Appropriateness of learning curve for carotid artery stenting: An analysis of periprocedural complications

Verzini, Fabio; Cao, Piergiorgio; Rango, Paola De; Parlani, Gianbattista; Maselli, A; Romano, Lydia; Norgiolini, Lucia; Giordano, Giuseppe

doi:10.1016/j.jvs.2006.08.027

Cited by 125 publications

(103 citation statements)

References 20 publications

(24 reference statements)

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“…Unfortunately, as has been showed recently by Verzini et al, a large number of complications can occur also outside the window of emboli protection device use (in 2% of procedures in the present study). 8 Despite the high-risk features of the consecutive patients described here, the procedural and follow-up results are favorable and comparable with previously published surgical results in low-risk patients, 3 or in highrisk-patient endovascular trials. 2,6,[9][10][11][12][13][14] The most important factor in achieving technical success in DCAS is being able to gain access to the common carotid artery through a long guiding sheath or guiding catheter.…”

Section: Discussionsupporting

confidence: 87%

Thirty-Day Outcomes of Direct Carotid Artery Stenting With Cerebral Protection in High-Risk Patients

Veselka

Černá

Zimolová

et al. 2007

Circ J

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everal trials have shown that carotid endarterectomy is superior to medical treatment alone for the prevention of stroke in patients with significant carotid artery stenosis. [1][2][3][4][5] The SAPPHIRE trial has established carotid artery stenting (CAS) in high-surgical-risk patients as an effective alternative to carotid endarterectomy. 6 CAS after previous balloon dilation has been shown to be a safe, effective, and durable method of treatment for carotid artery disease. 2 We started carotid artery interventions in 1998 and with the exception of the treatment of in-stent restenosis, every carotid intervention implies elective stent implantation. From an initial strategy of predilation followed by stent implantation, we now perform direct carotid artery stenting (DCAS) for the vast majority of lesions.The present prospective, single-center registry was designed to evaluate the feasibility and safety of DCAS with distal protection devices in consecutive patients who were scheduled for endovascular treatment of significant carotid stenoses. A safety and feasibility evaluation of the aggressive approach in indication to endovascular therapy (and only exceptional indication to carotid endarterectomy) was another aim of our study.Circ J 2007; 71: 1468 -1472 (Received February 27, 2007 revised manuscript received April 28, 2007; accepted June 4, 2007 Background Implantation of a carotid artery stent after predilation is a standard approach in the endovascular treatment of carotid artery stenoses. Stenting without predilation may be an alternative approach in a certain subset of patients. The present prospective, single-center registry was designed to evaluate the feasibility and safety of direct carotid artery stenting (DCAS) in high-risk patients. Methods and ResultsSymptomatic patients with stenosis >50% and asymptomatic patients with stenosis >70% were eligible for enrolment. Criteria for high-risk patients included: need or history of open heart surgery, history of myocardial infarction, multivessel coronary artery disease, left ventricular dysfunction (ejection fraction ≤40%), severe pulmonary or renal disease, significant contralateral carotid disease, previous endarterectomy, and age ≥80 years. All procedures were performed using a filter protection device. Patients underwent complete clinical examination before and after DCAS and at 30-day follow-up. A total of 83 consecutive patients (45 males, 68±9 years, 33% symptomatic) underwent 100 procedures and 103 stents were deployed successfully. The technical success rate of stenting was 100%. Predilation of carotid stenosis was necessary in 1 (1%) procedure. Carotid-artery stenoses before and after DCAS were 80±9% and 7±9%, respectively. The median fluoroscopic time for DCAS was 7 min. The overall rate of in-hospital major adverse cerebrovascular events (death, stroke, myocardial infarction) was 5% (2 minor strokes, 3 transient attacks). There was 1 (1%) minor stroke within the 30-day follow-up. Conclusion DCAS is feasible and can be performed with an accept...

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Section: Discussionsupporting

confidence: 87%

Thirty-Day Outcomes of Direct Carotid Artery Stenting With Cerebral Protection in High-Risk Patients

Veselka

Černá

Zimolová

et al. 2007

Circ J

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“…This confirms previous reports indicating a learning curve for carotid stenting [21][22][23][24], and is in keeping with multiple reports of the same phenomenon in CEA and other endovascular therapies [25][26][27].…”

Section: Increase In Physician Volume and Experiencesupporting

confidence: 92%

The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

Gray

Verta

2013

Cathet Cardio Intervent

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Background Carotid artery stenting (CAS) was introduced in the United States nearly a decade ago as a novel treatment of severe carotid stenosis. Voluminous and high‐quality prospective data permit analysis of longitudinal trends in CAS outcomes. Methods Outcomes from all prospective trials with the Food and Drug Administration (FDA) oversight from 2000–2011 were reviewed, as were the subset of studies using a single CAS system. All studies shared common inclusion/exclusion criteria, endpoints, independent assessment/adjudication of neurological events, and were conducted in accordance with FDA regulations. Death and stroke (DS) rates from FDA‐approved studies in high‐surgical‐risk patients were assessed. Results Between 2000 and 2011, two distinct periods with clustered and differentiated outcomes in CAS IDE trials were observed, separated by FDA approval and Centers for Medicare and Medicaid Services (CMS) coverage in 2004–2005. The mean 30‐day DS rate in the first wave (2000–2004) of CAS trials was 5.3% (95% CI: 4.6–6.2%), and fell significantly to 2.6% (95% CI: 1.9–3.7%; P = 0.0001) in the second wave (2006–2011). This decline occurred during a simultaneous, independent 24‐fold increase in monitored CAS activity. This decline in DS rates was observed in symptomatic and asymptomatic patients, alike independent of device tested. Conclusions Declines in periprocedural DS rates in CAS appear linked to regulatory and coverage approvals leading to increased operator experience along with continued regulatory oversight, and provide insight into the introduction of other novel therapies. © 2013 Wiley Periodicals, Inc.

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“…Similar phenomenon was demonstrated for neurointerventional procedures, such as carotid angioplasty and stent placement 13 and aneurysm embolization. 14 Institutions should pay particular attention to this issue and monitor the case volumes of neurointerventionalists and effect on patient outcomes.…”

Section: Discussionsupporting

confidence: 72%

Neurointerventional Procedural Volume per Hospital in United States

Grigoryan

Chaudhry

Hassan

et al. 2012

Stroke

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Background and Purpose-Availability of neurointerventional procedures is recommended as a necessary component of a comprehensive stroke center by various regulatory guidelines that also emphasize adequate procedural volumes. We studied the volumes of neurointerventional procedures performed in various hospitals across the United States with subsequent comparisons with rates of minimum procedural volumes recommended by various professional bodies or used in clinical trials to ensure adequate operator experience. Methods-We reviewed the Nationwide Inpatient Sample database in the United States for the years 2005 to 2008. UsingInternational Classification of Disease-Clinical Modification, 9th revision, and Medicare severity diagnosis-related group codes, we identified among hospitals that admit stroke patients those that met the minimum criteria for overall and individual procedural volumes specified in various guidelines. We then compared the characteristics between the high-volume hospitals that performed at least 100 cervicocerebral angiograms and met Ն1 other procedural criterion (nϭ79) and low-volume hospitals (nϭ958). Results-Proportions of hospitals that met individual procedural volume criteria over the 4-year period according to procedure were: cervicocerebral angiography (7.0%-7.8%); endovascular acute ischemic stroke treatments (0.4%-2.6%); carotid angioplasty/stent placement (3.0%-5.3%); intracranial angioplasty/stent placement (0.3%-1.3%); and aneurysm embolization (1.3%-2.6%). There were significant trends for increasing numbers of all the endovascular procedures except intracranial angioplasty/stent placement over the course of 4 years.

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Appropriateness of learning curve for carotid artery stenting: An analysis of periprocedural complications

Cited by 125 publications

References 20 publications

Thirty-Day Outcomes of Direct Carotid Artery Stenting With Cerebral Protection in High-Risk Patients

Thirty-Day Outcomes of Direct Carotid Artery Stenting With Cerebral Protection in High-Risk Patients

The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

Neurointerventional Procedural Volume per Hospital in United States

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