The DESolve® novolimus bioresorbable scaffold

A longtime aspiration of interventional cardiologists remains to improve the long-term impact of stent permanence in coronaries to restore original vessel patency and physiological endothelium response. Bioresorbable vascular scaffolds were considered revolutionary in coronary devices, but several trials were disappointing; thus, the challenge in this field remains. DESolve is a novolimus-eluting poly-L lactide-based polymer scaffold that dissolves through a bio-reabsorption mechanism, vanishing completely in 2 years. Its ability to supply the necessary radial strength to support the vessel for the critical early months after delivery is an important feature showing a unique self-correction property, which reduces incomplete stent apposition. Overexpansion has a good, safe margin with DESolve. This review aims to provide an overview of this controversial topic.

The Enterprise2 Stent for Endovascular Treatment of Intracranial Aneurysms: Short-Term Results From a Single Center Experience

Background: Self-expanding devices, such as the Enterprise VRD (EP-VRD) have widely used for stent-assisted coiling treatment in wided-necked aneuryms while some thromboembolic complications were reported due to its incomplete stent apposition (ISA). We report our experiences on the novel Enterprise2 (EP-VRD2) stent in vivo in the treatment of intracranial and cranial cervical junction aneurysms.Methods: Twenty-five consecutive patients with intracranial or cranial cervical junction aneurysms were treated with EP-VRD2 stents retrospectively collected in our institution. We use the ‘jailing' technique in all cases and deployed the stent by using pushing over the outer curve technique. The 3- or 6-monthS follow-up was done regularly by DSA.Results: Twenty-five EP-VRD2 stents were implanted to treat 21 aneurysms at the siphon segment of internal carotid artery (ICA), one at the petrous segment, two at the cervical segment, one at the verteral artery with five accompanied with stenosis. Two patients had kinking during the procedure and were solved by microwire or microcatheter massaging. Four patients with a larger arc angle and a smaller radius of the parent vessel was detected ISA. No patient underwent the ischemic event after the operation. Twenty-three of 25 patients were evaluated after 3- or 6-months by DSA, 22 showed complete occlusion (RROC1), one slight re-stenosis in the follow-up within those five patients with stenosis. A length of 23 mm seemed associated with ISA (p < 0.01).Conclusion: The EP-VRD2 performed well in our small patient series; however, ISA could still occur with a sharp angle of the parent vessel.

A Randomized Trial Evaluating Online 3-Dimensional Optical Frequency Domain Imaging–Guided Percutaneous Coronary Intervention in Bifurcation Lesions

Background: Clinical implications of online 3-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting for bifurcation lesions have not been investigated in the randomized controlled trials. The purpose of this study was to determine whether online 3D-OFDI-guided stenting is superior to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition at the bifurcation segment. Methods: The OPTIMUM trial (Online 3-Dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent) was a randomized, multicenter clinical trial. Eligible patients had an angiographically significant stenosis in the bifurcation lesion treated with a provisional single stent strategy using the Ultimaster sirolimus eluting stent. Patients were randomly allocated to either online 3D-OFDI-guided or angiography-guided PCI. Patients randomized to 3D-OFDI guidance underwent online 3D-OFDI assessment after rewiring into the jailed side branch after stenting and proximal optimization technique, while in the angiography guidance arm, rewiring was performed using conventional fluoroscopic/angiographic guidance. The primary end point of this trial was the postprocedural average percentage of malapposed struts per lesion assessed by OFDI in the confluence zone of the main and side branches. Results: Between June 8, 2017 and September 26, 2018, 110 patients with 111 bifurcation lesions were randomized at 4 Japanese centers. Of these, 56 patients with 57 lesions were treated with 3D-OFDI-guided PCI, whereas 54 patients with 54 lesions were treated with angiography-guided PCI. In the 3D-OFDI guidance arm, the feasibility of online 3D-OFDI was 98.2%. The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, P =0.008). The superiority of the 3D-OFDI guidance arm was also confirmed in the strut level analysis (odds ratio: 0.54 [95% CI, 0.36–0.81]; P =0.003). Conclusions: Online 3D-OFDI-guided bifurcation PCI was superior to angiography-guided bifurcation PCI in terms of acute incomplete stent apposition at bifurcation. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02972489.

Incomplete stent apposition of low-profile visualized intraluminal support stents in the treatment of cerebral aneurysms

ObjectiveThis study retrospectively analyzed the risk factors, management strategies, and complications of incomplete stent apposition (ISA) of low-profile visualized intraluminal support (LVIS) stents after initial deployment in the treatment of cerebral aneurysms.MethodsThe clinical characteristics of ISA or wall apposition (WA) of LVIS stent after initial deployment were analyzed. The risk factors of ISA were identified using univariate logistic regression analysis and multivariate logistic regression analysis. The clinical characteristics of ISA following different management strategies were also shown.ResultsThe retrospective study enrolled 303 patients with 315 LVIS stent-assisted aneurysms. Fifty-nine patients with 59 stents showed ISA after initial deployment. At the end of the study, the presence of ISA was only observed in eight patients (2.5%). The stent-subtended arc angle (>90) and the aneurysm of the internal carotid artery (ICA) were associated with ISA. The stent-subtended arc angle (>90) and stent size (4.5*20 mm) were independent risk factors of ISA. The incidence of thromboembolic events in the ISA group was significantly higher than that in the WA group. After the treatment of ISA, there was no significant difference in good outcomes between patients with ISA and those with WA after initial deployment.ConclusionsISA is more likely to occur at tortuous vessels. The stent-subtended arc angle (>90) and LVIS size (4.5*20 mm) were independent risk factors of ISA. ISA led to significantly increased incidence of thromboembolic events. However, ISA after initial deployment did not affect the patient's prognosis.

P5628Resolution of incomplete stent apposition in the early phase after stent implantation: serial optical coherence tomography analyses at 2-week and 4-month

Background Previous optical coherence tomography (OCT) study demonstrated that the incomplete stent apposition (ISA) distance <355 μm immediately after an index procedure was the corresponding cut-off point for predicting the resolution of ISA at 8–12 months follow-up in the second-generation DES. However, the natural course of acute ISA in the earlier phase remains unknown. The aim of the present study is to evaluate the natural course of acute ISA in the early phase after second-generation everolimus-eluting stent (EES) using serial OCT analyses at 2-week and 4-month. Methods From the population of the ACS-OCT trial, we identified a total of 45 patients who successfully underwent serial OCT examinations at post-stenting, 2-week follow-up, and 4-month follow-up. The presence of ISA was assessed in the OCT images, and ISA distance was measured within the stented segment. The target site for OCT analysis was the cross-section at the proximal edge of implanted stent. Serial OCT images at post-stenting, 2-week follow-up and 4-month follow-up were reviewed side by side on the screen, and maximum ISA distance and cross-sectional ISA area were measured. Results Incomplete stent apposition was observed in all EES at post-stenting, and it was persistent in 37.8% at 2-week follow-up and 11.1% at 4-month follow-up. Maximum ISA distance was significantly decreased over time (post-stenting, 144±150mm; 2-week follow-up, 88±146mm; 4-month follow-up, 34±111mm). Receiver-operating curve analysis identified that the best cut-off value of OCT-estimated ISA distance at post-stenting for predicting persistent ISA at 2-week follow-up and 4-month follow-up was >140μm and >215μm, respectively. ROC curve analysis Conclusion ISA distance at post-stenting is an useful predictor for the resolution of ISA in the early phase after EES implantation.