Comparison of acute versus stable coronary syndrome in patients treated with the Magmaris scaffold: Two-year results from the Magmaris Multicenter Italian Registry.

BACKGROUND: The magnesium Magmaris scaffold is the latest resorbable technology with low thrombogenicity, short scaffolding time, and almost complete resorption at 12 months (95 %). As compared with stable coronary artery disease (SCAD), acute coronary syndrome (ACS) is associated with increased risk of adverse clinical outcome after percutaneous coronary intervention. We analyzed the data of the Magmaris Multicenter Italian Registry to compare clinical outcomes in SCAD versus ACS patients. METHODS: We evaluated the 24-month rates of target lesion failure (TLF) and scaffold thrombosis (ST). Device implantation procedures were performed according to the manufacturer's recommendations (proper patient/lesion selection, pre-dilatation, proper scaffold sizing, and post-dilatation). Dual antiplatelet therapy was terminated after 12 months. RESULTS: Data from 207 patients (145 SCAD and 62 ACS) were collected from July 2016 to June 2018. The 2-year follow-up compliance was 92.8 % (192 patients). At 2 years, TLF rates were 7.4 % in the SCAD group and 8.8 % in the ACS group (p = 0.7); ST rates were 0 % in the SCAD group and 1.8 % in the ACS group (p = 0.1). CONCLUSION: The 2-year clinical results from the Magmaris Multicenter Italian Registry are favorable in terms of TLF and ST, indicating the safety and effectiveness of the Magmaris scaffold in both SCAD and ACS patients.

Maternal immune activation impairs endocannabinoid signaling in the mesolimbic system of adolescent male offspring.

Prenatal infections can increase the risk of developing psychiatric disorders such as schizophrenia in the offspring, especially when combined with other postnatal insults. Here, we tested, in a rat model of prenatal immune challenge by the viral mimic polyriboinosinic-polyribocytidilic acid, whether maternal immune activation (MIA) affects the endocannabinoid system and endocannabinoid-mediated modulation of dopamine functions. Experiments were performed during adolescence to assess i) the behavioral endophenotype (locomotor activity, plus maze, prepulse inhibition of startle reflex); ii) the locomotor activity in response to Δ9-Tetrahydrocannabinol (THC) and iii) the properties of ventral tegmental area (VTA) dopamine neurons in vivo and their response to THC; iv) endocannabinoid-mediated synaptic plasticity in VTA dopamine neurons; v) the expression of cannabinoid receptors and enzymes involved in endocannabinoid synthesis and catabolism in mesolimbic structures and vi) MIA-induced neuroinflammatory scenario evaluated by measurements of levels of cytokine and neuroinflammation markers. We revealed that MIA offspring displayed an altered locomotor activity in response to THC, a higher bursting activity of VTA dopamine neurons and a lack of response to cumulative doses of THC. Consistently, MIA adolescence offspring showed an enhanced 2-arachidonoylglycerol-mediated synaptic plasticity and decreased monoacylglycerol lipase activity in mesolimbic structures. Moreover, they displayed a higher expression of cyclooxygenase 2 (COX-2) and ionized calcium-binding adaptor molecule 1 (IBA-1), associated with latent inflammation and persistent microglia activity. In conclusion, we unveiled neurobiological mechanisms whereby inflammation caused by MIA influences the proper development of endocannabinoid signaling that negatively impacts the dopamine system, eventually leading to psychotic-like symptoms in adulthood.

Left atrial appendage closure with the II generation Ultraseal device: An international registry. The LIGATE study.

OBJECTIVES: To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF). BACKGROUND: LAAC with first-generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with NVAF. However, there is a paucity of data regarding the novel second-generation Ultraseal device. METHODS: All patients with NVAF undergoing second-generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicenter international registry. Periprocedural and post-discharge events were collected through 6-month follow-up. Co-primary efficacy endpoints were device success and technical success while primary safety endpoint was in-hospital major adverse event (MAE) occurrence. RESULTS: A total of 52 patients were included: mean age 75 ± 8, 30.8% women, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 50 patients (96.1%). In-hospital MAEs occurred in three patients (5.8%). The incidence of 6-month all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischemic attacks, systemic embolisms, or device embolization were reported after discharge. CONCLUSIONS: Second-generation Ultraseal device implantation was associated with high success rates and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to further evaluate the safety and the efficacy of this device, especially at long-term follow-up.

Sustained Safety and Efficacy of Magnesium Reabsorbable Scaffold: 2-Year Follow-Up Analysis From First Magmaris Multicenter Italian Registry.

BACKGROUND: Magnesium Reabsorbable Scaffold (MRS), is the newest reabsorbable technology with low thrombogenicity, short scaffolding time and almost complete resorption at 12-months (95%). Preliminary 12-months data in selected patients has shown that safety and efficacy are comparable with second generation Drug Eluting Stent (DES). Magmaris Multicenter registry showed 1-and 2-years clinical outcome on the first patients suitable for MRS enrolled in 4 Italian centers. METHODS: We evaluated 12- and 24-months clinical results in "real world" experience with Magnesium Reabosrbable Scaffold in terms of Target Lesion Failure (TLF) and scaffold thrombosis (ST). TLF is the primary endpoint and was defined as composite of cardiac mortality, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). 4P's strategy (Patient/lesion selection, Pre-dilatation, Proper scaffold sizing and Post-dilatation) was strongly recommended. Dual Antiplatelet Therapy (DAPT) has been recommended for 12 months. RESULTS: Data from 207 patients, including initial experience, have been collected. Patients were 83% male, 20% diabetic and Acute Coronary Syndrome (ACS) in 23%. Lesion type were A-B1 in 54% and B2C in 46%. 4P's strategy was respected in 94%. Procedural success was 98% (2% peri-procedural MI). Compliance at 12-months follow up was 97.6%, TLF rate was 5.4% (including 1 case of myocardial infarction with late scaffold thrombosis (ST), all patients were successfully treated with in-scaffold segment DES implantation). At 24-months compliance was 92.8% (192 patients) and TLF was 7.4%. In the period between 13 and 24 months only 4 patients had TLF (including 1 case of myocardial infarction, all patients were successfully treated with in-scaffold segment DES implantation). None of the patients died for a cardiac reason. CONCLUSION: Our 2-years results confirm safety and efficacy showed at 12-months, reinforcing long-term performance with only 2% rate of TLF increase and no ST after 1 year.

SICI-GISE Position Document on the Use of the Magmaris Resorbable Magnesium Scaffold in Clinical Practice.

Bioresorbable scaffolds have emerged as a potential breakthrough for the treatment of coronary artery lesions. The need for drug release and plaque scaffolding is temporary, and leaving a permanent stent once the process of plaque recoil and vessel healing has ended might be superfluous or even deleterious exposing the patient to the risk of very late thrombosis, eliminating vessel reactivity, impairing non-invasive imaging and precluding possible future surgical revascularization. This long-term potential limitation of permanent bare metal stents might be overcome by using a resorbable scaffold. The metallic and antithrombotic properties make the resorbable magnesium scaffold an appealing technology for the treatment of coronary artery lesions. Notwithstanding this, its mechanical properties substantially differ from those of conventional bare metal stents, and previous experience using polymer-based scaffolds has shown that a standardized implantation technique and optimal patient and lesion selection are key factors for a successful implantation. A panel of expert cardiologists gathered to find a consensus on the best practices for Magmaris implantation in a selected patient population and to discuss the rationale for new potential future indications.

Left atrial appendage closure device complicated by late-onset pericardial effusion and tamponade: a case report.

BACKGROUND: Late-onset complications of left atrial appendage occlusion (LAAO) device procedure are anecdotal and there are no such complications reported in literature using Cardia Ultraseal (Cardia, Inc., Eagan, MN, USA). CASE SUMMARY: We report the case of a 74-year-old Caucasian man affected by paroxysmal atrial fibrillation with significant bleeding risk (familiar thrombocytopenia, macroscopic haematuria episodes during therapy with direct oral anticoagulants, HAS-BLED risk score: 4) and ischaemic risk as well (CHADSVASC score: 3). The patient was treated with LAAO device implantation for high bleeding risk. Subsequently, after 26 days from LAAO procedure, he was admitted to the emergency department for haematic cardiac tamponade. The patient was successfully treated with subxyphoidal pericardiocentesis in the acute phase, unfortunately cardiac arrest occurred during the transfer to the referral hospital for urgent cardiac surgery. Permanent neurological damage was reported and the patient died on day 28. DISCUSSION: LAAO late-onset complications are very rare and the case presented is the first case described of late-onset pericardial effusion and tamponade secondary to the Cardia Ultraseal LAAO device implantation. We present a revision of the literature regarding the occurrence of similar adverse events and discuss the hypothetical mechanism of this major complication.

[SICI-GISE Position paper on the use of the magnesium bioresorbable scaffold Magmaris in clinical practice]. / Documento di posizione SICI-GISE sull'uso dello scaffold riassorbibile Magmaris nella pratica clinica.

Bioresorbable scaffolds have emerged as a potential breakthrough for the treatment of coronary artery lesions. The need for drug release and plaque scaffolding is temporary, and leaving a permanent stent once the process of plaque recoil and vessel healing has ended might be superfluous or even deleterious exposing the patient to the risk of very late thrombosis, eliminating vessel reactivity, impairing non-invasive imaging and precluding possible future surgical revascularization. This long-term potential limitation of permanent bare metal stents might be overcome by using a resorbable scaffold. The metallic and antithrombotic properties makes the resorbable magnesium scaffold an appealing technology for the treatment of coronary artery lesions. Notwithstanding this, its mechanical properties substantially differ from those of conventional bare metal stents, and previous experience using polymer-based scaffolds has shown that a standardized implantation technique and optimal patient and lesion selection are key factors for a successful implantation. A panel of expert cardiologists gathered to find a consensus on the best practices for Magmaris implantation in a selected patient population and to discuss the rationale for new potential future indications.

[Monocentric experience of left atrial appendage occlusion among patients with advanced chronic kidney disease and non-valvular atrial fibrillation].

Atrial fibrillation is the most common cardiac disorder among chronic nephropathic patients. Possible therapeutic approaches include the use of anticoagulants, which are able to reduce the risk of thromboembolism but lead to an increasing bleeding risk, especially in this cohort of patients. Also, novel oral anticoagulant agents (NAO), due to their mainly renal clearance, are a relative contraindication in advanced renal disease. As an alternative to the oral anticoagulant therapy, left atrial appendage occlusion seems a promising opportunity in high risk, difficult to manage patients. Since there is limited evidence of LAAO in advanced chronic renal disease or dialysis patients, we report here a monocenter experience on 12 patients (6 of which in regular dialytic treatment) with a median clinical follow-up of fourteen months (3-22 months).

Magnesium 2000 postmarket evaluation: Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold.

BACKGROUND: The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine. METHODS: This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients. RESULTS: From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months. CONCLUSION: Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice. SUMMARY FOR ANNOTATED TABLE OF CONTENT: The Magmaris 2000 program includes the first commercial cases at each hospital. Overall, data on 2018 implantations were collected. The high rate of pre- and post-dilatation as well as other parameters confirm that generally the implantation guidelines are adhered to and the good intraprocedural performance (rated as good or very good in 96%) confirm the theoretical advantages of a metallic scaffold in practice.

One-Year Results Following a Pre-Specified ABSORB Implantation Strategy in ST-Elevation Myocardial Infarction (BVS STEMI STRATEGY-IT Study).

BACKGROUND: data from clinical experiences with Absorb bioresorbable scaffold (BRS) in STEMI raised concerns among clinicians about the device safety because a noteworthy scaffold thrombosis (ScT) rate was reported at early and long-term follow-up. Nevertheless, pre-specified technical suggestions of how to perform an optimal BRS procedure in STEMI were lacking. In this study we sought to assess the 1-year results following a pre-specified BRS implantation strategy in ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI (pPCI). METHODS: This is a prospective, multicenter study on 505 STEMI patients undergoing pPCI with Absorb following a dedicated implantation protocol. The primary end-point (a device oriented composite end-point (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) within 30 days) was already reported. We here present DOCE, its singular components and ScT rates (secondary end-points) at 1-year. RESULTS: According to the study protocol direct Absorb implantation was feasible in 47 (9.3%) patients while post-dilatation was performed in 468 (92.7%) cases. The hierarchical DOCE rate at 1-year was 1.2% (0.4% cardiac death, 0.4% TV-MI and 0.8% ID-TLR) versus 0.6% at 30-day. Two episodes (0.4%) of ScT (one probable subacute and one late definite) were reported. At 1-year, 99.2% patients were on dual antiplatelet therapy (95% with ticagrelor or prasugrel). CONCLUSIONS: A pre-specified Absorb implantation strategy in STEMI patients was associated with persistent low DOCE and ScT rates at 1-year. Longer term follow-up is needed to assess the role of this strategy on preventing very-late events (NCT02601781).

One-year clinical performance of ABSORB bioresorbable vascular scaffold in patients presenting with acute coronary syndromes: Results from the RAI registry.

OBJECTIVES: To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. BACKGROUND: BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. METHODS: RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. RESULTS: Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). CONCLUSIONS: Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.

Percutaneous Left Atrial Appendage Closure With the Ultraseal Device: Insights From the Initial Multicenter Experience.

OBJECTIVES: This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk. BACKGROUND: The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy. METHODS: This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3. RESULTS: A total of 126 patients (mean age 75 ± 8 years; mean CHA2DS2-VASc score 5 ± 2; mean HAS-BLED score 4 ± 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartile range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis. CONCLUSIONS: In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very low incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembolic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device.

Left atrial appendage closure with the Ultraseal device: Initial experience and mid-term follow-up.

AIMS: Left atrial appendage (LAA) closure is considered an effective option in patients with non-valvular atrial fibrillation (NVAF) and contraindications to long-term oral anticoagulant (OAC) therapy. However, there are some concerns about safety of currently available devices. Our aim is to provide an initial assessment on feasibility and safety of the novel LAA closure Ultraseal device in patients with NVAF and contraindications to long-term OAC therapy. METHODS: Twenty-three consecutive patients with NVAF undergoing Ultraseal device implantation between July 2016 and February 2018 at two institutions were included. All patients performed transesophageal echocardiography and computed tomography angiography prior to LAA closure. RESULTS: Procedural success was achieved in all patients except two who experienced incorrect device deployment with incomplete LAA closure. Procedure duration halved from first to last procedure performed. The only periprocedural adverse events observed were a myocardial infarction and an in-hospital death due pneumonia. At mean follow-up (166 ± 80 days) all other patients were alive and free from major bleedings and ischaemic strokes. CONCLUSIONS: Our results suggest that the Ultraseal device is a feasible option for LAA occlusion. Notably, the learning curve in this registry was fast, paralleled by extremely low complication rates. These results should be considered hypothesis generating and larger studies are mandatory.

"Full-plastic jacket" with everolimus-eluting Absorb bioresorbable vascular scaffolds: Clinical outcomes in the multicenter prospective RAI registry (ClinicalTrials.gov Identifier: NCT02298413).

OBJECTIVES: The objective of this study was to investigate mid-term clinical outcomes of patients treated with 'full-plastic jacket' (FPJ) everolimus-eluting Absorb bioresorbable vascular scaffold (BRS) implantation. BACKGROUND: FPJ with BRS may represent an interesting option for patient with diffuse coronary artery disease (CAD), but data on the clinical impact of FPJ using the Absorb BRS are scant. METHODS: FPJ was defined as the implantation of >56 mm of overlapping BRS in at least one vessel. We compared outcomes of patients receiving Absorb FPJ vs. non-FPJ within the multicenter prospective RAI Registry. RESULTS: Out of 1505 consecutive patients enrolled in the RAI registry, 1384 were eligible for this analysis. Of these, 143 (10.3%) were treated with BRS FPJ. At a median follow-up of 649 days, no differences were observed between FPJ and non-FPJ groups in terms of the device-oriented composite endpoint (DoCE) (5.6% vs. 4.4%, p = 0.675) or the patient-related composite endpoint (PoCE) (20.9% vs. 15.9%, p = 0.149). Patients receiving FPJ had higher rates of target vessel repeat revascularization (TVR) (11.2% vs. 6.3%, p = 0.042). In the FPJ group, there was no cardiac death and only one (very late) stent thrombosis (ST) (0.7%). CONCLUSIONS: Mid-term outcomes of a FPJ PCI strategy in the setting of diffuse CAD did not show a significant increase in composite device- and patient-related events, with rates of cardiac death and ST comparable to non-FPJ Absorb BRS implantation. However, these findings are hypothesis generating and requiring further validation.

Clinical findings after bioresorbable vascular scaffold implantation in an unrestricted cohort of patients with ST-segment elevation myocardial infarction (from the RAI registry).

BACKGROUND: The bioresorbable vascular scaffold (BVS) technology may be an appealing option in ST-segment elevation myocardial infarction (STEMI) patients. However, the available evidence on its use in this challenging subset is limited. METHODS: Registro Absorb Italiano (RAI) is a multicenter, prospective registry that aims to assess BVS performance through a 5-year follow-up of all consecutive patients who undergone at least 1 successful BVS implantation. As a part of it, a subgroup analysis in STEMI patients was performed and the outcomes of this cohort compared to the remaining population (defined as "non-STEMI") are reported here. RESULTS: Among the 1505 patients enrolled, 317 (21.1%) had STEMI on admission. Among those, 232 (73.2%) underwent primary percutaneous coronary intervention (PCI) within 12 h from symptom onset; 64 (20.2%) were late-comers (>12 h); 16 (5%) underwent PCI after successful thrombolysis while 5 (1.6%) underwent rescue-PCI. At a median follow-up time of 12 months (IQR 6-20 months) no differences were noticed between STEMI and "non-STEMI" groups in terms of device-oriented composite endpoint (4.1% vs. 5.6%; p = 0.3) and its singular components: ischemia-driven target lesion revascularization (3.2% vs. 3.6%; p = 0.7), target-vessel myocardial infarction (3.2% vs. 2.8%; p = 0.7) and cardiac death (0.6% vs. 0.6%; p = 0.9). The rate of definite/probable scaffold thrombosis (ScT) was numerically higher but not significant in the STEMI group (2.5% vs. 1.3%; p = 0.1). CONCLUSIONS: BVS implantation in an unrestricted cohort of STEMI patients is associated with a numerically higher rate of ScT compared to the non-STEMI group. Further studies exploring the potential clinical impact of a pre-specified BVS implantation strategy in this high-risk clinical setting are needed.

Clinical outcomes of overlapping versus non-overlapping everolimus-eluting absorb bioresorbable vascular scaffolds: An analysis from the multicentre prospective RAI registry (ClinicalTrials.gov identifier: NCT02298413).

OBJECTIVES: To compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS. BACKGROUND: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. METHODS: We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry. RESULTS: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints. CONCLUSIONS: Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. © 2017 Wiley Periodicals, Inc.

One-year clinical outcomes after unrestricted implantation of the Absorb bioresorbable scaffold (RAI registry).

AIMS: The aim of this study was to assess outcomes following Absorb bioresorbable scaffold (BVS) implantation in an unrestricted clinical practice according to an "on-label" versus "off-label" indication. METHODS AND RESULTS: RAI is a prospective registry, investigating BVS performance in different lesion subsets. No specific exclusion criteria were applied. Co-primary endpoints were target lesion revascularisation (TLR) and definite/probable scaffold thrombosis (ScT) at one year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients, BVS was implanted in at least one off-label subset according to the manufacturer's instructions for use. Predilatation was performed in 98.5% of the cases, and post-dilatation in 96.8%. At one-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% vs. 2.2%, HR 1.8, 95% CI: 1.0-3.4; p=0.05) while a trend towards a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%, HR 2.7, 95% CI: 0.9-8.2; p=0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR. CONCLUSIONS: Our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcomes when meticulously implanted. However, a higher rate of adverse events was observed when this device was used in off-label lesions.

Thirty-Day Outcomes After Unrestricted Implantation of Bioresorbable Vascular Scaffold (from the Prospective RAI Registry).

The Absorb biovascular scaffold (BVS) is a bioresorbable, everolimus-eluting scaffold whose data on real-world patients with complex lesions are limited. Short-term follow-up from recent studies point to a higher rate of 30-day thrombosis than observed with drug-eluting stents. We aimed to understand the short-term safety and efficacy of BVS. Registro Absorb Italiano (RAI, ClinicalTrials.gov:NCT02298413) is an Italian, prospective, multicenter registry not funded, whose aim is to investigate BVS performance through a 5-year follow-up of all consecutive patients who have undergone successful implantation of ≥1 BVS in different clinical/lesion subsets. Co-primary end points were target lesion revascularization and definite/probable thrombosis. Secondary end point was the occurrence of device-oriented cardiac events. The registry involved 23 centers, with patient enrollment from October 2012 to December 2015. We here report the 30-day outcomes of the whole population of the registry. We enrolled 1,505 consecutive patients, of which 82% were men and 22.4% diabetic. At presentation, 59.6% of the patients had an acute coronary syndrome, including 21% ST-elevation myocardial infarction. All lesions were pre-dilated and in 96.8% of the cases BVS was post-dilated. At 30 days, the co-primary study end point target lesion revascularization occurred in 0.6% of patients and definite/probable BVS thrombosis in 0.8%. There were 2 cases of cardiac and overall death (0.13%). Device-oriented cardiac events occurred in 1% of the patients. In conclusion, our data of consecutive patients suggest that current use of BVS in a wide spectrum of coronary narrowings and clinical settings is associated with good outcome at 30 days.

The contribution of interventional cardiology procedures to the population radiation dose in a 'health-care level I' representative region.

This study evaluates per-procedure, collective and per capita effective dose to the population by interventional cardiology (IC) procedures performed during 2002-11 at the main hospital of Aosta Valley Region that can be considered as representative of the health-care level I countries, as defined by the UNSCEAR, based on its socio-demographic characteristics. IC procedures investigated were often multiple procedures in patients older than 60 y. The median extreme dose-area product values of 300 and 22 908 cGycm(2) were found for standard pacemaker implantation and coronary angioplasty, respectively, while the relative mean per-procedure effective dose ranged from 0.7 to 47 mSv. A 3-fold increase in frequency has been observed together with a correlated increase in the delivered per capita dose (0.05-0.27 mSv y(-1)) and the collective dose (5.8-35 man Sv y(-1)). Doses increased particularly from 2008 onwards mainly because of the introduction of coronary angioplasty procedures in the authors' institution. IC practice contributed remarkably in terms of effective dose to the population, delivering ∼10% of the total dose by medical ionising radiation examination categories.

Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design.

BACKGROUND: The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres. METHODS/DESIGN: The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413. CONCLUSIONS: The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres.