Transradial percutaneous iliac intervention, a feasible alternative to the transfemoral route

Cardiovascular Revascularization Medicine 13 (2012) 331–334

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Cardiovascular Revascularization Medicine

Transradial percutaneous iliac intervention, a feasible alternative to the transfemoral route☆ Bernardo Cortese a,⁎, Elisa Peretti b, Nicola Troisi b, Emanuele Siquilberti b, Marco Setti b, Antonino Pitì b a b

Interventional Cardiology, A.O. Fatebenefratelli, Milano, Italy Cardiovascular Department, Humanitas Gavazzeni, Bergamo, Italy

a r t i c l e

i n f o

Article history: Received 29 June 2012 Received in revised form 18 August 2012 Accepted 27 August 2012 Keywords: Iliac angioplasty Transradial intervention Stent Claudicatio intermittens

a b s t r a c t Background: Percutaneous angioplasty for atherosclerotic iliac disease is commonly performed via the femoral and/or brachial route. In the coronary field a transradial approach has been shown to reduce both major and minor access site bleedings, in experienced hands. However, this route has not yet been well studied for the majority of peripheral interventions, like those involving the iliac arteries. Methods: We investigated the feasibility and safety of a transradial approach in a consecutive series of patients undergoing percutaneous iliac intervention at our center, comparing it to a similar series of patients treated with a transfemoral approach in the same period. Endpoints of the study were procedural success, duration of procedure and event free survival at one month. Results: From our database we enrolled 42 patients undergone iliac percutaneous interventions (21 with a transradial and 21 with a transfemoral approach); the 2 populations had similar baseline characteristics. Procedural success was achieved in all of our patient population. Among the secondary study endpoints analyzed we observed similar duration of the procedure and one-month clinical follow up. Technical aspects of the transradial approach are discussed. Conclusions: A transradial approach is feasible for the treatment of atherosclerotic iliac disease and does not increase procedural time in experienced hands. Further studies are needed to confirm if this approach is as safe as the transfemoral one. © 2012 Elsevier Inc. All rights reserved.

1. Introduction

2. Methods

Percutaneous interventions are the preferred route of treatment of iliac stenotic atherosclerotic disease, to this day. In the vast majority of cases, a transfemoral or transbrachial approach is the access site chosen for intervention. However, such accesses are associated with a considerable rate of local bleeding complications, that result increased with larger sheaths. Thus, successful interventions are sometimes hampered by procedural-related complications. The transradial access has often been shown to reduce the risk of local complications after coronary interventions [1,2]. However, this route has not yet been validated for interventions of the peripheral tree. We here report the results of our experience with the radial access for iliac stenting.

2.1. Study population and enrollment criteria

☆ Conflicts of interest/financial disclosures/relationship with industries: none. ⁎ Corresponding author. Interventional Cardiology, A.O. Fatebenefratelli, Bastioni di Porta Nuova, 21; 20121 Milano, Italy. Tel.: +39 0263632210; fax: +39 0263632210. E-mail address: [email protected] (B. Cortese). 1553-8389/$ – see front matter © 2012 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.carrev.2012.08.006

The first aim of this study was to test the feasibility and safety of a right transradial approach for percutaneous stenting of iliac artery stenotic disease. From our database we enrolled all patients who had undergone percutaneous iliac interventions in the previous 6 months. The clinical indication to treatment was claudicatio intermittens in class IIb following the Leriche–Fontaine classification; exact lesion localization and extension of disease were given by preoperative magnetic resonance imaging, as per local practice. Exclusion criteria were: impossibility or contraindication to dual antiplatelet treatment for 1 month; known hemorrhagic diathesis; known allergy to contrast media; TASC D lesion at magnetic resonance imaging (a contraindication to PTA as per local practice); previous aorto-bisiliac bypass (for transfemoral access only); culprit lesion in the external iliac artery in patient with N2.0 m 2 of body surface area (for transradial access only, and due to the limited shaft length of dilation catheters and stents available). There was no specific criterion for the selection of access site, which was left to operator's discretion. We have to underline

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that there were no anatomical or clinical criteria for the choice of access site. All patients were pretreated with aspirin and clopidogrel (300 mg loading dose given the day preceding intervention). Dual antiplatelet treatment was mandatory for 1 month, followed by indefinite aspirin treatment. 2.2. Procedure In the catheterization laboratory the anticoagulant of choice was unfractionated heparin (repetitive boluses in order to obtain an activated clotting time of 200–250 s). Radial approach: if the right radial artery was found suitable for cannulation with the Allen test, the diagnostic angiography was performed with a 125 cm diagnostic catheter (MP2, Cordis Corp., USA) via a 6 Fr short introducer (Radifocus, Terumo Corp., Japan). Crossing from the aortic arch to descending aorta was performed in the 45°– 60° left anterior oblique projection; in case of inadequate anatomy, descending aorta engagement was performed with a pig-tail diagnostic catheter and a common or hydrophilic 0.035”, 260 cm guidewire. Once the necessity of the intervention was confirmed, a long guidewire was placed just proximally to the culprit lesion, and the radial sheath was replaced by a 7 Fr 90 cm long Destination introducer (Terumo Corp., Japan) that was carefully introduced and positioned in descending aorta. As an alternative, a 6.5 Fr, 120 cm long sheathless guiding catheter (Asahi Corp., Japan) was employed. Lesion crossing was attempted with a standard or an extrastiff M-wire (Terumo Corp., Japan). The shaft length of balloons used (Admiral Xtreme and In.Pact Admiral, Invatec-Medtronic, USA) was 130 cm, whereas the stents had a shaft 135 cm long (Visi-Pro, EV3, USA). For the stent size used (diameter 6–10 mm) the sheath of 6.5 or 7 Fr of inner diameter was enough both for prosthesis delivery and concomitant contrast media injections for its correct positioning. In this study we did not use a guiding catheter via a common introducer. The introducer was removed just at the end of procedure, and a common bandage was left for 3 h. 2.3. Study endpoints Primary study endpoint was procedural success (non-inferiority with the transfemoral group hypothesized), defined as angiographic success and the absence of ischemic complications during hospitalization. Angiographic success was defined as a resulting culprit stenosis b30% and the absence of major dissections, along with fast distal flow. Secondary endpoints were 30-day event-free survival and duration of procedure. Event-free survival consisted in the absence of target lesion revascularization, cardiovascular death and major bleedings (following the TIMI scale) at a clinical visit performed 30 days after index procedure. We recorded all clinical events for our population as well. Due to the possible traumatisms by the big introducer used, patients of the study group underwent echo color Doppler examination of the radial artery at 1-month clinical visit.

mean±SD. All continuous variables were compared with the use of the paired t-test, and categorical variables with the use of chi-square test. Statistical significance and the effect of treatment on outcomes were estimated with the use of appropriate statistical methods for matched data. All reported P values were two-sided, and P values of less than 0.05 were considered statistically significant. SPSS Statistics software (version 14.0; SPSS Inc., Chicago, Illinois, USA) was used for statistical analyses. 3. Results Between March and November 2011, 46 consecutive patients with symptomatic iliac stenosis were treated with a PTA at our institution, 22 with a transradial and 24 with a transfemoral approach (Fig. 1). Four patients were excluded due to incomplete procedural/clinical data, thus we retrospectively enrolled 21 patients for each study group; we did not register significant differences for both clinical and angiographic data (Table 1). TASC (Transatlantic Inter-Society Consensus) classification did not differ significantly as well: we observed a mixed lesion population with 40% having class C, although we excluded TASC D lesions following current guidelines (Fig. 2). In 4 and 5 cases, respectively in the transradial and the transfemoral group, we had to electively perform a bilateral iliac stenting due to the very proximal location of the lesion; in all these cases the second approach chosen was the radial artery, thus in the transradial group we performed a bilateral radial approach. Procedural success, the primary study endpoint, was accounted in 100% of patients of the whole population (P=1.0). The 30-day event free survival, a secondary study endpoint, was comparable as well: all patients except one in each group had complete symptom relief. One patient in the radial group had persistence of symptoms, and was treated with subsequent angioplasty of both the anterior and posterior tibial arteries that resulted occluded, with good symptom improvement. One patient in the femoral group had recurrence of claudicatio; the echo color Doppler showed early elastic recoil after simple balloon angioplasty with a drug-eluting balloon during index procedure, and the patient had to be rescheduled for further revascularization. The other secondary endpoint, duration of procedure, was similar among study groups (60±32 vs 69±28, p=0.37). Interestingly, the transradial procedure was not more complex than the standard one, as reflected by various recorded parameters. To

2.4. Statistical analysis Percutaneous intervention of iliac artery is a procedure associated with high success and low complication rates. Given previous series of patients treated with the transfemoral route and literature data (where a 95%–100% rate of procedural success was obtained) [2], we expected a similar result with the transradial route with a 5% threshold (2-sided alpha value of 0.05). The two study groups were well matched for clinical and angiographic characteristics. However, because of the small dimension of dataset, we did not perform propensity score analysis. Continuous variables were expressed as

Fig. 1. Study flow chart for patient enrollment and follow up. PTA=percutaneous transluminal angioplasty.

B. Cortese et al. / Cardiovascular Revascularization Medicine 13 (2012) 331–334 Table 1 Clinical and angiographic characteristics of the study population.

Male, n (%) Age, y Diabetes mellitus, n (%) Arterial hypertension, n (%) History of smoke, n (%) Dyslipidemia (LDL cholesterol N120 mg/dl), n (%) Rutherford classification type 2, 3, % Rutherford classification type 4, 5, % Stent use, n (%) Number of stents used per intervention (all balloon-expandable), n Total vessel occlusion, n (%) Severe iliac calcification, n (%) Need of N1 percutaneous approach, n (%) Bilateral iliac stenting

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Table 2 Main results of the study.

Transradial Approach (n=21)

Transfemoral Approach (n=21)

p

11 (53) 67 4 (20) 15 (75) 8 (40) 8 (40)

11 (53) 64 5 (25) 15 (71) 7 (33) 9 (45)

1.0 0.54 0.71 1.0 0.75 0.75

64 36 19 (92) 1,0

60 40 20 (96) 1,12

0.43 0.56 0.55 0.43

5 (25) 8 (40) 4 (20)

6 (29) 10 (50) 5 (25)

0.73 0.53 0.71

4 (20)

5 (25)

0.71

PTA=percutaneous transluminal angioplasty.

note, contrast load was not significantly different (97±78 vs. 102± 65, p=0.87), and there was with a trend toward lower fluoroscopic time in the transradial group (11±6 vs. 16±8, p=0.11) (Table 2). No patient in the transradial group experienced major or minor TIMI bleedings. One patient in the transfemoral group developed an access site hematoma after 3 days with N15% hematocrit drop and requiring blood transfusions (TIMI major bleeding); another patient experienced a N10% hematocrit drop not related to the access site (TIMI minor bleeding).

Fig. 2. Lesion type distribution across study population: lesion type is according the TASC definition in our study population. Of note, there was no statistical difference in the two study groups. TASC=Transatlantic Inter-Society Consensus.

Procedural success, n (%) Fluoroscopic time, min Procedural time, min Contrast dose, ml Perforation requiring intervention, n (%) TIMI Major bleeding complications, n (%) TIMI Minor bleeding complications, n (%) Length of stay, days Right radial artery patent at 1-month, n (%) Complete symptom relief at 1 month, n (%)

Transradial Approach (n=21)

Transfemoral Approach (n=21)

p

21 (100) 11±6 60±32 97±78 0 (0)

21 (100) 16±8 69±28 102±65 0 (0)

1.0 0.11 0.37 0.87 1.0

0 (0)

1 (6)

0.32

0 (0)

1 (6)

0.32

3,1±0,6 21 (100)

3,4±1,6 NA

0.43 NA

20 (96)

20 (96)

1.0

TIMI=Thrombolysis In Myocardial Infarction classification of bleedings.

Finally, the rate of radial occlusion at 30-day Doppler follow up showed no cases of vessel occlusion. 4. Discussion With this study we showed how a transradial approach for iliac stenting is feasible with very low risk and high success rate, and its efficacy seems comparable to the standard transfemoral approach. It is noteworthy that the mean duration of intervention and fluoroscopy time in the radial group were as low as in the femoral group, reflecting how the longer path that the devices have to undertake to reach the culprit lesion is not associated with an increase in the complexity of the intervention. Particularly, the ability of the guidewire to cross the lesion, even in case of total occlusion, was not influenced by the access route; the ability to deliver a stent was not hindered as well. It is noteworthy that after 1 month all patients had a patent radial artery at the echo color Doppler control, thus the use of big hydrophilic introducers of new generation seems adequate for such vessels. In the last decade, the transradial approach to treat coronary artery disease increased at a very fast rate [3]. Several studies have shown how this approach warrants significantly lower all-types of access site bleedings [4–6], and the association between severe bleedings and death has been widely demonstrated [7]. Continuously growing experience and technological improvements, achieved also thanks to a big environment by manufacturers, have totally covered the early technical gaps with the transfemoral route, thus resulting in the chance of treating substantially all the pathologies of the coronary tree [8,9]. The peripheral application of this approach may appear somewhat difficult and naif. However, the distance from entry site is only 20– 30 cm longer than for interventions of the coronary tree, and the advantages of reducing entry site bleeding complications are even bigger if we consider that a 7 or 8 Fr introducer is often used for peripheral interventions, thus carrying an even higher risk if compared with the common 6 Fr introducer used for coronary interventions. We have to admit that the technique used in this study is possible thanks to the already described dedicated devices, and that the use of “normal” 7 or 8 Fr introducers and guiding catheters may lead to different outcomes. Other authors have previously reported of iliac interventions performed via the radial access, but a feasibility study and a comparison with the transfemoral route have not yet been reported [10–14]. A short discussion on the techniques used for transradial interventions in our study is deemed necessary. In our first series of 10 patients we used a long, hydrophilic 7 Fr introducer with straight tip

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in all of our patients (Destination, Terumo Corp., Japan) without particular technical issues both for navigating in descending aorta and for achieving an adequate support. In our last 11 patients we used a sheathless guiding catheter (Asahi Corp., Japan), whose advantages along with a similar hydrophilic coating were the length (120 cm) that allowed to arrive with the tip just proximally to the lesion, and the external size that is equivalent to the common 6 Fr introducers, but allows a bigger inner diameter (around 2.5 mm). We are aware of different techniques practiced in other centers, firstly the use of a left radial approach, that we consider uncomfortable for the operator and not particularly advantageous given the easy navigability we showed from the right. This study has some limits. First of all, the low population enrolled does not allow to draw clinical conclusions; however our aim was to demonstrate the feasibility of the transradial compared to the standard transfemoral approach, and the sample size was calculated prospectively. After these results, a safety study with a bigger and more complex population is currently ongoing in 6 Italian and two U.S. centers with high level of expertise in the transradial approach. A limit of the technique is given by the materials, especially balloons and stents, that have been developed for a transfemoral approach. To this day, very distal external iliac lesions in tall patients represent a limit of this technique due to a limited number of devices with long usable shaft (in this study a body surface area N2.0 m 2 was an exclusion criterion). Finally, a further limit is given by the experience of operators, which limit this technique only to “expert radialists”, and would not be recommended in those catheterization laboratories where this technique is not widely used. 5. Conclusions This study shows that a transradial approach is a valid alternative to the standard transfemoral one for the treatment of atherosclerotic stenosis of the iliac arteries. The technical success of this approach is high, and possible advantages in terms of bleeding reduction are expected. Acknowledgments None.

References [1] Agostoni P, Biondi-Zoccai GL, de Benedictis ML, Rigattieri S, Turri M, Anselmi M, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol 2004;44(2):349-56. [2] Ichihashi S, Higashiura W, Itoh H, Sakaguchi S, Nishimine K, Kichikawa K. Longterm outcomes for systematic primary stent placement in complex iliac artery occlusive disease classified according to Trans-Atlantic Inter-Society Consensus (TASC)-II. J Vasc Surg 2011 Apr;53(4):992-9. [3] Turner S, Sacrinty M, Manogue M, Little W, Gandhi S, Kutcher M, et al. Transitioning to the radial artery as the preferred access site for cardiac catheterization: an academic medical center experience. Catheter Cardiovasc Interv 2012;80(2):247-57. [4] Joyal D, Bertrand OF, Rinfret S, Shimony A, Eisenberg MJ. Meta-analysis of ten trials on the effectiveness of the radial versus the femoral approach in primary percutaneous coronary intervention. Am J Cardiol 2012;109(6):813-8. [5] Hamon M, Mehta S, Steg PG, Faxon D, Kerkar P, Rupprecht HJ, et al. Impact of transradial and transfemoral coronary interventions on bleeding and net adverse clinical events in acute coronary syndromes. EuroIntervention 2011 May;7(1): 91-7. [6] Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011;377(9775):1409-20. [7] Doyle BJ, Rihal CS, Gastineau DA, Holmes Jr DR. Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice. J Am Coll Cardiol 2009;53(22):2019-27. [8] Coroleu SF, Burzotta F, Fernández-Gómez C, Tommasino A, Giammarinaro M, Coluccia V, et al. Feasibility of complex coronary and peripheral interventions by trans-radial approach using large sheaths. Catheter Cardiovasc Interv 2012;79(4): 597-600. [9] Trani C, Tommasino A, Burzotta F. Pushing the limits forward: transradial superficial femoral artery stenting. Catheter Cardiovasc Interv 2010;76(7): 1065-71. [10] American College of Cardiology Foundation, American Society of Interventional & Therapeutic Neuroradiology, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, Bates ER, et al. ACCF/SCAI/SVMB/SIR/ASITN 2007 clinical expert consensus document on carotid stenting: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus Document Committee on Carotid Stenting). J Am Coll Cardiol 2007:126-70. [11] Sanghvi K, Kurian D, Coppola J. Transradial intervention of iliac and superficial femoral artery disease is feasible. J Interv Cardiol 2008;21(5):385-7. [12] Staniloae CS, Kurian DC, Coppola JT. Transradial bilateral iliac stenting. J Invasive Cardiol 2006;18(10):E256-7. [13] Staniloae CS, Korabathina R, Yu J, Kurian D, Kurian D, Coppola J. Safety and efficacy of transradial aortoiliac interventions. Catheter Cardiovasc Interv 2010;75(5): 659-62. [14] Lorenzoni R, Mazzoni A, Lazzari M, Boni A, Gemignani C, Bovenzi F. Radial artery access for above the knee angioplasty: a feasibility study. EuroIntervention 2011;7:924-9.