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Antegrade popliteal artery approach for the treatment of critical limb ischemia in patients with occluded superficial femoral arteries

Andrew J. Feiring, MD, FACC, FSCAI , Amy A. Wesolowski, RN

Introduction

Patients with critical limb ischemia (CLI) have a bleak prognosis with a combined 1-year mortality and amputation rate that exceeds 50% [[1][2]]. These patients frequently have extensive above and below knee arterial disease [[3]]. Treating individuals with long superficial femoral artery (SFA) occlusions and jeopardized tibial-peroneal run-off is uniquely challenging especially when the SFA cannot be recanalized, thus precluding antegrade access to the tibial vessels. Surgical revascularizations are frequently precluded because of prohibitive operative risk and/or inappropriate conduit. Consequently, amputation is the therapy most often recommended for these patients [[4]].

In this report, we describe a defined subset of five patients with recent onset CLI secondary to jeopardized tibial run-off. Previously, these patients had stable claudication associated with long-standing unrecanalizable SFA occlusions. All patients were denied femoral-tibial bypass surgery because of co-morbidities and offered amputation as primary therapy. By combining antegrade popliteal arterial access and balloon expandable drug eluting coronary stents, limb salvage was obtained in all patients and all were restored to their pre-CLI status.

Index Case

An 84-year-old male (patient 1) was referred for right CLI. Five years earlier, his left leg was amputated for gangrene. At that time, contrast angiography of the right limb demonstrated a densely calcified and occluded SFA from the ostium to adductor canal. The proximal popliteal artery was reconstituted via profunda collaterals and there was single vessel continuous peroneal artery run-off. After amputation, he was able to ambulate with prosthesis.

One year prior to presentation his claudication worsened, and 6 months later he progressed to nocturnal resting pain, rubor on dependency, and minor ulcerations of the second and third toes. He was seen by two vascular surgeons who recommended amputation because of his high surgical risk and lack of venous conduit. His ABI was 0.31 with a digital toe pressure of 10 mm Hg. The patient had multiple co-morbidities including resting angina, ischemic cardiomyopathy (EF = 25%), prior coronary bypass surgery, hypertension, diabetes, and chronic renal insufficiency (Cr 2.0 mg/dl, eGFR = 34 ml/min/1.73 m2).

Figure 1.
(a) Femoral angiogram of index patient 1, demonstrating SFA occlusion and discontinuous single vessel peroneal artery run-off.
(b) Magnified view of peroneal artery lesion in patient 1.
(c) Magnified view of peroneal lesion post stenting with overlapping 3.0 × 28 mm2 and 3.0 × 18 mm2 Cypher stents.
(d) Same peroneal lesion 25 months post intervention demonstrating minimal in-stent restenosis or stent deformation.
(e) Appearance of same uncontrasted overlapping peroneal stent, note absence of deformation.

 

Right leg angiography demonstrated the previously occluded SFA and two new tandem proximal peroneal lesions (50 and 95%, Fig. 1a). An attempt at percutaneous contralateral recanalization was unsuccessful secondary to inability to engage a proximal SFA stump. Retrograde SFA recanalization via the popliteal approach was considered and rejected because of the poor likelihood of success (i.e. small caliber, long and heavily calcified vessel), and secondary to the risk of jeopardizing collateral flow if the attempt was unsuccessful. Since the patient had been stable up until the time that he developed the peroneal lesions, it was reasoned that successful peroneal intervention might alleviate his symptoms. Consequently, revascularization was attempted from the antegrade popliteal approach.

Methods

The patient was taking daily aspirin (81 mg) and clopidogrel (75 mg daily). He was placed in the prone position and the popliteal artery and vein were identified using duplex ultrasound (ATL-HDI Sono CT). Under direct visualization, avoiding the popliteal vein, a 21 gauge micropuncture needle and 0.018" wire (Cook, Bloomington, IN) was directed from medial to lateral to avoid the femoral nerve. The mid-popliteal artery was entered and a 4 Fr, 11 cm vascular sheath (Cordis, Miami Lakes, FL) was then placed. Heparin 40 U/kg was administered through the sheath and lower leg angiography performed with 8 ml of contrast (VisipaqueTM GE Healthcare), (1b). The lesion was crossed with a 0.014" Wisdom wire (Cordis) and dilated with a 2.5 × 15 mm Stormer (Medtronics) coronary balloon catheter, sized 0.5 mm less than the reference vessel. Thereafter, 3.0 × 28 mm and 3.0 × 18 Cypher stents (Cordis) were deployed in overlapping fashion at 18 atm (1c). Follow-up angiography revealed no residual stenosis and continuous peroneal run-off with brisk collateral filling of the pedal vessels. A total of 28 ml of contrast was used. Following manual hemostasis, a loading dose of Abcixamab 0.125/mg/kg, (Eli Lily, Indianapolis, IN) was administered followed by a 12 hr infusion (10 g/min). Immediately after the procedure, his resting foot pain resolved. He was discharged the following morning without dependent rubor. The post-procedure ABI increased to 0.53 and toe pressures to 42 mm Hg. Two months later, the ulceration had completely healed. Since intervention, the patient has been maintained on aspirin, clopidogrel, and aggressive lipid lowering therapy.

Twenty-three months later the patient returned with recurrent angina, necessitating coronary arteriography and subsequent coronary intervention. Lower extremity angiography demonstrated a patent tibial artery without evidence of in-stent restenosis or stent deformation (Fig. 1d and e). The patient continues to have stable claudication without recurrence of CLI.

Results

Patient demographics and pertinent clinical and technical data are presented in Table I. Mean age was 76 ± 9 years. All patients had CLI as defined by the European Work Group [[5]]. All were considered to be poor candidates for tibial bypass surgery, had been offered amputation as primary therapy, and all failed attempts at contralateral femoral SFA recanalization. Antegrade popliteal interventions with DES were angiographically and clinically successful.

Table I. Patient Demographics and Pertinent Clinical and Technical Data

Patient 1 Patient 2 Patient 3 Patient 4 Patient 5
Age/gender 87/M 80/M M/74 76/M 62/M
Diabetes + + + + +
Cigarettes - + + + +
Creatinine 2.0 1.6 2.3 3.0 1.9
CLI Ulcer Ulcer Ulcer Rest pain Rest pain
Access Duplex Duplex Duplex/SN SN/FA SN
SFA occlusion + + + + +
Culprit lesion(s) P P P/PT AT/PT TP
Sheath size (Fr) 4 4 4 4 4
Stent Cypher Cypher/Taxus Cypher/Cypher Cypher Cypher
Diameter 3.5/3.0 3.0/3.0 3.0/3.0 3.0/2.5/2.5 3.5
Stented length (mm) 28/18 33/28 28/18 33/28/28 24
GP 2b/3a A A I I -
Complication - - - - -
LOS >=24 h >=24 h >=24 h >=24 h >=24 h
ABI/TP-Pre 0.31/10 0.28/25 0.45/15 0.22/35 0.35/18
ABI/TP Post 0.53/42 0.5/50 0.50/38 0.63/45 0.57/56
Clinical follow-up/months 41 31 28 25 18

M, male; SN, smart needle; FA, femoral angiography; P, peroneal; AT, ant tibial; PT, post tibial; TP, tibioperoneal trunk; A, abcixamab; I, integrelin; LOS, length of stay; ABI, ankle brachial index; TP, toe pressure.

 

There were no procedural complications and all patients were discharged the following day. Mean clinical follow-up was 29 ± 8 months, (range 23-41). Post-procedure ABIs demonstrated a modest but significant improved ABI = 0.32 ± 0.09 vs. 0.58 ± 0.09 pre vs. post, P 0.01. Toe pressures also improved (21 ± 9 mm Hg vs. 46 ± 7 pre vs. post, P 0.01). Rest pain and all ulcerations resolved after the procedure. To date, there have been no amputations, acute or sub-acute stent thrombosis, or need for subsequent target lesion revascularization.

Patient 3 developed recurrent rest pain 19 months after initial treatment with DES. Lower extremity angiography revealed progressive disease in a previously untreated portion of an aberrant posterior tibial artery (originating from the popliteal artery) that could not be accessed from an antegrade approach. Eight months earlier, the patient underwent CABG, with subsequent improvement of ventricular function to the point where he could now be referred for above knee femoral-popliteal bypass surgery. After surgery, his rest pain resolved and straight in-line flow was maintained through the previously stented peroneal artery.

During follow-up, two patients underwent percutaneous coronary intervention, one coronary bypass surgery, and one repeat angiographic evaluation of the culprit limb. Angiographic evaluation was performed in 4 of 5 patients on an average of 17.5 ± 4 months after the procedure and did not demonstrate any evidence of restenosis.

Discussion

The methodology described combines two infrequently used endovascular techniques: (1) antegrade popliteal arterial approach to obtain access to the tibial vessels and (2) drug eluting stents (DES) for infra-popliteal endovascular intervention.

The endovascular approach described challenges the traditional surgical tenets that maintain that CLI can only be treated by establishing continuous in-line femoral-tibial arterial flow [[3]]. In contradistinction, we advanced the hypothesis that for a specifically defined subset of patients (i.e., previous long-standing SFA occlusions, well developed SFA/Popliteal collateral reconstitution, rest pain and/or minor ulcerations), successful treatment of the culprit tibial lesion(s) might return them to their previous state even in the absence of optimized femoral-popliteal inflow. Our data suggests that achieving even a modest increase in tibial flow may offer an alternative to those who would otherwise face amputation. The mechanism that results in improvement is unclear. However, in these patients, it is likely that the profunda collaterals developed over many years and thus were adequate to sustain a stable claudication. Thus, with the advent of a new outflow (tibial), lesion distal pressure fell to a point where resting tissue perfusion was compromised, thus resulting in CLI. Since the majority of the profunda/muscular collaterals came in above the tibial lesion, it was felt that treating the outflow would restore the patient to a more stable hemodynamic state.

DES were used in preference to BMS or other interventional techniques. The clinical success of the antegrade popliteal approach is predicated on employing a technically simple and durable means of stabilizing the tibial culprit lesions. Since popliteal artery access may be associated with significant vascular trauma, one goal was to minimize the need for repeated interventions as a result of restenosis. The decision to use balloon expandable stents was predicated on our previous experience with BMS that demonstrated its safety and efficacy when used for below-knee intervention in patients with CLI and severe claudication [[6]]. Furthermore, because BMS prevents elastic recoil and maximizes lumen area, it is the only below-knee endovascular technique that has been shown to improve post intervention ABI's [[6]]. However, our own experience and recently published data have demonstrated significant in-stent restenosis rates with BMS [[7]]. Consequently, extrapolating from the coronary experience with DES and based on our observations using DES for treatment of CLI, we felt that this approach offered the patients the best chance at avoiding restenosis and repeated intervention.

Recently a small randomized study confirmed the favorable restenosis and safety rate of DES compared with bare metal stents placed in the infrapopliteal arteries for CLI [[7]]. In this study, although both DES and BMS were equally effective in preventing amputation, the restenosis rate in the BMS group was 55% vs. 4% for DES. However, the duration of follow-up was only 6 months and thus it could not be determined whether DES would provide a long term benefit. Furthermore, these patients were limited to a single, short (13-14 mm) stent for bailout indications. In contradistinction, the patients in our study were stented with primary intent, had a mean stented length of 44 mm, were clinically followed for an average of 29 months, and had no evidence of angiographic restenosis at 17.5 ± 4 months. These findings thus represent the longest reported follow-up in patients who have undergone infrapopliteal DES implants. Despite all patients having high risk characteristics for restenosis (i.e. low flow arteries, diabetes, long lesions, and chronic kidney disease), there has been no angiographic or clinical restenosis.

In our previous study [[7]], we demonstrated normalization of ABI's in patients undergoing tibial stenting for CLI and claudication. However, in this report, there was only a modest improvement in ABI's. The failure to normalize ABIs was expected since antegrade SFA flow was not reestablished. Nevertheless, the improvement of below-knee antegrade flow appeared to have been sufficient enough to relieve symptoms, effect healing, and restore ambulation. Although there is no data regarding preferred pharmacologic treatment for patients with tibial stents, we have placed all our CLI patients on life thienopyridine and ASA based on data from the Caprie trial [[8]], as well as recent studies suggesting an increased subacute thrombosis in patients with coronary DES [[9]].

Technical Considerations

Antegrade SFA and tibial recanalization is preferred for both hemodynamic effect and technical ease. When this approach fails, a retrograde popliteal approach can be considered [[10-13]]. However, this approach is potentially hazardous since technical failure may worsen ischemia by compromising collaterals or by occlusion of the popliteal segment distal to collateralization. The retrograde pedal approach has been described [[11-13]] for culprit lesions in arteries other than the peroneal artery. This approach is both arduous (requiring cannulation or cut-down of a poorly perfused pedal vessel) and potentially jeopardizes foot run-off and surgical targets.

Antegrade popliteal intervention for popliteal angioplasty has been reported only once ([14] in the context of preparing a distal popliteal artery stenosis for above-knee femoral-popliteal bypass surgery). In contradistinction to this previous report, the current technique (Fig. 2a) was intended as definitive therapy for patients with CLI and few options. Additional innovations include (1) use of a small (4 Fr) arterial sheath, (2) PTA with a low profile 0.014" coronary system, (3) coronary DES supporting primary tibial intervention, and (4) the mid-term clinical follow-up in patients who received below-knee DES. A second case demonstrating popliteal access treatment of a total occlusion is depicted in Fig. 2a-c.

Figure 2.
(a) Patient 2 demonstrates antegrade sheath placement and total occlusion of anterior and posterior tibial arteries. The peroneal artery demonstrates diffuse proximal disease culminating in total occlusion. (b) Magnified view of same peroneal artery lesion. (c) Peroneal stenting with overlapping 3.0 × 32 and 3.0 × 28 Cypher stents.

 

Popliteal artery entry was facilitated by a number of methods. Direct popliteal artery visualization by duplex ultrasound in conjunction with a micropuncture needle was preferred. Since the anatomic relationship between the popliteal artery and vein is variable [[15]], direct visualization permits identification of the popliteal artery and vein and theoretically reduces the risk of arterial-venous fistula formation. However, when ultrasound was unavailable a Smart Needle (Escalon Vascular, New Berlin, WI) was used to identify the artery and separate arterial and venous signals. In one patient who had undergone repeated total knee replacements, the artery was suboptimally identified by either duplex or Smart Needle, and thus angiography from the contralateral approach (so as not to compromise ipsilateral collateral flow) was used to identify the popliteal artery. All endovascular intervention was performed via a 4 Fr sheath, which permitted passage of standard coronary balloons and stents with adequate visualization, and required minimal manual pressure for hemostasis.

Conclusion

In selected patients with CLI, antegrade popliteal arterial access in conjunction with DES provides a limb-sparing alternative for those with SFA occlusion and progressive below-knee tibial arterial disease. Although the numbers are small, our long-term angiographic and clinical follow-up has suggested that this approach is safe, durable, and associated with objective hemodynamic improvement. This approach may provide additional options for patients who have failed other endovascular options and are poor candidates for surgical revascularization.

Consideraciones

La isquemia critica crónica es, en la mayoría de los casos, una enfermedad ateroesclerotica obstructiva multisegmentaria, con la presencia no infrecuente de obstrucción total crónica de la arteria femoral superficial ipsi lateral. En estos casos, el severo compromiso obstructivo de la vasculatura infrapatelar, contraindica o reduce significativamente la tasa de éxito de la revascularización femoropoplitea, obligando, a veces, a realizar técnicas de revascularización más complejas que el by pass femoropopliteo, es decir by pass secuenciales ( por ejemplo: femoropopliteo y distal), es decir ,obligando a realizar cirugías muy prolongadas en pacientes con alto riesgo quirúrgico (comorbilidad asociada), con incisiones largas en territorios isquémicos que predisponen a infecciones, no cicatrización o evolución tórpida de las mismas; además, con lechos vasculares muy enfermos, a menudo calcificados, que le plantean al cirujano un difícil desafío para lograr una adecuada anastomosis y obtener una tasa de éxito mayor.

El éxito de la recanalización endovascular de las obstrucciones totales crónicas de la arteria femoral superficial, esta muy reducido en estos casos (oclusión larga, crónica, con arterias muy calcificadas), lo que tampoco hace atractivo dicha técnica en estos casos, a pesar que en los casos con contraindicación o alto riesgo quirúrgico para bypass Femoro –Poplíteo igual debe in tentarse. Estos artículos mencionan otra nueva opción terapéutica endovascular, que nos parece puede ser de utilidad en casos bien seleccionados. Como bien lo plantea el Dr. Thomas Zeller en el editorial de la misma revista, que revisa este artículo, esta técnica quizás deba también ser tenida en cuenta por el Intervencionista, junto a otras menos utilizadas como:

  1. Recanalización de la arteria femoral superficial por vía retrógrada del acceso popliteo.
  2. Recanalización infrapatelar por acceso pedal, por canulación o disección.

Todas estas técnicas tienen sus limitaciones, que nos gustaría enfatizar:

Otros conceptos del tema tratado a destacar, es la utilización para el acceso popliteo anterogrado de material de tipo coronario (guías, catéter balon), introductores 4 french, aguja de punción 21 y, primordialmente, tratar de visualizar la arteria poplitea con la ayuda del eco doppler o  la angiografía por administración de contraste por punción femoral ipsilateral (colocación de un introductor 4 french antes de colocar al paciente en posición prona?). También, otro concepto a destacar, es que a pesar que no existen trials randomizados que comparen los stents con droga con el bare stent, la tendencia de registros y pequeños estudios observacionales parece confirmar, la impresión clínica, que los stents con droga tienen mejor resultado, a corto y mediano plazo, que los stents convencionales.
Tras realizar estas breves consideraciones, creo nada mejor para finalizar, que el título del editorial del Dr. Thomas Zeller.

“Estrategias individuales de tratamiento son mandatorias para el tratamiento de la isquemia crítica crónica”

References

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Autor: Andrew J. Feiring, MD, FACC, FSCAI , Amy A. Wesolowski, RN

Fuente: Catheterization and Cardiovascular Interventions. Volume 69, Issue 5, Pages 665-670

Ultima actualizacion: 29 DE OCTUBRE DE 2007

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