Raffaella Manetti

Protected Carotid Stenting: Clinical Advantages and Complications of Embolic Protection Devices in 442 Consecutive Patients

Background and Purpose— Periprocedural embolization of debris during carotid stenting interventions may result in neurological deficit. This study was designed to evaluate in-hospital and 30-day adverse events in patients percutaneously treated for carotid artery disease with embolic protection devices. Methods— From 1999 to June 2002, a total of 442 consecutive patients underwent percutaneous angioplasty and/or stenting of the extracranial carotid artery. The endovascular procedure was conducted under embolic protection devices. Results— The percutaneous procedure was successful in 440 of 442 patients (99.5%). No periprocedural death occurred with any embolic protection device. All in-hospital stroke/death and 30-day ipsilateral stroke/death rate was 1.1%. The overall complication rate was 3.4%. Major adverse events included 1 major stroke (0.2%), 4 intracranial hemorrhages (0.9%), 1 carotid artery wall fissuration (0.2%), and 1 diffuse cardioembolism (0.2%). Minor adverse events included 4 minor strokes (0.9%) and 4 transient ischemic attacks (0.9%). The cerebral protection device–related complications were 4 (0.9%): 1 case of abrupt closure of the internal carotid artery because of spiral dissection (0.2%), 1 case of trapped guide wire (0.2%), and 2 cases of intimal dissection (0.5%). Transient loss of consciousness, tremors, and fasciculations were present in 6 of 40 patients (15%) in whom occlusive protection devices were used. Conclusions— Our data suggest that percutaneous stenting of the carotid artery when a cerebral protection device is used is feasible and effective but not without potential complications. However, a long learning curve may exist for the proper use of some embolic protection devices.

Impact of cerebral protection devices on early outcome of carotid stenting.

PURPOSE To evaluate the impact of cerebral protection devices on the procedural safety and outcome of carotid stent procedures. METHODS From June 1997 to July 2001, 275 consecutive patients (208 men; mean age 71 +/- 7.4 years) underwent percutaneous angioplasty and/or stenting of the extracranial carotid artery. In the first 125 (45.4%) patients, the procedures were performed without cerebral protection. After January 2000, protection devices were routinely used (150 [54.6%] patients), including the Angioguard filter, GuardWire occlusion system, TRAP Vascular Filtration System, EPI Filter Wire, NeuroShield, Parodi Anti-Embolism System, and Medicorp occlusive balloon. RESULTS The percutaneous procedures were effective in 273 (99.3%) patients. No death or major stroke occurred in either group. In the unprotected group, 5 (4.0%) complications occurred: 3 (2.4%) minor strokes, 1 (0.8%) transient ischemic attack (TIA), and 1 (0.8%) subarachnoid hemorrhage. In the patients treated under cerebral protection, there were 2 (1.3%) complications: 1 (0.7%) minor stroke and 1 (0.7%) subarachnoid hemorrhage. There were 4 (3.2%) periprocedural embolic complications in the unprotected group versus 1 (0.7%) in the protected patients. CONCLUSIONS Our data suggest that percutaneous dilation and stenting of the carotid arteries protected by cerebral protection devices is feasible and effective. In a consecutive series, the use of the cerebral protection systems reduced the acute neurological event rate related to embolic complications by 79%.

Safety, efficacy and long-term durability of endovascular therapy for carotid artery disease: the tailored-Carotid Artery Stenting Experience of a single high-volume centre (tailored-CASE Registry)

AIMS We aimed to determine the success, safety and long-term durability of carotid artery stenting (CAS) in stroke prevention for all-comers managed with mandatory neuroprotection and a tailored-approach to intervention. METHODS AND RESULTS From our CAS registry (beginning July 1997) all procedures up to September 2007 with intention-to-treat by stenting under distal filter or proximal occlusion neuroprotection devices were analysed (N=1523; mean age 72 years [237 >or=80 years, 15.5%]). Indications included symptomatic stenoses >or=50% (366, 24.1%) and asymptomatic stenoses >or=80% (1157, 75.9%). CAS success was 99.6% and the 30-day all-stroke/death rate was 1.5% (minor stroke 11 [0.7%], major stroke 8 [0.5%], death 5 [0.3%]). The risk was 1.2% for asymptomatic patients and 2.7% for symptomatic patients (p=0.042). Regarding octogenarians this risk was 2.1% versus 1.5% for patients <or=79 years (p=0.47). Symptomatic octogenarians had a higher risk than other groups (OR 3.9, 95% CI 1.06 to 14.0): asymptomatic <or=79 1.2%, asymptomatic >or=80 1.2%, symptomatic <or=79 2.3% and symptomatic >or=80 4.5%. The event free survival rates from all strokes or stroke-related deaths at eight years were 96% for asymptomatic and 92% for symptomatic patients. CONCLUSIONS Results from this large cohort show that carotid stenting in a real-world setting is safe and efficacious, and durable in the long-term prevention of stroke.

Endovascular treatment of soft carotid plaques: a single-center carotid stent experience.

Purpose: To report a prospective evaluation of the 30-day clinical neurological outcome in patients percutaneously treated for severe symptomatic and asymptomatic soft echolucent carotid plaques under cerebral protection from a proximal flow blockade system. Methods: From December 2001 to February 2005, 84 consecutive patients (63 men; mean age 70.7±7.1 years, range 58–81) with documented soft echolucent (gray scale median <25) extracranial carotid lesions were enrolled in a study of percutaneous stenting under cerebral protection achieved by a proximal endovascular clamping device. Primary end-point of the study was the all stroke and death rate at 30 days. Secondary endpoints were angiographic success and any complication between discharge and 30 days. All adverse events were analyzed by an independent neurological team. Results: Total neurological events at 30-day follow-up included 3 transient ischemic attacks and 1 minor stroke (4.8% neurological event rate). The 30-day rates of stroke and neurological death/stroke were both 1.2%; the all death/stroke rate was 2.4%. Clamping intolerance was observed in 5.9% of cases, but there was no interruption in the procedure or clinical sequelae. In 66.7% of patients, visible debris was collected during the procedure. Conclusion: Protected CAS with proximal flow blockage can successfully be applied in selected patients for soft carotid plaques at high risk for intraprocedural embolic events.

Cutting balloon angioplasty in percutaneous carotid interventions.

Purpose: To report a prospective feasibility study of Cutting Balloon angioplasty (CBA) applied in the predilation phase of carotid artery stenting (CAS) in highly calcified lesions. Methods: From January 2003 to February 2007, 178 consecutive patients (109 men; mean age 73.1±7.3 years) with highly calcified carotid lesions underwent CAS with CBA applied as a pre-specified strategy in the predilation phase of the procedure. All steps in the procedure were performed under cerebral filter protection. The cutting balloon ranged in diameter from 3 to 4 mm and was inflated at nominal pressures in the target lesion. Pre-CBA dilation with a low-profile coronary balloon was performed only when the Cutting Balloon was not able to cross the lesion. Selection of the filters and stents was at the operators discretion. Primary endpoints were the all stroke and death rates at 30 days and 6 months. Secondary endpoints included Cutting Balloon success (positioning and full balloon inflation), CAS technical success (residual angiographic stenosis <30%), CAS procedural success (technical success and no complications), and in-hospital major complications. Results: Cutting Balloon success was achieved in all 178 patients. In 32 (18.0%), pre-CBA dilation was necessary due to inability to cross the lesion with the Cutting Balloon initially. CAS technical success was achieved in all patients. One (0.6%) patient suffered transient neurological intolerance due to flow cessation from massive debris in the distal filter; this event was completely resolved after the filter was removed (CAS procedural success 99.4%). One patient suffered a major stroke at day 15 (0.6% 30-day all stroke and death rate). At the 6-month follow-up, 174 (97.7%) patients were evaluated; 1 patient died from myocardial infarction at day 35, and 2 patients died from non-neurological or cardiac causes at days 103 and 158. The cumulative all stroke and death rate was 2.2%. Conclusion: These data suggest that CBA performed during the predilation phase of CAS in highly calcified lesion is a safe and useful method to prepare this lesion subset for stenting.

Stent migration as a late complication following carotid angioplasty and stenting.

BACKGROUND A 69-year-old male patient with severe asymptomatic carotid artery stenosis was treated percutaneously with implant of two self-expandable stents in the right carotid overlapped to each other by 5 mm. The 15-month follow-up colour-Doppler ultrasound (CDU) revealed a severe stenosis in the target vessel and an image suggesting migration of the distal stent. INVESTIGATIONS Physical examination, laboratory test, CDU, carotid angiography, quantitative carotid angiography (QCA), brain computed tomography (CT). DIAGNOSIS Migration of the distal stent associated with severe stenosis on the unsupported arterial segment. MANAGEMENT Carotid artery angiography, QCA, antithrombotic therapy, carotid artery angioplasty and stenting (CAS).

Proximal protection in carotid artery stenting: rationale and recent findings

EuroInterv.2007;3:269-274 Introduction Carotid artery stenting (CAS) is a less invasive procedure for the treatment of extracranial bifurcation carotid artery stenosis, and might be an alternative to CEA in patients at high risk for perioperative complications1. Nevertheless, the “Achilles’ heel” of CAS is represented by the risk of cerebral embolic complications, possibly leading to major neurologic adverse events. The availability and appropriate selection of cerebral protection devices, together with the experience of the operators, are key factors in the achievement of a low rate of complications, as showed in single-centre series2,3. After a brief review of the rationale for cerebral protection and distal protection devices, we will deal with proximal endovascular clamping systems, recently introduced (Mo.Ma, Invatec, Roncadelle, Italy) or re-designed (NeuroProtection System, Gore, Flagstaff, AZ, USA), which seems to be highly effective in the prevention of embolic complications.

Clinical Experience with the NIR Stent: Retrospective Observation on Acute Results and Follow-up in 709 Patients.

The NIR stent is an expandable cellular coronary prosthesis with high flexibility and excellent trackability. the very low crossing profile, associated to the high flexibility, makes this stent suitable for complex and distal lesions. The aim of this study was to evaluate the feasibility, safety, and long-term (clinical follow-up) efficacy of elective and/or urgent deployment of the NIR stent in a broad patient group with coronary artery disease. Between June 1996 and May 1997, 986 NIR stents were implanted in 781 vessels (de novo or restenotic lesions in native vessels, saphenous vein grafts and internal mammary conduits) of 709 consecutive patients (498 men, 211 women) undergoing coronary angioplasty in two Villa Maria Group Catheterization Laboratories. Procedural angiographic success was achieved in 98.4% of all the lesions treated, ranging from 100% success rate in type A lesion to 97.6% in type C lesions (overall procedural success, 98.4%). Major adverse cardiac events (MACE) were considered from PTCA/stenting time to the patient discharge. The in-hospital MACE were limited and occurred in 15 patients: urgent surgical revascularization 0.8%, death 0.7%, sub-acute stent thrombosis 0.5% (overall in-hospital MACE rate 2.1%). Clinical follow-up data were obtained at 8.6±2.8 months following the stenting procedure. The event-free survival rate was 87.9%. The late MACE rate evaluation showed death, target lesion revascularization 9.9% (over-all late MACE rate 12.1%). The NIR stent performances in this broad patient population were excellent, showing very high procedural success rate both in normal and complex coronary anatomy. On the basis of the previous data, we can define NIR stent a safe multifunctional device suitable both for easy and complex situations. The clinical late results are very promising in term of event-free survivals and late MACE.