Renal artery stent revascularization with embolic protection in patients with ischemic nephropathy
2006; Elsevier BV; Volume: 70; Issue: 5 Linguagem: Inglês
10.1038/sj.ki.5001671
ISSN1523-1755
AutoresAndrew Holden, Andrew G. Hill, Michael R. Jaff, Helen Pilmore,
Tópico(s)Advanced X-ray and CT Imaging
ResumoA prospective analysis of renal artery stent revascularization with distal embolic protection in a high-risk patient population with ischemic nephropathy is presented. A total of 63 patients (median age 70.2 years, range 54–86 years) had significant atherosclerotic stenosis of 83 renal arteries documented on pre-procedural imaging. All patients had baseline chronic renal insufficiency with a documented deterioration in renal function in the 6 months before revascularization. The endovascular technique used in all patients involved primary passage of an embolic filter into the distal main renal artery followed by primary stent deployment with a balloon expandable stainless steel stent. The filter baskets were recaptured and contents submitted for pathological analysis. At 6 months post-intervention, 97% of patients demonstrated stabilization or improvement in renal function. Only 3% of patients had an inexorable decline in renal function, unchanged by the intervention. After a mean follow up of 16.0 months (6–27), 94% of patients demonstrated stabilization or improvement in renal function. One patient suffered an acute post-procedural deterioration in renal function. In total, 60% of the filter baskets contained embolic material. This study confirms the technical feasibility of renal artery stent deployment with adjuvant embolic protection. The excellent results for renal preservation at 6 months post-intervention also suggest that a distal embolic protection device may improve the impact of percutaneous renal revascularization on progressive deterioration in renal function. The postulated mechanism is through the prevention of atheromatous embolization and the embolic yield from the distal filters supports this hypothesis. Patients most likely to receive the greatest benefit are those with mild baseline chronic renal insufficiency and a recent decline in renal function. A prospective analysis of renal artery stent revascularization with distal embolic protection in a high-risk patient population with ischemic nephropathy is presented. A total of 63 patients (median age 70.2 years, range 54–86 years) had significant atherosclerotic stenosis of 83 renal arteries documented on pre-procedural imaging. All patients had baseline chronic renal insufficiency with a documented deterioration in renal function in the 6 months before revascularization. The endovascular technique used in all patients involved primary passage of an embolic filter into the distal main renal artery followed by primary stent deployment with a balloon expandable stainless steel stent. The filter baskets were recaptured and contents submitted for pathological analysis. At 6 months post-intervention, 97% of patients demonstrated stabilization or improvement in renal function. Only 3% of patients had an inexorable decline in renal function, unchanged by the intervention. After a mean follow up of 16.0 months (6–27), 94% of patients demonstrated stabilization or improvement in renal function. One patient suffered an acute post-procedural deterioration in renal function. In total, 60% of the filter baskets contained embolic material. This study confirms the technical feasibility of renal artery stent deployment with adjuvant embolic protection. The excellent results for renal preservation at 6 months post-intervention also suggest that a distal embolic protection device may improve the impact of percutaneous renal revascularization on progressive deterioration in renal function. The postulated mechanism is through the prevention of atheromatous embolization and the embolic yield from the distal filters supports this hypothesis. Patients most likely to receive the greatest benefit are those with mild baseline chronic renal insufficiency and a recent decline in renal function. Atherosclerotic renal artery stenosis is common, especially in older patients with atherosclerotic disease in other arterial systems.1.Missouris C.G. Buckenham T. Cappucio F.P. MacGregor G.A. Renal artery stenosis: a common and important problem in patients with peripheral vascular disease.Am J Med. 1994; 96: 10-14Abstract Full Text PDF PubMed Scopus (246) Google Scholar Atherosclerotic renal artery stenosis is a significant cause of refractory hypertension and chronic renal insufficiency (CRI),2.Mailloux L.U. Napolitano B. Bellucci A.G. et al.Renal vascular disease causing end-stage renal disease, incidence, clinical correlates, and outcomes: a 20 year experience.Am J Kidney Dis. 1994; 24: 622-629Abstract Full Text PDF PubMed Scopus (374) Google Scholar especially in the elderly.3.Hansen K.J. Prevalence of ischaemic nephropathy in the atherosclerotic population.Am J Kidney Dis. 1994; 24: 615-621Abstract Full Text PDF PubMed Scopus (69) Google Scholar It is known that hemodynamically significant renal artery stenoses progress.3.Hansen K.J. Prevalence of ischaemic nephropathy in the atherosclerotic population.Am J Kidney Dis. 1994; 24: 615-621Abstract Full Text PDF PubMed Scopus (69) Google Scholar,4.Zierler R.E. Bergelin R.O. Isaacson J.A. Strandness D.E. Natural history of atherosclerotic renal artery stenosis: a prospective study with duplex ultrasonography.J Vasc Surg. 1994; 19: 250-258Abstract Full Text Full Text PDF PubMed Scopus (268) Google Scholar Renal artery occlusion is associated with a loss of renal mass and deterioration in renal function.5.Strandness Jr, D.E. Natural history of renal artery stenosis.Am J Kidney Dis. 1994; 24: 630-635Abstract Full Text PDF PubMed Scopus (79) Google Scholar Unfortunately, the results of renal artery angioplasty and stenting for ischemic nephropathy have been mixed.6.Palmaz J.C. The current status of vascular intervention in ischaemic nephropathy.JVIR. 1998; 9: 539-543Abstract Full Text PDF Scopus (25) Google Scholar, 7.Zeller T. Frank U. Muller C. et al.Stent supported angioplasty of severe atherosclerotic renal artery stenosis preserves renal function and improves blood pressure control.J Endovasc Ther. 2004; 11: 95-106Crossref PubMed Scopus (116) Google Scholar, 8.Leertouwer T.C. Gussenhoven E.J. Bosch J.L. et al.Stent placement for renal artery stenosis: where do we stand? A meta-analysis.Radiology. 2000; 216: 78-85Crossref PubMed Scopus (367) Google Scholar Of concern is the reported incidence (10–20%) of procedure-related deterioration in renal function following renal artery stent revascularization.9.Harden P.N. MacLeod M.J. Rodger R.S.C. et al.Effect of renal artery stenting on progression of renovascular renal failure.Lancet. 1997; 349: 1133-1136Abstract Full Text Full Text PDF PubMed Scopus (407) Google Scholar, 10.Dorros G. Jaff M. Mathiak L. et al.Four year follow-up of Palmaz–Schatz stent revascularization as treatment for atherosclerotic renal artery stenosis.Circulation. 1998; 98: 642-647Crossref PubMed Scopus (393) Google Scholar, 11.Kuan Y. Hossain M. Surman J. et al.GFR prediction using the MDRD and Cockcroft and Gault equations in patients with end-stage renal disease.Nephrol Dial Transplant. 2005; 20: 2394-2401Crossref PubMed Scopus (107) Google Scholar Many have postulated that atheromatous embolization is a major cause of this acute decline in renal function and likely contributes to the mixed long-term results with this procedure. We report the results of primary renal angioplasty and stenting with distal embolic protection in a high-risk patient population with ischemic nephropathy. The patient group included 40 male (63%) and 23 female (37%) subjects with a median age of 70.2 years (54–86). Before treatment, 48 patients (76%) had a moderate decrease in estimated glomerular filtration rate (eGFR) (Kidney Disease Outcome Quality Initiative (K-DOQI) stage 3, eGFR 30–59 ml/min) and 15 patients (24%) had a severe decrease in eGFR (K-DOQI stage 4, eGFR 15–29 ml/min). For the purposes of more detailed analysis, the K-DOQI stage 3 patients were subdivided into two groups: K-DOQI stage 3A (eGFR 41–59 ml/min) and K-DOQI stage 3B (eGFR 30–40 ml/min). A total of 23 patients were classified as K-DOQI stage 3A (termed 'mild CRI' in this study) and 25 patients were classified as K-DOQI stage 3B (termed 'moderate CRI' in this study). A total of 44 patients (70%) were also hypertensive, receiving an average of 2.3 antihypertensive medications. The normotensive patients had a mean systolic blood pressure of 126 mm Hg (105–137) and a mean diastolic blood pressure of 84 mm Hg (72–88). The hypertensive patients had a mean systolic blood pressure of 164 mm Hg (140–196) and a mean diastolic blood pressure of 108 mm Hg (90–125). The alterations in renal function following stent revascularization with distal embolic protection at 6 months post-intervention are summarized in Table 1. There were improvements in sCRN for patients with K-DOQI stage 3A, 3B, and 4 pre-intervention CRI. The response rates are summarized in Table 2. Overall, 97% of patients had improvement or stabilization of renal function at 6 months post-intervention. Two patients (3%) had progressive deterioration in renal function after intervention. A Pearson χ2 test was performed on the data in Table 2 to assess if the impact on CRI after renal artery stent revascularization was significantly better for patients with mild CRI pre-intervention (K-DOQI 3A) as compared to patients with more severe CRI pre-intervention (K-DOQI 3B,4). In all, 52% of the mild group improved compared to 33% of the moderate/severe group, but this effect did not reach statistical significance (χ2=2.4, P=0.12). The mean follow-up period was 16.0 months (6–27). Few patients suffered a progressive decline in renal function after 6 months post-intervention (Figure 1) with 94% of patients having improvement or stabilization of renal function at latest follow-up.Table 1Serum creatinine after renal artery stent revascularization with protection according to level of pre-intervention renal insufficiencyLevel of pre-intervention CRI (K-DOQI stage)NMean (s.d.as.d.=standard deviation.) pre-intervention serum creatinine (μmol/l)Mean (s.d.as.d.=standard deviation.) 6-months post-intervention serum creatinine (μmol/l)Change (s.d.as.d.=standard deviation.) from pre-intervention to 6 months post-intervention serum creatinine (μmol/l)Mild (3A)23133 (17)121 (22)-11.3 (15.5)Moderate (3B)25160 (22)154 (22)-6.8 (16.5)Severe (4)15223 (48)213 (46)-10.0 (17.3)CRI, chronic renal insufficiency; K-DOQI, Kidney Disease Outcome Quality Initiative.a s.d.=standard deviation. Open table in a new tab Table 2Impact of renal artery stent revascularization with protection on renal function at 6 months post-intervention stratified to level pre-intervention chronic renal insufficiencyLevel of pre-intervention renal impairmentK-DOQI 3A (mild)K-DOQI 3B (moderate)K-DOQI 4 (severe)TotalN (%)N (%)N (%)N (%)Improved12 (52%)8 (32%)5 (33%)25 (40%)Stabilized11 (48%)15 (60%)10 (67%)36 (57%)Unchanged decline0 (0%)2 (8%)0 (0%)2 (3%)Total23251563CRI, chronic renal insufficiency; K-DOQI, Kidney Disease Outcome Quality Initiative.Improvement in renal function was most marked in the mild CRI (K-DOQI 3A), but this effect did not reach statistical significance (χ2=2.4, P=0.12). Open table in a new tab CRI, chronic renal insufficiency; K-DOQI, Kidney Disease Outcome Quality Initiative. CRI, chronic renal insufficiency; K-DOQI, Kidney Disease Outcome Quality Initiative. Improvement in renal function was most marked in the mild CRI (K-DOQI 3A), but this effect did not reach statistical significance (χ2=2.4, P=0.12). One patient with baseline mild CRI suffered an acute deterioration in renal function after the procedure. In this patient, the pre-intervention sCRN was 140 μmol/l and increased to 170 μmol/l at 24 h post-procedure. During the procedure marked intra-renal arterial vasospasm was encountered, only partially responsive to repeated boluses of glyceryl trinitrate. This deterioration was asymptomatic. The distal filter did contain embolic debris. The most recent sCRN had improved to 160 μmol/l, 12 months after the initial intervention. The distal embolic protection baskets contained macroscopic embolic contents in 38 of 63 cases (60%). The filter contents included fresh thrombus, chronic thrombus, atheromatous fragments, and cholesterol clefts. The remainder of the baskets was either empty or contained insufficient material to sustain processing. In all, 80% (20/25) of the patients with improved renal function after renal artery stent revascularization had filters with atheromatous embolization contents compared with 45% of the patients (17/38) with stabilized, unchanged decline or acute deterioration in renal function (Table 3). A Pearson χ2 test was performed on the data in Table 3 to assess if the impact on CRI after renal artery stent revascularization was significantly better for patients with or without filter contents. Patients with positive filter contents had a significantly improved outcome after revascularization compared to those without filter content (χ2=6.7, P=0.01).Table 3Impact of renal artery stent revascularization with protection on renal function at 6 months post-intervention stratified by presence of material in embolic protection basketsFilter contentsImprovedStabilized or unchanged declineTotaln (%)n (%)n (%)Positive20 (80)18 (47)38 (60)Negative5 (20)20 (53)25 (40)Total25 (100)38 (100)63 (100)Patients with positive filter contents had a significantly improved outcome after revascularization compared to those without filter contents (χ2=6.7, P=0.01). Open table in a new tab Patients with positive filter contents had a significantly improved outcome after revascularization compared to those without filter contents (χ2=6.7, P=0.01). All patients underwent a 6 weeks and 6 months post-procedural renovascular Doppler study. All treated renal arteries (100%) were patent at 6 weeks with no evidence of a significant residual stenosis. Five patients (8%) had significant instent restenosis demonstrated on renovascular Doppler at 6 months post-intervention. These patients underwent confirmatory angiography and were managed with repeat balloon dilatation, with embolic protection. No patients had cure of hypertension after the procedure, however 55% (24/44) of patients required fewer antihypertensive agents (mean number of medications 1.8/patient). In the hypertensive group, there was a reduction in both mean systolic blood pressure (132 mm Hg, range 118–162) and mean diastolic blood pressure (92 mm Hg, range 80–108). The impact of renal artery revascularization on the pre-procedural slope of decline in renal function has been demonstrated (Figure 2). By extrapolating the mean pre-procedural slope of decline, it is estimated that both these patient groups would require renal replacement therapy between 15 and 18 months. Conservatively, assuming only 15% of these elderly patients with end stage ischemic nephropathy will undergo dialysis,12.Sharafuddin M.J. Raboi C.A. Abu-Yousef M. et al.Renal artery stenosis: duplex US after angioplasty and stent placement.Radiology. 2001; 220: 168-173Crossref PubMed Scopus (34) Google Scholar it is estimated that nine of the 63 patients would require dialysis by 18 months without intervention. In 2005, the mean patient annual dialysis cost is NZD $55 000, so the savings in dialysis costs by intervening in these 63 patients is estimated at NZD $495 000 (9 × $55 000). By comparison, the interventional costs for treating these 63 patients was NZD $299 250, based on an individual patient cost of NZD $4750 (including procedural costs and in-patient hospital stay). The relationship between atherosclerotic renal artery stenosis, chronic renal insufficiency, resistant or refractory hypertension, and ischemic nephropathy is complex. The prevalence of renal artery stenosis is high in patients with symptomatic atherosclerotic disease in other arterial systems, particularly coronary, cerebral, and peripheral arteries.1.Missouris C.G. Buckenham T. Cappucio F.P. MacGregor G.A. Renal artery stenosis: a common and important problem in patients with peripheral vascular disease.Am J Med. 1994; 96: 10-14Abstract Full Text PDF PubMed Scopus (246) Google Scholar, 13.Uzu T. Takeji M. Yamada N. et al.Prevalence and outcome of renal artery stenosis in atherosclerotic patients with renal dysfunction.Hypertens Res. 2002; 25: 537-542Crossref PubMed Scopus (48) Google Scholar, 14.Rihal C.S. Textor S.C. Breen J.F. et al.Incidental renal artery stenosis among a prospective cohort of hypertensive patients undergoing coronary angiography.Mayo Clin Proc. 2002; 77: 309-316Abstract Full Text Full Text PDF PubMed Scopus (201) Google Scholar In these patients, renal artery stenosis provides a marker of higher mortality.13.Uzu T. Takeji M. Yamada N. et al.Prevalence and outcome of renal artery stenosis in atherosclerotic patients with renal dysfunction.Hypertens Res. 2002; 25: 537-542Crossref PubMed Scopus (48) Google Scholar The natural history of hemodynamically significant renal artery stenosis is the subject of some debate. Hemodynamically significant renal artery stenoses frequently progress with risk factors for progression including severe stenoses, high systolic blood pressure, or diabetes mellitus.3.Hansen K.J. Prevalence of ischaemic nephropathy in the atherosclerotic population.Am J Kidney Dis. 1994; 24: 615-621Abstract Full Text PDF PubMed Scopus (69) Google Scholar,4.Zierler R.E. 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Hansen K.J. et al.Evolution of renal insufficiency in ischaemic nephropathy.Ann Surg. 1991; 213: 446-455Crossref PubMed Scopus (163) Google Scholar In older patients with main renal artery stenosis, other factors also contribute to chronic renal impairment. Nephrosclerosis refers to primary disease in parenchymal renal arteries resulting in glomerular atrophy, tubulointerstitial lesions, and fibrosis.17.Meyrier A. Renal vascular lesions in the elderly: nephrosclerosis or atheromatous renal disease?.Nephrol Dial Transplant. 1996; 11: 45-52Crossref PubMed Scopus (27) Google Scholar These changes are seen in elderly and hypertensive patients and are irreversible. Meticulous control of blood pressure is required to prevent further deterioration.17.Meyrier A. 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Dorer D.J. et al.Preservation of renal function with surgical revascularization in patients with atherosclerotic renovascular disease.J Vasc Surg. 2004; 39: 322-329Abstract Full Text Full Text PDF PubMed Scopus (58) Google Scholar but is associated with a significant peri-operative morbidity and mortality in this older patient group. The results of endovascular revascularization performed for preservation of renal function have been mixed, with a paucity of controlled trial data. Meta-analyses,6.Palmaz J.C. The current status of vascular intervention in ischaemic nephropathy.JVIR. 1998; 9: 539-543Abstract Full Text PDF Scopus (25) Google Scholar,8.Leertouwer T.C. Gussenhoven E.J. Bosch J.L. et al.Stent placement for renal artery stenosis: where do we stand? A meta-analysis.Radiology. 2000; 216: 78-85Crossref PubMed Scopus (367) Google Scholar including available randomized controlled trial data,19.Nordmann A.J. Woo K. Parkes R. Logan A.G. 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Cox S.V. et al.Effects of renal artery stenting on renal function and size in patients with atherosclerotic renovascular disease.Circulation. 2000; 102: 1671-1677Crossref PubMed Scopus (259) Google Scholar but a relatively low incidence (15–30%) of improvement in renal function.7.Zeller T. Frank U. Muller C. et al.Stent supported angioplasty of severe atherosclerotic renal artery stenosis preserves renal function and improves blood pressure control.J Endovasc Ther. 2004; 11: 95-106Crossref PubMed Scopus (116) Google Scholar Stenting of atherosclerotic stenoses of the renal artery ostium is associated with improved procedural success, patency, and reduced restenosis rates,21.Van de Ven P.J. Kaatee R. Beutler J.J. et al.Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial.Lancet. 1999; 353: 282-286Abstract Full Text Full Text PDF PubMed Scopus (569) Google Scholar,22.Blum U. Krumme B. Flugel P. et al.Treatment of ostial renal artery stenoses with vascular endoprostheses after unsuccessful angioplasty.N Engl J Med. 1997; 336: 459-465Crossref PubMed Scopus (521) Google Scholar when compared to angioplasty alone although a significant benefit in blood pressure or renal function response has not been proven.21.Van de Ven P.J. Kaatee R. Beutler J.J. et al.Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial.Lancet. 1999; 353: 282-286Abstract Full Text Full Text PDF PubMed Scopus (569) Google Scholar There are few non-invasive predictors of a favorable response to revascularization in ischemic nephropathy. Patients with certain baseline characteristics (mild renal impairment, severe renal artery stenosis, non-diabetics, and those requiring 'global renal artery revascularization') are more likely to experience a favorable impact on renal function.7.Zeller T. Frank U. Muller C. et al.Stent supported angioplasty of severe atherosclerotic renal artery stenosis preserves renal function and improves blood pressure control.J Endovasc Ther. 2004; 11: 95-106Crossref PubMed Scopus (116) Google Scholar, 23.Giroux M.F. Soulez G. Therasse E. et al.Percutaneous revascularization of the renal arteries: predictors of outcome.JVIR. 2000; 11: 713-720Abstract Full Text Full Text PDF Scopus (25) Google Scholar, 24.Zeller T. Frank U. Muller C. et al.Predictors of improved renal function after percutaneous stent-supported angioplasty of severe atherosclerotic ostial renal artery stenosis.Circulation. 2003; 10: 1006-1014Google Scholar The most important predictor appears to be the rate of decline (slope of regression lines based on the reciprocal of the serum creatinine measurement) in renal function before the intervention. Patients with a rapid deterioration in renal function experience greater benefit in renal function with stent revascularization than those with stable chronic renal impairment.25.Gognet F. Gracier J.M. Dranssart M. et al.Percutaneous transluminal renal angioplasty in atheroma with renal failure: long term outcomes in 99 patients.Eur Radiol. 2001; 11: 2524-2530Crossref PubMed Scopus (17) Google Scholar,26.Murray S. Martin M. Amoedo M.L. et al.Rapid decline in renal function reflects reversibility and predicts outcome after angioplasty in renal artery stenosis.Am J Kidney Dis. 2002; 39: 60-66Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar Many studies of endovascular revascularization in ischemic nephropathy report a procedure-related acute decline in renal function of 10–20%.9.Harden P.N. MacLeod M.J. 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Atheromatous emboli may produce acute arterial occlusions but secondary inflammatory changes (localized arteritis with intimal thickening and cellular proliferation) may be more damaging.25.Gognet F. Gracier J.M. Dranssart M. et al.Percutaneous transluminal renal angioplasty in atheroma with renal failure: long term outcomes in 99 patients.Eur Radiol. 2001; 11: 2524-2530Crossref PubMed Scopus (17) Google Scholar There are two forms of atheromatous embolization – systemic and local. Systemic atheromatous embolization may occur spontaneously (usually as a result of a penetrating atheromatous aortic ulcer), but is more frequently reported after catheter or surgical manipulation of a severely atheromatous aorta.28.Gaines P.A. Cumberland D.C. Kennedy A. et al.Cholesterol embolisation: a lethal complication of vascular catheterisation.Lancet. 1988; 1: 168-170Abstract PubMed Scopus (72) Google Scholar,29.Scolari F. Tardanico R. 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Fioretti C. et al.Characteristics of cerebral microembolism during carotid stenting and angioplasty alone.Arch Neurol. 2001; 58: 1410-1413Crossref PubMed Scopus (85) Google ScholarEx vivo manipulation of the atheromatous renal artery ostium has been shown to release large numbers of embolic particles with angioplasty, and stenting the most embologenic part of the procedure.34.Hira
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