Changing pattern of surgical revascularization for critical limb ischemia over 12 years: endovascular vs. open bypass surgery

OBJECTIVE: This study is a review and evaluation of our 12-year experience of revascularization for critical limb ischemia (CLI) with angioplasty/stenting and bypass surgery to identify specific trends of procedure volume and outcomes in this particular group. METHODS: Endovascular and open bypass procedures done for CLI by a single surgeon between 1993 and 2004 were evaluated retrospectively. Thrombolysis and thrombectomy procedures done as the only revascularization procedure were excluded from analysis. The data were divided into three groups by time periods: the first period, 1993 to 1996; the second period, 1997 to 2000; and the third period, 2001 to 2004. Outcomes were defined according to the reporting standards of the Society for Vascular Surgery/International Society for Cardiovascular Surgery. The study included 416 procedures done in 237 limbs in 192 patients. The mean follow-up was 23 months (range, 1 to 122 months). RESULTS: Primary revascularization procedures for CLI were angioplasty in 153 limbs (65%) and bypass surgery in 84 (35%). Subsequent procedures were angioplasty in 102 limbs (57%) and open surgery (bypass and/or patch angioplasty) in 77 limbs (43%). The rates for technical and clinical success and complications in the entire group were 99%, 95%, and 4%, respectively. One patient died perioperatively (0.5%). Among the three periods, TransAtlantic Inter-Society Consensus lesion types were significantly more severe in patients in the first period (P < .05). Additionally, the complication rate was significantly higher and the mean hospital stay was significantly longer in the first period compared with the second and third periods (P < .05). Furthermore, between the first and third periods, the number of endovascular revascularization procedures done as primary and secondary procedures significantly increased from 15 to 84 (+460%) and from 13 to 57 (+340%), whereas the number of open surgical procedures done as primary and secondary procedures decreased from 39 to 20 (-49%) and from 35 to 18 (-49%), respectively (P < .0001). The assisted primary patency rates in the third period were significantly higher than those in the first and second periods (P = .012); otherwise, the long-term outcomes among the three periods were not statistically different. Multivariate analysis revealed that, while controlling for other factors, the third period showed improvement in the primary patency (P = .032) and assisted primary patency (P = .051), and the bypass group showed improvement in the primary patency (P = .008). CONCLUSIONS: In our experience, open surgical procedures for the treatment of CLI have been largely replaced by angioplasty procedures without compromising outcomes. Angioplasty is a feasible, safe, and effective procedure and can be the procedure of choice for the primary and secondary treatment of CLI. Open surgical procedures can be reserved for lesions technically unsuitable for endovascular procedures and patients who do not demonstrate clinical improvement after angioplasty.     

Comparison of specialties participating in the BEST-CLI trial to specialists treating peripheral arterial disease nationally

BackgroundThe Best Endovascular vs Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial compares open surgery and endovascular therapy for the treatment of critical limb ischemia (CLI). This report describes the types and proportion of investigators participating in BEST-CLI and determines how these compare with those specialists treating peripheral artery disease (PAD) outside of the trial.MethodsTo be credentialed to enroll in BEST-CLI, investigators must be approved by the Surgical and Interventional Management Committee to have sufficient experience and skill in the management of patients with CLI. Investigators must attest to having completed at least 12 below-knee interventions in the last 2 years on CLI patients for endovascular approval and 10 lower extremity below-knee bypass procedures in the last 2 years for open surgical treatment. Investigators who met these criteria but were within their first year of practice were conditionally approved to do procedures under the oversight of a fully approved investigator. The type and proportion of specialists credentialed in BEST-CLI were compared with those treating PAD on a national basis by auditing 10% of Medicare claims for PAD.ResultsAs of September 2017, a total of 865 physicians were credentialed to enroll in the BEST-CLI trial. Of these, 596 (69%) are vascular surgeons, 128 (15%) are interventional cardiologists, 123 (14%) are interventional radiologists, 7 (1%) are vascular medicine specialists, and 11 (1%) are other. Of the 596 vascular surgeons enrolling in the trial, 113 (19%) are credentialed for open surgery only, 409 (69%) are credentialed for both open surgery and endovascular therapy, and 3 (1%) are credentialed for only endovascular therapy. The remaining 71 participating vascular surgeons were conditionally approved. Of the 136 centers enrolling patients, multispecialty involvement is present in 98 (72%). In 38 (28%), vascular surgery alone is the service enrolling CLI patients. Endovascular treatment by specialty in BEST-CLI vs national Medicare claims is as follows: vascular surgery, 55% vs 51%; interventional cardiology, 17% vs 13%; interventional radiology, 16% vs 25%; and other, 2% vs 10%.ConclusionsBEST-CLI contains a diverse group of specialists enrolling and treating patients with CLI. Whereas a majority of the participating practitioners are vascular surgeons who do both open and endovascular procedures, a broad variety of specialists are represented in BEST-CLI in a pattern that represents national treatment patterns outside of the BEST-CLI trial. These treatment patterns will help ensure that findings from BEST-CLI are applicable to the real-world practice of treatments for PAD.     

Five-year follow-up of an endovascular program initiated by vascular surgeons

Strategies developed by vascular surgeons to establish an endovascular program and the 5-year results of the program are reported. In 1994, the operating room was chosen as the site for the endovascular suite. With this strategy, vascular surgeons would be able to 1) govern appropriate indications for intervention, 2) perform procedures independently and direct the course of the intervention, 3) treat unexpected findings during traditional surgical repair with endovascular techniques, and 4) teach these techniques to vascular surgery fellows. Initial procedures were performed under the supervision of radiologists or other vascular surgeons experienced with these techniques. Endovascular catheters were obtained with operating room capital. During a 5-year period (1/1/94-12/31/98), 224 balloon angioplasties (including placement of 65 stents) were performed for stenoses in 84 failing lower extremity arterial bypasses; 58 iliac, 35 femoral, 19 popliteal, 10 tibial, 7 aortic, and 7 subclavian arteries; and 3 subclavian veins and 1 superior vena cava. Ninety-eight procedures were performed concomitantly with an open surgical procedure and 102 interventions were performed as the sole intervention. There were ten (4%) technically unsatisfactory results treated with immediate surgery and two (0.8%) hematomas that required surgery. One-month primary patency was 94%. Endovascular skills gained with this experience has enabled the performance of endovascular aortic aneurysm repair independently. Developing an endovascular suite using the above model is a safe and effective approach. The operating room may be the most practical location to establish an endovascular suite for many vascular surgeons.     

Analysis of Endovascular Graft Treatment for Aortoiliac Occlusive Disease: What Is Its Role Based on Midterm Results?

OBJECTIVE: To analyze the authors' midterm results (up to 4 years) using endovascular grafts to treat aortoiliac occlusive disease in patients with limb-threatening ischemia. SUMMARY BACKGROUND DATA: Endovascular grafts are being used to manage some aortoiliac lesions formerly treated by aortofemoral or extraanatomic bypass grafts. However, widespread acceptance of these new grafts depends on their late patency and clinical utility. METHODS: Between January 1993 and December 1997, 52 patients with aortoiliac occlusive disease were treated with endovascular grafts. The primary indication for treatment was gangrene or ulceration in 42 patients (81%) and rest pain in 10 patients (19%). Sixteen patients had symptomatic contralateral limbs that were also treated, and 27 (52%) patients required a synchronous infrainguinal bypass. Results up to 4 years were evaluated by life table analysis. RESULTS: Forty-six (88%) of the patients had complete follow-up of 3 to 57 months (median 22 months). Six patients were lost to follow-up at a mean of 20 months after surgery. The 4-year primary and secondary patency rates for the endovascular grafts were 66.1% and 72.3% respectively. Six patients required a major amputation, and the limb salvage rate was 88.7%. Four-year patient survival was 37%, with 23 patients dying during this follow-up period. CONCLUSIONS: Endovascular grafts can often be used when conventional procedures are contraindicated or technically impractical. These grafts are a valuable alternative to extraanatomic and aortofemoral bypasses in high-risk patients with aortoiliac occlusive disease and critical ischemia.     

Analysis of Outcomes Following Failed Endovascular Treatment of Chronic Limb Ischemia

Despite recent studies highlighting the advantages of endoluminal intervention in the management of chronic limb ischemia (CLI), outcomes following failed peripheral angioplasty remain less well described. We present a retrospective analysis of failed transluminal infrainguinal percutaneous arterial angioplasty with or without stenting (PTA/S) in patients with CLI. A database of patients undergoing infrainguinal PTA/S between 2002 and 2005 was maintained. Patients underwent duplex scanning follow-up at 2 weeks, 3 months, and every 6 months after the intervention. Angiograms were reviewed in all cases to assess lesion characteristics. Results were standardized to current Transatlantic Inter-Society Consensus (TASC) criteria. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. In total, our analysis involved 246 patients who underwent treatment for CLI using PTA/S. Eighteen percent of procedures (n = 46) were considered an intervention failure secondary to restenosis by duplex ultrasound, returning clinical symptoms, a nonhealing foot lesion, or the absence of a prior palpable pulse. Indications for the original procedure in patients whose PTA/S failed were tissue loss in 44%, claudication in 44%, and rest pain in 12%, while TASC lesion grades were A (0%), B (18%), C (18%), and D (64%). Of patients failing PTA/S, 4% failed in the first 30 days, 78% failed between 1 and 18 months, while 18% failed following 18 months, with a mean time to failure of 8.7 months. Also, 82% of PTA/S failures were candidates for a second endovascular procedure, 11% were suitable for only traditional open bypass, and 4% demonstrated progression of disease necessitating amputation. Of patients undergoing a second endovascular procedure, limb salvage rates were 86% at 12-month follow-up and there was a single periprocedural mortality and complication rate of 6.6%. Of patients requiring open surgical bypass after failed PTA/S, 20% (n = 1) required a major amputation and there were no mortalities. Failure of endoluminal therapy for treatment of lower extremity arterial occlusive disease is amenable to subsequent endovascular intervention for limb salvage with limited morbidity and mortality.Presented at the Sixteenth Annual Winter Meeting of the Peripheral Vascular Surgery Society.     

Treatment of failed lower extremity bypass grafts with new autogenous vein bypass grafting

During the last 9 years we performed 111 bypass procedures for lower extremity ischemia, which occurred after failed infrainguinal bypass grafting. An all autogenous reversed vein bypass was achieved in 103 of 111 operations (93%). Five-year primary and secondary patency of bypasses placed as treatment for one or more failed prior bypass(es) was 57% and 71%, respectively, as compared to 80% and 83%, respectively, for 5-year primary and secondary patency of simultaneously placed first time leg bypasses. Five-year limb salvage for bypass procedures performed as treatment for failed bypass was 90%, which was identical to that achieved for first time bypasses.     

腘以远动脉闭塞所致下肢严重缺血的血供重建

目的 评价腘以远动脉闭塞所致下肢严重缺血(critical limb ischemia,CLI)的血供重建.方法 回顾性分析2003年12月至2009年1月,腘以远动脉闭塞所致CLI行经皮血管腔内成形(percutaneous transluminal angioplasty,PTA)和开放性重建(open reconstruction,OR)术的患者,详细记录患者的病史、病变特点、手术过程、并发症和随访信息.采用Kaplan-Meier生存分析重建血管通畅率和救肢率.结果 本组腘以远动脉闭塞所致CLI患者共167例,182条患肢.123条动脉硬化闭塞(arterios-clerosis occlusions,ASO)的患肢行腘以远动脉PTA治疗,33条血栓闭塞性脉管炎(thromboangiitis obliterans,TAO)和23条ASO患肢行腘以远动脉OR手术.PTA再管化通道6、12、24个月的通畅率分别是67%、54%和49%,其救肢率分别是91%、85%和78%,OR术后移植物6、12、24个月的通畅率分别是90%、83%和79%,其救肢率分别是92%、87%和80%,PTA重建血管的通畅率低于开放性手术(P＜0.05),但PTA和OR术的救肢率差异无统计学意义(P＞0.05).结论 对腘以远动脉ASO的CLI患者,PTA有效、安全,可作为首选治疗方式.PTA治疗失败可选择OR术.对TAO患者腘以远动脉闭塞者OR术仍是最好的治疗选择.

Abstract：

Objective To assess reconstructive options for critical limb ischaemia in infrapopliteal arteries. Methods A retrospective review of all CLI patients who underwent infrapopliteal reconstruction was carried out. Patient history, demographics, procedure details, complications, and follow-up information were collected and analyzed. Patency, limb salvage rate was determined by Kaplan-Meier analysis. Results During the period (from December 2003 to January 2008 ), 123 CLI patients with arteriosclerosis occlusions were treated on an intention-to-treat basis with infrapopliteal percutaneous transluminal angioplasty (PTA).Thirty-three thromboangiitis obliterans and twenty-three arteriosclerosis occlusions suffering CLI were treated by infrapopliteal bypass procedures. Primary patency and limb salvage rate of infrapopliteal PTA at 6, 12 and 24 months was 67%, 54%, 49% and 91%, 85%, 78% respectively, Primary patency and limb salvage rate of infrapopliteal surgical bypass at 6, 12 and 24 months was 90%, 83%, 79% and 92%,87%, 80% respectively, the patency of infrapopliteal PTA was lower than infrapopliteal surgical bypass (P ＜0. 01 ), but the limb salvage rate of infrapopliteal PTA and open surgery was no significant difference (P ＞ 0. 05 ). Conclusion Endovascular treatment (PTA) in patients with infrapopliteal arteriosclerosis occlusions and critical ischaemia is safe, effective. Infrapopliteal PTA can be used as the choice of therapy and surgical bypass reserved in those endovascular treatment failed. While in CLI patients with thromboangiitis obliterans infrapopliteal artery bypass remains the best treatment option.     

One hundred twenty-five concomitant endovascular and open procedures for lower extremity arterial disease

OBJECTIVE: Although the results of staged endovascular and open surgical reconstructions have been well documented, the safety and efficacy of concomitant procedures in the operating room are less well defined. Suboptimal performance of endovascular procedures in an operative setting, or inappropriate reliance on endovascular techniques, might theoretically compromise graft patency. We questioned whether late graft thrombosis is frequently attributable to failure at the endovascularly treated site in this setting. Materials and Methods: Between May 1, 1993, and June 30, 2001, we performed 125 concomitant endovascular and open arterial reconstructions (73 primary reconstructions, 52 graft revisions) in 106 patients. Endovascular techniques were used to treat inflow lesions in 72 cases, outflow lesions in 14 cases, both in four cases, and the graft itself in 35 cases. Fifty-five iliac, 18 femoral, 13 popliteal, six tibial, and 35 graft lesions were treated. For primary bypasses, 33 were to the popliteal level (21 prosthetic, 12 autogenous), 19 were to the tibial or pedal arteries (16 autogenous, three prosthetic or composite), and 12 were to the femoral arteries (one autogenous, 11 prosthetic). Nine patch angioplasties (eight femoral, one popliteal) were performed. For graft revisions, endovascular intervention was for inflow in 13 cases, outflow in three cases, both in one case, and of the graft itself in 35 cases. Surgical revisions involved segmental grafts in 33 cases, patch angioplasty in 18 cases, and both in one case. RESULTS: In the primary group, the initial technical success rate of the endovascular procedure was 93% (68/73), with five patients needing open conversion. The 30-day mortality rate was 1.4%, and the morbidity rate was 11.0%. Of the 19 grafts in the primary group that occluded during the follow-up period (mean, 11.9 months), five thromboses could possibly be attributed to failure at the endovascular site. In the revision group, the initial technical success rate of the endovascular procedure was 88% (46/52), with six patients undergoing conversion to open procedure. The 30-day mortality rate was 0%, and the morbidity rate was 15.4%. Of 22 late graft occlusions in the revision group, only three were attributed to failure at the endovascular site. CONCLUSION: This largest report to date of concomitant lower extremity endovascular and open revascularization procedures shows the approach to be safe. Few late graft occlusions were attributable to failure at the endovascularly treated site. The concomitant approach offers the efficiency and convenience of single stage therapy and allows immediate treatment for inadequate endovascular results or their complications and potential cost savings.     

Optimizing infrainguinal arm vein bypass patency with duplex ultrasound surveillance and endovascular therapy

OBJECTIVE: Infrainguinal bypass grafting with arm vein is associated with lower patency rates compared with saphenous vein conduits. In this study the effect of a duplex ultrasound surveillance program to enable identification and treat graft lesions with open or endovascular repair on patency was analyzed. METHODS: Over 9 years 89 infrainguinal arm vein (26% spliced vein) bypasses were performed to treat critical lower limb ischemia in 89 patients without adequate saphenous vein conduits. Seventy-six (85%) of the bypasses were repeat procedures. Grafts were assessed at operation with duplex ultrasound scanning, then enrolled in a surveillance program. Graft stenoses with peak systolic velocity greater than 300 cm/s and velocity ratio greater than 3.5, detected at duplex ultrasound scanning, were repaired with percutaneous transluminal balloon angioplasty (PTA) if specific criteria were met, including greater than 3 months since primary procedure, lesion length less than 2 cm, and graft diameter greater than 3.5 mm, or with open surgical repair for early appearing or extensive graft lesions. RESULTS: During a mean 26-month follow-up, duplex surveillance resulted in a 48% (43 bypasses) intervention rate. Primary patency rate was 43% at 3 years. Twenty-six (43%) of 61 lesions identified and repaired met criteria for PTA; the remaining 35 graft lesions (stenosis, n = 30; vein graft aneurysm, n = 5) were surgically corrected with vein patch angioplasty (n = 15), interposition grafting (n = 13), jump graft bypass (n = 6), or open repair (n = 1). At 3 years the assisted primary patency rate was 91% (7 graft failures). Multiple interventions were performed in 18 (42%) revised grafts because of metachronous (n = 6) or repair site stenosis (n = 12). In 18 graft interventions (PTA, n = 9; surgery, n = 9) recurrent stenosis developed, and endovascular therapy was used in one third (n = 6). At 3 years the stenosis-free patency rate for PTA (48%) and surgically repaired (53%) graft lesions was similar. CONCLUSIONS: Arm veins used in lower limb bypass procedures are prone to development of stenosis and aneurysm, lesions easily detected with a life-long duplex ultrasound surveillance program. Excellent long-term patency (91%) was achieved despite graft intervention being performed in nearly half of all bypasses and one third of revised grafts. Endovascular treatment was possible in half of all graft stenosis, with outcomes similar to those with surgical repair.     

Aneurysm-related death: primary endpoint analysis for comparison of open and endovascular repair

PURPOSE: The purpose of this study was to utilize an objective endpoint analysis of aneurysm treatment, which is based on the primary objective of aneurysm repair, and to apply it to a consecutive series of patients undergoing open and endovascular repair. METHOD: Aneurysm-related death was defined as any death that occurred within 30 days of primary aneurysm treatment (open or endovascular), within 30 days of a secondary aneurysm or graft-related treatment, or any death related to the aneurysm or graft at any time following treatment. We reviewed 417 consecutive patients undergoing elective infrarenal aortic aneurysm repair: 243 patients with open repair and 174 patients with endovascular repair. RESULTS: There was no difference between the groups (open vs endovascular) with regard to mean age +/- standard deviation (73 +/- 8 years vs 74 +/- 8 years) or aneurysm size (64 +/- 2 mm vs 58 +/- 10 mm) (P = not significant [NS]). The 30-day mortality for the primary procedure after open repair was 3.7% (9/243) and after endovascular repair was 0.6% (1/174, P <.05). The 30-day mortality for secondary procedures after open repair was 14% (6/41) compared to 0% after endovascular repair (P <.05). The aneurysm-related death rate was 4.1% (10/243) after open surgery and 0.6% (1/174) after endovascular repair (P <.05). Mean follow-up was 5 months longer following open repair (P <.05). Secondary procedures were performed in 41 patients following open surgery and 27 patients following endovascular repair (P = NS). Secondary procedures following open repair were performed for anastomotic aneurysms (n = 18), graft infection (n = 6), aortoenteric fistula (n = 5), anastomotic hemorrhage (n = 4), lower extremity amputation (n = 4), graft thrombosis (n = 3), and distal revascularization (n = 1). Secondary procedures following endovascular repair consisted of proximal extender cuffs (n = 11), distal extender cuffs (n = 11), limb thrombosis (n = 3), and surgical conversion (n = 2). The magnitude of secondary procedures following open repair was greater with longer operative time 292 +/- 89 minutes vs 129 +/- 33 minutes (P <.0001), longer length of stay 13 +/- 10 days vs 2 +/- 2 days (P <.0001) and greater blood loss 3382 +/- 4278 mL vs 851 +/- 114 mL (P <.0001). CONCLUSIONS: The aneurysm-related death rate combines early and late deaths and should be used as the primary outcome measure to objectively compare the results of open and endovascular repair in the treatment of infrarenal abdominal aortic aneurysms. In our experience, endovascular aneurysm repair reduced the overall aneurysm-related death rate when compared to open repair. Secondary procedures are required after both open and endovascular repair. However, the magnitude, morbidity, and mortality of secondary procedures are reduced significantly with endovascular repair.     

肝素涂层人工血管在腔内治疗失败的严重下肢缺血血运重建中的应用

目的:评价肝素涂层人工血管在腔内治疗失败的严重下肢缺血(CLI)患者行下肢动脉旁路移植术中的疗效。方法:回顾性分析2017年10月至2019年4月北京医院血管外科收治的腔内治疗失败的CLI患者行下肢动脉旁路移植术治疗的临床资料,根据患者临床症状、病变特点,选择个性化治疗方案,包括支架取出术、动脉内膜剥脱和成形术、人工血管或人工血管复合自体静脉旁路移植术等多种手术方式完成下肢动脉血运重建。分析围术期并发症、症状缓解和溃疡伤口愈合情况、桥血管通畅率及保肢率。结果:入组患者共27例,其中16例静息痛患者术后疼痛均有效缓解,11例有足部溃疡和组织坏死者中,9例完全愈合,2例术后半年溃疡面缩小。术后并发症6例,术后30 d无死亡病例。所有患者获得随访,随访时间为(13.0±8.9)个月(范围:2~35个月)。通过Kaplan-Meier曲线计算,术后6、12及24个月一期通畅率分别为83.3%、73.7%及49.1%;二期通畅率分别为91.8%、82.1%及70.8%;保肢率分别为91.8%、86.9%及76.6%。其中15例股-腘动脉旁路移植术术后1、2年一期通畅率分别为86.7%、49.5%;二期通畅率分别为93.3%、81.7%;保肢率分别为93.3%、81.7%。8例股-小腿动脉旁路移植术术后1、2年一期通畅率分别为45.0%、45.0%;二期通畅率分别为58.3%、58.3%;保肢率分别为58.3%、58.3%。结论:肝素涂层人工血管动脉旁路移植术为腔内治疗失败的下肢动脉复杂病变提供了一种安全有效的治疗方式,能够有效缓解症状及提高保肢率。     

Lower extremity limb salvage with cryoplasty: a single-center cohort study

Endovascular techniques have been playing an increasing role in managing lower extremity chronic critical limb ischemia (CLI) in patients considered poor or non-candidates for surgical revascularization secondary to co-morbidities such as coronary artery disease, uncontrolled hypertension, diabetes mellitus or inadequate conduit. This study reviews our recent clinical experience in the treatment of peripheral artery disease solely using cryoplasty. A retrospective cohort study was performed. The cohort consisted of 88 patients who underwent lower extremity revascularization utilizing cryoplasty between December 2003 and August 2007. Indications for intervention included poor wound healing after forefoot amputation or persistent ulceration of the foot, disabling claudication and rest pain. Kaplan-Meier analysis was performed to assess salvage rates. One hundred twenty-six lesions were treated in 88 patients. Technical success rate was 97%. Limb salvage rates were 75 and 63% for patients with critical limbs ischemia after one and three years, respectively. A history of smoking was associated with a threefold increased risk of limb loss. In conclusion, endovascular management of lower extremity lesions with cryoplasty is an emerging and viable paradigm in the treatment of CLI in an attempt to preserve limbs and avoid major amputations.     

Early results for below-knee bypasses using Distaflo

In patients who require lower extremity revascularization, prosthetic graft is a reasonable alternative in the absence of a suitable autologous vein conduit. However, prosthetic bypass grafts have limited patency, especially for infrageniculate reconstruction. Polytetrafluoroethylene grafts were geometrically modified at the distal end to increase their patency. The authors reviewed their experience with the Distaflo graft in patients who required lower extremity below-knee popliteal and tibial bypasses when no suitable autologous vein conduit was available. Chart review was conducted of the 57 patients who underwent 60 lower extremity bypasses over a 3-year period between June 2003 and April 2006. Twenty-four revascularizations were constructed to the tibial outflow sites, whereas the remaining grafts were placed to the below-knee (28) and above-knee (8) popliteal artery, respectively. Study endpoints were primary, assisted primary, secondary patency, and limb salvage at the time of follow-up. Distaflo bypass was performed at the infrageniculate level in 86.7% of cases (28 below-knee popliteal, 24 tibial). Mean follow-up time was 12 months (range, 0.5-37.5 months). At 1 year, primary, assisted primary, and secondary patencies and limb salvage rates for below-knee popliteal bypasses were 83.5%, 89.5%, 94.7%, and 94.4%, respectively. Primary, assisted primary, and secondary patencies and limb salvage rates for tibial bypasses were 44.4%, 44.4%, 63.2%, and 74.9%, respectively. Distaflo precuffed graft is a good alternative conduit for below-knee popliteal and tibial lower extremity reconstructions in the absence of an autologous vein and appears to have promising early patency and limb salvage rates even when used for tibial bypasses.     

Endovascular Treatment of Failed Prior Abdominal Aortic Aneurysm Repair

Failure of endovascular or conventional abdominal aortic aneurysm (AAA) repair may occur as a result of attachment site endoleak (type I) or paraanastomotic aneurysm and pseudoaneurysm formation. This study examined the results of the use of secondary endovascular grafts for the treatment of failed prior infrarenal AAA repair procedures. Forty-seven patients were treated with endovascular grafts. These included 14 patients with type I endoleaks (5 proximal, 8 distal, 1 proximal and distal) and 33 patients with paraanastomotic aneurysms after standard open surgical AAA repair (3 proximal aorta, 5 distal aorta, 21 iliac, 4 proximal and distal). The interval between the primary aortic procedure and the endovascular repair was significantly shorter for failed endovascular procedures (mean, 18.2 months; range, 1-42 months) than for failed conventional procedures (mean, 108.9 months; range, 12-216 months) (p <0.01). The endovascular devices used for correction of the failed AAA repairs were Talent (23), physician-made (19), AneuRx (2), Vanguard (2), and Excluder (1). Transrenal fixation was used for repair of all proximal anastomotic failures. Mean follow-up after reintervention was 12.2 months in patients with failed endovascular grafts and 10.6 months in patients with failed conventional grafts. Patient demographics were as follows: average age, 78 years; 36 male and 11 female; and 4.1 comorbid medical conditions per patient. The endovascular graft was successfully deployed in all 47 cases; 1 patient experienced a persistent proximal attachment site endoleak after endograft deployment. Endovascular grafts may be used to treat previously failed endovascular and conventional AAA repair procedures with good short- and intermediate-term results. Endovascular treatments in these cases may avoid the difficulties of aortic reoperation or AAA repair in the setting of prior endovascular aortic grafting.     

Outcome of surgical and endoluminal intervention for infrainguinal bypass anastomotic strictures

The objective of this study was to compare the outcomes of percutaneous transluminal angioplasty (PTA) versus open surgical repair of anastomotic strictures affecting infrainguinal bypasses. Anastomotic strictures affecting 39 bypasses in 36 patients were identified among 593 consecutive infrainguinal arterial reconstructions performed between 1994 and 2004. The mean age of affected patients was 65 +/- 2 years (range: 61 to 101 years). The original bypasses, with vein grafts outnumbering prosthetic grafts 2 to 1, were performed for acute (5%) and chronic (54%) limb-threatening ischemia, disabling claudication (28%), or popliteal aneurysms (13%). Anastomotic strictures were first recognized an average of 16 +/- 3 months (range 2 to 92 months) postoperatively. Strictures affected the distal anastomosis in 62% of cases and the proximal anastomosis in 38%. Primary patency, assisted primary patency, secondary patency, and limb salvage were assessed following PTA or open surgical repair of the strictures. Anastomotic strictures were detected following acute (41%) and chronic (18%) limb-threatening ischemia, claudication (13%), or during routine graft surveillance (28%) in asymptomatic patients. Graft thrombosis, occurring in 51% of patients at the time of presentation, was not affected by the site of anastomotic stricture, although prosthetic grafts were affected more than vein grafts (92% vs 31%). Interventions included PTA (67%) and conventional open procedures (33%). The latter included vein patch angioplasty, short interposition grafts, and redo bypasses. The stricture site and bypass material used in the original revascularization did not affect reintervention patency rates. Sixteen (62%) of the endovascular procedures were performed on a graft presenting with thrombosis, while only 4 (31%) were initially treated with operative therapy. Treatment of thrombosed grafts resulted in an 18-month patency of 32% compared to an 80% patency in treating grafts that were not occluded at the time of presentation (p < 0.05). No anastomotic stricture repaired operatively required reintervention, whereas 42% of those treated by PTA required a mean of 1.3 additional reinterventions (p < 0.03). Anastomotic strictures affecting infrainguinal bypass grafts contribute to low patency rates. Outcomes can be significantly improved if these strictures are identified before graft thrombosis. Open surgical repair, compared to PTA, provides improved graft function as evident by fewer subsequent interventions required to maintain graft patency.     

Perimalleolar and pedal thromboembolectomy and bypasses to treat distal embolization during aortoiliac aneurysm repairs

OBJECTIVES: Lower extremity embolization occurs during aortoiliac aneurysm repair and may require major amputation when distal arteries are occluded. Because nonoperative treatments are often ineffective, we evaluated an aggressive operative approach. METHODS: In the past 11 years, we performed 328 endovascular and 350 open aortoiliac aneurysm repairs. Excluding cases of embolization to iliac, femoral, popliteal, and more proximal tibial vessels, which were treated in a standard fashion, foot ischemia severe enough to produce cadaveric, pregangrenous, or gangrenous skin changes occurred from more distal embolization after seven endovascular and three open aortoiliac aneurysm repairs. Six of these 10 patients underwent thromboembolectomies of both their dorsalis pedis and perimalleolar posterior tibial arteries < or =4 hours of their original operation. In the other four patients, treatment was delayed 7 to 10 days. Because of progressive foot ischemia, arteriography was performed. From these results, four bypasses (3 autologous vein, 1 polytetrafluoroethylene graft) were performed to the transverse metatarsal arch, dorsalis pedis, perimalleolar peroneal artery, or perimalleolar anterior tibial artery. RESULTS: Patency and limb-salvage rates for both thromboembolectomy and bypass procedures were 100% at a mean follow-up of 3.0 years (range, 5 months-8 years). CONCLUSIONS: Perimalleolar and foot artery thromboembolectomy and bypasses to arteries as distal as the metatarsal arch can be effective treatment for distal embolization from aortoiliac aneurysm repair. Even when cadaveric, pregangrenous, or gangrenous lesions are present, distal arteriography and operative treatment (thromboembolectomy or bypass) may be indicated to successfully salvage the foot.     

Trends in the presentation and surgical management of the acute diabetic foot.

BACKGROUND: This study examines trends in the presentation and surgical management of acute diabetic foot problems in a single institution. METHOD: Prospective audit of all diabetic patients who had a primary procedure for critical lower limb ischaemia (CLI) and/or foot sepsis between 1st January 1990 and 31st December 2002. Primary and secondary intervention, mortality and limb salvage rate within 6 weeks of the index procedure were recorded. RESULTS: There were 661 patients (417 men and 244 women of median age 69, range 31-99, years) with 799 affected limbs. CLI alone was present in 625 (78%) limbs, combined CLI and foot sepsis in 53 (7%) and foot sepsis alone in 121 (15%). The primary intervention was minor amputation in 323 (40%) limbs, revascularisation in 288 (36%), major amputation in 185 (23%) and sympathectomy in three limbs. Within 6 weeks, 125 (16%) limbs required secondary intervention, the peri-procedural mortality rate was 38 of 924 (4%), and the limb salvage rates for patients with CLI, combined CLI and sepsis and sepsis alone were 66, 66 and 80%, respectively. There was a significant decline in the proportion of patients presenting with CLI alone and a significant increase in the proportion presenting with combined CLI and sepsis and sepsis alone. In patients with CLI alone, there was a significant increase in the primary major amputation rate and a significant decline in the minor amputation rate with no significant change in the revascularisation rate. CONCLUSION: There has been a progressive decline in the proportion of patients presenting with CLI alone and a greater proportion of patients presenting with an element of foot sepsis. In patients with CLI alone, the primary major amputation rate has increased at the expense of a decline in minor amputation rate.     

Adjunctive parenteral therapy with lipo-ecraprost, a prostaglandin E1 analog, in patients with critical limb ischemia undergoing distal revascularization does not improve 6-month outcomes

PURPOSE: In patients with critical limb ischemia (CLI), distal revascularization remains the procedure of choice for preventing limb loss, but long-term outcomes for pain relief, wound healing, and prevention of amputation remain suboptimal. Prostaglandin drug therapy as an adjuvant to revascularization may improve these outcomes. The current trial was designed to test the hypothesis that the use of lipo-ecraprost, a lipid encapsulated prostaglandin E(1) prodrug, as an adjunctive therapy after distal revascularization would improve amputation-free survival in patients with CLI. METHODS: The study was randomized, multicenter, double blind, and placebo controlled. Patients meeting clinical and hemodynamic criteria for CLI who were undergoing either bypass or endovascular revascularization of the below knee popliteal or more distal arteries were randomized to receive placebo or a 60-microg dose of lipo-ecraprost administered intravenously starting 相似文献   

Nature,frequency, and predictors of secondary procedures after endovascular repair of abdominal aortic aneurysm

OBJECTIVES: Endovascular stent grafting offers a potentially less invasive option for treatment of abdominal aortic aneurysm. Clinical benefit has been demonstrated with respect to early parameters such as blood transfusion, return of gastrointestinal function, and length of hospital stay. Endovascular repair, however, has been criticized on the basis of inferior long-term outcome. Secondary procedures may be necessary to address durability issues such as migration, high-pressure endoleak, graft limb thrombosis, and degeneration of the stent-fabric structure itself, issues that may compromise the primary goal of aneurysm repair, protection from rupture. METHODS: Between 1996 and 2002, 703 patients underwent endovascular treatment of infrarenal abdominal aortic aneurysm at The Cleveland Clinic Foundation. During this time, five devices were used: Ancure, AneuRx, Excluder, Talent, and Zenith. Outcome was assessed with physical examination, lower extremity arterial studies, plain abdominal radiography, and computed tomography at discharge, at 1, 6, and 12 months postoperatively, and annually thereafter. Secondary procedures were defined as any procedure, exclusive of diagnostic angiography, performed after stent graft implantation, directed at treatment of aneurysm-related events. Multivariable statistical techniques for censored data (Cox proportional hazards modeling) were used to determine baseline parameters associated with need for secondary procedures over follow-up, with calculation of hazards ratio (HR) and 95% confidence interval (CI). RESULTS: Patient follow-up averaged 12.2 +/- 11.7 months. Patient survival was 90% +/- 1.4% at 1 year, 78% +/- 2.6% at 2 years, and 70% +/- 3.8% at 3 years. Aneurysm rupture occurred in 3 patients (0.4%), accounting for rupture risk of 1.4% over the first 2 years of follow-up (Kaplan-Meier method). Overall, 128 secondary procedures were required in 104 patients (15%), with a cumulative risk of 12% +/- 1.5% at 1 year, 24% +/- 2.8% at 2 years, and 35% +/- 4.4% at 3 years after stent graft implantation. Among the secondary procedures, new stent grafts and extensions were placed in 34 patients (27%), embolization of endoleak was performed in 33 patients (26%), and open surgical conversion was undertaken in 11 patients (9%). Periprocedural mortality of secondary procedures was 8% overall, but was 18% for patients undergoing open surgical conversion. Multivariable modeling identified the date the procedure was performed (HR, 1.53 per 3-month period of study; CI, 1.22-1.92; P <.001) and aneurysm size (HR, 1.35 per centimeter of minor axis; CI, 1.13-1.60; P <.001) as independent predictors of need for secondary procedures. CONCLUSIONS: Current endovascular devices are associated with a relatively high rate of complications over mid-term follow-up, culminating in frequent need for secondary remedial procedures. With strict follow-up imaging compliance, however, risk for rupture and aneurysm-related death remain exceedingly low. Newer technology may achieve improved durability and a lower requirement for secondary procedures, while maintaining the minimally invasive nature of presently available devices.     

Peroneal bypass versus endovascular peroneal intervention for critical limb ischemia

Objective

The peroneal artery is a well-established target for bypass in patients with critical limb ischemia (CLI). The objective of this study was to evaluate the outcomes of peroneal artery revascularization in terms of wound healing and limb salvage in patients with CLI.