Abstract
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.
1
Introduction
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 . 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
Methods
2.1
Study population and enrollment criteria
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 > 2.0 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 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 < 30% 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.
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) , 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 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.
2
Methods
2.1
Study population and enrollment criteria
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 > 2.0 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 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 < 30% 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.
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) , 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 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.
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