Duplex-guided infrainguinal balloon angioplasty and stenting. A 4-year experience

AIM: The traditional technique of infrainguinal arterial balloon angioplasties involves the use of fluoroscopy and contrast material. We performed these procedures under duplex guidance to eliminate radiation exposure and avoid nephrotoxic effect of contrast. METHODS: Over the last four years, 274 patients (59% males) with a mean age of 74+/-9 years (range 42-97 years) had a total of 360 attempted balloon angioplasties of the superficial femoral (SFA) and/or popliteal arteries under duplex guidance. Cannulation of common femoral artery, manipulation of the guidewire across the stenoses and/or occlusions of the SFA and/or popliteal artery, and balloon dilation were achieved with duplex guidance alone. Infrapopliteal angioplasties of 80 arteries were attempted in 54 cases (15% of all cases). RESULTS: Overall technical success for femoral-popliteal segment was 95% (342/360 cases) and 96% (77/80 cases) for infrapopliteal segment. CONCLUSION: Duplex guided balloon angioplasty and stent placement appears to be a safe and effective technique for treatment of femoral-popliteal and infrapopliteal arterial occlusive disease.     

Plaque excision with the Silverhawk catheter: early results in patients with claudication or critical limb ischemia

OBJECTIVE: This study was conducted to detail the early experience after infrainguinal atherectomy using the Silverhawk plaque excision catheter for the treatment of symptomatic peripheral vascular disease. METHODS: A prospective database was established in August 2004 in which data for operations, outcomes, and follow-up were recorded for patients undergoing percutaneous plaque excision for peripheral arterial occlusive disease. Society for Vascular Surgery (SVS) ischemia scores and femoropopliteal TransAtlantic Inter-Society Consensus (TASC) criteria were assigned. A follow-up protocol included duplex ultrasound surveillance at 1, 3, and 6 months and then yearly thereafter. Standard statistical analyses were performed. RESULTS: During a 17-month period, 66 limbs of 60 patients (37 men [61.7%]) underwent 70 plaque excisions (four repeat procedures). Indications included tissue loss based on SVS ischemia at grades 5 and 6 (25/70), rest pain at grade 4 (22/70), and claudication at grades 2 to 3 (23/70). The mean lesion length was 8.8 +/- 0.7 cm. The technical success rate was 87.1% (61/70). Adjunctive treatment was required in 17 procedures (24.3%), consisting of 14 balloon angioplasties and three stents. Femoropopliteal TASC criteria included 5 TASC A lesions, 14 TASC B lesions, 32 TASC C lesions, and 19 TASC D lesions. Although 17 plaque excisions included a tibial vessel, no patient underwent isolated tibial atherectomy. The mean increase in ankle-brachial index was 0.27 +/- 0.04 and in toe pressure, 20.3 +/- 6.9 mm Hg. Mean duplex ultrasound follow-up was 5.2 months (range, 1 to 17 months). One-year primary, primary assisted, and secondary patency was 61.7%, 64.1%, and 76.4%, respectively. Restenosis or occlusion developed in 12 patients (16.7%) and was detected at a mean of 2.8 +/- 0.7 months. Restenosis or occlusion was significantly more common (P < .05) in patients with TASC C and D lesions compared with patients with TASC A and B lesions. Six (8.3%) of 12 patients underwent reintervention on the basis of duplex ultrasound surveillance results. Four (33.3%) of 12 patients experienced reocclusion during the same hospitalization, and amputation and open revascularization were required in two patients each. CONCLUSIONS: Percutaneous plaque excision is a viable treatment option for lower extremity revascularization. Outcomes are related to ischemia and lesion severity. Patency and limb salvage rates are equivalent to other endovascular modalities.     

Midterm patency following atherectomy for infrainguinal occlusive disease: a word of caution

There has been widespread initial enthusiasm for peripheral atherectomy using the SilverHawk device. We sought to evaluate our midterm patency following infrainguinal atherectomy. Nineteen consecutive patients underwent 23 separate atherectomy procedures on 20 limbs from March 2005 through June 2006 (11 males, age 66 +/- 14 years). The primary lesions were atherosclerotic (n = 18) and vein graft stenoses (n = 2). Three additional procedures were redo atherectomies for restenotic lesions. The TASC classification of the primary lesions was A in 3, B in 9, and C in 8. The median number of treated lesions per limb was 2 (range 1-4). The location of the most distal native vessel stenosis was the superficial femoral artery in 12, popliteal artery in six, and crural artery in two. Atherectomy was successful in 18 primary procedures and all three repeat atherectomy procedures. Touch-up balloon dilatation was used in five procedures. Complications included one groin hematoma and two perforations, treated with stenting in one and bypass grafting in one. Preoperative ankle-brachial index and transmetatarsal pulse volume recording were 0.51 +/- 0.16 and 3.3 +/- 0.8, respectively, which at 1-month improved to 0.80 +/- 0.16 and 2.4 +/- 0.4 (p < 0.001). Only two vessels remained patent at 12 months. Recurrence developed in 16 of the successful primary procedures, including both vein graft lesions and all three repeat atherectomy procedures. The mode of recurrence was restenosis in 14 and occlusion/thrombosis in five. Secondary interventions included balloon angioplasty/thrombolysis in two, stenting in three, redo atherectomy in three, vein bypass grafting in five, and observation alone in one. Major limb amputation was required in five patients. Primary patency rates per treated limb at 3, 6, and 12 months were 38%, 10%, and 10%. The corresponding assisted patency rates were 50%, 23%, and 10%. Our experience suggests a very poor midterm patency of excisonal atherectomy using the SilverHawk device, although a 74% limb salvage rate was maintained through secondary interventions. Liberal use of this technology is associated with high cost and frequent requirement of reintervention.     

Duplex-guided balloon angioplasty and stenting for femoropopliteal arterial occlusive disease: an alternative in patients with renal insufficiency

BACKGROUND: The technique of balloon angioplasty of infrainguinal arteries requires standard arteriography and fluoroscopic guidance. We attempted to perform this procedure under duplex guidance to avoid the use of nephrotoxic contrast material and radiation exposure in patients with renal insufficiency. METHODS: Over 16 months, 28 patients (17 men) with serum creatinine levels of 1.5 mg/dL or more underwent 37 lower extremity duplex-guided balloon angioplasties at our institution. Ages ranged from 58 to 92 years (mean +/- SD, 74 +/- 9 years). Disabling claudication was the indication in 24 cases (65%), and critical ischemia, in 13 cases. Preoperative duplex arterial mapping showed severe superficial femoral artery and/or popliteal artery stenoses in all cases. No arterial occlusions were treated in this series. Seven procedures (19%) were performed for restenosis. The ipsilateral common femoral artery was cannulated in 32 cases (86%), and the contralateral common femoral artery, in 5 cases (14%), under direct duplex visualization. Contralateral common iliac artery cannulations were performed with the help of fluoroscopy. By using sonographic visualization, a guidewire was directed into the origin of the superficial femoral artery, across the diseased segment, and into the popliteal artery. The diseased segment was then balloon-dilated. Balloon diameter and length were chosen according to arterial measurements obtained by duplex scan. Plaque dissections and recoils causing stenosis of 30% or more, a peak systolic velocity ratio of 2 or more, or both were stented under duplex guidance. Arterial duplex examinations and ankle/brachial indexes were obtained before hospital discharge, within 1 month after the procedure, and every 3 months thereafter. RESULTS: Thirty-day survival was 100%. Local complications included one open exploration for expanding hematoma. Technical success was achieved in all cases. Placement of intraluminal stents was deemed appropriate in 23 (62%) of 37 cases. The 1-month patency and limb salvage rates were 100%. Preprocedure and postprocedure ankle/brachial indexes ranged from 0.3 to 0.9 (mean +/- SD, 0.64 +/- 0.16) and 0.64 to 1.2 (mean +/- SD, 0.92 +/- 0.15), respectively (P < .0001). CONCLUSIONS: Duplex-guided balloon angioplasty seems to be a safe and effective technique that allows renal patients to experience continued limb salvage and relief from claudication without the risk of developing dye-induced acute renal failure. Other advantages include direct visualization of the puncture site, accurate selection of the proper size of balloon and stent, confirmation of the adequacy of the technique by hemodynamic and imaging parameters, and avoidance of radiation. Although this technique holds considerable potential, longer follow-up will help to fully evaluate its broader applicability.     

老年患者TASC C、D级髂股动脉闭塞的腔内治疗

目的探讨对泛大西洋协作组织(TASC)C、D级髂股动脉闭塞老年患者行腔内治疗的疗效。方法 104例老年TASC C、D级髂股动脉闭塞患者接受微创腔内介入手术,其中TASC C型73例、TASC D型31例,闭塞长度4.25~17.61cm,平均(13.46±1.24)cm。对腔内介入治疗的临床疗效、并发症、术后随访等情况进行分析。结果 94例成功开通闭塞动脉,技术成功率90.38%(94/104),其中单纯球囊扩张12例、联合支架植入92例。围手术期发生并发症8例,并发症发生率为7.69%(8/104),包括急性动脉血栓2例、穿刺处假性动脉瘤形成1例、心功能衰竭4例、对比剂肾病1例。术后7天踝肱指数由术前的0.32±0.12增至0.81±0.11(P0.01)。术后6个月、12个月各随访78例和53例患者,通畅率分别为88.46%(69/78)、81.13%(43/53)。结论对老年TASC C、D级髂股动脉闭塞患者,微创腔内介入治疗手术成功率高,并发症少,可取得满意的临床疗效。     

Duplex-guided balloon angioplasty and subintimal dissection of infrapopliteal arteries: early results with a new approach to avoid radiation exposure and contrast material

OBJECTIVE: Balloon angioplasties of stenotic or occluded infrapopliteal arteries may be helpful in selected high-risk patients threatened with limb loss. Thus far, these procedures have demanded fluoroscopy and the injection of potentially nephrotoxic contrast material. Herein, we proposed a new alternative to avoid the harmful effects of radiation exposure and the risk of acute renal failure. METHODS: Over the last 16 months, 30 patients (57% male) aged 74 +/- 9 years (mean +/- SD) had a total of 52 attempted balloon angioplasties of the infrapopliteal arteries in 32 limbs under duplex guidance. Indications for the procedure were critical ischemia in 20 limbs (63%), including rest pain, ischemic ulcers, and gangrene in 4 (13%), 10 (31%), and 6 (19%) limbs, respectively. Severe disabling claudication was an indication in the remaining 12 limbs (37%). All patients had concomitantly performed balloon angioplasties of the superficial femoral and popliteal arteries (28 cases) or the popliteal artery alone (4 cases). Balloon angioplasty of the infrapopliteal arteries was performed as an adjunct to improve runoff. Hypertension, diabetes, renal insufficiency, smoking, and coronary artery disease were present in 77%, 73%, 50%, 47%, and 37% of cases, respectively. There were 42 cases (81%) with infrapopliteal arterial stenoses (25 tibioperoneal trunks, 9 peroneal arteries, 4 anterior tibial arteries, and 4 posterior tibial arteries) in 26 limbs. The remaining 10 cases (19%) had infrapopliteal arterial occlusions (4 tibioperoneal trunks, 5 peroneal arteries, and 1 anterior tibial artery) in 6 limbs. All these cases were combined with more proximal endovascular procedures (21 femoropopliteal stenoses and 11 femoropopliteal occlusions). All patients had preprocedure duplex arterial mapping and ankle/brachial index (ABI) measurement. Local anesthesia with light sedation was used in all cases. The common femoral artery was cannulated under direct duplex visualization. Still under duplex guidance, a guidewire was directed into the proximal superficial femoral artery and distally, beyond the infrapopliteal diseased segment. The diseased segment was then balloon-dilated. Balloon diameter and length were chosen according to the arterial measurements obtained by duplex guidance. Completion duplex examinations were performed and postprocedure ABIs were obtained in all cases. RESULTS: Although the overall technical success was 94% (49/52 cases), it was 95% for those with stenoses (40/42 cases) and 90% for those with occlusions (9/10 cases; P < .5). Intraoperative thrombosis occurred in three infrapopliteal cases (two tibioperoneal trunks and one peroneal artery) and in one popliteal artery. All four cases were successfully managed with intra-arterial infusion of thrombolytic agents under duplex guidance. Overall, the preprocedure and postprocedure ABIs ranged from 0.4 to 0.8 (mean +/- SD, 0.58 +/- 0.15) and 0.7 to 1.1 (mean +/- SD, 0.9 +/- 0.16), respectively (P < .0001). Twenty-two (88%) of 25 patients experienced a significant (> 0.15) postoperative ABI increase. Overall 30-day survival and limb salvage rates were 100%. CONCLUSIONS: The proposed technique eliminates the need for radiation exposure and the use of contrast material, and it seems to be an effective alternative approach for the treatment of infrapopliteal occlusive disease. Additional advantages include accurate selection of the proper size of balloon and confirmation of the adequacy of the technique by hemodynamic and imaging parameters.     

Does subintimal angioplasty have a role in the treatment of severe lower extremity ischemia?

OBJECTIVE: Subintimal angioplasty (SIA) has been advocated to treat long segment lower extremity arterial occlusions, but many question its value. We evaluated the role of SIA in a group of patients with severe lower extremity arterial occlusive disease. METHODS: During a 2.5-year period, 39 patients with arterial occlusions (median length, 8 cm; range, 2 to 31 cm) were treated on an intention-to-treat basis with SIA. Twenty-five patients had gangrene, five had rest pain, and nine had disabling (相似文献   

Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease

OBJECTIVE: This randomized prospective study was designed to compare the effectiveness of treating superficial femoral artery occlusive disease percutaneously with expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent grafts vs surgical femoral-to-above knee (AK) popliteal artery bypass with synthetic graft material. METHODS: From March 2004 to May 2005, 100 limbs in 86 patients with femoral-popliteal arterial occlusive disease were identified. Patients had symptoms ranging from claudication to rest pain, with or without tissue loss, and were prospectively randomized for treatment into one of two groups. The limbs were treated percutaneously with angioplasty and one or more self-expanding stent grafts (n = 50) or surgically with femoral-to-AK popliteal artery bypass using synthetic Dacron or ePTFE grafts (n = 50). The mean +/- SD total length of artery stented was 25.6 +/- 15 cm. Follow-up evaluation with ankle-brachial indices and color flow duplex sonography imaging were performed at 3, 6, 9, and 12 months after treatment. RESULTS: Patients were monitored for a median of 18 months. No statistical difference was found in the primary patency (P = .895) or secondary patency (P = .861) between the two treatment groups. Primary patency at 3, 6, 9, and 12 months of follow-up was 84%, 82%, 75.6%, and 73.5% for the stent graft group and 90%, 81.8%, 79.7%, and 74.2% for the femoral-popliteal surgical group. Thirteen patients in the stent graft group had 14 reinterventions, and 12 reinterventions occurred in the surgical group. This resulted in secondary patency rates of 83.9% for the stent graft group and 83.7% for the surgical group at the 12-month follow-up. CONCLUSIONS: Management of femoral-popliteal arterial occlusive disease using percutaneous treatment with a stent graft is comparable with surgical revascularization with conventional femoral-to-AK popliteal artery bypass using synthetic material up to 12 months. Longer-term follow-up would be helpful in determining ongoing efficacy.     

Gray-scale median of the atherosclerotic plaque can predict success of lumen re-entry during subintimal femoral-popliteal angioplasty

OBJECTIVE: This study assessed whether the duplex ultrasound (DUS)-derived gray-scale median (GSM) of the most six distal portion of the occluded femoral-popliteal arterial segment can predict success of lumen re-entry for subintimal angioplasty. METHODS: During the last 3 years, 108 patients (62% men) with a mean age of 73 +/- 10 years underwent 116 primary attempted DUS-guided subintimal angioplasties of the femoral-popliteal segment. Preprocedural B-mode DUS images of the plaque at the most distal occlusion segment were digitalized and normalized using Photoshop (Adobe, San Jose, Calif) software and standard criteria (gray level, 0 to 5 for lumen blood and 185 to 190 for the adventitia on a linear scale of 0 to 255). Overall GSM of the plaque segment about 2 cm long, immediately before the planned re-entry point to the true arterial lumen, was used for retrospective correlation with procedure success and other clinical indicators. RESULTS: Mean plaque GSM for all cases was 22.5 +/- 12.6 (range, 3 to 60). The overall success rate of subintimal angioplasty procedures was 85%. Mean plaque GSM for 99 successful cases (18.4 +/- 7.8) was significantly lower than for 17 cases (46.4 +/- 8.1) where we failed (P < .0001). We failed in 90% of 19 cases with GSM >35, in 71% of 24 cases with GSM >20, and in 50% of 34 cases with GSM >25. There was no statistically significant difference (P = .45) between plaque GSM in 64 patients with diabetes (23.3 +/- 13.5) compared with 52 nondiabetic patients (21.5 +/- 11.4). Similarly, plaque GSM was not statistically different (P = .9) in 52 patients with renal insufficiency (22.7 +/- 13.2) compared with 64 patients with normal creatinine levels (22.4 +/- 12.2). At the 6-month follow-up, no statistically significant difference was found between mean GSM (17.8 +/- 7.8) in 47 stenosis-free cases compared with mean GSM (18 +/- 6.8) in 22 cases where severe restenosis (>70%) or reocclusion was identified by DUS scan (P = .4). CONCLUSIONS: Plaque echogenicity represented by DUS-derived GSM can be used to predict the success of primary subintimal femoral-popliteal angioplasties.     

Cryoballoon angioplasty broadens the role of primary angioplasty and reduces adjuvant stenting in complex superficial femoral artery lesions

BACKGROUND: Cryoballoon angioplasty (CP) for superficial femoral artery (SFA) occlusive disease has attracted attention as an adjunct to primary high-pressure balloon angioplasty (HP) and as an alternative to primary stenting in the SFA. STUDY DESIGN: A retrospective review from 1999 to 2005 of patients with chronic critical ischemia because of complex SFA lesions (TransAtlantic Inter-Society Consensus [TASC] C and D) was performed. Those patients treated with either standard HP or CP were examined. Vessels treated by primary stenting or atherectomy were excluded. RESULTS: Eight-five patients with 93 (67%) limbs underwent HP and 39 patients with 45 (33%) limbs underwent CP. Rest pain, tissue loss, or both, were the presenting symptoms in 49% of the HP group and 69% of the CP group. There was no significant difference in the final technical success rate between HP and CP, but significantly more stents were required in HP (75% versus 22%, HP versus CP; p < 0.05). Stenosis rather than occlusion is the more common mode of failure after CP (HP: 68% versus 32%; CP: 38% versus 62%). Despite this, there was no change in 1-year primary (66 +/- 6% versus 69 +/- 9%; HP versus CP; mean +/- SEM), assisted (78 +/- 5% versus 80 +/- 8%), or secondary patencies (78 +/- 5% versus 80 +/- 8%) between the 2 modalities. Freedom from recurrent symptoms and limb salvage for critical ischemia were equivalent. CONCLUSIONS: CP substantially increases the number of TASC C and D lesions for which balloon angioplasty alone is effective. Adjuvant stent usage is markedly reduced without a decrease in cumulative patency. Cryoballoon angioplasty should be considered a viable alternative for sole therapy for complex lesions of the SFA.     

Cutting balloon angioplasty of autogenous infrainguinal bypasses: short-term safety and efficacy

PURPOSE: This study evaluated the safety and efficacy of cutting balloon angioplasty in the treatment of infrainguinal vein bypass graft stenosis. METHODS: Data from a prospective database, supplemented by chart review, were obtained on all patients who underwent cutting balloon angioplasty of lower extremity vein bypass grafts at a single institution during a 4-year period. Noninvasive duplex ultrasound imaging of grafts, along with measurement of ankle-brachial indices and digital pressures, was performed on all patients before and after treatment with the cutting balloon. Efficacy of cutting balloon angioplasty and procedural complications were analyzed. Data from noninvasive vascular testing were compared using the two-tailed paired Student t test. Patency rates were calculated using the Kaplan-Meier method. Differences in patency rates were compared using the log-rank test. RESULTS: From July 2002 to February 2006, 109 cutting balloon angioplasties were performed on 70 bypasses in 61 patients. There were 12 complications in 109 procedures (11%), only one of which required immediate operative intervention. Initial technical success was 96%. Noninvasive vascular testing indicators significantly improved immediately after intervention: peak systolic graft velocity decreased from 360 +/- 158 cm/s to 143 +/- 67 cm/s (P < .001), ankle-brachial index improved from 0.55 +/- 0.3 to 0.85 +/- 0.2 (P < .001), and digital pressure increased from 31 +/- 30 mm Hg to 62 +/- 32 mm Hg (P < .001). Patency rates at 6 months according to the Kaplan-Meier method were primary patency, 48% (95% confidence interval [CI], 0.36 to 0.60); assisted primary patency, 72% (95% CI, 0.61 to 0.83); and secondary patency, 99% (95% CI, 0.97 to 1.00). At 6 months, cumulative limb salvage was 94% (95% CI, 0.89 to 1.00). CONCLUSIONS: Cutting balloon angioplasty of infrainguinal vein bypass graft stenosis is technically feasible but is associated with a relatively high complication rate and a relatively low short-term patency rate.     

Infrainguinal atherectomy: a retrospective review of a single-center experience

By decreasing plaque burden, atherectomy provides an alternative to angioplasty and stenting as a means of revascularizing patients with peripheral arterial disease. A new atherectomy device (SilverHawk) has recently been approved by the Food and Drug Administration, but the results with its use are unclear. We analyzed a series of consecutive patients undergoing atherectomy. We retrospectively reviewed the charts of 35 patients undergoing infrainguinal (IF) atherectomy in 38 limbs. The Trans-Atlantic Inter-Society Consensus (TASC) classification and Society of Vascular Surgery runoff scores were calculated. Time to event analysis was performed using Kaplan-Meier estimates. Risk factors affecting patency were analyzed with a multivariate Cox model. Mean patient age was 70 +/- 9.6 years. Indications for intervention were claudication (26%), rest pain (21%), and tissue loss (53%). Femoropopliteal (FP) atherectomy was performed in 68% and tibial atherectomy in 32%. For FP lesions, the TASC distribution was A, 42%; B, 23%; C, 4%; and D, 15%. The average lesion treatment length was 9.4 +/- 10.6 cm (range 1-40), and the runoff score was 5.1 +/- 3.5. For tibial lesions, the TASC distribution was A, 0%; B, 17%; C, 8%; and D, 75%. The average lesion treatment length was 9.2 +/- 6.0 cm (range 2-20), with a runoff score of 5.4 +/- 2.4. A total of 39% of patients had prior IF interventions. Adjunctive angioplasty of the atherectomized lesion was performed in 55% of cases, stenting in 0%, and adjunctive therapy for tandem lesions in 39%. The postoperative ankle-brachial index increased by 0.30 +/- 0.14 and toe pressures increased by 40 +/- 32.4 mm Hg. Mean follow-up was 10 +/- 8 months (range 0.3-23). During the studied period, seven patients required major limb amputation and five open surgical revascularization. Total primary and secondary patency rates were 66% and 70% at 1 year, respectively. Primary and secondary patency rates for FP atherectomy were 68% and 73% at 1 year, respectively. The limb salvage rate was 74% at 6 months. Patients with prior interventions in the atherectomized segment had an almost 10-fold decrease in primary patency. Atherectomy produces acceptable results, similar to those in reported series of conventional balloon angioplasty/stenting. Patients with prior IF interventions had a nearly 10-fold decrease in primary patency. A greater than sixfold decrease in patency rates was noted in patients who underwent simultaneous inflow or outflow procedures, but this finding did not reach statistical significance (p = 0.082). Future studies should focus on cost comparisons with other treatments such as angioplasty and stenting, and prospective randomized trials should be performed to compare these treatment alternatives.     

Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants.

PURPOSE: To assess the results of covered stents in the treatment of superficial femoral artery (SFA) occlusive disease. METHOD: From July 2000 till June 2003, 32 patients (34 limbs) were scheduled for procedures including Hemobahn deployment in the SFA. Indication for treatment was claudication (group I, N=15 patients and 16 limbs, 31.2% occlusions) or critical and acute ischemia (group II, N=17 patients and 18 limbs, 61.1% occlusions). TASC D SFA lesions were excluded. No limb artery was patent pre-operatively in 19% and 89% of limbs in groups I and II, respectively (p=0.00001). RESULTS: Outflow procedures were performed simultaneously in one limb in group I and 12 in group II (p=0.0003). The technical, hemodynamic and clinical success rates were 100, 100 and 94.1%, respectively. Mean follow-up was 18.1 months. Primary patency rates at 12 months were 81.3+/-10.6% in group I and 88.6+/-9.0% in group II (p=0.547). At 12 months, the secondary patency and limb salvage rates were, respectively, 87.5+/-8.9 and 100% in group I and 87.5+/-8.93 and 94.45+/-6.71% in group II. CONCLUSION: Treatment of SFA occlusive lesions (excluding TASC D lesions) with the Hemobahn covered stent yielded good results for both claudicants with good outflow and patients with critical or acute ischemia with bad outflow, if concomitant outflow-improving procedures were performed.     

Laser atherectomy for lower extremity revascularization: An adjunctive endovascular treatment option

Excimer laser atherectomy (LA) employs precision laser energy control (shallow tissue penetration) and safer wavelengths (ultraviolet as opposed to the infrared spectra in older laser technology), which decreases perforation and thermal injury to the treated vessels. Though extensively used by cardiologists for severe obstructive coronary artery disease, peripheral interventionalists have not accepted LA as a routine adjunctive technique for stenotic or occluded vessels. We report herein the technical and clinical outcomes with LA for complex peripheral vascular disease in patients deemed high-risk for conventional surgical revascularization. Over a 6-month period, 19 lesions in 15 high-risk patients (mean age 72 +/-10 years) were treated with LA (308-nm spectral wavelength) followed by balloon angioplasty for limb-threatening ischemia (n = 10) and severe disabling claudication (n = 5). The lesions were located at the superficial femoral artery (n = 8), popliteal artery (6), and/or tibial vessels (5). The mean occlusion length was 10.3 +/-2.3 cm. Laser catheter choice ranged from 1.4 to 2.5 mm depending on the target vessel diameter. Clinical examination, duplex ultrasound, and ankle-brachial indices were performed in follow-up visits. Immediate technical success was achieved in 16 (84%) lesions. In the 3 technical failures, inability to cross the lesion with a wire (n = 2) or vessel perforation (n = 1) precluded successful LA. Overall, primary patency as assessed by duplex was 57% (superficial femoral artery 71%, popliteal 60%, tibial vessels 25%). Clinical improvement was seen in 10 lesions (77%) that were successfully treated initially. One patient required below-knee amputation. At an average of 2-year follow-up, 6 patients who were initially successfully treated were alive (46%), including 3 patients (50%) with stable symptoms without the need for major amputation. Laser atherectomy is a useful adjunctive revascularization technique for high-risk patients with limb-threatening ischemia. This technique is especially beneficial in the treatment of ostial lesions, which may be prone to distal embolization, as well as total occlusions that can be traversed by a guide wire but not a balloon. Vascular surgeons should add LA to their endovascular armamentarium for the treatment of complex peripheral vascular disease in the high surgical risk patients. Further study of clinical outcome measures and comparison to other interventional techniques are warranted.     

Peripheral atherectomy in TransAtlantic InterSociety Consensus type C femoropopliteal lesions for limb salvage

BACKGROUND: The optimal therapy for TransAtlantic Societal Consensus (TASC) type C femoropopliteal lesions remains a critical issue in the treatment of infrainguinal occlusive disease. The purpose of this study was to evaluate the outcome of limbs with TASC C femoropopliteal lesions and critical limb ischemia treated with the FoxHollow SilverHawk atherectomy catheter. METHODS: From September 2004 to September 2005, 18 consecutive femoropopliteal procedures performed in 17 limbs in 16 patients were reviewed. Demographic data, baseline angiographic findings, and indications for the procedures were recorded. Clinical outcomes including symptom resolution and limb salvage were determined for the 17 primary procedures. Hemodynamic improvement was compared by using the paired Student t test. Stenosis-free patency was determined by the Kaplan-Meier method. RESULTS: The mean age was 72.5 years (range, 47-88 years). Fifty percent of the patients had four or more of the following risk factors: hypertension, diabetes, tobacco use, hyperlipidemia, renal insufficiency, and coronary artery disease. The indication was tissue loss in 13 limbs and rest pain in 4. All patients had a second level of disease, either inflow or tibial/pedal, which was treated concurrently when appropriate. Initial resolution of symptoms was achieved in 12 limbs, and partial healing was achieved in 2 others. Early amputation was necessary in the remaining three patients, but this was likely due to severe inframalleolar disease and advanced forefoot ischemia at the time of presentation. Five patients have remained symptom-free without restenosis at a mean follow-up of 6 months. Two patients have required late amputation for hemodynamic failure. The ankle-brachial index improved from 0.39 +/- 0.08 (mean +/- SEM) before surgery to 0.75 +/- 0.08 in the immediate postoperative period (P = .02). However, it returned toward baseline at 6 months after surgery, with a mean of 0.48 +/- 0.07. Stenosis-free patency of the femoropopliteal segment was 22% at 12 months. CONCLUSIONS: Peripheral atherectomy can achieve good early clinical and hemodynamic success in patients with TASC C lesions and critical limb ischemia. However, mid-term restenosis rates are high in this challenging cohort of patients.     

Percutaneous intervention for infrainguinal occlusive disease in women: equivalent outcomes despite increased severity of disease compared with men

OBJECTIVES: Experience with open surgical bypass suggests similar overall outcomes in women compared with men, but significantly increased risk of wound complications. Percutaneous treatment of lower extremity occlusive disease is therefore an attractive alternative in women, although it is not clear whether there is a difference in outcomes between women and men treated with this technique. We sought to determine the results and predictors of failure in women treated by percutaneous intervention. METHODS: Percutaneous infrainguinal revascularization was performed on 309 women between 2001 and 2006. Procedures, complications, demographics, comorbidities, and follow-up data were entered into a prospective database for review. Patency was assessed primarily by duplex ultrasonography. Outcomes were expressed by Kaplan-Meier curves and compared by log-rank analysis. RESULTS: A total of 447 percutaneous interventions performed in 309 women were analyzed and compared with 553 interventions in men. Mean age in women was 73.2 years; comorbidities included hypertension (HTN) (86%), diabetes melitus (DM) (58%), chronic renal insufficiency (CRI) (15%), hemodialysis (7%), hypercholesterolemia (52%), coronary artery disease (CAD) (42%), and tobacco use (47%). Indications in women included claudication (38.0%), rest pain (18.8%), and tissue loss (43.2%). Overall primary & secondary patency and limb-salvage rates for women were 38% +/- 4%, 66% +/- 3%, and 80% +/- 4% at 24 months. In this patient sample, women were significantly more likely than men to present with limb-threatening ischemia (61.6% vs 47.3%, P < 0.001) and have lesions of TASC C and D severity (71.4% vs 61.7%, P < .005). However, there were no significant differences in primary and secondary patency rates or limb-salvage rates between genders. Furthermore, while women with limb-threat, diabetes, and advanced TASC severity lesions were at increased risk of failure overall, there were no differences between women and men with these characteristics. CONCLUSIONS: Percutaneous infrainguinal revascularization is a very effective modality in women with lower extremity occlusive disease. Although women in this sample were more likely to present with limb-threat than men, patency and limb-salvage rates were equivalent between genders, even in high-risk subsets such as diabetics or those with lesions of increased TASC severity.     

Duplex guided balloon angioplasty of failing infrainguinal bypass grafts.

OBJECTIVE: To assess the results of angioplasty and stent placement under duplex guidance for failing grafts. METHODS: Over 22 months, 25 patients (72% males) with a mean age of 74+/-10 years presented to our institution with a failing infrainguinal bypass. The site of the most significant stenotic lesion was in the inflow in four cases, conduit in 18 cases and at the outflow in 11 cases. All arterial (20) or graft (13) entry sites cannulations were performed under direct duplex visualization. Duplex scanning was the sole imaging modality used to manipulate the guide wire and directional catheters from the ipsilateral CFA to a site beyond the most distal stenotic lesion. Selection and placement of balloons and stents were also guided by duplex. In 11 cases (33%), the contralateral CFA was used as the entry site and a standard approach (fluoroscopy and contrast material) was employed. Completion duplex exams were obtained in all cases. RESULTS: The overall technical success was 97% (32/33 cases). In only one case, the outflow stenotic lesion in the plantar artery could not be traversed with the guidewire due to extreme tortuosity. Overall local complications rate was 6% (two cases). One vein bypass pseudoaneurysm caused by rupture with a cutting balloon was repaired by patch angioplasty and one SFA pseudoaneurysm at the puncture site required open repair. Overall 30-day survival rate was 100%. Overall 6-month limb salvage and primary patency rates were 100 and 69%, respectively. CONCLUSIONS: Duplex guided endovascular therapy is an effective modality for the treatment of failing infrainguinal arterial bypasses.     

Long-term results of a multicenter randomized study on direct versus crossover bypass for unilateral iliac artery occlusive disease

OBJECTIVE: To compare late patency after direct and crossover bypass in good-risk patients with unilateral iliac occlusive disease not amenable to angioplasty. METHODS: Between May 1986 and March 1991, 143 patients with unilateral iliac artery occlusive disease and disabling claudication were randomized into two surgical treatment groups, ie, crossover bypass (n = 74) or direct bypass (n = 69). The size of the patient population was calculated to allow detection of a possible 20% difference in patency in favor of direct bypass with a one-sided alpha risk of 0.05 and a beta risk of 0.10. Patients underwent yearly follow-up examinations using color flow duplex scanning with ankle-brachial systolic pressure index measurement. Digital angiography was performed if hemodynamic abnormalities were noted. Median follow-up was 7.4 years. Primary endpoints were primary patency and assisted primary patency estimated by the Kaplan-Meier method with 95% confidence interval. Secondary endpoints were secondary patency and postoperative mortality and morbidity. RESULTS: Cardiovascular risk factors, preoperative symptoms, iliac lesions TASC class (C in 87 [61%] patients and D in 56 [39%] patients), and superficial femoral artery (SFA) run-off were comparable in the two treatment groups. One patient in the direct bypass group died postoperatively. Primary patency at 5 years was higher in the direct bypass group than in the crossover bypass group (92.7 +/- 6.1% vs 73.2 +/- 10%, P = .001). Assisted primary patency and secondary patency at 5 years were also higher after direct bypass than crossover bypass (92.7 +/- 6.1% vs 84.3 +/- 8.5%, P = .04 and 97.0 +/- 3.0% vs 89.8 +/- 7.1%, P = .03, respectively). Patency at 5 years after crossover bypass was significantly higher in patients presenting no or low-grade SFA stenosis than in patients presenting high-grade (> or =50%) stenosis or occlusion of the SFA (74.0 +/- 12% vs 62.5 +/- 19%, P = .04). In both treatment groups, patency was comparable using polytetrafluoroethylene (PTFE) and polyester grafts. Overall survival was 59.5 +/- 12% at 10 years. CONCLUSION: This study showed that late patency was higher after direct bypass than crossover bypass in good-risk patients with unilateral iliac occlusive disease not amenable to angioplasty. Crossover bypass should be reserved for high-risk patients with unilateral iliac occlusion not amenable to percutaneous recanalization.     

Non-randomized, prospective, multi-centre evaluation of the ABSOLUTE .035 peripheral self-expanding stent system for occluded or stenotic superficial femoral or proximal popliteal arteries (ASSESS Trial): acute and 30-day results

AIM: The aim of the paper was to investigate the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of superficial femoral or proximal popliteal arteries. Due to a lack of large controlled trials proving its long-term durability femoropopliteal artery stenting is still a matter of debate. In this paper we report the study design, the acute and short-term results of a prospective European registry on the treatment of TASC B and C femoropopliteal lesions with the use of the ABSOLUTE stent. METHODS: This prospective, non-randomized, multi-centre study enrolled 122 patients with symptomatic peripheral occlusive disease at 14 sites in Europe. Patients were included with obstructed femoropopliteal arteries. Key inclusion criteria were de novo lesions > or = 4.0 mm and < or = 7.0 mm in diameter, and > or = 40 mm and < or = 200 mm in length. Single target vessel treatment had to be performed with a maximum of three stents. RESULTS: Mean target lesion length was 108 +/- 44 mm (range 22.2 to 200 mm) and mean reference vessel diameter 4.6 +/- 0.8 mm by quantitative angiography; 71% of the lesions analyzable by quantitative angiography (QA) had total occlusions. A total of 227 stents were implanted, 224 of which were deployed successfully (98.7%). Mean percentage of diameter stenosis was reduced from 90.9 +/- 15.5 % (range 41.3 to 100) to 19.0 +/- 8.4% (range 2.3 to 41.5). Device and procedural success were 83.6% each whereas technical success reached 100%. Sixteen lesions had a > or = 30% residual stenosis post-procedure, 6 of them (37.5%) rated as being calcified. Eleven patients experienced major complications (9.1%) and 6 patients experienced minor complications (5%) within 30 days. Duplex ultrasound based 1-month restenosis rate was 9.3%. Target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were 0.8% and 1.7%, respectively and amputation rate was 0.8%. Mean ankle-brachial index (ABI) at rest and after exercise increased significantly from baseline to 30 days follow-up by 0.63 +/- 0.20 to 0.94 +/- 0.17 and from 0.44 +/- 0.23 to 0.85 +/- 0.21, respectively (P<0.001 each). CONCLUSION: The treatment of TASC B and C femoro-popliteal lesions with use of the ABSOLUTE stent is safe and feasible. Short-term follow-up documents persistent improvement of hemodynamics. The 6- and 12-month data have to be awaited for further conclusions:     

腔内支架治疗泛大西洋协作组(TASC)Ⅱ C、D级股动脉病变

目的探讨腔内支架置入治疗泛大西洋协作组(TransAtlantic Inter-Society Consensus,TASC)ⅡC、D级股动脉病变的可行性及近期疗效。方法 2008年1月～2010年12月,对24例患者(共27条股动脉,C级21条,D级6条)进行腔内治疗,开通成功后应用球囊扩张闭塞段并置入自膨式支架。结果成功开通25条股动脉,开通率92.6%(25/27),2条股动脉因病程较长、病变段钙化严重未能开通而行开放外科旁路术。25条股动脉共置入支架62枚。6条患肢的间歇性跛行距离由术前的61 m(30～150 m)增加至术后7天的560 m(300～950 m)(t=3.54,P=0.018)。12条患肢的疼痛消失,5条患肢疼痛可忍受,2条患肢疼痛偶尔需口服止痛药物缓解。所有患肢皮肤颜色变红润,腘动脉、足背和(或)胫后动脉搏动明确。踝肱指数由术前0.36±0.12增至术后7天的0.78±0.25(t=2.16,P=0.038)。19例(21条股动脉)随访4～25个月(平均9.8月):4例各有1条股动脉分别于术后7、11、12和15个月时出现支架内狭窄及血栓形成,其中3例经导管溶栓和球囊扩张后症状缓解,另1例行股腘动脉旁路术后症状缓解,其余15例(17条患肢)均无缺血症状加重表现。结论腔内支架治疗TASCⅡC、D级股动脉病变具有安全和微创的优点,短期效果良好。