Pierre Barrier Auriol Julien Canevet Guillaume Otal Philippe Rousseau Hervé Joffre Francis. Introduction

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1 Cardiovasc Intervent Radiol (2010) 33: DOI /s x CLINICAL INVESTIGATION Technical and Clinical Results After Percutaneous Angioplasty in Nonmedial Fibromuscular Dysplasia: Outcome After Endovascular Management of Unifocal Renal Artery Stenoses in 30 Patients Pierre Barrier Auriol Julien Canevet Guillaume Otal Philippe Rousseau Hervé Joffre Francis Received: 6 May 2009 / Accepted: 17 December 2009 / Published online: 18 February 2010 Ó Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2010 Abstract Although percutaneous transluminal renal angioplasty (PTRA) is associated with excellent results in medial fibromuscular dysplasia (FMD), the clinical and technical outcome in the less common nonmedial subtype of FMD is not clearly known. Angiographic PTRA results and clinical follow-up were documented, to report technical and clinical results in 30 patients with unifocal, nonmedial dysplastic stenoses. Balloon angioplasty was technically successful in only 65% of the lesions. Additional stenting, performed after PTRA failure in six patients, increased the initial technical success rate to 82%. Stenting was used in another lesion after restenosis, and long-term patency was achieved in only three of the seven stented lesions. Frequent restenoses and unusual complications were observed during follow-up. Stent fracture occurred in two cases. Overall, long-term clinical and technical successes were sustained in 70 and 76%, respectively. We conclude that nonmedial, unifocal renal artery dysplastic stenoses do not share the excellent prognosis of the medial type and that stenting should be avoided. Therefore, surgery should be considered in lesions remaining unresponsive to balloon dilatation, after a second PTRA attempt. Keywords Fibromuscular dysplasia Nonmedial Unifocal Angioplasty Stenting Renal artery stenosis P. Barrier (&) A. Julien C. Guillaume O. Philippe R. Hervé J. Francis Service d imagerie médicale, Hôpital de Rangueil, (Rangueil) Bâtiment H1, R.D.C, 1 avenue du Professeur Jean Poulhès, TSA Toulouse Cedex 9, France p.barrier@gmail.com Introduction Fibromuscular dysplasia (FMD) is an idiopathic, noninflammatory arteriopathy, involving small- and middle-caliber arteries. However, FMD actually includes heterogeneous pathologic lesions [1]. FMD subtypes, named in accordance to the mainly involved arterial layer, have long ago been correlated with angiography. The studies by McCormack et al. [2] and Kincaid et al. [3], though four decades old, are the only angiographic-pathologic correlations available, as operative specimens with pathology have become dramatically less frequent since the advent of percutaneous transluminal renal angioplasty (PTRA). According to these studies, a string-of-beads pattern, resulting from alternating stenoses and dilatation exceeding the caliber of the native artery, is pathognomonic of the medial subtype of FMD. Nonmedial types of FMD, related to intimal or perimedial involvement, are associated with focal or tubular stenoses, without any specific angiographic signature, and the string-of-beads pattern is never observed in these types of FMD. Perimedial type of FMD can be associated with multifocal stenoses mimicking a string-ofbeads pattern, but beads are in this case smaller than the anticipated renal artery diameter. Some limitations must be kept in mind, since coexisting involvement of different arterial layers may occur in a single patient, or even in a single lesion [4, 5], and since medial FMD stenoses do not always result in a string-ofbeads pattern. But as a pathologic correlation has become exceptional, these conclusions remain critical. Therefore, several authors have chosen to separate the medial type, exhibiting a string-of-beads pattern, from the nonmedial type, which less common and associated with unifocal (tubular or focal) stenoses.

2 P. Barrier et al.: Technical and Clinical Results After Percutaneous Angioplasty 271 PTRA technical and clinical results in medial FMD have been widely documented and are excellent, with hypertension cured in 70 98% of patients [6]. Renovascular hypertension related to FMD occurs in relatively young patients, in which cure of hypertension is seen as the ultimate goal. Therefore revascularization indications are large, and angioplasty should be considered, even if the blood pressure is controlled by medical treatment alone [7]. In this setting, PTRA has become the first therapeutic option, achieving excellent clinical results, with a lower morbidity in comparison with surgical revascularization. Nonmedial dysplasia is rare, and specific reports are seldom. In many studies, no clear distinction is made regarding the FMD subtype. Assuming that the medial subtype represents more than 80% of all FMD, these studies probably report prognosis and results of PTRA in this predominant medial subtype. Nevertheless, medial and nonmedial dysplasia do not share the same demographic and clinical features [8]. Some authors have reported issues with balloon dilatation in unifocal FMD lesions. Archibald, in a combination of his own experience with previous cases (with, in total, 27 patients from eight different studies), reported resistance to balloon dilatation in 26%, resulting in a residual stenosis in 19% [9]. Bonelli et al. [10], in the largest study of FMD renal stenoses published to date (105 patients), showed that PTRA technical results were significantly poorer in the intimal hyperplasia group (with a 71.4% success rate) than in the medial dysplasia group (85.7%). Unfortunately angiographic criteria for the different types of FMD are not clearly defined in this study, and all FMD patients are pooled concerning the clinical results. In keeping with these previous observations, we were motivated by previous adverse outcomes to evaluate the results of PTRA performed at our institution in this specific setting of nonmedial FMD. Evolution after additional endovascular treatment, should the balloon angioplasty be a failure, was also questionable, as there are no definite guidelines for PTRA-unresponsive FMD lesions. syndrome) or to inflammatory conditions (Takayashu s or Behcet s disease) were excluded. Eldery patients, in which atherosclerosis associated lesions were suspected, were excluded. The 24 female and six male patients had a mean age of years (range, years), with a median age of 28. Detailed demographic data are reported in Fig. 1. Renovascular hypertension was by far the most common clinical indication for PTRA in this study (28/30 patients). One patient, in which renal artery stenoses were bilateral, was treated because of worsening of pre-existing chronic renal failure, and another one because of renal artery stenosis with a solitary functioning kidney (i.e., nephronic protection). We excluded medial-type stenoses on the basis of their angiographic appearance: multifocal lesions, whether related to irregular stenoses or to stenoses alternating with aneurismal dilatations (string-of-beads), were considered medial type and therefore excluded. This distinction, previously used by Pannier Moreau et al. [8] to exclude the medial type of FMD, is restrictive and may have led to exclusion of perimedial lesion (where beads do not exceed the diameter of the renal artery). However, this distinction allowed the confident exclusion of medial lesions, and only focal lesions were included. Unifocal stenoses were considered focal (web, or lesion \1 cm in length) or tubular (lesion [1 cm in length). Angiographic examples of such stenoses are displayed in Figs. 2 and 3. Theses 34 lesions were anatomically divided into ostial ([0.5 cm from the renal artery ostium), troncular, or affecting the first branches of division. Twenty-six focal and eight tubular stenoses were included. No ostial lesion was highlighted, and troncular lesions involved the proximal third in four cases (12%), the middle third in 13 cases (38%), and the distal third in 14 cases (41%). Three lesions involved both the distal third and the first division branches of the renal artery. Materials and Methods We retrospectively evaluated the technical and clinical outcome of the PTRA procedure, performed in unifocal renal stenoses related to FMD, conducted between 1994 and 2006 in 30 patients. During this 12-year interim, about 400 angioplasties related to FMD (mostly medial type) were conducted at our institution. Thirty-four unifocal stenoses were considered to be related to the nonmedial subtype of FMD after exclusion of differential diagnoses. Renal artery stenoses related to genetic syndromes (Ehlers- Danlos disease, Marfan syndrome, neurofibromatosis, Williams Fig. 1 Demographic features: 30 patients with unifocal, nonmedial FMD-related stenoses

3 272 P. Barrier et al.: Technical and Clinical Results After Percutaneous Angioplasty Fig. 2 Unifocal stenosis of the focal type procedures. All PTRAs were conducted through a femoral arterial access. Balloon size was chosen according to unaffected renal artery segment diameter, after selective digital subtraction angiography (DSA). Five- and six-millimeter balloons were used. Dilatations were performed at balloon nominal pressure (10 atm). Technical results were evaluated according to international guidelines [7, 11], with technical failure defined as residual stenosis superior to 30%. An additional endovascular treatment was performed during the same procedure in seven lesions, because of technical initial failure of the PTRA. Six stents and one cutting balloon were used. Technical failure could be related to resistant stenosis, elastic recoil, or complication. In all resistant stenoses, dilatation with a high-pressure balloon was attempted first (this was not considered an addition endovascular treatment in this study). Additional stenting and cutting balloon dilatation were performed as a last resort. Because of the retrospective design of the study, dynamic data regarding stenotic behavior leading to PTRA failure were missing for some patients. Failure was related to resistant lesion in some patients and to elastic recoil in others, but no statistical conclusion could be drawn. As the study lasted for more than a decade, we used stents from several manufacturers (see Table 1). Clinical Initial and Long-Term Follow-Up Fig. 3 Unifocal stenosis of the tubular type PTRA was bilateral in four patients (13%). However, thorough review of the angiographic procedures revealed minor contralateral lesions without significant stenosis in five patients. In four other patients, a history of significant contralateral lesions was found, related to prior surgical treatment in two cases, to a multifocal stenosis in one case, and to a lesion limited to a distal division branch in one patient, out of reach of the PTRA. Overall, 13 patients (43%) had current or previous bilateral involvement, significant or not. When unilateral, stenosis was right-sided in 35% (9/26) and left-sided in 65%. PTA and Initial Results Percutaneous transluminal renal angioplasty in this study included both PTRA (referred to as plain PTRA ) and PTRA with associated stenting, when a stent was used because of failure of the plain PTRA (referred to in table as PTRA? stent ). A single trained operator performed all Clinical results were determined on the basis of the patient s blood pressure. Ambulatory monitoring of arterial pressure (AMAP) was performed regularly during follow-up. In accordance with current guidelines, renovascular hypertension was considered cured when a normal blood pressure was achieved without any medication. Hypertension was considered improved when diastolic blood pressure decreased, by at least 15 mmhg, using an equal or lesser number of antihypertensive drugs. A clinical benefit was achieved in a setting of cured or improved hypertension. In patients where recurrence was suspected because of uncontrolled blood pressure, renal artery Doppler was used to detect restenosis. Restenosis was diagnosed as the association of a recurrence of uncontrolled hypertension associated with a significant stenosis proven by any imaging modality. Complications were evaluated and graded according to guidelines given by the SIR [11] and Beek [12]. Results Immediate Technical Results Plain PTRA was successful in 65% (22/34). Technical failure was related to significant residual stenosis, associated

4 P. Barrier et al.: Technical and Clinical Results After Percutaneous Angioplasty 273 Table 1 Type of stents and evolution of stented stenoses Stent type Diameter Length Evolution during follow-up: treatment if any Genesis (Cordis) 6 14 Patent at end of follow-up (36 months) Genesis (Cordis) 6 14 Restenosis at 10 months, intrastent PTRA, restenosis at 15 months Tsunami (Terumo) 6 12 Fracture at 3 months Palmaz (Cordis) 5 12 Restenosis at 4 and at 10 months, intrastent PTRA followed by surgical treatment Genesis (Cordis) 6 11 Patent at end of follow-up (58 months) Genesis (Cordis) 6 13 Fracture at 5 months, surgical treatment Palmaz (Cordis) 6 15 Restenosis at 13 months, intrastent PTRA with dissection in one case. In seven of the failed attempts, additional therapy was performed during the same procedure. Stents were used in six cases and cutting balloons in one case. Cutting balloon dilatation resulted in renal artery dissection, considered a failure. Overall, after the first procedure, technical success was achieved in 82% (28/34). Complications Global complication rate was 30% (nine patients) and was related to stenting in three patients. Periprocedural complications occurred in six patients. Minor complications included hematoma at the puncture site (n = 2) and a minimal renal artery dissection with successful endovascular immediate treatment (balloon tamponade) (n = 1). Major immediate complications included arterial spasm resulting in a small segmental infarct without associated renal failure (n = 1), arterial rupture with successful endovascular immediate treatment (balloon tamponade), and renal artery dissection with failure of simple balloon tamponade requiring stenting (after failure of plain PTRA balloon tamponade). No PTRA-related death occurred, and every major adverse event was successfully managed with endovascular therapy, without requiring any emergent surgical procedure. Unusual postprocedural complications were observed during follow-up in three patients. In one patient successfully managed with plain PTRA, we observed the development of a pseudoaneurysm at the lesion site. In two lesions requiring stenting, stent fractures were highlighted during follow-up. Restenoses Restenoses occurred in seven cases, which were confirmed by angiography, and occurred in 27% of the overall initial technical success. Four restenoses occurred after plain PTRA (4/20; 20%), and three after stenting. In four more patients, whose stenoses were still superior to 30% after the initial PTRA, recurrence of hypertension after an initial clinical improvement was noted. However, this recurrence of an elevated blood pressure could not be considered as a restenosis, despite confirmation of the worsening of the residual stenosis via echo Doppler, because of the initial technical failure of the PTRA. Restenosis occurred on average after 9 months both in the native artery group (at 2, 5, 11, and 19 months, respectively) and in the stented artery group (at 4, 10, and 13 months). Except in one lesion, where recurrent restenosis occurred at 25 months after an initial restenosis at 10 months treated by stenting, all restenoses occurred during the first 2 years after the initial angioplasty. Eight endovascular procedures (eight ATP/eight ATP? stent) were performed and successful in the treatment of theses restenoses. One surgical procedure was required. No recurrent restenosis was observed in native arteries. However, three recurrent restenoses occurred in stented arteries. A stent fracture occurred after stenting motivated by restenosis in a native artery. Long-Term Arterial Patency Life-table analysis displays primary patency rates (after a single endovascular procedure) and secondary patency rates (after additional endovascular procedures), reflecting sustained technical benefit. Follow-up was available in 32 stenoses. Considering the technical results achieved with plain PTRA (requirement for additional endovascular therapy being considered a failure), primary and secondary patency rates were 49 and 62%, respectively. Overall, considering the results achieved by PTRA and associated stenting in these 32 lesions, primary and secondary patency rates were 45 and 70% at 8 years. In the subgroup of stented lesions (n = 7), initial failure occurred in one case, and four more technical failures occurred during the first 4 years of follow-up. This resulted in primary and secondary patency rates of 29 and 41%, respectively (cf. Table 2 and Fig. 4). Clinical Results and Long-Term Follow-Up Two patients were lost to follow-up after the initial procedure, and follow-up was available in 28 patients, with a

5 274 P. Barrier et al.: Technical and Clinical Results After Percutaneous Angioplasty Table 2 Technical results of angioplasty in 32 unifocal nonmedial dysplastic stenoses: survival table analysis Follow-up (months) Lesions at risk, beginning of interval Failure, restenosis complications with compromised patency Lost to follow-up Lesions at risk during the interval a Interval failure rate (%) Interval patency rate (%) Cumulative patency rate (%) P S P S P S P S P S P S P S Immediate Note: Primary results (P) are obtained after a single PTRA/PTRA? stent. Secondary results (S) are obtained after an additional PTRA procedure in the case of failure during follow-up. Plain PTRA results are reported on the top line of each cell (regular font). PTRA and PTRA? stent results are displayed on the second line of each cell (italics) a Lesions at risk during the interval = lesions at risk at beginning of interval one-half (lost to follow-up during interval) Secondary clinical failure occurred after a median time of 21 months. Clinical benefit was sustained in 76% at 8 years, requiring seven additional PTRAs. All of these endovascular procedures were technical successes. Four patients underwent surgical revascularization because of secondary failure or complication during the follow-up. Primary clinical benefit (after one endovascular procedure) and secondary clinical benefit (after additional PTRA) are reported in Table 3 and Fig. 5. Discussion Fig. 4 Cumulative patency rate. Primary single PTRA/PTRA? stent; secondary after an additional PTRA procedure mean duration of 57 months (range, months). Renovascular hypertension was the clinical issue in 26 of the 28 patients available to follow-up. An initial clinical success (improvement or cure of hypertension) was observed in 92%. However, recurrence of hypertension requiring an endovascular or a surgical treatment was observed in 42%. Nonmedial dysplasia is a rare clinical entity, distinct from the medial type. Patients are younger and the gender ratio is more balanced in the nonmedial type [8]. Nonmedial lesions are more severe and require revascularization more often [8]. In this study, nonmedial unifocal lesions were frequently bilateral, with evidence of bilateral involvement (not necessarily of hemodynamic significance) in 43% of the cases. In this series, significant bilateral involvement was often synchronous or mildly metachronous (\1 year). However in two patients, a significant interval was noted before clinical relevance and diagnosis of the contralateral stenosis (68 and 118 months, respectively). Moreover, three patients in this study had a history of contralateral surgery during childhood. Therefore, a continuum between nonmedial FMD stenoses observed in adult patients in this

6 P. Barrier et al.: Technical and Clinical Results After Percutaneous Angioplasty 275 Table 3 Clinical results of angioplasty in 32 unifocal nonmedial dysplastic stenoses: survival table analysis (PTRA and PTRA? stent) Follow-up (months) Patients at risk, beginning of interval Failure Lost to follow-up Patient at risk, during the interval a Failure rate (%) Interval benefit rate (%) Cumulative benefit rate (%) P S P S P S P S P S P S P S Note: Primary cumulative benefit (P) is obtained after a single PTRA/PTRA? stent. Secondary cumulative benefit (S) is obtained after an additional PTRA procedure in the case of failure during follow-up a Patients at risk during the interval = patients at risk at beginning of interval one-half (lost to follow-up during interval Fig. 5 Cumulative clinical benefit rate. Primary single PTRA/ PTRA? stent; secondary after an additional PTRA procedure work and pediatric unifocal dysplastic lesion is likely. Interestingly, the offspring of two patients (females) developed a unifocal lesion similar to their mother s. In the literature, the prevalence of the familial form of FMD is estimated as between 6 and 11% [8, 13]. Technical issues regarding balloon dilatation of unifocal dysplastic stenosis have previously led to case reports. However, because of the rarity of the disease, no large series exists. In our study, plain PTRA was associated with technical failure in 35% (12/34). This 65% success rate is a poor outcome in comparison to results expected for the medial type of dysplasia (with success rates ranging from 79 to 100%) [6]. Archibald et al. [9], in a small synthesis of isolated case reports, previously reported failure in 19%. Our results are closer to those of Bonelli, who reported a technical success rate of 71.4% in the treatment of 14 cases of intimal dysplasia [10]. Hughes et al. [14] also reported technical success in 69% of 13 cases with atypical dysplasia. All procedures in our study were performed by a trained operator, with known success rates in the range of those for the medial type in the literature [15 17]. We therefore conclude that PTRA technical results are lower in this specific setting of unifocal, nonmedial types of FMD, in comparison with the more common medial type. Because of the unsatisfactory results of the PTRA, stenting may be regarded as an option to overcome technical failure. In this study, seven stents were used (six during the first procedure and one because of the failure of the PTRA of a recurrent stenosis). With stenting, technical success in the initial procedure was achieved in 82%. However, long-term secondary patency was obtained in only three of these seven stented lesions. Intrastent restenosis occurred in three cases, and PTRA of these intrastent restenoses was durably successful in only one patient. Recurrent intrastent restenoses occurred in the two remaining lesions, requiring surgical management in one case. In two other stented stenoses, stent fractures compromised patency during follow-up. Overall 43% of the stented stenoses (three of seven) had required surgery or were amendable to surgery at the end of the follow-up. Restenosis after PTRA was observed in 20% of the patients in this study (n = 4 of 20), similar to the restenosis rate observed in previous studies, ranging from 12 to 27% [18 23], in which the distinction between medial and nonmedial type was rarely explained. Restenosis was observed on average after 9 months. All restenoses occurred during the two 2 years after treatment, except in one lesion, where a recurrent intrastent stenosis occurred at 25 months, after an initial restenosis at 10 months treated by PTRA and stenting. Surowiec et al. [23] previously reported restenosis during the first 2 years in most of their patients, and our results suggest that restenosis in nonmedial FMD lesions is also an early adverse event. Complications related to PTRA without additional endovascular treatment occurred in 20%, but this rate rose to 30% when patients treated with either stent or cutting

7 276 P. Barrier et al.: Technical and Clinical Results After Percutaneous Angioplasty balloon were included. When acute, complications were successfully managed by endovascular treatment, without requiring surgery in an emergent setting. Nevertheless, we encountered relatively uncommon complications in this specific population. One pseudoaneurysm was diagnosed during follow-up, involving a lesion previously dilated by PTRA. Retrospectively, no arterial rupture was highlighted during the final angiographic check performed immediately after PTRA. Because subtle rupture may be occult during the initial procedure, and may result in a delayed pseudoaneurysm, imaging should be performed in the follow-up of every patient treated with PTRA, regardless of the clinical evolution. Additionally, stent fractures occurred in two patients (seven stents were used, in total). This high rate of occurrence of this uncommon complication suggests that stented nonmedial dysplastic stenoses are prone to stent fracture. Resistant unifocal stenoses, with residual extrinsic imprints on the stent wall after expansion, in addition to neointimal hyperplasia secondary to the stent injury on the arterial wall, result in important mechanical stress, responsible for the stent technical failure. These stent fractures were observed after 3 and 4 months in this study, which is earlier than fracture occurrence observed in atheromatous stenoses [24]. A cutting balloon was used in only one patient in this study, therefore drawing conclusions from this simple case is difficult. However, this cutting balloon dilatation was complicated by an arterial rupture, a well-known complication related to this device [25]. Overall, primary cumulative clinical benefit was sustained in 52% of the patients after 8 years. With additional endovascular treatments, secondary clinical success at 8 years was 76%. This success rate is at the lower end of the range of clinical success after PTRA for medial dysplasia (70 98%) [6]. This respectable result was obtained after seven additional dilatations (7/26; 27%). In five of six cases, symptomatic restenoses were successfully treated by another PTRA without stenting, with a long-standing clinical benefit ([36 months). We conclude that a second PTRA without stenting is the treatment of choice in nonmedial dysplasia restenosis. Several limitations were encountered, most of them related to the retrospective design of the study and shared with similar studies. Given the rarity of the disease, conducting a prospective study was not feasible. Follow-up is therefore inhomogeneous, with a mean duration of 57 months, but only four patients were followed for \1 year. The demographic features of the population study, i.e., young, mobile patients with no associated comorbidities, may explain the losses to follow-up. Classical bias found in studies of this kind can also be mentioned, related to blood pressure measurement, patient selection, and angiographic quantification of stenosis [26]. Moreover, as previously discussed, the angiographicpathologic correlation is not perfect and some medial dysplasia may be associated with a unifocal stenosis angiographic appearance. We therefore proceeded to exclude irregular multifocal stenoses (without a string-ofbeads pattern), previously regarded as probably nonmedial by de Fraissinette et al. [27], and we preferred the dichotomy between medial and nonmedial previously chosen by Pannier-Morreau [8]. We observed a discrepancy between technical results and clinical outcomes, with clinical benefit achieved without technical success in some patients. This is probably related to the definition of technical success, requiring residual stenosis being less than 30%. Some patients experienced improvement of hemodynamic and angiographic features of their stenoses after PTRA, without fulfilling the criteria required to be classified as technical successes. Conclusions Among renal artery stenoses related to FMD, nonmedial, unifocal stenoses represent a specific entity which does not share the excellent prognosis with PTRA that is observed in the medial type. In this 30-patient study, the failure rate of PTRA without associated stenting (35%) was higher than those observed in the multifocal, more common, type of FMD. As suspected by experienced operators, stenting of resistant nonmedial stenoses after failure of balloon angioplasty is hazardous, unpredictable, and associated with high rates of complications and restenosis. Uncommon complications may be expected, as we reported two stent fractures in seven stented lesions, probably due to important stress applied by unifocal nonmedial stenoses on stent walls. Moreover, stenting may result in a more complex surgical treatment in the case of failure. Overall when encountering a unifocal, nonmedial FMD, balloon angioplasty may the first option. Should balloon angioplasty fails, we do not recommend stenting. Therapeutic planning should, at best, be elaborated in coordination with vascular surgeons, as surgical treatment should be recommended if repeated balloon angioplasties fail or in the case of recurrent stenosis. References 1. Hunt JC, Harrison EG Jr, Sheps SG et al (1965) Hypertension caused by fibromuscular dysplasia of the renal arteries. Postgrad Med 38: McCormack LJ, Poutasse EF, Meaney TF et al (1966) A pathologic-arteriographic correlation of renal arterial disease. Am Heart J 72:

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