Proximal Protection Device Research Articles

Proximal protection devices for carotid artery stenting - A benchtop assessment of flow reversal performance.

Proximal protection devices, such as TransCarotid Artery Revascularization (TCAR, SilkRoad Medical, Sunnyvale), aim to yield better outcomes in carotid artery stenting (CAS) than distal protection devices by preventing plaque embolization to the brain. However, transfemoral catheters may not fully reverse flow from the external carotid artery (ECA) to the internal carotid artery (ICA). We assess a new balloon-sheath device, Femoral Flow Reversal Access for Carotid Artery Stenting (FFRACAS), for this purpose. The FFRACAS prototype (ID = 0.117"; L=80cm) was compared to TCAR (ID=0.104", L=30cm) and MoMa (Medtronic, Minneapolis; ID=0.083", L=90cm) in a pulsatile flow model with blood simulant at 800mL/min. MoMa was used according to labeled instructions, with both CCA and ECA balloon inflation, without CCA-femoral vein shunt placement, and in an off-label fashion with single balloon occlusion in the CCA and shunt. Flow rates of the ICA, ECA, and shunt, when applicable, were monitored during CAS stages: CCA flow arrest, shunt activation, and stent delivery. Experiments were conducted under two ECA inflow conditions (-10 and -20 mL/min). Statistical comparison of ICA flow rates was conducted using ANOVA and Tukey's post-hoc tests. MoMa's on-label use maintained retrograde ICA flow (-0.3 mL/min) throughout CAS. Upon shunt activation, TCAR and FFRACAS reversed ICA flow similarly under low ECA inflow (ICA=-5.10 mL/min vs. -4.83 mL/min; p=0.349), but neither achieved ICA flow reversal under high ECA inflow or during stent delivery. MoMa off-label use failed to reverse ICA flow. FFRACAS presents a potential alternative to TCAR, achieving similar degrees of flow reversal from a transfemoral approach to that achieved with the transcarotid approach. The MoMa system reliably prevents anterograde flow in ICA during CAS. CAS = Carotid Artery Stenting; TCAR = Transcarotid Arterial Revascularization; CCA = Common Carotid Artery; ICA = Internal Carotid Artery; ECA = External Carotid Artery; VA = Vertebral Artery; FFRACAS = Femoral Flow Reversal Access for Carotid Artery Stenting; ID = Inner Diameter; OD = Outer Diameter.

470 Robotic Transcranial Doppler With Artificial Intelligence for Real-Time Intraoperative Neuromonitoring During Endovascular Carotid Revascularization – A Novel and Autonomous Neuromonitoring Tool

INTRODUCTION: Real-time intraoperative neuromonitoring is crucial to account for cerebral blood flow and embolic protection offered by proximal and distal cerebral protection devices during carotid revascularization procedures. METHODS: All patients diagnosed with high-grade carotid stenosis were prospectively enrolled between October 2021 thru February 2022. The TCD Robot head-brace system was used to secure the patients head, and the robot calibrated to automatically identify ipsilateral MCA or the terminal ICA. Patient demographics and procedural characteristics relevant to the robotic system such as signal strength, time to find signal, intracranial depth of the relevant vessel, cerebral waveform, and emboli count were recorded for the 4 critical phases: i- Access to crossing the lesion, ii- Filter and balloon deployment, iii- Stent placement and implantation, and iv- Removal of delivery system. RESULTS: Eight patients were included in our study (6 males [75%]; mean age 71.5 ± 3.9). Six out of 8 patients were symptomatic with a mean diameter stenosis of 83.5 ± 4.1. Average time taken to find a stable signal was 62 seconds (Range: 10-122). Terminal ICA was the vessel identified in all cases with a mean depth of 64mm (Range: 59-71). Flow arrest was demonstrated in all cases with flow reversal demonstrated in 2. Mean duration for the TCD Robotic surveillance was 23.6 ± 0.9 minutes with an average of 117 distal emboli (Range: 45-143) recorded by the device. Linear regression model identified stent placement and implantation as statistically significant (P = 0.0419) contributor to the final emboli count. CONCLUSIONS: To our knowledge, this is the first case series of real-time comprehensive neuromonitoring using a Robotic Transcranial Doppler system with Artificial Intelligence demonstrating various cerebral blood flow parameters including flow arrest and distal embolic incidence intra-operatively.

Endovascular Repair of Radiation-induced Bilateral Common Carotid Artery Stenosis and Pseudoaneurysm with Covered and Uncovered Stent Graft using Double Embolic Protection Device

Purpose: We present an unpublished case of bilateral carotid injury due to radiation-induced treated by endovascular therapy using double embolic protection device as a novel technique. Methods: Extracranial carotid artery pseudoaneurysm is a rare condition among head and neck cancer patients treated with radio therapy. We report a case of pseudoaneurysm in the right Common Carotid Artery (CCA) and critical stenosis in the left CCA. A 72 years-old patient laryngeal cancer treated with laryngectomy and radiotherapy 26 years before admission. He presented to us complaining of right neck pain and right hemispheric TIA symptoms. Results: Performed ultrasonography and magnetic resonance angiography revealed right Common Carotid Artery (CCA) pseudoaneurysm (size:13x25 mm) and critical stenosis in the left CCA. Endovascular treatment was performed in bilateral carotid artery using covered stent in pseudoaneurysms in the right CCA and uncovered stent due critical stenosis in the left CCA using double embolic protection device. Both procedures showed successful exclusion of the pseudoaneurysm and widely patent artery. Conclusion: Endovascular treatment in injury artery radiation-induced is safe and effective approach with low rate complications. The combined use of proximal cerebral protection devices and distal filter protection could decrease the rate of cerebral embolization procedure related.

Choice of cerebral protection devices for carotid stenting

The article analyzes a retrospective analysis of long-term results of 316 carotid stentings performed in patients with atherosclerotic stenosis of the extracranial parts of the internal carotid arteries using various types of cerebral protection devices – filters and proximal protection devices and their combinations. As a result of the analysis, we obtained data on the influence of the choice of cerebral protection devices on the risks of ischemic complications. The topic under consideration will be of interest to specialists in X-ray endovascular diagnostics and treatment, cardiovascular surgeons, and neurologists.

Endovascular revascularization of symptomatic chronic total occlusions of the internal carotid artery using a proximal balloon protection device.

To investigate the feasibility, efficacy, and safety of endovascular recanalization for symptomatic chronic internal carotid artery occlusions (ICAO). Thirty patients with symptomatic chronic ICAO were treated using the endovascular recanalization method. Proximal balloon protection devices were used to prevent embolic migration by completely blocking the blood flow. The morphology of the internal carotid artery (ICA) at the occluded segment based on catheter angiography was analyzed. Recanalization of symptomatic chronic internal carotid artery occlusion (CICAO) was successful in 20 of the 30 patients (66.7%). The time required for successful revascularization ranged from 120 to 180 min (mean, 150 min). Of the 20 successful patients, 14 were at the cervical ICAs, and six were at the intracranial ICAs. No permanent complications occurred in our study. Ischemic symptoms related to chronic ICAO did not occur during the 18.3 month follow-up period (range, 12-24 months) in the 20 successful patients. Endovascular revascularization can improve hemodynamic compromise. The treated sites of all 20 successfully recanalized patients were patent on computed tomographic angiography or carotid duplex sonography, and no case with >50% restenosis was observed during the follow-up period. Three patients with failed recanalization had a stroke during the follow-up period. Endovascular revascularization of symptomatic CICAO using a proximal balloon protection device is technically feasible in selected patients, and the outcomes are favorable for patients who benefit from revascularization.

Carotid Endarterectomy Using a Flow-Reversal Technique in the Acute Period: A Novel Approach That May Reduce Intraoperative Cerebral Events

Lesion manipulation during internal carotid artery (ICA) surgical dissection is the most crucial stage of carotid endarterectomy (CEA); a friable part of the carotid plaque or a thrombus may detach from the arterial wall, leading to cerebral embolism. Proximal protection devices used in carotid artery stenting reverse the blood flow to the brain eliminating, at least after their deployment, the chance of cerebral embolism. Based on the working principle of these devices, we propose a new approach to CEA making use of a flow-reversal technique, and we report its successful application in 2 high-risk patients with a soft and friable type 4 ICA plaque: a 62-year-old male patient presenting with crescendo transient ischemic attacks and a 61-year-old male patient presenting with a major stroke. Both were operated in the acute period. Once the reverse flow has been established, the surgeon can freely manipulate the carotid and perform a fast blunt dissection without the risk that the disturbance of the arterial wall may lead to cerebral embolism. A video recording of the procedure has been made and presented with this article. Despite the various limitations, including increased clamping time, transient intolerance to reverse flow, and increased blood loss, this technique may improve clinical outcomes, especially in symptomatic patients with friable plaque. A clinical trial is warranted to further study the results of the flow-reversal CEA.

Prospective multicentre study of carotid artery stenting using the MER™ Stent - the OCEANUS study - 30-day and one-year follow-up results.

IntroductionConstant technological progress in the field of carotid stenting translates into improved short- and long-term results of endovascular treatment. The introduction of a new generation, self-expanding, open-cell stent has provided a new treatment option in endovascular management of carotid stenosis.AimTo evaluate 30-day and 1-year clinical outcomes of non-consecutive patients with high risk of carotid endarterectomy, who underwent 5F cylinder-tapered MER™ open-cell carotid stent implantation.Material and methodsIt was a single-arm, prospective study conducted in four experienced catheterisation centres. The use of embolic protection devices was mandatory. The primary endpoint was stroke in 30-day follow-up. The secondary endpoints were 30-day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis ≤ 30%), restenosis rate (%DS ≥ 50%), and Serious Adverse Device Effect (SADE) rate in 1-year follow-up.ResultsIn total 100 patients were recruited for the study, with the majority being males (n = 61). The mean age was 68.3 ±8.2 years, and most of the patients were asymptomatic (n = 56). In 55 (55%) patients direct stenting was performed, with the use of proximal protection devices in 19 (19%) patients. Mean internal carotid artery/common carotid artery stenosis before and after stent implantation was 81.98 ±9.15% and 12.52 ±8.70%, respectively (p < 0.001). Procedural success was achieved in all cases. One ischaemic stroke was observed at 30 days (1%, primary endpoint). At 1-year follow-up two myocardial infarctions and three deaths occurred with no additional stroke.ConclusionsThe OCEANUS study indicated the safety and efficacy of the MER™ stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MER™ stents in detail.

Comparison of Embolic Protection with Proximal and Distal Protection Devices: Periprocedural Complications, Clinical Outcomes, and Cerebral Embolic Lesions on Diffusion-Weighted Magnetic Resonance Imaging

Two main types of embolic protection devices have been used during carotid artery stenting (CAS): distal protection devices (DPDs) and proximal protection devices (PPDs). We compared the complications, clinical outcomes, and new ischemic lesions on diffusion-weighted magnetic resonance imaging (DWI) studies between patients who had undergone CAS using a DPD or PPD. We performed a retrospective review of the data from patients who had undergone CAS from March 2010 to January 2016. The periprocedural and 30-day adverse events and new ischemic lesions on DWI studies after CAS were evaluated. CAS was performed in 103 patients (DPD, n=60; PPD, n= 43). The number of patients with new ischemic lesions was greater in the DPD than in the PPD group (78% vs. 56%; P= 0.014). Most lesions (>90%) were tiny (≤3 mm), and the average number of new tiny lesions per patient was significantly greater in the DPD than in the PPD group (mean, 9.6 vs. 4.0; P= 0.008). No significant differences in the periprocedural or 30-day adverse rates were noted between the 2 groups. Intolerance during the procedure occurred in 5 patients (12%) in the PPD group, 4of whom had poor collateral circulation. The number of new ischemic lesions per patient and the incidence of ischemic lesions found on DWI were significantly greater in the DPD than in the PPD group. The lack of differences in the periprocedural and 30-day adverse rates between the 2 groups suggests that cerebral microemboli might not be associated with the clinical outcomes. For patients with poor collateral status, DPDs should be used preferentially to avoid the neurologic compromise associated with PPDs.

Evaluation of Carotid Artery Stenting with Distal Filter Protection Device

Abstract Objectives To assess the use of proximal protection devices in consecutive patients as the preferred means of cerebral embolic protection for primary carotid stenting. Methods and Results This was a prospective single-center study to evaluate the technical and clinical success of proximal protection devices as the first choice for embolic protection in symptomatic (≥ 50%) and asymptomatic (≥ 70%) carotid stenosis. Proximal protection devices were used for embolic protection in 115 consecutive patients. No patients were excluded for anatomical reasons. The filter used was of diameters 6 mm in all cases (Emboshield NAV filter device, Abbotts Healthcare Pvt. Ltd. [Lake Bluff, Il]). In all cases, self-expanding closed-cell designed stent was used (X-act closed-cell self-expanding nitinol carotid-tapered stent, Abbotts Healthcare Pvt. Ltd.). Plaque characterization was done by using real-time high-resolution ultrasound (HR USG) equipment (Aloka Prosound Alpha 7 [Chiyoda, Tokyo, Japan]) using high-frequency linear transducers (&gt; 7 MHz). Follow-up duration was 30 days. Mean age was 61.9 ± 8.27 years. There was male predominance observed in study accounting for 73 out of total 115 studied population. Fifty-six of 115 (48.89%) treated stenoses were symptomatic. Technical success was achieved in 115 of 115 (100%) cases. In both the cases, additional distal filter devices were used. Carotid stenting was successful in 115 (100%) lesions. This study observed higher number of debris in symptomatic and high-risk plaques. This study also observed higher sensitivity, specificity, and accuracy of updated classification for assessing risk of microembolism (captured debris) (sensitivity 73.91%, specificity 95.65%, positive predictive value [PPV] 91.89%, negative predictive value [NPV] 84.62%, accuracy 86.95%). In our study, minor stroke was seen in three (2.61%) patients within 48 hours, and no adverse events were seen within 48 hours to 1 month. Conclusion Proximal protection is a safe method as the first choice for embolic protection. It can be used with a high rate of technical success.

Carotid Near-Occlusion Stent Experiences.

Treatment strategy for near-occlusions (NO) of the internal carotid artery (ICA) is still controversial. In this study, we aimed to present the clinical results of stent placement in 50 patients with carotid artery (NO) stenosis that presented to our center, and upon which revascularization will be performed. Between 2014 and 2017, 50 patients with (NO) from 180 patients who had stents in the Interventional Vascular Neurology clinic were retrospectively studied. All the patients whether using or not using the proximal and distal protection device during the procedure were included. Patients had clinical neurologic evaluation, and underwent carotid artery radiologic imaging before the carotid artery stent (CAS) procedure. Balloon dilatation was applied before the stent procedure for patients that had advanced stenosis. Post-dilatation was applied with a balloon of appropriate size in case of residual narrowing. Findings such as bradycardia, hypotension, reperfusion hemorrhage during and after the stent placement procedure, as well as patients that developed restenosis within 12 months were recorded. This study includes 50 (30 males, 20 females) patients that underwent carotid stent placement. The mean age of patients was 65 (28-81). Reperfusion hemorrhage was seen in 1 (2%) patient and the patient died in week 3. Ten (20%) patients complained of chills and tremor lasting less than 3 hours after the procedure. One (2%) patient had encephalopathy and agitation for less than 24 hours. Two (4%) patients had hypotension, and 15 (30%) patients had a headache for less than 24 hours. Three patients developed local hematoma at the site of the sheath, and were treated by applying compression. Restenosis signs in the stent site was observed in 6 patients (12%) in color Doppler ultrasonography of the carotid performed in the 6th and 12th months. Although the innate process of ICA NO is not well known, it might be more frequent than currently considered. Especially after the diagnosis of ICA stenosis, it is important to make the right diagnosis in patients that have new ipsilateral symptoms. After the diagnosis is made, CAS, when performed by an experienced neuro-interventional team, seems beneficial with low complication rates.

Endovascular prevention and treatment of stroke related to extracranial carotid artery disease.

Acute ischemic stroke (AIS) is the leading cause of premature mortality and morbidity worldwide for both men and women. Extracranial carotid artery stenosis/occlusion is responsible for approximately 11.5% of ischemic strokes, whereas extracranial large vessel disease comprises roughly 16.6% of ischemic strokes. Carotid artery disease has been the source of significant debate among neurovascular and cardiovascular specialists, as well as vascular surgeons, as to the best method of revascularization, surgical reconstruction versus endovascular recanalization. There are different treatment modalities and techniques related to AIS and extracranial carotid artery disease based on the different etiologies, and these include acute internal carotid artery occlusion (thrombectomy versus carotid stenting/angioplasty), tandem occlusions (stenting and thrombectomy), and non-emergent carotid stenting/angioplasty for chronic internal carotid artery stenosis. The continuing development of new endovascular technology has led to a major shift in treatment to a minimally invasive endovascular approach. Distal filter devices, proximal protection devices, balloon-guided catheters, open- or closed-cell stents, and flow-reversal stenting are some of the technologies that are now available. The latest treatment techniques, indications, and studies are discussed in this review.

Safety Outcomes Using a Proximal Protection Device in Carotid Stenting of Long Carotid Stenoses

Background: Embolic protection devices can prevent atherosclerotic emboli during carotid stenting. Newer proximal protection devices reverse flow in the internal carotid artery (ICA), leading to reduction in perioperative microemboli. The risk of stroke is high for carotid stenting of ICA lesions with a length >10 mm and/or angiographic string sign. Objective: We aimed to evaluate the safety outcomes of proximal embolic protection device usage in this high-risk group. Methods: This is a retrospective analysis of patients who underwent carotid stenting procedures with proximal embolic protection devices at a tertiary care center. High-risk features for adverse events with carotid stenting were identified. Peri- and postprocedural outcomes were recorded. We further compared outcomes in patients with a carotid stenosis length >10 mm to those with shorter stenosis. Results: From January 2011 to December 2014, we included 27 patients; 96.3% were symptomatic and 3.7% were asymptomatic. There was a stent placement technical success rate of 100%. No major stroke or coronary events were recorded. One minor stroke event developed in one patient. A carotid lesion length >10 mm and/or angiographic string sign was noted in 21/27 patients, with an average lesion length of 14.4 mm. One patient (4.8%) in this group developed a minor stroke event. Neither a coronary nor a major stroke event was recorded in this group. There was no significant difference in the complication rate between the long lesion and the control group. Conclusion: In our patient cohort, it was found that a proximal embolic protection device is safe for patients with carotid stenosis, including those with a carotid lesion length >10 mm and/or angiographic string sign.

PROXIMAL EMBOLIC PROTECTION DECREASES CEREBRAL MICROEMBOLIZATION COMPARED TO DISTAL PROTECTION FOR CAROTID STENTING: A META-ANALYSIS

Embolic protection devices have become standard of care during carotid artery stenting (CAS) to reduce periprocedural stroke risk. Distal Protection Devices (DPD) were the first and are the most commonly used devices. Proximal protection devices (PPD) avoid lesion crossing and thus are potentially

Comparison Between Proximal Versus Distal Protection Devices in 287 Cases of Carotid Revascularization Using Angioplasty and Stenting: Periprocedure Complications, Morbidity, and Mortality

Embolic protection devices may decrease periprocedural thromboembolic complications during carotid angioplasty and stenting (CAS). When using proximal-protection devices (PPDs), protection starts before crossing the lesion. However, in the medical literature, its use is scarcely reported compared with that of distal-protection filters (DPDs). The objective of this study was to compare periprocedure complications, morbidity, and mortality among 287 consecutive cases of CAS performed with PPDs or DPDs. This was a retrospective analysis of 287 patients treated with CAS at our hospital between January 2006 and March 2012. Periprocedure complications, morbidity, and mortality at 30 days, including ischemic stroke or transient ischemic attack, reperfusion syndrome, myocardial infarction (MI), and death, were globally registered, and the results in PPD and DPD groups were compared. Two hundred eight patients were treated with DPD and 79 with PPD; 80.8 % were symptomatic. CAS procedures performed with PPD presented a statistically significant greater grade of stenosis than those with DPD (82.5 vs. 74.5 %, p < 0.001). Death rates were 1.9 and 1.3 %; stroke rates were 4.3 and 3.8 %; MI rates were 1.4 and 1.3 %; and total morbidity and mortality rates were 6.2 and 5 % (DPD and PPD groups, respectively); all differences were nonstatistically significant. No statistical difference was found between symptomatic and asymptomatic patients. Carotid angioplasty and stenting is a safe procedure to treat carotid disease in our patients. PPDs are not always associated with a greater risk of periprocedure complications, morbidity, and mortality than DPDs despite the greater grade of carotid stenosis in the PPD group. This observation may be of interest in the design of future studies with CAS.

Comparison of anti-embolic protection with proximal balloon occlusion and filter devices during carotid artery stenting: clinical and procedural outcomes.

AimThe objective of this study was to compare the periprocedural and clinical outcomes after carotid artery stenting (CAS) with proximal protection devices versus with distal protection devices.Material and methodsPatients with internal carotid artery (ICA) stenosis undergoing CAS with cerebral embolic protection were randomly assigned to proximal balloon occlusion or distal filter protection. Adverse events were defined as death, major stroke, minor stroke, transient ischemic attack (TIA) and myocardial infarction (MI). Periprocedural and 30-day adverse events and ICA vasospasm rates were compared between the two embolic protection groups.ResultsEighty-eight consecutive patients were randomized: 48 patients with proximal protection (mean age 68.8 ±13.6, 66% male) and 40 patients with a distal protection device (mean age 65.4 ±12.3; 70% male). There was no significant difference in periprocedural or 30-day adverse event rates between the two groups (p > 0.05). However, there was a higher periprocedural ICA vasospasm rate in the distal filter protection group (9 patients, 23%) compared with the proximal balloon occlusion group (1 patient, 2%) (p = 0.019).ConclusionsThere was no difference between the clinical periprocedural and 30-day adverse event rates of distal filter and proximal balloon protection systems. However, distal filter protection systems showed higher rates of periprocedural ICA vasospasm.

Zastosowanie systemu proksymalnej protekcji mózgowej Mono Mo.MA w leczeniu świeżej niedrożności tętnicy kręgowej

ENWEndNote BIBJabRef, Mendeley RISPapers, Reference Manager, RefWorks, Zotero AMA Przewłocki T, Pieniążek P, Kabłak-Ziembicka A, Wrotniak L, Tekieli Ł, Podolec P. Temporary vertebral flow reversal by Mono Mo.Ma: a new proximal protection system in the treatment of recent vertebral artery occlusion. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2012;8(1):66-69. doi:10.5114/pwki.2012.28072. APA Przewłocki, T., Pieniążek, P., Kabłak-Ziembicka, A., Wrotniak, L., Tekieli, Ł., & Podolec, P. (2012). Temporary vertebral flow reversal by Mono Mo.Ma: a new proximal protection system in the treatment of recent vertebral artery occlusion. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 8(1), 66-69. https://doi.org/10.5114/pwki.2012.28072 Chicago Przewłocki, Tadeusz, Piotr Pieniążek, Anna Kabłak-Ziembicka, Leszek Wrotniak, Łukasz Tekieli, and Piotr Podolec. 2012. "Temporary vertebral flow reversal by Mono Mo.Ma: a new proximal protection system in the treatment of recent vertebral artery occlusion". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 8 (1): 66-69. doi:10.5114/pwki.2012.28072. Harvard Przewłocki, T., Pieniążek, P., Kabłak-Ziembicka, A., Wrotniak, L., Tekieli, Ł., and Podolec, P. (2012). Temporary vertebral flow reversal by Mono Mo.Ma: a new proximal protection system in the treatment of recent vertebral artery occlusion. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 8(1), pp.66-69. https://doi.org/10.5114/pwki.2012.28072 MLA Przewłocki, Tadeusz et al. "Temporary vertebral flow reversal by Mono Mo.Ma: a new proximal protection system in the treatment of recent vertebral artery occlusion." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 8, no. 1, 2012, pp. 66-69. doi:10.5114/pwki.2012.28072. Vancouver Przewłocki T, Pieniążek P, Kabłak-Ziembicka A, Wrotniak L, Tekieli Ł, Podolec P. Temporary vertebral flow reversal by Mono Mo.Ma: a new proximal protection system in the treatment of recent vertebral artery occlusion. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2012;8(1):66-69. doi:10.5114/pwki.2012.28072.

Tools &amp; Techniques: Percutaneous intervention of saphenous vein graft lesions

© Europa Digital & Publishing 2013. All rights reserved. Background The percutaneous treatment of patients with obstructive atherosclerotic disease in coronary saphenous vein bypass grafts (SVG) remains a challenge in interventional cardiology. Patients undergoing SVG intervention are often older, and suffer significant comorbidities. Moreover, SVGs usually present a degenerated pattern of atherosclerosis, with complex, friable, thrombotic-prone lesions. SVG interventions carry a higher risk of acute complications, mainly distal embolisation, and poorer long-term outcomes, mainly restenosis, than do native coronary vessel interventions1,2. The predictors of one-month major cardiac events after SVG intervention have been explored recently3. The degree of SVG degeneration assessed by the SVG degeneration score, the estimated plaque volume, angiographic evidence of thrombus, and increasing patient age are the correlates associated with the 30-day composite outcome of death, myocardial infarction (MI) and target lesion revascularisation (TLR). Thus, an important reason for poorer outcomes of percutaneous coronary interventions (PCI) in SVGs is the embolisation of atherothrombotic debris into the native coronary circulation, often resulting in periprocedural MI or reduced antegrade flow (“no-reflow”). Strategies for addressing this distal embolisation problem include both proximal and distal protection devices, as well as adjunctive pharmacology and stenting approaches. Embolic protection devices have demonstrated value in decreasing the risk of embolisation and post-procedural myocardial enzyme elevation after SVG intervention. While stenting has definitely been proved to be superior to balloon-only angioplasty for the treatment of SVG lesions, the choice of the type of stent (bare metal stent versus drugeluting stent) is still a matter of debate. Drug-eluting stents appear promising for the successful sealing of SVG disease; however, available long-term safety and effectiveness data are conflicting and give reason for caution.

Preliminary experience with optical coherence tomography imaging to evaluate carotid artery stents: safety, feasibility and techniques

Optical coherence tomography (OCT) is an increasingly used intravascular imaging modality to assess coronary stent implantation and vessel healing. A recently developed catheter (C7 Dragonfly; LightLab Imaging Inc.,Westford, MA, USA) allows visualisation of peripheral arteries up to 10 mm of diameter with high speed pullback. Safety, feasibility and the technique of OCT following carotid artery stenting (CAS) were evaluated in the present study. OCT was performed in seven consecutive patients following successful CAS using proximal cerebral protection devices, occluding the common and external carotid artery and gentle manual injection of a total of 8-14 ml of 50% diluted contrast media with normal saline in order to displace the blood from the artery. Once the blood was displaced, pullback was started through the stented segment continuing the gentle contrast injection. After completion of the pullback all injected contrast was aspirated and discarded. In the first three patients, OCT was also performed without internal carotid artery flow blockage. Due to the high blood flow in the ICA it was not possible to replace all residual blood and obtain adequate OCT images. No procedural, in-hospital, or 30-day follow-up complications occurred. One patient experienced transient intolerance to vessel occlusion without any neurological sequels. OCT images were of good quality providing important information regarding stent geometry, presence and lack of strut apposition, plaque fracture, and plaque prolapse. Intravascular OCT under occlusive proximal protection appears feasible and safe to assess stent implantation in carotid arteries.

Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stent of saphenous vein grafts trial

Background: We sought to evaluate the contemporary use of embolic protection devices (EPDs) in saphenous vein graft (SVG) interventions. Methods: We examined EPD use in the stenting of saphenous vein grafts (SOS) trial, in which 80 patients with 112 lesions in 88 SVGs were randomized to a bare metal stent (39 patients, 43 grafts, and 55 lesions) or paclitaxel-eluting stent (41 patients, 45 grafts, and 57 lesions). Results: An EPD was used in 60 of 112 lesions (54%). A Filterwire (Boston Scientific) was used in 70% of EPD-treated lesions, Spider (ev3, Plymouth, Minnesota) in 12%, Proxis (St. Jude, Minneapolis, Minnesota) in 12%, and Guardwire (Medtronic, Santa Rosa, California) in 7%. Of the remaining 52 lesions, an EPD was not utilized in 13 lesions (25%) because the lesion was near the distal anastomosis, in 14 lesions (27%) because of an ostial location, in one lesion (2%) because of small SVG size, in two in-stent restenosis lesions (4%) because of low distal embolization risk, and in 22 lesions (42%) because of operator's preference even though use of an EPD was feasible. Procedural success was achieved in 77 patients (96%); in one patient a Filterwire was entrapped requiring emergency coronary bypass graft surgery and two patients had acute stent thrombosis. Conclusion: In spite of their proven efficacy, EPDs were utilized in approximately half of SVG interventions in the SOS trial. Availability of a proximal protection device could allow protection of ∼25% of unprotected lesions, yet operator discretion appears to be the major determinant of EPD use. © 2010 Wiley-Liss, Inc.

Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stenting of saphenous vein grafts trial

We sought to evaluate the contemporary use of embolic protection devices (EPDs) in saphenous vein graft (SVG) interventions. We examined EPD use in the stenting of saphenous vein grafts (SOS) trial, in which 80 patients with 112 lesions in 88 SVGs were randomized to a bare metal stent (39 patients, 43 grafts, and 55 lesions) or paclitaxel-eluting stent (41 patients, 45 grafts, and 57 lesions). An EPD was used in 60 of 112 lesions (54%). A Filterwire (Boston Scientific) was used in 70% of EPD-treated lesions, Spider (ev3, Plymouth, Minnesota) in 12%, Proxis (St. Jude, Minneapolis, Minnesota) in 12%, and Guardwire (Medtronic, Santa Rosa, California) in 7%. Of the remaining 52 lesions, an EPD was not utilized in 13 lesions (25%) because the lesion was near the distal anastomosis, in 14 lesions (27%) because of an ostial location, in one lesion (2%) because of small SVG size, in two in-stent restenosis lesions (4%) because of low distal embolization risk, and in 22 lesions (42%) because of operator's preference even though use of an EPD was feasible. Procedural success was achieved in 77 patients (96%); in one patient a Filterwire was entrapped requiring emergency coronary bypass graft surgery and two patients had acute stent thrombosis. In spite of their proven efficacy, EPDs were utilized in approximately half of SVG interventions in the SOS trial. Availability of a proximal protection device could allow protection of approximately 25% of unprotected lesions, yet operator discretion appears to be the major determinant of EPD use.