© 2014, Wiley Periodicals, Inc. DOI: 10.1111/joic.12155
CORONARY ARTERY DISEASE Double Bifurcation Optimization Stent System Technique for Left Main Stenosis D. VASSILEV, M.D., P H .D., 1 H. MATEEV, M.D., 1 A. ALEXANDROV, M.D., 1 K. KARAMFILOFF, M.D., P H .D., 2 and R.J. GIL, M.D., P H .D. 3 From the 1National Heart Hospital, Sofia, Bulgaria; 2University Hospital “St. Ekaterina”, Sofia, Bulgaria; and 3CSK MSWiA, Warsaw, Poland
We present a first‐in‐man case with implantation in culottes’ fashion of two dedicated coronary bifurcation stents (BiOSS Lim) in distal left main stenosis. The immediate procedural and very short‐term result was excellent. (J Interven Cardiol 2014;27:570–573)
Introduction The conventional stent is not intended for bifurcations due to huge variation in vessel anatomy (vessel sizes and angulations differences, plaque distribution) and problems with stent deformation and drug coverage disruption.1–3 The restenosis and thrombosis rate are higher than in cases of nonbifurcation lesion interventions. The dedicated bifurcation stents are invented to solve all or most of these problems, but most of them are bulky devices with low implantation success rate. The Bifurcation Optimization Stent System (BIOSS, Balton, Poland) stent is a dedicated device, which consists of 2 parts with different diameters, connected with 2 longitudinal connections. The most recent version of this device is covered with sirolimus mixed with biodegradable polymer (BIOSS LIM stent). This dedicated stent system allows permanent access to the side branch, which is extremely important in case of left main (LM) bifurcation stenosis. Also, the difference in diameters of proximal and distal parts of the stent allows one to minimize the effect of carina displacement during the stent delivery, which is one of the most important mechanisms for side branch occlusion. Disclosure statement: Dobrin Vassilev is co‐author of patent of BOSS stent and is consultant for Balton, Poland. Robert J. Gil is consultant for Balton, Poland. Address for reprints: D. Vassilev, National Heart Hospital, 65 “Koniovitza” Str., 1309 Sofia, Bulgaria. Fax: 359‐2‐923‐0467; e‐mail: [email protected]
570
The NORDIC III study as well as the most recent report4,5 demonstrated, that culottes’ technique in bifurcation interventions is superior to the other 2 stent techniques, when 2 stent techniques are employed in coronary bifurcation stenosis. It is recommended in almost all anatomy variations. This case report describe a culottes type technique by using 2 dedicated BIOSS Lim stents.
Case Report The patient is a 60‐year‐old female with history of hypertension and dyslipidemia, admitted in our hospital with acute thrombosis of right external iliac artery. She had previous history of ovarian cancer (without additional documentation) and persistent atrial fibrillation, however she was in sinus rhythm at admission. After balloon thrombectomy in vascular surgery department, at second postoperative day, she was transferred to our intensive cardiology unit with signs of hemodynamic compromise, acute pulmonary edema and ECG changes of diffuse ST‐segment depression with troponin rise. Echocardiography showed mild systolic dysfunction with ejection fraction of 45 and anterolateral hypokinesia, without significant valvular lesions. After short compensation of pulmonary edema and hemodynamic support with intravenous inotropes (dopamine and dobutamine), the patient was transferred to the cath lab. The diagnostic angiography showed 3 vessel disease with significant stenosis of LM stem 75% distal LM lesion, bifurcation
Journal of Interventional Cardiology
Vol. 27, No. 6, 2014
DOUBLE BIFURCATION OPTIMIZATION STENT SYSTEM TECHNIQUE
Medina 111; proximal significant lesion of left anterior descending artery, a critical ostial lesion of left circumflex artery (LCx) – a big vessel with diameter comparable with LAD and angle between vessels of 70° and a significant lesion of mid right coronary artery (RCA). Due to very high surgical risk and hemodynamic instability we performed percutaneous coronary intervention (PCI) of all lesions. The first step, with right transradial access a direct stenting of RCA with 2 (Orsiro, Biotronik; 3.5/22 mm/14 atm) sirolimus eluting stent, was performed with excellent result. Then, a 6F Launcher guiding catheter JL 4 was placed in left coronary artery (Fig. 1). The next step was LM intervention: after wiring LAD and LCx with 2 Runthrough Hypercoat wires (Terumo, Japan), a predilatation of ostial LCx lesion (2.5 mm/20 mm balloon/14 atm) was done. Then BIOSS Lim stent 3.5/4.25/23 mm (distal part diameter, proximal part diameter, stent length) was implanted at 14 atmospheres from LM to LCx. Next, a dilatation of LM to the LAD with balloon (3.0 mm/20 mm at 16 atm) was performed, which was extremely easy due to lack of cell in the ostium of LAD (only longitudinal connections). A second BIOSS Lim stent (3.5/4.25/18 mm) was implanted at 16 atm from LM to LAD, due to unsatisfactory angiographic result in ostial LAD after single balloon dilatation. The 2 stents in LAD and in LCx were postdilated with balloon 3.0/20 mm at 18 atm
in terms to facilitate the next final kissing balloon step. The final kissing inflation with 2 noncompliant balloons in LAD (3.5/21 mm) and in LCx (3.0/12 mm) was performed at 14 atm. The final proximal optimization of LM was performed with 4.0/9 mm at 20 atm – with excellent angiographic result (Fig. 2). Figure 3 demonstrates stent per se and how its configuration on inflated balloon; in Figure 3C and D are presented intended and actual schemes of culottes’ technique. The whole procedure was performed for 17 minutes, starting from insertion of guiding catheter, with total fluoroscopy time of the procedure of 14 minutes. After the procedure, the patient was hemodynamically stable. Two days later, due to acute neurologic disturbances (during episode of atrial fibrillation and possible embolic etiology), computer tomography of the brain was performed with signs of acute ischemic stroke. On 5th post procedural day, after an episode of resuscitated bradi‐ asystolia, control angio was performed – with intact stents in all coronary arteries. However, the patient died 6 days after the procedure with signs of brain edema after acute ischemic stroke.
Discussion Our case demonstrates the first‐in‐man implantation of dedicated bifurcation stent BIOSS Lim with
Figure 1. Procedure steps: (a, b) diagnostic angiogram; (c, d) BiOSS Lim implantation to LCx; (e, f) implantation of BiOSS Lim to LAD; (g) final kissing balloons inflation; (h) final POT inflation.
Vol. 27, No. 6, 2014
Journal of Interventional Cardiology
571
VASSILEV, ET AL.
Figure 2. The final result.
Figure 3. (A) BIOSS stent construction; (B) BIOSS stent over dedicated bottle balloon; (C) intended strategy; (D) applied final strategy (schematic presentation from actual angiographic images).
culottes’ technique for high grade distal LM coronary bifurcation stenosis. Our patient was very high ischemic risk, with high prothrombitic state, based on data from patient history about untreated neoplasm, episodes of atrial fibrillation combined with operative intervention for thrombectomy. The BIOSS stent is intended for stenting of main vessel across the side branch, compatible with A‐type stenting procedure according to MADS – classification adopted from a European bifurcation club.6 However, in case of distal LM bifurcation stenosis it is difficult to
572
say which branch is main and which is side branch (both branches are equally important). The BIOSS stent, at least theoretically, based on its design, has an advantage of easy side branch access, with wide ostial opening and easy crossing with a second device.7 This is much easier accomplished in comparison with regular stents, where the appearance of stent struts against the side branch ostium is accidental and impossible to predict. The good side branch opening and struts extension, possibly permit good stent apposition when a second stent is implanted. The
Journal of Interventional Cardiology
Vol. 27, No. 6, 2014
DOUBLE BIFURCATION OPTIMIZATION STENT SYSTEM TECHNIQUE
BIOSS stent has a mid‐marker at the beginning of distal, narrower, part of stent and thus it could be positioned exactly at the carina tip. In difference with other dedicated devices, it is easy to implant 2 BIOSS stents in culottes’ technique, without compromising the result from firstly implanted stent. The historical data from our left main registry demonstrated good long‐ term results with paclitaxel eluting version of BIOSS.8 The proposed culottes’ technique with 2 dedicated stents could ensure better carina region coverage, without destruction of primary stent structure. We did not perform intravascular ultrasound evaluation, because of unstable patient condition and necessity to finish the procedure finish procedure immediately. However, the final angiographic result was excellent. Unfortunately, the patient died from a noncardiac reason and we could not obtain long‐term follow‐up.
References 1. Ajayi NO, Lazarus L, Vanker EA, et al. The impact of left main coronary artery morphology on the distribution of atherosclerotic lesions in its branches. Folia Morphol (Warsz) 2013;72(3):197– 201.
Vol. 27, No. 6, 2014
2. Yoshitaka Goto Y, Kawasaki T, Koga N, et al. Plaque distribution patterns in left main trunk bifurcations: Prediction of branch vessel compromise by multidetector row computed topography after percutaneous coronary intervention. EuroIntervention 2012;8(6): 708–716. doi: 10.4244/EIJV8I6A110 3. Tamburino C, Capranzano P, Capodanno D, et al. Plaque distribution patterns in distal left main coronary artery to predict outcomes after stent implantation. JACC Cardiovasc Interv 2010;3(6):624–631. doi: 10.1016/j.jcin.2010.03.016 4. Kervinen K, Niemelä M, Romppanen H, et al. Clinical outcome after crush versus culotte stenting of coronary artery bifurcation lesions: The Nordic stent technique study 36‐month follow‐up results. JACC Cardiovasc Interv 2013;6(11):1160–1165. doi: 10.1016/j.jcin.2013.06.009 5. Tiroch K, Mehilli J, Byrne RA, et al. Impact of coronary anatomy and stenting technique on long‐term outcome after drug‐eluting stent implantation for unprotected left main coronary artery disease. JACC Cardiovasc Interv 2014;7(1):29–36. doi: 10.1016/ j.jcin.2013.08.013 6. Stankovic G, Darremont O, Ferenc M, et al. Percutaneous coronary intervention for bifurcation lesions: 2008 Consensus document from the fourth meeting of the European Bifurcation Club. Euro Interv 2009;5:39–49. doi: 10.4244/EIJV5I1A08 7. Vassilev D, Gil R, Milewski K. Bifurcation Optimisation Stent System (BiOSS Lim) with sirolimus elution: Results from porcine coronary artery model. EuroIntervention 2011;7(5):614–620. doi: 10.4244/EIJV7I5A98 8. Bil J, Gil RJ, Vassilev D, et al. Dedicated bifurcation paclitaxel‐ eluting stent BiOSS Expert1 in the treatment of distal left main stem stenosis. J Interv Cardiol 2014;27(3):242–251. doi: 10.1111/ joic.12119
Journal of Interventional Cardiology
573
CORONARY ARTERY DISEASE Double Bifurcation Optimization Stent System Technique for Left Main Stenosis D. VASSILEV, M.D., P H .D., 1 H. MATEEV, M.D., 1 A. ALEXANDROV, M.D., 1 K. KARAMFILOFF, M.D., P H .D., 2 and R.J. GIL, M.D., P H .D. 3 From the 1National Heart Hospital, Sofia, Bulgaria; 2University Hospital “St. Ekaterina”, Sofia, Bulgaria; and 3CSK MSWiA, Warsaw, Poland
We present a first‐in‐man case with implantation in culottes’ fashion of two dedicated coronary bifurcation stents (BiOSS Lim) in distal left main stenosis. The immediate procedural and very short‐term result was excellent. (J Interven Cardiol 2014;27:570–573)
Introduction The conventional stent is not intended for bifurcations due to huge variation in vessel anatomy (vessel sizes and angulations differences, plaque distribution) and problems with stent deformation and drug coverage disruption.1–3 The restenosis and thrombosis rate are higher than in cases of nonbifurcation lesion interventions. The dedicated bifurcation stents are invented to solve all or most of these problems, but most of them are bulky devices with low implantation success rate. The Bifurcation Optimization Stent System (BIOSS, Balton, Poland) stent is a dedicated device, which consists of 2 parts with different diameters, connected with 2 longitudinal connections. The most recent version of this device is covered with sirolimus mixed with biodegradable polymer (BIOSS LIM stent). This dedicated stent system allows permanent access to the side branch, which is extremely important in case of left main (LM) bifurcation stenosis. Also, the difference in diameters of proximal and distal parts of the stent allows one to minimize the effect of carina displacement during the stent delivery, which is one of the most important mechanisms for side branch occlusion. Disclosure statement: Dobrin Vassilev is co‐author of patent of BOSS stent and is consultant for Balton, Poland. Robert J. Gil is consultant for Balton, Poland. Address for reprints: D. Vassilev, National Heart Hospital, 65 “Koniovitza” Str., 1309 Sofia, Bulgaria. Fax: 359‐2‐923‐0467; e‐mail: [email protected]
570
The NORDIC III study as well as the most recent report4,5 demonstrated, that culottes’ technique in bifurcation interventions is superior to the other 2 stent techniques, when 2 stent techniques are employed in coronary bifurcation stenosis. It is recommended in almost all anatomy variations. This case report describe a culottes type technique by using 2 dedicated BIOSS Lim stents.
Case Report The patient is a 60‐year‐old female with history of hypertension and dyslipidemia, admitted in our hospital with acute thrombosis of right external iliac artery. She had previous history of ovarian cancer (without additional documentation) and persistent atrial fibrillation, however she was in sinus rhythm at admission. After balloon thrombectomy in vascular surgery department, at second postoperative day, she was transferred to our intensive cardiology unit with signs of hemodynamic compromise, acute pulmonary edema and ECG changes of diffuse ST‐segment depression with troponin rise. Echocardiography showed mild systolic dysfunction with ejection fraction of 45 and anterolateral hypokinesia, without significant valvular lesions. After short compensation of pulmonary edema and hemodynamic support with intravenous inotropes (dopamine and dobutamine), the patient was transferred to the cath lab. The diagnostic angiography showed 3 vessel disease with significant stenosis of LM stem 75% distal LM lesion, bifurcation
Journal of Interventional Cardiology
Vol. 27, No. 6, 2014
DOUBLE BIFURCATION OPTIMIZATION STENT SYSTEM TECHNIQUE
Medina 111; proximal significant lesion of left anterior descending artery, a critical ostial lesion of left circumflex artery (LCx) – a big vessel with diameter comparable with LAD and angle between vessels of 70° and a significant lesion of mid right coronary artery (RCA). Due to very high surgical risk and hemodynamic instability we performed percutaneous coronary intervention (PCI) of all lesions. The first step, with right transradial access a direct stenting of RCA with 2 (Orsiro, Biotronik; 3.5/22 mm/14 atm) sirolimus eluting stent, was performed with excellent result. Then, a 6F Launcher guiding catheter JL 4 was placed in left coronary artery (Fig. 1). The next step was LM intervention: after wiring LAD and LCx with 2 Runthrough Hypercoat wires (Terumo, Japan), a predilatation of ostial LCx lesion (2.5 mm/20 mm balloon/14 atm) was done. Then BIOSS Lim stent 3.5/4.25/23 mm (distal part diameter, proximal part diameter, stent length) was implanted at 14 atmospheres from LM to LCx. Next, a dilatation of LM to the LAD with balloon (3.0 mm/20 mm at 16 atm) was performed, which was extremely easy due to lack of cell in the ostium of LAD (only longitudinal connections). A second BIOSS Lim stent (3.5/4.25/18 mm) was implanted at 16 atm from LM to LAD, due to unsatisfactory angiographic result in ostial LAD after single balloon dilatation. The 2 stents in LAD and in LCx were postdilated with balloon 3.0/20 mm at 18 atm
in terms to facilitate the next final kissing balloon step. The final kissing inflation with 2 noncompliant balloons in LAD (3.5/21 mm) and in LCx (3.0/12 mm) was performed at 14 atm. The final proximal optimization of LM was performed with 4.0/9 mm at 20 atm – with excellent angiographic result (Fig. 2). Figure 3 demonstrates stent per se and how its configuration on inflated balloon; in Figure 3C and D are presented intended and actual schemes of culottes’ technique. The whole procedure was performed for 17 minutes, starting from insertion of guiding catheter, with total fluoroscopy time of the procedure of 14 minutes. After the procedure, the patient was hemodynamically stable. Two days later, due to acute neurologic disturbances (during episode of atrial fibrillation and possible embolic etiology), computer tomography of the brain was performed with signs of acute ischemic stroke. On 5th post procedural day, after an episode of resuscitated bradi‐ asystolia, control angio was performed – with intact stents in all coronary arteries. However, the patient died 6 days after the procedure with signs of brain edema after acute ischemic stroke.
Discussion Our case demonstrates the first‐in‐man implantation of dedicated bifurcation stent BIOSS Lim with
Figure 1. Procedure steps: (a, b) diagnostic angiogram; (c, d) BiOSS Lim implantation to LCx; (e, f) implantation of BiOSS Lim to LAD; (g) final kissing balloons inflation; (h) final POT inflation.
Vol. 27, No. 6, 2014
Journal of Interventional Cardiology
571
VASSILEV, ET AL.
Figure 2. The final result.
Figure 3. (A) BIOSS stent construction; (B) BIOSS stent over dedicated bottle balloon; (C) intended strategy; (D) applied final strategy (schematic presentation from actual angiographic images).
culottes’ technique for high grade distal LM coronary bifurcation stenosis. Our patient was very high ischemic risk, with high prothrombitic state, based on data from patient history about untreated neoplasm, episodes of atrial fibrillation combined with operative intervention for thrombectomy. The BIOSS stent is intended for stenting of main vessel across the side branch, compatible with A‐type stenting procedure according to MADS – classification adopted from a European bifurcation club.6 However, in case of distal LM bifurcation stenosis it is difficult to
572
say which branch is main and which is side branch (both branches are equally important). The BIOSS stent, at least theoretically, based on its design, has an advantage of easy side branch access, with wide ostial opening and easy crossing with a second device.7 This is much easier accomplished in comparison with regular stents, where the appearance of stent struts against the side branch ostium is accidental and impossible to predict. The good side branch opening and struts extension, possibly permit good stent apposition when a second stent is implanted. The
Journal of Interventional Cardiology
Vol. 27, No. 6, 2014
DOUBLE BIFURCATION OPTIMIZATION STENT SYSTEM TECHNIQUE
BIOSS stent has a mid‐marker at the beginning of distal, narrower, part of stent and thus it could be positioned exactly at the carina tip. In difference with other dedicated devices, it is easy to implant 2 BIOSS stents in culottes’ technique, without compromising the result from firstly implanted stent. The historical data from our left main registry demonstrated good long‐ term results with paclitaxel eluting version of BIOSS.8 The proposed culottes’ technique with 2 dedicated stents could ensure better carina region coverage, without destruction of primary stent structure. We did not perform intravascular ultrasound evaluation, because of unstable patient condition and necessity to finish the procedure finish procedure immediately. However, the final angiographic result was excellent. Unfortunately, the patient died from a noncardiac reason and we could not obtain long‐term follow‐up.
References 1. Ajayi NO, Lazarus L, Vanker EA, et al. The impact of left main coronary artery morphology on the distribution of atherosclerotic lesions in its branches. Folia Morphol (Warsz) 2013;72(3):197– 201.
Vol. 27, No. 6, 2014
2. Yoshitaka Goto Y, Kawasaki T, Koga N, et al. Plaque distribution patterns in left main trunk bifurcations: Prediction of branch vessel compromise by multidetector row computed topography after percutaneous coronary intervention. EuroIntervention 2012;8(6): 708–716. doi: 10.4244/EIJV8I6A110 3. Tamburino C, Capranzano P, Capodanno D, et al. Plaque distribution patterns in distal left main coronary artery to predict outcomes after stent implantation. JACC Cardiovasc Interv 2010;3(6):624–631. doi: 10.1016/j.jcin.2010.03.016 4. Kervinen K, Niemelä M, Romppanen H, et al. Clinical outcome after crush versus culotte stenting of coronary artery bifurcation lesions: The Nordic stent technique study 36‐month follow‐up results. JACC Cardiovasc Interv 2013;6(11):1160–1165. doi: 10.1016/j.jcin.2013.06.009 5. Tiroch K, Mehilli J, Byrne RA, et al. Impact of coronary anatomy and stenting technique on long‐term outcome after drug‐eluting stent implantation for unprotected left main coronary artery disease. JACC Cardiovasc Interv 2014;7(1):29–36. doi: 10.1016/ j.jcin.2013.08.013 6. Stankovic G, Darremont O, Ferenc M, et al. Percutaneous coronary intervention for bifurcation lesions: 2008 Consensus document from the fourth meeting of the European Bifurcation Club. Euro Interv 2009;5:39–49. doi: 10.4244/EIJV5I1A08 7. Vassilev D, Gil R, Milewski K. Bifurcation Optimisation Stent System (BiOSS Lim) with sirolimus elution: Results from porcine coronary artery model. EuroIntervention 2011;7(5):614–620. doi: 10.4244/EIJV7I5A98 8. Bil J, Gil RJ, Vassilev D, et al. Dedicated bifurcation paclitaxel‐ eluting stent BiOSS Expert1 in the treatment of distal left main stem stenosis. J Interv Cardiol 2014;27(3):242–251. doi: 10.1111/ joic.12119
Journal of Interventional Cardiology
573
