Bruno Francaviglia

Anatomical features and management of bioresorbable vascular scaffolds failure: A case series from the GHOST registry

The Absorb bioresorbable vascular scaffold (Absorb BVS, Abbott Vascular, Santa Clara, California) promises to address some of the residual shortcomings of existing metallic stents, such as late events induced by permanent caging of the coronary vessel. Scaffold restenosis (ScR) of BVS has been poorly described so far and treatment strategies for this event remain to be codified. We report on a case series of 14 lesions in 12 patients presenting with ScR and discuss their anatomical features and management strategies.

New insights on acute expansion and longitudinal elongation of bioresorbable vascular scaffolds in vivo and at bench test: A note of caution on reliance to compliance charts and nominal length

We performed systematic optical coherence tomography (OCT) analyses after bioresorbable vascular scaffolds (BVS) implantation in a “real world” setting aiming at evaluating scaffold expansion and longitudinal integrity.

Usefulness of the logistic clinical SYNTAX score for predicting 1-year mortality in patients undergoing percutaneous coronary intervention of the left main coronary artery

To externally validate the logistic clinical SYNTAX in patients undergoing percutaneous coronary intervention (PCI) of the left main coronary artery (LMCA).

Impact of residual platelet reactivity on reperfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

Aim: Whether high platelet reactivity (HPR) immediately after diagnostic angiography is associated with worse coronary reperfusion prior to and after primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) is unknown. This study aimed to assess the impact of P2Y12-mediated HPR on angiographic outcomes in patients with STEMI undergoing PPCI. Methods: STEMI patients undergoing PPCI and pretreated with a P2Y12 receptor antagonist underwent platelet function testing with the VerifyNow™ assay at the time of angiography. Light transmission aggregometry (LTA) was performed in a subgroup. HPR was defined according to expert consensus definitions. Pre-PCI coronary patency, thrombotic burden and indices of impaired post-PCI reperfusion were compared between HPR and non-HPR patients. Results: Among 164 patients, the prevalence of VerifyNow™-derived HPR was 71.3% at a median (interquartile range (IQR)) of 55 (40–75) minutes after a P2Y12 inhibitor loading dose. Compared with non-HPR patients, those with HPR had significantly lower rates of pre-PCI Thrombolysis in Myocardial Infarction (TIMI) flow grades 2 or 3 (51.1% vs. 32.5%, p = 0.04), higher rates of thrombus score (TS) grade 3/4 (29.8% vs. 52.1%, p = 0.015) and 4 (14.9% vs. 32.5%, p = 0.037) and lower median (IQR) corrected TIMI frame count (cTFC; 23.2 (15.8–32.5) vs. 26.0 (21.0–35.0), p = 0.02), respectively. These findings were consistent using LTA-based data. HPR and TS grade 4 were predictors of higher cTFC. Conclusions: In patients with STEMI undergoing PPCI pretreated with P2Y12 receptor inhibitors, pre-PPCI HPR was found to be associated with lower pre-PCI coronary patency, higher thrombotic burden and a worse index of post-PCI coronary reperfusion.

Decision Analytic Markov Model Weighting Expected Benefits and Current Limitations of First-Generation Bioresorbable Vascular Scaffolds: Implications for Manufacturers and Next Device Iterations

Background— Relative benefits of bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents (EES) are expected to accrue after complete bioresorption. Methods and Results— We built a decision analytic Markov model comparing BVS and EES for a contemporary percutaneous coronary intervention population. Procedure-related morbidity and outcome data from the available literature were used to derive model probabilities. The net benefit of BVS and EES was estimated in terms of quality-adjusted life expectancy. Under the assumption of no risk for device thrombosis and target lesion revascularization with BVS beyond 3 years, the equipoise in quality-adjusted life expectancy (12.86) between BVS and EES was achieved 19 years after implantation. The maximum tolerable excess risk of 3-year BVS thrombosis equalizing the model-predicted quality-adjusted life expectancy of BVS and EES at 10 years was 1.40, corresponding to an absolute tolerable rate of 1.45%. Conclusions— At the currently observed relative increase in device thrombosis and under the extreme hypothesis of no scaffold thrombosis and target lesion revascularization beyond 3 years, the incremental benefit of BVS over EES becomes apparent only after 19 years. This simulation suggests that there is a small degree of benefit that clinicians and decision-makers may expect from the first-generation BVS at the current risk of device thrombosis. Manufacturers should target scaffold thrombosis rates <1.45% at 3 years to make their technologies attractive during a 10-year horizon.

Tecnica di impianto dello scaffold coronarico riassorbibile Absorb TM nel registro IT-DISAPPEARS

Currently, one of the most relevant innovations in interventional cardiology is the advent of bioresorbable vascular scaffolds (BVS). Among the BVS developed so far, the AbsorbTM BVS 1.1 (Abbott®) is one of the two devices that achieved the CE mark for the use in clinical practice. A reasonable amount of clinical evidence on AbsorbTM BVS has been built up from a large series of trials, of which some have been completed and others are in the enrollment and/or follow-up phases. However, at present there is paucity of data on the efficacy and safety of AbsorbTM BVS in patients with more complex coronary artery disease, who represent the majority of those undergoing coronary stenting in everyday clinical practice. To fill this gap, several all-comers registries are ongoing, with the aim to assess the efficacy and safety of the scaffold in subgroups with particularly complex coronary lesions. The AbsorbTM BVS 1.1 registries include IT-DISAPPEARS (NCT02004730), an Italian multicenter registry, started in December 2013, and endorsed by the Italian Society of Invasive Cardiology (GISE). This registry will enroll only patients with long lesions and/or multivessel coronary disease, with an expected considerable proportion of included patients having complex disease. Therefore, the implementation of meticulous and appropriate implantation technique is of key importance for the accurate assessment of scaffold performance in a broad spectrum of coronary lesions. With the aim of standardizing the procedure for patients included in the IT-DISAPPEARS registry, the present article reports the technical features of Absorb TM BVS 1.1 implantation.

Images in InterventionIs the Metallic Stent a Safe Treatment for Bioresorbable Scaffold Failure?: Insights From Optical Coherence Tomography

A 58-year-old diabetic man with unstable angina underwent implantation in overlapping of 3 (2.5/28, 2.5/28, and 3.0/28 mm) Absorb bioresorbable vascular scaffolds (BVS) (Abbott Vascular, Santa Clara, California) in a long and heavily fibrocalcified left anterior descending artery stenosis. Post-

Is the Metallic Stent a Safe Treatment for Bioresorbable Scaffold Failure?: Insights From Optical Coherence Tomography

A 58-year-old diabetic man with unstable angina underwent implantation in overlapping of 3 (2.5/28, 2.5/28, and 3.0/28 mm) Absorb bioresorbable vascular scaffolds (BVS) (Abbott Vascular, Santa Clara, California) in a long and heavily fibrocalcified left anterior descending artery stenosis. Post-

Update on clinical evidence (Part II): A summary of the main post market studies: Update on BVS Clinical Evidence (Part II)

Bioresorbable vascular scaffolds (BVS, Absorb, Abbott Vascular, Santa Clara, CA) received the CE mark in October 2011, and were approved by the Food and Drug Administration in July 2016. After their introduction in clinical practice a broad amount of post‐marketing clinical experience with BVS has been generated so far in Europe and outside the United States. The available BVS registries differ in many aspects, including their being single‐center or multicenter, single‐arm or controlled, sponsored or investigator‐initiated, published or presented at a large‐scale international meeting. This article provides an overview of clinical results of the main post‐marketing studies of BVS available.