Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients' Population.

Background: The long-term efficacy and safety of bioresorbable vascular scaffolds (BVS) in real world clinical practice including Magmaris need to be elucidated to better understand performance of this new and evolutive technology. The aim of this study was to evaluate long-term performance of Magmaris, drug-eluting bioresorbable metallic scaffold, in all-comers patients' population. Methods: We included in this prospective registry first 54 patients (54 ± 11 years; male 46) treated with Magmaris, with at least 30 months of follow-up. Diabetes mellitus and acute coronary syndrome were present in 33 (61%) and 30 (56%) of the patients, respectively. Patients were followed for device- and patient-oriented cardiac events during a median follow-up of 47 months (DOCE-cardiac death, target vessel myocardial infarction, and target lesion revascularization; POCE-all cause death, any myocardial infarction, any revascularization). Results: Event-free survivals for DOCE and POCE were 86.8% and 79.2%, respectively. The rate of DOCE was 7/54 (13%), including in total target vessel myocardial infarction in two patients (4%), target lesion revascularization in six patients (11%), and no cardiac deaths. The rate of POCE was 11/54 (21%), including in total any myocardial infarctions in 3 patients (6%), any revascularization in 11 patients (20%), and no deaths. Definite Magmaris thrombosis occurred in two patients (3.7%), and in-scaffold restenosis developed in five patients (9.3%). Variables associated with DOCE were implantation of ≥2 Magmaris BVS (HR: 5.4; 95%CI: 1.21-24.456; p = 0.027) and total length of Magmaris BVS ≥ 40 mm (HR: 6.4; 95%CI: 1.419-28.855; p = 0.016), whereas previous PCI was the only independent predictor of POCE (HR: 7.4; 95%CI: 2.216-24.613; p = 0.001). Conclusions: The results of the long-term clinical outcome following Magmaris implantation in patients with complex clinical and angiographic features were acceptable and promising. Patients with multi-BVS and longer multi-BVS in lesion implantation were associated with worse clinical outcome.

Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial.

AIMS: The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. METHODS AND RESULTS: COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001). CONCLUSIONS: Among DM patients with ≥1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients.

A case of mild-to-intermediate left-main lesion with high-risk plaque features: "Blindness of physiology" for PCI guidance?

In patients presenting with acute coronary syndrome without ST elevation, both FFR and OCT imaging may be necessary to adequately interrogate patients with intermediate and ambiguous left-main coronary stenosis.

The role of optical coherence tomography guidance in scaffold versus stent optimization.

BACKGROUND: Optical coherence tomography showed a great ability to identify adverse features during percutaneous coronary intervention with drug-eluting stents and resulted in better clinical outcomes. The study aimed to assess the impact of optical coherence tomography on intraoperative decision-making during implantation of Absorb bioresorbable scaffolds versus everolimus drug-eluting stents. RESULTS: We performed an observational study that included 223 consecutive patients post optical coherence tomography-guided implantation of either Absorb bioresorbable scaffolds (162 patients) or everolimus drug-eluting stents (61 patients). We studied the influence of optical coherence tomography on intraoperative decision-making during implantation of bioresorbable scaffolds versus drug-eluting stents by analyzing the total rate of optical coherence tomography-dependent modifications in each device. After satisfactory angiographic results, the total rate of required intervention for optical coherence tomography detected complications was significantly higher in the bioresorbable scaffolds arm compared to drug-eluting stents arm (47.8% versus 32.9%, respectively; p = 0.019). The additional modifications encompassed further optimization in the case of device underexpansion or struts malapposition, and even stenting in the case of strut fractures, or significant edge dissection. CONCLUSIONS: Compared to drug-eluting stents, Absord scaffold was associated with a significantly higher rate of optical coherence tomography-identified intraprocedural complications necessitating further modifications. The study provides some hints on the reasons of scaffolds failure in current PCI practice; it offers a new insight for the enhancement of BRS safety and presents and adds to the growing literature for successful BRS utilization.

Cellular and molecular approaches to enhance myocardial recovery after myocardial infarction.

Reperfusion therapy has resulted in significant improvement in post-myocardial infarction morbidity and mortality in over the last 4 decades. Nonetheless, it is well recognized that simply restoring patency of the epicardial artery may not stop or reverse damage at microvascular level, and myocardial salvage is often suboptimal. Numerous efforts have been undertaken to elucidate the mechanisms underlying extensive myonecrosis to facilitate the discovery of therapies to provide additional and incremental benefits over current therapeutic pathways. To date, conclusively effective strategies to promote myocardial recovery have not yet been established. Novel approaches are investigating the foundational cellular and molecular bases of myocardial ischemia and irreversible injury. Herein, we review the emerging concepts and proposed therapies that may improve myocardial protection and reduce infarct size. We examine the preclinical and clinical evidence for reduced infarct size with these strategies, including anti-inflammatory agents, intracellular ion channel modulators, agents affecting the reperfusion injury salvage kinase (RISK) and nitric oxide signaling pathways, modulators of mitochondrial function, anti-apoptotic agents, and stem cell and gene therapy. We review the potential reasons of failures to date and the potential for new strategies to further promote myocardial recovery and improve prognosis.

Implantation of bioresorbable vascular scaffold for the treatment of pudendal artery stenosis and erectile dysfunction.

Bioresorbable vascular scaffolds (BVS) have been designed to overcome long-term limitations of metallic drug-eluting stents including permanent metallic "caging" that might trigger late coronary adverse events. Here, we report for the first time a case of 72-year gentleman with previous coronary artery disease, treated by successful implantation of BVS (Absorb, Abbott Vascular) due to significant stenosis of internal pudenda artery and erectile dysfunction. After 2 years, BVS completely resorbed and there were no signs of pudendal artery restenosis on CT scan, whereas blood flow and sexual function improved.

Long-term outcome of first 300 implanted Absorb bioresorbable vascular scaffolds in an all-comers Middle East population.

OBJECTIVES: To evaluate long-term clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) system (Abbott Vascular) in an all-comers Middle East population. METHODS: This prospective registry study included an initial set of patients with coronary lesions treated using Absorb BVS. Patients were followed for target vessel failure (TVF) including cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization. RESULTS: A total of 217 patients (age, 55 ± 11 years; male, 169) with 300 treated lesions were included (median follow-up, 36 months [range, 26-41 months]; complete follow-up, 201 patients). Diabetes mellitus and acute coronary syndrome were present in 50% and 57% of patients, respectively. TVF rate was 32/201 (15.9%), including cardiac death in 10 (5%), target vessel MI in 13 (6.5%), and target lesion revascularization in 22 patients (10.9%). Definite or probable device thrombosis occurred in 11/201 patients (5.5%). TVF was associated with heart failure, worse ejection fraction, multi-vessel BVS, multi BVS in lesion, and total BVS length >50 mm. CONCLUSIONS: Long-term outcome following Absorb BVS implantation in a population with high prevalence of high-risk and complex patients is acceptable, but heart failure, worse ejection fraction, and multi-vessel or long BVS implantation were associated with worse outcomes.

Rotate-on-Retract Procedural Automation for Robotic-Assisted Percutaneous Coronary Intervention: First Clinical Experience.

The advent of percutaneous coronary intervention (PCI) has dramatically changed the outlook for patients with cardiovascular disease. However, room for improvement and advancement remains in the safety, speed, and efficiency of manually guided PCI. In recent years, the CorPath robotic platform (Corindus Inc., Waltham, MA) has been approved to aid the interventionalist during PCI and other endovascular interventions. Favorable results in several clinical studies suggest that robotic-assisted PCI may further improve patient outcomes while also benefiting the interventionalist through reduced orthopedic strain and less exposure to ionizing radiation. In this report, we communicate our experience with the first-in-human use of a new, optional automation feature that has been added to the platform's guidance software. This "Rotate-on-Retract" feature is designed to facilitate faster and more precise maneuvering of the guidewire through tortuous vessels by automatically rotating the guidewire whenever it is retracted by the operator. This movement changes the tip's orientation in preparation for the next advancement. We evaluated this feature in a patient undergoing PCI to treat a severe (90% stenotic), long, diffuse, and calcified lesion of the proximal to mid LAD segments.

Skirt followed by trouser stenting technique: True anatomical preservation of coronary Y-shaped bifurcation lesions while using "vanishing" bioresorbable scaffolds: A report of two cases.

We report on two cases in which Y-shaped coronary bifurcations were treated with the use of Bioresorbable scaffolds. The first case was of a 50-year-old man with NSTEMI. Coronary angiography showed stenosis involving a Y-shaped bifurcation of proximal to mid LAD and diagonal. The lesion was wired using two 0.14 BMW guide wires, followed by serial pre-dilatation of LAD and Diagonal branch. The stent into proximal LAD was deployed first as a skirt (3.5 × 12 BVS). Stent was post-dilated. A second 2.5 × 28 BVS was deployed into diagonal branch, protruding backwards; along with a 2.0 × 15 SC balloon continuing into the mid LAD. Both balloons where pulled back proximally and re-inflated. The technique was repeated in reversed order for stenting the mid LAD using the third BVS (3.0 × 18 BVS). Finally two NC balloons where used to post-dilate both legs of the newly-formed trouser. The result was checked by OCT. The second case was that of a 62-year-old man with chest pain and NSTEMI. He had a history of previous PCI to LCx using bare metal stent. Coronary angiogram showed severe in-stent restenosis in mid LCX, extending into two large obtuse marginal branches. After wiring both OMs, serial pre-dilatation was done with two NC 2.5 × 20 balloons, followed by initial stenting of mid LCx inside old stent, as the proximal segment of bifurcation, using a 3.5 × 12 BVS, followed by implanting a 2.5 × 28 BVS into OM2 and 2.5 × 18 into OM1. At 6 months a clinical follow up via telephone contact revealed no recurrence of chest pain in both cases and no further intervention required.

A case of dilated cardiomyopathy and severe mitral regurgitation treated using a combined percutaneous approach of MitraClip followed by CARILLON® mitral contour system.

Functional mitral regurgitation (FMR) is common in severe heart failure. Medical therapy is the standard of care since the role of surgery is less established. Various trans-catheter percutaneous techniques may avoid the risks of surgery; such as edge-to-edge repair using MitraClip system (Abbott Vascular, Illinois, USA) and CARILLON® Mitral Contour System® (Model XE2; Cardiac Dimensions., Kirkland, WA, USA). We present the case of a 41-year-old man with severe dilated cardiomyopathy, NYHA IIIb, and grade 3 MR. Due to high surgical risk (logistic EuroScore 35.1) he initially underwent single MitraClip insertion with significant echocardiographic and clinical improvement (MR reduced from 3+ to 1+, NYHA classes III to II). Fifteen months later, he developed heart failure symptoms due to recurrence of severe MR and was retreated with percutaneous CARILLON® Mitral Contour System® with resolution of MR and doing well at nine-month follow-up. A combined approach of MitraClip followed by percutaneous mitral annuloplasty demonstrated clinically meaningful reduction of MR and resulted in significant symptomatic improvement for up to 6months. Follow-up for longer period is warranted to ensure sustained favorable outcome.

Transcarotid Transcatheter Aortic Valve Replacement: Feasibility and Safety.

OBJECTIVES: The purpose of this study was to assess the feasibility and safety of transcarotid transcatheter aortic valve replacement (TAVR). BACKGROUND: Many candidates for TAVR have challenging vascular anatomy that precludes transfemoral access. Transcarotid arterial access may be an option for such patients. METHODS: The French Transcarotid TAVR Registry is a voluntary database that prospectively collected patient demographics, procedural characteristics, and clinical outcomes among patients undergoing transcarotid TAVR. Outcomes are reported according to the updated Valve Academic Research Consortium criteria. RESULTS: Among 96 patients undergoing transcarotid TAVR at 3 French sites (2009 to 2013), the mean age and Society of Thoracic Surgeons predicted risk of mortality were 79.4 ± 9.2 years and 7.1 ± 4.1%, respectively. Successful carotid artery access was achieved in all patients. The Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota) (n = 89; 92.7%) and Edwards SAPIEN valves (Edwards Lifesciences, Irvine, California) (n = 7; 7.3%) were used. Procedural complications included: valve embolization (3.1%), requirement for a second valve (3.1%), and tamponade (4.2%). There were no major bleeds or major vascular complications related to the access site. There were 3 (3.1%) procedural deaths and 6 (6.3%) deaths at 30 days. The 1-year mortality rate was 16.7%. There were 3 (3.1%) cases of Valve Academic Research Consortium-defined in-hospital stroke (n = 0) or transient ischemic attack (TIA) (n = 3). None of these patients achieved the criteria for stroke and none manifested new ischemic lesions on cerebral computed tomography or magnetic resonance imaging. At 30 days, a further 3 TIAs were observed, giving an overall stroke/TIA rate of 6.3%. CONCLUSIONS: Transcarotid vascular access for TAVR is feasible and is associated with encouraging short- and medium-term clinical outcomes. Prospective studies are required to ascertain if transcarotid TAVR yields equivalent results to other nonfemoral vascular access routes.

Left atrial appendage occlusion device-related thrombus: a case report and review of the literature.

A 75-year-old male with persistent atrial fibrillation underwent implantation of a left atrial occlusion device. After 6 weeks, a scheduled trans-esophageal echocardiogram showed a 1.1-cm × 1.1-cm mass within the occluded left atrial appendage, suspected to be thrombus. He was continued on warfarin for an additional 6 weeks and a repeat trans-esophageal echocardiogram showed obliteration of the left atrial appendage. This report describes an uncommon observation detected at scheduled follow up by trans-esophageal echocardiogram, which sheds some light on the mechanism by which this device "matures" after it is implanted inside the left atrial appendage.

Acute coronary syndrome. An acute inflammatory syndrome.

Atherosclerosis begins with the accumulation of small lipoprotein particles within arterial intima. These particles coalesce together and are modified and then they induce localized endothelial inflammation, thereby attracting leukocytes. Scavenger receptors over the surface of monocytes bind to the modified low density lipoprotein particles, which transform into foam cells that become a source for further inflammatory cytokines. The level of inflammation is heightened in ruptured coronary plaques. In patients dying of an acute myocardial infarction, the level of inflammation is heightened in all lesions in the coronary tree. The inflammatory reaction in acute coronary syndrome is not confined to cellular immunity, but also encompasses humoral immunity. High sensitivity CRP hs-CRP measures systemic inflammation, and at low levels it has emerged as a strong predictor of adverse cardiovascular events. It is mainly used to further stratify the intermediate-risk patients. Many other molecules have shown promise as markers for increased inflammation and increased risk of adverse cardiac events. That risk may be additive in nature, and some studies suggest that inflammatory markers can also predict response to various treatment strategies during acute coronary syndromes.