Clinical outcomes of transcarotid artery revascularization vs carotid endarterectomy from a large single-center experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) has been practiced as an alternative for both carotid endarterectomy (CEA) and transfemoral carotid artery stenting, specifically in high-risk patients. More recently, the Centers for Medicare and Medicaid Services expanded coverage for TCAR in standard surgical risk patients if done within the Society for Vascular Surgery Vascular Quality Initiative TCAR surveillance project. A few registry studies (primarily from the Society for Vascular Surgery Vascular Quality Initiative) compared the early and up to 1-year outcomes of TCAR vs CEA or transfemoral carotid artery stenting. There is no large single-center study that reported late clinical outcomes. The present study compares intermediate clinical outcomes of TCAR vs CEA. METHODS: This study retrospectively analyzed collected data from TCAR surveillance project patients enrolled in our institution and compare it with CEA patients done by the same providers at the same time period. The primary outcome was combined perioperative stroke/death and late stroke/death. Secondary outcomes included combined stroke, death, and myocardial infarction, cranial nerve injury (CNI), and bleeding. Propensity matching was done to analyze outcome. Kaplan-Meier analysis was used to estimate freedom from stroke, stroke/death, and ≥50% and ≥80% restenosis. RESULTS: We analyzed 646 procedures (637 patients) (404 CEA, 242 TCAR). There was no significant difference in the indications for carotid intervention. However, TCAR patients had more high-risk criteria, including hypertension, coronary artery disease, congestive heart failure, and renal failure. There was no significant differences between CEA vs TCAR in 30-day perioperative stroke (1% vs 2%), stroke/death rate (1% vs 3%; P = .0849), or major hematomas (2% vs 2%). The rate of CNI was significantly different (5% for CEA vs 1% for TCAR; P = .0138). At late follow-up (2 years), the rate of stroke was 1% vs 4% (P = .0273), stroke/death 8% vs 15% (P = .008), ≥80 % restenosis 0.5% vs 3% (P = .0139) for CEA patients vs TCAR patients, respectively. After matching 242 CEAs and 242 TCARs, the perioperative stroke rate was 1% for CEA vs 2% for TCAR (P = .5037), the stroke/death rate was 2% vs 3% (P = .2423), and the CNI rate was 3% vs 1% (P = .127). At late follow-up, rates of stroke were 1% for CEA vs 4% for TCAR (P = .0615) and stroke/death were 8% vs 15% (P = .0345). The rate of ≥80% restenosis was 0.9% for CEA vs 3% for TCAR (P = .099). The rates of freedom from stroke at 6, 12, 18, and 24 months for CEA vs TCAR were 99%, 99%, 99%, and 99% vs 97%, 95%, 93% and 93%, respectively (P = .0806); stroke/death were 94%, 90%, 87%, and 86% vs 93%, 87%, 76%, and 75%, respectively (P = .0529); and ≥80% restenosis were 100%, 99%, 98%, and 98% vs 97%, 95%, 93%, and 93%, respectively (P = .1132). CONCLUSIONS: In a propensity-matched analysis, both CEA and TCAR have similar perioperative clinical outcomes. However, CEA was superior to TCAR for the rates of late stroke/death and had a somewhat lower rate of ≥80% restenosis at 2 years, but this difference was not statistically significant.

Long-term durability and clinical outcome of a prospective randomized trial comparing carotid endarterectomy with ACUSEAL polytetrafluoroethylene patching versus pericardial patching.

BACKGROUND: Several studies have shown the superiority of carotid endarterectomy (CEA) with patch closure over primary closure. However, no definite study has shown any significant differences in clinical outcome between various types of patches. Because more vascular surgeons have used pericardial patching recently, this study will analyze the late clinical outcome (≥10 years) of our previously reported prospective randomized trial comparing CEA with ACUSEAL (polytetrafluoroethylene) vs pericardial patching. METHODS: A total of 200 CEAs were randomized (1:1) to either Vascu-Guard pericardial patching or ACUSEAL patching. All patients had immediate duplex ultrasound imaging, which was repeated at 6 months and annually thereafter. Kaplan-Meier analysis was used to estimate rates of freedom from stroke, stroke-free survival, and rates of freedom from ≥50% and ≥80% restenosis. RESULTS: Overall demographic and clinical characteristics were somewhat similar with a mean follow-up of 80 months (range: 0-149 months). The rates of freedom from stroke were 97, 97, 97, 96, 93 for ACUSEAL vs 99, 98, 97, 97, 92 for pericardial patching (P = .1112) at 1, 2, 3, 5, and 10 years, respectively. Similarly, the rates of freedom from stroke/death were 94, 93, 90, 76, 50 for ACUSEAL vs 99, 96, 91, 78, 47 for pericardial patching (P = .8591). The rates of freedom from ≥50% restenosis were 98, 98, 96, 89, 79 for ACUSEAL vs 87, 83, 83, 81, 71 for pericardial patching (P = .0489). The rates of freedom from ≥80% restenosis were 99, 99, 99, 96, 85 for ACUSEAL vs 96, 96, 96, 93, 93 for pericardial patching (P = .9407). The overall survival rates were 95, 94, 91, 77, 51 for ACUSEAL vs 100, 98, 93, 79, 50 for pericardial patching (P = .9123). Other patch complications (eg, rupture, aneurysmal dilation, infection, etc) were similar. CONCLUSIONS: Both CEA with ACUSEAL (polytetrafluoroethylene) and pericardial patching are durable and have similar clinical outcomes at 10 years except that ACUSEAL patching has significantly better rates of freedom from ≥50% restenosis.

Thirty-Day Perioperative Clinical Outcomes of Transcarotid Artery Revascularization vs Carotid Endarterectomy in a Single-Center Experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) has been proposed as a alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting in high-risk patients. Recently Centers for Medicare and Medicaid Services expanded coverage for TCAR to include standard surgical risk patients within the Society of Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project. Few single centers compared the clinical outcome of TCAR with CEA. This study compares 30-day perioperative clinical outcomes between TCAR and CEA. STUDY DESIGN: This is retrospective analysis of prospectively collected data from the TCAR Surveillance Project of TCAR patients enrolled in our institution and compared with CEAs done in the same time/with the same providers. The primary outcome was stroke and/or death. Secondary outcomes included stroke, death, MI, cranial nerve injury, bleeding, and others. Propensity matching was done to analyze outcomes. RESULTS: The study analyzed 501 patients (347 CEA, 154 TCAR). There were no significant differences in symptomatic status (43% for CEA vs 38% for TCAR, p = 0.303). TCAR had more patients with hypertension (p = 0.04), coronary artery disease (p = 0.028), and congestive heart failure (p = 0.039). The 30-day perioperative complication rates for CEA vs TCAR were as follows: stroke 1% vs 3% (p = 0.142), stroke/death 1% vs 3% (p = 0.185), MI 0.6% vs 0.7% (p = 1), death 0.6% vs 0% (p = 1), stroke/death/MI 2% vs 4% (p = 0.233), cranial nerve injury 4% vs 2% (p = 0.412), and major hematoma (requiring reintervention) 2% vs 3% (p = 1). After matching 154 CEA patients and 154 TCAR, 30-day perioperative complication rates were as follows: stroke 2% vs 3% (p = 0.723), stroke/death 3% vs 3% (p = 1), death 1.3% vs 0% (p = 0.498), MI 0.7% vs 0.7% (p = 1), and stroke/death/MI 3% vs 4% (p = 0.759). CONCLUSIONS: This study showed that using propensity match analysis, both CEA and TCAR have similar 30-day perioperative outcomes. Further long-term data are needed.

A single-center experience of 30-day perioperative and one year clinical outcomes of transcarotid artery revascularization in 100 consecutive patients.

BACKGROUND: Transcarotid Artery Revascularization (TCAR) using the ENROUTE system (Silk Road) has been proposed as a safe and effective alternative to both carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). Two large registries (ROADSTER 1 and ROADSTER 2) have shown that TCAR has acceptable/low rates of perioperative stroke/death. This study will analyze the 30-day perioperative and 1-year clinical outcomes from a single-center. PATIENT POPULATION AND METHODS: This is a retrospective analysis of prospectively collected data from SVS/VQI TCAR surveillance project (TSP) of 100 consecutive patients (102 TCAR procedures) done in our institution. These procedures were done for high-risk patients for CEA, which included anatomical (previous CEA, high cervical lesion, neck radiation, stoma, arch type, etc.), physiological (CHF, severe coronary artery disease, COPD on O2 therapy, etc.) and combined anatomical/physiological reasons. These procedures were done by vascular surgeons after receiving the appropriate training. The perioperative stroke, death, and MI rates were analyzed. Kaplan Meyer analysis was used to estimate rate of freedom from stroke/death and the incidence of ≥50% and ≥80% in-stent restenosis at 1 year. RESULTS: 100 consecutive high-risk patients for CEA included: 38% anatomical, 44% physiological, and 18% combined anatomical and physiological reasons. The mean age was 72.5 years (range 52-90 years). Indications for TCAR were 34% for symptomatic lesions (TIA/stroke) and 66% for asymptomatic lesions. Mean ipsilateral treated stenosis was 80.4%. Contralateral ≥50% stenosis/occlusion was present in 31% of patients. Technical success rate was 100%. 92% had pre-stenting PTA and 26% had post-stenting PTA. The mean flow reversal time was 8.5 min (range 3-26 min). The 30-day perioperative stroke rate was 2.9% (1/67, 1.5% for asymptomatic patients), the stroke/death rate was 2.9%, and stroke/death and MI rate was 3.9% (4/102). Other perioperative complications included cranial nerve injury 3/102 (2.9%), carotid artery dissection (2%), and major hematoma (necessitated operation evacuation) (5.9%). Freedom from stroke rates and stroke/death rates at 1 year were: 90% and 89%. Freedom from ≥50% and ≥80% in-stent restenosis rates at 1 year were 82% and 90%, respectively. None of these restenosis were symptomatic except two (2/13). Freedom from reintervention rate at 1 year was 98%. CONCLUSION: Although the perioperative events were somewhat higher than what has been reported in previous registries, TCAR for patients who are high-risk for CEA has a low perioperative stroke and stroke/death rates with satisfactory outcome at 1 year. Further long-term data is probably needed to verify long-term outcome.

Rates of progression of carotid in-stent stenosis and clinical outcomes.

BACKGROUND: We previously reported the incidence of ≥50% and ≥80% carotid in-stent stenosis. In the present study, we analyzed the rate of progression of in-stent stenosis and clinical outcomes with longer follow-up. METHODS: We performed a retrospective analysis of prospectively collected data for 450 patients who had undergone transfemoral carotid artery stenting with longer follow-up (mean, 70 months). The progression of in-stent stenosis was defined as stenosis advancing to a higher severity of disease (ie, from <50% to ≥50% and from ≥50% to ≥80%). Kaplan-Meier analysis was used to estimate the rate of progression from <50% to ≥50% and ≥50% to ≥80%, the overall rates of ≥50% and ≥80% in-stent stenosis, and survival at 1, 3, 5, and 10 years. RESULTS: At a mean follow-up of 70.3 months (range, 1-222 months), 121 of 446 patients (27%) had had progression to ≥50% and 39 (8.7%) to ≥80% in-stent stenosis. Of the 406 patients whose first duplex ultrasound findings were normal or showed in-stent stenosis of <50%, 82 had had progression from normal or <50% to ≥50% in-stent stenosis at a mean of 51.7 months (range, 1-213 months). Of the 121 patients with ≥50% stenosis, 14 (11.6%) had experienced progression to ≥80% at a mean of 33.6 months (range, 6-89 months). Of the 82 patients with progression from <50 to ≥50%, 10 (12%) had experienced a neurologic event (eight transient ischemic attacks [TIAs] and two strokes). Of the 14 with progression from ≥50% to ≥80%, 2 (14.3%) had experienced a TIA, and the remaining patients were asymptomatic. Of the 39 patients with ≥80% in-stent stenosis, 9 (23%) had experienced a neurologic event (eight TIAs and one contralateral stroke). Overall, 13 of the 121 patients with late ≥50% restenosis (10.7%) had experienced a neurologic event (10 ipsilateral TIA, 2 ipsilateral stroke, and 1 contralateral stroke. Thus, 12 of 446 patients (2.7%) had experienced an ipsilateral TIA or stroke at a mean follow-up of 70 months. The rates of freedom from <50% to ≥50% in-stent stenosis progression were 93%, 85%, 78%, and 66% at 1, 3, 5, and 10 years. The rates of freedom from progression from ≥50% to ≥80% in-stent stenosis were 89%, 81%, and 77% at 1, 3, and 5 years, respectively. The overall rates of freedom from ≥50% in-stent stenosis and ≥80% in-stent stenosis were 86%, 77%, 71%, and 59% and 96%, 93%, 91%, and 84% at 1, 3, 5, and 10 years, respectively. Finally, the stroke survival rates were 95%, 80%, 63%, and 31% at 1, 3, 5, and 10 years, respectively. CONCLUSIONS: The rate of progression of carotid in-stent stenosis was modest, with a low incidence of stroke events. Therefore, the use of duplex ultrasound surveillance after carotid artery stenting should be selective and its benefits and utility perhaps reevaluated.

Clinical Outcome of Drug-Eluted Stenting (Zilver PTX) in Patients With Femoropopliteal Occlusive Disease a Single Center Experience.

BACKGROUND: Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center. PATIENT POPULATIONS/METHODS: A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years. RESULTS: Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A-C lesions. Mean follow-up was 18.4 months (1-76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A-C vs 59% and 59% for D lesions, p=0.001). CONCLUSION: Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A-C lesions but inferior/unsatisfactory for TASC D lesions.

Clinical outcome of drug-coated balloon angioplasty in patients with femoropopliteal disease: A real-world single-center experience.

BACKGROUND: Several multicenter industry-sponsored clinical trials reported satisfactory results in the use of drug-coated balloons (DCBs) for treatment of femoropopliteal occlusive disease. However, few single-center studies have been published to verify the outcome from real-world experience. METHODS: In this study, 228 patients treated with DCB angioplasty (Lutonix 0.35; Bard, Tempe, Arizona) were analyzed. Perioperative major adverse events (death, amputation, target lesion thrombosis or reintervention) were calculated. Kaplan-Meier analysis was used to estimate primary patency rates (based on duplex ultrasound with or without ankle-brachial index) and limb salvage rates. RESULTS: Lesions treated were primarily TransAtlantic Inter-Society Consensus (TASC) type C and D lesions. Indications included claudication (Rutherford classes 2 and 3) in 40% and critical limb ischemia (CLI; Rutherford classes 4 and 5) in 60%. Lesions treated included 61% in the superficial femoral artery, 15% in the popliteal artery, and 24% in both superficial femoral artery and popliteal artery. Mean follow-up was 12.2 months (range, 1-42 months). Overall perioperative morbidity and mortality rates were 13% and 1%. The perioperative major adverse event rate was 3%. Symptom relief (improvement of one Rutherford category or more) was obtained in 64%. Primary patency rates were 56% and 39% at 1 year and 2 years, respectively. Limb salvage rates were 92% and 83% at 1 year and 2 years. Patients with claudication had a lower rate of early perioperative complications (4% vs 19%; P = .001). Symptom improvement was 76% for claudication vs 49% for CLI (P < .001). Overall, major amputation rate was 0% for claudication vs 13% for CLI (P < .001). The primary patency rates at 1 year and 2 years were 59% and 41% for claudication vs 54% and 37% for CLI (P = .307). The assisted primary patency rates at 1 year and 2 years were 72% and 52% for claudication vs 64% and 46% for CLI (P = .223). Primary patency rates at 1 year and 2 years were 82% and 71% for TASC A to C lesions vs 29% and 14% for TASC D lesions (P < .001). Limb salvage rates at 1 year and 2 years were 100% and 100% for claudication vs 85% and 74% for CLI (P < .001). CONCLUSIONS: Clinical outcomes after DCB angioplasty in femoropopliteal lesions were inferior to what has been reported in previous studies, particularly for TASC D lesions. Further investigation from real-world experience with long-term follow-up is needed to confirm these results.

The incidence of carotid in-stent stenosis is underestimated ≥50% or ≥80% and its clinical implications.

BACKGROUND: The incidence of carotid in-stent stenosis has been reported to vary between 1% and 30%. Most published studies have short follow-up, which may lead to underestimation of the incidence of in-stent stenosis. This study analyzed the incidence of ≥50% and ≥80% in-stent stenosis using validated duplex ultrasound criteria and its clinical implications. METHODS: This is a retrospective analysis of prospectively collected data of 450 carotid artery stenting (CAS) procedures (February 6, 2001-December 19, 2016). All patients had postoperative carotid duplex ultrasound examination, which was repeated at 1 month, 6 months, and every 6 to 12 months thereafter. A Kaplan-Meier analysis was used to estimate rates of freedom from ≥50% in-stent stenosis (internal carotid artery peak systolic velocity of ≥224 cm/s) and ≥80% in-stent stenosis (internal carotid artery peak systolic velocity of ≥325 cm/s), freedom from reintervention, and survival. RESULTS: The mean age was 68.3 years, with a mean follow-up of 40.3 months. A total of 201 patients (45% [201/450]) had CAS for symptomatic disease. Primary CAS was done in 291 patients (65%); in the remaining 35%, CAS was done for postcarotid endarterectomy (CEA) stenosis. A total of 101 patients (23%) had ≥50% late carotid in-stent stenosis, and of these, 33 (7.4%) had ≥80% in-stent stenosis. Nineteen patients (4.3%) developed late transient ischemic attack and three (0.7%) late stroke. Twenty-three (5.2%) patients had late reintervention. Rates of freedom from ≥50% in-stent stenosis in the whole series were 85%, 79%, 75%, 72%, and 70% at 1 year, 2 years, 3 years, 4 years, and 5 years, respectively. The rates of freedom from ≥50% in-stent stenosis for primary CAS and CAS for post-CEA stenosis were not statistically significant (P = .540). The rates of freedom from ≥80% in-stent stenosis for the whole series were 96%, 95%, 93%, 90%, and 89% at 1 year, 2 years, 3 years, 4 years, and 5 years, respectively. The rates of freedom from ≥80% in-stent stenosis for primary CAS and CAS for post-CEA stenosis were also not statistically significant (P = .516). Rates of freedom from reintervention were 98%, 96%, 93%, 93%, and 91% at 1 year, 2 years, 3 years, 4 years, and 5 years, respectively, and there were no significant differences between primary CAS and CAS for post-CEA stenosis (P = .939). The overall late survival rates were 99%, 97%, 96%, 94%, and 91% at 1 year, 2 years, 3 years, 4 years, and 5 years. CONCLUSIONS: The incidence of ≥50% in-stent stenosis is relatively high; however, the rates of ≥80% stenosis and late neurologic events are low. Longer follow-up of patients with ≥50% carotid in-stent stenosis may yield higher incidence of ≥80% stenosis.

Comparative study of clinical outcome of endovascular aortic aneurysms repair in large diameter aortic necks (>31 mm) versus smaller necks.

BACKGROUND: This study compares short-term (30 days) and intermediate term (3 years) clinical outcomes in patients with large (≥31 mm) versus small aortic neck diameters (≤28 and ≤31 mm). METHODS: Prospectively collected data from 741 patients who underwent endovascular aortic aneurysm repair were analyzed. Some surgeons have reported the threshold for a large aortic neck for endovascular aortic aneurysm repair to be 28 mm, whereas for others it is 31 mm. Therefore, we classified aortic neck diameter into less than or equal to 28 versus greater than 28 mm; and less than or equal to 31 versus greater than 31 mm. Logistic regression and Kaplan-Meier analyses were used to compare outcomes. RESULTS: There were 688 patients who had a defined aortic neck diameter: 592 with less than or equal to 28 mm, 96 with greater than 28 mm, 655 with less than or equal to 31 mm, and 33 with greater than 31 mm. The mean follow-up was 25.2 months for less than or equal to 31 mm versus 31.8 months for greater than 31 mm. Clinical characteristics were similar in all groups, except that there were more patients outside the instructions for use in the greater than 31 mm versus less than or equal to 31 mm group (94% vs 44%; P < .0001). There was a significant increase in early type I endoleak for patients with an aortic neck diameter of greater than 31 versus less than or equal to 31 mm (9 [27%] vs 74 [11%]; P = .01); late type I endoleaks (4 [14%] vs 18 [3%]; P = .01); sac expansion (5 [17%] vs 28 [5%]; P = .01); late intervention (5 [17%] vs 23 [4%]; P = .01); and death (9 [31%] vs 48 [8%]; P < .0001). There were no differences in outcomes between the patients with greater than 28 mm aortic neck diameters and the less than or equal to 28 mm diameters. Freedom from late type I endoleak at 1, 2, and 3 years were 96%, 88%, and 88% for patients with a neck diameter of greater than 31 mm versus 97%, 97%, and 97% for a diameter less than or equal to 31 mm (P = .19). The rate of freedom from sac expansion for patients with a diameter greater than 31 mm was 88%, 81%, and 81% at 1, 2, and 3 years versus 99%, 97%, and 92% for a diameter less than or equal to 31 mm (P = .02). Freedom from late intervention for 1, 2, and 3 years for patients with a diameter greater than 31 mm were 91%, 91%, and 91% versus 99%, 97%, and 96% for those with a diameter less than or equal to 31 mm. Survival rates at 1, 2, and 3 years for a diameter greater than 31 mm were 83%, 74%, and 68% versus 96%, 92%, and 90% for a diameter less than or equal to 31 mm (P < .001). Multivariate logistic regression analysis showed that patients with a diameter greater than 31 mm had an odds ratio of 6.1 (95% confidence interval [CI], 2.2-16.8) for mortality, 4.7 (95% CI, 1.4-15.5) for sac expansion, and 4.9 (95% CI, 1.4-17.4) for late type I endoleak. CONCLUSIONS: Patients with large aortic neck diameters (>31 mm) had higher rates of early and late type I endoleak, sac expansion, late intervention, and mortality.

Management of Immediate Post-Endovascular Aortic Aneurysm Repair Type Ia Endoleaks and Late Outcomes.

BACKGROUND: Post-endovascular aortic aneurysm repair (EVAR) endoleaks and the need for reintervention are challenging. Additional endovascular treatment is advised for type Ia endoleaks detected on post-EVAR completion angiogram. This study analyzed management and late outcomes of these endoleaks. STUDY DESIGN: This was a retrospective review of prospectively collected data from EVAR patients during a 10-year period. All post-EVAR type Ia endoleaks on completion angiogram were identified (group A) and their early (30-day) and late outcomes were compared with outcomes of patients without endoleaks (group B). Kaplan-Meier analysis was used for survival analysis, sac expansion, late type Ia endoleak, and reintervention. RESULTS: Seventy-one of 565 (12.6%) patients had immediate post-EVAR type Ia endoleak. Early intervention (proximal aortic cuffs and/or stenting) was used in 56 of 71 (79%) in group A vs 31 of 494 (6%) in group B (p < 0.0001). Late type Ia endoleak was noted in 9 patients (13%) in group A at a mean follow-up of 28 months vs 10 patients (2%) in group B at a mean follow-up of 32 months (p < 0.0001). Late sac expansion and reintervention rates were 9% and 10% for group A vs 5% and 3% for group B (p = 0.2698 and p = 0.0198), respectively. Freedom rates from late type Ia endoleaks at 1, 3, and 5 years for group A were 88%, 85%, and 80% vs 98%, 98%, and 96% for group B (p < 0.001); and for late intervention, were 94%, 92%, and 77% for group A, and 99%, 97%, and 95% for group B (p = 0.007), respectively. Survival rates were similar. CONCLUSIONS: Immediate post-EVAR type Ia endoleaks are associated with higher rates of early interventions, late endoleaks and reintervention, which will necessitate strict post-EVAR surveillance.

Aortic Neck Anatomic Features and Predictors of Outcomes in Endovascular Repair of Abdominal Aortic Aneurysms Following vs Not Following Instructions for Use.

BACKGROUND: A significant number of patients undergo endovascular repair of abdominal aortic aneurysms (EVAR) outside the instructions for use (IFU). This study will examine various aortic neck features and their predictors of clinical outcomes. STUDY DESIGN: We performed a retrospective analysis of prospectively collected data on EVAR patients. Neck features outside IFU were analyzed. Kaplan-Meier and multivariate analyses were used to predict their effect as single features, or in combination, on outcomes. RESULTS: Fifty-two percent of 526 patients had 1 or more features outside the IFU. The overall technical success rate was 99%, and perioperative complication rates were 7% and 12% for IFU vs outside IFU use, respectively (p = 0.04). Type I early endoleak and early intervention rates were 7% and 10% for IFU vs 18% and 24% for outside IFU (p = 0.0002 and p < 0.0001). At a mean follow-up of 30 months, freedom from late type I endoleak and late reintervention at 1, 2, and 3 years for IFU were 99.5%, 99.5%, and 98.4%, and 99.4%, 98%, and 96.8%; vs 98.9%, 98.1%, and 98.1%, and 97.5%, 96.2%, and 95.2% for outside IFU (p = 0.049 and 0.799), respectively. Survival rates at 1, 2, and 3 years for IFU were 97%, 93.5%, and 89.8%; vs 93.7%, 88.8%, and 86.3% for outside IFU (p = 0.035). Multivariate analysis showed that a neck angle > 60 degrees had odds ratios for death, sac expansion, and early intervention of 6, 2.6, and 3.3, respectively; neck length < 10 mm had odds ratios of 2.8 for deaths, 3.4 for early intervention, 4.6 for late reintervention, and 4.3 for late type I endoleak. CONCLUSIONS: Patients with neck features outside IFU can be treated with EVAR; however, they have higher rates of early and late type I endoleak, early intervention, and late death.

Biochemical markers in patients with open reconstructions with peripheral arterial disease.

The purpose of our study was to determine outcome differences as a function of baseline high-sensitivity C-reactive protein (hsCRP) and B-type natriuretic peptide (BNP) levels in patients receiving lower extremity open reconstructions for the treatment of peripheral arterial occlusive disease. We retrospectively examined patients who underwent surgical reconstructions performed by a single operator during a seven-year time span who received preoperative hsCRP and BNP testing and post-procedure imaging. Outcomes of interest included major adverse limb events, a composite end point of target vessel revascularization, limb amputation, and disease progression, and major adverse cardiovascular events comprised of stroke, myocardial infarction, and death. A total of 89 limbs in 82 patients were included in analysis. Multivariate analysis demonstrated that higher hsCRP levels (>3.0 mg/L) trended toward, but failed to significantly associate with major adverse limb events at 24 months (hazard ratio: 2.2 [1.0-5.2], p = 0.06), however the use of a vein bypass conduit (vs. prosthetic reconstruction) significantly predicted major adverse limb events (hazard ratio: 3.2 [1.5-6.9], p < 0.01). Elevated BNP levels (>100 pg/ml), but not hsCRP, associated with major adverse cardiovascular events (hazard ratio: 3.5 [1.2-10.3], p = 0.03). Preoperative biochemical markers may assist in clinical decision making and stratifying patients regarding adverse events following open reconstructions.

Gastric electrical stimulation for refractory gastroparesis: predictors of response and redefining a successful outcome.

Predictors of a favorable response and measures of success with gastric electrical stimulation (GES) for gastroparesis remain elusive. Published results remain inconsistent with respect to patient perceived benefit, despite statistical improvements in objective measures of symptom severity. We performed a retrospective analysis of 56 patients with gastroparesis who underwent insertion of a gastric electrical stimulator during the study period. Data included demographics, symptoms, total symptom severity score (TSS, range 0-24, initial and most recent), and gastric emptying times. TSS were grouped into four severity categories (0-10, 11-14, 15-18, 19-24). TSS improvement was defined as movement to a lower severity category. Perception of improvement was compared with that of TSS score improvement using χ(2) test. Etiology as a predictor of improvement was measured using logistic regression. Initial mean TSS was 21, and post-treatment TSS was 13.5. Improvement was significant for individual symptoms and in reduction of TSS for both diabetic/idiopathic etiologies (P ≤ 0.001). No correlation was noted between likelihood of success/failure and gastric emptying times (P = 0.32). Thirty-eight improved (moved to lower TSS category), whereas 18 failed (remained in same category) (P ≤ 0.001), which correlated with perception of improvement. Of 18 failures, 14 (77.7%) were idiopathic. On logistic regression, diabetics were more likely than idiopathic patients to move to a lower TSS category (odds ratio 14, P = 0.003) and even more likely to improve based on patient perception (odds ratio 45, P = 0.005). GES produces far more consistent improvement in diabetics. Further study of GES in idiopathic gastroparesis is needed. Application of the proposed TSS severity categories allowed differentiation of small, statistically significant (but clinically insignificant) reductions in TSS from larger, clinically significant reductions, thereby permitting more reliable application of TSS to the evaluation of GES efficacy.

The value and economic analysis of routine postoperative carotid duplex ultrasound surveillance after carotid endarterectomy.

BACKGROUND: Several studies have reported on the role of postoperative duplex ultrasound surveillance after carotid endarterectomy (CEA) with varying results. Most of these studies had a small sample size or did not analyze cost-effectiveness. METHODS: We analyzed 489 of 501 CEA patients with patch closure. All patients had immediate postoperative duplex ultrasound examination and were routinely followed up both clinically and with duplex ultrasound at regular intervals of 1 month, 6 months, 12 months, and every 12 months thereafter. A Kaplan-Meier analysis was used to estimate the rate of ≥50% and ≥80% post-CEA restenosis over time and the time frame of progression from normal to ≥50% or ≥80% restenosis. The cost of post-CEA duplex surveillance was also estimated. RESULTS: Overall, 489 patients with a mean age of 68.5 years were analyzed. Ten of these had residual postoperative ≥50% stenosis, and 37 did not undergo a second duplex ultrasound examination and therefore were not included in the final analysis. The mean follow-up was 20.4 months (range, 1-63 months), with a mean number of duplex ultrasound examinations of 3.6 (range, 1-7). Eleven of 397 patients (2.8%) with a normal finding on immediate postoperative duplex ultrasound vs 4 of 45 (8.9%) with mild stenosis on immediate postoperative duplex ultrasound progressed to ≥50% restenosis (P = .055). Overall, 15 patients (3.1%) had ≥50% restenosis, 9 with 50% to <80% and 4 with 80% to 99% (2 of these had carotid artery stenting reintervention), and 2 had late carotid occlusion. All of these were asymptomatic, except for one who had a transient ischemic attack. The mean time to ≥50% to <80% restenosis was 14.7 months vs 19.8 months for ≥80% restenosis after the CEA. Freedom from restenosis rates were 98%, 96%, 94%, 94%, and 94% for ≥50% restenosis and 99%, 98%, 97%, 97%, and 97% for ≥80% restenosis at 1 year, 2 years, 3 years, 4 years, and 5 years, respectively. Freedom from myocardial infarction, stroke, and deaths was not significantly different between patients with and without restenosis (100%, 93%, 83%, and 83% vs 94%, 91%, 86%, and 79% at 1 year, 2 years, 3 years, and 4 years, respectively; P = .951). The estimated charge of this surveillance was 3.6 × 489 (number of CEAs) × $800 (charge for carotid duplex ultrasound), which equals $1,408,320, to detect only four patients with ≥80% to 99% restenosis who may have been potential candidates for reintervention. CONCLUSIONS: This study shows that the value of routine postoperative duplex ultrasound surveillance after CEA with patch closure may be limited, particularly if the finding on immediate postoperative duplex ultrasound is normal or shows minimal disease.

Effect of statins on early and late clinical outcomes of carotid endarterectomy and the rate of post-carotid endarterectomy restenosis.

BACKGROUND: This study analyzed the effect of statins on clinical outcomes after carotid endarterectomy (CEA) and the rate of restenosis. STUDY DESIGN: We performed a retrospective analysis of prospectively collected data on 500 consecutive CEAs followed at 1, 6, and 12 months and every year. RESULTS: There were 299 patients on statins vs 201 without. Combined perioperative MI/death rates were 2.7% vs 4% (p = 0.416) and MI/stroke/death rates were 4% vs 5% (p = 0.607) for statins vs no statins. At mean follow-up (27 months), MI, stroke, and death rates were: 9.7%, 2.3%, and 2.3% vs 9%, 2.5% and 4.5% (p = 0.18) for statins vs no statins, respectively. Diabetic patients not on statins had 4 times more deaths (8.5% vs 2.3%) and twice as many strokes/deaths (10.2% vs 5.3%). Patients with hypercholesterolemia who were not on statins had twice as many deaths (4.3% vs 2.2%). Rates of freedom from stroke/MI/death at 1, 2, 3, and 4 years were: 94%, 90%, 85% and 77% vs 94%, 89%, 85%, and 82% (p = 0.87) for statins vs no statins, respectively. Rates of freedom from death only for patients on statins vs no statins at 1, 2, 3, and 4 years were: 98%, 98%, 97.4% and 97.4% vs 98%, 96%, 94.8% and 94.8%, respectively (p = 0.191). For diabetic patients, rates of freedom from death at 1, 2, 3, and 4 years were 99%, 99%, 97%, and 97% for statins vs 97%, 90%, 90%, and 90% without statins, respectively (p = 0.048). Post-CEA restenosis rates ≥ 50% were not significantly different between statins vs no statins (p = 0.64). CONCLUSIONS: Statins significantly lowered death rates in patients with diabetes and tended to lower both death and stroke rates in diabetic patients and patients with hypercholesterolemia. Statins had no effect on post-CEA restenosis.

False-negative results with the Bethesda System of reporting thyroid cytopathology: predictors of malignancy in thyroid nodules classified as benign by cytopathologic evaluation.

The benign category of the Bethesda System for reporting thyroid cytopathology (BSRTC) predicts an incidence of malignancy from zero to three per cent. However, recent series report higher rates of malignancy ranging from eight to 14 per cent. Surgery is often performed for reasons other than their fine needle aspiration biopsy (FNAB) such as symptoms, nodule enlargement, or worrisome imaging. We hypothesized that an analysis of patients who underwent thyroidectomy despite a benign FNAB would identify predictors of malignancy, an area not currently addressed by American Thyroid Association guidelines. We performed a retrospective analysis of patients with benign FNAB results who underwent thyroidectomy from October 2007 to October 2012. Data collected included symptoms, imaging findings, FNAB results, and operative and histopathology results, all of which were obtained by chart review. Findings were compared between patients with and without a diagnosis of malignancy. Statistical significance was set as P < 0.05. Of 3839 FNABs, 2838 were benign. Of these, 180 underwent surgery for indications other than the FNAB category. Twenty-four (13.4%) malignancies were identified: 12 (6.7%) incidental microcarcinomas and 12 (6.7%) significant cancers (papillary greater than 1.0 cm, any nonpapillary histology). No patient's symptoms or signs reached significance as a predictor of malignancy. Suspicious ultrasound appearance was significantly associated with an underlying carcinoma (P = 0.004). The false-negative result with benign FNAB is higher in surgical series than suggested by the BSRTC. Patients with tolerable symptoms may be observed in the face of a benign FNAB. Additionally, despite a benign FNAB, recommendations for closer follow-up or surgical intervention are warranted if the ultrasound appearance is suspicious.

Practice patterns of carotid endarterectomy as performed by different surgical specialties at a single institution and the effect on perioperative stroke and cost of preoperative imaging.

BACKGROUND: Carotid endarterectomy (CEA) is currently performed by various surgical specialties with varying outcomes. This study analyzes different surgical practice patterns and their effect on perioperative stroke and cost. METHODS: This is a retrospective analysis of prospectively collected data of 1000 consecutive CEAs performed at our institution by three different specialties: general surgeons (GS), cardiothoracic surgeons (CTS), and vascular surgeons (VS). RESULTS: VS did 474 CEAs, CTS did 404, and GS did 122. VS tended to operate more often on symptomatic patients than CTS and GS: 40% vs 23% and 31%, respectively (P < .0001). Preoperative workups were significantly different between specialties: duplex ultrasound (DUS) only in 66%, 30%, and 18%; DUS and computed tomography angiography in 27%, 35%, and 29%; and DUS and magnetic resonance angiography in 6%, 35%, and 52% for VS, CTS, and GS, respectively (P < .001). The mean preoperative carotid stenosis was not significantly different between the specialties. The mean heparin dosage was 5168, 7522, and 5331 units (P = .0001) and protamine was used in 0.2%, 19%, and 8% (P < .0001) for VS, CTS, and GS, respectively. VS more often used postoperative drains; however, no association was found between heparin dosage, protamine, and drain use and postoperative bleeding. Patching was used in 99%, 93%, and 76% (P < .0001) for VS, CTS, and GS, respectively. Bovine pericardial patches were used more often by CTS and ACUSEAL (Gore-Tex; W. L. Gore and Associates, Flagstaff, Ariz) patches were used more often by GS (P < .0001). The perioperative stroke/death rates were 1.3% for VS and 3.1% for CTS and GS combined (P = .055); and were 0.7% for VS and 3% for CTS and GS combined for asymptomatic patients (P < .034). Perioperative stroke rates for patients who had preoperative DUS only were 0.9% vs 3.3% for patients who had extra imaging (computed tomography angiography/magnetic resonance angiography; P = .009); and were 0.9% vs 3% for asymptomatic patients (P = .05). When applying hospital billing charges for preoperative imaging workups (cost of DUS only vs DUS and other imaging), the VS practice pattern would have saved $1180 per CEA over CTS and GS practice patterns; a total savings of $1,180,000 in this series. CONCLUSIONS: CEA practice patterns differ between specialties. Although the cost was higher for non-VS practices, the perioperative stroke/death rate was somewhat higher. Therefore, educating physicians who perform CEAs on cost-saving measures may be appropriate.

Endovascular repair of a pseudoaneurysm of the popliteal artery following arthroscopic knee surgery: case report and review of literature.

We report a case of a pseudoaneurysm of the popliteal artery following arthroscopic knee surgery. Endovascular repair was successfully used as the treatment for this patient and studies have shown this to be a safe alternative to surgery.

Primary carotid artery stenting versus carotid artery stenting for postcarotid endarterectomy stenosis.

BACKGROUND: Carotid artery stenting (CAS) has been advocated as an alternative to carotid endarterectomy (CEA) in high-risk surgical patients, including stenosis after CEA. This study compared early and midterm clinical outcomes for primary CAS vs CAS for post-CEA stenosis. METHODS: This study analyzed 180 high-risk surgical patients: 68 had primary CAS (group A), and 112 had CAS for post-CEA stenosis (group B). Patients were followed-up prospectively and had duplex ultrasound imaging at 1 month and every 6 months thereafter. All patients had cerebral protection devices. Kaplan-Meier life-table analysis was used to estimate rates of freedom from stroke, stroke-free survival, > or =50% in-stent stenosis, > or =80% in-stent stenosis, and target vessel reintervention (TVR). RESULTS: Patients had comparable demographic and clinical characteristics. Carotid stent locations were similar. Indications for CAS were transient ischemic attacks (TIA) or stroke in 50% for group A and 45% for group B. The mean follow-up was comparable, at 21 (range, 1-73) vs 25 (range, 1-78) months, respectively. The technical success rate was 100%. The perioperative stroke rates and combined stroke/death/myocardial infarction (MI) rates were 7.4% for group A vs 0.9% for group B (P = .0294). No perioperative MIs occurred in either group. One death was secondary to stroke. The combined early and late stroke rates were 10.8% for group A and 1.8% for group B (P = .0275). The stroke-free rates at 1, 2, 3, and 4 years for groups A and B were 89%, 89%, 89%, and 89%; and 98%, 98%, 98%, and 98%, respectively (P = .0105). The rates of freedom from > or =50% carotid in-stent stenosis were 94%, 83%, 83%, and 66% for group A vs 96%, 91%, 83%, and 72% for group B (P = .4705). Two patients (3%) in group A and seven patients (6.3%) in group B had > or =80% in-stent stenosis (all were asymptomatic except one). The freedom from > or =80% in-stent stenosis at 1, 2, 3, and 4 years for groups A and B were 100%, 98%, 98%, and 78% vs 99%, 96%, 92%, and 87%, respectively (P = .7005). Freedom from TVR rates at 1, 2, 3, and 4 years for groups A and B were 100%, 100%, 100%, and 100% vs 99%, 97%, 97%, and 92%, respectively (P = .261). CONCLUSIONS: CAS for post-CEA stenosis carried a lower risk of early postprocedural neurologic events than primary CAS, with a trend toward a higher restenosis rate during follow-up.

Prospective randomized trial of ACUSEAL (Gore-Tex) vs Finesse (Hemashield) patching during carotid endarterectomy: long-term outcome.

BACKGROUND: Several studies have reported that carotid endarterectomy with patch angioplasty is superior to primary closure. Conventional polytetrafluoroethylene (Gore-Tex, W. L. Gore & Associates, Flagstaff, Ariz) patching has been shown to have results similar to autogenous saphenous vein patching; however, it requires a longer hemostasis time. This study examined the long-term clinical outcome and incidence of restenosis after carotid endarterectomy using the new ACUSEAL (Gore-Tex) patching vs Hemashield Finesse (Boston Scientific Corp, Natick, Mass) patching. METHODS: The study randomized 200 patients (1:1) undergoing carotid endarterectomy to 100 with ACUSEAL patching and 100 with Hemashield-Finesse patching. All patients underwent immediate and 1-month postoperative duplex ultrasound studies, which were repeated at 6-month intervals. Kaplan-Meier analysis was used to estimate the freedom from stroke, stroke-free survival, and the risk of restenosis for both groups. RESULTS: The demographic and clinical characteristics, the mean operative diameter of the internal carotid artery, and the length of the arteriotomy were similar in both groups. The mean hemostasis time was 5.1 for the ACUSEAL patching vs 3.7 minutes for Finesse patching (P = .01); however, the mean operative times were similar for both groups (P = .61). The incidence of ipsilateral stroke was 2% for ACUSEAL patching (both early perioperative strokes) vs 3% for Finesse patching (2 early and 1 late stroke) at a mean follow-up of 21 months. The respective cumulative stroke-free rates at 1, 2, and 3 years were 98%, 98%, and 98% for ACUSEAL patching vs 97%, 97%, and 97% for Finesse patching (P = .7). The respective cumulative stroke-free survival rates at 1, 2, and 3 years were 97%, 92%, and 88% for ACUSEAL patching vs 96%, 96%, and 91% for Finesse patching (P = .6). The respective freedom from > or =70% carotid restenosis at 1, 2, and 3 years was 98%, 96%, and 89% for ACUSEAL patching vs 92%, 85%, and 79% for Finesse patching (P = .04). CONCLUSIONS: Carotid endarterectomy with ACUSEAL patching and Finesse patching had similar stroke-free rates and stroke-free survival rates. The mean hemostasis time for the ACUSEAL patch was 1.4 minutes longer than that for the Finesse patch; however, the Finesse patch had higher restenosis rates than the ACUSEAL patch.