Impact of Levovist ultrasonographic contrast agent on the diagnosis and management of hypertensive patients with suspected renal artery stenosis: a Canadian multicentre pilot study.

OBJECTIVES: To compare the diagnoses obtained with unenhanced ultrasonography (US), contrast-enhanced US and captopril-enhanced renal scintigraphy and to determine whether use of a contrast agent improves ability to assess the renal arteries with duplex Doppler US. SUBJECTS AND METHODS: The study was an open-label controlled trial involving 78 patients with hypertension suspected to have a renovascular cause. The patients underwent captopril-enhanced scintigraphy or routine unenhanced US (the usual diagnostic methods at the centres where the study was conducted) and contrast-enhanced US (with Levovist, Berlex Canada, Lachine, Que.). The patients were followed for 3 months after the diagnostic tests were performed. RESULTS: Enhanced US yielded a diagnosis for a significantly greater proportion of patients than did unenhanced US (77 [99%] v. 64 [82%] of 78 patients; p = 0.002) or captopril-enhanced scintigraphy (71 [99%] v. 58 [81%] of 72 patients; p = 0.002). Diagnosis was possible with both enhanced and unenhanced duplex Doppler US in only 64 (82%) of the 78 patients, and the diagnosis was the same with both methods for 63 (98%) of these 64 patients. In contrast, diagnosis was possible for only 58 (81%) of the 72 patients who underwent both enhanced US and captopril-enhanced scintigraphy; the same diagnosis was reported in 53 (91%) of these 58 cases. During follow-up, 11 patients (21 kidneys) underwent angiography. Significant stenosis was detected in 6 (55%) of the patients (8 [38%] of the kidneys). Both the enhanced and unenhanced US results agreed more often with angiography than did captopril-enhanced scintigraphy (9 [82%] v. 8 [73%] of the 11 patients). The proportion of patients in whom the left and right renal artery could be assessed by duplex Doppler US increased significantly (by 58% and 43%, respectively) with use of the contrast agent. CONCLUSION: Enhanced US had a higher rate of successful diagnosis than unenhanced US and captopril-enhanced renal scintigraphy. Enhanced US might therefore be suitable as a screening method for hypertensive patients with suspected renal artery stenosis.

Economic impact of an ultrasonographic contrast agent on the diagnosis and initial management of patients with suspected renal artery stenosis.

OBJECTIVES: To determine resource use in the diagnosis and management of Canadian hypertensive patients with suspected renal artery stenosis and to estimate the impact of diagnosis with contrast-enhanced duplex Doppler ultrasonography (US) on resource use. SUBJECTS AND METHODS: Seventy-eight patients with suspected renal artery stenosis underwent usual diagnostic tests (captopril-enhanced renal scintigraphy or duplex Doppler US) and contrast-enhanced US. A management pathway ("planned") describing the medical resources required for further patient care was outlined on the basis of results from each test (separately), and a modified management pathway ("recommended"), which considered data from both diagnostic methods, was also outlined. Medical resources and productivity losses were assessed prospectively for a 3-month period after patients underwent both tests ("actual" management pathway). RESULTS: With usual diagnostic methods, 14 (18%) of the tests were inconclusive, whereas only 1 (1%) of the enhanced US examinations was inconclusive; the cost-efficacy ratio was $422 and $343 per successful diagnosis, respectively. Further management costs for patients with an inconclusive diagnosis were estimated at $6370 after the usual diagnostic tests, but only $1278 with enhanced US. Although the costs of the planned and recommended management pathways were similar ($227 and $294 per patient respectively), the proportion of patients requiring further resources was lower with enhanced US (56% v. 46%). Three-month actual management costs ranged from $121 to $1605 per patient (mean $360). Diagnostic tests and surgical procedures were the major cost drivers in all pathways, and costs were highest for patients in whom stenosis was diagnosed. CONCLUSIONS: For patients with suspected renal artery stenosis, contrast-enhanced US had a higher diagnostic success rate than usual diagnostic methods and afforded savings through lower administrative costs and lower medical resource consumption for patients whose diagnosis was unclear after usual diagnostic tests.