Carotid Artery In-stent Restenosis Research Articles

First-in-Men Treatment of Carotid Artery In-Stent Restenosis with a Novel Sirolimus-Eluting Balloon Technology

First-in-Men Treatment of Carotid Artery In-Stent Restenosis with a Novel Sirolimus-Eluting Balloon Technology

Drug-Coated Balloon Angioplasty for Carotid Artery In-Stent Restenosis: Case Series

Objectives: Few case reports have demonstrated promising results of drug-coated balloons (DCBs) as an emerging management for carotid artery in-stent restenosis (CAISR). Herein, we report 6 cases of CAISR which were treated with a DCB with or without new stent deployment. Background: Carotid artery in-stent restenosis is a high-risk condition with an estimated incidence rate that varies widely from 6% to 40%. Several strategies are available now for the management of the CAISR including conventional balloon angioplasty, plaque modification balloon angioplasty, and new stent placement. Methods: A retrospective review of consecutive patients with a diagnosis of severe CAISR at Baylor Scott & White The Heart Hospital Plano from 2011 to 2021 was performed. This study was approved by the Baylor Scott & White Research Institute institutional review board. Results: Six patients underwent DCB angioplasty with or without stent placement under an embolic protection device. Resolution of CAISR was achieved in all cases with 0% to 10% residual stenosis in all cases. Following the procedure, 1 patient had a brief episode of syncope with balloon inflation with immediate recovery on deflation of the balloon. There were otherwise no significant neurological or cardiac events prior to discharge. All patients were asymptomatic at their follow-up visit with no neurological or cardiac events reported at 12, 24, and 36 months following the procedure. Conclusion: While CAISR treatment remains a challenging condition, our study shows that the use of DCB with or without stent placement is a feasible and promising treatment option when compared with other conventional treatment options. Clinical Impact Carotid artery in-stent restenosis treatment remains a challenging condition. Our study shows that the use of drug coated balloon with or without stent placement is a feasible and promising treatment option when compared with current conventional treatment options.

Defining Duplex Ultrasound Criteria for In-Stent Restenosis of the Carotid Artery Using Computed Tomographic Angiography.

IntroductionDuplex ultrasound (DUS) velocity measurement is the preferred method for evaluating carotid artery stenosis. However, velocity criteria based upon native carotid arteries may not apply to internal carotid artery stents. Previously, catheter-based angiography was used to determine DUS velocity criteria for in-stent restenosis (ISR), but conventional angiography is invasive and can be limited. This study sought to define duplex ultrasound velocity criteria for predicting internal carotid artery in-stent restenosis by correlating in-stent velocities with computed tomographic angiography (CTA) measurements of percent stenosis.MethodsA retrospective chart review was conducted on all patients who underwent internal carotid artery (ICA) stenting within our health system between January 2013 and February 2020. Thirty-eight surveillance DUS studies from 32 patients were found to have CTA performed within 30 days. Centerline reconstructions of internal carotid artery stents were created using Aquarius iNtuition software (TeraRecon, Durham, NC, USA). Two independent observers measured percent stenosis by three built-in methods. Stenotic areas were matched to DUS-measured peak systolic velocities (PSV) and end-diastolic velocities (EDV). Internal carotid artery PSV (stent) to common carotid artery (CCA) PSV ratios (ICA/CCA) were calculated, and receiver operating characteristic (ROC) curves were generated. The optimal DUS velocity criteria in the stented ICA were determined by maximizing Youden’s index.ResultsMean vessel diameter measurement of percent stenosis resulted in the most accurate model for all DUS velocity parameters (PSV, EDV, and ICA/CCA ratio) and was used for threshold determinations (area under the receiver operating characteristics (AUROC): 0.99, 0.96, and 0.96, respectively). A PSV cutoff of 240 cm/s for ≥60% ISR resulted in the highest Youden’s index (97%) with 100% sensitivity and 97% specificity. Secondary DUS parameters included an EDV ≥50 cm/s (Youden’s index 84%) and an ICA/CCA ratio ≥ 2.2 (Youden’s index 91%).ConclusionsVelocity criteria to predict internal carotid artery ISR is needed to inform decisions for possible reintervention. Using CTA, we found that a PSV ≥240 cm/s on carotid DUS can predict ≥60% ISR with high sensitivity and specificity. This value can be used as an alternative to current velocity criteria based on native carotid arteries. However, the optimal thresholds for EDV and ICA/CCA ratio were similar to native carotid arteries.

Recurrent stenosis following carotid artery stenting treated with a drug-eluting balloon: a single-center retrospective analysis.

Early in-stent restenosis after stent-protected angioplasty of the carotid artery (SPAC) is an infrequent, but potentially harmful condition for patients with carotid artery disease. In our retrospective single-center analysis of 176 patients with carotid artery stenting between 2009 and 2015, using duplex ultrasound, we detected 9 patients with high-grade carotid artery in-stent restenosis. All restenosis patients were treated with a drug-eluting balloon (DEB) to prevent recurrent neointimal hyperplasia. One patient had bilateral carotid artery disease with bilateral in-stent restenosis, and 1 patient needed repeated DEB treatment 19months after the first DEB intervention, so 11 DEB procedures, in total, were performed. The median time-interval between primary carotid artery stenting and first DEB-treatment was 9months. In 3 of the 11 interventions, the DEB treatment was assisted by an additional stent. One repeat DEB treatment was necessary, and three DEB treatments were followed by a secondary stent. No peri-interventional complications (TIA, stroke, or death) were observed during or after DEB intervention. Therefore, in the entire group, the 1y event-free survival (EFS) was 100%, and the 2y/3y/5y EFS was 83%. DEB intervention seems to be an effective and safe treatment for patients with high-grade in-stent restenosis after SPAC.

Prediction of carotid artery in-stent restenosis by quantitative assessment of vulnerable plaque using computed tomography

To assess the relationship between plaque volume evaluated by multidetector computed tomographic angiography (MDCT) and in-stent restenosis (ISR) after carotid artery stenting (CAS). From a retrospectively maintained database, data were collected for 52patients with carotid artery stenosis treated with CAS between 2007 and 2012. We defined ISR of≥50% as a peak systolic velocity≥200cm/s on echo-duplex scan. Carotid plaques were subdivided into four components according to radiodensity in Hounsfield units (HU) as follows: <0, 0-60, 60-130, and>600HU. Risk factors that influenced ISR were compared using univariate and multivariate Cox regression analyses. During a median follow-up period of 36months, ISR of≥50% was detected in five patients (9.6%). In the univariate Cox proportional hazard regression analysis, renal insufficiency, coronary artery disease, total plaque volume, and plaque volumes with radiodensities<0 and≥600HU increased the risk for ISR (P<0.10). When the significant risk factors determined from the univariate analysis were subjected to a multivariate analysis, only the volumes of the plaque components with radiodensities<0 HU independently predicted the development of ISR (hazard ratio: 1.041; 95% confidence interval: 1.006-1.078; P=0.021). Our data suggest that the high volume of the plaque components with radiodensities<0HU was independently associated with the increased risk of ISR after CAS. Quantitative and qualitative tissue characterizations of carotid plaques using MDCT might be a useful predictive tool of the development of ISR.

Plaque morphology detected with Duplex ultrasound before carotid angioplasty and stenting (CAS) is not a predictor of carotid artery in-stent restenosis, a case control study

BackgroundIn-stent restenosis (ISR) is an important factor endangering the long-term safety and efficacy of carotid artery angioplasty and stenting (CAS). It is plausible that soft vulnerable plaques are more likely to be injured during CAS procedure and are therefore more likely to initiate the cascade finally leading to ISR. The aim of this study was to investigate if plaque morphology detected by a simple applicable Duplex ultrasound score before CAS can be used as a predictor for ISR.MethodsWithin a prospectively collected single-centre CAS database of 281 patients (comprising 300 arteries) with high-grade carotid artery stenosis, who underwent CAS between May 2003 and January 2013, we conducted a nested case–control study. Plaque morphology before CAS was analysed by a blinded investigator and each parameter of the Total Plaque Risk Score (TPRS) as well as the whole score was evaluated with regard to its diagnostic validity for ISR.ResultsWe analysed the data of 10 patients with ISR and 50 patients without ISR. There were no significant differences with respect to baseline characteristics, vascular risk factors, and degree of stenosis between patients with and without ISR. The duration of follow-up was longer in patients with ISR (p = 0.024) and these patients were more likely to show increased PSV (p = 0.012) immediately after CAS than patients without ISR. Neither individual parameters of the TPRS score nor the score as a whole were suitable as a diagnostic test for ISR development.ConclusionsIn the present study we could demonstrate that the non-contrast enhanced DUS of the pre-interventional plaque formation cannot be used as a predictor for the development of ISR. Evaluating a more sophisticated, but not routinely available approach e.g. by ultrasound based plaque perfusion imaging or CT based plaque analysis could be helpful in the future in order to assess the role of plaque morphology in the context of ISR development.

Predictors of carotid artery in-stent restenosis

Carotid angioplasty and stenting (CAS) is increasingly being used as a treatment alternative to endarterectomy (CEA), especially in patients aged <70 years with significant carotid artery stenosis. However, an in-stent restenosis (ISR) might endangering the long-term efficacy of CAS. The aim of this article was to review the current literature regarding incidence and clinical significance as well as predictors of in-stent restenosis. We conducted a systematic review of the literature to identify all studies on the abovementioned factors. 3 randomized-controlled trials comparing CAS and CEA and 13 single centre studies fulfilled our inclusion criteria. The occurrence of ISR after CAS ranged from 2.7 to 33% and was detected within the first year in most of the studies. The clinical impact as well as the therapeutic consequence of ISR remains unclear, but many baseline characteristics (age, prior CEA or radiation), procedural (insufficient stent deployment, stent dimensions, inflammatory marker) and follow-up factors (reduced HDL, diabetes mellitus) could be found to identify patients at special risk for ISR. A wide heterogeneity related to the definition and their corresponding ultrasound criteria for ISR was observed. A close follow-up is suggested especially in those patients with predictors of an ISR. The wide range of ISR ultrasound definitions urges the need for an implementation of generally valid criteria in ISR diagnosis. Against the background of the unknown clinical significance of ISR and a lacking established treatment modality these findings should be taken into account when offering CAS as a treatment alternative to CEA.

Clinical impact and predictors of carotid artery in-stent restenosis

To assess the incidence and clinical significance as well as predictors of in-stent restenosis (ISR) after carotid artery stenting (CAS) diagnosed with serial duplex sonography investigations. We analyzed 215 CAS procedures that had clinical and serial carotid duplex ultrasound investigations. The incidence of in-stent restenosis (ISR) and periprocedural as well as long-term clinical complications were recorded. The influence of an ISR on clinical complication was analyzed using Kaplan-Meier curves and clinical risk factors for the development of an ISR with multivariate logistic regression. During a median follow-up time of 33.4 months (interquartile range 15.3–53.7) an ISR of ≥70% was detected in 12 (6.1%) of 215 arteries (mean age of 68.1 ± 9.8 years, 71.6% male). The combined stroke and death rate during long-term follow-up was significantly higher in the group with an ISR [odds ratio (OR): 3.59, 95% confidence interval (CI): 1.50–8.59, p = 0.004]. After applying multivariate logistic regression analysis contralateral carotid occlusion (OR 10.11, 95% CI 2.06–49.63, p = 0.004), carotid endarterectomy (CEA) restenosis (OR 8.87, 95% CI 1.68–46.84, p = 0.010) and postprocedural carotid duplex ultrasound with a PSV ≥120 cm/s (OR 6.33, 95% CI 1.27–31.44, p = 0.024) were independent predictors of ISR. ISR after CAS during long-term follow-up is associated with a higher proportion of clinical complications. A close follow-up is suggested especially in those patients with the aforementioned independent predictors of an ISR. Against the background of a lacking established treatment of ISR, these findings should be taken into account when offering CAS as a treatment alternative to CEA.

Carotid stent fracture and restenosis management

We report an unusual case of asymptomatic accelerated right carotid artery in-stent restenosis in a patient referred for revascularization of a de novo stenosis of her left internal carotid artery.

Results of cutting balloon angioplasty for carotid artery in-stent restenosis in six patients: description of the technique, long-term outcomes, and review of the literature

Background/purposeThe optimal management of carotid artery in-stent restenosis is not well described. Reported here is experience with cutting balloon angioplasty in six patients with long-term follow-up.MethodsA single-operator, prospective, elective, carotid...

034 Results of cutting balloon angioplasty for carotid artery instent restenosis in six patients: description of the technique and long term outcomes

Background/Purpose: The optimal management of carotid artery in-stent restenosis is not well described. Reported here is experience with cutting balloon angioplasty in six patients with …

3D-conformal radiotherapy for prevention of carotid recurrent in-stent restenosis: Initial experience

To investigate 3D-conformal external beam radiotherapy for prevention of recurrent instent restenosis after carotid artery angioplasty. Between Oct 2000 and Sep 2001 five patients with recurrent carotid artery in-stent restenosis of more than 50% lumen loss diagnosed with duplex sonography were enrolled. After successful revascularization, radiotherapy treatment planning was performed, which was based on the angioplasty protocol and all images documenting the intervention. A single dose of 5 Gy was prescribed to the 100% isodose. The treatment started on day one after angioplasty. In total, 4 fractions were given within 3 days. All patients tolerated the treatment well. No acute radiotherapy associated side effects were observed. Two patients developed recurrence within four months after therapy. In both cases, late total occlusion of the stent was noticed. One patient died and one developed a severe stroke. The other three patients remained asymptomatic with evidence of less than 50% restenosis. 3D-conformal radiotherapy is a feasible treatment option for highly selected patients with carotid artery in-stent restenosis. These preliminary results from a very small group of patients do show some potential for radiotherapy to prevent restenosis. However, due to the risk of late stent thrombosis, radiotherapy for the prevention of recurrent carotid artery in-stent restenosis is not recommended.

Operative management of carotid artery in-stent restenosis: First experiences and duplex follow-up

Objectives: Carotid Artery Stenting (CAS) may be comparable to Carotid Endarterectomy (CEA) as a durable and effective procedure in stroke prevention. Concern remains about the incidence of restenosis after stenting and its management. We evaluated the surgical managment of restenosis after CAS. Design: prospective study. Methods: between December 1997 and April 2001, 217 CAS procedures were performed in 217 patients (155 men and 62 women; age 70 years ± 8.2). After a mean of 8 months post-stenting four patients (two symptomatic, two asymptomatic with contralateral occlusion) with severe haemodynamic in-stent restenosis (90-99%) had surgical reintervention. Results: standard CEA with removal of the stent was performed in all four patients. No major complications occurred. Intima hyperplasia showed to be the predominant mechanism leading to in-stent restenosis. All four surgically treated patients remained asymptomatic and without recurrent restenosis over a mean follow-up time of 13 months (range 3-20 months). Conclusion: the optimal treatment of in-stent restenosis has yet to be defined, but standard CEA with removement of the stent appears to be feasible.Eur J Vasc Endovasc Surg 26, 137-140 (2003)