Abstract
PURPOSE: To assess SH U 508A in the diagnosis of suspected renal arterial stenosis by means of ultrasonography (US) and to confirm the safety of SH U 508A in a clinical setting.
MATERIALS AND METHODS: A randomized crossover study was performed in 198 patients from 14 European centers who were referred for renal arterial angiography because they were suspected of having renal arterial stenosis. All patients underwent nonenhanced and SH U 508A–enhanced Doppler US of the renal arteries. Doppler criteria included measurement of renal arterial peak systolic velocity (threshold, 1.4–2.0 m/sec) in all centers and renoaortic ratio (threshold, 3.0–3.5) in nine.
RESULTS: The number of examinations with successful results increased following enhanced Doppler US examination—160 (83.8%) compared with 122 (63.9%) with nonenhanced Doppler US (P = .001), including patients with obesity or renal dysfunction. Renal arterial stenosis (≥50%) was detected at angiography in 72 patients. Results at enhanced Doppler US were in agreement with results at angiography more often than with results at nonenhanced Doppler US in the diagnosis or exclusion of renal arterial stenosis (P = .001). For patients examined with nonenhanced and enhanced Doppler US, sensitivity (80.0% and 83.7%, respectively) and specificity (80.8% and 83.6%, respectively) remained unchanged. There were no clinically important adverse events following use of SH U 508A.
CONCLUSION: In patients suspected of having renal arterial stenosis, SH U 508A increased the number of diagnostic renal arterial Doppler studies.
References
- 1 Derkx FHM, Schalekamp MADH. Renal artery stenosis and hypertension. Lancet 1994; 344:237-239. Crossref, Medline, Google Scholar
- 2 Rimmer JM, Gennari FJ. Atherosclerotic renovascular disease and progressive renal failure. Ann Intern Med 1993; 118:712-719. Crossref, Medline, Google Scholar
- 3 Semple PF, Dominiczak AF. Detection and treatment of renovascular disease: 40 years on. J Hypertens 1994; 12:729-734. Crossref, Medline, Google Scholar
- 4 Anderson GH, Jr, Blakeman N, Streeten DHP. The effect of age on prevalence of secondary forms of hypertension in 4429 consecutively referred patients. J Hypertens 1994; 12:609-615. Crossref, Medline, Google Scholar
- 5 Streeten DHP, Anderson GH, Jr, Wagner S. Effect of age on response of secondary hypertension to specific treatment. Am J Hypertens 1990; 3:360-365. Crossref, Medline, Google Scholar
- 6 Berglund G, Andersson O, Wilhelmsen L. Prevalence of primary and secondary hypertension: studies in a random population sample. Br Med J 1976; 2:554-556. Crossref, Medline, Google Scholar
- 7 Lewin A, Blaufox MD, Castle H, Entwisle G, Langford H. Apparent prevalence of curable hypertension in the hypertension detection and follow-up program. Arch Intern Med 1985; 145:424-427. Crossref, Medline, Google Scholar
- 8 Havey RJ, Krumlowsky F, deGreco F, Martin HG. Screening for renovascular hypertension. JAMA 1985; 254:388-393. Crossref, Medline, Google Scholar
- 9 Davidson RA, Wilcox CS. Newer tests for the diagnosis of renovascular disease. JAMA 1992; 268:3353-3358. Crossref, Medline, Google Scholar
- 10 Fommei E, Mezzasalma L, Ghione S, et al. European Captopril Radionuclide Test Multicentric Study Group. European captopril radionuclide test multicentric study: preliminary results. Am J Hypertens 1991; 4(suppl 2):690-697. Crossref, Google Scholar
- 11 Rubin GD, Dake MD, Napel S, et al. Spiral CT of renal artery stenosis: comparison of three-dimensional rendering techniques. Radiology 1994; 190:181-189. Link, Google Scholar
- 12 Olbricht CJ, Paul K, Prokop M, et al. Minimally invasive diagnosis of renal artery stenosis by spiral computed tomography angiography. Kidney Int 1995; 48:1332-1337. Crossref, Medline, Google Scholar
- 13 Grist TM. Magnetic resonance angiography of renal artery stenosis. Am J Kidney Dis 1994; 24:700-712. Crossref, Medline, Google Scholar
- 14 Prince MR, Narasimham DL, Stanley JC, et al. Breath-hold gadolinium-enhanced MR angiography of the abdominal aorta and its major branches. Radiology 1995; 197:785-792. Link, Google Scholar
- 15 Wasser MN, Westenberg J, van der Hulst VPM, et al. Hemodynamic significance of renal artery stenosis: digital subtraction angiography versus systolically gated three-dimensional phase-contrast MR angiography. Radiology 1997; 202:333-338. Link, Google Scholar
- 16 Stavros AT, Parker SH, Yakes WF, et al. Segmental stenosis of the renal artery: pattern recognition of tardus and parvus abnormalities with duplex sonography. Radiology 1992; 184:487-492. Link, Google Scholar
- 17 Kliewer MA, Tupler RH, Carroll BA, et al. Renal artery stenosis: analysis of Doppler waveform parameters and tardus-parvus pattern. Radiology 1993; 189:779-787. Link, Google Scholar
- 18 Bude RO, Rubin JM, Platt JF, Fechner KP, Adler RS. Pulsus tardus: its cause and potential limitations in detection of arterial stenosis. Radiology 1994; 190:779-784. Link, Google Scholar
- 19 Bude RO, Rubin JM. Detection of renal artery stenosis with Doppler sonography: it is more complicated than originally thought (editorial). Radiology 1995; 196:612-613. Link, Google Scholar
- 20 Halpern EJ, Needelman L, Nack TL, East SA. Renal artery stenosis: should we study the main renal artery or segmental vessels?. Radiology 1995; 195:799-804. Link, Google Scholar
- 21 Berland LL, Koslin DB, Routh WD, Keller FS. Renal artery stenosis: prospective evaluation of diagnosis with color duplex US compared with angiography—work in progress. Radiology 1990; 174:421-423. Link, Google Scholar
- 22 Desberg AL, Paushter DM, Lammert GK, et al. Renal artery stenosis: evaluation with color Doppler flow imaging. Radiology 1990; 177:749-753. Link, Google Scholar
- 23 Postma CT, Van Aalen J, de Boo T, Rosenbusch G, Thien T. Doppler ultrasound scanning in the detection of renal artery stenosis in hypertensive patients. Br J Radiol 1992; 65:857-860. Crossref, Medline, Google Scholar
- 24 Strandness E. Duplex imaging for the detection of renal artery stenosis. Am J Kidney Dis 1994; 24:674-678. Crossref, Medline, Google Scholar
- 25 Olin JW, Piedmonte MR, Young JR, DeAnna S, Grubb M, Childs MB. The utility of duplex ultrasound scanning of the renal arteries for diagnosing significant renal artery stenosis. Ann Intern Med 1995; 122:833-838. Crossref, Medline, Google Scholar
- 26 Helenon O, El Rody F, Correas JM, et al. Color Doppler US of renovascular disease in native kidneys. RadioGraphics 1995; 15:833-854. Link, Google Scholar
- 27 Miralles M, Cairols M, Cotillas J, Gimenez A, Santiso A. Value of Doppler parameters in the diagnosis of renal artery stenosis. J Vasc Surg 1996; 23:428-435. Crossref, Medline, Google Scholar
- 28 van der Hulst VPM, van Baalen J, Schultze Kool L, et al. Renal artery stenosis: endovascular flow wire study for validation of Doppler US. Radiology 1996; 200:165-168. Link, Google Scholar
- 29 Schwarz KQ, Becher H, Schimpfky C, Vorwerk D, Bogdahn U, Schlief R. Doppler enhancement with SH U 508A in multiple vascular regions. Radiology 1994; 193:195-201. Link, Google Scholar
- 30 Blomley M, Cosgrove D. Microbubble echo-enhancers: a new direction for ultrasound? (commentary). Lancet 1997; 349:1855-1856. Crossref, Medline, Google Scholar
- 31 Schlief R. Galactose-based echo-enhancing agents. In: Goldberg BG, eds. Ultrasound contrast agents. London, England: Martin Dunitz, 1997; 137-148. Google Scholar
- 32 Agresti A. An introduction to categorical data analysis New York, NY: Wiley, 1996. Google Scholar
- 33 Hosmer DW, Lemeshow S. Applied logistic regression New York, NY: Wiley, 1989. Google Scholar
- 34 Missouris CG, Allen CM, Balen FG, Buckenham T, Lees WR, MacGregor GA. Non-invasive screening for renal artery stenosis with ultrasound contrast enhancement. J Hypertens 1996; 14:519-524. Medline, Google Scholar
- 35 Lees WR. Echo-enhanced renal ultrasound imaging with Levovist (SH U 508A). Angiology 1996; 47(suppl 2):31-35. Google Scholar
- 36 Melany ML, Grant EG, Duerinckx AJ, Watts TM, Levine BS. Ability of a phase shift US contrast agent to improve imaging of the main renal arteries. Radiology 1997; 205:147-152. Link, Google Scholar
- 37 Kliewer MA, Tupler RH, Hertzberg BS, et al. Doppler evaluation of renal artery stenosis: interobserver agreement in the interpretation of waveform morphology. AJR Am J Roentgenol 1994; 162:1371-1376. Crossref, Medline, Google Scholar
- 38 Rubin GD, Dake MD, Napel S, et al. Spiral CT of renal artery stenosis: comparison of three-dimensional rendering techniques. Radiology 1994; 190:181-189. Link, Google Scholar
- 39 Borrello JA, Li D, Vesely TM, Vining EP, Brown JJ, Haacke EM. Renal arteries: clinical comparison of three-dimensional time-of-flight MR angiographic sequences and radiographic angiography. Radiology 1995; 197:793-799. Link, Google Scholar
- 40 The sixth report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure Rockville, Md: National Institutes of Health, 1997; NIH Publication 98:4080.. Google Scholar
- 41 Moneta GL, Edwards JM, Chitwood RW, et al. Correlation of North American Symptomatic Carotid Endarterectomy Trial (NASCET) angiographic definition of 70% to 99% internal carotid artery stenosis with duplex scanning. J Vasc Surg 1993; 17:152-157. Crossref, Medline, Google Scholar







