Restenosis after Carotid Interventions and Its Relationship with Recurrent Ipsilateral Stroke: A Systematic Review and Meta-analysis.

OBJECTIVE: Do asymptomatic restenoses > 70% after carotid endarterectomy (CEA) and carotid stenting (CAS) increase the risk of late ipsilateral stroke? METHODS: Systematic review identified 11 randomised controlled trials (RCTs) reporting rates of restenosis > 70% (and/or occlusion) in patients who had undergone CEA/CAS for the treatment of primary atherosclerotic disease, and nine RCTs reported late ipsilateral stroke rates. Proportional meta-analyses and odds ratios (OR) at end of follow-up were performed. RESULTS: The weighted incidence of restenosis > 70% was 5.8% after "any" CEA, median 47 months (11 RCTs; 4249 patients); 4.1% after patched CEA, median 32 months (5 RCTs; 1078 patients), and 10% after CAS, median 62 months (5 RCTs; 2716 patients). In four RCTs (1964 patients), one of 125 (0.8%) with restenosis > 70% (or occlusion) after CAS suffered late ipsilateral stroke over a median 50 months, compared with 37 of 1839 (2.0%) in CAS patients with no significant restenosis (OR 0.87; 95% CI 0.24-3.21; p = .8339). In seven RCTs (2810 patients), 13 out of 141 (9.2%) with restenosis > 70% (or occlusion) after CEA suffered late ipsilateral stroke over a median 37 months, compared with 33 out of 2669 (1.2%) in patients with no significant restenoses (OR 9.02; 95% CI 4.70-17.28; p < .0001). Following data correction to exclude patients whose surveillance scan showed no evidence of restenosis > 70% before stroke onset, the prevalence of stroke ipsilateral to an untreated asymptomatic > 70% restenosis was seven out of 135 (5.2%) versus 40 out of 2704 (1.5%) in CEA patients with no significant restenosis (OR 4.77; 95% CI 2.29-9.92). CONCLUSIONS: CAS patients with untreated asymptomatic > 70% restenosis had an extremely low rate of late ipsilateral stroke (0.8% over 50 months). CEA patients with untreated, asymptomatic > 70% restenosis had a significantly higher risk of late ipsilateral stroke (compared with patients with no restenosis), but this was only 5% at 37 months. Overall, 97% of all late ipsilateral strokes after CAS and 85% after CEA occurred in patients without evidence of significant restenosis or occlusion.

Systematic review of randomized controlled trials of patch angioplasty versus primary closure and different types of patch materials during carotid endarterectomy.

BACKGROUND: Patch angioplasty during carotid endarterectomy (CEA) may reduce the risk for perioperative or late carotid artery recurrent stenosis and subsequent ischemic stroke. We performed a systematic review of randomized controlled trials to assess the effect of routine or selective carotid patch angioplasty compared with CEA with primary closure, and the effect of different materials used for carotid patch angioplasty. METHODS: Randomized trials were included if they compared carotid patch angioplasty with primary closure in any patients undergoing CEA or use of one type of carotid patch with another. RESULTS: Thirteen eligible randomized trials were identified. Seven trials involving 1281 operations compared primary closure with routine patch closure, and 8 trials with 1480 operations compared different patch materials (2 studies compared both). Patch angioplasty was associated with a reduction in risk for stroke of any type (P = .004), ipsilateral stroke (P = .001), and stroke or death during both the perioperative period (P = .007) and long-term follow-up (P = .004). Patching was also associated with reduced risk for perioperative arterial occlusion (P = .0001) and decreased recurrent stenosis during long-term follow-up (P < .0001). Seven trials that compared different patch types showed no difference in the risk for stroke, death, or arterial recurrent stenosis either perioperatively or at 1-year follow-up. One study of 180 patients (200 arteries) compared collagen-impregnated Dacron (Hemashield) patches with polytetrafluoroethylene patches. There was a significant increase in risk for stroke (P = .02), combined stroke and transient ischemic attack (P = .03), and recurrent stenosis (P = .01) at 30 days, and an increased risk for late recurrent stenosis greater than 50% (P < .001) associated with Dacron compared with polytetrafluoroethylene. CONCLUSIONS: Carotid patch angioplasty decreases the risk for perioperative death or stroke, and long-term risk for ipsilateral ischemic stroke. More data are required to establish differences between various patch materials.

Patch angioplasty versus primary closure for carotid endarterectomy.

BACKGROUND: Carotid patch angioplasty (with either a venous or a synthetic patch) may reduce the risk of carotid artery restenosis and subsequent ischaemic stroke. OBJECTIVES: The objective of this review was to assess the safety and efficacy of routine or selective carotid patch angioplasty compared to carotid endarterectomy with primary closure. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched November 2002). In addition, we searched the Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001), MEDLINE (1966 to December 2001), EMBASE (1980 to December 2001) and Index to Scientific and Technical Proceedings (1980 to 2001). We also handsearched eight journals and five conference proceedings. Reference lists were checked and we contacted experts in the field to identify further published and unpublished studies. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing carotid patch angioplasty with primary closure in any patients undergoing carotid endarterectomy. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility, trial quality and extracted the data. MAIN RESULTS: The previous review included six trials involving 794 patients undergoing 882 operations. Since the last review only one study of adequate quality to be included has been reported. This added 399 operations randomised to either primary closure, vein patch or synthetic patch groups resulting in 1127 patients undergoing 1307 operations being available for analysis. The quality of trials was generally poor. Follow-up varied from hospital discharge to five years. Carotid patch angioplasty was associated with a reduction in the risk of stroke of any type (OR = 0.33, p = 0.004), ipsilateral stroke (OR = 0.31, p = 0.0008), and stroke or death, during the perioperative period (OR = 0.39, p = 0.007) and long term follow-up (OR = 0.59, p = 0.004). It was also associated with a reduced risk of perioperative arterial occlusion (odds ratio 0.15, 95% confidence interval 0.06 to 0.37 p = 0.00004), and decreased restenosis during long-term follow-up in five trials, (odds ratio 0.20, 95% confidence interval 0.13 to 0.29 p < 0.00001). These results are more certain than those of the previous review since the number of operations and events have increased. However, the sample sizes are still relatively small, data were not available from all trials, and there was significant loss to follow-up. Very few arterial complications, including haemorrhage, infection, cranial nerve palsies and pseudo-aneurysm formation were recorded with either patch or primary closure. No significant correlation was found between use of patch angioplasty and the risk of either perioperative or long-term all-cause death rates REVIEWERS' CONCLUSIONS: Limited evidence suggests that carotid patch angioplasty may reduce the risk of perioperative arterial occlusion and restenosis. It would appear to reduce the risk of combined death or stroke and there is a non significant trend towards a reduction in all-cause mortality.

Redo carotid endarterectomy versus primary carotid endarterectomy.

BACKGROUND AND PURPOSE: Several authorities have recently advocated carotid stenting for recurrent carotid stenosis because of the perception that redo surgery has a higher complication rate than primary carotid endarterectomy (CEA). This study compares the early and late results of reoperations versus primary CEA. METHODS: All reoperations for recurrent carotid stenosis performed during a recent 7-year period by a single vascular surgeon were compared with primary CEA. Because all redo CEAs were done with polytetrafluoroethylene (PTFE) or vein patch closure, we only analyzed those primary CEAs that used the same patch closures. A Kaplan-Meier life-table analysis was used to estimate stroke-free survival rates and freedom from >/=50% recurrent stenosis. RESULTS: Of 547 primary CEAs, 265 had PTFE or saphenous vein patch closure, and 124 reoperations had PTFE or vein patch closure during the same period. Both groups had similar demographic characteristics. The indications for reoperation and primary CEA were symptomatic stenosis in 78% and 58% of cases and asymptomatic >/=80% stenosis in 22% and 42% of cases, respectively (P<0.001). The 30-day perioperative stroke and transient ischemic attack rates for reoperation and primary CEA were 4.8% versus 0.8% (P=0.015) and 4% versus 1.1%, respectively, with no perioperative deaths in either group. Cranial nerve injury was noted in 17% of reoperation patients versus 5.3% of primary CEA patients; however, most of these injuries were transient (P<0.001). Mean hospital stay was 1.8 days for reoperation versus 1.6 days for primary CEA. Cumulative rates of stroke-free survival and freedom from >/=50% recurrent stenosis for reoperation and primary CEA at 1, 3, and 5 years were 96%, 91%, and 82% and 98%, 96%, and 95% versus 94%, 92%, and 91% and 98%, 96%, and 96%, respectively (no significant differences). CONCLUSIONS: Reoperation carries higher perioperative stroke and cranial nerve injury rates than primary CEA. However, reoperations are durable and have stroke-free survival rates that are similar to primary CEA. These considerations should be kept in mind when carotid stenting is recommended instead of reoperation.

Comparative study of operative treatment and percutaneous transluminal angioplasty/stenting for recurrent carotid disease.

PURPOSE: This study is a nonrandomized parallel comparison of the outcome for carotid endarterectomy (CEA) and percutaneous transluminal angioplasty (PTA)/stenting for recurrent carotid artery stenosis (RCS). METHODS AND PATIENTS: Between June 1996 and June 2000, 83 carotid procedures (58 reoperations, Group I, and 25 PTA/stentings, Group II) were done for RCS. Patients were followed at regular intervals with duplex ultrasound scanning. The outcome of the stented group (Group II) was divided into early experience (Group IIA, first 12 cases) and late experience (Group IIB, last 13 cases) for learning curve consideration, and each was compared with the reoperation group. A Kaplan-Meier life table analysis was used to estimate the stroke-free survival rates and freedom from > or =50% recurrent restenosis for both groups. RESULTS: The demographic and clinical characteristics and indications for intervention were similar for both groups. The mean time from the original CEA to reoperation was 41 months in Group I versus 43 months in Group II. Overall, stenting had higher 30-day stroke rates than reoperations-16% (3 major and 1 minor stroke) versus 3.4% (1 out of 2 [1.7%] was a major stroke, P <.05). However, Group IIB had similar major stroke rates to Group I (0% versus 1.7%). Cranial nerve injury was noted in 10 patients (17%) in Group I (only 1 [1.7%] was permanent) versus 0% in Group II (P <.05). Recurrent > or =50% restenosis was higher in Group II than in Group I (24% versus 0%, P <.001). Stroke-free survival rates at 6 months and 1, 2, and 3 years for Group I were 97%, 97%, 94%, and 82%, respectively, versus 79%, 79%, 79%, and 79%, respectively, for Group II (P =.059). Freedom from recurrent > or =50% restenosis rates at 6 months and 1, 2, and 3 years were 100%, 100%, 100%, and 100%, respectively, for Group I versus 100%, 94%, 65%, and 44%, respectively, for Group II (P <.0001). CONCLUSIONS: Carotid PTA/stenting has a similar 30-day stroke rate to that of reoperation for RCS once experience is established. However, PTA/stenting has a higher incidence of restenosis than reoperation, which is associated with a percentage of cranial nerve injuries. Therefore, PTA/stenting can be an alternative to reoperation, particularly in marginal surgical risk patients.

A study of 510 carotid endarterectomies and a review of the recent carotid endarterectomy trials.

The release of several randomized trials comparing carotid endarterectomy (CEA) to other methods of stroke prevention in the early 1990s established CEA as the "gold standard" in the prevention of stroke from carotid occlusive disease. This study examines 510 of the CEAs performed by the first author at Charleston Area Medical Center in Charleston, W. Va., from 1991-99, which were part of three prospective randomized CEA trials at CAMC. All patients were observed clinically and underwent postoperative color duplex ultrasound scans at 30 days, six months, 12 months, and every year thereafter to assess the presence of recurrent stenoses. The overall perioperative stroke rate in the whole series was 2.7% (14/510). The incidence of perioperative ipsilateral stroke was 4.6% for CEA with primary closure vs. 1.9% for CEA with patching (p < 0.05). Patching using PTFE or vein patch closure had the lowest incidence of perioperative stroke rate (0.7%). Primary closure had a statistically significant higher incidence of recurrent stenoses than PTFE or vein patch closure (28% vs. 2.9%, p < 0.0001). The incidence of ipsilateral stroke and recurrent stenosis using the Hemashield patch was higher than either PTFE or vein patch closure. As the indications for CEA expand, the safety, utility, and cost-effectiveness of the procedure must be closely monitored at each institution. However, as shown in this study, CEA (using PTFE or vein patch closure) is a safe, effective, and well-established tool in the treatment of stroke in the 21st century.

Prospective controlled study of carotid endarterectomy with hemashield patch: is it thrombogenic?

The use of patch angioplasty after carotid endarterectomy (CEA) has been shown to have superior results to CEA with primary closure. Polytetrafluoroethylene (PTFE) patches have been shown to have comparable results to autogenous vein patching; however, PTFE has the disadvantage of prolonged hemostasis time. Therefore, many surgeons are using collagen-impregnated Dacron patches (Hemashield[HP]). We believe this is the first prospective controlled study of the use of HP in carotid endarterectomy. This study included 144 consecutive patients who had 151 CEAs with HP. Postoperative duplex ultrasounds were done at 1 month and every 6 months thereafter. The mean follow-up was 12 months (range: 1-30 months). Indications for CEA included symptomatic (64%) and asymptomatic (36%) stenoses. The overall incidence of ipsilateral stroke was 5% (4% perioperative), with a combined TIA and stroke rate of 12%. Incidence of > or =50% recurrent stenosis was 21% (7% symptomatic TIA/stroke) and > or =80% recurrent stenosis was 9%. Kaplan-Meier analysis showed that at 1 year and 2.5 years freedom from > or =50% recurrent stenosis was 78% and 57%, respectively, freedom from > or =80% recurrent stenosis was 92% and 77%, respectively, and a stroke-free survival rate of 94% and 72%, respectively. Women had a 22% and men a 14% recurrent stenosis rate (p=0.04). There was no correlation between other specific risk factors and recurrent stenosis except for hypertension (33% vs 12%, p=0.003). The authors concluded that CEA with HP had a higher incidence of recurrent stenosis (21%), and a higher perioperative stroke rate (4%) after a mean follow-up of 12 months than previously reported using PTFE or saphenous vein patching (2% and 9% recurrent stenosis rates, respectively, and 1% and 0% perioperative stroke rates, respectively after a mean follow-up of 30 months). This raises the question as to whether this patch is thrombogenic in this location. Therefore, a randomized controlled trial comparing this patch with other patches (PTFE or vein) is warranted.

Iliofemoral deep vein thrombosis: conventional therapy versus lysis and percutaneous transluminal angioplasty and stenting.

OBJECTIVE: To compare conventional treatment (heparin and warfarin) of iliofemoral venous thrombosis with multimodality treatment (lysis and stenting). SUMMARY BACKGROUND DATA: Several studies have reported on conventional therapy for iliofemoral venous thrombosis with disappointing results. However, more recent studies have reported better results with multimodality treatment. METHODS: Fifty-one consecutive patients with extensive iliofemoral venous thrombosis were treated during a 10-year period. If there were no contraindications, patients were given the option to choose between conventional therapy (group 1) and multimodality therapy (group 2). The multimodality treatment strategy included catheter-directed lysis followed by percutaneous transluminal balloon angioplasty (PTA) and stenting for residual iliac stenoses. All patients underwent routine venous duplex imaging at 30 days, 3 months, 6 months, and every 6 months thereafter. RESULTS: There were 33 patients in group 1 and 18 patients in group 2. Demographic and clinical characteristics were comparable for both groups. Initial lysis was achieved in 16 of 18 patients (89%) in group 2. Ten of 18 patients in group 2 had residual stenosis after lysis (8 primary and 2 secondary to malignancy), and they were treated with PTA/stenting with an initial success rate of 90%. Two patients in group 1 (6%) had a symptomatic pulmonary embolism (none in group 2). At 30 days, venous patency and symptom resolution were achieved in 1 of 33 patients (3%) in group 1 versus 15 of 18 (83%) in group 2. Kaplan-Meier analysis showed primary iliofemoral venous patency rates at 1, 3, and 5 years of 24%, 18%, and 18% and 83%, 69%, and 69% for groups 1 and 2, respectively. Long-term symptom resolution was achieved in 10 of 33 patients (30%) in group 1 versus 14 of 18 (78%) in group 2. Kaplan-Meier life table analysis showed similar survival rates at 1, 3, and 5 years of 100%, 93%, and 85% for group 1 and 100%, 93%, and 81% for group 2. CONCLUSIONS: Lysis/stenting treatment was more effective than conventional treatment in patients with iliofemoral vein thrombosis.

Endovascular caval interruption in pregnant patients with deep vein thrombosis of the lower extremity.

PURPOSE: The choice of therapy for deep vein thrombosis (DVT) of the lower extremity during pregnancy has been widely debated. Warfarin passes through the placenta to the fetus and may cause fetal complications and/or death. Heparin, in contrast, does not cross the placenta, but its long-term use may be impractical and may increase the risk of bleeding, osteoporosis, and neurologic complications. The use of inferior vena cava filters in pregnancy has only been described as case reports in the English medical literature; therefore, this study reviews our experience on this subject. METHODS: We analyzed 18 pregnant patients who had Greenfield filters (GFs) inserted for DVT of the lower extremity, pulmonary embolism (PE), or both. The DVT diagnosis was made by means of duplex imaging. Conventional full-dose intravenous heparin was initiated until the filter was inserted, followed by subcutaneous heparin until labor, and continued for 6 weeks postpartum in 13 patients who were breast-feeding. Warfarin was given postpartum in the other five patients. RESULTS: The mean age of the patients was 25 years. The indications for GF insertion included 3 patients who had a PE while on anticoagulation, 2 patients with significant bleeding caused by anticoagulation, 4 patients with free-floating iliofemoral DVT, 2 patients with heparin-induced thrombocytopenia, and 7 patients with iliofemoropopliteal DVT occurring 1 to 3 weeks before labor, for prophylactic reasons. Fourteen of 18 cases were diagnosed in the third trimester of the patient's pregnancy. Filters were inserted via the right internal jugular vein by means of a cut-down technique in the first four patients (stainless steel filters) and percutaneously in 14 patients. The mean fluoroscopy time during filter insertion was less than 2 minutes. There was no fetal or maternal morbidity or mortality. During long-term follow-up (mean, 78 months), no PE or filter-related complications were encountered. CONCLUSION: GF insertion in pregnant patients with DVT of the lower extremity is safe and effective. Its prophylactic use in pregnant patients who have extensive iliofemoral DVT right before labor may be justified.

Selecting patients for combined femorofemoral bypass grafting and iliac balloon angioplasty and stenting for bilateral iliac disease.

PURPOSE: This study examines the selection of patients for combined femorofemoral bypass (FFB) grafting and iliac balloon angioplasty (IBA) and stenting for bilateral iliac occlusive disease (successively or simultaneously) and the correlation of the length and location of stenoses of the donor iliac artery to the success of FFB grafts. METHODS: Forty-one patients with long iliac occlusion and significant contralateral iliac stenosis were treated with combined FFB grafting and IBA and stenting, which were performed simultaneously or percutaneously within 1 to 2 days before surgery. Stenting was performed for suboptimal IBAs. IBA/graft patency was evaluated by duplex scanning/ankle-brachial index at 1, 3, 6, and 12 months and every 12 months thereafter. A life-table analysis of patency was performed, according to the length of stenosis as classified by the Society of Cardiovascular Interventional Radiology (group A, < 3 cm and 3-5 cm; group B, > 5 cm). RESULTS: Indications for surgery were limb salvage (22%), rest pain (44%), and claudication (34%). The mean follow-up time was 34.1 months. Perioperative complications were 7% for group A versus 62% for group B (P = .0007) with no perioperative deaths or amputations. Stenting was needed in 12 of 13 patients (92%) in group B versus four of 28 patients (14%) in group A (P < .0001) and in 11 of 12 external iliac artery lesions versus five of 29 common iliac artery lesions (P < .0001). The overall early success rate was 100% for group A and 62% for group B (P = .0028). The primary patency rates at 1, 2, and 3 years were 96%, 85%, and 85% for group A, respectively, and for group B were 46%, 46%, and 31%, respectively (P < .01). The secondary patency rates for group A at 1, 2, and 3 years were 100%, 96%, and 87%, respectively; and for group B were 62%, 54%, and 27%, respectively (P < .001). The overall primary and secondary patency rates for common iliac and external iliac artery lesions were similar (72% and 72% versus 67% and 75%, respectively). The overall limb salvage rates were 96% for group A and 85% for group B. Seven of 13 patients (54%) of group B, in contrast with 0 of 28 patients in group A, had to undergo a revision of the procedure within 30 days (P < .01). CONCLUSION: Combined use of IBA and stenting and FFB grafting is effective and durable and can be performed simultaneously, if the donor iliac stenosis length is 5 cm or less. Percutaneous transluminal angioplasty/stenting of stenoses of 5 cm or more fail to support FFB grafting in most patients; therefore, their combination should be questioned.

Endovascular repair of abdominal aortic aneurysms: our early experience.

Endovascular repair of abdominal aortic aneurysms (AAA) seems to hold the potential for decreased perioperative mortality and morbidity associated with the standard open repair by eliminating major surgical exposure of the aorta and prolonged aortic cross-clamping. After several years of FDA-approved clinical trials of multiple aortic-stented grafts, the FDA, in September 1999, approved two devices (the ANCURE and the AneuRx) for commercial use in the United States. We implanted the first device in the Tri-State area at the Charleston Area Medical Center (CAMC) on Feb. 6, 2000, and this study reviews our early experiences with 15 patients utilizing these two devices at CAMC.

Frequency of postoperative carotid duplex surveillance and type of closure: results from a randomized trial.

BACKGROUND/PURPOSE: In several nonrandomized studies investigators have reported on the value of postoperative carotid duplex surveillance (PCDS) with mixed results; however the type of closure was not analyzed in these studies. In this study we analyze the frequency and timing of postoperative carotid duplex ultrasound scanning according to the type of closure from a randomized carotid endarterectomy (CEA) trial comparing primary closure (PC) versus patching. PATIENT POPULATION AND METHODS: We randomized 399 CEAs into 135 PCs, 134 polytetrafluoroethylene (PTFE) patch closures, and 130 vein patch closures (VPCs) with a mean follow-up of 47 months. PCDS was done at 1, 6, and 12 months and every year thereafter (a mean of 4.0 studies per artery). Kaplan-Meier analysis was used to estimate the rate of > or = 80% restenosis over time and the time frame of progression from < 50%, to 50%-79% and > or = 80% stenosis. RESULTS: Restenoses of > or =80% developed in 24 (21%) arteries with PC and nine (4%) with patching. Kaplan-Meier estimate of freedom of > or = 80% restenosis at 1, 2, 3, 4, and 5 years was 92%, 83%, 80%, 76%, and 68% for PC, respectively, and 100%, 99%, 98%, 98%, and 91% for patching, respectively, (P <.01). Of 56 arteries with 20% to 50% restenosis, two of 28 patch closures and 10 of 28 PCs progressed to 50% to < 80% restenosis (P =.02); none of the patch closures and six of 28 PCs progressed to > or =80% (P =.03). In PCs, the median time to progression from <50% to 50%-79%, < 50% to > or =80%, and 50%-79% to > or = 80% was 42, 46, and 7 months, respectively. Of the 24 arteries with > or =80% restenosis in PC, 10 were symptomatic. Thus, assuming th symptomatic restenosis would have undergone duplex scan examinations regardless, there were 14 asymptomatic arteries (12%) that could have been detected only with PCDS (estimated cost, $139, 200), and those patients would have been candidates for redo CEA. Of the 9 arteries (3 PTFE closures and 6 VPCs) with > or =80% restenosis with patch closures, 6 asymptomatic (4 VPCs and 2 PTFE closures) arteries (3%) could have been detected with PCDS. In patients with normal duplex scan findings at the first 6 months, only four (2%) of 222 patched arteries (two asymptomatic) developed > or = 80% restenosis versus five (38%) of 13 in patients with abnormal duplex scan examination findings (P<.001). CONCLUSIONS: PCDS is beneficial in patients with PC, but is less beneficial in patients with patch closure. PCDS examinations at 6 months and at 1- to 2-year intervals for several years after PC are adequate. For patients with patching, a 6-month postoperative duplex scan examination with normal results is adequate.

Cranial and cervical nerve injuries after repeat carotid endarterectomy.

BACKGROUND AND PURPOSE: The incidence of cranial and/or cervical nerve injuries after primary carotid endarterectomy (CEA) ranges from 3% to 48%; however, the clinical outcome of these injuries after repeat CEA has not been thoroughly analyzed in the English-language medical literature. This prospective study analyzes the incidence and outcome of cranial nerve injuries after repeat CEA. PATIENTS AND METHODS: This study includes 89 consecutive patients who had repeat CEAs. Preoperative and postoperative cranial nerve evaluations were performed, including clinical examinations (neurologic) and direct laryngoscopy. Patients with vagal or glossopharyngeal nerve injuries also underwent comprehensive speech evaluations, video stroboscopy, fluoroscopy, and methylene blue testing for aspiration. Patients with postoperative cranial nerve injuries were followed up for a long time to assess their recovery. RESULTS: Twenty-five cranial and/or cervical nerve injuries were identified in 19 patients (21%). They included 8 hypoglossal nerves (9%), 11 vagal nerves or branches (12%) (6 recurrent laryngeal nerves [7%], 3 superior laryngeal nerves [3%], and 2 complex vagal nerves [2%]), 3 marginal mandibular nerves (3%), 2 greater auricular nerves (2%), and 1 glossopharyngeal nerve (1%). Twenty-two (88%) of these injuries were transient with a complete healing time ranging from 2 weeks to 28 months (18 of 22 injuries healed within 12 months). The remaining three injuries (12%) were permanent (1 recurrent laryngeal nerve, 1 glossopharyngeal nerve, and 1 complex vagal nerve injury). The recurrent laryngeal nerve injury had a longer healing time than the other cranial nerve injuries. CONCLUSIONS: Repeat CEA is associated with a high incidence of cranial and/or cervical nerve injuries, most of which are transient. However, some of these have a long healing time, and a few can be permanent with significant disability.

Carotid-subclavian bypass grafting with polytetrafluoroethylene grafts for symptomatic subclavian artery stenosis or occlusion: a 20-year experience.

BACKGROUND AND PURPOSE: Since the advent of subclavian artery percutaneous transluminal angioplasty/stenting, several authorities advocate it as the treatment of choice for patients with subclavian artery disease, claiming results equal to or better than those of reconstructive vascular surgery. However, most of their quoted surgical series included patients who may have other brachiocephalic disease who were treated nonuniformly by means of various bypass grafts with different grafts in the same series (eg, Dacron, polytetrafluoroethylene [PTFE], or vein). In this study, we analyze the long-term results of a large series of carotid-subclavian bypass grafts for subclavian artery disease in which PTFE was uniformly used; the study can be used as a future reference to compare the results of subclavian artery percutaneous transluminal angioplasty/stenting. PATIENT POPULATION AND METHODS: Fifty-one patients with symptomatic subclavian artery disease (40 occlusions and 11 stenoses) who were treated with carotid-subclavian bypass grafts (PTFE [Goretex]) during a 20-year period were analyzed. Graft patency was determined clinically and confirmed with Doppler scanning pressures and duplex ultrasound scanning. The cumulative patency, overall survival, and symptom-free survival rates were calculated with the life table method. RESULTS: Indications for surgery were arm ischemia in 34 patients (67%), vertebrobasilar insufficiency (VBI) in 27 (53%), and symptomatic subclavian steal in 7 (14%). A combination of arm ischemia and VBI occurred in 17 (33%) of these patients. The mean follow-up was 7.7 years with a median of 7.0 years (range, 1-19 years). The 30-day morbidity rate was 6%, with no perioperative stroke or mortality. Immediate relief of symptoms was achieved in 100% of patients; however, four patients (8%) had late recurrent symptoms (three with VBI). The primary patency and secondary patency rates at 1, 3, 5, and 10 years were 100%, 98%, 96%, and 92% and 100%, 98%, 98%, and 95%, respectively. The symptom-free survival rates at 1, 3, 5, and 10 years were 100%, 96%, 82%, and 47%, respectively. The overall survival rates at 1, 3, 5, and 10 years were 100%, 98%, 86%, and 57%. The mean hospital stay was 3.5 days in the late 70s and 80s and 2.1 days in the 90s (P <. 001). CONCLUSIONS: Carotid-subclavian bypass grafts with PTFE grafts for subclavian artery disease are safe, effective, and durable and should remain the procedure of choice, particularly in good-risk patients.

Effort subclavian vein thrombosis: evolution of management.

PURPOSE: To analyze changes in the management of effort subclavian vein thrombosis at our institution. METHODS: Records of 23 patients with effort subclavian vein thrombosis treated over a 10-year period were analyzed to compare the results of conventional therapy (heparin/warfarin) used in the first half of this period to a multimodality treatment strategy (thrombolysis and other adjunctive treatment as indicated, e.g., first rib resection, angioplasty/stenting, and vein reconstruction). Diagnostic testing included duplex ultrasound and venography. All patients had at least 1-year follow-up. RESULTS: Eight patients (7 men; mean age 34 years, range 15-54) had conventional treatment (group A) and 15 patients (14 men; mean age 36 years, range 17-55) had multimodality therapy (group B). Demographics and clinical characteristics were comparable for both groups. Initial thrombolysis was achieved in 14 (93%) group B patients; 10 received adjunctive treatment to relieve external compression or vein stenosis. Four patients had successful first or cervical rib resection and scalenectomy, and first rib resection followed by angioplasty/stenting was successful in 2. However, angioplasty and stenting alone failed in 2 patients, while venous reconstruction was successful in only 1 of 2 cases. Mean follow-up was 72 months in group A patients and 59 months in group B. One (13%) group A patient and 12 (80%) group B patients demonstrated total venous recanalization and symptom resolution (p = 0.003). Overall, clinical resolution (total and partial symptom relief) was achieved in 3 (38%) group A patients and 13 (87%) group B patients (p = 0.026). CONCLUSIONS: Initial lytic therapy followed by adjunctive treatment to relieve external venous compression or venous stenosis is effective in treating patients with effort subclavian vein thrombosis.

Perioperative and late stroke rates of carotid endarterectomy contralateral to carotid artery occlusion : results from a randomized trial.

BACKGROUND AND PURPOSE: Several previous studies have reported the benefits of carotid endarterectomy (CEA) contralateral to carotid occlusion with mixed results, but none of these were randomized except for the North American Symptomatic Carotid Endarterectomy Trial. The purpose of this study was to analyze the results of surgery in patients with contralateral carotid artery occlusion in a randomized trial in which randomization was done according to the method of closure. METHODS: In 399 CEAs (357 patients) that were randomized into primary closure versus patching, 49 had contralateral occlusion. Strokes were designated as ipsilateral if they arose from the same CEA side and contralateral if they arose from the occluded side. A Kaplan-Meier analysis was used to estimate perioperative strokes and stroke-free survival in patients with contralateral occlusion (group A) versus those without contralateral occlusion (group B). RESULTS: Demographic characteristics and mean follow-up for both groups were similar (group A, 40 months; group B, 33 months). Group A had a higher incidence of contralateral transient ischemic attacks (TIAs) (12.2% versus 0.9%; P<0.0001), contralateral strokes (2% versus 0%; P=0.025), and combined contralateral TIAs/strokes (14.3% versus 0.9%; P<0.0001). The rates for perioperative and all strokes (operative and late) were 2% and 4. 1% (2% ipsilateral and 2% contralateral strokes) for group A and 2. 9% and 3.4% (all ipsilateral) for group B (P=0.60 and 0.85, respectively). The rates for perioperative and all TIAs were 0% and 14.3% for group A versus 2.6% and 6.3% for group B (P=0.918 and P=0. 08, respectively). The rates for perioperative and all neurological events (TIA and stroke) were 2% and 18.4% for group A and 5.4% and 9. 7% for group B (P=0.27 and 0.113, respectively). The cumulative stroke-free survival rates at 5 years were 84% for group A and 77% for group B (P>0.1). The cumulative stroke-free survival rates at 5 years for symptomatic and asymptomatic patients in group A and group B were also similar. The perioperative and late deaths were similar for both groups (group A, 8%; group B, 14%). CONCLUSIONS: Group A had a higher incidence of contralateral TIAs and strokes than group B; however, the perioperative and all late stroke rates and survival rates of CEA were comparable in patients with and without contralateral occlusion.

The role of oculopneumoplethysmography in detecting acute carotid artery thrombosis in patients with neurologic deficits after carotid endarterectomy.

BACKGROUND: This study analyzes the role of oculopneumoplethysmography (OPG/Gee) in detecting acute carotid thrombosis (CAT) after carotid endarterectomy (CEA) in a timely fashion for immediate exploration, and minimizing unnecessary surgery. PATIENTS AND METHODS: Fifty-three patients with neurologic deficits that were noticed after CEA in the operating or recovery room had immediate OPG/Gee. Patients with a positive OPG underwent immediate exploration. Patients with a negative OPG had a duplex ultrasound (DU), and if positive for >/=50% stenosis, the patient underwent exploration. If the DU was negative, the patient underwent cerebral computed tomography scanning and angiography. RESULTS: Thirty-one of 53 (58%) had a positive OPG, 30 (97%) of whom had CAT on exploration. Twenty-two of 53 (42%) with a negative OPG had a DU, 4 of whom had >/=50% stenosis (1 thrombosis) that was confirmed by exploration. The remaining 18 patients had a negative DU that was confirmed by angiography. OPG had an overall accuracy of 96% in detecting acute CAT, with a sensitivity of 97%, specificity of 95%, positive predictive value (PPV) of 97%, and a negative predictive value (NPV) of 95%. Combined OPG and selective DU had an overall accuracy of 98% in detecting surgically correctable lesions, with 100% sensitivity, 95% specificity 97% PPV, and 100% NPV. Mandatory exploration in all 53 patients would have resulted in 19 (36%) unnecessary surgeries versus 1 of 53 (2%) if exploration had been done based on OPG with selective DU (P <0.05). Even if exploration was done based only on the OPG, 30 of 34 surgical lesions would have been explored within a few minutes; only 4 would have been delayed until a DU was performed. CONCLUSIONS: OPG/Gee is very sensitive and timely in detecting acute CAT, and carotid exploration in these patients can improve the results of CEA. It also minimizes unnecessary explorations. Patients with a negative OPG should undergo DU, and if positive, they should undergo exploration.

Prospective controlled study of polytetrafluoroethylene versus saphenous vein in claudicant patients with bilateral above knee femoropopliteal bypasses.

BACKGROUND: Although several studies have compared the patency rates of polytetrafluoroethylene (PTFE) and saphenous vein grafts (SVG) for the above knee location, none have compared the 2 grafts when implanted in the same patient with claudication who needs bilateral above knee femoropopliteal bypasses. METHODS: Forty-three patients (86 limbs) with bilateral disabling claudication who had superficial femoral artery occlusion and above knee reconstitution with 2- to 3-vessel runoff were analyzed. Patients were treated on one side with PTFE and on the other side with SVG. They were sequentially assigned to PTFE-SVG alternating with SVG-PTFE. All patients were followed using duplex ultrasound and ankle/brachial indexes at 1 month and every 6 months thereafer. RESULTS: The perioperative complication rates were 5% for PTFE and 12% for SVG. There was no operative death or perioperative amputation for either procedure. The Kaplan-Meier estimate of primary, assisted primary, and secondary patency rates at 72 months were 68%, 68%, and 77% for PTFE and 76%, 83%, and 85% for SVG. There were no statistically significant differences between primary and secondary patency rates for both grafts; however; the assisted primary patency rates were higher for SVG (P < .05). The crude limb salvage rate at 72 months was 98% for PTFE and 98% for SVG. There were no risk factors identified that had an impact on graft patency. CONCLUSIONS: PTFE and SVG for above knee bypasses have comparable patency and limb salvage rates in claudicant patients with bilateral superficial femoral artery occlusion and 2- to 3-vessel runoff This may justify the use of PTFE for above knee locations in these selected patients.