Local anaesthesia for endovascular repair of infrarenal aortic aneurysms.

OBJECTIVE: The study aimed to analyse and report the results of a 'local anaesthesia first' approach in elective endovascular aneurysm repair (EVAR) patients. MATERIAL AND METHODS: Between January 2007 and August 2010, a total of 217 continuous patients (187 men, median age 76 years, range 52-94 years) underwent elective EVAR using this approach, with predefined exclusion criteria for local anaesthesia (LA). A retrospective analysis regarding technical feasibility, mortality, complication and endoleak rate was performed. The results are reported as an observational study. RESULTS: LA was applied in 183 patients (84%), regional anaesthesia (RA) in nine patients (4%) and general anaesthesia (GA) in 25 patients (12%). Anaesthetic conversion from LA to GA was necessary in 14 patients (7.6%). Airway obstruction (n = 4) and persistent coughing (n = 3) were the most common causes for conversion to GA. Thirty-day mortality in the LA group was 2.7%, with 16/183 patients (8.7%) experiencing postoperative complications. All type I endoleaks (n = 5, 2.7%) occurred in patients with LA and challenging aneurysm morphologies. CONCLUSIONS: A 'local anaesthesia first' strategy can successfully be applied in 75% of patients undergoing EVAR. The use of LA can impact imaging quality and thus precise endograft placement, which should be considered in patients with challenging aneurysm morphologies.

Risk stratification and outcomes of transluminal endografting for abdominal aortic aneurysm: 7-year experience and long-term follow-up.

PURPOSE: To determine early and late outcomes of transluminal endografting (TE) in patients with abdominal aortic aneurysm (AAA), stratified by predicted risk of procedure-related mortality with conventional operation. MATERIALS AND METHODS: A retrospective study was conducted in consecutive risk-stratified AAA patients undergoing TE at a not-for-profit cardiovascular referral center from March 1994 through November 2000 with follow-up through February 2001. With use of conventional risk strata (0 = low, 1 = minimal, 2 = moderate, and 3 = high), predicted procedure-related mortalities were 0%-1% in stratum 0 (n = 40), 1%-3% in stratum 1 (n = 118), 3%-8% in stratum 2 (n = 116), and 8%-30% in stratum 3 (n = 31). Main outcome measures were: (i) TE procedural success, (ii) procedure-related mortality, (iii) major nonfatal complications, (iv) composite adverse outcome (ii + iii), (v) length of stay (LOS), (vi) freedom from AAA rupture, (vii) late survival, (viii) late complications, and (ix) endoleaks and their classification and management. RESULTS: Women were significantly less likely than men to qualify for and undergo endografting: 24 of 91 (26.4%) women underwent TE, compared to 281 of 684 (41.1%) men. Of 305 attempted TE procedures, 291 (95.4%) were successful, four (1.3%) were urgently converted to open repair, and 10 (3.3%) were aborted. Procedure-related mortalities occurred in eight cases (2.6%) overall and one of 40 (2.5%), one of 118 (0.8%), four of 116 (3.4%), and two of 31 (6.5%) cases for risk strata 0-3, respectively. Perioperative survivors were significantly younger than nonsurvivors (74.3 y +/- 9 vs 81.6 y +/- 5.1; P =.0087). Forty-six patients (15.1%) had major complications. Composite adverse outcome was worse for patients in stratum 3 than those in stratum 1 (P =.0296) and those in strata 0, 1, and 2 combined (P =.026). Procedure-related mortality declined with institutional experience, from 4% among the first 100 patients undergoing TE to 1% among the last 105. For strata 0-3, median LOS were 2, 3, 3, and 4 days, respectively. Seventy patients (22.9%) had 75 endoleaks, of which 30 necessitated additional procedures, 17 self-resolved, and 22 were untreated as of March 1, 2001. Five patients with endoleak died of unrelated causes. One late-onset type IA endoleak (26 mo) resulted in the only AAA rupture and death in the follow-up period among the 291 patients who underwent successful transluminal endograft implantation. Actuarial survival rates at 1 year after TE were 90.3% +/- 1.9% for the overall study group and 97.5% +/- 2.5%, 94% +/- 2.5%, 86.9% +/- 3.3%, and 81.3% +/- 7.7% for risk strata 0-3, respectively. At 5 years, overall actuarial survival was 69.6% +/- 6.1%. Thirty-eight late deaths were attributable to post-TE AAA rupture (n = 1), AAA rupture late after failed TE with no further treatment (n = 1), other cardiovascular disorders (n = 7), cancer (n = 15), other causes (n = 10), and unknown causes (n = 4). Late deaths occurred in risk strata 0-3 at the following rates: two of 40 (5%), 10 of 118 (8.5%), 16 of 116 (13.8%), and 10 of 31 (32.3%), respectively (stratum 0 vs stratum 3, P =.0017; stratum 1 vs stratum 3, P =.003). CONCLUSIONS: TE is safe and confers durable protection against AAA rupture in treated populations. Still, protection is not absolute in patients with endoleaks, because late AAA enlargement and even rupture can occur. Given current knowledge, technology, and practice, careful patient selection and close surveillance of patients after implantation of transluminal endografts is essential.

The influence of female gender on the outcome of endovascular abdominal aortic aneurysm repair.

PURPOSE: Women appear to have a greater risk of death than men after open surgery for abdominal aortic aneurysm (AAA). The aim of this study is to compare outcomes after endovascular AAA repair in men and women. MATERIALS AND METHODS: From March 1994 to November 2000, 305 patients (281 men and 24 women) underwent AAA repair with use of endovascular techniques. Outcomes measured included perioperative mortality, percentage of procedures aborted or converted to open abdominal AAA repair, deployment success rate, angiographic success rate, major complication rate, and percentage of patients with endoleaks. RESULTS: Patients of both genders were comparable with respect to mean age (74.4 in men vs 75.9 in women; NS). According to the Society for Vascular Surgery/International Society of Cardiovascular Surgery risk stratification method, men and women were also comparable in age risk score (0.60 vs 0.67; NS), pulmonary risk score (0.50 vs 0.83; NS), and renal risk score (0.28 vs 0.17; NS). However, the cardiac risk score was higher in men (1.31 vs 0.80; P <.05) and maximum AAA diameter was greater in men (57.0 mm vs 52.1 mm; P <.01). Eight perioperative deaths (2.6%) occurred (2.8% of men, 0% of women; NS). Proportionately more procedures were aborted in women than men: four (16.7%) versus six (2.1%; P <.01). Conversion to open repair occurred in four men (1.4%) and no women (NS). Deployment success was achieved in 96.4% of men and 83.3% of women (P <.01). Angiographic success was achieved in 84.1% of men and 80% of women (NS). Of 46 major complications, 42 (14.9%) occurred in 281 men and four (16.7%) occurred in 24 women (NS). Sixty-seven patients had endoleaks: 60 were men (22.1%) and seven were women (35%; NS). CONCLUSIONS: There was no difference between men and women with respect to perioperative mortality and major complication rates. These findings indicate that being a woman does not adversely influence the outcome of endovascular AAA repair. However, women had a higher rate of aborted procedures. Precise preoperative evaluation may help reduce this problem in women.

Detection of isolated hook fractures 36 months after implantation of the Ancure endograft: a cautionary note.

Two cases of delayed (36-month) Ancure hook fracture are reported in patients who experienced a decrease in aneurysm size and no evidence of endoleak. Both devices used redesigned hooks and are otherwise identical to those devices currently used in clinical practice. Notably, hook fractures were not visualized on all abdominal radiographic views, nor were they noted on the final "institutional" report by the reviewing radiologist. Careful clinical follow-up with multiple-view abdominal radiographs remains essential for all patients treated with an endovascular graft, with particular attention directed to the integrity of the metal components. The broader clinical significance of this observation with respect to the Ancure endograft remains to be defined.

Percutaneous treatment of symptomatic vertebral artery stenosis with coronary stents.

Atherosclerotic disease of the vertebral artery can pose a significant clinical problem. The treatment of that disease is not uniformly accepted. We report two cases of patients with vertebral basilar insufficiency due to stenosis of the vertebral artery origins and contralateral occlusions that were treated percutaneously with coronary stent placement.

Results of an aortic endograft trial: impact of device failure beyond 12 months.

PURPOSE: Analysis endpoints of patient survival and aortic rupture at a reporting interval of 12 months are regularly used to compare endograft aortic aneurysm (EAG) repair to conventional open surgical (COS) repair. This study reports a multicenter EAG repair versus COS repair parallel cohort trial at 12 months and additional observations of specific device failure types and their impact on an aortic endograft design beyond that follow-up period. METHODS: From August 1997 to September 1998, 240 patients who were treated with bifurcation EAG repairs and 28 patients who were treated with straight EAG repairs were compared with 98 patients who were treated with COS repair for elective infrarenal aortic aneurysm repair. Allocation to treatment was based on aneurysm anatomy. All cohorts underwent infrarenal procedures. Data from concurrent, nonrandomized patient accrual from 17 United States institutions were prospectively gathered and independently adjudicated for safety and efficacy. An independent core laboratory evaluated all imaging data. RESULTS: There were 308 men and 58 women (mean age, 72 years; range, 42-94 years) treated for infrarenal aortic aneurysm (mean diameter, 55 mm; range, 40-115 mm). Mean preoperative aneurysm diameters were clinically similar (EAG repair, 54 mm vs COS repair, 57 mm). The two cohorts were not significantly different in terms of gender (P = .30) or age (P = .32). EAG repair technical success (aneurysm exclusion, graft patency, patient survival) at 30 days was 89.2%. Five patients required immediate conversion to COS repair, four caused by access complications and one caused by operator-induced EAG repair malposition. The 30-day mortality rate was 1.5% for EAG repair and 3.1% for COS repair (P = .59). The 12-month survival rate was 94.3% for EAG repair and 95.9% for COS repair. The intermediate-term cumulative survival rate at 24 months was 84.9% for EAG repair and 80.3% for COS repair (P = .48). EAG repair device failure occurred from fabric erosion in six patients, with two deaths from ruptured aneurysm at 18 and 28 months after endografting and four device failures resolved by secondary procedures. Five endograft limb dislocations were all resolved by secondary endovascular procedures. Major or minor endograft migration required secondary procedures in five patients, including conversion in two patients. CONCLUSION: The clinical outcome at 12 months demonstrated effective aneurysm treatment and comparable safety between EAG repair and COS repair by conventional endpoints. Ongoing follow-up beyond 12 months revealed device-related adverse events that required endograft design changes. Diligent surveillance of outcomes beyond 12 months is necessary to adequately evaluate EAG repair devices.

Current status of carotid bifurcation angioplasty and stenting based on a consensus of opinion leaders.

OBJECTIVE: Carotid bifurcation angioplasty and stenting (CBAS) has generated controversy and widely divergent opinions about its current therapeutic role. To resolve differences and establish a unified view of CBAS' present role, a consensus conference of 17 experts, world opinion leaders from five countries, was held on November 21, 1999. METHODS: These 17 participants had previously answered 18 key questions on current CBAS issues. At the conference these 18 questions and participants' answers were discussed and in some cases modified to determine points of agreement (consensus), near consensus, (prevailing opinion), or divided opinion (disagreement). RESULTS: Conference discussion added two modified questions, placing a total of 20 key questions before the participants, representing four specialties (interventional radiology, seven; vascular surgery, six; interventional cardiology, three; neurosurgery, one). It is interesting that consensus was reached on the answers to 11 (55%) of 20 of the questions, and near consensus was reached on answers to 6 (30%) of 20 of the questions. Only with the answers to three (15%) of the questions was there persisting controversy. Moreover, both these differences and areas of agreement crossed specialty lines. Consensus Conclusions: CBAS should not currently undergo widespread practice, which should await results of randomized trials. CBAS is currently appropriate treatment for patients at high risk in experienced centers. CBAS is not generally appropriate for patients at low risk. Neurorescue skills should be available if CBAS is performed. When cerebral protection devices are available, they should be used for CBAS. Adequate stents and technology for performing CBAS currently exist. There were divergent opinions regarding the proportions of patients presently acceptable for CBAS treatment (<5% to 100%, mean 44%) and best treated by CBAS (<3% to 100%, mean 34%). These and other consensus conclusions will help physicians in all specialties deal with CBAS in a rational way rather than by being guided by unsubstantiated claims.

Update on the bifurcated EXCLUDER endoprosthesis: phase I results.

Many devices are being investigated for treatment of infrarenal abdominal aortic aneurysms. This report describes the particular characteristics of a next generation modular endograft and the Phase I results in 29 patients. Larger comparative studies are in progress to assess the safety and efficacy of this new design.

Postoperative management: type I and III endoleaks.

The purpose of this article is to help the reader understand the importance of imaging findings and treatment strategies for type I and III endoleaks. Although the appearance of these leaks on computed tomography can be somewhat unremarkable and similar in appearance to type II endoleaks, it is critically important for the treating physician to make the correct diagnosis, as these endoleak types signify an incompletely treated aneurysm. Once the diagnosis of a type I or III endoleak is made, the next step in treatment is to identify the cause of the endoleak. Incomplete initial graft expansion, further arterial dilation, endograft migration, component separation, and tears within the graft fabric are all possible causes of type I and III endoleaks. A combination of computed tomography, plain film radiography, and diagnostic angiography may be necessary to make the diagnosis and identify the underlying cause of the complication. Once all of these factors have been determined, a decision has to be made of whether the endoleak can be treated through additional endovascular means or if endovascular therapy has failed for the patient, making open surgical revision necessary to treat the aneurysm. Illustrative cases of all endoleak types and their treatments are the focus of this article.

Postoperative management: buttock claudication and limb thrombosis.

As a result of endovascular repair of abdominal aortic aneurysms and the necessary associated adjunctive procedures, postoperative buttock claudication and limb thrombosis are complications that every physician who implants stent-grafts should be able to recognize and treat. Whereas the presenting complaints of these complications can be quite obvious, the treatment of them may be not so simple. Studies have shown that 28% of patients who underwent embolization of one or both hypogastric arteries develop buttock claudication. Yet 78% of these affected patients spontaneously resolve their symptoms. Strategies to both minimize and successfully treat this complication are obviously of the utmost importance. Likewise, limb thrombosis can be easy to recognize, but treatment strategies and methods to limit this complication can be quite complex and remain somewhat controversial. One center was able to reduce their limb thrombosis rate from 17% to 0% through the use of intravascular ultrasound and aggressive adjunctive stenting. The purpose of this article is to first review the data concerning these complications and then to discuss treatment strategies that are designed to minimize and treat the actual complication.

Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group.

PURPOSE: To evaluate the safety and efficacy of an endoluminal prosthesis for treatment of peripheral arterial occlusive disease (PAOD). MATERIALS AND METHODS: A self-expanding endoprosthesis with an expanded polytetrafluoroethylene tube inside a nitinol support structure was implanted in 127 patients with symptomatic PAOD in the iliac (61 limbs) and femoral arteries (80 limbs). Clinical category status, ankle-brachial index, and color duplex flow imaging results were recorded before treatment, at discharge, and at 1, 3, 6, and 12 months after treatment. Aspirin was administered throughout the study, and heparin was administered during and for 2 days after the procedure. RESULTS: Endoprosthesis deployment was technically successful in all patients. Complications occurred in 24 of 141 procedures and included three major complications. Early thrombosis (within 30 days) occurred in one iliac and three femoral arteries. Late restenosis or reocclusion was observed in five iliac and 14 femoral arteries within the 1st year. Primary patency rates in iliac arteries were 98% +/- 3% (standard error) and 91% +/- 4%, respectively, at 6 and 12 months after treatment. Primary patency rates in femoral arteries were 90% +/- 3% and 79% +/- 5%, respectively, at 6 and 12 months. Secondary patency rates were 95% and 93% for iliac and femoral arteries, respectively, at 12 months after treatment. CONCLUSION: The device used in this study can be implanted without additional risks to the patient and provided encouraging patency rates up to 1 year.

Initial results of reteplase in the treatment of acute lower extremity arterial occlusions.

PURPOSE: To assess the feasibility and efficacy of reteplase in transcatheter arterial thrombolysis for lower extremity occlusive disease. MATERIALS AND METHODS: Fifteen consecutive patients with acute lower extremity ischemia due to occlusive disease were treated by means of catheter-directed thrombolysis with reteplase. Following diagnostic angiography, thrombolysis was started either from an antegrade puncture site in cases of femoropopliteal occlusions, or from the contralateral groin in cases of thrombosis of the iliac artery, common femoral artery, or infrainguinal bypass grafts. Reteplase was infused at a rate of either 0.5 U/h (six patients) or 1.0 U/h (nine patients). RESULTS: Complete thrombolysis was achieved in all of the nine (100%) patients in the 1.0 U/h group and in four of six (66%) patients in the 0.5 U/h group for a combined success rate of 13 of 15 (87%). Clinical success was achieved in 11 of 15 patients overall (73%). Major bleeding complications occurred in none of the 9 patients in the 1.0 U/h group and in one (16%) of the six patients in the 0.5 U/h group for an overall rate of 6%. CONCLUSIONS: Reteplase shows promise as an alternative to urokinase in the treatment of lower extremity ischemia due to arterial occlusive disease.

May-Thurner syndrome in an adolescent: persistence despite operative management.

We describe a patient with May-Thurner syndrome who underwent operative transection and transposition of the right common iliac artery without direct venous repair, because preoperative and intraoperative intravascular ultrasound scans were negative for "spurs" in the left common iliac vein. When symptoms and signs persisted, a postoperative magnetic resonance venogram (MRV) showed severe stenosis in the left common iliac vein. Progressive, but incomplete, clinical improvement occurred with conservative management.

Stent grafts for aortic aneurysms: the next interventional challenge.

Stent grafts (endografts) have proved useful for the endoluminal exclusion of peripheral and aortic aneurysms, both those in native arteries and those resulting from prior surgery. In addition, their use may apply in some patients with occlusive vascular disease. Various types of endografts are being evaluated in clinical trials, including those that utilize unsupported grafts with stentlike attachment mechanisms and those having a metallic endoskeleton or exoskeleton. Relatively complex devices can be delivered through small arteriotomies and in some cases percutaneous approaches. Unsupported grafts, although more prone to kinking and incomplete expansion, appear to work well. Some devices employ modularity, which involves separate placement of contralateral limbs and, in some cases, extension devices. For performing endovascular grafting, pretreatment planning is critical and requires sophisticated imaging, including spiral computed tomography (CT) with 3-dimensional reconstruction and angiographic evaluation using catheters with calibrated markers. Potential advantages of endovascular grafts include a decreased hospital stay, a less invasive procedure, and lower morbidity and mortality. Several issues remain unresolved and should be addressed by the newer generation of these devices.

Creation of a modified angiography (endovascular) suite for transluminal endograft placement and combined interventional-surgical procedures.

PURPOSE: To describe early experience with an endovascular suite created for procedures requiring surgical access, endograft placement, or combined surgical and interventional radiologic expertise. MATERIALS AND METHODS: After examining the operating room and angiography environments, practice guidelines, state law, and regulatory agency requirements, a multidepartmental task force recommended reconfiguring an angiography suite to serve as an endovascular suite. Forty patients have been treated; 28 underwent vascular endograft placement and 12 underwent other combined procedures. RESULTS: Procedures included 31 femoral and axillary cutdowns; placement of one aortobifemoral graft, two iliofemoral grafts, two femoropopliteal grafts, and two femoral-femoral crossover grafts; two abdominopelvic exposures for aortic access, and five endarterectomies, including one at the carotid bifurcation performed in combination with common carotid stent placement. Three of the abdominopelvic procedures were not planned, including two emergency conversions. No patient had to be moved to an operating room. There was one major infection (2.5%), two minor wound infections (5%), and one wound with delayed healing (2.5%). CONCLUSION: Early experience with a combined surgical-interventional suite has been favorable, but a vigilant approach is warranted.