- Email: [email protected]
Combined Antegrade–Retrograde Intervention to Improve Chronic Total Occlusion Recanalization in High-risk Critical Limb Ischemia
Clinical Research Combined AntegradeeRetrograde Intervention to Improve Chronic Total Occlusion Recanalization in High-risk Critical Limb Ischemia Sridhar Venkatachalam, Mathew Bunte, Peter Monteleone, Aaron Lincoff, Michael Maier, and Mehdi H. Shishehbor, Cleveland, Ohio
Background: When conventional antegrade attempts (antegrade approach) to cross chronic total occlusion (CTO) lesions in critical limb ischemia (CLI) fail, and if surgical revascularization is not possible, limb outcomes may be expected to be poor. In this high-risk cohort, we sought to examine whether combined antegradeeretrograde intervention with the simultaneous use of a distal retrograde access (combined approach) improves recanalization success. Methods: From September 2011 to 2012, infrainguinal endovascular interventions were first attempted using antegrade approach in 27 consecutive patients (28 limbs) with CLI and infrainguinal CTO. All patients were poor surgical candidates. In the 11 limbs where antegrade approach failed, the combined approach was attempted. The primary end point was successful CTO lesion crossing. The secondary end points were technical success with 30% diameter residual stenosis of the target lesion, major amputation (transtibial or above), wound healing, target lesion revascularization (TLR), and access site complications that include hematoma requiring exploration or transfusion, arteriovenous fistula, or pseudoaneurysm. Results: Of the 11 limbs that underwent combined approach, the primary end point was achieved in 9 limbs (82%). More notably, among the 28 limbs overall, CTO lesion crossing improved from 61% (95% confidence interval [CI]: 0.41e0.78) using antegrade approach alone to 93% (95% CI: 0.75e0.99) when supplemented by the combined approach. Similarly, the secondary end point of technical success improved from 50% (95% CI: 0.31e0.69) to 79% (95% CI: 0.59e0.91), respectively. Major amputation, wound healing (inclusive of postamputation status), and TLR rates were 9%, 100%, and 18%, respectively, during a median follow-up of approximately 4 months. No major procedural complications occurred with the combined approach. Conclusion: Among CLI patients who are poor surgical candidates, the combined approach is a viable, safe, and effective strategy to improve overall success with endovascular therapies.
Dr Shishehbor is a consultant and an educator for Abbott Vascular, Medtronic, Bayer, Covidien, Spectranetics, and Gore, but has waived all compensations for this work. The authors declare no conflicts of interest. Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH. Correspondence to: Dr Mehdi H. Shishehbor, DO, MPH, PhD, Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue, J3-5, Cleveland, OH 44195, USA; E-mail: [email protected] Ann Vasc Surg 2014; -: 1–10 http://dx.doi.org/10.1016/j.avsg.2014.01.011 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: November 1, 2013; manuscript accepted: January 14, 2014; published online: ---.
In the spectrum of atherosclerotic lower extremity peripheral artery disease (PAD) syndromes, the development of critical limb ischemia (CLI) portends an extremely poor prognosis. At 1 year, less than half the patients with CLI would be alive with 2 limbs based on natural history data.1 The remaining would either undergo amputation or die.1 The rest pain and tissue loss seen in CLI are often precipitated by infrainguinal arterial occlusive disease at multiple levels.2 Therefore, timely revascularization therapies play an important role in limb salvage. 1
2 Venkatachalam et al.
Annals of Vascular Surgery
Fig. 1. An 85-year-old female with a prior left transmetatarsal amputation (TMA), diabetes mellitus, coronary artery disease, hypertension, hyperlipidemia, and chronic kidney disease presents with a recent right second toe amputation and rest pain. A right femoropopliteal bypass and TMA were offered, but the patient refused the TMA. (A) After successful bypass, she returned 4 weeks later with severe rest pain and worsening of the right foot ulcer. (B) Right ankle brachial index (ABI) was 0.18 with flat tracing in the metatarsal and digital vessels. Duplex ultrasound revealed a totally occluded femoropopliteal bypass graft. Multiple attempts at reestablishing flow in the bypass graft had failed and the patient was offered a right below-knee amputation; however, she had refused. At this point, as a final option, an endovascular antegrade approach from the left groin was considered. (C)It shows the occluded right femoropopliteal graft, totally occluded SFA (arrow), and a patent profounda. The SFA, proximal and mid popliteal arteries, and anterior and posterior tibial arteries (D) were totally occluded. The peroneal artery (arrow) was diffusely diseased (D) and provided a faint collateral to the posterior tibial and dorsalis pedis at the level of the ankle. (E) Antegrade approach was attempted, but the 0.03500 glide wire would not advance beyond the mid-SFA
(arrow) despite significant effort. (F) At this point, a retrograde peroneal access was obtained using road-map technique and micropuncture needle (arrow). A 4F sheath was placed. Using a 0.03500 glide wire and a 4F glide catheter, the popliteal and SFA were crossed; however, reentry into the common femoral artery was not possible. A 4.0 mm 40 mm balloon was used over the antegrade wire to create dissection channels and allow retrograde wire to pass, but this was also not successful. At this point, a 4.0 mm 10 cm balloon was placed in the proximal SFA using the retrograde wire and subsequently an Outback reentry catheter device was advanced over the antegrade wire to the level of the balloon in the proximal SFA. We then punctured the balloon using the reentry device and placed the 0.1400 wire into the lumen of the retrograde balloon. (G) Using the balloon as a snare, we then externalized the antegrade wire (arrow) through the 4F sheath in the peroneal artery. Subsequently, the long SFA lesion (arrow) was stented (H) and the distal popliteal and proximal tibial vessels were ballooned. (I) Post procedure ABI revealed a significant improvement from 0.18 to 0.68 with good wave form. (J) She then underwent TMA and has since healed completely.
Over the years, endovascular revascularization has improved and is now considered a first-line option for the management of CLI.3 This approach has been shown to improve limb salvage among the CLI population that is often characterized by older individuals, multiple medical comorbidities, and poor availability of suitable venous conduits.4,5 Furthermore, several innovative technologies over the last decade have made endovascular therapy feasible for lesions previously deemed to be challenging.6 However, the conventional antegrade approach using ipsilateral or contralateral common femoral artery access suffers from a roughly 20e40% failure rate in crossing infrainguinal chronic total occlusion (CTO) lesions, preventing the use of limb-saving
endovascular therapies, especially in those deemed poor candidates for surgical revascularization.4,7 A possible solution involves simultaneous use of retrograde distal access to perform combined antegradee retrograde intervention (combined approach) to improve success with crossing CTO lesions. In this regard, the so-called ‘‘Subintimal Arterial Flossing with AntegradeeRetrograde Intervention’’ (SAFARI) technique has been previously described.8 The aim of this study accordingly was to assess whether the combined approach would improve successful recanalization rates of CTO lesions in the high-risk CLI population in whom attempts at antegrade intervention had failed and no surgical revascularization option is available.
Vol.
-,
No.
-, -
2014
Antegradeeretrograde intervention 3
Fig. 1. (continued).
METHODS Study Population From September 2011 to 2012, infrainguinal endovascular interventions were attempted in 27 consecutive patients (28 limbs) with CLI and CTO of infrainguinal vessels. CLI was diagnosed using standard criteria that include chronic ischemic rest pain, ulcers, or gangrene in the setting of PAD with CTO. All patients were deemed poor surgical candidates based on the availability of suitable conduits, quality of runoffs, recent surgical revascularization with failure, or significant medical comorbidities. Highrisk CLI was defined based on unsuccessful recanalization using the conventional antegrade approach in patients without surgical revascularization options. The study patients were identified retrospectively using a prospective registry maintained by
the Heart and Vascular Institute at the Cleveland Clinic. Patient demographics, comorbidities, and outcomes were obtained from electronic medical records and managed using REDCap data capture tool.9 The study was approved by the institutional review board. All endovascular procedures were performed by a single experienced operator Dr. Mehdi H. Shishehbor. A common femoral artery access (ipsilateral or contralateral) was obtained in all patients to perform endovascular treatment in the usual antegrade fashion (antegrade approach). However, when this was unsuccessful (11 limbs), a distal retrograde access was attempted to perform endovascular treatment using both accesses simultaneously (combined approach). When possible we always tried to recanalize the appropriate angiosome. In addition to CTO lesions, interventions for severe peripheral artery
4 Venkatachalam et al.
Annals of Vascular Surgery
Fig. 1. (continued).
stenoses were performed if necessary. Patients with foot ulcers or gangrene were comanaged by a multidisciplinary team consisting of a podiatrist, vascular surgeon, and infectious disease specialist. All ulcers were documented and monitored for size and healing on a regular basis and the decision to perform limb amputation was approved by the multidisciplinary team. Nonhealing ulcer was defined based on tissue loss of 3e4 weeks duration that failed to resolve despite wound care, while gangrene was differentiated based on the presence of visible tissue necrosis. Lesion calcification on angiography was graded using a scale: 0 ¼ none, 1 ¼ minimal, 2 ¼ moderate, and 3 ¼ severe.10,11 The Retrograde Approach The procedural details of this approach are outlined using a representative case with right superficial femoral artery (SFA) and popliteal artery occlusion (Fig. 1). Antegrade recanalization was first attempted in all patients using multiple wiring techniques and reentry devices if necessary for at least 20 min. After a failed attempt at antegrade recanalization, a
retrograde access was attempted. Using a micropuncture needle and a road-map technique the tibial or pedal vessel was canalized and a 0.01400 or a 0.01800 wire was advanced into the tibial or pedal vessel. We typically start with hydrophilic wire such as Pilot 200 (Abbott Vascular, Santa Clara, CA) and change to CTO wires such as Confianza (Abbott Vascular, Santa Clara, CA), MiracleBros (Abbott Vascular, Santa Clara, CA), Astato (Asahi Intecc, Aichi, Japan), or Treasure 12 (Asahi Intecc, Aichi, Japan). At times we may also use Glidewire Gold 0.01800 (Terumo Medical Corp., Somerset, NJ). In general, crossing these lesions may require multiple wire exchanges. Subsequently, a 0.01800 support catheter was introduced over the wire into the lumen. If extra support was needed, a 4F sheath was used. The lesion was then crossed in retrograde fashion using standard techniques and the wire was externalized at the femoral access site. All interventions were then performed from the femoral access. In general, we obtained proximal anterior tibial, posterior tibial, or peroneal artery access for treating totally occluded SFA and popliteal arteries. This approach allows more
Vol.
-,
No.
-, -
2014
Antegradeeretrograde intervention 5
Fig. 1. (continued).
support and the ability to use larger catheters. For treating totally occluded tibial vessels, we used distal tibial (pedal) access. Unfractionated heparin was used during the procedure to obtain an activated clotting time of 250e300. For proximal anterior tibial, posterior tibial, or peroneal artery access, a manual blood pressure cuff was used for 5 min at 10 mm Hg above the systolic blood pressure. The access site was then checked for hemostasis. For distal tibial (pedal) access, hemostasis was obtained by manual pressure using 2 fingers for atleast 5 min. All patients received aspirin and clopidogrel for a minimum of 6 weeks following the procedure. However, because all patients had CLI, lifetime dual antiplatelet therapy was recommended, except in patients with major contraindications. End Points and Statistical Analysis The primary end point was successful CTO lesion crossing with a guidewire. The secondary end
points were technical success with 30% diameter residual stenosis of the target lesion, major amputation (transtibial or above), wound healing, target lesion revascularization (TLR), and access site complications that include hematoma requiring exploration or transfusion, arteriovenous fistula, or pseudoaneurysm. Categorical variables were presented as percentages and continuous variables as mean ± standard deviation. The primary end point and secondary end point of technical success were reported as percentages with 95% confidence intervals (CI). Because the study was not powered to demonstrate differences, P values were not included.
RESULTS The baseline characteristics of the combined approach group (11 patients) are presented in Table I. This cohort was predominantly male (82%) with a mean age of 73 ± 10 years. Diabetes,
6 Venkatachalam et al.
Annals of Vascular Surgery
Fig. 1. (continued).
chronic kidney disease, and history of smoking were noted in 64%, 55%, and 64%, respectively (Table I). The majority of limbs had a nonhealing ulcer (73%) with 27% complicated by osteomyelitis. Preexisting gangrene was encountered in 18%.
Only 1 limb (9%) had isolated rest pain. The median follow-up was 119 days (25th percentile: 77; 75th percentile: 170). The combined approach was attempted in 11 limbs following failed antegrade approach. This
Vol.
-,
No.
-, -
2014
Antegradeeretrograde intervention 7
Table I. Baseline characteristics of the combined approach population Characteristics
Combined approach (n ¼ 11)
Male Right lower extremity Black Age (years) Mean age (years) Hypertension Diabetes Diabetes on insulin Congestive heart failure Mean LVEF (%) History of CAD History of CABG Chronic kidney disease ESRD on dialysis Renal transplant status Current smoking Ex-smoker
9/11 6/11 5/11 60e84 73 ± 10 10/11 7/11 5/11 4/11 46 ± 8 6/11 3/11 6/11 1/11 1/11 2/11 5/11
(82%) (55%) (45%) (11) (11) (91%) (64%) (45%) (36%) (9) (55%) (27%) (55%) (9%) (9%) (18%) (45%)
CABG, coronary artery bypass graft surgery; CAD, coronary artery disease; ESRD, end-stage renal disease; LVEF, left ventricular ejection fraction. Values represent n with available patient number as denominator (%) or mean ± standard deviation (n represents available patient number).
permitted successful wiring of the occlusion in 9 limbs (82%). Importantly, the supplemental use of combined approach improved the overall success rate of crossing CTO with a guidewire (primary end point) to 93% (95% CI: 0.75e0.99) from 61% (95% CI: 0.41e0.78) with antegrade approach alone. Table II summarizes the CTO lesion characteristics of the combined approach group. Common femoral artery access was ipsilateral in 5 limbs (45%) and contralateral in the remaining. The artery used for retrograde access included popliteal (n ¼ 1), anterior tibial (n ¼ 3), posterior tibial (n ¼ 3), peroneal (n ¼ 1), dorsalis pedis (n ¼ 2), and digital artery (n ¼ 1). A sheath was used in the retrograde access location in 7 limbs (64%). The secondary end point of technical success was achieved in 8 limbs (73%) using the combined approach. Of note, technical success improved from 50% (95% CI: 0.31e0.69) with antegrade approach alone to 79% (95% CI: 0.59e0.91) when supplemented by combined approach. One limb in the combined approach group did not achieve technical success despite successful lesion crossing with a guidewire. No access site or intervention-specific complications occurred with the combined approach. During a median followup of approximately 4 months, TLRs were required
Table II. Chronic total occlusion lesion characteristics in the combined approach group
Artery
n/n (%)
Mean lesion length (cm)
SFA SFA + popliteal Tibial only Anterior tibial Posterior tibial
1/11 5/11 5/11 2/11 3/11
38.5 29.0 35.8 40.3 32.8
(9%) (45%) (45%) (18%) (27%)
± ± ± ±
16.9 7.3 2.5 8.4
Severe lesion calcification n/n (%)
1/1 3/5 1/5 1/2 0/3
(100) (60) (20) (50) (0)
Table III. Limb characteristics and short-term outcomes Limb characteristics Rest pain Ulcer without OM Ulcer with OM Gangrene Outcomes CTO lesion crossed (primary endpoint) Technical successa Access site complication Ulcer healingb Without OM With OM Amputation Without OM With OM With gangrene TLR
1/11 5/11 3/11 2/11
(9%) (45%) (27%) (18%)
9/11 8/11 0/11 8/8 5/5 3/3 5/10 1/5 2/3 2/2 2/8
(82%) (73%) (0%) (100%) (100%) (100%) (50%) (20%) (67%) (100%) (25%)
CTO, chronic total occlusion; OM, osteomyelitis; TLR, target lesion revascularization. a Technical success defined as 30% diameter residual stenosis of the target lesion. b Includes wound healing after surgical amputation.
in 2 limbs (Table III). Of the 8 limbs with ulcer in the combined approach group, healing was documented in all limbs, with wound healing following amputation in 3 limbs (Tables III and IV). One major amputation (transtibial) was performed for extensive osteomyelitis with subsequent wound healing (Table IV).
DISCUSSION In the management of CLI, our results demonstrate that the combined approach as described is associated with improved success in crossing CTOs and satisfactory limb outcomes in the short term (<6 months). The technique is safe and feasible in the majority of CLI patients. Importantly, in the high-risk CLI patient who failed the conventional
Digit
Yes Yes Yes Yes No No No No Yes No No 150a 247 71
38a 87a 72a 121a 266 NA NA
0.6 0.42
NC 0.76
0.68
0.66 0.56 0.46
NC
0.61
0.73 0.37 0.43
0.49
0.28
Healed Healed Healed Healed Healed Healed Healing NA Healed Healed Healed 1.1 0.71
No SFA Yes FP Yes FP Yes FP Yes FP FP Yes Yes Yes Yes No Yes No No Yes Yes Yes 0.86 0.39 NC 0.18 1 0 0.64 NC 0.55 0.49 0 Yes NA 40 Yes NA 1 No No 4 Yes NA 2 No 2 No No Plantar Dorsal, Plantar Lateral Dorsal, Plantar Lateral Lateral Plantar NA Dorsal Dorsal Dorsal Ulcer Gangrene Ulcer Gangrene Ulcer Ulcer Ulcer RP Ulcer Ulcer Ulcer LLE LLE RLE RLE LLE RLE RLE RLE RLE LLE LLE
BKA, below-knee amputation; FP, femoropopliteal intervention; LLE, left lower extremity; NA, data not available/not applicable; NC, noncompressible; OM, osteomyelitis; Post-pr, post procedure 1 month; RLE, right lower extremity; RP, rest pain; TMA, transmetatarsal amputation. a Time to heal ulcer from the time of amputation. b Angiosome-appropriate intervention.
55 NA 45 30 NA 35 12 33 94 NA 25 25 25 10 15 7 1 2 3 4 5 6 7 8 9 10 11
Syme’s Digit BKA TMA
1e3 3e6 6e9 Ulcer Time to Technical Amputation Post-pr Month Month Month status at heal ulcer Ulcer size (mm) OM Base ABI success Angiosomeb ABI ABI followup (days) Amputation level ABI ABI
Annals of Vascular Surgery
Ulcer No. Limb CLI feature location
Table IV. Limb outcomes with the combined approach in high-risk critical limb ischemia
8 Venkatachalam et al.
antegrade approach and in whom surgical options do not exist, the retrograde approach may be the last resort. Unfortunately, published data from the Unites States are very few and have not specifically studied this high-risk CLI population. When dealing with CTOs, deliberate subintimal angioplasty or percutaneous intentional extraluminal recanalization (PIER) first described by Bolia et al.12 in 1990 was a major step forward in the field of endovascular therapy. The lesions best suited for PIER are typically seen in the CLI population. These include long occlusions (>10 cm SFA/popliteal or >3 cm tibial artery), flush occlusions, and heavy calcification.13 In these situations, conventional intraluminal angioplasty would likely fail given the complex anatomy, while the subintimal plane being a path of minimum resistance can be used to wire the occlusion. However, roughly 20e25% of PIER may be unsuccessful.7,8,12 The most common reason for failed PIER is difficulty in reentering the true lumen after successful crossing of the occlusion in the subintimal dissecting plane.7,8 Several options are available when this is encountered: (1) extending the dissection distal to the occlusion to a point that is free from disease taking care not to compromise a major collateral; however, this may not be suitable when only a limited segment is available;8,13 (2) use of a dedicated reentry device, guidewire, support catheter, and/or balloons although they may not be suitable in most infrapopliteal CTO, or (3) perform the SAFARI technique using the combined approach. Another problem with antegrade PIER is the risk of inadvertent damage to the ostium of a runoff artery in the setting of a trifurcation lesion.14 This situation can be avoided with the combined approach. One of the first reports on the use of a distal retrograde access was published by Iyer et al.15 in 1990 using a posterior tibial artery cutdown. Subsequently, Botti et al.16 in 2003 reported on the use of simultaneous antegradeeretrograde access with successful recanalization of all patients (n ¼ 6) who had previously failed the conventional antegrade access despite attempted subintimal angioplasty. In 2005, Spinosa et al.8 used the term ‘‘SAFARI’’ to describe the technique of subintimal arterial flossing with antegradeeretrograde intervention. This study comprised 21 limbs with CLI where subintimal recanalization in the antegrade direction was met with unsuccessful reentry into the distal true lumen or a short target artery segment. Using a distal artery retrograde access (popliteal, anterior tibial, posterior tibial, or dorsalis pedis), a subintimal passage was created to achieve guidewire entry into the proximal subintimal space
Vol.
-,
No.
-, -
2014
obtained using the antegrade approach or entry into the true lumen. Angioplasty was then completed using the antegrade access. The procedure was successful in all limbs with a 90% limb salvage rate at 6 months.8 However, Montero-Baker et al.7 reported a procedural success rate of 86% in a cohort of 51 limbs, of which 45 had CLI. Similarly, Rogers et al.17 had a procedural success of 85% in 13 limbs (CLI in 8 limbs) and 1 patient required surgical exposure of the tibial artery for retrograde access. In this regard, ultrasound guidance has been shown to facilitate obtaining tibial access.18 Several factors may likely explain the increased success with retrograde wiring of occlusion. These include perhaps a lesser degree of distal fibrotic or calcific changes in the lesion and a lesser drift of the guidewire into one of the collaterals as suggested by MonteroBaker et al.7 More recently, additional retrograde access site options have emerged. In a recent report by Palena et al.,19 transmetatarsal artery access and transplantar arch access were shown to be feasible to treat limbs with extremely challenging anatomy. The goal of our study was to present the results of a rescue strategy using the combined approach in a high-risk CLI population without surgical revascularization options. Given the paucity of published data from the United States, it remains unclear if endovascular specialists routinely pursue this technique for antegrade approach failures. Based on our data and other published reports, it is evident that 25e40% of CTO lesions would not be crossed with a guidewire using the conventional antegrade approach.8,20 However, with the combined approach strategy, our failure rate dropped to 7%. Furthermore, we encountered no access site or intervention-specific complications with this approach. In the short term (<6 months), ulcer healing and limb salvage rates in our small study population were satisfactory. Therefore, we believe the combined approach may be a worthwhile option given the increased risk of mortality in those who undergo above- or belowknee amputations following failed attempts using conventional options for revascularization.21 Although advanced access options (transmetatarsal or transplantar) or techniques such as the ‘‘trans-collateral loop’’ are only possible in select institutions, the standard approach as described in our article would likely be feasible in most centers. Our study is limited by the retrospective design, small sample size, and short-term (<6 months) follow-up. Therefore, differences in CTO lesion crossing or technical success were not studied for statistical significance. For similar reasons, we could not examine predictors of antegrade or combined approach failure. However, the aim of this article
Antegradeeretrograde intervention 9
was to present our early findings. A prospective multicenter study using a strategy of combined approach for the high-risk CLI population will be needed. Our findings are based on a single operator’s experience in the setting of a tertiary-care center. As with any technique, a learning curve may be expected among new operators.
CONCLUSION Combined antegradeeretrograde intervention with the simultaneous use of common femoral and distal retrograde access (combined approach) is associated with better CTO lesion revascularization rates in CLI and may be used as a rescue strategy when antegrade attempts fail. We find this technique to be feasible in the majority of such patients with negligible procedural complication. Although larger prospective studies with long-term follow-up data are clearly required, it seems appropriate at the present time to offer this valuable strategy to the high-risk CLI population. REFERENCES 1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45(Suppl S):S5e67. 2. Graziani L, Silvestro A, Bertone V, et al. Vascular involvement in diabetic subjects with ischemic foot ulcer: a new morphologic categorization of disease severity. Eur J Vasc Endovasc Surg 2007;33:453e60. 3. Conrad MF, Crawford RS, Hackney LA, et al. Endovascular management of patients with critical limb ischemia. J Vasc Surg 2011;53:1020e5. 4. Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925e34. 5. Dosluoglu HH, O’Brien-Irr MS, Lukan J, et al. Does preferential use of endovascular interventions by vascular surgeons improve limb salvage, control of symptoms, and survival of patients with critical limb ischemia? Am J Surg 2006;192:572e6. 6. Venkatachalam S, Shishehbor MH, Gray BH. Basic data related to endovascular management of peripheral arterial disease in critical limb ischemia. Ann Vasc Surg 2012;26: 1039e51. 7. Montero-Baker M, Schmidt A, Braunlich S, et al. Retrograde approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther 2008;15:594e604. 8. Spinosa DJ, Harthun NL, Bissonette EA, et al. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) for subintimal recanalization to treat chronic critical limb ischemia. J Vasc Interv Radiol 2005;16:37e44. 9. Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)ea metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377e81. 10. Kashyap VS, Pavkov ML, Bishop PD, et al. Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther 2008;15:117e25.
10 Venkatachalam et al.
11. Kronenberg F, Mundle M, Langle M, et al. Prevalence and progression of peripheral arterial calcifications in patients with ESRD. Am J Kidney Dis 2003;41:140e8. 12. Bolia A, Miles KA, Brennan J, et al. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol 1990;13:357e63. 13. Bolia A. Subintimial angioplasty, the way forward. Acta Chir Belg 2004;104:547e54. 14. Gandini R, Pipitone V, Stefanini M, et al. The ‘‘Safari’’ technique to perform difficult subintimal infragenicular vessels. Cardiovasc Intervent Radiol 2007;30:469e73. 15. Iyer SS, Dorros G, Zaitoun R, et al. Retrograde recanalization of an occluded posterior tibial artery by using a posterior tibial cutdown: two case reports. Cathet Cardiovasc Diagn 1990;20:251e3. 16. Botti CF Jr, Ansel GM, Silver MJ, et al. Percutaneous retrograde tibial access in limb salvage. J Endovasc Ther 2003;10: 614e8.
Annals of Vascular Surgery
17. Rogers RK, Dattilo PB, Garcia JA, et al. Retrograde approach to recanalization of complex tibial disease. Catheter Cardiovasc Interv 2011;77:915e25. 18. Mustapha JA, Saab F, Diaz L, et al. Utility and feasibility of ultrasound-guided access in patients with critical limb ischemia. Catheter Cardiovasc Interv 2013;81:1204e11. 19. Palena LM, Manzi M. Extreme below-the-knee interventions: retrograde transmetatarsal or transplantar arch access for foot salvage in challenging cases of critical limb ischemia. J Endovasc Ther 2012;19:805e11. 20. Soder HK, Manninen HI, Jaakkola P, et al. Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: angiographic and clinical results. J Vasc Interv Radiol 2000;11:1021e31. 21. Feinglass J, Pearce WH, Martin GJ, et al. Postoperative and late survival outcomes after major amputation: findings from the Department of Veterans Affairs National Surgical Quality Improvement Program. Surgery 2001; 130:21e9.
Background: When conventional antegrade attempts (antegrade approach) to cross chronic total occlusion (CTO) lesions in critical limb ischemia (CLI) fail, and if surgical revascularization is not possible, limb outcomes may be expected to be poor. In this high-risk cohort, we sought to examine whether combined antegradeeretrograde intervention with the simultaneous use of a distal retrograde access (combined approach) improves recanalization success. Methods: From September 2011 to 2012, infrainguinal endovascular interventions were first attempted using antegrade approach in 27 consecutive patients (28 limbs) with CLI and infrainguinal CTO. All patients were poor surgical candidates. In the 11 limbs where antegrade approach failed, the combined approach was attempted. The primary end point was successful CTO lesion crossing. The secondary end points were technical success with 30% diameter residual stenosis of the target lesion, major amputation (transtibial or above), wound healing, target lesion revascularization (TLR), and access site complications that include hematoma requiring exploration or transfusion, arteriovenous fistula, or pseudoaneurysm. Results: Of the 11 limbs that underwent combined approach, the primary end point was achieved in 9 limbs (82%). More notably, among the 28 limbs overall, CTO lesion crossing improved from 61% (95% confidence interval [CI]: 0.41e0.78) using antegrade approach alone to 93% (95% CI: 0.75e0.99) when supplemented by the combined approach. Similarly, the secondary end point of technical success improved from 50% (95% CI: 0.31e0.69) to 79% (95% CI: 0.59e0.91), respectively. Major amputation, wound healing (inclusive of postamputation status), and TLR rates were 9%, 100%, and 18%, respectively, during a median follow-up of approximately 4 months. No major procedural complications occurred with the combined approach. Conclusion: Among CLI patients who are poor surgical candidates, the combined approach is a viable, safe, and effective strategy to improve overall success with endovascular therapies.
Dr Shishehbor is a consultant and an educator for Abbott Vascular, Medtronic, Bayer, Covidien, Spectranetics, and Gore, but has waived all compensations for this work. The authors declare no conflicts of interest. Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH. Correspondence to: Dr Mehdi H. Shishehbor, DO, MPH, PhD, Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue, J3-5, Cleveland, OH 44195, USA; E-mail: [email protected] Ann Vasc Surg 2014; -: 1–10 http://dx.doi.org/10.1016/j.avsg.2014.01.011 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: November 1, 2013; manuscript accepted: January 14, 2014; published online: ---.
In the spectrum of atherosclerotic lower extremity peripheral artery disease (PAD) syndromes, the development of critical limb ischemia (CLI) portends an extremely poor prognosis. At 1 year, less than half the patients with CLI would be alive with 2 limbs based on natural history data.1 The remaining would either undergo amputation or die.1 The rest pain and tissue loss seen in CLI are often precipitated by infrainguinal arterial occlusive disease at multiple levels.2 Therefore, timely revascularization therapies play an important role in limb salvage. 1
2 Venkatachalam et al.
Annals of Vascular Surgery
Fig. 1. An 85-year-old female with a prior left transmetatarsal amputation (TMA), diabetes mellitus, coronary artery disease, hypertension, hyperlipidemia, and chronic kidney disease presents with a recent right second toe amputation and rest pain. A right femoropopliteal bypass and TMA were offered, but the patient refused the TMA. (A) After successful bypass, she returned 4 weeks later with severe rest pain and worsening of the right foot ulcer. (B) Right ankle brachial index (ABI) was 0.18 with flat tracing in the metatarsal and digital vessels. Duplex ultrasound revealed a totally occluded femoropopliteal bypass graft. Multiple attempts at reestablishing flow in the bypass graft had failed and the patient was offered a right below-knee amputation; however, she had refused. At this point, as a final option, an endovascular antegrade approach from the left groin was considered. (C)It shows the occluded right femoropopliteal graft, totally occluded SFA (arrow), and a patent profounda. The SFA, proximal and mid popliteal arteries, and anterior and posterior tibial arteries (D) were totally occluded. The peroneal artery (arrow) was diffusely diseased (D) and provided a faint collateral to the posterior tibial and dorsalis pedis at the level of the ankle. (E) Antegrade approach was attempted, but the 0.03500 glide wire would not advance beyond the mid-SFA
(arrow) despite significant effort. (F) At this point, a retrograde peroneal access was obtained using road-map technique and micropuncture needle (arrow). A 4F sheath was placed. Using a 0.03500 glide wire and a 4F glide catheter, the popliteal and SFA were crossed; however, reentry into the common femoral artery was not possible. A 4.0 mm 40 mm balloon was used over the antegrade wire to create dissection channels and allow retrograde wire to pass, but this was also not successful. At this point, a 4.0 mm 10 cm balloon was placed in the proximal SFA using the retrograde wire and subsequently an Outback reentry catheter device was advanced over the antegrade wire to the level of the balloon in the proximal SFA. We then punctured the balloon using the reentry device and placed the 0.1400 wire into the lumen of the retrograde balloon. (G) Using the balloon as a snare, we then externalized the antegrade wire (arrow) through the 4F sheath in the peroneal artery. Subsequently, the long SFA lesion (arrow) was stented (H) and the distal popliteal and proximal tibial vessels were ballooned. (I) Post procedure ABI revealed a significant improvement from 0.18 to 0.68 with good wave form. (J) She then underwent TMA and has since healed completely.
Over the years, endovascular revascularization has improved and is now considered a first-line option for the management of CLI.3 This approach has been shown to improve limb salvage among the CLI population that is often characterized by older individuals, multiple medical comorbidities, and poor availability of suitable venous conduits.4,5 Furthermore, several innovative technologies over the last decade have made endovascular therapy feasible for lesions previously deemed to be challenging.6 However, the conventional antegrade approach using ipsilateral or contralateral common femoral artery access suffers from a roughly 20e40% failure rate in crossing infrainguinal chronic total occlusion (CTO) lesions, preventing the use of limb-saving
endovascular therapies, especially in those deemed poor candidates for surgical revascularization.4,7 A possible solution involves simultaneous use of retrograde distal access to perform combined antegradee retrograde intervention (combined approach) to improve success with crossing CTO lesions. In this regard, the so-called ‘‘Subintimal Arterial Flossing with AntegradeeRetrograde Intervention’’ (SAFARI) technique has been previously described.8 The aim of this study accordingly was to assess whether the combined approach would improve successful recanalization rates of CTO lesions in the high-risk CLI population in whom attempts at antegrade intervention had failed and no surgical revascularization option is available.
Vol.
-,
No.
-, -
2014
Antegradeeretrograde intervention 3
Fig. 1. (continued).
METHODS Study Population From September 2011 to 2012, infrainguinal endovascular interventions were attempted in 27 consecutive patients (28 limbs) with CLI and CTO of infrainguinal vessels. CLI was diagnosed using standard criteria that include chronic ischemic rest pain, ulcers, or gangrene in the setting of PAD with CTO. All patients were deemed poor surgical candidates based on the availability of suitable conduits, quality of runoffs, recent surgical revascularization with failure, or significant medical comorbidities. Highrisk CLI was defined based on unsuccessful recanalization using the conventional antegrade approach in patients without surgical revascularization options. The study patients were identified retrospectively using a prospective registry maintained by
the Heart and Vascular Institute at the Cleveland Clinic. Patient demographics, comorbidities, and outcomes were obtained from electronic medical records and managed using REDCap data capture tool.9 The study was approved by the institutional review board. All endovascular procedures were performed by a single experienced operator Dr. Mehdi H. Shishehbor. A common femoral artery access (ipsilateral or contralateral) was obtained in all patients to perform endovascular treatment in the usual antegrade fashion (antegrade approach). However, when this was unsuccessful (11 limbs), a distal retrograde access was attempted to perform endovascular treatment using both accesses simultaneously (combined approach). When possible we always tried to recanalize the appropriate angiosome. In addition to CTO lesions, interventions for severe peripheral artery
4 Venkatachalam et al.
Annals of Vascular Surgery
Fig. 1. (continued).
stenoses were performed if necessary. Patients with foot ulcers or gangrene were comanaged by a multidisciplinary team consisting of a podiatrist, vascular surgeon, and infectious disease specialist. All ulcers were documented and monitored for size and healing on a regular basis and the decision to perform limb amputation was approved by the multidisciplinary team. Nonhealing ulcer was defined based on tissue loss of 3e4 weeks duration that failed to resolve despite wound care, while gangrene was differentiated based on the presence of visible tissue necrosis. Lesion calcification on angiography was graded using a scale: 0 ¼ none, 1 ¼ minimal, 2 ¼ moderate, and 3 ¼ severe.10,11 The Retrograde Approach The procedural details of this approach are outlined using a representative case with right superficial femoral artery (SFA) and popliteal artery occlusion (Fig. 1). Antegrade recanalization was first attempted in all patients using multiple wiring techniques and reentry devices if necessary for at least 20 min. After a failed attempt at antegrade recanalization, a
retrograde access was attempted. Using a micropuncture needle and a road-map technique the tibial or pedal vessel was canalized and a 0.01400 or a 0.01800 wire was advanced into the tibial or pedal vessel. We typically start with hydrophilic wire such as Pilot 200 (Abbott Vascular, Santa Clara, CA) and change to CTO wires such as Confianza (Abbott Vascular, Santa Clara, CA), MiracleBros (Abbott Vascular, Santa Clara, CA), Astato (Asahi Intecc, Aichi, Japan), or Treasure 12 (Asahi Intecc, Aichi, Japan). At times we may also use Glidewire Gold 0.01800 (Terumo Medical Corp., Somerset, NJ). In general, crossing these lesions may require multiple wire exchanges. Subsequently, a 0.01800 support catheter was introduced over the wire into the lumen. If extra support was needed, a 4F sheath was used. The lesion was then crossed in retrograde fashion using standard techniques and the wire was externalized at the femoral access site. All interventions were then performed from the femoral access. In general, we obtained proximal anterior tibial, posterior tibial, or peroneal artery access for treating totally occluded SFA and popliteal arteries. This approach allows more
Vol.
-,
No.
-, -
2014
Antegradeeretrograde intervention 5
Fig. 1. (continued).
support and the ability to use larger catheters. For treating totally occluded tibial vessels, we used distal tibial (pedal) access. Unfractionated heparin was used during the procedure to obtain an activated clotting time of 250e300. For proximal anterior tibial, posterior tibial, or peroneal artery access, a manual blood pressure cuff was used for 5 min at 10 mm Hg above the systolic blood pressure. The access site was then checked for hemostasis. For distal tibial (pedal) access, hemostasis was obtained by manual pressure using 2 fingers for atleast 5 min. All patients received aspirin and clopidogrel for a minimum of 6 weeks following the procedure. However, because all patients had CLI, lifetime dual antiplatelet therapy was recommended, except in patients with major contraindications. End Points and Statistical Analysis The primary end point was successful CTO lesion crossing with a guidewire. The secondary end
points were technical success with 30% diameter residual stenosis of the target lesion, major amputation (transtibial or above), wound healing, target lesion revascularization (TLR), and access site complications that include hematoma requiring exploration or transfusion, arteriovenous fistula, or pseudoaneurysm. Categorical variables were presented as percentages and continuous variables as mean ± standard deviation. The primary end point and secondary end point of technical success were reported as percentages with 95% confidence intervals (CI). Because the study was not powered to demonstrate differences, P values were not included.
RESULTS The baseline characteristics of the combined approach group (11 patients) are presented in Table I. This cohort was predominantly male (82%) with a mean age of 73 ± 10 years. Diabetes,
6 Venkatachalam et al.
Annals of Vascular Surgery
Fig. 1. (continued).
chronic kidney disease, and history of smoking were noted in 64%, 55%, and 64%, respectively (Table I). The majority of limbs had a nonhealing ulcer (73%) with 27% complicated by osteomyelitis. Preexisting gangrene was encountered in 18%.
Only 1 limb (9%) had isolated rest pain. The median follow-up was 119 days (25th percentile: 77; 75th percentile: 170). The combined approach was attempted in 11 limbs following failed antegrade approach. This
Vol.
-,
No.
-, -
2014
Antegradeeretrograde intervention 7
Table I. Baseline characteristics of the combined approach population Characteristics
Combined approach (n ¼ 11)
Male Right lower extremity Black Age (years) Mean age (years) Hypertension Diabetes Diabetes on insulin Congestive heart failure Mean LVEF (%) History of CAD History of CABG Chronic kidney disease ESRD on dialysis Renal transplant status Current smoking Ex-smoker
9/11 6/11 5/11 60e84 73 ± 10 10/11 7/11 5/11 4/11 46 ± 8 6/11 3/11 6/11 1/11 1/11 2/11 5/11
(82%) (55%) (45%) (11) (11) (91%) (64%) (45%) (36%) (9) (55%) (27%) (55%) (9%) (9%) (18%) (45%)
CABG, coronary artery bypass graft surgery; CAD, coronary artery disease; ESRD, end-stage renal disease; LVEF, left ventricular ejection fraction. Values represent n with available patient number as denominator (%) or mean ± standard deviation (n represents available patient number).
permitted successful wiring of the occlusion in 9 limbs (82%). Importantly, the supplemental use of combined approach improved the overall success rate of crossing CTO with a guidewire (primary end point) to 93% (95% CI: 0.75e0.99) from 61% (95% CI: 0.41e0.78) with antegrade approach alone. Table II summarizes the CTO lesion characteristics of the combined approach group. Common femoral artery access was ipsilateral in 5 limbs (45%) and contralateral in the remaining. The artery used for retrograde access included popliteal (n ¼ 1), anterior tibial (n ¼ 3), posterior tibial (n ¼ 3), peroneal (n ¼ 1), dorsalis pedis (n ¼ 2), and digital artery (n ¼ 1). A sheath was used in the retrograde access location in 7 limbs (64%). The secondary end point of technical success was achieved in 8 limbs (73%) using the combined approach. Of note, technical success improved from 50% (95% CI: 0.31e0.69) with antegrade approach alone to 79% (95% CI: 0.59e0.91) when supplemented by combined approach. One limb in the combined approach group did not achieve technical success despite successful lesion crossing with a guidewire. No access site or intervention-specific complications occurred with the combined approach. During a median followup of approximately 4 months, TLRs were required
Table II. Chronic total occlusion lesion characteristics in the combined approach group
Artery
n/n (%)
Mean lesion length (cm)
SFA SFA + popliteal Tibial only Anterior tibial Posterior tibial
1/11 5/11 5/11 2/11 3/11
38.5 29.0 35.8 40.3 32.8
(9%) (45%) (45%) (18%) (27%)
± ± ± ±
16.9 7.3 2.5 8.4
Severe lesion calcification n/n (%)
1/1 3/5 1/5 1/2 0/3
(100) (60) (20) (50) (0)
Table III. Limb characteristics and short-term outcomes Limb characteristics Rest pain Ulcer without OM Ulcer with OM Gangrene Outcomes CTO lesion crossed (primary endpoint) Technical successa Access site complication Ulcer healingb Without OM With OM Amputation Without OM With OM With gangrene TLR
1/11 5/11 3/11 2/11
(9%) (45%) (27%) (18%)
9/11 8/11 0/11 8/8 5/5 3/3 5/10 1/5 2/3 2/2 2/8
(82%) (73%) (0%) (100%) (100%) (100%) (50%) (20%) (67%) (100%) (25%)
CTO, chronic total occlusion; OM, osteomyelitis; TLR, target lesion revascularization. a Technical success defined as 30% diameter residual stenosis of the target lesion. b Includes wound healing after surgical amputation.
in 2 limbs (Table III). Of the 8 limbs with ulcer in the combined approach group, healing was documented in all limbs, with wound healing following amputation in 3 limbs (Tables III and IV). One major amputation (transtibial) was performed for extensive osteomyelitis with subsequent wound healing (Table IV).
DISCUSSION In the management of CLI, our results demonstrate that the combined approach as described is associated with improved success in crossing CTOs and satisfactory limb outcomes in the short term (<6 months). The technique is safe and feasible in the majority of CLI patients. Importantly, in the high-risk CLI patient who failed the conventional
Digit
Yes Yes Yes Yes No No No No Yes No No 150a 247 71
38a 87a 72a 121a 266 NA NA
0.6 0.42
NC 0.76
0.68
0.66 0.56 0.46
NC
0.61
0.73 0.37 0.43
0.49
0.28
Healed Healed Healed Healed Healed Healed Healing NA Healed Healed Healed 1.1 0.71
No SFA Yes FP Yes FP Yes FP Yes FP FP Yes Yes Yes Yes No Yes No No Yes Yes Yes 0.86 0.39 NC 0.18 1 0 0.64 NC 0.55 0.49 0 Yes NA 40 Yes NA 1 No No 4 Yes NA 2 No 2 No No Plantar Dorsal, Plantar Lateral Dorsal, Plantar Lateral Lateral Plantar NA Dorsal Dorsal Dorsal Ulcer Gangrene Ulcer Gangrene Ulcer Ulcer Ulcer RP Ulcer Ulcer Ulcer LLE LLE RLE RLE LLE RLE RLE RLE RLE LLE LLE
BKA, below-knee amputation; FP, femoropopliteal intervention; LLE, left lower extremity; NA, data not available/not applicable; NC, noncompressible; OM, osteomyelitis; Post-pr, post procedure 1 month; RLE, right lower extremity; RP, rest pain; TMA, transmetatarsal amputation. a Time to heal ulcer from the time of amputation. b Angiosome-appropriate intervention.
55 NA 45 30 NA 35 12 33 94 NA 25 25 25 10 15 7 1 2 3 4 5 6 7 8 9 10 11
Syme’s Digit BKA TMA
1e3 3e6 6e9 Ulcer Time to Technical Amputation Post-pr Month Month Month status at heal ulcer Ulcer size (mm) OM Base ABI success Angiosomeb ABI ABI followup (days) Amputation level ABI ABI
Annals of Vascular Surgery
Ulcer No. Limb CLI feature location
Table IV. Limb outcomes with the combined approach in high-risk critical limb ischemia
8 Venkatachalam et al.
antegrade approach and in whom surgical options do not exist, the retrograde approach may be the last resort. Unfortunately, published data from the Unites States are very few and have not specifically studied this high-risk CLI population. When dealing with CTOs, deliberate subintimal angioplasty or percutaneous intentional extraluminal recanalization (PIER) first described by Bolia et al.12 in 1990 was a major step forward in the field of endovascular therapy. The lesions best suited for PIER are typically seen in the CLI population. These include long occlusions (>10 cm SFA/popliteal or >3 cm tibial artery), flush occlusions, and heavy calcification.13 In these situations, conventional intraluminal angioplasty would likely fail given the complex anatomy, while the subintimal plane being a path of minimum resistance can be used to wire the occlusion. However, roughly 20e25% of PIER may be unsuccessful.7,8,12 The most common reason for failed PIER is difficulty in reentering the true lumen after successful crossing of the occlusion in the subintimal dissecting plane.7,8 Several options are available when this is encountered: (1) extending the dissection distal to the occlusion to a point that is free from disease taking care not to compromise a major collateral; however, this may not be suitable when only a limited segment is available;8,13 (2) use of a dedicated reentry device, guidewire, support catheter, and/or balloons although they may not be suitable in most infrapopliteal CTO, or (3) perform the SAFARI technique using the combined approach. Another problem with antegrade PIER is the risk of inadvertent damage to the ostium of a runoff artery in the setting of a trifurcation lesion.14 This situation can be avoided with the combined approach. One of the first reports on the use of a distal retrograde access was published by Iyer et al.15 in 1990 using a posterior tibial artery cutdown. Subsequently, Botti et al.16 in 2003 reported on the use of simultaneous antegradeeretrograde access with successful recanalization of all patients (n ¼ 6) who had previously failed the conventional antegrade access despite attempted subintimal angioplasty. In 2005, Spinosa et al.8 used the term ‘‘SAFARI’’ to describe the technique of subintimal arterial flossing with antegradeeretrograde intervention. This study comprised 21 limbs with CLI where subintimal recanalization in the antegrade direction was met with unsuccessful reentry into the distal true lumen or a short target artery segment. Using a distal artery retrograde access (popliteal, anterior tibial, posterior tibial, or dorsalis pedis), a subintimal passage was created to achieve guidewire entry into the proximal subintimal space
Vol.
-,
No.
-, -
2014
obtained using the antegrade approach or entry into the true lumen. Angioplasty was then completed using the antegrade access. The procedure was successful in all limbs with a 90% limb salvage rate at 6 months.8 However, Montero-Baker et al.7 reported a procedural success rate of 86% in a cohort of 51 limbs, of which 45 had CLI. Similarly, Rogers et al.17 had a procedural success of 85% in 13 limbs (CLI in 8 limbs) and 1 patient required surgical exposure of the tibial artery for retrograde access. In this regard, ultrasound guidance has been shown to facilitate obtaining tibial access.18 Several factors may likely explain the increased success with retrograde wiring of occlusion. These include perhaps a lesser degree of distal fibrotic or calcific changes in the lesion and a lesser drift of the guidewire into one of the collaterals as suggested by MonteroBaker et al.7 More recently, additional retrograde access site options have emerged. In a recent report by Palena et al.,19 transmetatarsal artery access and transplantar arch access were shown to be feasible to treat limbs with extremely challenging anatomy. The goal of our study was to present the results of a rescue strategy using the combined approach in a high-risk CLI population without surgical revascularization options. Given the paucity of published data from the United States, it remains unclear if endovascular specialists routinely pursue this technique for antegrade approach failures. Based on our data and other published reports, it is evident that 25e40% of CTO lesions would not be crossed with a guidewire using the conventional antegrade approach.8,20 However, with the combined approach strategy, our failure rate dropped to 7%. Furthermore, we encountered no access site or intervention-specific complications with this approach. In the short term (<6 months), ulcer healing and limb salvage rates in our small study population were satisfactory. Therefore, we believe the combined approach may be a worthwhile option given the increased risk of mortality in those who undergo above- or belowknee amputations following failed attempts using conventional options for revascularization.21 Although advanced access options (transmetatarsal or transplantar) or techniques such as the ‘‘trans-collateral loop’’ are only possible in select institutions, the standard approach as described in our article would likely be feasible in most centers. Our study is limited by the retrospective design, small sample size, and short-term (<6 months) follow-up. Therefore, differences in CTO lesion crossing or technical success were not studied for statistical significance. For similar reasons, we could not examine predictors of antegrade or combined approach failure. However, the aim of this article
Antegradeeretrograde intervention 9
was to present our early findings. A prospective multicenter study using a strategy of combined approach for the high-risk CLI population will be needed. Our findings are based on a single operator’s experience in the setting of a tertiary-care center. As with any technique, a learning curve may be expected among new operators.
CONCLUSION Combined antegradeeretrograde intervention with the simultaneous use of common femoral and distal retrograde access (combined approach) is associated with better CTO lesion revascularization rates in CLI and may be used as a rescue strategy when antegrade attempts fail. We find this technique to be feasible in the majority of such patients with negligible procedural complication. Although larger prospective studies with long-term follow-up data are clearly required, it seems appropriate at the present time to offer this valuable strategy to the high-risk CLI population. REFERENCES 1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45(Suppl S):S5e67. 2. Graziani L, Silvestro A, Bertone V, et al. Vascular involvement in diabetic subjects with ischemic foot ulcer: a new morphologic categorization of disease severity. Eur J Vasc Endovasc Surg 2007;33:453e60. 3. Conrad MF, Crawford RS, Hackney LA, et al. Endovascular management of patients with critical limb ischemia. J Vasc Surg 2011;53:1020e5. 4. Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925e34. 5. Dosluoglu HH, O’Brien-Irr MS, Lukan J, et al. Does preferential use of endovascular interventions by vascular surgeons improve limb salvage, control of symptoms, and survival of patients with critical limb ischemia? Am J Surg 2006;192:572e6. 6. Venkatachalam S, Shishehbor MH, Gray BH. Basic data related to endovascular management of peripheral arterial disease in critical limb ischemia. Ann Vasc Surg 2012;26: 1039e51. 7. Montero-Baker M, Schmidt A, Braunlich S, et al. Retrograde approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther 2008;15:594e604. 8. Spinosa DJ, Harthun NL, Bissonette EA, et al. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) for subintimal recanalization to treat chronic critical limb ischemia. J Vasc Interv Radiol 2005;16:37e44. 9. Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)ea metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377e81. 10. Kashyap VS, Pavkov ML, Bishop PD, et al. Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther 2008;15:117e25.
10 Venkatachalam et al.
11. Kronenberg F, Mundle M, Langle M, et al. Prevalence and progression of peripheral arterial calcifications in patients with ESRD. Am J Kidney Dis 2003;41:140e8. 12. Bolia A, Miles KA, Brennan J, et al. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol 1990;13:357e63. 13. Bolia A. Subintimial angioplasty, the way forward. Acta Chir Belg 2004;104:547e54. 14. Gandini R, Pipitone V, Stefanini M, et al. The ‘‘Safari’’ technique to perform difficult subintimal infragenicular vessels. Cardiovasc Intervent Radiol 2007;30:469e73. 15. Iyer SS, Dorros G, Zaitoun R, et al. Retrograde recanalization of an occluded posterior tibial artery by using a posterior tibial cutdown: two case reports. Cathet Cardiovasc Diagn 1990;20:251e3. 16. Botti CF Jr, Ansel GM, Silver MJ, et al. Percutaneous retrograde tibial access in limb salvage. J Endovasc Ther 2003;10: 614e8.
Annals of Vascular Surgery
17. Rogers RK, Dattilo PB, Garcia JA, et al. Retrograde approach to recanalization of complex tibial disease. Catheter Cardiovasc Interv 2011;77:915e25. 18. Mustapha JA, Saab F, Diaz L, et al. Utility and feasibility of ultrasound-guided access in patients with critical limb ischemia. Catheter Cardiovasc Interv 2013;81:1204e11. 19. Palena LM, Manzi M. Extreme below-the-knee interventions: retrograde transmetatarsal or transplantar arch access for foot salvage in challenging cases of critical limb ischemia. J Endovasc Ther 2012;19:805e11. 20. Soder HK, Manninen HI, Jaakkola P, et al. Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: angiographic and clinical results. J Vasc Interv Radiol 2000;11:1021e31. 21. Feinglass J, Pearce WH, Martin GJ, et al. Postoperative and late survival outcomes after major amputation: findings from the Department of Veterans Affairs National Surgical Quality Improvement Program. Surgery 2001; 130:21e9.