Safety and efficacy of carotid angioplasty/stenting in 100 consecutive high surgical risk patients: immediate and long-term follow-up.

BACKGROUND/PURPOSE: This study analyzes the safety and efficacy of carotid angioplasty/stenting (CAS) with embolic protection devices in high surgical risk (HSR) patients. PATIENT POPULATION/METHODS: This study includes 100 consecutive HSR patients, who were followed prospectively, and had carotid duplex ultrasounds at 1 month and every 6 months thereafter. A Kaplan-Meier lifetable analysis was used to estimate survival rates, rates of freedom from stroke, and freedom from > or =50% in-stent restenosis. RESULTS: Mean age was 69.6 years. There were 59 men and 41 women. Mean follow-up was 26.1 months (range, 1-50). Indications for CAS were symptomatic > or =50% stenosis in 47% and > or =80% asymptomatic stenosis in 53%. Procedure success rate was 100%. HSR includes 33% with restenosis and cardiac comorbidity, 21% with restenosis and cardiac/medical comorbidities, 13% with restenosis only, and 33% with cardiac/medical comorbidities. The 30-day perioperative stroke rate was 2% with no perioperative deaths or MI. Stroke-free survival rates were 95%, 91%, 83%, 79%, and 73% at 1, 2, 3, and 4 years, respectively. There were no late strokes. Stroke-free rate was 98% at 1, 2, 3, and 4 years, respectively. Freedom from > or =50% in-stent restenosis was 98%, 93%, 90%, and 79% at 1, 2, 3, and 4 years, respectively. Six patients had asymptomatic > or =80% in-stent restenosis; 3 underwent reintervention (percutaneous transluminal angioplasty). The incidence of in-stent restenosis was not statistically significant between patients who had restenosis after carotid endarterectomy and patients with primary stenting (P = .21). CONCLUSIONS: CAS with embolic protection devices in HSR patients is safe and effective.

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.

Angioplasty and stenting versus carotid-subclavian bypass for the treatment of isolated subclavian artery disease.

PURPOSE: To compare the results of a large series of percutaneous transluminal angioplasty (PTA)/stenting procedures in the subclavian artery with the results of a series of carotid-subclavian bypass grafts (CSBG) performed at the same institution for subclavian artery disease. METHODS: Between 1993 and 2006, 121 patients (43 men; mean age 63 years, range 38-85) underwent subclavian artery PTA/stenting and were compared to a group of 51 patients (29 men; mean age 62 years, range 46-75) with isolated subclavian artery occlusive disease treated with CSBG using polytetrafluoroethylene grafts. Graft or PTA/stenting patency was determined clinically and confirmed by Doppler pressures and/or duplex ultrasound/angiography. The cumulative patency and overall survival rates were calculated using the life-table method. RESULTS: The mean follow-up for the PTA/stent group was 3.4 years versus 7.7 years for the CSBG group. The technical success rate for the CSBG group was 100% versus 98% (119/121) for the PTA/stent group. The overall perioperative complication rate in the stent group was 15.1% (18/119: 11 minor and 7 major complications) versus 5.9% (3/51: 2 phrenic nerve palsy and 1 myocardial infarction) in the bypass group (p=0.093). There was no perioperative stroke or mortality in the CSBG group. The major perioperative complications in the stent group included 4 thromboembolic events, 1 congestive heart failure, 1 reperfusion arm edema, and 1 pseudoaneurysm. There was 1 perioperative death in the stent group. The 30-day patency rate was 100% for the bypass group and 97% (118/121) for the PTA/stent group. The primary patency rates at 1, 3, and 5 years were 100%, 98%, and 96% for the CSBG group versus 93%, 78%, and 70% for the stent group, respectively (p<0.0001). Freedom from symptom recurrence was also statistically superior in the bypass group versus the stent group (p<0.0001). There were no significant differences in the survival rates between both groups at any time point (p=0.322). CONCLUSION: Both CSBGs using PTFE grafts and subclavian PTA/stenting are safe, effective, and durable; however, CSBG is more durable in the long term. PTA/stenting of the subclavian artery should be the procedure of choice for high-risk patients; however, CSBG should be offered to good-risk surgical candidates who may be seeking a more durable procedure.

All-terrain vehicle-related maxillofacial trauma in the pediatric population.

PURPOSE: Nearly 40% of all-terrain vehicle (ATV) crash-related fatalities involve pediatric patients, with many of these patients dying from head and neck injuries. West Virginia is in a unique position to examine these injuries because of its high rate of ATV use. This study examines craniofacial ATV-related trauma in children. PATIENTS AND METHODS: We conducted a single-center, retrospective, descriptive study of 26 children presenting with a craniofacial injury(ies) resulting from an ATV crash from January 2001 to December 2004. RESULTS: Twenty-six children (65% boys) with a mean age of 13.1 years presented with craniofacial injuries during the study period. Two patients were helmeted. Mortality was 3.8% (n = 1, head injury related, postinjury day 3). Patients were most often drivers of the ATV (65%), although girls were more likely to be passengers (P = .03). Facial contusions, lacerations, and abrasions were highly prevalent (62%, 69%, 65%, respectively), as were fractures of the facial bones and skull (77%). Thirty-five percent sustained closed head injuries, which were significantly associated with mandible fractures (odds ratio 12.8%; 95% CI, 1.15-143). Mean length of hospital stay was 4.6 +/- 5 days, and 36% required an ICU stay (mean, 5.1 +/- 3 days). Twenty-four percent required ventilator support (mean, 107 +/- 43 hours; range, 48 to 168 hours). Operative intervention was required in 72% of patients (n = 18). CONCLUSION: Maxillofacial injury patterns from ATV-related crashes in children suggest a high percentage of significant facial injuries and closed head injuries. As new ATV legislation that addresses operator use is enacted, a decrease in the number and severity of craniofacial injuries may be seen.