Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis.

Background: Single-cohort studies suggest that second-generation stents (SGS; "mesh stents") may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a "mesh stent" class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials.

Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial).

BACKGROUND: Prolonged dual-antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention can be challenging. We assessed the clinical safety of bare-metal stent (BMS) implantation followed by drug-coated balloon (DCB) treatment in HBR patients for whom drug-eluting stent implantation could be problematic in maintaining low ischemic event rate without increasing hemorrhagic events. METHODS: The study included patients with at least 1 de novo lesion who were either under long-term anticoagulant treatment or required semi-urgent non-coronary intervention. The strategy consisted of PRO-Kinetic Energy BMS stent (Biotronik AG) implantation followed by Pantera Lux DCB (Biotronik AG) and patients were followed for up to 12 months in 37 French centers. RESULTS: Between October 2013 and April 2015, a total of 432 patients with 623 de novo lesions who were either under long-term anticoagulant treatment (n = 300) or required semi-urgent non-cardiac surgery (n = 132) were treated by BMS plus DCB. Mean patient age was 74.1 ± 9.1 years, 76.4% were men, and 38% were diabetic. The composite primary endpoint rate (defined as target-lesion failure at 12 months) was 5.6% (95% confidence interval, 3.3-7.9). Median duration for DAPT treatment was 33 days. Hemorrhagic events, as defined by the Bleeding Academic Research Consortium, occurred in 31 patients (7.2%) and definite stent thrombosis occurred in 5 patients (1.3%). CONCLUSIONS: The combination of BMS plus DCB intervention is safe even with a short duration of DAPT. This strategy might be an alternative to DES implantation in HBR patients if future randomized trials support this approach.

Minimizing the risk of contrast-induced nephropathy and hemodynamic collapse during chronic total occlusion percutaneous coronary intervention with a percutaneous left ventricular assist device.

Candidates for percutaneous coronary revascularization are becoming progressively older and more complex. A combination of factors related to the patient, lesion, and/or hemodynamic conditions may increase the risk of adverse events. Therefore, when a high-risk procedure is identified, it is crucial to provide the patient with adequate support in order to safely perform percutaneous coronary intervention (PCI). We report the case of a 77-year-old man with moderate left ventricular dysfunction and stage IV chronic kidney disease who underwent successful recanalization of a chronically occluded left anterior descending artery. The procedure was performed with a micro-axial percutaneous left ventricular assist device (Impella 2.5) in order to provide stable hemodynamics, and with minimal contrast medium administration (14 ml) to minimize the risk of acute kidney injury. Despite the use of aggressive techniques (including rotational atherectomy), the patients remained stable throughout the procedure and did not experience contrast-induced nephropathy or periprocedural myocardial infarction, and was discharged two days later. Moreover, we provide recommendations to assist interventional cardiologist safely perform complex and high-risk PCI, with particular attention to renal function preservation.

Retinal embolization during carotid angioplasty and stenting: mechanisms and role of cerebral protection systems.

Carotid stenting has become an accepted alternative to endarterectomy, but fear of embolic stroke has impeded its generalized application. The retina provides a unique observatory for the study of emboli, which may occur either directly or indirectly via collaterals to the ophthalmic artery. Systems under development for cerebral protection differ in their capacity to trap small emboli and in their protection of the collateral circulation. We evaluated 118 sequential patients undergoing carotid stenting using fundoscopy, fluorescein retinal angiography, and visual field examination. The site and size of emboli was assessed, and degree of edema estimated. All patients were treated using distal protection during carotid stent implantation: 38 patients with the Théron system (using routine flushing toward the external carotid) and 80 patients with the Percusurge system (aspiration only). Retinal embolization occurred in 6 of the 118 patients (4%), of whom 2 were symptomatic (1.7%). Using the Théron system, 5 of 38 patients (13.2%) had emboli while 1 of 80 (1.25%) had emboli using the Percusurge system (P = 0.019). Symptoms occurred only with emboli >20 microm. Symptomatic retinal embolization is uncommon during carotid stenting, but is more likely when external to internal carotid collaterals are not protected. Cerebral protection system designs should take into consideration the existence of collaterals and the need to protect against smaller sized emboli, which may cause blindness in the retinal circulation.

Endovascular treatment of the subclavian artery: stent implantation with or without predilatation.

The endovascular treatment of subclavian artery (SA) lesions is less invasive than open surgical repair, with a low rate of complications. We report our experience in 89 subclavian obstructive lesions (n = 86) treated with stenting: 76 (85.3%) stenoses and 13 (14.6%) total occlusions. The left side was most frequently involved (83.1%), localized at the prevertebral segment in 91%. Technical success was obtained in 83 (93.3%) cases, 100% in stenotic lesions and 53.8% in total occlusions. There were nine global complications (10.1%): five (5.6%) at site of puncture, two distal embolization (2.2%), and two (2.3%) major events. The long-term follow-up was 3.51 +/- 1.98 years, during which time 13 (16.8%) restenoses and 2 (2.6%) reocclusions were noted. Subgroup analysis of patients with stenting after predilatation versus direct stenting technique showed in-hospital complications only in the first group, with a restenosis rate of 28.5% vs. 4.7%, respectively (P = 0.003). We consider stenting for SA obstructive lesions the first therapeutic option.

Nature and significance of endoleaks and endotension: summary of opinions expressed at an international conference.

OBJECTIVE: Endoleaks and endotension are critically important complications of some endovascular aortic aneurysm repairs (EVARs). For the resolution of controversial issues and the determination of areas of uncertainty relating to these complications, a conference of 27 interested leaders was held on November 20, 2000. METHODS: These 27 participants (21 vascular surgeons, five interventional radiologists, one cardiologist) had previously answered 40 key questions on endoleaks and endotension. At the conference, these 40 questions and participant answers were discussed and in some cases modified to determine points of agreement (consensus), near consensus (prevailing opinion), or disagreement. RESULTS: Conference discussion added two modified questions for a total of 42 key questions for the participants. Interestingly, consensus was reached on the answers to 24 of 42 or 57% of the questions, and near consensus was reached on 14 of 42 or 33% of the questions. Only with the answers to four of 42 or 10% of the questions was there persistent controversy or disagreement. CONCLUSION: The current endoleak classification system with some important modifications is adequate. Types I and II endoleak occur after 0 to 10% and 10% to 25% of EVARs, respectively. Many (30% to 100%) type II endoleaks will seal and have no detrimental effect, which never or rarely occurs with type I endoleaks. Not all endoleaks can be visualized with any technique, and increased pressure (endotension) can be transmitted through clot. Aneurysm pulsatility after EVAR correlates poorly with endoleaks and endotension. An enlarging aneurysm after EVAR mandates surgical or interventional treatment. These and other conclusions will help to resolve controversy and aid in the management of these vexing complications and should also point the way to future research in this field.