Abstract: Objectives. This study evaluated long-term results following successful endovascular therapy (EVT) for chronic total occlusion (CTO) below the knee (BTK) using the retrograde approach after a failed antegrade approach. Methods. Nineteen patients (19 limbs) with critical limb ischemia (CLI) who underwent successful EVT for BTK-CTO using the retrograde approach after a failed antegrade approach during 2010-2014 were studied. Results. Mean duration of the follow-up period was 25.5 ± 17.9 months, and mean age was 76.0 ± 8.6 years. Patients on hemodialysis accounted for 10 cases (52.6%). Patients with Rutherford class 4 constituted 3 cases (15.8%) , while 8 patients each (42.1%) were categorized as Rutherford class 5 and class 6, respectively. All lesions were de novo CTOs. The mean occlusion length was 203.7 ± 114.7 mm. Vascular access for the retrograde approach was obtained via distal puncture in 9 cases (47.4%), whereas the transcollateral approach was employed in 10 cases (52.6%). The amputation-free survival rates at 1, 2, 3, 4, and 5 years after the index procedure were 78.6%, 66.9%, 66.9%, 50.2%, and 50.2%, respectively. Conclusion. Successful EVT for BTK-CTO using various techniques via the retrograde approach provides promising long-term results in patients with CLI.
J INVASIVE CARDIOL 2017;29(1):2-8
Key words: peripheral artery disease, kissing-wire technique, amputation-free survival
Critical limb ischemia (CLI) is the most severe expression of peripheral artery disease (PAD).1 Below-the-knee (BTK) lesions are a frequent occurrence in these patients.1 A minimally invasive revascularization strategy is the preferred treatment for CLI because of frequent comorbidity and high surgical risks.2 Although distal bypass surgery is an important option for the treatment of CLI, endovascular therapy (EVT) confers distinct advantages in these patients.2,3 Because CLI occurs in the setting of severe progressive atherosclerosis disease, treatment of chronic total occlusion (CTO) in BTK lesions is challenging. The retrograde approach is sometimes needed to treat complex lesions in these patients, especially following a failed antegrade attempt at recanalization.4-8
Several techniques are available for use via the retrograde approach.9 However, long-term results following successful EVT for BTK-CTO lesions using various strategies of the retrograde approach after a failed antegrade approach have not been elucidated. In this study, we report the long-term results of successful EVT for BTK-CTO in patients with CLI using various strategies of the retrograde approach after a failed antegrade approach.
From 2010 to 2014, a total of 19 limbs in 19 consecutive patients with CLI who underwent successful EVT for BTK-CTO using the retrograde approach after a failed antegrade approach were studied. Angiography and electronic medical records were reviewed. The average follow-up duration was 25.5 ± 17.9 months. This study protocol was designed in accordance with the Declaration of Helsinki and was approved by the institutional ethics committee. All patients provided written informed consent.
Follow-up. Patients were followed up at the outpatient clinic at 2 weeks and 1, 3, 6, and 12 months after the index EVT procedure and at least once a year thereafter. Patients were asked to provide details of lower-limb symptoms, and the status of wound or pain in the lower limb was assessed.
EVT procedure. The common femoral artery was used for vascular access. A sheathless 4.5 Fr guiding catheter was used for access via an ipsilateral puncture. Unfractionated heparin (3000-5000 U) was administered through the sheathless guiding catheter. A 0.014˝ or 0.018˝ guidewire was manipulated through the microcatheter for support with an intraluminal procedure. First, the antegrade approach was attempted to pass the guidewire through the BTK-CTO. After a failed antegrade attempt, the retrograde approach was attempted by distal puncture or the transcollateral approach. The retrograde approach was used in the following two ways. (1) Distal puncture was performed with a 20 G needle under the contrast dye injection. After successful distal puncture, a floppy guidewire was inserted and advanced into the vessel. A microcatheter was then advanced over the floppy guidewire. The floppy guidewire was replaced by another stiff guidewire to traverse the CTO, if required. (2) In the transcollateral approach, a cruise guidewire was passed through a collateral vessel with a microcatheter for support. After traversing the cruise guidewire via the collateral vessel to an area distal to the target vessel and followed by the advancement of the microcatheter through the collateral vessel over the cruise guidewire, the cruise guidewire was replaced by another stiff guidewire to penetrate the CTO, if needed.
The following strategies were employed for passing the guidewire through the target CTO: (1) wire rendezvous technique, in which one guidewire was advanced into the microcatheter from the opposite site within the target lesion (Figure 1); (2) passage of the retrograde guidewire with or without a kissing-wire technique (Figure 2); and (3) passage of the antegrade guidewire using a kissing-wire technique (Figure 3). After traversing the guidewire through the CTO, the target lesion was dilated by a balloon catheter. A long balloon catheter was used with a longer inflation time, if required. A stent was implanted in case of unsatisfactory results after balloon dilation. Manual hand compression was performed for attaining hemostasis at the distal puncture site used for the retrograde approach. The reference vessel diameter and occlusion length were assessed using a balloon catheter as reference, when inflating it at nominal pressure.
Medication. Dual-antiplatelet therapy (DAPT; 75 mg clopidogrel or 200 mg cilostazol plus 100 mg aspirin) was started at least 3 days prior to the index procedure. DAPT was continued for at least 1 month after the procedure, and aspirin was continued for life.
Definitions. Major amputation was defined as amputation above the ankle joint. Target-lesion revascularization (TLR) was defined as reintervention for a target lesion for the recurrence of rest pain or wound. Major adverse events (MAEs) included death from any cause, TLR, and major amputation. Amputation-free survival (AFS) was defined as survival without major amputation. Clinical success was defined as the resolution of rest pain or complete wound healing without major amputation (minor amputation allowed). Complications of the retrograde approach were defined as any complications related to the distal puncture site or to the collateral vessel used for the retrograde approach.
Endpoints. The primary endpoint was AFS. The secondary endpoints were any death, major amputation, MAEs, complications attributable to the retrograde approach, and clinical success.
Of the 19 patients, 14 (73.7%) were men; the mean age of patients was 76.0 ± 8.6 years. The mean duration of follow-up was 25.5 ± 17.9 months. Ten patients (52.6%) were on hemodialysis, and 13 patients (68.4%) had underlying diabetes mellitus. Three patients (15.8%), 8 patients (42.1%), and 8 patients (42.1%) were categorized as Rutherford class 4, class 5, and class 6, respectively (Table 1).
In-flow procedure was performed in 2 patients; 1 patient had 75% narrowing of the popliteal artery (Trans-Atlantic Inter-Society Consensus [TASC] IIB lesion) and 1 patient had 75% narrowing of the superficial femoral artery (TASC IIA lesion). All target lesions were de novo CTOs. Target lesions were located in the anterior tibial artery in 10 patients (52.6%), posterior tibial artery in 5 patients (26.3%), peroneal artery in 2 patients (10.5%), and tibioperoneal trunk in 2 patients (10.5%). The mean occlusion length was 203.7 ± 114.7 mm. The retrograde approach was used through a distal puncture in 9 patients (47.4%) and the transcollateral approach was used in 10 patients (52.6%).
The techniques for guidewire externalization or for passage of the guidewire were as follows: (1) wire-rendezvous technique in 11 patients (57.9%); (2) passage of the retrograde guidewire using a kissing-wire technique in 1 patient (5.3%) or without a kissing-wire technique in 4 patients (21.1%); and (3) passage of the antegrade guidewire using a kissing-wire technique in 3 patients (15.7%). The EVT procedure was completed with plain old balloon angioplasty in 18 patients (94.7%), and a bare-metal (balloon-expandable) stent was implanted in 1 patient (5.3%). The number of treated BTK vessels per index procedure was 1.7 ± 0.7. The average skin perfusion pressure (SPP) increased from 31.0 mm Hg before the procedure to 60.2 mm Hg post procedure (Table 2). The procedural parameters, 30-day clinical outcomes, and 1-year clinical outcomes are shown in Table 3. Lesion success was achieved in all cases. Clinical success was achieved in 15 patients (78.9%). There was no statistically significant difference in the clinical success rates between the 7 patients (70.0%) with hemodialysis and the 8 patients (89.0%) without hemodialysis (P=.58). No retrograde access-site complication or procedural complications occurred. Three patients (15.8%) required major amputation, whereas 7 patients (36.8%) died during follow-up. None of the patients required distal bypass surgery during follow-up. Survival rates, freedom from major amputation rates, freedom from TLR rates, AFS rates, and freedom from MAE rates are summarized in Figures 4-6. Comparison of freedom from major amputation rates between patients with and without hemodialysis is shown in Figure 7 with a result of log rank test (P=.51).
The key message from the present study is the promising results of retrograde EVT for complex BTK-CTO, particularly after the failure of the antegrade approach, with respect to the AFS rate, survival rate, and freedom from major amputation rate in patients with CLI. The 30-day mortality rate in the present study was 0%, which met the objective performance goal (OPG) set at 6.6%. The major amputation rate at 30 days was 10.5%, which did not meet the OPG set at 7%.10 This was probably attributable to the relatively high proportion of patients with hemodialysis (52.6%) and patients with Rutherford class 6 (42.1%). At 1 year, the AFS rate was 78.6%, which met the OPG set at 68.0%, and the freedom from major amputation rate was 83.5%, which met the OPG set at 81.0%; the survival rate of 78.6% did not meet the OPG set at 80.0%.10 Considering these results, the 30-day and 1-year clinical outcomes were acceptable. At the 3-year follow-up, the AFS rate was 66.9%, whereas the freedom from major amputation rate was 83.5%. These results were better than those reported elsewhere.11
In the present study, the mean SPP increased from 30.1 mm Hg before the procedure to 60.2 mm Hg post procedure. Postprocedural SPP is known to be associated with complete wound healing and improved AFS.12,13 An increase in SPP prevented major amputation and resulted in superior long-term AFS and survival rates in the present study. Because patients with CLI frequently had significant comorbidity, a minimally invasive strategy for revascularization would be preferred. However, it still remains controversial whether EVT is better than surgical therapy for the treatment of patients with CLI. The BEST-CLI randomized trial is currently comparing and evaluating these therapies.14 EVT is a promising option in these patients; however, EVT for complex BTK-CTO is challenging.
In the present study, the retrograde approach was adopted after failed attempts to traverse the lesion via the antegrade approach. Procedural and clinical success would not have been achieved without the use of the retrograde approach in these patients. The key concern with the retrograde approach is vessel injury at the distal puncture site used for the retrograde approach or injury to the collateral vessel used for the transcollateral approach. Vessel injury at the distal puncture site used for the retrograde approach may deprive the anastomotic site for distal bypass graft if distal bypass surgery is eventually required for the treatment of CLI. In addition, injury to the collateral vessel may jeopardize circulation in the lower limb and precipitate severe limb ischemia. Although there were no complications resulting from the retrograde approach in the present study, the risks of the retrograde approach should be carefully considered when applying this technique to treat BTK-CTO lesions.
Study limitations. The present study has some limitations. First, it is a single-center, retrospective study design with a small sample size and limited follow-up period. Larger-scale studies with a longer follow-up period are warranted to draw definite conclusions. Second, although the long-term results of the present study are acceptable, patients with hemodialysis comprised over 50% of the study population; hence, the results of the present study are not applicable to the general population.
The present study underlines the promising results of a retrograde approach to EVT for BTK-CTO, particularly after a failed antegrade approach, with respect to long-term results, AFS rate, survival rate, and freedom from major amputation rate in patients with CLI.
1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5-67.
2. O’Hare AM, Feinglass J, Sidawy AN, et al. Impact of renal insufficiency on short-term morbidity and mortality after lower extremity revascularization: data from the Department of Veterans Affairs’ National Surgical Quality Improvement Program. J Am Soc Nephrol. 2003;14:1287-1295.
3. Adam DJ, Beard JD, Cleveland T, et al; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005;366:1925-1934.
4. Fusaro M, Agostoni P, Biondi-Zoccai G. “Trans-collateral” angioplasty for a challenging chronic total occlusion of the tibial vessels: a novel approach to percutaneous revascularization in critical lower limb ischemia. Catheter Cardiovasc Interv. 2008;71:268-272.
5. Montero-Baker M, Schmidt A, Braunlich S, et al. Retrograde approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther. 2008;15:594-604.
6. Rogers RK, Dattilo PB, Garcia JA, Tsai T, Casserly IP. Retrograde approach to recanalization of complex tibial disease. Catheter Cardiovasc Interv. 2011;77:915-925.
7. Yeh KH, Tsai YJ, Huang HL, Chou HH, Chang HJ, Ko YL. Dual vascular access for critical limb ischemia: immediate and follow-up results. Catheter Cardiovasc Interv. 2011;77:296-302.
8. Shimada Y, Kino N, Yano K, et al. Transcollateral retrograde approach with rendezvous technique for recanalization of chronically occluded tibial arteries. J Endovasc Ther. 2012;19:620-626.
9. Kawarada O, Sakamoto S, Harada K, Ishihara M, Yasuda S, Ogawa H. Contemporary crossing techniques for infrapopliteal chronic total occlusions. J Endovasc Ther. 2014;21:266-280.
10. Conte MS, Geraghty PJ, Bradbury AW, et al. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009;50:1462-1473.e1-e3.
11. Davies MG, El-Sayed HF. Outcomes of isolated tibial endovascular interventions for tissue loss in CLI patients on hemodialysis. J Endovasc Ther. 2015;22:681-689.
12. Utsunomiya M, Nakamura M, Nagashima Y, Sugi K. Predictive value of skin perfusion pressure after endovascular therapy for wound healing in critical limb ischemia. J Endovasc Ther. 2014;21:662-670.
13. Okamoto S, Iida O, Nakamura M, et al; OLIVE Investigators. Postprocedural skin perfusion pressure correlates with clinical outcomes 1 year after endovascular therapy for patients with critical limb ischemia. Angiology. 2015;66:862-866.
14. Menard MT, Farber A, Assmann SF, et al. Design and rationale of the best endovascular versus best surgical therapy for patients with critical limb ischemia (BEST-CLI) trial. J Am Heart Assoc. 2016;5:e003219.
From the Department of Cardiology and Catheterization, Laboratory and Cardiovascular R&D Center, Shonan Kamakura General Hospital, Kamakura, Japan.
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 July 5, 2016, provisional acceptance given July 28, 2016, final version accepted August 3, 2016.
Address for correspondence: Junya Matsumi, MD, Department of Cardiology, Shonan Kamakura General Hospital, 1370-1 Okamoto, Kamakura, Kanagawa 247-0072, Japan. Email: firstname.lastname@example.org