456
J ENDOVASC THER 2014;21:456–459
^ VASCULAR
IMAGES —————————————————————————————
^
Optical Frequency-Domain Imaging to Guide Implantation of a Paclitaxel-Eluting Stent in the Femoral Artery Italo Porto, MD1; Kenneth J. Ducci, MD1; Paolo Angioli, MD1; Simone Grotti, MD1; Giovanni Falsini, MD1; Rocco Vergallo, MD2; Francesco Liistro, MD1; and Leonardo Bolognese, MD1 1
Interventional Cardiology Unit, San Donato Hospital, Arezzo, Italy. 2Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
A relatively new advancement in the field of intravascular frequency-domain optical coherence tomography (FD-OCT) is demonstrated in a 67-year-old man with critical limb ischemia (CLI) and ulceration of the left first toe. Angiography through a 6-F sheath revealed extensive atheromatous disease of the superficial femoral artery (SFA) and proximal popliteal artery, followed by relatively disease-free mid and distal popliteal tracts. There was a patent but proximally diseased anterior tibial artery (ATA) and a diffusely diseased tibioperoneal trunk, with occlusion of the posterior tibial artery and a patent but diffusely infiltrated peroneal artery. A 0.014-inch guidewire (PT Graphix; Boston Scientific, Natick, MA, USA) was placed in the ATA, which was subsequently dilated with a Coyote 33120-mm balloon (Boston Scientific) with good result. The SFA was dilated multiple times with a 5360-mm Savvy balloon (Cordis/Johnson & Johnson, Miami Lakes, FL, USA), resulting in a complicated dissection of the distal region. At this point, we elected to use the newly available LUNAWAVE Optical Frequency Domain Imaging (OFDI) system with the FastView Imaging Catheter (Terumo, Tokyo, Japan) in order to reduce the amount of contrast needed to complete the procedure, to obtain the best possible evaluation of the extent of the dissection plane, and to identify a possible
landing zone for a stent, while also avoiding stenting near the knee joint. OFDI was performed using a normal saline flush technique with simultaneous manual obstruction of the common femoral artery. The flush was administered through the 6-F sheath’s sideport with an automated injector pump. Infusion settings were adjusted at a total volume of 50 mL, an injection rate of 10 mL/s, and a maximum pressure of 400 psi. OFDI-derived parameters were important for determining the subsequent treatment plan (Figure). The first run required ~5 seconds and allowed us to accurately estimate the length of the stent needed to cover the balloon-induced dissection and identify an appropriate, disease-free landing zone. A 6360-mm self-expanding, paclitaxel-eluting ZILVER PTX stent (Cook Medical, Bloomington, IN, USA) was deployed and optimized using a 6340-mm Savvy balloon, with good angiographic result. The post stent OFDI run demonstrated the acute performance of the ZILVER PTX stent (Figure). The additional procedure time required for OFDI assessment and evaluation was on the order of 15 minutes.
DISCUSSION Intravascular FD-OCT, a technology employed extensively in coronary interventions, has recently been used to guide treatment of
Italo Porto and Leonardo Bolognese have received an unrestricted research grant from Terumo Europe. The other authors declare no association with any individual, company, or organization having a vested interest in the subject matter/ products mentioned in this article. Corresponding author: Dr. Italo Porto, Interventional Cardiology Unit, San Donato Hospital, Arezzo, Italy. E-mail: italo. [email protected] Q 2014 INTERNATIONAL SOCIETY
OF
ENDOVASCULAR SPECIALISTS
doi:10.1583/13-4634.1
Available at www.jevt.org
J ENDOVASC THER 2014;21:456–459
OCT TO GUIDE STENT IMPLANTATION Porto et al.
457
OCT TO GUIDE STENT IMPLANTATION Porto et al.
Figure ^ Composite image depicting angiographic (A–C) and corresponding OFDI slices (D–M). After balloon predilation (see text for details), (A) angiography shows a large, non-flow-limiting dissection plane in the distal SFA. In the corresponding OFDI slice (D), an intimal tear (arrow) is clearly visible, with an underlying, angiographically visible, spiral intramural hematoma that dissects the media and travels caudally (asterisk in panels D–F). A residual severe stenosis is visible in E, while a possible landing zone with limited atheroma is obvious in H. (G) At this level, the distal stenosis is caused by a fibrocalcific plaque (thick fibrous cap, multiple sharply delineated low back-scattering areas) despite its angiographic haziness. Calculated minimal lumen area at this point is around 10 mm2, a value unlikely to produce a significant pressure gradient. After stent deployment, (B) the 6360mm ZILVER PTX is postdilated at high pressure with a 6340-mm balloon. Post stenting, (C) angiographic and (I–M) OFDI images show the appearance of the stent at its proximal (M) and distal (K) edges, with some acute malapposition that is expected to disappear as the self-expanding nitinol stent increases in diameter (L, also minimal in K). The slice (L) taken at the point of the previously severe stenosis shows the same dissection plane (asterisk) seen in pre-stenting images; prolapse of plaque material is evident (arrow). The stent is elliptical, probably to follow the vessel’s curvature, and areas of severe, non-concentric malapposition are seen between 2 and 3 and 6 and 7 o’clock.
458
J ENDOVASC THER 2014;21:456–459
femoropopliteal and below-the-knee districts.1–3 Images with resolution of 10 to 20 microns have proven useful in identifying angiographically invisible dissections4 and characterizing the underlying atherosclerotic process. Moreover, detailed images of neointimal hyperplasia and neoatherosclerosis developing within drug-eluting stents previously implanted below the knee have been obtained.3 The FD-OCT system employed in these publications1–4 (C7-XR; St. Jude, St. Paul, MN, USA), however, has some limitations that may hamper its routine use in the peripheral circulation. Indeed, patients with CLI, the most important indication for infrainguinal district revascularization, often present with very long lesions (.10 cm), while the maximum scan length of the C7 Dragonfly catheter is 54 mm. Maximum pullback speed is 20 mm/s, allowing the acquisition of 271 frames in 2.7 seconds. Thus, in peripheral applications, multiple runs have to be acquired, which must then be manually overlapped using fiduciary points to reconstruct the artery path. Multiple acquisitions also carry the risk of a large iodine load (angiographic dye is used to clear the blood) in patients who are generally at risk for contrastinduced kidney damage, although some authors have employed CO2 or dextran5 with good results. It has to be noted, however, that some of these limitations will be significantly reduced with the upcoming availability of the new Ilumien Optis system (St. Jude), which will support a new catheter with a 74-mm pullback length. In the case illustrated here, the LUNAWAVE OFDI system was used to assist paclitaxeleluting stent deployment in a diffusely diseased femoropopliteal segment. The OFDI is capable of acquiring images with high-speed automated pullback (up to 40 mm/s). Most importantly, the FastView catheter scan length of 150 mm makes it attractive for use in the infrainguinal district, as it requires only a short contrast injection (3.7 seconds at 40 mm/s) to clear the blood. Another important difference between the two systems is that the declared scan diameter in saline is 8.3 mm (St. Jude) vs. 10 mm (Terumo), which can have important implications in large vessels.
J ENDOVASC THER 2014;21:456–459
In our patient, only two runs (pre and post stenting) were performed to evaluate the entire tract of interest, using 100 mL of normal saline for both acquisitions. Not only did the OFDI help size the stent to span the dissection and land in a disease-free section of the artery, but it also reduced the total contrast load to only 60 mL. To the best of our knowledge, no intravascular images of a freshly implanted ZILVER PTX stent have been published until now. Our case clearly demonstrates that good quality pictures can be acquired without contrast using the OFDI system in the femoropopliteal district. Visualization of the arterial structures was good even at the more proximal part of the femoral artery (diameter ~7 to 8 mm).
REFERENCES 1. Karnabatidis D, Katsanos K, Paraskevopoulos I, et al. Frequency-domain intravascular optical
OCT TO GUIDE STENT IMPLANTATION Porto et al.
2.
3.
4.
5.
459
coherence tomography of the femoropopliteal artery. Cardiovasc Intervent Radiol. 2011;34: 1172–1181. Negi SI, Rosales O. The role of intravascular optical coherence tomography in peripheral percutaneous interventions. J Invasive Cardiol. 2013;25:E51–53. Paraskevopoulos I, Spiliopoulos S, Davlouros P, et al. Evaluation of below-the-knee drug-eluting stents with frequency-domain optical coherence tomography: neointimal hyperplasia and neoatherosclerosis. J Endovasc Ther. 2013;20:80– 93. Stefano GT, Mehanna E, Parikh SA. Imaging a spiral dissection of the superficial femoral artery in high resolution with optical coherence tomography-seeing is believing. Catheter Cardiovasc Interv. 2013;81:568–572. Allemang MT, Lakin RO, Kanaya T, et al. The use of dextran and carbon dioxide for optical coherence tomography in the superficial femoral artery. J Vasc Surg. 2014;59:238–240.
J ENDOVASC THER 2014;21:456–459
^ VASCULAR
IMAGES —————————————————————————————
^
Optical Frequency-Domain Imaging to Guide Implantation of a Paclitaxel-Eluting Stent in the Femoral Artery Italo Porto, MD1; Kenneth J. Ducci, MD1; Paolo Angioli, MD1; Simone Grotti, MD1; Giovanni Falsini, MD1; Rocco Vergallo, MD2; Francesco Liistro, MD1; and Leonardo Bolognese, MD1 1
Interventional Cardiology Unit, San Donato Hospital, Arezzo, Italy. 2Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
A relatively new advancement in the field of intravascular frequency-domain optical coherence tomography (FD-OCT) is demonstrated in a 67-year-old man with critical limb ischemia (CLI) and ulceration of the left first toe. Angiography through a 6-F sheath revealed extensive atheromatous disease of the superficial femoral artery (SFA) and proximal popliteal artery, followed by relatively disease-free mid and distal popliteal tracts. There was a patent but proximally diseased anterior tibial artery (ATA) and a diffusely diseased tibioperoneal trunk, with occlusion of the posterior tibial artery and a patent but diffusely infiltrated peroneal artery. A 0.014-inch guidewire (PT Graphix; Boston Scientific, Natick, MA, USA) was placed in the ATA, which was subsequently dilated with a Coyote 33120-mm balloon (Boston Scientific) with good result. The SFA was dilated multiple times with a 5360-mm Savvy balloon (Cordis/Johnson & Johnson, Miami Lakes, FL, USA), resulting in a complicated dissection of the distal region. At this point, we elected to use the newly available LUNAWAVE Optical Frequency Domain Imaging (OFDI) system with the FastView Imaging Catheter (Terumo, Tokyo, Japan) in order to reduce the amount of contrast needed to complete the procedure, to obtain the best possible evaluation of the extent of the dissection plane, and to identify a possible
landing zone for a stent, while also avoiding stenting near the knee joint. OFDI was performed using a normal saline flush technique with simultaneous manual obstruction of the common femoral artery. The flush was administered through the 6-F sheath’s sideport with an automated injector pump. Infusion settings were adjusted at a total volume of 50 mL, an injection rate of 10 mL/s, and a maximum pressure of 400 psi. OFDI-derived parameters were important for determining the subsequent treatment plan (Figure). The first run required ~5 seconds and allowed us to accurately estimate the length of the stent needed to cover the balloon-induced dissection and identify an appropriate, disease-free landing zone. A 6360-mm self-expanding, paclitaxel-eluting ZILVER PTX stent (Cook Medical, Bloomington, IN, USA) was deployed and optimized using a 6340-mm Savvy balloon, with good angiographic result. The post stent OFDI run demonstrated the acute performance of the ZILVER PTX stent (Figure). The additional procedure time required for OFDI assessment and evaluation was on the order of 15 minutes.
DISCUSSION Intravascular FD-OCT, a technology employed extensively in coronary interventions, has recently been used to guide treatment of
Italo Porto and Leonardo Bolognese have received an unrestricted research grant from Terumo Europe. The other authors declare no association with any individual, company, or organization having a vested interest in the subject matter/ products mentioned in this article. Corresponding author: Dr. Italo Porto, Interventional Cardiology Unit, San Donato Hospital, Arezzo, Italy. E-mail: italo. [email protected] Q 2014 INTERNATIONAL SOCIETY
OF
ENDOVASCULAR SPECIALISTS
doi:10.1583/13-4634.1
Available at www.jevt.org
J ENDOVASC THER 2014;21:456–459
OCT TO GUIDE STENT IMPLANTATION Porto et al.
457
OCT TO GUIDE STENT IMPLANTATION Porto et al.
Figure ^ Composite image depicting angiographic (A–C) and corresponding OFDI slices (D–M). After balloon predilation (see text for details), (A) angiography shows a large, non-flow-limiting dissection plane in the distal SFA. In the corresponding OFDI slice (D), an intimal tear (arrow) is clearly visible, with an underlying, angiographically visible, spiral intramural hematoma that dissects the media and travels caudally (asterisk in panels D–F). A residual severe stenosis is visible in E, while a possible landing zone with limited atheroma is obvious in H. (G) At this level, the distal stenosis is caused by a fibrocalcific plaque (thick fibrous cap, multiple sharply delineated low back-scattering areas) despite its angiographic haziness. Calculated minimal lumen area at this point is around 10 mm2, a value unlikely to produce a significant pressure gradient. After stent deployment, (B) the 6360mm ZILVER PTX is postdilated at high pressure with a 6340-mm balloon. Post stenting, (C) angiographic and (I–M) OFDI images show the appearance of the stent at its proximal (M) and distal (K) edges, with some acute malapposition that is expected to disappear as the self-expanding nitinol stent increases in diameter (L, also minimal in K). The slice (L) taken at the point of the previously severe stenosis shows the same dissection plane (asterisk) seen in pre-stenting images; prolapse of plaque material is evident (arrow). The stent is elliptical, probably to follow the vessel’s curvature, and areas of severe, non-concentric malapposition are seen between 2 and 3 and 6 and 7 o’clock.
458
J ENDOVASC THER 2014;21:456–459
femoropopliteal and below-the-knee districts.1–3 Images with resolution of 10 to 20 microns have proven useful in identifying angiographically invisible dissections4 and characterizing the underlying atherosclerotic process. Moreover, detailed images of neointimal hyperplasia and neoatherosclerosis developing within drug-eluting stents previously implanted below the knee have been obtained.3 The FD-OCT system employed in these publications1–4 (C7-XR; St. Jude, St. Paul, MN, USA), however, has some limitations that may hamper its routine use in the peripheral circulation. Indeed, patients with CLI, the most important indication for infrainguinal district revascularization, often present with very long lesions (.10 cm), while the maximum scan length of the C7 Dragonfly catheter is 54 mm. Maximum pullback speed is 20 mm/s, allowing the acquisition of 271 frames in 2.7 seconds. Thus, in peripheral applications, multiple runs have to be acquired, which must then be manually overlapped using fiduciary points to reconstruct the artery path. Multiple acquisitions also carry the risk of a large iodine load (angiographic dye is used to clear the blood) in patients who are generally at risk for contrastinduced kidney damage, although some authors have employed CO2 or dextran5 with good results. It has to be noted, however, that some of these limitations will be significantly reduced with the upcoming availability of the new Ilumien Optis system (St. Jude), which will support a new catheter with a 74-mm pullback length. In the case illustrated here, the LUNAWAVE OFDI system was used to assist paclitaxeleluting stent deployment in a diffusely diseased femoropopliteal segment. The OFDI is capable of acquiring images with high-speed automated pullback (up to 40 mm/s). Most importantly, the FastView catheter scan length of 150 mm makes it attractive for use in the infrainguinal district, as it requires only a short contrast injection (3.7 seconds at 40 mm/s) to clear the blood. Another important difference between the two systems is that the declared scan diameter in saline is 8.3 mm (St. Jude) vs. 10 mm (Terumo), which can have important implications in large vessels.
J ENDOVASC THER 2014;21:456–459
In our patient, only two runs (pre and post stenting) were performed to evaluate the entire tract of interest, using 100 mL of normal saline for both acquisitions. Not only did the OFDI help size the stent to span the dissection and land in a disease-free section of the artery, but it also reduced the total contrast load to only 60 mL. To the best of our knowledge, no intravascular images of a freshly implanted ZILVER PTX stent have been published until now. Our case clearly demonstrates that good quality pictures can be acquired without contrast using the OFDI system in the femoropopliteal district. Visualization of the arterial structures was good even at the more proximal part of the femoral artery (diameter ~7 to 8 mm).
REFERENCES 1. Karnabatidis D, Katsanos K, Paraskevopoulos I, et al. Frequency-domain intravascular optical
OCT TO GUIDE STENT IMPLANTATION Porto et al.
2.
3.
4.
5.
459
coherence tomography of the femoropopliteal artery. Cardiovasc Intervent Radiol. 2011;34: 1172–1181. Negi SI, Rosales O. The role of intravascular optical coherence tomography in peripheral percutaneous interventions. J Invasive Cardiol. 2013;25:E51–53. Paraskevopoulos I, Spiliopoulos S, Davlouros P, et al. Evaluation of below-the-knee drug-eluting stents with frequency-domain optical coherence tomography: neointimal hyperplasia and neoatherosclerosis. J Endovasc Ther. 2013;20:80– 93. Stefano GT, Mehanna E, Parikh SA. Imaging a spiral dissection of the superficial femoral artery in high resolution with optical coherence tomography-seeing is believing. Catheter Cardiovasc Interv. 2013;81:568–572. Allemang MT, Lakin RO, Kanaya T, et al. The use of dextran and carbon dioxide for optical coherence tomography in the superficial femoral artery. J Vasc Surg. 2014;59:238–240.
