Cutting Balloon Angioplasty for Resistant Renal Artery In-Stent Restenosis

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1 Cutting Balloon Angioplasty for Resistant Renal Artery In-Stent Restenosis Graham J. Munneke, MRCP, Christoph Engelke, MD, Robert A. Morgan, FRCR, and Anna-Maria Belli, FRCR A 76-year-old woman presented with recurrent arterial hypertension 6 months after uncomplicated primary renal artery stent placement. Diagnostic arteriography revealed severe renal artery in-stent restenosis. On repeat intervention, the lesion was resistant to attempted conventional percutaneous transluminal angioplasty (PTA) with unchanged systolic pressure gradients across the stent. Cutting balloon angioplasty (CBA) was performed with use of a 4-mm cutting balloon (IVT, San Diego, CA). CBA successfully reduced the pressure gradient to below the level of significance. Subsequent conventional PTA enhanced the lumen diameter inside the stent. The arterial hypertension reverted to normal values and duplex ultrasonography (US) at 10-month follow-up demonstrated normal renal artery hemodynamics without stenosis. CBA for potential use in renal artery in-stent restenosis and other peripheral neointimal hyperplasia is discussed. Index terms: Renal arteries, stenosis or obstruction Renal arteries, transluminal angioplasty J Vasc Interv Radiol 2002; 13: Abbreviations: PTA percutaneous transluminal angioplasty, CBA cutting balloon [percutaneous transluminal] angioplasty RENAL artery in-stent restenosis is a therapeutic challenge affecting between 9% and 25% of patients undergoing renal artery stent placement (1 3). It can occur less than 6 months after the initial intervention and is commonly caused by neointimal hyperplasia (4). Despite the reported success of percutaneous transluminal angioplasty (PTA) in the treatment of renal artery in-stent restenosis, there are a number of patients in whom PTA fails, necessitating further intervention (2). Alternative mechanical treatments of renal in-stent restenosis include repeat stent placement and rotational atherectomy with a single reported case (5). Repeat stent placement with a resulting stent sandwich offers excellent short-term technical success but has the disadvantage of overexpanding the arterial wall with the potential induction of further neointimal response (6). From the Department of Radiology, St. George s Hospital, Blackshaw Road, London SW17 0QT, United Kingdom. Received July 23, 2001; revision requested September 20; final revision received and accepted November 13. Address correspondence to C.E.; cengelke@hotmail.com SCVIR, 2002 Cutting balloon angioplasty (CBA) plays an increasing role in in-stent restenosis of the coronary territory (6,7), whereas its use in coronary atherosclerotic lesions has not resulted in patency rates different from those achieved with conventional coronary angioplasty. In the peripheral vascular system, the cutting balloon (Fig 1) has been successfully used for the treatment of neointimal hyperplasia in arterial bypass graft salvage (8) and in resistant stenoses of dialysis fistulas and grafts (9). We describe the successful treatment of a patient with renal artery in-stent restenosis with use of the Barath cutting balloon. CASE REPORT A 76-year-old woman presented at our institution in April 1999 with bilateral lower limb claudication. Initial diagnostic femoral arteriography incidentally demonstrated a tight proximal right renal artery stenosis, a left renal artery of decreased caliber, and a small left kidney, confirmed subsequently on abdominal US (7.0-cm craniocaudal length). The right kidney was normal in size (10.8-cm craniocaudal length). The serum urea and creatinine levels were normal. However, for the previous 3 years, the patient had refractory systemic arterial hypertension (blood pressure: 180/70), which was resistant to three different medications. In cooperation with our renal team, the decision was made to treat the right renal artery stenosis with the goal of improved management of the arterial hypertension. After informed consent was obtained, the right renal artery stenosis was treated with a 5-mm by 16-mm Bridge X3 renal artery balloon expandable stent (Medtronic AVE, Santa Rosa, CA) with use of a standard overthe-wire technique with a satisfactory angiographic result (Fig 2) and no postprocedural arterial pressure gradient across the stent. The patient s recovery was uneventful with improvement of her arterial hypertension to 125/70 mm Hg. Six months after initial treatment, she presented again at our center with recurrent arterial hypertension of 186/92 mm Hg. Repeat diagnostic renal arteriography revealed a significant in-stent restenosis across the entire length of the stent (Fig 3) with a systolic arterial pressure gradient of 30 mm Hg. 327

2 328 Cutting Balloon PTA for Renal Artery In-Stent Restenosis March 2002 JVIR Figure 1. Cutting balloon function: (a) the microsurgical blades are covered inside balloon folds in the deflated state (profile view). (b) During the inflation, the microtomes are exposed and pressed into adjacent structures. (Reprinted with permission from IVT Europe.) Figure 2. (a) Initial tight right proximal truncal renal artery stenosis (arrow), which was treated with primary stent placement with good angiographic result (b) and no significant residual pressure gradient across the lesion. The patient was readmitted for elective renal artery repeat intervention 2 months later and informed consent was obtained. On this occasion, a right common femoral artery access was created with a 35-cm-long 6-F introducer sheath (Cordis/Johnson & Johnson Europe, Roden, The Netherlands). The right renal artery in-stent restenosis was assessed with use of a 5-F cobra I catheter (Cordis/Johnson & Johnson Europe) crossed with a hydrophilic inch guide wire (Terumo Europe, Leuven, Belgium). After injection of a systemic bolus of 5,000 IU of heparin and a bolus of 150 g of glyceroltrinitrate into the renal artery, conventional in-stent PTA was attempted with use of a 6-mm by 2-cm balloon (Smash; Boston Scientific/Medi-tech, Natick, MA) over a inch TAD II wire (Mallinckrodt, St Louis, MO) with two separate overlapping balloon inflations of 10 seconds (12 14 bar). Conventional PTA failed to have any effect on the stenosis and a 30-mm Hg residual pressure gradient remained across the stent. Based on recent successful experience with use of the cutting balloon for treatment of neointimal hyperplasia in peripheral arterial bypass graft salvage (8), a decision was made to treat the renal artery in-stent restenosis with use of the cutting balloon (Fig 1)

3 Volume 13 Number 3 Munneke et al 329 in the event of conventional PTA failure. Conventional PTA was followed by CBA with a 4-mm by 100mm Barath cutting balloon (IVT, San Diego, CA) over a dedicated inch guide wire (Trackwire; IVT). Institutional review board was not required at our center for this treatment. The procedure was performed after informed consent was obtained. The use of the 3.9-F profile rapid exchange cutting balloon was straightforward and the CBPTA technique was analogous to standard renal PTA. No exchange of the access sheath to a larger device was required. The balloon was placed inside the renal artery stent and slowly inflated three times with pressures of approximately 6 8 atm in overlapping positions from the distal to the proximal end to cover the entire lesion. The device expanded completely on each inflation, without any residual balloon waist. Control digital subtraction angiography displayed an improved lumen with irregularities (Fig 3). CBA reduced the systolic arterial pressure gradient across the stent to 15 mm Hg. To improve the lumen diameter inside the stent, conventional CBA was followed by standard over-the-wire PTA with use of the same 6-mm by 20-mm balloon (Smash; Boston Scientific/Medi-tech) as previously used with two separate overlapping inflations of approximately 10 seconds each. The control angiogram showed a satisfactory result (Fig 3) and the postprocedural systolic pressure gradient across the stent was further reduced to 5 mm Hg, indicating no significant residual stenosis (10). The patient made an uneventful recovery. At 10-month follow-up, the patient had systemic arterial blood pressures of 129/65 mm Hg and the antihypertensive treatment was reduced to a single calcium antagonist. The serum creatinine level was unchanged. Arterial color duplex US displayed a patent right renal artery without significant peak systolic velocity gradient across the stent. DISCUSSION The beneficial short- and long-term results of renal artery stent placement have resulted in a rapid increase in stent use in the treatment of renal artery stenosis. Unfortunately, the longterm beneficial effect of renal artery stent placement is limited by a restenosis rate between 9% and 25% (1 3). The published data on the treatment of renal artery in-stent restenosis is scarce. In the study by Bakker et al (2) of repeat conventional intrastent PTA, the commonly used revascularization therapy was technically successful in only 10 of 15 cases. Other mechanical treatments that can overcome rigid or highly elastic stenosis of peripheral neointimal hyperplasia such as instent restenosis include repeat stent placement, atherectomy, and cutting balloon angioplasty (CBA). Repeat stent placement with a resulting stent sandwich has the conceptual disadvantage of overexpansion of the arterial wall, which acts as a stimulus for neointimal proliferation in a patient known to be prone to neointimal hyperplasia. This may explain the poor long-term results of repeat stent placement in coronary arteries (11). The use of atherectomy devices as an alternative to balloon catheters in the renal arteries is yet limited by their large caliber and rigidity and there is only one isolated report of atherectomy in the treatment of renal in-stent restenosis (5). However, the improvement of mechanical treatments for neointimal hyperplasia including in-stent restenosis is particularly important because other experimental therapies for neointimal hyperplasia prophylaxis including gene or radiation therapy suggest only a delay of neointimal hyperplasia and are unlikely to enter the clinical routine in the near future (6). This problem has been addressed particularly in recent studies of mechanical devices for treatment of in-stent restenosis in the coronary arteries, including repeat balloon angioplasty, rotational atherectomy, excimer laser atheroablation, and CBA. The 6-month results of conventional PTA are disappointing because of significant restenosis rates between 36% and 67% (12). Studies of CBA report more favorable results with 6-month restenosis rates of 20% 24% (7,13). A comparative retrospective study with 242 in-stent restenotic lesions suggested an advantage of CBA over conventional PTA and atherectomy with lower restenosis rates of 25%, 43%, and 34%, respectively (14). Cutting balloons (InterVentional Technologies, San Diego, CA) are relatively new devices that have been applied to the percutaneous treatment of resistant coronary artery stenosis. In renal artery in-stent restenosis, the low-profile (4-F), flexible catheters confer major handling advantages over atherectomy devices. The catheters comprise 3 4 microsurgical blades mounted longitudinally on the balloon, which cut directly into the stenotic lesion down to the stent cage during initial balloon inflation. These blades disrupt the fibroelastic continuity of the ring of neointimal hyperplasia, which prevents elastic recoil and enables effective dilation of rigid and highly elastic strictures to a larger diameter than stand-alone conventional PTA. Therefore, lesions that do not respond well to conventional PTA are amenable to CBA, which can achieve a better luminal gain than stand-alone PTA (15). Additionally, microincisions into the neointimal hyperplasia during balloon inflation induce a directed intimal disruption and less wall tension than the diffuse hoop stress produced by conventional PTA, thereby minimizing the intimal trauma, which may result in a decreased secondary restenosis rate (7,16). Complications of cutting balloon angioplasty are relatively few. To our knowledge, only one coronary artery aneurysm after CBA has been reported (17), and focal coronary artery dissection occurs less frequently after CBA than after standard conventional coronary angioplasty. The published experience with the cutting balloon device in the noncoronary circulation is limited to the treatment of anastomotic neointimal hyperplasia after peripheral arterial bypass graft surgery, the treatment of resistant stenoses in hemodialysis shunts and grafts, and an isolated report of CBA in pediatric pulmonary artery branch stenosis (8,9,18). The observation that the PTA attempt before CBA was unsuccessful supports that the in-stent restenosis in our patient 6 months after initial treatment had a high resistance and was caused by neointimal hyperplasia. The use of a 4-mm (undersized by 1 mm) cutting balloon in this situation appeared reliably safe, particularly because the stent cage protects the outer layers of the arterial wall. To our knowledge, there are no reports of stent damage caused by the cutting balloon mic-

4 330 Cutting Balloon PTA for Renal Artery In-Stent Restenosis March 2002 JVIR Figure 3. (a) Recurrent stenosis inside the renal artery stent 7 months after primary stent placement displaying in-stent restenosis along the lower aspect of the renal artery stent (white arrow). Additionally, the contrast column in the remaining stent lumen is less opaque than expected, suggesting further diffuse stenosis throughout the stent (black arrowheads). (b) After CBA, the stent lumen is markedly improved but irregular (white arrows). (c) Control angiogram obtained immediately after subsequent conventional PTA displays a smoothed appearance of the stent lumen with no residual stenosis. There is only minimal residual irregularity along the inferior aspect (black arrow). rotomes with the result of stent fracture or thrombosis. The current technical limitation of the cutting balloon in peripheral arterial use is its cardiologic device specification with a maximum balloon diameter of 4 mm. The combination with conventional PTA enables application of CBA in vessels as large as approximately 6 mm in diameter. For use in larger potential target vessels, such as in cases of iliac in-stent restenosis and anastomotic stenosis of aortoiliac surgical grafts, larger devices are required and a 6-mm cutting balloon has only recently become available. This report demonstrates the feasibility and potential efficacy of CBA for renal artery in-stent restenosis. It suggests that the cutting balloon can be used to achieve technical success when stand-alone PTA fails and could therefore significantly improve endovascular treatment of renal and other peripheral in-stent restenosis that is resistant to conventional balloon angioplasty. This merits further investigation to prove if CBA for the treatment of selected renal in-stent restenosis is more versatile and successful in comparison to competing endovascular techniques. References 1. Equine O, Beregi JP, Mounier-Vehier C, Gautier C, Desmoucelles F, Carre A. Anatomic results of the endoluminal revascularization of renal arterial stenoses: a retrospective study of 113 patients. Arch Mal Coeur Vaiss 1999; 92: Bakker J, Goffette PP, Henry M, et al. The Erasme study: a multicenter study on the safety and technical results of the Palmaz stent used for the treatment of atherosclerotic ostial renal artery stenosis. Cardiovasc Intervent Radiol 1999; 22: van de Ven PJ, Kaatee R, Beutler JJ, et al. Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial. Lancet ; 353: Leertouwer TC, Gussenhoven EJ, van Lankeren W, van Overhagen H. Response of renal and femoropopliteal arteries to Palmaz stent implantation assessed with intravascular ultrasound. J Endovasc Surg 1999; 6: Rao BH, Chandra KS. Renal artery instent restenosis: treatment with high

5 Volume 13 Number 3 Munneke et al 331 speed rotational atherectomy. Indian Heart J 2000; 52: Di Mario C, Marsico F, Adamian M, Karvouni E, Albiero R, Colombo A. New recipes for in-stent restenosis: cut, grate, roast, or sandwich the neointima? Heart 2000; 84: Adamian M, Colombo A, Briguori C, et al. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. J Am Coll Cardiol 2001; 38: Engelke C, Morgan RA, Belli AM. Cutting balloon angioplasty for salvage of lower limb arterial bypass grafts feasibility. Radiology 2002 (in press). 9. Vorwerk D, Adam G, Muller-Leisse C, Guenther RW. Haemodialysis fistulas and grafts: use of cutting balloons to dilate venous stenoses. Radiology 1996; 201: Gross CM, Kramer J, Weingartner O, et al. Determination of renal arterial stenosis severity: comparison of pressure gradient and vessel diameter. Radiology 2001; 220: Mehran R, Dangas G, Minz G, et al. In-stent restenosis: the great equalizer: disappointing clinical outcomes with all interventional strategies [abstract]. J Am Coll Cardiol 1999; 33:63A. 12. Galassi AR, Foti R, Azzarelli S, et al. Long-term angiographic follow-up after successful repeat balloon angioplasty for in-stent restenosis. Clin Cardiol 2001; 24: Muramatsu T, Tsukahara R, Ho M, et al. Efficacy of cutting balloon angioplasty for in-stent restenosis: an intravascular ultrasound evaluation. J Invas Cardiol 2001; 13: Adamian M, Marfico F, De Mario C, et al. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with conventional angioplasty and atherectomy [abstract]. Circulation 1999; 100:I Marti V, Salas E, Amyat RM, et al. Influence and residual stenosis in determining restenosis after cutting balloon angioplasty. Catheter Cardiovasc Intervent 2000; 49: Barath P. Microsurgical Dilation Concept: Animal Data. J Invas Cardiol 1996; 8(suppl A):2A 5A. 17. Bertrand OF, Mongrain R, Soualmi L, et al. Development of coronary aneurysm after cutting balloon angioplasty: assessment by intracoronary ultrasound. Cathet Cardiovasc Diagn 1998; 44: Schneider MB, Zartner PA, Magee AG. Images in cardiology: cutting balloon for treatment of severe peripheral pulmonary stenosis in a child. Heart 1999; 82:108.

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