Marc R. Mayberg
Adnan I. Qureshi, Charlene Knape, John Maroney, M. Fareed K. Suri and L. Nelson Hopkins
Object. Carotid angioplasty with stent placement has been proposed as an alternative method for revascularization of carotid artery (CA) stenosis. A novel stent with a coiled sheet design (NexStent; EndoTex Interventional Systems, Inc., Cupertino, CA) has been introduced because it provides improved flexibility over conventional tubular designs during navigation through tortuous arterial segments. The authors report the results of a multicenter study in which they evaluated the safety, feasibility, and effectiveness of this stent in the treatment of CA stenosis.
Methods. Enrollment was limited to patients with 70% or more symptomatic or asymptomatic stenosis of the internal CA. The primary end point was a technically successful implantation procedure (delivery of the stent to the target site and retrieval of the delivery device) resulting in less than 30% residual stenosis on angiograms obtained immediately postprocedure and no death or ipsilateral stroke immediately after or within 30 days following the procedure. The secondary effectiveness end point was prevention of an ipsilateral stroke within 31 days to 1 year postprocedure. The tertiary effectiveness end point was less than 70% residual stenosis demonstrated on CA Doppler ultrasonography performed at 6 and 12 months.
Forty-four patients (mean age 71 years, range 51–89 years; 30 patients were men and 18 [41%] had symptomatic stenotic lesions) were treated using 45 NexStents (two stents were placed in one patient). Residual stenosis on postprocedure angiograms was less than 30% in all patients. The 1-month primary end point was achieved in 41 patients (93%). The three major adverse events that occurred within 30 days were one death related to congestive heart failure and two ipsilateral strokes, one of which resulted in death. No ipsilateral stroke occurred between 1 and 12 months postprocedure among 35 patients who completed the follow-up evaluation. Asymptomatic recurrent stenosis was identified in one patient at 6 months postprocedure, requiring the performance of repeated angioplasty.
Conclusions. Placement of the NexStent was feasible and resulted in the effective treatment of patients with CA stenosis, with promising long-term results.
Adnan I. Qureshi, Malik M. Adil, Negin Shafizadeh and Shahram Majidi
Despite the recognition of racial or ethnic differences in preterm gestation, such differences in the rate of intraventricular hemorrhage (IVH), frequently associated with preterm gestation, are not well studied. The authors performed the current study to identify racial or ethnic differences in the incidence of IVH-related mortality within the national population of the US.
Using the ICD-10 codes P52.0, P52.1, P52.2, P52.3, and P10.2 and the Multiple Cause of Death data from 2000 to 2009, the authors identified all IVH-related mortalities that occurred in neonates and infants aged less than 1 year. The live births for whites and African Americans from the census for 2000–2009 were used to derive the incidence of IVH-related mortality for whites and African Americans per 100,000 live births. The IVH rate ratio (RR, 95% confidence interval [CI]) and annual percent change (APC) in the incidence rates from 2000 to 2009 were also calculated.
A total of 3249 IVH-related mortality cases were reported from 2000 to 2009. The incidence rates of IVH were higher among African American infants (16 per 100,000 live births) than among whites (7.8 per 100,000 live births). African American infants had a 2-fold higher risk of IVH-related mortality compared with whites (RR 2.0, 95% CI 1.2–3.2). The rate of increase over the last 10 years was less in African American infants (APC 1.6%) than in white infants (APC 4.3%).
The rate of IVH-related mortality is 2-fold higher among African American than white neonates and infants. Further studies are required to understand the underlying reasons for this prominent disparity in one of the most significant causes of infant mortality.
Qaisar A. Shah, Muhammad Zeeshan Memon, Ramachandra P. Tummala and Adnan I. Qureshi
Symptomatic occlusive lesions at the origins of the supra-aortic vessels pose challenges for treatment. Endovascular angioplasty and stent placement via the transfemoral approach is possible, but obtaining a stable position for the guide catheter via this approach is technically difficult. The authors describe the case of a 56-year-old man presenting with symptomatic occlusion of a previously placed stent at the origin of the left common carotid artery (CCA). An endovascular revascularization of the left CCA was planned. However, the absence of a lumen proximal to the stent prevented stable placement of a guide catheter via the transfemoral route. Consequently, the authors used a combined surgical and endovascular approach to gain access to the lesion. The left CCA was exposed surgically distal to the occlusion and clamped just proximal to its bifurcation to preserve flow from the external to the internal carotid artery (ICA) and to prevent embolism into the ICA. A wire was passed retrograde through the occlusive lesion and then was subsequently advanced proximally into the femoral sheath. This allowed transfemoral advancement of the appropriate endovascular devices to perform an angioplasty and placement of a stent. The patient remained neurologically stable, and postoperative studies showed improvement in cerebral perfusion. This case demonstrates the feasibility of distal-to-proximal stent delivery with a combined endovascular and surgical approach.
Adnan I. Qureshi, Ahmed A. Malik, Omar Saeed, Archie Defillo, Gregory T. Sherr and M. Fareed K. Suri
The incidence of subarachnoid hemorrhage (SAH) increases after menopause. Anecdotal data suggest that hormone replacement therapy (HRT) may reduce the rate of SAH and aneurysm formation in women. The goal of this study was to determine the effect of HRT on occurrence of SAH in a large prospective cohort of postmenopausal women.
The data were analyzed for 93, 676 women 50–79 years of age who were enrolled in the observational arm of the Women’s Health Initiative Study. The effect of HRT on risk of SAH was determined over a period of 12 ± 1 years (mean ± SD) using Cox proportional hazards analysis after adjusting for potential confounders. Additional analysis was performed to identify the risk associated with “estrogen only” and “estrogen and progesterone” HRT among women.
Of the 93, 676 participants, 114 (0.1%) developed SAH during the follow-up period. The rate of SAH was higher among women on active HRT compared with those without HRT used (0.14% vs 0.11%, absolute difference 0.03%, p < 0.0001). In unadjusted analysis, participants who reported active use of HRT were 60% more likely to suffer an SAH (RR 1.6, 95% CI 1.1–2.3). Compared with women without HRT use, the risk of SAH continued to be higher among women reporting active use of HRT (RR 1.5, 95% CI 1.0–2.2) after adjusting for age, systolic blood pressure, cigarette smoking, alcohol consumption, body mass index, race/ethnicity, diabetes, and cardiovascular disease. The risk of SAH was nonsignificantly higher among women on “estrogen only” HRT (RR 1.4, 95% CI 0.91–2.0) than “estrogen and progesterone” HRT(RR 1.2, 95% CI 0.8–2.1) after adjusting for the above-mentioned confounders.
Postmenopausal women, particularly those at risk for SAH due to presence of unruptured aneurysms, family history, or cardiovascular risk factors, should be counseled against use of HRT.
Ameer E. Hassan, Gabriela A. Villanueva, Ahmed A. Malik, Sonia Shariff and Adnan I. Qureshi
Recent studies have found an underutilization of in-hospital procedures in treatments of Hispanic patients admitted with coronary artery disease in states along the US-Mexico border (“border states”). The purpose of this study was to determine any treatment disparities between patients treated for subarachnoid hemorrhage (SAH) in border and nonborder states and whether this disparity was associated with differential hospital charges.
Using the National (Nationwide) Inpatient Sample, the authors retrieved data of Hispanic and non-Hispanic patients who were admitted in 2011 for SAH in a border state (California, Arizona, New Mexico, and Texas) or nonborder state (the remaining 46 US states). The authors determined the rates of use of endovascular coiling and surgical clipping treatments, hospital charges, and outcomes according to the patients' demographics and treatment in border or nonborder states.
In total, 18,368 patients were admitted with SAH in the selected time period, including 2310 Hispanic patients (12.6%). Of these patients, 1525 were admitted in a border state and 785 in a nonborder state. In border states, rates of surgical treatment significantly differed between patients of Hispanic (21.9%) and non-Hispanic (14.0%) origin (p = 0.02). In particular, Hispanic patients were more likely to undergo surgical clipping than were non-Hispanic patients. In the nonborder states, the rates of surgical treatment were similar for Hispanic and non-Hispanic patients (14.0% vs 15.6%, p = 0.6). Hispanic patients with SAH were billed significantly higher in-hospital charges in border states than in nonborder states ($219,260 and $192,418 [US dollars], respectively, p < 0.001).
Use of surgical treatments for Hispanic patients with SAH residing in border states has a unique pattern, which significantly increases in-hospital charges in this patient population.
Adnan I. Qureshi, M. Fareed K. Suri, Gishel New, Daniel C. Wadsworth Jr., Joan Dulin and L. Nelson Hopkins
Object. Carotid artery (CA) angioplasty with stent placement has been proposed as an alternative technique for revascularization in cases of CA stenosis. In this report the authors review the results of a multicenter Phase I study in which they evaluated the safety and feasibility of using a new self-expanding nitinol stent, the Bard Memotherm, to treat CA stenosis.
Methods. Enrollment was limited to patients in whom there was either 50% or greater symptomatic or 70% or greater asymptomatic stenosis of the internal CA. The primary endpoint was a technically successful implantation procedure (delivery of the stent to the target site and retrieval of the delivery device), resulting in less than 30% residual stenosis demonstrated on immediate postprocedure (control) angiograms, and no incidence of mortality, ipsilateral stroke, Q-wave myocardial infarction, or other major cardiovascular events immediately after or within 30 days following the procedure.
Stent placement was attempted for 73 lesions in 71 patients (mean age 71.3 ± 8.5 years), 43 (61%) of whom were men. The mean degree of stenosis was 82.6 ± 9%. The stenosis was symptomatic in 27 (37%) and asymptomatic in 46 (63%) of 73 lesions. In four procedures the stent could not be delivered or released. The mean residual stenosis observed on angiograms was 3.8 ± 6.9% in the 69 lesions treated with the Bard Memotherm stent; residual stenosis was greater than 30% in one of the 69 procedures. The primary endpoint was achieved in 65 (89%) of the 73 procedures. One patient experienced a major ischemic stroke and another patient died of intracerebral hemorrhage. The overall 1-month stroke rate was 2.7% for 73 attempted procedures. One patient died of pneumonia and acute respiratory distress syndrome, which occurred 3 weeks after the stent procedure and was unrelated to the procedure.
Conclusions. The Memotherm stent can be used to treat patients with CA stenosis and is associated with a low periprocedure complication rate. Long-term follow-up studies are underway to determine the impact of stent placement on the risk of ipsilateral ischemic events.
Stanley H. Kim, Adnan I. Qureshi, Elad I. Levy, Ricardo A. Hanel, Amir M. Siddiqui and L. Nelson Hopkins
✓ The authors report a case of emergency carotid artery (CA) stent placement for a symptomatic acute CA occlusion following carotid endarterectomy (CEA). This 43-year-old man underwent a right-sided CEA for an asymptomatic 80% CA stenosis detected using duplex ultrasound testing. The patient experienced hypotension and possibly a myocardial infarction intraoperatively and a left hemiplegia immediately postoperatively. He was referred to the authors' institution for consideration of emergency coronary intervention and evaluation of stroke. A computerized tomography scan of the head demonstrated subtle early ischemic changes in the right posterior parietal region. Cerebral angiography revealed occlusion of the right common CA (CCA) at the CA bifurcation. Two coronary stents (Magic Wall; Boston Scientific Scimed, Maple Grove, MN) were placed in tandem in the right CCA and internal CA (ICA), overlapping at the proximal cervical ICA. Complete recanalization of the CA was achieved, and the patient made a clinically significant recovery. Diagnostic angiography can provide important information about CA and intracranial circulation that will aid in the evaluation of postoperative stroke after CEA. Stent placement should be considered as an alternative method of treatment for acute CA occlusion or dissection following CEA.
Richard D. Fessler, Ajay K. Wakhloo, Giuseppe Lanzino, Adnan I. Qureshi, Lee R. Guterman and L. Nelson Hopkins
Symptoms of vertebrobasilar insufficiency may precede neurological sequelae in up to 50% of patients. Although select patients may benefit from microsurgical revascularization, combined perioperative morbidity and mortality rates can be as high as 20%. The authors present their preliminary clinical experience using stent placement for symptomatic vertebral artery (VA) occlusive disease.
Six patients with clinical symptoms of vertebrobasilar insufficiency in whom VA stents were placed from 1995 to 1998 were identified. Diagnostic four-vessel cerebral angiography identified causative stenotic, atherosclerotic lesions in all cases. A transfemoral or transradial artery approach after the patient had undergone full heparinization was chosen for endovascular stenting. Guidewire placement across the lesion followed by urokinase infusion preceded stenting. Prestent angioplasty was performed in two patients. Following the procedure, all patients were maintained on daily antiplatelet therapy.
Patient age ranged from 45 to 76 years (average 63 years). Four patients were men and two were women. Angiography revealed greater than 95% stenosis in five patients and greater than 70% stenosis in one. Three patients had complete occlusion of the contralateral VA; in one other, the VA supplied only the posterior inferior cerebellar artery; and the remaining two patients had VAs with greater than 70% stenosis. Ten stents were placed in six patients for five VA origin lesions and one distal VA stenosis. A VA dissection occurring poststenting was treated by placement of three additional stents. One patient had transient double vision. All had resolution of their presenting symptoms. Follow up ranged from 1 to 24 months (average 8.4 months). Angiograms obtained in four patients at least 3 months postprocedure have revealed stent patency in all cases without evidence of restenosis.
Vertebral artery stent placement can be safely performed and is a viable treatment option for carefully selected patients with vertebrobasilar insufficiency.
Asif A. Khan, Saqib A. Chaudhry, Kamesh Sivagnanam, Ameer E. Hassan, M. Fareed K. Suri and Adnan I. Qureshi
The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated that the risk of the primary composite outcome of stroke, myocardial infarction (MI), or death did not differ significantly in patients with an average surgical risk undergoing carotid artery stenting (CAS) and those undergoing carotid endarterectomy (CEA). However, the cost associated with CAS may limit its broad applicability. The authors' goal in this paper was to determine the cost-effectiveness of CAS with an embolic-protection device versus CEA in patients with moderate to severe carotid artery stenosis who are at average surgical risk.
The probability of the primary outcome was obtained from the results of the CREST trial. The quality-adjusted life years (QALYs) associated with each treatment modality were estimated by adjusting for the incidence of each quality-adjusted outcome (QALY weights of ipsilateral stroke, MI, death, and postprocedure QALYs). The total cost associated with each intervention was derived from hospitalization cost and cost associated with primary outcomes including stroke, MI, and death in each group. Costs are expressed in US dollars accounting for inflation up to October 2010. Incremental cost-effectiveness ratios (ICERs) were estimated for the 4-year period after the procedure. All values are expressed as means and 95% confidence intervals.
The estimated net costs for patients after treatment with CAS and CEA after consideration of the primary outcome were $18,335 and $13,276, respectively, from the definitive presimulation analysis. Postsimulation values were $19,210 (range $18,264–$20,156) and $14,080 (range $13,076–$15,084), respectively. Overall, QALYs for the CAS and CEA groups were 0.712 and 0.702, respectively (ranging from 0.0 [death] to 0.815 [no adverse events]). The estimated ICER for CAS versus CEA treatment was $229,429.
Although the CREST demonstrated equivalent results with CAS (compared with CEA) in patients at average surgical risk with severe carotid artery stenosis, broad applicability of CAS might be limited by the higher cost associated with this procedure.