Abstract
The best treatment strategy for below the knee bifurcation disease is not known. We present first two cases with successful implantation of dedicated coronary bifurcation sirolimus eluting stent BiOSS Lim (Balton, Poland) in complex bifurcation and trifurcation lesions of tibioperoneal trunk. Both implantations were uncomplicated with sustained short-term result at 30-day control Duplex ultrasound and remarkable clinical improvement. Our report demonstrates feasibility and short-term effectiveness of implantation of dedicated coronary bifurcation stent in below-the-knee bi- and tri-furcations.
1
Background
The experience with stenting of bifurcation lesions at the below-the-knee (BTK) region is very limited . The problem of best technique to perform angioplasty and stenting of this region increases as stenting BTK lesions became more popular, especially with advent of drug eluting stents (DES) because of the better results obtained with DES in comparison with bare metal stents and balloon angioplasty . Moreover, because at the level of tibial arteries, the main and side branch definition is not clear as both vessels are equally important for blood supply of the foot and the number of patent vessels supplying the foot is directly related with limb salvage rate , this issue becomes even more important. For coronary arteries, it is accepted that placement of one stent in main vessel across the side branch with or without final kissing balloons inflation gives better results, than two stenting techniques . The bifurcation of anterior tibial artery (ATA) and tibio-peroneal trunk (TPT) as well as bifurcation of posterior tibial artery (PTA) and peroneal artery (PA) is usually involved in BTK lesions — practically in 97% of the patients, at least one of those bifurcations is affected in patients with critical limb ischemia (CLI) and diabetes . Most of previous studies, suggested that ensuring patency of more BTK vessels results in good outcomes also because it allows a good run off for eventually previously treated femoral arteries .
For the bifurcation lesions, where both arteries are equally important, a dedicated bifurcation stent may be a good option, ensuring good final result in both branches (as for stenting of distal left main coronary bifurcation lesion). In previous studies from coronary bifurcations, we obtained good results with paclitaxel-eluting version of BiOSS stent . In the interim analysis from the first and the only randomized study with dedicated coronary bifurcation stent compared with any other drug-eluting stent, BiOSS Expert stent demonstrated numerically better results against paclitaxel eluting stents in bifurcations (target lesion revascularization rates (TLR) 10.9% vs. 12.3%, p = ns), but it was inferior to -olimus-eluting stents (TLR 10.9% vs. 6%, p = .001) . However, the results from newest version with sirolimus elusion of BiOSS stent (BiOSS Lim) are much better, with TLR rates of 6% at 9-month angiographic follow-up, comparable with best available drug-eluting stents used in above mentioned randomized study . Based on these results we decided to use BiOSS Lim stent for stenting of suboptimal result of balloon angioplasty of below-the-knee bifurcation lesions. This report describes our initial experience with implantation of dedicated coronary bifurcation stent BiOSS Lim (Bifurcation Optimization Stent System, Balton, Poland) in BTK bifurcation lesions.
2
Methods
We have reported previously our experience with paclitaxel-eluting version of this device in coronary bifurcation lesions . Now a sirolimus eluting version of a stent is available with biodegradable polymer. The stent consists of two different parts with different diameters, matching proximal and distal bifurcation vessel sizes, connected with two connection struts, permitting flexion of stent after balloon deflation, thus adapting stent to bifurcation main vessel angulations. The connector part is 1.5 mm long, which enough for adaptation to any bifurcation anatomy. The stent is available in lengths of 15, 18 and 23 mm, with distal diameters from 2.5 mm to 3.5 mm and proximal diameters 3.0 mm to 4.25 mm, permitting coverage of whole spectrum of sizes in coronary arteries and practically all sizes in BTK vessels. The stent system is introduced into the lesion over one wire, thus ensuring very low device profile, which could be introduced through 5 Fr guiding catheter or 4 Fr introducing sheath. The mid-marker, which denotes the beginning of thinner distal part of the stent, is placed exactly at the tip of the carina. After inflation at nominal pressure, balloon is deflated, permitting self-configuration of a stent according to local anatomy ( Fig. 1 ). The side branch ostium could be dilated if necessary, without requirement of final kissing balloon inflation, as both parts of the stent behave independently.
2
Methods
We have reported previously our experience with paclitaxel-eluting version of this device in coronary bifurcation lesions . Now a sirolimus eluting version of a stent is available with biodegradable polymer. The stent consists of two different parts with different diameters, matching proximal and distal bifurcation vessel sizes, connected with two connection struts, permitting flexion of stent after balloon deflation, thus adapting stent to bifurcation main vessel angulations. The connector part is 1.5 mm long, which enough for adaptation to any bifurcation anatomy. The stent is available in lengths of 15, 18 and 23 mm, with distal diameters from 2.5 mm to 3.5 mm and proximal diameters 3.0 mm to 4.25 mm, permitting coverage of whole spectrum of sizes in coronary arteries and practically all sizes in BTK vessels. The stent system is introduced into the lesion over one wire, thus ensuring very low device profile, which could be introduced through 5 Fr guiding catheter or 4 Fr introducing sheath. The mid-marker, which denotes the beginning of thinner distal part of the stent, is placed exactly at the tip of the carina. After inflation at nominal pressure, balloon is deflated, permitting self-configuration of a stent according to local anatomy ( Fig. 1 ). The side branch ostium could be dilated if necessary, without requirement of final kissing balloon inflation, as both parts of the stent behave independently.
3
Case Report
3.1
Case 1
An 83-year-old male patient with risk factors arterial hypertension, dyslipidemia, renal failure (GFR 43 ml/h), active smoker, operated for prostate carcinoma 2 months before admission, has been admitted to our hospital because of severe rest pain and non-healing wounds on left toe and medial part of the heel. The ankle–brachial index (ABI) was 0.33 with ankle pressure of 40 mmHg. On duplex scan and diagnostic angiography, an occlusion of popliteal artery, as well as proximal parts of all BTK arteries, was demonstrated ( Fig. 2 A–D ), with distal filling of posterior tibial artery and very distal part of anterior tibial artery. The distal part of peroneal artery gave collateral filling to distal part of tibial arteries. The patient was submitted to endovascular treatment. The patient received clopidogrel 300 mg and 325 mg aspirin day before the procedure. A 5 Fr introducer sheath was placed. A 100 U/kg heparin was given intravenously. A V-18 control wire (Boston Scientific Corp., USA) supported with 4 Fr Berenstein catheter (Merit Medical, USA) crossed the occlusions and was placed in distal peroneal artery. The popliteal artery and tibioperoneal trunk were dilated with 3.0 × 40 mm Passeo balloon (Biotronik, Germany) at 14 atm. Then anterior tibial artery was wired with Victory 14 (Boston Scientific Corp., USA) and the artery was dilated with Passeo balloon 3.00 × 100 mm at 8–15 atm. The popliteal artery was finally dilated with 5.00 × 120 mm Passeo balloon at 10 atm 2 times for 5 min. The final result was good, with non-flow limiting dissection at bifurcation of ATA and tibio-peroneal trunk ( Fig. 2 E–I). As it was impossible to recanalize the posterior tibial artery and there was a wound on his heel, the patient was scheduled for re-do PTA after two months. In the meantime 75 mg clopidogrel plus aspirin 81 mg was prescribed.
The patient was re-admitted two months later. He was without any pain in the leg and the wounds were starting to heal. The angiography demonstrated a good result, without restenosis in popliteal artery, ostial 80% restenosis of peroneal artery with proximal subtotal occlusion in proximal third and 50% stenosis and occlusion of ATA in proximal third ( Fig. 3 A–B ). A huge collateral developed between the proximal and distal ATA. This time it was not possible to place a wire in the distal ATA. The proximal two thirds, from the ostium, were dilated with Coyote balloon (Boston Scientific Corp., USA) 3. × 150 mm at 10 atm for 3 min ( Fig. 3 C). With the same balloon the proximal part of peroneal artery was dilated at 12 atm ( Fig. 3 D). A Pilot 50 wire (Abbott Vascular, USA) was placed in distal peroneal artery and then through collaterals consequently in distal posterior and anterior tibial arteries. Both collaterals and respective parts of tibial arteries were dilated with Passeo balloon 2.0 × 80 mm at 5–10 atm. As the peroneal artery was of utmost importance for sustaining of distal foot circulation and recoil at the ostium after balloon inflations, we decided to stabilize the result with placement of dedicated coronary bifurcation stent BiOSS Lim (Balton, Poland). The stent 3.0 × 3.5 × 23 mm (distal diameter, proximal diameter, stent length) was placed with the mid-marker positioned at the bifurcation carina tip ( Fig. 3 F–G). The stent was inflated at 12 atm ( Fig. 3 H–I). The result was good and to secure ATA access we made final kissing balloon inflation with 3.5 × 20 mm Sprinter NC balloon (Medtronics, USA) placed in peroneal artery and 3.0 × 20 Sprinter NC balloon placed in ATA, both inflated at 20 atm ( Fig. 3 I). The final result was excellent ( Fig. 3 M). The patient was uneventfully discharged and at 30-day control duplex scan there was a good flow in treated segments, with continuous wound healing. The control ABI was 0.68. He was left on double antiplatelet therapy with clopidogrel 75 mg for 12 months and aspirin 81 mg for life.
