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Native superficial femoral artery peripheral atherectomy site pseudoaneurysm: A case report
CASE REPORTS From the Society for Clinical Vascular Surgery
Native superficial femoral artery peripheral atherectomy site pseudoaneurysm: A case report Shivprasad D. Nikam, MD, Joe H. Morgan, MD, Emad M. Zakhary, MD, Spencer W. Galt, MD, James R. Elmore, MD, and David P. Franklin, MD, Danville, Pa A 45-year-old woman who presented with blue toe syndrome was treated with atherectomy for a focal plaque located in the superficial femoral artery. She subsequently developed a large pseudoaneurysm at the atherectomy site requiring multiple sequential endovascular procedures in order to maintain in-line blood flow to the foot. Pseudoaneurysm formation at native peripheral artery atherectomy site has not been reported previously. We discuss possible complications of atherectomy and the possible mechanism of pseudoaneurysm formation after atherectomy. We address the importance of understanding risks of these minimally invasive procedures along with planning follow-up duplex and potential bail-out tactics. (J Vasc Surg 2007;46:565-8.)
Peripheral atherectomy is a resurgent and exciting treatment as an alternative to lower extremity arterial bypass for treatment of superficial femoral artery (SFA) disease in symptomatic patients with critical limb ischemia and disabling claudication. Long-term efficacy of these endovascular technique remains to be established. However, the endovascular options such as atherectomy are often appealing since they are associated with a lower periprocedural morbidity and mortality. With the availability of the SilverHawk (FoxHollow Technologies Inc., Redwood City, Calif) atherectomy device, there has been a renewed interest in the atherectomy technique. Common early complications related to this device include need for emergency access site surgery, retroperitoneal hemorrhage, vascular perforation, or plaque dissection.1 A pseudoaneurysm formation at the atherectomy site in the native artery has not been reported in the noncoronary literature. We report a case of a patient who developed a large pseudoaneurysm in the segment of SFA treated by atherectomy. CASE REPORT A 45-year-old woman with 30-pack per year history of smoking was referred to our hospital with complaints of bluish discoloration of left great toe with burning pain. Physical examination revealed dusky discoloration of the toes and hyperesthesia. The ipsilateral pedal pulses were palpable. Multiple angiographic projections revealed a localized complex plaque in the left mid-SFA as a cause of distal embolization (Fig 1). The lesion was treated with atherectomy carried out using the SilverHawk atherectomy catheter (LS cutter) via contralateral femoral approach. Multiple passes of the catheter were used to excise From the Geisinger Medical Center. Competition of interest: none. Presented at the Thirty-fourth Annual Symposium of the Society for Clinical Vascular Surgery, Las Vegas, Nev, Mar 8-11, 2006. Reprint requests: Shivprasad Nikam, MD, Department of Vascular Surgery, Geisinger Medical Center, 100 N Academy Avenue, Danville, PA 178222150 (e-mail: [email protected]). 0741-5214/$32.00 Copyright © 2007 by The Society for Vascular Surgery. doi:10.1016/j.jvs.2007.04.046
the complex plaque in the left mid-SFA, while an Accunet (Abbott Laboratories, Abbott Park, Ill) embolic protection device was positioned in the popliteal artery. Each pass of atherectomy spanned a distance of 6 to 7 cm. At completion of atherectomy, irregularities were noted in the vessel wall proximal and distal to the main lesion (Fig 2). These irregularities were treated with placement of a short nitinol self-expanding SMART (Cordis Corporation, Miami Lakes, Fla) stent (7 mm ⫻ 40 mm). Balloon angioplasty was not performed. Patient was discharged on the first postoperative day with palpable pedal pulses. On the third postoperative day, she developed leg edema and was treated with fractionated heparin and warfarin for a diagnosis of deep vein thrombosis (DVT). Duplex examination revealed left popliteal vein DVT with an aneurysmal SFA measuring 2 cm in maximum diameter. She was seen in the clinic in 1 week and again in 3 months with improvement of edema. At the 4-month follow-up visit, her left SFA was found to have a maximum diameter of 2.8 cm. Angiography revealed a bi-lobed pseudoaneurysm distal to the stent in the atherectomized zone of SFA (Fig 3). The pseudoaneurysm extended over an 8 cm segment of the SFA. This was treated with placement of 7 mm ⫻ 10 cm and 7 mm ⫻ 5 cm Viabahn endoprostheses (W. L. Gore & Associates, Inc, Flagstaff, Ariz) with successful exclusion of the pseudoaneurysm (Fig 4). At the 6-week follow-up visit after the secondary procedure, there was evidence of in-stent stenosis of the Viabahn stent with peak systolic velocity of 250 cm/s and a fall in ABI to 0.7. This was treated by balloon angioplasty with no residual stenosis. Warfarin was discontinued at this stage due to completion of DVT treatment, but she was continued on aspirin and clopidogrel. One week later, she returned with sudden onset of rest pain in left forefoot with dusky discoloration. Angiography demonstrated occlusion of the Viabahn stent (Fig 5). In view of the small caliber of her saphenous vein and patient preference, this was treated with mechanical thrombectomy and placement of self-expanding stents in SFA and the popliteal artery. This included placement of a stent within the Viabahn endoprostheses as an attempt to salvage the in-line flow to the leg (Fig 6). Warfarin was resumed empirically but no hypercoagulable state was identified.
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566 Nikam et al
JOURNAL OF VASCULAR SURGERY September 2007
Fig 1. Localized complex plaque in left mid superficial femoral artery.
Fig 3. Bi-lobed pseudoaneurysm at the atherectomy site distal to original stent.
Fig 2. Postatherectomy flow limiting intimal irregularities.
Fig 4. Successful exclusion of the pseudoaneurysm using Viabahn endoprostheses.
At the 1- and 4-month follow-up visits after the last intervention, she has remained asymptomatic. Her duplex showed patent left SFA stents and ankle-brachial index was 1.0.
peripheral plaque excision system received FDA approval for use in peripheral vasculature based upon similarities with the previously approved Simpson AtheroCath2 (DVI, Redwood City, Calif) and has received marked enthusiasm in recent years. Randomized trials have shown higher restenosis rates with Simpson AtheroCath compared with angioplasty alone3 while the long-term restenosis rates for the SilverHawk system remain to be determined. While the debate over the long-term utility of this technique continues, interventionalists face an occasional
DISCUSSION A variety of new interventional tools are being added to the armamentarium of physicians involved with endovascular interventions. Interest for atherectomy has waxed and waned over the last few decades with several devices enjoying popularity primarily in the 1990s. The SilverHawk
JOURNAL OF VASCULAR SURGERY Volume 46, Number 3
Fig 5. Occlusion of Viabahn stent which caused acute foot ischemia.
Fig 6. Successful resumption of in-line blood flow by mechanical thrombectomy and placement of self expanding stents within the Viabahn stents.
local complication with the atherectomy devices. The national multicenter registry for tracking outcomes with the SilverHawk System (TALON) (FoxHollow Technologies Inc.) has reported minor complications such as perforation (0.8%) and dissection (3.6%) with rare reports of distal embolism, thrombosis, abrupt closures, or re-occlusions.1 Complications reported from older atherectomy devices have been very variable in different case series with prevalence ranging from 0% to 6.5%.4-7
Nikam et al 567
Development of a pseudoaneurysm in coronary artery after atherectomy8 has been reported as a rare occurrence. Histologic specimens from coronary atherectomy have been found to contain media in 67% and adventitia in 27% of specimens with infrequent clinical sequelae.8 Arterial media and adventitia was found frequently on histologic examination of specimen after peripheral atherectomy in vein grafts with one case of pseudoaneurysm formation reported in the treated vein graft segment.9 Atherectomy samples from peripheral arteries have been found to contain adventitia in only 1% specimens with medial component in 21% of specimens.10 We do not routinely send the atherectomy specimen for histopathologic analysis at our institution due to lack of concordance between histology and future formation of pseudoaneurysm. Our patient developed a pseudoaneurysm of the treated segment of the SFA probably as a result of debulking and unintentional atherectomy of relatively normal intima proximal and distal to original lesion, which weakened the arterial wall. This led to progressive degeneration and enlargement of the vessel under arterial pressure. Pathophysiologically, this is likely to be similar to aneurysmal degeneration of dissections. Natural history of iatrogenic pseudoaneurysms being unknown, we initially decided to follow it closely. Mechanical factors have been implicated in causation of trauma to the vessel wall during atherectomy. These include tortuous nature of the vessel, oversized atherectomy device, lesions close to prior surgical scar, and location of a lesion near side branches.11 These factors are likely to alter the depth of cut in the vessel wall predisposing to a weakness in the wall. Our patient had the lesion close to a branch vessel. Stresses due to the junction of mobile and immobile vessel segments at branch points may have predisposed to deeper cuts with the atherectomy device. A combination of above mentioned factors may make deeper cuts even more likely. Cadaveric studies have demonstrated difficulty in intentionally perforating or cutting through arteries with atherectomy device unless there was additional external compression and multiple passes of the device were made.10 The initial lesion is a TransAtlantic InterSociety Consensus (TASC) A lesion and is only moderately calcified. An endovascular option was chosen along the lines of TASC II recommendations to tackle the embolic source of blue toe syndrome. Secondary to unforeseen complications, she needed multiple endovascular interventions in order to preserve the in-line blood flow through the femoro-popliteal segment. Many of the endovascular techniques are still faced with inability to establish long-term patency as of now.2 Endovascular surgeons must recognize these risks, arrange appropriate follow up imaging where needed, and plan for bail-out procedures. REFERENCES 1. Ramaiah V, Gammon R, Kiesz S, Cardenas J, Runyon JP, Fail P, et al. Midterm outcomes from the TALON Registry: treating peripherals with SilverHawk: outcomes collection. J Endovasc Ther 2006;13:592-602.
568 Nikam et al
2. Yancey AE, Minion DJ, Rodriguez C, Patterson DE, Endean ED. Peripheral atherectomy in TransAtlantic InterSociety Consensus type C femoropopliteal lesions for limb salvage. J Vasc Surg 2006;44:503-9. 3. Vroegindeweij D, Kemper FJ, Tielbeek AV, Buth J, Landman G. Recurrence of stenoses following balloon angioplasty and Simpson atherectomy of the femoro-popliteal segment. A randomized comparative 1-year follow-up study using color flow duplex. Eur J Vasc Surg 1992;6:164-71. 4. Henry M, Amor M, Ethevenot G, Henry I, Allaoui M. Percutaneous peripheral atherectomy using the rotablator: a single-center experience. J Endovasc Surg 1995;2:51-66. 5. White CJ. Peripheral atherectomy with the pullback atherectomy catheter: procedural safety and efficacy in a multicenter trial. PAC Investigators. J Endovasc Surg 1998;5:9-17. 6. Zeller T, Krankenberg H, Reimers B, Frank U, Burgelin K, Schwarzwalder U, et al. Initial clinical experience with a new percutaneous peripheral atherectomy device for the treatment of femoro-popliteal stenoses (in German). Röfo Fortschr Geb Roentgenstr Neue Bildgeb Verfahr 2004;176:70-5.
JOURNAL OF VASCULAR SURGERY September 2007
7. Zeller T, Rastan A, Schwarzwalder U, Frank U, Burgelin K, Amantea P, et al. Midterm results after atherectomy-assisted angioplasty of below-knee arteries with use of the Silverhawk device. J Vasc Interv Radiol 2004;15:1391-7. 8. RD Safian, JS Gelbfish, RE Erny, SJ Schnitt, DA Schmidt, DS Baim. Coronary atherectomy. Clinical, angiographic, and histological findings and observations regarding potential mechanisms. Circulation 1990;82:69-79. 9. Porter DH, Rosen MP, Skillman JJ, Sheiman RG, Kent KC, Kim D. Mid-term and long-term results with directional atherectomy of vein graft stenoses. J Vasc Surg 1996;23:554-67. 10. Johnson DE. Directional peripheral atherectomy: histopathologic aspects of a new interventional technique. J Vasc Interv Radiol 1990;1:29-33. 11. Matsumoto AH, Selby JB Jr, Ladika JE Jr, Tegtmeyer CJ. Pseudoaneurysm formation following directional atherectomy. J Vasc Interv Radiol 1993;4: 283-6.
Submitted Jan 19, 2007; accepted April 16, 2007.
Native superficial femoral artery peripheral atherectomy site pseudoaneurysm: A case report Shivprasad D. Nikam, MD, Joe H. Morgan, MD, Emad M. Zakhary, MD, Spencer W. Galt, MD, James R. Elmore, MD, and David P. Franklin, MD, Danville, Pa A 45-year-old woman who presented with blue toe syndrome was treated with atherectomy for a focal plaque located in the superficial femoral artery. She subsequently developed a large pseudoaneurysm at the atherectomy site requiring multiple sequential endovascular procedures in order to maintain in-line blood flow to the foot. Pseudoaneurysm formation at native peripheral artery atherectomy site has not been reported previously. We discuss possible complications of atherectomy and the possible mechanism of pseudoaneurysm formation after atherectomy. We address the importance of understanding risks of these minimally invasive procedures along with planning follow-up duplex and potential bail-out tactics. (J Vasc Surg 2007;46:565-8.)
Peripheral atherectomy is a resurgent and exciting treatment as an alternative to lower extremity arterial bypass for treatment of superficial femoral artery (SFA) disease in symptomatic patients with critical limb ischemia and disabling claudication. Long-term efficacy of these endovascular technique remains to be established. However, the endovascular options such as atherectomy are often appealing since they are associated with a lower periprocedural morbidity and mortality. With the availability of the SilverHawk (FoxHollow Technologies Inc., Redwood City, Calif) atherectomy device, there has been a renewed interest in the atherectomy technique. Common early complications related to this device include need for emergency access site surgery, retroperitoneal hemorrhage, vascular perforation, or plaque dissection.1 A pseudoaneurysm formation at the atherectomy site in the native artery has not been reported in the noncoronary literature. We report a case of a patient who developed a large pseudoaneurysm in the segment of SFA treated by atherectomy. CASE REPORT A 45-year-old woman with 30-pack per year history of smoking was referred to our hospital with complaints of bluish discoloration of left great toe with burning pain. Physical examination revealed dusky discoloration of the toes and hyperesthesia. The ipsilateral pedal pulses were palpable. Multiple angiographic projections revealed a localized complex plaque in the left mid-SFA as a cause of distal embolization (Fig 1). The lesion was treated with atherectomy carried out using the SilverHawk atherectomy catheter (LS cutter) via contralateral femoral approach. Multiple passes of the catheter were used to excise From the Geisinger Medical Center. Competition of interest: none. Presented at the Thirty-fourth Annual Symposium of the Society for Clinical Vascular Surgery, Las Vegas, Nev, Mar 8-11, 2006. Reprint requests: Shivprasad Nikam, MD, Department of Vascular Surgery, Geisinger Medical Center, 100 N Academy Avenue, Danville, PA 178222150 (e-mail: [email protected]). 0741-5214/$32.00 Copyright © 2007 by The Society for Vascular Surgery. doi:10.1016/j.jvs.2007.04.046
the complex plaque in the left mid-SFA, while an Accunet (Abbott Laboratories, Abbott Park, Ill) embolic protection device was positioned in the popliteal artery. Each pass of atherectomy spanned a distance of 6 to 7 cm. At completion of atherectomy, irregularities were noted in the vessel wall proximal and distal to the main lesion (Fig 2). These irregularities were treated with placement of a short nitinol self-expanding SMART (Cordis Corporation, Miami Lakes, Fla) stent (7 mm ⫻ 40 mm). Balloon angioplasty was not performed. Patient was discharged on the first postoperative day with palpable pedal pulses. On the third postoperative day, she developed leg edema and was treated with fractionated heparin and warfarin for a diagnosis of deep vein thrombosis (DVT). Duplex examination revealed left popliteal vein DVT with an aneurysmal SFA measuring 2 cm in maximum diameter. She was seen in the clinic in 1 week and again in 3 months with improvement of edema. At the 4-month follow-up visit, her left SFA was found to have a maximum diameter of 2.8 cm. Angiography revealed a bi-lobed pseudoaneurysm distal to the stent in the atherectomized zone of SFA (Fig 3). The pseudoaneurysm extended over an 8 cm segment of the SFA. This was treated with placement of 7 mm ⫻ 10 cm and 7 mm ⫻ 5 cm Viabahn endoprostheses (W. L. Gore & Associates, Inc, Flagstaff, Ariz) with successful exclusion of the pseudoaneurysm (Fig 4). At the 6-week follow-up visit after the secondary procedure, there was evidence of in-stent stenosis of the Viabahn stent with peak systolic velocity of 250 cm/s and a fall in ABI to 0.7. This was treated by balloon angioplasty with no residual stenosis. Warfarin was discontinued at this stage due to completion of DVT treatment, but she was continued on aspirin and clopidogrel. One week later, she returned with sudden onset of rest pain in left forefoot with dusky discoloration. Angiography demonstrated occlusion of the Viabahn stent (Fig 5). In view of the small caliber of her saphenous vein and patient preference, this was treated with mechanical thrombectomy and placement of self-expanding stents in SFA and the popliteal artery. This included placement of a stent within the Viabahn endoprostheses as an attempt to salvage the in-line flow to the leg (Fig 6). Warfarin was resumed empirically but no hypercoagulable state was identified.
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JOURNAL OF VASCULAR SURGERY September 2007
Fig 1. Localized complex plaque in left mid superficial femoral artery.
Fig 3. Bi-lobed pseudoaneurysm at the atherectomy site distal to original stent.
Fig 2. Postatherectomy flow limiting intimal irregularities.
Fig 4. Successful exclusion of the pseudoaneurysm using Viabahn endoprostheses.
At the 1- and 4-month follow-up visits after the last intervention, she has remained asymptomatic. Her duplex showed patent left SFA stents and ankle-brachial index was 1.0.
peripheral plaque excision system received FDA approval for use in peripheral vasculature based upon similarities with the previously approved Simpson AtheroCath2 (DVI, Redwood City, Calif) and has received marked enthusiasm in recent years. Randomized trials have shown higher restenosis rates with Simpson AtheroCath compared with angioplasty alone3 while the long-term restenosis rates for the SilverHawk system remain to be determined. While the debate over the long-term utility of this technique continues, interventionalists face an occasional
DISCUSSION A variety of new interventional tools are being added to the armamentarium of physicians involved with endovascular interventions. Interest for atherectomy has waxed and waned over the last few decades with several devices enjoying popularity primarily in the 1990s. The SilverHawk
JOURNAL OF VASCULAR SURGERY Volume 46, Number 3
Fig 5. Occlusion of Viabahn stent which caused acute foot ischemia.
Fig 6. Successful resumption of in-line blood flow by mechanical thrombectomy and placement of self expanding stents within the Viabahn stents.
local complication with the atherectomy devices. The national multicenter registry for tracking outcomes with the SilverHawk System (TALON) (FoxHollow Technologies Inc.) has reported minor complications such as perforation (0.8%) and dissection (3.6%) with rare reports of distal embolism, thrombosis, abrupt closures, or re-occlusions.1 Complications reported from older atherectomy devices have been very variable in different case series with prevalence ranging from 0% to 6.5%.4-7
Nikam et al 567
Development of a pseudoaneurysm in coronary artery after atherectomy8 has been reported as a rare occurrence. Histologic specimens from coronary atherectomy have been found to contain media in 67% and adventitia in 27% of specimens with infrequent clinical sequelae.8 Arterial media and adventitia was found frequently on histologic examination of specimen after peripheral atherectomy in vein grafts with one case of pseudoaneurysm formation reported in the treated vein graft segment.9 Atherectomy samples from peripheral arteries have been found to contain adventitia in only 1% specimens with medial component in 21% of specimens.10 We do not routinely send the atherectomy specimen for histopathologic analysis at our institution due to lack of concordance between histology and future formation of pseudoaneurysm. Our patient developed a pseudoaneurysm of the treated segment of the SFA probably as a result of debulking and unintentional atherectomy of relatively normal intima proximal and distal to original lesion, which weakened the arterial wall. This led to progressive degeneration and enlargement of the vessel under arterial pressure. Pathophysiologically, this is likely to be similar to aneurysmal degeneration of dissections. Natural history of iatrogenic pseudoaneurysms being unknown, we initially decided to follow it closely. Mechanical factors have been implicated in causation of trauma to the vessel wall during atherectomy. These include tortuous nature of the vessel, oversized atherectomy device, lesions close to prior surgical scar, and location of a lesion near side branches.11 These factors are likely to alter the depth of cut in the vessel wall predisposing to a weakness in the wall. Our patient had the lesion close to a branch vessel. Stresses due to the junction of mobile and immobile vessel segments at branch points may have predisposed to deeper cuts with the atherectomy device. A combination of above mentioned factors may make deeper cuts even more likely. Cadaveric studies have demonstrated difficulty in intentionally perforating or cutting through arteries with atherectomy device unless there was additional external compression and multiple passes of the device were made.10 The initial lesion is a TransAtlantic InterSociety Consensus (TASC) A lesion and is only moderately calcified. An endovascular option was chosen along the lines of TASC II recommendations to tackle the embolic source of blue toe syndrome. Secondary to unforeseen complications, she needed multiple endovascular interventions in order to preserve the in-line blood flow through the femoro-popliteal segment. Many of the endovascular techniques are still faced with inability to establish long-term patency as of now.2 Endovascular surgeons must recognize these risks, arrange appropriate follow up imaging where needed, and plan for bail-out procedures. REFERENCES 1. Ramaiah V, Gammon R, Kiesz S, Cardenas J, Runyon JP, Fail P, et al. Midterm outcomes from the TALON Registry: treating peripherals with SilverHawk: outcomes collection. J Endovasc Ther 2006;13:592-602.
568 Nikam et al
2. Yancey AE, Minion DJ, Rodriguez C, Patterson DE, Endean ED. Peripheral atherectomy in TransAtlantic InterSociety Consensus type C femoropopliteal lesions for limb salvage. J Vasc Surg 2006;44:503-9. 3. Vroegindeweij D, Kemper FJ, Tielbeek AV, Buth J, Landman G. Recurrence of stenoses following balloon angioplasty and Simpson atherectomy of the femoro-popliteal segment. A randomized comparative 1-year follow-up study using color flow duplex. Eur J Vasc Surg 1992;6:164-71. 4. Henry M, Amor M, Ethevenot G, Henry I, Allaoui M. Percutaneous peripheral atherectomy using the rotablator: a single-center experience. J Endovasc Surg 1995;2:51-66. 5. White CJ. Peripheral atherectomy with the pullback atherectomy catheter: procedural safety and efficacy in a multicenter trial. PAC Investigators. J Endovasc Surg 1998;5:9-17. 6. Zeller T, Krankenberg H, Reimers B, Frank U, Burgelin K, Schwarzwalder U, et al. Initial clinical experience with a new percutaneous peripheral atherectomy device for the treatment of femoro-popliteal stenoses (in German). Röfo Fortschr Geb Roentgenstr Neue Bildgeb Verfahr 2004;176:70-5.
JOURNAL OF VASCULAR SURGERY September 2007
7. Zeller T, Rastan A, Schwarzwalder U, Frank U, Burgelin K, Amantea P, et al. Midterm results after atherectomy-assisted angioplasty of below-knee arteries with use of the Silverhawk device. J Vasc Interv Radiol 2004;15:1391-7. 8. RD Safian, JS Gelbfish, RE Erny, SJ Schnitt, DA Schmidt, DS Baim. Coronary atherectomy. Clinical, angiographic, and histological findings and observations regarding potential mechanisms. Circulation 1990;82:69-79. 9. Porter DH, Rosen MP, Skillman JJ, Sheiman RG, Kent KC, Kim D. Mid-term and long-term results with directional atherectomy of vein graft stenoses. J Vasc Surg 1996;23:554-67. 10. Johnson DE. Directional peripheral atherectomy: histopathologic aspects of a new interventional technique. J Vasc Interv Radiol 1990;1:29-33. 11. Matsumoto AH, Selby JB Jr, Ladika JE Jr, Tegtmeyer CJ. Pseudoaneurysm formation following directional atherectomy. J Vasc Interv Radiol 1993;4: 283-6.
Submitted Jan 19, 2007; accepted April 16, 2007.