Application of relay puncture technique in treating patients with complicated lower extremity arterial diseases

Eligibility

A total of 21 patients (16 male and five female patients), who were within 48–81 years old (median age: 68.5 years old) and suffered from lower extremity arterial disease, were collected in our hospital between December 2014 and July 2017. The diagnosis of each patient was confirmed by ultrasonography and computed tomography angiography (CTA) before the treatment. All patients had clinical symptoms of critical chronic lower extremity ischemia. The ankle–brachial index (ABI) and Rutherford clinical classification (RCC) before and after the operation were used to evaluate the improvement of the lower extremity ischemia of each patient after the procedure. According to the TASC classification, all patients in the present study were type D, and all patients declined to have open surgery, which was probably due to fear of major trauma, advanced age, and/or their family’s wishes.

Institutional review

The experimental protocol of the present study complied with the principles outlined in the Declaration of Helsinki, and was approved by the Ethics Committee of our institution. All subjects provided a signed informed consent.

Procedures of the relay puncture technique

The patient was placed in the supine position and hypodermically administered with heparin (5,000 units) after a 5-French sheath (Terumo, Tokyo, Japan or Cook, Bloomington, IN, USA) was inserted through the left brachial artery, followed by repeated heparin administration in prolonged procedures. After endovascular treatment of the iliac, femoral, or popliteal artery, the 5F sheath was changed to a 6F sheath, which is a 90-cm-long armored introducer sheath (COOK, Bloomington, IN, USA), in order to achieve adequate support and strengthen the control of the catheter. Then, a 0.035-inch J-type guidewire (Terumo, Tokyo, Japan) or 0.018-inch guidewire (V18; Boston Scientific, Marlborough, MA, USA) supported by a 5F vertebral artery angiography catheter (Cordis, Johnson & Johnson, New Brunswick, NJ, USA) was navigated in the proximal common femoral artery (CFA).

In the present study, the relay puncture technique was used on the ipsilateral femoral artery in the following situations: the contralateral femoral artery could not be punctured (the stents were implanted in the entire contralateral femoral artery in seven patients); the stents were implanted into the aortic artery in the iliac lesion (four patients); there was abdominal aortic aneurysm after the endovascular repair (five patients), which made it difficult for the devices to cross over the bifurcation; the amputation of the contralateral leg did not allow the on-site puncture of the femoral artery (five patients). These five patients only required the recanalization of the contralateral lower extremity artery due to cost problems, and the length of the devices was too short to treat the distal end of the femoral artery and popliteal artery through the brachial artery approach. The lesions in all these patients involved the area of the upper inguinal, through which an antegrade femoral puncture could not be successfully performed.

The detailed procedures of the puncture technique are described, as follows. After the recanalization of the proximal part of the femoral artery, the wire was left in place as a marker. Then, an antegrade puncture was performed at the groin under fluoroscopic guidance, and a 5F 10-cm sheath was inserted. Then, another J-type 0.035-inch guide wire or V18 was used to cross the femoropopliteal lesion, including the tibial disease, followed by a six to eight mm diameter classical percutaneous transluminal angioplasty (PTA) balloon (Inpact, Medtronic, Minneapolis, MN, USA) in the iliofemoral segment, a five to six mm diameter balloon in the femoropopliteal, and a two to three mm diameter balloon in arteries below the knee, and stenting. The balloon inflation times varied within 60–300 s at nominal pressure. Subintimal angioplasty was also used, and subintimal arterial flossing with the antegrade-retrograde intervention (SAFARI) technique was used for reentry. Immediately after the vascularization procedure, the sheath was removed from the femoral artery, and a 6-French vascular closer (Exoseal, Cordis; Johnson & Johnson, New Brunswick, NJ, USA) was used to stop the bleeding of the puncture site. The median compression time was 5 min (range: 3–10 min). The angioplasty inside the punctured site with a six-mm balloon was helpful in stopping the bleeding after the sheath was removed (6/16). Finally, PTA and percutaneous transluminal stenting were performed on the proximal part of the femoral artery and iliac artery through the left brachial artery approach without any open surgery. After the completion of all these procedures, the sheath in the left brachial artery was withdrawn. All the above-mentioned endovascular procedures were performed by experienced interventional radiologists in our center.

Endpoints and follow up

The primary endpoint was the efficacy of the relay puncture technique, as indicated by the acute technical success and post-procedure clinical improvement of critical limb ischemia symptoms. The secondary endpoint was the safety of this technique, as indicated by the number or severity of complications associated with this procedure.

Color Doppler ultrasonography and/or CT angiography were performed at 1, 3, 6, and 12 months, and annually, or when symptoms recurred after discharge. Antiplatelet therapy was administered during the whole life of each patient after treatment to prevent restenosis.

Statistical analysis

Data were presented as mean ± standard deviation. All statistical analyses were performed using SPSS software version 22.0 for PC (SPSS Inc., Chicago, IL, USA). Least significant difference t-test was used to compare the ABI before and after treatment. A P-value < 0.05 was considered statistically significant.

Short term outcomes

A total of 21 patients (16 male and five female patients; median age: 70 years old), who suffered from lower extremity arterial diseases from December 2014 to July 2017, were retrospectively collected. All patients were diagnosed with lower extremity arterial disease before treatment. Preoperative CTA clearly revealed the occlusive lesions of the lower extremity arteries (Figs. 1 and 2). For all these patients, the contralateral femoral artery was not available for puncture access, and the length of the devices was too short for the brachial artery approach. Among these patients, seven patients had cover stents on the entire contralateral femoral artery, four patients had kissing stents in the aortoiliac lesion, five patients experienced endovascular repair of abdominal aortic aneurysm, and five patients underwent amputation of the contralateral leg due to ischemia. After a detailed preoperative discussion and project design, all patients underwent the relay puncture procedure, and technical success was achieved in all occlusive arteries (Figs. 3 and 4). Furthermore, no complication occurred during the treatment. A total of 87 stents (median: 3) were implanted in 21 patients. Perioperative complications included hematoma (one patient) at the brachial artery puncture site and heart failure (one patient) before discharge. These two patients were successfully treated and discharged after treatment. Moreover, the postoperative ABI significantly increased (0.33 ± 0.18 vs. 0.75 ± 0.21, P < 0.05). Correspondingly, the ischemia symptoms were immediately alleviated after the treatment, as evaluated by RCC (Table 1).

Long-term outcomes

All patients were followed up for 4–28 months (mean: 16.6 months). During the follow-up period, no serious complications were observed. Color Doppler ultrasonography revealed that the 1-year primary patency rate was 71.43% (15/21). The changes in ABI of these patients during the follow up period are summarized in Table 1.

Relay puncture technique

Patients in the present study did not have access on the contralateral femoral artery due to different reasons. The hybrid operation, which is a combined endovascular and surgical technique, was used as an alternative to laparotomy to correct inflow lesions in patients with multilevel arterial diseases (Madera et al., 1997), and this has achieved appreciable patency rates and technical success rates (Mousa et al., 2010). However, the hybrid surgery exhibited several disadvantages, including the requirement of highly skilled surgeons (there are limited numbers of vascular surgeons), the need for an operating room (the cost of a hybrid operating room is high and cannot be sufficiently provided), and the potentially increased risk of complications and longer recovery period (including the risk correlated to further anesthesia) (Kaneko & Davidson, 2014). For example, one recent meta-analysis that compared the outcomes of the endovascular and open bypass treatment for TASC C–D aortoiliac occlusive disease reported more complications and greater 30-day mortality with open bypass (Tsai et al., 2015).

In the present study, the relay puncture technique, which is a new puncture method with different approaches, was proposed to handle these complex vascular lesions. The word “relay” was used in this technique, because the antegrade puncture on the femoral artery after the brachial artery puncture was just like a relay race. This technique has been applied in 21 patients, and the short- and long-term outcomes appeared to be satisfactory, as evidenced by the findings that the technical success rate was 100%, and that the primary long-term patency was 71.43%, which were similar to those previously reported in studies on patients after endovascular treatment (Klein & Ross, 2016).

For patients in the present study, there was no puncture site available on the lower extremity arteries. Thus, the investigators opted to puncture the left brachial artery first. However, all endovascular devices failed to reach the lesions at the distal part of the femoral and popliteal artery. The SAFARI technique should be able to establish a guidewire line through the whole lesion. However, the size of both the stent delivery catheter and balloon catheter were too big to be pulled into the arteries below the knee. This was the same with the atherectomy catheter and drug-coated balloon. Therefore, the SAFARI technique could not solve the problem of these patients in the present study, who had long lesions that involved the popliteal artery, or even those below the knee. Directly puncturing the stents on the contralateral femoral artery should have been a solution. However, that technology is not mature yet, and few studies have reported good long-term outcomes (Jongkind et al., 2010). Hence, directly puncturing the contralateral femoral artery appeared as the only option (Palena & Manzi, 2013). Another approach that might solve the above-mentioned issue for these patients was to insert a large sheath with a drug-coated balloon or debulking devices through the stent. This approach may damage the stent structure, subsequently accelerating the occurrence of stent rupture and/or restenosis within the stent. In addition, this technique cannot be used for patients with cover stents. Furthermore, in some cases, stents were implanted into the aortic artery in some aorticiliac lesions, and it was difficult for the devices to cross over the iliac branches. Most importantly, all patients in the present study had lesions that involved the area of the upper inguinal, which could not be directly antegrade punctured through the femoral artery. Based on the above-mentioned analysis, the investigators decided to use the new relay puncture technique.

Application of puncture closure devices

Endovascular treatment has been shown to be associated with several complications. For instance, the incidence of hematoma can reach up to 6% for patients undergoing brachial puncture (Alvarez-Tostado et al., 2009), and the incidence of complications following the antegrade puncture of SFA can reach up to 9% (Mlekusch et al., 2008). However, the use of closure devices exhibited a significant tendency to decrease these complications (Gutzeit et al., 2014). Consistent with these reports, in the present study, the median compression time was only 5 min (3–10 min), even in the presence of heparin, which was shorter than the traditional compression time for hemostasis. Furthermore, using the Exoseal device to close the antegrade puncture hole on the femoral artery, endovascular therapy could be quickly continued without bleeding in the present study. A variety of arterial closure devices have been introduced with the aim of reducing bleeding risk. However, all were indicated for femoral use only (Hon et al., 2009). In the present study, Exoseal was used for brachial artery puncture site closure, which is a safe technique with an acceptable rate of complications (6%). Thus, no clinical intervention was required.