 6.6 mg/dL (583 µmol/L), and the patient underwent dialysis owing to acute renal failure. Iodinated contrast material probably played an important role in the subsequent acute renal failure in this patient. Two patients in group 3 had a marked elevation in serum creatinine level. The cause of this elevation in one patient was believed to be secondary to acute and chronic rejection in a kidney transplant; in the second patient, the cause was believed to be due to cholesterol embolization. Although CO2 and gadodiamide may have contributed to the serum creatinine level elevations, all three patients had an etiology for worsening renal function other than CO2 and gadodiamide.
Our results suggest that gadodiamide appears to be a safe and useful intraarterial contrast agent when used in conjunction with CO2-enhanced angiography to help accurately diagnose and guide treatment of RAS in patients with renal insufficiency. By avoiding administration of iodinated contrast material, the risk of contrast material–induced nephropathy is minimized. More patients may then benefit from potential percutaneous renal revascularization, which may result in improvement or stabilization of renal function. These patients might not otherwise undergo angiographic evaluation for fear of worsening renal function due to contrast material–induced nephropathy.
Despite the added expense of gadodiamide as compared with that of nonionic contrast material (gadodiamide, $5 per milliliter; nonionic iodinated contrast material, $l per milliliter), we found that during the diagnostic and interventional procedures for RAS gadodiamide provided diagnostic images of equivalent or superior quality to the CO2-enhanced angiograms and was particularly helpful in patients with an occluded renal artery or incomplete filling of the renal artery with CO2 and for guiding the end point of intervention without the use of iodinated contrast material.
In conclusion, gadodiamide-enhanced angiography appears to be a safe and useful supplement to CO2-enhanced angiography for help with the accurate diagnosis and guidance in treatment of RAS in patients with renal insufficiency, without the use of iodinated contrast material. Further evaluation is necessary to determine if gadodiamide provides a safe and cost-effective alternative to iodinated contrast material in patients with renal insufficiency.
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Acknowledgments |
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Footnotes |
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Abbreviations: PTA = percutaneous transluminal angioplasty RAS = renal artery stenosis
Author contributions: Guarantor of integrity of entire study, D.J.S.; study concepts and design, D.J.S., A.H.M., J.F.A., K.D.H.; definition of intellectual content, D.J.S.; literature research, D.J.S.; clinical studies, D.J.S., A.H.M., J.F.A., K.D.H., J.K.M.; data acquisition and analysis, D.J.S.; statistical analysis, J.F.A.; manuscript preparation, D.J.S., A.H.M., J.F.A., K.D.H.; manuscript editing and review, D.J.S., A.H.M., J.F.A., K.D.H., C.A.
Received March 3, 1998;
revision requested May 5, 1998; revision received July 20, 1998;
accepted September 11, 1998.
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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