Author + information
- Received December 11, 2017
- Revision received February 26, 2018
- Accepted March 20, 2018
- Published online June 4, 2018.
- Zoltán Ruzsa, MD, PhDa,b,∗ (, )
- Robert Bellavics, MDb,
- Balázs Nemes, MD, PhDa,
- Artúr Hüttl, MDa,
- András Nyerges, MDa,
- Péter Sótonyi, MD, PhDa,
- Olivier Francois Bertrand, MD, PhDc,
- Kálmán Hüttl, MD, PhDa and
- Béla Merkely, MD, DsCa
- aSemmelweis University of Budapest, Heart and Vascular Center, Budapest, Hungary
- bBács-Kiskun County Hospital, Cardiology Division, Invasive Cardiology, Kecskemét, Hungary
- cQuebec Heart-Lung Institute, Laval University, Quebec City, Quebec, Canada
- ↵∗Address for correspondence:
Dr. Zoltán Ruzsa, Semmelweis University Heart and Vascular Center, 1122 Városmajor Street 68, Budapest, Hungary.
Objectives The purpose of this prospective study was to evaluate the acute success and complication rates of combined transradial and transpedal access for femoral artery intervention.
Background Improved equipment and techniques have resulted in transition from transfemoral to transradial access for intervention of superficial femoral artery.
Methods Between 2014 and 2016, clinical and angiographic data from 145 consecutive patients with symptomatic superficial femoral stenosis, treated via primary radial access using the 6-F SheathLess Eaucath PV guiding catheter were evaluated in a pilot study. Secondary access was achieved through the pedal or popliteal artery. The primary endpoints were major adverse events, target lesion revascularization, and rates of major and minor access-site complications. Secondary endpoints included angiographic outcome, procedural factors, crossover rate to femoral access site, and duration of hospitalization.
Results Technical success was achieved in 138 patients (95.2%). Combined radial and pedal access was obtained in 22 patients (15.1%). The crossover rate to a femoral access site was 2%. Stent implantation was necessary in 23.4% of patients. Chronic total occlusion recanalization was performed in 63 patients, with a 90.4% technical success rate. The mean contrast consumption, radiation dose, and procedure time were 112.9 ml (101.8 to 123.9 ml), 21.84 Gy/cm2 (9.95 to 33.72 Gy/cm2), and 34.9 min (31.02 to 38.77 min), respectively. The cumulative rate of access-site complications was 4.8% (0% major, 4.8% minor). The cumulative incidence rates of major adverse events at 3 and 12 months follow-up was 8.3% and 19.2%. The cumulative incidence rates of death at 3- and 12-month follow-up were 2.8% and 5.6%.
Conclusions Femoral artery intervention can be safely and effectively performed using radial and pedal access with acceptable morbidity and a high technical success rate.
The radial artery (RA) is the preferred access site for percutaneous coronary interventions. It is also gaining popularity for peripheral interventions (1–3) because of patient comfort and the higher risk for vascular complications when using femoral and brachial artery access (4,5). For percutaneous superficial femoral artery (SFA) intervention, the common anatomic limitations of the arteries in the upper extremity are the narrower access lumen and the distance between the puncture site and target lesion, while the main advantage is that atherosclerotic involvement is rare. The SheathLess Eaucath PV (Asahi Intecc, Tokyo, Japan) is a new hydrophilic sheathless guide (SG) catheter system available in 6-F size and 120-cm length, which does not require the use of an introducer sheath. The internal luminal size of the system is similar to or even larger than ordinary catheters, despite its smaller external diameter, which makes it more effective for SFA intervention without increasing the risk for RA complications (3,6,7). Another alternative to femoral access is the transpedal (TP) approach, but this access site has many limitations in everyday clinical practice and is therefore used mostly when the anterograde SFA intervention has failed (6–8). The purpose of our prospective pilot study was to evaluate the acute success and complication rates of transradial (TR) and transulnar access in combination with TP access for femoral artery percutaneous transluminal angioplasty (PTA), using SG catheters.
Clinical and angiographic data from 145 consecutive patients with symptomatic SFA stenosis were evaluated in a prospective pilot study. Between 2014 and 2016, the patients were treated using RA and ulnar artery (UA) access and 6-F peripheral SG catheters. We analyzed the impact of right- and left-hand access selection. The impact of the learning curve was analyzed after 50 TR cases. Our institutional review committee approved the study, and all patients provided written informed consent prior to study inclusion.
We included patients with significant SFA stenosis and intermittent claudication (Fontaine IIa, IIb, III, or IV) or critical limb ischemia (CLI) (crural ulcer, pedal gangrene, ischemic rest pain) with proven limb viability.
Patients with negative results on Allen tests or nonpalpable RA or UA were not included. The left-hand approach was used when the right RA was occluded but the left RA was patent. We also excluded patients in whom the 125-cm diagnostic catheter did not reach the common iliac artery from the right radial access site.
Duplex ultrasound protocol
Routine duplex ultrasound was used for RA access when the RA was weak by palpation or when distal TP access has been used. In these patients, the RA and UA diameters were measured at the wrist level. On the first post-operative day, the patency of the RA was evaluated when the RA was not palpable. The TP access site was investigated in all cases by vascular ultrasound.
Two skilled operators (Z.R. and B.N.) trained in bilateral TR access and SFA intervention performed all cases. The preferred access site was the right RA. The alternative access site was the right UA, which was used when Doppler ultrasound showed the RA to be smaller than 1.5 mm. Contralateral access was used in cases of right RA occlusion.
After a loading dose of 325 mg aspirin and 300 mg clopidogrel, patients who underwent stenting received dual-antiplatelet therapy (aspirin 100 mg and clopidogrel 75 mg) for 2 months. Patients who underwent only balloon angioplasty (PTA) were treated with lifelong aspirin.
In addition, 2.5 mg verapamil, 5,000 IU heparin sodium, and 250 μg nitroglycerin were administered directly to the RA through the sheath. Additional heparin sodium was given until reaching 100 IU/kg. Routine activated clotting time was not measured during the intervention.
The TR PTA technique is described in Figure 1.
After local anesthesia, the RA and UA were punctured with a dedicated TR needle and sheath (5-F, Terumo, Tokyo, Japan). Advancement of the guidewire (GW) in the descending aorta was performed by using a pigtail catheter and J-tip GW in a left lateral 40° view. In the case of a complex aortic arch, the loop technique with the pigtail catheter or Simmons catheter was used.
The aortofemoral anatomy was identified in an anterior-posterior view with aortography, using a 5-F, 125-cm pigtail catheter, which also proved helpful in estimating the distance between the puncture site and the lesion.
The diagnostic catheter and introducer sheath were exchanged for a dedicated TR SG system (6.5-F, 90 cm, or 6-F, 120 cm; Asahi Intecc) over a 260-cm 0.035-inch GW (Starter or JINDO, Amplatz). A short hemostasis valve (Terumo) was used to decrease the length of the delivery system. After angiography, the common femoral artery was selectively cannulated with a 125-cm MP diagnostic catheter (telescopic method), and the GW was advanced through the lesion (Figure 2A).
The procedure was performed under road map imaging (Figure 2B). A balloon with a 180-cm shaft (Pacific Extreme, Medtronic, Minneapolis, Minnesota) was used for PTA. Stent implantation was done only in cases of flow-limiting dissection and significant recoil. For the primary radial approach, self-expandable stents with a 180-cm shaft (Sinus Superflex, OptiMed, Ettlingen, Germany) were used (Figure 3). In very complex or calcified cases, stenting was performed from the TP approach with Supera (Abbott Vascular, Santa Clara, California) or Zilver PTX (Cook Medical, Bloomington, Indiana) stent (Figure 4). All self-expandable stents were post-dilated.
After the procedure, the sheath was immediately removed, and hemostasis was achieved by applying the Terumo Band dedicated compression device (Terumo) to the radial access site for 6 h. The TP sheath was removed before the radial sheath, and the patency of the pedal puncture site was checked with TR angiography. A Terumo compression device was used for 2 h at the puncture site after 2-min manual compression. The patency of the pedal artery was always checked by vascular ultrasound below the TR band, and the pressure was always released until the flow was visible (Figure 4G). All patients were immediately mobilized after the procedure.
Quantitative angiography and measurements were performed according to standard clinical practice. The vessels and lesions were analyzed using a computerized quantification system (Innova 3100, GE Medical Systems, Milwaukee, Wisconsin).
After the procedure, all patients underwent a physical examination. All patients were scheduled for a detailed clinical follow-up examination both 3 and 12 months after the procedure. Furthermore, patients with CLI and nonhealing wounds returned for the treatment of outflow disease.
Our primary endpoints were technical success, major adverse events (MAE), and the access-site complication rate. The secondary endpoints were angiographic outcomes of the femoral artery interventions, angioplasty equipment consumption, fluoroscopy time and radiation dose, procedural time, crossover rate to another puncture site, and hospitalization duration (in days).
MAE were assessed as the composite of death, stroke, myocardial infarction, major amputation, and repeated revascularization of the target vessel by PTA or surgery during the hospital stay and at the 6-month follow-up.
Major vascular complications were defined as diminished or lost arterial pulse or the presence of any pseudoaneurysm or arteriovenous fistula during the clinical follow-up. Minor complications were defined as hematomas requiring no further treatment, measuring 2 cm in diameter over the radial or ulnar puncture area or measuring 5 cm in diameter over the femoral puncture site. Major bleeding was defined as a drop in hemoglobin level of >3 g/dl, as well as any bleeding requiring blood transfusions.
Technical success was defined as PTA resulting in <50% residual stenosis with sufficient anterograde flow; an optimal result was characterized by residual stenosis <30% and fast flow, while a suboptimal result was characterized by sluggish flow and/or a residual stenosis between 30% and 50% after repeated dilatation.
Primary clinical success was defined as an improvement of at least 1 clinical category in the Rutherford-Becker classification (9).
Limb salvage was defined as the prevention of major amputation. Any amputation at or distal from the transmetatarsal level was classified as being minor, while any amputation above that level was considered to be major.
Statistical analysis was performed using GraphPad Prism version 7.0 (GraphPad Software, La Jolla, California). Continuous variables are expressed as mean ± SD or as median (interquartile range). Categorical variables were tabulated as percentages. The different patient cohorts were compared using either the Mann- Whitney U test or the Kruskal-Wallis test. Values of p < 0.05 were considered to indicate statistical significance.
PTA was performed in 145 patients with angiographically significant SFA stenosis, using RA (n = 142 [97.9%]) or UA (n = 3 [2.1%]) access. Crossover to femoral access was needed in 3 patients (2.1%). The indication for the intervention was intermittent claudication in 58 patients (40%), CLI in 85 patients (58.6%), and acute limb ischemia in 2 patients (1.4%). Demographic and clinical data are summarized in Table 1.
Procedural data are summarized in Tables 2 and 3⇓⇓. Technical success was achieved in 138 patients (133 patients [91.7%] with optimal and 5 patients [3.4%] with suboptimal results). Balloon angioplasty was performed in all patients, and stent implantation was done in 34 patients (23.4%).
Stent implantation was performed from the anterograde route in 21 patients (61.8%) and from the retrograde route in 13 patients (38.2%). Clinical success was achieved in 130 patients (89.6%). Additional inflow (iliac) and outflow (below-the-knee) interventions were done in the same setting in 4 (2.7%) and 3 (2.1%) patients. Additional femoropopliteal and below-the-knee interventions were performed in 16 patients in Fontaine stage IV. At 6 months, limb salvage was achieved in 137 patients (94.5%). Major amputation was necessary at 6 months in 11 of 85 patients with CLI and in no patients with intermittent claudication (12.9% and 0%). The indication of the intervention was to minimalize the level amputation in 8 patients with CLI (9.4%). Chronic total occlusion recanalization was performed in 63 patients, with a 90.4% technical success rate (4 unsuccessful and 2 with suboptimal results), but dual arterial access was necessary in 16 patients because of unsuccessful reentry (25.4%). The crossover rate of femoral access was 2% (1 failed puncture, 2 additional below-the-knee procedures) in patients with CLI. There were no significant differences in the fluoroscopy time, radiation dose, procedure time, and contrast consumption, whether right- or left-hand access was chosen (Table 4). To analyze the effect of the learning curve, we compared the procedural data obtained in the first 50 patients with the remaining patients. We did not find any significant differences in the procedure times, fluoroscopy times, radiation dose, or contrast consumption despite the higher number of complex cases after the first 50 patients. The crossover rate was significantly lower in the last 95 patients (n = 3 [8%] vs. n = 0 [0%]; p = 0.04) (Table 5).
Perioperative complications are summarized in Table 6. Major procedural complications were detected in 8 patients (5.5%) (1 distal embolization successfully treated with manual thrombus aspiration and 7 edge dissections successfully treated with additional stenting). RA access-site complications were encountered in 7 patients (4.8%) (6 asymptomatic RA occlusions and 1 forearm hematoma successfully treated with forearm bandage). The cumulative incidence rates of MAE at 3- and 12-month follow-up were 8.3% and 19.2%, respectively (Figure 5A). The cumulative incidence rates of death at 3- and 12-month follow-up was 2.8% and 5.6% (Figure 5B).
Our study is the largest study describing the feasibility and safety of using TR and TP access for treating SFA disease in a large cohort of consecutive patients using SG catheters. In this prospective, consecutive series of patients, we demonstrate several important findings: 1) the conversion rate to femoral access is low; 2) successful intervention using TR and TP access is feasible; 3) major radial access-site complications are rare, but minor complications are frequent; and 4) procedural pedal artery access-site complications are very low despite the use of 6-F TR sheaths.
Anterograde TF access is the traditionally used approach for SFA PTA because the puncture is straightforward, and the access method provides good backup support for the intervention and allows the use of large femoral sheaths (6- to 8-F). However, when the anterograde puncture is difficult or impossible, a crossover to the contralateral access becomes mandatory, which is not always possible in case of calcified, tortuous, or angled iliac arteries.
Brachial artery access could provide an alternative puncture site for SFA PTA; however, it is associated with a higher risk for vascular and nerve complications (5). Despite the high rate of vascular access complications, many operators use this access site because of easy puncture, easy access to the iliac vessels, and because nearly all currently available devices can reach the target from brachial artery access (10).
TP access as a primary access site for SFA PTA was assessed by Kwan et al. (6). The investigators treated 80 patients with 99% puncture and 64% procedural success rates; the access-site complication rate was 0%, with 8% femoral crossover. Tibial artery occlusion was 1.96% in a publication published by our group (7); however, the tibial occlusion was treated successfully from the anterograde femoral approach. In our recent study, the pedal artery complication rate was 0% despite liberal use of 6-F sheaths and devices.
TR access has been used as an alternative access site for SFA PTA in some case reports and pilot studies (9,11,12). The main advantage of RA access is the low rate of bleeding complications, improved patient comfort because of its fast mobilization, and decreased procedure costs (1–3). Despite these excellent results, the TR method has not gained widespread acceptance, because of its technical and anatomic limitations. In the past, the main technical reason for the infrequent use of TR access for SFA intervention was the short delivery shafts of the first-generation catheters and the lack of dedicated hydrophilic interventional sheaths. However, with recent advances in technology, there are dedicated balloons (Pacific Extreme and Pacific Plus [Medtronic] and Dilexx-18 [Optimed]) and stents (SuperFlex Stent, Optimed) available for SFA intervention with a length of 180 cm (Table 6).
Another important technical improvement was the development of the hydrophilic, flexible, kink-resistant long sheaths and SGs. In contemporary peripheral interventional practice, the use of TR access for SFA intervention has become much more feasible. Note that some anatomic limitations still remain for the RA. The artery is more difficult to puncture, and it is more prone to spasm, and sometimes the passage of the sheath in the tortuous and calcified subclavian artery and type II or III aortic arch can be difficult. It is also important to consider the previously reported complications (e.g., spasm, RA occlusion, perforation, brachial artery dissection, and pseudoaneurysm formation) (13–15). In our study group, RA and UA occlusion occurred in only 7 patients (4.8%), despite the use of large-bore SG catheters, and all patients remained asymptomatic. The hydrophilic coating and the distal conical tip of the SG catheter may have played important roles in the avoidance of symptomatic RA spasm in our study. UA access studies have not been previously published for femoral PTA, but it proved to be safe for iliac artery interventions using ultrasound guidance, when the RA is small or not palpable (3).
Combined TR and TP access was studied by Hanna and Prout (15). The investigators treated 15 patients using the hybrid technique (left radial and TP); 7 patients needed retrograde TP access because of anterograde failure (46.6%). In our patient population, dual access was necessary in only 15.1%. The main advantage of dual access is the high rate of technical success, especially in CTO recanalization, and the opportunity to use dedicated devices (atherectomy device, drug-eluting balloon, stent, and stent with high radial force (Supera), which are not yet available with a long shaft (180 cm) (Table 6). In our study group, a drug-eluting balloon was successfully used in 1 patient (0.6%), drug-eluting stents in 3 patients (2.1%), and the Supera in 5 patients (3.4%) from TP approach. The rate of distal access-site complication was 0% in the study group.
Puncturing and traversing the RA are the same as in coronary procedures, and it is important for the operator to be aware of RA anomalies, particularly the loops, to avoid complications. Catheter advancement in the descending aorta is sometimes difficult, particularly from the right RA, but by advancing a pigtail catheter oriented in the posterior position of the aortic arch, or using a Simmons 1 diagnostic catheter, a hydrophilic GW can easily be placed in the descending aorta. Knowing the compatibility of the devices is a crucial factor in achieving good angiographic results using the radial approach (Table 6).
The primary limitation of the study is the lack of direct comparison with the femoral approach; furthermore, a separate randomized analysis of left and right radial access would be worthwhile in future studies.
Femoral artery angioplasty can be safely and effectively performed through RA and UA access using SG systems with acceptable complication and high technical success rates.
WHAT IS KNOWN? TR access can be applied to noncomplex femoral artery interventions.
WHAT IS NEW? TR access can be applied to complex femoral artery interventions, and the overall procedural success rate is 95.2%. TP access can be the second access site for complex chronic total occlusion recanalizations using the dual access technique, outflow tract interventions, and for using special devices such as drug-eluting balloons and stents.
WHAT IS NEXT? The next step is to compare TR access with the gold standard, transfemoral access, in a prospective randomized study for femoral artery interventions.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- critical limb ischemia
- major adverse event(s)
- percutaneous transluminal angioplasty
- radial artery
- superficial femoral artery
- sheathless guide
- ulnar artery
- Received December 11, 2017.
- Revision received February 26, 2018.
- Accepted March 20, 2018.
- 2018 The Authors
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