Long-Term Follow-up After Retrograde Recanalization of Superficial Femoral Artery Chronic Total Occlusion

Abstract: Objectives. The aim of this study was to assess the safety of the retrograde procedure with long-term follow-up of 86 patients after retrograde recanalization of the superficial femoral artery (SFA). Background. Chronic total occlusion (CTO) of SFAs occurs in >50% of the patient population with peripheral artery disease. The retrograde technique is an option for patients with unsuccessful antegrade percutaneous interventions, but data from long-term follow-up after retrograde recanalization are still limited. Methods. The study included 86 patients (67% males), who underwent percutaneous retrograde recanalization. Major adverse cardiovascular or cerebrovascular events and major adverse peripheral events were assessed from long-term (47.5 ± 40 months) follow-up data. Results. Mean patient age was 64 ± 9 years. Retrograde puncture was successful in all cases. Procedural success rate was 93%. In-hospital observation showed vascular perforation/bleeding in 4.7%, proximal hematoma in 9.3%, distal hematoma in 4.7%, pseudoaneurysm in 1.2%, thrombosis in 1.2%, puncture-site bleeding in 3.5%, and local inflammation in 1.2%. Mortality rate was 6.98%. Target-vessel reintervention was needed in 20.9% of cases, and percutaneous transluminal angioplasty of another artery was done in 27% of cases. Amputation rate was 4.7%. Conclusions. Long-term follow-up shows that retrograde recanalization is connected with a high rate of technical success and low percentage of reinterventions. Retrograde technique is safe and related to low complication rates; most complications were localized in nature.  

J INVASIVE CARDIOL 2017;29(10):336-339. 

Key words: peripheral artery disease, superficial femoral artery, chronic total occlusion, retrograde recanalization

The prevalence of peripheral artery disease (PAD) increases with age.¹ Chronic total occlusion (CTO) of superficial femoral artery (SFA) occurs in >50% of patients presenting with PAD.² Artery occlusion is more common than artery stenosis in SFA localization. Moreover, occlusion length is usually challenging for endovascular procedures.³ Percutaneous transluminal interventions are respected methods for PAD treatment. There are a number of techniques that can be used for endovascular procedures. In patients with CTO lesions, an endovascular strategy can be an alternative for surgical bypass. However, the antegrade approach is unsuccessful in about 20%-25% of cases.^4,5 The retrograde technique might be an effective option for patients with unsuccessful antegrade percutaneous intervention. The data on retrograde recanalization procedures and especially on long-term follow-up are still limited. 

The aim of this study was to assess the safety of retrograde recanalization procedures and clinical outcomes during long-term follow-up.

Methods

Our study was conducted as a two-center, retrospective registry of consecutive patients scheduled for retrograde recanalization of a CTO of the SFA or popliteal artery (PA) after antegrade approach failure. Antegrade failure was defined as inability to cross the proximal part of the lesion. Patients were screened prior to the procedure for cardiovascular risk factors and were evaluated according to the Rutherford/Fontaine scales. The ankle-brachial index (ABI) was examined. Patients were scheduled for retrograde recanalization based upon clinical indication combined with angiography. Retrograde approach was defined as a procedure performed from an access site located distal to the SFA occlusion.

In-hospital observations included assessment of periprocedural complications, such as hematomas, bleeding, vessel perforation, pseudoaneurysms, damage of neurovascular bundle, and arteriovenous fistulas, as well as serious cardiac and peripheral events like death, acute coronary syndromes, stroke/transient ischemic attack (TIA), amputation, urgent target-lesion reintervention, and urgent percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG) surgery. At long-term follow-up, patients were evaluated for late presentation of neurovascular bundle damage, major adverse cardiac and cerebrovascular event (MACCE), and major adverse peripheral event (MAPE). MACCE was defined as occurrence of death, stroke/TIA, myocardial infarction, or emergency PCI/CABG. MAPE was defined as amputation, target-lesion reintervention, target-vessel reintervention, or surgical treatment. All bleeding complications were classified according to the Bleeding Academic Research Consortium (BARC) criteria. 

Results are presented as number of patients (percentage), mean value ± standard deviation), or median with interquartile range (IQR) where applicable.

Results

Patient population. Eighty-six patients with symptomatic PAD who were scheduled for retrograde recanalization were enrolled. Patients suffered from many comorbidities and were considered at high risk for cardiovascular events. In total, 58 (67.5%) were men and average age was 65 ± 4.2 years. Forty-five patients (52%) presented with coronary artery disease, 75 patients (87%) had hypertension, and 52 patients (60.5%) had hyperlipidemia. All patients underwent unsuccessful antegrade procedure (Table 1).

Invasive treatment and pharmacological treatment. Coagulation parameters (activated partial thromboplastin time, prothrombin time), blood count, and renal parameters were assessed before the index procedure. Angiography of lower-limb vessels was done prior to the index procedure in all cases. The patients remained in the supine position during the entire procedure. The retrograde procedure usually required proximal and distal approaches. The most common access site was femoral contralateral artery for proximal puncture and PA/SFA for distal puncture (12-15 cm, 21 G needle). Retrograde puncture was successful in all cases. Access-site punctures were performed with leg supination under fluoroscopic control in 28% and ultrasound in 72%. Proximal puncture was performed in the femoral artery in 72 patients (83.7%), brachial in 5 patients (5.8%), and in some cases other arteries, mostly with 6-7 Fr vascular sheaths. In the majority of cases with severe calcification, the puncture was facilitated by calcium. The distal puncture site was usually chosen in the reconnection area of the artery. Distal access site was located in the PA/SFA (at about 5-7 cm above the knee joint, medially) in 31 patients (36%), while tibial artery access in 15 patients (17%) (Figure 1) was performed during contrast injections from the antegrade site. Patients required a single puncture in 2 cases; in another 2 patients, 4 Fr vascular sheaths in the retrograde puncture site were needed to obtain proper support during the procedure. 

CTO lesions were located mostly in the SFA (Figure 2). A hydrophilic, stiff, J-shaped 0.035˝ guidewire (Terumo Corporation) was inserted through antegrade approach. All occlusions were crossed with retrograde approach using a soft V18, non-hydrophilic 0.018˝ guidewire (Boston Scientific). Procedure duration was 76.7 ± 40.6 min and mean contrast volume was 232 ± 115 mL. Anticoagulation was achieved by unfractionated heparin administration (bivalirudin was used in 1 case) with periprocedural activated clotting time monitoring. After using 2.5-4.0 cm balloon catheters for predilation, stents were implanted from the antegrade approach in 51 patients (mean diameter, 6 mm; mean length, 106 mm). Then, postdilation at high pressure up to 16 atm with 5-6 cm balloon catheters (Biotronik) was performed. After removal of distal balloon or sheath, cuff pressure manometer was used to maintain hemostasis at the distal puncture site. Antegrade vascular sheaths were left in the artery up to 4 hours after the procedure and then removed. Hemostasis was then achieved by manual compression.

Percutaneous retrograde recanalization was considered successful (<30% of residual stenosis and good flow) in 80 patients (93%).

At discharge, dual-antiplatelet therapy with aspirin 75 mg and clopidogrel 75 mg for the next 3 months and maximum tolerated dose of statin were administered. Low-molecular-weight heparin was administered for 4 weeks. Additional pharmacological therapy focused on eliminating adjustable cardiovascular risk factors and treatment of comorbidities.

Clinical observation. Median hospitalization time was 4 days (IQR, 3-5 days), while median procedure to discharge time was 2 days (IQR, 2-4 days). In-hospital observation showed the following puncture-site complications: 4 vascular perforations/bleeds (4.7%); 8 proximal hematomas (9.3%); 4 distal hematomas (4.7%); 1 pseudoaneurysm (1.2%); 1 thrombosis (1.2%), 3 puncture-site bleeds (3.5%); and 1 local inflammation (1.2%). All bleeding complications were classified as type 1 according to BARC criteria. No arteriovenous fistula or neurovascular bundle damage was observed. None of these complications were related to clinically significant hemoglobin drop or need for packed red blood cell transfusion. 

All-cause mortality rate for long-term follow-up at 47.5 ± 40 months was 6.98%. Acute coronary syndromes occurred in 3 patients (3.5%). Target-vessel reintervention was needed in 17 patients (20.9%), and PTA intervention of another artery was done in 24 patients (27%). There were 4 extremity amputations (4.7%).

Discussion

Our study demonstrated that retrograde approach for the revascularization of SFA-CTOs was safe and effective, and was associated with a low risk of complications at short-term and long-term follow-up exam. 

SFA-CTO prevalence reaches around 50% in symptomatic patients with PAD.² A great majority of patients can be successfully treated with antegrade approach.⁴ However, treatment of SFA-CTO is challenging due to plaque morphology.^6-8 SFA-CTO lesions are more common than stenotic lesions.³ The development of strategies and equipment has made endovascular treatment safe and effective for patients with PAD. According to the BASIL trial, there were no significant differences in amputation-free survival and health-related quality of life between bypass surgery and angioplasty treatment of infrainguinal disease.¹ However, the cumulative hospital cost of treatment is one-third lower with the angioplasty strategy.¹ Among endovascular treatment, the standard technique in long CTO recanalization is an antegrade approach.⁹ According to Montero’s report, the failure rate of antegrade recanalization can reach up to 20% in CTO lesions.⁵ Difficulty in forcing the occlusion relates to morphology of the plaque; CTOs are harder and more fibrous in the proximal cap, with diffuse calcification.^6-8 In case of antegrade access failure, especially in high-risk patients who are not suitable candidates for surgical treatment, the retrograde technique may be considered a valuable treatment option.^10-12 Retrograde puncture is performed in supine position, with moderate knee flexion. Modification of the patient’s position reduces the risk of bleeding and periprocedural complications.^6,13-14 For retrograde puncture, there are few arteries that can be chosen: the distal segment of the SFA, PA, tibial artery, and transpedal artery. The procedure is performed under fluoroscopy or ultrasound guidance to avoid additional bleeding complications and damage of the punctured artery.⁹ The most typical perioperative complications are related to local bleeding events and are reported in the range of 2.5%-5.0%.^12,15 Schmidt et al reported a perioperative complication rate of 8% (pseudoaneurysm, peripheral embolization, arteriovenous fistula).¹³ In his report, 50 patients underwent retrograde recanalization after failed antegrade angioplasty with a high procedural success rate of around 96% and a low periprocedural complication rate.¹³ El-Maadawy et al reported an 82% technical success rate and a few local complications (1 popliteal hematoma, 1 pseudoaneurysm, 2 dissections).¹⁶ In our patient cohort, there was a 1% pseudoaneurysm rate linked with puncture site. Pseudoaneurysms can be effectively treated with thrombin injection without longer in-hospital stay.¹⁷ However, Noory et al presented a higher perioperative complication rate (around 10%) and a 55% 1-year restenosis rate.¹⁵ When dual-femoropopliteal approach was used for SFA-CTO recanalization, patency rates at 1 month, 6 months, and 12 months were 100%, 80%, and up to 42%, respectively.¹⁸ Transpedal access can also be an option in cases of complex lesions of the femoropopliteal and infrapopliteal regions. Reports showed technical success rates of 69%-100%.^19-21 Furthermore, Walker listed no bleeding complications connected with the procedure. Similar outcomes were presented by Ruzsa et al after retrograde transpedal recanalization in 51 patients.²¹ However, Goltz et al reported a minor complication rate of 12.5% and amputation rate of 12.5%.^19,20 In addition, a study by Ruzsa et al reported a mortality rate of 23% at a mean follow-up of 17 months.²¹ 

Death and amputation rates were lower with angioplasty in comparison with surgical treatment (6.98% vs 53% death rate and 4.7% vs 9% amputation rate, respectively).¹ In patients with critical limb ischemia, who are unfit to undergo revascularization, amputation rates reached 5%-20%,²² with 1-year survival rate of 51.9%-75.4%.²³

Our data are in line with previous studies in terms of technical success rate and serious local complication rate. We presented a lower all-cause mortality rate (6.98%) and lack of long-term complications related to procedure or puncture site. Our amputation rate of 4.7% is favorable compared with other reports. Available data from long-term follow-up after CTO recanalization are limited, which makes it impossible to compare our study results with long-term results from other studies. 

Study limitations. Our study represents a two-center experience with a relatively small sample size. However, the complete analysis of consecutive patients without any exclusion criteria and with follow-up data available for all patients was performed.

Conclusion

SFA recanalization may be safe and effective by retrograde puncture. Retrograde recanalization is associated with a low serious complication rate at short-term and long-term follow-up.

References

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From the ¹Semmelweis University, Heart and Vascular Center, Cardiology Department, Hungary; ²Bács-Kiskun County Hospital, Invasive Cardiology Department, Teaching Hospital of the Szent-Györgyi Albert Medical University, Kecskemét, Hungary; and ³II Dept. of Cardiology, Jagiellonian University, Krakow, Poland. 

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript submitted April 6, 2017, provisional acceptance given June 7, 2017, final version accepted July 7, 2017.

Address for correspondence: Stanislaw Bartus, MD, PhD, II Dept. of Cardiology, Jagiellonian University, Krakow, Poland. Email: stanislaw.bartus@uj.edu.pl